Amarin Corporation plc (NASDAQ:AMRN), today announced financial
results for the quarter ended June 30, 2022 and provided an update
on company operations.
“In the second quarter of 2022, we made
important progress on our long-term growth strategy. Our
achievements give us confidence in the direction of and
opportunities for Amarin during the remainder of 2022 and into
2023,” said Karim Mikhail, president and chief executive officer of
Amarin.
“In Europe, we are pleased with our progress in
several major markets as we secured three favorable reimbursement
decisions for VAZKEPA so far this year. We received our first
reimbursement in Sweden, individual reimbursement in Denmark and
announced final guidance for reimbursement by the National
Institute for Health and Care Excellence (NICE) in England and
Wales, our first positive decision in an EU5 country. These
advances mark the transition to the next phase of our geographic
expansion strategy. We also made important progress in a second
major market, Spain, where we were able to accelerate into pricing
discussions during the second quarter. In addition, we previously
received a positive reimbursement assessment from Haute Autorité de
Santé (HAS), the French National Authority for Health, and we
continue to make progress on price negotiations in that
market.
“Market and macroeconomic conditions remain
difficult in Germany. That said, we continue to engage in price
negotiations and have taken prudent steps to ensure our financial
investments match the risk profile of the market. These actions
include a suspension of our contracted primary care field force,
and we remain committed to our presence in Germany pending the
outcome of price negotiations with the payer.
“We remain on track to deliver on our commitment
to obtain reimbursement status in up to eight European markets and
launch in up to six key European markets this year and remain
confident in our greater than $1 billion revenue opportunity in
Europe.
“In the U.S, while we are experiencing
additional pressure from the first full quarter with a third
generic entrant on the market and we are addressing these
challenges with our cost reduction program, I am pleased that our
second quarter revenue level was consistent with the first quarter
of 2022. In June, we implemented our comprehensive cost savings
plan, with anticipated cost savings of $100 million over the next
12 months to address the U.S. market dynamics. And internationally,
we continue to advance filings and hold active partnership
discussions in key territories.
“We remain steadfast in our conviction on the
depth and breadth of our clinical data based on REDUCE-IT, the
definitive, large, long-term outcomes study of icosapent ethyl with
gold standard cardiovascular clinical endpoints. Further, we remain
committed to maximizing the value of VASCEPA/VAZKEPA by maintaining
our strong presence at future medical meetings and supporting
potential publications, which will continue to highlight the
strength of this data and impact for patients. We also continue to
make progress on the development of our fixed-dose combination of
VASCEPA with a statin and enhance and expand our leadership team to
support the company’s long-term strategy.
“As we look forward, our progress in the quarter
and the first half of 2022, as well as our conviction in our robust
science and clinical data, gives us confidence that our long-term
strategy will allow us to execute against a BOLD vision to stop
heart disease from being the leading cause of death, worldwide,”
concluded Mr. Mikhail.
Europe
- Achieved final reimbursement
decision for VAZKEPA from the United Kingdom’s NICE for England and
Wales.
- Launch activities are underway in
Sweden, and England & Wales to drive formulary access and
education in those markets.
- Initiated the fourth round of price
negotiations in Germany, while we continue to receive temporary
reimbursement for VAZKEPA. Based on the status of negotiations and
current market conditions, we have suspended our contracted primary
care field force.
- Clinical and Health Technology Assessment processes and
reimbursement discussions are progressing across all of the
targeted markets in Europe where Amarin has submitted market access
dossiers, including Norway, Finland, France, Italy, Spain,
Portugal, Austria, Switzerland, Israel and the Netherlands:
- Price negotiations have begun with
Spain’s Ministry of Health, which could allow for a possible
pricing and reimbursement decision before the end of 2022.
- As a reminder, we received a
positive reimbursement assessment from HAS – the French National
Authority for Health – and price negotiations continue to
progress.
- New dossiers were submitted and
accepted in Portugal, Austria and Switzerland and are now in
pricing and reimbursement negotiations.
United States
U.S. product net revenue was $90.6 million in the second quarter
of 2022, a decline of $2.8 million versus the first quarter of
2022. Importantly, the second quarter was the first full quarter
where three generic entrants were in the market versus only one
generic entrant in the prior year period.
U.S. commercial operations continue to maintain
a strong core sales force to support branded VASCEPA sales
targeting the top prescribers and continue to focus on secondary
prevention. This business continues to support investments in
Europe and expansion into new markets. Amarin continues to actively
monitor key performance indicators in the U.S. market to support
its strategy moving forward.
