Release Date: February 27, 2025
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Q: Can you provide more details on how you are maximizing the opportunity for LUPKYNIS, especially with the addition to the ACR guidelines? Also, what data can we expect from the AUR200 asset in Q2? A: Peter Greenleaf, CEO: We are focusing on high prescribing rheumatology offices and hospital segments with lupus centers. The ACR guidelines are crucial as they address underdiagnosis and undertreatment. For AUR200, we expect to disclose pharmacodynamics and pharmacokinetic data, which will help determine the dose for the MAD study.
Q: How are you projecting LUPKYNIS growth beyond 2025, and will you disclose the dose for the MAD portion of AUR200? A: Peter Greenleaf, CEO: We don't provide long-term guidance but rely on historical trends. For AUR200, we will decide on disclosures after reviewing the SAD data, which will inform the MAD study structure.
Q: Your guidance seems conservative given the Q4 run rate. What informs your commercial outlook for 2025? Also, can you discuss LUPKYNIS's exclusivity and potential generic competition? A: Peter Greenleaf, CEO: Our guidance is based on historical financial results. We have a robust patent portfolio for LUPKYNIS, and we intend to defend our intellectual property rights vigorously, with potential generic competition not expected until mid-2028.
Q: Why did you decide to stop reporting PSS for the final quarter of 2024, and how does AUR200's potency compare to other assets? A: Peter Greenleaf, CEO: We believe our historical financial results provide sufficient insight into our business health. Greg Keenan, CMO: AUR200 has shown lower KD and IC50 in preclinical models, suggesting higher potency and potentially less frequent dosing.
Q: How do the ACR treatment guidelines impact prescriber behavior and LUPKYNIS uptake? What are the timelines for AUR200's development? A: Peter Greenleaf, CEO: The guidelines emphasize early diagnosis and continuous treatment, which benefits LUPKYNIS. Over 50% of prescriptions come from rheumatologists. For AUR200, we need to complete the SAD study before outlining the MAD study timeline.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
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