Chase Knickerbocker

Chase Knickerbocker asked for an update on the average number of treatments per patient and the typical interval between treatments in the real world. He also sought clarification on the new patient start assumptions embedded in the $100 million revenue guidance for 2026, asking if it represents a floor. Additionally, he inquired about the expected cadence of new center activations throughout the year and requested guideposts for R&D and SG&A expenses, as well as insights into patient enrollment modeling for ongoing studies.

Answer

Gerard Michel, CEO, confirmed that the average number of treatments per patient remains consistent at approximately 4.1, with treatment intervals stretching closer to 8 weeks, currently in the low 7s. For the 2026 guidance, Mr. Michel stated they assume an average of 0.5 new patient starts per site per month, consistent with 2025, with stronger Q1/Q2, Q3 seasonality, and a Q4 rebound. He expects new center activations to be weighted towards the second half of 2026 due to salesforce expansion, medical affairs team invigoration, and the anticipated impact of CHOPIN data. Sandra Pennell, CFO, guided for R&D expenses to increase by nearly 90% in 2026, with a significant bolus in Q1, and SG&A expenses to increase by nearly 50%, also with a substantial rise in Q1, primarily driven by commercial expansion.

Chase Knickerbocker asked for an update on the average number of treatments per patient and the typical interval between treatments. He also sought clarification on the assumptions for new patient starts embedded in the 2026 revenue guidance, specifically whether the $100 million target represents a floor and the assumed average new patients per site per month. Additionally, he inquired about the expected cadence of new center activations for 2026 and requested guideposts for R&D and SG&A expenses, particularly in relation to patient enrollment in ongoing studies.

Answer

Gerard Michel, CEO, confirmed the average treatments per patient remains around 4.1, with the interval between treatments stretching closer to 8 weeks, currently in the low 7s. For 2026 guidance, he stated they assume an average of 0.5 new patients per site per month, consistent with 2025, with revenue growth driven by an increasing number of sites. Michel anticipates more center activations in the second half of 2026 due to sales force expansion, reinvigorated medical affairs, and the CHOPIN publication. Sandra Pennell, CFO, projected nearly 90% R&D growth in 2026 over 2025, with Q1 2026 R&D increasing approximately 20% over Q4 2025, followed by roughly 15% quarterly increases. SG&A is expected to increase by nearly 50% overall in 2026, with Q1 2026 SG&A rising 30-40% over Q4 2025, then showing flat or modest increases thereafter.

Chase Knickerbocker inquired about the pace of new treatment center activations, the expected treatment volume per center, and the cadence of operating expenses and EBITDA for the remainder of the year.

Answer

CEO Gerard Michel clarified that new center additions will be more evenly spread throughout the year, targeting around 30 total by year-end. He noted new centers take about six months to ramp up, keeping the treatment average just under two per month. CFO Sandra Pennell projected a significant increase in both SG&A (~60%) and R&D (~150%) expenses for 2025 over 2024, but stated the company should remain EBITDA positive for the year.

Chase Knickerbocker of Craig-Hallum inquired about the activation timeline for centers in the queue, revenue concentration among top accounts, the competitive landscape with emerging systemic therapies, and the extent of any off-label use.

Answer

CEO Gerard Michel projected a back-half weighted activation schedule to reach 30 centers by year-end and noted revenue concentration is decreasing but still significant. He positioned HEPZATO as a necessary, complementary liver-directed therapy alongside systemic agents, a sequencing strategy already being adopted by physicians. He confirmed there is no meaningful off-label use currently.

Chase Knickerbocker from Craig-Hallum asked about learnings on center activation timelines, the potential for new centers to become top performers, the commercial impact of positive CHOPIN data, and the incremental R&D investment required for the new trials.

Answer

CEO Gerard Michel noted that center activation is complex and hard to predict, with a mean timeframe of 6-9 months, but he remains confident in reaching 20 active centers in Q1 2025. He believes positive CHOPIN data could make HEPZATO the standard of care, accelerating uptake and peak sales. SVP of Finance Sandra Pennell reiterated the 2025 R&D forecast of $35M-$40M, which includes the investment for the two new trials.

Chase Knickerbocker asked what 'inning' Phathom Pharmaceuticals' sales force is in regarding full productivity after shifting focus and changing geographical lines in the fall, and if increased productivity or efficiency has been observed.

Answer

Steven Basta, President and CEO, used a baseball analogy, stating the sales force is in the '7th or 8th inning' of achieving full effectiveness, as productivity takes several months post-onboarding and training. He noted that increased effectiveness leads to a cumulative growing effect over time, impacting incremental adoption and refills, rather than an immediate, sharp change in monthly revenue.

Chase Knickerbocker from Craig-Hallum asked about the current stage of sales reps reaching full productivity after the fall's strategic shift and geographical realignments, and whether increased productivity or additional efficiency gains are expected.

Answer

Steven Basta, President and CEO, estimated the sales force is in the '7th or 8th inning' of reaching full productivity, with new reps hitting the ground after January/February training. He explained that increased sales effectiveness leads to a cumulative growing effect on revenue over time, rather than an immediate, sharp change, as incremental conversions lead to ongoing refills.

Chase Knickerbocker of Craig-Hallum asked about the expected impact of DTC spending cuts on script growth, the 2025 revenue outlook, plans for the sales force, and clarification on the 2026 profitability target.

Answer

President and CEO Steven Basta stated that the DTC cuts are not expected to adversely affect the revenue ramp, as field sales are the core growth driver, and affirmed comfort with the current analyst consensus for 2025 revenue. He confirmed no sales force reductions are planned. Regarding profitability, he emphasized a commitment to cost discipline to reach that goal in 2026, with the exact timing dependent on the revenue ramp.

Chase Knickerbocker inquired about the progress of penetrating the primary care physician (PCP) market, asking if it was still early days. He also asked about the metrics used to track sales force success and the potential timing for 2025 financial guidance.

Answer

CCO Martin Gilligan confirmed that PCP awareness and prescribing have grown significantly, with new PCP writers now outpacing gastroenterologists. He said the sales force is tracked on call frequency and message delivery, with positive results. CFO Molly Henderson reiterated that while script trends are positive, the company needs several more months of NERD launch data before it can confidently provide 2025 guidance.

Chase Knickerbocker inquired about Indivior's 2026 guidance assumptions for LAI market growth and SUBLOCADE market share, the LAI market growth rate in Q4 2025, and the company's prioritization between share buybacks and M&A in its capital allocation strategy.

Answer

CEO Joe Ciaffoni indicated the 2026 SUBLOCADE guidance assumes mid-teen growth and continued market share stabilization. Chief Commercial Officer Patrick Barry reported Q4 LAI category growth approaching 18%. CFO Ryan Preblick clarified that capital allocation is an 'and' not 'or' approach, focusing on debt management, opportunistic share repurchases (with a new $400 million program), and evaluating commercial asset acquisitions, all aimed at driving shareholder value.

Chase Knickerbocker inquired about Indivior's 2026 guidance assumptions for LAI market growth and SUBLOCADE's market share. He also asked for an update on the LAI market growth in 2025 and the company's capital allocation priorities between share buybacks and M&A.

