- INBRIJA® (levodopa inhalation powder) Q1 2023 U.S. net revenue
of $5.6 million, a 52% increase from Q1 2022; ex-U.S. net revenue
of $0.5 million
- AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg Q1 2023
net revenue of $12.6 million, a 15% decrease from Q1 2022; FAMPYRA
royalty revenue of $2.9 million
- 2023 financial guidance reaffirmed
- Agreement with Chance Pharmaceuticals to commercialize INBRIJA
in China
- Tom Burns, Chief Financial Officer of XOMA, to be candidate for
Board of Directors at 2023 Annual Meeting of Stockholders; Jeff
Randall to rotate off the Board
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today provided a
business update and reported its financial results for the first
quarter ended March 31, 2023.
“We were very pleased to see INBRIJA’s strong performance in the
quarter, with U.S. net revenue up by 52% over the same quarter of
2022. In addition, new prescription request forms increased 45%
over the first quarter of 2022,” said Ron Cohen, M.D., Acorda’s
President and Chief Executive Officer. “We believe that our new
marketing programs are having an impact. In April, we launched an
INBRIJA television commercial on approximately 50 streaming
services, accompanied by a digital ‘surround sound’ campaign to
encourage viewers to take an action after viewing the commercial,
such as connecting with a nurse educator or speaking to their
physician. The initial response has been highly encouraging; in the
first six weeks, the commercial has been viewed over 2.5 million
times and is already driving substantial traffic to the INBRIJA
website.”
“Our agreement with Chance Pharmaceuticals is an important step
in bringing INBRIJA to those living with Parkinson’s in China; by
2030, it is estimated there will be approximately 5 million people
with Parkinson’s disease in that country,” Dr. Cohen continued. “We
are also very pleased that Tom Burns, who has decades of finance
and accounting experience in biotech and high tech, will stand for
election to Acorda’s board in June; we are deeply grateful to Jeff
Randall for his superb contributions to the Company since joining
the Board in 2006, and we wish him the very best.”
First Quarter 2023 Financial Results
For the quarter ended March 31, 2023, the Company reported
INBRIJA worldwide net revenue of $6.1 million, of which $5.6
million was derived from sales in the U.S., a 52.2% increase
compared to the same quarter in 2022. The Company also reported
ex-U.S. INBRIJA net revenue of $0.5 million in the first quarter
related to the recent launch in Spain in February.
For the quarter ended March 31, 2023, the Company reported
AMPYRA net revenue of $12.6 million, a 15.4% decrease compared to
$14.9 million for the same quarter in 2022. Additionally, for the
quarter ended March 31, 2023, the Company reported FAMPYRA royalty
revenues of $2.9 million, a 9.3% decrease compared to the same
quarter in 2022. As previously disclosed, AMPYRA lost its
exclusivity when generics entered the market in 2018, and the
Company expects AMPYRA revenue to continue to decline.
Research and development (R&D) expenses for the quarter
ended March 31, 2023 were $1.4 million, compared to $1.7 million
for the same quarter in 2022. Sales, general and administrative
(SG&A) expenses for the quarter ended March 31, 2023 were $22.5
million, compared to $26.9 million for the same quarter in
2022.
Non-GAAP adjusted operating expenses (adjusted OPEX) for the
quarter ended March 31, 2023 was $23.9 million, compared to $28.6
million for the same quarter in 2022. This quarterly non-GAAP
measure, more fully described below under “Non-GAAP Financial
Measures,” excludes costs of goods sold, amortization of intangible
assets, change in fair value of derivative liability, and change in
fair value of acquired contingent liability. A reconciliation of
the GAAP operating expenses to non-GAAP operating expenses is
included with the attached financial statements.
Benefit from income taxes for the quarter ended March 31, 2023
was $2 million, compared to a provision for income taxes of $0.3
million for the same quarter in 2022.
The Company reported a net loss of ($16.8) million for the
quarter ended March 31, 2023, or a net loss of ($0.69) per share on
both a basic and diluted basis. Net loss in the same quarter of
2022 was ($24.5) million, or a net loss of ($1.85) per share on
both a basic and diluted basis.
