Good day, and welcome to the Seres Therapeutics conference call. Today's conference is being recorded. At this time, I would like to turn the conference over to Dr. Carlo Tanzi, Head of Investor Relations. Please go ahead, sir.
Thank you and good morning. Our press release for the approval of VOWST became available yesterday evening and can be found on the Investors and News section of the company's website. We have posted slides accompanying this call on the Seres website, and I encourage you to view those during the presentation. I'll also remind you that we're making forward-looking statements, including the availability of VOWST product supply, the degree of market adoption, penetration, and accessibility, the results of payer engagement, the overall potential of microbiome therapeutics, the potential of future milestones, the ability of cash to fund operations, and other statements which are not historical facts. Actual results may differ materially. Additionally, these statements are subject to certain risks and uncertainties, which are discussed under the Risk Factors section of our recent SEC filings. Any forward-looking statements made on today's call represent our views as of today only.
We may update these statements in the future, but we disclaim any obligation to do so. On today's call with prepared remarks, I'm joined by Eric Shaff, Seres President and CEO, Dr. Lisa von Moltke, Chief Medical Officer, Dr. Terri Young, Chief Commercial and Strategy Officer, and David Arkowitz, Chief Financial Officer and Head of Business Development. During the Q&A portion, Dr. Matthew Henn, our Chief Scientific Officer, and Dr. Dave Ege, Chief Technology, will also be available to answer your questions. With that, I'll pass the call to Eric.
Thank you, Carlo, and good morning, everyone. We'll start our presentation on slide four. I am delighted to announce that the Food and Drug Administration has approved VOWST, formerly known as SER-109. VOWST is indicated for the prevention of recurrent C. diff infections in adults following antibiotic treatment for recurrent CDI. We believe VOWST has the opportunity to transform the management of recurrent C. diff infections and provides a meaningful new therapeutic option for patients. In addition, we are very pleased with the label that we have received. Adult patients who could benefit from using VOWST per the label can access it, including those with a first recurrence. Before we go further into VOWST, I want to acknowledge this moment for our company. Seres was founded over a decade ago by Flagship Pioneering based on the fundamental question: What if you could use bacteria as therapy?
Over the last decade, we've worked to answer that question by building proprietary platform capabilities intended to design, develop, and manufacture bacterial consortia. Our mission is to transform the lives of patients with revolutionary microbiome therapeutics. We are on the cusp of making that mission a reality with the first orally administered microbiome therapeutic approved by the FDA. As is typical in drug development, pioneering the creation of a new therapeutic modality has required skill, diligence, and a great deal of work. Our team persevered through some tough moments, including the unexpected Phase 2 results obtained in 2016. Our team has shown tremendous grit and followed the data in order to learn and optimize our approach.
Based on our scientific and clinical learnings, we made important modifications to our Phase 3 development program. We were ecstatic to see this work pay off with the remarkable SER-109 ECOSPOR III results. Developing a new treatment modality is difficult, and we will likely continue to need to overcome future obstacles. We've proven that our team has the culture and scientific capabilities to persevere and succeed. The FDA approval of VOWST is a testament to the unique capabilities and can-do attitude of the Seres team. I couldn't be prouder of their accomplishments. The approval of VOWST is an incredible moment for Seres. We think it's just the beginning of what is possible with microbiome therapeutics. We believe that our microbiome approach has the potential to address a range of infectious diseases and other Seres indications with new therapeutic options.
We have shown that Seres can develop effective orally administered microbiome therapeutics that are well-tolerated by patients and can change the gut microbiome and modulate its function in ways that improve human health. Our R&D team continues to advance a portfolio of drug candidates in our pipeline, which I'll address in my concluding remarks. Moving to slide five. Seres has a productive long-term collaboration with Nestlé Health Science that dates back almost 10 years, and we look forward to now co-commercializing VOWST in the United States with Nestlé. In a few minutes, Dr. Terri Young, our Chief Commercial and Strategy Officer, will speak to how we will work together to capture the commercial opportunity for VOWST. First, I'd like to pass the call to Dr. Lisa von Moltke, our Chief Medical Officer, to share the supporting data and profile of VOWST.
