Debanjana Chatterjee

Debanjana Chatterjee asked about the progress of insurance negotiations, the expected cadence of payers establishing policies in H1 2026, and how to think about EKTERLY's revenue trajectory in the immediate next couple of quarters given potential refill rate stabilization.

Answer

Nicole Sweeny (Chief Commercial Officer) detailed that medical exceptions are consistently used, and favorable policies are emerging from regional and national payers. She expects discussions with larger payers and PBMs to conclude with policies in early 2026. Ben Palleiko (CEO) acknowledged the difficulty in predicting immediate revenue trajectory due to EKTERLY's on-demand nature, the holiday period, and expected normalization of refill rates as adoption expands to lower-burden patients.

Debanjana Chatterjee asked about payer expectations regarding safety or efficacy failure on Acadevant for ECTERLEET approval, and whether the company would share a 'percentage covered' KPI in the future.

Answer

Nicole Sweeny, Chief Commercial Officer, explained that most patients have generic Acadevant experience, simplifying step-throughs. For the minority, physicians can cite failures based on injection site reactions, difficulty with abdominal sub-Q administration, or hand swelling. She indicated that the company would share more progress on payer efforts and clarity on ongoing paid access, but specific KPI details were to be determined.

Debanjana Chatterjee of Jones Trading inquired about the potential pricing strategy for Ampreloxetine and the reimbursement dynamics in the US versus ex-US markets.

Answer

Chief Business Officer Rhonda Farnum provided context by referencing an analysis of recent rare neuro drug launches (averaging ~$380k/year) and Northera's pricing (~$280k/year). She confirmed active engagement with US payers, focusing on the unmet need and Ampreloxetine's potential durability and safety profile. CEO Rick Winningham added that the OHSA composite score endpoint is a key differentiator for demonstrating value to payers.

Debanjana Chatterjee from Jones Trading asked for clarification on the success criteria for the ABS-201 data expected in 2026, specifically the benchmark for hair density and terminal hair count, and whether the trial would be controlled.

Answer

SVP Christian Stegmann confirmed that target area hair count is the primary efficacy endpoint for the androgenic alopecia trial. While the company has not yet disclosed a specific quantitative bar for success, he noted more details would be shared at a future R&D Day. He also confirmed the study will be a controlled trial.

Debanjana Chatterjee from Jones Trading asked about the efficacy bar for 'good data' from the ABS-201 trial in 2026 and whether the trial would be controlled.

Answer

SVP of Drug Creation, Christian Stegmann, confirmed that target area hair count is the primary efficacy endpoint and that more specific details on the success criteria will be shared at a future R&D Day. He also confirmed the study will be a controlled trial.

Debanjana Chatterjee from JonesTrading Institutional Services inquired about the potential design of a Phase II trial for ABS-101 and asked how Absci is positioned to leverage its AI platform in light of the FDA's shift away from animal testing.

Answer

CEO Sean McClain and SVP of Drug Creation Christian Stegmann responded. McClain stated that the Phase II design for ABS-101 has not been disclosed yet. On the FDA shift, McClain affirmed they are well-positioned, highlighting their 'naturalness' AI model. Stegmann added that this regulatory shift is an exciting opportunity for Absci as it will drive broader adoption of AI models.

Debanjana Chatterjee of JonesTrading asked how Absci is positioning its anti-TL1A asset to compete against recent positive data from competitors like Sanofi and Teva, particularly given the high bar set for efficacy and low ADA rates.

Answer

An executive, likely SVP of Drug Creation Christian Stegmann, responded by noting that the competitor's study had specific inclusion criteria that may complicate direct comparisons. He also highlighted that ABS-101 may have the potential to be dosed higher than competitors, which could potentially lead to greater efficacy, an avenue the company is exploring.

Debanjana Chatterjee from JonesTrading asked about potential implications of competitor trial delays in refractory chronic cough (RCC) for Trevi's plans and inquired if drug-drug interaction studies were planned with drugs other than nintedanib and pirfenidone.

Answer

Management, including CEO Jennifer Good and CCO Farrell Simon, stated that competitor timelines will not impact their own RCC trial initiation, citing confidence in their data and strategy. Chief Development Officer James Cassella confirmed that while other standard DDI studies are planned, the immediate focus is on the two key anti-fibrotics.

Debanjana Chatterjee requested additional color on the new data points from the full RIVER trial dataset that will be presented at the upcoming American Thoracic Society (ATS) conference.

