Stacy Ku

Stacy Ku sought clarification on the ONAPGO patient profile, frequency of use, and potential net pricing per year. She also asked about the interpretation of the 1,800 enrollment forms given past supply disruptions, the current demand dynamics, and logistics availability. Additionally, she inquired about expected gross-to-net for specialty products and Qelbree's Q1 seasonality.

Answer

Jack A. Khattar, President and CEO, described ONAPGO patients as advanced Parkinson's cases not well-controlled by oral medications, estimating a WAC of ~$100,000/year assuming one cartridge daily. He noted that 1,800 forms represent a demand funnel, with some attrition expected. He confirmed that the sales force is communicating a return to normal for new patient initiations. For specialty products, he estimated gross-to-net typically ranges 20-30%, higher in Q1. Regarding Qelbree, he explained Q1 seasonality is due to high deductibles, not school, and the company uses co-pay rules to mitigate pressure.

Stacy Ku inquired about the patient profile and frequency of ONAPGO use since launch, seeking to understand potential net pricing per year. She also asked if the 1,800 enrollment forms reflected limited clinician writing due to supply disruption and about the dynamics of ONAPGO demand and logistics availability as the sales force re-engages. She followed up on expected gross-to-net for a specialty product and Qelbree's Q1 seasonality.

Answer

Jack A. Khattar (President and CEO, Supernus Pharmaceuticals) described ONAPGO patients as advanced in their disease, not well-controlled by oral therapies. He estimated a WAC of $100,000/year assuming one cartridge/day, with typical specialty gross-to-nets of 20-30%. He explained the 1,800 forms represent a demand funnel, acknowledging some attrition. He noted the company is communicating with physicians about resumed new patient initiations. For Qelbree, he mentioned typical Q1 insurance seasonality, with efforts to offset pressure.

Stacy Ku of TD Cowen inquired about the net pricing dynamics and adult segment progress for KELBRE, as well as the early launch metrics for ONAPCO, including enrollment forms, prescriber numbers, and reimbursement timelines.

Answer

CEO Jack Khattar explained that KELBRE's net pricing remains strong, north of $300 per script, with gross-to-net improving from Q1. He highlighted that the adult segment now represents 35% of KELBRE prescriptions, showing robust 29% growth. For ONAPCO, Khattar noted the 750 enrollment forms are a strong leading indicator, with over 200 patients already on the drug as of July and reimbursement proceeding smoothly.

Stacy Ku of TD Cowen inquired about the impact of Q1 seasonality on Qelbree's net pricing and the gross-to-net outlook for the year. She also asked for the company's comfort level with the consensus revenue estimate for Qelbree and questioned the operational timeline for converting ONAPGO patient start forms into filled prescriptions.

Answer

Executive Jack Khattar confirmed that Q1 seasonality increased Qelbree's gross-to-net to the low 50% range as expected, with improvement anticipated in Q2 and Q3. He expressed comfort with the ~$290 million consensus revenue for Qelbree. Regarding ONAPGO, Khattar noted that while it's too early for precise timing, the company's established infrastructure for Parkinson's products typically yields fulfillment rates better than the industry average of 40-50%.

Stacy Ku inquired about the drivers of Qelbree's strong Q4 pricing and the gross-to-net outlook for 2025, the progress of the adult launch, the timing for a decision on SPN-820, and the expected launch trajectory and guidance contribution for ONAPGO.

Answer

CEO Jack Khattar attributed Qelbree's Q4 strength to prescription volume, not pricing, and projected a 2025 gross-to-net in the 50-55% range. He noted the adult launch is progressing well, with adults comprising 30-32% of prescriptions. A decision on SPN-820 is expected in the coming months. For ONAPGO, he anticipates a slow launch build with a minimal single-digit million-dollar contribution to 2025 guidance.

Stacy Ku of TD Cowen inquired about Qelbree's volume trajectory and its alignment with 2025 consensus estimates, the outlook for net pricing for the rest of 2024 and into 2025, and the potential for a more controlled placebo response in the SPN-820 TRD study due to a different dosing strategy.

Answer

Executive Jack Khattar expressed confidence in Qelbree's growth, highlighting an increasing share of 90-day prescriptions (now 11% of total) and strong retention rates as positive indicators for 2025. He confirmed healthy net pricing would continue in Q4 2024 but deferred comment on 2025. Regarding the SPN-820 placebo response, Khattar stated it is difficult to speculate on the impact of different dosing strategies and that they must await the Phase IIb data.