Answer

CEO Joe Ciaffoni indicated that the 2026 SUBLOCADE guidance assumes mid-teen dispense growth and continued stabilization of market share, without specifying LAI market penetration assumptions. CCO Patrick Barry reported LAI category growth approaching 18% in Q4 2025. CFO Ryan Preblick clarified that capital allocation is an 'and' strategy, including managing debt, opportunistic share repurchases (with a new $400 million program), and evaluating business development opportunities for phase III breakout, all aimed at driving shareholder value.

Chase Knickerbocker of Craig-Hallum Capital Group LLC asked about the second-half guidance, questioning the assumptions for SUBOXONE price compression and SUBLOCADE's sequential growth. He also sought details on the magnitude of cost savings from the 'Indivior Action Agenda' and long-term SUBLOCADE market share expectations.

Answer

CEO Joe Ciaffoni confirmed that while no SUBOXONE price erosion has occurred, it is conservatively factored into guidance, and SUBLOCADE guidance assumes demand-based growth. He described the cost savings as a 'meaningful and significant reduction' with a full-year effect in 2026. Regarding market share, he emphasized that overall LAI penetration is more critical than market share, but noted SUBLOCADE's share has stabilized in the mid-70s.

Chase Knickerbocker asked about SUBOXONE Film's performance, questioning if guidance assumes further pricing pressure or if declines are based on a potential fifth generic. He also asked what the key clearing event would be for OPVEE to become a material asset for the company.

Answer

CFO Ryan Preblick confirmed that guidance assumes continued price erosion for SUBOXONE Film, driven by the existing four generic players, not just the potential entry of a fifth. CEO Mark Crossley added that for OPVEE, the key focus for 2025 and 2026 is generating a bolus of real-world evidence to address fears of precipitated withdrawal, which he sees as the main hurdle to wider adoption despite its differentiated profile for treating synthetic opioid overdose.

Chase Knickerbocker of Craig-Hallum sought confirmation that the 2025 guidance fully accounts for a potential fifth generic SUBOXONE launch. He also asked about the underlying assumptions for overall LAI market growth and the performance of the Criminal Justice System (CJS) channel within the guidance.

Answer

CEO Mark Crossley confirmed the guidance encapsulates continued price erosion, whether from current competitors or a fifth entrant like Teva. CFO Ryan Preblick stated the guidance assumes 20-30% LAI market growth for 2025 and that SUBLOCADE's full-year share is expected to be around the 65% level seen with experienced prescribers. Crossley added that the CJS channel for SUBLOCADE is expected to be down 30-35% year-over-year due to funding constraints, not competitive pressure.

Chase Knickerbocker inquired about the commercial strategy for SUBLOCADE's potential label updates, sought more detail on the co-prescribing cohort data, and asked about potential SUBLOCADE price headwinds.

Answer

CEO Mark Crossley explained that upon the expected February 7 PDUFA date, the company will invest in HCP and patient awareness for the label updates. He noted the cohort sample size is around 500 physicians, showing share stabilizing in the mid-60% range. On pricing, Crossley clarified the overall market is stable, but acknowledged a competitor used aggressive pricing to gain access in a specific, price-sensitive Criminal Justice System (CJS) account.

Chase Knickerbocker from Craig-Hallum Capital Group inquired about the current macroeconomic environment, specifically whether the trends that impacted 2025 are now subsiding in 2026. He also asked about the opportunity for Butterfly Network with medical schools for one-to-one partnerships in the upcoming year.

Answer

CFO John Doherty stated that while not everything is entirely behind them, the company feels more confident moving forward, noting that some larger deals closed late in 2025 and the pipeline remains active, despite some timing shifts. He acknowledged a mild, unpredictable downward pressure from tariffs. CEO Joseph DeVivo highlighted medical schools as a strong contributor for 2026, particularly in Q2, noting strong student commitment to learning ultrasound and the brand loyalty built through these programs.

Chase Knickerbocker from Craig-Hallum Capital Group LLC sought more detail on the revised guidance, asking about the specific changes in assumptions and the relative impact on the enterprise, medical school, and direct-to-consumer channels. He also asked what customers need to see for purchasing timelines to normalize.

Answer

President, CEO & Chairman Joseph Devivo stated that the primary change in assumptions relates to the timing of large deal closures, which have been delayed. He specified that the public global health business saw a pause due to funding changes, and large enterprise and medical school deals in the pipeline were pushed out. He emphasized these deals are not lost. Devivo believes the delays are a temporary 'calibration' by customers to macro changes, not a permanent structural issue, and that the company is being conservative with its forecast.

Chase Knickerbocker inquired about the observed wound care market volume in Q1 2026 relative to Q4 2025, seeking insight into market stabilization. He also asked about volume bifurcation by site of service (e.g., HOPD) and the confidence behind the sequential volume growth assumed in the 2026 guidance, given the current market noise.

Answer

CEO Joe Capper noted a significant drop-off in wound care volume from Q4 2025 to Q1 2026, as anticipated, but highlighted continued exceptional growth in the surgical business. He stated it was too early to assess market share changes or significant increases in any specific care setting, as overall volume is down across all settings due to market resizing and overutilization correction. Capper reiterated expectations for substantial sequential revenue build throughout 2026, driven by new product rollouts and strong surgical growth, acknowledging the first couple of quarters would remain noisy.

Chase Knickerbocker asked about the observed wound care market volume trends in Q1 2026 relative to Q4 2025, seeking insight into market stabilization and the overall state of the market. He also questioned if volume shifts were occurring across different sites of service (e.g., HOPD) and how MiMedx's guidance for sequential volume growth in 2026 is anchored amidst current market noise.

Answer

CEO Joe Capper noted a significant drop-off in wound care volume from Q4 2025 to Q1 2026, attributing it to market shock and adjustments, while surgical business continued exceptional growth. He indicated it was too early to assess market share changes or shifts across care settings, as the market is resizing due to overutilization and clinic closures. Mr. Capper expressed confidence in sequential volume growth throughout 2026, driven by new products and surgical momentum, but cautioned that the first couple of quarters would remain noisy.

Chase Knickerbocker of Craig-Hallum Capital Group LLC asked about the potential size of the skin substitute market after the proposed reimbursement changes, the volume of market share Mimetics would need to gain to offset pricing impacts, and the expected timeline for the EpiEffect clinical trial readout.

Answer

CEO Joseph Capper responded that while it is too early to estimate the future market size, Mimetics is well-positioned to gain share and compete effectively in a more rational market driven by clinical evidence. He expressed high confidence in their ability to offset potential pricing headwinds with volume gains. Regarding the EpiEffect trial, Capper stated they hope to have data to report by the end of the year, though enrollment has been slower than anticipated.

Chase Knickerbocker of Craig-Hallum Capital Group asked for management's confidence level in seeing reimbursement reform by January 2026, the strategy for shifting volume to the new CELERA product, and the specific drivers behind the strong surgical growth, including HELIOGEN's contribution.

Answer

CEO Joe Capper stated that while the LCD delay was frustrating, the core issue is pricing methodology, which he has discussed with CMS. He positioned the CELERA distribution as a defensive tactic to protect business, not a major growth driver, noting physicians are wary of audit risks with the highest-priced products. He attributed the 16% surgical growth to strong execution across the entire portfolio, including AMNIOEFFECT and HELIOGEN, rather than a single product or new data set.

Chase Knickerbocker of Craig-Hallum Capital Group LLC inquired about the specific drivers behind the strong Q4 performance in the Wound segment, the growth assumptions for wound and surgical in the 2025 guidance, and the company's confidence in the upcoming LCD implementation.

