Seres Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates
VOWST net sales of
Significant adoption of VOWST since launch in
SER-155 Phase 1b placebo-controlled Cohort 2 clinical data anticipated in third quarter of 2024
Conference call at
“2023 was an historic year for Seres as we launched our first-in-class oral microbiome therapeutic, VOWST, for recurrent CDI into commercialization with our collaborators at Nestlé Health Science,” said
“Our 2023 results since the launch of VOWST in June, exceeded our expectations across multiple dimensions,” said
“In December, we were excited to announce the Fast Track Designation for SER-155 based on preclinical and cohort 1 data, with the cohort 2 data readout anticipated in the third quarter of 2024,” said
VOWST Commercial Performance (Previously announced on
Broad demand for VOWST has been observed across rCDI patients and healthcare providers since product launch in
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Fourth quarter net sales were approximately
$10.4 million and reflected a gross-to-net reduction of 11%. Total 2023 net sales since launch in June were approximately$19.6 million and reflected a gross-to-net reduction of 13%.
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Fourth quarter completed prescription enrollment forms received for VOWST were 1,322; of those 1,082 resulted in new patient starts by year-end 2023.
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From launch through year-end 2023, there were 2,833 completed prescription enrollment forms received for VOWST, of those 2,015 resulted in new patient starts by year-end 2023.
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In 2023, prescription enrollment forms were submitted by approximately 1,330 unique healthcare providers (HCPs) since launch, with approximately 65% from gastroenterology and the remainder from other specialties; approximately 340 HCPs have prescribed VOWST to more than one patient.
- VOWST demand has been observed across the recurrent CDI patient pool, including first recurrence, which is the largest recurrent CDI patient segment.
2023 and Recent Highlights
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VOWST received FDA approval in April as the first and only FDA approved oral microbiome therapeutic to prevent recurrence of CDI in patients 18 or older with rCDI, after treatment with standard of care antibacterials. Please see the full Indication, Limitation of Use, and Important Safety Information below.
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Strong adoption of VOWST since commercial launch in
June 2023 with broad utilization, continued quarter over quarter growth, and significant progress achieving patient access.
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Production of VOWST commercial supply enabled a strong commercial launch within weeks of approval; progress in expansion of VOWST manufacturing capacity.
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SER-155 Phase 1b Cohort 1 clinical data showed favorable tolerability, successful drug bacteria engraftment, and a substantial reduction in pathogen domination in the gastrointestinal microbiome as compared to a reference cohort of patients, supporting progression to the placebo-controlled Cohort 2.
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SER-155 was awarded FDA Fast Track Designation.
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Completed strategic restructuring of Company to focus resources and investment on continued VOWST growth, completion of SER-155 Phase 1b study and supporting longer-term business sustainability.
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Named to “TIME 100 Most Influential Companies” list of 100 companies making an extraordinary impact around the world.
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Announced the appointment of
Marella Thorell as Executive Vice President and Chief Financial Officer following the retirement ofDavid Arkowitz .
Anticipated 2024 Milestones
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Increase VOWST utilization into rCDI market:
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Expansion of the number of HCPs prescribing VOWST as a result of new efforts scaled by Nestlé Health Science in Q4 2023 such as strengthened promotional campaigns and expanded reach of digital promotion.
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Increase VOWST utilization earlier in the treatment paradigm including in patients experiencing their first recurrence.
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Maintenance of strong patient access and expansion of payer coverage for VOWST across Commercial and Medicare Part D plans.
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Increase penetration of the hospital outflow patient segment.
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Expansion of the number of HCPs prescribing VOWST as a result of new efforts scaled by Nestlé Health Science in Q4 2023 such as strengthened promotional campaigns and expanded reach of digital promotion.
- SER-155 Phase 1b placebo-controlled Cohort 2 data readout anticipated in third quarter of 2024.
Financial Results
Seres reported a net loss of
Net sales of VOWST for the fourth quarter and full year 2023, were
Research and development expenses for the fourth quarter of 2023 were
General and administrative expenses for the fourth quarter of 2023 were
In
Cash Runway
As of
Conference Call Information
Seres’ management will host a conference call today,
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.
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
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 ≥5% of participants) were abdominal distension (31.1%), fatigue (22.2%), constipation (14.4%), chills (11.1%), and diarrhea (10.0%).
To report SUSPECTED ADVERSE REACTIONS, contact
DRUG INTERACTIONS
Do not administer antibacterials concurrently with VOWST.