At March 31, 2023, the Company had cash, cash equivalents, and
restricted cash of $37.8 million, compared to $44.7 million at year
end 2022. Restricted cash includes $6.2 million in escrow related
to the semi-annual interest payment to the holders of its 6.00%
convertible senior secured notes (Convertible Notes).
2023 Financial Guidance
For the full year 2023, Acorda continues to target INBRIJA U.S.
net revenue to be $38 - $42 million, AMPYRA net revenue to be $65 -
$70 million, adjusted OPEX to be $93 - $103 million, and ending
cash balance to be $43 - $47 million.
INBRIJA Commercialization Agreement in China
Under the terms of the agreement, Acorda will receive an
up-front payment of $2.5 million, a near term milestone payment of
up to $6 million, $3 million upon regulatory approval, up to $132.5
million in sales milestones, and a fixed fee for each carton of
INBRIJA supplied to Chance. By 2030, it is estimated that China
will have approximately 5 million people with Parkinson’s disease
due to its aging population1. Chance plans to seek marketing
authorization as quickly as possible.
Board of Directors
Jeff Randall, who has served on Acorda’s Board since 2006, and
currently serves as Chair of the Audit Committee, will be rotating
off the Board as of the Company’s June 2023 annual meeting of
stockholders. Tom Burns, the Senior Vice President of Finance and
Chief Financial Officer of XOMA Corporation, will stand for
election to the Board at that meeting. Tom is responsible for all
financial matters affecting or involving the XOMA companies,
including directing XOMA's financial strategy, accounting,
budgeting, financial planning and analysis, and investor relations
functions. Mr. Burns has 25 years of experience in accounting and
finance in both biotechnology and high technology companies.
Annual Meeting of Stockholders
Acorda’s Annual Meeting of Stockholders will take place on
Thursday, June 22, 2023 at 9:00am ET. Stockholders are encouraged
to vote by internet, telephone, mail, or in person as described in
the materials sent to them so that all shares will be represented
at the Annual Meeting.
Webcast and Conference Call
To participate in the Webcast, please use the following
registration link:
- https://events.q4inc.com/attendee/539980595
If you register for the Webcast, you will have the opportunity
to submit a written question for the Q&A portion of the
presentation. After you have registered, you will receive a
confirmation email with the Webcast details. On the day of the
Webcast, you will receive an email 2 hours prior to the start of
the Webcast with the link to join. The presentation will be
available on the Investors section of www.acorda.com.
A replay of the call will be available from 8:30 p.m. ET on May
11, 2023 until 11:59 p.m. ET on June 10, 2023. To access the
replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658
(international); access code 270385. The archived webcast will be
available in the Investor Relations section of the Acorda website
at www.acorda.com.
Non-GAAP Financial Measures
This press release includes financial results prepared in
accordance with accounting principles generally accepted in the
United States (GAAP) and also certain historical and
forward-looking non-GAAP financial measures. Non-GAAP financial
measures are not an alternative for financial measures prepared in
accordance with GAAP, and the calculation of the non-GAAP financial
measures included herein may differ from similarly titled measures
used by other companies. The Company believes that the presentation
of these non-GAAP financial measures, when viewed in conjunction
with actual GAAP results, provides investors with a more meaningful
understanding of our ongoing and projected operating performance
because it excludes (i) expenses that pertain to corporate
restructurings not routine to the operation of our business, (ii)
non-cash charges that are substantially dependent on changes in the
market price of our common stock, and (iii) other items as set
forth above that are not ascertainable at the present time. We
believe these non-GAAP financial measures help indicate underlying
trends in the Company’s business and are important in comparing
current results with prior period results and understanding
expected operating performance. Also, management uses these
non-GAAP financial measures to establish budgets and operational
goals, and to manage the Company’s business and evaluate its
performance. In addition, management believes that adjusted OPEX is
important in evaluating the administrative costs of operating the
Company’s business.