Thanks, Eric. On slide seven, I'd like to begin with an overview of C. difficile infection and the burden this disease creates for patients and the U.S. healthcare system. C. difficile is a spore-forming, toxin-producing, gram-positive anaerobic bacterium. C. difficile infections manifest in simple diarrheal illnesses in some patients but can be as severe as colitis that can cause hospitalizations in many individuals. Antibiotic therapy is necessary to treat the initial infection, but can leave patients at risk for future recurrence. When the microbiome is significantly disrupted for any reason, such as by the use of broad-spectrum antibiotics, C. difficile spores can germinate into toxin-producing bacteria. C. difficile infections create a substantial healthcare burden and have been characterized as an urgent health threat by the Centers for Disease Control and Prevention, the CDC.
Recurrent CDI is not an easy cycle to interrupt and often results in hospitalization and can even lead to death. There are 156,000 recurrences in the United States per year and at least 20,000 deaths due to C. diff infections. Approximately 50% of all patients with recurrences have a CDI-related hospital readmission. Patients with C. diff infections suffer debilitating symptoms, such as frequent diarrhea, up to 15x a day, that prevent them from conducting their normal daily activities, and these symptoms significantly lower their quality of life. Quality of life data suggests that patients often feel anxious, depressed, lonely, and socially isolated, and the burden persists even after the active infection clears. They often live in fear, not knowing if their CDI will return again. Their doctors have had limited options to prevent recurrences. Moving to slide eight.
C. difficile infections are unique because of the two-phase life cycle of a C. difficile organism. Antibiotic treatment is necessary to remove vegetative cells but is often insufficient to prevent a recurrence. A microbiome disrupted by broad-spectrum antibiotics can allow C. diff spores to germinate into toxin-producing bacteria, entering patients into the cycle of recurrent infections. Restoration of a healthy microbiota after antibiotic treatment can inhibit spore germination and prevent recurrence of infection. VOWST is designed to restore the microbiota. VOWST is a consortium of Firmicutes bacteria in their spore form. Firmicutes spores have been shown to germinate into bacteria that have been observed to inhibit the germination and growth of C. difficile spores, though the exact mechanism by which VOWST induces effects has not been established. VOWST bacterial spores are resistant to gastric acid, allowing formulation into oral capsules.
Our manufacturing process is designed to ensure product consistency and mitigate the risk of pathogen transmission. Slide nine shows the summary of VOWST label. VOWST is indicated for the prevention of recurrent C. difficile infections in adults following antibiotic treatment for RCDI. Importantly, this indication is for the broad population of adult recurrent patients. VOWST has a straightforward oral dosing regimen of four capsules once a day for three days following antibiotic treatment and use of a laxative to remove residual antibiotics from the GI tract. VOWST is stored in the original packaging and has no refrigeration requirement. The full label is available on VOWST's website. VOWST approval was supported by two Phase 3 studies, which I'll summarize in the next few slides.
Slide 10 shows an outline of VOWST clinical data from our Phase 3 study, ECOSPOR III, which enrolled 182 patients with multiply recurrent C. diff infections. Our study subjects were treated with either vancomycin or fidaxomicin for 10-21 days as per investigator discretion. Subjects were randomly assigned 1-to-1 to either VOWST or matching placebo, administered orally for three days. Subjects were stratified by age, so age 18-64 years old or 65 and over, and by the antibiotic they received for our CDI. The primary endpoint was the proportion of subjects who had CDI recurrence by eight weeks after dosing. CDI recurrence was determined by the return of diarrhea, the need to reinitiate CDI antibiotics, and the confirmation of the clinical diagnosis with a positive toxin test.
This Phase 3 study met the primary endpoint with a highly statistically significant reduction in the relative risk of C. diff recurrence. The results indicated that approximately 88% of patients did not experience a recurrence at the primary eigh-week endpoint, compared to 60% in the group with antibiotics alone. We also evaluated VOWST efficacy over longer periods of time, and we observed durability of response out to 24 weeks. Slide 11 provides an overview of the safety information from the Phase 3 ECOSPOR III study. VOWST was well-tolerated, and patients administered the drug had no serious treatment-emergent adverse events or deaths that were attributed to study drug. The most common AEs were mild to moderate in nature and included abdominal distension, fatigue, constipation, chills, and diarrhea. These AEs were also observed in patients in the placebo arm. Slide 12 summarizes the adverse reactions reported on the VOWST package insert.
