Amarin Corporation plc (NASDAQ:AMRN), a pharmaceutical company
focused on improving cardiovascular health, today announced
financial results for the three and nine months ended September 30,
2019 and provided an update on company operations. Key Amarin
achievements since its last quarterly report include:
- Record total revenue: Reported
total revenue of $112.4 million and $286.5 million for the three
and nine months ended September 30, 2019, respectively,
representing increases of 103% and 89%, respectively, over the
corresponding periods of the prior year. The total revenue reported
for the first nine months of 2019 exceeded the full-year results
reported for 2018.
- Record prescriptions: Growth in net
product revenue was supported by increased prescription levels of
Vascepa® (icosapent ethyl) capsules. The increased prescription
levels reflect both a higher number of Vascepa prescribers and an
increase in the average prescriptions per prescriber.
- Preparing for anticipated label
expansion: Assuming that, on or before the previously announced
December 28, 2019 PDUFA date, Vascepa’s label will be expanded to
reflect cardiovascular risk reduction as demonstrated in the
REDUCE-IT® cardiovascular outcomes study, Amarin is taking broad
steps to prepare for commercialization of Vascepa as the first
therapy to address this important unmet medical need, including
preparation for increased education of healthcare professionals and
patients. Furthermore, to support FDA’s approval of Vascepa for
this expanded indication, Amarin has prepared for, and looks
forward to, the FDA’s advisory committee meeting scheduled for
November 14, 2019.
- International regulatory activities
on track: Amarin continues to target making its submission, before
the end of 2019, seeking regulatory approval of Vascepa in Europe.
Regulatory review of Vascepa in Canada continues to progress
through Amarin’s commercial partner in Canada with approval
anticipated near the end of 2019 (late 2019 or early 2020).
- Scientific advancement continues:
Thus far in 2019, Amarin has supported more than 40 scientific
manuscripts or scientific publications with additional
presentations anticipated before year-end, including multiple
presentations later this month at the American Heart Associations’
Annual Scientific Sessions.
- Medical community support for using
Vascepa to help patients: Following the American Diabetes
Association (ADA) new medical guidelines issued in March 2019,
leading cardiology, endocrinology and lipidology societies have
updated their clinical guidelines or provided varying other forms
of advisories that reflect the results of the REDUCE-IT study for
patients who despite well-controlled LDL-cholesterol have elevated
triglyceride levels (>135 mg/dL) and other cardiovascular risk
factors. In Amarin’s view, it is extraordinary to witness this
broad level of medical society support prior to FDA approval for
this important medical indication. These societies include the
National Lipid Association, American Heart Association, European
Society of Cardiology and the European Atherosclerosis Society.
Separately, an independent drug pricing watchdog group concluded
that Vascepa is cost effective for cardiovascular risk reduction
even under the most stringent standards of that group, which is
rarely achieved in their analysis.
“Our aim is to help as many patients as possible
with Vascepa. Accordingly, we are pleased to witness the
growth in Vascepa usage as reported in the third quarter. These
recent results are laying the foundation for our future growth as
we seek to make Vascepa a new standard of care for use in
appropriate at-risk patient populations based on REDUCE-IT,” stated
John F. Thero, president and chief executive officer. “We are
appreciative of the many patients and health care professionals who
have reached out to us expressing support for approval of Vascepa
for the expanded indication being sought. We are working with
leading physicians to ensure that the results of the landmark
REDUCE-IT study are well understood by regulatory authorities and
their advisors. We recognize that much work remains following the
anticipated approval of Vascepa. We remain guided by science and
highly motivated by the unmet medical need that we believe Vascepa
can address.”
Prescription Growth
Based on monthly compilations of data provided
by third parties, Symphony Health and IQVIA, the estimated number
of normalized total Vascepa prescriptions for the three months
ended September 30, 2019 were approximately 865,000 and
787,000, respectively, compared to 458,000 and 417,000,
respectively, in the three months ended September 30,
2018. These estimates reflect increases of 89% in the third
quarter of 2019 over the same period of 2018.
