Humacyte, Inc.(HUMAW)Q2 2025 法說會逐字稿

Good morning, everyone, and welcome to the Humacyte Second Quarter 2025 Results Conference Call. This conference is being recorded. I would now like to hand the call over to Tom Johnson with Lifesci Advisors. Please proceed.

Thank you, operator. Before we proceed with the call, I'd like to remind everyone that certain statements during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which after the filing may be accessed from the Investor page of the Humacyte website.

Joining me today on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; Dale Sander, Chief Financial Officer and Chief Corporate Development Officer; and B.J. Scheessele, Chief Commercial Officer. Dr. Niklason will provide a summary of the company's progress for the quarter and recent weeks, and Dale will review the company's financial results for the quarter ended June 30, 2025. Following their prepared remarks, B.J. will join Laura and Dale for a Q&A session. I'll now turn the call over to Dr. Laura Niklason. Go ahead, Laura.

Thank you, Tom, and good morning, everyone, and thank you for joining us for our second quarter 2025 financial results and business update call. Following the landmark success of obtaining FDA approval of Symvess for the treatment of extremity vascular trauma last year, we continue to execute on the commercial launch of this groundbreaking product. Progress during our second quarter and recent weeks was marked by continued expansion of our value analysis committee, or VAC, approvals. This has led to a major expansion of the number of approvals that are now able to purchase Symvess. Recently, we also announced that the U.S. Defense Logistics Agency granted electronic catalog or ECAT listing approval to Symvess. Along with this, we have recorded our first sale to a U.S. military facility. We did encounter some headwinds during April and May due to unsubstantiated public attacks by certain detractors.

However, we've seen an acceleration in VAC approval activity and commercial sales in June and July, coupled with the continued advancement of our acellular tissue engineered vessel or ATEV in our pipeline programs. We believe that we're positioned for growth and value generation in 2025 and beyond. During today's call, I'll review these developments in more detail before turning the call over to Dale for a review of our financial results. B.J. Scheessele, our Chief Commercial Officer, will then join us to help answer your questions. Beginning with our commercial launch of Symvess, we're pleased by the traction that we've continued to gain in our interactions with civilian hospitals. To date, a total of 13 organizations have completed the VAC process and have approved the purchase of Symvess. Because some of these VAC approvals include multi-hospital networks, a total of 82 civilian hospitals are now eligible to purchase Symvess.

This is an enormous increase from the 5 civilian hospitals that were eligible to purchase Symvess at our last quarterly earnings call. Furthermore, an additional 40 VAC sites are currently conducting reviews of Symvess, and we expect that the number of hospitals eligible to purchase Symvess will continue to grow. After VAC approval, contracting and negotiations with each individual hospital are completed before sales and shipments to that hospital can commence. Currently, our sales team is actively targeting high-volume centers having VAC approval for contracting negotiations. July product sales of approximately $0.3 million exceeded the total sales that we recorded for the first half of the year. Also in July, we announced that Symvess was awarded the electronic catalog or ECAT listing approval from the U.S. Defense Logistics Agency. ECAT is an Internet system that provides the Department of Defense and other federal agencies with access to manufacturers and distributors' products.

The ECAT approval makes Symvess available to health care professionals treating military service members, veterans, and other patients receiving care at approximately 35 military treatment facilities and approximately 160 U.S. Department of Veterans Affairs hospitals. With ECAT approval in place, it's not generally necessary to also obtain VAC approval at the military treatment facilities or VA sites. Instead, purchases are facilitated directly through the ECAT system. Since obtaining ECAT approval just a few weeks ago, we've already recorded our first commercial sale to a U.S. military facility. This facility is a state-of-the-art medical complex located on a major U.S. military base and provides health care to approximately 200,000 active duty service personnel, retirees, and their family members. Subsequent to the initial shipment, this facility has also reordered Symvess. We have great interest in improving the medical options that are available to health care professionals who are treating military personnel and their families, and we're actively advancing our discussions with additional military treatment facilities.

In August, we were notified that the Centers for Medicare and Medicaid Services, or CMS, declined to approve our application for the new technology add-on payment, or NTAP, for Symvess. Our application was submitted in October of 2024, and along with the majority of applications that were submitted to CMS this cycle, our application was denied. The reason provided by CMS was that Symvess does not have a unique mechanism of action as compared to veins or synthetic grafts and therefore, did not qualify for their newness criterion. This conclusion was extremely surprising to us. We believe that the potential impact of the NTAP on our commercial success is fairly limited because only about 4.3% of vascular trauma patients who are falling within our approved indication are covered under Medicare reimbursement. Private pay insurers are the most common source of reimbursement for vascular trauma patients that are falling within our indication.

