Financial Performance - Product revenue for the three months ended September 30, 2024, was 16.352million,comparedto0 for the same period in 2023[9] - Gross profit for the nine months ended September 30, 2024, was 21.430million,withagrossmarginreflectingasignificantincreasefrompreviousperiods[9]−ThenetlossforthethreemonthsendedSeptember30,2024,was85.577 million, compared to a net loss of 43.243millionforthesameperiodin2023[9]−Thecompanyreportedanetlossof259,875,000 for the nine months ended September 30, 2024, compared to a net loss of 122,022,000forthesameperiodin2023,indicatingasignificantincreaseinlosses[18]−Thecompanyreportedanetlossof85.6 million for the three months ended September 30, 2024, compared to a net loss of 43.2millionforthesameperiodin2023,indicatingaworseningfinancialperformance[9]OperatingExpenses−TotaloperatingexpensesforthethreemonthsendedSeptember30,2024,were84.792 million, up from 35.659 million in the same period last year, indicating increased investment in R&D and SG&A[9] - The total operating expenses for the nine months ended September 30, 2024, were 239.5 million, significantly higher than 97.4millionforthesameperiodin2023,reflectinganincreaseinresearchanddevelopmentandselling,general,andadministrativeexpenses[9]−ResearchanddevelopmentexpensesfortheninemonthsendedSeptember30,2024,totaled25.499 million, down from 36.505millioninthesameperiodlastyear,indicatingapotentialshiftinfocus[9]−Stock−basedcompensationfortheninemonthsendedSeptember30,2024,was17,360,000, down from 20,441,000forthesameperiodin2023[18]−AdvertisingandmarketingcostsforthethreeandninemonthsendedSeptember30,2024wereapproximately17.5 million and 41.0million,respectively[63]CashandLiquidity−Cashandcashequivalentsdecreasedto334.678 million as of September 30, 2024, down from 381.393millionattheendof2023[7]−Cashandcashequivalentsattheendoftheperiodwere337,540,000, up from 216,535,000attheendofSeptember2023[18]−Thecompanyhassufficientworkingcapitaltofundoperationsforatleastthenexttwelvemonths,butfuturefundingsuccessisuncertain[22]−Thecompanyhasincurrednetlossesandnegativecashflowsfromoperatingactivitiessinceinception,withnetproceedsfromequityofferingstotalingapproximately543.3 million as of September 30, 2024[21] Liabilities and Stockholders' Equity - Total liabilities increased to 574.156millionasofSeptember30,2024,comparedto486.601 million at the end of 2023, reflecting higher long-term debt[7] - The company’s stockholders' deficit increased to 1.188billionasofSeptember30,2024,from1.102 billion at the end of 2023[11] - The total additional paid-in capital increased to 1,001,442thousandasofSeptember30,2024,from869,149 thousand at June 30, 2024[11] Revenue Recognition - The company recognizes revenue when a customer obtains control of promised goods or services, following a five-step model as per ASC 606[43] - Revenues from product sales are recorded at the net sales price, which includes estimates of variable consideration such as discounts and rebates[45] - The company estimates variable consideration for net product revenues based on market events, industry data, and customer payment patterns, which may lead to adjustments in revenue recognition[47] Customer Concentration - As of September 30, 2024, three customers accounted for 90% of the accounts receivable balance, with each customer representing 28% to 31% of the total[35] - For the three and nine months ended September 30, 2024, three customers accounted for 70% and 68% of product sales, respectively[35] Inventory Management - The company recorded approximately 0.3millionand0.7 million in charges for inventory not expected to be sold prior to expiration for the three and nine months ended September 30, 2024, respectively[37] - The company states its inventory at the lower of cost or net realizable value, using a first-in, first-out basis for measurement[37] Financing Activities - The company generated net proceeds of approximately 121.8millionfromanunderwrittenpublicofferinginAugust2024,contributingtototalnetproceedsofapproximately543.3 million since inception[21] - The Company entered into a Fourth Amendment to the Loan Agreement, increasing the aggregate principal amount of term loans from 200millionto300 million, with various tranches available subject to milestones[93] - The Revenue Interest Financing Agreement allows the Company to receive up to 260million,with100 million received at the initial closing and an additional 160millionuponFDAapprovalofVOQUEZNA[103]StockandShareholderInformation−Thecompanyreportedaweighted−averagesharecountof64.628millionforthethreemonthsendedSeptember30,2024,comparedto56.782millionforthesameperiodin2023[9]−Thecompanyhasatotalof14,191,348commonstockreservesavailableforfutureissuanceasofSeptember30,2024[121]−ThecompanyfiledashelfregistrationstatementonFormS−3inNovember2023,allowingforthepotentialsaleofupto150 million of common stock[118] Regulatory Approvals and Product Launches - The FDA approved the NDA for VOQUEZNA tablets on November 1, 2023, and the commercial launch for VOQUEZNA began in Q4 2023[20] - The company initiated the commercial launch of VOQUEZNA TRIPLE PAK and VOQUEZNA DUAL PAK for H. pylori treatment in Q4 2023[20]