BioStem Technologies, Inc. (BSEM) Earnings Call Transcript

Thank you. Good afternoon and welcome everyone to the BioStem Technologies second quarter 2026 earnings call. Today's conference is being recorded. [Operator Instructions] At this time, I'd like to turn the conference over to Tripp Taylor, Investor Relations. Please go ahead.

Good afternoon, everyone, and thank you for joining our conference call to discuss BioStem's second quarter 2026 financial results and corporate highlights. Leading the call today will be Jason Matuszewski, the company's Chairman and Chief Executive Officer; Brandon Poe, the company's Chief Financial Officer; and Barry Hassett, the company's Chief Commercial Officer. Before we begin, I'd like to remind everyone that our remarks may contain forward-looking statements based on management's current expectations. These risks and uncertainties are more fully described in our press release issued today and in our filings with the U.S. Securities and Exchange Commission. Our SEC filings can be found on our website or the SEC's website. Investors are cautioned not to place undue reliance on forward-looking statements. Finally, this call also includes reference to non-GAAP financial measures. A reconciliation to comparable GAAP measures and related information can be found in our earnings press release posted on the Investor Relations section of BioStem's website. With that, I would now like to turn the call over to Jason Matuszewski.

Thank you, Tripp, and good afternoon, everyone. The second quarter was BioStem's first full quarter operating as a predominantly hospital-focused business. During the quarter, we increased hospital revenue sequentially to $6.7 million, completed the implementation of BioStem's own customer relationship management system, and continued building the commercial organization needed to support our growth strategy. After quarter end, we also completed our uplisting to the Nasdaq Capital Market, and our common stock began trading on Nasdaq on August 7. I want to congratulate our team and thank our shareholders, employees, and business partners whose hard work helped us reach this important milestone. The Nasdaq uplisting broadens BioStem's visibility, expands our access to the capital markets, and supports our ability to attract and retain talent. It is an important corporate achievement, and we are pleased to be trading on a national exchange that will enable us to maximize the value of the company through our fundamental business execution. We remain focused on 4 priorities designed to maximize value. First, completing and optimizing the integration of our product lines, internal systems, and commercial organization. Second, driving adoption and utilization across the hospital channel. Third, advancing our first 510(k) product and the broader product roadmap. And fourth, preparing for the manufacturing transfer of the NEOX and CLARIX product lines. We have made progress on each of these priorities during the quarter. Beginning with integration, our core commercial infrastructure is now in place and operating in line with our expectations. Until the beginning of August, BioTissue provided sales logistics, operational support, invoicing, and collections under a transition services agreement. That agreement provided business continuity while we built our internal systems and capabilities. We have transitioned those functions in-house and launched the first phase of our new customer relationship management platform, integrated with our enterprise resource planning system. This automates and connects order processing, invoicing, and collections across our organization. These capabilities give us better visibility into account activity, ordering patterns, product utilization, and sales performance. They also improve our ability to target new accounts and support the organization as it scales. In parallel, we continued integrating and expanding the commercial team. During the quarter, we introduced our BioRetain dry products to the hospital sales organization, giving the team an additional product line to offer across its customer base. As our systems, order processing, and logistics become more integrated and automated, we expect the organization to become increasingly productive. To discuss our commercial efforts and product roadmap in greater detail, I will turn the call over to Barry Hassett, our Chief Commercial Officer.

