CollPlant Biotechnologies Ltd. (CLGN) Q4 2024 Earnings Report, Transcript and Summary

Welcome to the CollPlant Biotechnologies Ltd. Investor Conference Call to discuss financial results for the full year and fourth quarter of 2024 and corporate updates. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. I would now like to turn the call over to Dory Kurowski of LifeSci Advisors. I would like to welcome everyone to CollPlant Biotechnologies Ltd. financial results conference call to discuss the results for the full year and fourth quarter ended December 31, 2024, where management will also provide a corporate business update. With us on the call today from CollPlant Biotechnologies Ltd., are Yehiel Tal, Chief Executive Officer, who will provide a brief overview of the company's programs and associated updates, and Eran Rotem, Deputy CEO and Chief Financial Officer, who will provide a summary of CollPlant Biotechnologies Ltd.'s financial results for the full year and fourth quarter ended December 31, 2024. Both will be available to answer questions on today's call. Before we get started, I would like to remind everyone that statements made on this conference call may include forward-looking statements. Actual events or results could differ materially from those expressed or implied by any forward-looking statements, as a result of various risks, uncertainties, and other factors including those set forth in the Risk Factors section of CollPlant Biotechnologies Ltd.'s filings with the Securities and Exchange Commission. These filings can be found at www.sec.gov or on CollPlant Biotechnologies Ltd.'s website at www.collplant.com. In addition, any forward-looking statements made on this call represent CollPlant Biotechnologies Ltd.'s views only as of today, March 26, 2025, and should not be relied upon as representing the company's views as of any subsequent date. CollPlant Biotechnologies Ltd. management specifically disclaims any obligation to update or revise any of these forward-looking statements. Finally, CollPlant Biotechnologies Ltd. management will refer to certain financial measures not reported in accordance with GAAP on this call. You can find reconciliations of these non-GAAP financial measures to the GAAP financial measures in the earnings press release that CollPlant Biotechnologies Ltd. published earlier today, which is available on CollPlant Biotechnologies Ltd.'s website at ir.collplant.com. Now let me turn the call over to Yehiel Tal, Chief Executive Officer of CollPlant Biotechnologies Ltd. Please go ahead, sir.

Good morning, everyone, and thank you for joining us today on CollPlant Biotechnologies Ltd.'s Investor Conference Call to discuss our fourth quarter and full year 2024 financial results and corporate developments as we pursue our mission to be a leader in regenerative medicine. You may have seen that the field of regenerative medicine was highlighted at the end of last year when the first lab-grown blood vessels were approved by the FDA for use by surgeons to restore blood flow in patients with traumatic injuries or in patients who need a coronary bypass. This approval is a major milestone for the sector, a research and development effort that has finally been able to translate from an exciting bedside idea to an actual FDA-approved product. As such, we want to emphasize our own proprietary programs in regenerative medicine and regenerative aesthetics, and that we are advancing these programs ourselves through preclinical and clinical studies and ultimately potential collaborative agreements. The advancement of our own programs represents additional opportunities for long-term value creation for our stakeholders at CollPlant Biotechnologies Ltd. Therefore, I would like to start by highlighting our photocurable dermal filler candidate, which is in the preclinical phase. The photocurable dermal filler is novel, and the market it is intended for is valued at approximately $6.3 billion with a compound annual growth rate of 10%. We have received very positive feedback from top leaders in the field of aesthetic medicine related to the experimental use of the photocurable dermal filler. Highlights from these testimonials mentioned that it could be a game-changer for facial plastic surgery and the soft tissue filler market, as well as a huge advance in the dermal and soft tissue market for facial plastic surgery, and that nothing like this is observed with available fillers with the potential to change the overall approach to long-lasting facial sculpting. Full video testimonials from each physician can be found within our corporate presentation on our website. In addition to our proprietary photocurable dermal filler development, our collaboration with AbbVie is focused on the development of another dermal and soft tissue filler product for the medical aesthetics market. In February 2025, CollPlant Biotechnologies Ltd. announced that AbbVie is collecting data and conducting a review of interim results from the first cohort of patients enrolled in the dermal and soft tissue filler clinical trials initiated in 2023. Next steps for the program are to be determined upon complete assessment. In addition, following the development achievement, CollPlant Biotechnologies Ltd. received a $2 million payment from AbbVie. Now onto our second proprietary program in regenerative medicine, our regenerative breast implant. This quarter, we continue to advance our preclinical testing of our commercial-sized breast implants, now 250cc in volume. This component, now using these commercial-sized prototypes, is critical to advancing our technology towards the market of products and creating significant shareholder value. In August 2024, CollPlant Biotechnologies Ltd. launched this preclinical study with two arms where the surgical protocol was refined to include implantation through a small incision while preventing implant displacement or inversion. We were able to accomplish this with an enhanced, more durable form of the implant that we were able to produce. Analysis of MRI and ultrasound data conducted early this year confirmed visual integration and vascularization, offering valuable diagnostic tools for future clinical applications. At six months post-implantation, one study arm has shown promising outcomes with the implant demonstrating depolarization and rapid tissue ingrowth within the clinical site implant. No complications such as capsular contracture, calcifications, and local tissue reactions were observed. Additionally, volume retention and mechanical properties were maintained in the successful study arm. Following this study, CollPlant Biotechnologies Ltd. will continue to optimize the characteristics of the breast implants to ensure longevity and remodeling of the neo-tissue with the goal of preparing the implants to enter the clinic. Our regenerative breast implant product candidate would be revolutionary for both women undergoing aesthetic enhancement as well as cancer patients undergoing breast reconstruction since it has the potential to overcome the challenges of existing breast implants made of silicone, saline, or autologous fat tissue. Our recombinant human collagen technology, which is the backbone of our product candidate pipeline and commercial products, is the most human-like collagen on the market today, including its molecular, biological, and physical properties. There is continuous demand for our bioink and other applications for recombinant human collagen. Along these lines, we have had additional large interest from a wide range of companies that want to gain access to our RH collagen and are engaged in discussions. That concludes my initial remarks. Now I will turn the call over to our Deputy CEO and Chief Financial Officer, Eran Rotem, to provide a recap of the financial results.

