JAZZ Shareholder/Stockholder Letter Transcript:
Jazz Pharmaceuticals plc
Proxy Statement
2023 Annual Report
EMILY
RYLAZE Patient
KASEN
EPIDIOLEX Patient
[THIS PAGE INTENTIONALLY LEFT BLANK]
Our cover features Kasen and his mom, Brittany.
Kasen experienced his first seizure at six
months old while he and his mom were playing
on the couch. Brittany noticed the left side of
Kasen s body tense up and, at first, it wasn t
clear what was happening to him. After a call
to 911, he was swiftly taken to a hospital in an
ambulance. Kasen s mom will never forget her
fear associated with that first seizure and feeling
helpless not knowing what caused it.
with prolonged and frequent seizures, movement
and balance issues, delayed language, speech
issues, sleeping difficulties and sensory
integration disorders.1
Rare epilepsies can be medically complex,
making diagnosis difficult. Physicians
understanding of epilepsy has evolved over
the past several decades from a single disease
to a multitude of epilepsy types and epilepsy
You re so
helpless during
the seizures, you
feel like you can t
do anything to
stop a seizure.
Brittany, Kasen s mom
Kasen continued to have prolonged back-toback seizures several times a month. His family
needed to be vigilant to ensure he didn t hit his
head and record how long the seizures were
lasting. If the seizure was longer than five minutes,
it required a trip to the hospital.
Finally, when he was two years old, Kasen was
diagnosed with Dravet syndrome (DS), a rare and
severe lifelong form of epilepsy that is associated
syndromes. 2 Genetic testing can help with
identifying the cause of epilepsy, especially in
DS where over 80% of people diagnosed have
changes in a specific gene, known as SCN1A.1
Once Kasen had a diagnosis, his journey to
find an appropriate therapy began and he was
prescribed several anti-seizure medicines while
physicians and his family worked together to
establish an effective treatment plan. Kasen
1. Dravet Syndrome Foundation. What is Dravet Syndrome? Available at https://www.dravetfoundation.org/what-is-dravet-syndrome/.
Accessed March 2024. 2. Miller IP. Raring for change: Confluence of scientific discovery and advocate alignment warrants vital new investments
in The Epilepsies. Epilepsy Behav. 2020 Oct;111:107276. doi: 10.1016/j.yebeh.2020.107276. Epub 2020 Aug 1.
was prescribed Epidiolex (cannabidiol) upon
approval in the U.S. in 2018, and he continues
to take Epidiolex for the treatment of seizures
associated with DS.
While Kasen still experiences seizures, the
frequency and length of the seizures has been
reduced. There was an 18-month span where
Kasen was free of tonic-clonic seizures, which
are characterized by convulsions that involve
the entire body. Since he began treatment with
Epidiolex, Kasen s mom and his family have
noticed he can play for longer periods of time
without having a seizure. Kasen especially enjoys
ninja warrior obstacle courses in his backyard
and at the gym.
Epidiolex /Epidyolex (cannabidiol) is the first
prescription, plant-derived cannabis-based
medicine approved by the U.S. Food and Drug
Administration (FDA), the European Commission
and the Medicines and Healthcare products
Regulatory Agency. Epidiolex/Epidyolex
is approved in nearly 40 countries outside of
the U.S.
In the U.S., Epidiolex is approved for the treatment
of seizures associated with Lennox-Gastaut
syndrome (LGS), Dravet syndrome (DS), or
tuberous sclerosis complex (TSC) in patients
1 year of age and older.
Epidyolex is approved by the European
Commission for use in addition to clobazam, to
treat patients from two years of age and older
with LGS or DS. It is also used to treat TSC with
other epilepsy treatments in patients aged two
and older.
A Phase 3 trial is ongoing in Japan evaluating
Epidyolex in patients with LGS, DS and TSC.
The patient story shared in this communication
depicts an individual patient s response to
Epidiolex and is not representative of all
patient responses.
Epidiolex is a great intervention for Kasen. It s the
small things that a lot of people take for granted.
Brittany, Kasen s mom
2023 was a highly productive year for Jazz and I
am pleased to report that we helped more patients,
generated more than $3.8 billion in revenues and
advanced multiple late-stage programs across
our pipeline. Our performance in 2023 is reflective
of the strong execution that has transformed our
business over the last several years, including the
diversification of our leading commercial medicines
for sleep disorders, epilepsy and cancer.
Xywav , Epidiolex and Rylaze , our key commercial
growth drivers, delivered 27% year-over-year
combined revenue growth. We remain confident
in the durability of our Sleep1 therapeutic area,
which generated more than $1.9 billion in revenue in
2023, and our Oncology therapeutic area revenue
surpassed $1 billion for the first time in 2023.
concept data and we believe we have strong rationale
for pursuing these indications. Importantly in 2023,
we generated meaningful data on zanidatamab, a
differentiated, bispecific antibody targeting HER2expressing cancers. In the first quarter of 2024,
we completed the submission of our biologics
license application (BLA) to the U.S. Food and Drug
Administration (FDA) for zanidatamab in second-line
(2L) biliary tract cancer (BTC). If approved, we expect
zanidatamab would be the first HER2-targeted
treatment specifically approved for BTC in the U.S.
We remain focused on exploring science-driven
approaches in areas where there are limited or no
options for patients.
Our strong financial position and disciplined capital
allocation underpin our progress towards Vision
2025. We ended 2023 with $1.6 billion in cash, cash
equivalents and investments, which supports our
ability to continue investing in key commercial growth
drivers for near-term growth, pipeline for long-term
growth and future corporate development. We
believe these accomplishments in 2023 position us
well for success in 2024 and to achieve Vision 2025
and beyond.
2023 ACCOMPLISHMENTS
COMMERCIAL
EMILY
RYLAZE Patient
As a global biopharmaceutical company with
in-house R&D capabilities, our innovative and
passionate team members advanced differentiated
assets in areas of significant unmet medical need.
Our robust pipeline has multiple late-stage catalysts
through 2025 in areas where we have proof-of-
Xywav: #1 treatment in narcolepsy and only
low-sodium oxybate. Xywav net product sales
grew 33% year-over-year in 2023. Xywav adoption
in idiopathic hypersomnia (IH) continued as
healthcare providers saw the profound impact
oxybate therapy has on sleep inertia in IH patients.
Epidiolex/Epidyolex : #1 branded epilepsy
treatment. Epidiolex net product sales grew
15% year-over-year in 2023, supported by global
expansion through launches and reimbursement
outside of the U.S. as well as meaningful data
generation. Long-term studies demonstrated
1. Total Sleep revenue includes: Xywav, branded Xyrem and high-sodium oxybate authorized generic royalty revenues.
6/14/2024 Letter Continued (Full PDF)