PART
I
ITEM
1.
BUSINESS
Overview
We
are a national leader in the development, production and dispensing of innovative proprietary compounded pharmaceuticals that
we aim to make available to physicians and patients at affordable prices. Under our
Imprimis Cares
program, we own,
market and dispense a portfolio of lower-cost compounded therapeutic alternatives to higher-priced FDA-approved drugs in several
therapeutic areas, including ophthalmology, urology, otolaryngology and infectious diseases. We believe our proprietary formulations
may offer competitive advantages and serve unmet needs in the marketplace. We plan to expand our
Imprimis Cares
program
by introducing additional customizable compounded drug formulations for patient populations that may not have available alternatives
to increasingly expensive FDA-approved medications. Our
Imprimis Cares
program aligns with our corporate mission, vision
and values of providing physicians and their patients high-quality individualized compounded medications at accessible prices.
We
are also developing our
Custom Compounding Choice™
business, which is focused on developing and dispensing a portfolio
of non-proprietary compounded drugs for humans and animals in therapeutic areas that may be overlooked by commercial pharmaceutical
companies. We also offer customizable compounding products that consist of sterile injectable and non-sterile integrative medicine
therapies that are used in various therapeutic areas, including oncology, autoimmunity, chronic infectious diseases and endocrine
and metabolic diseases.
We
own four ImprimisRx compounding pharmacies, based in New Jersey, California, Texas and Pennsylvania, through which we make, dispense
and sell our proprietary compounded formulations and other non-proprietary products. All of our customized formulations are made
in the United States of America.
All
of our proprietary compounded formulations are born from the clinical experience of a network of inventors, including physician
prescribers, clinical researchers and pharmacist formulators, who develop and prescribe customized medicines for individual patient
needs. We pursue a development pathway for potential formulation candidates that involves working collaboratively with these inventors
to identify and evaluate intellectual property related to the formulation, assess relevant markets for the formulation, and seek
to validate the clinical experience relating to the formulation with the objective of investing in commercialization activities.
Although our business is focused on a compounding commercialization strategy, we may also consider other commercialization pathways,
including pursuing FDA approval to market and sell a drug formulation or technology.
We
have incurred recurring operating losses and have had negative operating cash flows since July 24, 1998 (inception). In addition,
we have an accumulated deficit of approximately $58 million at December 31, 2015. Beginning on April 1, 2014, when we acquired
our first ImprimisRx compounding pharmacy, we began generating revenue from sales of certain of our proprietary drug formulations
and other non-proprietary formulations; however, we expect to incur further losses as we integrate and develop our pharmacy operations,
evaluate other programs and continue the development of our formulations.
Compounded
Formulations
We
produce and sell a portfolio of proprietary compounded formulations in the ophthalmology, otolaryngology, urology and infectious
diseases therapeutic areas under our
Imprimis Cares
business, as well as non-proprietary formulations under our
Custom
Compounding Choice
program. Below are descriptions of our currently available formulations. We also continue to evaluate and
assess intellectual property and other assets we have developed or acquired, including provisional patent applications, in order
to support our development and potential commercialization of additional formulations in these and other therapeutic areas, including
wound healing and dermatology.
Ophthalmic
Formulations
In
2013, we acquired intellectual property trademarked as SSP Technology
TM
, which relates to compounded formulations for
ocular injection of anti-inflammatory and anti-bacterial agents during ocular surgery. SSP Technology allows for increased solubility
of active pharmaceutical ingredients and the creation of small, uniform particle sizes, which allows these compounded formulations
to be used as an intraoperative injectable or as a topical eye drop. Since our acquisition of this technology, we have continued
its development to include additional active pharmaceutical ingredients, such as NSAIDs. These compounded ophthalmic formulations
have begun to impact the fast-growing cataract surgery eye drop market and the LASIK surgery eye drop market and may have potential
in other ophthalmology markets for procedures where there is a risk of inflammation and infection.
Our
proprietary ophthalmic formulations provide physicians with the ability to address a primary ocular complication of ophthalmic
surgery, infection risk and post-operative inflammation due to patient non-compliance with traditional multiple bottle eye drop
regimens, by reducing the complexity of, or in many cases altogether avoiding the need for, post-operative eye drop regimens.
We market these ophthalmic formulations as our Dropless Therapy® and LessDrops® formulations. We also package multiple
ophthalmic compounded formulations, which may include our proprietary Dropless Therapy or LessDrops formulations and other non-proprietary
formulations, as kits and dispense these kits to patients with needs for multiple ocular therapies.
Dropless
Therapy
Formulations
The
cataract surgery market continues to experience significant growth. According to a 2013 Market Scope report, 3.6 million cataract
surgeries were performed in the U.S. and nearly 22 million cataract surgeries were performed globally, with expected annual market
growth of approximately 3%. The National Eye Institute estimated that over 24 million Americans currently have cataracts and that
this number will grow to 38 million by 2030 and to more than 50 million by 2050. Transparency Market Research has estimated that
the ophthalmology drug market is expected to reach an estimated $21.6 billion by 2018.
Typically,
the treatment regimen for the prevention of post-cataract and other intraocular surgery complications is a pre-operative and post-operative
self-administered eye drop regimen, which requires strict patient compliance and careful adherence to a prescribed dosing schedule.
Physicians have reported and studies have shown that eye drop regimens can be confusing to patients, which can cause non-compliance
and incorrect dosing. Numerous published studies conducted in the U.S. and Europe have demonstrated that antibiotics administered
into the eye at the time of cataract surgery significantly reduced the risk of developing inflammation and infection.
Our
Dropless Therapy formulations, which we developed based on our SSP Technology, are used as an injectable during ocular surgery.
Ophthalmologists have reported that use of our Dropless Therapy formulations has substantially reduced or eliminated the need
for patient-administered eye drops following ocular surgeries they have performed, thereby largely eliminating patient non-compliance
and dosing errors with post-operative care regimens. Physicians have also reported spending less time on instructions and follow-up
with post-operative patients and receiving fewer calls from pharmacists seeking to change the physicians’ prescribed eye
drop regimens, which collectively can reduce the physicians’ costs of patient care. By reducing reliance on post-operative
eye drops, we believe the use of our Dropless Therapy formulations can simplify the post-operative care process, provide safeguards
against bacterial infection and inflammation and decrease overall costs. An economic study conducted in 2015 by researchers at
Andrew Chang & Co, LLC and co-sponsored by us demonstrated that, assuming the cost of Dropless Therapy is $100 per dose, our
Dropless Therapy formulations could provide collective savings to Medicare, Medicaid and patients of up to $13 billion, with a
most likely savings estimate of $8.7 billion, over a 10-year period. Since launching these formulations in April 2014, more than
450 ophthalmologists have adopted our Dropless Therapy formulations and a growing number of high-volume cataract surgery practices,
hospitals and ambulatory surgery centers throughout the U.S. have become Dropless Therapy customers.
LessDrops
Formulations
According
to the American Academy of Ophthalmology (AAO), over one-half of Americans require some form of vision correction, 43 million
of these individuals are candidates for refractive surgery, and nearly 96% of the refractive surgery procedures performed are
LASIK (laser in situ keratomileusis) surgeries, an outpatient surgical procedure used to treat nearsightedness, farsightedness,
and astigmatism. According to Statista, an estimated 693,000 LASIK procedures were performed in U.S in 2014.
Our
LessDrops topical compounded formulations, which we developed based on our SSP Technology, were initially formulated and dispensed
during the first quarter of 2015 as combination eye drop formulations for patients following laser refractive surgery, including
LASIK and photorefractive keratectomy (PRK), cataract and other ocular surgeries. We estimate that our LessDrops combination eye
drop formulations may require the administration of up to 50% fewer drops by patients post-surgery and may cost up to 75% less
than other currently available post-surgery drops regimens. We plan to add to our portfolio of LessDrops combination eye drop
formulations in order to deliver additional eye drop choices for our customers.
Otolaryngology
Formulations
In
October 2015, we acquired the assets of a leading U.S. provider of topical compounded sinus formulations, delivery systems and
patented packaging. Topical administration of sinusitis medications such as antibiotics, antifungals and steroids have gained
increasing popularity as an alternative to systemic oral therapies, as topical delivery may minimize the side effects seen with
systemic oral agents that non-specifically deliver medicine to the entire body. Our topical delivery platform delivers sinusitis
medications locally to the sinonasal mucosa, which is typically the direct site and probable source of the problem. The assets
we acquired consisted of customer lists of more than 8,000 active prescribers, representing eight out of 10 ear, nose and throat
physicians that serviced more than 38,000 patients annually.
According to the
American
Academy of Otolaryngology’s Head and Neck Surgery 2015 Guidelines, sinusitis affects about one in eight adults in the U.S
resulting in over 30 million annual diagnoses, and more than 20% of antibiotics prescribed for adults in the U.S. are to treat
sinus infections and the total direct cost of managing acute and chronic sinusitis exceeds $11 billion per year.
Urology
Formulations
HLA
Formulation
In
2014, we entered into a license agreement to acquire commercialization and distribution rights in the U.S. to a patented urologic
formulation of heparin and alkalinized lidocaine (HLA), which is delivered directly to the bladder for the treatment of interstitial
cystitis (IC), also known as painful bladder syndrome. Our commercialization and distribution rights for HLA became exclusive
in April 2015. Published studies have demonstrated that the use of HLA instillations in patients with IC alleviate IC symptoms,
including pain and frequency and urgency of urination, with the use of this combination of ingredients. During the first quarter
of 2015, we launched our Defeat IC™
©
national education campaign, which is designed to help increase
awareness among medical practitioners and patients about IC and our HLA treatment option. It is estimated that five to ten million
women and men in the U.S. are affected by this chronic disease, and based on our self-directed survey of over 400 patients, we
believe the total U.S. market opportunity for IC could exceed $4 billion a year.
Other
Available Urologic Formulations
We
also offer customizable compounded formulations of PPS-DR oral medication that may be prescribed by physicians as a lower-cost
therapeutic alternative to an off-patent oral drug, Elmiron
®
, for the treatment of symptoms associated with IC.
Our PPS-DR compounded formulations are customized to an individual patient and feature time delayed release that may allow for
reduced daily dosing requirements.
Our
other commercially available urologic compounded formulations consist of lyophilized (freeze-dried) formulations for the treatment
of erectile dysfunction (ED). Our ED compounded formulations are provided in a sterile powder and dispensed in single-dose
vials that can be conveniently transported and stored up to six months prior to reconstitution, and once reconstituted should
be used within 30 days. We are also developing and validating a proprietary injectable formulation that may also be used to treat
ED, as the American Urological Association has indicated that intracavernous vasoactive injections are considered the most effective
non-surgical treatment for ED.
Other
Imprimis Cares Compounded Therapeutic Alternatives
Our
Imprimis Cares
business aligns with our corporate mission and vision of providing physicians and their patients with affordable
access to the medicines they need. As part of our
Imprimis Cares
initiative, we recently introduced customizable compounded
formulations of pyrimethamine and leucovorin, which are available for physicians to consider prescribing for their patients as
a lower-cost therapeutic alternative to Daraprim
®
. The FDA-approved label for Daraprim indicates that it is prescribed
for toxoplasmosis, which can be of major concern for patients with weakened immune systems such as patients with HIV/AIDS, pregnant
women and children. Our formulations of pyrimethamine and leucovorin are now offered by Express Scripts, the largest pharmacy
benefit manager in the U.S., and by many other hospitals and healthcare organizations. We also recently announced plans to introduce
new patent-pending tiopronin and potassium citrate delayed release compounded formulations that may be prescribed by physicians
as a lower-cost therapeutic alternative to FDA-approved Thiola
®
for cystinuria patients. Cystinuria is an inherited
disease that causes stones made of the amino acid cystine to form in the kidneys, bladder and/or urethra. It is estimated that
the disorder occurs in one in 7,000 people worldwide. Our compounded alternative containing tiopronin, the active drug ingredient
in Thiola, and potassium citrate, may reduce the cost of therapy for cystinuria patients by more than 70% and is expected to be
available in April 2016. During 2016, we plan to introduce additional cost-effective compounded alternatives for other therapeutic
areas and to continue to partner with payors to provide their beneficiaries access to these alternatives.
Custom
Compounding Choice Formulations
Our
Custom Compounding Choice
business is focused on marketing a portfolio of non-proprietary customizable compounded drugs
for humans and animals, including sterile injectable and non-sterile integrative therapies, in therapeutic areas that may be overlooked
by commercial pharmaceutical companies, such as oncology, autoimmunity, chronic infectious diseases, and endocrine and metabolic
diseases. We also offer customizable hormone replacement therapies and a variety of weight loss and dermatology compounded formulations.
Many of these formulations are offered in different formats than other available alternatives, such as in suspension or lyophilized,
which we believe may provide differentiating and potentially beneficial factors as compared to competing therapies. As part of
these efforts, we develop educational campaigns about our products and we sponsor regional conferences related to furthering education
and awareness of our formulation options within the integrative medical community.
Compounding
Strategy
We
dispense and sell our proprietary compounded formulations and other non-proprietary products to physicians and patients through
our four ImprimisRx compounding pharmacies. We have begun developing “ImprimisRx” as a uniform brand for our compounding
facilities, with the intent of renaming all of our compounding facilities under this name.
Compounding
Pharmacies
Compounding
pharmacies combine different ingredients, some of which may be FDA-approved, to create specialized preparations prescribed by
a physician to treat an individually identified patient. Often this is because a standard medication approved by the FDA is not
appropriate for a particular patient’s needs. In some cases, compounded drugs for particular patients may have wide market
utility and appeal for larger patient populations. Examples of compounded formulations include medications with alternative dosage
strengths or unique dosage forms, such as topical creams or gels, suspensions, or solutions with more tolerable drug delivery
vehicles. A physician may also work together with a pharmacist to repurpose or reformulate FDA-approved drugs via the compounding
process to meet a patient’s specific medical needs. Our ImprimisRx compounding pharmacies receive their active pharmaceutical
ingredients from three main suppliers, which accounted for 43% of drug and chemical purchases in 2015. See Note 15 to our consolidated
financial statements included in this Annual Report for further information.
We
currently operate our pharmacy businesses under Section 503A of the Federal Food Drug and Cosmetic Act (FDCA). Under the FDA’s
current policy, a pharmacy operating under Section 503A of the FDCA is only permitted to compound a drug for an individually identified
patient based on a prescription for that patient, and is only permitted to distribute the drug interstate as long as the pharmacy
is licensed to do so in the states where it is compounded and where it is received. Our ImprimisRx compounding pharmacies are
collectively licensed to distribute compounded formulations in 50 states. These policies limit compounding pharmacies from engaging
in the practice of anticipatory compounding, which involves, preparing compounded medications before the actual receipt of a prescription
or practitioner’s order, thus prohibiting compounding pharmacies from compounding in large quantities for distribution.
Anticipatory compounding is an important component of pharmacy practice, particularly in sterile compounding. The law does allow
compounding pharmacies with a history of filling certain prescriptions to prepare larger batches so that medications will be ready
when they are needed. It also reduces the cost of compounded medications, as economies of scale can be realized by producing larger
batches and less wasted chemicals, dilutions, fillers, and other associated products are produced, and leads to more accuracy
and uniformity in finished medications, as larger batches decrease the variation caused by preparing multiple, smaller batches.
In order to enable us to more easily engage in anticipatory compounding, we are working to develop and register two of our four
pharmacy facilities as outsourcing facilities, as discussed below.
Outsourcing
Facility Strategy
Section
503B of the FDCA provides that a pharmacy engaged in preparing sterile compounded drug formulations may voluntarily elect to register
as an “outsourcing facility,” a new form of entity permitted to compound large quantities of drug formulations without
a prescription and distribute them out of state without limitation, if the drug formulations appear on the FDA’s drug shortage
list or the bulk drug substances contained in the formulations appear on the FDA’s “clinical need” list. According
to the University of Utah’s Drug Information Service, there were over 140 drugs on the FDA’s drug shortage list during
2015, while the “clinical need” list has not yet been established by FDA. Entities voluntarily registering as outsourcing
facilities are subject to additional requirements that do not apply to compounding pharmacies, including current good manufacturing
practices (cGMP) and regular FDA inspection. Due to the clinical need of the formulations we offer and the nature of the active
pharmaceutical ingredient components, we believe they will be eligible for compounding by and distribution from Section 503B outsourcing
facilities.
In
February 2015, we entered into a lease agreement for space in New Jersey and began construction efforts to build the majority
of this space into an outsourcing facility. The remaining space in the facility will be completely separate and secured and will
be constructed as a compounding pharmacy to replace our current New Jersey pharmacy location. From time to time during the construction
process, we have experienced temporary and intermittent delays in developing and outfitting this facility. As a result, we have
extended our estimated completion date and now expect the facility to be completed and registered as an outsourcing facility near
the end of the second quarter of 2016. In addition, we are near completion of our construction efforts to our Texas compounding
pharmacy and intend to register it with the FDA as a Section 503B outsourcing facility during the second quarter of 2016.
We estimate that our capital expenditures to build and equip these new facilities will be approximately $4 million.
We
believe that, with our current compounding pharmacy facilities and the successful completion and registration of our planned outsourcing
facilities, we will have the infrastructure to scale our business appropriately under the current regulatory landscape and meet
the growth in demand we are targeting in the ophthalmology, urology and other therapeutic areas. We plan to invest in one or more
of our pharmacies to further their capacity and efficiencies. We may seek to access greater redundancy and markets through acquisitions,
partnerships or other strategic transactions.
Sales
and Marketing
We
have developed and plan to continue to build small internal sales and commercialization teams that are focused on growing sales
of our available formulations. Our sales and marketing efforts are currently organized into two departments, one of which focuses
on our ophthalmology formulations and the other of which focuses on our available formulations in other therapeutic areas. We
have also begun to establish a sales and marketing team focused on the therapeutic areas served by our
Custom Compounding Choice
business. Our sales and marketing activities consist primarily of efforts to educate doctors, ambulatory surgery centers,
healthcare systems, hospitals and other users throughout the U.S. about our products. Although we believe that our proprietary
drug formulations could have commercial appeal in international markets and we have engaged distributors and entered into out-licensing
arrangements for certain of our proprietary formulations in certain non-U.S. markets, we expect to continue to focus our efforts
on our U.S. commercial opportunities during 2016. We also may choose to pursue commercialization of our proprietary formulations
in other selected markets through licensing or collaborative arrangements with strategic partners in the future.
Formulation
Development and Commercialization Pathway
Our
model for the selection and development of proprietary formulations focuses on assessing new development opportunities using a
four-step proprietary process, consisting of the identification, evaluation, validation, and ultimately commercialization of selected
opportunities. Our relationships with inventive physicians and pharmacists provide us with access to numerous formulation candidates
and technologies to evaluate and validate. These compounded drug formulations are initially made for individual patients and are
developed based on the physician’s and pharmacist’s experience formulating a new therapy to address an unmet need.
As a result of our review process, we focus our commercialization efforts on a select group of promising formulations that we
believe may be patentable and that could have broad appeal to patients and physicians. Our product development strategy is to
focus on a select few therapeutic areas in which we believe there is broad market potential, large unmet needs and/or unique value
to physicians and patients and to develop and offer formulations within these therapeutic areas that could afford us with gross
margins.
Identify
Our
innovation model, which serves as our research and development pipeline, relies on our relationships and partnerships with inventors
to identify and secure new development assets. We are strategically attentive to the ideas generated by pharmacists, who work
directly with doctors and their patients to address specific and often unmet patient needs, in our identification of formulations
to develop and commercialize. We believe that our collaborative relationships with a growing group of physicians and pharmacists
will bring additional clinically and commercially relevant formulation opportunities to us for potential development.
Evaluate
After
we have identified potential formulations and technology for development, we subject them to our proprietary evaluation process.
We invest heavily in intellectual property review and analysis at this stage, which includes analyzing the patentability of each
formulation and, more generally, trying to understand the surrounding intellectual property landscape. We also evaluate any existing
supportive clinical data, identify one or more appropriate commercialization pathways to potentially make the therapy available
to patients and, for selected candidates, ultimately seek to acquire, through ownership or licensing of development rights, the
formulations we believe are the most promising.
Validate
Following
the identification and evaluation process and our acquisition of development rights, we seek to validate our assessment of potential
drug formulations through our review of any existing clinical data and documented patient experience and through our sponsorship
of investigator-initiated studies, which are typically funded or co-funded by us and conducted by physician groups. Any clinical
data we obtain may be used to support physicians’ clinical confidence in prescribing the formulation in compounded form
or, if we decide to pursue FDA approval for a particular candidate, to support a development program in connection with the pursuit
of such approval. The costs associated with our validation approach may be significantly lower than a traditional FDA approval
process because, if we consider and select compounding as an appropriate commercialization pathway, we would not need to obtain
FDA approval in order to market and sell the formulation.
Commercialize
Following
successful results in the first three steps of our assessment, we focus on commercialization. As part of the development of potential
formulations, we evaluate and select an appropriate commercialization pathway to make these therapies available to patients. We
consider multiple commercialization pathways, including dispensing formulations through compounding pharmacies and outsourcing
facilities and pursuing FDA approval to market and sell a drug formulation or technology. We are pursuing, and expect to continue
to pursue, a compounding commercialization strategy for our currently available proprietary formulations and the other assets
that we currently own or have rights to develop, and we do not presently expect to pursue FDA approval for any of these formulations
or other assets. Depending on the selected commercialization pathway, we would build, or contract with a third party to build,
appropriately targeted commercialization teams in order to market the therapies to physicians and patients, consistent with our
sales and marketing structure discussed under the “Sales and Marketing” section above.
Competition
The
pharmaceutical and pharmacy industries are highly competitive. We compete against branded drug companies, generic drug companies,
outsourcing facilities and other compounding pharmacies. We are significantly smaller than some of our competitors, and we may
lack the financial and other resources needed to develop, produce, distribute, market and commercialize any of our proprietary
formulations or compete for market share in these sectors. The drug products available through branded and generic drug companies
with which our formulations compete have been approved for marketing and sale by the FDA and are required to be manufactured in
facilities compliant with cGMP standards. Although we prepare our compounded formulations in accordance with the standards provided
by United States Pharmacopoeia (USP) <795> and USP <797> and applicable state and federal law, our proprietary compounded
formulations are not required to be, and have not been, approved for marketing and sale by the FDA. As a result, some physicians
may be unwilling to prescribe, and some patients may be unwilling to use, our formulations. Additionally, under federal and state
laws applicable to our current compounding pharmacy operations, we are not permitted to prepare significant amounts of a specific
formulation in advance of a prescription, compound quantities for office use or utilize a wholesaler for distribution of our formulations;
instead, our compounded formulations must be prepared and dispensed in connection with a physician prescription for an individually
identified patient. Pharmaceutical companies, on the other hand, are able to sell their FDA-approved products to large pharmaceutical
wholesalers, who can in turn sell to and supply hospitals and retail pharmacies. Even if we are successful in registering certain
of our facilities as outsourcing facilities, our business may not be scalable on the scope available to our competitors that produce
FDA-approved drugs, which may limit our potential for profitable operations. These facets of our operations may subject our business
to limitations our competitors offering FDA-approved drugs may not face.
Biotechnology
and related pharmaceutical technologies have undergone and continue to be subject to rapid and significant change. Our future
success will depend in large part on our ability to maintain a competitive position with respect to these technologies. Products
developed by our competitors, including FDA-approved drugs and compounded formulations created by other pharmacies, could render
our products and technologies obsolete or unable to compete. Any products that we develop may become obsolete before we recover
expenses incurred in developing the products, which may require that we seek to raise additional funds that may or may not be
available to continue our operations. The competitive environment requires an ongoing, extensive search for medical and technological
innovations and the ability to develop and market these innovations effectively, and we may not be competitive with respect to
these factors. Other competitive factors include the safety and efficacy of a product, the size of the market for a product, the
timing of market entry relative to competitive products, the availability of alternative compounded formulations or approved drugs,
the price of a product relative to alternative products, the availability of third-party reimbursement, the success of sales and
marketing efforts, brand recognition and the availability of scientific and technical information about a product. Although we
believe we are positioned to compete favorably with respect to many of these factors, if our proprietary formulations are unable
to compete with the products of our competitors, we may never gain market share or achieve profitability.
