On October 16, 2024 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:​HCM; HKEX:​13) reported positive high-level results from the SAVANNAH Phase II trial that showed TAGRISSO (osimertinib) plus ORPATHYS (savolitinib) demonstrated a high, clinically meaningful and durable objective response rate ("ORR") for patients with epidermal growth factor receptor-mutated ("EGFRm") non-small cell lung cancer ("NSCLC") with high levels of MET overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with TAGRISSO (Press release, HUTCHMED, OCT 16, 2024, View Source [SID1234647228]). These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. In 2023, TAGRISSO plus ORPATHYS received Fast Track designation from the US Food and Drug Administration (FDA) in this setting.

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ORPATHYS is an oral, potent, and highly selective MET tyrosine kinase inhibitor ("TKI") being jointly developed by AstraZeneca and HUTCHMED and commercialized by AstraZeneca. It is approved in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.

While EGFR-targeted therapy can provide a substantial survival benefit to patients with EGFRm NSCLC, most will eventually develop resistance to their treatment, with MET being a common resistance biomarker.1 Among patients screened for enrollment in SAVANNAH, an estimated 62% had tumors with MET overexpression and/or amplification, and approximately 34% met the defined high MET level cut-off upon clinical progression.

Myung-Ju Ahn, MD, PhD, Professor of Hemato-Oncology at the Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, and principal investigator in the SAVANNAH Phase II trial, said: "Osimertinib can provide patients with EGFR-mutated lung cancer unprecedented survival and has transformed the treatment landscape, but patients can develop resistance due to genes like MET – a common resistance biomarker. These results show that adding savolitinib, a selective MET-inhibitor, while continuing osimertinib treatment helped to deliver a meaningful response among patients whose disease progressed, providing a potential new treatment option following standard-of-care osimertinib."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "These positive SAVANNAH results show the benefit of a targeted treatment approach in EGFR-mutated lung cancer patients who experience MET-driven resistance. The improved response rates from ORPATHYS added to TAGRISSO, which is the backbone EGFR-mutated lung cancer therapy, reinforce the importance of identifying MET aberration and validate our combination strategy to address resistance while allowing continued TAGRISSO treatment."

Weiguo Su, Chief Executive Officer and Chief Scientific Officer, HUTCHMED, said: "Previous results from the SAVANNAH Phase II trial provided a novel biomarker approach for identifying patients with MET overexpression and/or amplification who are most likely to benefit from a MET-directed therapy, an existing unmet need. These new, positive results affirm our selective, patient-centric approach, which could allow us to deliver the first biomarker-driven targeted therapy combination option in this setting."

The safety and tolerability of TAGRISSO plus ORPATHYS was consistent with the known safety profiles of the combination and each treatment alone. No new safety signals were identified.

In August 2022, initial positive ORR results from the SAVANNAH trial were presented at the International Association for the Study of Lung Cancer 2022 World Conference on Lung Cancer (WCLC).

The global SAFFRON Phase III trial sponsored by AstraZeneca will further assess the TAGRISSO plus ORPATHYS combination versus platinum-based doublet chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC following TAGRISSO. Patients are being prospectively selected using the high MET level cut-off identified in SAVANNAH.

About NSCLC and MET aberrations

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.2,3 Lung cancer is broadly split into NSCLC and small cell lung cancer.4 Each year there are an estimated 2.4 million people diagnosed with lung cancer globally, with 80-85% of patients diagnosed with NSCLC, the most common form of lung cancer.2,4,5 Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC. 6,7,8

MET is a tyrosine kinase receptor that has an essential role in normal cell development. MET overexpression and/or amplification can lead to tumor growth and the metastatic progression of cancer cells, and is the primary mechanism of acquired resistance to EGFR TKIs for metastatic EGFRm NSCLC. Among patients who experience disease progression post-osimertinib treatment, approximately 15-50% present with MET aberration. 9,10,11,12,13 The prevalence of MET depends on the sample type, detection method and assay cut-off used.14

About SAVANNAH

SAVANNAH is an ongoing global, randomised, Phase II trial sponsored by AstraZeneca studying the efficacy of ORPATHYS added to TAGRISSO in patients with EGFRm, locally advanced or metastatic NSCLC with MET overexpression and/or amplification who progressed following treatment with TAGRISSO. Based on the original single-arm trial design, patients were treated with ORPATHYS 300 or 600 mg once-daily (QD) or 300 mg twice-daily, in combination with oral TAGRISSO 80 mg QD. In 2022, a registrational component was added to the trial that compared ORPATHYS 300 mg twice-daily and TAGRISSO 80 mg QD to ORPATHYS 300 mg twice-daily and placebo.

