Chase Knickerbocker • Analyst

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI

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.

Ask Fintool Equity Research AI