On July 18, 2024 AVEO Oncology, an LG Chem company ("AVEO"), reported that the TiNivo-2 Phase 3 clinical trial in patients with advanced metastatic renal cell carcinoma (RCC) whose tumors had progressed following prior immune checkpoint inhibitor (ICI) treatment did not meet the primary endpoint of increasing progression free survival (PFS) when nivolumab was added to low dose (0.89 mg) FOTIVDA (tivozanib) (Press release, AVEO, JUL 18, 2024, View Source [SID1234644961]). Importantly, the clinical trial’s control arm using FOTIVDA as monotherapy at the standard dose (1.34 mg) demonstrated a clinically meaningful outcome in median PFS in the second-line following ICI combination therapy. These results build on the prior ICI dataset from the TIVO-3 clinical trial, FOTIVDA’s pivotal phase 3 study, and further support the approved use of FOTIVDA as a safe and effective treatment option in relapsed or refractory advanced RCC following two or more prior systemic therapies.

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 results from the TiNivo-2 clinical trial are consistent with other recent RCC phase 3 trials in a similar patient population, making this the second phase 3 clinical trial to suggest that there is no clinical benefit derived from rechallenging RCC patients with immunotherapy after receiving ICI beyond progression on previous ICIs.

"The PFS and safety of the FOTIVDA control arm in the second-line following ICI combinations adds to the growing body of evidence of the importance of a highly selective anti-VEGFR TKI therapy as an effective, well-tolerated treatment option for relapsed or refractory RCC patients treated with prior ICI combination therapy," says Michael P. Bailey, AVEO Oncology Chief Executive Officer and President. "While the addition of an ICI to low dose FOTIVDA did not improve PFS outcomes after prior ICI, we consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations."

Toni Choueiri, M.D., Director of the Lank Center for Genitourinary Oncology, Director of the Kidney Cancer Center at Dana-Farber Cancer Institute, Jerome and Nancy Kohlberg Chair and Professor of Medicine at Harvard Medical School, and lead investigator comments, "The PFS and safety results from the control arm support tivozanib as an effective and well-tolerated treatment option in the second-line following an ICI combination as prior systemic therapy."

The TiNivo-2 clinical trial was designed to evaluate the benefit of adding nivolumab, a PD-1 checkpoint inhibitor, to low dose FOTIVDA versus standard dose FOTIVDA in the second-line following ICI combinations or the third-line setting following prior ICI. The TiNivo-2 clinical trial enrolled patients across clinical sites in North America, Latin America, and Europe. Patients with RCC who progressed after receiving immunotherapy were randomized to either tivozanib single agent or in combination with nivolumab. The trial’s primary outcome was progression free survival; secondary endpoints included overall survival, overall response rate, duration of response, and safety.

Detailed findings are expected to be presented at an upcoming medical meeting.

TiNivo-2 Clinical Trial Details
Phase 3 clinical trial designed to evaluate the safety and efficacy of tivozanib in combination with nivolumab, as compared to tivozanib as a monotherapy, in RCC patients whose tumors have progressed following prior immune checkpoint inhibitor therapy, known as the TiNivo-2 trial.

About FOTIVDA (tivozanib)
FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021, for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies, based on data from the TIVO-3 trial comparing FOTIVDA to sorafenib. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner Recordati UK Ltd. for the treatment of adult patients with advanced RCC. FOTIVDA was discovered by Kyowa Kirin.

IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTION

Hypertension and Hypertensive Crisis: Hypertension was reported in 45% of FOTIVDA-treated patients with 22% of the events ≥Grade 3. Hypertensive crises were reported in 0.8% of patients. Do not initiate FOTIVDA in patients with uncontrolled hypertension. Monitor for hypertension and treat as needed. Reduce the FOTIVDA dose for persistent hypertension not controlled by anti-hypertensive medications. Discontinue FOTIVDA for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Cardiac Failure: Cardiac failures were reported in 1.6% of FOTIVDA-treated patients, with 1% of events reported as ≥Grade 3; 0.6% of events were fatal. Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA. Manage with dose interruption, dose reduction, or discontinuation.