The increase in prescriptions occurred broadly
across the United States with the fastest percentage growth
reported to come from cardiologists and endocrinologists and with
the largest overall volume growth coming from general practitioners
as there are many more general practitioners than specialists in
the United States. The growth came from areas supported by Amarin’s
legacy sales representatives and from faster than expected
productivity of new sales representatives added in early
2019. It is this increased productivity of new sales
representatives, together with feedback from physicians, that
convinced Amarin that the size of its sales force should be doubled
from 400 sales representatives (the level at which the company has
operated for most of 2019) to 800 sales representatives in
preparation for the launch of Vascepa for cardiovascular risk
reduction at the start of 2020, assuming FDA approval.
Regulatory Schedule in the United
States
December 28, 2019 is the Prescription Drug User
Fee Act (PDUFA) target date for action on Amarin’s supplemental New
Drug Application (sNDA) seeking approval of Vascepa as the first
drug approved for cardiovascular risk reduction in the patient
population studied in REDUCE-IT. An FDA advisory committee
meeting pertaining to the sNDA for Vascepa is scheduled to be held
on November 14, 2019 at the FDA’s offices in White Oak,
Maryland. The FDA makes information available regarding this
advisory meeting at
https://www.fda.gov/advisory-committees/november-14-2019-meeting-endocrinologic-and-metabolic-drugs-advisory-committee-meeting-announcement.
Holding an advisory committee meeting in conjunction with its
evaluation of a new drug is not uncommon for the FDA, particularly
when the indication being sought is first in class for a
potentially large patient population as is true for the sNDA under
review for Vascepa.
As is the usual protocol, briefing books will be
used for preparation of advisory committee panel members with
information related to Vascepa, the related science and questions
that the advisory committee panel members will be asked to vote on
at the meeting. The briefing books typically are made public
two days before the commencement of the advisory committee meeting.
We expect this process to be no different for the Vascepa-related
advisory committee meeting on November 14, 2019. Advisory committee
panel members may ask their own questions regardless of whether
such questions are covered in the briefing books or not.
The results of the REDUCE-IT study have been
published in The New England Journal of Medicine and the Journal of
the American College of Cardiology. And, as noted above,
leading medical societies and other groups support the use of
Vascepa to cost effectively address cardiovascular risk in studied
at risk patients beyond statin therapy. Based on data, if all
patients in the United States who have risk profiles similar to
what was studied in REDUCE-IT were to take Vascepa, this could
lower the number of major adverse cardiovascular events in the
United States by approximately 150,000 to 450,000 per year.
Amarin looks forward to the advisory committee
meeting on November 14, 2019 as an opportunity to further
illuminate the results of the REDUCE-IT study and to provide
further education on why Vascepa is a unique drug that should be
approved for cardiovascular risk reduction which would position the
drug to potentially help millions of patients. Amarin is
appreciative of the approximately 100 letters which have been sent
to the FDA from health care professionals, patients and others in
support of prompt approval of Vascepa for cardiovascular risk
reduction. The letters can be viewed with this link:
https://bit.ly/36ypKev.
Commercial Growth
As previously described, upon Amarin’s
anticipated FDA approval of an expanded indication for Vascepa,
Amarin’s goal is to launch a robust educational and promotional
campaign aimed at healthcare professionals and consumers regarding
the efficacy and safety profile of Vascepa as well as on the
significant unmet need to help patients with underlying
cardiovascular risks beyond cholesterol management.
One important element of the robust launch
Amarin is planning is an expanded sales team. The nucleus of
Amarin’s sales team is experienced and productive and has
experienced limited turnover. Amarin’s sales representatives enjoy
helping healthcare professionals learn about new treatment options
for their patients. As noted above, Amarin intends to increase the
size of the Amarin direct sales team to approximately 800 sales
representatives for the start of 2020. Amarin has received over
10,000 resumes for the 400 sales representatives Amarin seeks to
hire. While Amarin has hired some additional sales representatives,
Amarin’s plan is to hire most of the additional sales
representatives near the end of this year to support a launch of
Vascepa, if approved, after the December 28, 2019 PDUFA date. The
larger sales team is expected to educate a larger number of
healthcare professionals and have more frequent interactions with
targeted healthcare professionals. The increased sales force size
is expected to reach approximately 70,000 to 80,000 healthcare
professionals. Most of the sales management needed to support this
expansion has been hired or internally promoted and support systems
are in place with ample capacity to support this expansion.
