- CEO video / Q&A with shareholders on October 28, 2022 to
review business plan and ballot items for special meeting of
stockholders
Acorda Therapeutics, Inc. (Nasdaq: ACOR) today provided a
detailed, long-term business plan to drive shareholder value and
also provided long-term financial guidance.
Acorda has developed a long-term business plan to increase the
value of the Company, focused on growing INBRIJA® (levodopa
inhalation powder), maximizing AMPYRA® (dalfampridine), and
implementing additional operational and manufacturing efficiencies.
Due to the recent Alkermes arbitration award, along with continued
fiscal discipline, Acorda has substantial liquidity, which the
Company expects will allow it to execute on its business plan.
Acorda expects to be cash-flow positive in 2023. The outcome of the
reverse stock split proposal at the upcoming Special Meeting of
Stockholders, scheduled for November 4, 2022, will be a key
determinant of Acorda’s strategic alternatives and ability to
execute its business plan.
Key Assumptions Underlying Business Plan and Guidance
- INBRIJA will continue to grow in the U.S.
- INBRIJA will expand into additional ex-U.S. markets
- AMPYRA will continue to lose market share, but at a stabilizing
rate
- Acorda’s expectation is to be cash-flow positive in 2023
- Shareholder approval of reverse stock split proposal; continued
Nasdaq listing
INBRIJA
- The Company believes that INBRIJA has a significant opportunity
to expand the market for on-demand treatments
- INBRIJA currently enjoys a 67% market share within the
on-demand treatment class1
- Healthcare professionals report they are generally more
comfortable with INBRIJA than apomorphine-based on-demand
treatments2
- < 2% of the 380,000 people with Parkinson’s who experience
OFF periods are actively on any on-demand treatment3
- Acorda is implementing high-potential initiatives to grow the
INBRIJA business
- Launching new brand campaigns for physicians and people with
Parkinson’s
- Expanding usage of recently launched E-prescribing platform,
which removes barriers to prescribing and has increased fulfillment
rates
- Introducing cash-pay option to improve patient access
- Focusing sales team with a hyper-targeted call strategy
- Ex-U.S. revenue expected to increase in 2023 and 2024 as
Germany launch progresses and additional launches commence in Spain
and Latin America
- Partner discussions are in progress for Asia and additional EU
markets
AMPYRA
- Alkermes arbitration ruling significantly improves operating
margins
- $16.5M cash received October 2022
- No further royalty payments and ability to find lower-cost
supply, which has already been secured
- $10-$12M savings in 2023 annual cost of goods (based on
volume)
- AMPYRA net sales currently at ~13% of peak sales
- AMPYRA currently holds ~15% of dalfampridine market4
- Long-term value of the brand expected at ~10% of peak sales
through 2027
- Field team continues to promote the brand
- ~200 health care professionals resumed prescribing AMPYRA in
2022
- Tenacity of prescribers and patients has resulted in fewer
payer restrictions5
- ~70% of all covered lives have access to AMPYRA6
Financial Guidance
Acorda provided the following long-term financial guidance
ranges, assuming successful implementation of the business plan and
its key assumptions:
Guidance Ranges in US$M
2022
2023
2024
2025
2026
2027
NET REVENUE
Inbrija US
$27.8 - $28.7
$37.1 - $41.1
$50.1 - $55.3
$59.7 - $65.9
$64.1 - $70.9
$71.4 - $78.9
Inbrija OUS
$2.8 - $2.9
$7.3 - $8.1
$12.0 - $13.2
$22.7 - $25.1
$33.1 - $36.6
$45.0 - $49.7
Inbrija Sales
$30.6 - $31.6
$44.4 - $49.2
$62.1 - $68.5
$82.4 - $91.0
$97.2 - $107.5
$116.4 - $128.6
Ampyra US
$71.4 - $73.6
$64.6 - $71.4
$61.5 - $68.0
$59.5 - $65.8
$57.6 - $63.7
$55.8 - $61.7
Fampyra Royalty
$12.0 - $12.4
$9.5 - $10.5
$8.6 - $9.5
$7.6 - $8.4
$7.6 - $8.4
$6.7 - $7.4
Ampyra Sales
$83.4 - $86.0
$74.1 - $81.9
$70.1 - $77.5
$67.1 - $74.2
$65.2 - $72.1
$62.5 - $69.1
ARCUS Development
$0.0 - $0.0
$1.1 - $1.3
$1.5 - $1.6
$1.5 - $1.6
$1.5 - $1.6
$1.5 - $1.6
Neurelis Royalty
$2.0 - $2.1
$1.7 - $1.9
$0.4 - $0.5
$0.0 - $0.0
$0.0 - $0.0
$0.0 - $0.0
Net Revenue
$116.0 - $119.7