We're engaging in discussions with private payers about supplemental reimbursement for Symvess in the trauma indication. We believe that the results of our budget impact model, or BIM, which we published several months ago, along with our published clinical trial results, will encourage supplemental reimbursement from private payers. I'll now turn to the ATEV program, which is our next priority, focusing on dialysis access for patients with end-stage kidney failure. We're pleased to see that results from our V007 Phase III trial were presented in a plenary session at the Society of Vascular Surgery Annual Meeting in June. The V007 results presentation focused on patients at high risk of fistula non-maturation and was one of only three selected for special mention by the society in their own announcement. The V007 clinical trial enrolled a total of 242 patients, of which 110 were considered to be at high risk of fistula non-maturation.

Among this high-risk cohort, functional patency at 6 months and secondary patency at 12 months were significantly higher in ATEV recipients as compared with fistula. Duration of access usability over the first year was also significantly higher in the ATEV group at 8 months versus only 4.5 months for arteriovenous fistula with a p-value of 0.0002. The results of the V007 trial have also been accepted for presentation at the Annual Kidney Week meeting for 2025 later this year. Women and men having diabetes and obesity make up more than half of the dialysis access market. Patients with a high risk of fistula non-maturation have historically been underserved by the current standard of care since waiting for fistula maturation can result in prolonged catheter exposure, increased risk of infection, and additional procedures performed to assist in the maturation of the non-functioning fistula.

Because of these risks, patients with fistula non-maturation have a high unmet medical need. We believe that the efficacy and safety results of the V007 subgroup combined with the approximately 50% fistula failure rate in this high-risk group means that this is an excellent population for us to target in the market. We look forward to the publication of the results from the V007 Phase III trial in a major peer-reviewed medical journal later this year. After discussions with the FDA about a supplemental BLA filing in dialysis access, we're planning to target the general subgroup of patients at high risk of fistula non-maturation. Before we file a supplemental BLA, which we anticipate later in 2026, our plan is to complete the interim analysis of the currently ongoing V012 Phase III trial that's being conducted only in women and which compares the ATEV to fistula for hemodialysis access. To date, a total of 100 patients have been enrolled in the V012 Phase III trial out of a target of approximately 150 patients.

An interim analysis is planned when the first 80 patients reach 1 year of follow-up, and this enrollment threshold was achieved in April of 2025. Subject to these interim results, Humacyte's plan is to submit a supplemental BLA in the second half of 2026, including data from V012 and the V007 Phase III pivotal studies to expand the Symvess label and add AV access for hemodialysis as an indication. We're pleased with the progress that we're making in 2025, and we look forward to sharing our progress with all of you as the rest of the year unfolds. With that, I'll now turn it over to Dale for a review of our financial results and other business developments.

Thank you, Laura. We reported $0.3 million in revenue for the second quarter of 2025, of which $0.1 million related to U.S. sales of Symvess. The remaining $0.2 million resulted from a research collaboration with a large medical technology company to evaluate the potential use of our bioengineered human tissue in specific cardiovascular and vascular applications. Revenue for the 6 months ended June 30, 2025, was $0.8 million, of which $0.2 million related to U.S. sales of Symvess, and $0.6 million resulted from the research collaboration. There was no revenue for either the second quarter or the 6 months ended June 30, 2024. Cost of goods sold was $0.2 million for the second quarter of 2025 and $0.4 million for the 6 months ended June 30, 2025, and included overhead related to unused production capacity, which was recorded as an expense in the period. There was no cost of goods sold for either the second quarter of 2024 or the 6 months ended June 30, 2024.

As previously discussed, during the second quarter of 2025, we implemented a plan to reduce our workforce by 30 employees, defer additional planned new hires, and reduce other operating expenses. These cost reductions were made to extend our cash runway and to better align our organizational structure with our top business objectives. These reductions were made thoughtfully, and we retained key personnel, resources, and initiatives to meet our key corporate goals and milestones. These key objectives include the commercial launch of Symvess, including sales, marketing, and manufacturing, completion of the V012 Phase III pivotal study of the ATEV in dialysis, and the planned filing of a supplemental BLA with the FDA for the dialysis indication, as well as the filing of an IND to commence human studies of the small diameter ATEV in CABG. We estimate that we have incurred and will incur aggregate charges representing one-time cash expenditures for severance and other employee termination benefits of approximately $0.7 million, the majority of which was incurred during the second quarter of 2025.

