Sunshine Biopharma (SBFM) risk factors, FY2024 10-K

Sunshine Biopharma's FY2024 10-K, filed Apr 01, 2025, lists 12 risk factors in 2 groups. There is no earlier 10-K to compare against, so the most company-specific risks are listed below.

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Risk factors listed
122 groups
Section length
6k wordsItem 1A

Sunshine Biopharma's biggest risks in the FY2024 10-K

  • Sunshine Biopharma relies heavily on lower-margin Canadian generic drugs through Nora Pharma while funding development of proprietary candidates.

The risks most specific to Sunshine Biopharma

  • Risks Related to Our Business

    We have incurred losses and may never achieve profitability

    We accumulated a deficit of $69,084,565 as of December 31, 2024, and suffered a net loss of $5,178,907 for the year.

  • Risks Related to Our Business

    We are subject to the significant risks associated with the generic pharmaceutical business

    Our revenues depend primarily on sales of lower-profit generic pharmaceuticals in Canada via Nora Pharma.

  • Risks Related to Our Business

    Sales of our generic products may be adversely affected by the drug regulatory environment in Canada

    Canadian government pricing pressures and retail pharmacy buying fluctuations can reduce our generic product sales.

  • Risks Related to Our Business

    We may experience delays in launching our new generic products

    Delays in launching new generic products can fail to offset price erosion on existing drugs from competing approvals.

  • Risks Related to Our Business

    We may not receive required regulatory approval for any of our non-generic pharmaceutical product candidates

    We have not received FDA approval for any proprietary non-generic drug candidates and require extensive clinical trials.

  • Risks Related to Our Business

    We will require additional funding to satisfy our future capital needs, which may not be available

    We will need significant additional funding for preclinical and clinical testing because sales revenues remain insufficient.

  • Risks Related to Our Business

    Our manufacturing and third-party fulfillment activities are subject to certain risks

    We depend entirely on third-party manufacturing facilities in Canada and overseas for product fulfillment.

  • Risks Related to Our Common Stock

    Our common stock currently trades on Nasdaq, where it is subject to various listing requirements

    We faced Nasdaq delisting after our common stock closing bid price dropped to $0.10 or less.

  • Risks Related to Our Common Stock

    On September 9, 2024, we received a letter from Nasdaq confirming that we had regained compliance with the bid price requirement in Listing Rule 5550(a)(2) (the “Bid Price Rule”), as required by the Panel’s decision dated June 28, 2024

    We regained Nasdaq compliance but are subject to a Mandatory Panel Monitor for one year.

All 12 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Business

  1. 01We have incurred losses and may never achieve profitability
  2. 02We are subject to the significant risks associated with the generic pharmaceutical business
  3. 03Sales of our generic products may be adversely affected by the drug regulatory environment in Canada
  4. 04We may experience delays in launching our new generic products
  5. 05We may not receive required regulatory approval for any of our non-generic pharmaceutical product candidates
  6. 06We will require additional funding to satisfy our future capital needs, which may not be available
  7. 07A significant or prolonged economic downturn could have a material adverse effect on our results of operations
  8. 08Our business is subject to the effects of adverse publicity, which could negatively affect our sales and revenues
  9. 09Our manufacturing and third-party fulfillment activities are subject to certain risks

Risks Related to Our Common Stock

  1. 10Our common stock currently trades on Nasdaq, where it is subject to various listing requirements
  2. 11On September 9, 2024, we received a letter from Nasdaq confirming that we had regained compliance with the bid price requirement in Listing Rule 5550(a)(2) (the “Bid Price Rule”), as required by the Panel’s decision dated June 28, 2024
  3. 12We do not intend to pay dividends on our common stock for the foreseeable future

Other Sunshine Biopharma 10-Ks

  • FY2025 10-K risk factors
    12 risks2 new2 dropped3 reworded

    Accumulated deficit grew to $75,015,126 alongside ongoing net losses. Supplier concentration increased with 75% of drug portfolio manufactured by three overseas suppliers. Nasdaq compliance remains precarious despite trading slightly above the $1.00 minimum bid price.

    Filed Apr 03, 2026

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.