Annabel Samimy

Annabel Samimy asked if titration is needed when transitioning from weekly injectable to weekly oral 110 mg, and if any down-titration for maintenance is planned similar to the Venture Oral Dosing Study. She also inquired about leveraging maintenance data with payers for preferential adoption and persistence.

Answer

Brian Lian (President and CEO, Viking Therapeutics) stated that no titration is anticipated when transitioning from weekly injectable to weekly oral 110 mg, and no further down-titration is contemplated for oral maintenance doses. He emphasized that maintenance data is crucial for discussions with payers, as increased persistence rates are a significant factor for long-term benefits and cost savings.

Annabel Samimy asked if titration would be needed when moving from weekly injectable to weekly oral at 110 mg, and if any down-titration for maintenance (similar to the Phase 2 VENTURE-Oral Dosing Study) was planned. She also inquired about leveraging maintenance data with payers for preferential adoption and reimbursement.

Answer

Brian Lian (President and CEO, Viking Therapeutics) stated that no significant tolerability challenge or titration is anticipated when transitioning from weekly subcutaneous to weekly oral. He clarified that the transition from subcutaneous to oral itself acts as a down-titration, and further down-titration on oral is not contemplated. He emphasized that maintenance data is crucial for payers, as it demonstrates how to keep patients on therapy, leading to long-term benefits and cost savings, which could drive preferential adoption and reimbursement.

Annabel Samimy of Stifel asked for the rationale behind transitioning patients to maintenance dosing at the three-month mark in the planned study, given weight loss would still be ongoing. She also inquired about what Viking views as the most likely viable commercial doses for the oral formulation.

Answer

President & CEO Brian Lian clarified that the transition to maintenance happens after a titration period longer than three months; the maintenance evaluation itself lasts about three months. For oral doses, he noted that lower doses are attractive for maintenance but highlighted the 90mg-to-30mg step-down cohort as key. He also mentioned that falling peptide production costs might improve the feasibility of higher oral doses.

Annabel Samimy inquired about how the Phase III trial for injectable VK2735 will assess durability and whether a monthly dosing regimen would be incorporated. She also asked if the auto-injector must be integrated into the Phase III study.

Answer

Brian Lian, President and CEO, confirmed the auto-injector will be introduced into the Phase III program, which necessitates the planned bridging study. He stated that a monthly dosing regimen is not currently part of the Phase III protocols but could potentially be included in a future extension study, pending results from an initial trial evaluating the weekly-to-monthly transition.

Annabel Samimy questioned the broad dose range in the Phase II oral VENTURE trial, asking if the highest dose is a realistic target. She also requested an update on the status of manufacturing agreements.

Answer

CEO Brian Lian explained the dose range is to evaluate if lower doses show maturing efficacy over time. He noted the highest dose was deemed acceptable based on Phase I tolerability and the drug's slow accumulation. On manufacturing, he stated that Viking is making good progress on comprehensive agreements to support a substantial commercial launch.

Annabel Samimy asked about the potential for monthly dosing data for VK2735, its inclusion in the Phase III program, exploration of different oral dosing regimens, and the required infrastructure and personnel expansion for upcoming large-scale trials.

Answer

Executive Brian Lian stated that PK data supporting monthly dosing will be presented, but this regimen would likely be evaluated in a separate, stand-alone trial. Regarding infrastructure, he confirmed a significant, broad-based increase in staff across multiple departments, including regulatory, clinical operations, and manufacturing, to prepare for Phase III.

Annabel Samimy of Stifel Financial Corp. questioned how patient compliance is ensured in the 24-week CELVA trial, whether the CVM data could serve as a positive indicator for the MLM trial, and sought clarification on the basis for the MLM patient population estimates, which appear to be increasing.

Answer

President and CEO Wes Kaupinen attributed high compliance to the patient-friendly formulation and strong clinical operations support for trial sites. He clarified that CVM and MLM are distinct diseases, so CVM data is not a direct read-through for MLM. He also explained that the >30,000 patient estimate for MLM is a conservative figure derived from three separate epidemiological studies, which new CCO Ashley Klein will continue to refine.

Annabel Samimy inquired about the performance dynamics of KEDRAB and Cytogam, the adequacy of the company's cash position for impactful business development, and the competitive landscape for the inhaled AAT program.

