On July 18, 2024 Medivir AB (NASDAQ: MVIR) (STOCKHOLM: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that updated data from the phase 1b/2a study of fostrox (fostroxacitabine) in combination with Lenvima (lenvatinib) for the treatment of advanced hepatocellular carcinoma (HCC) has been accepted for presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in Barcelona, September 13-17, 2024 (Press release, Medivir, JUL 18, 2024, View Source;lenvima-in-hcc-at-esmo-conference-in-september-302200401.html [SID1234644962]).

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The abstract, titled "Fostrox (fostroxacitabine bralpamide) plus lenvatinib in patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) progressed on immunotherapy combinations. Results from a multi-center phase 1b/2a study." will be presented by Dr Hong Jae Chon, CHA Bundang Medical Center in Korea.

Updated clinical data from the ongoing phase 1b/2a study with fostrox in combination with Lenvima. will be presented. As patients are able to stay on treatment long-term, it enables a detailed update on the safety and tolerability profile and how it evolves over time. The presentation will also include additional updates on efficacy endpoints.

The poster will be available on Medivir’s website after the presentation.

For additional information, please contact:

Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100.
E-mail: [email protected]

About fostrox

Fostrox is a liver-targeted inhibitor of DNA replication that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. This design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing where it has shown encouraging anti-cancer efficacy with a good safety and tolerability profile.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide. Hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver and it is the fastest growing cancer in the USA. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1,2. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On July 18, 2024 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported that the first patient has been dosed in Pure Biologics’ exploratory Phase 0 clinical study of PBA-0405 (Press release, Twist Bioscience, JUL 18, 2024, View Source [SID1234644963]). PBA-0405 is a fully human IgG1 antibody that was discovered using Twist Biopharma Solutions’ synthetic antibody phage display libraries. Twist Biopharma Solutions, a division of Twist Bioscience, provides an integrated offering of in vitro, in vivo, and in silico tools for antibody discovery research. This exploratory study is designed to provide early insights into the biological effects of PBA-0405 within the tumor environment.

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"Solid tumors are historically difficult for drug developers to target and treat. This is the first antibody identified using our Twist Biopharma Solutions Library of Libraries to be tested in patients and it validates the potential of our synthetic antibody libraries to be used to discover novel drug candidates for hard-to-treat cancer indications," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "This is one of two of Pure’s candidates discovered using our synthetic antibody libraries and we look forward to seeing their progression."

PBA-0405 targets ROR1, a tumor-associated antigen expressed on many solid tumors and B cell malignancies. PBA-0405 is designed to make tumors visible to the immune system, and to induce an immune response by recruiting and activating tumor-killing cytotoxic immune cells.

Pure Biologics’ multi-center, single arm, open-label pharmacodynamic biomarker Phase 0 trial is designed to study the biological effects within the tumor microenvironment of PBA-0405 when administered intratumorally in microdose quantities via the CIVO device. The study will evaluate the pharmacodynamic activity of PBA-0405 in solid tumors including head and neck squamous cell carcinoma, certain subtypes of soft-tissue sarcomas and triple-negative breast cancer. Pure Biologics is conducting the clinical study and holds full responsibility for the development and potential regulatory submission of PBA-0405. ClinicalTrials.gov ID NCT06273852

"With the dosing of the first patient in our exploratory Phase 0 study, PBA-0405 is the first ROR1-targeting compound of its mode of action to enter into studies in patients. We’re encouraged by the preclinical data we’ve seen so far and are eager to evaluate its pharmacodynamic activity in human studies," said Pieter Spee, PhD, Chief Scientific Officer at Pure Biologics. "By working with Twist Bioscience to leverage their synthetic antibody libraries for early-stage discovery, we were able to move quickly to the development stage. We look forward to continuing to advance our pipeline of immuno-oncology antibody candidates and drive toward our goal of delivering first-in-class therapies to patients."

