SpringWorks Therapeutics, Inc. (Nasdaq: SWTX), a commercial-stage
biopharmaceutical company focused on severe rare diseases and
cancer, today reported financial results for the fourth quarter and
full year periods ended December 31, 2023 and provided an
update on recent company developments.
“In 2023, OGSIVEO became the first FDA-approved therapy for
adults with desmoid tumors with our approval in November and we are
very pleased with the initial progress of our launch. We are also
very excited by our opportunity in NF1-PN based on the positive
topline data from our pivotal Phase 2b ReNeu trial, which
demonstrated mirdametinib's best-in-class potential for both
children and adults with these devastating tumors. In addition, we
made strong progress across our broader pipeline and continued to
strengthen our financial position and our intellectual property
protection for our lead assets,” said Saqib Islam, Chief Executive
Officer of SpringWorks. “Our focus for 2024 is to continue
delivering a successful U.S. launch for OGSIVEO in desmoid tumors,
to file our NDA for mirdametinib with the goal of having our second
approval by 2025, to make progress towards expanding the reach of
OGSIVEO into additional geographies outside of the U.S., and to
unlock additional opportunities across our emerging portfolio.”
Recent Business Highlights and Upcoming
Milestones
OGSIVEO™ (Nirogacestat)
- Received U.S. Food and Drug Administration (FDA) approval for
OGSIVEO, an oral gamma secretase inhibitor, for the treatment of
adult patients with progressing desmoid tumors who require systemic
treatment on November 27, 2023.
- Launched OGSIVEO in the U.S. and achieved net product revenue
of $5.4 million in the first partial quarter of the launch. To
date, OGSIVEO has been reimbursed by payers representing over 98%
of commercial lives, as well as by Medicare and Medicaid, with
coverage aligned to the FDA-approved label.
- Highlighted the update of the NCCN Clinical Practice Guidelines
in Oncology (NCCN Guidelines®) in December 2023 which recommend
nirogacestat as an NCCN Category 1, Preferred treatment option for
desmoid tumors.
- Submitted a Marketing Authorization Application (MAA) for
nirogacestat for the treatment of adult patients with desmoid
tumors to the European Medicines Agency (EMA) in February
2024.
- Presented additional patient-reported outcome data from the
Phase 3 DeFi trial at the 2023 Connective Tissue Oncology Society
Annual Meeting.
- On track to report initial data from the Phase 2 trial
evaluating nirogacestat as a monotherapy in patients with recurrent
ovarian granulosa cell tumors in the second half of 2024.
- Continuing to support several industry and academic
collaborator studies evaluating nirogacestat as part of B-cell
maturation antigen (BCMA) combination therapy regimens across
treatment lines in patients with multiple myeloma.
Mirdametinib
- Presented positive topline data from the pediatric and adult
cohorts of the Phase 2b ReNeu trial evaluating mirdametinib, an
investigational MEK inhibitor, in NF1-associated plexiform
neurofibromas (NF1-PN) in November 2023. The confirmed objective
response rate was 52% in pediatric patients and 41% in adult
patients, as assessed by Blinded Independent Central Review, which
was the primary endpoint of the study. Mirdametinib treatment also
showed deep and durable responses and demonstrated significant
improvements in key secondary patient-reported outcome measures.
Mirdametinib was generally well tolerated in the trial, with the
majority of adverse events (AEs) being Grade 1 or Grade 2. The most
frequently reported AEs were rash, diarrhea, and vomiting in the
pediatric cohort and rash, diarrhea, and nausea in the adult
cohort.
- On track to submit an New Drug Application (NDA) to the FDA for
mirdametinib for the treatment of children and adults with NF1-PN
in the first half of 2024.
- Expect to present data from the pediatric and adult cohorts of
the ReNeu trial at a medical congress in the first half of 2024 and
to submit the trial results for publication in a peer-reviewed
journal in 2024.
Emerging Pipeline
- On track to present additional data from the dose expansion
portion of the Phase 1b trial evaluating brimarafenib (BGB-3245) in
adult patients with RAF mutant solid tumors in the second half of
2024. Brimarafenib is an investigational, selective RAF dimer
inhibitor being developed by MapKure, LLC, a joint venture between
SpringWorks and BeiGene, Ltd.
