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Evoke Pharma(EVOK) - 2024 Q3 - Quarterly Report
EVOKEvoke Pharma(EVOK)2024-11-07 21:11

Financial Performance - Gimoti net product sales for the quarter ended September 30, 2024, were approximately 2.7million,reflectinga2.7 million, reflecting a 0.1 million increase compared to the previous quarter[64]. - Net product sales for the three months ended September 30, 2024, increased by approximately 1.1million,a701.1 million, a 70% change compared to the same period in 2023, totaling 2,654,186[79]. - For the nine months ended September 30, 2024, net product sales reached 6,941,042,representinga986,941,042, representing a 98% increase compared to 3,504,636 in 2023[80]. - Net product sales increased by approximately 3.4millionfortheninemonthsendedSeptember30,2024,comparedtothesameperiodin2023,drivenbyincreasedproductadoptionandalargerpharmacynetwork[82].ExpensesandFinancialChallenges−Thecompanyincurredlossessinceinception,withongoingoperatinglossesexpecteduntilrevenuesfromGimotiexceedexpenses[60].−Selling,generalandadministrativeexpensesforthethreemonthsendedSeptember30,2024,increasedbyapproximately3.4 million for the nine months ended September 30, 2024, compared to the same period in 2023, driven by increased product adoption and a larger pharmacy network[82]. Expenses and Financial Challenges - The company incurred losses since inception, with ongoing operating losses expected until revenues from Gimoti exceed expenses[60]. - Selling, general and administrative expenses for the three months ended September 30, 2024, increased by approximately 692,753, totaling 3,824,142,a223,824,142, a 22% change compared to 2023[79]. - Selling, general and administrative expenses increased by approximately 2.0 million for the nine months ended September 30, 2024, with significant costs in wages, marketing, and legal expenses[82]. - Research and development expenses for the three months ended September 30, 2024, were 11,677,comparedtonoexpensesinthesameperiodin2023[79].−Researchanddevelopmentexpensesdecreasedbyapproximately11,677, compared to no expenses in the same period in 2023[79]. - Research and development expenses decreased by approximately 0.1 million for the nine months ended September 30, 2024, due to reduced ongoing stability testing costs[82]. - The company anticipates needing to raise additional funds to continue operations, as existing cash may not be sufficient beyond 12 months from the report date[60]. - The company anticipates needing to raise additional funds through various financing methods to support ongoing operations and achieve profitability[83]. Cash and Financing - As of September 30, 2024, the company had cash and cash equivalents of approximately 11.3million,expectedtofundoperationsintothefourthquarterof2025[60].−Cashprovidedbyfinancingactivitieswas11.3 million, expected to fund operations into the fourth quarter of 2025[60]. - Cash provided by financing activities was 10.8 million for the nine months ended September 30, 2024, primarily from stock sales and warrant exercises[86]. - The company raised approximately 6.2millionfromapublicofferingofcommonstockunitsinFebruary2024[84].ComplianceandCorporateActions−ThecompanyreceivedanoticefromNasdaqregardingnon−compliancewiththeminimumstockholders′equityrequirement,withstockholders′equityreportedat6.2 million from a public offering of common stock units in February 2024[84]. Compliance and Corporate Actions - The company received a notice from Nasdaq regarding non-compliance with the minimum stockholders' equity requirement, with stockholders' equity reported at 3.5 million as of March 31, 2024[61]. - A reverse stock split was executed on August 1, 2024, combining every twelve shares into one to regain compliance with Nasdaq's minimum bid price requirement[62]. - The company entered into a lease amendment extending the office lease term to March 31, 2027, with an initial monthly base rent of approximately 6,500[86].ProductDevelopmentandMarketStrategy−ThecompanylaunchedcommercialsalesofGimotiinOctober2020,withmodestsalesgeneratedtodate[60].−Futureproductdevelopmentandcommercializationstrategiesarecriticalforthecompany′sfinancialsustainabilityandgrowth[58].−ThecompanyisindiscussionswiththeFDAregardingapost−marketingcommitmentclinicaltrialforGimotitoassessdoseproportionalityforalowerdosestrength[74].−ThecompanyexpectstoincurexpensesrelatedtothecommercializationofGimoti,includingapost−marketingPKclinicaltrial[87].MarketImpactandPatientOutcomes−AstudyindicatedthatdiabeticgastroparesispatientsusingGimotihadreducedhealthcarecostsbyapproximately6,500[86]. Product Development and Market Strategy - The company launched commercial sales of Gimoti in October 2020, with modest sales generated to date[60]. - Future product development and commercialization strategies are critical for the company's financial sustainability and growth[58]. - The company is in discussions with the FDA regarding a post-marketing commitment clinical trial for Gimoti to assess dose proportionality for a lower dose strength[74]. - The company expects to incur expenses related to the commercialization of Gimoti, including a post-marketing PK clinical trial[87]. Market Impact and Patient Outcomes - A study indicated that diabetic gastroparesis patients using Gimoti had reduced healthcare costs by approximately 15,000 over six months compared to those using oral metoclopramide[59]. - A study presented at ACG 2024 showed that all-cause emergency department visits decreased by 55% for patients using nasal metoclopramide compared to those using oral metoclopramide[67]. - Approximately 34% of filled prescriptions for Gimoti were covered by Medicare and Medicaid programs for the nine months ended September 30, 2024[66]. - The ASPN platform has improved the proportion of prescriptions covered by insurance payors through enhanced patient communication and electronic automation[65]. - New prescribers increased by 8% during the quarter ended September 30, 2024[65]. Cost of Goods Sold - The cost of goods sold for the three months ended September 30, 2024, increased by approximately 69,116,a19869,116, a 198% change compared to the same period in 2023[79]. - Cost of goods sold rose by approximately 0.1 million for the nine months ended September 30, 2024, primarily due to stability testing completion timing[82].