Cardiac Ischemia and Arterial Thromboembolic Events: Cardiac ischemia in FOTIVDA-treated patients were reported in 3.2%; 0.4% of events were fatal. Arterial thromboembolic events were reported in 2.0% of FOTIVDA-treated patients, including death due to ischemic stroke (0.1%). Closely monitor patients who are at risk for, or who have a history of these events. Discontinue FOTIVDA in patients who develop severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thrombotic Events: Venous thromboembolic events were reported in 2.4% of FOTIVDA-treated patients, including 0.3% fatal events. Closely monitor patients who are at increased risk for these events. Discontinue FOTIVDA in patients who develop serious venous thromboembolic events.

Hemorrhagic Events: Hemorrhagic events were reported in 11% of FOTIVDA-treated patients; 0.2% of events were fatal. FOTIVDA should be used with caution in patients who are at risk for or who have a history of bleeding.

Proteinuria: Proteinuria was reported in 8% of FOTIVDA-treated patients, with 2% Grade 3. Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or interrupt treatment with FOTIVDA. Discontinue FOTIVDA in patients who develop nephrotic syndrome.

Thyroid Dysfunction: Thyroid dysfunction events were reported in 11% of FOTIVDA-treated patients, with 0.3% of events reported as ≥Grade 3. Monitor thyroid function before initiation and throughout treatment with FOTIVDA.

Wound Healing Complications: Withhold FOTIVDA for at least 24 days prior to elective surgery. Do not administer FOTIVDA for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by MRI, can occur with FOTIVDA. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-fetal Toxicity: FOTIVDA can cause fetal harm. Advise patients of the potential risk to a fetus, to avoid becoming pregnant and to use contraception during treatment and for one month after the last dose of FOTIVDA. Advise males with female partners of reproductive potential to use effective contraception during treatment and for one month after the last dose of FOTIVDA.

Allergic Reaction to Tartrazine: FOTIVDA 0.89 mg capsule contains FD&C Yellow No. 5 (tartrazine) as an imprint ink which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

The most commonly reported (≥20%) adverse reactions were: fatigue/asthenia, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis. Serious adverse reactions reported in >2% of patients included bleeding (3.5%), venous thromboembolism (3.5%), arterial thromboembolism (2.9%), acute kidney injury (2.3%), and hepatobiliary disorders (2.3%).

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during FOTIVDA treatment and for at least 1 month after the last dose.

Renal Impairment: The recommended dosage for patients with end-stage renal disease has not been established.

Hepatic Impairment: Reduce the FOTIVDA dose for patients with moderate hepatic impairment. The recommended dosage in patients with severe hepatic impairment has not been established.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see full Prescribing Information for FOTIVDA (tivozanib).

On July 18, 2024 Illumina, Inc. (NASDAQ: ILMN) reported that as previously announced on June 24, the company will present a Strategy Update on Tuesday, August 13, 2024 starting at 8:00am Pacific Time (Press release, Illumina, JUL 18, 2024, View Source [SID1234644960]). The event will feature presentations by members of Illumina’s executive team and conclude with a Q&A session.

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!

Webcast Details

The webcast can be accessed through the Events & Presentations section of Illumina’s Investor Relations website at investor.illumina.com. We recommend that participants pre-register for the event on our website or using the following link: Illumina 2024 Strategy Update Registration. A replay will be posted on Illumina’s Investor Relations website after the event and will be available for at least 30 days following.

On July 18, 2024 Harbour BioMed (the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, reported a positive profit alert for the six months ended June 30, 2024 (the "Reporting Period") (Press release, Harbour BioMed, JUL 18, 2024, View Source [SID1234644959]).

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!

