CollPlant Biotechnologies - Q2 2024

Transcript

Operator (participant)

Welcome to the CollPlant Biotechnologies investor conference call to discuss financial results for the second quarter of 2024 and corporate updates. At this time, all participants are in a listen-only mode. Question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. Now I'll turn the call over to Dan Ferry of LifeSci Advisors. Please go ahead, sir.

Dan Ferry (MD)

I would like to welcome everyone to CollPlant Biotechnologies financial results conference call to discuss the results for the second quarter ended June 13th,2024, where management will also provide a corporate business update. With us on the call today from CollPlant are Yehiel Tal, Chief Executive Officer, will provide an overview of the company's programs and associated updates, and Eran Rotem, Deputy CEO and Chief Financial Officer, will provide a summary of CollPlant's financial results for the second quarter, ending June 13th, 2024. Both will be available to answer questions at the end of the 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 and 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 www.sec.gov or on CollPlant's website at www.collplant.com. In addition, any forward-looking statements made on this call represent CollPlant's views only as of today, August 12th, 2024, and should not be relied upon as representing the Company's views as of any subsequent date. CollPlant 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.collplant.com. Now, let me turn the call over to Yehiel Tal, Chief Executive Officer of CollPlant Biotechnologies. Please go ahead, sir.

Yehiel Tal (CEO)

Good morning, everyone, and thank you for joining us today on CollPlant Investor Conference Call to discuss our second quarter 2024 financial results and corporate development as we continue our mission to be a leader in the field of regenerative medicine. As you may have seen, we have recently made great progress with our state-of-the-art novel breast implant program. Following the positive data from the preclinical studies that we announced earlier this year, we are happy to share our achievement to produce commercial-size implants composed of our proprietary rhCollagen-based Bioinks, printed with Stratasys Origin One 3D bioprinter. Furthermore, we are now testing 200 cc volume implants in preclinical studies. We have great excitement about the possibilities associated with our regenerative breast implant product candidate, since it has the potential to overcome the challenges of existing breast implants made of silicone or autologous fat tissue.

Dan Ferry (MD)

We remind you of the opportunity to address the global breast implant market, which is estimated at approximately $3 billion, with breast reconstruction and augmentation procedures representing the second most common plastic surgery procedures performed worldwide today. This market is projected to grow by another $3.5 billion by 2033 and become a $6.5 billion dollar market. Currently, this is a market that has been underserved in terms of safety and performance. In terms of safety, current materials can cause immunogenicity for patients and even form a cancer known as Breast Implant-Associated Anaplastic Large Cell Lymphoma. The availability of a regenerative breast implant could be a revolutionary alternative for aesthetic and reconstructive procedures, given the immunogenic-related adverse events associated with currently available implants.

In terms of performance, we believe that patients could potentially benefit from a regenerative breast implant that will be replaced over time with newly grown human breast tissue that is integrated with the host tissue, rather than having a synthetic substitute which may elicit immune response. The preclinical study that we are conducting with the commercial-size implant follows the study we initiated in December of last year, and it is intended to test the ability of the implants to grow natural breast tissue and simultaneously completely degrade over time. We remain encouraged about the prospect of these implants based on the results that we saw. With the January 2023 study report, we showed evidence of well-developed connective tissue containing blood vessels or neovascularization inside the implant. Progressing tissue ingrowth within the implant was also noticed, confirming tissue regeneration. Lastly, no adverse tissue reactions within the implantation site were present.

We look forward to reporting results from the current animal studies in the fourth quarter of this year and the first quarter of 2025. Now shifting to our other lead program, the dermal and soft tissue filler that we co-developed with our partner, AbbVie. Here we continue our important development efforts related to our collaboration with AbbVie on the dermal filler product, which is in the clinical phase. Last year, in the second quarter, we achieved a milestone, triggering a $10 million payment that was made from AbbVie to us, and of note, per our agreement with AbbVie, additional potential payments related to specified milestones are still applicable, plus meaningful product royalties on the candidate, should it become an approved product. Though the dermal filler market experienced a recent slowdown in growth, we have learned that it has recently bounced back.

This is also evidenced by recent merger and acquisition activity in this space. As it regains a foothold, innovation will be key to sustain growth in this large market that hasn't seen any significant advancement in the past decade. The dermal filler product candidate that we are collaborating with AbbVie on has its own potential to create a paradigm shift in the aesthetics market, since in addition to tissue filling, it is expected to impart regenerative properties to the skin tissue. In addition to our partner program with AbbVie, we have another version of a dermal filler in our pipeline under development, our photocurable dermal filler. We have been granted patents in multiple territories pertaining to our photocuring technology, specifically in the U.S., Europe, Brazil, Australia, and Israel. Furthermore, the application was recently allowed in China and will issue shortly.

