On October 18, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported the publication of results from the multicenter, multiregional, pivotal trial evaluating cosibelimab, a differentiated and potential best-in-class anti-PD-L1 antibody, in patients with metastatic cutaneous squamous cell carcinoma ("cSCC"), in the Journal for ImmunoTherapy of Cancer (JITC), the peer-reviewed, online journal of the Society of Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Checkpoint Therapeutics, OCT 18, 2023, View Source [SID1234636103]). The paper, entitled, "Efficacy and Safety of Cosibelimab, an Anti–PD-L1 Antibody, in Metastatic Cutaneous Squamous Cell Carcinoma" (doi:10.1136/jitc-2023-007637), describes safety and efficacy results from 78 patients with metastatic cSCC enrolled at clinical sites in eight countries.

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Patients received cosibelimab 800 mg every two weeks as an intravenous infusion until disease progression or unacceptable toxicity. The study’s primary endpoint was objective response rate ("ORR") assessed by independent central review using Response Evaluation Criteria in Solid Tumors, v.1.1. As of the pre-specified data cutoff date, the primary endpoint was met with highly clinically meaningful results. Median duration of response was not yet reached. The authors observed that cosibelimab treatment was associated with lower rates of severe immune-related adverse events ("irAEs") as compared with those reported for similar studies of PD-1-targeting agents, concluding that cosibelimab may address an area of unmet clinical need for effective and better tolerated treatments for patients with metastatic cSCC who are ineligible for curative surgery or radiation.

"The conclusions of the study are clear," commented Prof. Philip Clingan of Southern Medical Day Care Centre in Wollongong, Australia, Principal Investigator for this study and first author of the paper. "Cosibelimab is the first PD-L1-blocking antibody to demonstrate a robust and clinically meaningful ORR, with durable responses in participants, and a well-tolerated safety profile in patients with metastatic cSCC. While existing PD-1-blocking antibodies are approved to treat advanced cSCC, many patients don’t respond to treatment, experience severe irAEs or are simply not appropriate candidates for PD-1 therapy treatment, such as those that are immunocompromised, immunosuppressed or with preexisting autoimmune disease. There is therefore a significant need for improved therapies. Cosibelimab, if approved, would offer patients an important new treatment option through its dual activation of both innate and adaptive immunity to induce strong and durable anti-tumor responses, complemented by lower rates of severe adverse events as cosibelimab’s binding to PD-L1 leaves the interaction of PD-1 and PD-L2 unaltered."

"Publication of these data expands the growing evidence supporting the efficacy and safety of cosibelimab," said James Oliviero, President and Chief Executive Officer of Checkpoint. "We are encouraged by recently revealed longer-term data from our pivotal studies of cosibelimab, which demonstrate a deepening of response over time. We believe cosibelimab’s dual mechanism of action and potential favorable safety profile should position the product as the preferred immunotherapy of oncologists for the large number of high-risk cSCC patients upon its potential launch early next year. We continue to work with the U.S. Food and Drug Administration ("FDA") toward the January 3, 2024, action date for our Biologics License Application for cosibelimab."

About Cutaneous Squamous Cell Carcinoma
Cutaneous squamous cell carcinoma is the second most common type of skin cancer in the United States, with an estimated annual incidence of approximately 1 million cases according to the Skin Cancer Foundation. While most cases are localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from their disease each year. In addition to being a life-threatening disease, cSCC causes significant functional morbidities and cosmetic deformities based on tumors commonly arising in the head and neck region and invading blood vessels, nerves and vital organs such as the eye or ear.

