Third Quarter Net Product Revenue Up 52% vs.
Prior Year Period
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 three and nine months ended September 30,
2016, and provided an update on company operations.
Key Amarin achievements since June 30, 2016 include:
- Revenue growth: Recognized $32.4 million in net product revenue
from Vascepa® (icosapent ethyl) sales in Q3 2016 compared to $21.3
million in Q3 2015, an increase of 52%.
- Prescription growth: Increased normalized prescriptions, based
on data from Symphony Health Solutions and IMS Health, by 54% and
56%, respectively, compared to Q3 2015.
- R&D progress: REDUCE-IT cardiovascular outcomes study
continues to track towards achieving, before the end of 2017, the
onset of the targeted 1,612 aggregate primary cardiovascular events
for completion of the study. As expected, no modification to the
study was recommended based on the first pre-specified interim
efficacy analysis, the “60% review” as completed in September by
the study’s independent data monitoring committee (DMC).
- Vascepa franchise extension: Announced the introduction,
beginning in October, of a smaller 0.5-gram capsule size for
Vascepa that is now available in retail pharmacies nationwide. The
smaller capsule is in addition to the original and currently
available 1-gram size Vascepa capsule as an alternative for the
subset of patients who prefer a smaller capsule.
- Strengthened balance sheet: Through an equity financing of
approximately $65 million in August 2016 followed by a mandatory
exchange of $150 million in previously outstanding debt, Amarin
strengthened its balance sheet to support completion of the
REDUCE-IT trial while remaining on course to become cash flow
positive in 2017 from commercial operations, excluding REDUCE-IT
costs, interest and royalties.
“Q3 2016 was another quarter of considerable progress for
Amarin. Prescription growth for Vascepa was again greater than 50%
compared to the corresponding period of last year. REDUCE-IT
continues to progress as expected and is now approximately one year
from reaching the onset of 1,612 primary cardiovascular events
which is the completion target for the study. We are pleased
that over 100,000 patients are currently using Vascepa each month
to support their health,” stated John F. Thero, president and chief
executive officer. “We are working to increase usage of Vascepa
based on the drug’s already established positive efficacy, safety
and tolerability profile while increasingly preparing for a market
expanding opportunity for Vascepa upon achieving anticipated
successful results in the REDUCE-IT study.”
Commercial Update
During the third quarter, Amarin continued to see substantial
prescription growth and steady increases in prescription omega-3
and non-statin market share, particularly among detailed
physicians. Vascepa growth continues to be driven by focused
message delivery, compelling supportive data and improved managed
care coverage.
Amarin recorded net product revenue of $32.4 million and $21.3
million during the three months ended September 30, 2016 and 2015,
respectively, an increase of $11.1 million, or 52%. This increase
in revenue was driven primarily by an increase in estimated
normalized total Vascepa prescriptions. Based on data provided by
Symphony Health Solutions and IMS Health, estimated normalized
Vascepa prescriptions totaled approximately 260,000 and 274,000,
respectively, for the three months ended September 30, 2016. These
prescription levels represent growth of approximately 54% and 56%,
respectively, from prior year levels, and approximately 13% and
10%, respectively, compared to Q2 2016.
Inventory levels at wholesalers tend to fluctuate based on
seasonal factors, prescription trends and other factors. The level
of inventories held by Amarin’s distributors as of September 30,
2016 decreased as compared to inventories held at the beginning of
the quarter calculated based on estimated days of Vascepa sales on
hand. Amarin estimates that product revenues during the quarter
ended September 30, 2016 were negatively impacted by approximately
$0.5 million to $0.8 million due to a net overall decrease in
distributor inventory levels during the quarter. The decrease in
distributor inventory levels during the quarter ended September 30,
2016 follows an estimated $2.9 million to $3.2 million increase in
the quarter ended June 30, 2016.
REDUCE-IT Trial Progressing on Schedule
The REDUCE-IT cardiovascular outcomes trial continues to
progress on schedule. Amarin expects the onset of the final primary
cardiovascular event to occur in or about the fourth quarter of
2017 with the publication of results anticipated in 2018. The
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. 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) and 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.
The first interim efficacy and safety analysis by the DMC
concluded in September 2016 after the occurrence of approximately
60% of targeted primary events. As expected, the DMC recommended
that the trial continue as planned without modification.