The trial enrolled over 360 patients in more than 80 centers globally, including in North America, Europe, South America and Asia. The primary endpoint is ORR and key secondary endpoints include progression-free survival and duration of response.

About TAGRISSO

TAGRISSO (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. TAGRISSO (40mg and 80mg once-daily oral tablets) has been used to treat nearly 800,000 patients across its indications worldwide and AstraZeneca continues to explore TAGRISSO as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of TAGRISSO as standard of care in EGFRm NSCLC. TAGRISSO improved patient outcomes in early-stage disease in the ADAURA Phase III trial, locally advanced disease in the LAURA Phase III trial, late-stage disease in the FLAURA Phase III trial, and with chemotherapy in the FLAURA2 Phase III trial.

About ORPATHYS

ORPATHYS (savolitinib) is an oral, potent, and highly selective MET TKI that has demonstrated clinical activity in advanced solid tumors. It blocks atypical activation of the MET receptor tyrosine kinase pathway that occurs because of mutations (such as exon 14 skipping alterations or other point mutations), gene amplification or protein overexpression.

It is approved in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. It is the first selective MET inhibitor approved in China and the first in the National Reimbursement Drug List of China (NRDL).

It is currently under clinical development for multiple tumor types, including lung, kidney, and gastric cancers, as a single treatment and in combination with other medicines. In addition to SAVANNAH and SAFFRON, in China the combination of savolitinib and osimertinib in lung cancer is also being studied in the SACHI and SANOVO Phase III trials.

On October 16, 2024 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent, titled, "COMPOSITION OF BL-8040," which covers the composition of motixafortide (APHEXDA/BL-8040) (Press release, BioLineRx, OCT 16, 2024, View Source [SID1234647227]). The patent strengthens BioLineRx’s robust intellectual property (IP) estate and extends its patent protection on motixafortide in the U.S. through December 2041.

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"We are very pleased to significantly strengthen our motixafortide IP with this key Composition of Matter patent that, among other things, extends our protection on this drug substance through December 2041," stated Philip Serlin, Chief Executive Officer of BioLineRx. "We believe this allowance reflects the USPTO’s acknowledgment of the unique attributes of motixafortide that make it a significant advancement among mobilization agents for multiple myeloma patients undergoing autologous stem cell transplantation, as well as the other high-need indications in which it is being investigated, including pancreatic cancer and gene therapies for patients with sickle cell disease (SCD)."

In addition to a broad range of U.S. and international patents covering various aspects of motixafortide, including composition of matter, methods of synthesis, methods of use and combinations, BioLineRx was granted seven years of Orphan Drug market exclusivity beginning on September 8, 2023, the day APHEXDA (motixafortide) was approved by the FDA, in combination with G-CSF, for use by multiple myeloma patients undergoing autologous stem cell transplantation. Additionally, motixafortide was granted five years of data exclusivity across all indications as a New Chemical Entity (NCE). The NCE exclusivity also commenced on September 8, 2023.

Motixafortide has also been granted Orphan Drug Designation in the U.S. and Europe for the treatment of pancreatic cancer, as well as in the U.S. for the treatment of acute myeloid leukemia (AML).

On October 16, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will share research from studies evaluating BRUKINSA (zanubrutinib), Bruton tyrosine kinase (BTK) chimeric degradation activation compound (CDAC) degrader BGB-16673 and B-cell lymphoma 2 (BCL2) inhibitor sonrotoclax in patients with Waldenström’s macroglobulinemia at the 12th International Workshop on Waldenström’s Macroglobulinemia (IWWM) Oct. 17-19 in Prague, Czech Republic (Press release, BeiGene, OCT 16, 2024, View Source [SID1234647226]).