About Cosibelimab
Cosibelimab is a potential best-in-class, high affinity, fully-human monoclonal antibody of IgG1 subtype that directly binds to programmed death ligand-1 ("PD-L1") and blocks the PD-L1 interaction with the programmed death receptor-1 ("PD-1") and B7.1 receptors. Cosibelimab’s primary mechanism of action is based on the inhibition of the interaction between PD-L1 and its receptors PD-1 and B7.1, which removes the suppressive effects of PD-L1 on anti-tumor CD8+ T-cells to restore the cytotoxic T cell response. Cosibelimab is potentially differentiated from the currently marketed PD-1 and PD-L1 antibodies through sustained >99% target tumor occupancy to reactivate an antitumor immune response and the additional benefit of a functional Fc domain capable of inducing antibody-dependent cell-mediated cytotoxicity ("ADCC") for potential enhanced efficacy in certain tumor types.

On October 18, 2023 Caribou Biosciences, Inc. (Nasdaq: CRBU), a leading clinical-stage CRISPR genome-editing biopharmaceutical company, reported that it received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for CB-012, an allogeneic anti-C-type lectin-like molecule-1 (anti-CLL-1) CAR-T cell therapy (Press release, Caribou Biosciences, OCT 18, 2023, View Source [SID1234636102]). CB-012 will be evaluated in the multicenter, open-label, AMpLify Phase 1 clinical trial for patients with relapsed or refractory acute myeloid leukemia (r/r AML).

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"Clearance of our IND application for CB-012 represents another significant milestone for Caribou as our third off-the-shelf CAR-T cell therapy enters the clinic," said Rachel Haurwitz, PhD, Caribou’s president and chief executive officer. "We look forward to initiating patient enrollment in the AMpLify Phase 1 trial by the middle of 2024 to evaluate the safety and tolerability of CB-012 in patients suffering from AML."

CLL-1 is a compelling therapeutic target because it is highly expressed on AML cells and leukemic stem cells, but it is not expressed on hematopoietic stem cells.

"There is an urgent need to develop new treatments for patients with relapsed or refractory AML, for which the treatment options are predominantly limited to salvage chemotherapy regimens," said Naval Daver, MD, associate professor and director, Department of Leukemia, The University of Texas MD Anderson Cancer Center. "An allogeneic CAR-T cell therapy that could safely and effectively target AML blasts while preserving healthy hematopoietic stem cells could provide a much-needed off-the-shelf option for these patients."

Caribou’s patented next-generation CRISPR Cas12a chRDNA genome-editing technology platform maintains high genomic integrity and significantly improves the specificity of genome editing.

"CB-012 was engineered with five genome edits, and is the first allogeneic CAR-T cell therapy, to our knowledge, with both checkpoint disruption through a PD-1 knockout, and immune cloaking through a B2M knockout and B2M–HLA-E fusion transgene insertion," said Steve Kanner, PhD, Caribou’s chief scientific officer. "Both armoring strategies are designed to improve the antitumor activity of CB-012 that we believe are crucial for targeting this difficult to treat indication."

About the AMpLify trial
The AMpLify Phase 1 trial is an open-label, multicenter clinical trial designed to evaluate CB-012 in adult patients with relapsed or refractory acute myeloid leukemia (r/r AML). Part A, a 3+3 dose escalation design, will evaluate the safety and tolerability of CB-012 at ascending dose levels to determine the maximum tolerated dose and/or the recommended doses for expansion. Part B is the dose expansion portion with the primary objective of determining antitumor response, assessed by overall response rate (ORR), after a single dose of CB-012. AMpLify will include patients who have not responded to or relapsed after standard treatment and will exclude patients who have been treated with more than 3 prior lines of therapy and patients with proliferative disease. Caribou plans to initiate patient enrollment in the AMpLify trial to treat patients with a single administration of CB-012 at dose level 1 (25×106 CAR-T cells) by mid-2024.

About acute myeloid leukemia
Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow and is the most common type of acute leukemia in adults. It is estimated there will be 20,380 new cases of AML in the United States in 2023. The five-year survival rate for these patients is approximately 30%. AML is currently treated with chemotherapy, targeted therapies, and/or allogeneic or autologous stem cell transplant. For patients with relapsed or refractory AML, there are few treatment options and median overall survival is typically less than seven months.

