Serge Belanger

Serge Belanger asked for clarification on BAQSIMI's 2026 expectations, specifically regarding the mid-single-digit unit growth in the U.S. being offset by international sales discontinuation, and what this means for overall franchise growth. He also questioned the market opportunity for AMP-007 (Ipratropium Bromide HFA), potential for an authorized generic, and if the Atrovent market has stabilized after a significant decline in 2025.

Answer

Bill Peters, CFO, confirmed mid-single-digit U.S. unit growth for BAQSIMI, with international declines expected in the second half of 2026 as a three-year marketing commitment ends for unprofitable markets. Dan Dischner, SVP of Corporate Communications, added that the Atrovent market was $112 million last year, and Amphastar expects a meaningful share with 180 days of exclusivity, with no current visibility on an authorized generic. He believes the market decline was pricing-driven and is now fairly stable, a view supported by Bill Peters who noted generic entry often stabilizes unit demand.

Serge Belanger inquired about Amphastar's 2026 expectations for BAQSIMI, specifically the impact of mid-single-digit unit growth in the U.S. versus planned international sales discontinuation, and the overall growth outlook for the franchise. He also asked about the market opportunity for AMP-007 (Ipratropium Bromide HFA), the potential for an authorized generic, and whether the Atrovent market has stabilized after its 2025 decline.

Answer

Bill Peters, CFO, and Dan Dischner, Senior Vice President of Corporate Communications, explained that BAQSIMI's U.S. unit growth would be partially offset by discontinuing sales in unprofitable international markets in the second half of 2026, but overall growth is still expected. For AMP-007, Dan Dischner noted the Atrovent market was $112 million last year, presenting a meaningful opportunity with 180 days of exclusivity, and while there's no visibility on an authorized generic, the market is believed to be stabilizing due to pricing. Bill Peters added that the absence of an authorized generic could contribute to the higher end of the mid-to-high single-digit growth forecast.

Serge Belanger of Needham & Company inquired about Amphastar's full-year revenue guidance, second-half expectations for Baqsimi sales, and the company's confidence in the near-term approval of its drug candidate, AMP-002.

Answer

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.

Serge Belanger from Needham & Company, LLC requested more details on the BAQSIMI-MannKind collaboration, specifically regarding the increase in sales force size and prescriber targets. He also asked for an update on the competitive landscape for epinephrine and the likelihood of Pfizer's return to the market.

Answer

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.

Serge Belanger asked about the headwinds that led to ZILRETTA's relatively flat performance in 2025 and what factors could establish a growth profile in 2026 with the J&J MedTech partnership fully active.

Answer

CEO Frank Lee attributed ZILRETTA's flat 2025 performance to Pacira's prioritization of EXPAREL and sales force restructuring, with 2025 focused on training the J&J team. CCO Brendan Teehan added that for 2026, J&J has clear growth objectives with incentive compensation, appropriate target selection, and ZILRETTA provides a strong clinical complement to their viscosupplements with consistent reimbursement, leading to optimism for growth once traction is gained.

Serge Belanger from Needham & Company asked for color on recent surgical volume trends and whether the competitive landscape for EXPAREL has intensified, particularly from products like ZYNRELEF.

Answer

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.

Speaking on behalf of Serge Belanger, an analyst asked if iovera is expected to follow a similar uptake trajectory to EXPAREL given its new reimbursement code. The analyst also inquired about Pacira's appetite for a potential settlement agreement regarding the EXPAREL generic litigation.

Answer

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.

Serge Belanger from Needham & Company inquired about the 2026 guidance for the CINV franchise, specifically CINVANTI, and whether the NOPAIN Act is still expected to be a significant tailwind for ZYNRELEF's growth.

