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Sunshine Biopharma(SBFM) - 2024 Q4 - Annual Report
SBFMSunshine Biopharma(SBFM)2025-04-01 21:05

Market Presence and Product Offerings - Sunshine Biopharma currently has 70 generic prescription drugs on the market in Canada and 64 additional drugs in its pipeline, with 13 anticipated launches during the remainder of 2025[20][22]. - The Canadian generic drugs market is valued at approximately 9.7billionannually,providingsignificantgrowthopportunitiesforSunshineBiopharma[23].−SunshineBiopharmaowns200DrugIdentificationNumbers(DINs)forprescriptiondrugsinCanada,securedthroughin−licensesorcross−licensesfrominternationalmanufacturers[34].−SunshineBiopharma′ssubsidiary,NoraPharma,hasrightstosell10genericprescriptiondrugsinCanadathroughdistributionagreements,receivingapercentageofsales[34].−Thecompany’sgenericdrugsaresoldprimarilyinCanada,specificallyinQuebec,Ontario,Alberta,andBritishColumbia[43].−Thecompany’sOTCproductsaresoldintheU.S.andCanadathroughAmazon.comandAmazon.ca[44].−TheCanadianfederalgovernmenthasallocated9.7 billion annually, providing significant growth opportunities for Sunshine Biopharma[23]. - Sunshine Biopharma owns 200 Drug Identification Numbers (DINs) for prescription drugs in Canada, secured through in-licenses or cross-licenses from international manufacturers[34]. - Sunshine Biopharma's subsidiary, Nora Pharma, has rights to sell 10 generic prescription drugs in Canada through distribution agreements, receiving a percentage of sales[34]. - The company’s generic drugs are sold primarily in Canada, specifically in Quebec, Ontario, Alberta, and British Columbia[43]. - The company’s OTC products are sold in the U.S. and Canada through Amazon.com and Amazon.ca[44]. - The Canadian federal government has allocated 1.5 billion CAD for the Pharmacare Act, which is expected to enhance the market for generic drugs, aligning with Sunshine Biopharma's focus[150]. - The updated generic pricing agreement effective October 1, 2023, is valid for three years, with an option to extend for an additional two years, providing pricing stability for the company's products[150]. Research and Development - The company is developing two proprietary drugs: K1.1 mRNA for liver cancer and SBFM-PL4, a protease inhibitor for SARS Coronavirus, both currently in animal testing[24][27]. - K1.1 mRNA has shown effectiveness in reducing liver cancer tumor sizes in xenograft mice, with ongoing studies to confirm these results[26]. - The lead compound for SBFM-PL4 has demonstrated antiviral activity against SARS-CoV-2 and favorable pharmacokinetics, with significant reductions in virus load in infected animals[31]. - The company has filed multiple patent applications, including for mRNA molecules capable of destroying cancer cells and small molecules inhibiting Coronavirus proteases, with priority dates dating back to May 2020[32][33]. - Sunshine Biopharma is developing proprietary drugs including K1.1 mRNA for liver cancer and SBFM-PL4 for Coronavirus infections, indicating ongoing investment in R&D[151]. Financial Performance - Revenues for the fiscal year ended December 31, 2024, were 34,874,283,anincreaseofapproximately34,874,283, an increase of approximately 10.8 million from 24,092,787in2023,drivenbyexpandedsaleseffortsinQuebecandentryintoOntario,Alberta,andBritishColumbia[123].−Thecostofsalesfor2024was24,092,787 in 2023, driven by expanded sales efforts in Quebec and entry into Ontario, Alberta, and British Columbia[123]. - The cost of sales for 2024 was 24,204,489 (69.4% of revenues), compared to 15,753,616(65.415,753,616 (65.4%) in 2023, reflecting a 4% increase due to higher professional allowances for sales outside Quebec[123]. - General and administrative expenses increased to 16,481,915 in 2024 from 13,124,470in2023,ariseof13,124,470 in 2023, a rise of 3,357,445 associated with the expansion of sales operations[124]. - The net loss for the year ended December 31, 2024, was 5,134,116,comparedtoanetlossof5,134,116, compared to a net loss of 4,506,044 for the year ended December 31, 2023[125]. - The company has not paid any dividends and does not anticipate paying dividends in the foreseeable future, opting to retain earnings for future expansion[99]. - The company reported a net loss of 5,134,116for2024,comparedtoanetlossof5,134,116 