On October 18, 2023 Candel Therapeutics, Inc. (the Company or Candel) (Nasdaq: CADL), a clinical stage biopharmaceutical company focused on developing viral immunotherapies to help patients fight cancer, reported that Nature published results from the ongoing first-in-human phase 1 investigator-sponsored clinical trial of CAN-3110, a first-in-class, replication-competent herpes simplex virus-1 (HSV-1) oncolytic viral immunotherapy candidate, in patients with recurrent high-grade glioma (HGG), of which 86.7% were glioblastoma, that had returned after standard of care (SoC) treatment (Press release, Candel Therapeutics, OCT 18, 2023, View Source [SID1234636101]).

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The study is being conducted in a collaboration between Brigham and Women’s Hospital and Candel. The publication titled "Clinical trial links oncolytic immunoactivation to survival in glioblastoma" can be accessed at View Source

Key findings of the manuscript: Tolerability of a single injection of CAN-3110 in recurrent HGG with no dose limiting toxicity reported, improved median overall survival in 41 patients treated in Arm A (11.6 months as of data cutoff in October 2022) and correlation between anti-HSV-1 serology and survival. Importantly, CAN-3110 treatment was associated with a significant increase in immune cells in the tumor

microenvironment and in the peripheral blood. The activation of both local and systemic immune response, including the expansion of the T-cell repertoire diversity as well as HSV-1 immune status, correlate with survival suggesting that CAN-3110 can enhance anti-cancer immune responses even in immunosuppressive tumor microenvironments.

"There is an urgent need to develop novel therapies for recurrent HGG," said E. Antonio Chiocca, MD, PhD, Head of Department of Neurosurgery at Brigham and Women’s Hospital, Professor at Harvard Medical School, and Principal Investigator of the clinical trial. "Failure of standard of care and conventional immunotherapy in recurrent HGG largely resides in the inability of available therapies to efficiently activate the immune system in the cold tumor microenvironment that is characteristic for this condition. In this manuscript we provide evidence that, after a single injection, the direct oncolytic activity combined with the ability of CAN-3110 to elicit a strong anti-tumoral response, resulted in conversion of the cold tumor microenvironment and induced a systemic immune response linked to improved patient survival."

Dr. Chiocca continued, "Prolonged survival was associated with HSV-1 seropositivity, either before or after CAN-3110 treatment. Importantly, approximately 30% of seronegative patients at baseline seroconverted after CAN-3110 treatment. Those patients also exhibited increased survival suggesting the possibility of leveraging this mechanism and further improving survival upon multiple injections."

"This high impact publication detailing results from 41 patients in the phase 1 clinical trial of CAN-3110 is an important validation of how Candel, in collaboration with academic leaders in the field, are working to address the critical challenges in recurrent HGG," said Paul Peter Tak, MD, PhD, FMedSci, President and Chief Executive Officer of Candel. "In the clinical study, we observed a nearly doubling of the expected median overall survival after a single CAN-3110 injection, compared to historical reports of less than 6 to 9 months. We reported transformative improvements after a single injection of CAN-3110 in patients affected by aggressive tumors who had failed multiple resections, chemotherapy and radiotherapy."

Dr. Tak continued, "As a next step, we are currently evaluating the effects of multiple CAN-3110 injections in recurrent HGG, supported by the Break Through Cancer foundation. The data reported in the manuscript reinforce our confidence in CAN-3110 and its potential to change disease outcomes in difficult-to-treat solid tumors that express Nestin. In the future, we could possibly expand the development of this agent into other indications characterized by Nestin expression, such as triple negative breast cancer or sarcoma."