Based on a preliminary review of the Company’s unaudited consolidated management accounts for the Reporting Period, total profit is expected to be between US$1 million and US$1.5 million, compared to approximately US$2.9 million for the six months ended June 30, 2023 (the "HY2023"). The anticipated decrease in profit for the Reporting Period is mainly due to a change in the revenue structure. Specifically, the proportion of fees received from the service business as a percentage of total revenue during the Reporting Period has increased compared to HY2023. However, this type of revenue has a relatively slim profit margin compared to the licensing revenue, which constituted a larger proportion of the revenue in HY2023. As a result, the overall profit for the Reporting Period has decreased.

Despite the anticipated decrease in profit for the Reporting Period compared to HY2023, the Company emphasizes that it expects to maintain an overall profit for the Reporting Period. This optimistic outlook is primarily attributable to:

A stable source of income and a diverse revenue mix. The milestone payments received from existing out-licensing and collaboration of innovative products from the Company’s portfolio contributed significantly to the revenue for the Reporting Period.
Various new Licensing and Collaboration Agreements centered on innovative products and cutting-edge antibody discovery technology.
Consistent enhanced cost control in business operations.
Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed, commented: "Our business has shown remarkable resilience and adaptability in challenging market conditions, and our global operations continue to open new avenues for future growth. By leveraging Harbour BioMed’s core innovative capabilities, we are confident that we can enhance our value creation worldwide."

On July 18, 2024 OPKO Health, Inc. (NASDAQ: OPK) reported that its Board of Directors has authorized the repurchase of up to $100 million of shares of the Company’s common stock (Press release, Opko Health, JUL 18, 2024, View Source [SID1234644958]). Under the repurchase program, OPKO may repurchase shares of its common stock from time to time through open market purchases, block trades, privately negotiated transactions, accelerated share repurchase transactions and/or pursuant to Rule 10b5-1 plans, in compliance with applicable securities laws and other legal requirements.

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!

OPKO currently expects to fund the repurchase program from existing cash and cash equivalents, and future cash flows. The Company had approximately 697 million shares outstanding as of June 30, 2024. This new authorization represents approximately 10.1% of shares outstanding at the current stock price.

"We believe OPKO’s shares are significantly undervalued and offer an attractive investment opportunity. Buying back shares supports our conviction in OPKO’s strategy as we continue to advance our pipeline in the clinic and streamline our diagnostic segment on a path to profitability," said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO. "With the recent non-dilutive capital transaction with HealthCare Royalty and prior convertible debt refinancing, our balance sheet provides us with the financial flexibility for this repurchase program, which reflects our commitment to drive long-term value for our shareholders."

The volume and timing of any repurchases will be subject to general market conditions, as well as the Company’s management of capital, other investment opportunities and other factors. The repurchase program does not obligate the Company to repurchase any specific number of shares, has no time limit and may be modified, suspended or discontinued at any time at the Company’s discretion.

On July 18, 2024 reporting on Q2 2024 results, Vas Narasimhan, CEO of Novartis, said (Press release, Novartis, JUL 18, 2024, View Source [SID1234644957]):

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!

"Novartis delivered a strong Q2, with net sales up 11% and core operating income margin approaching 40%. Our performance reflects continued strong momentum of our key growth drivers, both in the US and ex-US, which has allowed us to upgrade our FY2024 guidance. We also advanced our pipeline in Q2, completing submissions to the FDA for Scemblix in first-line CML and atrasentan in IgAN, generating updated data in the NATALEE study to support the strong profile of Kisqali in eBC, and executing multiple deals to expand our pipeline in RLT and prostate cancer. We remain on track to achieve our mid-term sales growth (+5% cc CAGR 2023-2028) and margin (40%+ by 2027) guidance."

