Record Revenue of $181.1 Million and $53.9
Million for Full Year and Fourth Quarter 2017
Amarin Corporation plc (NASDAQ:AMRN), a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health, today announced
financial results for the quarter and year ended December 31, 2017,
and provided an update on company operations. Key Amarin
achievements in 2017 include:
- Revenue growth: Recognized total revenue of $181.1 million for
2017 comprised of $179.8 million in net product revenue from U.S.
sales of Vascepa® (icosapent ethyl) and $1.3 million in licensing
revenue related to collaborations for the commercialization of
Vascepa outside the United States. The net product revenue for 2017
represents an increase of $50.9 million over 2016. Included in
annual total revenue was $53.9 million recognized in the fourth
quarter of 2017, comprised of $53.5 million in net product revenue
and $0.4 million in licensing revenue. As previously reported,
Amarin has guided that 2018 net product revenue from sales of
Vascepa in the United States is anticipated to be approximately
$230 million without adjustment for the potential impact of
REDUCE-IT results. This guidance for 2018 will be reassessed
after REDUCE-IT results.
- Prescription growth: Increased normalized prescriptions for
Vascepa by 45% and 42% in 2017 compared to 2016 based on data from
Symphony Health and IQVIA (formerly QuintilesIMS),
respectively.
- R&D progress: REDUCE-IT,
Amarin’s potential landmark long-term cardiovascular outcomes
study, is designed to provide data to support a significantly
expanded market opportunity for Vascepa. An important step in
completing this study is having all living patients in the study
visit their clinical site for the final collection of data. In
accordance with the previously defined schedule, such final patient
visits are scheduled to commence March 1, 2018. The company
anticipates reporting top-line results from this study by the end
of the third quarter of 2018.
- Research data: During 2017, Amarin
supported 25 scientific publications or presentations including
four in the fourth quarter of 2017 with additional publications and
presentations anticipated in 2018. Two of the publications in the
fourth quarter of 2017 reported results of real world evidence
studies, both of which reported experience from managed care
databases suggesting that the cost of care and incidence of major
adverse cardiovascular events in statin-treated patients are
considerably higher when patients have high rather than normal
levels of triglycerides.
- Strengthened balance sheet: At December 31, 2017, Amarin
had $73.6 million of cash and cash equivalents. In February 2018,
Amarin received approximately $65.0 million of net proceeds from a
registered offering of our American Depositary Shares (ADSs).
“Amarin’s growth and operating progress in 2017
were substantial and position the company for further value
creation in 2018,” stated John F. Thero, president and chief
executive officer. “In 2018, we anticipate revenues to continue to
grow based on our current promotion of Vascepa and we expect to
significantly expand the promotion of Vascepa assuming the results
of our landmark cardiovascular outcomes study, the REDUCE-IT study,
are successful. Leaders in the medical community share our
interest in learning the results of this study, which results we
expect to learn before the end of Q3 2018.”
Increases in New and Recurring Prescriptions Drive
Steady Commercial Growth
During the fourth quarter, Amarin continued to
see prescription growth and increases in prescription omega-3 and
non-statin market share, particularly among detailed physicians.
Estimated normalized total Vascepa prescriptions, based on data
from Symphony Health and IQVIA (formerly QuintilesIMS), totaled
approximately 394,000 and 406,000, indicating increases of 38% and
40%, respectively, for the three months ended December 31, 2017
compared to the corresponding prior year period. Further,
prescription levels for the full year 2017 represented growth of
approximately 45% and 42%, respectively, from prior year levels
based on data from these sources. These increases in prescription
levels reflect sales and marketing activities of both Amarin and
our Vascepa co-promotion partner, Kowa Pharmaceuticals America,
Inc., with growth driven for the full year and fourth quarter of
2017 by new patient starts, focused message delivery, compelling
supportive data and improved managed care coverage.
REDUCE-IT Cardiovascular Outcomes Study Scheduled to
Read Out Before the End of Q3 2018
Based on scheduled commencement of final patient
site visits on March 1, 2018, Amarin expects study results to be
available and made public before the end of the third quarter of
2018, followed by publication of the results. The company
extends its appreciation to the patients and clinical sites
involved in this important study. Patient enrollment in this study
commenced in 2011. When completed, Amarin estimates that the
average duration of patients in this study of major adverse
cardiovascular events will, as initially projected, be between four
and five years.