Answer

CEO Amir London explained that KEDRAB and Cytogam are performing as planned, with current growth driven by other portfolio products like Glacia and VariZig. He affirmed that existing cash and other funding sources are sufficient for planned M&A activities targeting commercial-stage assets. Regarding the inhaled AAT program, London noted that while the market is growing with new entrants, Kamada's program is the most advanced pivotal efficacy study, positioning it well in what he expects to be a $2 billion market.

Annabel Samimy of Stifel Financial Corp. asked about the performance dynamics of KEDRAB and Cytogam versus the recent growth drivers, the sufficiency of the company's cash position for M&A, and the competitive landscape for the inhaled AAT program.

Answer

CEO Amir London explained that KEDRAB and Cytogam are performing as planned, with current growth driven by the portfolio's diversity, specifically Glacia and Varisig. He stated that the company has sufficient funding for its M&A strategy through existing cash and other financing options. Regarding the AAT program, he noted it is the most advanced in a pivotal efficacy study and that the growing market has room for multiple new technologies.

Annabel Samimy inquired about the key growth drivers for the quarter, questioning the impetus behind the expanded clinical investment in CYTOGAM and its potential to influence treatment guidelines. She also asked about the company's assessment of potential global tariff impacts and requested an update on the enrollment status for the Phase III InnovAATe trial.

Answer

Executive Amir London clarified that Q1 growth was driven by GLASSIA, KAMRAB, and VARIZIG, not CYTOGAM, whose sales were stable year-over-year. He explained the new CYTOGAM studies, initiated in 2023, are designed to generate fresh clinical data to support utilization and future guideline updates. Executive Chaime Orlev stated that based on current analysis, global tariffs are not expected to have a direct impact on Kamada's products. Finally, Amir London confirmed that the InnovAATe trial has reached approximately 55% enrollment.

Annabel Samimy asked for details on the upcoming futility analysis for the inhaled AAT program, inquired about the specific growth drivers for KEDRAB and CYTOGAM in 2025, and questioned the rationale for issuing a special dividend as a development-stage company.

Answer

Executive Amir London explained that the AAT futility analysis will be conducted by a blinded external group reviewing efficacy data, with potential outcomes to continue, modify, or stop the trial. He clarified that KEDRAB's growth is driven by the U.S. market and minimum purchase commitments, while CYTOGAM's growth is supported by new clinical work. Regarding the dividend, London stated that the company's strong 2024 results, robust 2025 outlook, and solid cash position allow it to reward shareholders while still having sufficient funds to pursue its M&A and business development strategy.

Annabel Samimy of Stifel inquired about several key growth drivers, including the sales breakdown and market share potential for KEDRAB and CYTOGAM, the specific factors contributing to EBITDA expansion, and the progress of the InnovAATe clinical trial, including enrollment status and partnership discussions. She also asked about advancements in business development and the preclinical pipeline.

Answer

Amir London, an executive, explained that while specific product-level revenues are reported annually, both KEDRAB and CYTOGAM are experiencing significant double-digit growth. He estimated KEDRAB's U.S. market share is between 40-50% with further growth potential. London attributed the strong EBITDA performance to economies of scale and an improved sales mix favoring these high-profitability products. Regarding the InnovAATe trial, he stated enrollment is around 50%, with ongoing FDA discussions about sample size. He also confirmed that the company is actively pursuing M&A and licensing opportunities, expecting a commercial contribution in 2025, and noted progress in the preclinical plasma eyedrops program.

Annabel Samimy of Stifel inquired about several key areas, including the sales breakdown for KEDRAB and CYTOGAM, the potential peak market share for KEDRAB, and the specific drivers of EBITDA expansion. She also asked for an update on the InnovAATe trial, including enrollment progress, potential challenges from competitors, and the status of partnership discussions. Finally, she sought information on progress in business development, M&A, and the preclinical pipeline.

Answer

Amir London, an executive at Kamada, explained that while specific product-level revenues are not disclosed quarterly, both KEDRAB and CYTOGAM are experiencing double-digit growth. He estimated KEDRAB's market share is 40-50% with further room for growth, both in the U.S. and internationally. London attributed EBITDA growth to economies of scale and a favorable sales mix toward more profitable products. He stated the InnovAATe trial is approximately 50% enrolled, with the final sample size pending FDA discussions. He confirmed that partnership discussions for the asset are ongoing, as is the active search for M&A opportunities, with an expected commercial impact in 2025. He also noted the preclinical plasma eyedrops program is progressing well.

