BeiGene Announces Appointment of Aaron Rosenberg as Chief Financial Officer

On July 18, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported the appointment of Aaron Rosenberg as Chief Financial Officer, effective July 22 (Press release, BeiGene, JUL 18, 2024, View Source [SID1234644949]). Mr. Rosenberg will succeed Julia Wang, who is departing to pursue external opportunities and will stay with the Company through August to support the transition.

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"We are thrilled to welcome Aaron amid a transformational year for BeiGene as we became a top 15 global oncology innovator by revenue with sustained progress to profitability and one of the most prolific and innovative pipelines in our industry including a plan to have at least 10 new molecular entities this year. Aaron’s financial leadership and impressive track record at Merck & Co. will be invaluable as we continue to responsibly scale our business and look to reinforce our global leadership in hematology as well as build future franchises in other highly prevalent cancers, including lung, breast and gastrointestinal," said John V. Oyler, Co-Founder, Chairman and CEO of BeiGene. "We extend our deep gratitude to Julia for her many significant contributions including scaling our financial capabilities to support our growth from 4,000 to over 10,000 employees across five continents, contributing to the launch of BRUKINSA, which is one of the most successful global drug launches in oncology, raising billions of dollars in capital from the global equity markets and helping drive financial excellence to improve operational efficiency. We wish Julia well in her future endeavors."

Mr. Rosenberg is a global finance executive with more than 20 years of experience at Merck & Co., Inc, known as Merck Sharp & Dohme outside of the United States and Canada. He was most recently Senior Vice President and Corporate Treasurer of Merck from 2021.

"I’m honored to join BeiGene at an inflection point in the Company’s growth with the opportunity to further strengthen this resilient global financial organization," said Mr. Rosenberg. "I deeply believe in BeiGene’s mission to develop and deliver innovative cancer medicines to more patients around the world, and I’m excited to be a part of this growing company and its experienced leadership team."

Prior to his role as Corporate Treasurer, Mr. Rosenberg served as Senior Vice President of Corporate Strategy and Planning at Merck from 2018 to 2021 with responsibilities including leading the enterprise-wide business transformation team and acting as Head of Financial Planning & Analysis. Mr. Rosenberg was Vice President and Finance Lead of Merck Animal Health from 2015 to 2018, leading a global team of 120 colleagues. He joined Merck in 2003 in ascending leadership roles in the global finance organization.

Mr. Rosenberg received a Bachelor of Science in Finance from the Warrington College of Business at the University of Florida and a Master of Business Administration from the Leonard N. Stern School of Business at New York University.

Abbott Reports Second-Quarter 2024 Results and Raises Full-Year Guidance

On July 18, 2024 Abbott (NYSE: ABT) reported financial results for the second quarter ended June 30, 2024 (Press release, Abbott, JUL 18, 2024, View Source [SID1234644948]).

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Second-quarter GAAP diluted EPS of $0.74 and adjusted diluted EPS of $1.14, which excludes specified items.
Abbott raised its full-year 2024 EPS guidance range. Abbott projects full-year diluted EPS on a GAAP basis of $3.30 to $3.40 and projects adjusted diluted EPS of $4.61 to $4.71.
Abbott narrowed its full-year 2024 organic sales growth guidance range, excluding COVID-19 testing-related sales, to 9.5% to 10.0%, which represents an increase at the midpoint of the range2.
In April, Abbott announced U.S. Food and Drug Administration (FDA) approval of the Esprit below-the-knee (BTK) system, a breakthrough innovation for people living with peripheral artery disease. This system is designed to keep arteries open and deliver a drug to support vessel healing prior to completely dissolving.
In June, Abbott announced U.S. FDA clearance for two new over-the-counter continuous glucose monitoring systems — Lingo and Libre Rio, which are based on Abbott’s world-leading FreeStyle Libre continuous glucose monitoring technology3.
In June, Abbott obtained CE Mark for its AVEIR dual chamber (DR) leadless pacemaker system, the world’s first dual chamber leadless pacemaker system that treats people with abnormal or slow heart rhythms.
During the first half of 2024, Abbott announced 10 new growth opportunities coming from the company’s highly productive R&D pipeline. These include a combination of new product approvals and new treatment indications.
"We achieved another quarter of strong growth in our underlying base business," said Robert B. Ford, chairman and chief executive officer, Abbott. "We have a lot of positive momentum heading into the second half of the year and are raising our full-year guidance."

