On March 4, 2021 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the fourth quarter and full year ended December 31, 2020 (Press release, Acorda Therapeutics, MAR 4, 2021, View Source [SID1234576083]).
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"We have improved our financial position materially through the sale of our manufacturing operations in Chelsea and our restructuring, which also have reduced both our annual operating expenses and cost of goods for INBRIJA," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "In 2020, we continued to improve access to INBRIJA and saw excellent results from our new patient education and training programs; for example, approximately 1,250 patients who had either never filled or had discontinued their original INBRIJA prescriptions responded to our educational outreach and training by returning to therapy. We also saw quarter over quarter growth in INBRIJA despite the substantial negative impact of COVID-19, and believe we are well-positioned for further growth when the pandemic subsides. We also believe that the reduced cost of goods for INBRIJA will help potentiate commercial partnerships outside the US."
Fourth Quarter 2020 Financial Results
For the fourth quarter ended December 31, 2020, the Company reported AMPYRA net revenue of $25.3 million compared to $40.8 million for the same quarter in 2019 and INBRIJA net revenue of $9.3 million compared to $6.1 million for the same quarter in 2019.
Research and development (R&D) expenses for the quarter ended December 31, 2020 were $4.3 million, including $0.3 million of share-based compensation, compared to $9.0 million, including $0.6 million of share-based compensation, for the same quarter in 2019.
Sales, general and administrative (SG&A) expenses for the quarter ended December 31, 2020 were $32.9 million, including $1.2 million of share-based compensation, compared to $41.2 million, including $2.0 million of share-based compensation, for the same quarter in 2019.
Benefit from income taxes for the quarter ended December 31, 2020 was $3.1 million, compared to a benefit from income taxes of $0.8 million for the same quarter in 2019.
The Company recorded a loss on assets held for sale related to the sale of the manufacturing operations in Chelsea, Massachusetts to Catalent. The Company recorded a loss on the assets held for sale of $57.9 million as of December 31, 2020, which represents the amount by which the carrying value of the assets to be sold exceeds the purchase price less estimated selling costs. The Company segregated the assets held for sale on the balance sheet at the resulting carrying amount of $71.8 million as of December 31, 2020.
The Company reported GAAP net loss of $83.0 million for the quarter ended December 31, 2020, or $9.82 per diluted share. GAAP net income in the same quarter of 2019 was $65.7 million, or $8.26 per diluted share.
Non-GAAP net loss for the quarter ended December 31, 2020 was $21.1 million, or $2.50 per diluted share. Non-GAAP net loss in the same quarter of 2019 was $7.1 million, or $0.89 per diluted share. This quarterly non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, losses on assets held for sale, gain on extinguishment of debt, and changes in the fair value of derivative liability related to the 2024 convertible notes. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.
Full Year Ended December 31, 2020 Financial Results
For the full year ended December 31, 2020, the Company reported AMPYRA net revenue of $98.9 million compared to $163.2 million for the full year 2019 and INBRIJA net revenue of $24.2 million compared to $15.3 million for the full year 2019.
Research and development (R&D) expenses for the full year ended December 31, 2020 were $23.0 million, including $1.7 million of share-based compensation, compared to $60.1 million, including $2.8 million of share-based compensation for the full year 2019.
Sales, general and administrative (SG&A) expenses for the full year ended December 31, 2020 were $152.6 million, including $6.0 million of share-based compensation, compared to $192.8 million, including $10.8 million of share-based compensation for the full year 2019.
Benefit from income taxes for the full year ended December 31, 2020 was $8.0 million, compared to a benefit from income taxes of $1.3 million for the full year 2019.
For the full year ended December 31, 2020, the Company reported GAAP net loss of $99.6 million, or $12.32 per diluted share, compared to a GAAP net loss for the full year 2019 of $273.0 million, or $34.43 per diluted share.
Non-GAAP net loss for the full year ended December 31, 2020 was $72.9 million, or $9.02 per diluted share. Non-GAAP net loss for the full year ended December 31, 2019 was $81.8 million, or $10.31 per diluted share. This full year non-GAAP net loss measure, more fully described below under "Non-GAAP Financial Measures," excludes share-based compensation charges, non-cash interest charges on our debt, restructuring expenses, changes in the fair value of acquired contingent consideration, asset impairment charges, losses on assets held for sale, gain on extinguishment of debt, and changes in the fair value of derivative liability related to the 2024 convertible notes. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.
