Prescription Growth Up >50%; Outcomes Study
Beyond 80% Complete
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 months ended March 31, 2017, and
provided an update on company operations.
Key Amarin achievements through March 31, 2017 include:
- U.S. revenue growth: Recognized $34.3 million in net product
revenue from Vascepa® (icosapent ethyl) sales in Q1 2017 compared
to $25.3 million in Q1 2016, an increase of 36%.
- U.S. prescription growth: Increased normalized prescriptions
for Vascepa by 52% and 58% compared to Q1 2016 based on data from
Symphony Health Solutions and IMS Health, respectively.
- International development: China regulatory authorities
approved the Vascepa clinical trial application (CTA) from Amarin’s
partner, Eddingpharm, paving the way for Eddingpharm to commence a
clinical trial of Vascepa in China before the end of 2017.
- R&D progress: Our REDUCE-IT cardiovascular outcomes study,
designed to provide data to support a significantly expanded market
opportunity for Vascepa, is progressing as planned. Our statistical
models indicate that in March 2017, the study reached the onset of
approximately 80% of the target aggregate number of primary
cardiovascular events. The onset of the target final primary
cardiovascular event will likely be reached near the end of 2017 in
this 8,175 patient study that commenced in 2011.
- Cash flow: Net cash outflow from operations during Q1 2017 was
less than $1.5 million, excluding costs for R&D, interest and
royalty. The company aims to be net cash flow positive on this
basis for the full year with continued quarterly variability.
- Cash balance: As of March 31, 2017, Amarin had a cash balance
of $96.1 million compared to $98.3 million at December 31,
2016. The March 31st cash balance includes approximately
$13.7 million in net cash proceeds from the January 2017 redemption
of debt and simultaneous issuance of $30.0 million face value of
new debt long-term.
“Historically, Q1 has been our most challenging quarter for
revenue growth due to seasonal factors. We are pleased that
both revenues and prescriptions for Vascepa grew significantly in
Q1, as prescription growth exceeded our internal projections. We
are on-track to achieve our full year 2017 product revenue guidance
of $155 to $165 million,” stated John F. Thero, president and chief
executive officer. “Our expectations are that REDUCE-IT study
results will be reported in mid-2018, and we are actively planning
for expanded promotion based on anticipated positive results from
this study. There is a large unmet medical need that we are seeking
to address through demonstration of positive results in
REDUCE-IT. We believe the efficacy, safety, oral
administration and affordable cost of Vascepa position the product
for substantial growth, assuming that REDUCE-IT results are
positive.”
Increases in New and Recurring Prescriptions Drive
Steady Commercial Growth
During the first quarter, Amarin again experienced substantial
prescription growth and continued increase in Vascepa market share,
particularly among detailed physicians. Overall, approximately
150,000 patients received prescriptions for Vascepa during the
quarter, with new prescriptions growing to approximately 5% of the
non-statin lipid modifying market and approaching 30% of the
prescription omega-3 market. Strong Vascepa growth is driven by
positive physician experience in conjunction with our focused
message delivery, compelling efficacy and safety data, and improved
managed care coverage.
Estimated normalized total Vascepa prescriptions, based on data
from Symphony Health Solutions and IMS Health, totaled
approximately 305,000 and 335,000, respectively, for the three
months ended March 31, 2017. These prescription levels represent
growth of approximately 52% and 58%, respectively, from prior year
levels.
During the first quarter of 2017, overall wholesaler inventory
levels decreased from year-end 2016 levels calculated based on
estimated days of Vascepa sales on hand. Consequently, we estimate
that this decrease in wholesaler inventory levels adversely
impacted net product revenue by approximately $2.8 million to $3.1
million for the first quarter of 2017. During the first quarter of
2016, wholesaler inventory levels adversely impacted net product
revenue by approximately $1.2 million to $1.5 million. We believe
that changes in channel inventory at these independent wholesalers
and retail pharmacies are common and impacted by numerous factors,
including holiday timing and recent order trends. We also deduce,
based on information available to us, that channel inventory levels
at the end of the first quarters of 2017 and 2016 are within
ordinary ranges, and that such levels will continue to vary from
quarter to quarter.
