Acorda Therapeutics(US:ACOR)2023-11-13 16:00Revenue Performance - U.S. net revenue for Inbrija was $8.1 million for Q3 2023, up from $7.8 million in Q3 2022, representing a 3.8% increase[122] - Net revenues for ex-U.S. Inbrija sales were $1.4 million for Q3 2023, compared to $1.0 million in Q3 2022, indicating a 40% increase[123] - U.S. net revenue for Ampyra was $15.7 million for Q3 2023, down from $21.1 million in Q3 2022, reflecting a 25.6% decline[125] - U.S. net revenue for Inbrija increased to $8.1 million for the quarter ended September 30, 2023, representing a 4% increase from $7.8 million in the same quarter of 2022[151] - U.S. net revenue for Ampyra decreased to $15.7 million for the quarter ended September 30, 2023, a decline of 26% from $21.1 million in the same quarter of 2022[152] - Ampyra's net revenues for the nine-month period ended September 30, 2023, were $45.2 million, a decrease of 16% from $54.2 million in the same period of 2022[171] - Inbrija's net revenues for the nine-month period ended September 30, 2023, increased to $22.0 million, a 16% increase from $19.0 million in the same period of 2022[169] Financial Commitments and Agreements - The company has minimum purchase commitments for Inbrija of $18 million annually through December 31, 2030, under a long-term supply agreement with Catalent[128] - Under the new manufacturing services agreement with Catalent, the company will have purchase commitments of 15 batches in 2023 at a total cost of $10.5 million and 24 batches in 2024 at a total cost of $15.5 million[131] - The company received a €5 million (approximately $5.9 million) upfront payment from Esteve Pharmaceuticals for the commercialization of Inbrija in Spain and Germany[142] - The company entered into a distribution agreement with Hangzhou Chance Pharmaceuticals for the exclusive distribution of Inbrija in China, receiving a non-refundable upfront payment of $2.5 million and potential milestone payments totaling up to $141.5 million[144] Regulatory and Market Expansion - The company is in discussions for commercialization of Inbrija in additional jurisdictions outside the U.S., with agreements already in place for Spain, Germany, Latin America, and China[140] - Biopas Laboratories is expected to submit regulatory filings for Inbrija in multiple Latin American countries, with up to five approvals anticipated in 2024[143] Financial Position and Cash Flow - As of September 30, 2023, the company had cash, cash equivalents, and restricted cash of approximately $33.6 million[138] - Cash and cash equivalents decreased to $32.5 million as of September 30, 2023, down from $37.5 million at December 31, 2022[188] - Net cash used in operations for the nine-month period ending September 30, 2023, was $11 million, primarily due to a net loss of $35.1 million and an increase in inventory of $5.2 million[200] - The company reported no net cash provided by financing activities for the nine-month period ending September 30, 2023[203] - The company maintains cash balances with financial institutions in excess of insured limits, with no anticipated losses[199] Expenses and Losses - Research and development expenses decreased by approximately $0.2 million, or 13%, to $1.2 million for the quarter ended September 30, 2023, primarily due to corporate restructuring[160] - General and administrative expenses increased by approximately $0.4 million, or 3%, to $13.5 million for the quarter ended September 30, 2023, primarily due to increased finance-related costs[162] - Selling and marketing expenses decreased by approximately $1.9 million or 6%, amounting to $28.7 million for the nine-month period ended September 30, 2023[179] - General and administrative expenses decreased by approximately $10.7 million or 22%, totaling $38.7 million for the nine-month period ended September 30, 2023[180] - The company incurred a net loss of $35.1 million for the nine-month period ended September 30, 2023[188] Changes in Fair Value and Other Financial Metrics - The company recorded a gain of $5.2 million related to changes in the fair value of acquired contingent consideration for the quarter ended September 30, 2023, compared to a gain of $4.6 million in the same quarter of 2022[165] - A gain of $7.1 million was recorded for changes in the fair value of acquired contingent consideration for the nine-month period ended September 30, 2023, compared to a gain of $10.7 million in 2022[182] Cost of Sales - Total cost of sales significantly decreased to $3.4 million for the quarter ended September 30, 2023, down from $11.0 million in the same quarter of 2022[158] - Cost of sales significantly decreased to $9.7 million for the nine-month period ended September 30, 2023, from $25.8 million in the same period of 2022[175] Accounting and Reporting - The company adopted new accounting guidance effective January 1, 2022, but significant accounting policies have not changed materially since December 31, 2022[206] - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[207] Inflation and Economic Factors - Inflation affects the company's expenses, particularly in employee compensation and contract services, which could increase overall expenses[205]