Answer

CFO Doug Rice attributed the Q4 strength to international sales and the EFFECT product lines, noting it was the company's highest revenue quarter since 2018. CEO Joe Capper explained that the 2025 guidance of at least high single-digit growth is not broken out by segment due to potential market disruption from the LCDs, but he expressed high confidence that the April 13 implementation will proceed. Doug Rice added that the main financial impact of the LCDs would be on gross margin due to a product mix shift.

Chase Knickerbocker inquired about the company's increased confidence in forthcoming reimbursement reforms, the quantitative impact of discontinued products on the surgical business, HELIOGEN's potential to fill that revenue gap, and the drivers of outperformance in the physician office segment.

Answer

CEO Joseph Capper attributed the renewed confidence in reimbursement reform to recent, urgent discussions with CMS and Congress, prompted by Medicare spend on skin substitutes exceeding $1 billion per month. CFO Douglas Rice quantified that neutralizing discontinued dental and AXIOFILL sales resulted in a 10-point positive swing for surgical growth. CEO Capper added that while HELIOGEN's launch is on track, it will take time to replace AXIOFILL's contribution fully. He also credited the strong physician office performance to the success of the EPIEFFECT product in regions unaffected by recent sales force turnover.

Chase Knickerbocker asked for an update on the strategic alternatives process, considering Ironwood's improved financial position. He also questioned the assumptions for the STARS-2 enrollment timeline compared to STARS-1 and sought insights into LINZESS's 2027 market dynamics, specifically regarding volume acceleration as it approaches a negotiated price.

Answer

Thomas McCourt, CEO, stated that Ironwood is in a much stronger financial position, allowing it to pursue its standalone path while remaining open to alternatives that increase shareholder value. Michael Shetzline, Chief Medical Officer, confirmed that STARS-2 enrollment timeline assumptions are largely based on the successful execution of STARS-1. Gregory Martini, SVP and CFO, noted that while 2027 guidance hasn't been provided, the company remains optimistic about LINZESS's future ability to drive strong net sales and cash flows.

Chase Knickerbocker from Craig-Hallum Capital Group asked for an update on Ironwood's strategic alternatives process, considering the company's improved standalone financial position and debt reduction plans. He also questioned the assumptions behind the STARS-2 enrollment timeline, especially in comparison to STARS-1 and other ongoing studies in the same patient population. Lastly, he inquired about the anticipated impact of the negotiated price on LINZESS volume acceleration in 2027.

Answer

Thomas McCourt, CEO, explained that Ironwood's financial position has significantly improved, allowing a clear path forward as a standalone entity, but the company remains open to alternatives that enhance shareholder value. Michael Shetzline, Chief Medical Officer, stated that STARS-2 enrollment assumptions are largely based on the successful execution of STARS-1, with the team pushing to meet the projected timelines. Mr. McCourt added that apraglutide's strong efficacy, tolerability, and once-weekly dosing make STARS-2 an attractive trial for patients, aiding enrollment. Gregory Martini, SVP and CFO, noted that while 2026 guidance is strong, 2027 guidance has not been provided, but the company remains optimistic about LINZESS's future net sales and cash flow generation.

Chase Knickerbocker inquired about the confidence in achieving high single-digit LINZESS volume growth with reduced in-person marketing, the timing of cost-saving recognition and R&D expense reduction, and the company's ability to maintain debt covenant compliance.

Answer

CEO Thomas McCourt expressed high confidence in LINZESS growth, attributing it to a strong marketing mix, consumer advertising, and dominant market share. Executive Greg Martini clarified that the full impact of cost savings will appear in Q2 2025, while R&D spending is not expected to decline until 2026. Martini also affirmed a high degree of confidence in maintaining debt covenant compliance throughout 2025, citing the adjusted EBITDA definition and other add-backs.

Chase Knickerbocker requested more detail on the LINZESS gross-to-net adjustment, the next steps for the apraglutide NDA filing, and confirmation that upcoming CNP-104 data would include both T-cell and liver function results. He also sought to confirm the revised guidance was solely due to the one-time adjustment.

Answer

CFO Sravan Emany attributed the gross-to-net adjustment to subsequent information from AbbVie related to government and contractual rebates. CMO Michael Shetzline confirmed the apraglutide submission is the top priority, with a pre-NDA meeting planned and a 2025 launch targeted, and that CNP-104 data will include both T-cell and liver function outcomes. Mr. Emany also affirmed the guidance change reflects the one-time adjustment, with CEO Thomas McCourt adding that they will continue to optimize the LINZESS marketing mix for profitability.

Chase Knickerbocker asked about the common characteristics of the top 20% of accounts, specifically regarding stakeholder support and the salesperson's approach, and the age of these high-volume accounts. He also inquired about the expected portion of BENEFIT-HF enrollment from outside the U.S. (OUS) and its revenue recognition, and the company's path to profitability, including cash burn, capital access, and future territory additions.

Answer

President and CEO Kevin Hykes identified common characteristics of top accounts as having multiple champions (clinical, administrative), a pool of referring cardiologists, and surgeon redundancy, which creates a 'flywheel effect.' He noted that while no top accounts are brand new, their age varies from 9-12 months to several years. Mr. Hykes stated that BENEFIT-HF enrollment OUS would be a very small number of centers, making it primarily a U.S.-focused trial with Medicare reimbursement. CFO Jared Oasheim detailed that with $86 million cash at the start of 2026 and access to an additional $40 million non-dilutive capital, the company has over two years of cash. He emphasized that the path to profitability involves generating leverage by driving faster top-line growth than SG&A, through increased sales rep productivity and continued territory additions.

Chase Knickerbocker asked about the common characteristics of CVRx's top-performing accounts (top 20% with ~19 implants/year), focusing on stakeholder engagement and salesperson approach. He also inquired about the age of these top accounts and the expected portion of BENEFIT-HF trial enrollment from outside the U.S. (OUS) and its revenue recognition. Finally, he asked about the company's path to profitability, considering trial expenses and potential strategies like slowing territory adds.

Answer

Kevin Hykes (President and CEO) described top accounts as having multiple champions (supportive administration, multiple heart failure specialists, community cardiologists, redundant surgeons) creating a 'flywheel' effect, which informed their revised go-to-market strategy. He noted that while no top accounts are brand new, their age varies from several years to as recent as 9-12 months. Kevin Hykes clarified that BENEFIT-HF will have a very small OUS enrollment, making it primarily a U.S.-focused, Medicare-covered trial. Jared Oasheim (CFO) stated that CVRx has sufficient cash ($86M at start of 2026) and access to additional non-dilutive capital, with no immediate need to raise more. The path to profitability involves generating leverage by driving top-line growth faster than SG&A expenses through increased rep productivity.

Chase Knickerbocker of Craig-Hallum followed up on the potential for a Level 6 APC code, asking for the basis of management's 'slim chance' assessment for this year and their view on CMS's long-term thinking. He also asked for the gross number of center additions to better understand whether the net increase was driven by fewer deactivations or higher gross adds.

Answer

President and CEO Kevin Hykes explained that based on expert consultation, changes to proposed rules are rare, but the risk of being moved out of the favorable New Tech APC 1580 is very low. CFO Jared Oasheim clarified that the net center add number is a combination of both gross additions and the sunsetting of 'dabbler' accounts, and that a high single-digit net add per quarter remains a reasonable expectation.