Intellectual
Property
Our
success and ability to compete depends upon our ability to protect our intellectual property. We conduct a fulsome analysis of
the intellectual property landscape prior to acquiring rights to formulations and filing patent applications. As of March 17,
2016, we owned two issued U.S. patent and one issued Canadian patent, which cover certain technology related to a former product
candidate that we are no longer pursuing. Our existing patents expire in 2016 in the U.S. and 2018 in Canada, and we do not expect
the life of these patents to be extended beyond these dates. In addition, as of March 17, 2016, we owned 25 U.S. patent applications,
including 18 utility and seven provisional patent applications, and we owned three international patent applications filed under
the Patent Cooperation Treaty and 19 foreign patent applications. Although our ophthalmology-related patent applications include
claims related to non-ophthalmology fields, we have primarily focused our intellectual property development efforts to date on
the proprietary compounded formulations in the field of ophthalmology. We presently have 10 U.S. and nine foreign patent applications
pending that relate to our SSP Technology. We expect to file additional patent applications in the U.S. and pursue patent protection
for certain of our formulations in other important international jurisdictions in the future.
As of March 17, 2016,
we had 84 issued trademarks, pending trademark and copyright applications, or registered copyright and/or trademarks for Imprimis
®
,
ImprimisRx
®
, Imprimis Pharmaceuticals™, Imprimis Cares!™, SSP Technology™, Go Dropless™,
LessDrops
®
, Dropless™, Dropless Cataract Surgery™, Dropless Cataract Therapy™, Dropless Therapy
®
,
Defeat IC™
©
, HLA Therapy™, Triple Drop™, PPS-DR™, Trimix-LP™, Stericheck™,
Trimoxi™, Pred-Moxi™, Pred-Moxi-Ketor™, Pred-Moxi-Brom™, Pred-Ketor™, Dex-Moxi™, Combination
Drop Therapy™, Compounded Alternative™, Compounded Choice™, Custom Compounding™, Custom Compounding Choice™,
and ED Free™. We may choose to pursue trademark protection in other jurisdictions for one or more of these or other
marks in the future.
We
also rely on unpatented trade secrets and know-how and continuing technological innovation in order to develop our formulations,
which we seek to protect, in part, by confidentiality agreements with our employees, consultants, collaborators and others, including
certain service providers. We also have invention or patent assignment agreements with our current employees and certain consultants.
However, our employees and consultants may breach these agreements and we may not have adequate remedies for any breach, or our
trade secrets may otherwise become known or be independently discovered by competitors. In addition, inventions relevant to us
could be developed by a person not bound by an invention assignment agreement with us, in which case we may have no rights to
use the applicable invention.
Governmental
Regulation
Our
business is subject to federal, state and local laws, regulations, and administrative practices, including, among others: federal,
state and local licensure and registration requirements concerning the operation of pharmacies and the practice of pharmacy; the
Health Insurance Portability and Accountability Act (HIPAA); the Patient Protection and Affordable Care Act and the Health Care
and Education Reconciliation Act of 2012 (collectively, the Health Reform Law); statutes and regulations of the FDA, the U.S.
Federal Trade Commission, the U.S. Drug Enforcement Administration and the U.S. Consumer Product Safety Commission, as well as
regulations promulgated by comparable state agencies concerning the sale, advertisement and promotion of the products we sell.
Below are descriptions of some of the various federal and state laws and regulations which may govern or impact our current and
planned operations.
Pharmacy
Regulation
Our
pharmacy operations are regulated by both individual states and the federal government. Every state has laws and regulations addressing
pharmacy operations, including regulations relating specifically to compounding pharmacy operations. These regulations generally
include licensing requirements for pharmacists, pharmacy technicians and pharmacies, as well as regulations related to compounding
processes, safety protocols, purity, sterility, storage, controlled substances, recordkeeping and regular inspections, among other
things. State rules and regulations are updated periodically, generally under the jurisdiction of individual state boards of pharmacy.
Failure to comply with the state pharmacy regulations of a particular state could result in a pharmacy being prohibited from operating
in that state, financial penalties and/or becoming subject to additional oversight from that state’s board of pharmacy.
In addition, many states are considering imposing, or have already begun to impose, more stringent requirements on compounding
pharmacies. If our pharmacy operations become subject to additional licensure requirements, are unable to maintain their required
licenses or if states place burdensome restrictions or limitations on pharmacies, our ability to operate in some states could
be limited.
Many
of the states into which we deliver pharmaceuticals have laws and regulations that require out-of-state pharmacies to register
with, or be licensed by, the boards of pharmacy or similar regulatory bodies in those states. These states generally permit the
dispensing pharmacy to follow the laws of the state within which the dispensing pharmacy is located. However, various state pharmacy
boards have enacted laws and/or adopted rules or regulations directed at restricting or prohibiting the operation of out-of-state
pharmacies by, among other things, requiring compliance with all laws of the states into which the out-of-state pharmacy dispenses
medications, whether or not those laws conflict with the laws of the state in which the pharmacy is located, or requiring the
pharmacist-in-charge to be licensed in that state. To the extent that such laws or regulations are found to be applicable to our
operations, we believe we comply with them.
Further,
under federal law, Section 503A of the FDCA seeks to limit the amount of compounded products that a pharmacy can dispense interstate.
The interpretation and enforcement of this provision is dependent on the FDA entering into a standard Memorandum of Understanding
(MOU) with each state setting forth limits on interstate compounding. The current draft standard MOU presented by the FDA in February
2015 would limit interstate shipments of compounded drug units to 30% of all compounded and non-compounded units dispensed or
distributed by the pharmacy per month. The FDA has stated in guidance issued in February 2015 that it will not enforce interstate
restrictions until after it publishes a final standard MOU and has made it available to states for signature for some designated
period of time. If the final standard MOU is not signed by a particular state, then interstate shipments of compounded preparations
from a pharmacy located in that state would be limited to quantities not greater than 5% of total prescription orders dispensed
or distributed by the pharmacy (the 5% rule); however, we are not aware that the FDA currently enforces or has in the past enforced
the 5% rule and, under current draft guidance, the FDA has stated that it will not enforce the 5% rule until a standard MOU has
been made available to states for signature. The FDA has proposed a 180-day period for states to agree to the standard MOU after
the final version is presented, after which it would begin to enforce the 5% rule. Until a final MOU is issued and presented to
states to consider, the extent of interstate dispensing restrictions imposed by Section 503A is unknown. However, if the final
standard MOU contains a 30% limit on interstate distribution or if the FDA begins to enforce the 5% rule, our pharmacy operations
could be materially limited.
Certain
provisions of the FDCA govern the preparation, handling, storage, marketing and distribution of pharmaceutical products. The Drug
Quality and Security Act of 2013 (DQSA) clarifies and strengthens the federal regulatory framework governing compounding pharmacies.
Title 1 of the DQSA, the Compounding Quality Act, modifies provisions of the Section 503A of the FDCA that were found to be unconstitutional
by the U.S. Supreme Court in 2002. In general, Section 503A provides that pharmacies are exempt from the provisions of the FDCA
requiring compliance with cGMP, labeling with adequate directions for use and FDA approval prior to marketing if the pharmacy
complies with certain other requirements. Among other things, to comply with Section 503A, a compounded drug must be compounded
by a licensed pharmacist for an identified individual patient on the basis of a valid prescription. Pharmacies may only compound
in limited quantities before receipt of a prescription for an individual patient and are subject to limitations on anticipatory
compounding for distribution, which generally permit anticipatory compounding only based on historical prescription volumes.
The
DQSA also contained new Section 503B of the FDCA, which established an outsourcing facility as a new form of entity that is permitted
to compound large quantities of drug formulations without a prescription, thus permitting the practice of anticipatory compounding,
and distribute them out of state without limitation, if the drug formulations appear on the FDA’s drug shortage list or
the bulk drug substances contained in the formulations appear on a “clinical need” list to be established by the FDA.
Entities voluntarily registering as outsourcing facilities are subject to cGMP requirements and regular FDA inspection, among
other requirements. As described above, our current pharmacy operations comply with Section 503A of the FDCA, and we are undergoing
efforts to construct and register two facilities as outsourcing facilities under Section 503B of the FDCA.
Confidentiality,
Privacy and HIPAA
Our
pharmacy operations involve the receipt, use and disclosure of confidential medical, pharmacy and other health-related information.
In addition, we use aggregated and blinded (anonymous) data for research and analysis purposes. The federal privacy regulations
under HIPAA are designed to protect the medical information of a healthcare patient or health plan enrollee that could be used
to identify the individual. Among other things, HIPAA limits certain uses and disclosures of protected health information and
requires compliance with federal security regulations regarding the storage, utilization and transmission of and access to electronic
protected health information. The requirements imposed by HIPAA are extensive. In addition, most states have enacted privacy and
security laws that protect identifiable patient information that is not health-related. Further, several states have enacted more
protective and comprehensive pharmacy-related privacy legislation that not only applies to patient records but also prohibits
the transfer or use for commercial purposes of pharmacy data that identifies prescribers. These regulations impose substantial
requirements on covered entities and their business associates regarding the storage, utilization and transmission of and access
to personal health and non-health information. Many of these laws apply to our business.
Medicare
and Medicaid Reimbursement
Medicare
is a federally funded program that provides health insurance coverage for qualified persons age 65 or older and for some disabled
persons with certain specific conditions. State-funded Medicaid programs provide medical benefits to groups of low-income and
disabled individuals, some of whom may have inadequate or no medical insurance. Currently, most of our commercially available
formulations are sold in cash transactions and our customers may choose to seek reimbursement opportunities from Medicare, Medicaid
and other third parties to the extent that they exist. As part of our
Imprimis Cares
initiative, we work with third-party
insurers, pharmacy benefit managers and buying groups to offer patient-specific customizable compounded formulations at accessible
prices. We plan to continue to devote time and other resources to seek reimbursement and patient pay opportunities for these and
other compounded formulations and we have hired pharmacy billers to process certain existing reimbursement opportunities for certain
formulations. However, we may be unsuccessful in achieving these goals, as many third-party payors have imposed significant restrictions
on reimbursement for compounded formulations in recent years. Moreover, third-party payors, including Medicare, are increasingly
attempting to contain health care costs by limiting coverage and the level of reimbursement for new drugs and by refusing, in
some cases, to provide coverage for uses of approved products for disease indications for which the FDA has not granted labeling
approval. Further, the Health Reform Law may have a considerable impact on the existing U.S. system for the delivery and financing
of health care and could conceivable have a material effect on our business. As a result, reimbursement from Medicare, Medicaid
and other third-party payors may never be available for any of our products or, if available, may not be sufficient to allow us
to sell the products on a competitive basis and at desirable price points.
To
the extent we obtain third-party reimbursement for our compounded formulations, we may become subject to Medicare, Medicaid and
other publicly financed health benefit plan regulations prohibiting kickbacks, beneficiary inducement and the submission of false
claims.
FDA
New Drug Application Process
We
may choose, alone or with project partners, to pursue FDA approval to market and sell one or more of our formulations through
the FDA’s new drug application (NDA) process. Since the active pharmaceutical ingredients in all of our formulations have
already been approved by the FDA, we could choose to pursue FDA approval of one or more of our formulations under Section 505(b)(2)
of the FDCA. Section 505(b)(2) permits the submission of an NDA where at least some of the information required for approval comes
from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. The applicant
may rely upon certain published nonclinical or clinical studies conducted for an approved product or the FDA’s conclusions
from prior review of such studies. The FDA may also require companies to perform additional studies or measurements to support
any changes from the approved product. The FDA may then approve the new product for all or some of the label indications for which
the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant. While references
to nonclinical and clinical data not generated by the applicant or for which the applicant does not have a right of reference
are allowed, all development, process, stability, qualification and validation data related to the manufacturing and quality of
the new product must be performed for the new product and included in the NDA.
To
the extent that the Section 505(b)(2) applicant is relying on the FDA’s conclusions regarding studies conducted for an already
approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the
FDA’s Orange Book publication. As a condition of approval, the FDA or other regulatory authorities may require further studies,
including Phase 4 post-marketing studies, to provide additional data. Other post-marketing studies may be required to gain approval
for the use of a product as a treatment for clinical indications other than those for which the product was initially tested and
approved. Also, the FDA or other regulatory authorities require post-marketing reporting to monitor the adverse effects of a drug.
Results of post-marketing programs may limit or expand the further marketing of a product.
The
FDA closely regulates the post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer
advertising, off-label promotion, industry-sponsored scientific and educational activities and promotional activities involving
the Internet. A company can make only those claims relating to safety and efficacy that are approved by the FDA. Failure to comply
with these requirements can result in adverse publicity, warning letters, corrective advertising, fines and potential civil and
criminal penalties.
International
Regulation
If
we pursue commercialization of our proprietary formulations in countries other than the United States, then we would need to obtain
the approvals required by the regulatory authorities of such foreign countries that are comparable to the FDA and state boards
of pharmacy, and we would be subject to a variety of other foreign statutes and regulations comparable to those relating to our
U.S. operations. Regulatory frameworks and requirements vary by country and could involve significant additional licensing requirements
and product testing and review periods.
Environmental
and Other Matters
We
are or may become subject to environmental laws and regulations governing, among other things, any use and disposal by us of hazardous
or potentially hazardous substances in connection with our research and preparation of our formulations. In addition, we are subject
to work safety and labor laws that govern certain of our operations and our employee relations. In each of these areas, as above,
the FDA and other government agencies have broad regulatory and enforcement powers, including, among other things, the ability
to levy fines and civil penalties, suspend or delay issuance of approvals, licenses or permits, seize or recall products, and
withdraw approvals, any one or more of which could have a material adverse effect on our business.
Research
and Development Expenses
Our
research and development expenses incurred in 2014 and 2015 primarily include expenses related to the development of intellectual
property and researcher and investigator-initiated evaluations and research related primarily to our ophthalmic formulations and
certain other assets.
During
the year ended December 31, 2015, we incurred $332,000 in research and development expenses, as compared to $237,000
during the year ended December 31, 2014.
Employees
As
of March 2, 2016, we employed 112 employees, of which 106 are full-time employees and 6 are part-time employees. Our employees
are engaged in pharmacy operations, sales, marketing, research, development, and general and administrative functions. We expect
to add additional employees in all departmental functions as we carry out our business plan in the next 12 months. We are not
party to any collective bargaining agreements with any of our employees. We have never experienced a work stoppage, and we believe
our employee relations are good. We hire independent contractor labor and consultants on an as-needed basis.
Company
Information
We
were incorporated in Delaware in January 2006 as Bywater Resources, Inc. In September 2007, we closed a merger transaction with
Transdel Pharmaceuticals Holdings, Inc. and changed our name to Transdel Pharmaceuticals, Inc. We changed our name to Imprimis
Pharmaceuticals, Inc. in February 2012.
On
June 26, 2011, we suspended our operations and filed a voluntary petition for reorganization relief under Chapter 11 of the United
States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of California, Case No. 11-10497-11. On
December 8, 2011, in connection with our entry into a line of credit agreement and securities purchase agreement with a third
party, our voluntary petition for reorganization relief was dismissed.
In
April 2014, January 2015 and August 2015, we completed our acquisitions of the capital stock Pharmacy Creations, Park and ImprimisRx
TX, respectively. In October 2015, ImprimisRx PA acquired substantially all of the assets of Thousand Oaks Holding Company and
its wholly-owned subsidiaries.
Our
executive offices are located at 12264 El Camino Real, Suite 350, San Diego, California 92130 and our telephone number at such
office is (858) 704-4040. Our website address is imprimispharma.com. Information contained on our website is not deemed part of
this Annual Report.
ITEM
1A. RISK FACTORS
You
should carefully consider the following risk factors in addition to the other information contained in this Annual Report. Our
business, financial condition, results of operations and stock price could be materially adversely affected by any of these risks.
Risks
Related to Our Business
We
have incurred losses in every year of our operations, and we may never become profitable.
We
have incurred losses in every year of our operations, including net losses of $(15.9 million) and $(10.1 million) for the years
ended December 31, 2015 and 2014, respectively. As of December 31, 2015, our accumulated deficit was $(57.8 million), much of
which was incurred in connection with our now-abandoned pursuit of FDA approval of a drug candidate, which activities we have
discontinued. We expect to incur increasing operating losses for the foreseeable future as we continue to incur costs for commercialization
activities, research and development and our pharmacy operations. Although we have been generating revenue from our pharmacy operations
since April 1, 2014 when we acquired the first of our ImprimisRx compounding pharmacies, our ability to generate significant revenues
and achieve profitability will depend on a number of factors, including, among others, the factors discussed in this “Risk
Factors” section, many of which are outside of our direct control. Our business plan and strategies involve costly activities
that are susceptible to failure, and we may never be able to generate sufficient revenue to support our business or reach the
level of sales and revenues necessary to achieve and sustain profitability.
We
aim to sell certain of our proprietary formulations primarily through a unified network of compounding pharmacies, but we may
not be successful in our efforts to establish such a network or integrate these businesses into our operations.
A
key aspect of our business strategy is to establish a unified compounding pharmacy network, whether through acquisitions, establishing
new pharmacies or entering into licensing arrangements with third-party pharmacies, through which we can market and sell our proprietary
formulations and other non-proprietary products in all 50 states. We acquired our New Jersey, California, Texas and Pennsylvania
compounding pharmacies in April 2014, January 2015, August 2015 and October 2015, respectively. Additionally, in February 2015,
we entered into a lease agreement for space in New Jersey and began construction efforts to build this space into an outsourcing
facility, which we expect to be completed and registered with the FDA near the end of the second quarter of 2016. In October 2015,
we announced plans to undertake construction efforts on our Texas compounding pharmacy with the intent of registering it with
the FDA as a Section 503B outsourcing facility, which we expect to be completed and registered during the second quarter
of 2016. We are working to expand our pharmacy operations and personnel and develop our facilities into a unified compounding
pharmacy network. For instance, we have begun developing “ImprimisRx” as a uniform brand for our compounding facilities,
with the intent of renaming all of our compounding facilities under this name. These efforts may also entail seeking to acquire
new pharmacies or outsourcing facilities to add to our existing infrastructure, as opportunities arise. However, we have limited
experience acquiring, building or operating compounding pharmacies or other prescription dispensing facilities or commercializing
our formulations through ownership of or licensing arrangements with pharmacies. As a result, we may experience difficulties implementing
our compounding pharmacy network strategy, including difficulties that arise as a result of our lack of experience, and we may
be unsuccessful. For instance, we have experienced delays and increased costs in our outsourcing facility construction efforts
and we may not be successful in completing them on a timely basis, within budget or at all, we may not be successful in our efforts
to integrate, manage or otherwise realize the benefits we expect from our acquisitions of our ImprimisRx compounding pharmacies
or any additional pharmacy businesses or outsourcing facilities we seek to acquire or build in the future, we may not be able
to satisfy applicable federal and state licensing and other requirements for any such pharmacy businesses in a timely manner or
at all, changes to federal and state pharmacy regulations may restrict compounding operations or make them more costly, we may
be unable to achieve a sufficient physician and patient customer base to sustain our pharmacy operations, market acceptance of
compounding pharmacies generally may be curtailed or delayed, and we may not be able to enter into licensing or other arrangements
with third-party pharmacies or outsourcing facilities when desired, on acceptable terms or at all. Moreover, all such efforts
to expand our pharmacy operations and establish a unified pharmacy network will involve significant costs and other resources,
which we may not be able to afford, disrupt our other operations and distract management and our other employees from other aspects
of our business. As a result, our business could materially suffer if we are unable to further develop this unified pharmacy network
and, even if we are successful, we may be unable to generate sufficient revenue to recover our costs.
We
are dependent on market acceptance of compounding pharmacies and compounded formulations, and physicians may be unwilling to prescribe,
and patients may be unwilling to use, our proprietary customizable compounded formulations.
We
currently distribute our proprietary formulations through compounding pharmacies. Formulations prepared and dispensed by compounding
pharmacies contain FDA-approved ingredients, but are not themselves approved by the FDA. As a result, our formulations have not
undergone the FDA approval process and only limited data, if any, may be available with respect to the safety and efficacy of
our formulations for any particular indication. In addition, certain compounding pharmacies have been the subject of widespread
negative media coverage in recent years, and the actions of these pharmacies have resulted in increased scrutiny of compounding
pharmacy activities from the FDA and state governmental agencies. As a result, some physicians may be hesitant to prescribe, and
some patients may be hesitant to purchase and use, these non-FDA approved compounded formulations, particularly when an FDA-approved
alternative is available. Other reasons physicians may be unwilling to prescribe or patients may be unwilling to use our proprietary
compounded formulations could include the following, among others: applicable law limits our ability to discuss the efficacy or
safety of our formulations with potential users to the extent applicable data is available; our pharmacy operations are primarily
operating on a cash-pay basis and reimbursement may or may not be available from third-party payors, including the government
Medicare and Medicaid programs; and our formulations are not required to be prepared and are not presently being prepared in a
manufacturing facility governed by cGMP requirements. Any failure by physicians, patients and/or third-party payors to accept
and embrace compounded formulations could substantially limit our market and cause our operations to suffer. I
n
addition, certain compounding pharmacies have been the subject of widespread negative media coverage in recent years related to
aggressive billing practices and quality assurance, such as the fungal meningitis outbreak in 2012, and the actions of these pharmacies
have resulted in increased scrutiny of compounding pharmacy activities from the FDA and state governmental agencies. As a
result some health care providers may be reluctant to purchase and use our formulations in general.
We
may not receive sufficient revenue through our ImprimisRx compounding pharmacies or other compounding pharmacies with which we
may partner to fund our operations and recover our development costs.
Our
business plan involves the preparation and sale of our proprietary formulations through a network of unified compounding pharmacies
and outsourcing facilities. This network presently consists of our four ImprimisRx compounding pharmacies, which are collectively
licensed to distribute compounded formulations in all 50 states. We are also pursuing additional means of expanding the reach
of this network, including our plans to open an outsourcing facility in New Jersey, which is currently under construction and
which we expect to be completed and registered near the end of the second quarter of 2016 and our plans to complete construction
of and register our Texas pharmacy as an outsourcing facility during the second quarter of 2016. We have limited experience
operating pharmacies and commercializing compounded formulations and we may be unable to successfully manage this business or
generate sufficient revenue to recover our development costs and operational expenses.
We
may have only limited success in marketing and selling our proprietary formulations through our network of compounding pharmacies.
Although we have established and plan to grow our internal sales teams to market and sell our proprietary formulations and other
non-proprietary products through our ImprimisRx compounding pharmacies, we have limited experience with such activities and may
not be able to generate sufficient physician and patient interest in our formulations to generate significant revenue from sales
of these products. In addition, we are substantially dependent on our ImprimisRx compounding pharmacies and any other pharmacies
or prescription dispensing facilities we acquire or develop and any pharmacy partners with which we may contract to compound and
sell our formulations in accordance with our quality standards and applicable specifications, in a timely manner and in sufficient
volumes to accommodate the number of prescriptions they receive. Our pharmacies may be unable to compound our formulations successfully
and we may be unable to acquire, build or enter into arrangements with pharmacies or outsourcing facilities of sufficient size,
reputation and quality to implement our business plan, which would cause our business to suffer.
We
are subject to risks associated with development and construction of our pharmacy facilities.
In
February 2015, we entered into a lease agreement for space in New Jersey and began construction efforts to build the majority
of this space into a Section 503B outsourcing facility and in November of 2015, we began construction efforts to improve our Texas
compounding pharmacy with the intent to register it as an outsourcing facility. We have encountered, and may continue to encounter,
unanticipated occurrences or conditions during construction that may delay the completion and increase the expense of the project.
Delays and cost overruns during construction could result in liabilities and expenses that could harm our business, prospects,
financial condition and results of operations.
Our
business is significantly impacted by state and federal statutes and regulations.
