Lachlan Hanbury-Brown

Lachlan Hanbury-Brown asked about the Empaveli launch trajectory, specifically whether the initial bolus of patients has been processed and if the company is now in a steady-state phase of monthly or quarterly new patient growth.

Answer

EVP of Commercial David Acheson confirmed that the initial bolus of patients typically occurs early in the launch, which was observed in Q4. He stated that the company is now in the steady-state phase, as previously discussed, and expressed confidence in the continued steadiness of growth moving forward.

Lachlan Hanbury-Brown asked whether Empaveli's launch has moved past the initial bolus of patients and is now in a steady state of monthly or quarterly growth for new patients.

Answer

EVP of Commercial David Acheson confirmed that the initial bolus of patients typically seen early in a launch, which occurred in Q3 and Q4, has now passed. He stated that the launch is currently in the steady state that was previously discussed and expressed confidence in the continued steadiness of growth moving forward.

Lachlan Hanbury-Brown of William Blair & Company asked about the progress in transitioning patients off co-pay support, noting that commercial vials were flat quarter-over-quarter.

Answer

EVP David Acheson said they are actively working with offices to transition patients to commercial drug after out-of-pocket maximums are met. CFO Tim Sullivan cautioned against focusing on quarterly commercial vial shipments due to ECP inventory dynamics, stating that injection growth is the true measure of demand.

Lachlan Hanbury-Brown of William Blair asked about the progress made in conducting benefits investigations for the 20% of patients previously using co-pay support, especially given that commercial vial numbers were flat quarter-over-quarter.

Answer

EVP David Acheson explained that the Apellis Assist program works closely with offices to transition patients to commercial product once their out-of-pocket max is met. CFO Tim Sullivan cautioned against reading too much into quarterly commercial vial data due to inventory dynamics at the physician office level, stating injection growth is the truer measure of demand.

Lachlan Hanbury-Brown of William Blair & Company asked about the progress made in the benefits investigation process for patients who previously used co-pay support, noting that commercial vials for Cyfovri were flat quarter-over-quarter.

Answer

EVP David Acheson explained that the Apellis Assist program works closely with offices to transition patients to commercial drug once their out-of-pocket max is met, but high program usage continues due to the funding issue. CFO Timothy Sullivan cautioned against reading too much into quarterly commercial vial numbers due to inventory dynamics at the physician office level, pointing to injection growth as the true demand measure.

Lachlan Hanbury-Brown of William Blair asked about the progress in transitioning patients who previously used co-pay support, noting that commercial vial volume was flat quarter-over-quarter.

Answer

EVP David Acheson confirmed they are actively working with offices to transition patients to commercial drug. CFO Tim Sullivan cautioned against focusing on quarterly commercial vial shipments due to inventory dynamics at the physician level, stating that injection growth is the true measure of demand.

Lachlan Hanbury-Brown asked if Apellis has seen any early signs that its investments in growing the overall geographic atrophy market, such as increasing diagnosis and referrals, are beginning to bear fruit.

Answer

Executive David Acheson acknowledged that while the overall market was relatively flat in Q1, Apellis has seen robust growth in its new-to-brand starts since late last year. He detailed market-growth initiatives, including a DTC campaign, programs to help identify GA patients in treating and non-treating offices, and a dedicated field team focused on educating optometrists and ophthalmologists to drive referrals to specialists.

Lachlan Hanbury-Brown of William Blair inquired about efforts to convert hesitant physicians and the assumptions made about IRA price negotiations for future indications.

Answer

CEO Dr. Cedric Francois stated that clear, long-term efficacy data, such as preserving a large amount of retinal tissue over four years, is resonating well and driving physician adoption. Regarding the IRA, he explained that the FSGS and DGF indications were selected after a thorough analysis of their viability, including patent life, giving the company confidence in the programs.

Lachlan Hanbury-Brown of William Blair asked management to reconcile the positive October trends, such as recovering new patient share, with the more conservative Q4 guidance for low to mid-single-digit volume growth.

Answer

CEO Dr. Cedric Francois explained that while long-term confidence in SYFOVRE's dominant efficacy profile is high, the commercial initiatives driving recent momentum, such as DTC campaigns, have a natural lag time before their full impact is reflected in revenue. The Q4 guidance is a prudent reflection of this dynamic, acknowledging that these positive trends take time to fully materialize.

Lachlan Hanbury-Brown asked about Tarsus' strategy for the DTC campaign, specifically if increased investment is warranted given its positive ROI, and requested more details on the Lyme disease program's Phase II study design, endpoints, and treatment duration.

