Full Press Release Details
Amarin Reports Third Quarter 2014 Financial Results
and Provides Update on Operations
- Conference Call Set for 4:30 p.m. EST Today -
BEDMINSTER, N.J., and DUBLIN, Ireland, November 6, 2014 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, 2014, and provided an update on company operations.
Key Amarin achievements since June 30, 2014 include:
Commenting on Amarin s
progress, John F. Thero, President and Chief Executive Officer, stated, Since changing the focus of our sales team earlier this year to increase targeting of the highest potential value physicians, we have witnessed increased Vascepa
prescription growth. Based on the strong efficacy and safety profile of Vascepa and regular reports of improved patient lipid parameters, we are confident that Vascepa revenues will continue to grow. Mr. Thero added, The primary
focus of Amarin is to improve patient care, grow revenues and advance REDUCE-IT in a cost-effective, opportunistic manner. Year-to-date results reflect broad progress which compels us to advance further.
Commercialization update
Normalized prescriptions
(estimated) for the quarter ended September 30, 2014, based on data from Symphony Health Solutions and IMS Health, totaled approximately 132,000 and 113,000, respectively. These prescription levels represent growth of approximately 20% and 22%,
respectively, compared to the quarter ended June 30, 2014, and an increase of approximately 78% and 80%, respectively, compared to the same quarter in 2013.
These increases were most significantly driven by increased prescriptions from the physicians who are the highest
past prescribers of Vascepa with increasing contribution from a broader group of physicians. Timing of shipments to wholesalers, upon which revenues are recognized, and prescription levels can vary between periods. Such timing differences
contributed to greater prescription growth than revenue growth in Q3 2014.
The increase in prescriptions during Q3 2014 reflects sales and marketing
activities of both Amarin and its Vascepa co-promotion partner, Kowa Pharmaceuticals America, Inc. (Kowa). Growth was noted from physicians targeted by Amarin sales representatives only, Amarin and Kowa sales representatives jointly and Kowa sales
representatives only.
Amarin s sales representatives in Q3 continued their approach of relatively high frequency detailing on the benefits of
Vascepa to a select group of the highest potential target physicians. These targets represent both the largest current prescribers of Vascepa and are believed to represent the greatest potential for further Vascepa prescription growth. While Amarin
anticipates the largest portion of its future sales growth to continue to come from efforts of Amarin s sales representatives, Amarin anticipates increasing contributions to overall Vascepa revenue growth from Kowa s co-promotion.
Kowa s sales team is targeting more than twice the number of physicians targeted by Amarin sales representatives. Kowa began promotion of Vascepa in
mid-Q2 2014. As anticipated, by the end of Q3 2014, Kowa s sales team had called on each of their Vascepa targets an average of approximately two times. As previously stated, Amarin believes detailing efforts for new therapies that treat
chronic asymptomatic conditions typically require five or more calls to significantly affect physician prescribing habits. There are early signs that Kowa is having a positive impact and more is expected from their promotional activities as more
time is invested in educating physicians about Vascepa.
During Q2, the prescription drug that most closely competes with Vascepa saw the launch of a
generic and during Q3, a second generic version of such drug became available. Generic versions of this competitive drug are currently priced such that they are more expensive than Vascepa under most managed care plans. After such generic launch,
formulary access to Vascepa, including tier-2 coverage, continues to improve overall with more than 119 million people in the United States currently insured by managed care plans that cover Vascepa on tier-2, 95% of which is already contracted
We continue to receive positive feedback about the effects of Vascepa, both in patients for whom Vascepa was their first triglyceride lowering
therapy and for patients switched from alternative triglyceride lowering therapies to Vascepa, including patients on statin therapy.
Research & development update
patients have been enrolled in the REDUCE-IT cardiovascular outcomes study representing approximately 90% of total targeted enrollment with study enrollment targeted to be completed in 2015. The REDUCE-IT study is designed to be completed after
reaching an aggregate number of cardiovascular
events. Based on projected event rates, we estimate the REDUCE-IT study can be completed in or about 2017 with results then expected to be available in 2018. Based on the results of REDUCE-IT, we
may seek additional indications for Vascepa beyond the indications studied in the ANCHOR or MARINE trials.
During Q3 2014, we completed a substantial
scientific and business focused analysis, leading to the decision to complete the REDUCE-IT study independent of FDA s review of the ANCHOR sNDA. The REDUCE-IT study, if successful, presents a major opportunity to improve patient care and
expand Vascepa usage.
As previously announced, in September 2014, we were notified that the Office of New Drugs (OND) within the U.S. Food and Drug
Administration (FDA) denied Amarin s appeal of the FDA s rescission of the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement. Based on the FDA s repeated position in its appeal denials and its internal consultation
with FDA officials at higher levels, we informed the FDA that we do not intend to appeal the SPA rescission further. Following this notification, our regulatory focus has shifted to advancing the ongoing REDUCE-IT outcomes study in pursuit of a
broader indication for Vascepa and to seeking action on the ANCHOR sNDA.
