On this page of StockholderLetter.com we present the latest annual shareholder letter from SpringWorks Therapeutics, Inc. — ticker symbol SWTX. Reading current and past SWTX letters to shareholders can bring important insights into the investment thesis.

 •  4/5/2024 Letter Continued (Full PDF)
 •  4/7/2023 SWTX Stockholder Letter
 •  More "Biotechnology" Category Stockholder Letters
 •  SWTX Benford's Law Stock Score = 83

SWTX Shareholder/Stockholder Letter Transcript:

A
LET   S
LAUNCH
MORE
SOLUTIONS
FO R
PATIENTS
2023
A N N UAL
R EP ORT
NASD AQ:
SWTX

1
WE ARE DELIVERING
ANTWAN,
LIVING
WITH
NF1-PN
the first and only FDA-approved
therapy for adults with desmoid tumors.
WE ARE ADVANCING
a potentially best-in-class treatment
for children and adults with NF1-PN.
WE ARE DRIVEN
to change the lives of people suffering from
devastating rare diseases and cancers.
LET   S GO

2
D EA R F EL L OW
SHAREHOLDERS,
2023 was a pivotal year for SpringWorks and the patients who
are the inspiration for our hard work.
On November 27, 2023, the United States
Food and Drug Administration (FDA)
approved OGSIVEO   (nirogacestat),
making it the first and only approved
therapy for adult patients with desmoid
tumors. This was a watershed moment
for the desmoid tumor community, which
had been waiting for decades for an
effective treatment, and the culmination
of a collaborative effort between the
patient community, academia and the
biopharmaceutical industry, who worked
together with tenacity and persistence
to advance this promising medicine.
In addition to the FDA approval of
OGSIVEO, we recently initiated the
New Drug Application (NDA) process
for our second therapy, mirdametinib,
for pediatric and adult patients with
neurofibromatosis type 1-associated
plexiform neurofibromas (NF1-PN),
which positions us to potentially have
two products on the market by 2025.
SpringWorks is just getting started in our
ambition to transform the lives of patients
with devastating rare diseases and cancers,
and in this letter, I am proud to share our
2023 accomplishments and our priorities
for 2024 and beyond.
OGSIVEO   (nirogacestat)
Our team is honored to have delivered
the first approved therapy to adults with
desmoid tumors. Desmoid tumors are
pernicious and persistent soft-tissue
tumors. Their tendril-like growths can
invade surrounding parts of the body
and cause severe, long-lasting pain and
disfigurement. When growing near vital
organs, they can be life-threatening as
well. We   ve heard time and again how the
unpredictable nature and high likelihood
of recurrence of these tumors cause a
great deal of fear and anxiety and upend
people   s lives, often leaving them unable
to work and look after their families.
2
WE EXPECT
TO HAVE
PRODUCTS ON
THE MARKET
BY 2025
With OGSIVEO, adult desmoid tumor
patients now have an oral pill that can
not only stop tumors from growing, but
can also shrink tumors and reduce pain.
We are very pleased that the broad
FDA-approved label enables us to serve
adult desmoid tumor patients at any
stage of their treatment journey.
Our top priority for 2024 is to continue
executing on a successful U.S. launch as
we seek to quickly establish OGSIVEO
as the standard-of-care treatment for
adults with desmoid tumors, and we are
very pleased with the strong start to our
launch. We had drug in channel and
available for patients within 5 business
days of approval. Additionally, NCCN
Clinical Practice Guidelines in Oncology

3
(NCCN Guidelines  ) were updated to
recommend nirogacestat as an NCCN
Category 1, Preferred treatment option
for desmoid tumors within two weeks
of approval.1 We also have also seen
strong reimbursement aligned to the
approved label across commercially
insured, Medicare, and Medicaid patients.
Our field teams are actively educating
physicians on desmoid tumors and on
the benefits of OGSIVEO, and we are
gaining traction across both academic
and community settings.
In addition to our U.S. launch, in February
2024, the European Medicines Agency
(EMA) validated our Marketing
Authorization Application for nirogacestat,
which begins the centralized review
process in the European Union. Desmoid
tumor patients in Europe have a pressing
need for a new treatment, and we look
forward to making progress on our
commitment to expanding the reach of
nirogacestat into additional geographies
outside of the United States.
U.S. DESMO ID
T U M OR P AT IE N T
POP ULATI O N
~1,000-1,650
NEW PATIENTS DIAGNOSED ANNUALLY
~5,500-7,000
PATIENTS ACTIVELY MANAGED ANNUALLY
30,000+
TOTAL DIAGNOSED PREVALENT PATIENTS
MIRDAMETINIB
Our second therapeutic candidate,
mirdametinib, is an investigational MEK
inhibitor. Our most advanced program
is for patients with NF1-PN, which are
devastating tumors that can grow
aggressively along peripheral nerves,
and can cause severe disfigurement,
pain, and functional impairment. NF1-PN
are very difficult to remove surgically,
and attempting resections in proximity
to nerves carries a high risk of permanent
nerve damage and disfigurement. Systemic
therapies are rapidly becoming the
foundation of NF1-PN treatment, and
MEK inhibitors, as a class, represent the
most validated treatment option to date.
In November 2023, we presented positive
topline data from our Phase 2b ReNeu
trial of mirdametinib in adult and pediatric
patients with NF1-PN, which showed
favorable confirmed objective response
rates by blinded independent central
review and robust depth of response, as
well as a favorable tolerability profile that
allowed patients to stay on therapy for
extended durations of time. On the primary endpoint, as of the data cutoff date of
September 20, 2023, mirdametinib treatment resulted in 52% of patients in the pediatric cohort and 41% in the adult cohort
having a confirmed objective response
within the 24-cycle treatment period, as
assessed by blinded independent central
review. Responses were deep and durable,
with a median best percentage reduction
from baseline in tumor volume of 42%
in pediatrics and 41% in adults. In addition,
patients on mirdametinib achieved
improvements across key patient-reported
outcomes, including pain and quality of
life. Mirdametinib was also generally
well-tolerated in both children and adults,
1 Referenced with permission from the NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines  ) for Soft Tissue
Sarcoma V.3.2023.    National Comprehensive Cancer Network,
Inc. 2023. All rights reserved. Accessed March 27, 2024. To view
the most recent and complete version of the guideline, go
online to NCCN.org. NCCN makes no warranties of any kind
whatsoever regarding their content, use or application and
disclaims any responsibility for their application or use in any way.

4
We have waited for so long.
Words cannot express what it
means to know that OGSIVEO
is available for people with
desmoid tumors. It is as if
someone has turned on a light
in a room that has been dark
for many years.

DANA,
LIVING WITH A
DESMOID TUMOR
I was diagnosed with NF
as a baby when I developed a
plexiform neurofibroma on my
leg. I   ve had many complications
related to my NF1-PN. Having
an approved therapy for adults
would be a much-needed
advance for those of us who
have been told for years that
there are no options that have
been rigorously studied in
adults with our condition.

LINDSEY,
LIVING WITH
NFI-PN



 4/5/2024 Letter Continued (Full PDF)