Company to host conference call today at
4:30pm ET
VIVUS, Inc. (NASDAQ: VVUS) (the "Company"), a specialty
pharmaceutical company committed to the development and
commercialization of innovative therapies focusing on treatments
for patients with serious unmet medical needs, today reported
financial results for the quarter ended December 31, 2018 and
provided a business update.
“We are pleased to have recorded a third
consecutive quarter of positive EBITDA, excluding one-time expenses
associated with the PANCREAZE acquisition and debt restructuring,
which demonstrates our ability to execute on our strategy of
returning VIVUS to profitability,” said John Amos, Chief Executive
Officer at VIVUS. “We intend to execute several new
initiatives in 2019 that we believe will further grow revenues from
our existing product portfolio, including launching PANCREAZE under
the VIVUS brand in the first quarter and streamlining the Qsymia
acquisition process for patients. The VIVUS Health Platform,
a new integrated strategy through which we will partner with
physicians, dieticians, nutritionists, self-insured employers,
private and public insurers and, most importantly, patients, is
expected to increase utilization of Qsymia and PANCREAZE as tools
for patients to achieve their healthy weight goals. We also intend
to continue evaluating additional in-licensing or acquisition
opportunities that can accelerate our trajectory toward
profitability.”
Recent Business Highlights
- Publishing of Data
Supporting the Cardiovascular Safety of QsymiaIn February
2019, results from a new retrospective study evaluating the
cardiovascular safety of Qsymia® (phentermine and topiramate
extended-release) capsules CIV were published in The Journal
of Clinical Endocrinology & Metabolism and are currently
available online. The new findings indicate that the
combined risk of major adverse cardiovascular events (MACE) was not
elevated in patients currently taking Qsymia, or concurrently
taking both phentermine and topiramate, compared with former users
of these medications. The number of MACE events (3 events during
3,245 person-years of follow-up) was too few to draw a definitive
conclusion from the data.
- Addition of Two New Members
to the Board of DirectorsIn October 2018, VIVUS announced
the appointments of Karen Ferrell and Edward A. Kangas to VIVUS’
board of directors. With these appointments, VIVUS’ board of
directors expands to nine members in total.
- Retirement of $8.574
Million of its Convertible Notes due 2020In October 2018,
VIVUS repurchased $8.574 million of its convertible notes due May
2020 at a discount to par plus accrued and unpaid interest. The
repurchase of the notes is expected to save the Company
approximately $2 million in principal and interest between the
transaction date and the due date.
Fourth Quarter Financial
Results
Revenue consisted of the following:
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(In thousands) |
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Three Months Ended |
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December 31, |
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2018 |
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2017 |
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Qsymia net product revenue |
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$ |
10,055 |
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$ |
8,934 |
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PANCREAZE net product revenue |
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7,363 |
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— |
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Supply revenue |
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1,660 |
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2,343 |
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Royalty revenue |
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1,036 |
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664 |
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Total
revenue |
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$ |
20,114 |
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$ |
11,941 |
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Total revenue for the fourth quarter of 2018 was
$20.1 million, an increase of 68% compared to $11.9 million during
the same period in 2017.
Qsymia net product revenue was $10.1 million and
$8.9 million in the fourth quarters of 2018 and 2017, respectively.
The increase was primarily due to improvements in Qsymia’s
gross to net deductions, including sales returns and discounts.
Shipments were approximately 87,000 and 88,000 units in the fourth
quarters of 2018 and 2017, respectively. Approximately 83,000
and 91,000 Qsymia prescriptions were dispensed in the fourth
quarters of 2018 and 2017, respectively. Sales of Qsymia tend to be
significantly impacted by seasonality and future sales of Qsymia
could differ materially from fourth quarter results.
PANCREAZE net product revenue was $7.4 million
in the fourth quarter of 2018. VIVUS acquired PANCREAZE in June
2018. During this period, the Company shipped approximately
32,000 units of PANCREAZE. Beginning in the first quarter of
2019, PANCREAZE net product revenues will be negatively impacted by
higher wholesaler fees as VIVUS takes over supply chain management
and potential promotional strategies, including the issuance of
discount coupons.
Total cost of goods sold excluding amortization
was $5.2 million and $3.8 million in the fourth quarters of 2018
and 2017, respectively. The growth was primarily due to the
addition of PANCREAZE revenue in 2018.
