CollPlant Biotechnologies Ltd. Price & Performance (CLGN)

With us on the call today from are Yahil Tal, Chief Executive Officer who will provide a brief overview of the company's programs and associated updates and Iran Rotem, Deputy CEO and Chief Financial Officer, will provide a summary of CollPlant's financial results, for the full year and fourth quarter ended 12/31/2024. 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's filings with the Securities and Exchange Commission. These filings can be found at wwwsec.gov or on CollPlant's website at www..com. In addition, any forward looking statements made on this call represent CollPlant's views only as of today 03/26/2025, and should not be relied upon as representing the company's views as of any subsequent date. Coal plant management specifically disclaims any obligation to update or revise any of these forward looking statements. Finally, CollPlant 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 published earlier today. And which is available on CollPlant's website at ir.coleplant.com. Now let me turn the call over to Yahil Taf, Chief Executive Officer of CollPlant Biotechnologies. Please go ahead, sir. Good morning, everyone, and thank you for joining us today on CollPlant'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 the last year when the first lab grown blood vessels were approved by FDA for use by surgeons to restore blood flow in patients with traumatic injuries or in patients who need coronary bypass. This approval is a major milestone for the sector the 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 investment of our wholly owned programs represent an additional opportunity for long term value creation for our stakeholders at CollPlant. Therefore, I would like to start with highlighting our photocurable dermal filler candidate which is in the preclinical phase. The photocurosal dermal filler is our own and the market it is intended for is valued approximately $6,300,000,000 and with compound annual growth rate of 10%. We have received very positive feedback from thought leaders in the field of aesthetic medicine related to the experimental use of the photocurable dermal filler. Highlights from these testimonials mention that it could be a game changer for facial plastic surgery and as a soft tissue filler. As well as huge advance in the dermal and soft tissue market. And for facial plastic surgery, and that nothing like this is observed with available fillers with the potential to change the overall approach of 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 photokurosal derma filler development, our collaboration with Abzi, is focused on the development of another dermal soft tissue filler product for the medical aesthetics market. In February 2025, CollPlant announced that AbbVie is collecting data and conducting review of interim results from the first cohort of patients enrolled in the dermal and soft tissue feeder clinical trials initiated in 2023.

Next steps for the program are to be determined upon complete assessment. In addition, following the development achievement CorePlant received a $2,000,000 payment from AbbVie. Now, on to our second proprietary lead program in regenerative medicine, our regenerative breast implants. This quarter we continue to advance the preclinical testing of our commercial size breast implants now 200 cc in volume. This study now using this commercial sized prototypes is critical to advancing our technology towards the marketed product and creating significant shareholder value. In August 2024, Kotlin launched this preclinical study with two arms, where the surgical protocol was refined to include implantation through [indiscernible] while preventing implant displacement or inversion. We were able to accomplish this with enhanced more durable form of the implant that we were able to produce. Analysis of MRI and ultrasound data conducted early this year confirmed tissue 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 vascularization and rapid tissue in growth within the clinical site implant. No complications such as capsule formation, calcifications, and local tissue reactions were observed. Additionally, volume retention and mechanical properties were maintained. In the successful study arm. Following this study, CollPlant will continue to optimize the regenerative breast implants to ensure longevity and remodeling of the nail tissue with the goal of [indiscernible] the implants to enter the clinic. Our regenerative breast implant product candidate could 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 characterized collagen on the market today. Including its molecular, biological, and physical properties. There is continuous demand for our bioinks and other applications for recombinant human core genes. Along these lines, we have had additional 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, [indiscernible] to provide a recap of the financial results. [indiscernible] Thank you, Yifir. Good morning, everyone. I will now review our financial results for the three and twelve month period ending 12/31/2024. GAAP revenues for the fourth quarter ended 12/31/2024, were $164,000 compared to $299,000 for the fourth quarter ended 12/31/2023. The decrease we see is mainly related to sales of our Rh Progen product. GAAP revenue for the year ended December thirty one, twenty twenty four, were $515,000 compared to $11,000,000 for the year ended 12/31/2023.

In 2023, we achieved a milestone with respect to the AbbVie agreement. Which triggered a $10,000,000 payment in 2023. This is the main reason for the decrease we see in revenues between these periods. GAAP cost of revenues for Q4 twenty twenty four was $272,000 compared to $773,000 in Q4 twenty twenty three. GAAP cost of revenue for the year ended 12/31/2024, was $1,600,000 compared to $2,000,000 for the year ended 12/31/2023. The decrease in cost of revenue [indiscernible] in the amount of approximately $400,000 mainly comprised of $312,000 in royalty expenses to the IAA, mainly related to the milestone payment we received from AbbVie in 2023, and a decrease of $324,000 related to BioWink and RH collagen cells offset by $247,000 related to inventory impairment. GAAP gross loss for Q4 twenty twenty four was $108,000 compared to $474,000 in Q4 twenty twenty three. GAAP gross loss for the year ended 12/31/2024 was $1,100,000 compared to a gross profit of 9,000,000 in 2023. GAAP operating expenses for Q4 twenty twenty four were $3,900,000 compared to $4,600,000 in Q4 twenty twenty three. The decrease in operating expenses approximately $700,000 is mainly related to a decrease of $303,000 in employees salaries, and share based compensation expenses, and a decrease of $386,000 in research and development activity.