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BeiGene has seven presentations at IWWM 2024, and Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene, will give the opening ceremony keynote, "Innovating for Impact: How BeiGene is Advancing Products and Pipeline to Address Waldenstrom’s Macroglobulinemia and Beyond."

"Waldenström’s macroglobulinemia is a rare and incurable cancer, and many patients face treatment failure after initial lines of therapy," Dr. Mobasher said. "Our BTK inhibitor BRUKINSA has become a standard of care for these patients and as shown through our long-term follow-up data at IWWM, continues to demonstrate deep and durable responses with favorable safety. Additional presentations demonstrate our continued commitment to developing and evaluating new treatment options for Waldenström’s macroglobulinemia patients and include results from Phase 1 studies of our BTK CDAC degrader BGB-16673 and BCL2 inhibitor sonrotoclax. We are encouraged by these results and look forward to advancing these assets to help more patients with WM."

During IWWM, BeiGene research will be shared in two invited talks, three oral presentations and two posters. Key presentations are outlined below.

IWWM Session
Title & Timing
(CEST)

Session
Type

Asset

Key Findings

BTK-Inhibitors in WM I

(Oct. 18, 11:30 a.m.-12:30 p.m.)

Oral presentation

BRUKINSA

Long-term safety and efficacy data from ASPEN LTE1, a long-term extension study evaluating ibrutinib-treated patients from ASPEN who switched to BRUKINSA, show that worsening of ibrutinib treatment-emergent AEs following transition to BRUKINSA was rare, as was the emergence of new events. The study also finds that efficacy is also maintained or improved in these patients.

BTK-I Intolerant and Resistant Disease

(Oct. 18, 2:30-3:30 p.m.)

Invited talk

BGB-16673

Preliminary safety and efficacy data from the phase 1 CaDAnCe-101 study demonstrates that BGB-16673 has a tolerable safety profile and shows promising antitumor activity in heavily pretreated patients with BTK inhibitor-exposed relapsed/refractory (R/R) WM, including those with BTK and CXCR4 mutations. BGB-16673 was recently granted Fast Track Designation by the U.S. Food and Drug Administration for R/R chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL).

Invited talk

BRUKINSA

Updated results from a Phase 2 study of WM patients who switched to BRUKINSA after becoming intolerant to other BTK inhibitors, including ibrutinib and acalabrutinib, show that most adverse events (AEs) that led to intolerance did not recur after treatment with BRUKINSA. Additionally, efficacy was maintained or improved in these patients.

WM Poster Presentations & Reception

(Oct. 18, 4:30-6:30 p.m.)

Poster

BRUKINSA

An analysis of the Phase 3 ASPEN study demonstrates that peripheral neuropathy (PN) symptom resolution with BTK inhibitors correlates with depth of disease response, with faster symptom resolution with BRUKINSA than ibrutinib in patients achieving PN resolution.

Poster

N/A

Results of a UK-wide patient-centered experience survey demonstrate that active monitoring for asymptomatic patients with WM is highly variable, with more than half of participants stating their experience could be improved.

Plenary Session II

(Oct. 19, 9-10 a.m.)

Oral Presentation

Sonrotoclax

Results from the Phase 1 study show that sonrotoclax was generally well tolerated and the preliminary antitumor activity is encouraging in patients with heavily pretreated R/R WM.

Clinical Trials in Progress for WM II

(Oct. 19, 4-5 p.m.)

Oral presentation

Sonrotoclax

Trial-in-progress presentation provides an overview of a Phase 2 study of sonrotoclax in patients with R/R WM, who have been previously treated with a BTK inhibitor therapy or anti-CD20–based systemic therapy.