Amortization of intangible assets was $3.6
million and $91,000 in the fourth quarters of 2018 and 2017,
respectively. The increase was due to the amortization of costs
capitalized with the acquisition of PANCREAZE.
Research and development expense was $1.8
million and $1.2 million in the fourth quarters of 2018 and 2017,
respectively. Research and development expenses were impacted by
increased development efforts of VI-0106 for the treatment of
pulmonary arterial hypertension. VIVUS also assumed post
marketing requirements from Janssen as part of the acquisition of
PANCREAZE. VIVUS expects research and development expenses to
increase in connection with initiation of enrollment in the Qsymia
adolescent safety and efficacy study (OB-0403) beginning in the
first quarter of 2019.
General and administrative expense was $4.6
million and $5.7 million for the fourth quarters of 2018 and 2017,
respectively. The decrease was primarily due to control of expenses
and financial discipline. VIVUS expects general and administrative
expenses to slightly increase as the Company continues the
integration of PANCREAZE activities.
Selling and marketing expense totaled $3.1
million and $3.0 million in the fourth quarters of 2018 and 2017,
respectively. VIVUS expects to increase commercialization
efforts for PANCREAZE, including additions to its field force to
support its re-launch in the first quarter of 2019, and potential
administrative, partnering and promotional activities.
Total interest and other expense was $6.3
million and $8.2 million for the fourth quarters of 2018 and 2017,
respectively. Fourth quarter 2018 results include a $1.4 million
gain on the repurchase of $8.6 million of convertible notes. On an
annual basis, VIVUS will make interest payments of approximately
$19.6 million on its convertible and senior secured notes.
Net loss for the fourth quarter of 2018 was $4.5
million, as compared to $10.1 million in the fourth quarter of
2017. Cash, cash equivalents and available-for-sale
securities were $111.2 million at December 31, 2018.
Non-GAAP EBITDA for the fourth quarter of 2018
was $6.1 million, as compared to a negative EBITDA of $1.0 million
in the fourth quarter of 2017.
Conference Call Details
VIVUS will hold a conference call and an
audio webcast to provide a business update and to discuss the 2018
fourth quarter financial results today, February 26, 2019,
beginning at 4:30PM Eastern Time. Investors may listen to this
call by dialing toll-free 1-877-359-2916 in the U.S. and
1-224-357-2386 from outside the U.S. The audience
passcode is 7583536. A webcast replay will be available for
30 days and may be accessed
at http://ir.vivus.com/events-and-presentations.
About Qsymia
Qsymia is approved in the U.S. and is indicated
as an adjunct to a reduced-calorie diet and increased physical
activity for chronic weight management in adults with an initial
body mass index (BMI) of 30 kg/m2 or greater (obese) or 27
kg/m2 or greater (overweight) in the presence of at least one
weight-related medical condition such as high blood pressure, type
2 diabetes, or high cholesterol.
The effect of Qsymia on cardiovascular morbidity
and mortality has not been established. The safety and
effectiveness of Qsymia in combination with other products intended
for weight loss, including prescription and over-the-counter drugs,
and herbal preparations, have not been established.
For more information about Qsymia, please
visit www.Qsymia.com.
Important Safety Information for
Qsymia
Qsymia® (phentermine and topiramate
extended-release) capsules CIV is contraindicated in pregnancy; in
patients with glaucoma; in hyperthyroidism; in patients receiving
treatment or within 14 days following treatment with monoamine
oxidase inhibitors; or in patients with hypersensitivity to
sympathomimetic amines, topiramate, or any of the inactive
ingredients in Qsymia.
Qsymia can cause fetal harm. Females of
reproductive potential should have a negative pregnancy test before
treatment and monthly thereafter and use effective contraception
consistently during Qsymia therapy. If a patient becomes
pregnant while taking Qsymia, treatment should be discontinued
immediately, and the patient should be informed of the potential
hazard to the fetus.
The most commonly observed side effects in
controlled clinical studies, 5% or greater and at least 1.5 times
placebo, include paraesthesia, dizziness, dysgeusia, insomnia,
constipation, and dry mouth.
About PANCREAZE
PANCREAZE is a prescription medicine used to
treat people who cannot digest food normally because their pancreas
does not make enough enzymes due to cystic fibrosis or other
conditions. PANCREAZE may help your body use fats, proteins,
and sugars from food. PANCREAZE contains a mixture of
digestive enzymes including lipases, proteases, and amylases from
pig pancreas. PANCREAZE is safe and effective in children
when taken as prescribed by your doctor.
Important Safety Information for PANCREAZE
What is the most important information I should know
about PANCREAZE?
- PANCREAZE may increase your chance of having a serious, rare
bowel disorder called fibrosing colonopathy that may require
surgery.
- The risk of having this condition may be reduced by following
the dosing instructions that your healthcare provider gave
you.
Call your doctor right away if you have any unusual
or severe stomach area (abdominal) pain, bloating,
trouble passing stool (having bowel movements), nausea, vomiting,
or diarrhea.
Take PANCREAZE exactly as prescribed by your doctor. Do
not take more or less PANCREAZE than directed by your doctor.
What are the possible side effects of
PANCREAZE?
PANCREAZE may cause serious side effects,
including:
- A rare bowel disorder called fibrosing
colonopathy.
- Irritation of the inside of your mouth.
This can happen if PANCREAZE is not swallowed
completely.
- Increase in blood uric acid levels. This
may cause worsening of swollen, painful joints (gout) caused by an
increase in your blood uric acid levels.
- Allergic reactions including trouble with
breathing, skin rashes, or swollen lips.
Call your doctor right away if you have any of these
symptoms.
The most common side effects include pain in your stomach
(abdominal pain) and gas.
Other possible side effects: PANCREAZE and other
pancreatic enzyme products are made from the pancreas of pigs, the
same pigs people eat as pork. These pigs may carry viruses.
Although it has never been reported, it may be possible for a
person to get a viral infection from taking pancreatic enzyme
products that come from pigs.
These are not all the side effects of PANCREAZE. Talk to
your doctor about any side effect that bothers you or does not go
away.
You may report side effects to FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
What should I tell my doctor before taking
PANCREAZE?
Tell your doctor if you:
- are allergic to pork (pig) products.
- have a history of blockage of your intestines, or scarring or
thickening of your bowel wall (fibrosing colonopathy).
- have gout, kidney disease, or high blood uric acid
(hyperuricemia).
- have trouble swallowing capsules.
- have any other medical condition.
- are pregnant or plan to become pregnant.
- are breast-feeding or plan to breast-feed.
Tell your doctor about all the medicines you
take, including prescription and nonprescription
medicines, vitamins, and herbal supplements.
The Product Information and Medication Guide for PANCREAZE is
available at www.pancreaze.com.
About STENDRA/SPEDRA
(Avanafil)
STENDRA® (avanafil) is approved in the U.S.
by the FDA for the treatment of erectile
dysfunction. Metuchen Pharmaceuticals LLC has exclusive
marketing rights to STENDRA in the U.S., Canada, South
America and India.
STENDRA is available through retail and mail
order pharmacies.
SPEDRA™, the trade name for avanafil in the EU,
is approved by the EMA for the treatment of erectile dysfunction in
the EU. VIVUS has granted an exclusive license to
the Menarini Group through its
subsidiary Berlin-Chemie AG to commercialize and promote
SPEDRA for the treatment of erectile dysfunction in over 40
European countries plus Australia and New Zealand.
Avanafil is licensed from Mitsubishi Tanabe
Pharma Corporation (MTPC). VIVUS owns worldwide
development and commercial rights to avanafil for the treatment of
sexual dysfunction, with the exception of certain Asian-Pacific Rim
countries. VIVUS is in discussions with other parties
for the commercialization rights to its remaining territories.
For more information about STENDRA, please
visit www.STENDRA.com.
Important Safety Information for
STENDRA
STENDRA® (avanafil) is prescribed to treat
erectile dysfunction (ED).
Do not take STENDRA if you take nitrates, often
prescribed for chest pain, as this may cause a sudden, unsafe drop
in blood pressure.
Discuss your general health status with your
healthcare provider to ensure that you are healthy enough to engage
in sexual activity. If you experience chest pain, nausea, or
any other discomforts during sex, seek immediate medical help.
STENDRA may affect the way other medicines work.