In the U.S., the company continues to focus on
positive contribution margin to support the growth and expansion of
VASCEPA/VAZKEPA globally.
International
Amarin continues to gain traction with its goal
to unlock the potential of VASCEPA internationally. The company is
in the process of filing regulatory submissions for approval of
VASCEPA in 20 additional countries to ensure that patients in the
top 50 cardiometabolic markets worldwide can benefit from VASCEPA.
In addition, Amarin continues to make meaningful progress in these
efforts with our partners.
- Amarin received acceptances of the
regulatory reviews of VASCEPA market authorization submissions in
Australia and New Zealand, with the filings advancing as per local
protocols.
- In Canada, HLS Therapeutics, Inc.
completed negotiations with Canada’s pan-Canadian Pharmaceutical
Alliance (pCPA) for the terms and conditions under which VASCEPA
would qualify for public market reimbursement in Canada and has
received approval from the provinces of Quebec, Ontario, New
Brunswick and Northwest Territories, Saskatchewan, as well as the
NIHB program for First Nations and Inuit peoples, expanding
reimbursement of VASCEPA across the country.
- Biologix, Amarin’s partner in the
Middle East and North Africa (MENA), received the official
registration certificate for VASCEPA from the Kingdom of Saudi
Arabia (KSA) regulatory authority for the treatment of severe
hypertriglyceridemia. This first approval in KSA enables the
preparation and submission of a variation to seek review and
approval for the CV risk reduction indication.
- Eddingpharm (Asia) Macao Commercial
Offshore Limited (Edding), Amarin’s partner in China, received
approval for VASCEPA in Hong Kong and is planning for commercial
launch by the end of the year. In addition, Edding continues to
expect to receive approval for VASCEPA in Mainland China this
year.
Financial Update
Total net revenue for the three months ended
June 30, 2022 was $94.4 million, compared to $154.5 million in the
corresponding period of 2021, a decrease of 39%. Net product
revenue for the three months ended June 30, 2022 was $93.8 million,
compared to $153.8 million in the corresponding period of 2021, a
decrease of 39%. This decrease was driven by a decline in volume
and net selling price due to the impact of an increase in generic
competition in the U.S. As a reminder, during the three months
ended June 30, 2022 there were three generic competitors in the
U.S. market as compared to one generic competitor in the U.S.
market during the three months ended June 30, 2021.
Amarin recognized licensing and royalty revenue
of approximately $0.6 million and $0.7 million during the three
months ended June 30, 2022 and 2021, respectively, from
VASCEPA-related commercial sales from our partners in Canada, the
China region and the Middle East.
Cost of goods sold for the three months ended
June 30, 2022 was $50.8 million, compared to $32.2 million in the
corresponding period of 2021. Amarin’s overall gross margin on net
product revenue for the three months ended June 30, 2022 was 46%,
compared with 79% for the corresponding period of 2021. During the
three months ended June 30, 2022, Amarin has taken steps to amend
supplier agreements to align supply arrangements with current and
future market demand resulting in a charge of $15.0 million and had
a charge of $9.6 million related to unsellable inventory not
related to product dating. Excluding the impact of these two items,
gross margin was 72% for the three months ended June 30, 2022.
Selling, general and administrative expenses for
the three months ended June 30, 2022 was $86.9 million, compared to
$107.2 million in the corresponding period of the prior year. This
decrease was primarily due to a decrease in U.S. commercial costs
and was partially offset by investments to support commercial
operations in Europe.
Research and development expenses for the three
months ended June 30, 2022 were $9.4 million, compared to $6.4
million in the corresponding period of the prior year. This
increase was primarily driven by costs incurred related to the
development of a fixed-dose combination of VASCEPA with a
statin.
In June, the company implemented a comprehensive
cost reduction plan in response to the market dynamics experienced
in the U.S. with the third generic entrant launching in the first
quarter of 2022. The Company will reduce its total operational
expenditure by approximately $100.0 million over 12 months* while
continuing its investments in European expansion. The cost
reduction plan included a significant workforce reduction across
the Company’s U.S. field force and corporate positions reductions
and reallocations in overall selling, general and administrative
(SG&A) expenses as well as savings related to refining the
Company’s R&D strategy to a more focused, stepwise approach for
its FDC program. As a result of these cost savings efforts, the
company incurred a total of $25.2 million in restructuring charges
during the second quarter 2022, $10.2 million relating to
restructuring charges and $15.0 million relating to the steps taken
to amend supplier agreements to align supply arrangements with
current and future market demand.