At December 31, 2020, the Company had cash, cash equivalents, investments, and restricted cash of $102.9 million. Restricted cash includes $31 million in escrow related to the 6% semi-annual interest portion, payable in cash or stock, of the convertible note exchange completed in December 2019. If the Company elects to pay interest due in stock, the restricted cash will be released from escrow.
Financial Guidance
Operating expenses for the full year 2021 are expected to be $130 – $140 million. This guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."
AMPYRA net revenue for the full year 2021 is expected to be $75-$85 million.
Recent Highlights
In February 2021, the Company announced that it has closed the deal to sell its manufacturing operations in Chelsea, Massachusetts to Catalent. Under the terms of the agreement, Catalent has paid Acorda $80 million in cash, resulting in expected net proceeds to Acorda of approximately $74 million after transaction fees and expenses and settlement of customary post-closing adjustments.
In connection with the sale, Acorda and Catalent have entered into a long-term global supply agreement under which Catalent will manufacture and package INBRIJA for Acorda, ensuring an uninterrupted drug supply for Acorda’s patients and continued adherence to best-in-class manufacturing quality and safety standards.
In January 2021, the Company announced a corporate restructuring, reducing its combined Ardsley, Waltham, and field headcount by approximately 16%.
The sale of the manufacturing operations, restructuring and other operating expense reductions are expected to reduce annual operating expenses by approximately $40 million.
On December 31, 2020, Acorda implemented a 1-for-6 reverse stock split of the Company’s shares of common stock and a proportionate reduction in the number of authorized shares of common stock. This was done to regain compliance with the $1.00 per share minimum closing price required to maintain continued listing on the Nasdaq Global Select Market.
Webcast and Conference Call
The Company will host a conference call and webcast in conjunction with its fourth quarter/year end 2020 update and financial results today at 4:30 p.m. EST.
To participate in the Webcast/Conference Call, please note there is a new pre-registration process.
To register for the Webcast, use the link below:
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To register for the Conference Call, use the link below:
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A replay of the call will be available from 7:30 p.m. EST on March 4, 2021 until 11:59 p.m. EDT on April 4, 2021. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 9854802. 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. In particular, Acorda has provided non-GAAP net loss, adjusted to exclude the items below, and has provided 2021 operating expense guidance on a non-GAAP basis. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of non-GAAP net loss, when viewed in conjunction with actual GAAP results, provides investors with a more meaningful understanding of our ongoing and projected operating performance because this measure excludes (i) non-cash compensation charges and benefits that are substantially dependent on changes in the market price of our common stock, (ii) 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 monetization and acquired Biotie debt, (iii) changes in the fair value of acquired contingent consideration which do not correlate to our actual cash payment obligations in the relevant periods, (iv) asset impairment charges that are not routine to the operation of the business, (v) gain on extinguishment of debt that pertains to an event that is not routine to the operation of the business, (vi) expenses that pertain to our 2019 restructuring, which is not routine to the operation of the business, (vii) changes in the fair value of derivative liability relating to the 2024 convertible notes, which is a non-cash charge and not related to the operation of the business, and (viii) losses on assets held for sale that pertain to a non-routine sale of manufacturing operations. The Company believes its non-GAAP net loss measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding projected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.
In addition to non-GAAP net loss, we have provided 2021 operating expense guidance on a non-GAAP basis, as the guidance excludes restructuring costs and share-based compensation charges. Due to the forward looking nature of this information, the amount of compensation charges needed to reconcile these measures to the most directly comparable GAAP financial measures is dependent on future changes in the market price of our common stock and is not available at this time. Non-GAAP financial measures are not an alternative for financial measures prepared in accordance with GAAP. However, the Company believes that the presentation of this non-GAAP financial measure, 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 non-routine restructuring events, and (ii) non-cash charges that are substantially dependent on changes in the market price of our common stock. We believe this non-GAAP financial measure helps indicate underlying trends in the Company’s business and is important in comparing current results with prior period results and understanding expected operating performance. Also, management uses this non-GAAP financial measure to establish budgets and operational goals, and to manage the Company’s business and to evaluate its performance.