"The publication of this manuscript in Nature, strongly underscores the relevance and novelty of our clinical and biological findings," said Francesca Barone, MD, PhD, Chief Scientific Officer of Candel. "The molecular construct of CAN-3110 makes this virus unique as a next generation viral immunotherapy candidate, combining in a single agent potent oncolysis and immune activation. Of importance, patients with recurrent HGG who had pre-existing antibodies to HSV-1 virus (66% of the patients) had a median overall survival of 14.2 months. In these patients, we observed clear evidence of immune activation in the tumor microenvironment. Those without antibodies (34%) had median overall survival of 7.8 months, which is in the same range as historical survival

times. Different from conventional immunotherapy, CAN-3110 is designed to expand but also diversify the immune response. Accordingly, we observed increased diversity of the T-cell receptor repertoire after a single injection of CAN-3110 in recurrent HGG patients. We have started to evaluate the effects of repeated injection with CAN-3110, which has the potential to result in the HSV-1 seroconversion associated with improved survival."

About the phase 1 clinical trial of CAN-3110 in recurrent HGG

This investigator-sponsored study is led by E. Antonio Chiocca, MD, PhD, Head of the Department of Neurosurgery at Brigham & Women’s Hospital and Professor at Harvard Medical School. The clinical trial comprises three arms. In arm A, 41 patients with recurrent HGG were treated by a single intratumoral injection of CAN-3110 (dose ranging from 1×106 plaque forming units (pfu) to 1×1010 pfu), including nine patients with multifocal/multicentric, deep or bilateral tumors associated with poor survival. After observing this regimen was generally well tolerated without dose-limiting toxicity, patients in arm B (n=9) were treated with a single dose of cyclophosphamide (24 mg/kg), two days before CAN-3110 injection at doses of 1 x 108 pfu (n=3) and 1 x 109 pfu (n=6). The rationale is based on findings in mouse models, where cyclophosphamide improved viral persistence in injected tumors. In arm C, supported by the Break Through Cancer foundation, two cohorts of 12 patients with recurrent HGG will receive up to six injections of CAN-3110 over a four-month period.

Early results from the phase 1 clinical trial were presented in May 2023 at the American Society of Gene and Cell Therapy 26th Annual Meeting. The oral presentation highlighted that in arm A (n=41), treatment with a single dose of CAN-3110 was generally well tolerated and resulted in median overall survival (mOS) of 11.8 months as of the data cutoff date on April 20, 2023. In addition, at the same data cutoff date, median overall survival in arm B (n=9) was ongoing at 12.0 months, supporting the encouraging clinical activity of CAN-3110 observed in in arm A. Of note, responses were shown in both injected and uninjected lesions in patients with multifocal disease. Analysis of post treatment samples demonstrated evidence of persistent HSV antigen expression and replication in uninjected tumor tissue associated with CD8+ T cell infiltration, which may explain the clinical responses observed in uninjected tumors.

On October 18, 2023 Abbott (NYSE: ABT) reported financial results for the third quarter ended Sept. 30, 2023 (Press release, Abbott, OCT 18, 2023, View Source [SID1234636100]).

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Third-quarter GAAP diluted EPS of $0.82 and adjusted diluted EPS of $1.14, which excludes specified items.
Abbott narrowed its full-year 2023 EPS guidance range. Abbott projects full-year diluted EPS on a GAAP basis of $3.14 to $3.18 and projects adjusted diluted EPS of $4.42 to $4.46, which represents an increase at the midpoint of the guidance range.

Abbott continues to project full-year 2023 organic sales growth, excluding COVID-19 testing-related sales1, to be in the low double-digits2.

In July, Abbott obtained CE Mark for its AVEIR single-chamber leadless pacemaker for treating patients with slow heart rhythms. Unlike traditional pacemakers, leadless pacemakers do not require an incision in the chest to implant or leads (wires) to deliver therapy.
In September, Abbott acquired Bigfoot Biomedical, a leader in developing insulin management systems, furthering Abbott’s efforts to develop connected solutions for making diabetes management even more personal and precise.
In September, Abbott expanded its existing collaboration with global biotech leader mAbxience Holdings S.L. to commercialize several biosimilar molecules, with the goal of broadening access to these therapies for people in emerging markets.

