Myeloid Therapeutics to Present at the Guggenheim Healthcare Talks 2023 Oncology Day

On January 31, 2023 Myeloid Therapeutics, Inc. ("Myeloid"), a clinical stage mRNA-immunotherapy company, reported that management will present at the Guggenheim Healthcare Talks 2023 Oncology Day, being held February 8-9, 2023, in New York, NY (Press release, Myeloid Therapeutics, JAN 31, 2023, View Source [SID1234626684]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Daniel Getts, Ph.D., CEO of Myeloid, will present a company overview on Wednesday, February 8, 2023, at 1:35 pm ET. Company management will also participate in one-on-one meetings with investors during the conference.

Aethlon Medical to Present at Sequire Biotechnology Conference on February 2nd, 2023

On January 31, 2023 Aethlon Medical, Inc. (Nasdaq: AEMD), a company developing medical technology to treat cancer and life-threatening infectious disease, reported that it will be presenting virtually at the upcoming Sequire Biotechnology Conference on Thursday, February 2nd, at 10:00 AM ET (Press release, Aethlon Medical, JAN 31, 2023, View Source [SID1234626683]). Steven LaRosa, M.D., Chief Medical Officer and Chief Scientific Officer of Aethlon Medical, will be giving the presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Event: Aethlon Medical, Inc. Presentation at the Sequire Biotechnology Conference
Date: Thursday, February 2nd, 2023
Time: 10:00 am ET

Guardant Health to integrate Lunit’s AI-based scoring algorithm for PD-L1 into its portfolio to enhance cancer biomarker detection

On January 31, 2023 Lunit (KRX:328130.KQ), in partnership with leading precision oncology company Guardant Health, reported the integration of its AI-based PD-L1 scoring algorithm into Guardant’s testing workflow to enhance biomarker detection in the Guardant360 TissueNextTM PD-L1 test for non-small cell lung cancer (NSCLC) (Press release, Guardant Health, JAN 31, 2023, View Source [SID1234626682]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The newly integrated algorithm will enable Guardant to offer augmented biomarker assessment for NSCLC patients through AI-based quantification of tissue samples using a scoring system generated by Lunit SCOPE PD-L1. The enhanced Guardant test is designed to support pathologists in diagnosing PD-L1 status with higher accuracy and efficiency. Through the AI software, the test showed improved detection of PD-L1 by more than 20 percent compared to manual pathologist interpretation in the most challenging cases in NSCLC1.

Lunit SCOPE PD-L1 is a CE-marked AI solution for detecting and analyzing PD-L1, a cancer biomarker. The solution may assist pathologists by minimizing interpretation discrepancy and allowing better prediction of treatment outcomes for non-small cell lung cancer (NSCLC) patients, as demonstrated in study findings published in the European Journal of Cancer.

Lunit SCOPE PD-L1’s integration with the Guardant360 TissueNext PD-L1 test is the first application in Guardant Galaxy, Guardant Health’s suite of technology applications developed internally and through outside partnerships to enhance the performance and utility of its portfolio of cancer tests.

The two companies have been in partnership since 2021, following a strategic investment from Guardant Health to Lunit.

"We are honored to partner with Guardant Health in leveraging the power of AI and digital pathology to enhance the capabilities of their comprehensive genomic profiling tests for cancer patients," said Brandon Suh, CEO of Lunit. "The development of the AI-supported scoring algorithm for the Guardant360 TissueNext PD-L1 test is a great example of using advanced medical image analytics to enhance precision diagnostics in lung cancer and help doctors find the right treatment for the right patients."

"With Guardant Galaxy, we are now accessing the most advanced AI techniques and the latest complementary technologies from leading companies in cancer diagnostics to enhance the capabilities of our tests and provide oncologists and researchers with precise and actionable information," said Helmy Eltoukhy, co-CEO of Guardant Health. "The digital pathology solution from Lunit has already demonstrated the power of AI to help improve detection of PD-L1 in certain cases of non-small cell lung cancer. We believe it has the potential to contribute much more broadly to advances in identifying cancer biomarkers and informing treatment decisions."