Under the agreement with AbbVie, CollPlant has granted AbbVie the right of first negotiation to obtain a worldwide exclusive license to the photocurable dermal filler product candidate. Shifting to our progress in corporate development, recently, we're proud to have released our very first environmental, social, and governance, or sustainability report. This was done after carefully establishing a corporate sustainability strategy with clear targets in key areas that we believe are crucial to our stakeholders. The report reflects CollPlant's commitment to fostering environmental sustainability and enhancing human health, as well as advancing social and corporate governance objectives. I would like to emphasize that our overall strategy is driven by our vision to lead in regenerative medicine and improve global health with our innovative collagen technology. This first report includes tangible steps we are taking toward enabling a sustainable future, and the goals can be seen here in the next slide.

Here, our areas of focus are represented by key pillars that span from climate action and energy efficiency to health and safety and sustainable sourcing. Examples of actions that the company plans to take include enhancing its plant-based production, reducing emissions, and delivering safe and reliable medical solutions. We believe these key areas hold the highest impact related to fostering environmental sustainability and enhancing human health, as well as furthering social and corporate governance objectives that contribute to the company overall advancement. CollPlant's unwavering dedication to responsible and sustainable business practices concurrently focuses on long-term value creation for our stakeholders. 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. Eran?

Eran Rotem (Deputy CEO and CFO)

Thank you, Yehiel. Good morning, everyone. I will now review our financial results for the three and six-month periods ending June 30, 2024. GAAP revenues for the second quarter, ended June 30, 2024, were $249,000, compared to $10.2 million for the second quarter, ended June 30, 2023. In 2023, we achieved a milestone with respect to the AbbVie agreement, which triggered a $10 million payment in 2023, and this is the main reason for the decrease we see in revenues between these quarters. Revenues in Q2, 2024, are mainly from sales to AbbVie, our business partner, for the development of the dermal filler product. GAAP cost of revenues for the second quarter ended June 30, 2024, was $536,000, compared to $615,000 in the second quarter ended June 30, 2023.

Dan Ferry (MD)

GAAP gross loss for Q2 2024 was $287,000, compared to gross profit of $9.6 million in Q2 2023. GAAP operating expenses for Q2 2024 were $4.1 million, compared to $3.9 million in Q2 2023. The increase of approximately $200,000 is mainly related to employees' salaries, expenses, and to share-based compensation expenses resulting from the extension of certain employee stock options expiry periods. On a non-GAAP basis, operating expenses for Q2 2024 and for Q2 2023 were similar, $3.6 million. Non-GAAP measures exclude certain non-cash expenses. GAAP financial income net for Q2 2024 totaled $196,000, compared to $85,000 in Q2 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 second quarter ended June 30, 2024, was $4.2 million, or $0.37 basic loss per share, compared to a net income of $5.8 million, or $0.51 basic income per share for the second quarter ended June 30, 2023. The difference between the quarters of the financial performance comes from CollPlant's achievement in 2023, upon reaching a milestone in the dermal filler development plan. Achieving the milestone, as you already know, led to a payment of $10 million from AbbVie to CollPlant in 2023, and this is the reason for the aforementioned variance. Non-GAAP net loss for Q2 2024 was $3.8 million, or $0.33 loss per share, compared to a net income of $6 million, or $0.53 basic income per share for Q2 2023.

Cash and cash equivalents as of June 30, 2024, were $18.9 million. The cash balance represents, as of August 2024, a company cash runway that are expected to satisfy the company's operation requirements at least until the end of 2025, based on current contemplated operations and plans. Cash used in operating activities during the six-month period ended June 30, 2024, and during the six months ended June 30, 2023, was $7.2 million. Cash used in investing activities during the six months ended June 30, 2024, was $341,000, compared to $541,000 during the six months ended June 30, 2023, and related primarily to the purchases of property and equipment.

Cash provided by financing activities during the six months ended June 30, 2024, was $9,000, compared to $892,000 during the six months ended June 30, 2023. The period last year included proceeds from the exercise of the last warrants 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.

Operator (participant)

Thank you. We will now be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for your questions.

Dan Ferry (MD)

Our first questions come from the line of Sean Lee with H.C. Wainwright. Please proceed with your questions.

