Seres Therapeutics, Inc. (NASDAQ:MCRB) Q4 2023 Earnings Call Transcript

Seres Therapeutics, Inc. (NASDAQ:MCRB) Q4 2023 Earnings Call Transcript March 5, 2024

Seres Therapeutics, Inc. beats earnings expectations. Reported EPS is $-0.32, expectations were $-0.4.
MCRB isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).

Operator: Ladies and gentlemen, good morning. My name is Abby, and will be your conference operator today. At this time, I would like to welcome everyone to the Seres Therapeutics Fourth Quarter 2023 Earnings Conference Call. Today’s conference is being recorded and all lines have been placed on mute to prevent any background noise. After the speaker’s remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. And I will now turn the conference over to Rob Windsor of Investor Relations. You may begin.

Rob Windsor: Thank you and good morning. Our press release for the company’s fourth quarter 2023 financial results became available at 7:00 a.m. Eastern Time this morning and can be found on the Investors and News section of the company’s website. I’d like to remind you that we’ll be making forward-looking statements, including the availability of cash to fund operations, the potential sales for VOWST including our ability to achieve sales targets and milestones, the timing and results of clinical studies 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’ Chief Executive Officer; Dr. Terri Young, Chief Commercial and Strategy Officer; Dr. Lisa von Moltke, Chief Medical Officer; and David Arkowitz, Chief Financial Officer. In addition to that, Dr. Matthew Henn, Chief Scientific Officer, and Dr. Dave Ege, Chief Technology Officer, will also be available to address questions. With that, I’ll pass it over to Eric.

Eric Shaff: Thank you, Rob, and good morning, everyone. 2023 was an historic year for Seres and an inflection point for our company and for patients. With the approval and launch of VOWST, we brought to market our first-in-class oral microbiome therapeutic for patients with recurrent C. diff infection. We are proud of the impact VOWST is having on patients, their families and the entire recurrent C. diff community. As we enter 2024, our top priorities remain: first, delivering VOWST to patients and, second, advancing the potential of microbiome therapeutics more broadly, including with our SER-155 Phase 1b readout in Allo-HSCT patients expected in Q3 of this year. Everything we do at Seres has been and always will be driven by a desire to support patients with significant unmet medical needs.

It is the hope and resilience of each patient and their families that inspires us and drives us to fulfill our mission. VOWST is a perfect example of this. In VOWST, we have developed an incredible and unique option for patients who battle recurrent C. diff infection. One with a strong efficacy and safety profile as well as a convenient oral route of administration. In a particularly complex disease where historically, innovation has been difficult, today VOWST is changing lives. The US launch of VOWST has exceeded our expectations. In partnership with Nestle Health Science, we are pleased with the broad patient access received thus far with more patients gaining access to VOWST than expected. The hospital team continues its efforts to enhance hospital outflow, which we expect will continue to bear fruit into 2024.

We are also seeing continued strong demand from a broad set of healthcare practitioners and across the recurrent C. diff patient pool, including utilization in patients at their first recurrence. Terri will cover our commercial metrics in more detail shortly. I am extremely proud that we achieved over 2,000 VOWST patient starts in 2023 following our launch in June. We continue to see substantial opportunity for growth given the broad label and the robust clinical profile of VOWST, which makes it an ideal choice for so many of the estimated 156,000 cases of recurrent CDI in the US each year. I would like to thank the team at Seres and Nestle for successfully executing our launch strategy together, collaborating with focus and urgency on behalf of our patients and their families.

We look forward to seeing continued growth of VOWST utilization in 2024 and expect this positive trend to continue as patient outcomes on VOWST are more broadly recognized. We are excited by the potential of VOWST to become the standard of care for preventing further C. diff occurrences. Building off our strong proof of concept with VOWST, we were excited to announce in December, receipt of fast-track designation for the SER-155 program with the Cohort 2 data readout anticipated in the third quarter of this year. We believe positive data from this readout would further validate the potential of our platform and infections, including in indications such as chronic liver disease, cancer neutropenia, solid organ transplant and AMR infections more broadly in settings of high risk such as intensive care units.

