On November 13, 2023 Acorda Therapeutics, Inc. (Nasdaq: ACOR) reported a business update and announced its financial results for the third quarter ended September 30, 2023 (Press release, Acorda Therapeutics, NOV 13, 2023, View Source [SID1234637526]).
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"We were pleased to see a 32% increase in new INBRIJA prescription requests in Q3 2023 over Q3 2022. New prescription requests have increased by 38% in the first three quarters of 2023 versus the same period in 2022. This is an encouraging sign for the long-term growth of the brand, and we are reiterating our 2023 INBRIJA guidance," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We are also delighted that Biopas has filed for the approval of INBRIJA in six countries in Latin America and expects to have up to five approvals in 2024. They also expect to file in Chile by the end of 2023 and in Brazil and Mexico in 2024."
Third Quarter 2023 Financial Results
For the quarter ended September 30, 2023, the Company reported INBRIJA worldwide net revenue of $9.5 million, a 7% increase, of which $8.1 million was derived from sales in the U.S., a 4% increase compared to the same quarter in 2022. The Company also reported ex-U.S. INBRIJA net revenue of $1.4 million in the third quarter related to sales in Spain.
For the quarter ended September 30, 2023, the Company reported AMPYRA net revenue of $15.7 million, a 26% decrease compared to $21.1 million for the same quarter in 2022. AMPYRA net revenue for the first three quarters of 2023 decreased by 17% over the same period in 2022. Additionally, for the quarter ended September 30, 2023, the Company reported FAMPYRA royalty revenues of $2.5 million, a 3% decrease compared to the same quarter in 2022. As previously disclosed, AMPYRA lost its exclusivity and generics entered the market in 2018. The Company expects AMPYRA revenue to continue to decline.
Research and development (R&D) expenses for the quarter ended September 30, 2023 were $1.2 million, compared to $1.4 million for the same quarter in 2022. Sales, general and administrative (SG&A) expenses for the quarter ended September 30, 2023 were $23.2 million, compared to $23 million for the same quarter in 2022.
Total operating expenses for the quarter ended September 30, 2023 was $30.2 million, compared to $38.5 million for the same quarter in 2022.
Non-GAAP adjusted operating expenses (adjusted OPEX) was $24.4 million for the quarters ended September 30, 2023 and September 30, 2022. This quarterly non-GAAP measure, more fully described below under "Non-GAAP Financial Measures," excludes costs of goods sold, amortization of intangible assets,
change in fair value of derivative liability, and change in fair value of acquired contingent liability. A reconciliation of the GAAP operating expenses to non-GAAP operating expenses is included with the attached financial statements.
Benefit from income taxes for the quarter ended September 30, 2023 was $1.1 million, compared to a provision for income taxes of $1.4 million for the same quarter in 2022.
The Company reported a GAAP net loss of $8.9 million for the quarter ended September 30, 2023, or a net loss of ($7.16) per share on both a basic and diluted basis. Net loss in the same quarter of 2022 was $13.9 million, or a net loss of ($11.17) per share on both a basic and diluted basis.
At September 30, 2023, the Company had cash, cash equivalents, and restricted cash of $33.6 million, compared to $44.7 million at year end 2022.
2023 Financial Guidance
For the full year 2023, the Company reaffirms INBRIJA U.S. net revenue guidance to be $34-$38 million, Adjusted OPEX guidance to be $93-$98 million, ending cash balance guidance to be $39-44 million, and AMPYRA net revenue guidance to be $65-$70 million.
Webcast and Conference Call
The Company will host a Webcast/Conference Call in conjunction with its third quarter update and financial results today at 4:30 p.m. ET.
To participate in the Webcast, please use the following registration link:
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 8:30 p.m. ET on November 13, 2023, until 11:59 p.m. ET on December 12, 2023. To access the replay, please dial 1 866 813 9403 (domestic) or +44 204 525 0658 (international); access code 197086. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.