Nordic Nanovector ASA announces that Ludvik Sandnes has been appointed interim Chief Executive Officer (CEO) and Chief Financial Officer (CFO)

On January 31, 2023 Nordic Nanovector ASA ("Nordic Nanovector" or the "Company") reported that Ludvik Sandnes, former Chairperson of Nordic Nanovector, has been appointed interim Chief Executive Officer (CEO) and Chief Financial Officer (CFO) of the Company as from 1 February 2023 (Press release, Nordic Nanovector, JAN 31, 2023, View Source [SID1234626681]). Ludvik Sandnes will no more attend the Oncoinvent Board. Malene Brondberg, current interim CEO and CFO, will transition out of the Company, as previously announced on 9 December 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Ludvik Sandnes commented "I have been asked by the board of Nordic Nanovector to become the interim CEO and CFO of the company. As a former chairman of the board, I know the company’s history and operations, many shareholders, employees and founders quite well. In today’s difficult stock market environment, the Board has concluded it will not be possible for Nordic Nanovector to raise new capital in the short term. Therefore, the Board, together with myself and our financial advisors, Carnegie, will assess the strategic options that may be open to the company and put forward any recommended proposals for resolution by the company’s shareholders in the coming months. Our key goal is to ensure Nordic Nanovector’s continued operation and to position it for future growth for the benefit of the current organisation, employees and shareholders".

The current Board of Directors, consisting of Jon Magne Asmyr (Chairperson) and Tina Bjørnlund Bønsdorff, will continue until the next Annual General Meeting on 26 April 2023, when a proposal will be made for the election of an additional new Board member to replace Eddie Berglund who resigned on 19 January 2023.

Nordic Nanovector confirms that its stand-alone cash position at end December 2022 is expected to be approximately NOK 98m. Further commitments related to the closure of PARADIGME during 2023 and transaction costs related to the proposed APIM transaction brings the uncommitted net cash level to be approximately NOK 60m. This is in line with previous communication.

Nordic Nanovector further confirms that it will report its Q4 2022 and full year results in line with the Oslo Børs regulations on 28 February.

The Company continues to minimise costs wherever possible, with six full time employees now remaining in the Company.

Novartis continues to grow with further core margin expansion and achieves important innovation milestones

On January 31, 2023 Novartis reported its fourth quarter and full year results for the year 2022 (Press release, Novartis, JAN 31, 2023, View Source [SID1234626680]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Full year
• Net sales grew +4% (cc1, -2% USD) with core operating income growing +8% (cc, 0% USD)
o IM sales grew +4% (cc, -2% USD) and core operating income +8% (cc, 0% USD), with IM core margin reaching 36.9% (+130 bps cc)
o Sandoz sales grew +4% (cc, -4% USD) with core operating income decreasing -1% (cc, -8% USD)
• Operating income declined -13% (cc, -21% USD), mainly due to higher restructuring and impairments. Net income declined -67% (cc, -71% USD), or -9% (cc) excluding the impact of Roche income2. Free cash flow was USD 11.9 billion (-10% USD)
• Core EPS was USD 6.12 +6% (cc, -3% USD); excluding Roche core income impact, core EPS grew +14% (cc)
Fourth quarter
• Net sales grew +3% (cc, -4% USD) with core operating income growing +15% (cc, +6% USD), mainly driven by higher sales and productivity
o Innovative Medicines (IM) sales grew +3% (cc, -3% USD), growth drivers include: Entresto (+44% cc), Kesimpta (+157% cc), Pluvicto (reaching USD 179 million) and Kisqali (+33% cc)
o Sandoz sales were in line with the prior year (0% cc, -8% USD) with continued growth in biopharmaceuticals
• Q4 selected innovation milestones:
o Pluvicto Ph3 PSMAfore positive results in mCRPC; EC approval for progressive PSMA+ mCRPC
o Iptacopan Ph3 APPLY-PNH demonstrated iptacopan superiority vs. anti-C5 in refractory PNH
o Iptacopan Ph3 APPOINT-PNH met primary endpoint in complement inhibitor naive PNH patients Share buyback, dividend and 2023 guidance
• Previously announced up-to USD 15 billion share buyback ongoing; USD 4.9 billion still to be executed3
• Dividend of CHF 3.20 per share, an increase of 3.2%, proposed for 2022
• 2023 guidance4
Group expected to grow sales low-to-mid single digit and core operating income mid single digit. IM expected to grow sales low-to-mid single digit and core operating income mid-to-high single digit