About Waldenström’s Macroglobulinemia (WM)

Waldenström’s macroglobulinemia (WM) is a rare B-cell lymphoma that occurs in less than 2% of patients with non-Hodgkin lymphomas.1 The disease usually affects older adults and is primarily found in bone marrow, although lymph nodes and the spleen may be involved.2 Typically, patients present between the ages of 60 and 70 years. For reasons that are unclear, WM is almost twice as common in men as in women and is more common in Caucasians than other ethnic groups.3 WM is a rare cancer seen only in approximately three to five per million people per year.2

About BRUKINSA (zanubrutinib)

BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

U.S. Indications and Important Safety Information for BRUKINSA (zanubrutinib)

INDICATIONS

BRUKINSA is a kinase inhibitor indicated for the treatment of adult patients with:

Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Waldenström’s macroglobulinemia (WM).
Mantle cell lymphoma (MCL) who have received at least one prior therapy.
Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
Relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy.
The MCL, MZL and FL indications are approved under accelerated approval based on overall response rate and durability of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Hemorrhage

Fatal and serious hemorrhage has occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher hemorrhage including intracranial and gastrointestinal hemorrhage, hematuria, and hemothorax was reported in 3.8% of patients treated with BRUKINSA in clinical trials, with fatalities occurring in 0.2% of patients. Bleeding of any grade, excluding purpura and petechiae, occurred in 32% of patients.

Bleeding has occurred in patients with and without concomitant antiplatelet or anticoagulation therapy. Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage.

Monitor for signs and symptoms of bleeding. Discontinue BRUKINSA if intracranial hemorrhage of any grade occurs. Consider the benefit-risk of withholding BRUKINSA for 3-7 days before and after surgery depending upon the type of surgery and the risk of bleeding.

Infections

Fatal and serious infections (including bacterial, viral, or fungal infections) and opportunistic infections have occurred in patients with hematological malignancies treated with BRUKINSA. Grade 3 or higher infections occurred in 26% of patients, most commonly pneumonia (7.9%), with fatal infections occurring in 3.2% of patients. Infections due to hepatitis B virus (HBV) reactivation have occurred.

Consider prophylaxis for herpes simplex virus, pneumocystis jirovecii pneumonia, and other infections according to standard of care in patients who are at increased risk for infections. Monitor and evaluate patients for fever or other signs and symptoms of infection and treat appropriately.

Cytopenias

Grade 3 or 4 cytopenias, including neutropenia (21%), thrombocytopenia (8%) and anemia (8%) based on laboratory measurements, developed in patients treated with BRUKINSA. Grade 4 neutropenia occurred in 10% of patients, and Grade 4 thrombocytopenia occurred in 2.5% of patients.

Monitor complete blood counts regularly during treatment and interrupt treatment, reduce the dose, or discontinue treatment as warranted. Treat using growth factor or transfusions, as needed.

Second Primary Malignancies

Second primary malignancies, including non-skin carcinoma, have occurred in 14% of patients treated with BRUKINSA. The most frequent second primary malignancy was non-melanoma skin cancers (8%), followed by other solid tumors in 7% of the patients (including melanoma in 1% of patients) and hematologic malignancies (0.7%). Advise patients to use sun protection and monitor patients for the development of second primary malignancies.

Cardiac Arrhythmias

Serious cardiac arrhythmias have occurred in patients treated with BRUKINSA. Atrial fibrillation and atrial flutter were reported in 4.4% patients treated with BRUKINSA, including Grade 3 or higher cases in 1.9% of patients. Patients with cardiac risk factors, hypertension, and acute infections may be at increased risk. Grade 3 or higher ventricular arrhythmias were reported in 0.3% of patients.

Monitor for signs and symptoms of cardiac arrhythmias (e.g., palpitations, dizziness, syncope, dyspnea, chest discomfort), manage appropriately, and consider the risks and benefits of continued BRUKINSA treatment.

Hepatotoxicity, Including Drug-Induced Liver Injury

Hepatotoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI), has occurred in patients treated with Bruton tyrosine kinase inhibitors, including BRUKINSA.

Evaluate bilirubin and transaminases at baseline and throughout treatment with BRUKINSA. For patients who develop abnormal liver tests after BRUKINSA, monitor more frequently for liver test abnormalities and clinical signs and symptoms of hepatic toxicity. If DILI is suspected, withhold BRUKINSA. Upon confirmation of DILI, discontinue BRUKINSA.