In September, Abbott published an analysis showing a complementary relationship between the company’s FreeStyle Libre continuous glucose monitoring system and GLP-1 medications. The analysis also showed that a growing number of people are using these tools together to support behavior change to optimize the treatment of diabetes and improve overall health.

"The investments we made during the pandemic continue to drive broad-based growth across our underlying base business," said Robert B. Ford, chairman and chief executive officer, Abbott. "We’re on track to deliver on the financial commitments we set at the beginning of the year, and the momentum we’re building across the portfolio positions us well as we head into 2024."

THIRD-QUARTER BUSINESS OVERVIEW

Management believes that measuring sales growth rates on an organic basis, which excludes the impact of foreign exchange, the impact of exiting the pediatric nutrition business in China, and the impact of the acquisition of Cardiovascular Systems, Inc. (CSI), 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 2023 Results (3Q23)

Sales 3Q23 ($ in millions)

Total Company

Nutrition

Diagnostics

Established

Pharmaceuticals

Medical Devices

U.S.

3,817

860

1,013

—

1,940

International

6,326

1,213

1,436

1,368

2,309

Total reported

10,143

2,073

2,449

1,368

4,249

% Change vs. 3Q22

U.S.

(6.8)

25.4

(40.8)

n/a

14.6

International

0.2

9.3

(25.6)

3.2

18.4

Total reported

(2.6)

15.5

(32.7)

3.2

16.6

Impact of foreign exchange

(1.4)

(1.4)

(0.8)

(7.9)

0.6

Impact of CSI acquisition

0.5

—

—

—

1.3

Impact of business exit

(0.2)

(1.2)

—

—

—

Organic

(1.5)

18.1

(31.9)

11.1

14.7

Impact of COVID-19 testing sales (3)

(15.3)

—

(42.0)

—

—

Organic (excluding COVID-19 tests)

13.8

18.1

10.1

11.1

14.7

U.S.

15.3

25.4

13.7

n/a

11.8

International

13.0

13.4

8.2

11.1

17.1

First Nine Months 2023 Results (9M23)

Sales 9M23 ($ in millions)

Total Company

Nutrition

Diagnostics

Established

Pharmaceuticals

Medical Devices

U.S.

11,503

2,553

3,309

—

5,631

International

18,365

3,563

4,145

3,844

6,813

Total reported

29,868

6,116

7,454

3,844

12,444

% Change vs. 9M22

U.S.

(17.4)

20.2

(51.8)

n/a

14.3

International

(6.5)

1.3

(34.5)

4.0

11.8

Total reported

(11.0)

8.4

(43.5)

4.0

12.9

Impact of foreign exchange

(2.4)

(2.8)

(1.4)

(7.6)

(1.7)

Impact of CSI acquisition

0.3

—

—

—

0.8

Impact of business exit

(0.2)

(1.5)

—

—

—

Organic

(8.7)

12.7

(42.1)

11.6

13.8

Impact of COVID-19 testing sales (3)

(20.5)

—

(49.3)

—

—

Organic (excluding COVID-19 tests)

11.8

12.7

7.2

11.6

13.8

U.S.

12.9

20.2

6.3

n/a

12.6

International

11.2

8.0

7.7

11.6

14.8

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

Nutrition

Third Quarter 2023 Results (3Q23)

Sales 3Q23 ($ in millions)

Total

Pediatric

Adult

U.S.

860

506

354

International

1,213

495

718

Total reported

2,073

1,001

1,072

% Change vs. 3Q22

U.S.

25.4

41.8

7.7

International

9.3

5.1

12.4

Total reported

15.5

20.9

10.8

Impact of foreign exchange

(1.4)

(1.4)

(1.6)

Impact of business exit

(1.2)

(2.6)

—

Organic

18.1

24.9

12.4

U.S.