All
of our proprietary formulations are comprised of active pharmaceutical ingredients that are components of drugs that have received
marketing approval from the FDA, although our proprietary compounded formulations have not themselves received FDA approval. FDA
approval is not required in order to market and sell our compounded formulations, although in the future we may choose to pursue
FDA approval to market and sell certain potential product candidates. The marketing and sale of compounded formulations is subject
to and must comply with extensive state and federal statutes and regulations governing compounding pharmacies. These statutes
and regulations include, among other things, restrictions on compounding for office use or in advance of receiving a patient-specific
prescription or, for outsourcing facilities, requirements regarding preparation, such as regular FDA inspections and cGMP requirements,
prohibitions on compounding drugs that are essentially copies of FDA-approved drugs, limitations on the volume of compounded formulations
that may be sold across state lines, and prohibitions on wholesaling or reselling. These and other restrictions on the activities
of compounding pharmacies and outsourcing facilities may significantly limit the market available for compounded formulations,
as compared to the market available for FDA-approved drugs.
Our
pharmacy business is impacted by federal and state laws and regulations governing, among other things: the purchase, distribution,
management, compounding, dispensing, reimbursement, marketing and labeling of prescription drugs and related services; FDA and/or
state regulation affecting the pharmacy and pharmaceutical industries, including state pharmacy licensure and registration or
permit standards; rules and regulations issued pursuant to HIPAA and other state and federal laws related to the use, disclosure
and transmission of health information; and state and federal controlled substance laws. Our failure to comply with any of these
laws and regulations could severely limit or curtail our pharmacy operations, which would materially harm our business and prospects.
Further, our business could be adversely affected by changes in these or any newly enacted laws and regulations, as well as federal
and state agency interpretations of such statutes and regulations. Such statutory or regulatory changes could require that we
make changes to our business model and operations and/or could require that we incur significantly increased costs in order to
comply with such regulations.
If
our ImprimisRx compounding pharmacies or any other pharmacy or outsourcing facility with which we partner fails to comply with
the Controlled Substances Act, FDCA, or state statutes and regulations, the pharmacy could be required to cease operations or
become subject to restrictions that could adversely affect our business.
State
pharmacy laws require pharmacy locations in those states to be licensed as an in-state pharmacy to dispense pharmaceuticals. In
addition, state controlled substance laws require registration and compliance with state pharmacy licensure, registration or permit
standards promulgated by the state’s pharmacy licensing authority. Pharmacy and controlled substance laws often address
the qualification of an applicant’s personnel, the adequacy of its prescription fulfillment and inventory control practices
and the adequacy of its facilities, and subject pharmacies to oversight by state boards of pharmacy and other regulators that
could impose burdensome requirements or restrictions on operations if a pharmacy is found not to comply with these laws. We believe
that our ImprimisRx compounding pharmacies are in material compliance with applicable regulatory requirements. However, if any
of our ImprimisRx compounding pharmacies fails to comply with such requirements, they could be forced to permanently or temporarily
cease or limit their sterile compounding operations, which would severely limit our ability to market and sell our proprietary
formulations and would materially harm our operations and prospects. Any such noncompliance could also result in complaints or
adverse actions by other state boards of pharmacy, FDA inspection of the facility to determine compliance with the FDCA, loss
of FDCA exemptions provided under Section 503A, warning letters, injunctions, prosecution, fines and loss of required government
licenses, certifications and approvals, any of which could involve significant costs and could cause us to be unable to realize
the expected benefits of these pharmacies’ operations. Although we ultimately expect to distribute our proprietary formulations
through a unified network of compounding pharmacies, we may not be successful in establishing such a network and the loss or limitation
of our ImprimisRx compounding pharmacies’ ability to compound sterile formulations would have an immediate adverse impact
on our ability to successfully and timely implement our business plan.
Many
of the states into which our ImprimisRx compounding pharmacies deliver pharmaceuticals have laws and regulations that require
out-of-state pharmacies to register with, or be licensed by, the boards of pharmacy or similar regulatory bodies in those states.
These states generally permit the dispensing pharmacy to follow the laws of the state within which the dispensing pharmacy is
located. However, various state pharmacy boards have enacted laws and/or adopted rules or regulations directed at restricting
the operation of out-of-state pharmacies by, among other things, requiring compliance with all laws of the states into which the
out-of-state pharmacy dispenses medications, whether or not those laws conflict with the laws of the state in which the pharmacy
is located, or requiring the pharmacist-in-charge to be licensed in that state.
Further,
under federal law, Section 503A of the FDCA seeks to limit the amount of compounded products that a pharmacy can dispense interstate.
The interpretation and enforcement of this provision is dependent on the FDA entering into a standard Memorandum of Understanding
(MOU) with each state setting forth limits on interstate compounding. The current draft standard MOU presented by the FDA in February
2015 would limit interstate shipments of compounded drug units to 30% of all compounded and non-compounded units dispensed or
distributed by the pharmacy per month. The FDA has stated in guidance issued in February 2015 that it will not enforce interstate
restrictions until after it publishes a final standard MOU and has made it available to states for signature for some designated
period of time. If the final standard MOU is not signed by a particular state, then interstate shipments of compounded preparations
from a pharmacy located in that state would be limited to quantities not greater than 5% of total prescription orders dispensed
or distributed by the pharmacy (the 5% rule); however, we are not aware that the FDA currently enforces or has in the past enforced
the 5% rule and, under current draft guidance, the FDA has stated that it will not enforce the 5% rule until a standard MOU has
been made available to states for signature. The FDA has proposed a 180-day period for states to agree to the standard MOU after
the final version is presented, after which it would begin to enforce the 5% rule. Until a final MOU is issued and presented to
states to consider, the extent of interstate dispensing restrictions imposed by Section 503A is unknown. However, if the final
standard MOU contains a 30% limit on interstate distribution or if the FDA begins to enforce the 5% rule, our pharmacy operations
could be materially limited
There
are many competitive risks related to marketing and selling our proprietary formulations and operating our compounding pharmacy
business.
The
pharmaceutical and pharmacy industries are highly competitive. We compete against branded drug companies, generic drug companies,
outsourcing facilities and other compounding pharmacies. We are significantly smaller than some of our competitors, and we may
lack the financial and other resources needed to develop, produce, distribute, market and commercialize any of our proprietary
formulations or compete for market share in these sectors. The drug products available through branded and generic drug companies
with which our formulations compete have been approved for marketing and sale by the FDA and are required to be manufactured in
facilities compliant with cGMP standards. Although we prepare our compounded formulations in accordance with the standards provided
by USP <795> and USP <797> and applicable state and federal law, our proprietary compounded formulations are not required
to be, and have not been, approved for marketing and sale by the FDA. As a result, some physicians may be unwilling to prescribe,
and some patients may be unwilling to use, our formulations. Additionally, under federal and state laws applicable to our current
compounding pharmacy operations, we are not permitted to prepare significant amounts of a specific formulation in advance of a
prescription, compound quantities for office use or utilize a wholesaler for distribution of our formulations; instead, our compounded
formulations must be prepared and dispensed in connection with a physician prescription for an individually identified patient.
Pharmaceutical companies, on the other hand, are able to sell their FDA-approved products to large pharmaceutical wholesalers,
who can in turn sell to and supply hospitals and retail pharmacies. Even if we are successful in registering certain of our facilities
as outsourcing facilities, our business may not be scalable on the scope available to our competitors that produce FDA-approved
drugs, which may limit our potential for profitable operations. These facets of our operations may subject our business to limitations
our competitors with FDA-approved drugs may not face.
Biotechnology
and related pharmaceutical technologies have undergone and continue to be subject to rapid and significant change. Our future
success will depend in large part on our ability to maintain a competitive position with respect to these technologies. Products
developed by our competitors, including FDA-approved drugs and compounded formulations created by other pharmacies, could render
our products and technologies obsolete or unable to compete. Any products that we develop may become obsolete before we recover
expenses incurred in developing the products, which may require that we seek to raise additional funds that may or may not be
available to continue our operations. The competitive environment requires an ongoing, extensive search for medical and technological
innovations and the ability to develop and market these innovations effectively, and we may not be competitive with respect to
these factors. Other competitive factors include the safety and efficacy of a product, the size of the market for a product, the
timing of market entry relative to competitive products, the availability of alternative compounded formulations or approved drugs,
the price of a product relative to alternative products, the availability of third-party reimbursement, the success of sales and
marketing efforts, brand recognition and the availability of scientific and technical information about a product. Although we
believe we are positioned to compete favorably with respect to many of these factors, if our proprietary formulations are unable
to compete with the products of our competitors, we may never gain market share or achieve profitability.
If
a compounded drug formulation provided through our compounding services leads to patient injury or death or results in a product
recall, we may be exposed to significant liabilities and reputational harm.
The
success of our business, including our proprietary formulations and pharmacy operations, is highly dependent upon medical and
patient perceptions of us and the safety and quality of our products. We could be adversely affected if we, any other compounding
pharmacies or our formulations and technologies are subject to negative publicity. We could also be adversely affected if any
of our formulations or other products we sell, any similar products sold by other companies, or any products sold by other compounding
pharmacies prove to be, or are asserted to be, harmful to patients. For instance, to the extent any of the components of approved
drugs or other ingredients used by our ImprimisRx compounding pharmacies to produce our compounded formulations have quality or
other problems that adversely affect the finished compounded preparations, our sales could be adversely affected. Also, because
of our dependence upon medical and patient perceptions, any adverse publicity associated with illness or other adverse effects
resulting from the use or misuse of our products, any similar products sold by other companies or any other compounded formulations
could have a material adverse impact on our business.
To
assure compliance with USP guidelines, we have implemented a policy whereby 100% of all sterile compound batches produced by our
ImprimisRx compounding pharmacies are tested both in-house and externally prior to their delivery to patients and physicians by
an independent, FDA-registered laboratory that has represented to us that it operates in compliance with current good laboratory
practices. However, we could still become subject to product recalls and termination or suspension of our state pharmacy licenses
if we fail to fully implement this policy, if the laboratory testing does not identify all contaminated products, or if our products
otherwise cause or appear to have caused injury or harm to patients. In addition, such laboratory testing may produce false positives,
which could harm our business and impact our pharmacy operations and licensure even if the impacted formulations are ultimately
found to be sterile and no patients are harmed by them. If adverse events or deaths or a product recall, either voluntarily or
as required by the FDA or a state board of pharmacy, were associated with one of our proprietary formulations or any compounds
prepared by our ImprimisRx compounding pharmacies or any pharmacy partner, our reputation could suffer, physicians may be unwilling
to prescribe our proprietary formulations or order any prescriptions from such pharmacies, we could become subject to product
and professional liability lawsuits, and our state pharmacy licenses could be terminated or restricted. If any of these events
were to occur, we may be subject to significant litigation or other costs and loss of revenue, and we may be unable to continue
our pharmacy operations and further develop and commercialize our proprietary formulations.
Although
we have secured product and professional liability insurance for our pharmacy operations and the marketing and sale of our formulations,
our current or future insurance coverage may prove insufficient to cover any liability claims brought against us. Because of the
increasing costs of insurance coverage, we may not be able to maintain insurance coverage at a reasonable cost or at a level adequate
to satisfy liabilities that may arise.
Our
ability to generate revenues will be diminished if we fail to obtain acceptable prices or an adequate level of reimbursement from
third-party payors.
Currently,
our ImprimisRx compounding pharmacies operate on mostly a cash-pay basis and do not submit large amounts of claims for reimbursement
through Medicare, Medicaid or other third-party payors, although our customers may choose to seek available reimbursement opportunities
to the extent that they exist. As part of our
Imprimis Cares
initiative, we work with third-party insurers, pharmacy benefit
managers and buying groups to offer patient-specific customizable compounded formulations at accessible prices. We plan to continue
to devote time and other resources to seek reimbursement and patient pay opportunities for these and other compounded formulations
and we have hired pharmacy billers to process certain existing reimbursement opportunities for certain formulations. However,
we may be unsuccessful in achieving these goals, as many third-party payors have imposed significant restrictions on reimbursement
for compounded formulations in recent years. Moreover, third-party payors, including Medicare, are increasingly attempting to
contain health care costs by limiting coverage and the level of reimbursement for new drugs and by refusing, in some cases, to
provide coverage for uses of approved products for disease indications for which the FDA has not granted labeling approval. Further,
the Health Reform Law may have a considerable impact on the existing U.S. system for the delivery and financing of health care
and could conceivable have a material effect on our business. As a result, reimbursement from Medicare, Medicaid and other third-party
payors may never be available for any of our products or, if available, may not be sufficient to allow us to sell the products
on a competitive basis and at desirable price points. If government and other third-party payors do not provide adequate coverage
and reimbursement levels for our formulations, the market acceptance for our formulations may be limited.
Additionally,
we are making efforts to normalize the pricing for our currently available proprietary compounded formulations. An economic study
conducted in 2015 by researchers at Andrew Chang & Co, LLC and co-sponsored by us demonstrated that, assuming the cost of
Dropless Therapy is $100 per dose (dollar amount not expressed in thousands), our Dropless Therapy formulations could provide
collective savings to Medicare, Medicaid and patients of up to $13 billion, with a most likely savings estimate of $8.7 billion,
over a 10-year period. Based on this research, we believe optimized pricing for our Dropless Therapy formulations would be $100
per dose (dollar amount not expressed in thousands). Any efforts to attain optimized pricing for our Dropless Therapy or any of
our other proprietary formulations could fail, which could make our products less attractive or unavailable to some patients or
could reduce our margins.
We
may not be able to correctly estimate our future operating expenses, which could lead to cash shortfalls.
Our
estimates of our future operating and capital expenditures are based upon our current business plan, the anticipated expenses
associated with our ImprimisRx compounding pharmacies’ operations and our current expectations regarding the commercialization
of our proprietary formulations. Our projections have varied significantly in the past as a result of changes to our business
model and strategy, including our discontinuation of efforts to pursue FDA approval of an abandoned product candidate in November
2013 and our acquisitions of our ImprimisRx compounding pharmacies and various product development opportunities in 2014 and 2015.
We have limited experience operating a pharmacy business and commercializing compounded formulations, and we may not accurately
estimate expenses and potential revenue associated with these activities. For example, we have incurred and expect to continue
to incur greater than anticipated expenses developing our Texas- and New Jersey-based pharmacy facilities into outsourcing facilities
and registering them as such with the FDA. Additionally, our operating expenses may fluctuate significantly as a result of a variety
of factors, including those discussed in this “Risk Factors” section, some of which are outside of our direct control.
If we are unable to correctly estimate the amount of cash necessary to fund our business, we could spend our available financial
resources much faster than we expect. If we do not have sufficient funds to continue to operate and develop our business, we could
be required to seek additional financing earlier than we expect, which may not be available when needed or at all, or be forced
to delay, scale back or eliminate some or all of our proposed operations.
If
we do not successfully identify and acquire rights to potential formulations and successfully integrate them into our operations,
our growth opportunities may be limited.
We
plan to pursue the development of new proprietary compounded formulations in the ophthalmology, urology, otolaryngology and/or
other therapeutic areas, which may include continued activities to develop and commercialize current assets or, if and as opportunities
arise, potential acquisitions of new intellectual property rights and assets. We also intend to seek opportunities to introduce
new lower-cost compounded formulation alternatives to higher-priced FDA-approved drugs, as part of our
Imprimis Cares
initiative.
However, we expect our acquisitions of our ImprimisRx compounding pharmacies to provide us with only limited research and development
support and access to additional novel compounded formulations. As a result, we have historically relied, and we expect to continue
to rely, primarily upon third parties to provide us with additional development opportunities. We may seek to enter into acquisition
agreements or licensing arrangements with third parties to obtain rights to develop new formulations in the future, but only if
we are able to identify attractive formulations and negotiate acquisition or license agreements with their owners on terms acceptable
to us, which we may not be able to do. Moreover, we have limited resources to acquire additional potential product development
assets and integrate them into our business and acquisition opportunities may involve competition among several potential purchasers,
which could include large multi-national pharmaceutical companies and other competitors that have access to greater financial
resources than we do. If we are unable to obtain rights to development opportunities from third parties and we are unable to rely
upon our ImprimisRx compounding pharmacies and current and future relationships with pharmacists, physicians and other inventors
to provide us with additional development opportunities, our growth and prospects could be limited.
Our
product development strategy is to focus on a select few therapeutic areas in which we believe there is broad market potential,
large unmet needs and/or unique value to physicians and patients and to develop and offer formulations within these therapeutic
areas that could afford us with gross margins. However, our expectations and assumptions about market potential and patient needs
may prove to be wrong and we may invest capital and other resources on formulations that do not generate sufficient revenues for
us to recoup our investment.
We
may be unable to successfully develop and commercialize our proprietary formulations or any other assets we may acquire.
Our
future results of operations will depend to a significant extent upon our ability to successfully develop and commercialize in
a timely manner any of the assets we have acquired or to which we may acquire rights in the future. Since May 2013, we have acquired
assets related to compoundable formulations and we have entered into one license agreement for rights to commercialize a compounding
formulation. We are currently pursuing development and commercialization opportunities with respect to certain of these formulations
and we are in the process of assessing certain of our other assets in order to determine whether to pursue their development or
commercialization. In addition, we expect to consider the acquisition of additional intellectual property rights or other assets
in the future. There are numerous difficulties and risks inherent in acquiring, developing and commercializing new formulations
and product candidates, including the risks identified in this “Risk Factors” section.
Once
we determine to pursue a potential product candidate, we develop a commercialization strategy for the product candidate. Potential
commercialization strategies could include, among others, marketing and selling the formulation in compounded form through compounding
pharmacies or outsourcing facilities, or pursuing FDA approval of the product candidate. We may incorrectly assess the risks and
benefits of our commercialization options with respect to one or more formulations or technologies, and we may not pursue a commercialization
strategy that proves to be successful. If we are unable to successfully commercialize one or more of our proprietary formulations,
our operating results would be adversely affected. Even if we are able to successfully sell one or more proprietary formulations,
we may never recoup our investment in acquiring or developing the formulations. Our failure to identify and expend our resources
on formulations and technologies with commercial potential and execute an effective commercialization strategy for each of our
formulations would negatively impact the long-term profitability of our business.
We
have incurred significant indebtedness, which will require substantial cash to service and which subjects us to certain financial
requirements and business restrictions.
On
May 11, 2015, we incurred $10 million of indebtedness under a loan agreement with IMMY Funding LLC (LSAF), an affiliate of Life
Sciences Alternative Funding LLC, and on January 22, 2016, we incurred an additional $3 million of indebtedness under a convertible
note we issued to LSAF. Pursuant to the terms of the $10 million loan agreement, we are obligated to pay interest on the principal
amount of the loan at a fixed per-annum rate of 12.5% and we are permitted to pay interest only for the first three years, which
may be reduced to 20 months if we do not meet certain minimum revenue or cash balance requirements. All amounts owed under the
LSAF loan agreement, including a final fee of 5% of the aggregate principal amount of the loan, will be due on the earlier of
May 11, 2021 or 24 months after the end of the interest-only period. Pursuant to the terms of $3 million convertible note, we
are obligated to pay interest monthly in cash at a fixed per-annum rate of 8.0% and we are obligated to repay the full principal
amount of the convertible note in cash on May 11, 2021. The note is convertible by the holder at any time into 277.77 shares
of our common stock per $1 outstanding principal amount of the convertible note, subject to adjustment upon certain events. Our
interest payment obligations under the LSAF loan agreement totaled approximately $0.7 million for our 2015 fiscal year, and we
expect our interest payment obligations under the LSAF loan agreement and the LSAF convertible note to total approximately $1.1
million for our 2016 fiscal year. The amounts owed to LSAF are secured by substantially all of our personal property, rights and
assets, including our intellectual property rights.
Our
ability to make scheduled payments on our indebtedness depends on our future performance and ability to raise additional capital,
which is subject to economic, financial, competitive and other factors, some of which are beyond our control. If we are unable
to generate sufficient cash to service our debt, we may be required to adopt one or more alternatives, such as selling assets,
restructuring our debt or obtaining additional capital through equity sales or incurrence of additional debt on terms that may
be onerous or highly dilutive to our stockholders. Our ability to engage in any of these activities would depend on the capital
markets and our financial condition at such time, and we may not be able to do so when needed, on desirable terms or at all, which
could result in a default on our debt obligations. Additionally, our LSAF debt instruments contain various restrictive covenants,
including, among others, our obligation to deliver to LSAF certain financial and other information, our obligation to comply with
certain notice and insurance requirements, and our inability, without LSAF’s prior consent, to dispose of certain of our
assets, incur certain additional indebtedness, enter into certain merger, acquisition or change of control transactions, pay certain
dividends or distributions on or repurchase any of our capital stock or incur any lien or other encumbrance on our assets, subject
to certain permitted exceptions. Any failure by us to comply with any of these covenants, subject to certain cure periods, or
to make all payments under the debt instruments when due, would cause us to be in default under the applicable debt instrument.
In the event of any such default, LSAF may be able to foreclose on our assets that secure the debt or declare all borrowed funds,
together with accrued and unpaid interest, immediately due and payable, thereby potentially causing all of our available cash
to be used to pay our indebtedness or forcing us into bankruptcy or liquidation if we do not then have sufficient cash available.
Any such event or occurrence could severely and negatively impact our operations and prospects.
We
may need additional capital in order to continue operating our business, and such additional funds may not be available when needed,
on acceptable terms, or at all.
We
only recently started generating cash from operations, but we do not presently receive sufficient revenues to support our operations.
Although we believe we have sufficient cash reserves to operate our business for at least the 12 months following the date of
this Annual Report, we may need significant additional capital to execute our business plan and fund our proposed business operations.
Additionally, our plans may change, our estimates of our operating expenses and working capital requirements could be inaccurate,
we may pursue acquisitions of pharmacies or other strategic transactions that involve large expenditures or we may experience
growth more quickly or on a larger scale than we expect, any of which may result in the depletion of capital resources more rapidly
than anticipated and could require us to seek additional financing earlier than we expect to support our operations.
We
have raised over $24 million in funds through equity and debt financings in 2014, 2015 and 2016 to date. We may seek to obtain
additional capital through additional equity or debt financings, funding from corporate partnerships or licensing arrangements,
sales of assets or other financing transactions. If we issue equity or convertible debt securities to raise additional funds,
our existing stockholders may experience substantial dilution, and the newly issued equity or debt securities may have more favorable
terms or rights, preferences and privileges senior to those of our existing stockholders. If we raise additional funds through
collaboration and licensing arrangements or sales of assets, we may be required to relinquish potentially valuable rights to our
product candidates or proprietary technologies, or grant licenses on terms that are not favorable to us. If we raise funds by
incurring additional debt, we may be required to pay significant interest expenses and our leverage relative to our earnings or
to our equity capitalization may increase. Obtaining commercial loans, assuming those loans would be available, would increase
our liabilities and future cash commitments and may impose restrictions on our activities, such as the financial and operating
covenants included in our loan agreement and convertible note with LSAF. Further, we may incur substantial costs in pursuing future
capital and/or financing transactions, including investment banking fees, legal fees, accounting fees, printing and distribution
expenses and other costs. We may also be required to recognize non-cash expenses in connection with certain securities we may
issue, such as options, convertible notes and warrants, which would adversely impact our financial results.
We
have in the past and may in the future participate in strategic transactions that could impact our liquidity, increase our expenses
and distract our management.
From
time to time we consider engaging in strategic transactions, such as out-licensing or in-licensing of compounds or technologies,
acquisitions of companies, and asset purchases. We may also consider a variety of different business arrangements in the future,
including strategic partnerships, joint ventures, spin-offs, restructurings, divestitures, business combinations and investments.
In addition, another entity may pursue us or certain of our assets or aspects of our operations as an acquisition target. Any
such transactions may require us to incur expenses specific to the transaction and not incident to our operations, may increase
our near- and long-term expenditures, may pose significant integration challenges, may require us to hire or otherwise engage
personnel with additional expertise, or may result in our selling or licensing of our assets or technologies under terms that
may not prove profitable, any of which could harm our operations and financial results. Such transactions may also entail numerous
other operational and financial risks, including, among others, exposure to unknown liabilities, disruption of our business and
diversion of our management’s time and attention in order to develop acquired products, product candidates, technologies
or businesses.
