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WKN: 907122 / ISIN: US66987V1098

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23.10.2026 13:29:49

Press Release: Novartis: Kisqali(R) shows -2-

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," or similar expressions, or by express or implied discussions regarding: potential new products; potential new indications for existing products; potential product launches or potential future revenues from any such products; results of ongoing clinical trials; or potential future, pending or announced transactions; potential future sales or earnings; strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or our capital structure. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations could be affected by, among other things, uncertainties concerning: global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the success of our key products, commercial priorities and strategy; research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of new technologies, including artificial intelligence, and new business models; potential significant breaches of information security or disruptions of our information technology systems; actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; future global exchange rates; future demand for our products; and other risks and factors referred to in Novartis AG's most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise.

About Novartis

Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

Reimagine medicine with us: Visit us at http://www.novartis.com www.novartis.com and connect with us on https://www.linkedin.com/company/novartis/ LinkedIn, https://www.facebook.com/novartis/ Facebook, https://twitter.com/Novartis X/Twitter and https://instagram.com/novartis?igshid=MzRlODBiNWFlZA==__;!!N3hqHg43uw!pjp8z253J5NjaOYrW65UbAAlHeHRdQ-w0m4ezZxEQEl0ptafXN2M99VRIk39pf49PAc8NbK93Pxp3uaSBQkAf8oEnzWXG8Sk$ Instagram.

References

1. Slamon D et al. Adjuvant ribociclib + nonsteroidal aromatase inhibitor in

patients with HR+/HER2- early breast cancer: NATALEE 6-year overall

survival and efficacy outcomes. Presented at the European Society of

Medical Oncology (ESMO) Congress. October 23-27, 2026. Madrid, Spain.

2. Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus Endocrine Therapy

in Early Breast Cancer. N Engl J Med. 2024;390(12):1080-1091.

doi:10.1056/NEJMoa2305488

3. Crown J, Stroyakovskii D, Yardley DA, et al. Adjuvant Ribociclib Plus

Nonsteroidal Aromatase Inhibitor Therapy in Patients With HR+/HER2- Early

Breast Cancer: NATALEE 5-Year Outcomes. Presented at the European Society

for Medical Oncology (ESMO) Congress; October 17-21, 2025; Berlin,

Germany.

4. Yardley DA et al. Pooled exploratory analysis of survival in patients

(pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases

(mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the

MONALEESA (ML) trials. Poster presented at the European Society of

Medical Oncology Congress. September 9-13, 2022. Paris, France.

5. Neven P et al. Updated overall survival (OS) results from the first-line

(1L) population in the Phase III MONALEESA-3 trial of postmenopausal

patients with HR+/HER2- advanced breast cancer (ABC) treated with

ribociclib (RIB) + fulvestrant (FUL). Mini oral presented at the European

Society for Medical Oncology Breast Cancer Congress. May 4, 2022. Paris,

France.

6. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall Survival with

Ribociclib plus Letrozole in Advanced Breast Cancer. N Engl J Med.

2022;386(10):942-950. doi:10.1056/NEJMoa2114663.

7. Hortobagyi GN et al. Overall survival (OS) results from the phase III

MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor

positive/human epidermal growth factor receptor 2 negative (HR+/HER2-)

advanced breast cancer (ABC) treated with endocrine therapy (ET) +/-

ribociclib. LBA 17. Proffered paper presented at the European Society of

Medical Oncology Congress, September 16-21, 2021. Lugano, Switzerland.

8. Im SA, Lu YS, Bardia A, et al. Overall survival with ribociclib plus

endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316.

doi:10.1056/NEJMoa1903765.

9. Slamon DJ, Neven P, Chia S, et al. Overall Survival with Ribociclib plus

Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020;382(6):514-524.

doi:10.1056/NEJMoa1911149.

10. Slamon DJ et al. Overall survival (OS) results of the Phase III

MONALEESA-3 trial of postmenopausal patients (pts) with hormone

receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-)

advanced breast cancer (ABC) treated with fulvestrant (FUL) +/-

ribociclib (RIB). LBA7_PR. Presented at the European Society of Medical

Oncology Congress. September 29, 2019. Barcelona, Spain.

11. Slamon DJ et al. Updated overall survival (OS) results from the Phase III

MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2-

advanced breast cancer (ABC) treated with fulvestrant (FUL) +/-

ribociclib (RIB). Presented at the American Society of Clinical Oncology

Annual Meeting. June 5, 2021. Chicago, USA.

12. Tripathy D et al. Updated overall survival (OS) results from the phase

III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2-

advanced breast cancer (ABC) treated with endocrine therapy (ET) +/-

ribociclib. Presented at the San Antonio Breast Cancer Symposium.

December 9, 2020. Texas, USA.

13. Yardley D et al. Overall survival (OS) in patients (pts) with advanced

breast cancer (ABC) with visceral metastases (mets), including those with

liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in

the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of

Clinical Oncology Annual Meeting. June 2020. Chicago, USA.

14. O'Shaughnessy J et al. Overall survival subgroup analysis by metastatic

site from the Phase III MONALEESA-2 study of first-line ribociclib +

letrozole in postmenopausal patients with HR+/HER2- advanced breast

cancer. Presented at the San Antonio Breast Cancer Symposium. December

7-10, 2021. Texas, USA.

15. Clinicaltrials.gov. NCT03701334. A Trial to Evaluate Efficacy and Safety

of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients

With HR+/ HER2- Early Breast Cancer (NATALEE). Accessed September 2026.

https://clinicaltrials.gov/study/NCT03701334

16. Kisqali. Prescribing Information (US FDA). Novartis Pharmaceuticals

Corporation; 2017. Accessed November 2025.

https://www.novartis.com/us-en/sites/novartis_us/files/kisqali.pdf

17. Kisqali. Summary of product characteristics (SmPC). Novartis Europharm

Limited; 2017. Accessed November 2025.

https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf

18. NCCN Guidelines. NCCN Clinical Practice Guidelines in Oncology (NCCN

Guidelines--Æ) - Breast Cancer. Accessed November 2025.

https://www.nccn.org

19. National Medical Products Administration. Drug Evaluation Information

Disclosure: Drug Evaluation Approval Results. National Medical Products

Administration. Published May 21, 2025. Accessed November 2025.

https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20250521151427103.html

20. European Society of Medical Oncology (ESMO). ESMO MCBS scorecards;

NATALEE. Available from:

(MORE TO FOLLOW) Dow Jones Newswires

October 23, 2026 07:30 ET (11:30 GMT)

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