Please see Full Prescribing Information and Patient Information
About
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 the commercial success and continued growth of VOWST, the timing and results of our clinical studies, access to additional debt tranches and/or achieve sales targets, 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 limited operating history; our novel approach to therapeutic intervention; our reliance on third parties and collaborators to conduct our clinical trials, manufacture our product or product candidates and develop and commercialize our product or product candidates, if approved; the unknown degree and competing factors of market acceptance for VOWST; 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 Quarterly Report on Form 10-Q filed with the
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CONSOLIDATED BALANCE SHEETS |
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(In thousands, except share and per share data) |
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2023 |
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2022 |
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Assets |
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Current assets: |
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|
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Cash and cash equivalents |
|
$ |
127,965 |
|
|
$ |
163,030 |
|
|
Short term investments |
|
|
— |
|
|
|
18,311 |
|
|
Collaboration receivable - related party |
|
|
8,674 |
|
|
|
— |
|
|
Inventories |
|
|
29,647 |
|
|
|
— |
|
|
Prepaid expenses and other current assets |
|
|
9,124 |
|
|
|
13,423 |
|
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Total current assets |
|
|
175,410 |
|
|
|
194,764 |
|
|
Property and equipment, net |
|
|
22,457 |
|
|
|
22,985 |
|
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Operating lease assets |
|
|
109,793 |
|
|
|
110,984 |
|
|
Restricted cash |
|
|
8,185 |
|
|
|
8,185 |
|
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Restricted investments |
|
|
1,401 |
|
|
|
1,401 |
|
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Other non-current assets (1) |
|
|
41,354 |
|
|
|
10,465 |
|
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Total assets |
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$ |
358,600 |
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$ |
348,784 |
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Liabilities and Stockholder's Equity |
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Current liabilities: |
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Accounts payable |
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$ |
3,641 |
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$ |
17,440 |
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Accrued expenses and other current liabilities (2) |
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|
80,611 |
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|
|
59,840 |
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Operating lease liabilities |
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|
6,677 |
|
|
|
3,601 |
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Short term portion of note payable, net of discount |
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|
— |
|
|
|
456 |
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Deferred income - related party |
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|
7,730 |
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|
— |
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Deferred revenue - related party |
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— |
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4,259 |
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Total current liabilities |
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98,659 |
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|
85,596 |
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Long term portion of note payable, net of discount |
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101,544 |
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|
|
50,591 |
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Operating lease liabilities, net of current portion |
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105,715 |
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|
|
107,942 |
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Deferred revenue, net of current portion - related party |
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|
95,364 |
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|
92,430 |
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Warrant liability |
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|
546 |
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|
— |
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Other long-term liabilities |
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1,628 |
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|
|
1,442 |
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Total liabilities |
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403,456 |
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|
338,001 |
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Commitments and contingencies (Note 16) |
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Stockholders’ (deficit) equity: |
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Preferred stock, |
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— |
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— |
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Common stock, |
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135 |
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|
125 |
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Additional paid-in capital |
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933,244 |
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875,181 |
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Accumulated other comprehensive loss |
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— |
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(12 |
) |
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Accumulated deficit |
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(978,235 |
) |
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(864,511 |
) |
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Total stockholders’ (deficit) equity |
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(44,856 |
) |
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|
10,783 |
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Total liabilities and stockholders’ equity |
|
$ |
358,600 |
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$ |
348,784 |
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[1] Includes |
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[2] Includes related party amounts of |
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CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS |
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(In thousands, except share and per share data) |
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Year Ended |
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2023 |
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2022 |
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2021 |
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Revenue: |
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Collaboration revenue - related party |
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$ |
126,325 |
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$ |
7,128 |
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$ |
143,857 |
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Grant revenue |
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— |
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|
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— |
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1,070 |
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Total revenue |
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126,325 |
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|
7,128 |
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|
144,927 |
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Operating expenses: |
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Research and development expenses |
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$ |
145,860 |
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$ |
172,920 |
|
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$ |
141,891 |
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General and administrative expenses |
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|
87,744 |
|
|
|
79,694 |
|
|
|
69,261 |
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Collaboration (profit) loss sharing - related party |
|
|
704 |
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|
1,004 |
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|
|
(1,732 |
) |
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Total operating expenses |
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234,308 |
|
|
|
253,618 |
|
|
|
209,420 |
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Loss from operations |
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(107,983 |
) |
|
|
(246,490 |
) |
|
|
(64,493 |
) |
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Other (expense) income: |
|
|
|
|
|
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|
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Interest income |
|
|
7,301 |
|
|
|
3,058 |
|
|
|
2,870 |
|
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Interest expense |
|
|
(13,176 |
) |
|
|
(6,020 |
) |
|
|
(2,910 |
) |
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Other income (expense) |
|
|
134 |
|
|
|
(705 |
) |
|
|
(1,045 |
) |
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Total other (expense) income, net |
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(5,741 |
) |
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|
(3,667 |
) |
|
|
(1,085 |
) |
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Net loss |
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$ |
(113,724 |
) |
|
$ |
(250,157 |
) |
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$ |
(65,578 |
) |
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Net loss per share attributable to common stockholders, basic and diluted |
|
$ |
(0.89 |
) |
|
$ |
(2.31 |
) |
|
$ |
(0.72 |
) |
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Weighted average common shares outstanding, basic and diluted |
|
|
128,003,294 |
|
|
|
108,077,043 |
|
|
|
91,702,866 |
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Other comprehensive income (loss): |
|
|
|
|
|
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|
|
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Unrealized gain (loss) on investments, net of tax of |
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|
10 |
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|
49 |
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(12 |
) |
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Currency translation adjustment |
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2 |
|
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(1 |
) |
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(1 |
) |
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Total other comprehensive income (loss) |
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12 |
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|
|
48 |
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|
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(13 |
) |
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Comprehensive loss |
|
$ |
(113,712 |
) |
|
$ |
(250,109 |
) |
|
$ |
(65,591 |
) |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240305321973/en/
Investor and Media:
Rwindsor@serestherapeutics.com
Source: