Dr. Terri Young
Thank you, Eric. I’m pleased to report that along with our collaborators at Nestle Health Science, we made significant progress on our launch priorities in the third quarter, building upon the already strong momentum from the previous quarter. These encouraging results support our view that VOWST can become a foundational treatment for recurrent C. diff infection and a highly significant commercial opportunity over time. In fact, with a strong HCP demand and patient access that you’re observing, it’s clear that VOWST is already changing the course of this disease for many patients caught in the vicious cycle of rCDI just months after approval. Today, I’ll provide an update on our 4 focused areas: Scaling HCP education efforts, creating a positive customer experience, establishing payer coverage, and optimizing hospital outflow. First, I’ll describe our HCP education efforts, which are focused on the importance of microbiome restoration in rCDI and the unprecedented efficacy and safety profile of VOWST. We have made significant progress in this area, supported by the promotional efforts of the Nestle field teams, which has now been deployed for a full 6 months post approval. Last month, we also participated along with our Nestle collaborators in both the Infectious Disease Week and the American College of Gastroenterology conference. We took the opportunity to broadly engage many of our leading KOLs at these conferences and the feedback we are hearing continues to embody excitement and a high level of interest in VOWST. As a result of our successful HCP education efforts, we have seen demand growth significantly in Q3 as reported to us by Nestle Health Science. In total, across both the second and third quarters, we received 1,513 completed prescription enrollment forms for VOWST, including 1,215 in the third quarter alone. Of the total second and third quarter enrollment, 934 culminated in new patient starts, including 837 in the third quarter alone. We received prescription enrollment forms from 698 unique prescribers between approval in September 30 with a continued split of approximately 70% from gastroenterology and the remainder from other specialties. Like in the previous quarter, we continue to see VOWST prescribers who are not on the Nestle field sales teams call list, in line with the high-unmet need and strong awareness across the provider and patient communities. Of the 698 HCPs who have prescribed VOWST, 129 of them have prescribed VOWST to more than 1 patient. As expected, the majority of utilization for VOWST in the early launch period has been in the multiply recurrent patient group. VOWST demand was also observed in patients with their first recurrence, and we expect this to grow over time as HCP stay in experience with an entirely new modality and develop an understanding of the foundational and distinct role that VOWST plays in preventing recurrence after completion of successful treatment with antibiotics. Our most recent market research supports this view and tells us that HCPs expect to continue to increase their use of VOWST over time. To grow breadth of use for VOWST, we continue to scale promotional efforts to deepen the understanding of the goal of VOWST across the recurrent-CDI population. For example, IDWeek, we launched an updated branded campaign for VOWST and subsequently trained the Nestle field teams and redeployed them to educate their HCPs accordingly. We are also increasing our investment in speaker programs, given the high level of interest we’ve seen from providers. We expect these efforts to translate into further growth in demand and, importantly, earlier use in the recurrent cycle at the time. In terms of providing a positive experience for patients and providers, our VOWST voyage hub continues with its mission of providing a high level of patient treatment and financial support. As expected, VOWST voyage significantly increased its successful conversion of enrollment to new patient starts in Q3. In terms of free drug utilization, we saw approximately 48% of the 934 second and third quarter new patient starts to spend via our free drug program. The use of free drug was mostly due to patient affordability challenges with co-pays or other cost-sharing requirement after the prescription was approved by their insurer. Our third focus area is engaging payers to ensure access and to date we have been pleased with the broad patient access we are seeing. In fact, more people have already gained access to VOWST than we had anticipated at this point in our launch, with the vast majority of patients able to gain access to VOWST through their insurer. As of September 30, we had received coverage for VOWST across approximately 50% of commercial and 35% of Medicare Part D lives and estimate that the remaining plans will issue coverage policies in the coming quarters. To date, we are seeing some coverage policies for VOWST that are quite broad for the approved indication and others with some utilization management restrictions. Through September 30, we saw 52% of our 934 new patient starts reimbursed through the patient’s drug benefit. Our gross to net rate remains modest with minimal discretionary rebates at this stage of the launch. David will say more about our gross to net rates momentarily. In summary, the vast majority of patients who are prescribed VOWST are able to obtain approval for the product, either through the medical exception process prior to a policy being issued or via a prior authorization. As the first recurrent demand for VOWST builds, we will continue to work with prominent payers to ensure that we preserve the broad patient access to VOWST that we are currently observing. Finally, the hospital selling team continues its efforts to enhance hospital outflow, and we believe that these efforts will begin to bear fruit later this year and into 2024. As of September 30, the hospital team had successfully engaged approximately 350 of the top volume hospitals more than once a month. We believe these conversations are critical to ensuring structural modifications to how rCDI patients are discharged. Education of hospital-based HCPs and development of protocols for rCDI that include VOWST will enable more consistent consideration of VOWST as patients flow from the inpatient to the outpatient setting. Ultimately, the hospitals will benefit as fewer patients return with recurrences, especially during the 30-day window after initial discharge where CMS financial penalties could be applied. These results representing our first full quarter of the launch so that we are off to a very strong start with the VOWST launch. While we are not completely surprised at the speed and magnitude of this early uptake, given the unmet need and the robust profile of VOWST, these results have exceeded the company’s expectations across multiple dimensions. We, along with our collaborators at Nestle Health Science, will continue our focus on HCP education, customer experience, payer coverage and hospital outflow and expect to see continued acceleration of demand and progress on our key priorities as we move through the coming quarters. As a result, we have confidence that we will ultimately achieve our goal of VOWST becoming a foundational therapy for rCDI, alleviating a significant burden experienced today by patients, HCPs, and the health care system. Now I’ll turn the call over to David for an update on our financials.