Full Press Release Details
Amarin Reports Fourth Quarter and Year-End 2014 Financial Results
and Provides Update on Operations
-Revenues of $54.2 million for 2014 more than double 2013 revenues of $26.4 million-
-REDUCE-IT cardiovascular outcomes study continuing on schedule-
-Ex-US licensing further validates Vascepa potential-
- Conference Call Set for 4:30 p.m. EST Today -
BEDMINSTER, N.J., and DUBLIN, Ireland, March 3, 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 and year ended December 31, 2014, and provided an update on company operations.
Key Amarin achievements since September 30, 2014 include:
Amarin made broad and significant progress in 2014 overcoming first quarter 2014 restructuring issues and
starting 2015 with significant positive momentum, commented John F. Thero, President and Chief Executive Officer of Amarin. The more than doubling of Vascepa product revenues in 2014 compared to 2013 and significantly lower cash burn
year over year is clear evidence of this progress. In addition, we witnessed the number of physicians prescribing Vascepa grow significantly and physician confidence in prescribing Vascepa increase as results in practice confirm Vascepa s
differentiated efficacy profile both for newly treated patients and for patients switched to Vascepa from earlier generation therapies. Peer reviewed third party research has also continued to confirm the favorable clinical profile of Vascepa.
Mr. Thero added, Moreover, review and analysis of epidemiological, genetic and clinical data has increased our confidence that our REDUCE-IT cardiovascular outcomes study is well-positioned to succeed which could potentially lead to a
significantly expanded indication for Vascepa. Adding to our momentum in 2015, our agreement to commercialize Vascepa in China further validates the Amarin investment hypothesis and marks our start of licensing Vascepa to leading commercialization
partners around the world.
Commercialization update United States
Revenue growth in both the year ended December 31, 2014 and the fourth quarter of 2014 primarily resulted from increased shipment volumes of Vascepa to
wholesalers in support of increased reorders and new orders of Vascepa. While the wholesale price of Vascepa increased 7% in late November 2014, the timing of this price increase, combined with rebates associated with expanded Tier 2 coverage,
resulted in the average net unit price of Vascepa across the fourth quarter increasing modestly from the prior quarter. Normalized prescriptions (estimated) for the fourth quarter of 2014, based on data from Symphony Health Solutions and IMS Health,
totaled approximately 146,000 and 131,000, respectively. These prescription levels represent growth of approximately 11% and 16%, respectively, compared to the quarter ended September 30, 2014, and an increase of approximately 55% and 66%,
respectively, compared to the same quarter in 2013.
The increase in prescriptions during Q4 2014 reflects upon the sales and marketing activities of both
Amarin and our Vascepa co-promotion partner, Kowa Pharmaceuticals America, Inc. Amarin s sales representatives in Q4 continued to detail in higher frequency a select group of the highest potential target physicians on the benefits of Vascepa.
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 in Q4 again witnessed increasing contributions to overall Vascepa revenue growth from Kowa Pharmaceuticals America, Inc. co-promotion. During Q4, growth was noted from physicians
targeted by Amarin sales representatives only, Amarin and Kowa Pharmaceuticals America, Inc. sales representatives jointly, and Kowa Pharmaceuticals America, Inc. sales representatives only.
Positive feedback on the effects of Vascepa continues to be reported by physicians treating both new and switched patients, consistent with data on patients
switched to Vascepa such as those reported by Dr. Amir Hassan in the November 2014 publication of Cardiology and Therapy. Physicians continue to recognize that for very high triglyceride patients also treated with statins for cholesterol
management, Vascepa can provide benefit without offsetting the bad cholesterol-lowering effect of statin therapy.
Research & development update
The REDUCE-IT cardiovascular outcomes study continues to be the centerpiece of Amarin s on-going 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 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 an opportunity comparable in size to cholesterol management therapy. In the REDUCE-IT study, we seek to demonstrate benefit by augmenting,
not replacing, statin therapy.
The REDUCE-IT study is designed to be completed upon documenting 1,612 patients with positively adjudicated primary
endpoint events. The study was initially designed for 6,990 patients. For added statistical strength, before the trial started, Amarin expanded target enrollment to 8,000 patients. Thus far, over 7,300 patients have been enrolled in the REDUCE-IT
cardiovascular outcomes study representing over 90% 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. Thus far the pooled, blinded event rate in the REDUCE-IT study is tracking to our expectations for 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 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 the results of the 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 be in 2017 with results anticipated to be published in 2018.
The U.S. Food and Drug Administration (FDA) has not provided us with a
timeline for action on the ANCHOR sNDA, the PDUFA date for which was December 20, 2013. As previously announced, in September 2014, we were notified that the Office of New Drugs within FDA denied Amarin s appeal of the FDA s
rescission of the ANCHOR clinical trial Special Protocol Assessment (SPA) agreement and we determined to not appeal further. While the FDA acknowledged that Vascepa lowered triglyceride levels in the ANCHOR study, based on the FDA rescinding the
ANCHOR SPA agreement and stated desire to see the REDUCE-IT results, we do not expect a positive determination on the ANCHOR sNDA.
Commercialization update ex-United States
Today 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 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.
The Chinese pharmaceutical market has been growing at an annual rate of
approximately 20% during the past ten years and currently is the third largest pharmaceutical market in the world. This trend is expected to continue and enable the territory to surpass Japan as the second largest pharmaceutical market in the world
by the end of this decade. The combination of the high prevalence rates of hypertriglyceridemia and large population size suggest that a great number of patients in China would benefit from therapy with Vascepa. To date, there has been no
prescription grade pharmaceutical omega-3 product in China, and thus there is a high unmet need for an efficacious and safe product to treat the millions of patients that have related lipid abnormalities.