Amarin reiterates its net revenue guidance for
2019 of $380 million to $420 million. Amarin does not plan to issue
quantified 2020 guidance until after it knows the details of the
label for Vascepa following the PDUFA date.
Financial Update
Amarin recorded net product revenue of $112.3
million and $285.3 million during the three and nine months ended
September 30, 2019, respectively, compared to $55.0 million and
$151.3 million in the corresponding periods of 2018, respectively,
representing increases of 104% and 89%, respectively. This increase
in net product revenue was driven primarily by an increase in
estimated normalized total Vascepa prescriptions in the United
States.
Net pricing of Vascepa in the third quarter of
2019 was relatively consistent with the prior year and channel
inventory levels were in the ordinary range at the beginning and
end of the period.
Licensing revenue during the nine months ended
September 30, 2019 and 2018 were $1.1 million and $0.6 million,
respectively.
Gross margin on net product revenue for the
three and nine months ended September 30, 2019 were 77% compared to
75% and 76%, respectively, in the same periods of 2018.
Selling, general and administrative (SG&A)
expense for the three and nine months ended September 30, 2019 were
$82.6 million and $227.6 million, respectively, compared to $50.0
million and $147.3 million, respectively, in the corresponding
periods of 2018, representing increases of 65% and 55%. These
increases in SG&A expense were due primarily to increased
commercial and other promotional costs for expansion following
successful REDUCE-IT results (announced on September 24, 2018),
including sales force expansion costs, partially offset by agreeing
not to extend beyond December 31, 2018 the company’s previous
co-promotion agreement for Vascepa.
Research and development (R&D) expense for
the three and nine months ended September 30, 2019 were $8.9
million and $23.3 million, respectively, compared to $14.1 million
and $44.0 million, respectively, in the corresponding periods of
2018, representing decreases of 37% and 47%, respectively. These
decreases in R&D expense is attributed to the decline in
REDUCE-IT related costs following presentation of such results in
November 2018.
Under U.S. GAAP, Amarin reported net losses of $3.5 million and
$29.7 million in the three and nine months ended September 30,
2019, or basic and diluted loss per share of $0.01 and $0.09,
respectively, compared to net losses of $24.5 million and $82.8
million in the corresponding periods of 2018, or basic and diluted
per share of $0.08 and $0.28, respectively. The net losses included
$8.0 million and $22.7 million in non-cash stock-based compensation
expense in the three and nine months ended September 30, 2019
compared to $6.7 million and $14.0 million in the corresponding
periods of 2018.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net income was $4.5
million and non-GAAP adjusted net loss was $7.0 million for the
three and nine months ended September 30, 2019, respectively, or
non-GAAP adjusted basic and diluted earnings per share of $0.01 and
loss per share of $0.02, respectively, compared to non-GAAP
adjusted net loss of $17.8 million and $68.7 million for the
corresponding periods of 2018, respectively, or non-GAAP adjusted
basic and diluted loss per share of $0.06 and $0.24,
respectively.Cash and cash equivalents were $673.2 million as of
September 30, 2019. Net accounts receivable were $103.6
million ($133.5 million in gross accounts receivable before
allowances and reserves) as of September 30, 2019.
Net cash flows, excluding net proceeds from the
equity offering completed in the third quarter of 2019, was
positive $11.3 million and negative $16.1 million for the three and
nine month periods ended September 30, 2019, respectively.
As of September 30, 2019, Amarin had
approximately 357.2 million American Depository Shares (ADSs) and
ordinary shares outstanding, 28.9 million common share equivalents
of Series A Convertible Preferred Shares outstanding and
approximately 16.3 million equivalent shares underlying stock
options at a weighted-average exercise price of $6.21, as well as
9.4 million equivalent shares underlying restricted or deferred
stock units.
Conference Call and Webcast Information
Amarin will host a conference call
at 7:30 a.m. ET today, November 5, 2019. 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. 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 55910.
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.