Basel, February 1, 2023 – commenting on 2022 results, Vas Narasimhan, CEO of Novartis, said: "Novartis is on track to become a pure-play innovative medicines company, uniquely positioned to leverage its global scale and R&D platforms. Our six multi-billion brands5 now represent 32% of our Innovative Medicines sales and are growing 26%. Pluvicto and Scemblix had very strong launch performances, and the Leqvio launch continues to progress. Pivotal Ph3 readouts for two iptacopan studies and Pluvicto in earlier lines of therapy provide strong confidence for near to mid-term growth. Looking ahead, we have a catalyst rich pipeline with 15 pivotal readouts in the mid-term. We expect to continue to deliver improved financials and strengthen Novartis ESG foundations, on our journey to become most trusted and valued medicines company in the world".

Q4 2022 Q4 2021 % change FY 2022 FY 2021 % change
USD m USD m USD cc USD m USD m USD cc
Net sales 12 690 13 229 -4 3 50 545 51 626 -2 4
Operating income 1 949 2 562 -24 -14 9 197 11 689 -21 -13
Net income 1 466 16 306 -91 -90 6 955 24 018 -71 -67
EPS (USD) 0.69 7.29 -91 -89 3.19 10.71 -70 -66
Free cash flow 3 552 3 027 17 11 945 13 282 -10
Core operating income 4 030 3 819 6 15 16 665 16 588 0 8
Core net income 3 251 3 135 4 14 13 352 14 094 -5 3
Core EPS (USD) 1.52 1.40 9 19 6.12 6.29 -3 6

Strategy Update

Our focus

During 2022, Novartis unveiled a new focused strategy with our transformation into a "pure-play"Innovative Medicines business. We have a clear focus on five core therapeutic areas (cardiovascular,immunology, neuroscience, solid tumors and hematology), with multiple significant in-market and pipeline assets in each of these areas, that address high disease burden and have substantial growth potential. In addition to two established technology platforms (chemistry and biotherapeutics), three emerging platforms (gene & cell therapy, radioligand therapy, and xRNA) are being prioritized for
continued investment into new R&D capabilities and manufacturing scale. Geographically, we are focused on growing in our priority geographies – the US, China, Germany and Japan.

Our priorities

1. Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
2. Deliver returns: Continuing to embed operational excellence and deliver improved financials. Novartis remains disciplined and shareholder-focused in our approach to capital allocation, with substantial cash generation and a strong capital structure supporting continued flexibility.
3. Strengthening foundations: Unleashing the power of our people, scaling data science and technology and continuing to build trust with society

Sandoz planned spin-off

The planned spin-off remains on track for H2 2023. Completion of the transaction is subject to certain conditions, including consultation with works councils and employee representatives (as required), general market conditions, tax rulings and opinions, final Board of Directors endorsement and shareholder approval in line with Swiss corporate law. The transaction is expected to be tax neutral to Novartis.

Financials

Fourth quarter
Net sales were USD 12.7 billion (-4%, +3% cc) in the fourth quarter driven by volume growth of 10 percentage points, partly offset by price erosion of 3 percentage points and the negative impact from generic competition of 4 percentage points.

Operating income was USD 1.9 billion (-24%, -14% cc), mainly due to higher restructuring costs (USD 0.6 billion), primarily related to the implementation of the previously announced streamlined organizational model.

Net income was USD 1.5 billion (-91%, -90% cc), impacted by Roche income in the prior year of USD 14.6 billion. Excluding the impact of Roche income, net income grew +2% (cc). EPS was USD 0.69 (- 91%, -89% cc). Excluding the impact of Roche income, EPS grew +7% (cc).