Embryo-Fetal Toxicity

Based on findings in animals, BRUKINSA can cause fetal harm when administered to a pregnant woman. Administration of zanubrutinib to pregnant rats during the period of organogenesis caused embryo-fetal toxicity, including malformations at exposures that were 5 times higher than those reported in patients at the recommended dose of 160 mg twice daily. Advise women to avoid becoming pregnant while taking BRUKINSA and for 1 week after the last dose. Advise men to avoid fathering a child during treatment and for 1 week after the last dose. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

Adverse Reactions

The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA (N=1729) are decreased neutrophil count (51%), decreased platelet count (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Drug Interactions

CYP3A Inhibitors: When BRUKINSA is co-administered with a strong CYP3A inhibitor, reduce BRUKINSA dose to 80 mg once daily. For coadministration with a moderate CYP3A inhibitor, reduce BRUKINSA dose to 80 mg twice daily.

CYP3A Inducers: Avoid coadministration with strong or moderate CYP3A inducers. Dose adjustment may be recommended with moderate CYP3A inducers.

Specific Populations

Hepatic Impairment: The recommended dose of BRUKINSA for patients with severe hepatic impairment is 80 mg orally twice daily.

Please see full U.S. Prescribing Information including U.S. Patient Information.

This information is intended for a global audience. Product indications vary by region.

On October 16, 2024 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2024 (Press release, Abbott, OCT 16, 2024, View Source [SID1234647225]).

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Third-quarter GAAP diluted EPS of $0.94 and adjusted diluted EPS of $1.21, which excludes specified items.
Abbott maintains its full-year 2024 organic sales growth guidance range of 9.5% to 10.0%, excluding COVID-19 testing-related sales2.
Abbott now projects full-year diluted EPS on a GAAP basis of $3.34 to $3.40 and projects adjusted diluted EPS of $4.64 to $4.70, which represents an increase at the midpoint of the guidance range.
In October, Abbott’s board of directors authorized a new share repurchase program of up to $7 billion of the company’s common shares.
In August, Abbott announced a unique global partnership with Medtronic to collaborate on connecting Abbott’s world-leading continuous glucose monitoring (CGM) system with Medtronic’s insulin delivery devices.
In September, Abbott announced the U.S. launch of Lingo, the company’s first continuous glucose monitoring system available without a prescription and designed for people interested in improving their overall health and wellness.
In September, Abbott announced a partnership with the Big Ten Conference to conduct a nationwide blood donation competition to help increase the U.S. blood supply.
In September, Abbott completed enrollment ahead of schedule in its VOLT-AF IDE trial, which is designed to evaluate the Volt Pulsed Field Ablation (PFA) System for treating patients with heart rhythm disorders such as atrial fibrillation (AFib).
"Our results this quarter demonstrate the strength of our diversified business model," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re well-positioned to achieve the upper end of our initial guidance ranges for the year and have great momentum heading into next year."

THIRD-QUARTER BUSINESS OVERVIEW
Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange and the impact of discontinuing the ZonePerfect product line in the Nutrition business, 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.

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

4,202

950

1,032

—

2,216

International

6,433

1,116

1,380

1,406

2,531

Total reported

10,635

2,066

2,412

1,406

4,747

% Change vs. 3Q23

U.S.

10.1

10.4

1.8

n/a

14.2

International

1.7

(7.9)

(3.8)

2.7

9.6

Total reported

4.9

(0.3)

(1.5)

2.7

11.7

Impact of foreign exchange

(2.5)

(3.1)

(2.9)

(4.3)

(1.6)

Impact of business exit*

(0.2)

(0.6)

—

—

—

Organic

7.6

3.4

1.4

7.0

13.3

Impact of COVID-19 testing sales (3)

(0.6)

—

(1.9)

—

—

Organic (excluding COVID-19 tests)

8.2

3.4

3.3

7.0

13.3

U.S.

11.0

11.9

2.4

n/a

14.2

International

6.5

(2.6)

3.8

7.0

12.5

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

11,982

2,761

2,775

—

6,435

International

18,994

3,523

4,046

3,926

7,499

Total reported

30,976

6,284

6,821

3,926

13,934

% Change vs. 9M23

U.S.