REDUCE-IT Cardiovascular Outcomes Study
The REDUCE-IT cardiovascular outcomes trial continues to
progress on schedule. Amarin anticipates the onset of the final
primary cardiovascular event to occur near the end of 2017, with
report of top-line results and publications in 2018. The projected
timing of available data from which we can report top-line results
should be easier to estimate after the interim look which, as
discussed below, is scheduled to complete in Q3 2017. We currently
estimate that we will report results of REDUCE-IT in mid-2018,
assuming the study goes to completion. These estimates reflect our
assumptions of the necessary time needed to collect vital data from
all patients in the study, compile the results, and subject the
results to scrutiny of the independent review committees and the
REDUCE-IT operational team.
The 8,175-patient outcomes study is evaluating whether treatment
with Vascepa reduces cardiovascular events in patients who despite
stabilized statin therapy, have elevated triglyceride levels and
other cardiovascular risk factors. The results of this important
trial, if successful, could lead to improved medical care for tens
of millions of patients. Amarin is positioned to be the first
company to complete an outcomes study in the population of patients
being studied in REDUCE-IT.
The primary endpoint of this global, double-blind study is the
time to the first occurrence of a composite of major adverse
cardiovascular events (MACE). Results will be compared
between the Vascepa and placebo groups. The study is being
conducted under a Special Protocol Assessment (SPA) agreement with
the FDA.
Preparations are underway for a second pre-specified interim
efficacy and safety analysis of REDUCE-IT by the independent DMC,
since we believe that approximately 80% of the primary
cardiovascular events occurred in the mid-March timeframe. The
ensuing analysis should be completed before the end of Q3
2017. Consistent with the trial design, Amarin continues to
believe that the REDUCE-IT study is most likely to continue to
completion of 100% of the target events. We surmise this
because the efficacy requirements detailed to the DMC for early
study stoppage after the 80% interim assessment are high. Unlike
the data analysis at the end of the study, the interim analysis and
review by the DMC also includes robustness thresholds for certain
secondary endpoints. There are potential statistical advantages for
the study to run to its full term.
Amarin will remain blinded to results of the REDUCE-IT study
until after the study is stopped and the database is locked at
either the 80% interim analysis or at the final analysis.
International Development of Vascepa
Our international initiatives are progressing positively. Our
partner for China, Eddingpharm, submitted the clinical trial
application (CTA) to the Chinese regulatory authorities in 2016.
This CTA was recently approved, enables Eddingpharm to progress
into the clinical testing phase, and potentially positions Vascepa
to be the first prescription grade EPA product to receive drug
approval in China. We believe the commercial opportunity in China
is large based on the prevalence of hypertriglyceridemia, which is
estimated to affect 11.9% of the adult Chinese population. Our
partner in China is responsible for the conduct and cost of the
clinical studies in China. Amarin will provide the clinical
trial material for this study.
Financial Update
Net product revenue for the three months ended March 31, 2017
and 2016 was $34.3 million and $25.3 million, respectively. This
increase in net product revenue was primarily attributable to
increases both in new and recurring prescriptions of Vascepa driven
by increased sales productivity and supported by expanded managed
care coverage.
In addition, Amarin recognized licensing revenue of $0.3 million
and $0.2 million in the three months ended March 31, 2017 and 2016,
respectively, related to agreements for the commercialization of
Vascepa outside the United States. Based upon current estimates,
Amarin anticipates approximately $1.2 million in licensing revenue
to be recognized in aggregate during 2017 from existing
agreements.