REDUCE-IT® Study
REDUCE-IT, an 8,179-patient cardiovascular
outcomes study, was completed in 2018.1 REDUCE-IT was the first
multinational cardiovascular outcomes study that evaluated the
effect of prescription pure EPA therapy as an add-on to statins in
patients with high cardiovascular risk who, despite stable statin
therapy, had elevated triglyceride levels (at least 135 mg/dL). A
large portion of the male and female patients enrolled in this
outcomes study were diagnosed with type 2 diabetes.
More information on the REDUCE-IT study results
can be found at 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.1,
2
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.3
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.4, 5, 6, 7
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.
The FDA has not completed its review and made a
final determination on a supplemental new drug application related
to REDUCE IT. FDA has not reviewed the information herein or
determined whether to approve Vascepa for use to reduce the risk of
major adverse cardiovascular events in the REDUCE-IT patient
population.
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.
Important Safety Information for Vascepa based
on REDUCE-IT, as previously reported in The New England Journal of
Medicine publication of the primary results of the REDUCE-IT
study:
- Excluding the major adverse
cardiovascular events (MACE) results described above, overall
adverse event rates in REDUCE-IT were similar across the statin
plus Vascepa and the statin plus placebo treatment groups.
- There were no significant
differences between treatments in the overall rate of treatment
emergent adverse events or serious adverse events leading to
withdrawal of study drug.
- There was no serious adverse event
(SAE) occurring at a frequency of >2% which occurred at a
numerically higher rate in the statin plus Vascepa treatment group
than in the statin plus placebo treatment group.
- Adverse events (AEs) occurring in
5% or greater of patients and more frequently with Vascepa than
placebo were:
- peripheral edema (6.5% Vascepa
patients versus 5.0% placebo patients), although there was no
increase in the rate of heart failure in Vascepa patients
- constipation (5.4% Vascepa patients
versus 3.6% placebo patients), although mineral oil, as used as
placebo, is known to lower constipation, and
- atrial fibrillation (5.3% Vascepa
patients versus 3.9% placebo patients), although there were
reductions in rates of cardiac arrest, sudden death and myocardial
infarctions observed in Vascepa patients
- There were numerically more SAEs
related to bleeding in the statin plus Vascepa treatment group
although overall rates were low with no fatal bleeding observed in
either group and no significant difference in adjudicated
hemorrhagic stroke or serious central nervous system or
gastrointestinal bleeding events between treatments.
- In summary, Vascepa was well
tolerated with a safety profile generally consistent with clinical
experience associated with omega-3 fatty acids and current
FDA-approved labeling of such products.
Important Cautionary Information About These
Data
Further REDUCE-IT data assessment and data
release is expected to yield additional useful information to
inform greater understanding of the trial outcome. For example,
detailed data assessment by regulatory authorities, such as the FDA
and Health Canada, will continue and take time to complete and
announce. The FDA advisory committee process and the final
evaluation by regulatory authorities of the totality of efficacy
and safety data from REDUCE-IT is anticipated to include some or
all of the following, as well as other considerations: new
information or analyses affecting the degree of treatment benefit
on studied endpoints; study conduct and data robustness, quality,
integrity and consistency; additional safety data considerations
and risk/benefit considerations; and consideration of REDUCE-IT
results in the context of other clinical studies. More detailed
presentation of such considerations is set forth in the risk
factors section of Amarin’s Quarterly Report on Form 10-Q filed
with the U.S. Securities and Exchange Commission. Because
regulatory reviews are typically fluid and not definitive
interactions between sponsor and agency on individual elements of
an application and related information, Amarin does not plan to
update investors further on ongoing communications with regulatory
authorities. Amarin plans to announce the final outcome of such
regulatory reviews when appropriate.
Forward-Looking Statements
This press release contains forward-looking
statements, including statements regarding the use of Vascepa to
potentially help millions of patients, commercial expansion plans
and anticipated regulatory reviews and related timing. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. 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 submissions, reviews and approvals;
the risk that data interpretations or other information from third
parties, the regulatory review process, regulatory authorities and
in connection with an advisory committee could be made public that
are negative or may delay approval or limit Vascepa’s
marketability; the risk that special protocol assessment (SPA)
agreements with the FDA are not a guarantee that FDA will approve a
product candidate; the risk associated with the FDA's rescinding
the REDUCE-IT SPA agreement; the risk related to FDA advisory
committee meetings; and the risk that the FDA may not complete its
review of the REDUCE-IT sNDA within the timing expected. 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 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.