4.2

8.1

(16.2)

n/a

14.3

International

3.4

(1.1)

(2.4)

2.1

10.1

Total reported

3.7

2.7

(8.5)

2.1

12.0

Impact of foreign exchange

(3.0)

(3.1)

(2.9)

(7.3)

(1.6)

Impact of business exit and acquisition*

0.1

(0.4)

—

—

0.4

Organic

6.6

6.2

(5.6)

9.4

13.2

Impact of COVID-19 testing sales (3)

(2.8)

—

(10.4)

—

—

Organic (excluding COVID-19 tests)

9.4

6.2

4.8

9.4

13.2

U.S.

10.0

9.0

3.0

n/a

13.3

International

9.0

4.2

5.9

9.4

13.1

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

*Quarter to date Sept. 30, 2024, reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024. Year to date Sept. 30, 2024, 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

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total

Pediatric

Adult

U.S.

950

568

382

International

1,116

387

729

Total reported

2,066

955

1,111

% Change vs. 3Q23

U.S.

10.4

12.2

7.9

International

(7.9)

(21.6)

1.5

Total reported

(0.3)

(4.5)

3.6

Impact of foreign exchange

(3.1)

(1.8)

(4.4)

Impact of business exit*

(0.6)

—

(1.1)

Organic

3.4

(2.7)

9.1

U.S.

11.9

12.2

11.5

International

(2.6)

(18.0)

8.0

Worldwide Nutrition sales decreased 0.3 percent on a reported basis and increased 3.4 percent on an organic basis in the third quarter, led by growth in Adult Nutrition.

In Adult Nutrition, global sales increased 3.6 percent on a reported basis and 9.1 percent on an organic basis, which was led by growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand.

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total

Pediatric

Adult

U.S.

2,761

1,646

1,115

International

3,523

1,377

2,146

Total reported

6,284

3,023

3,261

% Change vs. 9M23

U.S.

8.1

11.8

3.2

International

(1.1)

(6.8)

2.8

Total reported

2.7

2.5

3.0

Impact of foreign exchange

(3.1)

(1.6)

(4.4)

Impact of business exit*

(0.4)

—

(0.7)

Organic

6.2

4.1

8.1

U.S.

9.0

11.8

5.0

International

4.2

(3.6)

9.7

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

Diagnostics

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

1,032

332

37

103

560

International

1,380

982

91

43

264

Total reported

2,412

1,314

128

146

824

% Change vs. 3Q23

U.S.

1.8

4.5

(2.8)

6.0

(0.2)

International

(3.8)

(1.5)

(3.9)

0.7

(12.2)

Total reported

(1.5)

—

(3.6)

4.4

(4.4)

Impact of foreign exchange

(2.9)

(4.3)

(1.5)

(0.2)

(1.4)

Organic

1.4

4.3

(2.1)

4.6

(3.0)

Impact of COVID-19 testing sales (3)

(1.9)

(0.2)

(3.9)

—

(3.4)

Organic (excluding COVID-19 tests)

3.3

4.5

1.8

4.6

0.4

U.S.

2.4

4.8

4.5

6.0

(1.0)

International

3.8

4.4

0.8

1.3

2.8

As expected, Diagnostics sales growth in the third quarter was negatively impacted by year-over-year declines in COVID-19 testing-related sales3. Worldwide COVID-19 testing sales were $265 million in the third quarter of 2024 compared to $305 million in the third quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 0.2 percent on a reported basis and increased 3.3 percent on an organic basis.

Excluding COVID-19 testing-related sales, global Core Laboratory Diagnostics sales grew 0.1 percent on a reported basis and increased 4.5 percent on an organic basis, led by continued adoption of Abbott’s Alinity family of diagnostics systems and testing portfolios.

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

2,775

969

112

308

1,386

International

4,046

2,879

272

133

762

Total reported

6,821

3,848

384

441

2,148

% Change vs. 9M23

U.S.