We estimate net savings due to workforce reductions, operating cost reductions, and reduced capital expenditures, net of this termination severance and benefits totaling approximately $3.8 million in 2025. Net savings are estimated to be up to approximately $38 million in 2026 for a total estimated savings of over $50 million in 2025 and 2026 relative to the original budget forecast. Due to the timing of the cost reduction plan, any anticipated savings are expected to occur after June 30, 2025. Research and development expenses were $22.0 million for the second quarter of 2025 compared to $23.8 million for the second quarter of 2024 and were $37.4 million for the 6 months ended June 30, 2025, compared to $45.0 million for the 6 months ended June 30, 2024. The decrease in R&D expenses for the second quarter of 2025 compared to 2024 primarily related to the capitalization of overhead costs associated with the commercial manufacturing of Symvess, offset by higher non-commercial production runs.

The decrease in R&D expenses for the 6 months ended June 30, 2025, compared to 2024 resulted primarily from decreased material costs as the company began capitalizing expenditures for inventory following the commercial launch of Symvess, as well as the capitalization of overhead costs associated with this commercial manufacturing. Selling, general, and administrative expenses were $7.8 million for the second quarter of 2025 compared to $5.7 million for the second quarter of 2024 and were $15.9 million for the 6 months ended June 30, 2025, compared to $11.1 million for the 6 months ended June 30, 2024. The increase in 2025 expenses compared to the prior year resulted primarily from the U.S. commercial launch of Symvess in the vascular trauma indication, including increased personnel expenses. Other net income or expense for the second quarter of 2025 was a net expense of $7.9 million compared to a net expense of $27.2 million for the second quarter of 2024, and other net income of $54.4 million for the 6 months ended June 30, 2025, compared to other net expense of $32.5 million for the 6 months ended June 30, 2024.

The decrease in other net expense for the second quarter of 2025 and the increase in other net income for the 6 months ended June 30, 2025, compared to prior year results resulted primarily from the non-cash remeasurement of the contingent earn-out liability associated with our August 2021 merger with Alpha Healthcare Acquisition Corp. Net loss was $37.7 million for the second quarter of 2025 compared to a net loss of $56.7 million for the second quarter of 2024, and net income was $1.5 million for the 6 months ended June 30, 2025, compared to a net loss of $88.6 million for the 6 months ended June 30, 2024. The decrease in net loss for the second quarter of 2025 and the increase in net income for the 6 months ended June 30, 2025, compared to prior year periods was primarily due to the non-cash remeasurement of the contingent earn-out liability described above. We had cash, cash equivalents, and restricted cash of $88.4 million as of June 30, 2025.

Total cash used was $6.9 million for the 6 months of 2025 compared to net cash provided of $13.1 million for the first 6 months of 2024. The net cash used for the first 6 months of 2025 included $46.7 million in net proceeds from a public offering completed in March 2025. The total cash provided for the first 6 months of 2024 included $43.0 million in net proceeds from a public offering completed in March 2024 and the receipt of $20 million in proceeds from a draw under a loan arrangement that did not occur in 2025.

Thank you, Dale. The approval and launch of Symvess is a powerful example of our commitment to delivering truly transformative regenerative medicine solutions to improve patient outcomes. With our strong commercial execution, our promising pipeline, and our dedicated team, we're confident in our ability to continue making a positive impact. Thank you for joining our call today. And operator, we're now ready to take questions.

Our first question comes from Ryan Zimmerman with BTIG.

Appreciate it. Maybe just to start on some of the dynamics commercially, Laura. If you think about second quarter volume versus what's taken place in July and you noted that uptick, has anything changed in your view that you think you can identify in July that now becomes kind of more part of your commercial strategy in terms of launching Symvess?

Thank you for that, Ryan. A lot of it is just passage of time. We really embarked on the VAC process in late February and early March, and many of these committees just take months and months. So part of it was that. Part of the uptick in hospitals eligible to purchase Symvess was the fact that we did have several hospital systems approve the product in their VAC process. But I would also say we're looking at; we've looked at decreasing the price of Symvess from $29,500 to $24,250. This decrease in price still allows us to have good margins on the product. However, by coming in below $25,000, this has increased the ease with which VAC committees can review our product and agree to bring it on to the shelf.