Answer

CEO Craig Collard stated that the CINV franchise, primarily CINVANTI, is expected to see unit volume growth from the IBM team's hospital promotion, but price erosion will likely keep sales relatively flat in 2026. COO Mark Hensley confirmed the NOPAIN Act remains a strong tailwind for ZYNRELEF, with 2025 focused on provider education, and its combination with the permanent J-code will reduce institutional friction.

Serge Belanger inquired about Heron Therapeutics' 2026 guidance, specifically focusing on expectations for the CINV franchise, predominantly CINVANTI, and whether the NOPAIN Act is still anticipated to be a significant tailwind for ZYNRELEF's growth.

Answer

CEO Craig Collard stated that the CINV franchise is expected to see unit volume growth in hospitals due to the IBM team, but anticipated price erosion will likely keep sales relatively flat. COO Mark Hensley confirmed the NOPAIN Act, combined with the permanent J-code for ZYNRELEF, is a strong tailwind that will continue to reduce friction for institutions.

Asked if the salesforce changes involved expansion or just refocusing, inquired about any observed impact from the NO PAIN Act on ZINRALF uptake since April, and requested the new pro forma share count following the recent financing transactions.

Answer

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.

Serge Belanger questioned if the salesforce changes were a refocusing or an expansion, inquired about any noticeable changes in ZINRELEF uptake since the NO PAIN Act implementation, and asked for the new pro forma share count following the recent financing transactions.

Answer

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.

Serge Belanger asked about the overall Q1 business trends, whether typical seasonality was observed, and requested details on the drivers behind the increased full-year EBITDA guidance.

Answer

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.

Inquired about the drivers behind ZYNRELEF's recent momentum, the expected impact of the NOPAIN Act, and the outlook for operating expenses in 2025.

Answer

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.

Serge Belanger of Needham & Company asked if the lower Q3 operating expense represents a new baseline, inquired about the CINVANTI litigation timeline, and questioned the potential impact of the NOPAIN Act on ZYNRELEF in 2025.

Answer

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.

Serge Belanger with Needham & Company inquired about the pediatric opportunity for ZORYVE 0.05% cream in 2-5 year olds, specifically asking about the level of awareness and willingness to prescribe the product after nearly four months on the market. He also asked if the expanding sales force and growing cash balance would change Arcutis's appetite to add a commercial asset.

Answer

Chief Commercial Officer Todd Edwards reported strong willingness to prescribe and robust uptake of ZORYVE 0.05% cream for 2-5 year olds, citing its once-a-day, effective, and steroid-sparing profile. President and CEO Frank Watanabe stated that adding a commercial stage asset is not a high priority, as Arcutis has numerous opportunities with ZORYVE (6 approvals in 3 years, more expected) and aims to avoid distractions from its highest-margin commercial opportunity. He emphasized that the real value creation lies in mid-stage development assets, leveraging Arcutis's strong development organization.

Serge Belanger asked about the level of awareness and willingness to prescribe the 0.05% cream for pediatric atopic dermatitis (2-5 years old) after nearly four months on the market. He also inquired if the expanding sales force and growing cash balance change the company's appetite for adding a commercial asset.

Answer

Todd Edwards, Chief Commercial Officer, reported strong willingness to prescribe and robust uptake of the 0.05% cream for pediatric AD, highlighting its value proposition as a highly effective, once-daily, soothing, moisturizing vehicle suitable for any body area and duration, offering long-term disease control and a steroid alternative. Frank Watanabe, President and CEO, stated that adding a commercial stage asset is not a high priority. He emphasized the wealth of opportunities around ZORYVE, with six approvals in three years and more expected, and the focus on maximizing ZORYVE's growth. He sees greater value in mid-stage development assets, leveraging Arcutis's strong development organization and track record.

Serge Belanger of Needham & Company asked for a reconciliation between the 28% quarter-over-quarter revenue growth and the 13% script growth. He also inquired about the Medicare Part D opportunity, including its size and the expected timing for securing coverage, and asked if there were plans to expand the sales force.

Answer

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.

