Press Release: Novartis delivers 12% sales and -3-

Gleevec/Glivec 144 -19 -17 433 -24 -21

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Top 20 brands total 9 045 13 13 25 992 9 11

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nm= not meaningful

* Sales growth benefiting from a one-time revenue deduction adjustment in Europe

R&D update - key developments from the third quarter

New approvals

Leqvio Approved in China and Japan as the first and only

small interfering RNA (siRNA) therapy for LDL-C reduction

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Cosentyx In October, FDA approved the intravenous formulation

in three indications: Psoriatic Arthritis, Ankylosing

Spondylitis, and non-radiographic axial SpA

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Regulatory updates

Kisqali EU file submission in adjuvant early breast cancer

setting; US submission planned for Q4 2023

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Adakveo EC adopts decision endorsing CHMP recommendation to

revoke conditional marketing authorization

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Results from ongoing trials and other highlights

iptacopan In October, Ph3 APPLAUSE-IgAN study interim analysis

demonstrated clinically meaningful and highly statistically

significant proteinuria reduction in patients with

IgA nephropathy. The trial met its pre-specified interim

analysis (9 months) primary endpoint, demonstrating

superiority vs. placebo in proteinuria reduction,

with safety consistent with previously reported data.

Novartis plans to review interim data with regulatory

authorities for accelerated approval; study continues

with final readout at 24 months

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remibrutinib Ph3 REMIX-1 and REMIX-2 studies met all primary and

secondary endpoints, showing fast, clinically meaningful

improvements across urticaria disease activity scores.

Remibrutinib demonstrated a favorable safety profile

with rates of adverse events comparable to placebo

and balanced liver function tests across both studies.

Final (52 weeks) readout and submissions to health

authorities are expected in 2024. Full data will be

presented at upcoming medical meetings

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Pluvicto Ph3 PSMAfore study demonstrated clinically meaningful

and statistically significant rPFS benefit in patients

with PSMA+ mCRPC in the pre-taxane setting. Per updated

analysis presented at ESMO, median rPFS more than

doubled compared to ARPI switch. Patients on Pluvicto

showed improved quality of life compared to daily

oral ARPI, along with improvements in other clinically

meaningful efficacy endpoints including PSA response,

ORR, DOR and time to symptomatic skeletal event, with

favorable safety. Pre-specified crossover-adjusted

OS analysis demonstrated a HR of 0.80 (0.48, 1.33);

the unadjusted ITT OS analysis was confounded by a

high rate of crossover.

Novartis is continuing to collect OS data, regulatory

filings are anticipated in 2024

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Lutathera Ph3 NETTER-2 study demonstrated clinically meaningful

and statistically significant improvement in PFS (primary

endpoint) in patients with newly diagnosed somatostatin

receptor (SSTR)-positive, Grade 2 and 3, advanced

gastroenteropancreatic neuroendocrine tumors (GEP-NETs)

vs. high-dose long-acting octreotide alone. The trial

also met its key secondary endpoint of ORR. No new

or unexpected safety findings were observed and data

are consistent with the already well-established safety

profile of Lutathera.

Data to be presented at an upcoming medical meeting

and discussed with regulatory authorities, with submissions

to follow

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Kisqali Ph3 NATALEE iDFS 500 event analysis complete. Updated

data is consistent with the interim analysis results

announced in March 2023 and will be communicated at

an upcoming medical meeting.

Health-related quality of life (HRQoL) analyses from

Ph3 NATALEE trial demonstrated that patients with

early breast cancer receiving adjuvant Kisqali plus

ET for up to 3 years maintained physical and social

functioning; psychological well-being; and overall

health scores, compared to baseline. Data was presented

at the ESMO Virtual Plenary 2023

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Leqvio Long-term data from Ph3 ORION-8 demonstrated that

Leqvio, in addition to statin therapy, provides consistent

low-density lipoprotein cholesterol (LDL-C) reduction

beyond six years of treatment in patients with atherosclerotic

cardiovascular disease (ASCVD), increased risk of

ASCVD or heterozygous familial hypercholesterolemia.

Efficacy and safety were consistent with previously

reported Ph3 results. Data was presented at ESC 2023

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GT005 Development in Geographic Atrophy secondary to dry-Age-related

(PPY988) Macular Degeneration discontinued based on benefit-risk

assessment. No new safety signals identified. Patients

treated will be provided with long term safety follow

up

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Tislelizumab Novartis and BeiGene mutually agreed to terminate

the collaboration and license agreement for tislelizumab

for certain markets. With the termination, BeiGene

will re-assume all development and commercialization

rights for tislelizumab, and Novartis will manufacture

tislelizumab for certain markets. BeiGene will also

provide Novartis with ongoing clinical supply of tislelizumab

to support its clinical trials

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'Front of Divestment completed of 'front of eye' ophthalmology

Eye' Assets assets to Bausch + Lomb

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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.

During the first nine months of 2023, Novartis repurchased a total of 74.9 million shares for USD 7.2 billion on the SIX Swiss Exchange second trading line. These repurchases included 52.8 million shares (USD 4.9 billion) under the USD 15 billion share buyback (announced in December 2021 and completed in June 2023) and 10.4 million shares (USD 1.1 billion) under the new up-to USD 15 billion share buyback announced in July 2023. In addition, 11.7 million shares (USD 1.2 billion) were repurchased to mitigate dilution related to participation plans of associates. Furthermore, 1.4 million shares (for an equity value of USD 0.1 billion) were repurchased from associates. In the same period, 12.2 million shares (for an equity value of USD 0.8 billion) were delivered as a result of options exercised and share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 64.1 million versus December 31, 2022. These treasury share transactions resulted in an equity decrease of USD 6.5 billion and a net cash outflow of USD 7.3 billion.

As of September 30, 2023, net debt excluding net debt related to discontinued operations increased to USD 10.8 billion compared to USD 7.2 billion total net debt at December 31, 2022. The increase was mainly due to the USD 7.3 billion annual dividend payment, net cash outflow for treasury share transactions of USD 7.3 billion and net M&A / intangible assets transactions of USD 2.9 billion. This increase in net debt was partially offset by USD 11.0 billion free cash flow.

As part of the spin-off, Sandoz incurred total bank debt of approximately USD 3.7 billion and paid approximately USD 3.0 billion in cash, including payment in satisfaction of certain intercompany indebtedness owed by Sandoz and its subsidiaries to Novartis and its affiliates as of September 30, 2023. This reduced the net debt position of Novartis by USD 3.0 billion.

As of Q3 2023, the long-term credit rating for the company is A1 with Moody's Investors Service and AA- with S&P Global Ratings.

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October 24, 2023 01:00 ET (05:00 GMT)