Answer

David Nakasone, Head of Investor Relations, explained that the DTC campaign's strong ROI is driven by 1 in 4 patients being aware and doctors actively looking, leading to more efficient patient conversion. He noted that a similar spend level is planned for 2026, with a slight incremental investment in the sales force. Seshadri Neervannan, Chief Operating Officer, detailed the Lyme disease Phase IIb trial, which will enroll 700 participants in one tick season, focusing on safety and blood levels of lotilaner to generate a robust Phase III-ready package.

Lachlan Hanbury-Brown questioned the rationale for maintaining the DTC campaign spend at $80 million despite its positive ROI and early success, asking if increased investment was considered. He also requested more details on the TP-05 Lyme disease program's Phase 2b trial design, including endpoints, duration, and treatment specifics.

Answer

Aziz Mottiwala, Chief Commercial Officer, explained that the $80 million DTC spend is appropriate, as the campaign's ROI is improving due to increased patient awareness (now 1 in 4) and active doctor engagement, creating a compounding effect. He noted a strategic incremental investment in the sales force to deepen prescribing. Seshadri Neervannan, Chief Operating Officer, described the TP-05 Lyme disease Phase 2b trial as enrolling 700 participants in one tick season, focusing on safety and measuring lotilaner blood levels to infer effectiveness, aiming for a strong Phase 3-ready package.

Lachlan Hanbury-Brown of William Blair inquired why the DTC campaign is effective sooner than expected and asked for context on the growth in unaided brand awareness.

Answer

CCO Aziz Mottiwala attributed the early DTC success to a layered strategy of having a well-educated prescriber base, exceptionally high payer access (90%), and a highly motivating patient message. While not providing specific percentages on awareness, he stated there is 'lots more headroom' to grow with the goal of making Xtendi a household name.

Lachlan Hanbury-Brown inquired about potential FDA meeting disruptions for pipeline products and the current prescription volume split for XDEMVY between commercial and Medicare patients.

Answer

CEO Bobak Azamian confirmed there have been no delays in FDA meeting schedules for their pipeline. CCO Aziz Mottiwala added that XDEMVY prescription volume in Q1 was an approximately equal split between Medicare and commercial patients. He noted that the activation of Medicare coverage in Q1 was a significant catalyst, removing a key barrier to physician adoption and driving volume growth.

Lachlan Hanbury-Brown asked how the sales team's messaging evolves as physicians move along the prescribing continuum. He also inquired if the company now has better visibility into quarterly gross-to-net discounts with broad coverage established.

Answer

An executive detailed that the sales conversation evolves from touting broad insurance coverage to focusing on specific patient types, like cataract or contact lens patients, to encourage broader screening and use. Chief Financial Officer Jeff Farrow confirmed better visibility into gross-to-net, reiterating the Q1 guidance of 47-49% and expecting a sequential decrease to the low 40s by year-end.

Lachlan Hanbury-Brown of William Blair & Company asked about the key performance indicators (KPIs) used to measure the effectiveness of the expanded sales force and the anticipated impact of 2025 Medicare changes on the gross-to-net discount cadence.

Answer

CEO Bobak Azamian explained that while they track internal metrics like call productivity, the ultimate measure is prescription growth, which has shown a positive trend since the sales force expansion. He noted an increase in the prescriber base and the frequency of writing. CFO Jeff Farrow expects the 2025 Medicare changes to smooth out the donut hole's impact throughout the year, rather than concentrating it in specific periods as seen previously.

Lachlan Hanbury-Brown of William Blair & Company inquired about the total number of Nefi prescriptions shipped during the quarter and sought early indicators of the direct-to-consumer (DTC) campaign's impact on prescribing behavior, including trends among patients with lapsed prescriptions.

Answer

Co-Founder, President, and CEO Richard Lowenthal confirmed approximately 35,000 two-packs were shipped in Q2, a significant increase from Q1. He noted that while the full impact of the DTC campaign is expected in 12-16 weeks, anecdotal feedback is very positive. Chief Commercial Officer Eric Karas added that field reports indicate broad adoption across switching, re-engaged, and previously lapsed patient segments.

Lachlan Hanbury-Brown of William Blair requested details on Q1 prescription volumes, the percentage of prescriptions requiring prior authorization, and the correlation between the neffy Experience Program participants and high-volume prescribers. He also asked about the quarterly cadence of the DTC marketing spend.

