Carl Byrnes

Carl Byrnes inquired about the current system placements from minority partners and the expected incremental placements from future partnerships.

Answer

CEO Hadar Levy explained that each minority investment partner plans to open 10-15 new clinics annually. He highlighted that early investments (Stella Mental Health and Axis) saw over 50% utilization rate growth since collaboration began, aligning with expectations.

Carl Byrnes from Northland Capital Markets asked about the Deep TMS system placements observed from current minority partners and the projected incremental system placements expected from future partnerships, assuming an average of five new collaborations annually.

Answer

CEO Hadar Levy explained that each minority investment partner provides a business plan projecting the opening of 10-15 new clinics annually, either through mergers and acquisitions or de novo expansion, which aligns with BrainsWay's expectations. Mr. Levy noted that while specific install base data from minority investments isn't shared, early partners like Stella Mental Health and Axis have shown over 50% growth in Deep TMS system utilization since their collaboration began, indicating strong technology adoption and expansion.

Carl Byrnes from Northland Capital Markets asked for clarification on the composition of the company's backlog, specifically the contribution from enterprise customers, and also requested the number of OCD system placements during the quarter.

Answer

CEO Hadar Levy confirmed that the company continues to focus on multi-year lease agreements, with the majority originating from enterprise accounts. He emphasized that this strategy is key to increasing the backlog and providing future revenue visibility. Levy also reported that BrainsWay shipped 30 OCD systems during the second quarter.

Carl Byrnes from Northland Capital Markets asked for clarification on the composition of the revenue backlog, specifically its relation to enterprise customers, and requested the number of OCD system placements during the quarter.

Answer

CEO Hadar Levy confirmed that the backlog is primarily driven by multi-year lease agreements with enterprise accounts, which enhances revenue visibility. He also disclosed that the company shipped 30 Deep TMS systems for OCD treatment during the second quarter.

Carl Byrnes asked for clarification on the composition of the company's backlog, specifically the contribution from enterprise customers, and requested the number of OCD system placements during the quarter.

Answer

CEO Hadar Levy confirmed that the backlog growth is primarily driven by multi-year lease agreements with enterprise accounts, which enhances revenue visibility. He also stated that the company shipped 30 OCD systems in the second quarter.

Carl Byrnes from Northland Capital Markets asked for clarification on whether the revenue backlog is primarily composed of enterprise customers and inquired about the specific number of OCD system placements during the quarter.

Answer

CEO Hadar Levy confirmed that the company's focus on multi-year lease agreements with enterprise accounts is the primary driver of the growing backlog and future revenue visibility. He also specified that BrainsWay shipped 30 OCD systems in the second quarter.

Carl Byrnes of Northland Capital Markets questioned the company's confidence in achieving its year-end BLA approvals without any delays into 2026. He also asked for clarification on the implied second-half run-rate for product sales and milestone revenues required to meet the full-year guidance, given the expected softness in Q3.

Answer

CEO Róbert Wessman expressed high confidence in meeting the targeted PDUFA dates for BLA approvals, noting that slippage is not typical. He reiterated that the guidance is back-end loaded, with significant milestones and related product shipments expected in Q4 following anticipated approvals, similar to the pattern observed in the previous year.

Carl Byrnes from Northland Capital Markets asked for quantification of the initial stocking impact for the Stelara biosimilar within the Q1 net product sales of $110 million.

Answer

Joel Morales, Chief Financial Officer, clarified that he would not characterize the sales as 'stocking.' He emphasized Alvotech's B2B model, where shipments are based on purchase orders from commercial partners. Morales attributed the sales figures to the timing of these orders rather than inventory stocking, highlighting the potential for quarter-over-quarter lumpiness inherent in their business model.

Carl Byrnes from Northland Capital Markets asked about the company's gross profit margin expectations for the next 12-18 months, considering sales ramp-ups and efficiencies. He also requested a breakout of U.S. product sales for the third quarter and the first nine months of the year.

Answer

CFO Joel Morales noted that product gross margin expanded significantly from 17% in Q2 to 37% in Q3 and is expected to continue expanding, but he declined to provide specific 2025 guidance. Morales and Chief Strategy Officer Ming Li stated that the company does not currently provide a geographic sales breakout but highlighted that ex-U.S. revenue is expected to contribute up to one-third of total revenue in 2024, with more granular reporting planned as the business matures.

Carl Byrnes of Northland Capital Markets questioned the nature of discussions with BARDA regarding the specifics of the DeepView system's commercial rollout plan in the years following a potential FDA approval.