- Patients continue to be enrolled in the dose escalation phase
of the SpringWorks-sponsored Phase 1/2a combination study of
brimarafenib and mirdametinib.
- The FDA cleared the Investigational New Drug (IND) application
submitted by MapKure for a combination study of brimarafenib with
panitumumab, a monoclonal antibody targeting EGFR, in colorectal
and pancreatic cancer patients with known MAPK pathway mutations.
MapKure expects to initiate a Phase 1b trial in the first quarter
of 2024.
- Dose expansion cohort is ongoing in the BeiGene-sponsored Phase
1b/2 trial evaluating mirdametinib in combination with BeiGene’s
RAF dimer inhibitor, lifirafenib, in adult patients with NRAS
mutant solid tumors.
- The FDA cleared the IND application for SW-682, a novel, oral,
potent, and selective TEA Domain inhibitor designed to treat tumors
driven by Hippo pathway mutations. SpringWorks plans to initiate a
Phase 1a trial of SW-682 in Hippo mutant solid tumors in the first
half of 2024.
General Corporate
- Strengthened balance sheet with upsized public offering in
December 2023; gross proceeds from the offering, before deducting
underwriting discounts and commissions and offering expenses, were
approximately $316.2 million.
- The United States Patent and Trademark Office has recently
issued four new patents for OGSIVEO and one new patent for
mirdametinib, extending protection for both products into 2043. The
U.S. patent portfolio for OGSIVEO includes 16 Orange Book listed
patents; the U.S. patent portfolio for mirdametinib includes 10
patents that are expected to be Orange Book listed.
Fourth Quarter and Full Year
2023 Financial Results
- Revenues: OGSIVEO net product revenues were
$5.4 million in the fourth quarter of 2023, the first partial
quarter of the U.S. launch.
- Research and Development (R&D) Expenses:
R&D expenses were $43.7 million and $150.5 million for the
fourth quarter and full year 2023, respectively, compared to $37.9
million and $146.1 million for the comparable periods of 2022. The
increase in R&D expense for the fourth quarter and year ended
2023 was primarily attributable to an increase in employee costs
associated with head count growth, partially offset by a decrease
in costs related to drug manufacturing, clinical trials and other
research.
- Selling, General and Administrative (SG&A)
Expenses: SG&A expenses were $59.8 million and $197.6
million for the fourth quarter and full year 2023, respectively,
compared to $40.5 million and $134.6 million for the comparable
periods of 2022. The increase in SG&A expense for the fourth
quarter and the full year 2023 were largely attributable to
commercial readiness activities to support the U.S. launch of
OGSIVEO.
- Net Loss Attributable to Common Stockholders:
SpringWorks reported a net loss of $94.3 million, or $1.44 per
share, for the fourth quarter of 2023 and a net loss of $325.1
million, or $5.15 loss per share, for the year ended
December 31, 2023. This compares to a net loss of $74.2
million, or $1.19 per share, for the fourth quarter of 2022 and a
net loss of $277.4 million, or $5.21 per share for the year ended
December 31, 2022.
- Cash Position: Cash, cash equivalents and
marketable securities were $662.6 million as of December 31,
2023.
About SpringWorks Therapeutics
SpringWorks is a commercial-stage biopharmaceutical company
applying a precision medicine approach to developing and delivering
life-changing medicines for people with severe rare diseases and
cancer. OGSIVEO™ (nirogacestat), approved in the United States for
the treatment of adult patients with progressing desmoid tumors who
require systemic treatment, is the Company’s first FDA-approved
therapy. SpringWorks also has a diversified targeted therapy
pipeline spanning solid tumors and hematological cancers, with
programs ranging from preclinical development through advanced
clinical trials. In addition to its wholly owned programs,
SpringWorks has also entered into multiple collaborations with
innovators in industry and academia to unlock the full potential
for its portfolio and create more solutions for patients in
need.
For more information, visit www.springworkstx.com and follow
@SpringWorksTx on X (formerly Twitter), LinkedIn, and YouTube.