Sean Lee (VP and Equity Research)

Hi, good morning, guys. This is Sean standing in for RK, and thanks for taking my questions. My first one is on the latest breast implant study, so I was wondering, since I know dermal fillers are sometimes also used for breast augmentations, what are the key differences between this latest breast implant compared to what you're working on with AbbVie, and what are you looking to find out in the preclinical study?

Yehiel Tal (CEO)

Thank you, Sean, for your question. This is Yehiel Tal speaking. There is a big difference between the injectable fillers and the breast implants that we are making. The breast implants that we are making are basically comprised of 3D bioprinted scaffold, which is comprised of collagen and other biomaterials. This scaffold will basically, after implantation, recruit cells from the surrounding tissue, and basically, over time, it will degrade and be replaced with a naturally grown tissue, fat tissue. While the injectable fillers are intended for different purposes. There are injectable fillers that are made from fat only. This is one of the treatments for breast augmentation, as they usually don't last for a long time. They are losing volume and require repeatable injections.

Dan Ferry (MD)

There are the dermal fillers that are made usually from hyaluronic acid, which are intended for skin lifting and basically also require repeatable injections over time. So these are the key differences between the fillers.

Sean Lee (VP and Equity Research)

Great. That makes it more clear. What are the key findings you're looking for in the current preclinical study then?

Yehiel Tal (CEO)

Okay. So here, I guess that your question is referring to the breast implant, right?

Sean Lee (VP and Equity Research)

Uh, yes.

Yehiel Tal (CEO)

On the breast implant, I would divide because we have multiple studies on large animals, and the intention of the studies is basically to optimize, you know, the formulations, the design of the implant, and check, of course, the performance, the safety, and efficacy of the implant. For example, the ability to regenerate fat tissue, the degradation kinetics of the implant over time. We have reported on studies that we conducted in January 2023, and then December 2023. The studies showed evidence of a well-developed connective tissue, including blood vessels or neovascularization in the implant. Progressing tissue ingrowth within the implant, which is confirming the tissue regeneration. We did not see any adverse tissue reactions in the implantation site. This is very important finding.

Dan Ferry (MD)

The studies basically enabled us, the studies we did so far, to fine-tune the surgical protocol and optimize basically the scaffold the fabrication in a way that it will also mimic natural breast tissue, for example, in terms of filling. We basically report additional data from the December 2023 study by year-end 2024, and then Q1 of 2025. From the new results that will be reported, we expect to learn more about the formation of a new fat tissue, which is called also adipogenesis, as well as about the implant degradation kinetics.

Lastly, I would say that we reported about the launch of another study that we started this week with 200 cc size implant, which is basically a commercial-size implant, which was printed with the Stratasys printer. Of course, this study has different endpoints that go for 18 months, which means like six, three, 12, and 18 months. Hopefully this study will be the one that will enable us to move forward to a human pilot study.

Sean Lee (VP and Equity Research)

Great. Thanks for that. My last question is on the AbbVie collaboration. So I was wondering, what are the next steps to that? And, can we expect any additional milestones over the next couple of quarters? Thanks.

Eran Rotem (Deputy CEO and CFO)

Thank you, Sean. This is Eran. So with AbbVie, as everybody knows, we are working on the dermal filler product. It is now in a clinical phase, running a few clinical studies, and this is the phase of the product. We did not disclose, and we are not allowed to disclose, the timelines either for the study or for the next milestone. I will just maybe mention that, regarding that product alone, we are expecting to get by commercialization in a few, a milestone, a total of $26 million. And on top of that, of course, once this product will become commercial. We will see meaningful royalty rate and, of course, a return for the collagen that we will sell out of it.

Sean Lee (VP and Equity Research)

Yep, I understand. Thanks again for taking my questions.

Yehiel Tal (CEO)

Thank you.

Operator (participant)

Thank you. Our next question has come from the line of Jason Kolbert with EF Hutton. Please proceed with your questions.

Jason Kolbert (MD)

Good morning, guys. Congratulations. A lot of exciting progress. I'd like to understand a little bit better, beyond the collagen scaffold, what other growth factors are part of the scaffold itself? And is the idea that the scaffold integrates into the tissue, essentially dissolves and goes away, but leaves kind of the formed natural tissue in its place? If you could kinda describe that process and help us understand the longevity of the process, meaning the scaffold is a means to an end, but not the end. Thanks.

