Biohaven .(US:BHVN)2021-03-01 20:53Financial Data and Key Metrics Changes - Nurtec ODT achieved fourth quarter net revenues of approximately $35 million, representing an increase of over 98% from the third quarter [7][27] - Non-GAAP adjusted net loss for Q4 2020 was $161.7 million or $2.69 per share, compared to a loss of $124.4 million or $2.38 per share for the same period in 2019 [29] - Cash, marketable securities, and restricted cash totaled $357.4 million as of December 31, 2020, with immediate access to an additional $225 million from a debt facility [30] Business Line Data and Key Metrics Changes - Nurtec ODT has achieved over 450,000 prescriptions with more than 89% commercial coverage [7][8] - SG&A expenses for Q4 2020 on a non-GAAP basis were $114 million, an increase of $47.2 million from the prior year, reflecting investments in the launch of Nurtec [28] Market Data and Key Metrics Changes - The oral CGRP class is experiencing rapid growth, with Nurtec positioned to capture a significant share of the market [34] - Approximately 96% of neurologists perceive Nurtec ODT as an advancement over triptans, with nearly half anticipating it as their preferred acute migraine therapy [35] Company Strategy and Development Direction - The company aims to maximize patient and shareholder value by executing on the Nurtec launch and expanding its indications to include prevention of migraine and other pain-related disorders [9][10] - Biohaven is focused on establishing Nurtec as the first dual-acting migraine therapy for both acute and preventive treatment in one pill, aiming to simplify the treatment paradigm [11][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the future growth of Nurtec, anticipating continued market expansion and multiple pivotal trial readouts over the next year [60] - The company is preparing for a potential FDA decision on the approval of Nurtec for prevention by the end of Q2 2021 [42] Other Important Information - Biohaven's pipeline includes intranasal zavegepant, which is expected to file as the first intranasal CGRP antagonist for ultra-rapid treatment of migraine [23] - The company is also exploring non-migraine indications, including psoriasis and asthma, as part of its CGRP franchise expansion [47] Q&A Session Summary Question: Current situation with Nurtec in terms of persistence - Management indicated that refill rates for Nurtec align with expected usage based on migraine frequency, supporting the prevention strategy [64] Question: Insights on sNDA for prevention and EMEA filing - Management noted that they have not received negative comments from the mid-cycle review, which is seen as encouraging for the dual-acting indication in Europe [66] Question: Trends in sales force engagement and authorizations - Management reported that clinician offices are reopening, leading to increased patient access and engagement, which is expected to positively impact sales [70] Question: Impact of patient deductibles and reauthorizations on Q1 - Management explained that the reset of patient deductibles and prior authorizations is a standard occurrence at the beginning of the year, affecting gross-to-net dynamics [76] Question: Lifecycle extension indications for Nurtec - Management expressed excitement about lifecycle management opportunities, including pediatric indications, which are expected to provide significant upside potential [88]