Cost of goods sold for the three months ended March 31, 2017 and
2016 was $8.2 million and $6.9 million, respectively. Gross
margin on product sales improved to 76% in the quarter ended March
31, 2017 compared to 73% in the quarter ended March 31, 2016. The
improvement in gross margin on product sales was primarily driven
by lower active pharmaceutical ingredient cost.
Selling, general and administrative (SG&A) expenses in the
three months ended March 31, 2017 and 2016 were $34.2 million and
$28.0 million, respectively. The increase in SG&A
expenses primarily reflects a $1.7 million increase in co-promotion
fees accrued under our contract with Kowa Pharmaceuticals America,
Inc., increased promotional activities, and increased legal costs.
The co-promotion fee is calculated based on gross margin on Vascepa
product sales. The increase in co-promotion fees primarily reflects
an increase during Q1 2017 compared to Q1 2016 in gross margin on
product sales.
Research and development expenses in the three months ended
March 31, 2017 and 2016 were $10.8 million and $13.7 million,
respectively. This decrease in expense was primarily driven by the
timing of REDUCE-IT expenses.
Under GAAP, Amarin reported a net loss of $20.9 million in the
first quarter of 2017, or basic and diluted loss per share of
$0.08. This net loss included $3.4 million in non-cash stock-based
compensation expense. 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
stock-based compensation expense, a $1.3 million non-cash loss on
the change in fair value of derivatives.
Amarin reported cash and cash equivalents of $96.1 million at
March 31, 2017. Excluding cash flow related to research and
development and financing, net cash outflows in the quarter ended
March 31, 2017 were approximately $1.4 million. Cash outflows
relating to research and development in Q1 2017 were approximately
$10.4 million. Cash flow from financing-type activities
included approximately $13.7 million in net cash proceeds from the
previously announced January 2017 redemption of debt and
simultaneous issuance of $30.0 million face value of new debt
long-term. Cash paid for interest and royalties in Q1 2017 was
approximately $4.1 million in aggregate.
As of March 31, 2017, the company had $29.5 million in net
accounts receivable ($34.5 million in gross accounts receivable
before allowances and reserves) and $23.9 million in inventory.
As of March 31, 2017, Amarin had approximately 270.7 million
American Depository Shares (ADSs) and ordinary shares outstanding,
32.8 million common share equivalents of Series A Convertible
Preferred Shares outstanding and approximately 23.5 million
equivalent shares underlying stock options at a weighted-average
exercise price of $3.25, as well as 9.8 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 3, 2017. The call will be webcast
live with slides and accessible through the investor relations
section of the company’s website at www.amarincorp.com. The call
can also be heard 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
877-481-4010 (inside the United States) or 919-882-2331 (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 10316.
About Amarin
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 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
- VASCEPA (icosapent ethyl) is indicated as an adjunct to diet to
reduce triglyceride (TG) levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia.
- The effect of VASCEPA on the risk for pancreatitis and
cardiovascular mortality and morbidity in patients with severe
hypertriglyceridemia has not been determined.
Important Safety Information for VASCEPA
- VASCEPA is contraindicated in patients with known
hypersensitivity (e.g., anaphylactic reaction)
to VASCEPA or any of its components.
- Use with caution in patients with known hypersensitivity to
fish and/or shellfish.
- The most common reported adverse reaction (incidence >2% and
greater than placebo) was arthralgia (2.3% for VASCEPA, 1.0% for
placebo). There was no reported adverse reaction >3% and greater
than placebo.
- Patients receiving treatment with VASCEPA and other
drugs affecting coagulation (e.g., anti-platelet agents) should be
monitored periodically.
- In patients with hepatic impairment, monitor ALT and AST levels
periodically during therapy.
- Patients should be advised to
swallow VASCEPA capsules whole; not to break open, crush,
dissolve, or chew VASCEPA.
- Adverse events and product complaints may be reported by
calling 1‑855‑VASCEPA or the
FDA at 1‑800‑FDA‑1088.