Under U.S. GAAP, Amarin reported a net loss of
$70.0 million for the second quarter ended June 30, 2022, or basic
and diluted loss per share of $0.18. This net loss includes $9.1
million in non-cash stock-based compensation and $25.2 million in
restructuring expenses. For the second quarter ended June 30, 2021,
Amarin reported a net income of $7.8 million, or basic and diluted
earnings per share of $0.02. This net income included $2.5 million
in non-cash stock-based compensation expense. Excluding non-cash
stock-based compensation expense and restructuring expense,
non-GAAP adjusted net loss was $35.6 million for the second quarter
ended June 30, 2022 or non-GAAP adjusted basic and diluted loss per
share of $0.09, compared with non-GAAP adjusted net income of $10.3
million for the second quarter ended June 30, 2021, or non-GAAP
adjusted basic and diluted earnings per share of $0.03. As of June
30, 2022, Amarin reported aggregate cash and investments of $324.6
million.
*Compared to 2021 full year GAAP operating
expenses and excludes restructuring charges.
2022 Financial Outlook
Given the ongoing global impact of COVID-19, as
well as the uncertainty resulting from the impact of generic IPE
availability in the U.S. and challenges for most drugs seeking
market access in Europe, Amarin will continue to suspend 2022
revenue guidance.
Amarin reiterates its belief that current cash
and investments and other assets are adequate to support continued
operations, including European launch activities for at least the
next twelve months.
Conference Call and Webcast
Information:
Amarin will host a conference call on August 3,
2022, at 8:00 a.m. ET to discuss this information. The conference
call can be accessed on the investor relations section of the
company's website at www.amarincorp.com, or via telephone by
dialing 888-506-0062 within the United States, 973-528-0011 from
outside the United States, and referencing conference ID 316813. A
replay of the call will be made available for a period of two weeks
following the conference call. To listen to a replay of the call,
dial 877-481-4010 from within the United States and 919-882-2331
from outside of the United States, and reference conference ID
45865. 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) income was derived
by taking GAAP net loss and adjusting it for non-cash stock-based
compensation expense and restructuring 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 is an innovative pharmaceutical company
leading a new paradigm in cardiovascular disease management. From
our scientific research foundation to our focus on clinical trials,
and now our global commercial expansion, we are evolving and
growing rapidly. Amarin has offices in Bridgewater, New Jersey in
the United States, Dublin in Ireland, Zug in Switzerland, and other
countries in Europe as well as commercial partners and suppliers
around the world. We are committed to rethinking cardiovascular
risk through the advancement of scientific understanding of the
impact on society of significant residual risk that exists beyond
traditional therapies, such as statins for cholesterol
management.
About VASCEPA® (icosapent ethyl) Capsules
VASCEPA (icosapent ethyl) capsules are the
first-and-only prescription treatment approved by the U.S. Food and
Drug Administration (FDA) comprised solely of the active
ingredient, icosapent ethyl (IPE), a unique form of
eicosapentaenoic acid. VASCEPA was launched in the United States in
January 2020 as the first and only drug approved by the U.S. FDA
for treatment of the studied high-risk patients with persistent
cardiovascular risk after statin therapy. VASCEPA was initially
launched in the United States in 2013 based on the drug’s initial
FDA approved indication for use as an adjunct therapy to diet to
reduce triglyceride levels in adult patients with severe (≥500
mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been
prescribed over ten million times. VASCEPA is covered by most major
medical insurance plans. In addition to the United States, VASCEPA
is approved and sold in Canada, Lebanon and the United Arab
Emirates. In Europe, in March 2021 marketing authorization was
granted to icosapent ethyl in the European Union for the reduction
of risk of cardiovascular events in patients at high cardiovascular
risk, under the brand name VAZKEPA.
Indications and Limitation of Use (in the United
States)
VASCEPA is indicated:
- As an adjunct to maximally
tolerated statin therapy to reduce the risk of myocardial
infarction, stroke, coronary revascularization and unstable angina
requiring hospitalization in adult patients with elevated
triglyceride (TG) levels (≥ 150 mg/dL) and
- established cardiovascular disease or
- diabetes mellitus and two or more additional risk factors for
cardiovascular disease.