Thank you, Yehiel. Good morning, everyone. I will now review our financial results for the three and twelve months period ending December 31, 2024. Revenue for the fourth quarter ended December 31, 2024, was $164,000 compared to $299,000 for the fourth quarter ended December 31, 2023. The decrease we see is mainly related to sales of our RH collagen product. GAAP revenue for the year ended December 31, 2024, was $515,000 compared to $11 million for the year ended December 31, 2023. In 2023, we achieved a milestone with respect to the AbbVie agreement, which triggered a $10 million payment in 2023. This is the main reason for the decrease we see in revenues between these periods. GAAP cost of revenues for Q4 2024 was $272,000 compared to $773,000 in Q4 of 2023. GAAP cost of revenue for the year ended December 31, 2024, was $1.6 million compared to $2 million for the year ended December 31, 2023. The decrease in cost of revenues is in the amount of approximately $400,000, mainly comprised of $312,000 in royalty expenses to the IAA, mainly related to the milestone payment received from AbbVie in 2023, and a decrease of $324,000 related to bioink and RH collagen sales, offset by $247,000 related to inventory impairment. GAAP gross loss for Q4 2024 was $108,000 compared to $474,000 in Q4 2023. GAAP gross loss for the year ended December 31, 2024, was $1.1 million compared to a gross profit of $9 million in 2023. GAAP operating expenses for Q4 2024 were $3.9 million compared to $4.6 million in Q4 2023. The decrease in operating expenses of approximately $700,000 is mainly related to a decrease of $303,000 in employee salaries and share-based compensation expenses, and a decrease of $386,000 in research and development activity. GAAP operating expenses for the year ended December 31, 2024, were $16.1 million compared to $16.5 million for the year 2023. The decrease of approximately $400,000 is mainly related to a decrease in general administrative and marketing expenses, mainly comprised of $287,000 in share-based compensation expenses and $152,000 in insurance policy costs. Financial income net for Q4 2024 totaled $96,000 compared to $379,000 in Q4 2023. Financial income net for the year ended December 31, 2024, totaled $642,000 compared to $493,000 for the year ended December 31, 2023. The increase in financial income is due to exchange rate differences. GAAP net loss for Q4 2024 was $3.9 million or $0.34 basic loss per share compared to a net loss of $4.7 million or $0.41 basic loss per share for Q4 2023. GAAP net loss for the year ended December 31, 2024, was $16.6 million or $1.45 basic loss per share compared to a net loss of $7 million or $0.62 basic loss per share for the year 2023. The main difference in performance between the periods arises from CollPlant Biotechnologies Ltd.'s achievement in 2023 upon reaching a milestone in the dermal filler development plan, achieving this milestone, as you already know, led to a payment of $10 million from AbbVie to CollPlant Biotechnologies Ltd. in 2023. And now I will review some of the balance sheet and cash flow data. Cash and cash equivalents as of December 31, 2024, were $11.9 million. In addition, following the development achievement under the AbbVie agreement, CollPlant Biotechnologies Ltd. received a $2 million payment from AbbVie during Q1 2025. The cash balance represents, as of today, the company's cash runway that is expected to satisfy the company's operational requirements through the second quarter of 2026, based on currently contemplated operations and plans. Cash used in operating activities during the year ended December 31, 2024, was $14.1 million compared to $2.8 million for the year ended December 31, 2023. Cash used in investing activities during the year ended December 31, 2024, was $539,000 compared to $1.2 million provided by investing activities for the year ended December 31, 2023, and related primarily to the purchase of property and equipment. Cash provided by financing activities during the year ended December 31, 2024, was $9,000 compared to $1.1 million for the year ended December 31, 2023. The period last year included proceeds from the exercise of the last warrant that the company granted to investors in the previous year. This now concludes the financial summary. Operator, I believe that we can now open the call for questions.

Thank you. The floor is now open for questions. Our first question is coming from Swayampakula Ramakanth of H.C. Wainwright. Please go ahead.