Answer

Dr. Michael DiMaio, Chairman of the Board, responded cautiously, stating he could not speculate on BARDA's future actions or share details of their dialogue. He confirmed that the contract language includes provisions for BARDA to assist with the technology rollout but emphasized that it would be inappropriate to predict the exact methodology or extent of that support.

Carl Byrnes inquired about Spectral AI's commercial readiness for the DeepView system launch, asking about plans for staffing, regional focus, and potential co-promotion partnerships.

Answer

Executive Chairman Dr. Michael DiMaio explained that the company will precondition the market with studies and publications ahead of the launch. He noted that real-world evidence from the U.K. and Australia is building excitement. While co-promotion strategies are being discussed, nothing is material to disclose. Dr. DiMaio added that the initial 170-unit rollout under the BARDA contract will not require a large sales force, allowing for a smaller initial team.

Carl Byrnes inquired about Spectral AI's state of commercial readiness in the United States, specifically asking about future plans for training medical staff and establishing a dedicated sales force.

Answer

Dr. Michael DiMaio, Chairman of the Board, explained that the BARDA contract contains provisions to help initiate the sales force. He stated that the contract also facilitates the placement of approximately 200 devices into U.S. burn centers. In parallel, the company plans to conduct clinical workflow studies to demonstrate the device's value proposition, such as reducing operating room time or length of stay, which will in turn drive sales.

Carl Byrnes asked for the interest rate on the new senior credit facility with Hercules and the net cash amount that will be added to the balance sheet after all transaction-related expenses are settled.

Answer

CFO Ira Duarte disclosed that the interest rate on the new credit facility is slightly north of 10%. She also stated that the net cash added to the balance sheet from the financing, after all expenses, would be approximately $11 to $12 million.

Carl Byrnes questioned the sustainability of the high gross profit margin, the long-term peak sales potential for APONVIE, and the expected timing of a significant sales inflection for ZYNRELEF.

Answer

Craig Collard, Chief Executive Officer, clarified that the Q1 gross margin was unusually high due to strong CINVANTI sales from a higher-scale manufacturer and expects it to normalize to the mid-70s range. He positioned APONVIE as a potential multi-hundred million dollar drug, with growth driven by expanding usage beyond initial surgeries as reps gain more time for hospital-wide promotion. For ZYNRELEF, he anticipates a significant inflection in late Q3 and Q4, fueled by new accounts currently onboarding, which should be fully operational by June/July.

Asked about the ZYNRELEF sales trajectory for Q1, the impact of the CrossLink partnership on both ZYNRELEF and APONVIE sales, and the company's plans regarding the Baker Brothers debt.

Answer

Despite Q1 seasonality, ZYNRELEF daily sales are tracking higher than Q4, with a major inflection point expected mid-year. The CrossLink partnership frees up Heron's sales reps to drive deeper adoption and focus on APONVIE. The company plans to discuss options for the Baker Brothers debt soon, aided by the recent positive CINVANTI litigation outcome.

Carl Byrnes from Northland Capital Markets asked about the reasons for CINVANTI's sequential revenue decline in Q3 and its Q4 outlook, and later followed up with a question on the development status of the ZYNRELEF Prefilled Syringe.

Answer

CEO Craig Collard attributed the CINVANTI Q3 decline to the loss of a large account in a highly competitive market but projected a strong Q4 rebound, driven by the 'One Heron' sales strategy gaining traction in the 340B hospital setting. For the second question, EVP and Chief Development Officer Bill Forbes stated that the Prefilled Syringe program is progressing as expected, with a target approval in late 2026 or Q1 2027, positioning it as a future 'gold standard' beyond the VAN.

Carl Byrnes of Northland Capital Markets asked about the long-term potential for SUBLOCADE's commercial channel penetration, seeking to understand what a realistic target would be, given that commercial patients represent 60% of covered lives but only 25% of current volume.

Answer

CEO Joe Ciaffoni clarified that while Indivior expects the contribution from the commercial business to become 'meaningfully higher' than the current 25%, he would not set an expectation that it would ever be on par with or near the level of the Medicaid business, which will remain the primary contributor.

Carl Byrnes of Northland Capital Markets inquired about the potential for CMS to be flexible on the proposed $125.38 fixed reimbursement rate, the risk of stocking anomalies ahead of new LCDs taking effect, and the timeline for the Vaprox partnership to contribute materially to revenue.

Answer

CEO Joseph Capper stated he could not handicap CMS's flexibility on the price point but confirmed Mimetics would submit comments and recommendations. On inventory, he noted the company is experienced in managing stock levels and will monitor the situation closely, with CFO Doug Rice adding they are well-prepared due to their strong balance sheet. Regarding the Vaprox partnership, Capper clarified that a material revenue contribution is not expected in the near term and would likely not be seen until next year.

