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CFO & COO Michael Kaseta explained that the 'vast, vast majority' of Q2 revenue was from initial channel loading, which has been largely absorbed in Q3. He confirmed contracts are signed with three major payers to achieve parity access. General Counsel Rusty Schundler stated that post-trial briefing for the '327 patent case is complete, and while timing is uncertain, the judge's accelerated schedule could indicate a faster decision.

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Chief Commercial Officer Scott Moomaw stated that while pre-launch communication is limited, a 'loud' launch with a full suite of marketing activities will rapidly build awareness. He anticipates the initial focus will be on new patients, though some demand may come from physicians seeking to transition patients who have reverted to nebulized TYVASO. CEO Dr. Roger Jeffs added that the long-term strategy includes competing with oral prostacyclins, targeting a total $4 billion market opportunity.

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General Counsel Russell Schundler responded that the court has not yet indicated whether it will hold an oral argument or rule on the briefs for the motion to dismiss, so no timeline is available. He reiterated the company's policy of not commenting on specific communications with the FDA or speculating on what influences the agency's decision-making process.

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The salesforce change was a strategic refocusing to create dedicated teams without a significant expansion or cost increase. The company has not seen an immediate impact from the NO PAIN Act but noted that reimbursement conversations are changing, expecting a gradual shift as commercial payers come on board. The pro forma common share count is approximately 183 million, and on a fully converted basis, it's about 208 million shares.

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COO Mark Hensley confirmed the salesforce change is a refocusing to create dedicated teams without meaningfully adding to costs. CEO Craig Collard stated there has been no immediate impact from the NO PAIN Act, but reimbursement conversations are becoming more productive, with a significant shift expected over the next year as commercial payers come on board. CFO Ira Duarte provided the pro forma share count as approximately 183 million common shares, or 208 million on a fully converted basis.

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Craig Collard, Chief Executive Officer, confirmed that Q1 trends were consistent with typical seasonality (e.g., co-pay resets) but was pleased that Heron's unit volume grew while the market declined. He also mentioned plans for targeted commercial expansion. Ira Duarte, Chief Financial Officer, added that the revised EBITDA guidance was a result of the strong Q1 performance, operational spending efficiencies, and anticipated lower legal costs following the recent litigation settlement.

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ZYNRELEF's momentum is driven by multiple factors including the CrossLink partnership, which is showing 30% higher growth in associated accounts. The NOPAIN Act is creating positive 'noise' for non-opioid alternatives. Operating expenses are expected to be slightly higher in 2025 due to specific R&D and legal costs.

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CFO Ira Duarte clarified that the Q3 OpEx dip was due to timing and not a new baseline, suggesting a blend of Q2 and Q3 levels is more representative. CEO Craig Collard stated a decision on the CINVANTI litigation is expected by December 14, expressing high confidence in a favorable outcome. Regarding the NOPAIN Act, Collard believes it will be a 'tremendous help' by significantly increasing awareness for ZYNRELEF as a non-opioid alternative, creating a major tailwind for the franchise.

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CFO Bill Peters confirmed the company maintains its guidance for flat year-over-year sales, supported by two potential product approvals. He stated that Baqsimi is on track for high single-digit unit growth and a 3% price increase. EVP Tony Marrs added that the company remains optimistic about an AMP-002 approval due to ongoing, productive engagement with the FDA.

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CFO William Peters explained that the MannKind partnership more than doubles the number of salespeople detailing BAQSIMI, expanding national coverage. On epinephrine, he noted that while the multi-dose vial market has 4-5 competitors, Amphastar remains the sole U.S. supplier of the prefilled syringe. He added that a key competitor's return to the market is not expected in the first or second quarter.

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Chief Development Officer James Cassella highlighted the statistically significant improvements across all LCQ domains, which complement the objective cough data. Chief Commercial Officer Farrell Simon noted the importance of LCQ for demonstrating value and reimbursement. CFO Lisa Delfini confirmed that operating expenses are expected to remain relatively flat for the remainder of the year.

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Executive Jennifer Good confirmed the respiratory physiology study is currently screening patients and remains on track to provide data for the end-of-Phase II meeting with the FDA. She mentioned that given recent findings, the team is contemplating whether the highest dose of 108mg is still necessary for this study.

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EVP & CCO Scott Dreyer explained that the key levers for Jornay PM growth are raising awareness among both healthcare providers (HCPs) to drive adoption and among patients/caregivers to stimulate direct requests for the brand. EVP & CFO Colleen Tupper addressed the generics question, confirming no new threats have emerged. She reiterated that for BELBUCA, the last filer has received five CRLs, and for Nucynta, potential entrants lack access to commercial-scale quantities of the active ingredient, tapentadol, with the earliest potential entry for Teva in January 2027 remaining contingent on approval.

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Chief Commercial Officer Scott Dreyer stated that the overall ADHD market is growing at approximately 5-6%. He detailed the prescriber base as roughly 40% pediatricians, 40% neuropsychiatry, and the remaining 20% split between PCPs and mid-level practitioners. Dreyer explained that the primary driver of Jornay's market share growth is patients switching from generic immediate-release products, supplemented by some switching from other branded medications.