Annabel Samimy of Stifel Financial Corp questioned the rationale for the parallel design in the non-IPF ILD study and commented on Haduvio's favorable tolerability and quality of life scores from the CORAL trial, asking if any changes were needed.

Answer

James Cassella, Chief Development Officer, explained the non-IPF ILD trial will have broad inclusion criteria based on fibrosis and cough, and the parallel design is suitable since proof-of-concept is established. He confirmed satisfaction with the CORAL trial's consistent tolerability profile and stated no significant changes are planned for the Phase 3 design, pending FDA discussions.

Annabel Samimy asked about the CORAL trial's discontinuation rate, specifically what rate the study was powered for versus the actual observed rate, and questioned what management views as the biggest remaining risk for the IPF study.

Answer

Chief Development Officer Dr. James Cassella confirmed the study was powered for a 30% discontinuation rate, while the actual rate was under 10%. Executive Jennifer Good added that despite positive interim data, the trial's complexity, involving 60 sites across 10 countries, remains a key variable until the final data is unblinded.

Annabel Samimy of Stifel asked about the efficacy observed at the 54mg dose in the RIVER trial, its comparison to the initial IPF trial, the potential for lower dosing in future studies to improve the AE profile, and whether AEs were dose-dependent. She also inquired about the inclusion criteria for the next RCC trial.

Answer

Executive Jennifer Good explained that the RIVER data suggests the effective dose for RCC is in the 27-54mg range, and the 108mg dose will likely not be needed, which provides flexibility for managing adverse events. She added that the team is even exploring doses below 27mg. For the next RCC trial, she stated it will target refractory patients but will no longer stratify by moderate versus severe cough counts.

Annabel Samimy of Stifel Financial Corp. questioned the tipping point for transitioning to the primary care market to achieve blockbuster status and inquired how the Medicare cash-pay program via BlinkRx might affect gross-to-net margins over time.

Answer

Steven Basta, President, CEO & Director, asserted that Voquezna can reach blockbuster status within the GI market alone, viewing the PCP market as a future additive opportunity. He explained the Medicare cash-pay option is a tool to ensure patient access and physician confidence, not a primary revenue driver, and is intended to simplify prescribing regardless of patient insurance type.

Annabel Samimy from Stifel questioned the decision to cut direct-to-consumer (DTC) advertising in a promotion-sensitive market and its potential impact on expanding the physician target audience for VOQUEZNA.

Answer

President and CEO Steven Basta explained that the decision was based on ROI analysis, which showed that broadcast DTC spend was not converting new prescribers effectively. He stated the company will now focus on the higher-return field sales organization to drive growth, suggesting that DTC may be more effective later in the product's lifecycle once physician awareness is more established.

Annabel Samimy questioned whether the increase in prescribers is driven more by the DTC campaign or physician education, the rationale for a new campaign, and how the increased spending balances with the cash runway to profitability.

Answer

CCO Martin Gilligan explained the new campaign is an evolution of the successful current one, which has driven a 55% increase in patient requests. CFO Molly Henderson noted the 2025 non-GAAP operating expense guidance of $360M-$390M includes this DTC investment and the company will re-evaluate ROI mid-year to ensure it's the best use of resources.

Annabel Samimy inquired about the drivers behind the impressive prescription growth, asking to distinguish between the impact of expanded market access and the new non-erosive GERD (NERD) indication. She also asked about prescription duration patterns and the rationale for delaying the as-needed dosing trial.

Answer

Chief Commercial Officer Martin Gilligan stated the growth is a mix of both expanded access and increased demand from the NERD launch, evidenced by a sharp rise in the 10mg dose prescriptions. He noted most scripts are for 30 days, with duration largely dictated by health plans. CEO Terrie Curran explained the as-needed trial was paused to evaluate real-world utilization data and physician feedback, which already indicates strong clinical response.

Annabel Samimy from Stifel Financial Corp. questioned the drivers behind reduced demand, probing whether it was consumer sentiment or competition, the cause of the sharp decline in the last two weeks of Q2, and the breakdown of Evolisse's launch revenue between initial stocking and pull-through.

Answer

President & CEO David Moatazedi attributed the slowdown to a high single-digit decline in market-wide procedural demand, which Evolus felt acutely in the final two weeks as top-tier accounts held back on large orders. He clarified this was a market-wide issue, not a competitive share loss. For Evolisse, he suggested the launch revenue was a "relatively even mix" of initial stocking and reorder pull-through.

