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Acorda Therapeutics(ACOR) - 2023 Q1 - Quarterly Report

Financial Performance - U.S. net revenue for Inbrija was 5.6millionforthequarterendedMarch31,2023,comparedto5.6 million for the quarter ended March 31, 2023, compared to 3.7 million for the same quarter in 2022, representing a 51.35% increase[128]. - U.S. net revenue for Ampyra was 12.6millionforthequarterendedMarch31,2023,downfrom12.6 million for the quarter ended March 31, 2023, down from 14.9 million for the same quarter in 2022, indicating a decline of 15.43%[131]. - Net revenues for ex-U.S. Inbrija sales were 0.5millionforthequarterendedMarch31,2023[129].Thecompanyincurredanetlossof0.5 million for the quarter ended March 31, 2023[129]. - The company incurred a net loss of 16.8 million for the three-month period ended March 31, 2023[176]. - Royalty revenues decreased to 3.5millionforthequarterendedMarch31,2023,comparedto3.5 million for the quarter ended March 31, 2023, compared to 4.0 million in the same quarter of 2022, a decrease of 12.5%[164]. - The company recorded a gain of 1.0millionrelatedtochangesinthefairvalueofacquiredcontingentconsiderationforthequarterendedMarch31,2023,comparedtoagainof1.0 million related to changes in the fair value of acquired contingent consideration for the quarter ended March 31, 2023, compared to a gain of 3.0 million in the same quarter of 2022[172]. Cash and Cash Equivalents - The company had cash, cash equivalents, and restricted cash of approximately 37.8millionasofMarch31,2023[145].AsofMarch31,2023,thecompanyhad37.8 million as of March 31, 2023[145]. - As of March 31, 2023, the company had 30.3 million in cash and cash equivalents, down from 37.5millionatDecember31,2022[176].AsofMarch31,2023,cashandcashequivalentswereapproximately37.5 million at December 31, 2022[176]. - As of March 31, 2023, cash and cash equivalents were approximately 30.3 million, down from 37.5millionatDecember31,2022,anddonotinclude37.5 million at December 31, 2022, and do not include 57.5 million of restricted cash[189]. - The company anticipates that existing cash and cash equivalents will cover cash flow requirements for at least the next twelve months[181]. Expenses - The company recorded a cost of sales of 3.2millionforthequarterendedMarch31,2023,downfrom3.2 million for the quarter ended March 31, 2023, down from 6.0 million in the same quarter of 2022[165]. - Research and development expenses decreased to 1.4millionforthequarterendedMarch31,2023,areductionofapproximately17.61.4 million for the quarter ended March 31, 2023, a reduction of approximately 17.6% from 1.7 million in the same quarter of 2022[166]. - General and administrative expenses decreased to 12.8millionforthequarterendedMarch31,2023,down23.812.8 million for the quarter ended March 31, 2023, down 23.8% from 16.8 million in the same quarter of 2022[168]. Agreements and Partnerships - The company has entered into agreements to commercialize Inbrija in Spain, Germany, Latin America, and China, with a €5 million (approximately 5.9million)upfrontpaymentfromEstevePharmaceuticals[150].InMay2023,thecompanyenteredintoadistributionagreementwithHangzhouChancePharmaceuticalsfortheexclusivedistributionofInbrijainChina,receivinganonrefundableupfrontpaymentof5.9 million) upfront payment from Esteve Pharmaceuticals[150]. - In May 2023, 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 141.5million[152].ManufacturingandOperationalChangesThenewmanufacturingservicesagreementwithCatalentincludesreducedminimumannualcommitmentsof141.5 million[152]. Manufacturing and Operational Changes - The new manufacturing services agreement with Catalent includes reduced minimum annual commitments of 10.5 million and 15.5millionfor2023and2024,respectively[137].Thecompanyisobligatedtopaya15.5 million for 2023 and 2024, respectively[137]. - The company is obligated to pay a 4 million termination fee to Catalent, payable in April 2024, following the termination of the previous manufacturing services agreement[136]. Market and Compliance Issues - The COVID-19 pandemic has caused volatility in new Inbrija prescriptions, impacting the company's business and financial condition[146]. - The company received notice of non-compliance with Nasdaq's listing requirements due to stock price falling below 1.00forover30consecutivetradingdays,withadeadlinetoregaincompliancebyJune20,2023[180].ThecompanyhascommittedtoeffectingareversestocksplitifcompliancewiththeMinimumBidRequirementisnotachievedbythedeadline[180].DebtandFinancialObligationsThe2024ConvertibleSeniorSecuredNoteshaveanaggregateprincipalamountof1.00 for over 30 consecutive trading days, with a deadline to regain compliance by June 20, 2023[180]. - The company has committed to effecting a reverse stock split if compliance with the Minimum Bid Requirement is not achieved by the deadline[180]. Debt and Financial Obligations - The 2024 Convertible Senior Secured Notes have an aggregate principal amount of 207.0 million, with a semi-annual interest rate of 6.00%[182]. - The 2024 Notes will mature on December 1, 2024, unless converted earlier, and interest payments will be made in cash following the June 1, 2023 payment[183]. - The company has restrictions under the 2024 Indenture that limit its ability to pay dividends, incur additional debt, or sell assets[185]. Market Potential - Approximately 40% of people with Parkinson's in the U.S. experience OFF periods, with an estimated one million diagnosed in the U.S. and 1.2 million in Europe[128]. - The ARCUS platform allows for the delivery of substantially higher doses of medication than conventional dry powder technologies, enhancing the potential for inhaled therapeutics[147].