This 8,175-patient outcomes study is evaluating
whether treatment with Vascepa reduces cardiovascular events in
patients who despite stabilized statin therapy have elevated
triglyceride levels and other cardiovascular risk factors. The
results of this important trial, if successful, could lead to
improved medical care for tens of millions of patients.
Amarin is positioned to be the first company to complete an
outcomes study in the high cardiovascular risk patient population
being studied in REDUCE-IT.
The primary endpoint of this global,
double-blind study is the time to the first occurrence of a
composite of major adverse cardiovascular events (MACE).
Results will be compared between the Vascepa and placebo
groups. The study is being conducted under a Special Protocol
Assessment (SPA) agreement with the FDA. Amarin is intentionally
blinded to the results of the study and will remain blinded to the
results of the study until after the study is completed and the
database is locked.
Over the multi-year term of this first ever
study of the at-risk patient population being studied in REDUCE-IT,
the number of deaths from cardiovascular disease has further
increased as has the cost of care for cardiovascular disease. In
the United States and most of the world, the number of deaths and
the cost of care resulting from cardiovascular disease are greater
than any other medical condition, more than all cancers
combined1. Vascepa, if proven effective in the REDUCE-IT
study at lowering the incidence of major adverse cardiovascular
events, is positioned to potentially become a cost-effective
alternative for preventing such tragic and expensive events in
millions of patients who are at risk despite the current standard
of care.
As detailed in the Investor Relations section of
the company’s website at www.amarincorp.com, there is substantial
epidemiological, genetic and clinical data supporting that the
broad positive effects of Vascepa on biomarkers, as demonstrated in
Phase 3 studies, should translate into positive results in the
REDUCE-IT study. As is true for any pioneering therapy, there
are risks and uncertainties whenever addressing a population which
has not been previously studied. Earlier generation therapies have
not been prospectively studied in the REDUCE-IT patient population
and are limited by data which shows that while they lower
triglyceride levels in patients with high triglycerides, in doing
so they raise bad cholesterol (LDL-cholesterol) or have
tolerability issues or other safety concerns which may discourage
their further study in this population. Vascepa is unique
and, Amarin believes, well positioned for potential success in the
REDUCE-IT study.
Financial Update
Net product revenue for the three months ended
December 31, 2017 and 2016 was $53.5 million and $38.4 million,
respectively. Net product revenue for the years ended
December 31, 2017 and 2016 was $179.8 million and $129.0 million,
respectively. Increased revenue is mainly attributed to increased
Vascepa prescriptions.
In addition, Amarin recognized licensing revenue
of $1.3 million and $1.1 million for the years ended December 31,
2017 and 2016, respectively, related to agreements for the
commercialization of Vascepa outside the United States. Amarin's
partner for Vascepa in China recently commenced a clinical trial in
China of Vascepa studying patients with triglyceride levels >500
mg/dL.
Cost of goods sold for the three months ended
December 31, 2017 and 2016 was $13.4 million and $10.2 million,
respectively. Cost of goods sold for the years ended December
31, 2017 and 2016 was $45.0 million and $34.4 million,
respectively. Gross margin on product sales was 75% in the
quarter and year ended December 31, 2017, as compared to 74% and
73% in the quarter and year ended December 31, 2016, respectively.
This improvement was primarily driven by lower unit cost API
purchases.
Selling, general and administrative expenses for
the years ended December 31, 2017 and 2016 were $134.5 million
$111.4 million, respectively. This increase is due primarily to
increased promotional activities, including commercial spend for
anticipated expansion following successful REDUCE-IT results, and
increased legal costs, which are subject to quarterly
variability.
Research and development expenses for the years
ended December 31, 2017 and 2016 were $47.2 million and $50.0
million, respectively. This decrease is primarily due to timing of
the REDUCE-IT trial and related costs.
Amarin reported a net loss of $67.9 million in
the year ended December 31, 2017, or basic and diluted loss per
share of $0.25. This net loss included $14.0 million in non-cash
stock-based compensation expense. This net loss, as previously
guided, also included an allowance offsetting deferred income
taxes. This non-cash allowance represents most of the
company’s reported $13.0 million provision for income taxes.
