REDUCE-IT™ Study On-Track for Reporting Top-Line
Results by the End of September 2018
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 and six months ended June 30, 2018,
and provided an update on company operations.
Key Amarin achievements since its last quarterly
report include:
- R&D progress: The Vascepa
cardiovascular outcomes study, REDUCE-IT™, is designed to provide
data to support a significantly expanded market opportunity for
Vascepa® (icosapent ethyl). The company announced that, as
expected, it is making progress towards completion of this
important study. The company reiterated that it anticipates
reporting top-line results from REDUCE-IT before the end of
September 2018.
- U.S. revenue growth: Recognized
$52.5 million in net product revenue from Vascepa sales in Q2 2018
compared to $44.9 million in Q2 2017, an increase of 17%.
- U.S. prescription growth: Increased
normalized prescriptions for Vascepa by 22% and 24% compared to Q2
2017 based on data from Symphony Health Solutions and IQVIA,
respectively.
- International development:
Announced regulatory approval for Vascepa in the United Arab
Emirates. Announced a strategic collaboration with Mochida
Pharmaceutical Co., Ltd. to further develop preventative healthcare
solutions on a worldwide basis through continued innovation,
research and development of product opportunities based on the
unique properties of eicosapentaenoic acid (EPA).
- Intellectual property: Announced a
settlement agreement with Teva Pharmaceuticals USA, Inc. that
resolves Amarin’s previously reported Vascepa patent litigation as
it relates to Teva’s abbreviated new drug application seeking U.S.
Food and Drug Administration approval of generic forms of Vascepa
capsules.
- Cash balance: As of June 30, 2018, Amarin had a cash balance of
$102.3 million.
“There is an urgent need to help more patients,
and it is becoming increasingly evident that lowering cholesterol
is not enough,” stated John F. Thero, president and chief executive
officer. “After decades of decline in the death rate from
cardiovascular disease, the number of deaths from cardiovascular
disease is rising again in spite of increased statin use and
increased focus on other LDL-lowering therapies.1 Vascepa could
potentially be used for tens of millions of at-risk patients. We
look forward with excitement to very soon having the results of the
landmark REDUCE-IT study to report.”
REDUCE-IT Cardiovascular Outcomes
Study
The Vascepa cardiovascular outcomes study,
REDUCE-IT, is progressing closer to completion with top-line
results from the study anticipated to be reported before the end of
September 2018. Amarin commented that final vital status data now
has been secured for more than 99.5% of the 8,175 patients enrolled
in the study. Consistent with late stage activities for large
outcomes studies, efforts remain ongoing to adjudicate reported
events, including major adverse cardiovascular events (MACE) within
the primary endpoint that could not be adjudicated until after the
last patient visits occurred. Efforts are also underway to complete
the review of data for consistency and completeness across the more
than 35,000 patient years in the trial, with emphasis on resolving
remaining data queries to contribute to a robust and accurate
database.
Amarin continues to be intentionally blinded to
the results of the study and will remain blinded to such results
until after the study is completed and the database is locked.
Furthermore, all parties associated with the REDUCE-IT study,
including the contract research organizations, independent review
committees, clinical sites and patients, remain blinded to the
final results of the study. As previously stated, once the
REDUCE-IT database is locked, consistent with other outcomes
studies, the company and a team of experts plan to confidentially
review and analyze the data and promptly announce top-line results
publicly. Broader reporting of results is targeted for a scientific
conference in Q4 2018. The time between locking the database
and reporting top-line results is intended to be as brief as is
possible to support both timely and accurate reporting of the
results. Consistent with the practices of most other companies,
Amarin does not plan to separately announce the date the
database is locked. Rather, the company will focus on reporting the
top-line results promptly after top-line results are known
following database lock. Amarin’s anticipation of reporting
top-line results before the end of September 2018 is consistent
with the end of study wind-down timing periods observed for other
large outcomes studies.
