Record Revenue of $229.2 Million and $77.3
Million for Full Year and Fourth Quarter 2018
Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, today announced
financial results for the quarter and year ended December 31, 2018
and provided an update on company operations.
Key Amarin achievements in 2018 include:
- Unprecedented positive clinical
trial: Results of the REDUCE-IT™ cardiovascular outcomes study
of Vascepa® demonstrated, compared to placebo, a 25% reduction in
major adverse cardiovascular events, with a number needed to treat
of 21, and including a 20% reduction in cardiovascular death.1
These results are the largest shown as an add-on to statin therapy
by any therapy in any studied patient population. This important
result, recognized by the Journal Watch Cardiology section of The
New England Journal of Medicine as the top story of 2018, positions
Vascepa to potentially help millions of patients.
- Revenue growth: Net total revenue, the majority of which was
recorded prior to REDUCE-IT results, reached a record level of
$229.2 million in 2018, including net total revenue of $77.3
million in the fourth quarter of 2018. The results represent
increases of approximately 27% and 44% for full year and fourth
quarter of 2018 over the corresponding periods of 2017,
respectively, primarily reflecting Vascepa prescription
growth.
- Commercialization evolution: Amarin began its transition from a
U.S. sales presence with a relatively small specialty sales team
reliant on a co-promotion partner promoting Vascepa based on
biomarker data to a broader direct sales model with more sales
representatives, more physician targets and promotion which
includes reference to cardiovascular outcomes study results.
Further promotional expansion, particularly consumer-based
promotion, is anticipated following label expansion for Vascepa
based on the REDUCE-IT study results.
- Strengthened balance sheet: At December 31, 2018, Amarin
had $249.2 million of cash and cash equivalents.
“The tremendous progress Amarin made in 2018
helps position us for further significant achievement and
accelerated revenue growth in the future,” commented John Thero,
Amarin’s president and chief executive officer. “Our
excitement regarding the REDUCE-IT study results is being
reinforced by feedback from healthcare professionals as they begin
to understand these unprecedented results and the positive impact
it could have on patient care.”
Guidance Reaffirmed
Amarin provided financial guidance for 2019 in
its press release on January 4, 2019. Amarin today reaffirms
that such earlier guidance has not changed, including its guidance
regarding its planned sNDA and expected 2019 revenue as
follows:
- sNDA Submission: Based on the unprecedented results from the
REDUCE-IT cardiovascular outcomes study, Amarin intends to submit a
supplemental new drug application (sNDA) to the U.S. Food and Drug
Administration (FDA) seeking labeling for Vascepa which reflects
the cardiovascular risk reduction results demonstrated in this
landmark study. Amarin remains on-track to submit this sNDA before
the end of the first quarter of 2019 (i.e. before the end of March
2019) with a normal 10-month regulatory review period assumed prior
to a PDUFA date. While priority review for this sNDA is not
currently assumed, after the sNDA is submitted, consistent with FDA
practices, Amarin will seek to clarify whether priority review by
the FDA is possible for this important submission. Amarin’s
sNDA will consist of over 200,000 pages of data, all of which is
undergoing extensive medical, statistical and quality review.
- 2019 Revenue: Net total revenue for 2019 is anticipated to
increase by more than 50% over 2018 to approximately $350 million,
mostly from U.S. sales of Vascepa. Amarin believes that
continued quarterly variability in revenues is likely. This
guidance assumes that the timing of the expanded label for Vascepa
which Amarin is seeking, subject to FDA approval, will not be
available until late 2019 or early 2020 such that the expanded
label has little or no impact on revenue growth in 2019.
Prescription Growth
Normalized prescriptions for Vascepa
(prescription of 120 grams of Vascepa representing a one-month
supply) increased by 25% and 27% in 2018 compared to 2017 based on
data from Symphony Health and IQVIA, respectively, and increased by
33% and 32% in the fourth quarter of 2018 compared to the same
period in 2017, respectively. Estimated normalized Vascepa
prescriptions, based on data from Symphony Health and IQVIA,
totaled approximately 539,000 and 538,000 in the fourth quarter of
2018. Since Vascepa was made commercially available in 2013, more
than five million estimated normalized total prescriptions of
Vascepa have been reported by Symphony Health.