Last year, we made the difficult decision to restructure the company and focus on VOWST and SER-155. This was an extremely difficult decision but a necessary one for positioning Seres optimally for the future. David will touch upon this later in the call, but financial discipline is at the forefront of Seres priorities in 2024 and beyond. We will continue to evaluate all options to strengthen our balance sheet. As we do so, we believe we will be well positioned to create value for our shareholders and deliver our mission for patients now and in the future. Recently, we announced the appointment of Marella Thorell, as Executive Vice President and Chief Financial Officer of Seres, following David’s retirement. We welcome Marella and look forward to benefiting from her extensive strategy, corporate finance and operational experience.

I would also like to thank David for his leadership and significant contributions over the past three years, and we wish him the very best in retirement. With the continued success of the VOWST launch and the clinical readout from SER-155 later this year, we look forward to 2024 as a year that will further validate Seres platform and the promise in microbiome therapeutics. I would like to now pass the call over to Terri to cover the significant progress we’ve made bringing VOWST to patients.

Terri Young: Thank you, Eric. I’m pleased to report that along with our collaborators at Nestle Health Science, we continue to make significant progress on our launch priorities in the fourth quarter, building upon earlier momentum observed with the VOWST launch. As you’ll recall, our four focus areas are: scaling HCP education efforts; creating a positive customer experience; establishing payer coverage; and optimizing hospital outflow. I’ll now provide an update on each of these. Our HCP education efforts emphasize the importance of microbiome restoration and recurrent CDI 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 team.

As a result, demand continued to grow in the fourth quarter as reported to us by Nestle Health Science. In total, between our June launch and year-end, we received 2,833 completed prescription enrollment forms for VOWST, including 1,322 in the fourth quarter alone. Of the total enrollments last year, 2015 culminated in new patient starts, including 1,082 in the fourth quarter alone. We received prescription enrollment forms from 1,330 unique prescribers between approval and year-end, nearly doubling the number of prescribers versus what we saw at the end of Q3. Approximately 65% of these prescribers of VOWST were from gastroenterology with the remainder from other specialties. Of these 1,330 HCPs who prescribe VOWST, 340 of them prescribe VOWST to more than one patient.

Although as expected, the majority of 2023 utilization for VOWST was in the multiply recurrent patient group. We continue to see use in patients with their first recurrence. We expect this to continue to grow over time as HCPs gain experience with an entirely new modality and developed an understanding of the foundational and distinct role that VOWST plays in preventing recurrence. We recently completed a round of market research with HCPs who have used VOWST. Findings from that research support that HCPs remains highly receptive to the profile of VOWST and users have had a positive experience of gaining patient access, supported by the Nestlé field teams and the VOWST VOYAGE patient hub. These encouraging results align with our view that VOWST can become a foundational treatment for recurrent CDI and a highly significant commercial opportunity over time.

Providing a positive experience for patients and providers is our second launch priority. Our VOWST VOYAGE hub continued to increase its successful conversion of enrollment to new patient starts in Q4. In terms of free drug utilization, approximately 46% of the 2015 new patient starts in 2023 were dispensed via our free drug programs. In the fourth quarter specifically, that percentage was down — was 44%, down from the 48% we reported for Q3. As a reminder, the use of free drug that we are seeing is mostly due to patient affordability challenges with co-pays or other cost-sharing requirements after the prescription was approved by their insurer. We believe these programs are an important investment to support future demand across the broad rCDI patient population and the need for these programs is likely to decline as the Inflation Reduction Act provisions, governing Medicare Part D benefit design and specifically patient cost sharing requirements come into effect over the next year.

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 with the vast majority of patients able to gain access to VOWST through their insurer. As of year-end, we had received coverage for VOWST across approximately 80% of commercial and 54% of Medicare Part D lives and estimate that the remaining plans will issue coverage policies in the coming quarters. Through year-end, we saw 54% of our 2015 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 the prior authorization or appeals process.

As 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 these efforts will accelerate demand in 2024. As a result of this team’s efforts, we are starting to see VOWST added to discharge protocols at some of the large institutions as well as added to inpatient formularies. Scaling these efforts are critical to ensuring structural modifications to how our rCDI patients are discharged. Education of hospital-based HCPs and development of protocols for rCDI that can include VOWST, will enable more consistent consideration of VOWST as patients flow from the inpatient to the outpatient setting.