Stacy Ku asked about the demand for YCANTH in Q4 2025, competitive headwinds, and prescriber feedback on competitor Zelsuvmi's efficacy.

Answer

Jayson Rieger, President and CEO, noted that the momentum from September continued into Q4. He emphasized that the largest competitor remains 'watch and wait' behavior, and viewed Zelsuvmi's launch as positive for market awareness, reinforcing YCANTH as a best-in-class option with most patients seeing results in one to two treatments.

Stacy Ku asked about the demand for YCANTH in Q4, competitive headwinds, specific counter-detailing observed, and prescriber feedback regarding Zilretc's efficacy.

Answer

Jayson Rieger, President and Chief Executive Officer, noted that the momentum from September continued into Q4. He identified 'watch and wait' as the primary competitor and viewed Zilretc's launch positively for market awareness, reinforcing YCANTH's position as a best-in-class therapy.

Stacy Ku inquired about the specifics of the YCANTH sales force expansion, the key drivers behind its adoption, the current competitive landscape with compounded cantharidin, and management's view on revenue consensus and potential quarterly lumpiness.

Answer

Jayson Rieger, President & CEO, explained that the sales force is expected to grow modestly from approximately 35 representatives. He attributed YCANTH's success to sales team tenacity, strong clinical data, and improved pharmacy access. Rieger noted that while compounded cantharidin is still used, its use is shifting away from molluscum. He declined to provide forward guidance on revenue but affirmed the company's focus on executing its growth strategy quarter-over-quarter.

Stacy Ku inquired about Verrica's success in targeting pediatricians versus dermatologists, preparations for potential summer seasonality for YCANTH, and the company's perspective on the full-year 2025 revenue consensus.

Answer

Executive Jayson Rieger explained that YCANTH is seeing prescription growth from both pediatricians and dermatologists, rather than a shift between the two. He acknowledged potential summer seasonality and noted ongoing marketing efforts. Rieger declined to provide 2025 revenue guidance but confirmed the company will continue reporting dispensed applicator units, which are expected to track revenue more closely now that distributor inventory has normalized.

Stacy Ku inquired about EKTERLY's refill rates, average number of doses for high-burden patients, and expectations for normalization compared to claims data. She also asked about payer quantity limits for chronic use, the implications of patient bolus dynamics for Q4 2025, and the company's comfort with 2026 consensus estimates.

Answer

Ben Palleiko (CEO) stated that current refill frequencies are higher (monthly or more) and volumes are larger than expected due to high-burden patients, anticipating normalization over time. Nicole Sweeny (Chief Commercial Officer) confirmed quantity limits are consistent with other branded on-demand treatments and have not impeded access. She also anticipated potential demand disruption in Q4 2025 due to the holiday season. Brian Piekos (CFO) noted a wide range in consensus estimates due to modeling challenges and the company's fiscal year change.

Stacy Ku inquired about EKTERLY's refill rates, the average number of doses for high-burden patients, and how these compare to expected normalization, including payer quantity limits. She also asked about patient bolus dynamics for the remainder of the year versus Q3 and the company's comfort with consensus estimates for next year. Finally, she sought confirmation on the number of doses per carton.

Answer

Ben Palleiko, Chief Executive Officer, stated that current refill frequencies are about once a month or more, with multiple cartons per refill, driven by high-burden patients, but expects normalization to multi-month refills with lower volumes. Nicole Sweeney, Chief Commercial Officer, confirmed that quantity limits are consistent with other products and have not impeded access. Ms. Sweeney also anticipated potential demand disruption in Q4 2025 due to the holiday season. Brian Piekos, Chief Financial Officer, noted a wide range in consensus estimates due to modeling challenges and a fiscal year change. Mr. Palleiko confirmed that a carton contains two doses.

Stacy Ku inquired about the mechanics of the Quick Start program, including prior authorizations and medical exemptions, and the expected timeline for patients to receive paid drug. She also asked about observed prescribing patterns, potential for chronic ECTERLEET use, and details regarding the 4,000-member patient database.

Answer

Nicole Sweeny, Chief Commercial Officer, explained that the Quick Start program provides immediate, no-charge access while KalVista works with physician offices to secure paid access via medical exceptions, with formal coverage policies expected within six months. She noted the patient database growth was encouraging, with members clustered around key physicians, and that clinician visits for prescriptions varied. Benjamin Palleiko, CEO, clarified audio issues.