Adjusted OPEX includes (i) research and development expenses and
(ii) selling, general, and administrative expenses, and excludes
(i) costs of goods sold, (ii) amortization of intangible assets,
(iii) change in fair value of derivative liability, and (iv) change
in fair value of acquired contingent liability. We are unable to
reconcile our guidance for this non-GAAP measure to GAAP due to the
forward-looking nature of the adjustments that are needed to
determine this information, which includes information regarding
future compensation charges, future changes in the market price of
our common stock, and changes in the fair value of derivative and
contingent liabilities, none of which are available at this
time.
About Acorda Therapeutics
Acorda Therapeutics develops therapies to restore function and
improve the lives of people with neurological disorders. INBRIJA®
is approved for intermittent treatment of OFF episodes in adults
with Parkinson’s disease treated with carbidopa/levodopa. INBRIJA
is not to be used by patients who take or have taken a nonselective
monoamine oxidase inhibitor such as phenelzine or tranylcypromine
within the last two weeks. INBRIJA utilizes Acorda’s innovative
ARCUS® pulmonary delivery system, a technology platform designed to
deliver medication through inhalation. Acorda also markets the
branded AMPYRA® (dalfampridine) Extended Release Tablets, 10
mg.
Forward-Looking Statements
This press release includes forward-looking statements. All
statements, other than statements of historical facts, regarding
management's expectations, beliefs, goals, plans or prospects
should be considered forward-looking. These statements are subject
to risks and uncertainties that could cause actual results to
differ materially, including: we may not be able to successfully
market INBRIJA, AMPYRA or any other products under development; the
COVID-19 pandemic, including related restrictions on in-person
interactions and travel, and the potential for illness, quarantines
and vaccine mandates affecting our management, employees or
consultants or those that work for other companies we rely upon,
could have a material adverse effect on our business operations or
product sales; our ability to attract and retain key management and
other personnel, or maintain access to expert advisors; our ability
to raise additional funds to finance our operations, repay
outstanding indebtedness or satisfy other obligations, and our
ability to control our costs or reduce planned expenditures; risks
associated with the trading of our common stock; risks related to
the successful implementation of our business plan, including the
accuracy of its key assumptions; risks related to our corporate
restructurings, including our ability to outsource certain
operations, realize expected cost savings and maintain the
workforce needed for continued operations; risks associated with
complex, regulated manufacturing processes for pharmaceuticals,
which could affect whether we have sufficient commercial supply of
INBRIJA or AMPYRA to meet market demand; our reliance on
third-party manufacturers for the timely production of commercial
supplies of INBRIJA and AMPYRA; third-party payers (including
governmental agencies) may not reimburse for the use of INBRIJA or
AMPYRA at acceptable rates or at all and may impose restrictive
prior authorization requirements that limit or block prescriptions;
reliance on collaborators and distributors to commercialize INBRIJA
and AMPYRA outside the U.S.; our ability to satisfy our obligations
to distributors and collaboration partners outside the U.S.
relating to commercialization and supply of INBRIJA and AMPYRA;
competition for INBRIJA and AMPYRA, including increasing
competition and accompanying loss of revenues in the U.S. from
generic versions of AMPYRA (dalfampridine) following our loss of
patent exclusivity; the ability to realize the benefits anticipated
from acquisitions because, among other reasons, acquired
development programs are generally subject to all the risks
inherent in the drug development process and our knowledge of the
risks specifically relevant to acquired programs generally improves
over time; the risk of unfavorable results from future studies of
INBRIJA (levodopa inhalation powder) or from other research and
development programs, or any other acquired or in-licensed
programs; the occurrence of adverse safety events with our
products; the outcome (by judgment or settlement) and costs of
legal, administrative or regulatory proceedings, investigations or
inspections, including, without limitation, collective,
representative or class-action litigation; failure to protect our
intellectual property, to defend against the intellectual property
claims of others or to obtain third-party intellectual property
licenses needed for the commercialization of our products; and
failure to comply with regulatory requirements could result in
adverse action by regulatory agencies.