Amarin Contact Information
Investor Inquiries:Elisabeth SchwartzInvestor
RelationsAmarin Corporation plcIn U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com
Lee M. SternSolebury TroutIn U.S.: +1 (646) 378-2992
lstern@soleburytrout.com
Media Inquiries:Gwen FisherCorporate
Communications Amarin Corporation plcIn U.S.: +1 (908) 325-0735
pr@amarincorp.com
|
|
|
|
|
CONSOLIDATED
BALANCE SHEET DATA |
(U.S.
GAAP) |
Unaudited |
|
|
|
|
|
|
|
|
September 30, 2019 |
|
|
December 31, 2018 |
|
|
|
|
|
|
|
|
|
|
|
(in
thousands) |
ASSETS |
|
|
|
|
Current Assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
673,207 |
|
|
$ |
249,227 |
|
Restricted cash |
|
|
3,904 |
|
|
|
1,500 |
|
Accounts receivable, net |
|
|
103,583 |
|
|
|
66,523 |
|
Inventory |
|
|
54,557 |
|
|
|
57,802 |
|
Deferred tax assets, current |
|
|
— |
|
|
|
— |
|
Prepaid and other current assets |
|
|
12,859 |
|
|
|
2,945 |
|
Total current assets |
|
|
848,110 |
|
|
|
377,997 |
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
2,124 |
|
|
|
63 |
|
Operating lease right-of-use asset |
|
|
8,633 |
|
|
|
- 0 |
|
Other long-term assets |
|
|
1,074 |
|
|
|
174 |
|
Intangible asset, net |
|
|
6,996 |
|
|
|
7,480 |
|
TOTAL ASSETS |
|
$ |
866,937 |
|
|
$ |
385,714 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
Current Liabilities: |
|
|
|
|
Accounts payable |
|
$ |
42,042 |
|
|
$ |
37,632 |
|
Accrued expenses and other current liabilities |
|
|
134,542 |
|
|
|
84,171 |
|
Current portion of long-term debt from royalty-bearing
instrument |
|
|
51,166 |
|
|
|
34,240 |
|
Deferred revenue, current |
|
|
1,962 |
|
|
|
1,220 |
|
Total current liabilities |
|
|
229,712 |
|
|
|
157,263 |
|
|
|
|
|
|
Long-Term Liabilities: |
|
|
|
|
Long-term debt from royalty-bearing instrument |
|
|
8,878 |
|
|
|
46,108 |
|
Deferred revenue, long-term |
|
|
17,617 |
|
|
|
19,490 |
|
Long-term operating lease liability |
|
|
9,432 |
|
|
|
- 0 |
|
Other long-term liabilities |
|
|
5,402 |
|
|
|
10,523 |
|
Total liabilities |
|
|
271,041 |
|
|
|
233,384 |
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
Preferred stock |
|
|
21,850 |
|
|
|
21,850 |
|
Common stock |
|
|
266,878 |
|
|
|
246,663 |
|
Additional paid-in capital |
|
|
1,745,946 |
|
|
|
1,282,762 |
|
Treasury stock |
|
|
(20,533 |
) |
|
|
(10,413 |
) |
Accumulated deficit |
|
|
(1,418,245 |
) |
|
|
(1,388,532 |
) |
Total stockholders’ equity |
|
|
595,896 |
|
|
|
152,330 |
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
$ |
866,937 |
|
|
$ |
385,714 |
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED
STATEMENTS OF OPERATIONS DATA |
(U.S.