Yes. That was my next question about the pricing strategy, specifically regarding unit volumes compared to revenue. Is this now a standard practice across all facilities? How should we view your pricing strategy moving forward? Should we consider this the new price point for the future?

I believe this is the new price point we should consider. We implemented this price point on July 1, which aligns with the increase in sales. However, I don't believe that was the sole factor, as we had centers purchasing before the price drop. Nonetheless, this price reduction will now be the standard for the next year. Similar to other medical products, we will evaluate annual price increases each year.

Our next question comes from the line of Josh Jennings with TD Cowen.

I wanted to ask about the challenges you mentioned earlier in the year related to unsubstantiated criticism. Could you discuss the accumulation of real-world evidence and any registry data that might be developed in the upcoming quarters and years to help counteract this criticism?

We have some commitments with the FDA to establish a registry of trauma patients and monitor at least 100 patients for a year. We're still finalizing the protocol with the FDA, so the registry hasn't officially started yet, but we are on track with our timelines and milestones. I believe that real-world evidence will continue to accumulate in various hospitals using the product. Several hospitals have reordered it, and many are experiencing significant success. Thus, I think that word of mouth, along with publications from actual use of the product, will greatly strengthen our commercial position.

Real quick, Josh, it's B.J. here. I was just going to jump in and add to what Laura was saying. Obviously, we had published our budget impact model, but we continue to publish our trauma data, both civilian and military, be it the U.S. and work in Ukraine. First, it was 30-year data, and we have upcoming 1-year data to continue to show the durability of our product. I think that's important. And just to round out around the public attacks, how that has played out, and it was somewhat to Ryan's point, too, is that it's just really slowed the approval process. The majority of the effect is that it's just now taking longer to get through hospitals, but we have been able to overcome that. I believe the tough economy has made it tougher for any new products. You talked to other companies that have launched new products recently, and it's just, in general, a longer process. However, given our full funnel and working through this process and the success that we had end of June and beginning of July, I feel that we're turning the corner.

And I wanted to touch on the inclusion on the electronic catalog and open up access to the 190 military treatment facilities. Any help just thinking through the commercial effort in this VA hospital channel to drive increased traction? I know you've had your first order, but wanted to kind of get help thinking about the back half of the year in this channel and into 2026 and how you guys can go on offense more fully here?

Yes. I see this as both working with individual hospitals and pursuing larger purchases from groups of hospitals. In the short term, the ECAT opens up access to military treatment facilities, which we view as key targets, along with a broader number of VA facilities. However, within the VA hospitals, we will be more selective, focusing on those that perform trauma procedures. We have received initial orders and reorders, and we've met with major facilities involved in our clinical work, as well as those we've had discussions with that have used our products in the military. They are introducing us to other hospitals and surgeons. Throughout the rest of this year, we plan to penetrate these target hospitals. Additionally, we are concurrently working on the procurement process for bulk purchases. I believe that as we gain more successful military experience, and as we work through the procurement process towards the end of this year and into next year, larger purchases will become more attainable for us.

You enrolled 80 patients for the AV access indication back in April and have increased that number to 100 today. Can you provide a forecast for completing enrollment for the trial of 150 patients by the end of 2025? Additionally, could you outline the timelines for the interim analysis after the last patient completes their 12-month follow-up in April 2026 and how that might unfold next year?

Yes, Josh. So we're aiming to complete 150 patients by the end of the year. It's always hard to know. It's very hard to predict trial enrollment. So it could be before the end of the year or a little after the end of the year, hard to know. However, the interim analysis is now fixed, as you mentioned, in April of 2026. I would imagine we will have top-line results from that, certainly by May or June for that interim analysis. Then we would be able to share those results with the market. As far as the way the trial is designed, the way it was originally written is that if we are successful on the interim analysis, and if our vessel is superior to fistula with those 80 patients, then we're done. The trial is successful, and we move on. In that situation, we would then, as we've said, anticipate filing a supplemental BLA in the second half of 2026. If we don't hit that interim analysis, then we just continue following the 150 patients, and we would feel pretty confident that we're going to hit the analysis at 150. All of those patients would already have been enrolled, and the additional time lag there would be, I don't know, 6 or 8 months, something like that.

Our next question comes from the line of RK with H.C. Wainwright.

