Revenue Performance - U.S. net revenue for Inbrija was 8.3millionforthequarterendedJune30,2023,comparedto7.4 million for the same quarter in 2022, representing a 12.16% increase [126]. - U.S. net revenue for Ampyra was 16.9millionforthequarterendedJune30,2023,downfrom18.2 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,up117.4 million in the same quarter of 2022 [160]. - Net revenues for ex-U.S. Inbrija sales were 0.8millionforthequarterendedJune30,2023[160].−Ampyranetrevenuesdecreasedto16.9 million for the quarter ended June 30, 2023, down 7% from 18.2millioninthesamequarterof2022[162].−ThecompanyrecognizednetrevenuesfromU.S.salesofInbrijaof13.9 million for the six-month period ended June 30, 2023, an increase of 25% from 11.1millioninthesameperiodof2022[178].−Ampyranetrevenuesforthesix−monthperiodendedJune30,2023,were29.5 million, a decrease of 3.6millionor1133.1 million in the same period of 2022 [179]. - Royalty revenues decreased to 7.2millionforthesix−monthperiodendedJune30,2023,down0.3 million or 4% from 7.5millionin2022[183].ExpensesandFinancialPosition−ResearchanddevelopmentexpensesforthequarterendedJune30,2023,were1.6 million, slightly up from 1.5millioninthesamequarterof2022[168].−Selling,generalandadministrativeexpensesdecreasedto21.8 million for the quarter ended June 30, 2023, down from 30millioninthesamequarterof2022,areductionofapproximately272.9 million for the six-month period ended June 30, 2023, a decrease of approximately 0.3millionor93.2 million in 2022 [186]. - Selling and marketing expenses decreased to 19.1millionforthesix−monthperiodendedJune30,2023,downapproximately1.7 million or 8% from 20.8millionin2022[187].−Generalandadministrativeexpenseswere25.2 million for the six-month period ended June 30, 2023, a decrease of approximately 11millionor3036.2 million in 2022 [187]. - The company incurred a net loss of 26.2millionforthesix−monthperiodendedJune30,2023[195].−Cashandcashequivalentsdecreasedto25.3 million as of June 30, 2023, down from 37.5millionatDecember31,2022[195].−Netcashusedinoperationsforthesix−monthperiodendingJune30,2023was18.6 million, primarily due to a net loss of 26.2million[207].−Thecompanymaintainscashbalancesexceedinginsuredlimits,withnoanticipatedlossesfromthesebalances[206].AgreementsandCollaborations−ThecompanyhasenteredintoagreementstocommercializeInbrijainSpain,Germany,LatinAmerica,andChina,withex−U.S.netrevenuesforInbrijasalesat0.8 million for the quarter ended June 30, 2023 [127]. - The company received a €5 million (approximately 5.9million)upfrontpaymentfromEstevePharmaceuticalsforthecommercializationofInbrijainSpainandGermany[151].−AdistributionagreementwithHangzhouChancePharmaceuticalsforInbrijainChinaincludesanon−refundableupfrontpaymentof2.5 million and potential milestone payments of up to 132.5millionbasedonsalesvolumes[153].−ThecompanyisdiscussingpotentialcollaborationsfortheARCUSplatformwithothercompaniesinterestedinformulatingnovelmoleculesforpulmonarydelivery[128].ManufacturingandOperationalChanges−ThenewmanufacturingservicesagreementwithCatalentincludesreducedminimumannualcommitmentsof10.5 million in 2023 and 15.5millionin2024forInbrijaproduction[135].−Thecompanyisobligatedtopaya4 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 4millionforthesix−monthperiodendedJune30,2023,comparedtoaprovisionforincometaxesof(26.8) million in 2022 [191]. - The company recorded a gain of 0.8millionrelatedtochangesinthefairvalueofacquiredcontingentconsiderationforthequarterendedJune30,2023,comparedto3.1 million in the same quarter of 2022 [172]. - The fair value of acquired contingent consideration recorded a gain of 1.9millionforthesix−monthperiodendedJune30,2023,comparedtoincomeof6.1 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].