SECOND-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, the impact of discontinuing the ZonePerfect product line in the Nutrition business, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI) during the first year post-acquisition, is an appropriate way for investors to best understand the core underlying performance of the business. Management further believes that measuring sales growth rates on an organic basis excluding COVID-19 tests is an appropriate way for investors to best understand underlying base business performance as the COVID-19 pandemic has shifted to an endemic state, resulting in significantly lower demand for COVID-19 tests.

Note: In order to compute results excluding the impact of exchange rates, current year U.S. dollar sales are multiplied or divided, as appropriate, by the current year average foreign exchange rates and then those amounts are multiplied or divided, as appropriate, by the prior year average foreign exchange rates.

Second Quarter 2024 Results (2Q24)

Sales 2Q24 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

3,934

933

812

2,185

International

6,443

1,217

1,383

1,294

2,549

Total reported

10,377

2,150

2,195

1,294

4,734

% Change vs. 2Q23

U.S.

4.7

6.0

(15.5)

n/a

14.2

International

3.6

1.7

1.9

0.6

7.0

Total reported

4.0

3.5

(5.3)

0.6

10.2

Impact of foreign exchange

(3.5)

(3.6)

(3.8)

(7.5)

(2.2)

Impact of business exit and acquisition*

0.1

(0.4)

0.3

Organic

7.4

7.5

(1.5)

8.1

12.1

Impact of COVID-19 testing sales (4)

(1.9)

(7.4)

Organic (excluding COVID-19 tests)

9.3

7.5

5.9

8.1

12.1

U.S.

9.0

6.9

(0.3)

n/a

13.5

International

9.4

7.9

9.5

8.1

10.9

First Half 2024 Results (1H24)

Sales 1H24 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

7,780

1,811

1,743

4,219

International

12,561

2,407

2,666

2,520

4,968

Total reported

20,341

4,218

4,409

2,520

9,187

% Change vs. 1H23

U.S.

1.2

7.0

(24.1)

n/a

14.3

International

4.3

2.4

(1.6)

1.8

10.3

Total reported

3.1

4.3

(11.9)

1.8

12.1

Impact of foreign exchange

(3.2)

(3.1)

(2.9)

(9.0)

(1.7)

Impact of business exit and acquisition*

0.2

(0.2)

0.7

Organic

6.1

7.6

(9.0)

10.8

13.1

Impact of COVID-19 testing sales (4)

(3.9)

(14.7)

Organic (excluding COVID-19 tests)

10.0

7.6

5.7

10.8

13.1

U.S.

9.5

7.5

3.3

n/a

12.8

International

10.3

7.7

7.1

10.8

13.4

Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

*Reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024 and the acquisition of CSI on April 27, 2023. Organic sales growth excludes the impact of the acquired business from January through April 2024.

Nutrition

Second Quarter 2024 Results (2Q24)

Sales 2Q24 ($ in millions)

Total

Pediatric

Adult

U.S.

933

564

369

International

1,217

495

722

Total reported

2,150

1,059

1,091

% Change vs. 2Q23

U.S.

6.0

11.3

(1.2)

International

1.7

(4.4)

6.4

Total reported

3.5

3.4

3.7

Impact of foreign exchange

(3.6)

(1.6)

(5.4)

Impact of business exit*

(0.4)

(0.8)

Organic

7.5

5.0

9.9

U.S.

6.9

11.3

0.8

International

7.9

(1.0)

14.7

Worldwide Nutrition sales increased 3.5 percent on a reported basis and 7.5 percent on an organic basis in the second quarter.

In Pediatric Nutrition, global sales increased 3.4 percent on a reported basis and 5.0 percent on an organic basis. Sales in the U.S. reflect continued market share gains in the infant formula business.