Key figures
Continuing operations3

Q2 2024
Q2 2023
% change
H1 2024
H1 2023
% change

USD m
USD m
USD
cc

USD m
USD m
USD
cc
Net sales
12 512
11 437
9
11

24 341
22 235
9
11
Operating income
4 014
2 807
43
47

7 387
5 425
36
43
Net income
3 246
2 271
43
49

5 934
4 421
34
43
EPS (USD)
1.60
1.09
47
52

2.91
2.12
37
47
Free cash flow
4 615
3 292
40

6 653
5 976
11

Core operating income
4 953
4 240
17
19

9 490
8 146
16
21
Core net income
4 008
3 502
14
18

7 689
6 735
14
19
Core EPS (USD)
1.97
1.69
17
21

3.77
3.23
17
22

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 43 of the Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year. 2. Please see detailed guidance assumptions on page 7. 3. As defined on page 33 of the Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities and Discontinued operations include operational results from the Sandoz business.

Strategy

Our focus

In 2023, Novartis completed its transformation into a "pure-play" innovative medicines business. We have a clear focus on four core therapeutic areas (cardiovascular-renal-metabolic, immunology, neuroscience and oncology), 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.

Financials

Following the September 15, 2023, shareholder approval of the spin-off of Sandoz, Novartis reported its consolidated financial statements as "continuing operations" and "discontinued operations."

Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities. Discontinued operations include the Sandoz Division and selected portions of corporate activities attributable to Sandoz’s business, as well as certain expenses related to the spin-off.

While the commentary below focuses on continuing operations, we also provide information on discontinued operations.

Continuing operations

Second quarter

Net sales were USD 12.5 billion (+9%, +11% cc), with volume contributing 15 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing had a negative impact of 2 percentage points.

Operating income was USD 4.0 billion (+43%, +47% cc), mainly driven by higher net sales and lower impairments, partly offset by higher R&D investments.

Net income was USD 3.2 billion (+43%, +49% cc), mainly driven by higher operating income. EPS was USD 1.60 (+47%, +52% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 5.0 billion (+17%, +19% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 39.6% of net sales, increasing 2.5 percentage points (+2.7 percentage points cc).

Core net income was USD 4.0 billion (+14%, +18% cc), mainly due to higher core operating income. Core EPS was USD 1.97 (+17%, +21% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow from continuing operations amounted to USD 4.6 billion (+40% USD), compared with USD 3.3 billion in the prior-year quarter, driven by higher net cash flows from operating activities from continuing operations.

First half

Net sales were USD 24.3 billion (+9%, +11% cc), with volume contributing 15 percentage points to growth. Generic competition had a negative impact of 2 percentage points and pricing had negative impact of 2 percentage points.

Operating income was USD 7.4 billion (+36%, +43% cc), mainly driven by higher net sales and lower impairments and restructuring charges, partly offset by a prior-year one-time income from legal matters.

Net income was USD 5.9 billion (+34%, +43% cc), mainly driven by higher operating income. EPS was USD 2.91 (+37%, +47% cc), benefiting from the lower weighted average number of shares outstanding.

Core operating income was USD 9.5 billion (+16%, +21% cc), mainly driven by higher net sales, partly offset by higher R&D investments. Core operating income margin was 39.0% of net sales, increasing 2.4 percentage points (+3.1 percentage points cc).

Core net income was USD 7.7 billion (+14%, +19% cc), mainly due to higher core operating income. Core EPS was USD 3.77 (+17%, +22% cc), benefiting from the lower weighted average number of shares outstanding.

Free cash flow from continuing operations amounted to USD 6.7 billion (+11% USD), compared with USD 6.0 billion in the prior-year period, driven by higher net cash flows from operating activities from continuing operations.

Discontinued operations

Discontinued operations include the Sandoz generic pharmaceuticals and biosimilars division, certain corporate activities attributable to Sandoz and certain other expenses related to the spin-off of the Sandoz business.

Second quarter

As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the second quarter of 2024 related to discontinued operations. In the second quarter of 2023, discontinued operations net sales were USD 2.4 billion, operating income amounted to USD 113 million and net income from discontinued operations was USD 46 million. For further details see Note 3 "Significant acquisition of businesses and spin-off of Sandoz business" and Note 11 "Discontinued operations" to the condensed interim consolidated financial statements.

