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EyePoint Pharmaceuticals(EYPT) - 2022 Q4 - Annual Report
EYPTEyePoint Pharmaceuticals(EYPT)2023-03-09 16:00
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Financial Performance - Product sales increased by 4.6million,or134.6 million, or 13%, to 39.9 million in 2022 compared to 35.3millionin2021,drivenbyareturnofcustomerdemandasproceduresresumed[457].−Licenseandcollaborationagreementrevenuesdecreasedby35.3 million in 2021, driven by a return of customer demand as procedures resumed [457]. - License and collaboration agreement revenues decreased by 394,000, or 52%, to 362,000in2022,primarilyduetoreducedrevenuefromOcumensionfortechnicalassistance[460].−Royaltyincomeincreasedby362,000 in 2022, primarily due to reduced revenue from Ocumension for technical assistance [460]. - Royalty income increased by 266,000, or 31%, to 1.1millionin2022,attributedtoOcumensionroyaltiesof1.1 million in 2022, attributed to Ocumension royalties of 269,000 [461]. - The company recorded a total revenue of 41.4millionin2022,anincreaseof41.4 million in 2022, an increase of 4.5 million, or 12%, from 36.9millionin2021[457].−Thenetlossfor2022was36.9 million in 2021 [457]. - The net loss for 2022 was 102.3 million, compared to a net loss of 58.4millionin2021,representinganincreaseof58.4 million in 2021, representing an increase of 43.8 million, or 75% [457]. - Total operating expenses increased by 48.8million,or5348.8 million, or 53%, to 141.0 million in 2022, with significant contributions from impairment of acquired intangible assets [457]. - General and administrative expenses increased by 9.2million,or369.2 million, or 36%, to 34.8 million for 2022 from 25.6millionfortheprioryear[465].−Researchanddevelopmentexpensesroseby25.6 million for the prior year [465]. - Research and development expenses rose by 21.1 million, or 74%, to 49.6millionin2022,mainlyduetopersonnelcostsandincreasedclinicaltrialexpenses[463].RegulatoryandClinicalDevelopments−TheFDAhasupdatedregulatoryrequirementsforcombinationdrug/deviceproducts,necessitatingadditionalclinicaltrialsforYUTIQ50,leadingtoincreasedprogramcostsandapauseinenrollmentfortheclinicaltrial[428].−EYP−1901iscurrentlyinPhase2clinicaltrialsforwetAMD,withinitialtop−linedataexpectedinthesecondhalfof2023[428].−Thetwelve−monthDAVIOPhase1clinicaltrialdataforEYP−1901showedatreatmentburdenreductionof7549.6 million in 2022, mainly due to personnel costs and increased clinical trial expenses [463]. Regulatory and Clinical Developments - The FDA has updated regulatory requirements for combination drug/device products, necessitating additional clinical trials for YUTIQ 50, leading to increased program costs and a pause in enrollment for the clinical trial [428]. - EYP-1901 is currently in Phase 2 clinical trials for wet AMD, with initial top-line data expected in the second half of 2023 [428]. - The twelve-month DAVIO Phase 1 clinical trial data for EYP-1901 showed a treatment burden reduction of 75% at six months and 73% at twelve months [428]. - YUTIQ 0.18mg was approved by China's CDE for the treatment of posterior segment uveitis in June 2022 [426]. Cash Flow and Financing - Cash, cash equivalents, and investments in marketable securities totaled 144.6 million as of December 31, 2022, expected to fund operations into the second half of 2024 [478]. - Operating cash outflows for the year ended December 31, 2022 totaled 65.0million,primarilyduetoanetlossof65.0 million, primarily due to a net loss of 102.3 million [482]. - Net cash used in investing activities for 2022 was 17.3million,comparedto17.3 million, compared to 33.1 million in 2021 [484]. - The company entered into a loan agreement with Silicon Valley Bank providing for a senior secured term loan facility of 30.0millionandarevolvingcreditfacilityofupto30.0 million and a revolving credit facility of up to 15.0 million [472]. - The repayment of loans under the Credit Facilities is due on January 1, 2027, with interest rates based on the Wall Street Journal prime rate plus a margin [473]. - Net cash used in financing activities for fiscal 2022 totaled 690,000[485].−690,000 [485]. - 38.2 million was used to pay off the CRG loan in fiscal 2022 [485]. Market and Operational Impact - The fiscal year ended December 31, 2022, was impacted by a reduction in physician office visits due to the ongoing pandemic, adversely affecting YUTIQ sales, particularly in early 2022 [426]. - Customer demand for YUTIQ in Q4 2022 increased by 11% compared to Q3 2022, while demand for DEXYCU decreased by 70% due to the loss of pass-through coverage by CMS [433]. - The company received a subpoena from the U.S. Attorney's Office regarding sales and marketing practices, which may have a material adverse effect on its business [428]. - Sales and marketing expenses decreased by 2.0million,or72.0 million, or 7%, to 25.5 million in 2022, mainly due to lower promotional activities for DEXYCU [464]. - Impairment of acquired intangible assets amounted to 20.7millioninQ42022,relatedtotheDEXYCUtechnology[456].DebtandInterest−Interestexpensetotaled20.7 million in Q4 2022, related to the DEXYCU technology [456]. Debt and Interest - Interest expense totaled 3.2 million for 2022, down from 5.5millionin2021duetoalowerinterestrateontheSVBLoan[467].−Interestincomefrominvestmentsinmarketablesecuritiesincreasedto5.5 million in 2021 due to a lower interest rate on the SVB Loan [467]. - Interest income from investments in marketable securities increased to 2.1 million for fiscal 2022 compared to 292,000intheprioryear[468].−Thetotalaccumulateddeficitreached292,000 in the prior year [468]. - The total accumulated deficit reached 671.3 million as of December 31, 2022, with operations financed primarily through equity sales and debt issuance [470]. Company Structure and Reporting - The company does not have any off-balance sheet arrangements that would materially affect financial conditions [486]. - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures [487].