Annabel Samimy inquired about aesthetic market trends, asking whether the filler market's weakness is due to macroeconomic pressures or a negative consumer sentiment toward the word 'filler.' She also questioned the slowdown in the typically resilient neuromodulator market, the classification of neuromodulators regarding potential tariffs, and the intended use of capital from the recent debt refinancing.

Answer

CEO David Moatazedi stated the filler market pressure is a combination of reduced consumer spending and negative sentiment, which the 'Drop the F Word' campaign aims to counteract. He noted the toxin market saw a slight Q1 dip but expects it to avoid negative annual growth. CFO Sandra Beaver clarified that Jeuveau is currently classified as a pharmaceutical for import purposes, making it exempt from current tariffs. She also explained the new debt facility provides non-dilutive capital capacity for potential strategic growth initiatives, emphasizing the company's focus on capital efficiency.

Annabel Samimy inquired about the challenging market conditions for U.S. facial injectables, the potential impact of GLP-1 weight-loss drugs on patient demand, and the performance of the new Club Evolus subscription model.

Answer

CEO David Moatazedi stated that Evolus is not observing the challenging market conditions mentioned by competitors, citing continued high single-digit growth in the toxin market and stable treatment intervals among its loyalty program members. He identified the GLP-1 patient trend as a significant tailwind for HA fillers, especially given Evolysse's unique label mentioning weight loss as a cause of wrinkles. Regarding the Club Evolus subscription, he noted positive early results from the initial pilot of ~100 accounts but prefers to wait for a full year of data before sharing specific metrics.

Annabel Samimy of Stifel inquired about the strategy for leveraging Evolus's digital platform for the upcoming Evolysse filler launch, competitive pricing dynamics in the filler market, and the rationale for narrowing the full-year revenue guidance.

Answer

President and CEO David Moatazedi explained that the existing digital platform will be fully leveraged for Evolysse, capitalizing on the company's cash-pay model, and that the product will be priced competitively. CFO Sandra Beaver added that narrowing the guidance range in Q4 is standard practice to provide more clarity with only one quarter remaining and does not indicate any concern.

Annabel Samimy from Stifel Financial Corp. asked about the potential total market penetration for GA, referencing a competitor's goal of 35%, and whether patients are delaying treatment due to the co-pay funding gap.

Answer

CEO Cedric Francois noted that physicians who adopt Cyfovri treat 30-50% of their GA patients, suggesting a potential target. CMO Dr. Caroline Baumal, a practicing ophthalmologist, confirmed that some patients are unable to start treatment due to the funding gap, as it represents a long-term commitment. She stressed that resolving the issue would be very helpful for patients.

Annabel Samimy from Stifel Financial Corp. inquired about the potential total market penetration for geographic atrophy, referencing a competitor's goal of 35% by 2029. She also asked if patients are delaying treatment initiation due to the co-pay funding gap.

Answer

CEO Dr. Cedric Francois noted that physicians who adopt Cyfovri treat 30-50% of their GA patients, suggesting this as a potential target. CMO Dr. Caroline Baumal confirmed that the funding gap is unfortunately causing some patients to be unable to start treatment, as it requires a long-term commitment.

Annabel Samimy from Stifel Financial Corp. inquired about the potential total market penetration for GA and asked if patients are delaying treatment due to the co-pay funding gap.

Answer

CEO Dr. Cedric Francois noted that adopting physicians treat 30-50% of their GA patients with Cyfovri, suggesting a potential target. CMO Dr. Caroline Baumal confirmed that the funding gap is unfortunately causing some patients to be unable to start treatment, and highlighted the importance of the 48-month GALE data in physician education.

Annabel Samimy of Stifel asked about the potential total market penetration for GA, referencing a competitor's goal, and whether patients are delaying treatment due to the co-pay funding gap.

Answer

CEO Dr. Cedric Francois noted that adopting physicians treat 30-50% of their GA patients with Cyfovri, suggesting a potential target. Speaking as a clinician, CMO Dr. Caroline Baumal confirmed that the funding gap is unfortunately causing some patients to be unable to start the long-term treatment.

Annabel Samimy asked for more detail on the Q4 inventory build, questioning how much was driven by the competitor's regulatory issues and whether physician conversations have changed since the competitor's label update. She also requested a quantification of the inventory impact.