First half

As the Sandoz spin-off was completed on October 3, 2023, there were no operating results in the first half 2024 related to discontinued operations. In the first half 2023, discontinued operations net sales were USD 5.0 billion, operating income amounted to USD 351 million and net income from discontinued operations was USD 190 million. For further details see Note 3 "Significant acquisition of businesses and spin-off of Sandoz business" and Note 11 "Discontinued operations" to the condensed interim consolidated financial statements.

Total Company

Second quarter

Total Company net income was USD 3.2 billion in 2024, compared to USD 2.3 billion in 2023 and basic EPS was USD 1.60 compared to USD 1.11 in prior year quarter. Net cash flows from operating activities for total Company amounted to USD 4.9 billion and free cash flow amounted to USD 4.6 billion.

First half

Total Company net income was USD 5.9 billion in 2024, compared to USD 4.6 billion in 2023 and basic EPS was USD 2.91 compared to USD 2.20 in prior year. Net cash flows from operating activities for total Company amounted to USD 7.1 billion and free cash flow amounted to USD 6.7 billion.

Q2 key growth drivers

Underpinning our financial results in the quarter is a continued focus on key growth drivers (ranked in order of contribution to Q2 growth) including:

Entresto
(USD 1 898 million, +28% cc) sustained robust demand-led growth, with increased penetration in the US and Europe following guideline-directed medical therapy in heart failure, as well as in China with increased penetration in hypertension
Kesimpta
(USD 799 million, +65% cc) sales grew across all regions reflecting increased demand and strong access for a high efficacy product with convenient self-administered dosing
Cosentyx
(USD 1 526 million, +22% cc) sales grew mainly in the US, driven by recent launches (including the HS indication and the IV formulation in the US) in addition to volume growth in core indications
Kisqali
(USD 717 million, +50% cc) sales grew strongly across all regions, based on increasing recognition of its overall survival benefit in HR+/HER2- advanced breast cancer and Category 1 NCCN guidelines recommendation
Leqvio
(USD 182 million, +134% cc) continued to show steady growth, with a focus on increasing account and patient adoption, growing customer confidence in acquisition and access, and continuing medical education
Pluvicto
(USD 345 million, +44% cc) grew in the US and Europe. With supply now unconstrained, the focus is on increasing share in established RLT sites, opening new sites and referral pathways, and initiating new patients
Xolair
(USD 427 million, +22% cc) growth was driven mainly by emerging growth markets and Europe
Ilaris
(USD 368 million, +20% cc) sales grew across all regions, mainly US and Europe
Scemblix
(USD 164 million, +56% cc) sales grew across all regions, demonstrating the high unmet need in later lines of CML
Jakavi
(USD 471 million, +13% cc) sales grew across all regions, with strong demand in both myelofibrosis and polycythemia vera indications
Tafinlar + Mekinist
(USD 523 million, +9% cc) sales grew in all regions, led by emerging growth markets
Lutathera
(USD 175 million, +17% cc) sales grew across all regions due to increased demand, following the presentation of NETTER-2 results in 1L GEP-NET
Fabhalta
(USD 22 million) continued to show encouraging early launch indicators in the US, as the first oral monotherapy approved for PNH patients
Emerging Growth Markets*
Grew +16% (cc) overall. China grew +27% (cc) to USD 1.1 billion, mainly driven by Entresto and Xolair
*All markets except the US, Canada, Western Europe, Japan, Australia, and New Zealand