Core operating income was USD 4.0 billion (+6%, +15% cc) driven by higher sales and productivity, including initial savings from the previously announced streamlined organizational model. Core operating income margin was 31.8% of net sales, increasing by 2.9 percentage points (+3.5 percentage points cc).

Core net income was USD 3.3 billion (+4%, +14% cc), mainly driven by growth in core operating income, partly offset by the loss of Roche core income. Excluding the impact of Roche core income, core net income grew +17% (cc). Core EPS was USD 1.52 (+9%, +19% cc), benefiting from lower weighted average number of shares outstanding. Excluding the impact of Roche core income, core EPS grew +23% (cc).

Free cash flow amounted to USD 3.6 billion (+17% USD), mainly driven by higher net cash flows from operating activities and lower purchases of intangible assets.
___

Innovative Medicines net sales were USD 10.4 billion (-3%, +3% cc) with volume contributing 11 percentage points to growth, mainly driven by continued strong performance from Entresto, Kesimpta, Pluvicto and Kisqali. Generic competition had a negative impact of 5 percentage points, mainly due to Gilenya, Exjade and Afinitor. Pricing had a negative impact of 3 percentage points, including approximately 1 percentage point impact from a revenue deduction true-up for Cosentyx in the US, which was related to prior quarters in 2022. Sales growth for the quarter was also negatively impacted by the prior year reclassification of contract manufacturing from other revenues to sales. Excluding the contract manufacturing reclassification impact, sales would have grown +4% (cc). Sales in the US were USD 4.2
billion (+7%) and in the rest of the world USD 6.2 billion (-9%, +1% cc).

Sandoz net sales were USD 2.3 billion (-8%, 0% cc) with volume contributing 5 percentage points to growth. Pricing had a negative impact of 5 percentage points. Sales in Europe were USD 1.3 billion (-7%, +3% cc), in the US USD 429 million (-10%) and in the rest of the world USD 612 million (-8%, +1% cc). Sales were negatively impacted by a prior year biopharmaceuticals contract manufacturing revenue reclassification. Excluding this impact, overall Sandoz sales would have grown +1% (cc). Global sales of Biopharmaceuticals grew to USD 517 million (-7%, +3% cc), with growth in Europe, Canada and Latin America.

Full year

Net sales were USD 50.5 billion (-2%, +4% cc) in the full year, driven by volume growth of 11 percentage points, partly offset by price erosion of 4 percentage points and the negative impact from generic competition of 3 percentage points.

Operating income was USD 9.2 billion (-21%, -13% cc), mainly due to higher restructuring (USD 1.2 billion) primarily related to the implementation of the previously announced streamlined organizational model, higher impairments (USD 1.0 billion) and lower divestment gains (USD 0.6 billion).

Net income was USD 7.0 billion (-71%, -67% cc), impacted by Roche income in the prior year. Excluding the impact of Roche income, net income declined -9% (cc). EPS was USD 3.19 (-70%, -66% cc). Excluding the impact of Roche income, EPS declined -7% (cc).

Core operating income was USD 16.7 billion (0%, +8% cc) benefiting from higher sales, partly offset by higher R&D investments. Core operating income margin was 33.0% of net sales, increasing by 0.9 percentage points (+1.3 percentage points cc).

Core net income was USD 13.4 billion (-5%, +3% cc) as growth in core operating income was partly offset by the loss of Roche core income. Excluding the impact of Roche core income, core net income grew +11% (cc). Core EPS was USD 6.12 (-3%, +6% cc), benefiting from lower weighted average number of shares outstanding. Excluding the impact of Roche core income, core EPS grew +14% (cc).

Free cash flow amounted to USD 11.9 billion (-10% USD), mainly due to a decrease in net cash flows from operating activities and lower divestment proceeds, partly offset by lower purchases of property, plant and equipment.