GAAP) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
Three months
ended September 30, |
|
Nine months
ended September 30, |
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
Product revenue, net |
$ |
112,250 |
|
|
$ |
54,973 |
|
|
$ |
285,347 |
|
|
$ |
151,286 |
|
Licensing revenue |
|
158 |
|
|
|
350 |
|
|
|
1,131 |
|
|
|
598 |
|
Total revenue, net |
|
112,408 |
|
|
|
55,323 |
|
|
|
286,478 |
|
|
|
151,884 |
|
Less: Cost of goods sold |
|
25,444 |
|
|
|
13,541 |
|
|
|
65,354 |
|
|
|
37,035 |
|
Gross margin |
|
86,964 |
|
|
|
41,782 |
|
|
|
221,124 |
|
|
|
114,849 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
82,559 |
|
|
|
49,960 |
|
|
|
227,598 |
|
|
|
147,310 |
|
Research and development (1) |
|
8,923 |
|
|
|
14,072 |
|
|
|
23,295 |
|
|
|
43,993 |
|
Total operating expenses |
|
91,482 |
|
|
|
64,032 |
|
|
|
250,893 |
|
|
|
191,303 |
|
|
|
|
|
|
|
|
|
Operating loss |
|
(4,518 |
) |
|
|
(22,250 |
) |
|
|
(29,769 |
) |
|
|
(76,454 |
) |
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
1,146 |
|
|
|
(2,163 |
) |
|
|
238 |
|
|
|
(6,188 |
) |
Other expense, net |
|
(90 |
) |
|
|
(58 |
) |
|
|
(182 |
) |
|
|
(134 |
) |
Loss from operations before taxes |
|
(3,462 |
) |
|
|
(24,471 |
) |
|
|
(29,713 |
) |
|
|
(82,776 |
) |
(Provision for) benefit from income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(3,462 |
) |
|
$ |
(24,471 |
) |
|
$ |
(29,713 |
) |
|
$ |
(82,776 |
) |
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.01 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.28 |
) |
Diluted |
$ |
(0.01 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.28 |
) |
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
350,994 |
|
|
|
295,595 |
|
|
|
336,938 |
|
|
|
291,526 |
|
Diluted |
|
350,994 |
|
|
|
295,595 |
|
|
|
336,938 |
|
|
|
291,526 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Excluding
non-cash stock-based compensation, selling, general and
administrative expenses were $75,803 and $44,357 for the three
months ended September 30, 2019 and 2018, respectively, and
research and development expenses were $7,716 and $13,024,
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 $75,803 and $33,200 for the three months ended
September 30, 2019 and 2018, respectively. |
|
|
|
|
|
|
|
|
|
RECONCILIATION OF NON-GAAP NET INCOME (LOSS) |
|
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended September 30, |
|
Nine months ended September 30 |
|
|
|
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
|
2019 |
|
|
2018 |
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss for EPS1 - GAAP |
|
$ |
(3,462 |
) |
|
|
$ |
(24,471 |
) |
|
|
$ |
(29,713 |
) |
|
|
$ |
(82,776 |
) |
|
|
Non-cash stock-based compensation expense |
|
|
7,963 |
|
|
|
|
6,651 |
|
|
|
|
22,729 |
|
|
|
|
14,032 |
|
|
Adjusted net income (loss) for EPS1 - non-GAAP |
|
$ |
4,501 |
|
|
|
$ |
(17,820 |
) |
|
|
$ |
(6,984 |
) |
|
|
$ |
(68,744 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic - non-GAAP |
|
$ |
0.01 |
|
|
|
$ |
(0.06 |
) |
|
|
$ |
(0.02 |
) |
|
|
$ |
(0.24 |
) |
|
Diluted - non-GAAP |
|
|
0.01 |
|
|
|
|
(0.06 |
) |
|
|
|
(0.02 |
) |
|
|
|
(0.24 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
350,994 |
|
|
|
|
295,595 |
|
|
|
|
336,938 |
|
|
|
|
291,526 |
|
|
Diluted |
|
|
379,926 |
|
|
|
|
295,595 |
|
|
|
|
336,938 |
|
|
|
|
291,526 |
|
|
References
1 American Heart Association. 2018. Disease and Stroke
Statistics-2018 Update.
2 American Heart Association. 2017. Cardiovascular disease: A
costly burden for America projections through 2035.
3 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.
4 Budoff M. Triglycerides and triglyceride-rich lipoproteins in
the causal pathway of cardiovascular disease. Am J Cardiol.
2016;118:138-145.
5 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.
6 Nordestgaard BG. Triglyceride-rich lipoproteins and
atherosclerotic cardiovascular disease - New insights from
epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
7 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular
disease. Lancet. 2014;384:626–635.
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Amarin (NASDAQ:AMRN)
Historical Stock Chart
From Apr 2023 to Apr 2024