Preparations for the second planned interim efficacy analysis will
be triggered by the onset of approximately 80% of the target
aggregate number of primary cardiovascular events in the study.
Based on historical event rates, Amarin anticipates that the onset
of approximately 80% of events will occur in the first half of
2017, with the second pre-specified interim efficacy and safety
analysis by the DMC expected in or about Q3 2017. As is typical of
interim analyses, the statistical threshold for defining
overwhelming efficacy on the primary endpoint that would call for
stopping the study early in connection with such analysis is
considerably higher than the threshold for defining statistical
significance after the expected completion of the study.
Accordingly, Amarin continues to expect that the 80% interim
analysis will result in a recommendation by the DMC to continue the
REDUCE-IT study as planned to completion of 100% planned
events.
Amarin will remain blinded to results of the REDUCE-IT study
until after the study is stopped and the database is locked at
either the second interim analysis or at the final analysis.
Financial Update
Net product revenue for the three months ended September 30,
2016 and 2015 was $32.4 million and $21.3 million,
respectively. Net product revenue for the nine months ended
September 30, 2016 and 2015 was $90.6 million and $54.6 million,
respectively. These increases in net product revenue were
primarily attributable to increases both in new and recurring
prescriptions of Vascepa driven by increased sales productivity.
In addition, Amarin recognized licensing revenue of $0.8 million
and $0.5 million in the nine months ended September 30, 2016 and
2015, respectively, related to agreements for the commercialization
of Vascepa outside the United States. Amarin’s partners for China
and for the Middle East and North Africa are working towards
regulatory approval of Vascepa in their respective territories.
Cost of goods sold for the three months ended September 30, 2016
and 2015 was $8.5 million and $7.5 million, respectively.
Cost of goods sold for the nine months ended September 30, 2016 and
2015 was $24.2 million and $19.5 million, respectively. Gross
margin on product sales improved to 74% and 73% in the three and
nine months ended September 30, 2016, respectively, as compared to
65% and 64% in the three and nine months ended September 30, 2015,
respectively. The improvement in gross margin on product sales was
primarily driven by lower active pharmaceutical ingredient
cost.
Selling, general and administrative (SG&A) expenses in the
nine months ended September 30, 2016 and 2015 were $80.1 million
and $77.5 million, respectively. The increase in SG&A
expenses primarily reflects an increase in co-promotion fees
payable to Kowa Pharmaceuticals America, Inc.
Research and development expenses in the nine months ended
September 30, 2016 and 2015 were $39.8 million and $37.7 million,
respectively. This increase in expenses was primarily driven by
quarterly variability in costs related to the REDUCE-IT
study.
Under GAAP, Amarin reported a net loss applicable to common
shareholders of $15.8 million in the third quarter of 2016, or
basic and diluted loss per share of $0.08. This net loss
included $3.4 million in non-cash stock-based compensation expense
and a $3.6 million non-cash gain on the change in fair value of
derivatives. Amarin reported a net loss applicable to common
shareholders of $32.3 million in the third quarter of 2015, or
basic and diluted loss per share of $0.18. This net loss
included $3.9 million in non-cash stock-based compensation expense,
a $0.2 million non-cash loss on the change in fair value of
derivatives, and a $1.6 million charge for a non-cash deemed
dividend for accounting purposes.
Under GAAP, Amarin reported a net loss applicable to common
shareholders of $58.9 million in the nine months ended September
30, 2016, or basic and diluted loss per share of $0.31. This
net loss included $10.4 million in non-cash stock-based
compensation expense and an $8.2 million non-cash gain on the
change in fair value of derivatives. For the nine months
ended September 30, 2015, Amarin reported a net loss applicable to
common shareholders of $127.2 million, or basic and diluted loss
per share of $0.71. This net loss included $10.2 million in
non-cash stock-based compensation expense, a $0.4 million non-cash
loss on the change in fair value of derivatives, and $33.9 million
in charges for non-cash deemed dividends for accounting
purposes.
Excluding non-cash gains or losses for stock-based compensation,
change in fair value of derivatives, and the non-cash deemed
dividend, non-GAAP adjusted net loss was $16.0 million for the
third quarter of 2016, or non-GAAP adjusted basic and diluted loss
per share of $0.08, compared to non-GAAP adjusted net loss of $26.5
million for the third quarter of 2015, or non-GAAP adjusted basic
and diluted loss per share of $0.14.