Carl Byrnes from Northland Capital Markets inquired about the discrepancy between the strong Q1 adjusted gross margin of 84% and the full-year guidance of 82-83%, asking if product mix was the driver. He also requested a progress update on EPIFIX sales in Japan.

Answer

CFO Doug Rice confirmed that the expected moderation in gross margin throughout the year is indeed due to product mix, as some product ASPs have decreased. CEO Joe Capper added that EPIFIX in Japan is performing as expected and growing on track, but its overall revenue contribution is not yet material enough to be disclosed separately.

Carl Byrnes of Northland Capital Markets asked for more detail on the drivers behind the significant year-over-year growth for EpiFix in Japan.

Answer

CEO Joe Capper explained that the high growth is off a very low base, as MiMedx was the first to introduce human tissue products to the Japanese market. The growth is driven by the successful targeting of key opinion leaders and top wound care doctors who are now seeing positive results and reordering the product. CFO Doug Rice clarified that while international sales were a key driver, the 'other' revenue category's growth was not solely attributable to Japan.

Carl Byrnes asked about the likelihood of CMS adopting a price-per-square-centimeter reimbursement model and how the HELIOGEN launch process differs from previous product introductions.

Answer

CEO Joseph Capper confirmed that MiMedx has advocated for a price-per-square-centimeter model but believes such a change is unlikely before the 2025 physician fee schedule at the earliest. He stated the HELIOGEN launch is similar to past surgical rollouts, while Executive Matthew Notarianni added the key difference is the need to navigate the hospital-by-hospital value analysis committee process, which is not a factor in physician office settings.

Carl Byrnes inquired about the breakdown of system placements between smaller and larger customers, the outlook for this mix, and the typical length of the sales cycle from initial contact to a purchase order.

Answer

CEO Morgan Frank explained that distinguishing between large and small customers is complex, as large chains often have individual facilities making independent purchasing decisions. He noted that the sales cycle can vary significantly, ranging from a few days for simple inbound requests to several months for larger, more complex negotiations.

Carl Byrnes of Northland Capital Markets asked for a breakdown of Q4's 135 UltraMIST placements between large enterprise and smaller accounts, and how the company plans to manage potential revenue lumpiness from larger customers in 2025.

Answer

CEO Morgan Frank stated that Q4 placements were a mix of new small customers and existing customers expanding, including one significant customer who ordered nearly 20 systems. He explained that the company's base business planning assumes a steady pace of smaller sales, with large orders considered upside. Frank noted they are preparing operationally to handle large orders by increasing manufacturing capacity to 25 systems per week, with the ability to double that on 60 days' notice. He emphasized that the company will not delay large orders to smooth out quarterly results.

Carl Byrnes asked for clarification on the expected incremental operating expense from the PanTHERA acquisition for the remainder of the year.

Answer

CFO Troy Wichterman confirmed that the acquisition is expected to add approximately $1 million in incremental R&D-related operating expenses for the remaining nine months of 2025.

Carl Byrnes from Northland Capital Markets asked for an update on potential strategic partnerships or business development discussions, including co-development or regional licensing, to fund the Phase III study for larsucosterol.

Answer

Chief Financial Officer Timothy Papp responded, confirming that DURECT has ongoing and active efforts to explore a full range of strategic options. While he could not comment on specific discussions or timing, Papp expressed optimism about finding a solution to fund the product's development despite challenging capital market conditions.

Carl Byrnes asked whether DURECT recognized any royalty revenue from its partner Innocoll for POSIMIR during the third quarter.

Answer

Timothy Papp (Chief Financial Officer) confirmed that no royalty revenue from Innocoll was recognized in the third quarter.

Carl Byrnes asked about the mechanics of revenue recognition for the hospital division, specifically how revenue is recognized at the time of service versus after the Independent Dispute Resolution (IDR) process. He also sought to understand the Q4 adjusted EBITDA, how much was attributable to IDR awards, and what a normalized figure might look like. He later asked to quantify the normalized year-over-year increase in revenue per visit driven by higher acuity.

Answer

CFO Jon Bates clarified that the company estimates the realizable value for each visit upon service, using a model that incorporates historical data and is now being updated with results from the arbitration process. Regarding EBITDA, he suggested its quarterly attribution would follow a similar trajectory to the revenue recognized from IDR. For revenue per visit, he noted it was ~$1,514 in 2023 and ~$2,600 for the full year 2024, suggesting the go-forward normalized rate is still being determined but will fall in that range.