Answer

Executive Timothy Sullivan explained that the competitor's CRL in December led to a sharp increase in SYFOVRE demand, new patient share, and switches, all contributing to the inventory build. Executive David Acheson added that while the competitor's product is now more likely to be reimbursed, SYFOVRE's every-other-month dosing with high efficacy remains a powerful differentiator with both physicians and payers, which continues to drive business.

Annabel Samimy from Stifel sought to reconcile SYFOVRE's >60% total market share with its ~50% new patient share and asked about the expected launch trajectory for EMPAVELI in C3G/MPGN.

Answer

CEO Dr. Cedric Francois and CMO Dr. Caroline Baumal explained the new patient share trend is positive and that the competitive field is now level, which favors SYFOVRE's superior long-term, flexible-dosing data. For C3G/MPGN, Dr. Francois reiterated the high unmet need and the significant market opportunity, as Apellis will likely only compete for about 20% of the total patient population.

Annabel Samimy of Stifel asked about the dynamics of patient referrals, including patient severity, and whether the '6 conversations' needed to convert a physician becomes more challenging as less severe patients are referred.

Answer

CMO Dr. Caroline Baumal explained that they see a wide range of patients and that physician conversations now center on efficacy and dosing flexibility, bolstered by real-world data. COO Adam Townsend added that it takes 6-9 conversations to onboard a new physician and that their educational efforts with optometrists and ophthalmologists help prepare patients before they see a retina specialist. He noted access to physicians is not a problem.

Annabel Samimy of Stifel asked about the potential to shorten MASH development timelines in Phase 3, the FDA's evolving stance on biomarkers, and any recent changes in interactions with the agency.

Answer

CBO Ray Jordt stated that a 6-month readout and rapid enrollment could shorten the development path, a possibility they will discuss with the FDA. He noted that while biomarkers are gaining acceptance, biopsy endpoints are likely still required for approval. He reported no change in FDA interactions. CEO Dr. Vipin Garg added that Altimmune's large existing safety database might allow for a more efficient Phase 3 trial design.

Annabel Samimy from Stifel Financial Corp. questioned what would define a competitive success for the IMPACT trial and sought commentary on the evolving NASH market landscape with competitors like semaglutide, Rezdiffra, and FGF21s. She also asked if exploratory endpoints would be released in the top-line data.

Answer

CEO Dr. Vipin Garg positioned pemvidutide as a complete solution for NASH by treating both the liver and obesity. CMO Dr. Scott Harris added that achieving statistical significance at 24 weeks would be a key differentiator from other incretins and that pemvidutide's weight loss benefit separates it from FGF21s and Rezdiffra. CFO Gregory Weaver confirmed they would aim to provide as much data as possible in the top-line readout.

Annabel Samimy of Stifel questioned if the FDA's safety focus could create higher hurdles for gene therapies in non-life-threatening conditions like retinal disease and asked about the potential impact of political inquiries on newborn screening efforts.

Answer

Chief Medical Officer Dr. Steve Pakola explained that retinal programs follow a standard, not accelerated, approval path and that their compartmentalized delivery methods offer a strong safety profile. President and CEO Curran Simpson added that newborn screening efforts continue to be a priority driven at the state level with advocacy groups, independent of federal inquiries.

Annabel Samimy of Stifel inquired about regulatory discussions for diabetic retinopathy (DR), asking about key differences between U.S. and ex-U.S. regulators. She also sought clarity on the upcoming DMD functional data update and whether the reported 50% pivotal trial enrollment includes patients from the Phase I/II study.

Answer

CEO Curran Simpson clarified that the upcoming DMD functional data will include longer follow-up on previously disclosed patients, new patient data from the Phase I/II cohort, and long-term data from dose level 1. He also confirmed the pivotal enrollment figure includes both new patients and eligible patients from the Phase I/II study. Chief Medical Officer Dr. Steve Pakola explained that for DR, the U.S. has a clear regulatory precedent using the DRSS scale, whereas this path is less established in Europe, necessitating further discussions with the EMA and in Japan.

Annabel Samimy asked about Ligand's annual investment capacity and willingness to increase it to capitalize on the current market environment, and also inquired about future plans for the NitroCil platform beyond the ZELSUVMI launch.

Answer

CEO Todd Davis responded that Ligand would likely invest at an above-average pace this year given the opportunities, but will remain disciplined by adhering to diversification limits and internal bandwidth. Regarding the NitroCil platform, he explained it was a key part of the potential outsized return from the Novan special situation. The team is currently evaluating other therapies from the platform and will likely seek partners for their development, with an expectation of at least two commercial products emerging from it.