Innovative Medicines net sales were USD 41.3 billion (-2%, +4% cc), with volume contributing 12 percentage points to growth. Sales growth was mainly driven by continued strong growth from Entresto, Kesimpta, Kisqali, Pluvicto and Cosentyx. Generic competition had a negative impact of 4 percentage points, mainly due to Gilenya, Afinitor/Votubia and Gleevec/Glivec. Pricing had a negative impact of 4 percentage points. Sales in the US were USD 15.9 billion (+6%) and in the rest of the world USD 25.4 billion (-6%, +3% cc).

Sandoz net sales were USD 9.2 billion (-4%, +4% cc) with volume contributing 10 percentage points to growth. Pricing had a negative impact of 6 percentage points. Sales in Europe were USD 4.9 billion (-7%, +4% cc), in the US USD 1.8 billion (-4%) and in the rest of the world USD 2.6 billion (+2%, +9% cc). Global sales of Biopharmaceuticals grew to USD 2.1 billion (-1%, +9% cc) across all regions.

Q4 key growth drivers

Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q4 growth) including:

Entresto (USD 1,291 million, +44% cc) sustained robust demand-led growth, with increased patient share across all geographies

Kesimpta (USD 369 million, 157% cc) driven by strong launch uptake, access and increased demand; approved in 80 countries

Pluvicto (USD 179 million, nm cc) with strong US launch performance, more than 160 active centers

Kisqali (USD 357 million, +33% cc) grew strongly across all geographies, based on increasing recognition of its overall survival and quality of life benefits in HR+/HER2- advanced breast cancer

Promacta/Revolade (USD 540 million, +11% cc) showed growth across most regions, driven by increased use in chronic ITP and as first-line and/or second-line treatment for severe aplastic anemia

Scemblix (USD 52 million, nm cc) continued its strong launch uptake demonstrating the high unmet need in CML, particularly patients previously treated with 2 or more tyrosine kinase inhibitors, or with the T315I mutation

Leqvio (USD 42 million, nm cc) launch is ongoing, with focus on patient on-boarding, removing access hurdles and enhancing medical education

Ilaris (USD 301 million, +14% cc) showed continued growth across all geographies

Tafinlar + Mekinist (USD 465 million, +8% cc) sales grew across all geographies, driven by demand in BRAF+ adjuvant melanoma and NSCLC indications

Jakavi (USD 388 million, +8% cc) sales grew (cc) mainly in Europe, Emerging Growth Markets and Japan, driven by strong demand in both the myelofibrosis and polycythemia vera indications

Piqray (USD 112 million, +30% cc) sales grew mainly in the US, benefiting from indication expansion into PIK3CA-related overgrowth spectrum (PROS)

Mayzent (USD 99 million, +28% cc) continued to grow in patients with multiple sclerosis showing signs of progression despite being on other treatments

Lutathera (USD 128 million, +15% cc) sales grew across all geographies, with approximately 500 centers actively treating patients globally

Cosentyx (USD 1,080 million, -9% cc), with ex-US growing +5% (cc). US sales growth was impacted by a revenue deduction true-up for Cosentyx (mainly due to higher than expected Medicaid patient mix), which was related to prior quarters in 2022. For the full year, Cosentyx grew +5% (cc) worldwide

Sandoz
Biopharmaceuticals
(USD 517 million, +3% cc) with growth in Europe, Canada and Latin America

Emerging Growth
Markets*
Grew +5% (cc) overall. China declined (-2% cc) to USD 581 million, with sales impacted by COVID-19 related regional lockdowns. For the full year, China grew +6% (cc)

Net sales of the top 20 Innovative Medicines products in 2022

Q4 2022 % change FY 2022 % change
USD m USD cc USD m USD cc
Cosentyx / excl. revenue deduction true-up* 1 080 -13 / -6* -9 / -2* 4 788 1 5
Entresto 1 291 36 44 4 644 31 37
Promacta/Revolade 540 4 11 2 088 4 9
Gilenya 346 -47 -44 2 013 -28 -24
Tasigna 475 -6 0 1 923 -7 -1
Lucentis 398 -22 -12 1 874 -13 -4
Tafinlar + Mekinist 465 2 8 1 770 5 11
Jakavi 388 -5 8 1 561 -2 9
nm= not meaningful
___