As
part of our efforts to complete any significant transaction, we would need to expend significant resources to conduct business,
legal and financial due diligence, with the goal of identifying and evaluating material risks involved in the transaction. Despite
our efforts, we may be unsuccessful in ascertaining or evaluating all such risks and, as a result, we may not realize the expected
benefits of any such transaction, whether due to unidentified risks, integration difficulties, regulatory setbacks or other events,
and we may incur material liabilities for the past activities of any businesses we partner with or acquire. If any of these events
were to occur, we could be subject to significant costs and damage to our reputation, business, results of operations and financial
condition.
We
may be unable to obtain financing when necessary as a result of, among other things, our performance, general economic conditions,
conditions in the pharmaceuticals and pharmacy industries, or our operating history, including our past bankruptcy proceedings.
In addition, the fact that we are not and have never been profitable could further impact the availability or cost to us of future
financings. As a result, sufficient funds may not be available when needed from any source or, if available, such funds may not
be available on terms that are acceptable to us. If we are unable to raise funds to satisfy our capital needs when needed, then
we may need to forego pursuit of potentially valuable development or acquisition opportunities, we may not be able to continue
to operate our business pursuant to our business plan, which would require us to modify our operations to reduce spending to a
sustainable level by, among other things, delaying, scaling back or eliminating some or all of our ongoing or planned investments
in corporate infrastructure, business development, sales and marketing and other activities, or we may be forced to discontinue
our operations entirely.
If
we are unable to establish, train and maintain an effective sales and marketing infrastructure, we will not be able to commercialize
our product candidates successfully.
We
have started to build an internal sales and marketing infrastructure to implement our business plan by developing internal sales
teams and education campaigns to market our proprietary formulations. We will need to expend significant resources to further
establish and grow this internal infrastructure and properly train sales personnel with respect to regulatory compliance matters.
We may also choose to engage or enter into other arrangements with third parties to provide sales and marketing services for us
in place of or to supplement our internal commercialization infrastructure. We may not be able to secure sales personnel or relationships
with third-party sales organizations that are adequate in number or expertise to successfully market and sell our proprietary
formulations and pharmacy services. Further, any third-party organizations we may seek to partner with or engage may not be able
to provide sales and marketing services in accordance with our expectations and standards, may be more expensive than we can afford
or may not be available on otherwise acceptable terms or at all. If we are unable to establish and maintain compliant and adequate
sales and marketing capabilities, through our own internal infrastructure or third-party services or other arrangements, we may
be unable to sell our formulations or services or generate meaningful revenue.
Our
business and operations would suffer in the event of cybersecurity or other system failures.
Despite
the implementation of security measures, our internal computer systems and those of any third parties with which we partner are
vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical
failures. While we have not experienced any such cybersecurity or system failure, accident or breach to date, if such an event
were to occur, it could result in a material disruption of our operations, substantial costs to rectify or correct the failure,
if possible, and potentially violation of HIPAA and other privacy laws applicable to our pharmacy operations. If any disruption
or security breach resulted in a loss of or damage to our data or applications or inappropriate disclosure of confidential or
protected information, we could incur liability, further development of our proprietary formulations could be delayed, and our
pharmacy operations could be disrupted, subject to restriction or forced to terminate their operations, any of which could severely
harm our business and prospects.
We
depend upon consultants, outside contractors and other third-party service providers for key aspects of our business.
We
are substantially dependent on consultants and other outside contractors and service providers for key aspects of our business.
For instance, we rely upon our pharmacist, physician and research consultants and advisors to provide us with significant assistance
in our evaluation of product development opportunities, and we have engaged or supported, and expect to continue to engage or
support, consultants, advisors, clinical research organizations (CROs) and others to design, conduct, analyze and interpret the
results of any clinical or non-clinical trials or other studies in connection with the research and development of our products.
If any of our consultants or other service providers terminates its engagement with us, or if we are unable to engage highly qualified
replacements as needed on commercially reasonable terms, we may be unable to successfully execute our business plan. We must effectively
manage these third-party service providers to ensure that they successfully carry out their contractual obligations and meet expected
deadlines. However, these third parties often engage in other business activities and may not devote sufficient time and attention
to our activities and we may have only limited contractual rights in connection with the conduct of the activities we have engaged
the service providers to perform. If we are unable to effectively manage our outsourced activities or if the quality, timeliness
or accuracy of the services provided by third-party service providers is compromised for any reason, our development activities
may be extended, delayed or terminated, and we may not be able to commercialize our formulations or advance our business.
If
we seek FDA approval to market and sell any of our proprietary formulations, we may be unable to demonstrate the necessary safety
and efficacy to obtain such FDA approval.
Although
our current business strategy is focused on developing and commercializing product opportunities as compounded formulations, we
may in the future choose, alone or with project partners, to seek FDA regulatory approval to market and sell one or more of our
assets as a FDA-approved drug. The process of obtaining FDA approval to market and sell pharmaceutical products is costly, time
consuming, uncertain and subject to unanticipated delays. If we choose to pursue FDA approval for one or more product candidates,
the FDA or other regulatory agencies may not approve the product candidate on a timely basis or at all. Before we could obtain
FDA approval for the sale of any potential product candidates, we would be required to demonstrate through preclinical studies
and clinical trials that the product candidate is safe and effective for each intended use, which we may not be able to do. A
failure to demonstrate safety and efficacy of a product candidate to the FDA’s satisfaction would result in our failure
to obtain FDA approval. Moreover, even if the FDA were to grant regulatory approval of a product candidate, the approval may be
limited to specific therapeutic areas or limited with respect to its distribution, which could reduce revenue potential, and we
would be subject to extensive and costly post-approval requirements and oversight with respect to commercialization of the product
candidate.
Delays
in the completion of, or the termination of, any clinical or non-clinical trials for any product candidates for which we may seek
FDA approval could adversely affect our business.
Clinical
trials are very expensive, time consuming, unpredictable and difficult to design and implement. The results of clinical trials
may be unfavorable, they may continue for several years and they may take significantly longer to complete and involve significantly
more costs than expected. Delays in the commencement or completion of clinical testing could significantly affect product development
costs and plans with respect to any product candidate for which we seek FDA approval. The commencement and completion of clinical
trials can be delayed and experience difficulties for a number of reasons, including delays and difficulties caused by circumstances
over which we may have no control. For instance, approvals of the scope, design or trial site may not be obtained from the FDA
and other required bodies in a timely manner or at all, agreements with acceptable terms may not be reached in a timely manner
or at all with CROs to conduct the trials, a sufficient number of subjects may not be recruited and enrolled in the trials, and
third-party manufacturers of the materials for use in the trials may encounter delays and problems in the manufacturing process,
including failure to produce materials in sufficient quantities or of an acceptable quality to complete the trials. If we were
to experience delays in the commencement or completion of, or if we were to terminate, any clinical or non-clinical trials we
pursue in the future, the commercial prospects for the applicable product candidates may be limited or eliminated, which may prevent
us from recouping our investment in research and development efforts for the product candidate and would have a material adverse
effect on our business, results of operations, financial condition and prospects.
Even
if we successfully develop any product candidate into an FDA-approved drug, failure to comply with continuing federal and state
regulations could result in the loss of approvals to market the drug.
Even
if we successfully develop any product candidate into an FDA-approved drug, we would be subject to extensive continuing regulatory
requirements and review, including review of adverse drug experiences and clinical results from any post-marketing tests or continued
actions required as a condition of approval. The manufacturer and manufacturing facilities we would use to produce any such drug
preparations would be subject to periodic review and inspection by the FDA, and we would be reliant on these third parties to
maintain their manufacturing processes in compliance with FDA and all other applicable regulatory requirements. Any changes to
a product that may have achieved approval, including the way it is manufactured or promoted, would often require FDA approval
again before the product, as modified, could be marketed and sold. In addition, we and the manufacturers of the drug would be
subject to ongoing FDA requirements for submission of safety and other post-market information. If we or the manufacturers of
the drug failed to comply with these or any other applicable regulatory requirements, a regulatory agency may, among other things,
issue warning letters, impose civil or criminal penalties, suspend or withdraw regulatory approval, impose restrictions on our
operations, close the facilities of the manufacturers, seize or detain products or require a product recall.
Regulatory
review also covers a company’s activities in the promotion of its FDA-approved drugs, with significant potential penalties
and restrictions for promotion of a drug for an unapproved use. Sales and marketing programs are under scrutiny for compliance
with various mandated requirements, such as illegal promotions to health care professionals. Failure to comply with these requirements
could expose us to negative publicity, fines and penalties that could harm our business.
If
we are unable to protect our proprietary rights, we may not be able to prevent others from using our intellectual property, which
may reduce the competitiveness and value of the related assets.
Our
success will depend in part on our ability to obtain and maintain patent protection for our formulations and technologies and
prevent third parties from infringing upon our proprietary rights. We must also operate without infringing upon patents and proprietary
rights of others, including by obtaining appropriate licenses to patents or other proprietary rights held by third parties, if
necessary. The primary means by which we will be able to protect our formulations and technologies from unauthorized use by third
parties is to obtain valid and enforceable patents that cover them. Currently, we own 25 U.S. patent applications, including 18
utility and seven provisional patent applications, and we own three international patent applications filed under the Patent Cooperation
Treaty and 19 foreign patent applications. However, the applications we have filed or may file in the future may never yield patents
that protect our inventions and intellectual property assets. Failure to obtain patents that sufficiently cover our formulations
and technologies would limit our protection against other compounding pharmacies and outsourcing facilities, generic drug manufacturers,
pharmaceutical companies and other parties who may seek to copy our products, produce products substantially similar to ours or
use technologies substantially similar to those we own. We have made, and expect to continue to make, significant investments
in certain of our proprietary formulations prior to the grant of any patents covering these formulations, and we may not receive
a sufficient return on these investments if patent coverage or other appropriate intellectual property protection is not obtained
and their competitiveness and value decreases.
The
patent and intellectual property positions of pharmacies and pharmaceutical companies, including ours, are uncertain and involve
complex legal and factual questions. There is no guarantee that we have developed or obtained or will in the future develop or
obtain the rights to products or processes that are patentable, that patents will issue from any pending applications or that
claims allowed will be sufficient to protect the technology we have developed or may in the future develop or to which we have
acquired or may in the future acquire development rights. In addition, we cannot be certain that patents issued to us will not
be challenged, invalidated, infringed or circumvented, including by our competitors, or that the rights granted thereunder will
provide competitive advantages to us.
We
also rely on unpatented trade secrets and know-how and continuing technological innovation in order to develop our formulations,
which we seek to protect, in part, by confidentiality agreements with our employees, consultants, collaborators and others, including
certain service providers. We also have invention or patent assignment agreements with our current employees and certain consultants.
However, our employees and consultants may breach these agreements and we may not have adequate remedies for any breach, or our
trade secrets may otherwise become known or be independently discovered by competitors. In addition, inventions relevant to us
could be developed by a person not bound by an invention assignment agreement with us, in which case we may have no rights to
use the applicable invention.
We
may face additional competition outside of the U.S. as a result of a lack of patent coverage in some territories and differences
in patent prosecution and enforcement laws in foreign counties.
Filing,
prosecuting, defending and enforcing patents on our proprietary formulations throughout the world is extremely expensive. While
we currently have three international patent applications filed under the Patent Cooperation Treaty and nineteen pending
foreign patent applications, we do not currently have patent protection outside of the U.S. that covers any of our proprietary
formulations or other assets that we are currently pursuing. Competitors may use our technologies to develop their own products
in jurisdictions where we have not obtained patent protection.
Even
if the international patent applications we have filed or may in the future file are issued or approved, it is likely that the
scope of protection provided by such patents would be different from, and possibly less than, the scope provided by corresponding
U.S. patents. As a result, any patent rights we are able to obtain may not be sufficient to prevent generic competition. Further,
the extent of our international market opportunity may be dependent upon the enforcement of patent rights in various other countries.
A number of countries in which we could file patent applications have a history of weak enforcement and/or compulsory licensing
of intellectual property rights. Moreover, the legal systems of certain countries, particularly certain developing countries,
do not favor the aggressive enforcement of patents and other intellectual property protection, particularly those relating to
biotechnology and/or pharmaceuticals, which would make it difficult for us to stop a third party from infringing any of our intellectual
property rights. Moreover, attempting to enforce our patent rights in foreign jurisdictions could result in substantial costs
and divert our efforts and attention from other aspects of our business.
Our
proprietary formulations and technologies could potentially conflict with the rights of others.
The
preparation or sale of our proprietary formulations and use of our technologies may infringe on the patent or other intellectual
property rights of others. If our products infringe or conflict with the patent or other intellectual property rights of others,
third parties could bring legal actions against us claiming damages and seeking to enjoin our manufacturing and marketing of our
affected products. Patent litigation is costly and time consuming and may divert management’s attention and our resources.
We may not have sufficient resources to bring any such actions to a successful conclusion. If we are not successful in defending
against these legal actions should they arise, we may be subject to monetary liability or be forced to alter our products, cease
some or all of our operations relating to the affected products, or seek to obtain a license in order to continue manufacturing
and marketing the affected products, which may not available on acceptable terms or at all.
We
are dependent on our Chief Executive Officer, Mark L. Baum, for the continued growth and development of our Company.
Our Chief Executive Officer,
Mark L. Baum, has played a primary role in creating and developing our current business model. Further, Mr. Baum has played a
primary role in securing and developing much of our material intellectual property rights, commercial programs and related assets,
as well as the means to make and distribute our current products. We are highly dependent on Mr. Baum for the implementation of
our business plan and the future development of our assets and our business, and the loss of Mr. Baum’s services and leadership
would likely materially adversely impact our Company. We presently maintain key man insurance for Mr. Baum.
If
we are unable to attract and retain key personnel and consultants, we may be unable to maintain or expand our business.
We
developed a new business model in December 2011 and again in November 2013, and we have been focusing on building our management,
pharmacy, research and development, sales and marketing and other personnel in order to pursue our current business model. However,
we may have significant difficulty attracting and retaining necessary employees, which may be amplified because of our bankruptcy
filing in 2011. In addition, because of the specialized nature of our business, our ability to develop products and to compete
will remain highly dependent upon our ability to attract and retain qualified pharmacy, scientific, technical and commercial employees
and consultants. The loss of key employees or consultants or the failure to recruit or engage new employees and consultants could
have a material adverse effect on our business. There is intense competition for qualified personnel in our industry, and we may
be unable to continue to attract and retain the qualified personnel necessary for the development of our business.
Changes
in the healthcare industry that are beyond our control may have an adverse impact on our business.
The
healthcare industry is changing rapidly as consumers, governments, medical professionals and the pharmaceutical industry examine
ways to broaden medical coverage while controlling the increase in healthcare costs. Such changes could include changes to make
the government’s Medicare and Medicaid reimbursement programs more restrictive, which could limit or curtail the potential
for our proprietary formulations to obtain eligibility for reimbursement from such payors, or changes to expand the reach of HIPAA
or other health privacy laws, which could make compliance with these laws more costly and burdensome. Further, the Health Reform
Law may have a considerable impact on the existing U.S. system for the delivery and financing of health care and conceivably could
have a material effect on our business. Any changes to laws and regulations affecting the healthcare industry could impose significant
additional costs on our operations in order to maintain compliance or could otherwise negatively affect our business, operations
or financial performance.
Risks
Related to Our Common Stock
Because
of their significant stock ownership, some of our existing stockholders are able to exert control over us and our significant
corporate decisions.
Our
executive officers and directors collectively own, or have the right to acquire within 60 days after March 22, 2016, approximately
15% of our common stock that would be outstanding following such issuances. In addition, five individual stockholders collectively
own, or have the right to acquire within 60 days after March 22, 2016, an additional approximately 35% of our common stock
that would be outstanding following such issuances. These persons, acting together, have the ability to exercise significant influence
over or control the outcome of all matters submitted to our stockholders for approval, including the election and removal of directors
and any significant transaction involving us, and to control our management and affairs. Additionally, since our Amended and Restated
Certificate of Incorporation and Amended and Restated Bylaws permit our stockholders to act by written consent, a limited number
of stockholders may approve stockholder actions without holding a meeting of stockholders. This concentration of ownership may
harm the market price of our common stock by, among other things: delaying, deferring, or preventing a change in control of our
Company or changes to our board of directors; impeding a merger, consolidation, takeover or other business combination involving
our Company; causing us to enter into transactions or agreements that are not in the best interests of all stockholders; or discouraging
a potential acquiror from making a tender offer or otherwise attempting to obtain control of our Company.
If
we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results, which
could cause our stock price to fall.
Effective
internal controls are necessary for us to provide reliable financial results. If we cannot provide reliable financial results,
our financial statements could be misstated, our reputation may be harmed and the trading price of our common stock could decline.
As we discuss in Item 9A of this Annual Report, our management concluded that our internal controls over financial reporting were
effective as of December 31, 2015. However, our controls over financial processes and reporting may not continue to be effective
or we may identify material weaknesses or significant deficiencies in our internal controls in the future. Any failure to remediate
any future material weaknesses or successfully implement required new or improved controls, could harm our operating results,
cause us to fail to meet our reporting obligations or result in material misstatements in our financial statements or other public
disclosures. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which
could have a negative effect on the trading price of our common stock.
A
consistently active trading market for shares of our common stock may not be sustained.
Historically,
trading in our common stock has been sporadic and volatile and our common stock has been “thinly-traded.” There have
been, and may in the future be, extended periods when trading activity in our shares is minimal, as compared to a seasoned issuer
with a large and steady volume of trading activity. The market for our common stock is also characterized by significant price
volatility compared to seasoned issuers, and we expect that such volatility may continue. As a result, the trading of relatively
small quantities of shares may disproportionately influence the market price of our common stock. A consistently active and liquid
trading market in our securities may never develop or be sustained.
Our
stock price may be volatile.
The
market price of our common stock is likely to be highly volatile and could fluctuate widely in response to various factors, many
of which are beyond our control, including the following: our ability to execute our business plan; operating results that fall
below expectations; industry or regulatory developments; investor perception of our industry or our prospects; economic and other
external factors; and the other risk factors discussed in this “Risk Factors” section.
In
addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated
to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market
price of our common stock.
We
have the right to issue shares of preferred stock without obtaining stockholder approval. If we were to issue preferred stock,
it may have rights, preferences and privileges superior to those of our common stock.
We
are authorized to issue 5,000,000 shares of “blank check” preferred stock, with such rights, preferences and privileges
as may be determined from time to time by our board of directors. Although we have no shares of preferred stock issued and outstanding
and we have no immediate plans to issue shares of preferred stock, our board of directors is empowered, without stockholder approval,
to issue preferred stock at any time in one or more series and to fix the dividend rights, dissolution or liquidation preferences,
redemption prices, conversion rights, voting rights and other rights, preferences and privileges for any series of our preferred
stock that may be issued. The issuance of shares of preferred stock, depending on the rights, preferences and privileges attributable
to the preferred stock, could reduce the voting rights and powers of our common stockholders and the portion of our assets allocated
for distribution to our common stockholders in a liquidation event, and could also result in dilution to the book value per share
of our common stock. The preferred stock could also be utilized, under certain circumstances, as a method for raising additional
capital or discouraging, delaying or preventing a change in control of our Company.
We
have not paid dividends in the past and do not expect to pay dividends in the future. Any return on an investment will be limited
to any appreciation in the value of our common stock.
We
have never paid cash dividends on our common stock and do not anticipate doing so in the foreseeable future. Any payment of dividends
on our common stock would depend on contractual restrictions, such as those contained in our LSAF loan agreement and convertible
note, as well as our earnings, financial condition and other business and economic factors as our board of directors may consider
relevant. If we do not pay dividends, our common stock may be less valuable because a return on your investment will only occur
if our stock price appreciates.
Offers
or availability for sale of a substantial number of shares of our common stock may cause the price of our common stock to decline.
The
sale of substantial amounts of our common stock in the public market, or the perception that such sales could occur, could cause
the market price of our common stock to fall. Such sales could occur upon the expiration of any statutory holding period, such
as under Rule 144 under the Securities Act of 1933, as amended, applicable to outstanding shares, upon expiration of any lock-up
periods applicable to outstanding shares, such as those agreed to in connection with our March 2016 public offering, upon our
issuance of shares upon the exercise of outstanding options or warrants, or upon our issuance of shares pursuant offerings of
our equity securities, such as the pursuant to our March 2016 public offering or our Controlled Equity Offering™ sales agreement
with Cantor Fitzgerald & Co. The availability for sale of a substantial number of shares of our common stock, whether or not
sales have occurred or are occurring, also could make it more difficult for us to raise additional financing through the sale
of equity or equity-related securities in the future when needed, on acceptable terms or at all.
ITEM
1B. UNRESOLVED STAFF COMMENTS
Not
applicable.
ITEM
2. PROPERTIES
We
lease approximately 7,600 square feet of office space in San Diego, California, the current lease term for which expires on October
31, 2018. This facility serves as our corporate headquarters.
We
lease approximately 8,600 square feet of lab, warehouse and office space in Roxbury, New Jersey, the current lease term for which
expires on July 31, 2022. This facility is currently under construction to serve as an outsourcing facility and pharmacy and will
replace our current New Jersey-based pharmacy facility upon completion.
We
lease approximately 3,100 square feet of lab and office space in Randolph, New Jersey, which we are currently leasing on a month-to-month
basis and intend to vacate by March 31, 2016. This facility is the current location for our New Jersey-based pharmacy.
We
lease approximately 4,500 square feet of lab and office space in Irvine, California, the current lease term for which expires
on December 31, 2020. This facility is our California-based pharmacy.
We
lease approximately 5,600 square feet of lab and office space in Folcroft, Pennsylvania, the current lease term for which expires
on March 31, 2017. This facility is our Pennsylvania-based pharmacy.
We
lease approximately 1,100 square feet of lab space in Allen, Texas, the current lease term for which expires on October 31, 2019.
This facility is our Texas-based pharmacy, which we are seeking to register as an outsourcing facility during second quarter
2016.
We
lease approximately 3,800 square feet of office space in San Diego, California, the current lease term for which expires on September
30, 2016. This space previously served as our corporate headquarters and is currently being subleased through the lease term.
We
do not believe additional space will be required in the near-term.
ITEM
3. LEGAL PROCEEDINGS
Urigen
Litigation
In
December of 2015, we, as the plaintiff, filed civil action with the San Diego Superior Court against Urigen Pharmaceuticals, Inc.
(“Urigen”), wherein we outlined serious concerns regarding material failures and inaccuracies of the representation
and warranties provided by Urigen in the License Agreement between the Company and Urigen entered into on October 24, 2014 (the
“Urigen License Agreement”), which have affected our ability to realize the expected benefit of the Urigen License
Agreement. Urigen, as the defendant, has yet to file any responsive pleading to the case and the case is at a preliminary stage.
Management believes the outcome of this claim may have a material effect on our consolidated financial position and results of
operations, although such amount cannot be reasonably estimated at this time.
We
are not aware of any other pending legal proceedings to which we are a party or of which any of our property is subject the adverse
outcome of which, individually or in the aggregate, is likely to have a material adverse effect on our financial position or results
of operations.
ITEM
4. MINE SAFETY DISCLOSURES
Not
applicable.
NOTES
TO THE CONSOLIDATED FINANCIAL STATEMENTS
For
the years ended December 31, 2015 and 2014
(all
dollar amounts are expressed in thousands, except share and per share data)
NOTE
1. ORGANIZATION
Imprimis
Pharmaceuticals, Inc. (together with its subsidiaries, unless the context indicates or otherwise requires, the “Company”
or “Imprimis”) is a national leader in the development, production and dispensing of novel compounded pharmaceuticals.
The Company’s two business programs,
Imprimis Cares
and
Custom Compounding Choice
™, focus on
patient outcomes and affordability by offering high quality customizable compounded drugs in all 50 states. Imprimis is headquartered
in San Diego, California and operates four pharmacy facilities located in California, Texas, New Jersey and Pennsylvania.