for 2024, compared to a net loss of 4,506,044 in 2023[144]. - The company raised 8,522,411fromapublicofferingin2024,comparedto8,522,411 from a public offering in 2024, compared to 4,089,218 in 2023, which is an increase of approximately 108%[147]. Operational Challenges - The company faces intense competition in the generic pharmaceuticals market, with over 35 active players, where the top 3 hold approximately 50% market share[45]. - The company has incurred losses and may never achieve profitability, relying primarily on sales of generic pharmaceutical products[53]. - The company requires significant additional funding for operations and may not be able to raise funds on favorable terms[62]. - The company’s proprietary drug candidates may never receive required regulatory approval, impacting future revenue generation[60]. - The company relies heavily on Dr. Steve N. Slilaty for strategic and operational management, and his departure could significantly delay research and development efforts[65]. - The company faces potential product liability risks, which could lead to decreased cash reserves and a significant drop in stock price if successful claims are made against it[66]. - The company is subject to regulations regarding hazardous materials, and violations could result in substantial fines or damage claims, adversely affecting financial condition and operations[68]. - The company may struggle to establish sales and marketing capabilities for its non-generic pharmaceutical operations, limiting its ability to generate revenues[70]. - Competition from larger pharmaceutical companies with greater resources poses a significant threat to the company's market position and profitability[79]. - The company may experience delays in clinical trials due to various factors, which could increase development costs and hinder revenue generation[75]. - Rising costs of raw materials and supply chain disruptions have been observed, with expectations of continued upward pressure through fiscal 2024[88]. - The company does not currently have a pollution and remediation insurance policy, which could expose it to significant liabilities related to environmental regulations[68]. - The company may face challenges in recruiting and retaining qualified personnel, which could impact its operational capabilities and growth[85]. Assets and Liabilities - As of December 31, 2024, the company had cash and cash equivalents of 9,686,529,adecreasefrom9,686,529, a decrease from 16,292,347 in 2023[143]. - Total assets increased to 30,560,392in2024from30,560,392 in 2024 from 27,346,961 in 2023, driven by growth in current and long-term assets[143]. - The total shareholders' equity rose to 23,500,754in2024,upfrom23,500,754 in 2024, up from 21,207,361 in 2023, indicating improved financial stability[143]. - The company had cash and cash equivalents of 9,686,529attheendof2024,downfrom9,686,529 at the end of 2024, down from 16,292,347 at the end of 2023, reflecting a decrease of about 40%[157]. - Sunshine Biopharma's accounts receivable increased to 3,868,418in2024from3,868,418 in 2024 from 2,552,362 in 2023, marking a growth of approximately 52%[155]. - The company completed a public offering in February 2024, raising net proceeds of 8,522,411fromtheissuanceof35,714sharesofcommonstock[127].−Thecompanycompleteda1−for−100reversestocksplitonApril17,2024,followedbya1−for−20reversestocksplitonAugust8,2024[199].Acquisitions−TheCompanyacquiredNoraPharmaInc.foratotalconsiderationof8,522,411 from the issuance of 35,714 shares of common stock[127]. - The company completed a 1-for-100 reverse stock split on April 17, 2024, followed by a 1-for-20 reverse stock split on August 8, 2024[199]. Acquisitions - The Company acquired Nora Pharma Inc. for a total consideration of 18,860,637, which included 14,346,637incashand3,700,000sharesvaluedat14,346,637 in cash and 3,700,000 shares valued at 4,514,000[187]. - The allocation of the purchase price for Nora Pharma included 1,358,121inaccountsreceivable,1,358,121 in accounts receivable, 3,181,916 in inventory, and 18,326,719ingoodwill[188].−TheCompanyanticipatespayingaremainingearnoutbalanceof18,326,719 in goodwill[188]. - The Company anticipates paying a remaining earnout balance of 479,208 CAD ($295,797 USD) in April 2025, related to Nora Pharma's performance[189].