SpringWorks uses its website as a means of disclosing material
non-public information and for complying with its disclosure
obligations under Regulation FD. Such disclosures will be included
on SpringWorks' website in the Investors & Media section.
Accordingly, investors should monitor such portions of the
SpringWorks website, in addition to following press releases, SEC
filings and public conference calls and webcasts.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, relating to our business, operations, and
financial conditions, including but not limited to current beliefs,
expectations and assumptions regarding the future of our business,
future plans and strategies, our development and commercialization
plans, our preclinical and clinical results, the market potential
of OGSIVEO for adult patients with desmoid tumors, expectations
regarding timing and results of the EMA’s review of the MAA for
nirogacestat, including its ongoing validation of our submission
package, and the adequacy of the data contained in the MAA to serve
as the basis for marketing approval of nirogacestat for the
treatment of desmoid tumors in the European Union, the potential
for the results of the Phase 2b ReNeu clinical trial to support an
NDA submission for mirdametinib in first half of 2024, our plans to
report additional data from the Phase 2b ReNeu clinical trial at an
upcoming medical conference and submit for publication data from
such clinical trial in a peer-reviewed medical journal in 2024, the
potential for mirdametinib to become an important new treatment for
patients with NF1-PN, our plans for seeking regulatory approval for
and making mirdametinib available for NF1-PN patients, if approved,
expectations regarding the timing and initial data from the Phase 2
trial evaluating nirogacestat in patients with recurrent ovarian
granulosa cell tumors, our plans to initiate a Phase 1a trial of
SW-682 in Hippo mutant solid tumors in the first half of 2024, our
plans to report additional clinical data of nirogacestat in
combination with BCMA-directed therapies and initiate additional
planned Phase 1 collaborator studies, our expectations regarding
the potential for the Phase 1b dose expansion phase of
brimarafenib, our plans to present additional data for brimarafenib
monotherapy in MAPK-mutant solid tumors in second half of 2024, our
plans to support MapKure’s initiation of a Phase 1b trial of
brimarafenib with panitumumab in CRC and pancreatic cancer patients
in first quarter of 2024, expectations about whether our patents
for our lead assets will adequately protect SpringWorks against
competition, as well as relating to other future conditions. Words
such as, but not limited to, “look forward to,” “believe,”
“expect,” “anticipate,” “estimate,” “intend,” “plan,” “would,”
“should” and “could,” and similar expressions or words, identify
forward-looking statements. New risks and uncertainties may emerge
from time to time, and it is not possible to predict all risks and
uncertainties. Any forward-looking statements in this presentation
are based on management’s current expectations and beliefs and are
subject to a number of risks, uncertainties and important factors
that may cause actual events or results to differ materially from
those expressed or implied by any forward-looking statements
contained in this presentation, including, without limitation,
risks relating to: (i) the success of our commercialization efforts
with respect to OGSIVEO, (ii) our limited experience as a
commercial company, (iii) our ability to obtain or maintain
adequate coverage and reimbursement for OGSIVEO, (iv) the success
and timing of our product development activities, including the
initiation and completion of our clinical trials, (v) our
expectations regarding the potential clinical benefit of OGSIVEO
for adult patients with desmoid tumors who require systemic
treatment, (vi) the potential for OGSIVEO to become the new
standard of care for adult patients with desmoid tumors, (vii)
estimates regarding the number of adult patients who are diagnosed
with desmoid tumors annually per year in the U.S. and the potential
market for OGSIVEO, (viii) the fact that topline or interim data
from clinical studies may not be predictive of the final or more
detailed results of such study or the results of other ongoing or
future studies, (ix) the success and timing of our collaboration
partners’ ongoing and planned clinical trials, (x) the timing of
our planned regulatory submissions and interactions, including the
timing and outcome of decisions made by the FDA, EMA, and other
regulatory authorities, investigational review boards at clinical
trial sites and publication review bodies, (xi) whether FDA, EMA,
or other regulatory authorities will require additional information
or further studies, or may fail or refuse to approve or may delay
approval of our product candidates, including nirogacestat and
mirdametinib, (xii) our ability to obtain regulatory approval of
any of our product candidates or maintain regulatory approvals
granted for our products, (xiii) our plans to research, discover
and develop additional product candidates, (xiv) our ability to
enter into collaborations for the development of new product
candidates and our ability to realize the benefits expected from
such collaborations, (xv) our ability to maintain adequate patent
protection and successfully enforce patent claims against third
parties, (xvi) the adequacy of our cash position to fund our
operations through any time period indicated herein, (xvii) our
ability to establish manufacturing capabilities, and our and our
collaboration partners’ abilities to manufacture our product
candidates and scale production, and (xviii) our ability to meet
any specific milestones set forth herein.