25.4

41.8

7.7

International

13.4

11.5

14.8

Worldwide Nutrition sales increased 15.5 percent on a reported basis and 18.1 percent on an organic basis in the third quarter. Refer to table titled "Non-GAAP Revenue Reconciliation" for a reconciliation of adjusted historical revenue to reported revenue.

In Pediatric Nutrition, global sales increased 20.9 percent on a reported basis and 24.9 percent on an organic basis. In the U.S., sales growth of 41.8 percent was primarily driven by continued market share recovery in the infant formula business following a voluntary recall of certain products last year.

In Adult Nutrition, global sales increased 10.8 percent on a reported basis and 12.4 percent on an organic basis, which was led by strong global growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand.

First Nine Months 2023 Results (9M23)

Sales 9M23 ($ in millions)

Total

Pediatric

Adult

U.S.

2,553

1,472

1,081

International

3,563

1,477

2,086

Total reported

6,116

2,949

3,167

% Change vs. 9M22

U.S.

20.2

32.8

6.4

International

1.3

(0.9)

2.9

Total reported

8.4

13.5

4.1

Impact of foreign exchange

(2.8)

(2.1)

(3.3)

Impact of business exit

(1.5)

(3.5)

—

Organic

12.7

19.1

7.4

U.S.

20.2

32.8

6.4

International

8.0

8.1

7.9

Diagnostics

Third Quarter 2023 Results (3Q23)

Sales 3Q23 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid

Diagnostics *

U.S.

1,013

317

38

97

561

International

1,436

997

95

43

301

Total reported

2,449

1,314

133

140

862

% Change vs. 3Q22

U.S.

(40.8)

12.7

(42.0)

5.7

(55.9)

International

(25.6)

6.3

(19.9)

21.8

(64.1)

Total reported

(32.7)

7.8

(27.8)

10.2

(59.2)

Impact of foreign exchange

(0.8)

(1.9)

(0.3)

0.4

(0.3)

Organic

(31.9)

9.7

(27.5)

9.8

(58.9)

Impact of COVID-19 testing sales (3)

(42.0)

(0.7)

(23.9)

—

(72.0)

Organic (excluding COVID-19 tests)

10.1

10.4

(3.6)

9.8

13.1

U.S.

13.7

13.4

(15.9)

5.7

20.1

International

8.2

9.5

1.7

20.4

2.9

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 $305 million in the third quarter of 2023 compared to $1.671 billion in the third quarter of the prior year.

Excluding COVID-19 testing-related sales, global Diagnostics sales increased 8.8 percent on a reported basis and 10.1 percent on an organic basis.

First Nine Months 2023 Results (9M23)

Sales 9M23 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid

Diagnostics *

U.S.

3,309

917

128

289

1,975

International

4,145

2,872

293

127

853

Total reported

7,454

3,789

421

416

2,828

% Change vs. 9M22

U.S.

(51.8)

9.7

(58.7)

1.9

(63.7)

International

(34.5)

3.0

(42.2)

14.6

(70.8)

Total reported

(43.5)

4.6

(48.4)

5.5

(66.2)

Impact of foreign exchange

(1.4)

(3.5)

(0.9)

(0.4)

(0.6)

Organic

(42.1)

8.1

(47.5)

5.9

(65.6)

Impact of COVID-19 testing sales (3)

(49.3)

(1.1)

(36.2)

—

(73.8)

Organic (excluding COVID-19 tests)

7.2

9.2

(11.3)

5.9

8.2

U.S.

6.3

10.6

(19.5)

1.9

7.7

International

7.7

8.8

(7.7)

16.0

9.0

*The Acelis Connected Health business was internally transferred from Rapid Diagnostics to Heart Failure on January 1, 2023. As a result, $30 million of sales in the third quarter of 2022 and $87 million in the first nine months of 2022 were moved from Rapid Diagnostics to Heart Failure.