These data further highlight how well-tolerated VOWST was. Following receipt of the positive ECOSPOR III data, we had further discussions with the FDA regarding the requirements for a BLA filing. At that time, the FDA indicated that they would require a total safety database that included at least 300 patients followed for six months. Based on that guidance, we subsequently enrolled a study, ECOSPOR IV, which was an open-label single-arm study that included over 260 additional individuals. Slide 13 shows the safety profile from ECOSPOR IV. Overall, safety profile on ECOSPOR IV through 24 weeks of follow-up indicated that VOWST was well-tolerated, with the most common AEs being flatulence, diarrhea, and nausea, all at rates of less than 5%. This was consistent with the safety profile observed in the placebo-controlled ECOSPOR III study. No serious adverse events were considered related to VOWST.
On slide 14, we show an overview of the CDI recurrence rates in ECOSPOR IV. Overall, we observed that 91% of subjects were free of recurrence at up to eight weeks, which was remarkably similar to the 88% rate observed in ECOSPOR III. This study included a meaningful proportion of first recurrence patients, where we observed that only 6.5% of patients experienced a recurrence, meaning 93.5% remained recurrence-free in this group. Our clinical results in this first recurrence population are consistent with our understanding of the underlying pathophysiology of the disease, which is believed to be similar across our CDI patients, regardless of the number of prior episodes. We have engaged clinicians and other stakeholders throughout the development of VOWST. We continue to hear their enthusiasm for an oral therapy with the efficacy results and safety profile that VOWST has.
We are now excited to bring VOWST to them and their patients. I'd like now to pass the call to Terri to describe the commercial opportunity for VOWST.
Thank you, Lisa, good morning, everyone. As Eric said earlier, this is an incredibly exciting day for patients, HCPs, and for all of us at Seres Therapeutics who've worked so hard over the past years to bring VOWST to patients. We believe we are on the cusp of a paradigm shift in the management of recurrent C. diff infection. For the first time, HCPs will be able to stop the vicious cycle of CDI recurrence in approximately nine out of 10 patients by restoring the microbiome with an easy-to-administer oral therapy. We therefore believe that VOWST has the potential to become the new foundational option to prevent our CDI. We and our colleagues at Nestlé Health Science are focused, excited, and ready to deliver an innovative treatment option to help HCPs more effectively manage the estimated 156,000 cases that they will encounter this year alone.
I'll dive in on slide 16. During our investor event last December, you may have heard Dr. Carl Crawford from Weill Cornell Medicine describe recurrent C. difficile infections as the bane of his existence. On the left-hand side of this slide, you can view his perspective regarding what the approval of VOWST could mean for both him and the patients he treats. Our recent interactions with HCPs at congresses and in market research reaffirms a broad need for better options to prevent recurrence. VOWST uniquely fills that unmet need as the first and only microbiome therapeutic with robust efficacy as observed across our clinical program and in a well-tolerated three-day oral regimen that a patient can self-administer in his or her own home. As a result, HCPs indicate a high intent to prescribe VOWST.
As you can see in the accompanying graph, approximately 75% of surveyed physicians indicated that they definitely or probably will prescribe VOWST. These are highly supportive numbers, not often seen for a new product launch, especially within an entirely new modality. On the next slide, HCPs consistently tell us that preventing recurrence is their top treatment goal for patients with RCDI. They also tell us that preventing recurrences remains their top unmet need, reflecting the inability of standard of care to deliver. Gastroenterologists, infectious disease specialists, and other HCPs expressed the need for a product profile like VOWST, a highly efficacious and well-tolerated therapeutic for preventing recurrences of RCDI. Moving to slide 18. Given the high level of unmet need in the category, it's no surprise that many of the physicians who regularly treat RCDI have patients in mind for initial trial of VOWST.
This is very typical for a new therapy, where HCPs initially choose to try a new option with a patient who is in dire need of something better. These same HCPs tell us that after an initial trial period, they fully expect to expand use to the broader population of RCDI patients. Over time, we expect a paradigm shift away from antibiotic use alone, with significant penetration of antibiotic share as utilization of a multi-step regimen takes hold. We are excited about the ability to fundamentally change this landscape. Moving to slide 19. I'll take this opportunity to remind you that at launch, we will be focused on patients who will complete their treatment for RCDI in the outpatient setting, where the medicine will be reimbursed via the outpatient pharmacy benefit.