Stacy Ku asked for details on several growth drivers, including adoption rates in Class IV heart failure, early learnings from the CKD launch, fulfillment rate progression, and the percentage of sales from the IDN channel in Q2.

Answer

CEO John Tucker explained that fulfillment rates improved in Q2 and are expected to continue rising, driven by lower patient co-pays. He noted that due to the growing IDN business, specific fill rates are not disclosed. SVP of Commercial, Steve Parsons, added that the nephrology launch shows faster individual physician adoption than cardiology did, with nephrologists prescribing higher doses. Regarding the IDN channel, John Tucker stated that while it grew 70% quarter-over-quarter and is a significant part of sales, the company will not break out the specific percentage due to its lumpy nature.

Stacy Ku asked for a comparison of the new CKD launch versus the initial heart failure launch, details on reimbursement access for both indications, and data on the percentage of Medicare patients utilizing the new copay smoothing program.

Answer

SVP of Commercial, Steve Parsons, described the CKD launch adoption as 'way faster' than the heart failure launch, with immediate prescriptions following sales calls. He also confirmed reimbursement is identical to heart failure, with no new hurdles. Executive John Tucker addressed the smoothing program, explaining that while direct data is limited, they infer its impact from a significant increase in $0 copay patients, which helped boost the fill rate from 46% in Q1 to 55% in April.

Stacy Ku inquired about the market potential of the upcoming FUROSCIX launch in Chronic Kidney Disease (CKD), the company's early outreach to nephrologists, and expectations for adoption, market access, and payer dynamics throughout 2025.

Answer

Executive John Tucker explained that pre-launch awareness among nephrologists is three times higher than it was for cardiology, and the company has already established a presence in large nephrology offices. An executive noted the prescriber base is more concentrated, with 50% of patients having comorbid heart failure. SVP of Commercial Steve Parsons added that significant revenue impact from the CKD launch is expected in Q3 and Q4 2025. Tucker also confirmed that payer notifications are complete and access should be seamless as it uses the same NDC code.

Stacy Ku of TD Cowen inquired about the expected percentage of Class IV heart failure patients using FUROSCIX by year-end and its long-term stabilization point. She also asked for an update on the initial reception from nephrologists ahead of the potential CKD launch.

Answer

CEO John Tucker stated that Class IV patients currently represent about 10% of scripts but noted the more significant impact is the larger prescription size, averaging 8 doses. SVP of Commercial Steve Parsons described the reception from nephrologists as 'pretty positive,' noting they have a significant need for an at-home treatment like FUROSCIX and that their adoption rate appears faster than that of cardiologists.

Stacy Ku of TD Cowen asked about the potential long-term impact of an oral on-demand therapy launch on Orlodeyo, the quarterly cadence of paid shipments, and the competitive landscape for Netherton syndrome.

Answer

President & CCO Charlie Gayer stated that an all-oral treatment regimen would be a net positive, potentially increasing Orlodeyo's attractiveness and retention. He expects a normal quarterly revenue cadence for the remainder of the year. CEO Jon Stonehouse addressed the Netherton landscape, suggesting that competitor programs appear to be stalled or terminated, which could position BioCryst's candidate as a first-in-class therapy for the high-unmet-need condition.

Stacy Ku asked about expectations for new ORLADEYO prescriber additions and for any early results from the Netherton syndrome program's SAD/MAD study. She also followed up on the Netherton trial design, asking if the proof-of-concept could be broadened to younger patients.

Answer

Chief Commercial Officer Charlie Gayer confirmed continued consistency in prescriber growth, with 59 new prescribers in Q1. On the Netherton program, Chief R&D Officer Dr. Helen Thackray indicated that data from healthy volunteers gave them confidence to proceed with patient dosing, with a full data package expected by year-end. She explained that the trial's extension (Part 4) is designed to evaluate longer-term exposure, with Chief Commercial Officer Charlie Gayer adding that the immense hope for a new therapy is a powerful factor in patient recruitment.

Stacy Ku requested more specific timing on when Netherton syndrome patients would be dosed, asked about ORLADEYO's real-world attack-free rates compared to other therapies, and sought clarity on the key factors driving the conviction behind the new revenue guidance.