- As an adjunct to diet to reduce TG
levels in adult patients with severe (≥ 500 mg/dL)
hypertriglyceridemia. The effect of VASCEPA on the risk for
pancreatitis in patients with severe hypertriglyceridemia has not
been determined.
Important Safety Information
- VASCEPA is contraindicated in
patients with known hypersensitivity (e.g., anaphylactic reaction)
to VASCEPA or any of its components.
- VASCEPA was associated with an
increased risk (3% vs 2%) of atrial fibrillation or atrial flutter
requiring hospitalization in a double-blind, placebo-controlled
trial. The incidence of atrial fibrillation was greater in patients
with a previous history of atrial fibrillation or atrial
flutter.
- It is not known whether patients
with allergies to fish and/or shellfish are at an increased risk of
an allergic reaction to VASCEPA. Patients with such allergies
should discontinue VASCEPA if any reactions occur.
- VASCEPA was associated with an
increased risk (12% vs 10%) of bleeding in a double-blind,
placebo-controlled trial. The incidence of bleeding was greater in
patients receiving concomitant antithrombotic medications, such as
aspirin, clopidogrel or warfarin.
- Common adverse reactions in the
cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent
than placebo): musculoskeletal pain (4% vs 3%), peripheral edema
(7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial
fibrillation (5% vs 4%).
- Common adverse reactions in the
hypertriglyceridemia trials (incidence >1% more frequent than
placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs
0.3%).
- Adverse events may be reported by
calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.
- Patients receiving VASCEPA and
concomitant anticoagulants and/or anti-platelet agents should be
monitored for bleeding.
FULL U.S. FDA-APPROVED
VASCEPA PRESCRIBING INFORMATION
CAN BE FOUND AT WWW.VASCEPA.COM.
Forward-Looking Statements
This press release contains forward-looking
statements, within the meaning of U.S. securities laws, including,
but not limited to, including beliefs about the world-wide market
potential for VASCEPA; expectations regarding financial metrics and
performance such as prescription growth, revenue growth, operating
expenses, inventory purchases, and managed care coverage for
VASCEPA, including the impact of the COVID-19 pandemic, the
disappointing outcome of patent litigation and the launch of
generic competition on these metrics; beliefs that Amarin is well
positioned to deliver on its goals to grow VASCEPA in the U.S. and
beyond; beliefs about patient needs for VASCEPA; effects of the
COVID-19 pandemic on Amarin's operations and on the healthcare
industry more broadly, which effects continue to be fluid; beliefs
that Amarin's strategy for reducing the effects of cardiovascular
disease is sound and that Amarin is efficiently reaching
physicians, payors, pharmacists and patients; the timing and
outcome of regulatory filings and reviews, recommendations and
approvals and related reimbursement decisions and commercial
launches in Europe, the China region and elsewhere; plans for
Amarin's expected launch of VASCEPA directly in major markets in
Europe, directly and indirectly; beliefs about the cardioprotective
and other benefits of VASCEPA; beliefs about the strength of data
in market access dossiers and other reports; expectations for the
timing, effectiveness and outcome of promotional activities,
including patient-oriented campaigns, conference and posted
presentations and education of healthcare professionals; commercial
and international expansion, prescription growth and revenue growth
and future revenue levels, including the contributions of sales
representatives and the new leadership team; beliefs that Amarin's
current resources are sufficient to fund projected operations; and
the impact of the COVID-19 pandemic on all of the foregoing. These
forward-looking statements are not promises or guarantees and
involve substantial risks and uncertainties. Amarin's ability to
effectively commercialize VASCEPA and maintain or grow market share
will depend in part on Amarin’s ability to continue to effectively
finance its business, VASCEPA approval in geographies outside the
U.S., efforts of third parties, Amarin’s ability to create and
increase market demand for VASCEPA through education, marketing and
sales activities, to achieve broad 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 secure, maintain and defend its patent protection for
VASCEPA. Among the factors that could cause actual results to
differ materially from those described or projected herein include
the following: the possibility that VASCEPA may not receive
regulatory approval in the China region or other geographies on the
expected timelines or at all; the risk that additional generic
versions of VASCEPA will enter the market and that generic versions
of VASCEPA will achieve greater market share and more commercial
supply than anticipated, particularly in light of the disappointing
outcome of Amarin's litigation against two generic drug companies
and subsequent requests for appeal; the risk that the scope and
duration of the COVID-19 pandemic will continue to impact access to
and sales of VASCEPA; the risk that Amarin has overestimated the
market potential for VASCEPA in the U.S., Europe and other
geographies; risks associated with Amarin's expanded enterprise;
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; and the risk that patents may be determined to
not be infringed or not be valid 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 Amarin’s annual report on Form
10-K for the year ended December 31, 2021, and quarterly
report on Form 10-Q for the quarter ended June 30, 2022. Existing
and prospective investors are cautioned not to place undue reliance
on these forward-looking statements, which speak only as of the
date they are made. Amarin undertakes no obligation to update or
revise the information contained in its forward-looking statements,
whether as a result of new information, future events or
circumstances or otherwise. Amarin’s forward-looking statements do
not reflect the potential impact of significant transactions the
company may enter into, such as mergers, acquisitions,
dispositions, joint ventures or any material agreements that Amarin
may enter into, amend or terminate.
