Sunshine Biopharma, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Sunshine Biopharma, Inc. has filed its 2023 annual report (10-K) detailing its operations and financial standing for the fiscal year ending December 31, 2023.</b>

AI Summary

Sunshine Biopharma, Inc (SBFMW) filed a Annual Report (10-K) with the SEC on March 28, 2024. Sunshine Biopharma, Inc. filed its 2023 Form 10-K on March 28, 2024. The filing covers the fiscal year ended December 31, 2023. The company's principal business is pharmaceutical preparations. Sunshine Biopharma, Inc. was formerly known as Mountain West Business Solutions, Inc. The company's business address is in New York, NY.

Why It Matters

For investors and stakeholders tracking Sunshine Biopharma, Inc, this filing contains several important signals. This 10-K filing provides a comprehensive overview of Sunshine Biopharma's financial performance, strategic initiatives, and risk factors for the fiscal year 2023, crucial for investors to assess the company's current health and future prospects. The filing includes detailed financial statements and disclosures, offering insights into revenue streams, operational expenses, and any significant changes in the company's capital structure or debt levels, which are vital for investment decisions.

Risk Assessment

Risk Level: — Sunshine Biopharma, Inc shows moderate risk based on this filing. The company's financial performance and future viability are subject to the inherent risks of the pharmaceutical industry, including regulatory hurdles, clinical trial outcomes, and market competition, as detailed in the risk factors section of the 10-K.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Sunshine Biopharma's operational performance and potential challenges in the pharmaceutical sector.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-28 — Filing Date (Date of submission)
• 001-41282 — SEC File Number (Company's SEC file number)

Key Players & Entities

• Sunshine Biopharma, Inc. (company) — Filer name
• Mountain West Business Solutions, Inc (company) — Former company name
• New York (location) — Business address city
• 2024-03-28 (date) — Filing date
• 2023-12-31 (date) — Fiscal year end

FAQ

Industry Context

Sunshine Biopharma operates within the pharmaceutical preparations industry, which is characterized by extensive research and development, stringent regulatory oversight, and significant market competition.

Regulatory Implications

As a pharmaceutical company, Sunshine Biopharma is subject to regulations from bodies like the FDA, governing drug development, manufacturing, and marketing. Compliance with these regulations is critical for market access and product approval.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management's discussion and analysis.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing the company.
3. Compare the company's performance in fiscal year 2023 with previous years to identify trends and assess progress.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K filing.
• 2024-03-28: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This filing is the annual report for fiscal year 2023, providing updated financial and operational information compared to previous filings.

Key Financial Figures

• $0.001 — ch registered Common Stock, par value $0.001 Warrants SBFM SBFMW Nasdaq Capi
• $9.7 billion — strengthen our presence in the Canadian $9.7 billion a year generic drugs market and provide

Filing Documents

• sunshine_i10k-123123.htm (10-K) — 899KB
• sunshine_ex2101.htm (EX-21.1) — 2KB
• sunshine_ex2301.htm (EX-23.1) — 2KB
• sunshine_ex3101.htm (EX-31.1) — 8KB
• sunshine_ex3102.htm (EX-31.2) — 8KB
• sunshine_ex3201.htm (EX-32.1) — 4KB
• sunshine_ex9701.htm (EX-97.1) — 50KB
• image_001.jpg (GRAPHIC) — 6KB
• image_002.jpg (GRAPHIC) — 7KB
• 0001683168-24-001818.txt (&nbsp;) — 4919KB
• sbfm-20231231.xsd (EX-101.SCH) — 40KB
• sbfm-20231231_cal.xml (EX-101.CAL) — 56KB
• sbfm-20231231_def.xml (EX-101.DEF) — 160KB
• sbfm-20231231_lab.xml (EX-101.LAB) — 347KB
• sbfm-20231231_pre.xml (EX-101.PRE) — 296KB
• sunshine_i10k-123123_htm.xml (XML) — 507KB

Forward Looking Statements

Forward Looking Statements ii PART I 1

Risk Factors

Item 1A. Risk Factors 7

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 17

Cybersecurity

Item 1C. Cybersecurity 17

Properties

Item 2. Properties 17

Legal Proceedings

Item 3. Legal Proceedings 17

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 17 PART II 18

Market for the Registrant's Common Equity Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for the Registrant's Common Equity Related Stockholder Matters and Issuer Purchases of Equity Securities 18