For the year ended December 31, 2016, Amarin reported a net loss of
$86.4 million, or basic and diluted loss per share of $0.41.
This net loss included $13.6 million in non-cash stock-based
compensation expense, an $8.2 million non-cash gain on the change
in fair value of derivatives, and a provision for income taxes of
$13.0 million, the majority of which was non-cash.
As of December 31, 2017, the company had $45.3
million in net accounts receivable ($57.8 million in gross accounts
receivable before allowances and reserves), which are current, and
$30.3 million in inventory. As of December 31, 2017, the company
had accounts payable and accrued expenses of $84.1 million which
increased from $43.8 million at December 31, 2016 primarily due to
company growth, including the magnitude and timing of rebates and
certain supplier payments associated with supporting increased
revenue.
As of December 31, 2017, Amarin had
approximately 271.0 million ADSs and ordinary shares outstanding,
32.8 million common share equivalents of Series A Convertible
Preferred Shares outstanding and approximately 24.1 million
equivalent shares underlying stock options at a weighted-average
exercise price of $3.26, as well as 12.0 million equivalent shares
underlying restricted or deferred stock units. Additionally, in
February 2018 Amarin completed a registered offering of
approximately 19.2 million ADSs.
Financial Guidance
Amarin provided financial guidance for 2018 in
its press release on January 4, 2018. That guidance is
unchanged, except that Amarin’s recently completed financing has
firmed up its commitment to increase awareness of Vascepa through
additional promotional efforts beginning in Q2 2018, including
piloting multi-media awareness initiatives to assess the potential
effectiveness of such communication for potential broader use after
REDUCE-IT results, assuming study success. The incremental cost of
this pilot promotion prior to REDUCE-IT results is estimated at
between $15 and $20 million. The priority will be to
establish brand awareness with consumers and healthcare
professionals, most of whom are currently unfamiliar with
Vascepa. The company believes that creating greater Vascepa
awareness prior to REDUCE-IT results will help the value of
REDUCE-IT results be better appreciated. Amarin has not done any
promotion of this nature in the past.
Amarin's core strategy is as follows: 1) Continue to
aggressively grow revenues; 2) Complete the REDUCE-IT study on
a timely basis while maximizing the likelihood of success; and
3) Operate in a cost-effective, opportunistic manner.
The company's outlook for 2018 is divided
between the timeframes before and after anticipated results of the
REDUCE-IT cardiovascular outcomes study. REDUCE-IT is
expected to be completed in 2018 with top-line results reported
before the end of Q3 2018. The degree of cardiovascular relative
risk reduction achieved in this study will impact future levels of
Vascepa promotion and revenues. Assuming a statistically
significant relative risk reduction of at least 15% is achieved
and, as expected, there is no major negative safety issue
identified, the company intends to expand its U.S.-based sales
force promptly after the outcomes study results. This
post-REDUCE-IT plan would increase Amarin’s current level of
approximately 150 sales representatives calling on targeted
physicians in limited geographies, to more than 400 sales
representatives with considerably broader reach and increased
frequency of sales calls. Amarin plans to support this sales force
growth with increased promotional outreach to consumers and other
expanded promotion of Vascepa.
The financial guidance described below reflects
expectations prior to the impact of REDUCE-IT results. The company
intends to update guidance after such outcomes study results are
known. The company begins 2018 expecting to achieve the
following results:
U.S. Product Revenue:
Without adjustment for the impact of REDUCE-IT results, the company
estimates full year 2018 net product revenue from Vascepa will grow
approximately $50 million to reach
approximately $230 million. Amarin estimates that in each
quarter of 2018, net product revenue should grow approximately 30%
or more as compared to the same quarter in 2017. This
guidance for 2018 will be updated after REDUCE-IT results.
The company anticipates quarterly variability to continue with
respect to net product revenue. For example, seasonal factors
associated with large beginning of the year insurance deductibles
for patients under certain medical insurance plans have
historically slowed prescription rates in the first quarter of each
year. Amarin estimates that its net product revenue in Q1 2018 will
be between $45 and $48 million, representing
significant growth over the same period in the prior year. Further,
consistent with prior year results, Amarin anticipates that Q2 2018
results will rebound on a consecutive quarter basis with net
product revenue anticipated in Q2 2018 of $55 million or
more.