Thanks, Jason. Turning to our second priority, driving adoption of our product portfolio, including the NEOX, CLARIX, and VENDAJE brands in the hospital channel. These products are used across a broad and growing set of surgical and wound care applications, including urology, orthopedics, spine, women's health, foot and ankle, colorectal surgery, and acute and chronic wound care. Collectively, these applications represent an estimated $26 billion addressable market for BioStem. Our commercial focus is straightforward, continuing to add new surgeons and new hospital accounts while increasing utilization among surgeons and hospitals already using the NEOX and CLARIX allografts. With the core integration substantially complete, we have continued to expand our direct sales organization and remain on track to reach more than 40 W-2 representatives and more than 30 independent sales agents by year-end, more than doubling our direct sales force since the time of the acquisition. This expansion increases our coverage of hospital call points nationwide, supports deeper engagement with existing customers, and extends our reach into new accounts. As we complete the scaling of our commercial organization, we believe we are well positioned to drive broader adoption of our portfolio and support sustained growth. We are also working to convert our broad contractual access to drive market penetration. We have agreements with major hospital group purchasing organizations whose member facilities represent access to more than 70% of U.S. hospital beds. We are working to add the VENDAJE product line to applicable GPO contracts, giving surgeons access to our full portfolio of products, all of which are supported by clinical evidence. At the local level, our team remains focused on value analysis committee approvals, surgeon education, and recurring case utilization. Product differentiation is also central to our strategy. During the quarter, we received 8 new U.S. design patents covering aspects of our fenestrated human placental allograft designs. These patents expand the protection around our product form factors and complement our clinical and commercial differentiation. Turning to our third priority, advancing our product roadmap, we continue to anticipate launching our first 510(k) cleared product later this year. We believe this product can provide an additional point of differentiation between BioStem and our competitors and support the continued expansion of our portfolio. We are also evaluating whether selected existing products could benefit from alternative regulatory pathways. This review considers clinical need, market opportunity, development requirements, and appropriate regulatory next steps. Clinical evidence remains a central pillar of our commercial strategy, and we believe it is another increasingly important differentiator in this market. Our BioRetain DFU and VLU programs, anchored by the Level 1 randomized control trial results, reflect a deep level of investment in clinical data generation as demonstrated by the publication of our top-line DFU results in late 2025. We expect to publish additional results from our DFU trial in the coming months and complete the VLU study with top-line published data later this year. As the reimbursement landscape evolves, we believe high-quality clinical evidence will play an increasingly important role in product selection and coverage decisions. We intend to use our data to support both continued adoption and expanded payer coverage. This evidence base also informs how we engage directly with surgeons and clinicians. During the quarter, we expanded our presence at key professional society meetings, hosted hands-on training events, and worked alongside key opinion leaders to increase awareness of our products and the clinical experience, supporting them across multiple specialties. These activities are increasing clinician familiarity with our differentiated portfolio, reinforcing confidence in our products' performance, and creating additional opportunities to expand utilization in both existing and new accounts. Finally, I would like to briefly address the physician office market. Results during the quarter were stronger than we expected, but 1 quarter does not indicate broader stabilization or recovery of the market. We continue to anticipate gradual stabilization during the second half of the year. Venture Medical, along with our recently launched pilot program, continue to serve physician office, mobile wound care, and alternative site customers. We will continue supporting this market segment through these channels while directing the majority of our incremental commercial resources toward the hospital market. I'll now turn it back to Jason to discuss our technology transfer in further detail.

Thanks, Barry. Our fourth priority is the technology transfer of the manufacturing of the NEOX and CLARIX product lines to BioStem's facilities. Our operations team continues to review product requirements and the transfer plan with BioTissue. We remain on track to initiate the technology transfer in the first half of 2027. We are able to manufacture NEOX and CLARIX products in our existing facility with minimal capital expenditures required. The synergies created by bringing manufacturing of these products in-house will improve our operating leverage and drive increases in gross margin and profitability. We expect the gross margin benefit to begin after the transfer is successfully completed with further opportunity as production volumes scale. Throughout the transition, we expect product continuity will be maintained under our manufacturing and supply agreement with BioTissue. With that, I'll turn the call over to Brandon to walk through our financial results in the quarter.