Serge Belanger from Needham & Company asked why Arcutis was able to avoid the typical Q1 seasonality seen with other products and inquired if the 80% insurance coverage rate for ZORYVE prescriptions could improve further.

Answer

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.

Serge Belanger from Needham & Company asked about the extent of Medicare and Medicaid coverage at the start of 2025 and the timeline for further expansion. He also posed a broader strategic question about the company's priority between near-term profitability versus pipeline and business development investments.

Answer

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.

Serge Belanger of Needham & Company asked about the expected proportion of the Medicare Part D market Arcutis will have coverage for in 2025 and whether the company anticipates changes in the competitive landscape given a competitor's product has changed ownership.

Answer

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.

Serge Belanger asked about the discontinuation rate in ACACIA-HCM compared to prior studies and whether there has been any change in the variability of the endpoints being monitored.

Answer

President and CEO Robert Blum and EVP of R&D Fady Malik stated that the study was designed to withstand a 10% discontinuation rate and remains within that metric. They cannot comment on endpoint variability as they are blinded to the data.

Serge Belanger asked about the discontinuation rate in ACACIA-HCM compared to prior studies and any observed changes in the variability of the endpoints.

Answer

Robert Blum, President and CEO, and Fady Malik, EVP of R&D, stated that the study was designed to withstand a 10% discontinuation rate and remains within its design parameters. They could not comment on endpoint variability as they are blinded to the data.

Serge Bellinger (represented by John) asked about KOL feedback on the new YCANTH Rx non-dispensing pharmacy, its potential to boost dispensed applicator growth, and whether the sales force expansion aims for broader call points or deeper engagement with existing prescribers.

Answer

Jayson Rieger, President and CEO, reported very positive KOL feedback on YCANTH Rx for simplifying the prescription process for clinicians and patients. He clarified that the sales force expansion targets both increased breadth by expanding into pediatric and primary care, and greater depth by allowing reps more time with existing dermatology customers.

Serge Belanger questioned the split between commercial and Medicaid coverage within the total addressable market for molluscum and asked about the current and expected gross-to-net percentage for YCANTH.

Answer

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.

Asked about the potential for new YCANTH distributor partnerships and their impact on net pricing, whether the VP-315 data derisks development for squamous cell carcinoma, the current prescriber mix between dermatologists and pediatricians, and any observed off-label use.

Answer

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.

Serge Belanger sought an update on DefenCath's Q3 pricing and whether guidance could be provided once the ESRD rule for post-TDAPA calculation is published. He also asked about any pending legislation in Congress that could modify TDAPA reimbursement.

Answer

CEO Joe Todisco stated that specific pricing is not disclosed, but noted slight quarter-over-quarter ASP erosion, which has been more than offset by volume growth. He explained that the TDAPA rule methodology will inform pricing agreements, and they await the final ESRD rule to determine if a blended price negotiation is needed for Q3/Q4 2026 versus 2027. Todisco mentioned a bipartisan bill (Senator Booker, Marshall Blackburn) that proposes expanding ASP-based pricing to three years, making the post-TDAPA add-on permanent, and tracking drug utilization based on claims, hoping for its advancement in early 2026.

Serge Belanger with Needham & Company sought an update on DefenCath's pricing during Q3 and how the upcoming ESRD rule will influence post-TDAPA period calculations and future guidance. He also inquired about any pending legislation in Congress that could modify TDAPA reimbursement.

Answer

CEO Joe Todisco stated that specific pricing is not disclosed but noted historical slight erosion quarter-over-quarter due to ASP discounts, which has been offset by volume growth. He explained that the ESRD rule's methodology will inform pricing agreements, particularly regarding potential differences in adjustments between Q3/Q4 2026 and 2027. Todisco mentioned a bipartisan bill proposed by Senators Booker, Marshall, and Blackburn that aims to expand ASP-based pricing to three years, make the post-TDAPA add-on permanent, and link it to drug utilization claims, expressing hope for its advancement in early 2026.