In Adult Nutrition, global sales increased 3.7 percent on a reported basis and 9.9 percent on an organic basis, which was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand.

First Half 2024 Results (1H24)

Sales 1H24 ($ in millions)

Total

Pediatric

Adult

U.S.

1,811

1,078

733

International

2,407

990

1,417

Total reported

4,218

2,068

2,150

% Change vs. 1H23

U.S.

7.0

11.6

0.8

International

2.4

0.7

3.6

Total reported

4.3

6.1

2.6

Impact of foreign exchange

(3.1)

(1.5)

(4.6)

Impact of business exit*

(0.2)

(0.4)

Organic

7.6

7.6

7.6

U.S.

7.5

11.6

1.9

International

7.7

3.7

10.5

*Reflects the impact of discontinuing the ZonePerfect product line. This action was initiated in March 2024.

Diagnostics

Second Quarter 2024 Results (2Q24)

Sales 2Q24 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

812

327

33

107

345

International

1,383

1,002

94

49

238

Total reported

2,195

1,329

127

156

583

% Change vs. 2Q23

U.S.

(15.5)

5.1

(22.5)

8.1

(32.1)

International

1.9

2.1

(4.9)

14.1

2.1

Total reported

(5.3)

2.8

(10.3)

9.9

(21.3)

Impact of foreign exchange

(3.8)

(5.8)

(0.9)

(0.1)

(1.5)

Organic

(1.5)

8.6

(9.4)

10.0

(19.8)

Impact of COVID-19 testing sales (4)

(7.4)

(0.2)

(3.8)

(20.2)

Organic (excluding COVID-19 tests)

5.9

8.8

(5.6)

10.0

0.4

U.S.

(0.3)

5.3

(19.0)

8.1

(6.6)

International

9.5

9.9

14.5

11.0

As expected, Diagnostics sales growth in the second quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales4. Worldwide COVID-19 testing sales were $102 million in the second quarter of 2024 compared to $263 million in the second quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 1.8 percent on a reported basis and 5.9 percent on an organic basis.

Excluding COVID-19 testing-related sales, global Core Laboratory Diagnostics sales increased 3.0 percent on a reported basis and 8.8 percent on an organic basis, led by continued strong adoption of Abbott’s Alinity family of diagnostics systems and testing portfolios.

First Half 2024 Results (1H24)

Sales 1H24 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

1,743

637

75

205

826

International

2,666

1,897

181

90

498

Total reported

4,409

2,534

256

295

1,324

% Change vs. 1H23

U.S.

(24.1)

6.2

(16.3)

6.9

(41.6)

International

(1.6)

1.2

(8.8)

6.9

(9.7)

Total reported

(11.9)

2.4

(11.1)

6.9

(32.7)

Impact of foreign exchange

(2.9)

(4.9)

(0.6)

(1.1)

Organic

(9.0)

7.3

(10.5)

6.9

(31.6)

Impact of COVID-19 testing sales (4)

(14.7)

(0.3)

(7.3)

(34.6)

Organic (excluding COVID-19 tests)

5.7

7.6

(3.2)

6.9

3.0

U.S.

3.3

6.5

(6.7)

6.9

0.3

International

7.1

7.9

(1.8)

7.1

7.1

Established Pharmaceuticals

Second Quarter 2024 Results (2Q24)

Sales 2Q24 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

International

1,294

988

306

Total reported

1,294

988

306

% Change vs. 2Q23

U.S.

n/a

n/a

n/a

International

0.6

(0.2)

3.1

Total reported

0.6

(0.2)

3.1

Impact of foreign exchange

(7.5)

(9.0)

(2.6)

Organic

8.1

8.8

5.7

U.S.

n/a

n/a

n/a

International

8.1

8.8

5.7

Established Pharmaceuticals sales increased 0.6 percent on a reported basis and 8.1 percent on an organic basis in the second quarter.

Key Emerging Markets include several emerging countries that represent the most attractive long-term growth opportunities for Abbott’s branded generics product portfolio. Sales in these geographies decreased 0.2 percent on a reported basis and increased 8.8 percent on an organic basis, led by growth in several geographies and therapeutic areas, including cardiometabolic, gastroenterology, and central nervous system/pain management.