Annabel Samimy of Stifel inquired about the growth prospects for Rylaze, specifically asking about the expected pace of adoption in the adolescent and young adult (AYA) market and the timeline for it to gain critical mass and return the product to growth.

Answer

Renée Galá, President and COO, acknowledged that educating adult treaters in the AYA segment takes time but noted they are seeing momentum. She expressed confidence that revenue would normalize in the second quarter of 2025 as the impact of pediatric protocol changes subsides. CFO Phil Johnson added that Q1 2025 sales were also impacted by having one fewer shipping week compared to Q1 2024.

Annabel Samimy from Stifel inquired about a slight compression in Zepzelca sales in Q4 and asked about the 2025 outlook, including the possibility of securing NCCN guideline or compendia listings for the first-line maintenance indication ahead of the formal sNDA approval.

Answer

Renée Galá, President and COO, attributed the Q4 sales dynamic partly to fewer distributor buying days, a pattern also seen in the prior year, while noting the product's 11% full-year growth. For 2025, she confirmed Jazz will not promote the first-line indication before approval but is working diligently to get the data published, which is a key step toward potential inclusion in treatment guidelines.

Annabel Samimy of Stifel asked about a potential Q4 sales compression for Zepzelca and its 2025 outlook, including the possibility of compendia listing ahead of a formal sNDA approval.

Answer

President & COO Renée Galá attributed the Q3 to Q4 dynamic partly to fewer distributor buying days, a pattern also seen in 2023. She noted Zepzelca grew 11% for the full year. For 2025, she stated the company will work diligently to get data into a peer-reviewed journal to support potential treatment guideline inclusion ahead of the sNDA approval.

An analyst on behalf of Annabel Samimy at Stifel asked about the peak sales opportunity for Zepzelca following its first-line maintenance data, physician adoption rates, and potential cannibalization of the second-line market.

Answer

President and COO Renée Galá and EVP, Global Head of R&D, Rob Iannone, both responded. They believe the data is practice-changing and will significantly increase the addressable market by reaching a larger patient population for a longer duration. They clarified that while patients treated in the first line would not receive Zepzelca again in the second line, this preemptive use ultimately expands the drug's reach and overall revenue potential.

An analyst on behalf of Annabel Samimy asked if the positive first-line maintenance data for Zepzelca provides a clearer view of its peak opportunity, how physicians might adopt it, and whether it would cannibalize the second-line setting.

Answer

President and COO Renée Galá and EVP, Global Head of R&D Robert Iannone both responded. They believe the data is 'practice changing' and will drive significant uptake upon approval. While first-line use would preclude second-line use, the move into a larger patient population with longer treatment duration is expected to increase the overall revenue opportunity for Zepzelca.

Annabel Samimy asked about the strategic rationale for developing an oral semaglutide (RT-116) given capital constraints and future competition, inquiring if it was primarily a validation tool. She also questioned if the company's current capital could fund the RT-114 Phase 1 trial, whether other programs were being deprioritized, and what the expected cost of goods sold (COGS) would be for an oral biologic.

Answer

An executive, Talat Imran, clarified that RT-114 is the primary focus due to capital constraints and that the RT-116 semaglutide program is a discovery/validation effort not currently planned for clinical trials. He confirmed the budget covers the RT-114 Phase 1 study. Regarding COGS, Imran stated the goal is to be competitive with injectable biologics, leveraging manufacturing automation, rather than with cheaper small molecules.

Annabel Samimy of Stifel inquired about payer coverage expectations based on different ranges of blood pressure reduction and asked about the size of the third and fourth-line hypertension market and how that affects the drug's opportunity.

Answer

Executive Jon Congleton stated that based on four separate payer research projects, the company is 'very bullish' on gaining access. He explained that a base case of an 8-10 millimeter mercury improvement is expected to allow them to 'own' the fourth-line resistant hypertension space and is also viewed favorably by payers for targeted third-line use, such as in patients with a BMI over 30.

Annabel Samimy of Stifel questioned the sufficiency of a 6-week primary endpoint for the Launch-HTN trial given real-world variability. She also asked about the potential to see a statistically significant separation between obese and non-obese cohorts and whether to expect a clear dose-response between the 50mg and 100mg arms.

