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Viking Therapeutics(VKTX) - 2024 Q4 - Annual Report
VKTXViking Therapeutics(VKTX)2025-02-26 21:32
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Financial Performance - The company has not generated any revenue to date and does not expect to until regulatory approval and commercialization of drug candidates [386]. - The company has incurred operating losses since inception and has not generated any revenues to date [410]. - In 2024, the net cash used in operating activities was 87.8million,anincreaseof19.587.8 million, an increase of 19.5% from 73.4 million in 2023 [422][423]. - The net cash used in investing activities in 2024 was 553.4million,significantlyhigherthan553.4 million, significantly higher than 179.1 million in 2023, primarily due to investments of 1.1billion[424].−In2024,netcashprovidedbyfinancingactivitieswas1.1 billion [424]. - In 2024, net cash provided by financing activities was 612.5 million, a substantial increase from 271.4millionin2023,mainlyfromcommonstockissuance[425][426].−Thecompanyanticipatescontinuedlossesintheforeseeablefutureasitdevelopsdrugcandidatesandseeksregulatoryapprovals,necessitatingadditionalcapital[427].−Thecompanyplanstofinancefuturecashneedsthroughpublicorprivateequityordebtofferings,butavailabilityonacceptabletermsisuncertain[427].−AsofDecember31,2024,cashandcashequivalentsdecreasedto271.4 million in 2023, mainly from common stock issuance [425][426]. - The company anticipates continued losses in the foreseeable future as it develops drug candidates and seeks regulatory approvals, necessitating additional capital [427]. - The company plans to finance future cash needs through public or private equity or debt offerings, but availability on acceptable terms is uncertain [427]. - As of December 31, 2024, cash and cash equivalents decreased to 26.7 million from 55.5millionin2023,whileshort−terminvestmentsincreasedto55.5 million in 2023, while short-term investments increased to 875.9 million from 306.6million[432].−Thetotalcashandcashequivalentsandshort−terminvestmentscombinedamountedto306.6 million [432]. - The total cash and cash equivalents and short-term investments combined amounted to 902.6 million as of December 31, 2024, compared to 362.1millionin2023[432].ResearchandDevelopment−Thecompanyincurred362.1 million in 2023 [432]. Research and Development - The company incurred 101.6 million in research and development expenses for the year ended December 31, 2024, compared to 63.8millionin2023,reflectingasignificantincreaseofapproximately5963.8 million in 2023, reflecting a significant increase of approximately 59% [387]. - Research and development expenses increased to 101,644,000 in 2024 from 63,806,000in2023,representinga59.363,806,000 in 2023, representing a 59.3% increase [402]. - Research and development expenses were primarily driven by increased manufacturing costs, stock-based compensation, and salaries, despite a decrease in clinical study expenses [403]. - The Phase 2 VENTURE study of VK2735 demonstrated statistically significant mean body weight reductions of up to 14.7% from baseline after 13 weeks, with a 13.1% reduction compared to placebo [372]. - The Phase 1 clinical trial of VK2735's oral formulation showed dose-dependent mean body weight reductions of up to approximately 5.3% after 28 days [373]. - The VOYAGE study for VK2809 achieved its primary endpoint, with significant reductions in liver fat content from baseline to Week 12 compared to placebo [379]. - In the VOYAGE study, up to 75% of VK2809-treated patients achieved NASH/MASH resolution with no worsening of fibrosis, compared to 29% for placebo (p=0.0001) [380]. - The company plans to initiate Phase 3 clinical studies of VK2735 in the first half of 2025 based on FDA feedback [372]. - The company aims to pursue partnering or licensing opportunities for VK0214 prior to conducting additional clinical studies [383]. Administrative Expenses - General and administrative expenses are expected to continue increasing due to hiring, stock-based compensation, and compliance costs associated with being a public company [390]. - General and administrative expenses rose to 49,277,000 in 2024 from 37,021,000in2023,a33.137,021,000 in 2023, a 33.1% increase [404]. Financing Activities - The company completed an underwritten public offering in April 2023, raising gross proceeds of 287.5 million by selling 19,828,300 shares at 14.50pershare[415].−InMarch2024,thecompanycompletedanotherpublicoffering,raisingnetproceedsof14.50 per share [415]. - In March 2024, the company completed another public offering, raising net proceeds of 597.1 million by selling 7,441,650 shares at 85.00pershare[418].−AstockrepurchaseprogramwasauthorizedinFebruary2025,allowingthecompanytobuybackupto85.00 per share [418]. - A stock repurchase program was authorized in February 2025, allowing the company to buy back up to 250 million in shares over two years [419]. - The company has entered into an At-The-Market Equity Offering Sales Agreement with a potential offering price of up to 200millionunderthe2023ShelfRegistrationStatement[417].InvestmentPortfolio−TheinvestmentportfolioisprimarilycomposedofU.S.governmentsecurities,investment−gradecorporatebonds,andmoneymarketfunds,withnotradingpurposes[429][430].−Ahypothetical100basispointchangeininterestrateswouldaffectinterestincomebyapproximately200 million under the 2023 Shelf Registration Statement [417]. Investment Portfolio - The investment portfolio is primarily composed of U.S. government securities, investment-grade corporate bonds, and money market funds, with no trading purposes [429][430]. - A hypothetical 100 basis point change in interest rates would affect interest income by approximately 0.9 million in 2024 and 0.3millionin2023[431].−Otherincome,netincreasedsignificantlyto0.3 million in 2023 [431]. - Other income, net increased significantly to 40,958,000 in 2024 from $14,932,000 in 2023, marking a 174.3% increase [407].