Laura and Dale, a couple of quick questions from me. The first question is, looking back at the first quarter press release, you were stating 45 hospitals had initiated the VAC process. So how many of those have actually ordered at this point? And also, any insight into what the timeline is in general for getting through the VAC to the ordering process itself?

Laura, I can jump in on that.

Yes, why don't you take that, B.J., you'll be better.

It is a mix of hospitals that we started early and then hospitals that we've approached more recently. A mix of them that have worked through the process to then have the approval to then be able to sell into. As we stated in the press release, we've had 12 hospitals to date order Symvess, and then a number of them actually already having reordered. So our success rate with VAC is strong. As I mentioned before, in Q2, some of the public attacks did slow us down with value analysis committees. From my commercial experience, you could think of 3 to 6 months to get through a value analysis committee and then obviously contracting on the back end. We view that as 6 to 9 or more months now, in general, because of the economy, but then also some of the attacks. However, we have a full sales funnel, and not all of them take the upper end and not all of them in the lower end. So if you have a full funnel, you always have something coming through on the back end to approval and then be able to sell into. That's something that we've accounted for, and as I mentioned, I believe that we're turning the corner on.

The second question is regarding the negative decision by the CMS. What sort of an impact, if any, would it have on the private payers' reimbursement decisions?

Yes, Laura, I can jump in on that one, too, and feel free to add. As Laura had mentioned, obviously, a disappointment for us, newness. I think we can kind of all agree that our product is new and a one-of-one type. However, we were denied, which was disappointing. There are pathways that we think you can refile. That's something we will look at and consider. However, when it rolls to private payers, they are the ones that pay the majority of these vascular trauma repair type procedures in these patients. We believe that our product is new. However, more importantly, how private payers view this is based on your clinical and health economic data. Therefore, not only what we've gathered but also published peer-reviewed data, both on the clinical side and following these patients over time, and our budget impact model that is also published, which reduces costly complications like infections and amputations versus products that are used today. We believe private insurers will see this as a strong value proposition and work with them to get them to incrementally pay for our product.

I would add to that, RK, that our success rate with VACs has been pretty good, and we've gotten into an enormous number of hospitals just in the last couple of months, up to 84, which is very exciting for us. When hospitals look at the financial prospects for a product, they are really just looking at the puts and takes on that initial hospitalization because this is a DRG process. Hospitals are focused on the cost to take care of that patient during the hospitalization. Payers, on the other hand, are responsible for longer-term complications. Particularly with infection and amputation, which drive a lot of costs, the initial hospitalization continues to drive costs after discharge because of readmissions, physical therapy, and repeated procedures. Insurance companies are on the hook for all of that. We believe that our financial case for providing a supplemental payment for Symvess in trauma will be even stronger with private payers. We are preparing our case and aligning with private payers, and we're going to start those conversations very soon.

Our next question comes from the line of Bruce Jackson with the Benchmark Company.

I was wondering if we could get an update on the coronary artery bypass graft program.

Yes, absolutely. We have a paper that's been accepted for publication about our primate results in coronary artery bypass that we expect to publish in the near future, and we will put out a press release with that when that happens. We're also making excellent headway on our IND filing with the FDA. So we're in the process of pulling that filing together, and we expect to have that in later in 2025, as we've messaged to the market previously. After we submit the IND, we anticipate that the FDA will spend some time looking at it. We're a first-in-class product, and we're going into the human coronary system. Therefore, we expect that there will be some review time. However, once they approve it, and I certainly anticipate that they will, we would start our clinical trial sometime in 2026. Everything is on track with what we've messaged to the market previously.

Ladies and gentlemen, that concludes our question-and-answer session. I'll turn the floor back to Dr. Niklason for any final comments.

Thank you, everyone, for joining us this morning. Our fantastic commercial team has continued to execute during this exciting time. I personally am very excited by the fact that so many hospitals and both civilian and military treatment facilities and VAs are now eligible to purchase our product, more than 200 facilities. If we compare that to the 5 facilities that were on tap to purchase our product just 3 months ago, I think this is huge progress. We'll continue working on the contract negotiations and continue shipping and selling product. It's about making products and selling products. That's where our focus is, and I'm so glad that we're getting traction here. I appreciate your time, and I look forward to sharing more results with you later this year.

Thank you. This concludes today's conference call. You may disconnect your lines at this time. Thank you for your participation.