Tell your healthcare provider if you take any of the
following; medicines called HIV protease inhibitors, such as
ritonavir (Norvir®), indinavir (Crixivan®), saquinavir
(Fortavase® or Invirase®) or atazanavir (Reyataz®); some types
of oral antifungal medicines, such as ketoconazole (Nizoral®), and
itraconazole (Sporanox®); or some types of antibiotics, such as
clarithromycin (Biaxin®), telithromycin (Ketek®), or
erythromycin.
In the rare event of an erection lasting more
than 4 hours, seek immediate medical help to avoid long-term
injury.
In rare instances, men taking PDE5 inhibitors
(oral erectile dysfunction medicines, including STENDRA) reported a
sudden decrease or loss of vision. It is not possible to
determine whether these events are related directly to these
medicines or to other factors. If you experience sudden
decrease or loss of vision, stop taking PDE5 inhibitors, including
STENDRA, and call a doctor right away.
Sudden decrease or loss of hearing has been
rarely reported in people taking PDE5 inhibitors, including
STENDRA. It is not possible to determine whether these events
are related directly to the PDE5 inhibitors or to other factors.
If you experience sudden decrease or loss of hearing, stop
taking STENDRA and contact a doctor right away. If you have
prostate problems or high blood pressure for which you take
medicines called alpha blockers or other anti-hypertensives, your
doctor may start you on a lower dose of STENDRA.
Drinking too much alcohol when taking STENDRA
may lead to headache, dizziness, and lower blood pressure.
STENDRA in combination with other treatments for
ED is not recommended.
STENDRA does not protect against sexually
transmitted diseases, including HIV.
The most common side effects of STENDRA are
headache, flushing, runny nose and congestion.
Please see full patient prescribing information
for STENDRA (50 mg, 100 mg, 200 mg) tablets.
About VIVUS
VIVUS is a specialty pharmaceutical company
committed to the development and commercialization of innovative
therapies that focus on advancing treatments for patients with
serious unmet medical needs. For more information about the
Company, please visit www.vivus.com.
Forward-Looking Statements
Certain statements in this press release are
forward-looking within the meaning of the Private Securities
Litigation Reform Act of 1995 and are subject to risks,
uncertainties and other factors, including risks and uncertainties
related to our ability to execute on our business strategy to
enhance long-term stockholder value; risks and uncertainties
related to our ability to address or potentially reduce our
outstanding balance of the convertible notes due in 2020; risks and
uncertainties related to our expected future revenues, operations
and expenditures; risks and uncertainties related to our ability to
identify and acquire cash flow generating assets and opportunities;
risks and uncertainties related to the timing, strategy, tactics
and success of the marketing and sales of PANCREAZE; risks and
uncertainties related to our commercialization of PANCREAZE as a
new product and our recently changed management team initiating the
commercialization of PANCREAZE; risks and uncertainties related to
our, or our current or potential partner's, ability to successfully
commercialize Qsymia; risks and uncertainties related to our
ability to successfully develop or acquire a proprietary
formulation of tacrolimus; risks and uncertainties related to our
ability to identify, acquire and develop new product pipeline
candidates; risks and uncertainties related to our ability to
develop a proprietary formulation and to demonstrate through
clinical testing the quality, safety, and efficacy of our current
or future investigational drug candidates; risks and uncertainties
related to the timing, strategy, tactics and success of the
launches and commercialization of STENDRA/SPEDRA (avanafil) by our
current or potential collaborators; risks and uncertainties related
to our ability to successfully complete on acceptable terms, and on
a timely basis, avanafil partnering discussions for territories
under our license with MTPC in which we do not have a commercial
collaboration; risks and uncertainties related to our ability to
work with FDA to significantly reduce or remove the requirements of
the clinical post-approval cardiovascular outcomes trial (“CVOT”);
risks and uncertainties related to our dialog with the European
Medicines Agency (“EMA”) relating to the U.S.-based CVOT for
Qsymia, and the resubmission of an application for the grant of a
marketing authorization to the EMA, the timing of such
resubmission, if any, the results of any required CVOT, the
assessment by the EMA of the application for marketing
authorization, and their agreement with the data from any required
CVOT; risks and uncertainties related to the failure to
obtain FDA or foreign authority clearances or approvals
and noncompliance with FDA or foreign authority
regulations; and risks and uncertainties related to our ability to
successfully integrate changes to our Board of Directors and senior
management team. These risks and uncertainties could cause actual
results to differ materially from those referred to in these
forward-looking statements. The reader is cautioned not to rely on
these forward-looking statements. Investors should read the
risk factors set forth in VIVUS’ Form 10-K for the year ended
December 31, 2018 as filed on February 26, 2019, and periodic
reports filed with the Securities and Exchange Commission.