Zolgensma 309 -10 -5 1 370 1 5
Xolair 323 -13 -3 1 365 -4 6
Sandostatin 305 -12 -8 1 238 -12 -10
Kisqali 357 25 33 1 231 31 38
Ilaris 301 6 14 1 133 7 15
Kesimpta 369 151 157 1 092 194 200
Galvus Group 209 -25 -16 859 -21 -12
Gleevec/Glivec 175 -25 -18 745 -27 -22
Exforge Group 159 -19 -12 743 -18 -12
Diovan Group 142 -25 -16 652 -16 -9
Kymriah 139 -3 5 536 -9 -2
Afinitor/Votubia 106 -39 -32 512 -45 -41
Top 20 products total 7 877 -4 2 32 137 -1 5
* Sales growth with/without true-up: US Cosentyx sales growth was impacted by a revenue deduction true-up (mainly
due to higher than expected Medicaid patient mix), which was related to prior quarters in 2022

R&D update – key developments from the fourth quarter

New approvals

Pluvicto EC approval for treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen-receptor pathway inhibition and taxane-based chemotherapy
Results from ongoing trials and other highlights

Pluvicto Ph3 PSMAfore trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in radiographic PFS in patients with PSMApositive mCRPC who have been treated with androgen-receptor pathway inhibition. No unexpected safety findings were observed. Detailed data to be presented at an upcoming medical meeting with submission to regulatory authorities for approval planned for 2023

Iptacopan Ph3 APPLY-PNH study met both primary and most secondary endpoints demonstrating iptacopan’s superiority over anti-C5 treatment in adult PNH patients with residual anemia despite prior anti-C5 treatment. Iptacopan demonstrated an 80% difference to anti-C5 in the estimated proportion of patients achieving ≥2 g/dL Hb-level increases from baseline and a 67% difference to anti-C5 in the estimated proportion of patients achieving ≥12 g/dL Hb levels without the need for red blood cell transfusions. Iptacopan also provided blood-transfusion independence for almost all patients with no serious cases of breakthrough hemolysis and clinically meaningful patient-reported fatigue improvements. Data presented at ASH (Free ASH Whitepaper) 2022 Ph3 APPOINT-PNH study (evaluating iptacopan in complement-inhibitor-naïve PNH patients) met its primary endpoint. With iptacopan, a significant proportion of patients achieved clinically meaningful Hb-level increases of ≥2 g/dL from baseline without the need for blood transfusions at 24 weeks. Detailed data to be presented at an upcoming medical meeting and included in iptacopan PNH global regulatory submissions planned in 2023

Kisqali Ph2 RIGHT Choice trial demonstrated approximately one year PFS benefit of Kisqali plus ET over combination chemotherapy (24 months compared to 12.3 months; HR=0.54; p=.0007) in the 1L setting for pre- and perimenopausal patients with aggressive forms of HR+/HER2− mBC, including patients with visceral crisis.

RIGHT Choice is the first randomized study comparing a CDK4/6i plus ET vs. combination CT in aggressive HR+/HER2− mBC. Data presented at SABCS 2022

Leqvio New long-term data from the ORION-3 open-label study demonstrated effective and sustained reductions in LDL cholesterol over four years of treatment. At any

time throughout the trial, approximately 80% of patients reached an LDL-C level of <70mg/dL. Data presented at AHA 2022

Ganaplacide/
lumefantrine-SDF
combination

Novartis and Medicines for Malaria Venture announced that ganaplacide/ lumefantrine would advance to a Ph3 study in patients with acute uncomplicated malaria due to Plasmodium falciparum

Branaplam Novartis ended the development of branaplam in Huntington’s Disease based onan overall assessment of potential benefit-risk from the Ph2b VIBRANT-HD study

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.