Answer

Chief Commercial Officer Eric Karas stated that while IQVIA data is incomplete, it shows about 13,000 units, and the percentage of prescriptions needing a PA has dropped from 70% to 45%. He confirmed that doctors in the Experience Program prescribe 2.5-3x more than the average. CFO Kathleen Scott and CEO Richard Lowenthal clarified that the bulk of the DTC spend will occur in Q2 and Q3 to build awareness ahead of the peak season.

Lachlan Hanbury-Brown of William Blair inquired about the process for re-engaging patients after payer coverage is obtained and the typical time lag between a new payer contract and a noticeable increase in prescriptions.

Answer

CEO Richard Lowenthal and CCO Eric Karas explained their dual approach: BlinkRx proactively contacts patients from its database, while the sales force informs physicians about new coverage for retail scripts. Regarding the time lag, Karas noted they are already seeing a positive trend in market share with payers like Express Scripts a few weeks after coverage begins, though it takes time for the full impact to materialize as patients see their doctors at different intervals.

Lachlan Hanbury-Brown from William Blair questioned the sentiment among potentially hesitant physicians, how the additional cash from the ALK deal could accelerate launch plans like DTC advertising, and the accounting treatment for the upfront payment.

Answer

Executive Richard Lowenthal observed a rapid decline in physician reluctance, supported by positive engagement at medical conferences. Executive Eric Karas highlighted that the 'neffy Experience' program has enrolled over 1,100 allergists to build firsthand confidence. Richard Lowenthal confirmed the new capital allows for the acceleration of plans, especially DTC marketing. CFO Kathleen Scott explained the $145 million ALK payment will be recognized as revenue over time as performance obligations are met, per GAAP rules.

Lachlan Hanbury-Brown of William Blair asked for confirmation on the number of Nefi prescriptions shipped during the quarter, inquired about early signs of the DTC campaign translating into prescribing behavior, and questioned the trend of previously lapsed patients returning to therapy.

Answer

Co-Founder, President, and CEO Richard Lowenthal confirmed approximately 35,000 two-pack units were sold in Q2, derived from $12.8 million in net sales and a gross-to-net of around 52%. He stated that while significant DTC impact is expected in 12-16 weeks, anecdotal feedback is positive. Chief Commercial Officer Eric Karas added that early feedback indicates a broad mix of patient adoption, including those switching, re-engaging, and previously lapsed, with a detailed claims analysis planned for year-end.

Lachlan Hanbury-Brown asked if VEVYE's strong performance per prescriber warrants more commercial investment to add new prescribers and sought to clarify if the ApolloCare agreement expands physical distribution or enhances insurance coverage.

Answer

CEO Mark Baum confirmed that more commercial investment is warranted and planned, but the company is first ensuring it has sufficient safety stock to meet rising demand before 'pouring fuel on the fire.' He clarified that the ApolloCare agreement is about enhancing insurance coverage to secure better reimbursement for commercial scripts, not about expanding the physical distribution network.

Lachlan Hanbury-Brown of William Blair questioned the timing of the open-label extension studies, asking why they were being initiated now instead of being part of the original trial design.

Answer

Pravin Dugel, Executive Chairman, President & CEO, attributed the timing to logistics and evolving strategy. He explained that as the company gains confidence from observing the masked trial data, it can better identify the most clinically relevant long-term questions to answer. He noted that more details on the extension study design would be shared at the upcoming Investor Day.

Lachlan Hanbury-Brown from William Blair & Company asked for details on MIPLYFFA's 38% covered lives figure, including coverage requirements and its impact on the time from prescription to a patient receiving the drug. He also sought clarification on whether all former EAP patients were now on reimbursed commercial product.

Answer

Chief Commercial Officer Joshua Schafer clarified that the 38% covered lives represents plans that have formally reviewed and added MIPLYFFA to their formulary, but other patients can gain access via a medical exception pathway. President and CEO Neil McFarlane confirmed that enrollment forms for all EAP patients have been submitted for commercial product. He explained the timeline to get a patient on paid drug varies, but the team works to provide the product quickly while navigating the benefits investigation process.

Asked for clarification on the quarterly revenue number, which was down despite an increase in MydCombi centers, and requested more detail on the initial market traction for clobetasol.

Answer

The MydCombi revenue was low because the initial phase focuses on sampling and training in new offices, with reorders expected to increase in Q4. The sales team was also preparing for the clobetasol launch. For clobetasol, doctors are showing strong interest, particularly in the simplified distribution model that bypasses insurance hurdles by selling through local pharmacies at a fixed price. Reorders from these pharmacies are already occurring.