Thanks, Jason. In the second quarter, revenue was $7.9 million compared with $6.1 million in the first quarter of 2026. The sequential increase reflects continued execution against our hospital-focused strategy, including the ramp-up of the expanded sales organization and increased utilization across our GPO contract base. The comparison also benefited from a full quarter of revenue from the acquired business in Q2, whereas the acquisition closed partway through the first quarter. Hospital revenue was $6.7 million compared with $5.4 million in the first quarter, while physician office revenue was $1.1 million compared with $772,000 in the first quarter. We continue to direct our strategy and resources toward growth in the hospital market while monitoring the recovery of the physician office segment. Gross profit was $4.8 million, representing a gross margin of 61%, compared with gross profit of $3.8 million and gross margin of 61% in the first quarter. The increase in gross profit was a result of higher revenue, while gross margin was unchanged sequentially. As discussed on our first quarter call, we expect modest gross margin pressure during the second half of the year as we work through the pre-existing NEOX and CLARIX inventory that we purchased shortly after the acquisition at a discount to supply agreement pricing. We expect gross margin to improve following a successful manufacturing transfer with additional opportunity as internal production scales. Operating expenses were $13.2 million compared with $12.6 million in the first quarter. The sequential increase was driven primarily by continued investment in the commercial organization and supporting infrastructure, partially offset by lower clinical trial and administrative spending. Our GAAP net loss was $9 million, or $0.52 per share, compared with net income of $10,000, or $0.00 per share in the second quarter of 2025. Adjusted EBITDA loss was $4.6 million compared with adjusted EBITDA income of $2.5 million in the second quarter of 2025. Cash and cash equivalents were $7 million as of June 30, 2026, compared with $13.7 million as of March 31, 2026. Operating cash use was $5.5 million during the quarter. Also during the quarter, we completed a $2.5 million institutional financing. And as a reminder, in late April, we also made a $3.5 million cash payment and issued a secured promissory note with a principal amount of $1 million to resolve $3 million of outstanding promissory notes and $2.3 million of accrued interest. In order to support our growth plans, we will look to further bolster our balance sheet as we determine the optimal capital structure for the business. We are evaluating multiple options, including non-dilutive alternatives. Now turning to guidance, we've been pleased with the performance of the newly acquired hospital business and are raising our full year 2026 revenue guidance to be in the range of $26 million to $29 million, an increase from our prior guidance of $25 million to $29 million. In the hospital business, we continue to expect sequential growth through this year as sales rep productivity and scale ramps, GPO account utilization deepens, and seasonality increases elective surgical procedure volume in the second half of this year. In the physician office market, while we are encouraged by our performance this quarter, we continue to expect a gradual recovery through the second half of the year rather than a durable inflection. On the expense front, we anticipate operating expenses to be approximately flat sequentially for the remainder of the year, excluding the Q3 impact of costs related to our Nasdaq uplisting. Increases in sales and marketing spend are expected to be offset primarily by reductions in general and administrative costs for legal and accounting fees related to our uplisting as we move into Q4, as well as reductions in stock-based compensation and R&D costs for both Q3 and Q4. I will now turn the call back to Jason for closing remarks.

Thanks, Brandon. The second quarter advanced BioStem's transition to a hospital-focused commercial model. We completed the core operational transition, expanded the commercial organization, advanced our product and clinical programs, and completed our uplisting to the Nasdaq Capital Market after quarter end. For the remainder of 2026, our focus is on 3 measurable areas: converting broader hospital access into increased product utilization, improving productivity across the expanded commercial organization, and completing the operational and regulatory preparation required for the NEOX and CLARIX manufacturing transfer. The Nasdaq uplisting gives us a broader platform, but execution against these priorities will drive value creation for our shareholders. With that, operator, please open the line for questions.

Thank you. [Operator Instructions] We'll take our first question from Swayampakula Ramakanth at H.C. Wainwright.

This is RK from H.C. Wainwright. The first question is on the balance sheet item. It shows a $10 million contingent consideration. I'm assuming this is the catalyst that is expected on August 13. Against your cash balance, how should we think about this? And is there any portion of this balance that can be paid as stock or deferrable, or is there any other format by which it can be satisfied?

Yes, hey, RK. This is Brandon. Yes, you're right. The $10 million in the balance sheet that you see is the contingent consideration that is directly related to the $10 million paper for the milestone. And to your point, we're working through the payment at this point. We're working through our options there to make that payment. Part of that is balled up in our comments around financing for the company and looking at different options for financing. So we're working through that right now. We did work through an extension of the payment with BioTissue. And so we feel like we're in good shape right now to sort of meet that extension, but we're still working through that and more to come on that at this point. Jason, anything you want to add?

Yes, I would just add, the 510(k) is really, frankly, a really good value-accretive addition to our portfolio. And I think when we look at the product and the opportunity, especially for the value of the asset, I think there's a huge opportunity for the product going forward in the hands of Barry and his team.

Then on the guidance range, I see that you raised the lower end of the guidance a bit, but also it implies that you're expecting somewhere between $12 million and $15 million for the second half, and you just printed out $14 million for the first half. What is making you a bit conservative still, and what is the push and pull on that number to get to the high end of that guidance?

I think, listen, we've been really happy so far with the performance of the acquired hospital business. I think we've said before that the first half of the year goal was to sustain what we had, both in terms of revenue, people, and customers. I think Barry and the team on the commercial side have done an incredible job with that. And we're excited about the second half of the year. We continue to expect sequential growth in the hospital business, as we've talked about with sales productivity, GPO account utilization, and some of the seasonality in the business that we've talked about. At this point, listen, we're newly uplisted to Nasdaq, and we're trying to give what we think is prudent guidance as we think about the risks that are out there. But we're excited about the back half of the year, I guess is the best thing I can say. I'm excited about where we're going from here.

Okay, then last question from me before I step back into the queue. Thinking about the pipeline in terms of the VLU study, it's fully enrolled, I believe, at this point. Do we still expect data to be published in the second half of 2026, at least the top-line, or do you think there's a little bit of a change in the plan?