We also plan to focus on the HCPs who see the most patients and who may have a propensity to adopt VOWST earlier than their colleagues. We will be deploying our field teams to reach the top writers in the top volume institutions with the 150-person Nestlé Health Science gastroenterology field team and a new 20-person hospital team that was hired by Nestlé in Q4 of last year. Our colleagues at Nestlé will be training these two field teams on the final label for VOWST in the coming days and will then pivot to full deployment. As a reminder, the Nestlé gastroenterology team already covers 85% of GI practices for their current in-line product, ZENPEP. This is a highly experienced team, bringing an average of 10 years in pharma and five years in GI.
It's also a team that has successfully accelerated ZENPEP growth after Nestlé acquired the brand. The hospital team will cover the top 300 hospitals in terms of RCDI patient volume, as well as engage infectious disease physicians in these organizations. Recall that this team was deployed in Q1 to start profiling top institutions. They will now pivot to work directly with HCPs at the institutions to ensure that VOWST is readily available to patients at discharge. Within the prescribing universe for RCDI, there is a significant group of physicians who may only treat a single patient with a recurrent CDI each year. It would not make sense for those physicians or for us to engage them with a traditional field model. Instead, we will be investing in non-personal promotion to drive awareness of VOWST for this group of HCPs, as well as for the patients who may see them.
As you might imagine, Nestlé, as an organization, has a deep understanding of digital engagement customer models, and we will be leveraging those capabilities for VOWST. Moving on to slide 20. It is important to us that every patient who needs VOWST to prevent a recurrent CDI has the chance to get it. We remain mindful of the narrow time window a patient has to obtain a prescription, fill it, and take the medicine upon completion of their antibiotic regimen. To that end, we are working to get the appropriate coverage to ensure patients have access to this innovation. Last year, we deployed the Nestlé Health Science payer field team for VOWST pre-approval information exchange. That team is now ready to engage the top payers to continue the process to achieve broad coverage for VOWST.
You can see on this slide 20 our estimated timelines to achieve coverage across the various payer channels. We do expect VOWST to be subject to the typical review and approval processes that each payer uses for new medicines. As a result, we estimate that many patients receiving VOWST early on will need to go through a medical exception process to navigate the new-to-market blocks that payers utilize for new products. Our ability to ensure broad and easy access, especially with the three largest PBMs, will smooth the way to deliver VOWST to patients. This is particularly important as more than half of our CDI patients have commercial insurance. Moving to slide 21. Payers understand the high burden of recurrent C. diff infections on patients and on the healthcare system.
This disease takes a toll on patients, both physically and emotionally, as well as imposing a significant economic burden on our healthcare system. VOWST brings an innovative profile supported by unique and safety and efficacy data, thus providing a robust solution for patients, HCPs, and payers. Taking all of this into account, after doing extensive research to understand the value that VOWST brings relative to other options, we, along with our collaborators at Nestlé, have priced VOWST at the wholesale acquisition cost of $17,500 per course of therapy. This price reflects the substantial value that VOWST offers to patients and society, and of course, is the price before any mandated or discretionary discounts and rebates to payers. We believe this price supports our approach to allow for broad access and foundational use of VOWST for patients with RCDI, including in patients with first recurrence.
We are very focused on creating an environment that permits broad patient access to VOWST and plan to provide financial assistance and treatment support for eligible patients through the VOWST Voyage program, which will be managed by our collaborators at Nestlé Health Science. Moving to slide 22. During the initial launch period, we will work to ensure physicians are aware of VOWST, that they gain an initial positive experience with it, and achieve their treatment goal of preventing recurrence. We will also work to gain broad payer coverage and enhance the ability for hospitals to prescribe VOWST for patients to take in the outpatient setting. Finally, we are focused on providing the support needed to create a positive experience for the patients and HCPs who use VOWST.
Once we have made significant progress in these areas, we will then focus on driving repeat HCP use of VOWST and continuing to expand patient access. Our supply and distribution teams across the companies are well prepared for launch, and we expect to have product available in June. In summary, the teams across Seres and Nestlé are poised to act upon this historic approval for patients and our companies and will focus on laying the foundations needed to ultimately transform standard of care in this space, thereby achieving the full potential for VOWST. I will now turn the call to David to talk about financial considerations for our company.
