Full Press Release Details
Amarin Reports First Quarter 2016 Financial Results and Provides Update on Operations
Product revenue up 63% over prior year
REDUCE-IT cardiovascular outcomes study achieves target enrollment
Preparation for interim analysis by independent data monitoring committee underway
Management to host conference call at 8:00 a.m. ET today
BEDMINSTER, N.J., and DUBLIN, Ireland, May 5, 2016 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, 2016, and provided an update on company operations.
Key Amarin achievements since December 31, 2015 include:
Amarin s passionate field organization and managed care teams leveraged the
strong underlying data that differentiates Vascepa s clinical profile from its omega-3 competitors to increase managed care coverage and drive greater utilization, resulting in our strongest first quarter yet, commented John F. Thero,
president and chief executive officer of Amarin. Our net product revenue exceeded our internal revenue expectations for the quarter and our market share continued to expand approaching 20% of the current prescription omega-3 category. On the clinical development front, REDUCE-IT remains on schedule and our confidence remains high that this important study is positioned for success. As we look toward the balance of 2016, our
focus remains on executing on REDUCE-IT, driving U.S. revenue growth and continuing to opportunistically increase shareholder value.
Amarin s continued year-over-year revenue growth resulted primarily from increased volume of Vascepa prescribed, with the number of
physicians prescribing Vascepa and rate at which they do so both increasing.
Normalized prescriptions (estimated) for the first quarter of 2016, based on
data from Symphony Health Solutions and IMS Health, totaled approximately 201,000 and 214,000, respectively. These prescription levels represent growth of approximately 55% and 56%, respectively, compared to the same quarter in 2015. As has been
true in the first quarter of prior years for Vascepa and many other drugs, product revenue and prescription growth were impacted by the reset of patient deductible amounts for many healthcare plans at the beginning of the calendar year which
negatively affect prescription refills by patients at retail pharmacies.
REDUCE-IT Cardiovascular Outcomes Study Achieves Target Enrollment
During the first quarter of 2016, Amarin s REDUCE-IT cardiovascular outcomes study reached its target enrollment and now has over 8,000 patients enrolled
in this study evaluating the effectiveness of Vascepa in preventing the occurrence of a first major cardiovascular event in a population of patients at high residual risk despite statin therapy. 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, a
positive result in REDUCE-IT could potentially expand the market opportunity for Vascepa, reflecting a potential market opportunity comparable in size to cholesterol management therapy.
The cardiovascular event rate in this events-driven study continues to track to prior estimates. Late in the first quarter, the onset of approximately 60% of
the target aggregate number of primary cardiovascular events triggered formal preparation for a protocol pre-specified interim efficacy and safety analysis by the independent Data Monitoring Committee (DMC). The interim analysis is anticipated
to occur in September or October 2016, after all patients in the study complete a study visit and the data are collected
and prepared for transfer to and analysis by the DMC. The study has undergone multiple prior safety analyses by the DMC with each analysis resulting in a DMC recommendation that REDUCE-IT
continue as planned. The pending interim analysis in September or October 2016 will represent the first review of unblinded efficacy data by the DMC. Amarin will remain blinded to the interim and ongoing results of the REDUCE-IT study until
after the study is ready to be stopped either at the interim analysis or at the final analysis. Given the nature of outcomes studies and the design of REDUCE-IT, Amarin expects the DMC will recommend that REDUCE-IT continue until attainment of 100%
of the target 1,612 primary events, which is estimated to occur in 2017 with results anticipated to be published in 2018.