Thank you. This is RK from H.C. Wainwright. A couple of quick questions. So just trying to understand when would we potentially get an update from AbbVie on the studies that they are doing and in 2025, should we expect any milestone payments?

RK, this is Eran. Thank you for joining us, and thank you for the question. So just to remind everyone, under the agreement between CollPlant Biotechnologies Ltd. and AbbVie, AbbVie is developing a dermal filler product. And as we updated about a month ago, the dermal filler product candidate is currently in the clinical phase. AbbVie is collecting data and conducting a review of interim results on the first cohort of patients enrolled under the trial initiated in 2023. The next steps of the program are to be determined by AbbVie upon conducting their assessments. We are not a part of the timelines here, and we are following AbbVie. So whenever they update us, of course, we will update the market. I will mention maybe in this relation that last month, following a development achievement, we received a $2 million payment from AbbVie in February, which is according to the agreement. Also, you remember probably that in 2023, we received another $10 million from another milestone. The product development process is under the complete control of AbbVie, and we cannot estimate when there will be another milestone.

Okay. Thank you for that. And then very recently, you expanded your distribution channels for the VerGenix product in Europe and some parts of Asia. What's the market there for this product? And how should we think about revenue flow from this relationship? Is there anything that you can help us estimate on the flow of payments?

So first of all, this is Yehiel. Let me explain about the product itself. The product is called VerGenix STR, STR stands for soft tissue repair. The product is basically intended for the treatment of tendinopathy, which is tendon inflammations, like, for example, tennis elbow, rotator cuff, Achilles tendon, plantar fasciitis, and others. The product is based on collagen with PRP, which is autologous. It's platelet-rich plasma, which is harvested from the patient. The market for this product is sports medicine, mostly from sports injuries. In terms of the market potential, the market potential is between 1% to 3% of the population. This is the market potential for tendon injuries. So, basically, what we are trying to do now is establish a distribution network in Europe, as well as in Asia. This is in the initial stage. Each country should go through a regulatory process, so we are working on that. Hopefully, after establishing this regulatory approval for the Asian countries, we should be able to start selling the product. Again, it will be a market penetration process, but we feel very comfortable about the potential because the competitor product is an injection of steroids, and repeat injections of steroids harm the treated tissue, and it's not going to basically cure the tendinopathy issue. Our product, usually, a single injection will take care of the inflammation. This is based on data that we collected from European customers. For this reason, we feel very comfortable about the potential, and hopefully, we'll start to see sales in the next year.

Okay. Thank you. Thank you for taking my question.

Thank you. At this time, I'd like to turn the floor back over to Mr. Rotem for any web-submitted questions.

Thank you. So we had a few questions coming through regarding the company's cash flow, the burn rate of the cash, the estimated cash flow, and if I'm summarizing those questions, then I can address them as follows. Some of them mention that the company has $11.9 million at the end of the year in cash, and that we had some reduction plans to cut costs and are wondering about how long it can take us, what is the bandwidth. Please note that the balance is not including the additional $2 million that CollPlant Biotechnologies Ltd. just received from AbbVie in February. The cost reduction that we implemented in the company is not impacting materially the main development programs, by the way, or the AbbVie collaboration. The cash runway guidance that we are counting on is not including any additional potential partnership revenues. So all in all, with this current cash position that we are holding and under conservative assumptions, we are saying that we will be able to continue operations into the second quarter of 2026, more than a year from now. So relatively, we are in a stable position in these shaky markets. We are all aware of the market conditions and the share price, and we see that our situation is, of course, a macro event. It's not something that happened in the company, and we have enough cash for more than a year as of today. So this is regarding a few questions that we received from the audience. That concludes the questions from the audience, and I'll now turn the call back to Yehiel Tal, CollPlant Biotechnologies Ltd.'s Chief Executive Officer, for any closing remarks.

Yes. Thank you, Eran. CollPlant Biotechnologies Ltd. continues to carefully focus on our core programs and our supportive partners to discover, develop, and provide collagen technology and regenerative medicine products to improve and prolong lives. As a result, we want to be sure that we are transparent with you, our shareholders, about our upcoming catalysts for the company for the remainder of the year related to our proprietary programs. For our photocurable dermal and soft tissue filler product candidate, our plan is to potentially launch a clinical trial within two years. For our regenerative breast implant program, we will continue to optimize the characteristics of the implant to ensure optimal regeneration of the neo-tissue as well as optimize our clinical protocol with the aim to reach readiness for a clinical trial. Related to our VerGenix STR marketed product, we will continue to extend the distribution network of this product in Europe and Asia. For our portfolio of novel bioinks, we plan to broaden our product offerings to support various bioprinting technologies. Finally, related to the sales of our RH collagen as a raw product, we plan to expand sales to selected customers that comply with our business model. We will, of course, continue to focus on advancing the development of the dermal filler program with AbbVie. We will also continue to advance any potential partnership discussions. Thank you, everyone, for your time this morning and for joining us on today's conference call. I want to thank our very important and valued CollPlant Biotechnologies Ltd. team members who have contributed to another successful and productive quarter.

Ladies and gentlemen, this concludes today's event. You may disconnect your lines and log off the webcast at this time. Enjoy the rest of your day.