Sales Force Expansion
Prior to topline results from the REDUCE-IT
study which became available in September 2018, Amarin’s U.S. sales
force consisted of approximately 150 sales representatives plus
their managers. Upon learning the positive REDUCE-IT results,
Amarin proceeded to hire and train additional sales representatives
such that it currently has approximately 400 sales representatives
plus their managers in the U.S. The majority of this
increase in the U.S. sales force for Vascepa promotion occurred
during the late part of 2018 or early in 2019. Corresponding to the
increase in the size of its direct sales force, Amarin also
significantly expanded the number of healthcare professionals it
plans to call on for Vascepa education to approximately 54,000
healthcare professionals and expanded various other marketing and
medical education programs. In parallel, as previously described
and intended, the company’s co-promotion arrangement for Vascepa
reached its scheduled conclusion on December 31, 2018 such that
Amarin’s prior co-promotion partner is no longer promoting Vascepa.
Amarin believes that, while there may be some transition period
required for new sales representatives to become productive,
Vascepa revenue growth will be most cost-effectively achieved by
having this expanded Amarin sales team giving priority to Vascepa
promotion.
Scientific Publication
During 2018, Amarin supported 40 scientific
publications and presentations, up from 25 Amarin supported
scientific publications and presentations in 2017. These included
results of the REDUCE-IT study, as published in The New England
Journal of Medicine online in November 2018, which became available
in its print edition in early 2019, as well as real-world evidence
data, evaluation of multiple mechanisms of action for the active
ingredient in Vascepa and various demographic information
pertaining to cardiovascular disease.
Results from Amarin’s earlier phase 3 studies of
Vascepa, the MARINE and ANCHOR studies, resulted in multiple years
of scientific publications. Similarly, Amarin continues to analyze
the REDUCE-IT data to further assess additional scientific results.
We anticipate further scientific publication and presentation to
result from this analysis that potentially progress the
understanding of cardiovascular disease and the use of Vascepa to
further reduce the risk of major adverse cardiovascular events in
an at-risk patient population.
In early 2019, we already witnessed additional
publication of scientific study of the mechanism of action of
Vascepa and the acceptance of various scientific posters for
presentation at the upcoming American College of Cardiology’s (ACC)
68th Annual Scientific Session on March 18, 2019 in New Orleans, LA
(ACC scientific session). This includes, as previously
announced, presentation as late-breaking clinical trial data of new
data on the reduction of total major adverse cardiovascular (i.e.,
ischemic) events shown in REDUCE-IT. Amarin looks forward to all
such data being presented at ACC and intends to issue one or more
press releases describing the data once it is
public.
Financial Update
Net product revenue for the years ended December
31, 2018 and 2017 was $228.4 million and $179.8 million,
respectively. Net product revenue for the three months ended
December 31, 2018 and 2017 was $77.1 million and $53.5 million,
respectively. Increased revenue is mainly attributed to
increased Vascepa prescriptions in the U.S.
In addition, Amarin recognized licensing revenue
of $0.8 million and $1.3 million for the years ended December 31,
2018 and 2017, respectively, under agreements for the
commercialization of Vascepa outside the U.S.
Cost of goods sold for the three months ended
December 31, 2018 and 2017 was $17.5 million and $13.4 million,
respectively. Cost of goods sold for the years ended December
31, 2018 and 2017 was $54.5 million and $45.0 million,
respectively. Gross margin on product sales was approximately
77% and approximately 76% in the quarter and year ended December
31, 2018, as compared to approximately 75% in the quarter and year
ended December 31, 2017, respectively.