VIVUS does not undertake an obligation to update or revise any
forward-looking statements.
VIVUS, Inc. |
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Investor Relations: Lazar
Partners |
Mark Oki |
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David Carey |
Chief Financial Officer |
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dcarey@lazarpartners.com |
oki@vivus.com |
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212-867-1768 |
650-934-5200 |
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VIVUS, INC. |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(In thousands, except par value) |
(Unaudited) |
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December 31, |
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December 31, |
|
2018 |
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2017 |
ASSETS |
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Current assets: |
|
|
|
|
|
|
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Cash and
cash equivalents |
$ |
30,411 |
|
|
|
|
$ |
66,392 |
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Available-for-sale securities |
|
80,838 |
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|
|
|
159,943 |
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Accounts
receivable, net |
|
25,608 |
|
|
|
|
|
12,187 |
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Inventories |
|
23,132 |
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|
|
|
|
17,712 |
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Prepaid
expenses and other current assets |
|
7,538 |
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|
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|
|
7,178 |
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Total
current assets |
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167,527 |
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263,412 |
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Property and equipment,
net |
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341 |
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542 |
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Intangible and other
non-current assets |
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134,279 |
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|
1,014 |
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Total
assets |
$ |
302,147 |
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$ |
264,968 |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current
liabilities: |
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Accounts
payable |
$ |
8,921 |
|
|
|
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$ |
10,072 |
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Accrued
and other liabilities |
|
33,044 |
|
|
|
|
|
21,475 |
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Deferred
revenue |
|
1,235 |
|
|
|
|
|
2,075 |
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Current
portion of long-term debt |
|
— |
|
|
|
|
|
5,147 |
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Total
current liabilities |
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43,200 |
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|
38,769 |
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Long-term
debt, net of current portion |
|
294,446 |
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|
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|
|
230,536 |
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Deferred
revenue, net of current portion |
|
4,290 |
|
|
|
|
|
4,674 |
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Non-current accrued and other liabilities |
|
234 |
|
|
|
|
|
327 |
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Total
liabilities |
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342,170 |
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|
274,306 |
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Commitments and
contingencies |
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Stockholders’
deficit: |
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Preferred
stock; $.001 par value; 5,000 shares authorized; no shares issued
and outstanding at December 31, 2018 and 2017 |
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— |
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— |
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Common
stock; $.001 par value; 200,000 shares authorized; 10,636 and
10,603 shares issued and outstanding at December 31, 2018 and
2017, respectively |
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11 |
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11 |
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Additional paid-in capital |
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840,751 |
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834,824 |
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Accumulated other comprehensive loss |
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(270 |
) |
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|
(608 |
) |
Accumulated deficit |
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(880,515 |
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(843,565 |
) |
Total
stockholders’ deficit |
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(40,023 |
) |
|
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|
|
(9,338 |
) |
Total
liabilities and stockholders’ deficit |
$ |
302,147 |
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|
|
|
$ |
264,968 |
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|
|
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|
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VIVUS, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(In thousands, except per share
data) |
(Unaudited) |
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Three Months Ended |
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Year Ended |
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December 31, |
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December 31, |
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2018 |
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2017 |
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2018 |
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2017 |
Revenue: |
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|
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Net
product revenue |
$ |
17,418 |
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$ |
8,934 |
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$ |
