Financial Performance - U.S. net revenue for Inbrija was 5.6millionforthequarterendedMarch31,2023,comparedto3.7 million for the same quarter in 2022, representing a 51.35% increase[128]. - U.S. net revenue for Ampyra was 12.6millionforthequarterendedMarch31,2023,downfrom14.9 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].−Thecompanyincurredanetlossof16.8 million for the three-month period ended March 31, 2023[176]. - Royalty revenues decreased to 3.5millionforthequarterendedMarch31,2023,comparedto4.0 million in the same quarter of 2022, a decrease of 12.5%[164]. - The company recorded a gain of 1.0millionrelatedtochangesinthefairvalueofacquiredcontingentconsiderationforthequarterendedMarch31,2023,comparedtoagainof3.0 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,thecompanyhad30.3 million in cash and cash equivalents, down from 37.5millionatDecember31,2022[176].−AsofMarch31,2023,cashandcashequivalentswereapproximately30.3 million, down from 37.5millionatDecember31,2022,anddonotinclude57.5 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,downfrom6.0 million in the same quarter of 2022[165]. - Research and development expenses decreased to 1.4millionforthequarterendedMarch31,2023,areductionofapproximately17.61.7 million in the same quarter of 2022[166]. - General and administrative expenses decreased to 12.8millionforthequarterendedMarch31,2023,down23.816.8 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,receivinganon−refundableupfrontpaymentof2.5 million and potential milestone payments totaling up to 141.5million[152].ManufacturingandOperationalChanges−ThenewmanufacturingservicesagreementwithCatalentincludesreducedminimumannualcommitmentsof10.5 million and 15.5millionfor2023and2024,respectively[137].−Thecompanyisobligatedtopaya4 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].DebtandFinancialObligations−The2024ConvertibleSeniorSecuredNoteshaveanaggregateprincipalamountof207.0 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].