Kyntra Bio, Inc 8-K, filed Jul 10, 2020
Kyntra Bio, Inc. (KYNB)
About this 8-K
Kyntra Bio, Inc filed this 8-K on July 10, 2020, reporting on events of July 8, 2020.
Items reported
- Item 1.01: Entered into a material agreement
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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FibroGen, Inc.
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Item 1.01 |
Entry into a Material Definitive Agreement. |
On July 8, 2020, FibroGen China Anemia Holdings, Ltd., FibroGen (China) Medical Technology Development Co., Ltd. (“FibroGen Beijing”), and FibroGen International (Hong Kong) Limited (collectively, “FibroGen China”) and AstraZeneca AB (“AstraZeneca”, and together with FibroGen China, the “Parties”) entered into an amendment, effective July 1, 2020, to the Amended and Restated License, Development and Commercialization Agreement effective as of July 30, 2013 (the “China Agreement”), relating to the development and commercialization of roxadustat in China (the “Amendment”).
The Amendment provides for the establishment of a jointly owned entity (the “Distribution Entity”) that will perform roxadustat distribution, as well as conduct sales and marketing through AstraZeneca. FibroGen Beijing will continue to hold all of the regulatory licenses issued by China regulatory authorities and will continue to be primarily responsible for regulatory, clinical, manufacturing, medical affairs and pharmacovigilance.
While the responsibilities of the Parties under the China Agreement remain largely the same, and the Parties will continue to share equally in the economics resulting from roxadustat operations in China, certain changes are being made. With effect from April 1, 2020, the Parties have changed the method under which commercial expenses are billed, and the collaboration has been adjusted to more fully account for the cost of manufacturing. AstraZeneca’s sales and marketing costs billed to the joint venture are now subject to an annual cap at a percentage of net sales, until they have been fully reimbursed for their costs, at which point AstraZeneca will invoice based on actual costs. FibroGen Beijing will now manufacture and supply commercial product to the joint venture, at a percentage of net sales and such percentage will be subject to a cap.
Once the Distribution Entity is fully operational, FibroGen will recognize revenue based on its sales to the Distribution Entity. AstraZeneca is expected to consolidate the Distribution Entity, and recognize revenue based on sales to customers. The Amendment better aligns the Parties’ interests and is expected to enable profitability for roxadustat commercialization in China at an earlier point in time.
In addition, AstraZeneca’s right to share in the economic benefits of the collaboration will largely continue to be deferred until certain measures of profitability have been met, but will no longer be subject to a minimum cash level at FibroGen Beijing.
Development costs will continue to be shared 50/50 between the Parties.
The Parties are concurrently amending the Amended and Restated License, Development and Commercialization Agreement for roxadustat for the U.S. and all other countries not previously licensed to Astellas Pharma, effective as of July 13, 2013 (such amendment, together with the Amendment, the “Amendments”) to reflect minor changes in the governance structure under the China Agreement.
The foregoing description of the Amendments is not a complete description thereof, and is qualified in its entirety by reference to the full text of the Amendments, which will be filed with the Securities and Exchange Commission as exhibits to FibroGen, Inc.’s Quarterly Report on Form 10-Q for the quarter ending June 30, 2020.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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FIBROGEN, INC. |
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Dated: July 10, 2020 |
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By: |
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/s/ Michael Lowenstein |
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Michael Lowenstein |
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Chief Legal Officer |