Serge Belanger inquired about the inpatient market opportunity a year after launch, its potential size relative to the outpatient segment, and any ongoing efforts to modify or improve the TDAPA reimbursement process.

Answer

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.

Serge Belanger of Needham & Company asked about the concentration of Q3 sales from the anchor customer, U.S. Renal Care, and whether their successful implementation process could be replicated with new partners. He also inquired about the upcoming transition from WAC to ASP-based reimbursement under TDAPA and its potential impact on ordering patterns.

Answer

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.

Serge Belanger requested an update on securing formulary coverage, expectations for parity with other products regarding step-throughs, prior authorizations, and quantity limits. He also asked about the assumptions behind the increased projected market growth shown on slide 14 of the updated slide deck.

Answer

Nicole Sweeny, Chief Commercial Officer, confirmed that access is progressing as anticipated, with medical exceptions leading to early paid access, and that parity access to branded therapies is expected. She noted one instance of a generic Acadevant step-through, but patients still gained access due to prior experience. Ben Palleiko, CEO, explained that the increased market growth projection reflects updated, higher branded pricing expectations based on the current WAC and market position.

Serge Belanger requested an update on formulary coverage, including expectations for parity access compared to other products regarding step-throughs, prior authorizations, and quantity limits. He also asked about the assumptions behind the 25% increase in projected market growth noted in the updated slide deck.

Answer

Nicole Sweeny, Chief Commercial Officer, confirmed that access is progressing as anticipated, utilizing medical exceptions, and that parity access to branded therapies is expected. She noted one instance of a generic Acadevant step-through requirement, which was overcome as 80% of patients have prior experience. Ben Palleiko, CEO, explained that the increased market growth projection reflects an updated, meaningfully higher branded price expectation based on WAC and current market conditions, with some additional growth factored in.

Serge Belanger requested an update on formulary coverage, expectations for parity with other products regarding step-throughs, prior authorizations, and quantity limits. He also asked about the assumptions behind the increased projected market growth presented on slide 14.

Answer

Nicole Sweeny, Chief Commercial Officer, stated that access was progressing as anticipated, with early paid access via medical exception, and reiterated expectations for parity access to branded therapies. She noted that a single instance of a generic Acadevant step-through was overcome by most patients' prior experience. Benjamin Palleiko, CEO, explained the increased market growth projection was due to revising branded prices to reflect a meaningfully higher WAC and current market conditions.

Serge Belanger from Needham & Company asked for a breakdown of the Q2 revenue between channel inventory and patient demand, an update on payer coverage status, and the latest on the '327 patent litigation, including decision timing.

Answer

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.

Serge Belanger of Needham & Company asked about the current level of physician awareness of YUTREPIA and whether the launch would see initial warehousing demand or a more gradual, evaluation-based uptake.

Answer

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.

Serge Belanger of Needham & Company, LLC asked for an update on the timeline for the United Therapeutics lawsuit against the FDA and questioned how this case might be a gating factor for the YUTREPIA NDA decision.

Answer

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.

Serge Belanger of Needham & Company requested more context on the Lester Cough Questionnaire (LCQ) data from the CORAL trial and asked about future presentations of other secondary endpoints. He also asked about operating expense projections.

Answer

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.

Serge Belanger of Needham & Company requested an update on the respiratory physiology study, asking if it remains on track and if its design has been modified in light of the recent data from the RCC trial.

Answer

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.

John, on behalf of Serge Belanger from Needham and Company, asked about the specific growth levers Collegium plans to use for Jornay PM during the critical Q3 back-to-school season. He also requested an update on the generic competition landscape for the company's pain portfolio.

Answer

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.

Serge Belanger asked for an update on the overall ADHD market growth rate, the breakdown of Jornay's prescriber base between pediatricians and psychiatrists, and the source of Jornay's recent market share gains.