(16.2)

5.6

(12.3)

6.6

(29.8)

International

(2.4)

0.3

(7.2)

4.8

(10.6)

Total reported

(8.5)

1.5

(8.7)

6.0

(24.0)

Impact of foreign exchange

(2.9)

(4.8)

(0.8)

(0.1)

(1.1)

Organic

(5.6)

6.3

(7.9)

6.1

(22.9)

Impact of COVID-19 testing sales (3)

(10.4)

(0.2)

(6.3)

—

(25.0)

Organic (excluding COVID-19 tests)

4.8

6.5

(1.6)

6.1

2.1

U.S.

3.0

5.9

(3.3)

6.6

(0.1)

International

5.9

6.7

(0.9)

5.1

5.7

Established Pharmaceuticals

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,406

994

412

Total reported

1,406

994

412

% Change vs. 3Q23

U.S.

n/a

n/a

n/a

International

2.7

0.7

8.1

Total reported

2.7

0.7

8.1

Impact of foreign exchange

(4.3)

(4.7)

(3.1)

Organic

7.0

5.4

11.2

U.S.

n/a

n/a

n/a

International

7.0

5.4

11.2

Established Pharmaceuticals sales increased 2.7 percent on a reported basis and 7.0 percent on an organic basis in the third 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 increased 0.7 percent on a reported basis and increased 5.4 percent on an organic basis, led by growth in several geographies and therapeutic areas, including gastroenterology, cardiometabolic, and central nervous system/pain management.

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

3,926

2,910

1,016

Total reported

3,926

2,910

1,016

% Change vs. 9M23

U.S.

n/a

n/a

n/a

International

2.1

0.7

6.4

Total reported

2.1

0.7

6.4

Impact of foreign exchange

(7.3)

(9.0)

(2.2)

Organic

9.4

9.7

8.6

U.S.

n/a

n/a

n/a

International

9.4

9.7

8.6

Medical Devices

Third Quarter 2024 Results (3Q24)

Sales 3Q24 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,216

288

285

252

258

270

190

673

International

2,531

309

325

70

441

288

46

1,052

Total reported

4,747

597

610

322

699

558

236

1,725

% Change vs. 3Q23

U.S.

14.2

6.0

15.8

16.7

2.8

21.1

0.8

23.6

International

9.6

5.7

9.2

5.2

4.5

9.2

17.8

13.3

Total reported

11.7

5.9

12.2

14.0

3.9

14.6

3.8

17.1

Impact of foreign exchange

(1.6)

(1.1)

(2.1)

(0.4)

(1.0)

(1.9)

(1.4)

(2.0)

Organic

13.3

7.0

14.3

14.4

4.9

16.5

5.2

19.1

U.S.

14.2

6.0

15.8

16.7

2.8

21.1

0.8

23.6

International

12.5

7.9

13.0

6.6

6.2

12.6

25.7

16.5

Worldwide Medical Devices sales increased 11.7 percent on a reported basis and 13.3 percent on an organic basis in the third quarter, including double-digit organic growth in both the U.S. and internationally.

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

In Electrophysiology, sales grew 12.2 percent on a reported basis and 14.3 percent on an organic basis, which included double-digit growth in catheters and cardiac mapping-related products.

In Diabetes Care, sales of continuous glucose monitors exceeded $1.6 billion and grew 19.1 percent on a reported basis and 20.7 percent on an organic basis.

First Nine Months 2024 Results (9M24)

Sales 9M24 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

6,435

851

841

733

787

761

563

1,899

International

7,499

915

983

215

1,325

876

142

3,043

Total reported

13,934

1,766

1,824

948

2,112

1,637

705

4,942

% Change vs. 9M23

U.S.

14.3

6.4

15.3

11.0

7.4

16.7

6.5

24.3

International

10.1

4.8

12.6

8.2

4.2

10.3

16.5

13.5

Total reported

12.0

5.6

13.8

10.4

5.4

13.2

8.4

17.4

Impact of foreign exchange

(1.6)

(1.2)

(2.6)

(0.1)

(1.3)

(1.9)

(1.5)

(1.9)

Impact of acquisition*

0.4

—

—

—

2.8

—

—

—

Organic

13.2

6.8

16.4

10.5

3.9

15.1

9.9

19.3

U.S.