Thanks, Terri. Now to slide 24. I'll begin with a reminder of some of the terms of our July 2021 co-commercialization agreement with Nestlé Health Science. Per the agreement, Nestlé is the lead commercialization party with input from Seres through the joint steering committee and other governance structures that were established when we entered into the agreement. Seres received a license payment of $175 million upfront at the time of the signing of the agreement, and we are now due to receive an additional $125 million based on the FDA approval of VOWST. The agreement also includes sales target milestones, which, if achieved, could total up to $225 million. Upon commercialization, we are entitled to share equally in commercial profits and losses.
We expect that our 50% share of VOWST operating income or loss will be recognized in our P&L in the operating expense section as collaboration profit or loss sharing related party. VOWST operating income or loss will be determined based on VOWST net sales, cost of goods sold, and sales and marketing expenses in support of VOWST commercialization. For Seres, all entries related to VOWST commercialization will be recorded to the collaboration profit or loss sharing related party line item on our P&L. In conjunction with our future quarterly financial results, we plan on rolling out key launch metrics to provide additional information regarding VOWST commercialization progress. In addition, Seres is responsible for supplying VOWST inventory to Nestlé, and we have been building commercial supply in anticipation of approval.
We expect to receive payments from Nestlé in the near term related to their purchase of the VOWST inventory that we have already produced, and in the future, we expect a more steady pattern of inventory purchases by Nestlé to meet market demand. We are also pleased to announce this morning that we have entered into a $250 million secured debt facility with Oaktree. This is a term loan debt facility and includes $110 million in funding at closing, with three additional tranches available after closing, including $90 million in two tranches of $45 million, each available upon the achievement of certain VOWST sales targets, and an additional $50 million will be available at Oaktree's discretion to facilitate potential future business development activities.
A portion of the debt financing proceeds, approximately $53 million, will be used to pay out and retire our existing debt facility. Our cash balance as of March 31, 2023 was approximately $107 million. Our pro forma cash balance as of that date, including the VOWST approval milestone and the net proceeds from our debt financing with Oaktree, is approximately $282 million. As a result, we believe that Seres is well-positioned to support the commercialization of VOWST and the continued advancement of our pipeline. I'll now pass the call back to Eric.
Thanks, David. On slide 25. We are tremendously excited by the FDA's approval of VOWST. This is an important milestone for our company and demonstrates that our approach can result in FDA-approved medicines for serious diseases. Our pipeline includes programs in multiple disease areas, including both infection and immune modulation. Our immune modulation pipeline includes continued efforts such as those in inflammatory bowel disease. We see the data from VOWST development as scientifically and medically relevant for future development efforts. Clinical data from VOWST studies provides strong proof of concept of the potential of this novel technology to address additional infectious diseases, as well as modulate the function of the GI with relevance to multiple chronic diseases. In the near term, we believe that there are multiple opportunities to protect medically vulnerable patient populations from life-threatening infections with new microbiome therapeutic candidates. Slide 26 describes SER-155.
SER-155 is our next program that builds on what we've learned in the development of VOWST. SER-155 is an investigational cultivated consortia that we are developing to reduce the risk of infection, including antimicrobial-resistant infections and Graft-versus-Host Disease in patients receiving allogeneic stem cell transplants. SER-155 was rationally designed to target multiple pathways, reducing the abundance of pathogens that frequently appear in patients receiving allo-HSCT and producing metabolites that have the potential to prevent bacterial translocation and reduce GvHD. We have completed the first cohort of our Phase 1b study, which included 13 subjects and was designed to assess safety and drug pharmacology. We expect to report preliminary safety and pharmacology data next month. We have also initiated enrollment into Cohort 2 of the study after clearance from the DSMB. Slide 27 shows our potential path forward in fighting antimicrobial-resistant infections.
We believe the functions targeted by SER-155 are appropriate for a number of medically vulnerable patient populations at risk for antimicrobial-resistant infections. These populations include autologous HSCT recipients and patients with cancer neutropenia. We have a broad portfolio of preclinical programs, and we are on track to potentially deliver two or more additional programs in the next three years. We are excited by the opportunity to serve patients and build on the proof of concept that VOWST provides. Before we open up the call to questions, we'd like to thank everybody involved in the journey we've been on to discover and develop VOWST. We thank the team's Flagship Pioneering, who founded the company over a decade ago, and our long-term valued partners at Nestlé. We are grateful to the patients who participated in our clinical trials, their families and caregivers, and the investigators in the studies.