Answer

Chief R&D Officer Dr. Helen Thackray indicated that Netherton patient dosing would likely begin around the middle of the year or in the third quarter. Chief Commercial Officer Charlie Gayer stated that real-world data shows ORLADEYO provides competitive attack rate reduction, boosting physician confidence. He confirmed the primary drivers for the guidance increase are the accelerated transition of Medicare patients to paid therapy under the IRA and continued strong underlying demand.

Stacy Ku asked about the company's goals for new clinician additions in 2025, expectations for the transition to paid therapy, and the primary audience for the results of the Phase IV transition study.

Answer

Chief Commercial Officer Charlie Gayer stated the goal is to continue the current strong pace of physician additions and to make further progress toward the 85% paid rate goal, with Medicare being a key variable. Chief R&D Officer Dr. Helen Thackray clarified that the transition study data is primarily intended to provide guidance and confidence to physicians who are less experienced with switching patients to ORLADEYO.

Stacy Ku inquired about the expected quarterly sales cadence for LUPKYNIS in 2025 and the primary drivers of its growth, such as new patient additions versus restarts. She also asked about expectations for the upcoming AUR200 Phase I data update and potential strategies for accelerating its path to market.

Answer

President and CEO Peter Greenleaf advised looking at historical quarterly performance to model the year, noting a typical summer slowdown followed by a rise in the latter half. He stated that growth is driven by a holistic improvement across all factors, including new patients and persistency, with a notable increase in rheumatology prescribing. Regarding AUR200, Greenleaf deferred detailed comments, stating that the single ascending dose data and program direction would be shared by the end of June.

Stacy Ku inquired about the rationale for the corporate restructuring, asking if it reflects confidence in AUR200 or concerns about LUPKYNIS growth drivers like patient starts (PSFs), restarts, and hospital captures. She also asked for specifics on the data to be disclosed from the AUR200 Phase I study.

Answer

President and CEO Peter Greenleaf clarified that the restructuring is a strategic move to focus on key growth drivers and does not signal a lack of confidence; in fact, he believes it can accelerate growth. He emphasized that investors should look at the combination of PSFs, hospital fills, and patient restarts for a complete picture of new patient growth. Regarding AUR200, he stated that the company will share pharmacokinetic profiles and relevant biomarker data from the upcoming single-ascending and multi-ascending dose studies.

Asked for details on the new DAXXIFY accounts added in Q2, the progress of the broader DAXXIFY launch, the drivers of RHA's Q2 performance, and whether Q3 would show a clear signal of recovery for the DAXXIFY relaunch.

Answer

The company saw good acceleration in DAXXIFY accounts, growing from ~3,000 to 3,700 in Q2, driven by the new pricing strategy. RHA's performance was aided by the new lip launch and a focus on its 'natural look' profile. For DAXXIFY, the company expects continued sequential quarterly growth through the rest of the year, indicating the recovery is underway and not just a Q4 event.

Inquired about the drivers for RHA growth, the timing of DAXXIFY sales acceleration in Q2, the depth of DAXXIFY adoption in existing accounts, and whether 'portfolio programs' means bundling.

Answer

The company expects RHA growth from the new lip indication and upcoming portfolio programs. DAXXIFY sales are expected to accelerate from adding new accounts and increasing utilization in existing ones. A minority of accounts currently use DAXXIFY as their primary toxin, but the goal is to increase penetration. The company confirmed that 'portfolio programs' does mean bundling, which is planned for 2024.

Inquired about the target clinician profile for the Q2 expansion, the sales force's capacity for new account activation, and the progress of 'relationship repair' with existing accounts.

Answer

Mark Foley explained that the sales team has latitude to target both existing RHA accounts and new accounts intrigued by DAXXIFY, with the new pricing opening a broader opportunity. He stated there's no fixed new account target, but the plan supports the guidance, and training remains key. Regarding account relationships, he noted positive signals, with a high percentage of Q4 revenue from reorders indicating that customers appreciate the strategy and price adjustments.

Asked for clarification on practices working through older, higher-priced DAXXIFY inventory, the strategy for building consumer awareness, and the potential impact of new neurotoxin market entrants.

Answer

The company confirmed they are working with accounts to move through existing inventory. Their consumer awareness strategy is currently focused on targeted, in-office marketing rather than broad DTC until more practices carry the product. Regarding competitors, they believe new short-acting toxins will have minimal impact on DAXXIFY, and while a new long-acting toxin could raise awareness for the category, its path to market is uncertain.