Seres Therapeutics Reports First Quarter 2024 Financial Results and Provides Business Updates
Seres Therapeutics, Inc. (Nasdaq: MCRB) reported first quarter 2024 financial results highlighting net sales of $10.1 million for VOWST, accelerating sales growth since launch, and progress in clinical trials. The company aims to expand its product franchise into additional patient populations and secure more capital for pipeline development.
Net sales of VOWST reached $10.1 million in Q1 2024, reflecting accelerated growth.
Successful completion of enrollment for SER-155 Phase 1b Cohort 2 study, with positive clinical data expected in Q3 2024.
Progress in expanding manufacturing capacity to support commercial supply of VOWST.
Net loss of $40.1 million for Q1 2024, indicating ongoing financial challenges.
Reduced research and development expenses compared to the same period in 2023, potentially impacting innovation and pipeline advancement.
General and administrative expenses totaled $15.5 million in Q1 2024, highlighting ongoing operational costs.
Insights
Analyzing Seres Therapeutics' Q1 2024 financials, the most striking element is the reported net sales from their product VOWST, which reached
From a financial standpoint, the gross-to-net reduction of
On the R&D front, the decrease in expenses to
The data presented indicates that VOWST is gaining traction in the treatment of recurrent Clostridioides difficile infection (rCDI), with an impressive adoption rate. Observing the patient enrollment and new patient starts is an encouraging sign for the drug's uptake and effectiveness in a real-world setting.
Additionally, the SER-155 Phase 1b study's progress is promising, with anticipated data set to provide further insights into the efficacy of this microbiome therapeutic. The FDA Fast Track Designation for SER-155 is an important detail, as it could expedite review and approval processes, potentially leading to quicker market entry. As a long-term implication, the expansion of the microbiome therapeutic candidates into other medically vulnerable populations could substantially broaden the company's market reach.
However, investors must consider the risks inherent in clinical development. The therapeutic landscape for rCDI and other indications that Seres targets is competitive and commercial success depends on clinical outcomes, regulatory approval and market penetration against established treatments. The success of SER-155 and other pipeline candidates will be important for sustained growth and diversification of the company's revenue streams.
From a market perspective, Seres Therapeutics’ increasing provider engagement, with a substantial percent from gastroenterology, indicates a strong adoption within the specialist communities likely to prescribe VOWST. The breadth of utilization reflects physicians' confidence in the treatment, which can drive long-term growth.
Moreover, the mention of Nestlé Health Science's role in refining the launch execution and contributing to the acceleration of sales is noteworthy. Their involvement suggests that Seres Therapeutics is not alone in its commercialization efforts, benefiting from Nestlé's vast experience and resources.
The commercial sector reacts favorably to such strategic alliances, which can enhance a product's market presence and credibility. The short-term impact is already visible in the sales acceleration. Long-term, if the trend continues, it could lead to sustained revenue growth. Nevertheless, the success of such partnerships relies on continuous innovation and competitive marketing strategies, especially in a field as dynamic as biotechnology.
Continued market adoption of VOWST® with approximately 1,411 patient enrollment forms received, approximately 1,083 new patient starts, and net sales of
SER-155 Phase 1b placebo-controlled Cohort 2 clinical readout expected end of Q3 2024
Further microbiome therapeutic candidates have potential to expand product franchise into additional medically vulnerable patient populations
Conference call at 8:30 a.m. ET today
"With a broad indication and compelling clinical profile to prevent the recurrence of Clostridioides difficile infection (CDI) in adults following antibacterial treatment for recurrent CDI (rCDI), VOWST enables healthcare providers to fundamentally transform how they treat this life-threatening disease. Along with our collaborators at Nestlé Health Science, we have continued to make progress with the launch of VOWST. Nestlé continues to refine its launch execution, and we have seen a resulting acceleration of VOWST sales during March and April,” said Eric Shaff, President and Chief Executive Officer of Seres.
“Additionally, we completed enrollment of Cohort 2 in our ongoing SER-155 Phase 1b study and look forward to sharing a comprehensive topline dataset during the third quarter. These clinical results could further validate the vast potential of microbiome therapeutics in preventing adverse outcomes linked to gastrointestinal pathogens,” continued Mr. Shaff. “Our goal remains to leverage Seres’ industry-leading microbiome capabilities to advance the development of SER-155 and other product candidates in additional indications such as chronic liver disease, cancer neutropenia, and solid organ transplants, which could protect millions of medically vulnerable patients from life-threatening infections. In support of this objective, we are evaluating various options to provide the Company with additional capital and to advance our pipeline.”
VOWST Commercial Performance
Commercial adoption of VOWST has continued since its June 2023 launch in the
-
First quarter 2024 net sales were approximately
$10.1 million 15% . -
An acceleration of net sales occurred with March net sales of approximately
$4.6 million - In the first quarter of 2024, approximately 1,411 completed prescription enrollment forms were received for VOWST and there were approximately 1,083 new patient starts.
