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Amarin Reports Third Quarter 2013 Financial Results and Provides Update on Operations - Amarin pursuing reinstatement of Special Protocol Assessment agreement for ANCHOR study - BEDMINSTER, N.J., and

Key Takeaway: Amarin Reports Third Quarter 2013 Financial Results and Provides Update on Operations - Amarin pursuing reinstatement of Special Protocol Assessment agreement for ANCHOR study - BEDMINSTER, N.J., and DUBLIN, Ireland, November 7, 2013 Amarin Corporation plc (Nasdaq: AMRN), a la

Full Press Release Details

Amarin Reports Third Quarter 2013 Financial Results
and Provides Update on Operations
- Amarin pursuing reinstatement of Special Protocol Assessment agreement for ANCHOR study -
BEDMINSTER, N.J., and DUBLIN, Ireland, November 7, 2013 Amarin Corporation plc (Nasdaq: AMRN), a late stage biopharmaceutical company focused
on the commercialization and development of therapeutics to improve cardiovascular health, today announced financial results for Q3, the quarter ended September 30, 2013, and provided an update on company operations.
Key Amarin accomplishments and setbacks since June 30, 2013 include:
We continue to witness the growth of awareness, Tier 2 managed care
conversions, and prescription volume for Vascepa, seeing an increase of 58% in normalized TRxs from Q2 to Q3 of this year, said Joseph Zakrzewski, Chairman and Chief Executive Officer of Amarin. We believe our dedicated and talented
employees will be able to continue to grow our commercial business. We also believe that the efficacy and safety profile of Vascepa for its approved indication reflects a unique and favorably differentiated product which is well positioned to help
clinicians provide improved care to their patients.
Commenting on the FDA s recently expressed position that the results from the ACCORD-Lipid, AIM-HIGH, and
HPS2-THRIVE trials fail to support the hypothesis that a TG-lowering drug significantly reduces the risk for cardiovascular (CV) events among statin-treated patients and that such results constitute a new substantial scientific issue, Steven B.
Ketchum, Ph.D., President of Research and Development of Amarin provided, We intend to continue to work vigorously in support of improved patient care and labeling of Vascepa for the ANCHOR indication. Toward that end, we have submitted to the
FDA all materials needed to appeal the FDA rescission of the ANCHOR Special Protocol Assessment, or SPA, agreement and have begun the formal appeal process with FDA. We believe that had the FDA advisory committee been asked to vote on the indication
supported by the SPA agreement for ANCHOR and by the ANCHOR results submitted in our sNDA, the outcome would have favored Vascepa approval. Amarin plans on today s conference call to further discuss this appeal and Amarin s
perspective on why the ANCHOR indication should be approved.
Commercialization update
Vascepa is being marketed
as an adjunct to diet to reduce triglyceride levels in adult patients with severe (>500 mg/dL) hypertriglyceridemia, the MARINE indication. The quarter ended September 30, 2013 represents the second full quarter of Vascepa sales
following its launch by Amarin s direct sales force on January 28, 2013. The number of clinicians prescribing Vascepa continues to increase with now over 13,000 prescribers. Continued expansion of Tier 2 coverage is expected to support
further sales growth. In October, as previously announced, Amarin reduced its worldwide workforce by half. This included a reduction of the company s U.S. sales team to approximately 150 members, including approximately 130 sales
representatives. While in doing so Amarin is no longer directly detailing Vascepa in certain lower potential geographies, the territories of our existing team covers the majority of Vascepa prescription volume and growth since its launch earlier
this year. Amarin believes that sales will continue to grow for Vascepa and that Vascepa is well differentiated in this market based on its safety profile, which is comparable to placebo, and on its spectrum of demonstrated lipid benefit at 4 g/day,
including statistically significant reductions in TGs, Apo B, VLDL-C, and non-HDL-C, with no increase in LDL-C, also known as bad cholesterol.
Vascepa additional indication
In parallel with marketing Vascepa for the MARINE indication, Amarin is vigorously pursuing FDA approval of Vascepa for the ANCHOR indication, a second
indication as an adjunct to diet and exercise for adult patients with mixed dyslipidemia who despite optimized statin therapy have TG levels between 200 and 499 mg/dL.
As previously announced, in a clinical trial of the use of Vascepa in the ANCHOR indication, Vascepa demonstrated statistically significant reductions in a
broad spectrum of lipid and inflammatory markers, on top of optimized statin therapy, including significant reduction in LDL-C compared to placebo. The FDA held an advisory committee meeting on October 16, 2013 regarding the ANCHOR indication
and had previously assigned a PDUFA action date of December 20, 2013 for this sNDA.
