8-K: FibroGen Terminates Key License Agreement, Licenses Anti-CCR8 and Anti-Gal-9 IP to HiFiBiO with Royalty Potential

FibroGen, Inc. has terminated its 2021 Exclusive License and Option Agreement with HiFiBiO Inc., simultaneously licensing its anti-CCR8 and anti-Gal-9 intellectual property to HiFiBiO in exchange for potential future royalties and revenue shares.

Summary

• On June 12, 2025, FibroGen, Inc. (FibroGen) entered into a Termination, Asset Transfer and License Agreement (the Agreement) with HiFiBiO Inc. (HiFiBiO).
• This new Agreement formally terminates the Exclusive License and Option Agreement between the parties, originally dated June 16, 2021, and amended on February 14, 2024.
• All rights and obligations of FibroGen under the original License Agreement have ceased, subject to certain survival terms.
• Under the new Agreement, FibroGen has licensed its anti-CCR8 and anti-Gal-9 intellectual property, including Gal-9 (FG-3165) and CCR8 (FG-3175) assets, to HiFiBiO.
• FibroGen is eligible to receive a mid single-digit to low double-digit share of HiFiBiO's license revenues if HiFiBiO sublicenses Gal-9 and/or CCR8 assets.
• FibroGen is also eligible for a low double-digit share of HiFiBiO's commercial royalties from sublicensing.
• If HiFiBiO commercializes either asset directly, FibroGen has the potential to receive single-digit royalties based upon worldwide net sales.

Sentiment

Score: 6

Explanation: The sentiment is moderately positive. While the termination of a prior agreement could be seen as a setback, the new licensing deal allows FibroGen to potentially generate future revenue from assets without ongoing R&D costs, which is a favorable outcome for intellectual property that may not be central to their current strategic focus.

Positives

• FibroGen has monetized its anti-CCR8 and anti-Gal-9 intellectual property without incurring further development costs.
• The agreement provides a potential future revenue stream through royalties and revenue shares from HiFiBiO's efforts.
• It allows FibroGen to streamline its pipeline and focus resources on other core assets.

Negatives

• FibroGen is no longer directly developing the anti-CCR8 and anti-Gal-9 assets, potentially indicating a strategic shift away from these programs or challenges in their prior development.
• Future revenue is contingent on HiFiBiO's success in sublicensing or commercializing the assets, introducing an element of uncertainty.
• The termination of the prior agreement could imply that the initial collaboration did not yield the expected results for FibroGen.

Risks

• FibroGen's ability to generate revenue from these assets is now entirely dependent on HiFiBiO's strategic decisions and commercial success.
• The actual amount of future royalties or revenue shares is uncertain and may be minimal if HiFiBiO does not successfully sublicense or commercialize the assets.
• The termination of the original agreement could be perceived negatively by investors if it suggests a lack of progress or viability for the terminated programs under FibroGen's direct control.

Future Outlook

FibroGen's future outlook for the anti-CCR8 and anti-Gal-9 assets is now tied to HiFiBiO's success in developing, sublicensing, or commercializing these programs, potentially providing FibroGen with non-dilutive revenue streams in the future.

Management Comments

• John Alden, General Counsel of FibroGen, signed the report on behalf of the company, indicating the official nature of the termination and new licensing agreement.

Industry Context

It is common in the biotechnology and pharmaceutical industries for companies to license out intellectual property or terminate agreements for non-core assets. This allows the licensor to potentially gain future revenue without the significant R&D investment, while the licensee can focus on specific therapeutic areas or development stages. This move by FibroGen suggests a strategic portfolio optimization, focusing on its core pipeline while still retaining a financial interest in these divested assets.

Comparison to Industry Standards

• The royalty and revenue share structures (mid single-digit to low double-digit for license revenues/commercial royalties and single-digit for net sales) are within the typical range for early-stage or non-core asset licensing deals in the biopharmaceutical industry, where the licensor retains a passive financial interest.

Stakeholder Impact

• Shareholders: Potential for future non-dilutive revenue streams from the licensed assets, which could positively impact long-term value if HiFiBiO succeeds.
• Employees: No direct impact mentioned, but strategic shifts can influence resource allocation.
• Customers/Suppliers: No direct impact mentioned.

Next Steps

• FibroGen will monitor HiFiBiO's progress in sublicensing or commercializing the anti-CCR8 and anti-Gal-9 assets to realize potential future royalty and revenue share payments.

Key Dates

Recommendation

Keywords

FibroGen, HiFiBiO, License Agreement, Termination, Intellectual Property, anti-CCR8, anti-Gal-9, FG-3165, FG-3175, Biotechnology, Pharmaceutical, Royalties, Asset Transfer