Net product revenues for the
three months ended December 31, 2014 and 2013 were $16.5 million and $10.1 million, respectively. Net product revenues for the years ended December 31, 2014 and 2013 were $54.2 million and $26.4 million, respectively. These increases in
product revenues are primarily attributable to increases both in new and recurring prescriptions of Vascepa.
Cost of goods sold for the three months
ended December 31, 2014 and 2013 were $5.8 million and $4.1 million, respectively. Cost of goods sold for the years ended December 31, 2014 and 2013 were $20.5 million and $11.9 million, respectively. Gross margin improved to 65% and 62%
in the quarter and year ended December 31, 2014 compared to 59% and 55% in the quarter and year ended December 31, 2013. The improvement in gross margins in 2014 was primarily driven by lower unit cost active pharmaceutical ingredient, or
Selling, general and administrative expenses in the three months ended December 31, 2014 and 2013 were $18.4 million and $22.3
million, respectively, reflecting an intentional reduction in expenditures. Selling, general and administrative expenses in the years ended December 31, 2014 and 2013 were $79.3 million and $123.8 million, respectively. The decrease in such
expenses was primarily driven by previously announced decisions to decrease sales force staffing in the fourth quarter of 2013 and decreased marketing program spend and other costs associated with the commercialization of Vascepa. In addition, 2013
was the year in which we commenced selling Vascepa and as such, included certain launch-year related costs. Other than anticipated growing costs for Kowa Pharmaceutical America, Inc. s co-promotion, which is scheduled to increase based on
increased contribution to gross margins from anticipated increases in levels of Vascepa revenues, future selling, general and administrative expenses are anticipated to be generally consistent in 2015. 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 December 31, 2014 and 2013 were $12.4 million and $16.6 million, respectively. Research and
development expenses in the years ended December 31,
2014 and 2013 were $50.3 million and $72.8 million, respectively. The decrease in such expenses was primarily driven by supply purchases in 2013 which were expensed prior to FDA approval of the
related API suppliers and to reduced staffing and overhead costs in 2014. The decrease in expenses in the year to date period was also driven by a decrease in REDUCE-IT expenses reflecting both quarterly variability and some efficiency savings given
that the trial was fully operational in 2014 across all countries and clinical sites. 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 $19.7 million in the
fourth quarter of 2014, or basic and diluted loss per share of $0.11. This net loss included $2.7 million in non-cash share-based compensation expense and a $1.6 million non-cash gain on the change in fair value of derivatives. Amarin reported a net
loss of $15.4 million in the fourth quarter of 2013, or basic and diluted loss per share of $0.09 and $0.27, respectively. This net loss included $0.5 million in non-cash share-based compensation expense, $2.5 million in non-cash warrant
compensation income, and a $26.7 million non-cash gain on the change in the fair value of derivatives.
For the year ended December 31, 2014, Amarin
reported a net loss of $56.4 million, or basic and diluted loss per share of $0.32 and $0.36, respectively. This net loss included $9.0 million in non-cash share-based compensation expense, $0.5 million in non-cash warrant compensation income, a
$13.5 million non-cash gain on the change in fair value of derivatives, and a $38.0 million non-cash gain on extinguishment of debt. For the year ended December 31, 2013, Amarin reported a net loss of $166.2 million, or basic and diluted loss
per share of $1.03 and $1.28, respectively. This net loss included $14.7 million in non-cash share-based compensation expense, $3.7 million in non-cash warrant compensation income, and a $47.7 million non-cash gain on the change in the fair value of
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 $18.5 million for the fourth quarter of 2014, or non-GAAP adjusted basic and diluted loss per share of $0.11, compared to non-GAAP adjusted net loss of $44.1 million for the three months ended
December 31, 2013, or non-GAAP adjusted basic and diluted loss per share of $0.26. Adjusted net loss was $99.4 million for the year ended December 31, 2014, or non-GAAP adjusted basic and diluted loss per share of $0.57, compared to
adjusted net loss of $203.0 million for the year ended December 31, 2013, or non-GAAP adjusted basic and diluted loss per share of $1.26.
reported cash and cash equivalents of $119.5 million at December 31, 2014, representing a net decrease of $15.9 million from reported cash and cash equivalents of $135.4 million as of September 30, 2014 and a net decrease of $72.0 million
from reported cash and cash equivalents of $191.5 million as of December 31, 2013. Net cash used in operating activities in the year ended December 31, 2014 included approximately $44.3 million in sales and marketing related expenses and
approximately $30.5 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 used in operating activities from operations to $72.3 million in the year ended December 31, 2014 compared to $190.3 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 used in
operating activities in the future.
Amarin s liabilities as of December 31, 2014, excluding the fair value of the non-cash warrant derivative
liability, totaled approximately $259.4 million, which includes $124.4 million for the carrying value of exchangeable debt and $94.4 million for the carrying value of the hybrid debt-like financing that we entered into in December 2012. The face
value of the exchangeable debt is $150 million, of which $31.3 million could be called for repayment or exchange in or after January 2017 and $118.7 million could be called for repayment or exchange in January 2019. The hybrid debt-like instrument
is repaid as a percentage of Vascepa revenues subject to quarterly maximum amounts. During 2014, $5.3 million was paid as interest on the exchangeable debt and $4.8 million was paid under the royalty formula associated with the hybrid debt-like