R&D Spending: The REDUCE-IT
study, which commenced in December 2011, is expected to be
completed in 2018 with top-line results made public before the end
of Q3 2018 and, if all goes as expected, publication and
presentation of the results at a medical congress before the end of
2018. REDUCE-IT R&D costs generally have been
between $10 and $15 million per quarter with
variability from quarter to quarter. This level and quarterly
variability of spending are likely to continue until the study is
completed and published. Realized savings after patients in
the study complete their final study visits are anticipated to be
offset by costs of preparing for publication and other activities
intended to support robust reporting and presentation of results
from this first ever prospective study of the large population of
patients being evaluated in REDUCE-IT. While the company is
evaluating various potential product development projects to
emphasize after REDUCE-IT, the primary thrust of the company's
development efforts in 2018 are anticipated to be related to
completing the REDUCE-IT study and then publishing and presenting
its results.
SG&A Spending: After
learning the results of the REDUCE-IT study, assuming the results
are positive, the company intends to significantly expand the size
of its U.S.-based sales force and to otherwise significantly
expand commercial promotion of Vascepa in the United States,
including direct to consumer promotion. Prior to REDUCE-IT results,
the company, consistent with its growth over the past four years,
will work to continue to increase sales productivity from its
existing field team. During the period prior to REDUCE-IT
results, the company intends to continue to expand medical
education and market awareness initiatives. In addition, as
described above, Amarin intends to pilot test new promotional
initiatives for potential broader application following REDUCE-IT
results.
Balance Sheet: Based on its
current cash balance and anticipated net cash flows, Amarin
believes that it has adequate cash to get to REDUCE-IT results,
including top-line results and subsequent presentation at a medical
congress. The extent to which, if any, additional capital may be
needed to expand promotion of Vascepa following REDUCE-IT results
cannot currently be determined. In some respects, the more
favorable the results are from REDUCE-IT, the greater the amount
that the company may determine it is best to spend on product
promotion. During the period of 2018 that is prior to
REDUCE-IT results, the company expects to be net cash flow
positive, excluding interest, royalties and payments for REDUCE-IT
R&D and other costs incurred (mostly medical affairs and
supply-related expenditures) in preparation for positive REDUCE-IT
results. However, these results will continue to vary from quarter
to quarter, including, as seen in prior years, the impact of
certain annual payments in Q1 which will likely result in Q1 2018
net cash outflows exceeding those in Q4 2017. The company
anticipates that accounts receivable will grow in proportion to net
revenue growth and remain current. The company anticipates
that inventory balances will grow in proportion to anticipated
revenue growth, plus up to approximately $10 million for
incremental inventory build prior to REDUCE-IT results. The
company periodically reviews proposals to borrow against accounts
receivable and inventory balances, and such opportunities may
expand after REDUCE-IT results. However, no commitment currently
exists for such arrangements.
Conference Call and Webcast Information
Amarin will host a conference call
at 7:30 a.m. ET today, February 27, 2018. The
call will be webcast live with slides and accessible through the
investor relations section of the company’s website at
www.amarincorp.com. The call can also be heard via telephone by
dialing 877-407-8033 within the United States or 201-689-8033 from
outside the United States. A replay of the call will be made
available for a period of two weeks following the conference call.
To hear a replay of the call, dial 877-481-4010. A replay of the
call will also be available through the company's website shortly
after the call. For both dial-in numbers please use conference PIN
25598.
About Amarin
Amarin Corporation plc is a biopharmaceutical
company focused on the commercialization and development of
therapeutics to improve cardiovascular health. Amarin's
product development program leverages its extensive experience in
lipid science and the potential therapeutic benefits of
polyunsaturated fatty acids. Vascepa® (icosapent ethyl),
Amarin's first FDA-approved product, is a highly-pure, omega-3
fatty acid product available by prescription. For more
information about Vascepa visit www.vascepa.com. For more
information about Amarin visit www.amarincorp.com.