Net sales of the top 20 brands in Q2 2024

Q2 2024
% change
H1 2024
% change

USD m
USD
cc
USD m
USD
cc
Entresto
1 898
25
28
3 777
30
32
Cosentyx
1 526
20
22
2 852
21
23
Kesimpta
799
63
65
1 436
64
66
Kisqali
717
45
50
1 344
48
52
Promacta/Revolade
544
-7
-5
1 064
-6
-4
Tafinlar + Mekinist
523
5
9
997
5
7
Jakavi
471
8
13
949
12
15
Tasigna
446
-6
-4
841
-10
-9
Xolair
427
18
22
826
15
18
Ilaris
368
16
20
724
12
17
Sandostatin Group
313
-5
-4
668
1
3
Pluvicto
345
44
44
655
45
45
Zolgensma
349
12
14
644
4
6
Lucentis
275
-30
-28
589
-27
-26
Exforge Group
178
-3
1
370
0
3
Lutathera
175
17
17
344
15
16
Leqvio
182
133
134
333
135
137
Gilenya
138
-49
-47
313
-38
-36
Scemblix
164
55
56
300
65
67
Diovan Group
160
3
9
300
-4
1
Top 20 brands total
9 998
15
18
19 326
16
18

R&D update – key developments from the second quarter

New approvals
Fabhalta
(iptacopan)
EU, Japan and China approval for the treatment of adults with the rare blood disorder paroxysmal nocturnal hemoglobinuria (PNH).
Lutathera
(lutetium Lu 177 dotatate)
FDA approval for the treatment of pediatric patients (≥12 years) with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Regulatory updates
Scemblix
(asciminib)
FDA granted Breakthrough Therapy designation to Scemblix for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP).

FDA submission for first-line CML is completed and under Real-Time Oncology Review.
Atrasentan
FDA filing accepted for the treatment of adult patients with IgA nephropathy (IgAN).

Lutathera
(lutetium Lu 177 dotatate)
EU filing accepted for the treatment of newly diagnosed, unresectable or metastatic, well-differentiated (G2 and G3), somatostatin receptor-positive GEP-NETs in adults.

Results from ongoing trials and other highlights
Scemblix
(asciminib)
In the Phase III ASC4FIRST study, Scemblix demonstrated superior major molecular response rates at week 48 vs investigator-selected standard-of-care tyrosine kinase inhibitors (TKIs) (67.7% vs 49.0%) and vs imatinib alone (69.3% vs 40.2%) in adults with newly diagnosed Ph+ CML-CP. Scemblix also demonstrated a favorable safety and tolerability profile. These results have been submitted to the FDA under Real-Time Oncology Review. Data presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) 2024 and published in the New England Journal of Medicine.
Kisqali
(ribociclib)
New analyses following the end of Kisqali treatment for all patients in the Phase III NATALEE study in HR+/HER2- early breast cancer showed a continued clinically meaningful benefit with a consistent safety profile. Results to be presented at an upcoming medical meeting.

In addition, a subgroup analysis from the NATALEE study at the time of final iDFS data cut-off showed the addition of Kisqali to endocrine therapy in patients with high-risk node-negative (N0) disease resulted in a 28% risk reduction in iDFS. The efficacy, safety and tolerability profile observed in the high-risk N0 subgroup​ is consistent with the overall NATALEE study population. Data presented at ASCO (Free ASCO Whitepaper) 2024.
Fabhalta
(iptacopan)
Phase III APPEAR-C3G data showed a 35.1% proteinuria reduction vs placebo at 6 months for C3G patients treated with Fabhalta in addition to supportive care. Secondary endpoint data for estimated glomerular filtration rate showed numerical improvement over 6 months vs placebo. The study also showed Fabhalta has a favorable safety profile with no new safety signals. Submissions to the FDA and EMA for the adult C3 glomerulopathy indication are planned for H2 2024. Data presented at ERA 2024.