Except as required by applicable law, we do not plan to publicly
update or revise any forward-looking statements contained herein,
whether as a result of any new information, future events, changed
circumstances or otherwise. Although we believe the expectations
reflected in such forward-looking statements are reasonable, we can
give no assurance that such expectations will prove to be correct.
Accordingly, readers are cautioned not to place undue reliance on
these forward-looking statements.
For further information regarding the risks, uncertainties and
other factors that may cause differences between SpringWorks’
expectations and actual results, you should review the “Risk
Factors” in Item 1A of Part I of SpringWorks’ Annual Report on Form
10-K for the year ended December 31, 2023, as well as discussions
of potential risks, uncertainties and other important factors in
SpringWorks’ subsequent filings.
|
SpringWorks Therapeutics, Inc.Condensed Consolidated
Statements of Operations(Unaudited) |
|
|
Year Ended December 31, |
(in thousands, except share and per-share
data) |
2023 |
|
2022 |
|
2021 |
Revenue: |
|
|
|
|
|
Product revenue, net |
$ |
5,447 |
|
|
$ |
— |
|
|
$ |
— |
|
Total revenue |
|
5,447 |
|
|
|
— |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
Cost of product revenue |
|
422 |
|
|
|
— |
|
|
|
— |
|
Research and development |
|
150,487 |
|
|
|
146,122 |
|
|
|
101,676 |
|
Selling, general and administrative |
|
197,551 |
|
|
|
134,552 |
|
|
|
71,792 |
|
Total operating expenses |
|
348,460 |
|
|
|
280,674 |
|
|
|
173,468 |
|
|
|
|
|
|
|
Loss from operations |
|
(343,013 |
) |
|
|
(280,674 |
) |
|
|
(173,468 |
) |
Interest and other
income: |
|
|
|
|
|
Interest and other income, net |
|
22,947 |
|
|
|
6,147 |
|
|
|
546 |
|
Total interest and other income |
|
22,947 |
|
|
|
6,147 |
|
|
|
546 |
|
Equity method investment
loss |
|
(5,038 |
) |
|
|
(2,890 |
) |
|
|
(988 |
) |
Net loss |
$ |
(325,104 |
) |
|
$ |
(277,417 |
) |
|
$ |
(173,910 |
) |
|
|
|
|
|
|
Net loss per share, basic and
diluted |
$ |
(5.15 |
) |
|
$ |
(5.21 |
) |
|
$ |
(3.59 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
63,123,936 |
|
|
|
53,290,528 |
|
|
|
48,497,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
SpringWorks Therapeutics, Inc.Selected Balance Sheet
Data(Unaudited) |
|
|
As of December 31, |
|
2023 |
|
2022 |
(in
thousands) |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
662,588 |
|
|
$ |
597,006 |
|
Working Capital (1) |
|
422,742 |
|
|
|
548,711 |
|
Total assets |
|
725,788 |
|
|
|
630,242 |
|
Total liabilities |
|
99,569 |
|
|
|
72,050 |
|
Accumulated deficit |
|
(895,034 |
) |
|
|
(569,930 |
) |
Total stockholders’
equity |
|
626,219 |
|
|
|
558,192 |
|
(1) We define Working Capital as current assets
less current liabilities.
Contacts:Kim DiamondVice President,
Communications and Investor RelationsPhone: 203-561-1646Email:
kdiamond@springworkstx.com
Samantha Hilson SandlerSenior Director, Investor RelationsPhone:
203-461-5501Email: samantha.sandler@springworkstx.com
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