Full Press Release Details
Amarin Reports First Quarter 2015 Financial Results
and Provides Update on Operations
-REDUCE-IT cardiovascular outcomes study continuing on schedule-
-Product revenue increased 42% over same period last year-
- Conference Call Set for 8:00 a.m. EST Today -
BEDMINSTER, N.J., and DUBLIN, Ireland, May 8, 2015 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 ended March 31, 2015, and provided an update on company operations.
Key Amarin achievements since December 31, 2014 include:
Executing on REDUCE-IT and increasing revenues, while being opportunistic along the way, continue to be our top priorities, commented John F.
Thero, President and Chief Executive Officer of Amarin. REDUCE-IT is on-track and remains, we believe, positioned for success. Seasonal challenges caused a slow start for prescription growth in 2015, but in March we achieved a new all-time
high in monthly prescriptions and market share. We re working to build on this momentum for the balance of 2015. The Eddingpharm deal and our increased cash balance provide us greater resources as we market Vascepa for use in our currently
approved indication and pursue the potentially multi-billion dollar market the REDUCE-IT cardiovascular outcomes study is intended to open for Vascepa, assuming successful results and further regulatory approval.
Commercialization update United States
Normalized prescriptions (estimated) for the first quarter of 2015, based on data from Symphony Health Solutions and IMS Health, totaled approximately 154,000
and 137,000, respectively. These prescription levels represent growth of approximately 5% for each data set compared to the quarter ended December 31, 2014, and an increase of approximately 66% and 76%, respectively, compared to the same
Revenue and prescription growth in the first quarter of 2015 was impacted by the effects of severe winter weather throughout much of the
United States as well as by beginning of the calendar year healthcare plan issues (e.g., new year patient deductible amounts) which affected prescription refills by patients at retail pharmacies. Additionally, wholesalers on average stocked
approximately four fewer days of sales of Vascepa at the end of Q1 2015 than at the end of Q4 2014 and the average net unit price of Vascepa decreased modestly in Q1 2015 from the prior quarter primarily as a result of rebates from Amarin associated
with expanded managed care and Medicare Part D coverage. As a result of continued expanding payor coverage of Vascepa, including recently contracted coverage at Humana, Amarin anticipates that prescription growth will continue to be most pronounced
for patients under medical plans to which Amarin provides rebates.
Research on EPA continues to support potential atheroprotective benefits
Recent research findings continue to support the potential benefits of EPA, the active pharmaceutical ingredient in Vascepa. An in vitro
study presented in March at the American College of Cardiology Scientific Session in San Diego, California showed that pretreatment with EPA reduced oxidation of small-dense LDL and resulted in improved endothelial function when compared to other
triglyceride-lowering agents, including fenofibrate, niacin and gemfibrozil. Another in vitro study presented in March at the DEUEL Conference on Lipids suggests that the combination of EPA and atorvastatin may provide atheroprotective
benefit through additive antioxidant and endothelial benefits not observed with other triglyceride-lowering agents.
REDUCE-IT cardiovascular
outcomes study continuing on-track
The REDUCE-IT cardiovascular outcomes study continues to be the centerpiece of Amarin s ongoing R&D
efforts. This is the first prospective double-blinded cardiovascular outcomes study of any drug in a population of patients who, despite stable statin therapy, have elevated triglyceride levels. Unlike outcomes studies for many drugs that are
designed to validate a currently approved drug indication, based on the results of REDUCE-IT, we plan to seek additional regulatory approval for indicated uses for Vascepa that include and extend beyond the populations studied in the MARINE and
ANCHOR trials. These additional indications would potentially address tens of millions of patients in the United States and worldwide with elevated triglyceride levels representing a market opportunity comparable in size to cholesterol management
therapy. In the REDUCE-IT study, we seek to demonstrate benefit by augmenting, not replacing, statin therapy.
Thus far over 7,400 patients have been enrolled in the REDUCE-IT cardiovascular outcomes study representing
approximately 93% of total targeted enrollment. We anticipate completing study enrollment in 2015. The REDUCE-IT study was designed with 90% power to detect a 15% relative risk reduction, and the study protocol pre-specifies one interim analysis
after 60% of events accrue. The pooled, blinded event rate in the REDUCE-IT study to date is tracking to our expectations such that we expect the 60% interim look by the independent DMC to occur during 2016. Based on the efficacy and safety results
at the interim look, the DMC could recommend to the study s independent Steering Committee and to Amarin to continue or stop the study. If the study is stopped based on overwhelming efficacy results, Amarin intends at that time to progress
towards seeking approval for an expanded indication for Vascepa based on such results.
Amarin is blinded to all data from the ongoing REDUCE-IT study and
is planning for REDUCE-IT to continue until attainment of 100% of the 1,612 primary events, which is estimated to occur in 2017 with results anticipated to be published in 2018.
Commercialization update Outside the United States
In February 2015, we announced an exclusive agreement with Eddingpharm Ltd. to develop and commercialize Vascepa capsules in the territories of Mainland China,
the Hong Kong and Macao Special Administrative Regions, and Taiwan for uses that are currently commercialized and under development by Amarin in the United States based on the MARINE, ANCHOR and ongoing REDUCE-IT clinical trials of Vascepa.