FULL 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 expectations for continued event rates, interim data
review, results and related timing and announcements with respect
to Amarin's REDUCE-IT cardiovascular outcomes study; expectations
related to the interim and final outcomes of the REDUCE-IT study
and the anticipated successful completion of the REDUCE-IT study;
and statements regarding the potential 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 develop and
commercialize Vascepa will depend in part on its ability to
continue to effectively finance its business, efforts of third
parties, its ability to create market demand for Vascepa through
education, marketing and sales activities, to achieve increased
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 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 legal
determinations and interactions with regulatory authorities may
impact Vascepa marketing and sales rights and efforts; the risk
that Vascepa may not show clinically meaningful effects in
REDUCE-IT or support regulatory approvals for cardiovascular risk
reduction; and the risk that patents may not be upheld in
anticipated patent litigation. A further list and description
of these risks, uncertainties and other risks associated with an
investment in Amarin can be found in Amarin’s filings with the U.S.
Securities and Exchange Commission, including its most recent
Quarterly Report on Form 10-Q. Existing and prospective
investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of the date
hereof. Amarin undertakes no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise.
Availability of other information about
Amarin
Investors and others should note that we communicate with our
investors and the public using our company website
(www.amarincorp.com), our investor relations website
(http://investor.amarincorp.com), including but not limited to
investor presentations and investor FAQs, Securities and
Exchange Commission filings, press releases, public conference
calls and webcasts. The information that we post on these
channels and websites could be deemed to be material
information. As a result, we encourage investors, the media,
and others interested in Amarin to review the information that we
post on these channels, including our investor relations website,
on a regular basis. This list of channels may be updated from
time to time on our investor relations website and may include
social media channels. The contents of our website or these
channels, or any other website that may be accessed from our
website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933.
|
|
|
|
CONSOLIDATED BALANCE SHEET DATA |
|
|
(U.S. GAAP) |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017 |
|
December 31, 2016 |
|
|
|
|
(in thousands) |
|
|
ASSETS |
|
|
|
|
|
|
Current
Assets: |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
96,076 |
|
|
$ |
98,251 |
|
|
|
Restricted cash |
|
|
600 |
|
|
|
600 |
|
|
|
Accounts
receivable, net |
|
|
29,450 |
|
|
|
19,985 |
|
|
|
Inventory |
|
|
23,879 |
|
|
|
20,507 |
|
|
|
Prepaid
and other current assets |
|
|
4,785 |
|
|
|
6,983 |
|
|
|
Total current assets |
|
|
154,790 |
|
|
|
146,326 |
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net |
|
|
69 |
|
|
|
78 |
|
|
|
Deferred
tax assets |
|
|
11,082 |
|
|
|
11,082 |
|
|
|
Other
long-term assets |
|
|
652 |
|
|
|
741 |
|
|
|
Intangible asset, net |
|
|
8,610 |
|
|
|
8,772 |
|
|
|
TOTAL ASSETS |
|
$ |
175,203 |
|
|
$ |
166,999 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS’ DEFICIT |
|
|
|
|
|
|
Current
Liabilities: |
|
|
|
|
|
|
Accounts
payable |
|
$ |
15,117 |
|
|
$ |
6,062 |
|
|
|
Accrued
expenses and other current liabilities |
|
|
44,434 |
|
|
|
37,720 |
|
|
|
Current