These 2023 results since the launch of VOWST in June show the strong start of a significant opportunity to change the treatment paradigm across the entire rCDI patient pool. In fact, our results exceeded our expectations across multiple dimensions. We, along with our collaborators at Nestlé 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 2024. As a result, we have confidence that we will ultimately achieve our goal of VOWST becoming a foundational therapy for our CDI, potentially reaching or surpassing the highest sales-based milestone threshold in the 2021 Nestle co-commercialization agreement of $750 million.

I would now like to pass the call over to Lisa to give more details about SER-155 and our ongoing clinical trial.

Lisa von Moltke: Thank you, Terri. As a reminder, SER-155 is a cultivated microbiome therapeutic candidate that is designed to prevent enteric infections, including those that may harbor antibiotic resistance, and to reduce the incidence of graft-versus-host disease in patients undergoing hematopoietic stem cell transplantation. The peer-reviewed literature supports a strong connection between a disrupted GI microbiome and pathogen domination in the GI tract with the endpoint of infection graft-versus-host disease and mortality in patients undergoing Allo-HSCT. Last year, we reported promising Phase 1b Cohort 1 clinical data with SER-155 being well tolerated in highly immunocompromised HSCT patients. Our data indicated that only a single patient had enteric pathogen domination within 30 days following stem cell transplant, which was a markedly lower incident than that observed in a large reference cohort of patients.

Enrollment is ongoing in Cohort 2, which incorporates a randomized, double-blinded, placebo-controlled design to further evaluate safety and engraftment as well as clinical outcomes. This portion of the study will enroll approximately 50 subjects administered either SER-155 or placebo at a 1:1 ratio. And we anticipate obtaining Cohort 2 study data in Q3 of this year. In addition to continued evaluation of the safety profile and drug pharmacology, outcomes assessed will be the ability of SER-155 to decrease rates of pathogen domination, Grade 3 or 4 acute GVHD and the incidence of GI and related bloodstream infections. We also will assess the ability of SER-155 to decrease rates of fever during neutropenia and the initiation of attendant antibiotic therapy.

We believe positive data from this readout would further validate the promise of this novel therapeutic modality in addressing serious infections in medically vulnerable populations including patients with chronic liver disease, cancer neutropenia and solid organ transplant. We also believe that this approach could impact the problem of antimicrobial resistance more broadly in settings of high risk such as intensive care units. These additional opportunities have the potential to extend the utility of SER-155 and our preclinical stage pipeline and to establish a new approach in protecting immunocompromised patients from life-threatening infections and related clinical events. With that, I’ll turn the call over to David for an update on financials.

David Arkowitz: Thanks, Lisa, and good morning. I’d like to discuss our financial performance for the fourth quarter, starting with VOWST. Let me first remind everyone that Seres has not recognized VOWST net sales in its financial statements, but instead, we share equally with Nestle, the commercial profits and losses, and we record our share in collaboration, profit and loss sharing related party. VOWST profits and losses are determined based on VOWST net sales, cost of goods sold and sales and marketing expenses. Consistent with our prerelease in January, net sales of VOWST for the fourth quarter were $10.4 million and based on 673 units of VOWST sold during the period to specialty pharmacies and distributors. The net sales reflect estimated gross to net reductions of approximately 11%.

We estimate that at the end of last year, there was approximately two weeks of VOWST inventory in the channel at specialty pharmacies. Seres supplies VOWST inventory to Nestle, and we received payments from Nestle related to their VOWST supply purchases to meet market demand. During the fourth quarter, Nestle purchased approximately $9 million of valve supply from us, and we received approximately $17 million in payments from Nestle related to prior quarter purchases. The total VOWST loss in the fourth quarter was $20.5 million, and our share of that was $10.3 million. The fourth quarter VOWST collaboration expenses, meaning COGS and sales and marketing expenses for VOWST increased from the prior quarter. This increase was due to higher COGS given the variability of manufacturing costs for VOWST produced prior to approval as well as some prior period adjustments and higher sales and marketing expenses due to increased free goods and the initiation and ramp-up of some key marketing activities.