In 2022, Novartis repurchased a total of 126.2 million shares for USD 10.8 billion on the SIX Swiss Exchange second trading line, including 115.3 million shares (USD 9.9 billion) under the up-to USD 15 billion share buyback announced in December 2021 and 10.9 million shares (USD 0.9 billion) to mitigate dilution related to participation plans of associates. In addition, 1.4 million shares (USD 0.1 billion) were repurchased from associates. In the same period, 12.3 million shares (for an equity value of USD 0.9 billion) were delivered as a result of option exercises and share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 115.3 million versus December 31, 2021. These treasury share transactions resulted in a decrease in equity of USD 10.0 billion and a net cash outflow of USD 10.6 billion.

As of December 31, 2022, the net debt increased to USD 7.2 billion compared to USD 0.9 billion at December 31, 2021. The increase was mainly due to the USD 7.5 billion annual dividend payment and the net cash outflow for treasury share transactions of USD 10.6 billion, partially offset by USD 11.9 billion free cash flow during 2022.

As of Q4 2022, the long-term credit rating for the company is A1 with Moody’s Investors Service and AAwith S&P Global Ratings.

2023 outlook

Barring unforeseen events; growth vs prior year in cc

Innovative Medicines Sales expected to grow low-to-mid single digit Core OpInc expected to grow mid-to-high single digit

Novartis ex. Sandoz
(IM + Corporate)
Sales expected to grow low-to-mid single digit Core OpInc expected to grow mid-to-high single digit

Novartis incl. Sandoz
(IM + Sandoz + Corporate)*
Sales expected to grow low-to-mid single digit Core OpInc expected to grow mid single digit

* Novartis Group guidance, assuming Sandoz would remain within the Group for the entire FY 2023

Barring unforeseen events; growth vs prior year in cc

Sandoz Sales expected to grow low-to-mid single digit Core OpInc expected to decline low double digit, reflecting required stand-up investments to transition Sandoz to a separate company and continued inflationary pressures

Our guidance assumes that we see a continuing return to normal global healthcare systems, including prescription dynamics, and that no Sandostatin LAR generics enter in the US in 2023. We continue to expect that the planned Sandoz spin-off is completed in H2 2023.

Foreign exchange impact
If late-January exchange rates prevail for the remainder of 2023, the foreign exchange impact for the year would be zero to positive 1 percentage points on net sales and negative 1 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

Annual General Meeting

Dividend proposal

The Novartis Board of Directors proposes a dividend payment of CHF 3.20 per share for 2022, up 3.2% from CHF 3.10 per share in the prior year, representing the 26th consecutive dividend increase since the creation of Novartis in December 1996. Shareholders will vote on this proposal at the Annual General Meeting on March 7, 2023.

Reduction of share Capital

The Novartis Board of Directors proposes to cancel 126 243 500 shares (repurchased under the authorizations of March 2, 2021 and March 4, 2022) and to reduce the share capital accordingly by CHF 63.1 million, from CHF 1 201 860 626 to CHF 1 138 738 876.

Potential further share repurchases

As of December 31, 2022, the remaining available amount under the existing shareholder authorities granted at the 2021 and 2022 annual general meetings is CHF 8.3 billion. To allow for the full execution of the already announced share buyback of up to USD 15 billion and potential additional share buybacks, the Board of Directors proposes that shareholders, in addition to the remaining authorization of CHF 8.3 billion, authorize the Board of Directors to repurchase shares as deemed appropriate from time to time up to a maximum of CHF 10 billion between the 2023 Annual General Meeting and the 2026 Annual General Meeting.

Nomination for election to the Board of Directors

The Novartis Board of Directors announced today that it is nominating John D. Young for election to the Board. He retired from Pfizer in June 2022 where he held several senior positions over more than 30 years and served as a member of Pfizer’s Executive Leadership Team since 2012. John successfully led and developed multi-ten-billion dollar global businesses and brings a wealth of industry experience in leadership, strategy, business development and commercialization of innovative medicines to the Board of Directors. John D. Young currently serves on the Boards of Johnson Controls International, Haleon PLC, Arvinas Inc, and privately held biotech, Imbria Pharmaceuticals.