Net product revenue for the three months ended March 31, 2016 and 2015 was $25.3 million and $15.6 million, respectively. This increase in product revenue
was primarily attributable to increases both in new and recurring prescriptions of Vascepa. In addition, licensing revenue during the three months ended March 31, 2016 and 2015 was $0.2 million and $0.4 million, respectively. Based on first quarter
2016 results and anticipated trends, the company reiterates its guidance estimate of total 2016 net product revenue of between $105 million and $120 million. Revenue within this range is expected to position Amarin to enter 2017 cash flow positive
from commercial operations, excluding REDUCE-IT and other R&D expense not required to sustain current commercial operations.
during the three months ended March 31, 2016 and 2015 was $6.9 million and $5.6 million, respectively. Gross margin on product sales improved to 73% in the quarter ended March 31, 2016 compared to 64% in the quarter ended March 31,
2015. The improvement in gross margin on product sales was primarily driven by lower unit cost active pharmaceutical ingredient purchases.
general and administrative, or SG&A, expense in the three months ended March 31, 2016 and 2015 was $28.0 million and $24.7 million, respectively. This increase in expense primarily reflects increased co-promotion fees earned by Kowa
Pharmaceuticals America, Inc., increased sales and marketing spend associated with Amarin s expanded marketing initiatives, and an increase in non-cash stock-based compensation expense, partially offset by quarterly variability in legal costs.
Co-promotion fees for the three months ended March 31, 2016 and 2015 were $3.5 million and $1.5 million, respectively. Amarin currently anticipates that prior to REDUCE-IT data, with the exception of increases in co-promotion fees expected to be
earned by Kowa Pharmaceuticals America, Inc. and non-cash costs, its SG&A expense taken as a whole will be relatively flat during 2016 as compared to 2015.
Research and development expense in the three months ended March 31, 2016 and 2015 was $13.7 million and $12.6 million, respectively. This increase in expense
was primarily driven by the timing of REDUCE-IT expenses. Research and development costs in 2016, excluding non-cash costs, are expected to be similar in aggregate to 2015 including annual REDUCE-IT costs of approximately $30 million to $40
million until study completion with quarterly variability due to the timing of study-related costs.
Under GAAP, Amarin reported a net loss of $29.8
million in the first quarter of 2016, or basic and diluted loss per share of $0.16. This net loss included $3.6 million in non-cash share-based compensation expense and a $1.3 million non-cash loss on the change in fair value of derivatives.
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.
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 $24.9 million for the first quarter of 2016, or non-GAAP adjusted basic and diluted loss per share of $0.14, compared to non-GAAP adjusted net loss
of $28.6 million for the first quarter of 2015, or non-GAAP adjusted basic and diluted loss per share of $0.16.
Amarin reported cash and cash equivalents of $81.4 million as of March 31, 2016. Net cash used in operating activities in the quarter ended March 31, 2016
increased year-over-year primarily as a result of $15.0 million in up-front proceeds from the Eddingpharm license agreement received in the corresponding quarter of 2015. Increased sales and marketing spend in 2016 in support of expanded Vascepa
promotion was more than offset by higher collections from product sales. As of March 31, 2016, Amarin reported $15.0 million in net accounts receivable ($19.3 million in gross accounts receivable before allowances and reserves) and $21.3 million in
As of March 31, 2016, Amarin had approximately 184.4 million American Depository Shares (ADSs) and ordinary shares outstanding, 32.8 million
common share equivalents of Series A Convertible Preferred Shares outstanding and approximately 20.8 million equivalent shares underlying stock options at a weighted-average exercise price of $3.41, as well as 10.7 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 today, May 5, 2016. The conference call can be heard live on 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 13635415.
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
share-based compensation, warrant compensation, change in value of derivatives, gain on extinguishment of debt and preferred stock purchase option and beneficial conversion features. 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 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 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
Important Safety Information for VASCEPA
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 Vascepa sales, revenue, expense and other financial metrics for the quarter ended March 31, 2016; expectations related to
Amarin s anticipated financial position and outlook in 2016 and the years that follow such as the company s potential to enter 2017 as cash flow positive from commercial operations excluding certain expenses; expectations for event rates,
interim data review, 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, including the potential impact on the market opportunity for Vascepa in the event of a positive result in 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, 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), 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 regulatory reviews may impact the current design of the REDUCE-IT study or cause a change in strategic direction with respect to continuation of the study; the risk that future
litigation, court decisions and interpretation and interactions with regulatory authorities may impact Vascepa marketing and sales rights and efforts; the