About VASCEPA® (icosapent ethyl)
Capsules
Vascepa® (icosapent ethyl) capsules are a
single-molecule prescription product consisting of the omega-3 acid
commonly known as EPA in ethyl-ester form. Vascepa is not fish oil,
but is derived from fish through a stringent and complex
FDA-regulated manufacturing process designed to effectively
eliminate impurities and isolate and protect the single molecule
active ingredient. Vascepa, known in scientific literature as
AMR101, has been designated a new chemical entity by the FDA.
Amarin has been issued multiple patents internationally based on
the unique clinical profile of Vascepa, including the drug’s
ability to lower triglyceride levels in relevant patient
populations without raising LDL-cholesterol levels.
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is
indicated as an adjunct to diet to reduce triglyceride (TG) levels
in adult patients with severe (≥500 mg/dL)
hypertriglyceridemia.
- The effect of Vascepa on the risk
for pancreatitis and cardiovascular mortality and morbidity in
patients with severe hypertriglyceridemia has not been
determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- Use with caution in patients with
known hypersensitivity to fish and/or shellfish.
- The most common reported adverse
reaction (incidence > 2% and greater than placebo) was
arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no
reported adverse reaction > 3% and greater than placebo.
- Patients receiving treatment with
Vascepa and other drugs affecting coagulation (e.g., anti-platelet
agents) should be monitored periodically.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
therapy.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
1-800-FDA-1088.
FULL VASCEPA PRESCRIBING INFORMATION CAN BE
FOUND AT WWW.VASCEPA.COM.
Vascepa has been approved for use by the United
States Food and Drug Administration (FDA) as an adjunct to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Nothing in this press release should
be construed as promoting the use of Vascepa in any indication that
has not been approved by the FDA.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.1,
2
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease. 3, 4, 5, 6
Leading clinical investigations seeking to
address cardiovascular risk reduction beyond lowering LDL-C focus
on interrupting the atherosclerotic process (e.g., plaque formation
and instability) by beneficially affecting other lipid, lipoprotein
and inflammation biomarkers and cellular functions thought to be
related to atherosclerosis and cardiovascular events.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements about the future promotion and
commercialization plans for Vascepa; expectations regarding future
Vascepa sales and resulting revenue and company expenses for 2018
and inclusive quarterly periods; expectations related to multiple
elements of Amarin's 2018 financial outlook such as anticipated
expenses, cash balances and financing needs under various
scenarios; expectations for continued event rates, timing of last
patient visits, results and related announcement timing associated
with Amarin's REDUCE-IT cardiovascular outcomes study; expectations
related to the successful completion of REDUCE-IT; and statements
regarding the potential efficacy, safety and therapeutic benefits
of Vascepa, regulatory reviews and approvals of Vascepa
internationally and related commercial potential. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. In particular, as
disclosed in its previous filings with the U.S. Securities and
Exchange Commission, Amarin's ability to effectively commercialize
Vascepa will depend in part on efforts of third parties, its
ability to create market demand for Vascepa through education,
marketing and sales activities, to achieve market acceptance of
Vascepa in new and current uses, to receive adequate levels of
reimbursement from third-party payers, to develop and maintain a
consistent source of commercial supply at a competitive price, to
continue to effectively finance its business, to comply with legal
and regulatory requirements in connection with the sale and
promotion of Vascepa and to maintain patent protection for Vascepa.
Among the factors that could cause actual results to differ
materially from those described or projected herein include the
following: uncertainties associated generally with research and
development, clinical trials and related regulatory approvals; the
risk that related cost may increase beyond expectations; the risk
that Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for intended uses; the
risk that patents may not be upheld in patent litigation and
applications may not result in issued patents sufficient to protect
the Vascepa franchise. A further list and description of these
risks, uncertainties and other risks associated with an investment
in Amarin can be found in Amarin's filings with the U.S. Securities
and Exchange Commission, including its most recent Annual Report on
Form 10-K. Existing and prospective investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Amarin undertakes no obligation
to update or revise the information contained in this press
release, whether as a result of new information, future events or
circumstances or otherwise.
