PEARL RIVER, N.Y.–(Enterprise WIRE)–Acorda Therapeutics, Inc. (Nasdaq: ACOR) these days delivered a thorough, lengthy-time period business enterprise system to travel shareholder worth and also supplied prolonged-expression monetary steering.
Acorda has made a extensive-term small business strategy to enhance the worth of the Company, focused on escalating INBRIJA® (levodopa inhalation powder), maximizing AMPYRA® (dalfampridine), and implementing supplemental operational and producing efficiencies. Thanks to the recent Alkermes arbitration award, together with continued fiscal discipline, Acorda has sizeable liquidity, which the Business expects will let it to execute on its enterprise program. Acorda expects to be funds-move good in 2023. The end result of the reverse inventory break up proposal at the upcoming Special Assembly of Stockholders, scheduled for November 4, 2022, will be a important determinant of Acorda’s strategic possibilities and skill to execute its enterprise approach.
Vital Assumptions Fundamental Organization Program and Direction
- INBRIJA will continue to increase in the U.S.
- INBRIJA will increase into further ex-U.S. marketplaces
- AMPYRA will continue to lose sector share, but at a stabilizing charge
- Acorda’s expectation is to be income-move beneficial in 2023
- Shareholder acceptance of reverse stock split proposal continued Nasdaq listing
INBRIJA
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The Firm believes that INBRIJA has a significant prospect to grow the industry for on-need solutions
- INBRIJA at present enjoys a 67{8ba6a1175a1c659bbdaa9a04b06717769bcea92c0fdf198d429188ebbca09471} sector share within just the on-demand from customers treatment course1
- Healthcare pros report they are generally a lot more snug with INBRIJA than apomorphine-based on-need therapies2
- < 2{8ba6a1175a1c659bbdaa9a04b06717769bcea92c0fdf198d429188ebbca09471} of the 380,000 people with Parkinson’s who experience OFF periods are actively on any on-demand treatment3
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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
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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
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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-$12M savings in 2023 annual cost of goods (based on volume)
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AMPYRA net sales currently at ~13{8ba6a1175a1c659bbdaa9a04b06717769bcea92c0fdf198d429188ebbca09471} of peak sales
- AMPYRA currently holds ~15{8ba6a1175a1c659bbdaa9a04b06717769bcea92c0fdf198d429188ebbca09471} of dalfampridine market4
- Long-term value of the brand expected at ~10{8ba6a1175a1c659bbdaa9a04b06717769bcea92c0fdf198d429188ebbca09471} of peak sales through 2027
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Field team continues to promote the brand
- ~200 health care professionals resumed prescribing AMPYRA in 2022
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Tenacity of prescribers and patients has resulted in fewer payer restrictions5
- ~70{8ba6a1175a1c659bbdaa9a04b06717769bcea92c0fdf198d429188ebbca09471} of all covered lives have access to AMPYRA6
Financial Guidance
Acorda provided the following long-term financial guidance ranges, assuming successful implementation of the business plan and its key assumptions:
Guidance Ranges in US$M |
2022 |
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2023 |
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2024 |
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2025 |
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2026 |
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2027 |
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NET REVENUE |
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Inbrija US |
$27.8 – $28.7 |
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$37.1 – $41.1 |
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$50.1 – $55.3 |
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$59.7 – $65.9 |
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$64.1 – $70.9 |
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$71.4 – $78.9 |
Inbrija OUS |
$2.8 – $2.9 |
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$7.3 – $8.1 |
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$12.0 – $13.2 |
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$22.7 – $25.1 |
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$33.1 – $36.6 |
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$45.0 – $49.7 |
Inbrija Sales |
$30.6 – $31.6 |
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$44.4 – $49.2 |
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$62.1 – $68.5 |
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$82.4 – $91.0 |
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$97.2 – $107.5 |
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$116.4 – $128.6 |
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Ampyra US |
$71.4 – $73.6 |
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$64.6 – $71.4 |
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$61.5 – $68.0 |
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$59.5 – $65.8 |
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$57.6 – $63.7 |
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$55.8 – $61.7 |
Fampyra Royalty |
$12.0 – $12.4 |
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$9.5 – $10.5 |
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$8.6 – $9.5 |
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$7.6 – $8.4 |
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$7.6 – $8.4 |
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$6.7 – $7.4 |
Ampyra Sales |
$83.4 – $86.0 |
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$74.1 – $81.9 |
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$70.1 – $77.5 |
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$67.1 – $74.2 |
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$65.2 – $72.1 |
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$62.5 – $69.1 |
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ARCUS Development |
$0.0 – $0.0 |
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$1.1 – $1.3 |
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$1.5 – $1.6 |
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$1.5 – $1.6 |
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$1.5 – $1.6 |
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$1.5 – $1.6 |
Neurelis Royalty |
$2.0 – $2.1 |
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$1.7 – $1.9 |
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$0.4 – $0.5 |
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$0.0 – $0.0 |
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$0.0 – $0.0 |
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$0.0 – $0.0 |
Net Revenue |
$116.0 – $119.7 |
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$121.3 – $134.3 |
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$134.1 – $148.1 |
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$151.0 – $166.8 |
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$163.9 – $181.2 |
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$180.4 – $199.3 |
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OPEX |
$113.7 – $117.1 |
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$90.0 – $99.4 |
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$90.6 – $100.2 |
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$93.5 – $103.3 |
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$96.3 – $106.4 |
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$99.2 – $109.6 |
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EBITDA |
($13.5) – ($13.9) |
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$29.0 – $32.1 |
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$40.8 – $45.1 |
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$58.3 – $64.5 |
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$72.1 – $79.7 |
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$89.3 – $98.7 |
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Ending Cash Balance |
$43.6 – $44.9 |
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$51.7 – $57.2 |
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$73.9 – $81.6 |
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$103.0 – $113.9 |
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$139.1 – $153.7 |
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$183.7 – $203.1 |
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Cash Flow |
($20.6) – ($21.3) |
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$9.7 – $10.7 |
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$22.2 – $24.5 |
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$29.2 – $32.2 |
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$36.0 – $39.8 |
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$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:
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 [email protected].
- 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{8ba6a1175a1c659bbdaa9a04b06717769bcea92c0fdf198d429188ebbca09471} 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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