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Executive Scott Dreyer stated the current sales force is approximately 150 people and that the company is assessing an expansion to maximize Jornay PM's potential, with details to be included in future OpEx guidance. Regarding formulary changes, Dreyer explained that the removal from one Part D plan affects about 12% of Belbuca and 18% of Xtampza prescriptions but will be net revenue positive. The new formulary addition will not report prescription data to IQVIA, resulting in a net negative impact on reported scripts but a positive impact on revenue.

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Chief Commercial Officer Todd Edwards explained the variance was primarily due to the recovery of distribution channel inventory to normal levels after a drawdown in Q1, not abnormal stocking. CEO Frank Watanabe and CCO Todd Edwards noted that securing Medicare Part D coverage is challenging due to financial disruption for payers from the IRA, making timing uncertain. Frank Watanabe also confirmed there are no current plans to expand the Arcutis dermatology sales force.

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Todd Edwards, Chief Commercial Officer, attributed the strong Q1 demand growth (10% QoQ) to the franchise's momentum and the 'portfolio effect,' where clinicians prescribing for multiple indications use more ZORYVE overall. He noted this drove new-to-brand prescriptions, offsetting typical Q1 headwinds. Regarding coverage, he stated that the 80% reimbursement rate is considered an 'optimal steady state' and he expects it to remain in that range, with minimal changes expected.

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Chief Commercial Officer Todd Edwards reported that as of early 2025, 1 in 2 Medicaid beneficiaries have access to ZORYVE, with ongoing negotiations for Medicare Part D. President and CEO Frank Watanabe stated that the top priority remains investing in ZORYVE's growth to drive shareholder value, viewing the 2026 cash break-even target as a means to gain operational flexibility rather than an end in itself. He characterized the company's approach to pipeline and BD as opportunistic, not imperative.

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Chief Commercial Officer Todd Edwards and CEO Frank Watanabe clarified that Medicare Part D coverage will be a progressive, plan-by-plan process similar to commercial insurance, not a single event covering the entire market. On the competitive front, Frank Watanabe noted that a competitor's delayed AD approval is a positive, but Arcutis's primary competition remains topical steroids and Opzelura, and it is too early to assess the impact of the competitor's ownership change.

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President & CEO David Moatazedi suggested this downturn is unique because it disproportionately affects consumers earning under $150,000, who are feeling the effects of inflation. He stated that he has not seen significant market-wide price changes related to tariffs, noting that neurotoxins are currently exempt.

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CEO David Moatazedi explained that while Evolus has historically bucked market seasonality due to high growth, its moderating growth rate will likely cause it to align more with traditional patterns. He noted the market slowdown in the back half of last year will affect year-over-year comps. CFO Sandra Beaver stated that while Evolus is taking prudent steps to manage inventory ahead of potential tariffs, the company has not seen any change in purchasing behavior from practices, as there is no immediate view that costs will be passed on.

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CEO David Moatazedi stated that new account additions will likely decrease from the historical rate of ~500 per quarter as the sales team prioritizes training existing customers on Evolysse. CMO Rui Avelar added that Evolysse training is straightforward, as the gel is well-balanced, forgiving with a low inflammation profile, and efficient, meaning less product is often needed to achieve optimal correction.

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Chief Business Officer Betty Swartz highlighted that the new field reimbursement team has already reached 1,100 targets, achieving approval rates well over 80%, with specific payers like CVS and Aetna exceeding 90%. She noted 192 million lives are now aligned with the new label. CFO Ben Halladay explained that the working capital benefit will appear as reduced inventory on Esperion's balance sheet in the second half of 2025 as their production ramps down and Daiichi Sankyo's ramps up.

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The negative Medicare gross-to-net impact from Q4 is not expected to linger in 2025 due to reforms. The early Q1 prescription slowdown is a typical seasonal trend due to insurance deductible resets, and the company still anticipates growth for the quarter.

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Executives stated that product use has expanded into primary prevention and statin-intolerant patients, taking some market share from ezetimibe and PCSK9s. The 65% Medicare coverage is current, having been accelerated by payers, with more contracts expected. The Otsuka milestones are tied to regulatory filing, approval, and pricing in Japan, with payments expected by the end of 2025.

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President & CCO Charlie Gayer confirmed the gross-to-net is in the lower end of the 15-20% range and that Q2 new patient adds significantly surpassed Q1, which was already the best quarter since launch year. He stated that the sales force is perfectly sized and highly efficient, and adding more reps would be unnecessary. CEO Jon Stonehouse reinforced that this efficient commercial infrastructure is a key asset to be leveraged for future products.

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Chief Commercial Officer Charlie Gayer confirmed they will strive to exceed the 85% paid-rate goal, noting that the rate in the Medicare segment is already at 89%, which shows further improvement is possible. He also stated that the mix of new patients in Q1 was fundamentally very similar to the trends seen since launch, with a balanced contribution from different prescriber tiers, indicating broad and sustainable growth.