About the Collaboration

PBA-0405 was discovered as part of an ongoing collaboration between Twist Bioscience and Pure Biologics. Under the terms of the agreement announced in 2021, Twist Biopharma Solutions, a division of Twist Bioscience, grants Pure Biologics access to select synthetic antibody phage display libraries derived only from sequences that exist in the human body and further optimized by leveraging state-of-the-art approaches, including artificial intelligence and big data analytics. Certain libraries among the portfolio are deliberately tailored to match chosen classes of biological targets as well as to enhance bispecific antibody forming capabilities. Together, the companies work to discover, validate and optimize new antibody candidates against targets useful for immuno-oncology applications. Pure Biologics will pay Twist annual maintenance fees in addition to future payments for clinical and commercial achievement for any antibodies resulting from the collaboration. The Phase 0 study does not trigger a milestone payment for Twist.

On July 18, 2024 Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC), reported it was granted a U.S. patent that expands its intellectual property portfolio for lasofoxifene, its lead investigational drug (Press release, Sermonix Pharmaceuticals, JUL 18, 2024, View Source [SID1234645004]). The newly issued patent covers methods for treating aromatase inhibitor (AI)-resistant, estrogen receptor-positive (ER+) breast cancer in the absence of ESR1 mutations.

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Evidence of lasofoxifene’s antitumor activity in breast cancers with ESR1 mutations was previously demonstrated during the Phase 2 Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) trials. In ELAINE-1, lasofoxifene as a monotherapy led to numerically longer progression-free survival than fulvestrant (5.6 vs. 3.7 months; P=0.138) in patients with ESR1-mutated mBC who had progressed after prior CDK4/6i treatment. In ELAINE-2, the combination of lasofoxifene and abemaciclib was associated with a median progression-free survival of approximately 13 months in heavily pre-treated post-CDK4/6i patients with ESR1 mutations. Sermonix is currently enrolling for ELAINE-3, a global registrational Phase 3 study.

The new patent, U.S. Patent No. 12,023,321 B2, titled "Lasofoxifene Treatment of Aromatase-Resistant ER+ Cancer," is based on Sermonix-sponsored research conducted in the laboratory of Dr. Geoffrey Greene, M.D., Ph.D., chair of the Ben May Department for Cancer Research at the University of Chicago. Dr. Greene observed positive findings during a preclinical study examining the effects of oral lasofoxifene in an AI-resistant, ER+ breast cancer model in the absence of ESR1 mutations. Those findings were recently published in the peer-reviewed journal Breast Cancer Research.

"This new patent signals Sermonix’s continued momentum toward the broader study of and potential use of lasofoxifene beyond that in the ESR1-mutated setting, including use in earlier lines of therapy in patients with wild-type (WT) ER," said Dr. David Portman, Sermonix founder and chief executive officer. "There is great medical need for efficacious and well-tolerated new therapies for this large population of breast cancer patients with WT ER who recur in the adjuvant setting or progress in the advanced setting on aromatase inhibitors. We look forward to investigating lasofoxifene’s potential as an effective therapy option for all hormone-treatment resistant breast tumors."

ELAINE-3, with clinical trial sites enrolling across the U.S., Europe, Israel and Canada, is assessing the efficacy of oral lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal women and men with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation.

On July 18, 2024 Agenus Inc. (NASDAQ: AGEN), a leader in developing novel immunological agents to treat various cancers, reported the results of its end-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA), for the advancement of its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for the treatment of adult patients with relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) with no active liver metastases (NLM) (Press release, Agenus, JUL 18, 2024, View Source [SID1234644964]).

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Key Outcomes of the EOP2 Meeting:

Dosing Regimen: Agenus gained agreement on the proposed BOT/BAL combination dosing regimen of 75mg BOT once every 6 weeks for up to 4 doses in combination with 240mg BAL once every 2 weeks for up to 2 years.
Randomized Phase 2 Interim Data: Topline interim data suggest best activity seen at 75 mg BOT/240mg BAL combination (ORR 19.4%; 6-month survival rate of 90%; data continues to mature).
Accelerated Approval: FDA advised against submission of these results in support of an Accelerated Approval based on their view that objective response rates may not translate to survival benefit.
Phase 3 Protocol Design: The FDA recommended the inclusion of a BOT monotherapy arm at Agenus’ discretion in the Phase 3 study.
Dr. Steven O’Day, Agenus’ Chief Medical Officer, stated, "Based on the high level of enthusiasm from significant numbers of global clinical experts and the promising clinical activity we have seen in the Phase 1 and 2 studies, our commitment to seek all possible pathways to make BOT/BAL available to patients is unwavering. This includes exploring opportunities to partner in the U.S. to accomplish a successful Phase 3 trial."