Re-elections of the Board Chair and the members of the Board of Directors

The Novartis Board of Directors proposes the re-election of Joerg Reinhardt (also as Board Chair), Nancy C. Andrews, Ton Buechner, Patrice Bula, Elizabeth Doherty, Bridgette Heller, Frans van Houten, Daniel Hochstrasser, Simon Moroney, Ana de Pro Gonzalo, Charles L. Sawyers, and William T. Winters as members of the Board of Directors.

Andreas von Planta has already announced that he will not stand for re-election. The Board of Directors and the Executive Committee of Novartis thank him for many years of distinguished services on the Board and his outstanding contributions to the company.

Re-elections and elections to the Compensation Committee

The Novartis Board of Directors proposes the re-election of Patrice Bula, Bridgette Heller, Simon Moroney, and William T. Winters as members of the Compensation Committee. The Board of Director intends to designate Simon Moroney again as Chairman of the Compensation Committee.

Key figures1
Excluding Roche income Reported
Group Q4 2022 Q4 2021 % change Q4 2021 % change
USD m USD m USD cc USD m USD cc
Net sales 12 690 13 229 -4 3 13 229 -4 3
Operating income 1 949 2 562 -24 -14 2 562 -24 -14
As a % of sales 15.4 19.4 19.4
Core operating income 4 030 3 819 6 15 3 819 6 15
As a % of sales 31.8 28.9 28.9
Net income 1 466 1 671 -12 2 16 306 -91 -90
EPS (USD) 0.69 0.75 -8 7 7.29 -91 -89
Core net income 3 251 3 044 7 17 3 135 4 14
Core EPS (USD) 1.52 1.36 12 23 1.40 9 19
Cash flows from
operating activities 4 111 3 884 6 3 884 6
Free cash flow 3 552 3 027 17 3 027 17
Innovative Medicines Q4 2022 Q4 2021 % change USD m USD m USD cc
Net sales 10 360 10 704 -3 3
Operating income 1 945 2 468 -21 -12
As a % of sales 18.8 23.1 Core operating income 3 768 3 596 5 14
As a % of sales 36.4 33.6

Sandoz Q4 2022 Q4 2021 % change USD m USD m USD cc
Net sales 2 330 2 525 -8 0
Operating income 273 386 -29 -20
As a % of sales 11.7 15.3
Core operating income 391 528 -26 -18
As a % of sales 16.8 20.9

Corporate Q4 2022 Q4 2021 % change USD m USD m USD cc
Operating loss -269 -292 8 2 Core operating loss -129 -305 58 57
Excluding Roche income Reported
Group FY 2022 FY 2021 % change FY 2021 % change
USD m USD m USD cc USD m USD cc
Net sales 50 545 51 626 -2 4 51 626 -2 4
Operating income 9 197 11 689 -21 -13 11 689 -21 -13
As a % of sales 18.2 22.6 22.6
Core operating income 16 665 16 588 0 8 16 588 0 8
As a % of sales 33.0 32.1 32.1
Net income 6 955 8 661 -20 -9 24 018 -71 -67
EPS (USD) 3.19 3.86 -17 -7 10.71 -70 -66
Core net income 13 352 13 099 2 11 14 094 -5 3
Core EPS (USD) 6.12 5.84 5 14 6.29 -3 6
Cash flows from
operating activities 14 236 14 549 -2 15 071 -6
Free cash flow 11 945 12 760 -6 13 282 -10

Innovative Medicines FY 2022 FY 2021 % change
USD m USD m USD cc
Net sales 41 296 41 995 -2 4 Operating income 8 786 10 688 -18 -9
As a % of sales 21.3 25.5
Core operating income 15 237 15 215 0 8
As a % of sales 36.9 36.2

Sandoz FY 2022 FY 2021 % change USD m USD m USD cc
Net sales 9 249 9 631 -4 4
Operating income 1 448 1 600 -10 -2
As a % of sales 15.7 16.6 Core operating income 1 903 2 064 -8 -1 As a % of sales 20.6 21.4

Corporate FY 2022 FY 2021 % change USD m USD m USD cc
Operating loss -1 037 -599 -73 -84
Core operating loss -475 -691 31 28