Chase Knickerbocker sought granular details on the impact of rep turnover, asking if accounts reduced utilization or stopped implants altogether. He also questioned why 'dabbler' accounts remain low-volume and what specific qualities define the ideal new sales representative profile. Finally, he asked if sales territory turnover has now normalized.

Answer

Executive Kevin Hykes explained that accounts experienced decreased productivity rather than abandoning the therapy. He described a two-pronged strategy for 'dabblers': sunsetting those without long-term potential and re-engaging promising ones with a new, structured program-building approach. Hykes emphasized the shift to hiring reps with therapy development experience over pure relationship sellers and confirmed that the bulk of the turnover is complete, advising to model three new territories per quarter going forward.

Chase Knickerbocker followed up on the 'North Star' account concept, asking about the quarterly unit volume in the most developed, top-decile centers. He also asked about advocacy efforts for future reimbursement and expectations for the RVUs assigned to the new Category 1 CPT code.

Answer

Executive Jared Oasheim confirmed that top-tier centers are performing 'well above' the goal of one implant per month but did not provide specific numbers. Executive Kevin Hykes added that their market access team is actively engaged with CMS to secure a permanent Level 6 code. Regarding the Category 1 code, he stated they expect the first visibility on RVUs in July and anticipate they will align with the current negotiated range of $500-$850 per procedure.

Chase Knickerbocker asked about the quarterly unit volume in the most developed 'North Star' accounts, the company's advocacy efforts related to 2026 reimbursement decisions, and expectations for the RVUs that will be assigned to the new Category 1 CPT code.

Answer

Executive Jared Oasheim confirmed that top-performing centers are well above the goal of one implant per month but did not provide specific numbers. Executive Kevin Hykes stated that advocacy with CMS for a permanent Level 6 code is already underway. Regarding the Category 1 code, he noted they cannot influence the process but expect the RVUs to be in the $500-$850 range, with the first official proposal visible in July.

Chase Knickerbocker from Craig-Hallum Capital Group asked if recent new account additions reflect the new targeting strategy and how the sales 'blueprint' has changed. He also inquired about sales force retention and productivity, and the specific reasons for the company's confidence in a favorable OPPS final rule.

Answer

CEO Kevin Hykes stated that Q3 new accounts do not yet fully reflect the new targeting strategy but that the new 'blueprint' is designed to accelerate adoption. He expressed satisfaction with sales team talent and retention. CFO Jared Oasheim explained that confidence in the OPPS rule is based on strong hospital cost data, unanimous advisory panel support for a Level 6 code, and overwhelming positive feedback during the public comment period.

Chase Knickerbocker from Craig-Hallum Capital Group asked if the Q3 new account additions reflect the new targeting strategy and how the sales blueprint has changed. He also inquired about sales force retention and productivity. Finally, he asked for more detail on the company's confidence in a favorable OPPS final rule.

Answer

Executive Kevin Hykes explained that the Q3 new accounts do not yet fully reflect the new targeting strategy, as the process is organic. He noted the new sales leadership has brought more intentionality and best-practice sharing to build sustainable programs. He expressed satisfaction with sales team turnover and the onboarding process. CFO Jared Oasheim detailed that confidence in the OPPS rule stems from hospital cost data, unanimous panel support for a Level 6 code, and over 100 supportive comments from stakeholders during the review period.

Chase Knickerbocker inquired about the scope of the D-PLEX100 label following pre-NDA discussions, specifically regarding colorectal versus broader abdominal indications, and potential risk factors or incision size considerations. He also asked about plans for further D-PLEX100 label expansion and future applications for PolyPid's platform, including the metabolic GLP-1 program.

Answer

CEO Dikla Czaczkes Akselbrad stated that PolyPid is targeting an initial label for abdominal colorectal surgery, supported by SHIELD II data and breakthrough therapy designation, with potential for broader abdominal expansion. She confirmed FDA alignment on the adequacy of Phase III data for NDA submission. Regarding future applications, Ms. Akselbrad emphasized D-PLEX100's near-term focus but highlighted the preclinical GLP-1 program leveraging the Kynatrix technology for sustained release, with additional data expected mid-year.

Chase Knickerbocker asked about the FDA's pre-NDA feedback regarding the D-PLEX100 label scope, specifically whether it would be colorectal-specific or broader abdominal, and investor expectations for any risk factors or incision size limitations. He also inquired about plans for broader label expansion and future applications of the platform, including the metabolic program.

Answer

CEO Dikla Czaczkes Akselbrad stated that PolyPid is targeting an initial label for prevention of surgical site infections in abdominal colorectal surgery, directly supported by SHIELD II data and breakthrough therapy designation. She noted an opportunity for label expansion into broader abdominal applications during the review process. The FDA confirmed the NDA pathway and the adequacy of Phase 3 data. For future applications, Ms. Akselbrad emphasized the near-term focus on D-PLEX100 but mentioned expanding into GLP-1 and metabolic health, expecting additional preclinical data around mid-year, leveraging the Kynatrix platform for sustained release.

Asked about the remaining steps for the NDA filing, specifically CMC preparations; the future plans and data timeline for the GLP-1 program; and potential milestones from the ADVANCE partnership.

Answer

The company is finalizing the CMC and clinical modules for the NDA, planning a pre-NDA meeting with the FDA by year-end for a Q1 2026 submission, while GMP facility preparations are ongoing. For the GLP-1 program, they are moving into robust preclinical studies to show PK data and are seeking a collaboration with a large player. Regarding the ADVANCE partnership, a milestone is expected, and adjustments to the agreement are being assessed as pre-launch activities begin.

Inquired about the timeline and requirements for the NDA filing, preparations for the CMC module and potential FDA audits, and what to expect from the upcoming top-line data release.

Answer

The NDA filing is planned for early 2026 after finalizing the clinical module and holding a pre-NDA meeting with the FDA. For CMC, the company is preparing for FDA inspection with mock audits and external consultants. The top-line data release will include the primary endpoint and key secondary endpoints.

Inquired about the patient characteristics in the ongoing trial enrollment, the current enrollment rate, and the timeline for the top-line data readout.

Answer

Patient characteristics and geography are consistent with expectations and the interim analysis group. The enrollment rate has returned to approximately 80 patients per month, and the company is confident it will announce the last patient enrolled in March. This positions them for a top-line data readout in the late second quarter of 2025, about one quarter after enrollment completion.

Asked about the format of the upcoming interim analysis announcement, the sustainability of the current patient enrollment pace, and recent discussions with Key Opinion Leaders (KOLs) regarding the commercial opportunity and unmet need.

Answer

The company will issue a press release with the formal recommendation from the Data Safety Monitoring Board (DSMB) regarding the trial's path forward. The current high rate of patient enrollment (approx. 80 per month) is expected to continue, allowing for full enrollment by December. Recent conversations with KOLs and surgeons confirm a significant and unanimously recognized unmet need for a product like D-PLEX100.

Chase Knickerbocker from Craig-Hallum asked for commentary on the competitive landscape in the PIK3CA mutant population and for an update on the company's confidence in its Chemistry, Manufacturing, and Controls (CMC) package for the upcoming NDA submission.

