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Aldeyra Therapeutics(ALDX) - 2018 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the year ended December 31, 2018, the company reported a net loss of approximately $38.9 million, compared to a net loss of approximately $22.3 million for the year ended December 31, 2017, indicating a significant increase in losses [11] - Basic and diluted net loss per share was $1.79 for the year ended December 31, 2018, compared to $1.40 per share for the same period last year [11] - Total operating expenses were approximately $39.7 million in 2018, compared to $22.5 million in the prior year [13] Business Line Data and Key Metrics Changes - Research and development (R&D) expenses were $29.8 million for the year ended December 31, 2018, compared to $16.3 million for the same period in 2017, reflecting an increase of $13.5 million primarily due to increased clinical trial costs [11] - General and administrative expenses were $9.9 million for the year ended December 31, 2018, compared to $6.2 million for the year ended December 31, 2017, with the increase attributed to legal, patent-related, and consulting costs [12] Market Data and Key Metrics Changes - The company has five Phase 3 programs in progress or expected to be initiated in 2019, focusing on ocular diseases and select systemic conditions [6][7] - The market for dry eye disease is highlighted as one of the largest in ophthalmology, with current treatments deemed inadequate by patients and physicians [7] Company Strategy and Development Direction - The company aims to transition to a commercial stage company with a focus on developing next-generation medicines for immune-mediated diseases [6] - The acquisition of Helio Vision adds another Phase 3 ready product candidate, ADX-2191, targeting proliferative vitreoretinopathy, a rare retinal disease [8] - The company is exploring the potential for expanding its pipeline into systemic diseases, leveraging RASP inhibition as a new anti-inflammatory mechanism [37][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming milestones for 2019, including results from the ALLEVIATE Phase 3 clinical trial and the initiation of the RENEW Phase 3 clinical trial for dry eye disease [14] - The management emphasized the importance of frequent interactions with regulatory agencies to ensure alignment on clinical trial designs, particularly for reproxalap, a new chemical entity [25] Other Important Information - Cash, cash equivalents, and marketable securities were reported at $93.6 million as of December 31, 2018, which is expected to fund operating expenses through 2020 [13] Q&A Session Summary Question: Strategy regarding concentrations of reproxalap in AC and DED trials - Management explained the rationale for testing different concentrations in the trials to maintain flexibility in product profiles and to gather more information on safe and effective dosing [17][18] Question: Update on the ALLEVIATE trial and FDA discussions - Management confirmed ongoing discussions with the FDA regarding the ALLEVIATE trial and the potential for a second Phase 3 trial based on the results [25] Question: Insights on PVR and surgical quality - Management acknowledged the importance of surgical quality and variability among surgeons in the context of PVR and emphasized the need for a standardized surgical protocol [30] Question: Expansion plans in the dermatology space - Management indicated that there are no current limitations on the potential applications of reproxalap in dermatology beyond Sjögren-Larsson Syndrome, considering its anti-inflammatory properties [34] Question: Details on systemic pipeline products - Management highlighted the systemic program's potential and the decision to initiate clinical testing for systemic applications of RASP inhibition in 2019 [37][38]