On August 4, 2022 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported its financial results for the second quarter ended June 30, 2022 (Press release, Acorda Therapeutics, AUG 4, 2022, View Source [SID1234617527]).

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"Second quarter 2022 INBRIJA U.S. net sales doubled over the first quarter of 2022, following a challenging Q1 due to the COVID Omicron surge; U.S. net sales also grew 16% over Q2 2021. New prescriptions also increased in the second quarter over the first, and continued to increase into July," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "In June, Esteve launched INBRIJA in Germany. We reported $1.9 million in revenue from our distribution agreement with Esteve. Our double-digit, tiered royalties on Biogen’s ex-U.S. sales of Fampyra also reverted to us late in the second quarter, with the fulfillment of our obligation to Healthcare Royalty Partners, and we will begin to receive the full value of these royalties in the third quarter. In addition, we are pleased that Biogen has now launched Fampyra in China."

Second Quarter 2022 Financial Results

For the quarter ended June 30, 2022, the Company reported INBRIJA U.S. net revenue of $7.4 million, compared to $6.4 million for the same quarter in 2021. The Company also reported Ex-U.S. INBRIJA net revenue of $1.9 million in the second quarter related to the Esteve launch in Germany.

The Company reported AMPYRA net revenue of $18.2 million, compared to $21.8 million for the same quarter in 2021.

Research and development (R&D) expenses for the quarter ended June 30, 2022 were $1.5 million, including negligible share-based compensation expenses, compared to $2.4 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 June 30, 2022 were $30.1 million, including $0.4 million of share-based compensation, compared to $32.4 million, including $0.7 million of share-based compensation for the same quarter in 2021.

Change in fair value of derivative liability for the quarter ended June 30, 2022 was negligible, compared to $(0.8) million for the same quarter in 2021.

Provision (non-cash) for income taxes for the quarter ended June 30, 2022 was $26.6 million, compared to a benefit from income taxes of $0.5 million for the same quarter in 2021.

The Company reported a GAAP net loss of $46.7 million for the quarter ended June 30, 2022, or $2.78 per diluted share. GAAP net loss in the same quarter of 2021 was $22.9 million, or $2.29 per diluted share. The increased GAAP net loss in the current period reflects the application of Internal Revenue Code Section 382, which resulted in a reduction of the Company’s deferred tax assets with no impact to cash.

Non-GAAP net loss for the quarter ended June 30, 2022 was $52.8 million, or $3.15 per diluted share. Non-GAAP net loss in the same quarter of 2021 was $18.7 million, or $1.87 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 June 30, 2022, the Company had cash, cash equivalents, and restricted cash of $36.5 million, compared to $65.2 million at year end 2021. Restricted cash includes $12.4 million in escrow related to the 6% semi-annual interest portion of the convertible note exchange completed in December 2019.

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 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. After you have registered, you will receive a confirmation email with the Webcast details. On the day of the Webcast, 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 August 4, 2022 until 11:59 p.m. ET on September 4, 2022. To access the replay, please dial 1 800 770 2030 (domestic) or 1 647 362 9199 (international); reference code 95455. 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.