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Acorda Therapeutics(ACOR) - 2023 Q2 - Quarterly Report

Revenue Performance - U.S. net revenue for Inbrija was 8.3millionforthequarterendedJune30,2023,comparedto8.3 million for the quarter ended June 30, 2023, compared to 7.4 million for the same quarter in 2022, representing a 12.16% increase [126]. - U.S. net revenue for Ampyra was 16.9millionforthequarterendedJune30,2023,downfrom16.9 million for the quarter ended June 30, 2023, down from 18.2 million for the same quarter in 2022, indicating a decline of 7.13% [129]. - Inbrija net revenues from U.S. sales increased to 8.3millionforthequarterendedJune30,2023,up118.3 million for the quarter ended June 30, 2023, up 11% from 7.4 million in the same quarter of 2022 [160]. - Net revenues for ex-U.S. Inbrija sales were 0.8millionforthequarterendedJune30,2023[160].Ampyranetrevenuesdecreasedto0.8 million for the quarter ended June 30, 2023 [160]. - Ampyra net revenues decreased to 16.9 million for the quarter ended June 30, 2023, down 7% from 18.2millioninthesamequarterof2022[162].ThecompanyrecognizednetrevenuesfromU.S.salesofInbrijaof18.2 million in the same quarter of 2022 [162]. - The company recognized net revenues from U.S. sales of Inbrija of 13.9 million for the six-month period ended June 30, 2023, an increase of 25% from 11.1millioninthesameperiodof2022[178].AmpyranetrevenuesforthesixmonthperiodendedJune30,2023,were11.1 million in the same period of 2022 [178]. - Ampyra net revenues for the six-month period ended June 30, 2023, were 29.5 million, a decrease of 3.6millionor113.6 million or 11% compared to 33.1 million in the same period of 2022 [179]. - Royalty revenues decreased to 7.2millionforthesixmonthperiodendedJune30,2023,down7.2 million for the six-month period ended June 30, 2023, down 0.3 million or 4% from 7.5millionin2022[183].ExpensesandFinancialPositionResearchanddevelopmentexpensesforthequarterendedJune30,2023,were7.5 million in 2022 [183]. Expenses and Financial Position - Research and development expenses for the quarter ended June 30, 2023, were 1.6 million, slightly up from 1.5millioninthesamequarterof2022[168].Selling,generalandadministrativeexpensesdecreasedto1.5 million in the same quarter of 2022 [168]. - Selling, general and administrative expenses decreased to 21.8 million for the quarter ended June 30, 2023, down from 30millioninthesamequarterof2022,areductionofapproximately2730 million in the same quarter of 2022, a reduction of approximately 27% [170]. - Research and development expenses were 2.9 million for the six-month period ended June 30, 2023, a decrease of approximately 0.3millionor90.3 million or 9% from 3.2 million in 2022 [186]. - Selling and marketing expenses decreased to 19.1millionforthesixmonthperiodendedJune30,2023,downapproximately19.1 million for the six-month period ended June 30, 2023, down approximately 1.7 million or 8% from 20.8millionin2022[187].Generalandadministrativeexpenseswere20.8 million in 2022 [187]. - General and administrative expenses were 25.2 million for the six-month period ended June 30, 2023, a decrease of approximately 11millionor3011 million or 30% from 36.2 million in 2022 [187]. - The company incurred a net loss of 26.2millionforthesixmonthperiodendedJune30,2023[195].Cashandcashequivalentsdecreasedto26.2 million for the six-month period ended June 30, 2023 [195]. - Cash and cash equivalents decreased to 25.3 million as of June 30, 2023, down from 37.5millionatDecember31,2022[195].NetcashusedinoperationsforthesixmonthperiodendingJune30,2023was37.5 million at December 31, 2022 [195]. - Net cash used in operations for the six-month period ending June 30, 2023 was 18.6 million, primarily due to a net loss of 26.2million[207].Thecompanymaintainscashbalancesexceedinginsuredlimits,withnoanticipatedlossesfromthesebalances[206].AgreementsandCollaborationsThecompanyhasenteredintoagreementstocommercializeInbrijainSpain,Germany,LatinAmerica,andChina,withexU.S.netrevenuesforInbrijasalesat26.2 