Answer

CEO Brian Sullivan addressed competition by noting that recently approved drugs like inavolisib target a different, first-line patient population, and positioned Gadafelicitinib as potentially superior due to its efficacy regardless of PIK3CA status and its favorable safety profile. On the CMC package, Sullivan expressed high confidence, stating that all required studies are complete, the data is robust, and the company has engaged with the FDA to ensure alignment, leaving no open questions.

Chase Knickerbocker of Craig-Hallum Capital Group inquired about the success criteria for the upcoming prostate cancer study data and asked for guidance on the R&D expense trajectory for 2025.

Answer

CEO Brian Sullivan explained the benchmark for the prostate cancer trial is the 5-5.5 month median PFS seen with re-treatment with an AR inhibitor, with their primary endpoint being landmark PFS at 6 months. CFO Vicky Hahne suggested that Q4's R&D and G&A spend is a relevant base for 2025, with a potential 10% increase for pre-launch activities.

Chase Knickerbocker of Craig-Hallum asked about enrollment expectations for the VIKTORIA-2 study, considering the experience with VIKTORIA-1 sites. He also inquired about the level of excitement and feedback from investigators regarding the new trial.

Answer

Executive Brian Sullivan expressed high confidence in VIKTORIA-2 enrollment, noting that desired VIKTORIA-1 sites are eager to participate, which he views as a reflection of their positive experience with gedatolisib. He added that first-line studies typically enroll faster and expects the VIKTORIA-2 enrollment rate to be at least as good as, or better than, VIKTORIA-1. Sullivan confirmed the company is on track to enroll the first patient in Q2 2025.

Chase Knickerbocker from Craig-Hallum Capital Group LLC inquired about specific metrics for active prescribers and accounts, particularly in the AYA population. He also asked about the typical ramp-up cadence for new accounts and the amount of royalty revenue from the Norgene partnership in the EU.

Answer

CEO Jeff Hackman stated that Fennec does not disclose cumulative prescriber or active account numbers but may consider it for future quarters. CFO Robert Andrade added that growth typically begins with a single patient at a center and then expands, noting the addition of 14 new accounts in Q2. Hackman emphasized that a key growth driver in Q2 was the expansion of PEDMARK use within existing accounts. Regarding the EU, Andrade explained that royalty revenue is not yet material enough to report separately but shows significant sequential traction, with future milestones tied to aggregate sales and German pricing.

Chase Knickerbocker asked for specifics on Q4 performance, including whether the pediatric business returned to sequential growth and the contribution from the Adolescent and Young Adult (AYA) segment. He also questioned the expected second-half 2025 growth inflection and sought confidence indicators from early Q1 2025 performance.

Answer

CEO Jeffery Hackman confirmed that the pediatric segment continues to grow and is an important part of the business. He stated that overall growth is coming from both pediatric and AYA segments but declined to provide a specific breakdown. Hackman attributed the expected second-half growth acceleration to the cumulative effect of ongoing business-building initiatives and investments, which will continue throughout 2025. He affirmed that early 2025 trends give the company confidence that growth will continue.

Chase Knickerbocker inquired about Fennec's readiness to accelerate growth in the Adolescent and Young Adult (AYA) market and whether to expect meaningful sequential growth, also asking for guidance on modeling Q4 revenue.

Answer

CEO Jeff Hackman confirmed the AYA market is a significant opportunity, noting that Q3 saw initial patient adoption with successful reimbursement, which he views as a strong positive signal for future growth. Executive Robert Andrade added that momentum in Q3 was driven by new customers in both AYA and pediatric segments, including large institutions that had not previously ordered PEDMARK, forming a solid foundation for growth in the coming quarters.

Chase Knickerbocker of Craig-Hallum Capital Group LLC inquired about the current number of active sites and enrollment trends for the REMEDY two stroke study. He also asked about management's confidence in the Q2 2026 interim analysis timeline and whether the U.S. preeclampsia Phase 2b study would have a primary endpoint that could reflect a pivotal Phase 3 endpoint.

Answer

President & CEO Rick Pauls stated there are approximately 40 active sites for the REMEDY two trial, with a recent encouraging uptick in enrollment giving them confidence in the Q2 2026 guidance. He confirmed the U.S. preeclampsia study will focus on expectant management. Regarding the Phase 2b primary endpoint, Pauls noted they are finalizing the protocol based on expert opinion and recent FDA feedback and will share details once nailed down.

Chase Knickerbocker of Craig-Hallum Capital Group requested details on the ReMEDy2 stroke trial enrollment, including the performance of high-volume centers, the total number of active sites, international contributions, and the enrollment trajectory.

Answer

Executive Dietrich Pauls stated that high-enrolling sites are achieving the target of 1-2 patients per month and overall enrollment is currently ahead of plan. He noted the number of active sites is in the mid-30s, with non-performing sites being shut down, and highlighted strong performance from sites in the country of Georgia. He affirmed the enrollment trajectory is steepening, supporting the H1 2026 guidance for the interim analysis.

Chase Knickerbocker asked for the key assumptions underlying the revised first half 2026 timeline for the ReMEDy2 interim analysis, including expected enrollment rates, the ultimate number of trial sites, and the current ramp-up progress at activated sites.

Answer

Dr. Lorianne Masuoka, Chief Medical Officer, stated the company plans to double its number of sites by expanding into Canada, Australia, and Europe, targeting an enrollment rate of 1-2 patients per month per site. She noted that while the interim analysis is delayed, the larger sample size could ultimately reduce the total number of patients needed for the trial. Specific site enrollment rates will be disclosed after 25% total enrollment is reached.

Chase Knickerbocker asked for the underlying assumptions that suggest a faster final readout despite a larger interim cohort, whether any specific enrollment data prompted the protocol changes, the number of tPA non-responders in the prior Phase II study, and the potential impact on DM199's commercial opportunity.

Answer

Dr. Lorianne Masuoka, Chief Medical Officer, clarified that a larger interim analysis in a Bayesian design provides greater precision, potentially reducing the final sample size and overall trial duration. She confirmed the changes were based on expert statistical consultation, not ongoing study data. CEO Dietrich Pauls stated the prior study included 20 tPA non-responders who showed a strong response to DM199 with a zero placebo response. He estimated that expanding the label to include these patients could represent over a $1 billion additional revenue opportunity in the U.S.

Chase Knickerbocker inquired about the sequential outlook for VEVYE's Average Selling Price (ASP) following the onboarding of Apollo Care and other business rule changes, and also asked about the potential financial contribution from the newly acquired Samsung biosimilars portfolio in 2026 and 2027.

Answer

CEO Mark Baum explained that VEVYE's ASP has stabilized after Q2 adjustments and expects an upward bias by year-end due to the ApolloCare partnership capturing more high-value commercial claims. CFO Andrew Boll added that while he is very excited about the synergistic biosimilar portfolio, it is too early to provide specific financial contribution details for 2026, though the company hopes to launch BioViz that year with immediate uptake.

Chase Knickerbocker sought to understand the sequential revenue changes for IHEEZO, specifically the impact of Q4 stocking, and asked about volume inflection for TRIESENCE and the drivers behind VEVYE's gross-to-net improvements.

Answer

CEO Mark L. Baum and CFO Andrew Boll attributed the IHEEZO sequential decline to a recurring Q4 stocking and Q1 destocking pattern, confirming unit demand is now returning to growth. For TRIESENCE, Baum noted that new accounts are starting with small trial orders post-reimbursement changes, with momentum expected to build. Regarding VEVYE, he stated that while the ASP will moderate slightly from Q1's peak, it will stabilize at a highly attractive level, with massive new prescription growth from the VAFA program being the primary value driver.