Yehiel Tal (CEO)

Yeah. Thank you, Jason, for the question. This is Yehiel speaking. We are not using growth factors. Growth factors eventually will be a regulatory nightmare, and we are avoiding the use of growth factors for this reason. What we do is a scaffold, which is comprised of our collagen and other biomaterials, and the collagen itself has cell-binding domains, which will basically attract cells that will infiltrate from the surrounding tissue, which is, in most cases, going to be a fat tissue. And basically, these cells will infiltrate into the implant, and while they will proliferate and basically form a new fat tissue, at the same time, there is an implant degradation. And the degradation of the implant is done by three mechanisms of action.

Dan Ferry (MD)

One of them is enzymatic degradation, the second one is hydrolysis, and the third one is oxidation. So we are controlling these three mechanisms in a way that the implant or the scaffold will serve its purpose in terms of load-bearing, until the newly grown tissue will basically take the responsibility on the load-bearing, and then the scaffold will degrade. The degradation time is between six to 12 months, and this is enough time for the newly grown tissue to basically take over the load-bearing capacity of the scaffold. So this is the process in general. There might be, in the future, cases that we will need to assist the scaffold with the addition of autologous fat, which will be injected, in addition to the administration of the scaffold.

Jason Kolbert (MD)

It's amazing, and I agree with you that growth factors at this early stage is kind of a nightmare. It's amazing to me that within a year, the scaffold is gone, and the tissue integrates. How predictive are the animal models you're using in man? It strikes me that they would be very predictive. How confident are you of that?

Yehiel Tal (CEO)

There are basically animal models, and I cannot elaborate in great details about the models because it took us a while. We tried different large animal models, and it took us a while and a lot of effort to develop the surgical protocol in a way that we today can say that the animal model is going to be quite predictive of the growth of the new tissue in human. In addition to that, we also developed a new discipline in the company, which is a breakthrough discipline. This is called modeling and simulation or computational biomechanics.

Dan Ferry (MD)

Here we are using finite element algorithms that we developed, which are enabling us to mimic the scaffold behavior in the human body after implantation under different loading conditions, and also to assess the degradation kinetics of the implant. Basically, this is going to be also part of the submission package to the FDA in addition to the preclinical study. It's like a complementary package, which is basically going to provide a good rationale to the FDA about the implant longevity, about the implant reliability, how we avoid fatigue points, for example, under different loading conditions in the body. I think that altogether, the preclinical package and the modeling and simulation should satisfy the FDA requirements in terms of, you know, the draft guidance.

Jason Kolbert (MD)

Going forward, are you talking to the major implant makers who must recognize that a paradigm shift is in front of them? You must be thinking about, you know, the next level of BD deal with this product?

Yehiel Tal (CEO)

Yes. Basically, this is a technology platform that can later on be, you know, expanded to other areas, for example, facial implants. To your question, yes, we are basically talking to, you know, major players in this arena. But we are not yet obligated to anybody. We want to take the product as far as possible to the market.

Jason Kolbert (MD)

I think as far as possible for definitive proof of concept to get the best business deal.

Yehiel Tal (CEO)

Yes. You are correctly correct.

Jason Kolbert (MD)

Thank you, guys. Appreciate it. Thanks for the update.

Yehiel Tal (CEO)

Thank you.

Operator (participant)

Thank you. I believe that is the last question from our live audience participants, so I'll turn it back to Mr. Rotem for any questions that came in online.

Eran Rotem (Deputy CEO and CFO)

Thank you, operator. We have no additional questions from the audience, so I will move forward and say that this is concluding the questions, and I will now turn the call back to Yehiel Tal, [CollPlant's] Chief Executive Officer, for any closing remarks. Yehiel?

Yehiel Tal (CEO)

Yes. Thank you, Ron. So CollPlant's mission is to discover, develop, and deliver collagen technology and regenerative medicine products to improve and prolong lives. We continue to carefully focus on our core programs and our supportive partners to advance this mission, with the goal of creating products that enable the regeneration of tissues and organs. Our vision is to be the leaders in regenerative medicine, helping people live longer and better through our innovative collagen technology. In closing, I want to reiterate our upcoming goals for this year. For the remainder of 2024 and into the beginning of 2025, we plan to focus on advancing the development of the dermal filler program with AbbVie, generate additional safety and efficacy data related to our regenerative breast implants in support of future clinical studies and commercialization of this product candidate.

Dan Ferry (MD)

Continue to form collaborations with industry leaders for utilizing our rhCollagen and Bioink technologies, and continue discussions related to potential collaborations on our existing programs and products. Thank you, everyone, for your time this morning and for joining us today to for today's conference call. We want to thank our very important and valued CollPlant team members who have contributed to another successful and productive quarter. Operator?

Operator (participant)

Thank you. That now concludes today's conference call, and you may now disconnect.