13.3

6.4

15.3

11.0

0.1

16.7

6.5

24.3

International

13.1

7.1

17.4

8.9

6.0

13.7

24.6

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 $3.34 to $3.40. Abbott forecasts specified items for the full-year 2024 of $1.30 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 $4.64 to $4.70 for the full-year 2024.

Abbott projects fourth-quarter 2024 diluted earnings per share under GAAP of $0.96 to $1.02. Abbott forecasts specified items for the fourth-quarter 2024 of $0.35 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 $1.31 to $1.37 for the fourth quarter 2024.

ABBOTT DECLARES 403RD CONSECUTIVE QUARTERLY DIVIDEND
On Sept. 19, 2024, the board of directors of Abbott declared the company’s quarterly dividend of $0.55 per share. Abbott’s cash dividend is payable Nov. 15, 2024, to shareholders of record at the close of business on Oct. 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.

On October 15, 2024 Atavistik Bio, a biotechnology company discovering the next generation of precision allosteric therapeutics inspired by the body’s natural regulators, reported its precision oncology development candidate ATV-1601, an orally bioavailable selective allosteric small molecule inhibitor for AKT1 E17K-driven cancers (Press release, Atavistik Bio, OCT 15, 2024, View Source [SID1234647394]). ATV-1601 was developed leveraging the company’s AMPSTM technology, which is seamlessly integrated with its AI-enabled drug discovery engine to rapidly advance programs from discovery into development.

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"ATV-1601’s nomination as our first oncology development candidate is a major milestone for the company, validating the capabilities of our proprietary platform to rapidly discover and advance novel precision allosteric therapeutics for targets that have historically been hard to drug. We anticipate significant progress in our portfolio in the upcoming year for high value oncology targets that address the unmet needs of large patient populations," said Bryan Stuart, Chief Executive Officer, Atavistik Bio. "We are working to quickly advance ATV-1601 to the clinic and to achieve early clinical proof of concept for this program. We believe our precision allosteric small molecule offers several advantages to target the difficult-to-drug AKT1 E17K mutation, with the potential to improve the lives of many cancer patients."

AKT1 E17K mutation is a clinically validated oncogene that impacts greater than 40,000 cancer patients per year in the United States, with the highest prevalence in breast, endometrial, and prostate cancers. In addition, early evidence indicates that the AKT1 E17K mutation appears to be an emerging mechanism of resistance to PI3Kα-targeted cancer therapies. A selective allosteric AKT1 E17K inhibitor has the potential to be a transformative therapy against the validated AKT1 E17K oncogenic driver as well as resistance mutations emerging from PI3Kα-targeted therapies.

The only approved AKT-targeted therapy is a pan-AKT inhibitor that blocks all three isoforms of AKT (AKT1, AKT2, and AKT3). Pan-AKT inhibitors offer limited efficacy for patients with AKT1 E17K-driven mutant tumors due to insufficient inhibition of the AKT1 E17K mutation. Additionally, pan-AKT inhibitors can cause significant adverse events, such as AKT2-driven hyperglycemia, rash, and diarrhea, which leads to treatment discontinuation or dose-reductions in a considerable subset of patients. ATV-1601, a selective allosteric AKT1 E17K inhibitor, has the potential to provide enhanced target inhibition, superior efficacy and improved tolerability compared to pan-AKT inhibitors for AKT1 E17K-driven cancers. Atavistik Bio anticipates initiating a first-in-human study with ATV-1601 in patients with AKT1 E17K-mutant tumors in early 2025.

"Behind ATV-1601, we have a robust pipeline of precision oncology programs derived from our AMPS platform, said Marion Dorsch, Ph.D., President and Chief Scientific Officer, Atavistik Bio. "We look forward to advancing our internal pipeline with urgency while also broadening the reach of our platform through partnerships to discover important new allosteric therapeutics across other diseases."

Atavistik Bio EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium Data Presentation Details

Date: Wed., October 23, 2024
Time: 12.00 – 19.00 CET
Poster Session: New Drugs
Poster Title: ATV-1601 is a Potent and Selective Allosteric Inhibitor of AKT1 E17K and Shows Profound and Durable Regressions in AKT1 E17K-Driven Patient-Derived Xenograft Models
Poster #: PB128