Chase Knickerbocker inquired about the drivers for VEVYE's significant gross-to-net improvement, the potential impact of the new 'VEVYE Access For All' program, and guidance for 2025 operating expense growth and cash flow conversion.

Answer

CEO Mark L. Baum attributed VEVYE's Q4 revenue and ASP improvement to prior business rule changes and fewer co-pay buydowns, but stressed that the new 'VEVYE Access For All' program will be a far more significant growth driver. CFO Andrew Boll advised modeling 2025 SG&A from the H2 2024 run-rate, anticipating strong operating leverage and that most adjusted EBITDA will convert to cash flow, less interest and newly anticipated tax payments.

Chase Knickerbocker inquired about the Q4 outlook for TRIESENCE, focusing on inventory levels and sales pull-through. He also asked for a financial quantification of the Q3 VEVYE inventory disruption, details on its new Medicare Part D coverage, and clarification on the impressive VEVYE refill rate metric.

Answer

CEO Mark Baum and CFO Andrew Boll explained that while it's early for precise TRIESENCE guidance, all regional MACs are reimbursing, and the initial response is positive, with more inventory planned for 2025. Baum stated the VEVYE inventory issue represented "several million dollars" in Q3 revenue that will be recaptured in Q4. He described the new Part D contract as a "preferred brand position." Boll confirmed the high VEVYE refill rate is based on patients eligible for each refill, which has significantly exceeded their financial models.

Chase Knickerbocker inquired about the early launch momentum for Candivy, clinician feedback on its age-restricted label, and the expected patient growth for the adrenal insufficiency franchise. He also asked for details on the proposed FDA trial design for expanding Increlex's label and the outlook for its patient growth. A follow-up question concerned the operating expense ramp for the second half of the year.

Answer

CEO Sean Brynjelsen explained that while Eton does not break out Candivy and Alkindi sales, the combined franchise is performing well, with Candivy being additive rather than cannibalizing Alkindi. He noted the significant opportunity lies in the future label expansion for younger patients. For Increlex, Brynjelsen described a plan to open an IND to enroll patients in the -2 to -3 standard deviation range, similar to the European standard. CFO James Gruber addressed the follow-up, stating that R&D and SG&A expenses are expected to be flat or decline in the second half of 2025 due to non-recurring Q2 fees and front-loaded marketing spend for recent launches.

Chase Knickerbocker of Craig-Hallum Capital Group inquired about Eton's late-stage pipeline and revenue outlook, seeking details on recent FDA interactions for ET-400, the potential clinical pathway for Amglidia, and whether the strong patient growth for Increlex de-risks the company's $80 million Q4 revenue run-rate target.

Answer

CEO Sean Brynjelsen confirmed that final labeling discussions with the FDA for ET-400 are complete, suggesting an approval is on track. For Amglidia, he noted the FDA provided a clear and feasible clinical pathway, likely requiring a straightforward PK study. Regarding the revenue outlook, Mr. Brynjelsen expressed strong confidence in the $80 million run-rate target, citing powerful sales momentum from Increlex and other products, and indicated a potential guidance revision could be considered after Q2.

Chase Knickerbocker of Craig-Hallum Capital Group inquired about the physician feedback driving the Increlex acquisition, its expected impact on revenue and SG&A, the growth outlook for Carglumic acid, and the confidence in the ET-400 FDA review.

Answer

Executive David Krempa shared that physicians view Increlex as a critical product with opportunities for greater awareness. CEO Sean Brynjelsen detailed plans to drive growth with a dedicated sales team and medical advisory boards. CFO James Gruber confirmed SG&A would increase due to sales force expansion and ex-U.S. investments. Gruber also noted Carglumic acid's growth is likely limited, while Brynjelsen expressed high confidence in the ET-400 review, expecting approval by its February 2025 PDUFA date.

Chase Knickerbocker of Craig-Hallum Capital Group LLC inquired about the market reception for PKU GOLIKE post-relaunch, patient trends for Carglumic Acid, drivers for gross margin fluctuations, and the working capital outlook. He also asked for details on the ET-600 pivotal trial, commercial launch preparations for ET-400, the potential scale of upcoming business development deals, and the expected SG&A expense cadence for the second half of the year.

Answer

Executive David Krempa stated that PKU GOLIKE has received a good reception and an uptick in referrals since promotional activities began in April, despite a loss of momentum prior to acquisition. CEO Sean Brynjelsen confirmed that Carglumic Acid is seeing strong net patient additions, driven by its room-temperature formulation and Eaton's patient support program. He also detailed that the ET-600 pivotal trial is a straightforward repeat of a successful pilot study and that the ET-400 launch could occur as early as March or April 2025. Regarding business development, Mr. Brynjelsen noted the company is pursuing deals for commercial assets that could add $10M+ in revenue. CFO James Gruber attributed the slight gross margin dip to product mix, projected positive operating cash flow to continue, and guided for H2 SG&A expenses to return to Q1 levels.

Chase Knickerbocker of Craig-Hallum Capital Group LLC asked a strategic question about Avadel's business development plans, given its strengthening balance sheet. He inquired about the potential profile for an acquisition, whether clinical-stage or a commercial asset.

Answer

CEO Gregory Divis emphasized that the company's primary focus is on executing the LUMRYZ launch and its lifecycle management, including the IH indication. While the team evaluates market opportunities, he stated they will be very disciplined. Any inorganic growth would likely leverage their existing commercial infrastructure in the sleep space, but this is not the main priority.

Chase Knickerbocker of Craig-Hallum asked how Avadel sees the narcolepsy market evolving with the potential arrival of Orexin agonists. He also sought clarification on the company's exposure to potential new pharmaceutical tariffs, given its manufacturing setup.

Answer

CEO Gregory Divis stated that based on clinician feedback, he believes oxybates like LUMRYZ will retain a critical role due to their nighttime benefits, potentially complementing Orexin therapies. CFO Thomas McHugh added that Orexins are still likely 2-3 years from market. Regarding tariffs, McHugh reiterated that Avadel is well-positioned with its U.S.-based manufacturing and supply chain, which substantially mitigates any potential impact.

Chase Knickerbocker of Craig-Hallum Capital Group LLC inquired about Gvoke's gross-to-net benefit, its back-half script growth outlook, the physician source for RECORLEV prescriptions, average patient dosage, and the potential market impact of a new competitor.

Answer

CFO Steve Pieper confirmed the Gvoke gross-to-net favorability is expected to persist through year-end. CEO John Shannon projected a Q3 Gvoke script growth surge due to back-to-school trends, followed by stabilization. He noted RECORLEV prescriptions are mainly from endocrinologists, with high new patient starts keeping the average dose stable. Shannon also viewed a new competitor as a positive for growing the overall hypercortisolism market.

Chase Knickerbocker asked for an update on the competitive dynamics in the glucagon market, the formulary and competitive outlook for Keveyis, and the company's manufacturing footprint in relation to potential sector-specific tariffs.

Answer

CEO John Shannon stated that Xeris is driving market growth for Gvoke, with prescription growth outpacing the market, and that Keveyis performance is expected to remain stable. CFO Steven Pieper confirmed that the company's operations are U.S.-centric with no sourcing from China, and therefore no material impact from tariffs is anticipated.