- From launch through March 31, 2024, approximately 4,239 completed prescription enrollment forms were received for VOWST; of which approximately 3,096 resulted in new patient starts.
-
From launch through March 31, 2024, prescription enrollment forms were submitted by approximately 1,939 unique healthcare providers (HCPs) (including approximately 609 added in the first quarter); with approximately
65% from gastroenterology and the remainder from other specialties; approximately 604 HCPs have prescribed VOWST to more than one patient. - VOWST demand has been observed across the recurrent CDI patient pool, including first recurrence, the largest CDI patient segment.
Additional Program and Corporate Highlights
- In April, the Company announced the completion of enrollment of Cohort 2 of the SER-155 Phase 1b study. Initial Cohort 2 study data, anticipated late in the third quarter, will include safety, drug pharmacology, and efficacy measures through day 100 following Allogeneic Hematopoietic Stem Cell Transplantation (Allo HSCT), a period in which many patients experience infections. The Company previously announced SER-155 Phase 1b Cohort 1 clinical data that showed favorable tolerability, successful drug bacteria engraftment, and a substantial reduction in pathogen domination in the gastrointestinal (GI) microbiome compared to a reference cohort of patients. SER-155 has been awarded FDA Fast Track Designation.
- Favorable SER-155 clinical results could support its continued development and provide broader validation of the promise of microbiome therapeutics in preventing poor outcomes associated with pathogens in the GI tract. Seres intends to evaluate SER-155 and other microbiome therapeutic candidates in other medically vulnerable patient populations, including chronic liver disease, cancer neutropenia, and solid organ transplants.
- Production of VOWST commercial supply remains strong, and the Company has continued to make progress in expanding manufacturing capacity.
- In February, Seres announced Marella Thorell's appointment as Executive Vice President and Chief Financial Officer following David Arkowitz's retirement.
Financial Results
-
Seres reported a net loss of
$40.1 million $71.2 million -
Net sales of VOWST for the first quarter were
$10.1 million $7.1 million -
Research and development (R&D) expenses for the first quarter of 2024 were
$21.7 million $44.0 million -
General and administrative (G&A) expenses for the first quarter of 2024 were
$15.5 million $22.5 million
Cash Runway
As of March 31, 2024, Seres had
The Company’s operating plans include drawing down the
Conference Call Information
Seres’ management will host a conference call today, May 8, 2024, at 8:30 a.m. ET. The conference call may be accessed by calling 1-800-715-9871 (international callers dial 1-646-307-1963) and referencing the conference ID number 5686561. To join the live webcast, please visit the “Investors and News” section of the Seres website at www.serestherapeutics.com. A webcast replay will be available on the Seres website beginning approximately two hours after the event and will be archived for at least 21 days.
INDICATION AND IMPORTANT SAFETY INFORMATION FOR VOWST
INDICATION
VOWST (fecal microbiota spores, live-brpk) is indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).
Limitation of Use: VOWST is not indicated for treatment of CDI.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Transmissible infectious agents: Because VOWST is manufactured from human fecal matter, it may carry a risk of transmitting infectious agents. Report any infection that is suspected to have been transmitted by VOWST to Aimmune Therapeutics, Inc. at 1-833-246-2566.
Potential presence of food allergens: VOWST may contain food allergens. The potential to cause adverse reactions due to food allergens is unknown.
ADVERSE REACTIONS
The most common adverse reactions (reported in ≥
To report SUSPECTED ADVERSE REACTIONS, contact Aimmune Therapeutics at 1-833-AIM-2KNO (1-833-246-2566), or the FDA at 1-800-FDA-1088, or visit www.fda.gov/MedWatch.
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
Please see Full Prescribing Information and Patient Information
About Seres Therapeutics
Seres Therapeutics, Inc. (Nasdaq: MCRB) is a commercial-stage company developing novel microbiome therapeutics for serious diseases. Seres’ lead program, VOWST™, obtained
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements about the potential for VOWST; the timing and results of our clinical studies; future product candidates and development plans; our ability to generate additional capital; operating plans and the sufficiency of cash to fund operations; and other statements which are not historical fact.
These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have incurred significant losses, are not currently profitable and may never become profitable; our need for additional funding; our history of operating losses; the restrictions in our debt agreement; the ability of our restructuring plan to deliver cash savings; our novel approach to therapeutic intervention; our reliance on third parties to conduct our clinical trials and manufacture our product candidates; the competition we will face; our ability to protect our intellectual property; and our ability to retain key personnel and to manage our growth. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC), on March 5, 2024, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
SERES THERAPEUTICS, INC.