Selling, general and administrative expenses for
the years ended December 31, 2018 and 2017 were $227.0 million and
$134.5 million, respectively. This increase is due primarily to
increased promotional activities, including commercial spend in
preparation for and following the successful REDUCE-IT results
(announced on September 24, 2018), including pilot consumer
promotion, and increased co-promotion fees calculated on increased
gross profit resulting from higher net product revenue plus an
accrual of $16.4 million for co-promotion tail payments. The tail
co-promotion fees, which were calculated as a percentage of the
2018 co-promotion fee, are payable in 2019 through 2021. No further
expense from this prior co-promotion arrangement is anticipated
beyond 2018.
Research and development expenses for the years
ended December 31, 2018 and 2017 were $55.9 million and $47.2
million, respectively. This increase is primarily due to the
REDUCE-IT trial and related costs and the recording of $2.7 million
in expense related to the company’s previously announced strategic
collaboration with Mochida Pharmaceutical Co., Ltd.
Under U.S. GAAP, Amarin reported a net loss of
$33.7 million in the three months ended December 31, 2018, or basic
and diluted loss per share of $0.11. This net loss included $4.8
million in non-cash stock-based compensation expense. Amarin
reported a net loss of $22.5 million in the fourth quarter of 2017,
or basic and diluted loss per share of $0.08. This net loss
included $3.5 million in non-cash stock-based compensation
expense.
Under U.S. GAAP, Amarin reported a net loss of
$116.4 million for the year ended December 31, 2018, or basic and
diluted loss per share of $0.39. This net loss included $18.8
million in non-cash stock-based compensation expense. For the year
ended December 31, 2017, Amarin reported a net loss of $67.9
million, or basic and diluted loss per share of $0.25. This net
loss included $14.0 million in non-cash stock-based compensation
expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $28.9
million for the fourth quarter of 2018, or non-GAAP adjusted basic
and diluted loss per share of $0.09, compared to non-GAAP adjusted
net loss of $19.0 million for the fourth quarter of 2017, or
non-GAAP adjusted basic and diluted loss per share of $0.07.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $97.6
million for the year ended December 31, 2018, or non-GAAP adjusted
basic and diluted loss per share of $0.33, compared to non-GAAP
adjusted net loss of $53.9 million for the year ended December 31,
2017, or non-GAAP adjusted basic and diluted loss per share of
$0.20.
As of December 31, 2018, the company had $66.5
million in net accounts receivable ($86.1 million in gross accounts
receivable before allowances and reserves), which are current, and
$57.8 million in inventory. As of December 31, 2018, the company
had accounts payable and accrued expenses of $121.8 million which
increased from $84.1 million at December 31, 2017 primarily due to
the company’s growth, including supplier payments associated with
the increased levels of Vascepa inventory associated with
supporting increased revenue and the magnitude and timing of
rebates.
As of December 31, 2018, Amarin had
approximately 325.9 million ADSs and ordinary shares outstanding,
28.9 million common share equivalents of Series A Convertible
Preferred Shares outstanding and approximately 19.3 million
equivalent shares underlying stock options at a weighted-average
exercise price of $4.29, as well as 9.6 million equivalent shares
underlying restricted or deferred stock units.
Conference Call and Webcast Information
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
877-481-4010, PIN: 43356. A replay of the call will also be
available through the company's website shortly after the call.
Use of Non-GAAP Adjusted Financial
Information
Included in this press release 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 stock-based
compensation expense. Management uses these non-GAAP adjusted
financial measures for internal reporting and forecasting purposes,
when publicly providing its business outlook, to evaluate the
company’s performance and to evaluate and compensate the company’s
executives. The company has provided these non-GAAP financial
measures in addition to GAAP financial results because it believes
that these non-GAAP adjusted financial 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.
About Amarin
Amarin Corporation plc is a rapidly growing,
innovative pharmaceutical company focused on developing
therapeutics to improve cardiovascular health. Amarin’s product
development program leverages its extensive experience in
polyunsaturated fatty acids and lipid science. Vascepa® (icosapent
ethyl) is Amarin's first FDA-approved drug and is available by
prescription in the United States, Lebanon and the United Arab
Emirates. Amarin’s commercial partners are pursuing
additional regulatory approvals for Vascepa in Canada, China and
the Middle East. For more information about Amarin, visit
www.amarincorp.com.
