Tim Lugo

Tim Lugo from William Blair asked about FDA discussions regarding self-administration versus HCP-administration for fasedienol and its potential impact on the label, as well as the timeline for the Phase IIb trial for itruvone in Major Depressive Disorder (MDD).

Answer

Chief Executive Officer Shawn Singh explained that HCP administration in current trials is for consistency and is not expected to alter the intended on-demand, patient-administered label. For the itruvone MDD trial, Singh clarified that the protocol is being finalized with KOLs for submission to the FDA before year-end, with the trial itself not expected to start in the current calendar year.

The analyst asked for details on Mydcombi adoption cadence and reasons for non-adoption, whether the company is still open to more dry eye deals, and for an update on the Clobetasol launch timing, specifically regarding Formosa's export license.

Answer

The company stated that Mydcombi adoption is accelerating as the sales team refines its process, targeting practices focused on patient experience. The company is open to more non-exclusive dry eye deals. The Clobetasol launch is pending logistics and paperwork, and Formosa does not yet have the required export license but is working on it.

Representing Tim Lugo, John asked for updated thoughts on the company's strategy for in-licensing new programs, given its healthy balance sheet and upcoming revenue growth.

Answer

CFO Ian Estepan stated that the company will leverage its proven capabilities in development, manufacturing, and commercialization to evaluate new assets. He emphasized that while they will have more resources, they will maintain the same financial discipline, looking for strategic fits in neuromuscular and adjacent areas like CNS or cardiovascular. He noted they are well-positioned to transact but have no imminent need, allowing them to be selective on valuation.

Tim Lugo from William Blair inquired about Lyra's manufacturing capacity and future scaling plans, the significance of winning the Clinical Science Maurice Cottle Award, and the development timeline for their Asian partner, LianBio.

Answer

President and CEO Maria Palasis confirmed that manufacturing technology has been transferred to a contract manufacturer, with current capacity sufficient for upcoming clinical trials and plans to scale up for commercialization. Chief Medical Officer Dr. Robert Kern attributed the award win to the striking magnitude of response from a single administration. SVP of Commercial Strategy & Market Development Corinne Noyes stated that the LianBio collaboration is on track for them to participate in the second Phase 3 study, aiming for a commercial launch shortly after the U.S.

Tim Lugo from William Blair asked for a physician's perspective on how LYR-210 will be differentiated from biologics and requested details on the LianBio agreement, including the regulatory pathway and market prevalence in China.

Answer

CMO Dr. Robert Kern explained that biologics are for a small, post-surgery patient subset (~100k), are systemic, and extremely costly, whereas LYR-210 is a non-systemic, office-based procedure for a vast, pre-surgery population (~2.4M). President & CEO Maria Palasis and SVP Corinne Noyes added that the LianBio collaboration is progressing well, they can leverage US data for the China regulatory process, and the market opportunity in China is at least as large as in the US.

Tim Lugo from William Blair asked for details on the efficacy across individual cardinal symptoms in the LANTERN study and for Dr. Kern's personal perspective on why he joined Lyra and how a six-month treatment could impact the ENT field.

Answer

President & CEO Maria Palasis indicated that since the composite four cardinal symptom score showed a dramatic effect, a significant effect would be seen in each individual symptom, with full data to be released at an upcoming conference. CMO Dr. Rob Kern stated he joined Lyra because he believes LYR-210 is a potential game-changer that could alter daily practice, citing its six-month duration of action as a key differentiator that could make a real difference for patients.

Tim Lugo from William Blair noted the improvement in gross-to-net (GTN) pricing in Q3 and asked for directional guidance on GTN for the coming quarters, particularly considering the impact of the prevention launch.

Answer

CFO Jim Engelhart confirmed the company was pleased with the GTN improvement in Q3, which aligned with prior predictions. While not providing specific guidance, he acknowledged that securing broad payer access for the prevention indication could create some pressure on GTN, but reiterated confidence in the overall long-term pricing strategy.

Tim Lugo from William Blair questioned the company's cash position, noting it seemed thin given the high investment in NURTEC and clinical programs, and asked about potential partnerships or non-dilutive financing options.

Answer

CEO Vlad Coric affirmed the company's track record of being well-funded and sensitive to shareholder dilution, with a goal of reaching profitability to self-fund operations. He noted there is no imminent need for a capital raise. CFO Jim Engelhart added that with current cash and access to capital from existing facilities, the company is well-capitalized and positioned for success.

On behalf of Tim Lugo of William Blair, an analyst asked for quantification of the expected productivity increase as markets reopen and whether the company experienced any unexpected payer pushback during the first quarter.

Answer

CCO BJ Jones stated that while he could not precisely quantify the productivity upside, they expect a return to a more substantive growth trajectory as patient visits and representative access improve. He confirmed that discussions with payers regarding the preventive indication are progressing well with significant interest and no notable pushback.

Tim Lugo from William Blair & Company asked about the dosing regimen for the Rocket study in Fragile X, potential differences in disease progression between adolescent and adult Angelman patients based on natural history, and the method for capturing seizure data in the OV935 trial.

Answer

Executive Amit Rakhit, directed by CEO Jeremy Levin, stated that dosing details for the Rocket study would be released later. Regarding Angelman syndrome, Rakhit noted Ovid's study would create one of the largest databases to analyze age-related differences, with Executive Matthew During adding it would be the first to use direct measurements in adults. For the OV935 trial, Rakhit confirmed seizure data is captured via EEGs and seizure diaries, with analysis planned for different seizure types.

Tim Lugo of William Blair inquired about the patient target for the Phase 3 CAPSTONE trial, whether patients were already identified for enrollment, the clinical reason for the LDH trend between days 60 and 90 in the COBALT study, patient compliance with self-administration, and Akari's perspective on the evolving PNH market with the emergence of Alexion's ALXN1210.

Answer

CEO David Solomon stated that patients are identified for the first CAPSTONE site and the total trial size will be smaller than Alexion's pivotal study. He explained that the slight upward drift in LDH levels in the COBALT study is often seen with subcutaneous self-administration and is likely a compliance issue, which the company will address with active programs. Regarding market competition, Solomon highlighted Coversin's subcutaneous delivery as a key differentiator against IV-infused therapies like ALXN1210 and noted that pricing would be another important factor.