Excluding non-cash gains or losses for stock-based compensation,
warrant compensation, change in fair value of derivatives, and the
non-cash deemed dividends, non-GAAP adjusted net loss was $56.7
million for the nine months ended September 30, 2016, or non-GAAP
adjusted basic and diluted loss per share of $0.29, compared to
non-GAAP adjusted net loss of $82.8 million for the nine months
ended September 30, 2015, or non-GAAP adjusted basic and diluted
loss per share of $0.46.
Amarin reported cash and cash equivalents of $117.6 million as
of September 30, 2016. The cash balance includes an increase of
$64.6 million in net proceeds from an equity financing completed in
August. The primary purpose of that financing was to fund REDUCE-IT
to completion. During the quarter ended September 30, 2016, net
cash used in operating activities, including REDUCE-IT costs, was
$18.7 million, or approximately $2.7 million excluding REDUCE-IT
costs, interest and royalties. As of September 30, 2016, the
company had $17.5 million in net accounts receivable ($22.5 million
in gross accounts receivable before allowances and reserves) and
$19.8 million in inventory.
As of September 30, 2016, Amarin had approximately 269.2 million
American Depository Shares (ADSs) and ordinary shares outstanding,
32.8 million common share equivalents of Series A Convertible
Preferred Shares outstanding and approximately 21.2 million
equivalent shares underlying stock options at a weighted-average
exercise price of $3.36, as well as 10.3 million equivalent shares
underlying restricted or deferred stock units.
Conference call and webcast
information
Amarin will host a conference call at 7:30 a.m.
ET today, November 3, 2016. The call will be
webcast live with slides and accessible through the investor
relations section of the company’s website at www.amarincorp.com,
or 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 877-660-6853
(inside the United States) or 201-612-7415 (outside the United
States). 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 ID 13649077.
Use of non-GAAP adjusted financial
information
Included in this press release and the conference call
referenced above are non-GAAP adjusted financial information as
defined by U.S. Securities and Exchange Commission Regulation
G. The GAAP financial measure most directly comparable to
each non-GAAP adjusted financial measure used or discussed, and a
reconciliation of the differences between each non-GAAP adjusted
financial measure and the comparable GAAP financial measure, is
included in this press release after the condensed consolidated
financial statements.
Non-GAAP adjusted net loss was derived by taking GAAP net loss
and adjusting it for non-cash gains or losses for stock-based
compensation, warrant compensation, change in fair value of
derivatives, and non-cash deemed dividends. Management uses
these non-GAAP adjusted financial measures for internal reporting
and forecasting purposes, when publicly providing its business
outlook, to evaluate the company’s performance and to evaluate and
compensate the company’s executives. The company has provided these
non-GAAP financial measures in addition to GAAP financial results
because it believes that these non-GAAP adjusted financial measures
provide investors with a better understanding of the company's
historical results from its core business operations.
While management believes that these non-GAAP adjusted financial
measures provide useful supplemental information to investors
regarding the underlying performance of the company’s business
operations, investors are reminded to consider these non-GAAP
measures in addition to, and not as a substitute for, financial
performance measures prepared in accordance with GAAP.
Non-GAAP measures have limitations in that they do not reflect all
of the amounts associated with the company’s results of operations
as determined in accordance with GAAP. In addition, it should
be noted that these non-GAAP financial measures may be different
from non-GAAP measures used by other companies, and management may
utilize other measures to illustrate performance in the future.
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.
Amarin's clinical program includes a commitment to an ongoing
outcomes study. 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 1-gram or 0.5-gram 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 is known in scientific literature as
AMR101.
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. Vascepa is under various stages of
development for potential use in other indications that have not
been approved by the FDA. 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.