Phase III APPLAUSE-IgAN data showed a 38.3% proteinuria reduction at nine months vs placebo for patients with IgAN. Fabhalta was well tolerated with a favorable safety profile consistent with previously reported data. Data presented at WCN 2024.
Atrasentan
Results from a pre-specified interim analysis of Phase III ALIGN data showed patients treated with atrasentan, in addition to supportive care with a renin-angiotensin system inhibitor, achieved a statistically significant 36.1% reduction in proteinuria vs placebo on top of supportive care at 36 weeks. Results presented at ERA 2024.
Remibrutinib
Phase III REMIX-1 and REMIX-2 data showed sustained efficacy and long-term safety of oral remibrutinib in chronic spontaneous urticaria (CSU) patients, with improvements in weekly urticaria activity scores observed as early as week 1 and sustained to week 52. Across both studies, remibrutinib demonstrated a favorable and consistent safety profile up to one year, including balanced liver function tests vs placebo. Novartis plans to submit remibrutinib for regulatory approval in 2025. Data presented at EAACI 2024.
Coartem (artemether- lumefantrine)
Phase II/III CALINA study data demonstrated that an optimized dose of Coartem developed for babies weighing <5kg with malaria has the required pharmacokinetic profile and good efficacy and safety. Data presented at the Multilateral Initiative on Malaria Pan-African Malaria Conference 2024.
Deals
In line with our strategic focus on oncology, Novartis acquired >90% of the total share capital of MorphoSys AG, adding to our pipeline pelabresib, a late-stage investigational BET inhibitor for myelofibrosis, and tulmimetostat, an early-stage investigational dual inhibitor of EZH2 and EZH1 for solid tumors or lymphomas.

Novartis acquired Mariana Oncology, a biotech company focused on developing novel radioligand therapies (RLTs) across a range of solid tumors. The acquisition brings a robust portfolio of RLT programs, including MC-339, an actinium-based RLT being investigated in small cell lung cancer.

Novartis expanded its peptide discovery collaboration with PeptiDream. Under the multi-program agreement, PeptiDream will identify and optimize novel macrocyclic peptides against targets selected by Novartis, for potential application in RLT.

Novartis signed an exclusive strategic license agreement with Arvinas for the worldwide development and commercialization of ARV-766, a second generation PROTAC androgen receptor (AR) degrader, complementing our RLT platform in prostate cancer.

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 2024, Novartis repurchased a total of 26.7 million shares for USD 2.7 billion on the SIX Swiss Exchange second trading line. These purchases included 25.9 million shares (USD 2.6 billion) under the up-to USD 15 billion share buyback announced in July 2023 (with up to USD 10.1 billion still to be executed). In addition, 0.8 million shares (USD 0.1 billion) were repurchased to mitigate dilution related to participation plans of associates, with the remainder of repurchases for this purpose to be executed in H2 2024. Further, 1.1 million shares (for an equity value of USD 0.1 billion) were repurchased from associates. In the same period, 8.4 million shares (for an equity value of USD 0.5 billion) were delivered as a result of share deliveries related to participation plans of associates. Consequently, the total number of shares outstanding decreased by 19.4 million versus December 31, 2023. These treasury share transactions resulted in an equity decrease of USD 2.3 billion and a net cash outflow of USD 2.7 billion.

As of June 30, 2024, net debt increased to USD 18.8 billion compared to USD 10.2 billion net debt at December 31, 2023. The increase was mainly due to the USD 7.6 billion annual dividend payment, net cash outflow for M&A / intangible assets transactions of USD 5.0 billion and cash outflow for treasury share transactions of USD 2.7 billion, partially offset by USD 6.7 billion free cash flow.

As of Q2 2024, the long-term credit rating for the company is Aa3 with Moody’s Ratings and AA- with S&P Global Ratings.

2024 outlook

Barring unforeseen events; growth vs prior year in cc
Previous guidance
Net sales
Expected to grow high single to low double-digit
(unchanged)
Core operating income
Expected to grow mid- to high teens
(from low double-digit to mid-teens)

Key assumptions:
•
Our guidance assumes that no Entresto generics and no Promacta generics launch in the US in 2024

Foreign exchange impact

If mid-July exchange rates prevail for the remainder of 2024, the foreign exchange impact for the year would be negative 2 to negative 1 percentage points on net sales and negative 3 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.