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains
the #1 killer of men and women. In the United States CVD leads to
one in every three deaths – one death approximately every 38
seconds – with annual treatment cost in excess of $500 billion.2,
3
Multiple primary and secondary
prevention trials have shown a significant reduction of 25% to
35% in the risk of cardiovascular
events with statin therapy, leaving significant
persistent residual risk despite the achievement of target LDL-C
levels.4
Beyond the cardiovascular risk associated with
LDL-C, genetic, epidemiologic, clinical and real-world data suggest
that patients with elevated triglycerides (TG) (fats in the blood),
and TG-rich lipoproteins, are at increased risk for cardiovascular
disease. 5, 6, 7, 8
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 from degradation. Vascepa, known in scientific
literature as AMR101, has been designated a new chemical entity by
the FDA. Amarin has been issued multiple patents
internationally based on the unique clinical profile of Vascepa,
including the drug’s ability to lower triglyceride levels in
relevant patient populations without raising LDL-cholesterol
levels.
Indication and Usage Based on Current
FDA-Approved Label (not including REDUCE-IT results)
- 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 Based
on Current FDA-Approved Label (not including REDUCE-IT results)
(Includes Data from Two 12-Week Studies (n=622) (MARINE and ANCHOR)
of Patients with Triglycerides Values of 200 to 2000 mg/dL)
- Vascepa is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to Vascepa or any of its components.
- In patients with hepatic
impairment, monitor ALT and AST levels periodically during
therapy.
- 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.
- Adverse events and product
complaints may be reported by calling 1-855-VASCEPA or the FDA at
1-800-FDA-1088.
- Patients receiving treatment with
Vascepa and other drugs affecting coagulation (e.g., anti-platelet
agents) should be monitored periodically.
- Patients should be advised to
swallow Vascepa capsules whole; not to break open, crush, dissolve,
or chew Vascepa.
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. 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 regarding planned scientific
presentation, publication, regulatory review and related timing
thereof, including plans to submit an sNDA before the end of March
2019 seeking an expanded indication for Vascepa in the United
States; and expectations regarding further advancement, commercial
expansion and revenue growth. These forward-looking statements are
not promises or guarantees and involve substantial risks and
uncertainties. In addition, Amarin's ability to effectively
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, its ability to obtain an
expanded indication for Vascepa in the United States, 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 sales may not meet expectations and related cost may
increase beyond expectations; the risk that patents may not be
upheld in patent litigation and applications may not result in
issued patents sufficient to protect the Vascepa franchise. 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 annual report on Form 10-K. 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 Amarin
communicates with its investors and the public using the company
website (http://www.amarincorp.com/), the 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 Amarin posts on
these channels and websites could be deemed to be material
information. As a result, Amarin encourages investors, the
media, and others interested in Amarin to review the information
that is posted on these channels, including the investor relations
website, on a regular basis. This list of channels may be
updated from time to time on Amarin’s investor relations website
and may include social media channels. The contents of
Amarin’s website or these channels, or any other website that may
be accessed from its website or these channels, shall not be deemed
incorporated by reference in any filing under the Securities Act of
1933.
References
1 Bhatt DL, Steg PG, Miller M, Brinton EA,
Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C,
Tardif JC, Ballantyne CM, for the REDUCE-IT Investigators.
Cardiovascular Risk Reduction with Icosapent Ethyl for
Hypertriglyceridemia. N Engl J Med 2019;380:11-22.
2 American Heart Association. 2018.
Disease and Stroke Statistics-2018 Update.
3 American Heart Association. 2017.
Cardiovascular disease: A costly burden for America projections
through 2035.
4 Ganda OP, Bhatt DL, Mason RP, et al. Unmet
need for adjunctive dyslipidemia therapy in hypertriglyceridemia
management. J Am Coll Cardiol. 2018;72(3):330-343.
5 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.