We appreciate the feedback and passion of the C. diff patient community, including patients, caregivers, and healthcare professionals. We would not be here without the tireless efforts of all of our team at Seres. We are grateful to be here today and excited about the path forward. Operator, please open the call to questions.
Thank you. Ladies and gentlemen, if you would like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. We will take our first question today from Joseph Thome with TD Cowen. Please go ahead.
Hi there. Good morning. Thank you for taking our questions, and big congratulations to the whole team here. Maybe first one, can you touch a little bit just on initial capacity, production capacity as it stands right now? Maybe where do you sit with Bacthera in terms of expanding that? Is that necessary, especially given sort of the broad label that you were given? Can you kinda just set the stage for that as well? Maybe the second question, I know you walked through sort of the initial adoption, population and then how that might change over time. I guess based on your physician feedback, what sort of a cadence do you expect to really get penetration to that first recurrent patient population?
Is that gonna take, you know, a year, a couple years? What has been sort of your feedback on that point? Thank you.
Yeah. Joe, good morning, and thank you for the question. On the first, in terms of capacity, I'm gonna invite Dave to comment. I'll just start off by saying, we feel strongly that we're well positioned to handle the number of different scenarios that we've mapped out. Maybe Dave can comment further, talk about where we are with, Bacthera, and then we can kick it to Terri.
Great. Thanks. Good morning. As a reminder, the supply chain for VOWST supply is well established. It's the same supply chain we used for Phase 3. It brought us to this point. We've been manufacturing product for launch for quite some time, and we have very favorable room temperature shelf life approved in our label. We're very happy with the performance of our CMO partner, Recipharm, and we're ready for launch and supplying those various scenarios that Eric talked about. To enable redundancy of supply, we do have the agreement with Bachtera, as we talked about. That program is moving along very well. Both of these agreements are designed to increase our longer-term VOWST supply and add to our existing capabilities for the future.
Joe, maybe I can ask Terri Young to comment on adoption.
Sure. Well, first let me start by saying we are thrilled with our label, right? It really allows us to reach into the entire population. One of the interesting aspects of this marketplace when we started engaging physicians early on that we realized is that, as I said in my prepared remarks, every physician has a patient in mind who could benefit from a product like VOWST. The interesting aspect of that is that for every physician, it's a different patient. It's a different type of patient. Actually, if you think about that initial trial patient population, it's quite broad and it crosses recurrences. That's one of the reasons we are very, very excited about the label that we have, and we do expect adoption across the recurrence pool in perhaps patients who are perceived as more severe by the doctor.
That can be driven by medical severity, either they have comorbid conditions or even, you know, like lifestyle obligations. You know, perhaps they're a caregiver for their family as well as an elderly parent or, you know, they're working two jobs. The patient type really is highly variable and crosses the recurrent population. Hope that helps.
Yep, perfect. Thank you very much, and congrats again.
Thank you.
Thanks, Joe.
Thank you. Our next question comes from Mark Breidenbach with Oppenheimer. Please go ahead.
Good morning, guys, and congrats on the approval. Maybe one question aimed at David. I was hoping he could give us a little bit more granularity on the sales target milestones per your co-commercialization agreement with Nestlé. You know, what do you have to achieve to trigger those? You know, how well do they mesh up with the terms in your debt financing agreement to access the additional tranches of debt per your agreement announced this morning? That's one question. Then the other question I have is just with respect to whether or not you have an indication on price that CMS is willing to pay for this product, or is that something that's still yet to be determined? Thank you for taking the questions.
David, you wanna start?
Sure. Yeah. Thanks for the questions, Mark.
As it relates to the Nestlé sales milestones, we have disclosed those. Those are at three breakpoints, $250 million in annual sales, $500 million in annual sales, and $750 million in annual sales, and there's $50 million, $75 million, and $100 million milestones that accompany those. So those were established when we entered into the agreement, almost two years ago. We have not disclosed the sales targets that are part of the loan agreement at this juncture. That's where we stand on that.
Terri, you wanna comment on the question around, price and CMS?
Yep, absolutely. You know, we along with Nestlé have been on a journey in terms of our considerations around price and arriving at our decision that really began on the back of the receipt of the ECOSPOR data a few years ago. We considered a number of factors when making this decision. First of all, the innovation that VOWST is bringing to the space, right? It's the first approved oral microbiota-based therapeutic that provides a robust efficacy profile as demonstrated in our trials and in a well-tolerated three-day oral regimen that a patient can take in their own home without additional costly procedures. We feel like we're bringing enormous value to all of the stakeholders across the chain, and, you know, this decision is a result of extensive engagement with all of those stakeholders.