Forward-looking statements
This press release contains forward-looking statements,
including statements about the future commercialization of Vascepa;
expectations regarding TRx trends and wholesaler inventory levels;
expectations regarding Vascepa sales, revenue, costs and other
financial metrics; expectations related to Amarin’s anticipated
financial position and outlook in 2016 and the years that follow
such as the company’s potential to be cash flow positive from
commercial operations in 2017; expectations for event rates,
interim data reviews, results and related announcements with
respect to Amarin’s REDUCE-IT cardiovascular outcomes study;
expectations related to the interim and final outcome of the
REDUCE-IT study and the anticipated successful completion of the
REDUCE-IT study; and statements regarding the potential efficacy,
safety and therapeutic benefits of Vascepa. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. In particular,
as disclosed in filings with the U.S. Securities and Exchange
Commission, these risks and uncertainties include the following:
Amarin’s ability to effectively commercialize Vascepa will depend
in part on its ability to continue to effectively finance its
business (including the REDUCE-IT study), is based on management’s
current expectations concerning TRx trends and wholesaler inventory
levels, which tend to fluctuate based on seasonal factors,
prescription trends and other factors and accordingly may be lower
in subsequent periods, efforts of third parties, its ability to
create market demand for Vascepa through education, marketing and
sales activities, to achieve market acceptance of Vascepa, 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 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
historical REDUCE-IT clinical trial event rates may not be
predictive of future results and related cost may increase beyond
expectations; the risk that future litigation, court decisions and
interpretation and interactions with regulatory authorities may
impact Vascepa marketing and sales rights and efforts; the risk
that Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for cardiovascular risk
reduction; and the risk that patents may not be upheld in patent
litigation and applications may not result in issued patents.
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 Quarterly Report on Form
10-Q. 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.
Important information regarding prescription data and
product revenue
The historical prescription data provided in this press release
is based on data published by third parties. References to
normalized prescriptions equate to one month’s supply of 1-gram
Vascepa capsules (120 count). Although Amarin believes these data
are prepared on a period to period basis in a manner that is
generally consistent and that such results are indicative of
current prescription trends, these data are based on estimates and
should not be relied upon as definitive. These data may overstate
or understate actual prescriptions. Based on other data available
to Amarin and the history of such third-party prescription
estimates in similar stages of launch of other pharmaceutical
products, Amarin believes that the trends provided by this
information can be useful to gauge current prescription levels.
There is a limited amount of information available to determine the
actual number of total prescriptions for prescription products like
Vascepa. Amarin believes that investors should view these data with
caution, as data for this single and limited period may not be
representative of a trend consistent with the results presented or
otherwise predictive of future results. Seasonal fluctuations in
pharmaceutical sales may affect future prescription trends of
Vascepa on a monthly and quarterly basis, for example, as could
changes in prescriber sentiment and other factors. Amarin believes
investors should consider its results during this quarter together
with its results over several future quarters, or longer, and in
light of seasonal fluctuations before making an assessment about
potential future performance. The commercialization and
co-promotion of a new pharmaceutical product are complex
undertakings, and Amarin's ability to effectively and profitably
commercialize Vascepa will depend in part on its ability to
continue to generate market demand for Vascepa through education,
marketing and sales activities, its ability to achieve market
acceptance of Vascepa, its ability to generate product revenue and
its ability to receive adequate levels of reimbursement from
third-party payers and its ability to benefit from continued
contributions of its Vascepa co-promotion partner, Kowa
Pharmaceuticals America, Inc. See “Risk Factors—Risks Related
to the Commercialization and Development of Vascepa” included in
Part II, Item 1A. Risk Factors in Amarin’s most recent Quarterly
Report on Form 10-Q.
Availability of other information about
Amarin
Investors and others should note that we communicate with our
investors and the public using our company website
(www.amarincorp.com), our investor relations website
(http://www.amarincorp.com/investor-splash.html), 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 we post on these channels and websites could be
deemed to be material information. As a result, we encourage
investors, the media, and others interested in Amarin to review the
information that we post on these channels, including our investor
relations website, on a regular basis. This list of channels
may be updated from time to time on our investor relations website
and may include social media channels. The contents of our
website or these channels, or any other website that may be
accessed from our website or these channels, shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933.
