VOWST net sales of $10.4 million for the
fourth quarter of 2023 and $19.6 million since launch in June
through year-end 2023
Significant adoption of VOWST since launch
in June 2023 through year-end 2023 with 2,833 patient enrollment
forms received and 2,015 new patient starts
SER-155 Phase 1b placebo-controlled Cohort 2
clinical data anticipated in third quarter of 2024
Conference call at 8:30 a.m. ET
today
Seres Therapeutics, Inc. (Nasdaq: MCRB), a leading microbiome
therapeutics company, today reported fourth quarter and full year
2023 financial results and provided business updates.
“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 Eric Shaff, President and Chief Executive Officer of
Seres. “We are proud of the impact VOWST is having on patients and,
as we enter 2024, our top priority remains continuing to deliver
VOWST to patients and advancing the potential of microbiome
therapeutics. VOWST is indicated to prevent the recurrence of
Clostridioides difficile infection (CDI) in adults following
antibacterial treatment for recurrent CDI. We are also excited
about obtaining clinical results from the Phase 1b study with
SER-155 and the potential to prevent enteric infections and
resulting blood stream infections and GvHD in allo-HSCT patients.
These complications are far too frequent, potentially fatal, and
costly to the healthcare system.”
“Our 2023 results since the launch of VOWST in June, exceeded
our expectations across multiple dimensions,” said Terri Young,
Ph.D., Chief Commercial and Strategy Officer at Seres. “We saw
quarterly acceleration in demand in terms of new patient starts and
prescription enrollment forms as well as progress on the
reimbursement front. In close collaboration with our colleagues at
Nestlé Health Science, we will continue our focus on HCP education,
customer experience, payer coverage and hospital outflow.”
“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 Mr. Shaff. “We believe positive data from this readout
would further validate the promise of this novel therapeutic
modality in addressing difficult to tackle infections, including in
immunocompromised patients such as those with chronic liver
disease, cancer neutropenia, solid organ transplant, and AMR
infections more broadly in settings of high-risk such as intensive
care units. These additional opportunities have the potential to
extend the value of SER-155 or our pre-clinical stage assets
significantly and establish a new standard of care in protecting
immunocompromised patients from life-threatening infections.”
VOWST Commercial Performance (Previously announced on January
9, 2024)
Broad demand for VOWST has been observed across rCDI patients
and healthcare providers since product launch in June 2023:
- 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%.
- 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.
- 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.
- 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
- 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.
- Strong adoption of VOWST since commercial launch in June 2023
with broad utilization, continued quarter over quarter growth, and
significant progress achieving patient access.
- Production of VOWST commercial supply enabled a strong
commercial launch within weeks of approval; progress in expansion
of VOWST manufacturing capacity.
- 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.
- SER-155 was awarded FDA Fast Track Designation.
- 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.
- Named to “TIME 100 Most Influential Companies” list of 100
companies making an extraordinary impact around the world.
- Announced the appointment of Marella Thorell as Executive Vice
President and Chief Financial Officer following the retirement of
David Arkowitz.
Anticipated 2024 Milestones
- Increase VOWST utilization into rCDI market:
- 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.
- Increase VOWST utilization earlier in the treatment paradigm
including in patients experiencing their first recurrence.
- Maintenance of strong patient access and expansion of payer
coverage for VOWST across Commercial and Medicare Part D
plans.
- Increase penetration of the hospital outflow patient
segment.
- SER-155 Phase 1b placebo-controlled Cohort 2 data readout
anticipated in third quarter of 2024.
Financial Results
Seres reported a net loss of $113.7 million for the full year of
2023, as compared to a net loss of $250.2 million for the prior
year. Seres reported a net loss of $41.2 million for the fourth
quarter of 2023, as compared to a net loss of $68.8 million for the
same period in 2022.
Net sales of VOWST for the fourth quarter and full year 2023,
were $10.4 million and $19.6 million, respectively based on 673 and
1,284 units of VOWST sold. Following the first commercial sale of
VOWST, Seres shares equally with Nestlé, its collaborator, in the
VOWST commercial profits and losses. Seres’ share of the VOWST net
loss for the fourth quarter and full year 2023 was $10.3 million
and $18.9 million, respectively, which was included in the
Company’s operating results within Collaboration (profit) loss
sharing—related party.
Research and development expenses for the fourth quarter of 2023
were $26.8 million, compared with $46.2 million for the same period
in 2022. The research and development expenses were primarily
related to Seres’ VOWST clinical development program and
manufacturing costs, as well as personnel costs. The year-over-year
decrease in R&D expenses is primarily driven by VOWST
commercial manufacturing costs no longer being recognized in the
Seres P&L following the product approval in April 2023, but
instead capitalized and recognized on the Company’s balance
sheet.
General and administrative expenses for the fourth quarter of
2023 were $17.2 million, compared with $22.4 million for the same
period in 2022. General and administrative expenses were primarily
related to personnel expenses, professional fees, including VOWST
commercial readiness and pre-launch expenses incurred prior to the
launch of VOWST in June 2023, and facility costs.
In November 2023, Seres announced a significant corporate
restructuring to substantially reduce expenses and prioritize the
commercialization of VOWST. The restructuring, which is expected to
achieve approximately $75 million to $85 million in annual cash
saving in 2024, was substantially implemented around year-end 2023.