Answer

Executive Jon Congleton expressed confidence in the 6-week endpoint, citing Target-HTN data where most of the effect was seen by week 4. He noted the 6-week endpoint was chosen to increase statistical power for subset analyses, such as the obese cohort. CMO Dr. David Rodman added that the 50mg to 100mg titration is designed to get individual patients to an effective dose, which could be driven by either drug exposure or individual biology, rather than demonstrating a classic dose-response curve.

Annabel Samimy inquired about physician feedback from the AAO meeting on CLS-AX, focusing on the trial's retreatment design and the proposed 3-to-6 month dosing flexibility. She also asked about the timing of the initial CLS-AX dose, data on early patient rescues, and the potential non-inferiority margin for the Phase III trial.

Answer

CEO George Lasezkay confirmed that the data was very favorably received at AAO. Chief Medical Officer Dr. Victor Chong added that the message of flexible dosing is a key differentiator resonating with physicians. He clarified that the Phase II trial demonstrated the ability to redose with CLS-AX and that no patients required any intervention before 12 weeks. Dr. Chong noted the FDA's draft guideline suggests a 4.5-letter non-inferiority margin, which Mr. Lasezkay stated will be finalized with the FDA in early 2025.

Asked if there were lingering effects from the Q1 pricing change, for details on the 'Beauty of Savings' loyalty program, and about future consumer couponing plans. Also questioned why no therapeutic revenue was reported despite positive progress on coverage and reorders.

Answer

The Q1 coupon program is finished with no lingering effects. The 'Beauty of Savings' program links purchases to training and provides economic benefits for bundling. No new consumer couponing is planned currently. Therapeutic revenue is minimal because the launch was recent (May) and practices adopt slowly, buying small amounts and waiting for a full reimbursement cycle before reordering in volume.

Asked about the structure of future portfolio programs, evidence of cross-selling, and details on the therapeutic launch, including injection frequency and physician comfort with the technique.

Answer

Future portfolio programs will involve a mix of price incentives and value-added services, not just rebates. On the therapeutic side, physicians are using DAXXIFY both to provide better symptom control within the standard 12-week cycle and, in some cases, to extend the injection interval. The injection technique is the same, and physicians are comfortable, with some payers providing broad toxin coverage beyond the specific CD indication.

Inquired about the progress of re-engaging existing accounts with the new pricing, the learning curve for injectors to achieve optimal results, and the expected adoption curve for DAXXIFY in therapeutics compared to aesthetics.

Answer

The company stated that re-engaging accounts is a priority, though it's hard to quantify the exact progress. The new pricing is intended to help injectors gain more experience to master the product. For therapeutics, the adoption curve is expected to be slower than in aesthetics, and more data from the PrevU program is needed to provide specific adoption metrics.

Asked for specifics on the upcoming KIND program data disclosure, the potential impact of patients with >10% body surface area on the results, and whether to assume KORSUVA use will cease post-TDAPA due to reimbursement issues.

Answer

The company will report top-line efficacy and safety data for the KIND program, including the 4-point response analysis. They are comfortable with the patient mix, as those with larger BSA are on topical corticosteroids. Post-TDAPA, it is expected that dialysis providers will severely limit KORSUVA access due to unfavorable reimbursement policy.

Annabel Samimy from Stifel asked what healthcare practitioners still need to learn about the company's products to drive a sales inflection, what specific areas are being cut to achieve cost savings, and what options are available to adjust the capital structure.

Answer

Chief Commercial Officer Mark Glickman stated that for products like IMVEXXY, the key is consistent reminders and awareness for physicians about ideal patient types, rather than new education. President Hugh O'Dowd clarified that the $40 million in core cost savings will primarily come from reducing DTC media ad buys and shifting focus to HCP engagement. CFO James D'Arecca added that addressing the capital structure will begin with the VitaCare divestiture, with proceeds informing next steps like refinancing to ease restrictive covenants.

Annabel Samimy from Stifel asked for the timeline and potential impact of negotiating new payer contracts, the go-forward strategy for balancing copay assistance with costs, the company's cash runway, and the specific dynamics of the recent meetings with policymakers in Washington D.C.

Answer

CEO Saundra Pelletier estimated that new contracts covering 30 million lives could be implemented by Q2 2022. She explained that the current copay program will be adjusted in Q1 2022 to improve gross-to-net. CFO Jay File stated the current cash runway extends into Q1 2022 and the company is pursuing non-dilutive capital from licensing deals. Pelletier described the D.C. meetings as productive, with policymakers taking action, but she expressed frustration with the government's lack of urgency.