Key Assumptions Underlying Business Plan and Guidance Remain Unchanged
- 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 expects to be cash-flow positive in 2023
- Continued Nasdaq listing
- Refinancing of 6.00% convertible senior secured notes due December 1, 2024
INBRIJA
- The Company believes that INBRIJA has a significant opportunity to expand the total 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 has increased fulfillment rates
- Introducing cash-pay option to improve patient access
- Ex-U.S. revenue is expected to increase in 2023 and 2024 as the 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
- An aggregate of $18.2 million received in fourth quarter 2022, which is $1.7 million greater than previously announced due to correction of a computational error by the arbitration panel subsequent to the initial award
- No further royalty payments and ability to find lower-cost supply, which has already been secured
- $10 – $12 million savings in 2023 annual cost of goods (based on volume)
- AMPYRA net sales currently at ~13% of peak sales
- AMPYRA currently holds ~15% of dalfampridine market4
- Long-term value of the brand expected at ~10% of peak sales through 2027
- Field team continues to promote the brand
- ~200 health care professionals resumed prescribing AMPYRA in 2022
- ~70% of all covered lives have access to AMPYRA5
2022-2027 Financial Guidance
For the full year 2022, Acorda continues to expect AMPYRA net revenue and adjusted operating expenses to be within the original guidance ranges. The financial guidance provided below includes non-GAAP projections of adjusted operating expenses (adjusted OPEX) and adjusted earnings before income taxes depreciation and amortization (adjusted EBITDA), as described below under “Non-GAAP Financial Measures.”
The EBITDA, Ending Cash Balance and Cash Flow figures in the table below have been revised to reflect the correction of an error embedded in the Company’s financial forecasting model that did not impact other line items. Net revenue figures increased slightly as a result of the Company’s year-end budgeting process.
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Guidance Ranges in U.S.$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 U.S. |
$27.8 – $28.7 |
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$37.3 – $41.2 |
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$50.3 – $55.6 |
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$58.8 – $65.0 |
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$63.2 – $69.8 |
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$70.3 – $77.7 |
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Inbrija OUS |
$2.8 – $2.9 |
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$7.3 – $8.1 |
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$15.1 – $16.7 |
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$27.3 – $30.2 |
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$36.9 – $40.8 |
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$48.2 – $53.2 |
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Inbrija Sales |
$30.6 – $31.6 |
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$44.6 – $49.3 |
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$65.4 – $72.2 |
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$86.1 – $95.1 |
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$100.1 – $110.7 |
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$118.5 – $131.0 |
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Ampyra U.S. |
$71.4 – $73.6 |
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$64.9 – $71.7 |
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$61.9 – $68.4 |
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$61.6 – $68.1 |
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$64.3 – $71.0 |
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$62.2 – $68.8 |
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Fampyra Royalty |
$12.0 – $12.4 |
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$9.7 – $10.7 |
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$8.6 – $9.5 |
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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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Ampyra Sales |
$83.4 – $86.0 |
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$74.6 – $82.4 |
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$70.4 – $77.8 |
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$70.1 – $77.5 |
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$71.9 – $79.4 |
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$69.8 – $77.2 |
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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 |
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Neurelis Royalty |
$2.0 – $2.1 |
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$1.9 – $2.1 |
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$0.0 – $0.0 |
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$0.0 – $0.0 |
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$0.0 – $0.0 |
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$0.0 – $0.0 |
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Net Revenue |
$116.0 – $119.7 |
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$122.2 – $135.1 |
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$137.3 – $151.7 |
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$157.7 – $174.2 |
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$173.5 – $191.7 |
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$189.8 – $209.8 |
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Adjusted OPEX |
$110.2 – $113.5 |
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$89.6 – $99.0 |
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$90.3 – $99.8 |
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$93.0 – $102.8 |
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$95.8 – $105.8 |
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$98.6 – $109.0 |
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Adjusted EBITDA |
$5.6 – $5.8 |
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$22.0 – $24.3 |
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$29.6 – $32.7 |
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$39.1 – $43.2 |
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$45.2 – $50.0 |
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$50.5 – $55.8 |
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Ending Cash Balance |
$43.2 – $44.5 |
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$42.5 – $47.0 |
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$55.4 – $61.2 |
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$75.0 – $82.8 |
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$97.6 – $107.9 |
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$122.8 – $135.8 |
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Cash Flow |
($21.0) – ($21.7) |
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($0.4) – $2.8 |
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$12.9 – $14.2 |
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$19.6 – $21.6 |
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$22.6 – $25.0 |
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$25.3 – $27.9 |
Non-GAAP Financial Measures
This press release includes certain forward-looking non-GAAP financial measures. In particular, Acorda has provided 2022-2027 adjusted operating expense and adjusted EBITDA guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP.
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. Adjusted EBITDA is GAAP net income (loss) before income taxes excluding (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) interest due on our convertible debt, (iii) non-cash interest charges related to the accounting for our convertible debt which are in excess of the actual interest expense owing on such convertible debt, as well as non-cash interest related to the Fampyra royalty monetization and acquired Biotie debt, (iv) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (v) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (vi) changes in the fair value of derivative liability relating to the 2024 convertible senior secured notes, which is a non-cash charge and not related to the operation of the business. We are unable to reconcile these forward-looking non-GAAP measures 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.
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 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.
