COLLPLANT BIOTECHNOLOGIES REPORTS 2024 THIRD QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE

PR Newswire

REHOVOT, Israel, Nov. 27, 2024

-Promising results obtained from the pre-clinical study with CollPlant's commercial sized rhCollagen-based regenerative breast implants, demonstrating significant implant vascularization and rapid ingrowth of native tissue

-Innovative breast implant technology designed to address a $3.0 billion market opportunity

-Cash and cash equivalents balance as of September 30, 2024 was $15.4 million

-Conference call to be held today at 10:00 a.m. U.S. EDT --

REHOVOT, Israel, Nov. 27, 2024 /PRNewswire/ -- CollPlant Biotechnologies (Nasdaq: CLGN), a regenerative and aesthetics medicine company developing innovative technologies and products based on its non-animal-derived collagen for tissue regeneration and medical aesthetics, today announced financial results for the third quarter ending September 30, 2024, and provided a corporate update.

"We are now one step closer to advancing our breast implant program into human studies, after developing a biocompatible commercial-sized, 3D-printed implant with a natural feel that has shown promising results in preclinical trials," commented Yehiel Tal, Chief Executive Officer of CollPlant Biotechnologies. "So far, the study is showing encouraging outcomes three months post implantation, with evidence of significant implant vascularization and rapid ingrowth of native tissue, both of which are critical factors in enabling effective integration of the implant with the physiological system and supporting long-lasting regenerative processes. We are looking forward to reporting additional results from this program in the first quarter of 2025. "

Mr. Tal, continued, "We have recently adjusted our development and operation plans so that the Company is capitalized for a period of at least one year from today. In addition, we are prioritizing raising non-dilutive cash through the creation of additional collaborations and to that end we are engaging in dialog with companies in the medical and aesthetics fields that have interest in our rhCollagen technology. "

Dr. Sachin M. Shridharani, board-certified Plastic Surgeon, founder of LUXURGERY(c) New York and Associate Clinical Professor of Plastic Surgery at Washington University School of Medicine added, "CollPlant's novel, 3D-printed, biocompatible and regenerative breast implant technology is an incredibly exciting development with multiple applications. There is an unmet need in aesthetic and reconstructive plastic surgery for highly biocompatible materials to be employed for breast augmentation and reconstruction. Eliminating immune responses to materials implanted in the breast or any portion of the body serves as a holy grail in plastic surgery."

Q3 and Recent Program Highlights

   -- In August, CollPlant announced the launch of a pre-clinical study with 
      200cc commercial-sized breast implants printed using CollPlant's bioinks 
      and Stratasys' (Nasdaq: SSYS) Origin 3D printer. The collaboration 
      between CollPlant and Stratasys has been focused on the development of a 
      bioprinting solution for CollPlant's regenerative breast implants.  In 
      addition, the companies aim to develop solutions for scaling-up the 
      implant bioprinting process. If successfully developed, the novel 
      implants could provide a revolutionary alternative to the implants that 
      are currently on the market. 
 
   -- To date, the study has shown promising results three months post 
      implantation, demonstrating significant implant vascularization and rapid 
      ingrowth of native tissue, both of which are critical factors in enabling 
      effective integration of the implant with the physiological system and 
      supporting long-lasting regenerative processes. 

Collaboration Updates

   -- The collaboration with AbbVie continues to develop a dermal and soft 
      tissue filler product for the medical aesthetics market.  According to 
      the agreement between the parties, CollPlant granted AbbVie worldwide 
      exclusive rights to use its rhCollagen for the production and 
      commercialization of a final dermal filler product. In return, CollPlant 
      is entitled to receive, among other terms, up to $50 million and a 
      fixed-fee royalty payment for each product commercialized. As of today, 
      $24 million has been paid to CollPlant. AbbVie is responsible for all the 
      costs of the dermal and soft tissue filler product candidate development, 
      including the costs of clinical trials. 
   -- On November 11, 2024, CollPlant presented at the ISBF (International 
      Society for Biofabrication) 2024 conference.  ISBF is a professional 
      society promoting biofabrication research and development for medical 
      applications. During the conference, CollPlant demonstrated its 
      technology platform for mass production of human collagen and 
      biofabrication of its innovative regenerative breast implants. 
 
