Press Release: Novartis reports strong Q2 with -3-

Novartis

91.99 CHF -0.90%

• Charts
• News
• Analysen

Kaufen Verkaufen

--------------------------------------- ------------------------------------------------------------------

Scemblix In the Phase IIIb ASC4START trial evaluating the tolerability

(asciminib) and efficacy of Scemblix versus nilotinib in adult

patients with newly diagnosed Ph+ CML-CP, patients

treated with Scemblix had a 55% lower risk of discontinuation

due to AEs vs nilotinib, and 12.7% more patients treated

with Scemblix achieved major molecular responses by

week 12 vs those treated with nilotinib. Data presented

at ASCO and EHA.

--------------------------------------- ------------------------------------------------------------------

Votoplam The Phase II PIVOT-HD study of votoplam in patients

with Stage 2 and Stage 3 Huntington's disease met

its primary endpoint of reduction in blood Huntingtin

(HTT) protein levels at Week 12 (p<0.0001), with durable,

dose-dependent lowering observed through Month 12.

Across all dose levels and disease stages, votoplam

showed a favorable safety and tolerability profile,

with no treatment-related serious adverse events or

neurofilament light chain protein (NfL) spikes. Together

with our partner, PTC Therapeutics, we are evaluating

the results and plan to engage with the HD community

and regulatory authorities to inform next steps.

--------------------------------------- ------------------------------------------------------------------

Remibrutinib A Phase II study with remibrutinib in food allergy

met its primary endpoint with a statistically significant

and clinically meaningful benefit. These data support

remibrutinib's potential as a first-in-class oral

BTK inhibitor that reduces the risk of severe allergic

reactions, including anaphylaxis. Phase III study

planning is underway.

--------------------------------------- ------------------------------------------------------------------

Ianalumab Novartis will not advance investigation of ianalumab

in hidradenitis suppurativa following a Phase II proof-of-concept

study which did not meet our target criteria despite

demonstrating efficacy vs placebo. No new safety signals

were observed and all other studies for ianalumab

in B-cell driven diseases continue as planned.

--------------------------------------- ------------------------------------------------------------------

Rapcabtagene autoleucel A Phase I/II study of rapcabtagene autoleucel, a rapidly

(YTB323) manufactured CD19 CAR-T therapy using the T-Charge

platform, demonstrated the expansion of CAR-T cells,

deep B cell depletion, early and sustained improvement

in overall disease activity, and a favorable benefit/risk

profile in 21 patients with severe refractory SLE

up to 12 months after treatment. Data presented at

EULAR.

--------------------------------------- ------------------------------------------------------------------

Zigakibart Updated results from the Phase I/II study for zigakibart

in IgAN showed a robust and clinically meaningful

reduction in proteinuria of 60.4% from baseline and

eGFR stabilization over 100 weeks of treatment. To

date, this is the longest duration of treatment reported

for an anti-APRIL agent, demonstrating long-term safety

and efficacy. Data presented at ERA. The Phase III

BEYOND trial is ongoing with anticipated readout in

2026.

--------------------------------------- ------------------------------------------------------------------

Selected transactions Novartis has completed the acquisition of Regulus

Therapeutics, a clinical-stage biopharmaceutical company

focused on developing microRNA therapeutics. Regulus'

lead asset, farabursen, is a potential first-in-class

oligonucleotide targeting miR-17 for the treatment

of autosomal dominant polycystic kidney disease (ADPKD)

that recently completed Phase Ib. The acquisition

is aligned with the therapeutic area focus of Novartis

and leverages its strength and expertise in renal

disease.

In July, Novartis entered into an agreement with Sironax,

granting Novartis an exclusive option to acquire its

Brain Delivery Module (BDM) platform, a differentiated

blood-brain-barrier crossing technology designed to

enhance the brain delivery of therapeutics of various

modalities.

--------------------------------------- ------------------------------------------------------------------

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 half of 2025, Novartis repurchased a total of 48.8 million shares for USD 5.3 billion on the SIX Swiss Exchange second trading line under the USD 15 billion share buyback (announced in July 2023 and completed on July 1, 2025, with a total of 140.9 million shares repurchased over this period). In addition, 1.6 million shares (equity value of USD 0.2 billion) were repurchased from employees. In the same period, 11.2 million shares (equity value of USD 0.6 billion) were delivered to employees related to equity-based compensation plans. Novartis aims to offset the dilutive impact from equity-based compensation plans of employees over the remainder of the year. Consequently, the total number of shares outstanding decreased by 39.2 million versus December 31, 2024. These treasury share transactions resulted in an equity decrease of USD 4.9 billion and a net cash outflow of USD 5.4 billion.

Net debt increased to USD 23.8 billion at June 30, 2025, compared to USD 16.1 billion at December 31, 2024. The increase was mainly due to the free cash flow of USD 9.7 billion being more than offset by the USD 7.8 billion annual dividend payment, cash outflows for treasury share transactions of USD 5.4 billion and net cash outflow for M&A, intangible assets transactions and other acquisitions of USD 3.1 billion.

As of Q2 2025, the long-term credit rating for the company is Aa3 with Moody's Ratings and AA- with S&P Global Ratings.

2025 outlook

Barring unforeseen events; growth vs. prior year in

cc

Net sales Expected to grow high single-digit

--------------------- ----------------------------------

Core operating income Expected to grow low-teens

----------------------------------

Key assumption:

-- We continue to assume Entresto US generic entry in mid-2025 for

forecasting purposes, though timing of generic entry is subject to

ongoing IP and regulatory litigation

Foreign exchange impact

If mid-July exchange rates prevail for the remainder of 2025, the foreign exchange impact for the year would be positive 1 percentage point on net sales and negative 1 percentage point on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

(MORE TO FOLLOW) Dow Jones Newswires

July 17, 2025 01:00 ET (05:00 GMT)