portion of exchangeable senior notes, net of discount |
|
|
192 |
|
|
|
15,351 |
|
|
|
Current
portion of long-term debt from royalty-bearing instrument |
|
|
17,004 |
|
|
|
15,944 |
|
|
|
Deferred
revenue, current |
|
|
1,197 |
|
|
|
1,172 |
|
|
|
Total current liabilities |
|
|
77,944 |
|
|
|
76,249 |
|
|
|
|
|
|
|
|
|
|
Long-Term
Liabilities: |
|
|
|
|
|
|
Exchangeable senior notes, net of discount |
|
|
28,831 |
|
|
|
— |
|
|
|
Long-term
debt from royalty-bearing instrument |
|
|
82,405 |
|
|
|
85,155 |
|
|
|
Deferred
revenue, long-term |
|
|
13,625 |
|
|
|
13,943 |
|
|
|
Other
long-term liabilities |
|
|
1,167 |
|
|
|
710 |
|
|
|
Total liabilities |
|
|
203,972 |
|
|
|
176,057 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ Deficit: |
|
|
|
|
|
|
Preferred
stock |
|
|
24,364 |
|
|
|
24,364 |
|
|
|
Common
stock |
|
|
208,465 |
|
|
|
207,166 |
|
|
|
Additional paid-in capital |
|
|
967,073 |
|
|
|
964,914 |
|
|
|
Treasury
stock |
|
|
(3,726 |
) |
|
|
(1,498 |
) |
|
|
Accumulated deficit |
|
|
(1,224,945 |
) |
|
|
(1,204,004 |
) |
|
|
Total stockholders’ deficit |
|
|
(28,769 |
) |
|
|
(9,058 |
) |
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
$ |
175,203 |
|
|
$ |
166,999 |
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
DATA |
|
|
(U.S. GAAP) |
|
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
(in thousands, except per share
amounts) |
|
|
|
|
2017 |
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
34,344 |
|
|
$ |
25,307 |
|
|
|
Licensing revenue |
|
293 |
|
|
|
236 |
|
|
|
Total revenue, net |
|
34,637 |
|
|
|
25,543 |
|
|
|
Less: Cost
of goods sold |
|
8,198 |
|
|
|
6,896 |
|
|
|
Gross margin |
|
26,439 |
|
|
|
18,647 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
34,171 |
|
|
|
28,020 |
|
|
|
Research and development (1) |
|
10,823 |
|
|
|
13,730 |
|
|
|
Total operating expenses |
|
44,994 |
|
|
|
41,750 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(18,555 |
) |
|
|
(23,103 |
) |
|
|
|
|
|
|
|
|
|
|
|
Loss on change in fair value of derivative liabilities (2) |
|
— |
|
|
|
(1,250 |
) |
|
|
Interest expense, net |
|
(2,381 |
) |
|
|
(5,586 |
) |
|
|
Other expense, net |
|
(5 |
) |
|
|
(121 |
) |
|
|
Loss from operations before taxes |
|
(20,941 |
) |
|
|
(30,060 |
) |
|
|
Benefit from income taxes |
|
— |
|
|
|
289 |
|
|
|
Net loss |
$ |
(20,941 |
) |
|
$ |
(29,771 |
) |
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.08 |
) |
|
$ |
(0.16 |
) |
|
|
Diluted |
$ |
(0.08 |
) |
|
$ |
(0.16 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
270,163 |
|
|
|
184,052 |
|
|
|
Diluted |
|
270,163 |
|
|
|
184,052 |
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Excluding non-cash stock-based compensation, selling,
general and administrative expenses were $31,343 and $25,136 for
the three months ended March 31, 2017 and 2016, respectively, and
research and development expenses were $10,300 and $13,017,
respectively, for the same periods. Excluding non-cash stock-based
compensation as well as co-promotion fees paid to our U.S.
co-promotion partner, selling, general and administrative expenses
were $26,111 and $21,638 for the three months ended March 31, 2017
and 2016, respectively. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
Non-cash gains and losses result from changes in the fair value
of a warrant derivative liability, long-term debt derivative
liabilities, and a preferred stock purchase option derivative
liability. |
|
Amarin contact information:
Investor Relations:
Elisabeth Schwartz
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. Stern
Trout Group
In U.S.: +1 (646) 378-2992
lstern@troutgroup.com
Amarin (NASDAQ:AMRN)
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From Mar 2024 to Apr 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Apr 2023 to Apr 2024