Last week, the FDA informed Amarin that it rescinded the ANCHOR
SPA agreement because the FDA has determined that a substantial scientific issue essential to determining the effectiveness of Vascepa in the studied population was identified after testing began. Specifically, consistent with discussion at the
advisory committee meeting, the FDA cited results from the ACCORD-Lipid and AIM-HIGH outcome trials, as well as the publicly presented results from the HPS2-THRIVE outcome trial, which the FDA stated fail to support the hypothesis that a
triglyceride-lowering drug significantly reduces the risk for cardiovascular events among statin-treated patients with mixed dyslipidemia and residually high serum triglyceride levels (200-499 mg/dL).
Amarin plans to continue to pursue approval of the ANCHOR indication vigorously. Amarin has submitted to the FDA
all materials needed to appeal the FDA rescission of the ANCHOR SPA agreement and has begun the formal appeal process with FDA. The company is being encouraged in these efforts by many clinicians who want to see approval of the ANCHOR indication.
Based on planned discussions with the FDA, Amarin will assess its options with respect to the ANCHOR sNDA and the extent to which Amarin should continue its other clinical trials, including the ongoing REDUCE-IT outcomes trial.
Vascepa exclusivity update
make significant progress in its effort to expand patent protection for Vascepa and now has 37 patents issued or allowed in the United States with over 30 additional U.S. patent applications being prosecuted. This patent portfolio includes claims
directed at Vascepa s pharmaceutical composition and methods of use for the MARINE indication, ANCHOR indication and other potential uses of Vascepa. Amarin is also pursuing patent applications related to Vascepa in multiple jurisdictions
outside the United States. In May 2013, the European Patent Office granted a patent directed at the use of Vascepa based on the results from the MARINE trial. All but two of the granted patents in the United States have expiry dates extending
into 2030 and the majority of U.S. patent applications, if and when allowed, are anticipated to have expiry dates in or beyond 2030. Patent protection for Vascepa is augmented by protection provided by trade secrets, existing manufacturing barriers
to entry and anticipated three- or five-year regulatory exclusivity.
REDUCE-IT and other Vascepa-related clinical development
Enrollment for the REDUCE-IT outcomes trial of Vascepa continues at over 450 sites spanning 11 countries. In Q3 of this year enrollment for the REDUCE-IT trial
surpassed 6,000 patients. As previously reported, the mean and median baseline triglyceride levels for patients participating to date in the REDUCE-IT cardiovascular outcomes study has been confirmed to be >200 mg/dL. As intended, these are
higher baseline TG levels than levels studied in other recent outcomes trials of other lipid modifying therapies. Results of the REDUCE-IT study will not be available until a specified number of cardiovascular events have been observed. Based on
current expectations, unless feedback from pending discussion with the FDA regarding the ANCHOR sNDA results in modification or termination of the REDUCE-IT study, results of this blinded study are anticipated in 2017. Amarin estimates that over
$100 million is required to complete this study. While Amarin remains scientifically committed to continuing the REDUCE-IT study, Amarin anticipates that the trial may be difficult to complete without the expected revenues from the previously
anticipated ANCHOR indication.
Amarin reported cash and cash equivalents on-hand of $225.9 million at September 30, 2013. On July 12, 2013, Amarin completed a public offering
resulting in net proceeds to Amarin of approximately $121.2 million, after deducting the company s portion of estimated offering expenses.
product revenues for the three and nine months ended September 30, 2013 were $8.4 million and $16.2 million, as compared to no revenues in the corresponding periods of 2012 and as compared to revenue of $5.5 million for the three months ended
2013. In accordance with U.S. Generally Accepted Accounting Principles (US GAAP), and consistent with previously reported revenue results, until the company has more operating history with the
commercialization of Vascepa, it is recognizing revenue based not on its sales to wholesalers but based on the resale of Vascepa for the purpose of filling prescriptions. For the nine months ended September 30, 2013, the net value of Vascepa
sold to wholesalers was $17.8 million, and, as a result, in addition to $16.2 million in recognized revenue, Amarin recorded deferred revenue of $1.6 million at September 30, 2013. Cash collections from the sale of Vascepa in the quarter ended
September 30, 2013 were approximately $9.1 million for a total of $18.5 million collected from wholesalers since the launch of Vascepa.