Availability of Other Information About
Amarin
Investors and others should note that Amarin
communicates with its investors and the public using the company
website (http://www.amarincorp.com/), the investor relations
website (http://investor.amarincorp.com/), including but not
limited to investor presentations and investor FAQs, Securities and
Exchange Commission filings, press releases, public conference
calls and webcasts. The information that Amarin posts on
these channels and websites could be deemed to be material
information. As a result, Amarin encourages investors, the
media, and others interested in Amarin to review the information
that is posted on these channels, including the investor relations
website, on a regular basis. This list of channels may be
updated from time to time on Amarin’s investor relations website
and may include social media channels. The contents of
Amarin’s website or these channels, or any other website that may
be accessed from its website or these channels, shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933.
References
1 American Heart Association. 2018. Disease and
Stroke Statistics-2018 Update.
2 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.
3 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
4 Toth PP, Granowitz C, Hull M, et al. High triglycerides
increase cardiovascular events, medical costs, and resource
utilization in a real-world analysis of statin-treated patients
with high cardiovascular risk and well-controlled low-density
lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl
1):A15187.
5 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
6 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular
disease. Lancet. 2014; 384: 626–635.
Amarin Contact Information
Investor Relations:Elisabeth Schwartz Investor
Relations and Corporate Communications Amarin Corporation plc
In U.S.: +1 (908) 719-1315 investor.relations@amarincorp.com
Lee M. Stern Trout Group In U.S.: +1 (646) 378-2992
lstern@troutgroup.com Media Inquiries: Kristie Kuhl Finn Partners
In U.S.: +1 (212) 583-2791 Kristie.kuhl@finnpartners.com
|
|
|
|
CONSOLIDATED BALANCE SHEET DATA |
|
|
(U.S. GAAP) |
|
|
Unaudited* |
|
|
|
|
|
|
|
|
|
|
|
December 31, 2017 |
|
December 31, 2016 |
|
|
|
|
(in thousands) |
|
|
ASSETS |
|
|
|
|
|
|
Current
Assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
73,637 |
|
|
$ |
98,251 |
|
|
|
Restricted cash |
|
|
600 |
|
|
|
600 |
|
|
|
Accounts
receivable, net |
|
|
45,318 |
|
|
|
19,985 |
|
|
|
Inventory |
|
|
30,260 |
|
|
|
20,507 |
|
|
|
Prepaid
and other current assets |
|
|
3,455 |
|
|
|
6,983 |
|
|
|
Total
current assets |
|
|
153,270 |
|
|
|
146,326 |
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net |
|
|
28 |
|
|
|
78 |
|
|
|
Deferred
tax assets |
|
|
— |
|
|
|
11,082 |
|
|
|
Other
long-term assets |
|
|
174 |
|
|
|
741 |
|
|
|
Intangible asset, net |
|
|
8,126 |
|
|
|
8,772 |
|
|
|
TOTAL ASSETS |
|
$ |
161,598 |
|
|
$ |
166,999 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
25,155 |
|
|
$ |
6,062 |
|
|
|
Accrued
expenses and other current liabilities |
|
|
58,902 |
|
|
|
37,720 |
|
|
|
Current
portion of exchangeable senior notes, net of discount |
|
|
481 |
|
|
|
15,351 |
|
|
|
Current
portion of long-term debt from royalty-bearing instrument |
|
|
22,348 |
|
|
|
15,944 |
|
|
|
Deferred
revenue, current |
|
|
1,644 |
|
|
|
1,172 |
|
|
|
Total
current liabilities |
|
|
108,530 |
|
|
|
76,249 |
|
|
|
|
|
|
|
|
|
|
Long-Term
Liabilities: |
|
|
|
|
|
|
Exchangeable senior notes, net of discount |
|
|
28,992 |
|
|
|
— |
|
|
|
Long-term
debt from royalty-bearing instrument |
|
|
70,834 |
|
|
|
85,155 |
|
|
|
Deferred
revenue, long-term |
|
|
17,192 |
|
|
|
13,943 |
|
|
|
Other
long-term liabilities |
|
|
1,150 |
|
|
|
710 |
|
|
|
Total
liabilities |
|
|
226,698 |