Company Preparations for REDUCE-IT
Conclusion
Amarin continues to prepare its commercial
infrastructure for the announcement of the results of the REDUCE-IT
study, including recent promotion of three high performing district
sales managers to newly defined roles as regional directors in
preparation for potential rapid sales force expansion and
increasing levels of available Vascepa inventory. As previously
stated, during 2018 we anticipate incremental inventory increases
prior to REDUCE-IT results of up to approximately $10 million. As
of June 30, 2018, we had increased inventory levels during 2018 by
approximately half of the target increase amount with the balance
of the increase scheduled for coming months.
Financial Update
Net product revenue for the three months ended
June 30, 2018 and 2017 was $52.5 million and $44.9 million,
respectively. Net product revenue for the six months ended June 30,
2018 and 2017 was $96.3 million and $79.3 million, respectively.
The increase in net product revenue was primarily attributable to
increases in new and recurring prescriptions of Vascepa.
During the second quarter, based on data from
Symphony Health Solutions and IQVIA, Amarin experienced continued
prescription growth and increase in Vascepa market share,
particularly among detailed physicians. These sources both reported
estimated normalized total Vascepa prescriptions of approximately
430,000 for the three months ended June 30, 2018, representing
growth of approximately 22% and 24%, respectively, over levels
estimated by these sources for the same three months of the prior
year.
Despite record levels of estimated Vascepa
prescriptions reported by these third-party sources for the second
quarter of 2018 and record levels of physicians reported to have
prescribed Vascepa during the same period, Vascepa growth during
this period appears to have been limited by patients lost to
therapy during the first quarter of 2018 who did not resume filling
Vascepa prescriptions during the second quarter of 2018. As
previously described, beginning of the year insurance deductibles
increased in 2018 under various health insurance plans. This
industry-wide phenomenon, which is particularly impactful to
prescriptions for therapies addressing asymptomatic medical
conditions, resulted in some patients not filling prescriptions
early in 2018. Once patients cease filling prescriptions, they
become less prone, or unable, to resume filling prescriptions until
they again visit their doctors. Net pricing of Vascepa in the
second quarter of 2018 is relatively consistent with the prior year
and channel inventory levels remain in the ordinary range.
Licensing revenues recognized by the company
were $0.2 million and $0.6 million in the six months ended June 30,
2018 and 2017, respectively, related to timing of milestones and
other factors impacting revenue recognition for licensing fees
under agreements for the commercialization of Vascepa outside the
United States.
Cost of goods sold for the three months ended
June 30, 2018 and 2017 was $12.8 million and $11.4 million,
respectively. Cost of goods sold for the six months ended
June 30, 2018 and 2017 was $23.5 million and $19.6 million,
respectively. Gross margin on net product revenue for the three and
six months ended June 30, 2018 and 2017 was 76% and 75%,
respectively.
Selling, general and administrative (SG&A)
expenses in the six months ended June 30, 2018 and 2017 were $97.4
million and $65.7 million, respectively, an increase of 48%. This
increase is due primarily to increased promotional activities,
including commercial spend for anticipated expansion following
successful REDUCE-IT results, and increased co-promotion fees
calculated on increased gross profit resulting from higher net
product revenue, including an accrual of $6.8 million for
co-promotion tail payments. The tail co-promotion fees, which are
calculated as a percentage of the 2018 co-promotion fee, are
payable in 2019 through 2021. SG&A expenses for the six months
ended June 30, 2018 also include $2.0 million related to the
settlement agreement with Teva Pharmaceuticals USA, Inc. which
resolved Amarin’s previously reported Vascepa patent litigation
related to Teva’s abbreviated new drug application (ANDA) seeking
U.S. Food and Drug Administration approval of generic forms of
Vascepa capsules. As previously disclosed, ANDA-related patent
litigation continues in the United States District Court for the
District of Nevada with West-Ward Pharmaceuticals Corp. and Dr.
Reddy’s Laboratories, Inc. and their affiliated entities.
Research and development (R&D) expenses in
the six months ended June 30, 2018 and 2017 were $29.9 million and
$24.5 million, respectively, an increase of 22%. This increase in
expense is primarily driven by the timing of REDUCE-IT 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. We continue to anticipate that our
level of spending on R&D will decline after completion of the
REDUCE-IT and initial publication of results from this important
study.
