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Sunshine Biopharma(SBFM) - 2023 Q4 - Annual Report
SBFMSunshine Biopharma(SBFM)2024-03-28 20:05

Company Overview - Sunshine Biopharma operates two wholly owned subsidiaries: Nora Pharma, which has 52 prescription drugs on the market in Canada, and Sunshine Biopharma Canada, which develops and sells OTC supplements[17]. - The company has 32 additional drugs scheduled for launch in 2024 and 2025, targeting various health areas including cardiovascular, oncology, and diabetes[24]. - Sunshine Biopharma aims to strengthen its presence in the Canadian 9.7billiongenericdrugsmarketwiththeadditionofnewproducts[25].−NoraPharmaoperatesina23,500squarefootfacilityandemploys44staffmembers,contributingtothecompany′soperationalcapacity[22].−SunshineBiopharma′sOTCproductsaresoldintheU.S.andCanadathroughAmazonplatforms,enhancingmarketreach[43].ProprietaryDrugDevelopment−TheproprietarydrugdevelopmentprogramincludesK1.1mRNAforlivercancer,SBFM−PL4forSARSCoronavirus,andAdva−27aforpancreaticcancer,withAdva−27a′sdevelopmentcurrentlypausedduetounfavorableresults[18][26].−TheK1.1mRNAprojecthasshowneffectivenessinreducinglivercancertumorsizesinxenograftmicestudies,withfurtherexperimentsplanned[30].−Thecompanyhasfiledmultiplepatentapplications,includingforanewtreatmentforCoronavirusinfectionsandmRNAmoleculescapableofdestroyingcancercells[36][37].−SunshineBiopharmaisdevelopingproprietarydrugs,includingK1.1mRNAforlivercancerandSBFM−PL4forCoronavirusinfections,withIND−enablingstudiesforAdva−27apausedduetounfavorableresults[155].FinancialPerformance−Thecompanyhasanaccumulateddeficitof9.7 billion generic drugs market with the addition of new products[25]. - Nora Pharma operates in a 23,500 square foot facility and employs 44 staff members, contributing to the company's operational capacity[22]. - Sunshine Biopharma's OTC products are sold in the U.S. and Canada through Amazon platforms, enhancing market reach[43]. Proprietary Drug Development - The proprietary drug development program includes K1.1 mRNA for liver cancer, SBFM-PL4 for SARS Coronavirus, and Adva-27a for pancreatic cancer, with Adva-27a's development currently paused due to unfavorable results[18][26]. - The K1.1 mRNA project has shown effectiveness in reducing liver cancer tumor sizes in xenograft mice studies, with further experiments planned[30]. - The company has filed multiple patent applications, including for a new treatment for Coronavirus infections and mRNA molecules capable of destroying cancer cells[36][37]. - Sunshine Biopharma is developing proprietary drugs, including K1.1 mRNA for liver cancer and SBFM-PL4 for Coronavirus infections, with IND-enabling studies for Adva-27a paused due to unfavorable results[155]. Financial Performance - The company has an accumulated deficit of 63,905,658 as of December 31, 2023, with a net loss of 4,506,044fortheyearendedDecember31,2023,andanetlossof4,506,044 for the year ended December 31, 2023, and a net loss of 26,744,440 for the year ended December 31, 2022[56]. - Revenues for the fiscal year ended December 31, 2023, were 24,092,787,asignificantincreasefrom24,092,787, a significant increase from 4,345,603 in 2022, primarily due to twelve months of Nora Pharma sales included in 2023 results[121]. - The net loss for the year ended December 31, 2023, was 4,506,044,animprovementcomparedtoanetlossof4,506,044, an improvement compared to a net loss of 26,744,440 in 2022[123]. - The company reported total assets of 27,346,961asofDecember31,2023,downfrom27,346,961 as of December 31, 2023, down from 29,243,848 in 2022, indicating a decrease in overall financial position[144]. - The balance of accumulated deficit increased to 63,905,658asofDecember31,2023,comparedto63,905,658 as of December 31, 2023, compared to 59,399,614 in 2022, indicating ongoing financial challenges[148]. - Sunshine Biopharma's total shareholders' equity decreased to 21,207,361in2023from21,207,361 in 2023 from 21,627,570 in 2022, reflecting the impact of net losses on equity[148]. Market and Competition - The Canadian generic pharmaceuticals market was valued at approximately 9.7billionUSDin2023,withgenericcompaniesproducingover709.7 billion USD in 2023, with generic companies producing over 70% of prescribed medicines[51]. - The company faces intense competition in the generic drug market, which may lead to price declines and affect profitability[61]. - Competition from larger pharmaceutical companies poses a significant threat; they may develop more effective or cost-efficient products[86]. Regulatory and Legal Risks - The company is subject to significant regulatory requirements that could delay or prevent the commercialization of its drug candidates[70]. - The company has not made any filings with the FDA or other regulatory bodies for its proprietary drug candidates as of the date of the report[47]. - Company may face significant legal expenses and management distraction due to potential litigation, which could adversely affect business operations and cash flow[71]. Funding and Capital Needs - The company will require significant additional funding to satisfy future capital needs, which may not be available on favorable terms[67]. - The company has no committed sources of capital and may face challenges in raising additional funds on acceptable terms[129]. - The company completed a private placement on May 16, 2023, raising approximately 5 million in gross proceeds, with net proceeds of about 4.1million[126].OperationalChallenges−Theabilitytocommercializepharmaceuticalproductcandidatesdependsonthird−partymanufacturers,andanyfailureinmanufacturingcapacitycoulddelayproductlaunches[76].−Establishingsalesandmarketingcapabilitiesfornon−genericpharmaceuticalsiscrucial;failuretodosomayseverelylimitrevenuegeneration[77].−Supplychaindisruptionsfromserviceprovidersandsupplierscouldadverselyaffectoperationalresultsandleadtolossofsales[95].ShareholderInformation−ThecommonstockislistedontheNasdaqCapitalMarket,withatotalof99,452,865sharesissuedandoutstandingasofMarch28,2024[116].−Thecompanyhasdeclarednodividendssinceinception,maintainingafocusonreinvestmentandgrowth[207].−Thecompanyissued10,793,369sharesofcommonstockinconnectionwithwarrantexercises,generatingaggregatenetproceedsof4.1 million[126]. Operational Challenges - The ability to commercialize pharmaceutical product candidates depends on third-party manufacturers, and any failure in manufacturing capacity could delay product launches[76]. - Establishing sales and marketing capabilities for non-generic pharmaceuticals is crucial; failure to do so may severely limit revenue generation[77]. - Supply chain disruptions from service providers and suppliers could adversely affect operational results and lead to loss of sales[95]. Shareholder Information - The common stock is listed on the Nasdaq Capital Market, with a total of 99,452,865 shares issued and outstanding as of March 28, 2024[116]. - The company has declared no dividends since inception, maintaining a focus on reinvestment and growth[207]. - The company issued 10,793,369 shares of common stock in connection with warrant exercises, generating aggregate net proceeds of 13,196,681 in 2022 and 2023[205]. Tax and Deferred Tax Assets - The Company's effective tax rate is -9.62%, with a pre-tax book income of (826,953)andvariousadjustmentsimpactingtherate[215].−Netdeferredtaxassetstotal(826,953) and various adjustments impacting the rate[215]. - Net deferred tax assets total 176,764, while net deferred tax liabilities amount to (225,491),resultinginanetdeferredtaxliabilityof(225,491), resulting in a net deferred tax liability of (48,727)[215]. - The Company has deferred tax assets related to net operating loss, credits, and carryforwards amounting to $5,277,829[215].