|
CONSOLIDATED BALANCE SHEET DATA |
|
|
(U.S. GAAP) |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
September 30, 2016 |
|
December 31, 2015 |
|
|
|
|
(in thousands) |
|
|
ASSETS |
|
|
|
|
|
|
Current
Assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
117,562 |
|
|
$ |
106,961 |
|
|
|
Restricted cash |
|
|
600 |
|
|
|
600 |
|
|
|
Accounts
receivable, net |
|
|
17,504 |
|
|
|
13,826 |
|
|
|
Inventory |
|
|
19,773 |
|
|
|
18,985 |
|
|
|
Prepaid
and other current assets |
|
|
5,741 |
|
|
|
3,152 |
|
|
|
Total
current assets |
|
|
161,180 |
|
|
|
143,524 |
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net |
|
|
102 |
|
|
|
243 |
|
|
|
Deferred
tax assets |
|
|
23,006 |
|
|
|
19,872 |
|
|
|
Other
long-term assets |
|
|
682 |
|
|
|
174 |
|
|
|
Intangible asset, net |
|
|
8,933 |
|
|
|
9,417 |
|
|
|
TOTAL ASSETS |
|
$ |
193,903 |
|
|
$ |
173,230 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ EQUITY (DEFICIT) |
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
6,864 |
|
|
$ |
10,832 |
|
|
|
Accrued
expenses and other current liabilities |
|
|
38,334 |
|
|
|
24,226 |
|
|
|
Current
portion of exchangeable senior notes, net of discount |
|
|
15,273 |
|
|
|
2,266 |
|
|
|
Current
portion of long-term debt from royalty-bearing instrument |
|
|
13,471 |
|
|
|
12,476 |
|
|
|
Deferred
revenue, current |
|
|
1,172 |
|
|
|
923 |
|
|
|
Total
current liabilities |
|
|
75,114 |
|
|
|
50,723 |
|
|
|
|
|
|
|
|
|
|
Long-Term
Liabilities: |
|
|
|
|
|
|
Exchangeable senior notes, net of discount |
|
|
— |
|
|
|
136,734 |
|
|
|
Long-term
debt from royalty-bearing instrument |
|
|
88,645 |
|
|
|
91,512 |
|
|
|
Long-term
debt derivative liabilities |
|
|
— |
|
|
|
8,170 |
|
|
|
Deferred
revenue, long-term |
|
|
14,236 |
|
|
|
13,308 |
|
|
|
Other
long-term liabilities |
|
|
731 |
|
|
|
335 |
|
|
|
Total
liabilities |
|
|
178,726 |
|
|
|
300,782 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ Equity (Deficit): |
|
|
|
|
|
|
Preferred
stock |
|
|
24,364 |
|
|
|
24,364 |
|
|
|
Common
stock |
|
|
207,023 |
|
|
|
149,978 |
|
|
|
Additional paid-in capital |
|
|
961,691 |
|
|
|
816,171 |
|
|
|
Treasury
stock |
|
|
(1,350 |
) |
|
|
(411 |
) |
|
|
Accumulated deficit |
|
|
(1,176,551 |
) |
|
|
(1,117,654 |
) |
|
|
Total
stockholders’ equity (deficit) |
|
|
15,177 |
|
|
|
(127,552 |
) |
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
|
$ |
193,903 |
|
|
$ |
173,230 |
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
DATA |
|
|
(U.S. GAAP) |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
|
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
|
32,441 |
|
|
$ |
|
21,320 |
|
|
$ |
|
90,563 |
|
|
$ |
|
54,585 |
|
|
|
Licensing revenue |
|
|
293 |
|
|
|
|
163 |
|
|
|
|
825 |
|
|
|
|
538 |
|
|
|
Total revenue, net |
|
|
32,734 |
|
|
|
|
21,483 |
|
|
|
|
91,388 |
|
|
|
|
55,123 |
|
|
|
Less: Cost
of goods sold |
|
|
8,451 |
|
|
|
|
7,478 |
|
|
|
|
24,208 |
|
|
|
|
19,486 |
|
|
|
Gross margin |
|
|
24,283 |
|
|
|
|
14,005 |
|
|
|
|
67,180 |
|
|
|
|
35,637 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
|
26,061 |
|
|
|
|
26,727 |
|
|
|
|
80,147 |
|
|
|
|
77,522 |
|
|
|
Research and development (1) |
|
|
13,490 |
|
|
|
|
13,092 |
|
|
|
|
39,798 |
|
|
|
|
37,715 |
|
|
|
Total operating expenses |
|
|
39,551 |
|
|
|
|
39,819 |
|
|
|
|
119,945 |
|
|
|
|
115,237 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(15,268 |
) |
|
|
|
(25,814 |
) |
|
|
|
(52,765 |
) |
|
|
|
(79,600 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain (loss) on change in fair value of derivative liabilities
(2) |
|
3,610 |
|
|
|
|
(230 |
) |
|
|
|
8,170 |
|
|
|
|