On
April 1, 2014, the Company acquired Pharmacy Creations, LLC (“PC”), a New Jersey based compounding pharmacy and on
January 1, 2015, the Company acquired South Coast Specialty Compounding, Inc. D/B/A Park Compounding (“Park”), a California
based compounding pharmacy. Effective with the acquisition of PC, the Company commenced sales and marketing efforts for Imprimis’
portfolio of proprietary and non-proprietary compounded drug formulations. On August 4, 2015, the Company acquired JT Pharmacy,
Inc. d/b/a Central Allen Pharmacy (“CAP”), a Texas based compounding pharmacy whose name has been changed to ImprimisRx
TX, Inc., and on October 15, 2015, the Company, through a wholly-owned subsidiary ImprimisRx PA, Inc. (“ImprimisRx PA”),
acquired substantially all of the assets and tradenames of Thousand Oaks Holding Company’s wholly-owned subsidiaries Topical
Apothecary Group, LLC (d/b/a TAG Pharmacy), Aerosol Science Laboratories, Inc. (d/b/a ASL Pharmacy), SinuTopic, Inc. (d/b/a Sinus
Dynamics Pharmacy) and Mycotoxins, LLC (collectively “TOHC”).
NOTE
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
Imprimis
has prepared the accompanying consolidated financial statements in accordance with accounting principles generally accepted in
the United States of America (“GAAP”). The accompanying consolidated financial statements include the accounts of
the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
Use
of Estimates
The
preparation of financial statements in conformity with GAAP requires management to make estimates and judgments that affect the
reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements
and reported amounts of revenues and expenses during the reporting periods. Significant estimates made by management include,
among others, those related to allowance for doubtful accounts and contractual adjustments, realizability of inventories, valuation
of deferred taxes, goodwill and intangible assets, recoverability of long-lived assets and goodwill, valuation of contingent acquisition
obligations and deferred acquisition obligations, valuation of note payable and valuation of stock-based compensation issued to
employees and non-employees. Actual results could differ from these estimates.
Liquidity
The
Company has incurred significant operating losses and negative cash flows from operations since its inception. The Company incurred
net losses of $15,899 and $10,118 for the years ended December 31, 2015 and 2014, respectively, and had an accumulated deficit
of $57,764 and $41,865 as of December 31, 2015 and 2014, respectively. In addition, the Company used cash in operating activities
of $11,143 and $7,057 for the years ended December 31, 2015 and 2014, respectively.
While
there is no assurance, the Company believes its existing cash resources and restricted investments of approximately $2,835 at
December 31, 2015 and net cash proceeds from the sale of the Company’s common stock of $11,100 and issuance of a convertible
note of $3,000 subsequent to December 2015 (see Note 16), will be sufficient to sustain the Company’s planned level of operations
for at least the next twelve months. However, estimates of operating expenses and working capital requirements could be incorrect,
and the Company could use its cash resources faster than anticipated. Further, some or all of the ongoing or planned activities
may not be successful and could result in further losses.
The
Company may seek to increase liquidity and capital resources by one or more measures, to the extent necessary. These measures
may include, but are not limited to, the following: obtaining financing through the issuance of equity, debt, or convertible securities;
and working to increase revenue growth through pharmacy sales. There is no guarantee that the Company will be able to obtain capital
when needed on terms it deems as acceptable, or at all.
Revenue
Recognition and Deferred Revenue
The
Company recognizes revenues when all of the following criteria have been met: (1) persuasive evidence of an arrangement exists;
(2) delivery has occurred; (3) the selling price is fixed and determinable; and (4) collectability is reasonably
assured. The Company began generating revenues upon the acquisition of PC in the second quarter of 2014, which include sales of
certain of the Company’s proprietary compounded drug formulations and non-proprietary formulations and products.
Product
Revenues
Determination
of criteria (3) and (4) is based on management’s judgments regarding the fixed nature of the selling prices of the
products delivered and the collectability of those amounts. Estimated returns and allowances and other adjustments are provided
for in the same period during which the related sales are recorded. The Company will defer any revenues received for a product
that has not been delivered or is subject to refund until such time that the Company and the customer jointly determine that the
product has been delivered and no refund will be required.
License
Revenues
License
arrangements may consist of non-refundable upfront license fees, data transfer fees, research reimbursement payments, exclusive
license rights to patented or patent pending compounds, technology access fees, and various performance or sales milestones. These
arrangements can be multiple element arrangements.
Non-refundable
fees that are not contingent on any future performance by the Company and require no consequential continuing involvement on the
part of the Company, are recognized as revenue when the license term commences and the licensed data, technology, compounded drug
preparation and/or other deliverable is delivered. Such deliverables may include physical quantities of compounded drug preparations,
design of the compounded drug preparations and structure-activity relationships, the conceptual framework and mechanism of action,
and rights to the patents or patent applications for such compounded drug preparations. The Company defers recognition of non-refundable
fees if it has continuing performance obligations without which the technology, right, product or service conveyed in conjunction
with the non-refundable fee has no utility to the licensee and that are separate and independent of the Company’s performance
under the other elements of the arrangement. In addition, if the Company’s continued involvement is required, through research
and development services that are related to its proprietary know-how and expertise of the delivered technology or can only be
performed by the Company, then such non-refundable fees are deferred and recognized over the period of continuing involvement.
Guaranteed minimum annual royalties are recognized on a straight-line basis over the applicable term.
Cost
of Sales
Cost
of sales includes direct and indirect costs to manufacture formulations and other products sold, including active pharmaceutical
ingredients, personnel costs, packaging, storage, royalties (see Note 14), shipping and handling costs and the write-off of obsolete
inventory.
Research
and Development
The
Company expenses all costs related to research and development as they are incurred. Research and development expenses consist
of expenses incurred in performing research and development activities, including salaries and benefits, other overhead expenses,
and costs related to clinical trials, contract services and outsourced contracts.
Intellectual
Property
The
costs of acquiring intellectual property rights to be used in the research and development process, including licensing fees and
milestone payments, are charged to research and development expense as incurred in situations where the Company has not identified
an alternative future use for the acquired rights, and are capitalized in situations where we have identified an alternative future
use for the acquired rights. Patents and trademarks are recorded at cost and capitalized at a time when the future economic benefits
of such patents and trademarks become more certain (see Goodwill and Intangible Assets). The Company began capitalizing certain
costs associated with acquiring intellectual property rights during 2015, if costs are not capitalized they are expensed as incurred.
Income
Taxes
As
part of the process of preparing the Company’s consolidated financial statements, the Company must estimate the actual current
tax liabilities and assess temporary differences resulting from differing treatment of items for tax and accounting purposes.
These differences result in deferred tax assets and liabilities, which are included within the consolidated balance sheet.
The Company must assess the likelihood that the deferred tax assets will be recovered from future taxable income and, to the extent
the Company believes that recovery is not likely, a valuation allowance must be established. To the extent the Company establishes
a valuation allowance or increase or decrease this allowance in a period, the impact will be included in income tax expense in
the consolidated statement of operations.
The
Company accounts for income taxes under the provisions of Financial Accounting Standards Board (the “FASB”) Accounting
Standards Codification (“ASC”) 740, “Income Taxes”, or ASC 740. As of December 31, 2015, there were no
unrecognized tax benefits included in the consolidated balance sheet that would, if recognized, affect the effective tax rate.
The Company’s practice is to recognize interest and/or penalties related to income tax matters in income tax expense. The
Company had no accrual for interest or penalties in its consolidated balance sheets at December 31, 2015 and 2014, and has not
recognized interest and/or penalties in the consolidated statements of operations for the years ended December 31, 2015 and 2014.
The Company is subject to taxation in the United States, California, New Jersey, Texas and Pennsylvania. The Company’s tax
years since 2000 are subject to examination by the federal and state tax authorities due to the carryforward of unutilized net
operating losses.
Cash
and Cash Equivalents
Cash
equivalents include short-term, highly liquid investments with maturities of three months or less at the time of acquisition.
Concentrations
of Credit Risk
The
Company places its cash with financial institutions deemed by management to be of high credit quality. The Federal Deposit Insurance
Corporation (“FDIC”) provides basic deposit coverage with limits up to $250,000 per owner. At December 31, 2015, the
Company had approximately $2.1 million in cash deposits in excess of FDIC limits.
Accounts
Receivable
Accounts
receivable are stated net of allowances for doubtful accounts and contractual adjustments. The accounts receivable balance primarily
includes amounts due from customers the Company has invoiced or from third-party providers (e.g., insurance companies and governmental
agencies), but for which payment has not been received. Charges to bad debt are based on both historical write-offs and specifically
identified receivables. Contractual adjustments are determined by the amount expected to be collected from third-party providers.
Accounts receivable are presented net of allowances for doubtful accounts and contractual adjustments in the amount of $180 and
$4 as of December 31, 2015 and 2014, respectively.
Inventories
Inventories
are stated at the lower of cost or market. Cost is determined on a first-in, first-out basis. The Company evaluates the carrying
value of inventories on a regular basis, based on the price expected to be obtained for products in their respective markets compared
with historical cost. Write-downs of inventories are considered to be permanent reductions in the cost basis of inventories.
The
Company also regularly evaluates its inventories for excess quantities and obsolescence (expiration), taking into account such
factors as historical and anticipated future sales or use in production compared to quantities on hand and the remaining shelf
life of products and active pharmaceutical ingredients on hand. The Company establishes reserves for excess and obsolete inventories
as required based on its analyses.
Furniture
and Equipment
Furniture
and equipment is stated at cost less accumulated depreciation and amortization. Depreciation and amortization is calculated using
the straight-line method over the estimated useful life of the asset. Leasehold improvements and capital lease equipment are amortized
over the estimated useful life or remaining lease term, whichever is shorter. Computer software and hardware and furniture and
equipment are depreciated over three to five years.
Business
Combinations
The
Company accounts for business combinations by recognizing the assets acquired, liabilities assumed, contractual contingencies,
and contingent consideration at their fair values on the acquisition date. The purchase price allocation process requires management
to make significant estimates and assumptions, especially with respect to intangible assets, estimated contingent consideration
payments and pre-acquisition contingencies. Examples of critical estimates in valuing certain of the intangible assets the Company
has acquired or may acquire in the future include but are not limited to:
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●
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future
expected cash flows from product sales, support agreements, consulting contracts, other customer contracts, and acquired developed
technologies and patents; and
|
|
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●
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discount
rates utilized in valuation estimates.
|
Unanticipated
events and circumstances may occur that may affect the accuracy or validity of such assumptions, estimates or actual results.
Additionally, any change in the fair value of the acquisition-related contingent consideration subsequent to the acquisition date,
including changes from events after the acquisition date, such as changes in our estimates of relevant revenue or other targets,
will be recognized in earnings in the period of the estimated fair value change. A change in fair value of the acquisition-related
contingent consideration or the occurrence of events that cause results to differ from our estimates or assumptions could have
a material effect on the consolidated financial position, statements of operations or cash flows in the period of the change in
the estimate.
Goodwill
and Intangible Assets
Patents
and trademarks are recorded at cost and capitalized at a time when the future economic benefits of such patents and trademarks
become more certain. At that time, the Company capitalizes third party legal costs and filing fees associated with obtaining and
prosecuting claims related to its patents and trademarks. Once the patents have been issued, the Company amortizes these costs
over the shorter of the legal life of the patent or its estimated economic life, generally 20 years, using the straight-line method.
Trademarks are an indefinite life intangible asset and are assessed for impairment based on future projected cash flows as further
described below.
The
Company reviews its goodwill and indefinite-lived intangible assets for impairment as of January 1 of each year and when an event
or a change in circumstances indicates the fair value of a reporting unit may be below its carrying amount. Events or changes
in circumstances considered as impairment indicators include but are not limited to the following:
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●
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significant
underperformance of the Company’s business relative to expected operating results;
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●
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significant
adverse economic and industry trends;
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●
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significant
decline in the Company’s market capitalization for an extended period of time relative to net book value; and
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expectations
that a reporting unit will be sold or otherwise disposed.
|
The
goodwill impairment test consists of a two-step process as follows:
Step
1. The Company compares the fair value of each reporting unit to its carrying amount, including the existing goodwill. The fair
value of each reporting unit is determined using a discounted cash flow valuation analysis. The carrying amount of each reporting
unit is determined by specifically identifying and allocating the assets and liabilities to each reporting unit based on headcount,
relative revenues or other methods as deemed appropriate by management. If the carrying amount of a reporting unit exceeds its
fair value, an indication exists that the reporting unit’s goodwill may be impaired and the Company then performs the second
step of the impairment test. If the fair value of a reporting unit exceeds its carrying amount, no further analysis is required.
Step
2. If further analysis is required, the Company compares the implied fair value of the reporting unit’s goodwill, determined
by allocating the reporting unit’s fair value to all of its assets and its liabilities in a manner similar to a purchase
price allocation, to its carrying amount. If the carrying amount of the reporting unit’s goodwill exceeds its fair value,
an impairment loss will be recognized in an amount equal to the excess.
Impairment
of Long-Lived Assets
Long-lived
assets, such as furniture and equipment, purchased intangibles subject to amortization and patents and trademarks, are reviewed
for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable.
Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to estimated undiscounted
future cash flows expected to be generated by the asset. If the carrying amount of an asset exceeds its estimated future cash
flows, an impairment charge is recognized in the amount by which the carrying amount of the asset exceeds the fair value of the
asset. Assets to be disposed of would be separately presented in the consolidated balance sheet and reported at the lower of the
carrying amount or fair value less costs to sell, and are no longer depreciated. The assets and liabilities of a disposal group
classified as held-for-sale would be presented separately in the appropriate asset and liability sections of the consolidated
balance sheet, if material.
During
the years ended December 31, 2015 and 2014, the Company did not recognize any impairment of its long-lived assets.
Third
Party Billing and Collection Agreements
In
connection with its acquisition of Park, the Company entered into a billing and collection agreement with a third party to assist
in the billing and collection of workers’ compensation claims. Under the terms of the agreement, the Company is obligated
to pay a fixed fee to the third party equal to 55% of the amounts billed and collected under the workers’ compensation claims.
The Company accrues for such fees in accounts payable and accrued expenses in the accompanying consolidated balance sheet. Total
billing and collection management expense under this agreement for the year ended December 31, 2015 was $142, and is included
in selling and marketing expenses in the accompanying consolidated statement of operations. The amount due under the agreement
as of December 31, 2015 was $81.
Deferred
Rent
The Company accounts for rent expense related to
its
operating leases by determining total minimum rent payments on the leases over their respective periods and recognizing the rent
expense on a straight-line basis. The difference between the actual amount paid and the amount recorded as rent expense in each
fiscal year and interim periods within each fiscal year is recorded as an adjustment to deferred rent and is included in accounts
payable and accrued expenses.
Debt
Issuance Costs and Debt Discount
Debt issuance costs and the debt discount
are recorded net of note payable in the consolidated balance sheet. Amortization expense of debt issuance costs and the debt discount
is calculated using the effective interest method over the term of the debt and is recorded in interest expense in the accompanying
consolidated statement of operations.
Fair
Value Measurements
Fair
value measurements are determined based on the assumptions that market participants would use in pricing an asset or liability.
GAAP establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes
the use of unobservable inputs by requiring that the most observable inputs be used when available. The established fair value
hierarchy prioritizes the use of inputs used in valuation methodologies into the following three levels:
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Level
1: Applies to assets or liabilities for which there are quoted prices (unadjusted) for identical assets or liabilities in
active markets. A quoted price in an active market provides the most reliable evidence of fair value and must be used to measure
fair value whenever available.
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Level
2: Applies to assets or liabilities for which there are significant other observable inputs other than Level 1 prices, such
as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are
observable or can be corroborated by observable market data.
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Level
3: Applies to assets or liabilities for which there are significant unobservable inputs that reflect a reporting entity’s
own assumptions about the assumptions that market participants would use in pricing an asset or liability. For example, Level
3 inputs would relate to forecasts of future earnings and cash flows used in a discounted future cash flows method.
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At
December 31, 2015 and 2014, the Company did not have any financial assets or liabilities that are measured on a recurring basis.
The Company’s financial instruments includes cash and cash equivalents, restricted short-term investments, accounts receivable,
accounts payable and accrued expenses, accrued payroll and related liabilities, deferred revenue and customer deposits, contingent
acquisition obligations, deferred acquisition obligations, note payable and capital leases. The carrying amount of these financial
instruments, except for deferred acquisition obligations, note payable, and the capital leases, approximates fair value due to
the short-term maturities of these instruments. The Company’s restricted short-term investments are carried at amortized
cost, which approximates fair value. Based on borrowing rates currently available to the Company, the carrying values of the deferred
acquisition obligations, note payable, and capital leases approximate their respective fair values.
Stock-Based
Compensation
All
stock-based payments to employees, directors and consultants, including grants of stock options, warrants, restricted stock units
(“RSUs”) and restricted stock, are recognized in the consolidated financial statements based upon their estimated
fair values. The Company uses the Black-Scholes-Merton option pricing model and Monte Carlo Simulation to estimate the fair value
of stock-based awards. The estimated fair value is determined at the date of grant. The financial statement effect of forfeitures
is estimated at the time of grant and revised, if necessary, if the actual effect differs from those estimates.
The
Company’s accounting policy for equity instruments issued to consultants and vendors in exchange for goods and services
follows FASB guidance. As such, the value of the applicable stock-based compensation is periodically remeasured and income or
expense is recognized during the vesting terms of the equity instruments. The measurement date for the estimated fair value of
the equity instruments issued is the earlier of (i) the date at which a commitment for performance by the consultant or vendor
is reached or (ii) the date at which the consultant or vendor’s performance is complete. In the case of equity instruments
issued to consultants, the estimated fair value of the equity instrument is primarily recognized over the term of the consulting
agreement. According to FASB guidance, an asset acquired in exchange for the issuance of fully vested, nonforfeitable equity instruments
should not be presented or classified as an offset to equity on the grantor’s balance sheet once the equity instrument is
granted for accounting purposes. Accordingly, the Company records the estimated fair value of nonforfeitable equity instruments
issued for future consulting services as prepaid stock-based consulting expenses in its consolidated balance sheets.
Basic
and Diluted Net Loss per Common Share
Basic
net loss per common share is computed by dividing net loss attributable to common stockholders for the period by the weighted
average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing the net loss
attributable to common stockholders for the period by the weighted average number of common and common equivalent shares, such
as stock options and warrants, outstanding during the period.
Basic
and diluted net loss per share is computed using the weighted average number of shares of common stock outstanding during the
period. Common stock equivalents (using the treasury stock or “if converted” method) from deferred acquisition obligations,
stock options, unvested RSUs and warrants were 3,313,169 and 3,024,217 at December 31, 2015 and 2014, respectively, and are excluded
from the calculation of diluted net loss per share for all periods presented because the effect is anti-dilutive. Included in
the basic and diluted net loss per share calculation were RSUs awarded to directors that had vested, but the issuance and delivery
of the shares are deferred until the director resigns. The number of shares underlying these vested RSUs at December 31, 2015
and 2014 was 55,824 and 27,218, respectively,
The
following table shows the computation of basic and diluted net loss per share of common stock for the years ended December 31,
2015 and 2014:
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For the
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For the
|
|
|
|
Year Ended
|
|
|
Year Ended
|
|
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|
December
31, 2015
|
|
|
December
31, 2014
|
|
|
|
|
|
|
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Numerator
– net loss
|
|
$
|
(15,899
|
)
|
|
$
|
(10,118
|
)
|
Denominator – weighted average
number
of shares outstanding, basic and diluted
|
|
|
9,576,142
|
|
|
|
9,132,989
|
|
Net
loss per share, basic and diluted
|
|
$
|
(1.66
|
)
|
|
$
|
(1.11
|
)
|
Recently
Adopted Accounting Pronouncements
In
April 2015, the FASB issued Accounting Standard Update (“ASU”) 2015-03
Simplifying the Presentation of Debt Issuance
Costs
. This update requires capitalized debt issuance costs to be classified as a reduction to the carrying value of debt
rather than a deferred charge, as is currently required. This update will be effective for the Company for all annual and interim
periods beginning after December 15, 2015 and is required to be adopted retroactively for all periods presented, and early adoption
is permitted. The Company has elected early adoption of this policy for the periods presented, and the Company is currently presenting
debt issuance costs as a reduction in the carrying value of the note payable in accordance with this ASU.
In
November 2015, the FASB issued ASU 2015-17,
Income Taxes: Balance Sheet Classification of Deferred Taxes
, an update to
accounting guidance to simplify the presentation of deferred income taxes. The guidance requires an entity to classify all deferred
tax liabilities and assets, along with any valuation allowance, as noncurrent in the balance sheet. The guidance is effective
for public companies with annual reporting periods beginning after December 15, 2016, including interim periods within these reporting
periods. Early adoption is permitted. The Company has elected to early adopt ASU 2015-17 during the year ended December 31, 2015
with retrospective application. The adoption of ASU 2015-17 did not have a material impact on the Company’s consolidated financial
statements.
Recently
Issued Accounting Pronouncements
In February 2016, the FASB issued ASU 2016-02,
Leases
, which requires the lease rights and obligations arising from lease
contracts, including existing and new arrangements, to be recognized as assets and liabilities on the balance sheet. ASU 2016-02
is effective for reporting periods beginning after December 15, 2018 with early adoption permitted. While the Company is still
evaluating ASU 2016-02, the Company expects the adoption of ASU 2016-02 to have a material effect on the Company’s consolidated
financial condition due to the recognition of the lease rights and obligations as assets and liabilities. The Company does not
expect ASU 2016-02 to have a material effect on the Company’s results of operations and cash flows.
In
January 2016, the FASB issued ASU 2016-01,
Financial Instruments: Recognition and Measurement of Financial Assets and Financial
Liabilities
, which addresses certain aspects of recognition, measurement, presentation and disclosure of financial statements.
This guidance will be effective in the first quarter of fiscal year 2019 and early adoption is not permitted. The Company is currently
evaluating the impact that this guidance will have on its consolidated financial statements.
In
September 2015, the FASB issued ASU 2015-16,
Simplifying the Accounting for Measurement-Period Adjustments,
which eliminates
the requirement to retrospectively adjust the financial statements for measurement-period adjustments that occur in periods after
a business combination is consummated. Measurement period adjustments are calculated as if they were known at the acquisition
date, but are recognized in the reporting period in which they are determined. Additional disclosures are required about the impact
on current-period income statement line items of adjustments that would have been recognized in prior periods if prior-period
information had been revised. The guidance is effective for annual periods beginning after December 15, 2015 and is to be applied
prospectively to adjustments of provisional amounts that occur after the effective date. Early application is permitted. The Company
is evaluating the impact of adoption of this guidance on its financial position and results of operations.
In
July 2015, the FASB issued ASU 2015-11,
Simplifying the Measurement of Inventory,
which requires entities to measure most
inventory “at the lower of cost and net realizable value (“NRV”),” thereby simplifying the current guidance
under which an entity must measure inventory at the lower of cost or market. Under the new guidance, inventory is “measured
at the lower of cost and net realizable value,” which eliminates the need to determine replacement cost and evaluate whether
it is above the ceiling (NRV) or below the floor (NRV less a normal profit margin). The guidance defines NRV as the “estimated
selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.”
The guidance is effective for annual periods beginning after December 15, 2016, and interim periods therein. Early application
is permitted. The Company is evaluating the impact of adoption of this guidance on its financial position and results of operations.
In
August 2014, the FASB issued new accounting guidance which defines management’s responsibility to assess an entity’s
ability to continue as a going concern, and to provide related footnote disclosures in certain circumstances. This guidance will
be effective for annual periods ending after December 15, 2016 and interim periods within annual periods beginning after
December 15, 2016. Early adoption is permitted for annual or interim reporting periods for which the financial statements
have not previously been issued. The Company is currently evaluating the new guidance and has not determined the impact this standard
may have on its consolidated financial statements.
In
May 2014, the FASB issued ASU 2014-09,
Revenue from Contracts with Customers.