|
|
|
176,057 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ Deficit: |
|
|
|
|
|
|
Preferred
stock |
|
|
24,364 |
|
|
|
24,364 |
|
|
|
Common
stock |
|
|
208,768 |
|
|
|
207,166 |
|
|
|
Additional paid-in capital |
|
|
977,866 |
|
|
|
964,914 |
|
|
|
Treasury
stock |
|
|
(4,229 |
) |
|
|
(1,498 |
) |
|
|
Accumulated deficit |
|
|
(1,271,869 |
) |
|
|
(1,204,004 |
) |
|
|
Total
stockholders’ deficit |
|
|
(65,100 |
) |
|
|
(9,058 |
) |
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
$ |
161,598 |
|
|
$ |
166,999 |
|
|
|
|
|
|
|
|
|
|
* Unaudited
as standalong schedule; copied from consolidated financial
statements. |
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
DATA |
|
(U.S. GAAP) |
|
|
|
Unaudited |
|
Unaudited* |
|
|
|
Three months ended
December 31, |
|
Year Ended December 31, |
|
|
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
|
|
2017 |
|
|
2016 |
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
53,482 |
|
|
$ |
38,403 |
|
|
$ |
179,825 |
|
|
$ |
128,966 |
|
|
Licensing revenue |
|
384 |
|
|
|
293 |
|
|
|
1,279 |
|
|
|
1,118 |
|
|
Total revenue, net |
|
53,866 |
|
|
|
38,696 |
|
|
|
181,104 |
|
|
|
130,084 |
|
|
Less: Cost
of goods sold |
|
13,432 |
|
|
|
10,155 |
|
|
|
44,952 |
|
|
|
34,363 |
|
|
Gross margin |
|
40,434 |
|
|
|
28,541 |
|
|
|
136,152 |
|
|
|
95,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
35,639 |
|
|
|
31,225 |
|
|
|
134,549 |
|
|
|
111,372 |
|
|
Research and development (1) |
|
11,947 |
|
|
|
10,177 |
|
|
|
47,158 |
|
|
|
49,975 |
|
|
Total operating expenses |
|
47,586 |
|
|
|
41,402 |
|
|
|
181,707 |
|
|
|
161,347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(7,152 |
) |
|
|
(12,861 |
) |
|
|
(45,555 |
) |
|
|
(65,626 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on change in fair value of derivative liabilities (2) |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
8,170 |
|
|
Interest expense, net |
|
(2,240 |
) |
|
|
(2,190 |
) |
|
|
(9,337 |
) |
|
|
(18,443 |
) |
|
Other (expense) income, net |
|
(26 |
) |
|
|
(101 |
) |
|
|
74 |
|
|
|
(482 |
) |
|
Loss from operations before taxes |
|
(9,418 |
) |
|
|
(15,152 |
) |
|
|
(54,818 |
) |
|
|
(76,381 |
) |
|
Provision for income taxes (3) |
|
(13,047 |
) |
|
|
(12,301 |
) |
|
|
(13,047 |
) |
|
|
(9,969 |
) |
|
Net loss |
$ |
(22,465 |
) |
|
$ |
(27,453 |
) |
|
$ |
(67,865 |
) |
|
$ |
(86,350 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
(0.08 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.41 |
) |
|
Diluted |
$ |
(0.08 |
) |
|
$ |
(0.10 |
) |
|
$ |
(0.25 |
) |
|
$ |
(0.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
270,906 |
|
|
|
269,223 |
|
|
|
270,652 |
|
|
|
211,874 |
|
|
Diluted |
|
270,906 |
|
|
|
269,223 |
|
|
|
270,652 |
|
|
|
211,874 |
|
|
* Unaudited as standalong schedule, copied from
consolidated financial statements. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excluding non-cash
stock-based compensation, selling, general and administrative
expenses were $122,711 and $100,011 for 2017 and 2016,
respectively, and research and development expenses were $45,036
and $47,723, respectively, for the same periods. Excluding non-cash
stock-based compensation as well as co-promotion fees paid to the
company's U.S. co-promotion partner, selling, general and
administrative expenses were $100,204 and $82,042 for 2017 and
2016, respectively. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2) Non-cash gains and losses result from
changes in the fair value of long-term debt derivative
liabilities. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) Included in the
provisions for the years ended December 31, 2017 and 2016 is
non-cash tax expense related to increases in our valuation
allowance against deferred tax assets. |
|
|
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