Chase Knickerbocker inquired about the drivers of Recorlev's strength, asking whether growth stemmed from existing prescribers or an expanding writer base. He also asked for color on the overall hypercortisolism market growth, the confidence behind the strong 2025 guidance, and the expected performance of Keveyis in 2025.

Answer

CEO John Shannon confirmed that Recorlev's growth is driven by both an expanding prescriber base and deeper penetration with existing writers. He noted a lack of precise market data but stated that the business acceleration seen in the second half of 2024 underpins the confident 2025 outlook. Regarding Keveyis, Shannon suggested the brand may have found its bottom and is holding its patient base steady.

Chase Knickerbocker inquired about the specific drivers of Recorlev's growth, seeking to distinguish between market expansion and team execution, and asked for an outlook on the path to cash flow breakeven, considering future investments like the levothyroxine Phase III program.

Answer

CEO John Shannon attributed Recorlev's success to strong execution by Xeris's commercial and patient access teams, which are capitalizing on market tailwinds by accelerating patient referrals and new starts. CFO Steven Pieper expressed confidence in the company's trajectory toward breakeven, citing strong revenue growth and disciplined expense management, but deferred specific 2025 guidance until early next year.

Chase Knickerbocker inquired about the expected market share in European markets that have converted to pre-filled syringes, the growth rate of the domestic SCIG market, the reason for the new consumable set's development delay, and the progress on the next-gen pump.

Answer

President & CEO Linda Tharby stated that overall European market share has increased from a 10-15% range to the low 20s due to pre-filled syringe conversions. She confirmed the domestic SCIG market continues to grow at a high-single to low-double-digit rate. Tharby explained the consumable set delay allows for incorporating additional market feedback to enhance comfort and convenience, while the next-gen pump remains on track for a 510(k) submission by the end of Q1 2026.

Chase Knickerbocker asked for an update on the international e-Pump consumable opportunity and whether Q1's strong results signaled rising demand from that channel. He also inquired about the oncology pilot program, specifically the key metrics for a full launch and the unique economic benefits for oncology clinics.

Answer

Executive Linda Tharby confirmed that increased sales of KORU's consumables for use with third-party e-Pumps contributed to Q1's international growth, alongside the complete system win with prefilled syringes. Regarding the oncology pilot, she stated the focus is on validating safety, efficacy, and a dual economic benefit for clinics: improved workflow efficiency allowing for more patient throughput, and access to higher reimbursement codes for pump-assisted infusions. She also confirmed a distribution partner is already in place.

Chase Knickerbocker inquired about the specific growth assumptions for domestic, international, and pharma services in the 2025 guidance, the drivers of above-market growth, and the remaining steps for the oncology opportunity.

Answer

CFO Tom Adams provided the 2025 growth outlook: 10-15% for domestic, over 20% for international, and $2-3 million for Novel Therapies. He cited new geographies for international strength and new customer wins for domestic growth. CEO Linda Tharby added that the oncology opportunity's current focus is on market assessment, including value proposition, reimbursement, and distribution, rather than the FDA filing.

Chase Knickerbocker asked for clarification on the filing cadence for the two new drug indications relative to the next-generation device and for commentary on the overall health of the SCIg market.

Answer

President and CEO Linda Tharby explained that the rare disease biologic filing is tied to the new consumables and will be submitted in parallel by mid-2025. The oncology biologic filing is expected by end-of-2025 and is not dependent on the new device platform. She described the SCIg market as very healthy, with strong underlying demand drivers, robust supply, and KORU continuing to outpace the market's high single-digit growth.

Chase Knickerbocker inquired about the Pain Treatments segment, asking for the normalized organic growth rate excluding prior-year rebate adjustments, details on Duralane's volume growth, and the drivers for the expected acceleration in the second half of the year. He also asked about the Bone Graft Substitutes (BGS) growth rate and whether the overall Surgical franchise growth would accelerate.

Answer

SVP & CFO Mark Singleton stated that normalized growth for Pain Treatments was 4-5% and that Duralane volume grew slightly above the mid-single-digit market rate. He noted BGS grew at a high-single-digit rate in Q2. CEO Robert Claypoole added that lapping unfavorable comparisons would account for over half of the required H2 acceleration, with BGS momentum providing the rest. He also highlighted strong capital placements for Ultrasonics, signaling continued momentum for the Surgical segment.

Chase Knickerbocker inquired about the competitive landscape for pain treatments, particularly the single-injection market, and asked about any price benefits for DUROLANE. He also questioned the drivers behind the tough Q2 comparison, the recent account wins supporting the second-half growth ramp, and the company's potential exposure to pharmaceutical tariffs.

Answer

CEO Rob Claypoole confirmed a market shift to single-injection products, where Bioventus is well-positioned with DUROLANE's clinical value and contract backbone. He attributed Q2's tough comp to a competitor's supply issues last year and noted recent account wins are driven by clinical differentiation and smarter targeting. On tariffs, he stated that pharmaceuticals are currently excluded and the company remains vigilant. CFO Mark Singleton added that while the CMS ASP for DUROLANE was up 10%, the financial ASP was only slightly positive due to timing differences and rebates.

Chase Knickerbocker inquired about the 2025 guidance assumptions by business segment, the competitive positioning of the DUROLANE HA business, and the company's capital allocation priorities as leverage decreases.

Answer

President and CEO Robert Claypoole confirmed segment growth expectations, projecting double-digit growth for Surgical Solutions, above-market growth for Pain Treatments, and low-single-digit growth for Restorative Therapies. He stated that HA growth in 2025 will be volume-driven with stable pricing, insulated by DUROLANE's clinical differentiation and strong payer contracts. Both Claypoole and SVP and CFO Mark Singleton noted that while lower debt provides flexibility, the immediate focus remains on disciplined execution and selective, strategic portfolio opportunities.

Chase Knickerbocker questioned the implied Q4 growth slowdown despite a strong Q3, asking for color on seasonality or other headwinds. He also inquired about the Q4 outlook for the Pain Treatments business and sought an early perspective on 2025 growth and margin expansion.

Answer

CEO Robert Claypoole attributed the softer Q4 growth outlook to unfavorable year-over-year comps, particularly in Exogen, and a temporary slowdown in Bone Graft Substitutes (BGS) growth due to delayed distributor onboarding. CFO Mark Singleton added that for the Pain business, they expect continued momentum driven by DUROLANE's differentiation and volume growth. Regarding 2025, Claypoole reaffirmed goals for above-market growth and at least 100 basis points of EBITDA margin expansion, driven by multiple growth drivers across the portfolio.

Chase Knickerbocker inquired about the remaining steps for the NexoBrid manufacturing scale-up, the timing for regulatory approvals, the progress on establishing U.S.-based manufacturing capacity, and feedback from clinicians on the EscharEx VLU study enrollment.

Answer

Ofer Gonen (executive) stated that the new manufacturing facility is in its commissioning phase and on track for operational readiness by year-end 2025, with regulatory approvals anticipated in 2026. He noted that a BARDA-supported project for a U.S. site should provide clarity on location and timing by Q3 2025. Gonen also confirmed that clinician excitement for the EscharEx trial is high and recruitment is progressing as planned toward the mid-2026 interim data milestone.

Chase Knickerbocker asked about enrollment rate expectations for the VLU study, the progress of early site activations, potential competition for patients from other trials, and how to model R&D spending for 2025 as the trial ramps up.