This updated guidance supersedes the current
revenue recognition guidance, including industry-specific guidance. The updated guidance introduces a five-step model to achieve
its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that
reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The updated guidance
is effective for interim and annual periods beginning after December 15, 2016, and early adoption is not permitted. In July 2015,
the FASB decided to delay the effective date of ASU 2014-09 until December 15, 2017. The FASB also agreed to allow entities to
choose to adopt the standard as of the original effective date. The Company is currently evaluating which transition method it
will adopt and the expected impact of the updated guidance, but does not believe the adoption of the updated guidance will have
a significant impact on its consolidated financial statements.
NOTE
3. ACQUISITIONS
Acquisition
of Pharmacy Creations
On
April 1, 2014, the Company acquired all of the outstanding membership interests of PC (the “PC Acquisition”) from
J. Scott Karolchyk and Bernard Covalesky (the “PC Sellers”), such that PC became a wholly-owned subsidiary of the
Company. The acquisition of PC permits the Company to make and distribute its patent-pending proprietary drug formulations and
other pharmaceutical preparations through PC.
The
transaction has been accounted for as a business combination and the financial results of PC have been included in the Company’s
consolidated financial statements for the period subsequent to its acquisition.
The
estimated acquisition date fair value of consideration transferred, assets acquired and liabilities assumed for PC are presented
below and represent the Company’s best estimates.
Fair
Value of Consideration Transferred
At
the closing of the PC Acquisition, the Company paid to the PC Sellers an aggregate cash purchase price of $600. In addition, the
PC Sellers were entitled to receive additional contingent consideration upon the satisfaction of certain conditions, as follows:
●
|
A
contingent cash payment of $50, payable if PC earns revenues of over $3,500 for the 12 month period ended March 31, 2015 which
was forfeited as the milestone was not met; and
|
|
|
●
|
A
contingent stock payment of up to an aggregate of 215,190 shares of the Company’s common stock, issuable only if the
following revenue milestones are met:
|
|
●
|
if
PC earns revenue of over $7,500 during the 12 month period ending March 31, 2016, all 215,190 shares; and
|
|
|
|
|
●
|
if
PC earns revenue of between $3,500 and $7,500 during the 12 month period ending March 31, 2016, an aggregate of that number
of shares of Imprimis common stock equal to the amount that such revenue exceeds $3,500 divided by 18.5882, rounded down to
the lower whole number (not to exceed 215,190 shares).
|
Although
management estimates that certain of the contingent consideration will be paid, it has applied a discount rate to the contingent
consideration amounts in determining fair value to represent the risk of these payments not being made. The total acquisition
date fair value of the consideration transferred and to be transferred is estimated at approximately $1,114, as follows:
Cash payment to the PC Sellers
at closing
|
|
$
|
600
|
|
Contingent common stock issuance to
the PC Sellers
|
|
|
483
|
|
Contingent cash
consideration to the PC Sellers
|
|
|
31
|
|
Total acquisition
date fair value
|
|
$
|
1,114
|
|
A $514 liability was recognized for the estimated acquisition date fair value of the future contingent common
stock and cash payments. During the year ended December 31, 2015, the Company decreased the contingent liability amount related
to the cash payment and recognized a gain in other income of $31 due to the revenue milestone not being met. Contingent acquisition
obligations related to the PC Acquisition were $483 and $514 at December 31, 2015 and 2014, respectively.
Allocation
of Consideration Transferred
The
identifiable assets acquired and liabilities assumed were recognized and measured as of the acquisition date based on their estimated
fair values as of April 1, 2014, the acquisition date. The excess of the acquisition date fair value of consideration transferred
over the estimated fair value of the net tangible assets and intangible assets acquired was recorded as goodwill.
The
following table summarizes the estimated fair values of the assets acquired and liabilities assumed at the acquisition date.
Cash and cash equivalents
|
|
$
|
5
|
|
Accounts receivable
|
|
|
58
|
|
Prepaid expenses and other assets
|
|
|
30
|
|
Inventory
|
|
|
213
|
|
Property and equipment
|
|
|
45
|
|
Intangible assets
|
|
|
659
|
|
Total identifiable
assets acquired
|
|
|
1,010
|
|
Accounts payable and accrued liabilities
|
|
|
120
|
|
Other liabilities
|
|
|
107
|
|
Total
liabilities assumed
|
|
|
227
|
|
Total identifiable
assets less liabilities assumed
|
|
|
783
|
|
Goodwill
|
|
|
331
|
|
|
|
|
|
|
Net
assets acquired
|
|
$
|
1,114
|
|
Results
of Operations
The
amount of revenues and operating loss of PC included in the Company’s consolidated statement of operations from the acquisition
date through the period ended December 31, 2014 are as follows:
Total
revenues
|
|
$
|
1,652
|
|
Operating loss
|
|
$
|
(663
|
)
|
Intangible
Assets
Management
engaged a third-party valuation firm to assist in the determination of the fair value of the acquired intangible assets of PC.
In determining the fair value of the intangible assets, the Company considered, among other factors, the best use of acquired
assets, analyses of historical financial performance of PC and estimates of future performance of PC. The fair values of the identified
intangible assets related to PC’s customer relationships, trade name, non-competition covenant, and state pharmacy licenses.
The fair value of customer relationships and the non-competition covenant were calculated using the income approach. The fair
value of the trade name and state pharmacy licenses were calculated using the cost approach. The following table sets forth the
components of identified intangible assets associated with the PC Acquisition and their estimated useful lives.
|
|
Fair
Value
|
|
|
Useful
Life
|
Customer relationships
|
|
$
|
596
|
|
|
10 - 15 years
|
Trade name
|
|
|
5
|
|
|
5 years
|
Non-competition covenant
|
|
|
50
|
|
|
4 years
|
State pharmacy
licenses
|
|
|
8
|
|
|
25 years
|
|
|
$
|
659
|
|
|
|
The
Company determined the useful lives of intangible assets based on the expected future cash flows and contractual lives associated
with the respective asset. Trade name represents the fair value of the brand and name recognition associated with the marketing
of PC’s formulations and services. Customer relationships represent the expected benefit from customer contracts that, at
the date of acquisition, were reasonably anticipated to continue given the history and operating practices of PC. The non-competition
covenant represents the contractual period and expected degree of adverse economic impact that would exist in its absence. Licenses
represent eight state pharmacy licenses PC held at the date of acquisition.
Goodwill
Of
the total estimated purchase price, $331 was allocated to goodwill and is attributable to expected synergies between the combined
companies, including access for the Company to fulfill prescriptions with its patent-pending proprietary drug formulations through
PC’s market channels and assembled workforce. Goodwill represents the excess of the purchase price of the acquired business
over the estimated fair value of the underlying net tangible and intangible assets acquired. Goodwill resulting from the PC Acquisition
will be tested for impairment at least annually and more frequently if certain indicators of impairment are present. In the event
the Company determines that the value of goodwill has become impaired, it will incur an accounting charge for the amount of the
impairment during the fiscal quarter in which the determination is made. None of the goodwill is expected to be deductible for
income tax purposes.
Acquisition
of Park
On
January 1, 2015, the Company acquired all of the outstanding capital stock of Park (the “Park Acquisition”) from its
previous owners (the “Sellers”), such that Park became a wholly owned subsidiary of the Company. The acquisition of
Park permits the Company to make and distribute its patent-pending proprietary drug formulations and other novel pharmaceutical
solutions through Park and introduces the Company to new geographic and compounded formulation markets.
The
transaction has been accounted for as a business combination and the financial results of Park have been included in the Company’s
consolidated financial statements for the period subsequent to the acquisition.
The
estimated acquisition date fair value of consideration transferred, assets acquired and liabilities assumed for Park are presented
below and represent the Company’s best estimates.
Fair
Value of Consideration Transferred
At
the closing of the Park Acquisition, the Company paid to the Sellers an aggregate cash purchase price of $3,000, net of fees and
expenses, and a $100 payment for cash remaining in a Park bank account, and the Company issued to the Sellers 63,525 shares of
the Company’s restricted common stock, valued at $500 based on the average closing price of the Company’s common stock
for the 10 trading days preceding the closing. In addition, the Company is obligated to make 12 quarterly cash payments to the
Sellers collectively of $53 each over the three years following the closing of the Park Acquisition, totaling $638; provided that
the Sellers will have the option to receive the last six of such payments, totaling up to an aggregate of $319, in the form of
6,749 shares of the Company’s common stock for each such payment. The convertible features of the deferred consideration
provide for a rate of conversion that is at market value, and as a result no value was attributed to the conversion feature. The
Company also recorded a deferred tax liability of $1,047 related to the Park acquisition.
Management
applied a discount rate of 15% to the restricted common stock issued at the closing of the Park Acquisition due to a lack of marketability
of such shares as a result of certain restrictions on their transfer. The total acquisition date fair value of the consideration
transferred and to be transferred is estimated at approximately $5,163.
A
$591 liability was recognized for the estimated acquisition date fair value of the deferred consideration and is included in the
deferred acquisition obligations in the accompanying consolidated balance sheet at December 31, 2015.
The
total acquisition date fair value of consideration transferred and to be transferred is estimated as follows:
Cash payment to Sellers
at closing
|
|
$
|
3,100
|
|
Restricted common stock issuance to
Sellers at closing
|
|
|
425
|
|
Deferred tax liability
|
|
|
1,047
|
|
Deferred consideration
to Sellers
|
|
|
591
|
|
Total acquisition
date fair value
|
|
$
|
5,163
|
|
Allocation
of Consideration Transferred
The
identifiable assets acquired and liabilities assumed were recognized and measured as of the acquisition date based on their estimated
fair values as of January 1, 2015, the acquisition date. The excess of the acquisition date fair value of consideration transferred
over the estimated fair value of the net tangible assets and intangible assets acquired was recorded as goodwill.
The
following table summarizes the estimated fair values of the assets acquired and liabilities assumed at the acquisition date.
Cash and cash equivalents
|
|
$
|
95
|
|
Accounts receivable
|
|
|
399
|
|
Inventories
|
|
|
232
|
|
Furniture and equipment
|
|
|
252
|
|
Intangible assets
|
|
|
2,629
|
|
Total identifiable
assets acquired
|
|
|
3,607
|
|
Accounts payable and accrued expenses
|
|
|
304
|
|
Other liabilities
|
|
|
35
|
|
Total
liabilities assumed
|
|
|
339
|
|
Total identifiable
assets less liabilities assumed
|
|
|
3,268
|
|
Goodwill
|
|
|
1,895
|
|
Net
assets acquired
|
|
$
|
5,163
|
|
During
the year ended December 31, 2015 the discount rate of the common stock issued at the time of the Park Acquisition was adjusted
from 25% to 15% which resulted in an increase of $46 and $4 in goodwill and intangible assets, respectively, compared to the initial
allocation of the purchase price. The final allocation was based on estimates and appraisals that was based on the Company’s
final evaluation of Park’s assets and liabilities, including both tangible and intangible assets.
Results
of Operations
The
amount of revenues and net income of Park included in the Company’s consolidated statement of operations from the acquisition
date through the period ended December 31, 2015 are as follows:
Total
revenues
|
|
$
|
6,134
|
|
Net income
|
|
$
|
1,088
|
|
Intangible
Assets
Management
engaged a third-party valuation firm to assist in the determination of the fair value of the acquired intangible assets of Park.
In determining the fair value of the intangible assets, the Company considered, among other factors, the best use of the acquired
assets, analyses of historical financial performance of Park and estimates of future performance of Park. The fair values of the
identified intangible assets related to Park’s customer relationships, trade name, non-competition clause, and state pharmacy
licenses. Customer relationships and the non-competition clause were calculated using the income approach. Trade name and state
pharmacy licenses were calculated using the cost approach. The following table sets forth the components of identified intangible
assets associated with the Park Acquisition and their estimated useful lives.
|
|
Fair
Value
|
|
|
Useful
Life
|
Customer relationships
|
|
$
|
2,387
|
|
|
3 - 15 years
|
Trade name
|
|
|
10
|
|
|
5 years
|
Non-competition clause
|
|
|
224
|
|
|
3 years
|
State pharmacy
licenses
|
|
|
8
|
|
|
25 years
|
|
|
$
|
2,629
|
|
|
|
The
Company determined the useful lives of intangible assets based on the expected future cash flows and contractual life associated
with the respective assets. Trade name represents the fair value of the brand and name recognition associated with the marketing
of Park’s formulations and services. Customer relationships represent the expected future benefit from contracts and relationships
which, at the date of acquisition, were reasonably anticipated to continue given the history and operating practices of Park.
The non-competition clause represents the contractual period and expected degree of adverse economic impact that would exist in
its absence. Licenses represent twelve state pharmacy licenses Park held at the date of acquisition.
Goodwill
Of
the total estimated purchase price for the Park Acquisition, $1,895 was allocated to goodwill and is attributable to expected
synergies between the combined companies, including access for the Company to fulfill prescriptions with its patent-pending proprietary
drug formulations through Park’s market channels and assembled workforce. Goodwill represents the excess of the purchase
price of the acquired business over the fair value of the underlying net tangible and intangible assets acquired. Goodwill resulting
from the business will be tested for impairment at least annually and more frequently if certain indicators are present. In the
event the Company determines that the value of goodwill has become impaired, it will incur an accounting charge for the amount
of the impairment during the fiscal quarter in which the determination is made. None of the goodwill is expected to be deductible
for income tax purposes.
Other
2015 Acquisitions
During 2015, the Company acquired CAP and purchased the assets of TOHC, primarily to expand its compounding
pharmacy infrastructure and offerings. These acquisitions were not individually significant. The Company has included the financial
results of the CAP acquisition in its consolidated financial statements from its acquisition date, August 4, 2015, and the results
from this company were not individually material to the Company’s consolidated financial statements. The preliminary purchase
price for these acquisitions totaled, collectively, approximately $945, which was paid entirely in cash. The Company has preliminarily
recorded $641 of net tangible assets and $65 of identifiable intangible assets, based on their estimated fair values, and $239
of residual goodwill.
The
initial purchase price calculation and related accounting for these acquisitions are preliminary. The preliminary fair value estimates
for the assets acquired and liabilities assumed for these acquisitions were based upon preliminary calculations and valuations,
and estimates and assumptions for these acquisitions are subject to change as the Company obtains additional information during
the respective measurement periods (up to one year from the applicable acquisition date). The primary areas of these preliminary
estimates that are not yet finalized relate to certain tangible assets and liabilities acquired and identifiable intangible assets.
Pro
Forma Financial Information
The
following table presents the Company’s unaudited pro forma results (including CAP, Park and PC) for the year ended December
31, 2014, as though the companies had been combined as of January 1, 2014. The acquisition of CAP was not individually significant
and the 2015 results from this company were not individually material to our consolidated financial statements. The pro forma
information is presented for informational purposes only and is not indicative of the results of operations that would have been
achieved if the acquisitions had taken place at the beginning of each period presented, nor is it indicative of results of operations
which may occur in the future. The unaudited pro forma results presented include amortization charges for intangible assets, interest
charges, acquisition costs, and eliminations of intercompany transactions.
|
|
For the
|
|
|
|
Year Ended
|
|
|
|
December
31, 2014
|
|
Total
revenues
|
|
$
|
7,847
|
|
Net loss
|
|
$
|
(9,850
|
)
|
The
Company incurred approximately $201 in acquisition expenses related to the Park Acquisition, $135 in expenses related to the acquisition
of the assets of TOHC and did not incur material acquisition expenses related to the PC Acquisition and the acquisition of CAP.
NOTE
4. RESTRICTED SHORT-TERM INVESTMENTS
The
restricted short-term investments at December 31, 2015 consist of certificates of deposit, which are classified as held-to-maturity.
At December 31, 2015 and 2014, the restricted short-term investments were recorded at amortized cost which approximates fair value.
At
December 31, 2015 and 2014, the certificates of deposit of $150 were classified as a current asset. The certificates of deposit
are required as collateral under the Company’s corporate credit card agreement and additional security for the Company’s
office space lease and they automatically renew every twelve months.
NOTE
5. INVENTORIES
Inventories
are comprised of over-the-counter and prescription retail pharmacy products, commercial pharmaceutical products, related laboratory
supplies and active pharmaceutical ingredients. The composition of inventories as of December 31, 2015 and 2014 was as follows:
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
Raw materials
|
|
$
|
775
|
|
|
$
|
146
|
|
Work in progress
|
|
|
-
|
|
|
|
98
|
|
Finished goods
|
|
|
637
|
|
|
|
129
|
|
Total inventories
|
|
$
|
1,412
|
|
|
$
|
373
|
|
NOTE
6. PREPAID EXPENSES AND OTHER CURRENT ASSETS
Prepaid
expenses and other current assets at December 31, 2015 and 2014 consisted of the following:
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
Prepaid
insurance
|
|
$
|
297
|
|
|
$
|
124
|
|
Other prepaid expenses
|
|
|
370
|
|
|
|
82
|
|
Deposits and other
current assets
|
|
|
119
|
|
|
|
35
|
|
Total prepaid expenses
and other current assets
|
|
$
|
786
|
|
|
$
|
241
|
|
NOTE
7. FURNITURE AND EQUIPMENT
Furniture
and equipment at December 31, 2015 and 2014 consisted of the following:
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
Furniture and equipment,
net:
|
|
|
|
|
|
|
|
|
Computer
software and hardware
|
|
$
|
323
|
|
|
$
|
53
|
|
Furniture
and equipment
|
|
|
350
|
|
|
|
153
|
|
Lab
and pharmacy equipment
|
|
|
538
|
|
|
|
62
|
|
Leasehold
improvements
|
|
|
1,746
|
|
|
|
20
|
|
|
|
|
2,957
|
|
|
|
288
|
|
Accumulated
depreciation and amortization
|
|
|
(300
|
)
|
|
|
(45
|
)
|
|
|
$
|
2,657
|
|
|
$
|
243
|
|
The
Company recorded depreciation and amortization expense of $255 and $37 during the years ended December 31, 2015 and 2014, respectively.
NOTE
8. INTANGIBLE ASSETS AND GOODWILL
The
Company’s intangible assets at December 31, 2015 consisted of the following:
|
|
Amortization
|
|
|
|
|
|
|
|
|
|
|
|
periods
|
|
|
|
|
Accumulated
|
|
|
Net
|
|
|
|
(in
years)
|
|
Cost
|
|
|
amortization
|
|
|
Carrying
value
|
|
Patents
|
|
17-19
years
|
|
$
|
64
|
|
|
$
|
(1
|
)
|
|
$
|
63
|
|
Trademarks
|
|
Indefinite
|
|
|
121
|
|
|
|
-
|
|
|
|
121
|
|
Customer relationships
|
|
3-15 years
|
|
|
2,998
|
|
|
|
(297
|
)
|
|
|
2,701
|
|
Trade name
|
|
5 years
|
|
|
16
|
|
|
|
(4
|
)
|
|
|
12
|
|
Non-competition clause
|
|
3-4 years
|
|
|
294
|
|
|
|
(99
|
)
|
|
|
195
|
|
State
pharmacy licenses
|
|
25
years
|
|
|
45
|
|
|
|
(2
|
)
|
|
|
43
|
|
|
|
|
|
$
|
3,538
|
|
|
$
|
(403
|
)
|
|
$
|
3,135
|
|
The
Company’s intangible assets at December 31, 2014 consisted of the following:
|
|
Amortization
|
|
|
|
|
|
|
|
|
|
|
|
periods
|
|
|
|
|
Accumulated
|
|
|
Net
|
|
|
|
(in
years)
|
|
Cost
|
|
|
amortization
|
|
|
Carrying
value
|
|
Customer
relationships
|
|
10-15
years
|
|
$
|
596
|
|
|
$
|
(37
|
)
|
|
$
|
559
|
|
Trade name
|
|
5 years
|
|
|
5
|
|
|
|
(1
|
)
|
|
|
4
|
|
Non-competition clause
|
|
4 years
|
|
|
50
|
|
|
|
(9
|
)
|
|
|
41
|
|
State pharmacy licenses
|
|
25 years
|
|
|
8
|
|
|
|
(1
|
)
|
|
|
7
|
|
|
|
|
|
$
|
659
|
|
|
$
|
(48
|
)
|
|
$
|
611
|
|
Amortization
expense for intangible assets for the years ended December 31, 2015 and 2014 was as follows:
|
|
For the
|
|
|
For the
|
|
|
|
Year
Ended
|
|
|
Year
Ended
|
|
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
Patents
|
|
$
|
1
|
|
|
$
|
-
|
|
Customer relationships
|
|
|
260
|
|
|
|
37
|
|
Trade name
|
|
|
3
|
|
|
|
1
|
|
Non-competition clause
|
|
|
90
|
|
|
|
9
|
|
State pharmacy licenses
|
|
|
1
|
|
|
|
1
|
|
|
|
$
|
355
|
|
|
$
|
48
|
|
Estimated
future amortization expense for the Company’s intangible assets at December 31, 2015 is as follows:
Years
ending December 31,
|
|
|
|
2016
|
|
$
|
365
|
|
2017
|
|
|
365
|
|
2018
|
|
|
219
|
|
2019
|
|
|
208
|
|
2020
|
|
|
206
|
|
Thereafter
|
|
|
1,772
|
|
|
|
$
|
3,135
|
|
The
changes in the carrying value of the Company’s goodwill during the years ended December 31, 2015 and 2014 were as follows:
Balance at January 1, 2014
|
|
$-
|
|
Acquistion
of PC (see Note 3)
|
|
|
332
|
|
Balance at December 31, 2014
|
|
|
332
|
|
Acquisition
of Park (see Note 3)
|
|
|
1,895
|
|
Acquisition
of CAP (see Note 3)
|
|
|
239
|
|
Balance at December
31, 2015
|
|
$
|
2,466
|
|
NOTE
9. ACCOUNTS PAYABLE AND ACCRUED EXPENSES
Accounts
payable and accrued expenses at December 31, 2015 and 2014 consisted of the following:
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
Accounts
payable
|
|
$
|
3,185
|
|
|
$
|
699
|
|
Deferred rent
|
|
|
63
|
|
|
|
5
|
|
Accrued interest (see
Note 10)
|
|
|
90
|
|
|
|
-
|
|
Accrued exit fee for
note payable (see Note 10)
|
|
|
500
|
|
|
|
-
|
|
Building lease liability(1)
|
|
|
46
|
|
|
|
74
|
|
Other
accrued expenses (2)
|
|
|
23
|
|
|
|
39
|
|
Total accounts payable
and accrued expenses
|
|
|
3,907
|
|
|
|
817
|
|
Less:
Current portion
|
|
|
(3,407
|
)
|
|
|
(787
|
)
|
Non-current
total accrued expenses
|
|
$
|
500
|
|
|
$
|
30
|
|
|
(1)
|
In September 2014,
the Company relocated its corporate headquarters to a 7,565 square foot office facility in San Diego, California. In February
2015, the Company entered into an agreement to sublet 3,874 square feet of its previously occupied headquarters office space
through the remaining term of the lease for a monthly rent amount of $8. The Company recognized a loss of approximately $117
during the year ended December 31, 2014 related to the estimated remaining lease liability, net of expected sublease income,
of the previously occupied office space. The obligations were discounted based on current prevailing market rates.
|
|
|
|
|
(2)
|
The amount consists
of a $23 and $39 stock-based compensation accrual at December 31, 2015 and 2014 respectively, for stock options to be granted
for services performed. The stock-based compensation expense related to the accruals was $23 and $39 during the years ended
December 31, 2015 and 2014, respectively. The $39 was recorded to additional paid-in-capital upon issuance of the stock options
in 2015.
|
NOTE
10. DEBT
On
May 11, 2015, the Company entered into a loan and security agreement (the “Loan Agreement”) with IMMY Funding LLC,
(“LSAF”), an affiliate of Life Sciences Alternative Funding LLC, as lender and collateral agent. Pursuant to the terms
of the Loan Agreement, as amended subsequent to December 31, 2015 (see Note 16), LSAF made available to the Company a term loan
in the aggregate principal amount of up to $10,000, all of which was drawn on May 11, 2015. The term loan bears interest at a
fixed per-annum rate of 12.5% and allows for 2% of the interest to be paid-in-kind until either February 2017 or May 2017, such
date dependent upon the Company’s ability to meet certain revenue or cash balance measures. The Company is permitted to
pay interest only for the first three years and after the end of the interest-only period, the Company will be required to pay
interest, plus repayments of the principal amount of the term loan, in 36 equal monthly installments. The interest-only period
may be reduced to 20 months if the Company does not meet certain minimum revenue or cash balance requirements, in which case the
Company would be required to pay interest, plus repayments of the principal amount of the term loans, in 24 equal monthly installments.
