Innoviva(US:INVA)2019-03-05 00:52Financial Data and Key Metrics Changes - For Q4 2018, GIAPREZA net product sales were $4.2 million, up from $3.5 million in Q3 2018, $1.6 million in Q2 2018, and $0.8 million in Q1 2018 [16] - For the full year 2018, GIAPREZA net product sales totaled $10.1 million, with a net loss of $45.4 million for Q4 and $199.5 million for the full year [16] - Cash and cash equivalents increased to $172 million as of December 31, 2018, compared to $90.9 million a year earlier, primarily due to proceeds from stock offerings and royalty financing [17] Business Line Data and Key Metrics Changes - GIAPREZA was launched in March 2018 and has been ordered by approximately 380 hospitals, with a focus on securing formulary approvals to access about 70% of patients treated for distributive shock [13][14] - The company expects net product sales for GIAPREZA in 2019 to be between $24 million and $28 million [16] Market Data and Key Metrics Changes - In the U.S., there are approximately 800,000 cases of distributive shock annually, with 300,000 patients unable to achieve adequate blood pressure despite existing treatments [12] - In the European Union, the annual incidence of sepsis is estimated to exceed 500,000, with over 170,000 patients progressing to septic shock [14] Company Strategy and Development Direction - The company aims to file an NDA for LJPC-0118 for severe malaria in Q4 2019 and expects to report top-line results for LJPC-401 in mid-2020 [25] - The strategic focus includes expanding the commercialization of GIAPREZA and advancing clinical development programs for other product candidates [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of GIAPREZA to change treatment for patients with septic or distributive shock and highlighted the importance of securing hospital access [10][25] - The company anticipates a significant reduction in operating expenses in 2019 compared to 2018, with a focus on maintaining efficiency in generating GIAPREZA sales [39] Other Important Information - The company has no debt as of December 31, 2018, and expects net cash used for operating activities in 2019 to be between $89 million and $94 million [17] - The company is preparing for potential partnerships in Europe following the expected decision on the MAA for GIAPREZA in June 2019 [49] Q&A Session Summary Question: What amount of iron induction in the heart would be needed for the drug to be commercially viable? - Management indicated that the effectiveness of current chelators varies, and achieving statistical significance in the trial would be clinically meaningful [28] Question: What is the current access percentage of GIAPREZA for patients with distributive shock? - Management stated that they are currently in the 35% to 40% range for access, aiming for 70% [35] Question: What are the plans for beta thalassemia in the U.S.? - Management confirmed that the FDA is aware of their protocol and they are confident in achieving a good chance of approval if statistical significance is reached [38] Question: What is the cash runway? - Management indicated that the current cash balance allows for operations into the second half of 2020 [33] Question: What data is being used for the NDA filing for LJPC-0118? - Management confirmed that they are finalizing a clinical study and have sufficient data showing a survival benefit for the active ingredient [52] Question: What is the expected marketing strategy for LJPC-0118? - Management believes that the existing infrastructure will support marketing efforts, given the limited number of severe malaria cases in the U.S. [55]