Agenus previously disclosed data from the Phase 1 trial, which showed an overall response rate (ORR) of 23% in the 77 MSS mCRC patients without active liver metastases, with a median follow up of 13.6 months. The estimated 6-month, 12-month and 18-month overall survival (OS) rates were 86%, 71%, and 62%, respectively. The estimated median OS was 21.2 months.

Topline interim data (below) from the Phase 2 trial are showing trends consistent with the Phase 1 study, including an ORR of 19.4% and 6-month survival rate of 90% for the BOT 75mg/BAL combination. The safety profile was manageable and no new signals were observed. Agenus plans to continue future discussions with FDA as the Phase 2 data mature and will present these data in totality at an upcoming medical conference.

Topline Interim Phase 2 Data

BOT + BAL

75 mg

(n= 62)

BOT+BAL

150 mg

(n=61)

BOT

75 mg

(n=38)

BOT

150 mg

(n=40)

SOC

(n=33)

ORR %

(95% CI)

n/nn

19.4*

(10.4, 31.4)

12/62

8.2

(2.7, 18.1)

5/61

0

(0.0, 9.3)

0/38

7.5

(1.6, 20.4)

3/40

0

(0.0, 10.6)

0/33

Follow-Up (m)

Mean (SD)

Range

9.5

(2.77)

1.2, 15.7

9.1

(3.25)

0.1, 16.6

7.8

(4.37)

0.2, 14.8

8.2

(4.53)

0.7, 17.1

5.5

(5.30)

0.0, 13.0

*Pending confirmation of two additional responses in 75mg BOT + BAL arm. No responses are pending confirmation in other arms.

​These results are particularly meaningful, as the landscape of MSS colorectal cancer treatment has seen little advancement leaving a significant gap in effective therapies for patients.

"MSS colorectal cancer, representing approximately 95% of colorectal cancer cases, remains a disease setting with substantial unmet need and is considered to be one of the most challenging types of cancer due to its high incidence and mortality rates," said Michael Sapienza, Chief Executive Officer of Colorectal Cancer Alliance. "The rapidly growing number of diagnoses in younger individuals is particularly alarming. There is an urgent need for new treatment options that can transform the trajectory of MSS colorectal cancer and provide lasting benefits for patients."

In addition to the progress in the U.S., Agenus is advancing its efforts to bring BOT/BAL to patients in Europe. Engagements with the European Regulatory Authority to explore registration paths are scheduled for later this summer. These discussions aim to align on the regulatory path for approval of the BOT/BAL combination in Europe.

Other areas of BOT/BAL clinical development:

Agenus continues to pursue opportunities for BOT/BAL development in earlier lines of CRC and other tumor types where BOT/BAL has demonstrated clinical activity, such as lung, melanoma, and pancreatic cancers. The company expects to present data from some of these programs at future medical congresses, including BOT/BAL in sarcoma at European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) in September 2024.

About Botensilimab

Botensilimab is a human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses.

Approximately 1100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316.

About Colorectal Cancer

Colorectal cancer (CRC) is the second leading cause of cancer death in the United States, and is estimated to be the number one killer of men aged 50 and above and second leading killer of women in the same age category. Microsatellite stable (MSS) colorectal cancer is the most prevalent form of the disease, representing approximately 95% of patients with colorectal cancer. Survival remains poor for advanced disease, and the burden is shifting to a younger population. Alarmingly, from 1995 to 2019, the number of patients under the age of 55 who were diagnosed with CRC in the United States nearly doubled.

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.