As a result, research and development and general and
administrative expenses for the fourth quarter of 2023 were
minimally impacted by the restructuring. In addition, included
within research and development and general and administrative
expenses for the fourth quarter of 2023 were $5.6 million of
one-time charges related to the restructuring.
Cash Runway
As of December 31, 2023, Seres had $128.0 million in cash, cash
equivalents and marketable securities as compared with $181.3
million at the end of 2022. Seres anticipates that this year-end
cash balance, in conjunction with the planned savings from the
restructuring announced in November 2023 and, assuming continued
quarter-over-quarter revenue growth of VOWST, the expected receipt
of the $45 million Tranche B under its existing senior secured debt
facility (the Term Loan Facility) with Oaktree Capital Management,
L.P. (Oaktree), will support its operations into the fourth quarter
of 2024.
Conference Call Information
Seres’ management will host a conference call today, March 5,
2023, 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 reference the conference ID number 4030622. 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.
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 ≥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 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 U.S. FDA approval
in April 2023 as the first orally administered microbiome
therapeutic to prevent recurrence of C. difficile infection (CDI)
in adults following antibacterial treatment for recurrent CDI and
is being commercialized in collaboration with Nestlé Health
Science. Seres is evaluating SER-155 in a Phase 1b study in
patients receiving allogeneic hematopoietic stem cell
transplantation. For more information, please visit
www.serestherapeutics.com.
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
Securities and Exchange Commission (SEC), on November 2, 2023, 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.
CONSOLIDATED BALANCE
SHEETS
(In thousands, except share
and per share data)
December 31,
2023
2022
Assets
Current assets:
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
Total current assets
175,410
194,764
Property and equipment, net
22,457
22,985
Operating lease assets
109,793
110,984
Restricted cash
8,185
8,185
Restricted investments
1,401
1,401
Other non-current assets (1)
41,354
10,465
Total assets
$
358,600
$
348,784
Liabilities and Stockholder's
Equity
Current liabilities:
Accounts payable
$
3,641
$
17,440
Accrued expenses and other current
liabilities (2)
80,611
59,840
Operating lease liabilities
6,677
3,601
Short term portion of note payable, net of
discount
—
456
Deferred income - related party
7,730
—
Deferred revenue - related party
—
4,259
Total current liabilities
98,659
85,596
Long term portion of note payable, net of
discount
101,544
50,591
Operating lease liabilities, net of
current portion
105,715
107,942
Deferred revenue, net of current portion -
related party
95,364
92,430
Warrant liability
546
—
Other long-term liabilities
1,628
1,442
Total liabilities
403,456
338,001
Commitments and contingencies (Note
16)
Stockholders’ (deficit) equity:
Preferred stock, $0.001 par value;
10,000,000 shares authorized at December 31, 2023 and 2022; no
shares issued and outstanding at December 31, 2023 and 2022
—
—
Common stock, $0.001 par value;
240,000,000 and 200,000,000 shares authorized at December 31, 2023
and 2022, respectively; 135,041,467 and 125,222,273 shares issued
and outstanding at December 31, 2023 and 2022, respectively
135
125
Additional paid-in capital
933,244
875,181
Accumulated other comprehensive loss
—
(12
)
Accumulated deficit
(978,235
)
(864,511
)
Total stockholders’ (deficit) equity
(44,856
)
10,783
Total liabilities and stockholders’
equity
$
358,600
$
348,784
[1] Includes $38,877 and $8,828 as of
December 31, 2023 and December 31, 2022 respectively, of milestones
related to the construction of the Company's dedicated
manufacturing suite at BacThera AG, or Bacthera.
[2] Includes related party amounts of
$28,053 and $34,770 at December 31, 2023 and December 31, 2022,
respectively
SERES THERAPEUTICS,
INC.
CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share
and per share data)
Year Ended December
31,
2023
2022
2021
Revenue:
Collaboration revenue - related party
$
126,325
$
7,128
$
143,857
Grant revenue
—
—
1,070
Total revenue
126,325
7,128
144,927
Operating expenses:
Research and development expenses
$
145,860
$
172,920
$
141,891
General and administrative expenses
87,744
79,694
69,261
Collaboration (profit) loss sharing -
related party
704
1,004
(1,732
)
Total operating expenses
234,308
253,618
209,420
Loss from operations
(107,983
)
(246,490
)
(64,493
)
Other (expense) income:
Interest income
7,301
3,058
2,870
Interest expense
(13,176
)
(6,020
)
(2,910
)
Other income (expense)
134
(705
)
(1,045
)
Total other (expense) income, net
(5,741
)
(3,667
)
(1,085
)
Net loss
$
(113,724
)
$
(250,157
)
$
(65,578
)
Net loss per share attributable to common
stockholders, basic and diluted
$
(0.89
)
$
(2.31
)
$
(0.72
)
Weighted average common shares
outstanding, basic and diluted
128,003,294
108,077,043
91,702,866
Other comprehensive income (loss):
Unrealized gain (loss) on investments, net
of tax of $0
10
49
(12
)
Currency translation adjustment
2
(1
)
(1
)
Total other comprehensive income
(loss)
12
48
(13
)
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: Rob Windsor
Rwindsor@serestherapeutics.com
Seres Therapeutics (NASDAQ:MCRB)
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