I guess the final comment is the price is designed to facilitate access not only across the different payer groups, and you may recall that over half of our patients are commercial patients, but also across the groups that are covered by our broad label, including those with first recurrence. We're very confident in our decision. I guess the final comment I'll make is that because access is so important to us, we're also providing a robust suite of patient assistance programs, both in terms of treatment support as well as financial assistance via the VOWST Voyage program that will be managed by Nestlé.
Okay, terrific. Congrats again, thanks for taking our questions.
Certainly.
Thank you, Mark.
Thank you. We take our next question from Ted Tenthoff with Piper Sandler. Please go ahead.
Great. Thank you very much. My sincere congratulations. I know how long and hard this path's been. It is a great day for Seres and patients. I wanted to start, did I hear Terri mention that the supply of VOWST would begin in June? Is that the planning for the launch, or is that something I misheard? Also, do you have plans to, you know, profile this approval at upcoming DDW in Chicago, I think, in just a couple weeks here? Thank you very much.
Ted, good morning, and thanks for the question. June is correct. That is our plan and target. And maybe Lisa might be able to comment on plans for DDW.
We will be at DDW in force, both as Seres as with Nestlé.
Yes.
We have planned engagements as well as product theater, as CME events, so we will be there.
Great. It'll be a great event for you guys. Sincere congratulations.
Yeah.
Thanks.
Thank you, Ted.
Thank you. We take our next question from John Newman with Canaccord. Please go ahead.
Hi, guys. Let me add my congratulations as well. Really great execution on the study and the regulatory side to get the approval. Just two quick questions. The first one is, I'm wondering how we should be thinking about formulary uptake, mainly on the commercial side? I know that the hospital side will take a bit more time, but wondering if formulary uptake will be kind of a factor early in the launch. The second question is, I'm curious if yourself or Nestlé has any plans for DTC here in the future. Thanks.
Terri, why don't you take the first one?
Sure. Good morning, John. In terms of payer uptake, we anticipate that VOWST will be subject to the very typical payer review processes that all new medicines undergo. Until each payer does undertake their review and write their policies, VOWST will be available to patients and physicians via a medical exception process. It's not that we won't see any utilization out of the gate, but these days you have to get through that new to market block period, achieve your coverage and go from there. We're estimating, as you can see on the one side, I think it was slide 20, we've got about a six to 12-month period of getting through that. We think we're well-positioned because we actually deployed the Nestlé field team, you may recall, in April of last year.
They've been out there for a year educating and engaging payers. They have a plan to go on day one now and progress those efforts.
You know, John, I think in Terri's comments, she talked about the unique capabilities that Nestlé brings in terms of digital, but maybe you can comment on the second part of the question too.
Sure. I think that the patient is definitely a group that we want to engage. They've told us over time that. You might imagine from Lisa's remarks in terms of the patient experience, these patients are very motivated to find out what is going on with themselves and how they can get better quickly. They are online, they are searching for information, and our job is to be there when they're looking. We are up to the task working with Nestlé. Thanks, John. Thanks for the questions.
Thank you. We take our next question from Tessa Romero with J.P. Morgan. Please go ahead.
Hi, guys. Good morning. I'd extend my congratulations on the milestone for Seres and for patients as well here.
First one from us is a little bit of a clarifying question. Did I hear correctly that you think you might have coverage for the top 3 PBMs in the first kind of six to 12 months post-launch? If this is the case, what's the right way to think about sales trajectory in 2023 and 2024 for VOWST, kind of broadly across the population underneath the label? Thanks so much.
Tessa, thanks. Good morning. Appreciate the question, and maybe I'll ask Terri to comment.
Sure. Certainly the three largest PBMs will provide access to the vast majority of commercial patients, so they are absolutely a priority for us in terms of payer engagement. The payer field team has obviously met with these three large customers during the pre-approval information exchange period and will actively engage them again post-approval. Yes, we do estimate that we will have outcomes from those engagements in the first 6-12 months along with the vast majority of other influential commercial health plans and Part D plans. I think that's the first question. The second question more generally around trajectory.