$121.3 - $134.3
$134.1 - $148.1
$151.0 - $166.8
$163.9 - $181.2
$180.4 - $199.3
OPEX
$113.7 - $117.1
$90.0 - $99.4
$90.6 - $100.2
$93.5 - $103.3
$96.3 - $106.4
$99.2 - $109.6
EBITDA
($13.5) - ($13.9)
$29.0 - $32.1
$40.8 - $45.1
$58.3 - $64.5
$72.1 - $79.7
$89.3 - $98.7
Ending Cash Balance
$43.6 - $44.9
$51.7 - $57.2
$73.9 - $81.6
$103.0 - $113.9
$139.1 - $153.7
$183.7 - $203.1
Cash Flow
($20.6) - ($21.3)
$9.7 - $10.7
$22.2 - $24.5
$29.2 - $32.2
$36.0 - $39.8
$44.7 - $49.4
CEO Video Q&A Friday, October 28 at 1:00pm ET / 10:00am
PT
Acorda will hold a video Q&A with its CEO, Ron Cohen, M.D.,
on Friday, October 28 at 1:00pm ET / 10:00am PT. The call will
review Acorda’s long-term business plan and the items on the ballot
for Acorda’s Special Meeting of Shareholders on November 4, 2022.
Participants will be able to submit questions to Dr. Cohen, which
he will address live.
Video Q&A Participation Instructions
To participate in the video event:
- Click the link below from a laptop or mobile device. (Mobile
device users will be prompted to download the BlueJeans app.)
https://primetime.bluejeans.com/a2m/live-event/rraraavy
- If prompted, enter the following case-sensitive Event ID:
rraraavy
To participate over the phone:
- Dial 1-800-520-9950 (U.S.: Toll Free)
- Enter Meeting ID: 4091564#
- Smartphone users can click on the following link to
automatically be connected:
800-520-9950,,, 4091564#
To submit a question:
- Prior to the Q&A, questions can be emailed to
investorrelations@acorda.com.
- During the live Q&A, questions can be typed into the
BlueJeans chat window.
How Shareholders Can Vote:
Stockholders are encouraged to cast your vote promptly FOR the
Reverse Split proposal without further delay.
By phone: Call 1-800-967-5051, Monday - Friday 9am - 10pm
ET; Saturday 10am - 6pm ET. If you call after hours, leave a
message and the call center will call you back the next day.
Online: www.proxyvote.com Please have the control
number that was sent to you in the mail.
Mail: Sign, date, and return your proxy card in the
postage-paid, stamped envelope provided.
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 AMPYRA, INBRIJA 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 and our credit
agreements, including the potential delisting of our common stock
from the Nasdaq Global Select Market which would result in a
default under the indenture dated as of December 23, 2019 for
Acorda’s 6.00% convertible senior secured notes, and could prevent
the implementation of our business plan, and the success of actions
that we may take, such as a reverse stock split, in order to
attempt to maintain such listing and avoid a default; 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.
The Proxy Statement
On September 22, 2022, the Company filed the Notice of Special
Meeting and Proxy Statement (the “Proxy
Statement”) and definitive form of proxy card with the
United States Securities and Exchange Commission (the “SEC”) in connection with its solicitation of
proxies from the Company’s stockholders. On October 7, 2022, the
Company filed a Supplement to the Proxy Statement (the
“Supplement”). Investors and
stockholders are strongly encouraged to read the Proxy Statement
and Supplement, the accompanying proxy card, and other documents
filed by the Company in their entirety, as they contain important
information.
We urge Stockholders to review the Proxy Statement. Stockholders
can obtain copies of the Proxy Statement, Supplement, any other
amendments or supplements to the Proxy Statement, and other
documents filed by the Company with the SEC for no charge at the
SEC’s website at www.sec.gov. Copies are also available at no
charge on the Investors section of our website at www.acorda.com.
You may also obtain additional copies of the Proxy Statement and
other proxy solicitation materials by contacting our proxy
solicitor, D.F. King & Co., Inc., as directed above.
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View source
version on businesswire.com: https://www.businesswire.com/news/home/20221027005410/en/
Tierney Saccavino (914) 326-5104 tsaccavino@acorda.com
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