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Nektar(NKTR) - 2024 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q2 2024 with $290.6 million in cash and investments, with no debt on the balance sheet [30] - Revenue for Q2 2024 was $23.5 million, with full-year revenue expected to be between $75 million and $85 million [30] - R&D expenses for Q2 2024 were $29.7 million, with full-year R&D expenses anticipated to range between $120 million and $130 million [30] - The net loss for Q2 2024 was $52.4 million, or $0.25 per share, with a non-GAAP net loss of $39.1 million, or $0.19 per share [31] Business Line Data and Key Metrics Changes - The lead program, Rezpegaldesleukin (REZPEG), is advancing in two Phase 2b studies for atopic dermatitis and alopecia areata, with enrollment on track [6][8] - REZPEG has shown promising Phase 1b efficacy data in atopic dermatitis, indicating potential for a differentiated treatment [5][14] - NKTR-255, the IL-15 program in oncology, is completing a study in large B-cell lymphoma, with ongoing studies funded by collaborators [11][12] Market Data and Key Metrics Changes - Approximately 30 million people in the U.S. have atopic dermatitis, with half diagnosed with moderate-to-severe disease, indicating a significant market opportunity [8] - There is a high unmet medical need for new mechanisms to treat atopic dermatitis, as under 10% of eligible patients currently receive biologics [8] - Nearly seven million people in the U.S. have or will develop alopecia areata, highlighting the potential market for REZPEG in this indication [9] Company Strategy and Development Direction - The company is focused on building a best-in-class pipeline in immunology and inflammation, with a strong emphasis on REZPEG and NKTR-255 [4][13] - The strategy includes advancing multiple novel therapies towards the clinic, with a cash runway extending into Q3 2026 [13][30] - The company is exploring strategic partnership opportunities for NKTR-255 to enhance its role in cell therapy [12][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of REZPEG to address significant unmet needs in atopic dermatitis and alopecia areata [8][19] - The company remains optimistic about the upcoming data readouts from ongoing studies, which are expected in 2025 and 2026 [7][16] - Management highlighted the importance of novel treatment mechanisms in growing the market for atopic dermatitis [8] Other Important Information - The company reported $13.3 million in noncash impairment charges related to real estate obligations due to market declines [31] - The Phase 2b study for REZPEG has been amended to extend the treatment duration, enhancing the robustness of the data set [15] Q&A Session Summary Question: Next steps for NKTR-255 and potential synergy with CAR-T for autoimmune diseases - Management discussed the promising findings from the Stanford study and the potential for NKTR-255 to enhance CAR-T efficacy [32][33] Question: Timeline for alopecia areata study and value proposition versus JAK inhibitors - Management confirmed that top line data for the alopecia study is expected in mid-2025 and discussed the safety and efficacy advantages of REZPEG over JAK inhibitors [40][42][43] Question: Update on litigation with Lilly - Management confirmed ongoing discussions and mediation with Lilly regarding a mathematical error in data interpretation [47] Question: Historical controls in studies - Management provided insights into the careful selection of control groups in studies to ensure comparable baseline characteristics [49][50]