Rockwell Medical(US:RMTI)2020-11-10 01:49Financial Data and Key Metrics Changes - The company ended the third quarter with cash, cash equivalents, and investments of more than $67 million, with cash used in operating activities for the nine months ended September 30 being approximately $21 million, comparable to the same period last year [58] - Net sales for the third quarter were $15.3 million, which is comparable to the same period last year, with Triferic net sales for the three months ended September 30, 2020, being approximately $284,000 [59] - The net loss for the third quarter improved to approximately $7.4 million from $7.9 million in the third quarter of last year, driven primarily by reductions in both commercial and G&A spending [61] Business Line Data and Key Metrics Changes - The number of contracted patients for Triferic increased to approximately 3,400, translating to an annualized treatment volume of approximately 500,000, a meaningful increase compared to the last quarter [35] - The overall growth in Triferic sales was lower than expected due to restrictions on in-person visits to dialysis clinics, but virtual engagement tactics helped maintain progress [36][70] Market Data and Key Metrics Changes - The company is focused on expanding its global commercial reach, with significant progress in international partnerships, including in China, India, and South Korea [53][54][56] - The home infusion therapy market is rapidly growing, with over 3.2 million patients served annually, and an estimated 60% incidence of iron deficiency anemia in this patient population [23] Company Strategy and Development Direction - The company aims to maximize U.S. sales of Triferic Dialysate and the soon-to-be-launched Triferic AVNU, while also expanding global commercial reach and developing new indications for its FPC platform [19][63] - The top priority for new indications is FPC for treating iron deficiency anemia in patients undergoing home infusion therapy, with plans to submit a clinical development plan to the FDA [22][66] Management Comments on Operating Environment and Future Outlook - Management acknowledged the ongoing challenges posed by the COVID-19 pandemic, which has impacted the dialysis industry and restricted access to clinics [30][33] - The company expects to see a reacceleration of adoption of Triferic once the pandemic begins to resolve, and is making final preparations for the commercial launch of Triferic AVNU [64] Other Important Information - The company has a solid core business generating over $60 million annually, with one branded product in the market and a second one about to be launched [15] - The company has entered into partnerships for the commercialization of Triferic in key international markets, which are expected to generate significant growth over time [16][56] Q&A Session Summary Question: Can you talk about any gating factors that are still required or needed to get through before the launch of Triferic AVNU? - The delay was minor and related to scheduling of the production of packaging, with no further manufacturing issues anticipated [77] Question: Can you provide any color on the gross margin in the quarter? - The improvement in gross margin was primarily due to product mix, with ongoing efforts to make processes more efficient and cost-effective [79] Question: How long is Wanbang expected to take to reach full enrollment in the pivotal Triferic trial in China? - Full enrollment is anticipated in the first half of 2023, depending on the speed of enrollment [83] Question: What is the status of the regulatory review in India? - There is no firm answer on when the suspension of regulatory review will be lifted, as it is related to the incidence rate of COVID-19 cases [84] Question: What is the status of the evaluation programs for Triferic AVNU? - The first evaluation programs started in early October, and it is too early to report comprehensive results [86]