Under U.S. GAAP, Amarin reported a net loss of $34.2 million in the
three months ended June 30, 2018, or basic and diluted loss per
share of $0.12. This net loss included $3.6 million in non-cash
stock-based compensation expense. Amarin reported a net loss of
$13.6 million in the second quarter of 2017, or basic and diluted
loss per share of $0.05. This net loss included $3.6 million in
non-cash stock-based compensation expense.
Under GAAP, Amarin reported a net loss of $58.3
million in the six months ended June 30, 2018, or basic and diluted
loss per share of $0.20. This net loss included $7.4 million in
non-cash stock-based compensation expense. For the six months ended
June 30, 2017, Amarin reported a net loss of $34.6 million, or
basic and diluted loss per share of $0.13. This net loss included
$7.0 million in non-cash stock-based compensation expense.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $30.6
million for the second quarter of 2018, or non-GAAP adjusted basic
and diluted loss per share of $0.10, compared to non-GAAP adjusted
net loss of $10.0 million for the second quarter of 2017, or
non-GAAP adjusted basic and diluted loss per share of $0.04.
Excluding non-cash gains or losses for
stock-based compensation, non-GAAP adjusted net loss was $50.9
million for the six months ended June 30, 2018, or non-GAAP
adjusted basic and diluted loss per share of $0.18, compared to
non-GAAP adjusted net loss of $27.6 million for the six months
ended June 30, 2017, or non-GAAP adjusted basic and diluted loss
per share of $0.10.
Amarin reported cash and cash equivalents of
$102.3 million as of June 30, 2018. Net cash flows for the six
months ended June 30, 2018, excluding the $70.0 million in net
proceeds from the equity offering completed in the first quarter,
was negative $41.4 million. Net cash flows for the same period was
positive $9.3 million excluding cash outflows associated with
financing and REDUCE-IT. More specifically, net cash flow was
positive for this period excluding finance related proceeds and
expenses (interest and royalty), excluding research and development
payments (most of which relates to the REDUCE-IT study), excluding
payments made in preparation for expansion upon positive REDUCE-IT
results, and excluding the one-time payment made related to the
settlement agreement with Teva Pharmaceuticals USA, Inc.
As of June 30, 2018, the company had $50.3
million in net accounts receivable ($67.0 million in gross accounts
receivable before allowances and reserves) and $40.1 million in
inventory.
As of June 30, 2018, Amarin had approximately
293.9 million American Depository Shares (ADSs) and ordinary shares
outstanding, 32.8 million common share equivalents of Series A
Convertible Preferred Shares outstanding and approximately 25.3
million equivalent shares underlying stock options at a
weighted-average exercise price of $3.35, as well as 12.2 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, August 1, 2018. 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 34827.
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 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. Vascepa® (icosapent ethyl),
Amarin's first FDA-approved product, is a highly-pure, EPA 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 REDUCE-IT
Amarin's clinical development program for
Vascepa includes a trial known as the REDUCE-IT cardiovascular
outcomes study, an 8,175-patient study commenced in 2011. REDUCE-IT
is the first multinational cardiovascular outcomes study evaluating
the effect of prescription pure EPA therapy, or any
triglyceride-lowering therapy, as an add-on to statins in patients
with high cardiovascular risk who, despite stable statin therapy,
have elevated triglyceride levels (150-499 mg/dL). A large portion
of the male and female patients enrolled in this outcomes study are
anticipated to also be diagnosed with type 2 diabetes. As reported
previously, Amarin expects to announce top-line results of this
important study before the end of Q3 2018. The REDUCE-IT
trial is being conducted under a Special Protocol Assessment
agreement with the U.S. Food and Drug Administration.
Additional information on clinical studies of
Vascepa can be found at www.clinicaltrials.gov.
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, 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.
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. 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.
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
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. 3, 4, 5, 6
Leading clinical investigations seeking to
address cardiovascular risk reduction beyond lowering LDL-C focus
on interrupting the atherosclerotic process (e.g., plaque formation
and instability) by beneficially affecting other lipid, lipoprotein
and inflammation biomarkers and cellular functions thought to be
related to atherosclerosis and cardiovascular events.