For the fourth quarter, we also recognized as collaboration profit or loss sharing related party approximately $14 million of profit on the transfer of VOWST inventory to Nestle. This profit represents the supply price to Nestle, net of the cost of the inventory for the units sold and free goods distributed by Nestle during the quarter. Because the vast majority of this vast inventory was manufactured prior to approval, its cost was largely previously expensed and therefore, the inventory value is very low, resulting in the profit on the transfer of the VOWST inventory that is close to its supply price. Over time, as the VOWST pre-approval inventory is consumed, the magnitude of this profit component from the transfer of inventory will diminish.

Research and development expenses for the fourth quarter of 2023 were $26.8 million, reduced from $46.2 million for the same period in 2022. The year-over-year decrease in R&D expense is primarily driven by VOWST commercial manufacturing costs no longer being recognized in the Seres P&L following the product approval in April 2023, instead capitalized and recognized on our balance sheet. General and administrative expenses for the fourth quarter of 2023 were $17.2 million, reduced from $22.4 million from the same period in 2022. As you know, in November of last year, we announced a significant corporate restructuring, which is expected to achieve $75 million to $85 million in annual cash savings in 2024. The restructuring was substantially implemented around year-end last year.

As a result, R&D and G&A expenses for the fourth quarter were minimally impacted by the restructuring as the reduced spend related to the restructuring started in earnest at the beginning of this year. We ended 2023 with $128 million in cash, cash equivalents and investments. And additionally, we have received net proceeds of approximately $18.5 million from the sale of common stock under our at-the-market equity or ATM program thus far this year. We anticipate that our cash balance in conjunction with the anticipated savings from the restructuring and assuming continued quarter-over-quarter revenue growth of VOWST, the expected receipt of the $45 million Tranche B under our existing term loan facility with Oaktree will support our operations into the fourth quarter of 2024.

Thank you, and I’ll now turn the call back to Eric.

Eric Shaff: Thank you, David, and thank you again for all your contributions to Seres. We wish you well in your retirement. Before opening the call up to Q&A, I would like to express how proud I am of the team at Seres and the team at Nestle for bringing a first-in-class oral therapy to the market. 2023 was truly a trailblazer year for Seres as well as for microbiome therapeutics. As we look forward into 2024, I’m excited about the continued success of VOWST, as well as the possibilities with SER-155. With that, we will conclude our remarks and open the line up to questions.

Operator: [Operator Instructions] And we’ll take our first question from Jeff Jones with Oppenheimer. Your line is open.

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Q&A Session

Jeff Jones: Thank you. Can you hear me?

Eric Shaff: Yes, we can, Jeff. Good morning.

Jeff Jones: Great. Thanks, Eric. I guess can you speak to the main drivers of what looks to be about a $170 million spend in 2024? I know we’ve spoken to your second manufacturing site in the past? And then any discussions you might be having with Nestle regarding the now about 10 months runway?

Eric Shaff: Yeah. Maybe I can ask David to start on the parameters of investment and then I can take the second question on our partners.

David Arkowitz: Yeah. I would just say, Jeff, at a high level, about half of that relates to R&D. And a big chunk of that R&D spend relates to really ramping up our upcoming manufacturing facility in Bacthera, so you’re talking about — we’re talking about tech transfer and really driving towards approval of that facility. So that’s driving a lot of the spend. Keep in mind that we are also operating — we will be operating Bacthera and our existing CMO simultaneously in 2024. As we get into 2025, that will drop off. We will move to primarily one CMO, so you’ll see some of that spend dissipate. And then we’ve got G&A expenditures to operate as a public company as well as our share of the VOWST collaboration profit and loss.

Eric Shaff: Maybe I can just add, Jeff, to the second part of the question. In general, we are highly focused on cash, on runway, on investments and ways in which we can continue to support the company. And certainly, you saw at the end of last year, action from us with the restructuring, 41% reduction in headcount. We estimate between $75 million to $85 million reduction in 2024 spend. So our three priorities for this year are, one, supporting the launch of VOWST. Two, driving towards a SER-155 readout. And three, supporting the company, both through augmenting the balance sheet, reducing spend and looking actively at ways in which we can continue to support our operations. I would say from our partners’ perspective, I think we both are pleased with the launch to date.