with industry practice, the net price of Vascepa for the three and nine months ended September 30, 2013 reflects deductions for costs of Amarin s co-payment rebate card program and customary payor rebates and allowances. The net price also
includes adjustments for other customary amounts as well as the deduction of one-time discounts paid to wholesalers to stock Vascepa in advance of Vascepa s launch in January 2013, which discounted stock was principally sold during the first
Cost of goods sold for the three and nine months ended September 30, 2013 was $3.7 million and $7.8 million, respectively. Gross
margin improved to 56% in Q3 2013 from 48% and 45% in Q2 and Q1, respectively, which was primarily driven by lower unit cost API purchases. Average gross margin was 52% for the nine months ended September 30, 2013. The majority of Vascepa
capsules included in cost of goods sold for the nine months ended September 30, 2013 included API sourced from a single API supplier. Amarin s purchases of API from this supplier in 2012 and 2013 are at higher cost per kilogram than
expected future purchases from this supplier. The unusually high cost of goods, as a percentage of revenue, is attributable to a number of things including the geographic location of our suppliers, exchange rate exposures and lower volume and less
favorable economic terms than those with other API suppliers. Amarin expects steady state gross margin as a percentage of product revenues to continue to increase over time into the sixties and seventies and, with significantly higher API purchase
volumes potentially into the low eighties in the longer term.
Under U.S. GAAP, Amarin reported a net loss of $48.9 million in Q3 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. In Q3
2012, GAAP net loss was $26.4 million, or basic and diluted loss per share of $0.18, and included $4.6 million in non-cash share-based compensation expense, $1.2 million in non-cash warrant compensation income, and a $16.5 million non-cash gain on
the change in the fair value of derivatives.
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. 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.
For the nine months ended September 30, 2012, GAAP net loss was $168.6 million, or basic and diluted loss per share of $1.19, and included $13.3 million in non-cash share-based compensation expense, $3.0 million in non-cash warrant compensation
expense, and a $68.7 million loss on the change in the fair value of derivatives.
Excluding non-cash gains or losses for share-based compensation, warrant compensation and change in value of
derivatives, non-GAAP adjusted net loss was $43.0 million for Q3 2013, or non-GAAP adjusted basic and diluted loss per share of $0.25, as compared to non-GAAP adjusted net loss of $39.4 million, or non-GAAP adjusted basic and diluted loss per share
of $0.26 for the same period in 2012. Adjusted net loss was $158.8 million for the nine months ended September 30, 2013, or non-GAAP adjusted basic and diluted loss per share of $1.01, as compared to non-GAAP adjusted net loss of $83.6 million,
or non-GAAP adjusted basic and diluted loss per share of $0.59 for the same period in 2012.
Amarin reported cash and cash equivalents decreased in
aggregate by $34.3 million from December 31, 2012 as compared to September 30, 2013. Net cash outflows from operations were $157.2 million for the nine months ended September 30, 2013. Net cash outflows from operations for the three
months ended September 30, 2013 were $44.9 million as compared to $52.8 million in net cash outflows from operations for the three months ended June 30, 2013, representing a net decrease of $7.9 million. As a result of the headcount
reductions in October 2013 and additional anticipated reductions in spend, Amarin expects that it will experience continued reductions in quarterly net cash outflows from operations with future quarterly cash outflows below the results of the third
quarter. Amarin estimates that during 2014 that operating activities will result in a net use of cash of less than $80 million.
During the nine months
ended September 30, 2013, net cash outflows included approximately $71.3 million in sales and marketing related expenses in conjunction with the initial commercial launch of Vascepa, approximately $34.2 million of expenses in support of the
REDUCE-IT cardiovascular outcomes study inclusive of clinical trial materials and approximately $20.4 million for Vascepa API, purchased in conjunction with the buildup of commercial supply and for clinical trial material.
Amarin s liabilities as of September 30, 2013, excluding the fair value of the non-cash warrant derivative liability, totaled approximately $272.0
million, which includes $145.3 million for the carrying value of exchangeable debt and $87.3 million for the carrying value of the hybrid debt financing that we entered into in December 2012.
As of September 30, 2013, Amarin had approximately 172.6 million American Depository Shares (ADSs) and ordinary shares outstanding as well as
approximately 9.8 million, and 10.9 million equivalent shares underlying warrants and stock options, respectively, at average exercise prices of $1.44 and $7.32, respectively, and 0.8 million equivalent shares underlying restricted or
deferred stock units. In addition, $150 million in exchangeable senior notes issued in January 2012 are exchangeable into an aggregate of 17.0 million ADSs (based on an initial exchange price of approximately $8.81 per ADS), subject
to certain specified conditions. The notes accrue interest at an annual rate of 3.5%, payable semiannually in arrears on January 15 and July 15. The notes will mature on January 15, 2032, unless earlier repurchased or redeemed by the
company or exchanged by the holders. In conjunction with Amarin s financing in July 2013, Amarin issued 21.7 million additional ADSs, which are included in the total outstanding shares above.
Amarin s operational priorities
operational priorities of Amarin are:
Conference call and webcast information
host a conference call at 4:30 p.m. ET (8:30 p.m. UTC/GMT) today, November 7, 2013. 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 100291.
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
Last updated: Nov 7, 2013