million [207]. - The company maintains cash balances exceeding insured limits, with no anticipated losses from these balances [206]. Agreements and Collaborations - The company has entered into agreements to commercialize Inbrija in Spain, Germany, Latin America, and China, with ex-U.S. net revenues for Inbrija sales at 0.8 million for the quarter ended June 30, 2023 [127]. - The company received a €5 million (approximately 5.9million)upfrontpaymentfromEstevePharmaceuticalsforthecommercializationofInbrijainSpainandGermany[151].AdistributionagreementwithHangzhouChancePharmaceuticalsforInbrijainChinaincludesanonrefundableupfrontpaymentof5.9 million) upfront payment from Esteve Pharmaceuticals for the commercialization of Inbrija in Spain and Germany [151]. - A distribution agreement with Hangzhou Chance Pharmaceuticals for Inbrija in China includes a non-refundable upfront payment of 2.5 million and potential milestone payments of up to 132.5millionbasedonsalesvolumes[153].ThecompanyisdiscussingpotentialcollaborationsfortheARCUSplatformwithothercompaniesinterestedinformulatingnovelmoleculesforpulmonarydelivery[128].ManufacturingandOperationalChangesThenewmanufacturingservicesagreementwithCatalentincludesreducedminimumannualcommitmentsof132.5 million based on sales volumes [153]. - The company is discussing potential collaborations for the ARCUS platform with other companies interested in formulating novel molecules for pulmonary delivery [128]. Manufacturing and Operational Changes - The new manufacturing services agreement with Catalent includes reduced minimum annual commitments of 10.5 million in 2023 and 15.5millionin2024forInbrijaproduction[135].Thecompanyisobligatedtopaya15.5 million in 2024 for Inbrija production [135]. - 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 [134]. - A 1-for-20 reverse stock split was executed on June 2, 2023, reducing the number of authorized shares from 61,666,666 to 3,083,333, which helped regain compliance with Nasdaq's minimum bid requirement [144]. - The ARCUS platform allows for the systemic delivery of medication through inhalation, enabling higher doses than conventional dry powder technologies [149]. Tax and Financial Gains - The effective income tax rate for the quarter ended June 30, 2023, was 17.3%, compared to an effective tax rate of (132.0)% for the same quarter of 2022 [174]. - The company recorded a benefit from income taxes of 4millionforthesixmonthperiodendedJune30,2023,comparedtoaprovisionforincometaxesof(4 million for the six-month period ended June 30, 2023, compared to a provision for income taxes of (26.8) million in 2022 [191]. - The company recorded a gain of 0.8millionrelatedtochangesinthefairvalueofacquiredcontingentconsiderationforthequarterendedJune30,2023,comparedto0.8 million related to changes in the fair value of acquired contingent consideration for the quarter ended June 30, 2023, compared to 3.1 million in the same quarter of 2022 [172]. - The fair value of acquired contingent consideration recorded a gain of 1.9millionforthesixmonthperiodendedJune30,2023,comparedtoincomeof1.9 million for the six-month period ended June 30, 2023, compared to income of 6.1 million in 2022 [190]. Debt and Financing - Biotie Therapies Ltd. subsidiary received non-convertible capital loans totaling 20.5 million for R&D, with a gain on extinguishment of debt recorded at 27.1 million in December 2022 [205]. - The company filed for a waiver of loans and accrued interest, which was granted by Business Finland in July 2022 [205]. - The company’s long-term contractual obligations include royalties and license fees, but the timing and amount of payments are uncertain [210]. Inflation Impact - Inflation affects the company's expenses, particularly in employee compensation and contract services [211].