Reserved

Item 6. Reserved. 18

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 18

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 21

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 22

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 41

Controls and Procedures

Item 9A. Controls and Procedures 41

Other Information

Item 9B. Other Information 41

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. 41 PART III 42

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 42

Executive Compensation

Item 11. Executive Compensation 45

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 46

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 48

Principal Accounting Fees and Services

Item 14. Principal Accounting Fees and Services 48 PART IV 49

Exhibits, Financial Statement Schedules

Item 15. Exhibits, Financial Statement Schedules 50

Signatures

Signatures 51 DEFINED TERMS Unless the context requires otherwise, references to "Sunshine," "the Company," "we," "us" or "our" in this Form 10-K refer to Sunshine Biopharma, Inc. and its subsidiaries. The following are definitions for terms or abbreviations used in this Form 10-K: Adva-27a The laboratory designation of the Company's chemotherapy small molecule under development ASC Accounting Standards Codification ASU Accounting Standards Update issued by FASB CAD Canadian Dollar COSO Committee of Sponsoring Organizations of the Treadway Commission COVID-19 Novel coronavirus disease of 2019 DIN Drug Identification Number, an eight-digit number issued by Health Canada authorizing the sale of a drug in Canada EPS Earnings per share EUA Emergency Use Authorization FASB Financial Accounting Standards Board FDA U.S. Food and Drug Administration FDIC Federal Deposit Insurance Corporation FTC Federal Trade Commission G&A General and administrative GAAP Generally Accepted Accounting Principles GMP Good Manufacturing Practice GST Goods and Services Tax (Canada) Health Canada The Canadian drug regulatory body IND Investigational New Drug IT Information Technology LNP Lipid Nano Particle K1.1 mRNA The laboratory designation of the Company's mRNA based anticancer therapy under development MD&A

Management's Discussion and Analysis of Financial

Management's Discussion and Analysis of Financial Condition and Results of Operations MERS-CoV Middle East Respiratory Syndrome Coronavirus Mpro Coronavirus main protease mRNA Messenger ribonucleic acid NDA New Drug Application NOC A Notice of Compliance issued by Health Canada to a drug manufacturing facility Nora Pharma Nora Pharma Inc., a wholly-owned subsidiary of the Company acquired on October 20, 2022 NPN Natural Product Number, an eight-digit number issued by Health Canada authorizing the sale of a natural product or a supplement in Canada OTC Over-The-Counter pCPA pan-Canadian Pharmaceutical Alliance, an alliance of the provincial, territorial and federal governments that determines generic drugs pricing based on a percentage of the brand-name reference products PCT Patent Cooperation Treaty PLpro Coronavirus papain-like protease QST Quebec Sales Tax (Canada) R&D Research and Development ROU Right of Use SARS Coronavirus Severe Acute Respiratory Syndrome Coronavirus, the group of coronaviruses that includes SARS-CoV-2, MERS-CoV, and SARS-CoV SARS-CoV Severe Acute Respiratory Syndrome Coronavirus that first appeared in 2003 SARS-CoV-2 Severe Acute Respiratory Syndrome Coronavirus 2, the virus that causes COVID-19 SBFM-PL4 Laboratory designation of the Company's COVID-19 treatment under development SEC U.S. Securities and Exchange Commission SOC Security Operations Center street name Securities held in the name of a brokerage firm on behalf of a client Sunshine Canada Sunshine Biopharma Canada Inc., a wholly owned subsidiary of the Company U.S. United States of America USD U.S. Dollars. All applicable references in this report refer to US Dollars and not Canadian Dollars (CAD) unless otherwise specifically stated. i

FORWARD LOOKING STATEMENTS

FORWARD LOOKING STATEMENTS This Annual Report on Form 10-K contains forward-looking Securities Exchange Act of 1934, as amended, or the Exchange Act. The statements regarding Sunshine Biopharma Inc. contained in this Report that are not historical in nature, particularly those that utilize terminology such as "may," "will," "should," "likely," "expects," "anticipates," "estimates," "believes" or "plans," or comparable terminology, are forward-looking statements based on current expectations and assumptions, and entail various risks and uncertainties that could cause actual results to differ materially from those expressed in such forward-looking statements. Important factors known to us that could cause such material differences are identified in this Report. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable law. You are advised, however, to consult any future disclosures we make on related subjects in future reports to the SEC. ii PART I

BUSINESS

ITEM 1. BUSINESS About Sunshine Biopharma We are a pharmaceutical company offering and researching life-saving medicines in a wide variety of therapeutic areas, including oncology and antivirals. We operate two wholly owned subsidiaries: (i) Nora Pharma Inc. ("Nora Pharma"), a Canadian corporation with a portfolio consisting of 52 prescription drugs on the market in Canada, and (ii) Sunshine Biopharma Canada Inc. ("Sunshine Canada"), a Canadian corporation which develops and sells OTC supplements. In addition, we are conducting a proprietary drug development program which is comprised of (i) K1.1 mRNA targeted for liver cancer, (ii) SBFM-PL4, PLpro protease inhibitor for SARS Coronavirus infections, and (iii) Adva-27a for pancreatic cancer. Development of the latter has been paused pending further analysis of unfavorable in vitro results obtained in the second half of 2023. See "Drugs in Development," below. History We were incorporated in the State of Colorado on August 31, 2006, and on October 15, 2009, we acquired Sunshine Biopharma, Inc. in a transaction classified as a reverse acquisition. Sunshine Biopharma, Inc. held an exclusive license to a new anticancer drug bearing the laboratory name, Adva-27a (the "License Agreement"). Upon completion of the reverse acquisition transaction, we changed our name to Sunshine Biopharma, Inc. and began operating as a pharmaceutical company focusing on the development of the licensed Adva-27a anticancer drug. In December 2015, we acquired all worldwide issued (US Patent Number 8,236,935, and 10,272,065) and pending patents under PCT/FR2007/000697 and PCT/CA2014/000029 for the Adva-27a anticancer compound and terminated the License Agreement. Development of Adva-27a has been paused pending further analysis of unexpected in vitro results obtained in the latter part of 2023. See "Drugs in Development," below. In early 2020, we initiated a new R&D project focused on the development of a treatment for COVID-19 and on May

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