First Half 2024 Results (1H24)

Sales 1H24 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

International

2,520

1,916

604

Total reported

2,520

1,916

604

% Change vs. 1H23

U.S.

n/a

n/a

n/a

International

1.8

0.7

5.3

Total reported

1.8

0.7

5.3

Impact of foreign exchange

(9.0)

(11.3)

(1.6)

Organic

10.8

12.0

6.9

U.S.

n/a

n/a

n/a

International

10.8

12.0

6.9

View News Release Full Screen
Medical Devices

Second Quarter 2024 Results (2Q24)

Sales 2Q24 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,185

292

287

244

275

258

192

637

International

2,549

315

340

77

449

306

51

1,011

Total reported

4,734

607

627

321

724

564

243

1,648

% Change vs. 2Q23

U.S.

14.2

8.5

16.8

7.7

4.3

17.9

3.7

26.3

International

7.0

0.4

10.5

11.4

(0.4)

9.4

21.7

10.0

Total reported

10.2

4.2

13.3

8.6

1.3

13.2

7.0

15.8

Impact of foreign exchange

(2.2)

(1.7)

(3.4)

(0.3)

(2.0)

(2.4)

(1.2)

(2.4)

Impact of acquisition*

0.3

2.1

Organic

12.1

5.9

16.7

8.9

1.2

15.6

8.2

18.2

U.S.

13.5

8.5

16.8

7.7

(0.8)

17.9

3.7

26.3

International

10.9

3.7

16.7

12.8

2.5

13.8

28.4

13.7

Worldwide Medical Devices sales increased 10.2 percent on a reported basis and 12.1 percent on an organic basis in the second quarter, including double-digit organic growth in both the U.S. and internationally.

Sales growth was led by double-digit growth in Diabetes Care, Electrophysiology, and Structural Heart. Several recently launched products and new indications contributed to the strong performance, including Amplatzer Amulet, Navitor, TriClip, and AVEIR.

In Electrophysiology, sales grew 13.3 percent on a reported basis and 16.7 percent on an organic basis, which included double-digit growth in catheters and cardiac mapping-related products, and double-digit growth in all major geographic regions.

In Diabetes Care, FreeStyle Libre sales were $1.6 billion, which represents sales growth of 18.4 percent on a reported basis and 20.4 percent on an organic basis.

View News Release Full Screen
First Half 2024 Results (1H24)

Sales 1H24 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

4,219

563

556

481

529

491

373

1,226

International

4,968

606

658

145

884

588

96

1,991

Total reported

9,187

1,169

1,214

626

1,413

1,079

469

3,217

% Change vs. 1H23

U.S.

14.3

6.6

15.0

8.2

9.8

14.4

9.6

24.6

International

10.3

4.4

14.4

9.7

4.1

10.9

15.9

13.6

Total reported

12.1

5.4

14.7

8.6

6.1

12.5

10.9

17.6

Impact of foreign exchange

(1.7)

(1.3)

(2.8)

(0.1)

(1.5)

(1.8)

(1.6)

(1.8)

Impact of acquisition*

0.7

4.3

Organic

13.1

6.7

17.5

8.7

3.3

14.3

12.5

19.4

U.S.

12.8

6.6

15.0

8.2

(1.3)

14.4

9.6

24.6

International

13.4

6.8

19.6

10.1

6.0

14.3

24.1

16.5

*Abbott completed the acquisition of CSI on April 27, 2023. For purposes of calculating organic sales growth, the impact from this acquired business has been excluded from January through April 2024.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2024 diluted earnings per share under GAAP of $3.30 to $3.40. Abbott forecasts specified items for the full-year 2024 of $1.31 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $4.61 to $4.71 for the full-year 2024.

Abbott projects third-quarter 2024 diluted earnings per share under GAAP of $0.85 to $0.89. Abbott forecasts specified items for the third-quarter 2024 of $0.33 per share primarily related to intangible amortization, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $1.18 to $1.22 for the third quarter 2024.