Under the agreement, Eddingpharm will be responsible for development and commercialization activities in the territory and associated expenses. Amarin will
provide development assistance and be responsible for supplying the product. Terms of the agreement include up-front and milestone payments to Amarin of up to $169.0 million, including a non-refundable $15.0 million up-front payment received in
February 2015 and development, regulatory and sales-based milestone payments of up to an additional $154.0 million. Eddingpharm will also pay Amarin tiered double-digit percentage royalties on net sales of Vascepa in the territory escalating to the
high teens. Amarin will supply finished product to Eddingpharm under negotiated supply terms.
Net product revenue for the three months ended March 31, 2015 and 2014 was $15.6 million and $11.0 million, respectively. This increase in product revenue
was primarily attributable to increases both in new and recurring prescriptions of Vascepa. In accordance with GAAP, prior to 2014 revenue was recognized based on the resale of Vascepa for the purposes of filling patient prescriptions and not based
on sales to distributors. During the three months ended March 31, 2014, we developed sufficient history to reliably estimate returns and, as a result, began to recognize revenue based on sales to distributors. Consequently, during the three
months ended March 31, 2014, we recognized revenues of $11.0 million based on sales to distributors, compared to revenues of $10.0 million that we would have recognized based on the resale of Vascepa for the purposes of filling patient
prescriptions during the period. No change in revenue recognition method has occurred since that previously reported change in early 2014. In addition, we recognized licensing revenue of $0.4 million for the three months ended March 31, 2015,
related to the recently executed Eddingpharm development and commercialization agreement.
Cost of goods sold for the three months ended March 31, 2015 and 2014 was $5.6 million and $4.2 million,
respectively. Gross margin on product sales improved to 64% in the quarter ended March 31, 2015 compared to 61% in the quarter ended March 31, 2014. The improvement in gross margin on product sales was primarily driven by lower unit cost
active pharmaceutical ingredient purchases.
Selling, general and administrative, or SG&A, expenses in the three months ended March 31, 2015 and
2014 were $24.7 million and $20.6 million, respectively. The increase in expenses reflects quarterly variability in legal costs, the addition of co-promotion fees payable to Kowa Pharmaceuticals America, Inc., which were not applicable in the
quarter ended March 31, 2014, and an increase in non-cash stock-based compensation expense. SG&A expenses are anticipated to be largely flat in 2015 compared to 2014 other than variability in legal costs and anticipated growing costs for
Kowa Pharmaceutical America, Inc. s co-promotion, which is scheduled to increase based on further contribution to gross margins from anticipated increases in levels of Vascepa revenues. While we anticipate that our level of SG&A expenses
will be variable quarter to quarter, we do not plan a significant increase in our SG&A spending until supported by considerably higher revenues.
Research and development expenses in the three months ended March 31, 2015 and 2014 were $12.6 million and $11.7 million, respectively. The increase in
expenses was driven by an increase in REDUCE-IT expenses reflecting quarterly variability. Research and development costs are expected to be slightly higher during 2015 as compared to 2014 as a result of the timing of REDUCE-IT costs, and such costs
are expected to decline modestly thereafter upon completion of enrollment for REDUCE-IT.
Under GAAP, Amarin reported a net loss of $32.0 million in the
first quarter of 2015, or basic and diluted loss per share of $0.18. This net loss included $3.0 million in non-cash share-based compensation expense, a $0.5 million non-cash gain on the change in fair value of derivatives, and a $0.9 million
non-cash deemed dividend for accounting purposes related to a preferred stock purchase option. Amarin reported a net loss of $26.0 million in the first quarter of 2014, or basic and diluted loss per share of $0.15. This net loss included $2.0
million in non-cash share-based compensation expense, $0.1 million in non-cash warrant compensation income, and a $4.4 million non-cash 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 the non-cash deemed dividend,
non-GAAP adjusted net loss was $28.6 million for the first quarter of 2015, or non-GAAP adjusted basic and diluted loss per share of $0.16, compared to non-GAAP adjusted net loss of $28.5 million for the first quarter of 2014, or non-GAAP adjusted
basic and diluted loss per share of $0.16.
Amarin reported cash and cash equivalents of $161.2 million at March 31, 2015, representing a net
increase of $41.7 million from reported cash and cash equivalents of $119.5 million as of December 31, 2014. The increase was driven by the receipt of a $15.0 million up-front licensing fee and net proceeds from a preferred stock issuance of
$52.2 million, partially offset by cash used in operating activities. Net cash used in operating activities in the quarter ended March 31, 2015 included approximately $14.5
million in sales and marketing related expenses and approximately $15.8 million of costs incurred through our contracted clinical research organization and for clinical trial materials in support
of the REDUCE-IT cardiovascular outcomes study.
As of March 31, 2015, Amarin had approximately 177.0 million American Depository Shares (ADSs)
and ordinary shares outstanding, 35.2 million common share equivalents of Series A Convertible Preferred Shares outstanding and approximately 12.1 million equivalent shares underlying stock options at a weighted average exercise price of
$4.38, as well as 4.1 million equivalent shares underlying restricted or deferred stock units.
Conference call and webcast information
Amarin will host a conference call at 8:00 a.m. ET (1:00 p.m. UTC/GMT) today, May 8, 2015. 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 13606146.
Use of non-GAAP adjusted financial
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.
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, changes in value of derivatives and a non-cash deemed dividend. 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 cardiovascular
outcomes study. Amarin s first product, Vascepa (icosapent ethyl) capsules, is a highly pure EPA omega-3 prescription product. 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, known in scientific literature as AMR101, is a highly
pure-EPA omega-3 prescription product in a 1 gram capsule.
Indications and Usage