6 Toth PP, Granowitz C, Hull M, et al. High
triglycerides are associated with increased cardiovascular events,
medical costs, and resource use: A real-world administrative claims
analysis of statin-treated patients with high residual
cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.
7 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
8 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014;384:626–635.
Amarin Contact Information
Investor Relations:
Elisabeth SchwartzInvestor Relations and Corporate
CommunicationsAmarin Corporation plcIn U.S.: +1 (908)
719-1315investor.relations@amarincorp.com (investor
inquiries)PR@amarincorp.com (media inquiries)
Lee M. Stern Solebury Trout In U.S.: +1 (646)
378-2992lstern@soleburytrout.com
|
CONSOLIDATED BALANCE SHEET DATA |
(U.S. GAAP) |
Unaudited* |
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2018 |
|
December 31, 2017 |
|
|
|
|
|
(in thousands) |
ASSETS |
|
|
|
|
Current
Assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
249,227 |
|
|
$ |
73,637 |
|
Restricted cash |
|
|
1,500 |
|
|
|
600 |
|
Accounts
receivable, net |
|
|
66,523 |
|
|
|
45,318 |
|
Inventory |
|
|
57,802 |
|
|
|
30,260 |
|
Prepaid
and other current assets |
|
|
2,945 |
|
|
|
3,455 |
|
Total
current assets |
|
|
377,997 |
|
|
|
153,270 |
|
Property,
plant and equipment, net |
|
|
63 |
|
|
|
28 |
|
Other
long-term assets |
|
|
174 |
|
|
|
174 |
|
Intangible asset, net |
|
|
7,480 |
|
|
|
8,126 |
|
TOTAL ASSETS |
|
$ |
385,714 |
|
|
$ |
161,598 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
|
Current
Liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
37,632 |
|
|
$ |
25,155 |
|
Accrued
expenses and other current liabilities |
|
|
84,171 |
|
|
|
58,902 |
|
Current
portion of exchangeable senior notes, net of discount |
|
|
— |
|
|
|
481 |
|
Current
portion of long-term debt from royalty-bearing instrument |
|
|
34,240 |
|
|
|
22,348 |
|
Deferred
revenue, current |
|
|
1,220 |
|
|
|
1,644 |
|
Total
current liabilities |
|
|
157,263 |
|
|
|
108,530 |
|
Long-Term
Liabilities: |
|
|
|
|
Exchangeable senior notes, net of discount |
|
|
— |
|
|
|
28,992 |
|
Long-term
debt from royalty-bearing instrument |
|
|
46,108 |
|
|
|
70,834 |
|
Deferred
revenue, long-term |
|
|
19,490 |
|
|
|
17,192 |
|
Other
long-term liabilities |
|
|
10,523 |
|
|
|
1,150 |
|
Total
liabilities |
|
|
233,384 |
|
|
|
226,698 |
|
Stockholders’ Equity (Deficit): |
|
|
|
|
Preferred
Stock |
|
|
21,850 |
|
|
|
24,364 |
|
Common
stock |
|
|
246,663 |
|
|
|
208,768 |
|
Additional paid-in capital |
|
|
1,282,762 |
|
|
|
977,866 |
|
Treasury
stock |
|
|
(10,413 |
) |
|
|
(4,229 |
) |
Accumulated deficit |
|
|
(1,388,532 |
) |
|
|
(1,271,869 |
) |
Total
stockholders’ equity (deficit) |
|
|
152,330 |
|
|
|
(65,100 |
) |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
$ |
385,714 |
|
|
$ |
161,598 |
|
* Unaudited as standalone schedule; copied from consolidated
financial statements. |
|
|
|
|
|
|
|
|
CONSOLIDATED STATEMENTS OF OPERATIONS
DATA |
(U.S. GAAP) |
|
|
|
Unaudited |
|
Unaudited* |
|
|
Three months ended December 31, |
|
Twelve months ended December 31, |
|
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
Product revenue, net |
$ |
77,085 |
|
|
$ |
53,482 |
|
|
$ |
228,371 |
|
|
$ |
179,825 |