ABBOTT DECLARES 402ND CONSECUTIVE QUARTERLY DIVIDEND
On June 14, 2024, the board of directors of Abbott declared the company’s quarterly dividend of $0.55 per share. Abbott’s cash dividend is payable Aug. 15, 2024, to shareholders of record at the close of business on July 15, 2024.

Abbott has increased its dividend payout for 52 consecutive years and is a member of the S&P 500 Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

Novartis continues to deliver strong sales growth and core margin expansion in Q2; raises FY 2024 bottom-line guidance

On July 18, 2024 commenting on Q2 2024 results, Vas Narasimhan, CEO of Novartis, said (Press release, Novartis, JUL 18, 2024, View Source [SID1234644938]):

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"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
Accelerate growth: Renewed attention to deliver high-value medicines (NMEs) and focus on launch excellence, with a rich pipeline across our core therapeutic areas.
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.
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

Faeth Therapeutics to Present at Raymond James Biotech Private Company Showcase

On July 17, 2024 Faeth Therapeutics (Faeth), a clinical-stage biotechnology company, reported that Oliver Maddocks, Co-Founder and Chief Scientific Officer, and Debbie Chirnomas, M.D., Chief Medical Officer, will present today at the Raymond James Biotech Private Company Showcase (Press release, Faeth Therapeutics, JUL 17, 2024, View Source [SID1234644945]). Oliver and Debbie will discuss Faeth’s lead PIKTOR program development plans and participate in a Q&A following 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!

Faeth’s lead program, FTH-001/003 or "PIKTOR," features the combination of serabelisib, a PI3Kɑ inhibitor, and sapanisertib, an mTORC 1/2 inhibitor. This combination effectively targets and shuts down the PI3K pathway, one of the most frequently mutated pathways in cancer. PIKTOR has demonstrated impressive outcomes in a Phase 1b trial across endometrial, ovarian, and breast cancers in conjunction with paclitaxel. Additionally, Faeth’s second clinical initiative involves FTH-002, a specially designed amino acid sachet administered alongside an amino acid-restricted diet and radio/chemotherapy.

Faeth boasts a strong clinical and preclinical pipeline, fueled by its MetabOS discovery platform. This platform utilizes AI, machine learning, and carefully selected data sets to pinpoint targets tailored to specific tumor genotypes.

Established by luminary oncology researchers including Drs. Lew Cantley, Siddhartha Mukherjee, and Karen Vousden, Faeth is dedicated to developing therapies that target cancer metabolism. While the significance of metabolism in cancer growth is recognized, it is still largely underutilized in treatment, with only a handful of therapies available. Faeth employs a unique strategy that combines an in-depth understanding of cancer metabolism, functional genomics, and computational biology to create effective, less toxic treatments.

TME Pharma Announces Oral Presentation of NOX-A12 GLORIA Phase 1/2 Trial in Glioblastoma at ESMO Congress 2024

On July 17, 2024 TME Pharma N.V. (Euronext Growth Paris: ALTME), a clinical-stage biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that an abstract featuring results from the NOX-A12 GLORIA Phase 1/2 trial in first-line brain cancer (glioblastoma) has been selected for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress taking place in Barcelona, Spain, September 13-17, 2024 (Press release, TME Pharma, JUL 17, 2024, View Source [SID1234644944]).

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 oral presentation will provide further analysis of the dual inhibition of NOX-A12 and bevacizumab in glioblastoma in the expansion arm of the GLORIA Phase 1/2 trial. The full abstract will be published online via the ESMO (Free ESMO Whitepaper) Congress website. 00:05 a.m. CEST on Monday, September 09, 2024. It will be available concurrently on the TME Pharma website.

Title: Dual inhibition of postradiogenic angio-vasculogenesis in glioblastoma: Results of the phase 1/2 GLORIA trial
Presenter: Dr. Frank A. Giordano, Chair of the Department of Radiation Oncology, University Medical Center Mannheim, Germany
Session: Mini oral session: CNS tumors
Time and Date: 08.30-8.35 a.m. CEST, Sunday, September 15, 2024