Workflow
BioCryst Pharmaceuticals(BCRX) - 2025 Q1 - Quarterly Report
BCRXBioCryst Pharmaceuticals(BCRX)2025-05-06 20:03
Transcript
Slide

Financial Performance - Revenues for Q1 2025 were 145,534,a57145,534, a 57% increase compared to 92,761 in Q1 2024[22] - Net income for Q1 2025 was 32,comparedtoanetlossof32, compared to a net loss of 35,379 in Q1 2024[22] - Total revenues for the three months ended March 31, 2025, were 145,534,000,a57145,534,000, a 57% increase from 92,761,000 in the same period of 2024[37] - Net product sales for ORLADEYO amounted to 143,787,000forthethreemonthsendedMarch31,2025,comparedto143,787,000 for the three months ended March 31, 2025, compared to 89,272,000 in the prior year, reflecting a 61% growth[37] - The Company recorded a segment net income of 32,000forQ12025,asignificantrecoveryfromanetlossof32,000 for Q1 2025, a significant recovery from a net loss of 35,379,000 in Q1 2024[178] - Total revenues for the three months ended March 31, 2025, were 145.5million,upfrom145.5 million, up from 92.8 million for the same period in 2024, driven by a 45.4millionincreaseinORLADEYOnetrevenue[212]Expenses−Researchanddevelopmentexpensesdecreasedto45.4 million increase in ORLADEYO net revenue[212] Expenses - Research and development expenses decreased to 37,270 from 46,493inQ12024,areductionofapproximately2046,493 in Q1 2024, a reduction of approximately 20%[22] - Selling, general and administrative expenses increased to 82,469 from 59,491,ariseofapproximately3859,491, a rise of approximately 38%[22] - The Company incurred 82,469,000 in selling, general and administrative expenses for Q1 2025, up from 59,491,000inQ12024[178]−Stock−basedcompensationexpenseincreasedfrom59,491,000 in Q1 2024[178] - Stock-based compensation expense increased from 13,652,000 in Q1 2024 to 21,368,000inQ12025,anincreaseofabout56.721,368,000 in Q1 2025, an increase of about 56.7%[152] - Selling, general and administrative expenses for Q1 2025 were 82.5 million, up from 59.5millioninQ12024,reflectingincreasedcommercialexpensesandstock−basedcompensation[217]AssetsandLiabilities−Totalcurrentassetsdecreasedto59.5 million in Q1 2024, reflecting increased commercial expenses and stock-based compensation[217] Assets and Liabilities - Total current assets decreased to 409,977 from 421,968asofDecember31,2024[21]−Totalliabilitiesdecreasedto421,968 as of December 31, 2024[21] - Total liabilities decreased to 931,974 from 966,354asofDecember31,2024[21]−Cashandcashequivalentsincreasedto966,354 as of December 31, 2024[21] - Cash and cash equivalents increased to 105,190 from 104,713asofDecember31,2024[21]−TheCompanyreportedatotalstockholders′deficitof104,713 as of December 31, 2024[21] - The Company reported a total stockholders' deficit of 451,927 as of March 31, 2025, improved from 475,934asofDecember31,2024[21]−TheCompanyhadinvestmentswithatotalestimatedfairvalueof475,934 as of December 31, 2024[21] - The Company had investments with a total estimated fair value of 210,450,000 as of March 31, 2025, down from 236,460,000atDecember31,2024[110]RevenueRecognitionandReceivables−TradereceivablesareprimarilyduefromspecialtypharmacycustomersintheU.S.andthird−partydistributors,withstandardpaymenttermsof30to90days[58]−TheCompanyrecognizesrevenuefromlicensefeesandroyaltieswhentheearningsprocessiscomplete,withroyaltiesbasedonlicensees′netsalesofcoveredproducts[48][50]−TheCompanyevaluatestradereceivablesforestimatedlossesandprovidesreservesbasedoncurrenteconomicconditionsandhistoricalcollectionexperience[60]−TheCompanyrecordedapproximately84236,460,000 at December 31, 2024[110] Revenue Recognition and Receivables - Trade receivables are primarily due from specialty pharmacy customers in the U.S. and third-party distributors, with standard payment terms of 30 to 90 days[58] - The Company recognizes revenue from license fees and royalties when the earnings process is complete, with royalties based on licensees' net sales of covered products[48][50] - The Company evaluates trade receivables for estimated losses and provides reserves based on current economic conditions and historical collection experience[60] - The Company recorded approximately 84% and 87% of total net revenues from sales of ORLADEYO through a single specialty pharmacy for the three months ended March 31, 2025 and 2024, respectively[94] Inventory and Production - The Company’s inventory primarily consists of ORLADEYO and peramivir, valued at the lower of cost or estimated net realizable value[61] - Total inventory as of March 31, 2025, was 31,970,000, slightly up from 31,274,000atDecember31,2024[115]−TheCompanyexpensescostsrelatedtoproductionofpre−launchinventoryasresearchanddevelopmentexpenseuntilregulatoryapprovalisreceived,afterwhichinventorycostsarecapitalized[64]−TheCompanyhassignificantjudgmentindeterminingtheneedforvaluationreservesforinventory,whichincludesexcess,obsolete,orunmarketableinventory[63]DebtandFinancing−TheCompanyhasenteredintoroyaltypurchaseagreementswithRPIandOMERS,totaling31,274,000 at December 31, 2024[115] - The Company expenses costs related to production of pre-launch inventory as research and development expense until regulatory approval is received, after which inventory costs are capitalized[64] - The Company has significant judgment in determining the need for valuation reserves for inventory, which includes excess, obsolete, or unmarketable inventory[63] Debt and Financing - The Company has entered into royalty purchase agreements with RPI and OMERS, totaling 275,000,000 in cash for future royalty payments[116] - As of March 31, 2025, the carrying value of royalty financing obligations was approximately 500,918,witheffectiveinterestratesof21.6500,918, with effective interest rates of 21.6% for the 2020 RPI Agreement and 10.0% for the OMERS Agreement[127] - The Company had total borrowings of 300,000 under the Pharmakon Loan Agreement as of March 31, 2025, with interest expense of 9,153forthequarter[138]−ThePharmakonLoanAgreementallowsforquarterlyinterest−onlypaymentsuntilthematuritydateofApril17,2028,withaneffectiveinterestrateof12.319,153 for the quarter[138] - The Pharmakon Loan Agreement allows for quarterly interest-only payments until the maturity date of April 17, 2028, with an effective interest rate of 12.31% for the three months ended March 31, 2025[134] - The Company incurred debt fees and issuance costs of 11,147 associated with the Tranche A Loan, which are being amortized over the term of the loan[141] Clinical Development and Regulatory - The FDA has cleared the investigational new drug application for BCX17725, enabling clinical trials to enroll patients in the United States[209] - The company expects to submit a new drug application to the FDA in 2025 to expand the ORLADEYO label to children aged 2 to 11[206] - The ongoing APeX-P clinical trial is assessing an oral granule formulation of ORLADEYO in pediatric patients aged 2 to 11[189] - The Company anticipates initial clinical data from the avoralstat program targeted by the end of 2025[210] Market and Competitive Landscape - The Company is seeking to defend its intellectual property rights against Annora Pharma's ANDA filing for a generic version of ORLADEYO, which could impact future revenues[179] - ORLADEYO is projected to reach a global peak of $1 billion in annual net revenues, with approximately 80% expected from the United States[190] - The percentage of U.S. HAE patients preferring an oral prophylaxis therapy increased to 70% in 2025, up from 50% in 2023[207]