Amarin reported cash and cash equivalents of $135.4 million at September 30, 2014, representing a net decrease of $15.1 million from reported cash and
cash equivalents of $150.5 million as of June 30, 2014 and a net decrease of $56.1 million from reported cash and cash equivalents of $191.5 million as of December 31, 2013. Net cash outflows in the nine months ended September 30,
2014 included approximately $33.3 million in sales and marketing related expenses and approximately $20.5 million of costs incurred through our contracted clinical research organization and for clinical trial materials in support of the REDUCE-IT
cardiovascular outcomes study.
The improvement in net cash outflow from operations to $58.7 million in the nine months ended September 30, 2014
compared to $157.2 million in the same period in 2013 reflects our focus on cash preservation and efficient spend targeting to maximize Vascepa revenues and minimize cash burn. It is anticipated that the company will experience fluctuations in
quarterly net cash outflows. Amarin continues to estimate that, during 2014, net cash outflows will be less than $80 million.
Net product revenues for
the three months ended September 30, 2014 and 2013 were $14.1 million and $8.4 million, respectively. Net product revenues for the nine months ended September 30, 2014 and 2013 were $37.7 million and $16.2 million, respectively. These
increases in product revenues are attributable to increases both in new and recurring prescriptions of Vascepa.
Cost of goods sold for the three months
ended September 30, 2014 and 2013 was $5.4 million and $3.7 million, respectively. Cost of goods sold for the nine months ended September 30, 2014 and 2013 was $14.6 million and $7.8 million, respectively. Gross margin improved to 62% and
61% in the three and nine months ended September 30, 2014 compared to 56% and 52% in the three and nine months ended September 30, 2013. The improvement in gross margins in 2014 was primarily driven by lower unit cost active pharmaceutical
ingredient, or API, purchases.
Under GAAP, Amarin reported a net loss of $26.1 million in the third quarter of 2014, or basic and diluted loss
per share of $0.15 and $0.17, respectively. This net loss included $1.9 million in non-cash share-based compensation expense, $0.3 million in non-cash warrant compensation income and a $4.5 million gain on the change in fair value of derivatives.
Amarin reported a net loss of $48.9 million in the third quarter of 2013, or basic and diluted loss per share of $0.29. This net loss included $4.3 million in non-cash share-based compensation expense, $0.3 million in non-cash warrant compensation
expense, and a $1.4 million loss on the change in the fair value of derivatives.
For the nine months ended September 30, 2014, Amarin reported a net
loss of $36.7 million, or basic and diluted loss per share of $0.21 and $0.25, respectively. This net loss included $6.3 million in non-cash share-based compensation expense, $0.5 million in non-cash warrant compensation income, a $11.9 million gain
on the change in fair value of derivatives, and a $38.0 million gain on extinguishment of debt. For the nine months ended September 30, 2013, Amarin reported a net loss of $150.8 million, or basic and diluted loss per share of $0.96 and $1.02,
respectively. This net loss included $14.2 million in non-cash share-based compensation expense, $1.2 million in non-cash warrant compensation income, and a $21.1 million gain on the change in the fair value of derivatives.
Excluding non-cash gains or losses for share-based compensation, warrant compensation, change in fair value of derivatives and gain on extinguishment of debt,
non-GAAP adjusted net loss was $28.9 million for the third quarter of 2014, or non-GAAP adjusted basic and diluted loss per share of $0.17, compared to non-GAAP adjusted net loss of $43.0 million for the three months ended September 30, 2013,
or non-GAAP adjusted basic and diluted loss per share of $0.25. Adjusted net loss was $80.8 million for the nine months ended September 30, 2014, or non-GAAP adjusted basic and diluted loss per share of $0.47, compared to adjusted net loss of
$158.8 million for the nine months ended September 30, 2013, or non-GAAP adjusted basic and diluted loss per share of $1.01.
liabilities as of September 30, 2014, excluding the fair value of the non-cash warrant derivative liability, totaled approximately $254.5 million, which includes $124.9 million for the carrying value of exchangeable debt and $93.8 million for
the carrying value of the hybrid debt-like financing that we entered into in December 2012.
As of September 30, 2014, Amarin had approximately
174.6 million American Depository Shares (ADSs) and ordinary shares outstanding as well as approximately 8.1 million and 11.2 million equivalent shares underlying warrants and stock options, respectively, at average exercise prices of
$1.50 and $5.33, respectively, and 2.3 million equivalent shares underlying restricted or deferred stock units.
Conference call and webcast
Amarin will host a conference call at 4:30 p.m. ET (9:30 p.m. UTC/GMT) today, November 6, 2014. The conference
call can be heard live via 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 13592466.
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, are 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 share-based compensation, warrant compensation, and change in value of derivatives. Management believes that these non-GAAP adjusted 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.
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 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.
Vascepa (icosapent ethyl) capsules
Vascepa (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly
pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications and Usage
Important Safety Information for Vascepa
FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.