Answer

CEO Ofer Gonen explained that they selected trial sites with no competing studies and that their trial is financially more attractive, minimizing patient competition. He confirmed the enrollment target is a feasible half-patient per center per month and that site activation is proceeding well. CFO Hani Luxenburg affirmed that R&D expenses will increase substantially in 2025, driven by the per-patient cost of approximately $100,000 for the VLU trial.

Chase Knickerbocker asked for the doses per script in Q1, initial trends for CKD patients, specifics on the fill rate improvement drivers, and management's comfort level with full-year Street revenue estimates given the observed volume inflection.

Answer

SVP of Commercial, Steve Parsons, reported 7.4 doses per script in Q1, up from 6.8 in Q4, with similar trends for new CKD patients. Executive John Tucker attributed the improved fill rate (55% in April) and higher script volume to more patients having $0 copays. Regarding full-year estimates, Tucker expressed comfort and bullishness for Q2 and the full year, stating the volume growth from lower copays should more than offset GTN headwinds.

Chase Knickerbocker asked about the early impact of the Medicare redesign on Q1 fill rates and demand, the expected gross-to-net (GTN) for Q1, the fill rate in Q4, and the outlook for 2025 SG&A and gross margins.

Answer

Executive John Tucker noted that after a slow start, the company saw an increase in patients using the smoothing option and receiving $0 co-pays in March. He estimated the Q1 GTN would be around 25%. SVP of Commercial Steve Parsons revealed the Q4 fill rate was 53% overall but reached 58% in December, fueling optimism for 2025. For fiscal 2025, Tucker suggested annualizing Q4 SG&A is a reasonable approach, while CFO Rachael Nokes indicated gross margins would not see a significant impact until the auto-injector launch.

Chase Knickerbocker of Craig-Hallum Capital Group asked about the Q3 prescription conversion rate, the reasons for any deceleration in script growth, the conversion rate trend in Q4, the expected impact of the 2025 Medicare Part D redesign, and the early returns from the recent sales force expansion.

Answer

SVP of Commercial Steve Parsons reported the Q3 fill rate was 53%, up from 48% in Q2, and was trending at 54-55% early in Q4. CEO John Tucker projected the Medicare Part D redesign could lift the fill rate to 65% in 2025 by reducing patient out-of-pocket costs. He also confirmed that the new sales reps, who started in October, were already contributing to prescription growth.

Chase Knickerbocker inquired about the assumptions for amnio deal payments in the 2025 guidance, the key drivers of Q1 biologics growth, the outlook for the new in-house growth factor product, and the expected trajectory of EBITDA and cash flow for the remainder of the year.

Answer

CFO Scott Neils explained that guidance conservatively excludes additional minimums from royalty agreements and that a $1.5 million upfront payment is now being recognized over two years, with about $700,000 expected in 2025. CEO Sean Browne added that caution is warranted due to potential government policy changes. Browne identified amnio and VBM products as key biologics growth drivers and stated the initial focus for the new growth factor product is retaining the existing $6.5 million business before pursuing expansion. Neils projected positive cash flow from operations in Q2, a tighter Q3, and a healthy Q4, with revenue expected to grow at high single digits quarter-over-quarter after Q2.

Chase Knickerbocker inquired about the drivers of Q4 biologics growth, specifically the mix between white-label and internally developed VBM products. He also asked about the 2025 outlook for VBM, the launch timing for the new growth factor product, and the specific basis point impacts on Q4 gross margin from inventory write-offs and throughput issues, as well as the gross margin forecast for 2025.

Answer

Executive Sean Browne clarified that Q4 biologics growth was mostly from white-label VBM, but he anticipates a 50/50 split with Xtant-branded products in 2025. He also noted the new growth factor product should be finished in Q1 2025, with margin benefits expected in the second half of the year. Executive Scott Neils quantified the Q4 gross margin headwinds, citing a 680 basis point impact from the Surgalign inventory charge and a 570 basis point impact from production throughput. For 2025, Neils projected a 4-5 point improvement in gross margin by Q4.

Inquired about the amniotic product opportunity (direct vs. OEM) and supply sourcing, the supply and ramp-up plan for in-house stem cells, the underlying growth drivers in the hardware business masked by cannibalization, and the sustainability of achieving positive operating cash flow beyond Q4.

Answer

The company sees the largest opportunity for amniotics in OEM but is currently supply-constrained; the new COO is working to increase placenta sourcing. For stem cells, they will prioritize their own demand and then serve a growing OEM business, with a full ramp-up by Q1 2025. The hardware business is benefiting from modern Surgalign systems replacing dated X-spine products, with the Cortera system showing strong growth. Positive operating cash flow is expected in Q4 and should be sustainable after a seasonal compensation payout in Q1.

Chase Knickerbocker asked for details on the advertising efficiency improvements following the Meta platform issues, the sustainability of these changes, the target cost per pipeline add, reasons for pipeline drops, and the expected cadence for the second-half revenue ramp.

Answer

CEO Paul Gudonis explained that while the specific adjustments to their advertising approach are proprietary, they have proven successful, leading to a record number of leads in April. He noted that pipeline drops are due to typical patient dynamics. CFO David Henry clarified that a realistic cost per pipeline add would be around the $1,400-$1,500 seen in 2024. He added that the second-half revenue ramp is supported by the faster conversion of Medicare patients, which requires a smaller backlog to achieve a given revenue forecast.

Chase Knickerbocker inquired about the 2025 guidance assumptions for the O&P channel's revenue contribution, goals for the channel, the expected ramp in advertising spend, and the outlook for Average Selling Prices (ASPs).

Answer

CEO Paul Gudonis clarified that the direct provider business will remain the primary revenue source in 2025, though the O&P channel is expected to show meaningful growth. CFO Dave Henry noted that while advertising spend will double, the efficiency in cost per pipeline add is uncertain due to platform changes. Paul Gudonis added that ASPs will see an uplift from higher CMS fees, which will be partially offset by a greater mix of O&P revenue in the second half of the year.

Chase Knickerbocker of Craig-Hallum Capital Group inquired about the drivers of the Average Selling Price (ASP), the potential for future ASP growth, the revenue ramp timeline for the O&P channel, and the company's manufacturing capacity and expansion plans.

Answer

CFO David Henry explained that the current record ASP of $52,700 was influenced by prior-period supplemental payments and that future ASP will depend on the patient mix, including those with supplemental insurance (20-25% of patients) and the growth of the lower-ASP O&P channel. CEO Paul Gudonis detailed the O&P ramp, projecting a 3-4 month cycle from clinician training to initial orders, with a gradual volume increase expected in 2025. Gudonis also confirmed manufacturing is exceeding 80 units/month and the new facility will double capacity within six months.

Chase Knickerbocker inquired about Myomo's manufacturing capacity, specifically their confidence in scaling beyond the 80 units produced in July and the timeline for needing a larger facility. He also asked about the strategic goals for the new O&P channel team and when this channel is expected to become a material revenue contributor.

Answer

CEO Paul Gudonis confirmed that plans for a larger Boston-area facility are being finalized to expand capacity beyond 80 units per month by Q4, with a runway for further growth in 2025. He stated that 2024 is for building O&P channel infrastructure and relationships, with a goal of training 80-100 clinicians by year-end. Gudonis anticipates a linear growth in order flow from this channel starting in 2025, rather than a material impact this year.