56,784 |
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$ |
44,983 |
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License
and milestone revenue |
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— |
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— |
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|
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— |
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7,500 |
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Supply
revenue |
|
1,660 |
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|
|
2,343 |
|
|
|
4,863 |
|
|
|
10,407 |
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Royalty
revenue |
|
1,036 |
|
|
|
664 |
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|
3,415 |
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|
|
2,483 |
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Total
revenue |
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20,114 |
|
|
|
11,941 |
|
|
|
65,062 |
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|
65,373 |
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Operating
expenses: |
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Cost of
goods sold (excluding amortization) |
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5,213 |
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3,845 |
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14,613 |
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16,643 |
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Amortization of intangible assets |
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3,638 |
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|
|
91 |
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|
8,640 |
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|
544 |
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Selling,
general and administrative |
|
7,706 |
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|
8,681 |
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|
37,941 |
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|
|
40,130 |
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Research
and development |
|
1,800 |
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|
1,204 |
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|
|
7,347 |
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|
|
5,263 |
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Total
operating expenses |
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18,357 |
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|
13,821 |
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|
68,541 |
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|
62,580 |
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Income (loss) from
operations |
|
1,757 |
|
|
|
(1,880 |
) |
|
|
(3,479 |
) |
|
|
2,793 |
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Interest
expense and other expense, net |
|
6,257 |
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|
8,190 |
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|
|
33,419 |
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|
|
33,302 |
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Loss before income
taxes |
|
(4,500 |
) |
|
|
(10,070 |
) |
|
|
(36,898 |
) |
|
|
(30,509 |
) |
Provision for (benefit
from) income taxes |
|
— |
|
|
|
5 |
|
|
|
52 |
|
|
|
2 |
|
Net
loss |
$ |
(4,500 |
) |
|
$ |
(10,075 |
) |
|
$ |
(36,950 |
) |
|
$ |
(30,511 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share: |
$ |
(0.42 |
) |
|
$ |
(0.95 |
) |
|
$ |
(3.48 |
) |
|
$ |
(2.89 |
) |
Shares used in per
share computation: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
10,633 |
|
|
|
10,594 |
|
|
|
10,621 |
|
|
|
10,574 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VIVUS, INC. |
GAAP to NON-GAAP RECONCILIATION |
NET LOSS to EBITDA |
(In thousands) |
(Unaudited) |
|
|
|
|
A
reconciliation between net loss on a GAAP basis and non-GAAP EBITDA
is as follows: |
|
|
|
|
|
Three Months Ended |
|
Year Ended |
|
December 31, |
|
December 31, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Net loss |
$ |
(4,500 |
) |
|
$ |
(10,075 |
) |
|
$ |
(36,950 |
) |
|
$ |
(30,511 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
Interest
expense and other expense, net |
|
6,257 |
|
|
|
8,190 |
|
|
|
33,419 |
|
|
|
33,302 |
|
Depreciation of fixed assets |
|
40 |
|
|
|
64 |
|
|
|
235 |
|
|
|
267 |
|
Amortization of intangible assets |
|
3,638 |
|
|
|
91 |
|
|
|
8,640 |
|
|
|
544 |
|
Share-based compensation expense |
|
635 |
|
|
|
721 |
|
|
|
3,285 |
|
|
|
2,942 |
|
Provision
for (benefit from) income taxes |
|
— |
|
|
|
5 |
|
|
|
52 |
|
|
|
2 |
|
Non-GAAP
EBITDA |
$ |
6,070 |
|
|
$ |
(1,004 |
) |
|
$ |
8,681 |
|
|
$ |
6,546 |
|
Non-recurring revenue |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(7,500 |
) |
Impact of
change in accounting estimate |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(6,037 |
) |
Non-recurring transaction costs |
|
— |
|
|
|
— |
|
|
|
2,034 |
|
|
|
— |
|
Non-GAAP
Recurring EBITDA |
$ |
6,070 |
|
|
$ |
(1,004 |
) |
|
$ |
10,715 |
|
|
$ |
(6,991 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Use of Non-GAAP Financial Measures
We supplement our condensed consolidated
financial statements presented on a GAAP basis by providing an
additional measure which is considered non-GAAP under applicable
SEC rules. We believe that the disclosure of this non-GAAP measure
provides investors with additional information that reflects the
basis upon which our management assesses and operates our business.
This non-GAAP financial measure is not in accordance with GAAP and
should not be viewed in isolation or as a substitute for GAAP net
loss and is not a substitute for, or superior to, measures of
financial performance performed in conformity with GAAP.
We define non-GAAP EBITDA as net loss before
interest and other expense, depreciation of fixed assets,
amortization of intangible assets, share-based compensation expense
and provision for or benefit from income taxes. We define non-GAAP
Recurring EBITDA as non-GAAP EBITDA adjusted for certain
non-recurring revenues and expenses, such as non-recurring
milestone revenues, non-recurring restructuring and transaction
costs and the one-time impact of changes in accounting estimates or
the impact of new accounting standards. Management believes that
non-GAAP EBITDA is a meaningful indicator of our performance and
provides useful information to investors regarding our results of
operations and financial condition.
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