Established Pharmaceuticals

Third Quarter 2023 Results (3Q23)

Sales 3Q23 ($ in millions)

Total

Key Emerging

Markets

Other

U.S.

—

—

—

International

1,368

987

381

Total reported

1,368

987

381

% Change vs. 3Q22

U.S.

n/a

n/a

n/a

International

3.2

(1.4)

17.2

Total reported

3.2

(1.4)

17.2

Impact of foreign exchange

(7.9)

(10.2)

(1.2)

Organic

11.1

8.8

18.4

U.S.

n/a

n/a

n/a

International

11.1

8.8

18.4

Established Pharmaceuticals sales increased 3.2 percent on a reported basis and 11.1 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 decreased 1.4 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, women’s health, and central nervous system/pain management.

First Nine Months 2023 Results (9M23)

Sales 9M23 ($ in millions)

Total

Key Emerging

Markets

Other

U.S.

—

—

—

International

3,844

2,889

955

Total reported

3,844

2,889

955

% Change vs. 9M22

U.S.

n/a

n/a

n/a

International

4.0

1.3

13.2

Total reported

4.0

1.3

13.2

Impact of foreign exchange

(7.6)

(8.7)

(3.9)

Organic

11.6

10.0

17.1

U.S.

n/a

n/a

n/a

International

11.6

10.0

17.1

View News Release Full Screen
Medical Devices

Third Quarter 2023 Results (3Q23)

Sales 3Q23 ($ in millions)

Total

Rhythm

Management

Electro-

physiology

Heart

Failure *

Vascular

Structural

Heart

Neuro-

modulation

Diabetes

Care

U.S.

1,940

271

246

217

251

223

188

544

International

2,309

292

298

67

421

264

39

928

Total reported

4,249

563

544

284

672

487

227

1,472

% Change vs. 3Q22

U.S.

14.6

3.7

9.1

5.0

17.5

7.6

20.9

28.5

International

18.4

8.2

22.5

30.9

7.3

23.8

7.4

24.8

Total reported

16.6

6.0

16.0

10.2

10.9

15.8

18.3

26.2

Impact of foreign exchange

0.6

0.2

(0.8)

1.0

0.2

1.1

(0.5)

1.7

Impact of CSI acquisition

1.3

—

—

—

7.9

—

—

—

Organic

14.7

5.8

16.8

9.2

2.8

14.7

18.8

24.5

U.S.

11.8

3.7

9.1

5.0

(4.1)

7.6

20.9

28.5

International

17.1

7.8

24.0

26.3

6.5

21.6

9.9

22.3

Worldwide Medical Devices sales increased 16.6 percent on a reported basis and 14.7 percent on an organic basis in the third quarter. Sales growth was led by double-digit organic growth in Diabetes Care, Electrophysiology, Structural Heart, and Neuromodulation. Several recently launched products and new indications contributed to the strong performance, including Amplatzer Amulet, Navitor, TriClip, and AVEIR.

In Electrophysiology, internationally, sales grew more than 20 percent on a reported and organic basis, which includes mid-teens growth in Europe.

In Diabetes Care, FreeStyle Libre sales were $1.4 billion, which represents sales growth of 30.5 percent on a reported basis and 28.5 percent on an organic basis.

View News Release Full Screen
First Nine Months 2023 Results (9M23)

Sales 9M23 ($ in millions)

Total

Rhythm

Management

Electro-

physiology

Heart

Failure *

Vascular

Structural

Heart

Neuro-

modulation

Diabetes

Care

U.S.

5,631

800

729

661

733

652

528

1,528

International

6,813

873

873

199

1,271

794

122

2,681

Total reported

12,444

1,673

1,602

860

2,004

1,446

650

4,209

% Change vs. 9M22

U.S.