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March 31, |
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December 31, |
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2024 |
|
|
2023 |
|
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Assets |
|
|
|
|
|
|
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Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
111,184 |
|
|
$ |
127,965 |
|
Collaboration receivable - related party |
|
|
7,418 |
|
|
|
8,674 |
|
Inventories |
|
|
41,973 |
|
|
|
29,647 |
|
Prepaid expenses and other current assets |
|
|
4,606 |
|
|
|
9,124 |
|
Total current assets |
|
|
165,181 |
|
|
|
175,410 |
|
Property and equipment, net |
|
|
19,115 |
|
|
|
22,457 |
|
Operating lease assets |
|
|
105,669 |
|
|
|
109,793 |
|
Restricted cash |
|
|
8,430 |
|
|
|
8,185 |
|
Restricted investments |
|
|
1,401 |
|
|
|
1,401 |
|
Other non-current assets (1) |
|
|
41,466 |
|
|
|
41,354 |
|
Total assets |
|
$ |
341,262 |
|
|
$ |
358,600 |
|
Liabilities and Stockholders’ Deficit |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
5,219 |
|
|
$ |
3,641 |
|
Accrued expenses and other current liabilities (2) |
|
|
76,317 |
|
|
|
80,611 |
|
Operating lease liabilities |
|
|
8,833 |
|
|
|
6,677 |
|
Deferred income - related party |
|
|
8,109 |
|
|
|
7,730 |
|
Total current liabilities |
|
|
98,478 |
|
|
|
98,659 |
|
Long term portion of note payable, net of discount |
|
|
102,009 |
|
|
|
101,544 |
|
Operating lease liabilities, net of current portion |
|
|
103,341 |
|
|
|
105,715 |
|
Deferred revenue - related party |
|
|
95,364 |
|
|
|
95,364 |
|
Warrant liabilities |
|
|
130 |
|
|
|
546 |
|
Other long-term liabilities |
|
|
1,678 |
|
|
|
1,628 |
|
Total liabilities |
|
|
401,000 |
|
|
|
403,456 |
|
Commitments and contingencies (Note 15) |
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|
|
|
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Stockholders’ deficit: |
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|
|
|
|
|
||
Preferred stock, |
|
|
— |
|
|
|
— |
|
Common stock, |
|
|
151 |
|
|
|
135 |
|
Additional paid-in capital |
|
|
958,479 |
|
|
|
933,244 |
|
Accumulated other comprehensive loss |
|
|
— |
|
|
|
— |
|
Accumulated deficit |
|
|
(1,018,368 |
) |
|
|
(978,235 |
) |
Total stockholders’ deficit |
|
|
(59,738 |
) |
|
|
(44,856 |
) |
Total liabilities and stockholders’ deficit |
|
$ |
341,262 |
|
|
$ |
358,600 |
|
[1] Includes |
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[2] Includes related party amounts of |
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SERES THERAPEUTICS, INC.
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Three Months Ended
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2024 |
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2023 |
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Revenue: |
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|
|
|
|
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Collaboration revenue - related party |
$ |
— |
|
|
$ |
(522 |
) |
Total revenue |
|
— |
|
|
|
(522 |
) |
Operating expenses: |
|
|
|
|
|
||
Research and development expenses |
|
21,702 |
|
|
|
43,969 |
|
General and administrative expenses |
|
15,466 |
|
|
|
22,470 |
|
Collaboration (profit) loss sharing - related party |
|
2,418 |
|
|
|
3,607 |
|
Total operating expenses |
|
39,586 |
|
|
|
70,046 |
|
Loss from operations |
|
(39,586 |
) |
|
|
(70,568 |
) |
Other income (expense): |
|
|
|
|
|
||
Interest income |
|
1,648 |
|
|
|
1,032 |
|
Interest expense |
|
(4,663 |
) |
|
|
(1,948 |
) |
Other income |
|
2,468 |
|
|
|
310 |
|
Total other expense, net |
|
(547 |
) |
|
|
(606 |
) |
Net loss |
$ |
(40,133 |
) |
|
$ |
(71,174 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
$ |
(0.27 |
) |
|
$ |
(0.57 |
) |
Weighted average common shares outstanding, basic and diluted |
|
146,101,581 |
|
|
|
125,862,975 |
|
Other comprehensive income (loss): |
|
|
|
|
|
||
Unrealized gain (loss) on investments, net of tax of |
|
— |
|
|
|
12 |
|
Currency translation adjustment |
|
— |
|
|
|
2 |
|
Total other comprehensive income (loss) |
|
— |
|
|
|
14 |
|
Comprehensive loss |
$ |
(40,133 |
) |
|
$ |
(71,160 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240508453019/en/
Investor and Media Contact:
IR@serestherapeutics.com
Source: Seres Therapeutics, Inc.
FAQ
What were the first quarter 2024 net sales for VOWST?
When is the SER-155 Phase 1b Cohort 2 clinical readout expected?
What is the goal of Seres Therapeutics in terms of product development?
How much cash and cash equivalents did Seres have as of March 31, 2024?
What warning is associated with the use of VOWST?
