Press Release: Novartis delivers strong sales -2-
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uptake demonstrating the high unmet need in CML
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Leqvio (USD 64 million) launch progressing steadily including
expansion into new geographies
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Jakavi (USD 414 million, +13% cc) sales grew in Emerging
Growth Markets, Europe and Japan, driven by strong
demand in both myelofibrosis and polycythemia vera
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Piqray (USD 116 million, +61% cc) sales grew mainly in the
US, benefiting from indication expansion into PIK3CA-related
overgrowth spectrum (PROS)
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Lutathera (USD 149 million, +22% cc) sales grew mainly in the
US and Japan due to increased demand
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Cosentyx (USD 1,076 million, -4% cc) continued demand growth
across key geographies, offset by revenue deduction
adjustments in the US. Ex-US sales grew +17% (cc)
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Sandoz (USD 518 million, +17% cc) driven by ex-US growth
Biopharmaceuticals
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Emerging Growth Overall, grew +14% (cc). China returned to growth
Markets* post COVID lockdowns. (+1% cc, USD 829 million), with
Innovative Medicines growing +5%
*All markets except the US, Canada, Western Europe,
Japan, Australia, and New Zealand
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Net sales of the top 20 Innovative Medicines products in Q1 2023
Q1 2023 % change
USD m USD cc
------- ---- ----
Entresto 1 399 28 32
---------------------- ------- ---- ----
Cosentyx 1 076 -7 -4
---------------------- ------- ---- ----
Promacta/Revolade 547 11 15
---------------------- ------- ---- ----
Tasigna 462 0 4
---------------------- ------- ---- ----
Tafinlar + Mekinist 458 14 18
---------------------- ------- ---- ----
Lucentis 416 -20 -15
---------------------- ------- ---- ----
Kisqali 415 74 81
---------------------- ------- ---- ----
Jakavi 414 6 13
---------------------- ------- ---- ----
Kesimpta 384 97 100
---------------------- ------- ---- ----
Xolair 354 -4 2
---------------------- ------- ---- ----
Sandostatin 329 3 5
---------------------- ------- ---- ----
Ilaris 328 15 19
---------------------- ------- ---- ----
Zolgensma 309 -15 -14
---------------------- ------- ---- ----
Gilenya 232 -62 -60
---------------------- ------- ---- ----
Pluvicto 211 nm nm
---------------------- ------- ---- ----
Exforge Group 186 -7 -1
---------------------- ------- ---- ----
Galvus Group 183 -15 -9
---------------------- ------- ---- ----
Diovan Group 158 -17 -11
---------------------- ------- ---- ----
Lutathera 149 19 22
---------------------- ------- ---- ----
Gleevec/Glivec 147 -26 -21
---------------------- ------- ---- ----
Top 20 products total 8 157 4 8
---------------------- ------- ---- ----
nm= not meaningful
R&D update - key developments from the first quarter
New approvals
Pluvicto In April FDA approved Millburn facility for commercial
production of Pluvicto. Expected to contribute meaningfully
to supply in Q3 after the anticipated approval of
additional lines
---------------- ------------------------------------------------------------
Tafinlar + Approved in the US for the treatment of pediatric
Mekinist patients >=1 year of age with low-grade glioma with
a BRAF V600E mutation who require systemic therapy
---------------- ------------------------------------------------------------
Hyrimoz FDA approved biosimilar Hyrimoz (adalimumab-adaz)
(adalimumab) high-concentration formulation to treat seven indications
covered by the reference medicine, Humira(R)
EC approved (April 3, 2023) citrate-free high concentration
formulation of adalimumab biosimilar to treat all
indications covered by the reference medicine, Humira(R)
---------------- ------------------------------------------------------------
Regulatory updates
Entresto Positive CHMP opinion for pediatric heart failure
indication. If approved, this would support extension
of regulatory data protection in Europe to November
2026
-------------------- ------------------------------------------------------
Denosumab biosimilar FDA accepted BLA for proposed biosimilar denosumab.
The application includes all indications covered by
the reference medicines Prolia(R) and Xgeva(R)
-------------------- ------------------------------------------------------
Results from ongoing trials and other highlights
Kisqali Ph3 NATALEE trial met its primary endpoint (iDFS)
at an interim analysis. Kisqali plus ET significantly
reduced the risk of disease recurrence, compared to
ET alone, demonstrating consistent benefit in a broad
population of patients with stage II and III HR+/HER2-
early breast cancer, including those with no nodal
involvement. Data will be presented at an upcoming
meeting and submitted to regulatory authorities
---------------------------- ------------------------------------------------------------
Cosentyx Long-term data from the pivotal SUNSHINE and SUNRISE
trials evaluating Cosentyx in moderate-to-severe HS,
demonstrated continued improvement in treatment response
rates with over 55% of patients achieving a HiSCR
at Week 52 and over 50% of patients demonstrating
a meaningful reduction in pain. Data published in
Lancet and presented at the 2023 AAD annual meeting
---------------------------- ------------------------------------------------------------
Zolgensma Data from two long-term follow-up studies, LT-001
and LT-002, show continued efficacy and durability
of Zolgensma up to 7.5 years post-dosing, across a
range of patient populations, with an overall benefit-risk
profile that remains favorable. All pre-symptomatic
children treated maintained or achieved all assessed
motor milestones. Data presented at the 2023 MDA conference
---------------------------- ------------------------------------------------------------
R&D Portfolio Prioritization Novartis continues to focus its R&D portfolio prioritizing
high value medicines with transformative potential
for patients. During the quarter, a comprehensive
review of R&D projects resulted in decisions to discontinue
or out-license projects for reasons including strategic
fit and commercial potential, representing approximately
10% of the Novartis pipeline.
---------------------------- ------------------------------------------------------------
FAP-2286 Acquired FAP-2286 (Ph1/2), a potential first-in-class
radioligand therapy with the respective radioligand
imaging agent, from Clovis Oncology
---------------------------- ------------------------------------------------------------
Bicycle Peptides Novartis entered into research collaboration on bicyclic
peptides with Bicycle Therapeutics
---------------------------- ------------------------------------------------------------
Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority.
(MORE TO FOLLOW) Dow Jones Newswires
April 25, 2023 01:00 ET (05:00 GMT)
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