14.3

3.4

9.3

8.3

12.7

7.9

15.8

31.1

International

11.8

5.1

13.0

19.2

3.5

19.1

8.5

15.6

Total reported

12.9

4.3

11.3

10.7

6.7

13.8

14.4

20.8

Impact of foreign exchange

(1.7)

(1.7)

(2.8)

(0.2)

(2.1)

(1.5)

(1.1)

(1.5)

Impact of CSI acquisition

0.8

—

—

—

4.9

—

—

—

Organic

13.8

6.0

14.1

10.9

3.9

15.3

15.5

22.3

U.S.

12.6

3.4

9.3

8.3

(0.5)

7.9

15.8

31.1

International

14.8

8.6

18.3

20.1

6.2

21.9

14.1

17.9

*The Acelis Connected Health business was internally transferred from Rapid Diagnostics to Heart Failure on January 1, 2023. As a result, $30 million of sales in the third quarter of 2022 and $87 million in the first nine months of 2022 were moved from Rapid Diagnostics to Heart Failure.

ABBOTT’S EARNINGS-PER-SHARE GUIDANCE
Abbott projects full-year 2023 diluted earnings per share under GAAP of $3.14 to $3.18. Abbott forecasts specified items for the full-year 2023 of $1.28 per share primarily related to intangible amortization, costs associated with acquisitions, restructuring and cost reduction initiatives and other net expenses. Excluding specified items, projected adjusted diluted earnings per share would be $4.42 to $4.46 for the full-year 2023.

ABBOTT DECLARES 399TH CONSECUTIVE QUARTERLY DIVIDEND
On Sept. 21, 2023, the board of directors of Abbott declared the company’s quarterly dividend of $0.51 per share. Abbott’s cash dividend is payable Nov. 15, 2023, to shareholders of record at the close of business on Oct. 13, 2023.

Abbott has increased its dividend payout for 51 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 18, 2023 Circio reported that it intends to close the subsidiary Targovax OY in Finland, which owned and managed the ONCOS-102 program (Press release, Circio, OCT 18, 2023, View Source [SID1234636097]). All activities relating to the wind-down of ONCOS-102 clinical development and manufacturing will soon be completed and is not expected to incur further costs. There are currently no plans to reinitiate ONCOS-102 development, but this may change if investor and partnering interest for oncolytic viruses reemerges in the future.

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As a result of this new strategic focus and after discussions with the Nomination Committee, the three Directors Bente-Lill Romøren, Sonia Quaratino and Raphael Clynes have tendered their resignations from Circio’s Board. In parallel, the management team has been reorganized with VP and Head of Clinical Development, Margrethe Sørgaard, moving on to take up a new external role. The remaining management team has also taken a temporary pay reduction as a further cost-saving initiative. This restructuring of the Board and management, together with the previously communicated staff reductions during 2Q 2023, enables around 40% lower payroll costs from 2H 2023 onwards.

Damian Marron, Chairman of Circio, commented: "I wish to sincerely thank Bente-Lill, Sonia and Raphael for their service and important contributions to Circio over the years. In addition, I extend my gratitude to Margrethe for her deep dedication to the ONCOS-102 and TG01 clinical development programs. Although we are very sorry to lose the valuable experience and contributions these talented individuals have brought to the Board and management, we are now implementing a new strategy that requires a different toolbox and skillset. With these adjustments we believe that we have a strong, right-sized team to continue building Circio into the clear leader in vector-delivered circular RNA therapeutics."

Following the resignations, Circio´s Board will, effective 17 October 2023 and until the 2024 Annual General Meeting, be comprised of four Directors: Damian Marron (Chairman), Diane Mellet, Robert Burns and Thomas Falck. Circio’s management team will consist of five members: Erik D Wiklund (CEO), Lubor Gaal (CFO), Victor Levitsky (CSO), Thomas B Hansen (VP & Head of Research) and Ola Melin (VP & Head of Manufacturing).