We know that VOWST is important to Nestle. We know that there’s real synergy between Zenpep and VOWST and I won’t go forward than that. But obviously, we care deeply about supporting the company, and we’re actively working to try to put ourselves in the best position to serve patients in the long term.

Jeff Jones: Just one quick follow-up on that and the work at Bacthera, which involves manufacturing batches. Any chance that some of those batches can be used commercially? And so that spend there actually goes to saleable product?

Eric Shaff: Yes, I can comment on Bacthera, but maybe we’ve got Dave here who can comment on the specific question around the batches.

Dave Ege: Hi, good morning. Yes, the simple answer is that is correct. Like it’s anticipated that the PPQ batches for validation will be salable and ultimately would go into commercial supply.

Eric Shaff: And I would just add, we continue to make progress with Bacthera in supporting continued augmentation of our capacity. And we’re working with them as well to think about ways in which we can continue to support both companies and our relationship moving forward.

Jeff Jones: Great. Appreciate it. I’ll jump back into the queue guys.

Eric Shaff: Thanks, Jeff.

Operator: We will take our next question from John Newman with Canaccord. Your line is open.

John Newman: Hi guys, good morning. Great progress about the hard work on the VOWST launch, very good. Obviously, appreciating that you are currently very focused on commercialization, excuse me, of VOWST, as well as the current SER-155 Phase 1b study, I’m just curious where do you see future opportunities for the drug technology itself?

Eric Shaff: Yeah, John, good morning, and thank you for the question. Maybe I can start now and I’ll invite Matt, who’s here to provide some commentary as well. But I think I’ll start with your question led off, which is we are focused. Our priorities for 2024 are VOWST launch, 155 and supporting the financial condition of the company. So we are deeply committed to the strict allocation of capital along those key priorities and focus, I think, is the name of the game for us in the short term. That said, that doesn’t mean that we can’t — also can’t be excited about what could potentially be opened up with a positive readout in the 155 study. So we are particularly excited about that. Maybe I can invite Matt to comment further.

Matthew Henn: Yeah, John. I mean, thinking about that kind of potential, as Eric said, that could be opened up. Really, when you think about the past decade, there’s really just been an incredible explosion in the research that’s defined a really substantial role for the microbiome in both states of disease, states of health. And importantly, we’ve learned a tremendous amount mechanistically about how that happens. So — and this is best understood in the context of the gastrointestinal track which is where Seres is focused. Our research to date and our programs to date. And there’s a role to be played around infections, as we’ve talked about, priming both the adaptive and the immune systems, general metabolism and quite frankly, data supporting gut brain access, et cetera.

But I would like to think about the development of microbiome therapeutics and the various strategies that we can pursue here. I think of it similar to gene therapy. It’s early. There’s really sound science. There’s really a lot of potential, but translation takes some time and to succeed here, people need to build platforms that can really kind of get at the heart of scientifically and mechanistically what’s happening and as well, strategically broaden our pipeline. And in short, Seres has built such a platform and we’re pursuing such a pipeline strategy, right? We have the ability to go from early-stage discovery all the way through to manufacturing of these therapeutics. We can interrogate a very, very high resolution micro, micro, micro post interactions that allows us to really get at specific pathway specific targets that we can target.

And then our portfolio strategy has been building incrementally. So VOWST provides us a very strong proof of concept around the concept to be able to address infections in the gut. And our SER-155 program is building on that knowledge to go after a broader set of pathogens as well as leverage critical insights we have from a preclinical and clinical standpoint on how we can have an impact on preventing infections and colonization of various pathogens, how we can actually induce immune tolerance in the gastrointestinal track as well as actually look at the epithelial barrier and have impacts there. So this is all built into this 155 program. And as you heard on the call today, that — we see that really just as the initial point for that expansion, where we can move into additional medically-compromised patients where we see disruptive microbiome, people at risk for these same kinds of factors that include cancer neutropenia, solid organ transplant, liver — chronic liver disease and really that problem of AMR more broadly in the ICU.