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, U.S. 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
InformationInvestor Inquiries:Lisa DeFrancescoInvestor
Relations Amarin Corporation
plcinvestor.relations@amarincorp.com
Media Inquiries:Mark MarmurCorporate Communications, Amarin
Corporation plcPR@amarincorp.com
-Tables to Follow-
CONSOLIDATED BALANCE SHEET DATA |
(U.S. GAAP) |
Unaudited |
|
|
|
|
|
June 30, 2022 |
|
December 31, 2021 |
|
(in thousands) |
ASSETS |
|
|
|
Current Assets: |
|
|
|
Cash and cash equivalents |
$ |
228,001 |
|
|
$ |
219,454 |
|
Restricted cash |
|
3,918 |
|
|
|
3,918 |
|
Short-term investments |
|
85,232 |
|
|
|
234,674 |
|
Accounts receivable, net |
|
143,942 |
|
|
|
163,653 |
|
Inventory |
|
225,772 |
|
|
|
234,676 |
|
Prepaid and other current assets |
|
32,259 |
|
|
|
22,352 |
|
Total current assets |
|
719,124 |
|
|
|
878,727 |
|
Property, plant and equipment, net |
|
1,137 |
|
|
|
1,425 |
|
Long-term investments |
|
11,395 |
|
|
|
34,996 |
|
Long-term inventory |
|
210,252 |
|
|
|
121,254 |
|
Operating lease right-of-use asset |
|
8,599 |
|
|
|
7,660 |
|
Other long-term assets |
|
456 |
|
|
|
456 |
|
Intangible asset, net |
|
22,274 |
|
|
|
23,547 |
|
TOTAL ASSETS |
$ |
973,237 |
|
|
$ |
1,068,065 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current Liabilities: |
|
|
|
Accounts payable |
$ |
116,312 |
|
|
$ |
114,922 |
|
Accrued expenses and other current liabilities |
|
243,064 |
|
|
|
253,111 |
|
Current deferred revenue |
|
2,198 |
|
|
|
2,649 |
|
Total current liabilities |
|
361,574 |
|
|
|
370,682 |
|
Long-Term Liabilities: |
|
|
|
Long-term deferred revenue |
|
13,810 |
|
|
|
14,060 |
|
Long-term operating lease liability |
|
10,174 |
|
|
|
8,576 |
|
Other long-term liabilities |
|
7,636 |
|
|
|
7,648 |
|
Total liabilities |
|
393,194 |
|
|
|
400,966 |
|
Stockholders’ Equity: |
|
|
|
Common stock |
|
294,659 |
|
|
|
294,027 |
|
Additional paid-in capital |
|
1,869,770 |
|
|
|
1,855,246 |
|
Treasury stock |
|
(61,419 |
) |
|
|
(60,726 |
) |
Accumulated deficit |
|
(1,522,967 |
) |
|
|
(1,421,448 |
) |
Total stockholders’ equity |
|
580,043 |
|
|
|
667,099 |
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
973,237 |
|
|
$ |
1,068,065 |
|
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) |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Product revenue, net |
$ |
93,796 |
|
|
$ |
153,773 |
|
|
$ |
187,782 |
|
|
$ |
295,156 |
|
Licensing and royalty revenue |
|
644 |
|
|
|
715 |
|
|
|
1,288 |
|
|
|
1,502 |
|
Total revenue, net |
|
94,440 |
|
|
|
154,488 |
|
|
|
189,070 |
|
|
|
296,658 |
|
Less: Cost of goods sold |
|
35,810 |
|
|
|
32,155 |
|
|
|
58,049 |
|
|
|
60,481 |
|
Less: Cost of goods sold - restructuring inventory |
|
15,000 |
|
|
|
- |
|
|
|
15,000 |
|
|
|
- |
|
Gross margin |
|
43,630 |
|
|
|
122,333 |
