6-K
CollPlant Biotechnologies Ltd (CLGN)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,DC 20549
Form 6-K
REPORTOF FOREIGN PRIVATE ISSUER
PURSUANTTO RULE 13a-16 OR 15d-16UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of February 2021
Commission File Number 001-38370
CollPlantBiotechnologies Ltd.
(Exact name of registrant as specified in its charter)
4Oppenheimer St, Weizmann Science Park
Rehovot7670104, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulations S-T Rule 101(b)(7): ☐
This Report on Form 6-K (excluding Exhibit 99.1 and Exhibit 99.2) is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-229163 and 333-248479) and Form F-3 (File No. 333-229486, 333-228054 and 333-238731), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
On February 5, 2021, CollPlant Ltd. (“CollPlant”), a wholly-owned subsidiary of CollPlant Biotechnologies Ltd. (the “Company”), entered into a Development, Exclusivity and Option Products Agreement (the “Agreement”) with certain wholly-owned subsidiaries of AbbVie Inc. (collectively, “AbbVie”), pursuant to which CollPlant and AbbVie will collaborate in the development and commercialization of dermal and soft tissue filler products for the medical aesthetics market, using CollPlant’s recombinant human collagen (rhCollagen) technology.
Pursuant to the Agreement, CollPlant agreed to undertake projects for the development of an aseptic process for sterile rhCollagen that meets or exceeds certain specifications as set forth in the Agreement. Prior to the second anniversary of the Agreement, AbbVie may elect to have CollPlant undertake additional projects for the development of a more concentrated rhCollagen that meets or exceeds certain specifications.
Pursuant to the Agreement, CollPlant granted to AbbVie and its affiliates, worldwide exclusive rights to use its rhCollagen in combination with AbbVie proprietary technologies, for the production and commercialization of dermal and soft tissue filler products (the “Exclusive Products”). Further, pursuant to the Agreement, CollPlant granted to AbbVie and its affiliates, a right of first negotiation to enter into a definitive agreement to obtain exclusive, worldwide rights to the use of CollPlant rhCollagen for the commercialization and sale of an injectable breast implant product and a right of first negotiation to enter into a definitive agreement to obtain exclusive, worldwide rights to the use of CollPlant rhCollagen for the commercialization and sale of a photocurable dermal filler product (each an “Option Product” and together, the “Option Products”). Other than under the Agreement, CollPlant has agreed not to research, develop or commercialize its rhCollagen for use with any Exclusive Products during the term of the Agreement or grant any third party any rights to CollPlant’s rhCollagen technology that would conflict with rights granted to AbbVie.
The Agreement provides that later on CollPlant and AbbVie will enter into a supply agreement whereby CollPlant will manufacture and supply AbbVie with rhCollagen, at a pre-agreed price, to be used solely for the development and manufacture of the Exclusive Products and Option Products.
The Agreement provides that with respect to the Exclusive Products CollPlant shall be entitled to receive up to $50 million comprised of an upfront cash payment of $14 million and up to $36 million in proceeds upon the achievement of certain development, clinical trial, regulatory and commercial sale milestones. In addition, CollPlant shall be entitled to a fixed-fee royalty payment (subject to certain adjustments) for each product commercially sold during the applicable royalty term as well as a fee for the supply of rhCollagen to AbbVie. In addition, with respect to the Option Products, CollPlant shall be entitled to receive up to $53 million, as further described below, plus a fixed-fee royalty payment (subject to certain adjustments) for each product commercially sold during the applicable royalty term and a fee for the supply of rhCollagen to AbbVie. The $53 million in proceeds includes a one-time non-refundable payment of $6 million upon signing a definitive agreement with regard to the injectable breast implant product; a one-time non-refundable payment of $4 million for signing a definitive agreement with regard to the photocurable dermal filler product; and up to an additional $43 million payable upon the achievement of certain clinical trial, regulatory approval and commercial sale milestones.
Unless earlier terminated, the Agreement will continue in effect on a product-by-product and country-by-country basis until the later of (i) the expiration, invalidation or abandonment of the last CollPlant patent covering a product in a particular country, and (ii) 10 years from the first commercial sale of such product in such country. Following expiration (unless earlier terminated), the rights granted to AbbVie in the Agreement will continue on a non-exclusive, fully paid-up, royalty-free, perpetual and irrevocable basis. The Agreement may be terminated early by either party for material breach or bankruptcy. In addition, AbbVie may terminate the Agreement at any time immediately upon written notice to CollPlant if AbbVie reasonably believes that it is not advisable for AbbVie to continue to develop or commercialize the Exclusive Products under the Agreement as a result of a perceived serious safety issue regarding the use of any Exclusive Product or upon 60 days’ written notice, for any or no reason, with respect to its rights under the Agreement on an Exclusive Product-by-Exclusive Product or country-by-country basis.