   -- On July 29, 2024, CollPlant announced the release of its inaugural 
      Environmental, Social and Corporate Governance $(ESG.NZ)$ and Sustainability 
      Report covering the fiscal year 2023. The report reflects CollPlant's 
      wide commitment to fostering environmental sustainability and enhancing 
      human health, as well as advancing social and corporate governance 
      objectives that contribute to the Company's impact. 

Three- and Nine-Month-Period Ended September 30, 2024 Financial Results

GAAP revenues for the third quarter ended September 30, 2024, were $4,000 compared to $43,000 for the third quarter ended September 30, 2023. The decrease in revenues is mainly related to the decrease in sales of rhCollagen to the Company's largest customer. The deliveries to this customer are in accordance with the development plan of the customer, and in the third quarter no deliveries were planned or made. In accordance with the plan, CollPlant is prepared to supply rhCollagen to this customer this quarter, during December 2024.

GAAP revenues for the nine months ended September 30, 2024, were $351,000 compared to $10.7 million for the nine months ended September 30, 2023. The decrease of approximately $10.3 million is related to the achievement of a milestone in 2023, which triggered a $10 million payment under the AbbVie Agreement, as well as an approximate $300,000 decrease in sales of rhCollagen and VergenixFG.

GAAP cost of revenues for the third quarter ended September 30, 2024, was $272,000, compared to $278,000 for the third quarter ended September 30, 2023.

GAAP cost of revenues for the nine months ended September 30, 2024, was $1.4 million, compared to $1.2 million for the nine months ended September 30, 2023. The increase in cost of revenues in the amount of approximately $200,000 mainly comprised of (i) a $452,000 increase related to inventory impairment, offset by (ii) a decrease of $308,000 in royalty expenses to the IIA, mainly related to the milestone payment received from AbbVie in 2023.

GAAP gross loss for the third quarter ended September 30, 2024, was $268,000, compared to $235,000 in the third quarter ended September 30, 2023.

GAAP gross loss for the nine months ended September 30, 2024, was $1.0 million, compared to gross profit of $9.4 million for the nine months ended September 30, 2023.

GAAP operating expenses for the third quarter ended September 30, 2024, were $4.3 million, compared to $4.4 million in the third quarter ended September 30, 2023. The decrease of approximately $100,000 is mainly related to (i) a decrease of $213,000 in employees' salaries expense and related share-based compensation expenses, offset by (ii) an increase of $358,000 in research and development activities mainly related to the breast implants program. On a non-GAAP basis, operating expenses for the third quarter ended September 30, 2024 were $3.8 million, compared to $3.9 million for the third quarter ended September 30, 2023. Non-GAAP measures exclude certain non-cash expenses.

GAAP operating expenses for the nine months ended September 30, 2024, were $12.3 million, compared to $11.9 million for the nine months ended September 30, 2023. The increase of approximately $400,000 is mainly related to an increase in research and development activities mainly related to the breast implants program. On a non-GAAP basis, operating expenses for the nine months ended September 30, 2024, were $11.0 million, compared to $10.6 million for the nine months ended September 30, 2023.

GAAP financial income, net, for the third quarter ended September 30, 2024, totaled $216,000, compared to $225,000 in the third quarter ended September 30, 2023.

GAAP financial income, net, for the nine months ended September 30, 2024, totaled $546,000, compared to $114,000 for the nine months ended September 30, 2023. The increase in financial income is due to interest received from the Company's short-term cash deposits and exchange rate differences.

GAAP net loss for the third quarter ended September 30, 2024, was $4.3 million, or $0.38 basic loss per share, compared to a net loss of $4.4 million, or $0.38 basic loss per share, for the third quarter ended September 30, 2023. Non-GAAP net loss for the third quarter ended September 30, 2024, was $3.8 million, or $0.33 loss per share, compared to a net loss of $4.0 million, or $0.35 basic loss per share, for the third quarter ended September 30, 2023.

GAAP net loss for the nine months ended September 30, 2024, was $12.7 million, or $1.11 basic loss per share, compared to a net loss of $2.3 million, or $0.2 basic loss per share, for the nine months ended September 30, 2023. Non-GAAP net loss for the nine months ended September 30, 2024, was $11.5 million, or $1.0 loss per share, compared to a net loss of $1.2 million, or $0.11 basic loss per share, for the nine months ended September 30, 2023.

Balance Sheet and Cash Flow

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