2025 Annual General Meeting

Nomination for election to the Board of Directors

The Novartis Board of Directors announced today that it is nominating Elizabeth M. McNally, MD, PhD, for election to the Board. Dr. McNally is Director of the Center for Genetic Medicine at Northwestern University, Feinberg School of Medicine, and as a practicing cardiologist and renowned research leader specializing in the genetics of cardiovascular and neuromuscular disorders, her clinical and scientific expertise will add greatly to the Novartis Board of Directors. Dr. McNally completed her MD and PhD at the Albert Einstein College of Medicine, and trained in Internal Medicine and Cardiology at the Brigham and Women’s Hospital at Harvard Medical School. She is a member of the National Academy of Medicine, serves on the Board of the Muscular Dystrophy Association, and is also the Founder and CEO of Ikaika Therapeutics.

Board of Directors announcements

The Board also noted Charles L. Sawyers and William T. Winters will not stand for re-election at the AGM 2025 in accordance with the 12-year term limit. The Board of Directors and the Executive Committee of Novartis thank them for their outstanding contributions and many years of distinguished service.

Key figures1

Continuing operations2
Q2 2024
Q2 2023
% change

H1 2024
H1 2023
% change

USD m
USD m
USD
cc

USD m
USD m
USD
cc
Net sales
12 512
11 437
9
11

24 341
22 235
9
11
Operating income
4 014
2 807
43
47

7 387
5 425
36
43
As a % of sales
32.1
24.5

30.3
24.4

Net income
3 246
2 271
43
49

5 934
4 421
34
43
EPS (USD)
1.60
1.09
47
52

2.91
2.12
37
47
Cash flows from
operating activities
4 875
3 517
39

7 140
6 369
12

Non-IFRS measures

Free cash flow
4 615
3 292
40

6 653
5 976
11

Core operating income
4 953
4 240
17
19

9 490
8 146
16
21
As a % of sales
39.6
37.1

39.0
36.6

Core net income
4 008
3 502
14
18

7 689
6 735
14
19
Core EPS (USD)
1.97
1.69
17
21

3.77
3.23
17
22


Discontinued operations2
Q2 2024
Q2 2023
% change

H1 2024
H1 2023
% change

USD m
USD m
USD
cc

USD m
USD m
USD
cc
Net sales

2 449
nm
nm

4 952
nm
nm
Operating income

113
nm
nm

351
nm
nm
As a % of sales

4.6

7.1

Net income

46
nm
nm

190
nm
nm
Non-IFRS measures

Core operating income

428
nm
nm

935
nm
nm
As a % of sales

17.5

18.9

Total Company
Q2 2024
Q2 2023
% change

H1 2024
H1 2023
% change

USD m
USD m
USD
cc

USD m
USD m
USD
cc
Net income
3 246
2 317
nm
nm

5 934
4 611
nm
nm
EPS (USD)
1.60
1.11
nm
nm

2.91
2.20
nm
nm
Cash flows from
operating activities
4 875
3 576
nm
nm

7 140
6 533
nm
nm
Non-IFRS measures

Free cash flow
4 615
3 275
nm
nm

6 653
5 995
nm
nm
Core net income
4 008
3 811
nm
nm

7 689
7 425
nm
nm
Core EPS (USD)
1.97
1.83
nm
nm

3.77
3.54
nm
nm
nm=not meaningful

1. Constant currencies (cc), core results and free cash flow are non-IFRS measures. An explanation of non-IFRS measures can be found on page 43 of the Interim Financial Report. Unless otherwise noted, all growth rates in this Release refer to same period in prior year.
2. As defined on page 33 of the Interim Financial Report, Continuing operations include the retained business activities of Novartis, comprising the innovative medicines business and the continuing corporate activities and Discontinued operations include operational results from the Sandoz business.

Detailed financial results accompanying this press release are included in the Interim Financial Report at the link below:
View Source