All amounts owed under the Loan Agreement, including a final fee of 5% of the aggregate principal amount of the term loan, will
be due on the earlier of May 11, 2021, or 24 months after the end of the interest-only period. The Company incurred expenses of
approximately $735 in connection with the Loan Agreement. The final fee and expenses are being amortized as interest expense over
the term of the debt using the interest method and the related liability of $500 for the final fee is included in accrued expenses
(see Note 9) in the accompanying consolidated balance sheet.
Pursuant
to the terms of the Loan Agreement, the Company is bound by certain affirmative covenants setting forth actions that the Company
must take during the term of the Loan Agreement, including, among others, certain information delivery requirements, obligations
to maintain certain insurance and certain notice requirements. Additionally, the Company is bound by certain negative covenants
setting forth actions that the Company may not take during the term of the Loan Agreement without LSAF’s consent, including,
among others, disposing of certain of the Company’s or its subsidiaries’ business or property, incurring certain additional
indebtedness, entering into certain merger, acquisition or change of control transactions, paying certain dividends or distributions
on or repurchasing any of the Company’s capital stock, or incurring any lien or other encumbrance on the Company’s
or its subsidiaries’ assets, subject to certain permitted exceptions. Upon the occurrence of an event of default under the
Loan Agreement (subject to cure periods for certain events of default), all amounts owed by the Company thereunder may be declared
immediately due and payable by LSAF. Events of default include, among others, the following: the occurrence of certain bankruptcy
events; the failure to make payments under the Loan Agreement when due; the occurrence of a material adverse change in the business,
operations or condition of the Company or any of its subsidiaries; the breach by the Company or its subsidiaries of certain of
their material agreements with third parties; the initiation of certain regulatory enforcement actions against the Company or
its subsidiaries; the rendering of certain types of fines or judgments against the Company or its subsidiaries; any breach by
the Company or its subsidiaries of any covenant (subject to cure periods for certain covenants) made in the Loan Agreement; and
the failure of any representation or warranty made by the Company or its subsidiaries in connection with the Loan Agreement to
be correct in any material respect when made.
The
Company’s obligations under the Loan Agreement are guaranteed on a secured basis by its wholly owned subsidiaries. Each
of the Company and its subsidiaries has granted LSAF a security interest in substantially all of its personal property, rights
and assets, including intellectual property rights and equity ownership, to secure the payment of all amounts owed under the Loan
Agreement.
In
connection with the Loan Agreement, the Company issued to LSAF a warrant to purchase up to 125,000 shares of the Company’s
common stock, (the “Warrant”), which was exercisable immediately, had an exercise price of $7.85 per share upon issuance
and has a term of ten years. The relative fair value of the Warrant was approximately $840 and was estimated using the Black-Scholes-Merton
model with the following assumptions: fair value of the Company’s common stock at issuance of $7.97 per share; ten-year
contractual term; 109% volatility; 0% dividend rate; and a risk-free interest rate of 1.25%. The relative fair value of the Warrant
was recorded as a debt discount, decreasing notes payable and increasing additional paid-in capital on the accompanying consolidated
balance sheet. The debt discount is being amortized to interest expense over the term of the debt using the interest method. For
the year ended December 31, 2015, debt discount and issuance costs amortization was approximately $281.
Subsequent
to December 31, 2015, the Loan Agreement was amended as further described in Note 16.
Note
payable at December 31, 2015 were as follows:
|
|
December
31, 2015
|
|
LSAF 12.5%
note payable
|
|
$
|
10,000
|
|
Add: Interest paid-in-kind
|
|
|
130
|
|
Less: Discount on note
for issuance costs
|
|
|
|
|
and
relative fair value of warrants
|
|
|
(1,794
|
)
|
Less:
Current portion
|
|
|
-
|
|
Long-term
portion
|
|
$
|
8,336
|
|
Future
minimum payments under notes payable outstanding at December 31, 2015 are as follows:
Years
Ending December 31, 2015
|
|
Amount
|
|
2016
|
|
$
|
1,076
|
|
2017
|
|
|
1,214
|
|
2018
|
|
|
2,979
|
|
2019
|
|
|
4,183
|
|
2020
|
|
|
4,183
|
|
Thereafter
|
|
|
1,743
|
|
Total minimum payments
|
|
|
15,378
|
|
Less:
amount representing interest and interest paid-in-kind
|
|
|
5,378
|
|
Note payable, gross
|
|
|
10,000
|
|
Add: interest paid-in-kind
|
|
|
130
|
|
Less:
unamortized discount and issuance costs
|
|
|
(1,794
|
)
|
Note
payable and interest paid-in-kind, net of unamortized debt discount and issuance costs
|
|
$
|
8,336
|
|
NOTE
11. STOCKHOLDERS’ EQUITY (DEFICIT) AND STOCK-BASED COMPENSATION
Common
Stock
On
September 10, 2014, the Company decreased the number of authorized shares of its capital stock to 95,000,000.
At
December 31, 2015 and 2014, the Company had 90,000,000 shares of common stock, $0.001 par value, authorized.
Issuances
During the Year Ended December 31, 2014
In
April 2014, the Company issued 6,868 shares of restricted common stock, valued at $50, in connection with the resolution of a
contract dispute.
In
October 2014, the Company issued 4,000 shares of restricted common stock to a consultant, valued at $29 in consideration for consulting
services provided. The fair value of the shares of common stock issued was recorded as stock-based compensation during the year
ended December 31, 2014.
During
the year ended December 31, 2014, the Company issued a total of 227,216 shares of common stock as a result of stock option exercises.
Of these, the Company received net cash proceeds of $584 for the issuance of 160,777 shares of common stock upon the exercise
of stock options to purchase the same number of shares of common stock with exercise prices ranging from $3.68 to $4.00 per share
and the Company received no cash proceeds for the issuance of 66,439 shares of common stock upon the exercise pursuant to cashless
exercise provisions of stock options to purchase 146,652 shares of common stock with exercise prices ranging from $3.60 to $6.00
per share.
During
the year ended December 31, 2014, the Company issued 1,954 shares of common stock to employees related to the vesting of RSUs.
In connection with these common stock issuances, the Company withheld 1,518 shares of common stock for payroll tax withholdings
totaling $13.
During
the year ended December 31, 2014, the Company issued a total of 47,829 shares of common stock as a result of warrant exercises.
Of these, the Company received gross cash proceeds of $38 for the issuance of 6,391 shares of common stock upon the exercise of
warrants to purchase the same number of shares of common stock with an exercise price of $5.925 and the Company received no cash
proceeds for the issuance of 41,438 shares of common stock upon the exercise pursuant to cashless exercise provisions of warrants
to purchase 123,715 shares of common stock with an exercise price of $5.25 per share.
During
the year ended December 31, 2014, 27,218 shares of the Company’s common stock underlying RSUs issued to directors vested,
but the issuance and delivery of these shares are deferred until the respective director resigns.
Issuances
During the Year Ended December 31, 2015
During
the year ended December 31, 2015, the Company issued a total of 130,457 shares of common stock as a result of option exercises.
The Company received no cash proceeds for the issuance of the shares of common stock upon the exercise pursuant to cashless exercise
provisions of stock options to purchase 255,600 shares of common stock with exercise prices ranging from $3.20 to $4.51 per share.
During
the year ended December 31, 2015, the Company issued 1,611 shares of common stock to employees related to the vesting of RSUs,
net of 1,241 shares of common stock withheld for payroll tax withholdings totaling $10.
Additionally,
in January 2015, the Company issued 8,521 shares of its common stock in connection with RSUs that had been awarded to a non-employee
director and had vested, but were not issued and settled until the resignation of the director on January 1, 2015.
During
the year ended December 31, 2015, the Company issued a total of 220,912 shares of common stock as a result of warrant exercises.
Of these, the Company received cash proceeds of $1,248 for the issuance of 209,980 shares of common stock upon the exercise on
a cash basis of warrants to purchase the same number of shares of common stock with an exercise price of $5.925, and the Company
received no cash proceeds for the issuance of 10,932 shares of common stock upon the exercise pursuant to cashless exercise provisions
of warrants to purchase 30,457 shares of common stock with an exercise price of $5.25 per share.
In
November 2015, the Company entered into a Controlled Equity Offering
SM
sales agreement (the “Sales Agreement”)
with Cantor Fitzgerald & Co., as agent (“Cantor Fitzgerald”), pursuant to which the Company may offer and sell,
from time to time through Cantor Fitzgerald, shares of our common stock having an aggregate offering price as set forth in the
Sales Agreement and a related prospectus supplement filed with the Securities and Exchange Commission. The Company agreed to pay
Cantor Fitzgerald a cash commission of 3.0% of the aggregate gross proceeds from each sale of shares under the Sales Agreement
and to reimburse Cantor Fitzgerald for certain fees and expenses in an amount not to exceed $50. During the fourth quarter of
2015, 72,421 shares of common stock were sold under the Sales Agreement for gross proceeds of approximately $529 and net proceeds,
after deducting $16 in commission fees and $109 in offering expenses payable by the Company, of approximately $404. As of December
31, 2015, approximately $9,470 remained available for sale pursuant to this Sales Agreement, although such amount was subsequently
reduced in March 2016 (see Note 16).
In
January 2015, the Company issued 63,525 shares of restricted common stock, valued at $425, in connection with the Park Acquisition
(see Note 3).
During
the year ended December 31, 2015, 28,606 shares of the Company’s common stock underlying RSUs issued to directors vested,
but the issuance and delivery of these shares are deferred until the director resigns.
Preferred
Stock
At
December 31, 2015 and 2014, the Company had 5,000,000 shares of preferred stock, $0.001 par value, authorized and no shares of
preferred stock issued and outstanding.
Stock
Option Plan
On
September 17, 2007, the Company’s Board of Directors and stockholders adopted the Company’s 2007 Incentive Stock and
Awards Plan, which was subsequently amended on November 5, 2008, February 26, 2012, July 18, 2012, May 2, 2013 and September 27,
2013 (as amended, the “Plan”). As of December 31, 2015, the Plan provides for the issuance of a maximum of 5,000,000
shares of the Company’s common stock. The purpose of the Plan is to provide an incentive to attract and retain directors,
officers, consultants, advisors and employees whose services are considered valuable, to encourage a sense of proprietorship and
to stimulate an active interest of such persons in the Company’s development and financial success. Under the Plan, the
Company is authorized to issue incentive stock options intended to qualify under Section 422 of the Internal Revenue Code, non-qualified
stock options, RSUs and restricted stock. The Plan is administered by the Compensation Committee of the Company’s Board
of Directors. The Company had 1,353,379 shares available for future issuances under the Plan at December 31, 2015.
Stock
Options
A
summary of the stock option activity under the Plan for the year ended December 31, 2015 is as follows:
|
|
Number
of shares
|
|
|
Weighted
Avg. Exercise Price
|
|
|
Weighted
Avg. Remaining Contractual Life
|
|
|
Aggregate
Intrinsic Value
|
|
Options outstanding - January
1, 2015
|
|
|
1,029,240
|
|
|
$
|
5.74
|
|
|
|
|
|
|
|
|
|
Options granted
|
|
|
825,946
|
|
|
$
|
7.80
|
|
|
|
|
|
|
|
|
|
Options exercised
|
|
|
(255,600
|
)
|
|
$
|
3.86
|
|
|
|
|
|
|
|
|
|
Options
cancelled/forfeit
|
|
|
(55,560
|
)
|
|
$
|
9.21
|
|
|
|
|
|
|
|
|
|
Options outstanding
- December 31, 2015
|
|
|
1,544,026
|
|
|
$
|
7.03
|
|
|
|
5.81
|
|
|
$
|
1,216
|
|
Options
exercisable
|
|
|
653,558
|
|
|
$
|
6.22
|
|
|
|
5.71
|
|
|
$
|
1,073
|
|
Options
vested and expected to vest
|
|
|
1,454,979
|
|
|
$
|
6.99
|
|
|
|
5.81
|
|
|
$
|
1,202
|
|
The
aggregate intrinsic value in the table above represents the total pre-tax amount of the proceeds, net of exercise price, which
would have been received by option holders if all option holders had exercised and immediately sold all options with an exercise
price lower than the market price on December 31, 2015, based on the closing price of the Company’s common stock of $6.93
on that date. The aggregate intrinsic value of stock options exercised during the year ended December 31, 2015 was approximately
$1,023.
During
2015 and 2014, the Company granted stock options to certain employees, directors and consultants. The stock options were granted
with an exercise price equal to the current market price of the Company’s common stock, as reported by the securities exchange
on which the common stock was then listed, at the grant date and have contractual terms ranging from three to 10 years. Vesting
terms for options granted in 2015 and 2014 to employees, directors and consultants typically included one of the following vesting
schedules: 25% of the shares subject to the option vest and become exercisable on the first anniversary of the grant date and
the remaining 75% of the shares subject to the option vest and become exercisable quarterly in equal installments thereafter over
three years; quarterly vesting over three years; or 100% vesting associated with the provision or completion of services provided
under contracts with consultants. Certain option awards provide for accelerated vesting if there is a change in control (as defined
in the Plan) and in the event of certain modifications to the option award agreement.
The
fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model. The expected
volatility is based on the historical volatilities of the common stock of the Company and comparable publicly traded companies
based on the Company’s belief that it currently has limited relevant historical data regarding the volatility of its stock
price on which to base a meaningful estimate of expected volatility. The expected term of options granted was determined in accordance
with the “simplified approach,” as the Company has limited, relevant, historical data on employee exercises and post-vesting
employment termination behavior. The expected risk-free interest rate is based on the U.S. Treasury yield for a period consistent
with the expected term of the option in effect at the time of the grant. The financial statement effect of forfeitures is estimated
at the time of grant and revised, if necessary, if the actual effect differs from those estimates. For option grants to employees
and directors, the Company assigns a forfeiture factor of 10%. These factors could change in the future, which would affect the
determination of stock-based compensation expense in future periods. Utilizing these assumptions, the fair value is determined
at the date of grant.
On
July 31, 2015, the Company granted to its Chief Executive Officer, Mark Baum, an option (the “Baum
Performance Option”) to purchase 600,000 shares of the Company’s common stock at an exercise
price of $7.87 per share under the Plan subject to the satisfaction of certain market-based vesting criteria.
The market-based vesting criteria are separated into five tranches and require that the Company achieve
and maintain certain average stock price targets ranging from $9 per share to $15 per share during the
five year period following the grant date. These market-based vesting conditions are as follows:
Tranche
|
|
Number
of Shares
|
|
Target
Share Price
|
Tranche 1
|
|
200,000 shares
|
|
$9.00 or greater
|
Tranche 2
|
|
100,000 shares
|
|
$10.00 or greater
|
Tranche 3
|
|
100,000 shares
|
|
$12.00 or greater
|
Tranche 4
|
|
100,000 shares
|
|
$14.00 or greater
|
Tranche 5
|
|
100,000 shares
|
|
$15.00 or greater
|
The
Baum Performance Option terminates on the fifth anniversary of the grant date. The fair value of the Baum Performance Option was
$2,784 using a Monte Carlo Simulation with a five-year life, 80% volatility and a risk free interest rate of 1.54 %.
The
table below illustrates the fair value per share determined using the Black-Scholes-Merton option pricing model with the following
assumptions used for valuing options granted to employees and directors:
|
|
2015
|
|
|
2014
|
|
Weighted-average
fair value of options granted
|
|
$
|
6.22
|
|
|
$
|
5.22
|
|
Expected terms (in
years)
|
|
|
5.81 - 6.11
|
|
|
|
5.81 - 6.91
|
|
Expected volatility
|
|
|
101 - 121%
|
|
|
|
96 - 102%
|
|
Risk-free interest
rate
|
|
|
1.39 - 1.68%
|
|
|
|
1.37 - 1.65%
|
|
Dividend yield
|
|
|
-
|
|
|
|
-
|
|
The
table below illustrates the fair value per share determined using the Black-Scholes-Merton option pricing model with the following
assumptions used for valuing options granted to consultants:
|
|
2015
|
|
|
2014
|
|
Weighted-average
fair value of options granted
|
|
$
|
6.49
|
|
|
$
|
6.15
|
|
Expected terms (in
years)
|
|
|
10
|
|
|
|
2.5 - 10
|
|
Expected volatility
|
|
|
108 - 109%
|
|
|
|
78 - 97%
|
|
Risk-free interest
rate
|
|
|
1.06- 1.63%
|
|
|
|
0.10 - 1.68%
|
|
Dividend yield
|
|
|
-
|
|
|
|
-
|
|
The
following table summarizes information about stock options outstanding and exercisable at December 31, 2015:
|
|
|
Options Outstanding
|
|
|
Options Exercisable
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
Remaining
|
|
|
Average
|
|
|
|
|
|
Average
|
|
|
|
|
Number
|
|
|
Contractual
|
|
|
Exercise
|
|
|
Number
|
|
|
Exercise
|
|
Range of Exercise Prices
|
|
|
Outstanding
|
|
|
Life in Years
|
|
|
Price
|
|
|
Exercisable
|
|
|
Price
|
|
$2.40
|
|
|
|
125,000
|
|
|
|
6.07
|
|
|
$
|
2.40
|
|
|
|
125,000
|
|
|
$
|
2.40
|
|
$
3.68 - $4.50
|
|
|
|
207,123
|
|
|
|
4.06
|
|
|
$
|
4.27
|
|
|
|
165,252
|
|
|
$
|
4.31
|
|
$
5.49 - $7.99
|
|
|
|
958,316
|
|
|
|
6.02
|
|
|
$
|
7.55
|
|
|
|
159,222
|
|
|
$
|
6.66
|
|
$
8.06 - $8.99
|
|
|
|
248,557
|
|
|
|
6.32
|
|
|
$
|
8.90
|
|
|
|
199,054
|
|
|
$
|
8.93
|
|
$42.80
|
|
|
|
5,030
|
|
|
|
4.62
|
|
|
$
|
42.80
|
|
|
|
5,030
|
|
|
$
|
42.80
|
|
|
|
|
|
1,544,026
|
|
|
|
5.81
|
|
|
$
|
7.03
|
|
|
|
653,558
|
|
|
$
|
6.22
|
|
As
of December 31, 2015, there was approximately $3,649 of total unrecognized compensation expense related to unvested stock options
granted under the Plan. That expense is expected to be recognized over the weighted-average remaining vesting period of 3.8 years.
The stock-based compensation for all stock options was $1,747 and $1,138 during the years ended December 31, 2015 and 2014, respectively.
Restricted
Stock Units
RSU
awards are granted subject to certain vesting requirements and other restrictions, including performance and market based vesting
criteria. The grant-date fair value of the RSUs, which has been determined based upon the market value of the Company’s
common stock on the grant date, is expensed over the vesting period of the RSUs. Unvested portions of RSUs issued to consultants
are remeasured on an interim basis until vesting criteria is met.
Grants
During the Year Ended December 31, 2014
During
the year ended December 31, 2014, the Company granted an aggregate of 26,492 RSUs to its non-employee directors valued at $200.
These RSUs vest in equal quarterly installments over a one year period subject to the director’s continued service at the
vesting date, but the issuance and delivery of these shares are deferred until the director resigns.
Grants
During the Year Ended December 31, 2015
During
February 2015, the Company granted 30,000 RSUs to its Chief Financial Officer, Andrew R. Boll and 30,000 RSUs to its Chief Commercial
Officer, John P. Saharek, valued at $442 in the aggregate. The RSUs were granted pursuant to the Plan and will vest on the third
anniversary of the RSU grant date, subject to the applicable employee’s continued employment with the Company on such date
and accelerated vesting of all unvested shares thereunder upon the occurrence of a change in control (as defined in the Plan).
During
February 2015, the Company granted 157,500 RSUs to Mr. Boll, which are subject to the satisfaction of certain market-based and
continued service conditions (the “Boll Performance Equity Award”). The market-based vesting criteria are separated
into five tranches and require that the Company achieve and maintain certain stock price targets ranging from $10 per share to
$30 per share during the three-year period following the grant date. With certain limited exceptions, Mr. Boll must be employed
with the Company on the third anniversary of the grant date in order for the Boll Performance Equity Award to vest.
The
market-based vesting conditions applicable to the Boll Performance Equity Award are as follows:
Tranche
|
|
Number
of Shares
|
|
Target
Share Price
|
Tranche 1
|
|
30,000 shares
|
|
$10.00 or greater
|
Tranche 2
|
|
30,000 shares
|
|
$15.00 or greater
|
Tranche 3
|
|
30,000 shares
|
|
$20.00 or greater
|
Tranche 4
|
|
30,000 shares
|
|
$25.00 or greater
|
Tranche 5
|
|
37,500 shares
|
|
$30.00 or greater
|
The
initial fair value of the Boll Performance Equity Award was $228 using a Monte Carlo Simulation with a three-year life, 60% volatility
and a risk free interest rate of 0.77%.
During
the year ended December 31, 2015, the Company granted an aggregate of 34,166 RSUs to its non-employee directors valued at $270.
These RSUs vest in equal quarterly installments over a one year period subject to the director’s continued service at the
vesting date, but the issuance and delivery of these shares are deferred until the director resigns.
A
summary of the Company’s RSU activity and related information for the year ended December 31, 2015 is as follows:
|
|
Number
of RSUs
|
|
|
Weighted
Average Grant Date Fair Value
|
|
RSUs unvested - January 1,
2015
|
|
|
1,276,815
|
|
|
$
|
3.20
|
|
RSUs granted
|
|
|
251,666
|
|
|
$
|
3.74
|
|
RSUs vested
|
|
|
(31,458
|
)
|
|
$
|
7.40
|
|
RSUs
cancelled/forfeit
|
|
|
(9,062
|
)
|
|
$
|
5.98
|
|
RSUs unvested
at December 31, 2015
|
|
|
1,487,961
|
|
|
$
|
3.18
|
|
As
of December 31, 2015, the total unrecognized compensation expense related to unvested RSUs was approximately $1,153 which is expected
to be recognized over a weighted-average period of 0.60 years, based on estimated vesting schedules. The stock-based compensation
for RSUs was $1,671 and $1,332 during the years ended December 31, 2015 and 2014, respectively.
Warrants
From
time to time, the Company issues warrants to purchase shares of the Company’s common stock to investors, lenders (see Notes
10 and 16), underwriters and other non-employees for services rendered or to be rendered in the future.
In
April 2015, warrants to purchase 334,819 shares of the Company’s common stock with an exercise price of $5.925 were cancelled
following the expiration of their contractual term.
A
summary of warrant activity during the year ended December 31, 2015 is as follows:
|
|
Number
of Shares Subject to Warrants Outstanding
|
|
|
Weighted
Avg.
Exercise Price
|
|
|
|
|
|
|
|
|
Warrants outstanding - January
1, 2015
|
|
|
690,944
|
|
|
$
|
6.05
|
|
Granted
|
|
|
125,000
|
|
|
$
|
7.85
|
|
Exercised
|
|
|
(240,437
|
)
|
|
$
|
5.45
|
|
Expired
|
|
|
(334,819
|
)
|
|
$
|
5.93
|
|
Warrants
outstanding and exercisable - December 31, 2015
|
|
|
240,688
|
|
|
$
|
7.41
|
|
Weighted
average remaining contractual life of the outstanding warrants in years - December 31, 2015
|
|
|
5.99
|
|
|
|
|
|
The
fair value of each warrant is estimated on the date of grant using the Black-Scholes-Merton option pricing model. The intrinsic
value of warrants exercised during the year ended December 31, 2015 was approximately $528.