These and other risks are described in greater detail in our
filings with the Securities and Exchange Commission. We may not
actually achieve the goals or plans described in our
forward-looking statements, and investors should not place undue
reliance on these statements. Forward-looking statements made in
this press release are made only as of the date hereof, and we
disclaim any intent or obligation to update any forward-looking
statements as a result of developments occurring after the date of
this press release, except as may be required by law.
Financial Statements Acorda
Therapeutics, Inc. Condensed Consolidated Balance Sheet
Data (in thousands)
March 31,
December 31,
2023
2022
(unaudited)
Assets
Cash and cash equivalents
$
30,255
$
37,536
Restricted cash - short term
6,989
6,884
Trade receivable, net
9,190
13,866
Other current assets
8,195
11,077
Inventories, net
13,465
12,752
Property and equipment, net
2,383
2,603
Intangible assets, net
297,393
305,086
Restricted cash - long term
510
255
Right of use assets, net
5,029
5,287
Other assets
1,497
247
Total assets
$
374,906
$
395,595
Liabilities and stockholders'
equity
Accounts payable, accrued expenses and
other current liabilities
$
29,871
$
33,872
Current portion of lease liability
1,556
1,545
Current portion of royalty liability
—
—
Current portion of contingent
consideration
3,312
2,532
Convertible senior notes
171,496
167,031
Derivative liability related to conversion
option
—
-
Non-current portion of acquired contingent
consideration
36,488
38,668
Non-current portion of lease liability
4,055
4,341
Non-current portion of loans payable
-
—
Deferred tax liability
41,805
44,202
Other long-term liabilities
9,363
9,780
Total stockholders' equity
76,960
93,622
Total liabilities and stockholders'
equity
$
374,906
$
395,595
Acorda Therapeutics, Inc.
Consolidated Statements of Operations (in thousands,
except per share amounts) (unaudited)
Three Months Ended
March 31,
2023
2022
Revenues:
Net product revenues
$
18,719
$
18,575
Royalty revenues
3,528
3,959
License revenue
11
-
Total revenues
22,258
22,534
Costs and expenses:
Cost of sales
3,234
5,967
Research and development
1,386
1,694
Selling, general and administrative
22,514
26,938
Amortization of intangible assets
7,691
7,691
Change in fair value of derivative
liability
—
(30
)
Change in fair value of acquired
contingent consideration
(1,091
)
(3,023
)
Other operating expense, net
-
-
Total operating expenses
33,734
39,237
Operating income (loss)
$
(11,476
)
$
(16,703
)
Other income (expense), net:
Interest expense, net
(7,477
)
(7,561
)
Other income (expense), net
91
-
Total other income (expense), net
(7,386
)
(7,561
)
Income (loss) before income taxes
(18,862
)
(24,264
)
(Provision for) benefit from income
taxes
2,038
(258
)
Net income (loss)
$
(16,824
)
$
(24,522
)
Net income (loss) per common share -
basic
$
(0.69
)
$
(1.85
)
Net income (loss) per common share -
diluted
$
(0.69
)
$
(1.85
)
Weighted average common shares - basic
24,338
13,251
Weighted average common shares -
diluted
24,338
13,251
Acorda Therapeutics, Inc. Adjusted
Operating Expenses Reconciliation (in thousands, except per
share amounts) (unaudited)
Three Months Ended
Three Months Ended
March 31,
March 31,
2023
2022
Operating Expenses per Income Statement
(GAAP)
$
33,734
$
39,237
Adjustments:
Cost of goods sold
(3,234
)
(5,967
)
Amortization of intangible assets
(7,691
)
(7,691
)
Change in fair value of derivative
liability
-
30
Change in fair value of acquired
contingent consideration
1,091
3,023
Total adjustments
(9,834
)
(10,605
)
Adjusted operating expenses (non-GAAP)
$
23,900
$
28,632
1Li, G., Ma, J., Cui, S. et al. Parkinson’s disease in China: a
forty-year growing track of bedside work. Transl Neurodegener 8, 22
(2019). https://doi.org/10.1186/s40035-019-0162-z
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230511005653/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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