GAAP operating expenses for the year ended 12/31/2024, were $16,100,000 compared to $16,500,000 for the year 2023. The decrease of approximately $400,000 is mainly related to addictive in general, administrative, and marketing expenses, mainly comprised of hundred and $87,000 in share based compensation expenses, and 152,000 in insurance policy costs. Financial income net for Q4 twenty twenty four totaled $96,000 compared to $379,000 in Q4 twenty twenty three. Financial income net for the year ended 12/31/2024, [indiscernible] $642,000 compared to $493,000 in the year ended 12/31/2023. The increase in financial income is due to exchange rate differences. GAAP net loss for Q4 twenty twenty four was $3,900,000 or $0.34 basic loss per share, compared to a net loss of $4,700,000 or $0.41 basic loss per share for Q4 twenty twenty three. GAAP net loss for the year ended December 31, 2024, was $16,600,000 or $1.45 basic loss per share. Compared to a net loss $7,000,000 or 62¢ basic loss per share, for the year 2023. The main difference in performance between the periods arises from Coppant's achievement in 2023 upon reaching a milestone in the dermal failure development plan, achieving the milestone, as you already know, led to a payment of $10,000,000 from AbbVie to Copel in 2023.

Now I will review some of the balance sheet and cash flow data. Cash and cash equivalents as of 12/31/2024 were $11,900,000 In addition, following a development achievement under the AbbVie agreement, CollPlant received a $2,000,000 payment from AbbVie during Q1 twenty twenty five and the cash balance represents as of today the company cash runway that is expected to satisfy the company's [indiscernible] requirements. Through the second quarter of twenty twenty six, based on currently contemplated operations and plans. Cash used in operating activities during the year ended December 3124, was $14,100,000 compared to $2,800,000 for the year ended 12/31/2023, Cash used in investing activities during the year ended 12/31/2024, was $539,000 compared to $1,200,000 that was provided by investing activities for the year ended 12/31/2023, and related primarily to the purchase of property and equipment. Cash provided by financing activities during the year ended 12/31/2024 was $9,000 compared to $1,100,000 for the year ended 12/31/2023. The period last year included proceeds from the exercise of the last void that the company granted to investors in previous years. 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 Tzui Ramakanth of H. C. Wainwright. Please go ahead.

Thank you. This is RK from H. C. Wainwright. Couple of quick questions. So just trying to understand when would we potentially get an get an update from AbbVie on the studies that they are doing and in 2025, should we expect any milestone payments Hi, LK. This is Eran. Thank you for joining us, and you for the question. So just to remind everyone, under the agreement, between CollPlant 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. And AbbVie is collecting data and conducting a review of interim results from 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 assessment. We are not a part of the timelines here, and we are following AbbVie. So whenever they will update us, of course, we will update the market. And I will mention maybe in this relation that at the last month following development achievement, we $2,000,000 payment from AbbVie. In February, which is according to the agreement. And also, you remember probably that in 2023, we received another $10,000,000 from another milestone, And the product development process is under the complete control of AbbVie.

And we cannot estimate, therefore we cannot estimate when will be another milestone.

Okay.

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

So first of all, this is Yigael. Let me explain about the product itself. The product is called Vergenx STR. STR stands for soft tissue repair the product is basically intended for the treatment of tendinopathy, which is tendons inflammations. Like for example, tennis elbow, rotator cuff, Achilles tendon, plantar fasciitis, and others. The product is based on collagen in combination with PRP, which is a autologous, it's platelets rich plasma which is harvested from the patient. The market for this product is sports medicine, mostly from sport injuries, In terms of the market potential, the market potential is between one to three percent of the population This is the market potential for tendon injuries. And so basically what we are trying to do now is establishing 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. And hopefully after establishing this regulatory approval for the Asian countries we should be able to start selling the product. And again, it will be a market penetration process, but we feel very comfortable about the potential because a competitor product is injection of steroids and repeat injections of steroids is harming the tissue, the treated tissue, and it's not going to basically cure the tendinopathy issue.

Our product usually a single injection will take care about the inflammation. This is based on data that we collected from European customers And 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 questions.

Thank you.

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

Thank you.

So, had a few questions coming through regarding the company's cash flow.

Cash the burn rate of the cash, the estimated cash flow, and if I'm summarizing those questions, then I can address them as follows: I mean, some of them mentioning that the company has $11,900,000 at the end of the year in cash, and that we had some reduction plan to cut costs and wondering about for how long it can take us, what is the bandwidth. So So please note that the balance is not including the additional $2,000,000 that the CollPlant received just to received from AbbVie in February. And the cost reduction that we implemented in the company, and it is not impacting materially the main development programs. By the way, or the AbbVie collaboration. And 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, [indiscernible] we are saying that [indiscernible] [indiscernible] we will be able to continue operation into the second quarter of twenty twenty six, more than a year from now. So relatively, we are in a stable position in this [indiscernible] And we are all aware to the market to the market condition and the share price [indiscernible] we see that all situation is, of course, as 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.

So, concludes the questions from the audience. And I'll now turn the call back to Yaghiel Tal the CollPlant's Chief Executive Officer for any closing remarks. [indiscernible] Yes. Thank you, Ron. CollPlant 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 catalyst for the company for the remainder of the year related to our proprietary programs.

For our photocurable dermal and soft tissue filler, candidate, our plan is to potentially launch 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 neotissue as well as optimize our clinical protocol with the aim to reach readiness for clinical trial.

Related to our VERGENX STR Marketed Product, We Will Continue To Expand The Distribution Network Of This Product In Europe and Asia For our portfolio of novel bio we plan to broaden our product offerings, support support various bioprinting technologies. And finally, related to the sales of our Rh Collagen as a raw product, we plan to expand cells 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. And we will also continue to advance any potential partnership discussions. Thank you everyone for your time this morning and for joining us today for today's conference call.

I want to thank our very important and valued Cortland 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. And enjoy the rest of your day.