You know, the three areas where we'll really be focused that will govern that is the payer review process that I just spoke about, but also our need to educate physicians about a transformational way with an entirely new modality of treating patients. There's the education process. Finally, I've referenced in previous calls this segment that I call the hospital-to-home segment of patients, where these patients are beginning their treatment for recurrent C. diff in the hospital because their symptoms are so severe. Once the antibiotic regimens start to take hold and relieve those symptoms, they're subsequently discharged to finish the antibiotic regimen. These patients would ideally receive a prescription for VOWST at discharge, along with the continuation of their antibiotic regimen and take VOWST in the outpatient setting on completion of the antibiotics. Those are sort of the three areas.
We have work to do with the hospital team in the hospitals in terms of smoothing that discharge process and ensuring VOWST is consistently available for patients that need them coming out of the hospital. Those are the three areas we're focused out of the gate to govern the ramp.
Great. Great. Thanks so much for taking our questions.
Certainly.
Thanks for the question, Tessa.
Thank you. We take our next question from Chris Shibutani with Goldman Sachs. Please go ahead.
Hi, this is Stephen on for Chris. I'll pass along my congratulations to the team. This is a big milestone. I had a question on the label. I noticed that it refers to the mechanism of VOWST not being established. I'm just curious if that was something proposed by your team or the FDA, and then how you think about not having a known mechanism. Do you feel that will impact physicians' view of the product at all? Thank you.
Stephen, good morning, and thank you for the question. You know, I will ask Matt to comment on the mechanism, and then I think you asked about the commercial implications or potential commercial implications, and I'll ask Terri to comment on that.
Yeah. You know, while antibiotics are a necessary part of recurrent CDI treatment, they leave patients at risk for future recurrences, because they don't restore the functionality of the disrupted microbiome, and we see that as one of the root causes of CDI recurrence. VOWST, as we've talked about, is a suspension of these Firmicutes bacteria spores, that we source from the gastrointestinal microbiome of healthy donors. We are still in the process of elucidating the specific mechanism of action of VOWST, but, you can review our January New England Journal of Medicine paper, where we provide additional context around that.
In that NEJM paper, we report on the kinetics and magnitude of the engraftment of these Firmicutes bacteria, as well as, the associated functional changes in that disruptive microbiome, that are connected to the C. difficile life cycle.
Yeah. I would say the vast majority of physicians who treat these patients really see the problem and solution very simply. The problem they have with this disease is that despite their best efforts, it keeps coming back. It's a very simple problem with fortunately today, a very simple solution with very high efficacy in a well-tolerated three-day oral regimen. I don't anticipate this label language to impact physician utilization because the product so uniquely hits their number one unmet need. Thanks for the question.
Got it. Okay. Thank you very much.
Thanks, Stephen.
Thank you. Thank you. We take our question from Keay Nakae with Chardan. Please go ahead.
Yes, thanks. A question for Terri. Maybe just digging deeper on your response to the earlier question about physician uptake. In your assessment with them, you know, how much do they differentiate between a first recurrence and second recurrence, you know, appreciating the fact that dysbiosis is implicated in both?
No, it's a great question, and I would refer you actually back to our December investor event as well, where you can hear Dr. Carl Crawford's point of view on that. There's a slide in there that shows a fork in the road. I think we've utilized that visual in our current deck as well. physicians. It's such a great visual because it shows you how they think of the disease, whereby you have a patient who has primary C. diff infection, and some of those patients get better, and they leave the physician's office, and they never come back. There is a significant portion of patients who do come back, and there's a bit of a reaction from the physician, the treating physician of, "Oh, no. Now I have one of those."
They recognize that they have a patient who needs microbiome restoration, and it's a different problem that they're now trying to solve. They see, really see the recurrent patient as having a singular problem that keeps coming back that they don't, or prior to today, rather, didn't have good tools to address. I hope that makes sense.
Okay, thanks.
You're welcome.
Thank you. With this, I would like to turn the conference back over to your hosts today for any additional or closing remarks. Thank you.
Well, thank you, operator, and thanks to everyone for joining this morning's call. We are incredibly excited about the FDA approval of VOWST. We look forward to speaking with you soon in May when we'll share our first quarter 2023 earnings and provide a business update. Thanks again. Have a great morning, and we look forward to connecting soon.
Thank you. That will conclude today's conference call. Thank you for your participation. You may now disconnect.