Answer

Executive Jennifer Good detailed that the ATS presentation will include deeper analysis on the timing of adverse events and discontinuations, patient vignettes, quality-of-life data from the Leicester Cough Questionnaire, and potentially an analysis of the treatment period effect from the crossover design.

Debanjana Chatterjee from JonesTrading asked for confirmation on whether the patient stratification arms (moderate vs. high coughers) in the Phase IIa RIVER trial for RCC were balanced upon completion of enrollment.

Answer

Chief Development Officer Dr. James Cassella stated that the arms are not perfectly balanced. The company extended enrollment to get more subjects in the moderate arm but ultimately decided to stop enrollment without achieving complete balance. He noted this does not impact the primary analysis, which is based on the total trial population, and that there will be sufficient numbers for future planning.

Debanjana Chatterjee inquired about EyePoint's regulatory plans, the timeline for an NDA submission after data readout, the scope of the required safety package, and the pros and cons of a traditional filing versus a 505(b)(2) pathway.

Answer

CEO Dr. Jay Duker and CMO Dr. Ramiro Ribeiro responded. Dr. Ribeiro noted the identical trial designs will accelerate the NDA preparation. Dr. Duker confirmed they will exceed the FDA's safety requirement of 300 evaluable patients and stated that while a 505(b)(2) pathway can be faster, EyePoint is confident in its first-to-file position with its traditional filing approach for a new chemical entity.

Debanjana Chatterjee from Jones Trading asked for more color on regulatory plans, the timeline for an NDA submission after top-line data, and the scope of the safety package required by the FDA.

Answer

CMO Ramiro Ribeiro noted that having two identical studies allows for learnings from the first readout (Lugano) to accelerate the analysis of the second (Lucia), enabling a rapid NDA submission. CEO Jay Duker added that the FDA requires 300 evaluable patients at the desired dose and interval for the safety database. He confirmed EyePoint will have 'well over 400 patients' at the six-month interval, comfortably meeting this requirement.

Debanjana Chatterjee inquired about the potential impact of biosimilars on the wet AMD commercial landscape, price erosion, and any implications for DURAVYU's positioning.

Answer

President and CEO Dr. Jay Duker stated that DURAVYU's distinct mechanism and 6-month durability differentiate it from biosimilars. CFO George Elston added that the value proposition is strong, as one DURAVYU treatment replaces three standard anti-VEGF injections, which will be a key factor in pricing and payer negotiations.

Debanjana Chatterjee of JonesTrading asked about the potential impact of biosimilars, like Amgen's PAVBLU, on the wet AMD commercial landscape and any implications for DURAVYU's pricing.

Answer

CEO Dr. Jay Duker stated that biosimilars will not impact DURAVYU's acceptance due to its different mechanism of action (MOA) and 6-month durability. CFO George Elston added that DURAVYU is not another anti-VEGF and its value proposition is based on sustained delivery and a new MOA. He suggested that a good starting point for pricing models is that one DURAVYU injection replaces three standard anti-VEGF injections.

Debanjana Chatterjee asked how DURAVYU's potential 6-month label would position it against competitors and how the company plans to leverage a potential first-to-market advantage.

Answer

President and CEO Dr. Jay Duker asserted that a 6-month label is preferred by physicians for its flexibility. He expressed confidence in being first-to-market and noted that the company has been conducting early commercial preparation for two years, engaging with KOLs, payers, and retina groups to position DURAVYU for a successful launch.

Debanjana Chatterjee requested more details on the financing strategy and initiation timeline for the Phase 3 trial. She also asked for clarification on the study's sham administration protocol.

Answer

CFO Charlie Deignan confirmed the company is preparing for a second-half 2025 study start and is actively pursuing all funding options, including potential partnerships. Dr. Victor Chong, Chief Medical Officer, explained the masking protocol involves an assessment followed by a procedure at every visit for all patients, which could be an active drug, sham, or aflibercept injection, a design agreed upon with the FDA to maintain the study blind.

Debanjana Chatterjee asked if Clearside plans to share additional data analysis from the ODYSSEY trial, and if so, when and what specific data points would be reported.

Answer

Chief Medical Officer Dr. Victor Chong confirmed that more data from the ODYSSEY trial will be presented at upcoming medical conferences, including APVRS in Singapore, Floretina in Italy, and the Angiogenesis meeting in the U.S. in late 2024 and early 2025. He explained the presentations will include additional analysis and aim to clarify areas of potential confusion from the top-line results.