|
|
|
116,021 |
|
|
|
236,177 |
|
Operating expenses: |
|
|
|
|
|
|
|
Selling, general and administrative (1) |
|
86,893 |
|
|
|
107,203 |
|
|
|
177,540 |
|
|
|
213,001 |
|
Research and development (1) |
|
9,356 |
|
|
|
6,357 |
|
|
|
19,407 |
|
|
|
15,734 |
|
Restructuring |
|
10,213 |
|
|
|
— |
|
|
|
10,213 |
|
|
|
— |
|
Total operating expenses |
|
106,462 |
|
|
|
113,560 |
|
|
|
207,160 |
|
|
|
228,735 |
|
Operating (loss) income |
|
(62,832 |
) |
|
|
8,773 |
|
|
|
(91,139 |
) |
|
|
7,442 |
|
Interest income, net |
|
288 |
|
|
|
285 |
|
|
|
491 |
|
|
|
756 |
|
Other expense, net |
|
(2,255 |
) |
|
|
(191 |
) |
|
|
(2,501 |
) |
|
|
(333 |
) |
(Loss) income from operations before taxes |
|
(64,799 |
) |
|
|
8,867 |
|
|
|
(93,149 |
) |
|
|
7,865 |
|
Income tax provision |
|
(5,157 |
) |
|
|
(1,059 |
) |
|
|
(8,370 |
) |
|
|
(1,683 |
) |
Net (loss) income |
$ |
(69,956 |
) |
|
$ |
7,808 |
|
|
$ |
(101,519 |
) |
|
$ |
6,182 |
|
(Loss) earnings per share: |
|
|
|
|
|
|
|
Basic |
$ |
(0.18 |
) |
|
$ |
0.02 |
|
|
$ |
(0.26 |
) |
|
$ |
0.02 |
|
Diluted |
$ |
(0.18 |
) |
|
$ |
0.02 |
|
|
$ |
(0.26 |
) |
|
$ |
0.02 |
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
398,187 |
|
|
|
395,899 |
|
|
|
397,997 |
|
|
|
395,272 |
|
Diluted |
|
398,187 |
|
|
|
401,767 |
|
|
|
397,997 |
|
|
|
402,778 |
|
|
|
|
|
|
|
|
|
(1) Excluding non-cash stock-based compensation, selling, general
and administrative expenses were $79,244 and $104,550 for the three
months ended June 30, 2022 and 2021, respectively, and research and
development expenses were $7,905 and $6,531, respectively, for the
same periods. |
RECONCILIATION OF NON-GAAP NET (LOSS) INCOME |
Unaudited |
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
(in thousands, except per share amounts) |
|
(in thousands, except per share amounts) |
|
|
2022 |
|
|
|
2021 |
|
2022 |
|
|
2021 |
Net (loss) income for EPS1 - GAAP |
|
(69,956 |
) |
|
|
7,808 |
|
|
(101,519 |
) |
|
|
6,182 |
Non-cash stock-based compensation expense |
|
9,100 |
|
|
|
2,479 |
|
|
15,178 |
|
|
|
16,403 |
Restructuring inventory |
|
15,000 |
|
|
|
— |
|
|
15,000 |
|
|
|
— |
Restructuring expense |
|
10,213 |
|
|
|
— |
|
|
10,213 |
|
|
|
— |
Adjusted net (loss) income for
EPS1 - non-GAAP |
$ |
(35,643 |
) |
|
$ |
10,287 |
|
$ |
(61,128 |
) |
|
$ |
22,585 |
|
|
|
|
|
|
|
|
1basic and diluted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) earnings per
share: |
|
|
|
|
|
|
|
Basic - non-GAAP |
$ |
(0.09 |
) |
|
$ |
0.03 |
|
$ |
(0.15 |
) |
|
$ |
0.06 |
Diluted - non-GAAP |
$ |
(0.09 |
) |
|
$ |
0.03 |
|
$ |
(0.15 |
) |
|
$ |
0.06 |
|
|
|
|
|
|
|
|
Weighted average shares: |
|
|
|
|
|
|
|
Basic |
|
398,187 |
|
|
|
395,899 |
|
|
397,997 |
|
|
|
395,272 |
Diluted |
|
398,187 |
|
|
|
401,767 |
|
|
397,997 |
|
|
|
402,778 |
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