On May 11, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the first quarter ended March 31, 2022 (Press release, Acorda Therapeutics, MAY 11, 2022, View Source [SID1234614214]).

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"Although Q1 over Q1 net sales decreased, we believe that this is not reflective of a trend for either Inbrija or Ampyra. We were pleased to see that as the Omicron wave waned, net sales of both products rebounded substantially. In particular, Inbrija sales, which were similar in January and February, increased by approximately 85% in March over February and continued to increase through April," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "In addition, while we historically have seen Q4 to Q1 declines due to patient overstocking in Q4 and insurance resetting in January, the decline was exacerbated this year due in part to a significantly higher estimate for discounts and allowances, or D&A, in Q1 2022 compared to Q1 2021. We expect D&A charges to be lower over the remainder of the year, and we are reiterating our 2022 guidance of $68M-$78M in Ampyra net sales."

INBRIJA Ex-US
Today Acorda announced distribution and supply agreements with Biopas Laboratories to commercialize INBRIJA in nine countries within Latin America, including Brazil and Mexico. Under the terms of the agreements, Acorda will receive a significant, double-digit, tiered percentage of the selling price of INBRIJA in Latin America in exchange for supply of the product. Acorda will also receive sales-based milestones.

Esteve plans to launch INBRIJA in Germany in June 2022. Germany is the largest pharmaceutical market in Europe, and the fourth largest in the world.

First Quarter 2022 Financial Results
For the quarter ended March 31, 2022, the Company reported INBRIJA net revenue of $3.7 million, compared to $5.0 million for the same quarter in 2021.

The Company reported AMPYRA net revenue of $14.9 million, compared to $20.3 million for the same quarter in 2021. As previously disclosed, AMPYRA lost its exclusivity and 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, 2022 were $1.7 million, including negligible share-based compensation expenses, compared to $4.7 million, including $0.2 million of share-based compensation for the same quarter in 2021.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2022 were $26.9 million, including $0.5 million of share-based compensation, compared to $34.0 million, including $0.5 million of share-based compensation for the same quarter in 2021.

Change in fair value of derivative liability for the quarter ended March 31, 2022 was negligible, compared to $0.2 million for the same quarter in 2021.

Provision for income taxes for the quarter ended March 31, 2022 was $0.2 million, compared to a benefit from income taxes of $3.2 million for the same quarter in 2021.

The Company reported a GAAP net loss of $25.6 million for the quarter ended March 31, 2022, or $1.93 per diluted share. GAAP net loss in the same quarter of 2021 was $33.5 million, or $3.53 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2022 was $22.0 million, or $1.66 per diluted share. Non-GAAP net loss in the same quarter of 2021 was $23.3 million, or $2.46 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, changes in the fair value of acquired contingent consideration, changes in the fair value of derivative liability related to our 2024 convertible senior secured notes, and expenses that pertain to non-routine corporate restructurings. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2022, the Company had cash, cash equivalents, and restricted cash of $51.5 million, compared to $65.2 million at year end 2021. Restricted cash includes $18.6 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, a corresponding amount of the restricted cash will be released from escrow.

Financial Guidance
For the full year 2022, Acorda continues to expect AMPYRA net revenue to be $68 – $78 million, and operating expenses to be $110 – $120 million. The operating expense guidance is a non-GAAP projection that excludes restructuring costs and share-based compensation as more fully described below under "Non-GAAP Financial Measures."

Webcast
To participate in the Webcast, please use the following pre-registration link:

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If you register for the Webcast, you will have the opportunity to submit a written question for the Q&A portion of the presentation. Once you have registered, you will receive a confirmation email with Webcast details. 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 7:30 p.m. ET on May 11, 2022 until 11:59 p.m. ET on June 10, 2022. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); reference code 258745. 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 income (loss), adjusted to exclude the items below, and has provided 2022 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 income (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 royalty 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) expenses that pertain to corporate restructurings which are not routine to the operation of the business, and (v) 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. The Company believes its non-GAAP net income (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 income (loss), we have provided 2022 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 this measure to the most directly comparable GAAP financial measure 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 corporate restructurings not routine to the operation of our business, 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.