Forward-Looking Statements
This press release contains forward-looking
statements, including expectations regarding adjudication of MACE
events, results and related timing and announcements with respect
to Amarin's REDUCE-IT cardiovascular outcomes study; expectations
related to the 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 related cost may increase beyond expectations; 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 Amarin
communicates with its investors and the public using the company
website (www.amarincorp.com), the investor relations website
(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 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 Budoff M. Triglycerides and triglyceride-rich
lipoproteins in the causal pathway of cardiovascular disease. Am J
Cardiol. 2016;118:138-145.
4 Toth PP, Granowitz C, Hull M, et al. High
triglycerides increase cardiovascular events, medical costs, and
resource utilization in a real-world analysis of statin-treated
patients with high cardiovascular risk and well-controlled
low-density lipoprotein cholesterol [abstract]. Circulation.
2017;136(suppl 1):A15187.
5 Nordestgaard BG. Triglyceride-rich
lipoproteins and atherosclerotic cardiovascular disease - New
insights from epidemiology, genetics, and biology. Circ Res.
2016;118:547-563.
6 Nordestgaard BG, Varbo A. Triglycerides and
cardiovascular disease. Lancet. 2014; 384: 626–635.
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 Media Inquiries: Christy Maginn
Burson-Marsteller In U.S.: +1 (646) 280-5210
Christy.Maginn@bm.com
|
CONSOLIDATED BALANCE SHEET
DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2018 |
|
December 31, 2017 |
|
|
(in thousands) |
ASSETS |
|
|
|
|
Current
Assets: |
|
|
|
|
Cash and
cash equivalents |
|
$ |
102,257 |
|
|
$ |
73,637 |
|
Restricted cash |
|
|
600 |
|
|
|
600 |
|
Accounts
receivable, net |
|
|
50,309 |
|
|
|
45,318 |
|
Inventory, net |
|
|
40,093 |
|
|
|
30,260 |
|
Prepaid
and other current assets |
|
|
2,878 |
|
|
|
3,455 |
|
Total
current assets |
|
|
196,137 |
|
|
|
153,270 |
|
|
|
|
|
|
|
|
|
|
Property,
plant and equipment, net |
|
|
17 |
|
|
|
28 |
|
Other
long-term assets |
|
|
174 |
|
|
|
174 |
|
Intangible asset, net |
|
|
7,803 |
|
|
|
8,126 |
|
TOTAL ASSETS |
|
$ |
204,131 |
|
|
$ |
161,598 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
|
|
|
Current
Liabilities: |
|
|
|
|
Accounts
payable |
|
$ |
34,471 |
|
|
$ |
25,155 |
|
Accrued
expenses and other current liabilities |
|
|
73,753 |
|
|
|
58,902 |
|
Current
portion of exchangeable senior notes, net of discount |
|
|
481 |
|
|
|
481 |
|
Current
portion of long-term debt from royalty-bearing instrument |
|
|
27,876 |
|
|
|
22,348 |
|
Deferred
revenue, current |
|
|
1,056 |
|
|
|
1,644 |
|
Total
current liabilities |
|
|
137,637 |
|
|
|
108,530 |
|
|
|
|
|
|
|
|
|
|
Long-Term
Liabilities: |
|
|
|
|
Exchangeable senior notes, net of discount |
|
|
29,103 |
|
|
|
28,992 |
|
Long-term
debt from royalty-bearing instrument |
|
|
59,564 |
|
|
|
70,834 |
|
Deferred
revenue, long-term |
|
|
17,750 |
|
|
|
17,192 |
|
Other
long-term liabilities |
|
|
6,764 |
|
|
|
1,150 |
|
Total
liabilities |
|
|
250,818 |
|
|
|
226,698 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ Deficit: |
|
|
|
|
Preferred Stock |
|
|
24,364 |
|
|
|
24,364 |
|
Common stock |
|
|
225,507 |
|
|
|
208,768 |
|
Additional paid-in capital |
|
|
1,040,743 |
|
|
|
977,866 |
|
Treasury stock |
|
|
(6,909 |
) |
|
|