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Chief Commercial Officer Charlie Gayer did not provide a specific patient count but confirmed that new patient additions in 2024 were well above the annual average required to meet long-term revenue goals. He acknowledged that improved reimbursement confidence from the IRA could potentially boost new patient starts over time, though this has not been a direct driver yet. CEO Jon Stonehouse highlighted the company's patient services as a key competitive advantage.

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Chief Commercial Officer Charlie Gayer confirmed that patient additions are 'very much on track' with their goals. He stated that market research indicates new injectable competitors will primarily compete with existing injectables, not with ORLADEYO's oral formulation. CEO Jon Stonehouse added that increased discussion about switching therapies presents a net opportunity, as patients and physicians open to change would logically consider the oral option first.

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Executive Jayson Rieger noted that pediatricians typically see a higher percentage of Medicaid patients while dermatologists see more commercially insured patients, with growth occurring in both segments. Interim CFO John Kirby declined to provide a specific gross-to-net figure but suggested it could be estimated using the reported revenue and dispensed applicator unit numbers.

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The company remains opportunistic about new partnerships and expects net pricing to remain in the 45-50% range. For VP-315, the current focus is on basal cell carcinoma, though other indications like squamous cell may be considered later. They noted that while dermatologists are the main prescribers, the pediatric sales force is making quick inroads. The company cannot comment on or support any off-label use.

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CCO Brendan Teehan noted a nominal, low single-digit decline in surgery room hours during the first quarter. CEO Frank Lee stated that the competitive landscape has not significantly changed, emphasizing that the primary competition remains short-acting bupivacaine and that Pacira has substantial room for market penetration growth.

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CEO Frank Lee declined to comment on any potential settlement discussions but reiterated strong confidence in the company's IP estate and noted more patents are expected. An executive, likely CCO Brendan Teehan, addressed the iovera question, highlighting the new C-code as a key growth driver that provides physicians up to $256 in additional reimbursement. He noted that iovera is at a different stage in its lifecycle than EXPAREL and will receive selective investment to capitalize on the improved reimbursement landscape and new SmartTip for low back pain.

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CEO Joseph Todisco acknowledged the slow ramp in the inpatient market but highlighted recent progress, with shipments doubling to 6% of the total in April and a dedicated sales team now operational. He stated its ultimate size depends on LDO uptake. Regarding TDAPA, he mentioned monitoring the upcoming CMS proposed rule and supporting legislative initiatives aimed at codifying and improving the pathway, though he cautioned the legislative route is challenging.

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CEO Joseph Todisco confirmed that U.S. Renal Care accounted for over 90% of Q3 sales and that CorMedix is actively working to replicate their successful implementation model with other customers, particularly the new LDO. Regarding reimbursement, Todisco stated the transition from WAC to ASP is anticipated, has been structured into agreements, and is not expected to impact ordering patterns or be problematic, as significant ASP erosion is not expected initially.

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CFO Charlie Deignan stated that while not providing a specific number, similar Phase 3 studies cost around $55-60 million each, and he reminded listeners that Clearside has experience running concurrent Phase 3 trials. Dr. Victor Chong, Chief Medical Officer, added that the two non-inferiority trial design is a proven, less risky regulatory path that is well-established with the FDA for retinal drugs.

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The executive attributed the early rescues in the open-label OASIS trial to site-specific nervousness and does not expect a similar issue in the double-masked ODYSSEY trial. He confirmed that for now, CLS-AX development is focused solely on wet AMD. The CFO addressed the XIPERE question by stating they cannot report sales ahead of their partner and that Clearside is not yet eligible for royalties.

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Chairman and CEO Gregory Demopulos and Chief Commercial Officer Nadia Dac responded. Dr. Demopulos confirmed that the company has sufficient drug supply manufactured to support the narsoplimab launch for the first two to three years. Ms. Dac added that a targeted field team has been building awareness of TA-TMA diagnosis and treatment with top transplant centers, noting that the topic is now a mainstream discussion among physicians who are actively seeking a solution.

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Executive Gregory Demopulos stated that Omeros is confident it can advance the program independently but remains open to partnering discussions. Chief Medical Officer Andreas Grauer specified that each of the two randomized trials is expected to enroll slightly below 100 patients. VP of Clinical J. Whitaker added that strong prior efficacy data allows for smaller trials and that rapid enrollment is anticipated, which should positively impact costs.

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The Q1 net price reduction was solely due to a consumer coupon pilot, and future programs will be structured differently. The coupon was designed to drive trial in a subset of accounts. After focusing first on re-engaging providers, the company is now increasing its social and digital marketing spend to build consumer brand awareness.

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Mark Foley detailed that they have secured over 50% of commercial lives, with nearly two-thirds of that being for first-line therapy without restrictive step-edits, giving them a strong competitive position. Regarding off-label use, coverage will vary by payer policy. For Medicare, which represents about 20% of the market, he stated they already have 100% coverage, positioning them well for the launch.

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The company noted that Q3 was back-end loaded, with September showing strong reorder volume after the price change. The new pricing is primarily aimed at facilitating the switch of existing toxin users at the practice level, rather than attracting new patients. They do not plan to hold a 'DAXXI day' in Q4, as their strategy focuses on product differentiation and education over promotions.

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