(366 |
) |
|
|
Interest expense, net |
|
|
(5,051 |
) |
|
|
|
(5,061 |
) |
|
|
|
(16,253 |
) |
|
|
|
(14,753 |
) |
|
|
Other expense, net |
|
|
(78 |
) |
|
|
|
(102 |
) |
|
|
|
(381 |
) |
|
|
|
(135 |
) |
|
|
Loss from operations before taxes |
|
|
(16,787 |
) |
|
|
|
(31,207 |
) |
|
|
|
(61,229 |
) |
|
|
|
(94,854 |
) |
|
|
Benefit from income taxes |
|
|
1,015 |
|
|
|
|
532 |
|
|
|
|
2,332 |
|
|
|
|
1,541 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(15,772 |
) |
|
|
|
(30,675 |
) |
|
|
|
(58,897 |
) |
|
|
|
(93,313 |
) |
|
|
Preferred stock purchase option |
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
(868 |
) |
|
|
Preferred stock beneficial conversion features |
|
|
— |
|
|
|
|
(1,646 |
) |
|
|
|
— |
|
|
|
|
(32,987 |
) |
|
|
Net loss applicable to common shareholders |
$ |
|
(15,772 |
) |
|
$ |
|
(32,321 |
) |
|
$ |
|
(58,897 |
) |
|
$ |
|
(127,168 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
$ |
|
(0.08 |
) |
|
$ |
|
(0.18 |
) |
|
$ |
|
(0.31 |
) |
|
$ |
|
(0.71 |
) |
|
|
Diluted |
$ |
|
(0.08 |
) |
|
$ |
|
(0.18 |
) |
|
$ |
|
(0.31 |
) |
|
$ |
|
(0.71 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
209,149 |
|
|
|
|
183,245 |
|
|
|
|
192,618 |
|
|
|
|
179,780 |
|
|
|
Diluted |
|
|
209,149 |
|
|
|
|
183,245 |
|
|
|
|
192,618 |
|
|
|
|
179,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Excluding non-cash stock-based compensation,
selling, general and administrative expenses were $23,215 and
$23,613 for the three months ended September 30, 2016 and 2015,
respectively, and research and development expenses were $12,922
and $12,287, respectively, for the same periods. Excluding non-cash
stock-based compensation as well as co-promotion fees paid to our
U.S. co-promotion partner, selling, general and administrative
expenses were $18,657 and $21,536 for the three months ended
September 30, 2016 and 2015, respectively. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
Non-cash gains and losses result from changes in
the fair value of a warrant derivative liability, long-term debt
derivative liabilities, and a preferred stock purchase option
derivative liability. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET
LOSS |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
|
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
|
|
|
2016 |
|
2015 |
|
2016 |
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for EPS1 - GAAP |
|
$ |
(15,772 |
) |
|
|
$ |
(32,321 |
) |
|
|
$ |
(58,897 |
) |
|
|
$ |
(127,168 |
) |
|
|
|
Stock-based
compensation expense |
|
|
3,414 |
|
|
|
|
3,919 |
|
|
|
|
10,376 |
|
|
|
|
10,177 |
|
|
|
|
Warrant
compensation income |
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
(9 |
) |
|
|
|
(Gain)
loss on change in fair value of derivatives |
|
|
(3,610 |
) |
|
|
|
230 |
|
|
|
|
(8,170 |
) |
|
|
|
366 |
|
|
|
|
Preferred stock purchase option |
|
|
— |
|
|
|
|
— |
|
|
|
|
— |
|
|
|
|
868 |
|
|
|
|
Preferred stock beneficial conversion features |
|
|
— |
|
|
|
|
1,646 |
|
|
|
|
— |
|
|
|
|
32,987 |
|
|
|
Adjusted net loss for EPS1 - non GAAP |
|
$ |
(15,968 |
) |
|
|
$ |
(26,526 |
) |
|
|
$ |
(56,691 |
) |
|
|
$ |
(82,779 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted - non GAAP |
|
$ |
(0.08 |
) |
|
|
$ |
(0.14 |
) |
|
|
$ |
(0.29 |
) |
|
|
$ |
(0.46 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
209,149 |
|
|
|
|
183,245 |
|
|
|
|
192,618 |
|
|
|
|
179,780 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amarin contact information:
Investor Relations:
Gene Mack
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
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