|
Licensing revenue |
|
245 |
|
|
|
384 |
|
|
|
843 |
|
|
|
1,279 |
|
Total revenue, net |
|
77,330 |
|
|
|
53,866 |
|
|
|
229,214 |
|
|
|
181,104 |
|
Less: Cost of goods sold |
|
17,509 |
|
|
|
13,432 |
|
|
|
54,543 |
|
|
|
44,952 |
|
Gross margin |
|
59,821 |
|
|
|
40,434 |
|
|
|
174,671 |
|
|
|
136,152 |
|
Operating expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
79,686 |
|
|
|
35,639 |
|
|
|
226,996 |
|
|
|
134,549 |
|
Research and development (1) |
|
11,906 |
|
|
|
11,947 |
|
|
|
55,900 |
|
|
|
47,158 |
|
Total operating expenses |
|
91,592 |
|
|
|
47,586 |
|
|
|
282,896 |
|
|
|
181,707 |
|
Operating loss |
|
(31,771 |
) |
|
|
(7,152 |
) |
|
|
(108,225 |
) |
|
|
(45,555 |
) |
Interest expense, net |
|
(1,611 |
) |
|
|
(2,240 |
) |
|
|
(7,798 |
) |
|
|
(9,337 |
) |
Other (expense) income, net |
|
(192 |
) |
|
|
(26 |
) |
|
|
(326 |
) |
|
|
74 |
|
Loss from operations before taxes |
|
(33,574 |
) |
|
|
(9,418 |
) |
|
|
(116,349 |
) |
|
|
(54,818 |
) |
Provision for income taxes (2) |
|
(96 |
) |
|
|
(13,047 |
) |
|
|
(96 |
) |
|
|
(13,047 |
) |
Net loss |
$ |
(33,670 |
) |
|
$ |
(22,465 |
) |
|
$ |
(116,445 |
) |
|
$ |
(67,865 |
) |
Loss per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.11 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.25 |
) |
Diluted |
$ |
(0.11 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.25 |
) |
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
314,183 |
|
|
|
270,906 |
|
|
|
297,237 |
|
|
|
270,652 |
|
Diluted |
|
314,183 |
|
|
|
270,906 |
|
|
|
297,237 |
|
|
|
270,652 |
|
|
|
|
|
|
|
|
|
|
* Unaudited as standalone schedule; copied from
consolidated financial statements. |
|
|
|
|
|
|
|
|
|
(1) Excluding non-cash stock-based compensation,
selling, general and administrative expenses were $211,088 and
$122,711 for 2018 and 2017, respectively, and research and
development expenses were $53,002 and $45,036, respectively, for
the same periods. Excluding non-cash stock-based compensation as
well as co-promotion fees paid to the company's U.S. co-promotion
partner, selling, general and administrative expenses were $164,267
and $100,204 for 2018 and 2017, respectively. |
|
|
|
|
|
|
|
|
|
(2) Included in the provision for the year ended
December 31, 2017 is non-cash tax expense related to increases in
our valuation allowance against deferred tax assets. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET
LOSS |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended December 31, |
|
Twelve months ended December 31, |
|
|
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
|
Net loss for EPS1 - GAAP |
$ |
(33,670 |
) |
|
$ |
(22,465 |
) |
|
$ |
(116,445 |
) |
|
$ |
(67,865 |
) |
|
|
Non-cash
stock-based compensation expense |
|
4,775 |
|
|
|
3,489 |
|
|
|
18,806 |
|
|
|
13,960 |
|
|
Adjusted net loss for EPS1 - non-GAAP |
$ |
(28,895 |
) |
|
$ |
(18,976 |
) |
|
$ |
(97,639 |
) |
|
$ |
(53,905 |
) |
|
|
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted - non-GAAP |
$ |
(0.09 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.20 |
) |
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
314,183 |
|
|
|
270,906 |
|
|
|
297,237 |
|
|
|
270,652 |
|
|
|
|
|
|
|
|
|
|
|
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Sep 2023 to Sep 2024