On February 8, 2021, the Company issued a press release announcing entry into of the Agreement. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In addition, the Company has posted to its website an updated corporate presentation. A copy of the presentation is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
| Exhibit | |
|---|---|
| 99.1 | Press Release, dated February 8, 2021 |
| 99.2 | Corporate Presentation, dated February 8, 2021 |
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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, thereunto duly authorized.
| COLLPLANT BIOTECHNOLOGIES LTD. | |||
|---|---|---|---|
| Date: February 8, 2021 | By: | /s/<br> Eran Rotem | |
| Name: | Eran Rotem | ||
| Title: | Deputy CEO and Chief Financial Officer |
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Exhibit 99.1
CollPlant Announces Development and GlobalCommercialization Agreement with Allergan Aesthetics, an AbbVie company, for rhCollagen in Dermal and Soft Tissue Filler Products
Potential to receive up to$103 million in upfront and milestone payments, in addition to royalties and other payments
REHOVOT, Israel, February8, 2021 /PRNewswire/ — CollPlant Biotechnologies (NASDAQ:CLGN) today announced it has entered into a worldwide exclusive development and commercialization agreement for dermal and soft tissue filler products with Allergan Aesthetics, an AbbVie company.
CollPlant has granted Allergan Aesthetics worldwide exclusivity to use its plant-derived recombinant human collagen (rhCollagen) in combination with Allergan Aesthetics’ proprietary technologies, for the production and commercialization of dermal and soft tissue fillers. In addition, Allergan Aesthetics has the right of first negotiation for CollPlant’s technology in two future additional products.
CollPlant will receive an upfront payment of $14 million and is entitled to receive up to an additional $89 million in milestone payments. In addition, CollPlant is eligible to receive royalty payments and a fee for the manufacture and supply of rhCollagen to Allergan Aesthetics.
Yehiel Tal, Chief Executive Officer of CollPlant, stated, “We are very pleased to formalize this collaboration with Allergan Aesthetics, the worldwide leader in dermal and soft tissue fillers. We believe that combining technologies from Allergan Aesthetics and CollPlant will create a paradigm shift in the medical aesthetics field. CollPlant’s rhCollagen is non-immunogenic and non-allergenic, and offers better tissue regeneration performance over animal-derived collagen which is currently used in medical aesthetics. This agreement further validates CollPlant’s technology as the gold standard collagen for regenerative and aesthetic medicine. We look forward to a highly productive partnership.”
Roger J. Pomerantz, MD, FACP, Chairman of the Board of Directors at CollPlant, said, “Our company is extremely excited to expand our work in medical aesthetics towards commercialization in the dermal filler market, which is projected to reach $10 billion by 2026. This collaboration is a major step forward, firmly placing CollPlant at the next level in applying our regenerative medicine technology to tackle new areas in biomedicine.”
About CollPlant
CollPlant is a regenerative and aesthetic medicine company focused on 3D bioprinting of tissues and organs, and medical aesthetics. CollPlant's products are based on its rhCollagen (recombinant human collagen) that is produced with CollPlant's proprietary plant based genetic engineering technology.
CollPlant's products address indications for the diverse fields of tissue repair, aesthetics and organ manufacturing, and are ushering in a new era in regenerative and aesthetic medicine.
CollPlant's flagship rhCollagen BioInk product line is ideal for 3D bioprinting of tissues and organs. In 2018, CollPlant entered into a licensing agreement with United Therapeutics, whereby United Therapeutics is using CollPlant's BioInks in the manufacture of 3D bioprinted lungs for transplant in humans.
For more information, visit http://www.collplant.com.
Contacts at CollPlant:
Eran Rotem
Deputy CEO & Chief Financial Officer
Tel: + 972-73-2325600/631
Email: Eran@collplant.com
Safe Harborfor Forward-Looking Statements
This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to CollPlant's objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that CollPlant intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause CollPlant's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: CollPlant’s history of significant losses and its need to raise additional capital and its inability to obtain additional capital on acceptable terms, or at all; CollPlant’s expectations regarding the timing and cost of commencing clinical trials with respect to products which are based on CollPlant’s rhCollagen; CollPlant’s ability to obtain favorable pre-clinical and clinical trial results; regulatory action with respect to the products, including but not limited to acceptance of an application for marketing authorization, review and approval of such application, and, if approved, the scope of the approved indication and labeling; commercial success and market acceptance of the products; CollPlant’s ability to establish sales and marketing capabilities or enter into agreements with third parties and its reliance on third-party distributors and resellers; CollPlant’s ability to establish and maintain strategic partnerships and other corporate collaborations; CollPlant’s reliance on third parties to conduct some aspects of its product manufacturing; the scope of protection CollPlant is able to establish and maintain for intellectual property rights and the companies’ ability to operate their business without infringing the intellectual property rights of others; the overall global economic environment; the impact of competition and new technologies; general market, political, and economic conditions in the countries in which the companies operate; projected capital expenditures and liquidity; changes in the companies’ strategy; and litigation and regulatory proceedings. More detailed information about the risks and uncertainties affecting CollPlant is contained under the heading "Risk Factors" included in CollPlant's most recent annual report on Form 20-F, respectively, filed with the SEC, and in other filings that CollPlant has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect CollPlant's current views with respect to future events, and neither company undertakes, and each company specifically disclaims, any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Exhibit 99.2