(4,229 |
) |
Accumulated deficit |
|
|
(1,330,392 |
) |
|
|
(1,271,869 |
) |
Total
stockholders’ deficit |
|
|
(46,687 |
) |
|
|
(65,100 |
) |
|
|
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ DEFICIT |
|
$ |
204,131 |
|
|
$ |
161,598 |
|
CONSOLIDATED STATEMENTS OF
OPERATIONS DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
Product revenue, net |
$ |
52,537 |
|
|
$ |
44,948 |
|
|
$ |
96,313 |
|
|
$ |
79,292 |
|
Licensing revenue |
|
106 |
|
|
|
293 |
|
|
|
248 |
|
|
|
586 |
|
Total
revenue, net |
|
52,643 |
|
|
|
45,241 |
|
|
|
96,561 |
|
|
|
79,878 |
|
Less: Cost of goods sold |
|
12,846 |
|
|
|
11,401 |
|
|
|
23,494 |
|
|
|
19,599 |
|
Gross margin |
|
39,797 |
|
|
|
33,840 |
|
|
|
73,067 |
|
|
|
60,279 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Selling,
general and administrative (1) |
|
53,944 |
|
|
|
31,545 |
|
|
|
97,350 |
|
|
|
65,716 |
|
Research
and development (1) |
|
18,159 |
|
|
|
13,694 |
|
|
|
29,921 |
|
|
|
24,517 |
|
Total
operating expenses |
|
72,103 |
|
|
|
45,239 |
|
|
|
127,271 |
|
|
|
90,233 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(32,306 |
) |
|
|
(11,399 |
) |
|
|
(54,204 |
) |
|
|
(29,954 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net |
|
(1,773 |
) |
|
|
(2,315 |
) |
|
|
(4,025 |
) |
|
|
(4,696 |
) |
Other (expense) income, net |
|
(131 |
) |
|
|
80 |
|
|
|
(76 |
) |
|
|
75 |
|
Loss from operations before taxes |
|
(34,210 |
) |
|
|
(13,634 |
) |
|
|
(58,305 |
) |
|
|
(34,575 |
) |
(Provision for) benefit from income taxes |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Net loss |
$ |
(34,210 |
) |
|
$ |
(13,634 |
) |
|
$ |
(58,305 |
) |
|
$ |
(34,575 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.12 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.13 |
) |
Diluted |
$ |
(0.12 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.13 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
Basic |
|
293,662 |
|
|
|
270,725 |
|
|
|
289,458 |
|
|
|
270,445 |
|
Diluted |
|
293,662 |
|
|
|
270,725 |
|
|
|
289,458 |
|
|
|
270,445 |
|
|
|
|
|
|
|
|
|
|
(1 |
) |
Excluding non-cash stock-based compensation,
selling, general and administrative expenses were $50,878 and
$28,478 for the three months ended June 30, 2018 and 2017,
respectively, and research and development expenses were $17,607
and $13,136, 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 $40,594 and $23,909 for the three
months ended June 30, 2018 and 2017, respectively. |
RECONCILIATION OF NON-GAAP NET
LOSS |
Unaudited |
|
|
|
|
|
|
|
|
|
|
|
Three months ended June
30, |
|
Six months ended June
30, |
|
|
(in thousands, except per share
amounts) |
|
(in thousands, except per share
amounts) |
|
|
|
2018 |
|
|
|
2017 |
|
|
|
2018 |
|
|
|
2017 |
|
Net loss for EPS1 - GAAP |
$ |
(34,210 |
) |
|
$ |
(13,634 |
) |
|
$ |
(58,305 |
) |
|
$ |
(34,575 |
) |
|
Non-cash stock-based compensation expense |
|
3,618 |
|
|
|
3,625 |
|
|
|
7,381 |
|
|
|
6,976 |
|
Adjusted net loss for EPS1 - non-GAAP |
$ |
(30,592 |
) |
|
$ |
(10,009 |
) |
|
$ |
(50,924 |
) |
|
$ |
(27,599 |
) |
|
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per share: |
|
|
|
|
|
|
|
Basic and diluted - non-GAAP |
$ |
(0.10 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.18 |
) |
|
$ |
(0.10 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic and
diluted |
|
293,662 |
|
|
|
270,725 |
|
|
|
289,458 |
|
|
|
270,445 |
|
|
|
|
|
|
|
|
|
|
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