Answer

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.

Serge Belanger of Needham & Company inquired about the integration of Jornay PM, specifically asking about the current size of its sales force and any planned modifications. He also sought clarity on recent formulary changes for Xtampza and Belbuca, asking about the volume of prescriptions at risk from a formulary removal and the potential for conversion on a new formulary addition.

Answer

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.

Serge Belanger from Needham & Company noted the historical resilience of the aesthetics market and asked what makes the current consumer slowdown different. He also inquired about any observed changes in market pricing due to tariffs or competition.

Answer

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.

Serge Belanger asked about market seasonality, specifically if the typical Q4 to Q1 revenue step-down was more pronounced this year and if that could signal a strong Q2 rebound. He also inquired if Evolus has observed any changes in injector purchasing behavior, such as stocking up ahead of potential new tariffs on pharmaceuticals.

Answer

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.

Serge Belanger inquired about the outlook for new account additions in 2025 given the Evolysse launch and whether the Evolysse injection procedure requires significantly different training compared to other fillers.

Answer

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.

Serge Belanger of Needham & Company inquired about the remaining prior authorizations for NEXLETOL and NEXLIZET, the potential for improving the current 80%+ approval rate, and the expected balance sheet impact from the working capital benefits of the manufacturing tech transfer to Daiichi Sankyo Europe.

Answer

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.

Asked if the Q4 Medicare contract impact would continue into 2025 and questioned the reasons for a prescription slowdown in early Q1.

Answer

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.

Inquired about how product usage has changed with updated utilization management, its position relative to PCSK9 inhibitors, the timing of the 65% Medicare coverage, and the structure of milestone payments from the Otsuka collaboration.

Answer

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.

Serge Belanger from Needham & Company asked for more detail on the gross-to-net improvement, a comparison of new patient additions to 2024 levels, and whether the current sales force requires expansion.

Answer

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.

Serge Belanger asked if there is potential for the ORLADEYO paid rate to improve further beyond the current level, which is near the 85% target. He also inquired if the source of new patients (e.g., from prophylaxis vs. acute-only) had changed in the first quarter.

Answer

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.

Serge Belanger asked for the number of patients on ORLADEYO at year-end 2024 compared to 2023 and questioned whether the positive impact from the IRA on paid rates could also help drive new patient volume.

Answer

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.

Serge Belanger asked how current patient additions are tracking against the company's long-term targets and how the launch of new competitive prophylactics in 2025 might impact the switching opportunity for ORLADEYO.

Answer

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.

Serge Belanger asked for an estimate of the total cost for the planned Phase 3 program, questioned Clearside's capacity to run such a large trial, and inquired about the rationale for choosing a non-inferiority design over a superiority trial.

Answer

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.

Asked if the early rescues seen in the prior OASIS trial created an expectation for higher dropouts in the ODYSSEY trial, inquired about potential expansion of CLS-AX into other indications like DME, and asked for an update on XIPERE's commercial performance.

Answer

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.

John, on behalf of Serge Belanger from Needham & Company, asked about Omeros's manufacturing scalability for narsoplimab to support market demand and its pre-launch efforts to increase physician awareness.

Answer

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.

Serge Belanger of Needham & Company asked for the potential size and cost of the OMS906 (zaltenibart) Phase III program and whether Omeros's current cash balance is sufficient to fund it or if a partner would be sought.

Answer

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.

Asked about DAXXIFY's net pricing in Q1, the specific goal of the coupon program, and the company's plans to increase DAXXIFY's low consumer awareness.

Answer

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.

Asked about the DAXXIFY launch in cervical dystonia, focusing on the nature of the secured commercial payer coverage, how it compares to competitors, and plans for Medicare.

Answer

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.

Asked about Q3 vial volume trends before the price change, whether the new price better positions DAXXIFY for new patients, and if a promotional 'DAXXI day' is planned for Q4.

Answer

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.