On May 5, 2020 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported its financial results for the first quarter ended March 31, 2020 (Press release, Acorda Therapeutics, MAY 5, 2020, View Source [SID1234557017]).

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"As we continue navigating the unprecedented operating environment created by COVID-19, our entire team remains focused on ensuring that the Parkinson’s disease and multiple sclerosis communities have continued access to Acorda’s critical medications," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "I am proud of how rapidly our team has evolved our business practices and developed new ways of working that enable us to keep our Acorda associates safe, while continuing to manufacture therapies that improve the lives of patients."

Dr. Cohen continued, "Despite significant disruption in the healthcare sector during the first quarter, INBRIJA and AMPYRA sales were consistent with our expectations, which took into account typical seasonal variability. We remain confident in our full-year expectations for AMPYRA, which is an established franchise supported by ongoing prescription renewals. For INBRIJA, which is a newer product driven by growth in new prescriptions, we are withdrawing our 2020 guidance. Due to COVID-19 stay-at-home orders and a widespread decrease in physician office visits, we do not have visibility into how changes in patient behavior may impact new prescription starts over the remainder of the year."

First Quarter 2020 Business Update

In response to the COVID-19 pandemic, Acorda launched a new, remote communications program, enabling it to communicate effectively and safely with healthcare professionals and patients to provide product education, information and support. The Company also launched virtual speaker programs and product webinars with meaningful attendance, including an Inbrija patient program that had over 500 participants. In addition, Acorda launched a new digital marketing program to drive awareness and educate people with Parkinson’s about INBRIJA.

First Quarter 2020 Financial Results

For the quarter ended March 31, 2020, the Company reported INBRIJA net revenue of $4.4 million, compared to $1.3 million for the same quarter in 2019.

For the quarter ended March 31, 2020, the Company reported AMPYRA net revenue of $20.1 million compared to $40.1 million for the same quarter in 2019. In September 2018, AMPYRA lost its exclusivity and generics entered the market. Consequently, the Company expects AMPYRA revenue to continue to decline.

Research and development (R&D) expenses for the quarter ended March 31, 2020 were $7.7 million, including $0.4 million of share-based compensation compared to $16.0 million, including $0.7 million of share-based compensation for the same quarter in 2019.

Sales, general and administrative (SG&A) expenses for the quarter ended March 31, 2020 were $41.1 million, including $1.5 million of share-based compensation compared to $52.7 million, including $2.8 million of share-based compensation for the same quarter in 2019.

Change in fair value of derivative liability for the quarter ended March 31, 2020 was $26.5 million compared to $0 for the same quarter in 2019.

Benefit from income taxes for the quarter ended March 31, 2020 was $7.0 million compared to a benefit from income taxes of $0.7 million for the same quarter in 2019.

The Company reported a GAAP net loss of $6.5 million for the quarter ended March 31, 2020, or $0.14 per diluted share. GAAP net loss in the same quarter of 2019 was $47.6 million, or $1.00 per diluted share.

Non-GAAP net loss for the quarter ended March 31, 2020 was $24.4 million, or $0.51 per diluted share. Non-GAAP net loss in the same quarter of 2019 was $26.5 million, or $0.56 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, asset impairment charges, changes in the fair value of the derivative liability, and expenses that pertain to a non-routine restructuring event. A reconciliation of the GAAP financial results to non-GAAP financial results is included with the attached financial statements.

At March 31, 2020, the Company had cash, cash equivalents, short-term investments and restricted cash of $126.3 million compared to $168.9 million at year end 2019. Restricted cash includes $42.7 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.

2020 Financial Guidance

For the full-year 2020, Acorda continues to expect AMPYRA net revenue to be $85 – $110 million, and operating expenses to be $170 – $180 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."

As a result of declines in physician office visits due to COVID-19 stay-at-home orders, the Company is withdrawing its previously announced 2020 INBRIJA net revenue guidance. This also necessitates the withdrawal of 2020 total net product revenue. Acorda continues to expect INBRIJA peak sales to be $300 – $500 million.

Webcast and Conference Call

The Company will host a conference call today at 4:30 p.m. ET. To participate in the conference call, please dial (833) 236-2756 (domestic) or (647) 689-4181 (international) and reference the access code 7999873. The presentation will be available on the Investors section of www.acorda.com.

A replay of the call will be available from 8:30 p.m. ET on May 5, 2020 until 11:59 p.m. ET on June 5, 2020. To access the replay, please dial (800) 585-8367 (domestic) or (416) 621-4642 (international); reference code 7999873. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.