All
warrants outstanding as of December 31, 2015 are included in the following table:
|
|
Warrants
Outstanding
|
|
Warrants
Exercisable
|
|
|
|
|
|
Warrants
|
|
|
Exercise
|
|
|
Warrants
|
|
|
Expiration
|
|
Warrant
Series
|
|
Issue
Date
|
|
Outstanding
|
|
|
Price
|
|
|
Exercisable
|
|
|
Date
|
|
Lender
warrants (see Notes 10 and 16)
|
|
5/11/2015
|
|
|
125,000
|
|
|
$
|
7.85
|
|
|
|
125,000
|
|
|
|
5/11/2025
|
|
Underwriter warrants
|
|
2/7/2013
|
|
|
55,688
|
|
|
$
|
5.25
|
|
|
|
55,688
|
|
|
|
2/7/2018
|
|
Warrants
issued to investor relations consultant
|
|
7/19/2013
|
|
|
60,000
|
|
|
$
|
8.50
|
|
|
|
60,000
|
|
|
|
7/19/2018
|
|
|
|
|
|
|
240,688
|
|
|
$
|
7.41
|
|
|
|
240,688
|
|
|
|
|
|
The
stock-based compensation for warrants issued was $0 and $27 during the years ended December 31, 2015 and 2014, respectively.
The
Company recorded stock-based compensation (including issuance of common stock for services and accrual for stock-based compensation)
related to equity instruments granted to employees, directors and consultants as follows:
|
|
For the
|
|
|
For the
|
|
|
|
Year
Ended
|
|
|
Year
Ended
|
|
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
Employees
- selling and marketing
|
|
$
|
370
|
|
|
$
|
79
|
|
Employees - general
and administrative
|
|
|
2,720
|
|
|
|
2,095
|
|
Directors - general
and administrative
|
|
|
268
|
|
|
|
146
|
|
Consultants - selling
and marketing
|
|
|
83
|
|
|
|
89
|
|
Consultants - general
and administrative
|
|
|
-
|
|
|
|
147
|
|
Consultants
- research and development
|
|
|
-
|
|
|
|
9
|
|
Total
|
|
$
|
3,441
|
|
|
$
|
2,565
|
|
NOTE
12. INCOME TAXES
The
Company is subject to taxation in the United States, California, New Jersey, Texas and Pennsylvania. The provision for income
taxes for the years ended December 31, 2015 and 2014 are summarized below:
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
Current:
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
-
|
|
|
$
|
-
|
|
State
|
|
|
5
|
|
|
|
3
|
|
Total
current
|
|
$
|
5
|
|
|
$
|
3
|
|
|
|
|
|
|
|
|
|
|
Deferred:
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
3,141
|
|
|
$
|
3,023
|
|
State
|
|
|
988
|
|
|
|
871
|
|
Change
in valuation allowance
|
|
|
(4,129
|
)
|
|
|
(3,894
|
)
|
Total
deferred
|
|
|
-
|
|
|
|
-
|
|
Income
tax provision
|
|
$
|
5
|
|
|
$
|
3
|
|
Income
taxes for the years ended December 31, 2015 and 2014, are recorded in the general and administrative expenses line item in the
accompanying consolidated statements of operations.
A
reconciliation of income taxes computed by applying the statutory U.S. income tax rate to the Company’s loss before income
taxes to the income tax provision is as follows:
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
U.S. federal
statutory tax rate
|
|
|
35.00
|
%
|
|
|
35.00
|
%
|
Benefit of lower tax
brackets
|
|
|
(1.00
|
)%
|
|
|
(1.00
|
)%
|
State tax benefit,
net
|
|
|
(0.03
|
)%
|
|
|
(0.03
|
)%
|
Research and development
credits
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
Employee stock based
compensation
|
|
|
(0.67
|
)%
|
|
|
(1.03
|
)%
|
Loss on debt conversion
|
|
|
0.00
|
%
|
|
|
0.00
|
%
|
Other
|
|
|
(0.71
|
)%
|
|
|
(0.21
|
)%
|
Valuation
allowance
|
|
|
(32.62
|
)%
|
|
|
(32.76
|
)%
|
Effective
income tax rate
|
|
|
(0.03
|
)%
|
|
|
(0.03
|
)%
|
Deferred
tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities
for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred
tax assets are as follows:
|
|
December
31, 2015
|
|
|
December
31, 2014
|
|
Deferred tax assets
(liabilities):
|
|
|
|
|
|
|
|
|
NOL’s
|
|
$
|
15,099
|
|
|
$
|
10,923
|
|
Depreciation
and amortization
|
|
|
121
|
|
|
|
(7
|
)
|
Other
|
|
|
346
|
|
|
|
65
|
|
Research
& development credits
|
|
|
556
|
|
|
|
556
|
|
Deferred
stock compensation
|
|
|
3,237
|
|
|
|
2,646
|
|
Park
stock purchase identifiable intangibles
|
|
|
(1,047
|
)
|
|
|
-
|
|
Unrealized
gain or loss on investments
|
|
|
-
|
|
|
|
-
|
|
Total
net deferred tax assets
|
|
|
18,312
|
|
|
|
14,183
|
|
Valuation
allowance
|
|
|
(19,359
|
)
|
|
|
(14,183
|
)
|
Net
deferred tax liabilities
|
|
$
|
(1,047
|
)
|
|
$
|
-
|
|
Realization of deferred tax assets is dependent upon future earnings, if any, the timing and amount of which
are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. The valuation allowance
increased by approximately $4,900 and $3,900 in 2015 and 2014, respectively.
As
of December 31, 2015, the Company had net operating loss carryforwards for federal income tax purposes of approximately $38,289
which expire beginning in the year 2027 and federal research and development tax credits of approximately $354 which expire beginning
in the year 2026. As of December 31, 2015, the Company had net operating loss carryforwards for state income tax purposes of approximately
$35,114 which expire beginning in the year 2017 and state research and development tax credits of approximately $305 which do
not expire.
The
deferred tax asset at December 31, 2015 does not include approximately $1,030 and $1,030 of excess tax benefits from employee
stock option exercises and RSU vests that are a component of the federal and California net operating loss carryover, respectively.
The Company’s stockholders’ equity balance will be increased if and when such excess tax benefits are ultimately realized.
Utilization
of the net operating losses may be subject to substantial annual limitation due to federal and state ownership change limitations
provided by the Internal Revenue Code and similar state provisions. Such annual limitations could result in the expiration of
the net operating losses ad credits before their utilization.
The
Company did not have any unrecognized tax benefits as of December 31, 2015 and 2014, all of which is offset by a full valuation
allowance. These unrecognized tax benefits, if recognized, would not affect the effective tax rate.
NOTE
13. EMPLOYEE SAVINGS PLAN
The
Company has established an employee savings plan pursuant to Section 401(k) of the Internal Revenue Code, effective January 1,
2014. The plan allows participating employees to deposit into tax deferred investment accounts up to 100% of their salary, subject
to annual limits. The Company makes certain matching contributions to the plan in amounts up to 4% of the participants’
annual cash compensation, subject to annual limits. The Company contributed approximately $146 and $56 to the plan during the
years ended December 31, 2015 and 2014, respectively.
NOTE
14. COMMITMENTS AND CONTINGENCIES
Capital
Leases
The
Company leases equipment under capital leases with an interest rate of 4.25% per annum. At December 31, 2015, future payments
under the Company’s capital leases were as follows:
Year
ending December 31, 2015
|
|
|
|
2016
|
|
|
22
|
|
2017
|
|
|
1
|
|
Total minimum lease
payments
|
|
|
23
|
|
Less
amount representing interest
|
|
|
(1
|
)
|
Present value of
future minimum lease payments
|
|
|
22
|
|
Less
current portion
|
|
|
(21
|
)
|
Capital
lease obligation, net of current portion
|
|
$
|
1
|
|
The
value of the equipment under capital leases as of December 31, 2015 and 2014 was $60 and $53, respectively, with related accumulated
depreciation of $28 and $9, respectively.
Operating
Leases
In
June 2014, the Company entered into a lease agreement for 7,565 square feet of office space that commenced on September 1, 2014
and continues until October 31, 2018. Monthly rent began on September 1, 2014 in the amount of $20,426, with a 3% increase in
the base rent amount on an annual basis. The lease agreement allows for the monthly rent amount to be abated for two months at
various times during the lease agreement.
In
January 2015, the Company entered into a commercial lease agreement, for the lease to Park of approximately 4,500 square feet
of laboratory and office space. The monthly rent amount is $10 and includes annual increases of approximately 3%. The current
lease term expires on December 31, 2020.
In
February 2015, the Company entered into a lease agreement for approximately 8,602 square feet of laboratory, warehouse and office
space in Roxbury, New Jersey. The current lease term expires on July 31, 2022. The monthly rent amount is $10 and includes annual
increases of approximately 3.75%, and the lease allows for the first five months of rent amounts to be abated. This facility is
currently undergoing construction to serve as an outsourcing facility and pharmacy.
In
August 2015, the Company entered into a lease agreement for approximately 1,100 square feet of laboratory,
warehouse and office space in Allen, Texas. The lease term expired on April 30, 2016, and subsequent
to December 31, 2015 the lease was extended through October 31, 2019. The monthly rent amount is $3 and
includes annual increases of approximately 2%.
Rent
expense for the years ended December 31, 2015 and 2014 was $641 and $306, respectively. The following represents future annual
minimum lease payments, net of expected sublease income, as of December 31, 2015:
2016
|
|
$
|
570
|
|
2017
|
|
|
495
|
|
2018
|
|
|
496
|
|
2019
|
|
|
257
|
|
2020
|
|
|
266
|
|
Thereafter
|
|
|
213
|
|
Total
|
|
$
|
2,297
|
|
Legal
Urigen
Litigation
The
Company, as the plaintiff, filed civil action with the San Diego Superior Court against Urigen Pharmaceuticals, Inc. (“Urigen”),
wherein the Company outlined serious concerns regarding material failures and inaccuracies of the representation and warranties
provided by Urigen in the Urigen License Agreement (defined below), which have affected the Company’s ability to realize
the expected benefit of the Urigen License Agreement. Urigen, as the defendant, has yet to file any responsive pleading to the
case and the case is at a preliminary stage. Management believes the outcome of this claim may have a material effect on the Company’s
consolidated financial position and results of operations, although such amount cannot be reasonably estimated at this time.
General
and Other
In
the ordinary course of business, the Company may face various claims brought by third parties and the Company may, from time to
time, make claims or take legal actions to assert the Company’s rights, including intellectual property disputes, contractual
disputes and other commercial disputes. Any of these claims could subject the Company to litigation. Management believes the outcomes
of currently pending claims are not likely to have a material effect on the Company’s consolidated financial position and
results of operations.
Indemnities
In
addition to the indemnification provisions contained in the Company’s charter documents, the Company generally enters into
separate indemnification agreements with each of the Company’s directors and officers. These agreements require the Company,
among other things, to indemnify the director or officer against specified expenses and liabilities, such as attorneys’
fees, judgments, fines and settlements, paid by the individual in connection with any action, suit or proceeding arising out of
the individual’s status or service as the Company’s director or officer, other than liabilities arising from willful
misconduct or conduct that is knowingly fraudulent or deliberately dishonest, and to advance expenses incurred by the individual
in connection with any proceeding against the individual with respect to which the individual may be entitled to indemnification
by the Company. The Company also indemnifies its lessors in connection with its facility leases for certain claims arising from
the use of the facilities. These indemnities do not provide for any limitation of the maximum potential future payments the Company
could be obligated to make. Historically, the Company has not incurred any payments for these obligations and, therefore, no liabilities
have been recorded for these indemnities in the accompanying consolidated balance sheets.
Urigen
License
On
October 24, 2014 (the “Urigen Effective Date”), the Company entered into a license agreement (the “Urigen License”)
with Urigen, pursuant to which Urigen granted to the Company a license under certain U.S. patents and patent applications to develop
and sell in the U.S. Urigen’s URG101 product (“HLA”), a heparin and alkalinized lidocaine compounded formulation,
for the prevention or treatment of disorders of the lower urinary tract.
As
consideration for the license granted under the Urigen License, the Company agreed to pay Urigen annual tiered royalties based
on sales of HLA, subject to certain minimum annual royalty payments. The annual tiered royalties consist of the greater of (i)
$0.50 per dose (dollar amount not presented in thousands), and (ii) 15%-20% of the Company’s net sales of HLA, with the
royalty amount within such range depending on the Company’s aggregate sales of HLA during the period to which the royalty
payment applies. The minimum annual royalty payment consists of (a) for the 2015 calendar year, the greater of (i) 110% of the
aggregate royalties paid to Urigen under the Existing Sublicenses during the preceding 12 months, on a prorated basis, and (ii)
$800, less the aggregate royalties paid to Urigen under the Existing Sublicenses during the 2015 calendar year, and (b) for each
calendar year thereafter, 110% of the aggregate amount owed by the Company to Urigen under the Urigen License during the prior
calendar year. The Company is obligated to pay such royalties beginning with its first commercial sale of HLA and continuing until
the expiration of the patents subject to the license granted under the Urigen License. The Company has also agreed to use commercially
reasonable efforts to develop and commercialize HLA according to the terms of a diligence plan agreed to by the parties, which
efforts will include, without limitation, the Company’s investment of $2,000 in commercialization efforts of HLA, which
investment and timeline can be adjusted dependent on market circumstances, and is expected to be incurred over 18-24 months following
the Urigen Effective Date. The Company has accrued an amount based on the terms of the agreement related to the minimum annual
royalty.
The
Urigen License was non-exclusive until April 24, 2015, when the Company exercised its option to convert the non-exclusive license
to an exclusive license for the remaining term of the Urigen License. Legacy sublicensees, who previously had non-exclusive licensed
rights to compound and sell HLA (the “Existing Sub-licensees”), were provided written notice of the Company’s
intent to terminate those non-exclusive license agreements, on or about April 24, 2015. Over the following 60 to 90 days (the
“Transition Period”) the Company entered into agreements with the Existing Sub-licensees to transfer existing refill
prescriptions to the Company’s wholly owned pharmacies. These agreements required various one-time payments and limited
future payments related to transferred prescriptions. Urigen agreed that any revenue received from the Existing Sub-licensees
from HLA sales that are consistent with their respective agreements with Urigen, will be retained by the Company (without any
related royalty obligation to Urigen). Beginning on April 24, 2015, the Company was due royalty payments on any HLA prescriptions
filled by Existing Sub-licensees during the Transition Period and any additional period the sublicenses filled prescriptions for
HLA. During the year ended December 31, 2015, the Company recognized $51 in royalty revenues related to HLA prescriptions filled
by the Existing Sub-licensees.
Subject
to certain conditions and each party’s right to terminate the Urigen License earlier under certain circumstances, the Urigen
License will continue in effect until the expiration of the Company’s royalty obligations under the Urigen License. The
Urigen License terminates upon the first commercial sale of HLA by Urigen, its affiliates, or a third party after the U.S. Food
and Drug Administration (the “FDA”) grants Urigen approval to market HLA in the U.S., if market approval is granted.
The Company shall have the option, at its discretion, to become a non-exclusive distributor of HLA following the FDA grants Urigen
such market approval.
PCCA
Commission Agreement
On
December 21, 2015, the Company entered into a Commission Agreement (the “PCCA Commission Agreement) with Professional Compounding
Centers of America, Inc. (“PCCA”). The PCCA Commission Agreement replaces a Strategic Alliance Agreement (the “PCCA
Strategic Alliance Agreement”) entered into on February 18, 2013 and a License Agreement (the “PCCA License Agreement)
entered into on August 30, 2012, in each case between the Company and PCCA. Upon the execution of the PCCA Commission Agreement,
the Company and PCCA mutually agreed to terminate the PCCA Strategic Alliance Agreement and PCCA License Agreement. No amounts
were due or paid under either the PCCA Strategic Alliance Agreement or PCCA License Agreement.
PCCA
has previously introduced to the Company certain PCCA members, which led to the Company’s acquisition of certain intellectual
property (the “PCCA Member IP”) from such PCCA members. Under the terms of the PCCA Strategic Alliance Agreement,
PCCA had the right to receive certain commissions based on the Company’s net sales, if any, of any products utilizing the
PCCA Member IP. The primary purpose of the PCCA Commission Agreement is to specifically identify the PCCA Member IP subject to
this arrangement and to revise the terms and the amount of the commission payments. As a result, pursuant to the terms of the
PCCA Commission Agreement, PCCA continues to hold its right to receive commissions based on the Company’s net sales, if
any, of any products utilizing the PCCA Member IP. No commission amounts were paid or accrued under this agreement for the year
ended December 31, 2015.
Asset
Purchase Agreements
The
Company has acquired intellectual property rights related to certain proprietary innovations from certain inventors (the “Inventors”)
through multiple asset purchase agreements. The asset purchase agreements provide that the Inventors will cooperate with the Company
in obtaining patent protection for the acquired intellectual property and that the Company will use commercially reasonable efforts
to research, develop and commercialize a product based on the acquired intellectual property. In addition, the Company has acquired
a right of first refusal on additional intellectual property and drug development opportunities presented by these Inventors.
In
consideration for the acquisition of the intellectual property rights, the Company is obligated to make payments to the Inventors
based on the completion of certain milestones, generally consisting of: (1) a payment payable within 30 days after the issuance
of the first patent in the United States arising from the acquired intellectual property (if any); (2) a payment payable within
30 days after the Company files the first investigational new drug application (“IND”) with the FDA for the first
product arising from the acquired intellectual property (if any); (3) for certain of the Inventors, a payment payable within 30
days after the Company files the first new drug application with the FDA for the first product arising from the acquired intellectual
property (if any); and (4) certain royalty payments based on the net receipts received by the Company in connection with the sale
or licensing of any product based on the acquired intellectual property (if any), after deducting (among other things) the Company’s
development costs associated with such product. If, following five years after the date of the applicable asset purchase agreement,
the Company either (a) for certain of the Inventors, has not filed an IND or, for the remaining Inventors, has not initiated a
study where data is derived, or (b) has failed to generate royalty payments to the Inventors for any product based on the acquired
intellectual property, the Inventors may terminate the applicable asset purchase agreement and request that the Company re-assign
the acquired technology to the Inventors. No royalty amounts were paid or accrued under these agreements during the years ended
December 31, 2015 and 2014.
NOTE
15. SEGMENT INFORMATION AND CONCENTRATIONS
The
Company operates the business on the basis of a single reportable segment, which is the business of developing proprietary drug
therapies and providing such therapies through sterile and non-sterile pharmaceutical compounding services. The Company’s
chief operating decision-maker is the Chief Executive Officer, who evaluates the Company as a single operating segment.
The
Company categorizes revenues by geographic area based on selling location. All operations are currently located in the United
States; therefore, total revenues for 2015 and 2014 are attributed to the United States. All long-lived assets at December 31,
2015 and 2014 are located in the United States.
The
Company sells its compounded formulations to a large number of customers. No single customer contributed 10% or more of the Company’s
total pharmacy sales in the years ended December 31, 2015 and 2014.
The
Company receives its active pharmaceutical ingredients from three main suppliers. These suppliers collectively accounted for 43%
and 84% of drug and chemical purchases during the years ended December 31, 2015 and 2014, respectively.
NOTE
16. SUBSEQUENT EVENTS
The
Company has performed an evaluation of events occurring subsequent to December 31, 2015 through the filing date of this Annual
Report on Form 10-K (the “Annual Report”). Based on its evaluation, nothing other than the events described below
needs to be disclosed.
LSAF
Note
On
January 22, 2016, the Company entered into a note purchase agreement (the “NPA”) with, and issued an 8.00% Convertible
Senior Secured Note in the principal amount of $3,000 (the “LSAF Note”) to, LSAF. Pursuant to the terms of the NPA,
on the date thereof, the Company issued the LSAF Note to LSAF and, as consideration therefor, LSAF paid the Company in cash the
full principal amount of the LSAF Note.
Pursuant
to the terms of the LSAF Note, the Company is obligated to pay interest on the principal amount of the LSAF Note monthly in cash
at a fixed per-annum rate of 8.00%, and the Company is obligated to repay the full principal amount of the LSAF Note in cash on
May 11, 2021. The Company is permitted to redeem the LSAF Note prior to its maturity at any time on or after March 1, 2018
for cash purchase prices equal to 109% - 105% of the outstanding principal amount of the LSAF Note, depending on the date of redemption.
The LSAF Note is convertible by the holder at any time into 169.4915 shares of the Company’s common stock, per $1 outstanding
principal amount of the LSAF Note, subject to anti-dilution adjustment upon the Company’s first equity financing while the
LSAF Note is outstanding in which it receives gross proceeds of at least $3,000, if such equity financing is completed at a per
share price that is less than the conversion rate of the LSAF Note, and also subject to adjustment upon stock combinations or
splits, certain recapitalizations, stock or cash dividends or other distributions of property or equity rights. Additionally,
in the event of certain change of control events affecting the Company, the Company may be required, at the option of LSAF, to
repurchase the LSAF Note in cash for the greater of 105% of the outstanding principal amount of the LSAF Note or the value of
the shares of common stock issuable upon conversion of the LSAF Note.
In
connection and concurrently with the execution of the NPA and the issuance of the LSAF Note, the Company and LSAF also entered
into an amendment (the “Loan Agreement Amendment”) to the Loan Agreement (See Note 10). The Loan Agreement Amendment
modifies the terms of the Loan Agreement in order to eliminate the potential borrowing of a second term loan thereunder and to
permit the Company to issue the LSAF Note. Additionally, the Company and LSAF entered into an amendment (the “Warrant Amendment”)
to the Warrant that was issued to LSAF in connection with the Loan Agreement. The Warrant Amendment modifies the terms of the
Warrant in order to reduce the exercise price thereof to $5.90, which is consistent with the initial conversion rate of the LSAF
Note, and to add an anti-dilution adjustment provision that is consistent with the same such provision in the LSAF Note.
On
March 16, 2016, upon the closing of the Offering (as defined and described below), and pursuant to the anti-dilution adjustment
provisions of the LSAF Note and the Warrant, the conversion rate of the LSAF Note was adjusted so that the note is convertible
by the holder at any time into 277.77 shares of the Company’s common stock, per $1 outstanding principal amount of
the LSAF Note, and the exercise price of the Warrant was adjusted to $3.60 per share.
Option
Exercises
In
February 2016, the Company issued 15,000 shares of common stock as a result of option exercises. The Company received $55 in cash
proceeds for the issuance of the shares of common stock upon the exercise on a cash basis of stock options to purchase 15,000
shares of common stock with an exercise price of $3.68 per share.
Offering
of Common Stock
On
March 11, 2016, the Company entered into an Underwriting Agreement (the “Underwriting Agreement”) with National Securities
Corporation (the “Representative”), as the representative of the several underwriters named therein (collectively,
the “Underwriters”), pursuant to which the Company agreed to sell to the Underwriters, and the Underwriters agreed,
severally and not jointly, to purchase from the Company, in a firm-commitment public offering (the “Offering”), 2,900,000
shares of the Company’s common stock and up to an additional 435,000 shares of the Company’s common stock within 45
days from the date of the Underwriting Agreement to cover over-allotments, if any. Pursuant to the terms of the Underwriting Agreement,
the Underwriters purchased the shares of common stock from the Company at a price of $3.348 per share, and the Underwriters sold
the shares of Common Stock to the public at a public offering price of $3.60 per share. The Offering, including the Underwriters’
exercise of the over-allotment option, closed on March 16, 2016. Upon the closing of the Offering, the Company received net proceeds
of approximately $11,100, after deducting the underwriting discount and the estimated offering expenses payable by the Company.
The Company intends to use the net proceeds from the Offering for working capital and general corporate purposes.
Sales
Agreement
On
March 16, 2016, in connection with the Offering, the Company reduced the amount available for sale pursuant to the Sales Agreement
with Cantor Fitzgerald to shares of its common stock having an aggregate offering price of $2,625, leaving an aggregate of $2,100
available for future sales of shares thereunder as of March 23, 2016.