On April 16, 2025 Abbott (NYSE: ABT) reported financial results for the first quarter ended March 31, 2025 (Press release, Abbott, APR 16, 2025, View Source [SID1234651954]).

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First-quarter sales increased 4.0 percent on a reported basis, 6.9 percent on an organic basis, or 8.3 percent when excluding COVID-19 testing-related sales.
First-quarter GAAP diluted EPS of $0.76 and adjusted diluted EPS of $1.09, which excludes specified items and reflects double-digit growth compared to the prior year.
Abbott reaffirms all previously provided full-year 2025 financial guidance.
In March, Abbott obtained CE Mark for its Volt PFA System to treat patients battling atrial fibrillation (AFib). With the earlier-than-expected CE Mark, Abbott has begun commercial PFA cases in the EU with physicians who have already gained experience with the Volt PFA System through participation in Abbott’s PFA clinical studies. The company will further expand the use of Volt in EU markets throughout the second half of the year.
In March, Abbott announced the initiation of its U.S. pivotal trial, TECTONIC, to evaluate its investigational Coronary Intravascular Lithotripsy (IVL) System in treating severe calcification in coronary arteries prior to implanting a stent.
In March, Abbott presented new two-year data from its TRILUMINATE pivotal trial that showed Abbott’s TriClip device significantly reduced the rate of heart failure-related hospitalizations, while continuing to provide a sustained reduction of tricuspid regurgitation and significant improvements in quality of life.
Abbott’s two new manufacturing and R&D investments in Illinois and Texas, totaling $0.5 billion, are projected to go live by the end of 2025.
"Once again, Abbott’s diversified business model delivered top-tier sales and EPS growth," said Robert B. Ford, chairman and chief executive officer, Abbott. "It is this diversification and execution that allows Abbott to navigate through periods of uncertainty and continually deliver sustainable growth."

FIRST-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.

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.

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total Company

Nutrition

Diagnostics

Established
Pharmaceuticals

Medical Devices

U.S.

4,168

955

871

—

2,339

International

6,190

1,191

1,183

1,260

2,556

Total reported

10,358

2,146

2,054

1,260

4,895

% Change vs. 1Q24

U.S.

8.4

8.8

(6.4)

n/a

15.0

International

1.2

0.1

(7.8)

2.7

5.7

Total reported

4.0

3.8

(7.2)

2.7

9.9

Impact of foreign exchange

(2.8)

(2.4)

(2.3)

(5.1)

(2.7)

Impact of business exit*

(0.1)

(0.6)

—

—

—

Organic

6.9

6.8

(4.9)

7.8

12.6

U.S.

8.8

10.4

(6.4)

n/a

15.0

International

5.7

4.2

(3.8)

7.8

10.5

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

*Quarter to date March 31, 2025, reflects the impact of discontinuing the ZonePerfect product line in the Nutrition business in March 2024.

Total company sales increased 4.0 percent on a reported basis, 6.9 percent on an organic basis, or 8.3 percent when excluding COVID-19 testing-related sales1.

Nutrition

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total

Pediatric

Adult

U.S.

955

588

367

International

1,191

453

738

Total reported

2,146

1,041

1,105

% Change vs. 1Q24

U.S.

8.8

14.2

1.1

International

0.1

(8.4)

6.1

Total reported

3.8

3.2

4.4

Impact of foreign exchange

(2.4)

(1.7)

(2.9)

Impact of business exit*

(0.6)

—

(1.4)

Organic

6.8

4.9

8.7

U.S.

10.4

14.2

4.8

International

4.2

(4.8)

10.6

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

Worldwide Nutrition sales increased 3.8 percent on a reported basis and 6.8 percent on an organic basis in the first quarter.

In Pediatric Nutrition, global sales increased 3.2 percent on a reported basis and 4.9 percent on an organic basis. Sales growth in the U.S. was driven by growth across Abbott’s comprehensive portfolio of products designed to meet the unique nutrition needs of infants and children.

In Adult Nutrition, global sales increased 4.4 percent on a reported basis and 8.7 percent on an organic basis, which was led by strong growth of Ensure, Abbott’s market-leading complete and balanced nutrition brand, and Glucerna, Abbott’s market-leading brand of products designed to meet the nutritional requirements for people with diabetes.

Diagnostics

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total

Core Laboratory

Molecular

Point of Care

Rapid
Diagnostics

U.S.

871

332

40

100

399

International

1,183

845

82

42

214

Total reported

2,054

1,177

122

142

613

% Change vs. 1Q24

U.S.

(6.4)

7.1

(4.4)

1.5

(16.9)

International

(7.8)

(5.6)

(6.7)

4.4

(17.9)

Total reported

(7.2)

(2.3)

(5.9)

2.4

(17.3)

Impact of foreign exchange

(2.3)

(3.2)

(2.4)

(0.8)

(1.2)

Organic

(4.9)

0.9

(3.5)

3.2

(16.1)

U.S.

(6.4)

7.1

(4.4)

1.5

(16.9)

International

(3.8)

(1.3)

(3.1)

7.3

(14.6)

Global Diagnostics sales decreased 7.2 percent on a reported basis, decreased 4.9 percent on an organic basis, or increased 0.5 percent when excluding COVID-19 testing-related sales1.

Diagnostics sales growth was impacted by the year-over-year decline in COVID-19 testing-related sales and volume-based procurement programs in China.

COVID-19 testing-related sales were $84 million in the quarter, compared to $204 million in the first quarter of the prior year.

Global Core Laboratory Diagnostics sales decreased 2.3 percent on a reported basis and increased 0.9 percent on an organic basis. Growth in the quarter was impacted by volume-based procurement programs in China.

Established Pharmaceuticals

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total

Key Emerging
Markets

Other

U.S.

—

—

—

International

1,260

965

295

Total reported

1,260

965

295

% Change vs. 1Q24

U.S.

n/a

n/a

n/a

International

2.7

4.0

(1.2)

Total reported

2.7

4.0

(1.2)

Impact of foreign exchange

(5.1)

(5.3)

(4.3)

Organic

7.8

9.3

3.1

U.S.

n/a

n/a

n/a

International

7.8

9.3

3.1

Established Pharmaceuticals sales increased 2.7 percent on a reported basis and 7.8 percent on an organic basis in the first 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 4.0 percent on a reported basis and 9.3 percent on an organic basis, led by double-digit growth in several countries across Asia, Latin America and the Middle East.

Medical Devices

First Quarter 2025 Results (1Q25)

Sales 1Q25 ($ in millions)

Total

Rhythm
Management

Electro-

physiology

Heart
Failure

Vascular

Structural
Heart

Neuro-
modulation

Diabetes
Care

U.S.

2,339

304

299

262

268

282

176

748

International

2,556

281

330

77

442

295

52

1,079

Total reported

4,895

585

629

339

710

577

228

1,827

% Change vs. 1Q24

U.S.

15.0

12.3

11.1

10.6

5.5

20.9

(2.8)

27.1

International

5.7

(3.7)

4.0

14.3

1.6

4.6

16.3

10.1

Total reported

9.9

4.0

7.3

11.4

3.0

11.9

1.0

16.5

Impact of foreign exchange

(2.7)

(2.1)

(2.6)

(1.0)

(2.7)

(2.8)

(1.2)

(3.3)

Organic

12.6

6.1

9.9

12.4

5.7

14.7

2.2

19.8

U.S.

15.0

12.3

11.1

10.6

5.5

20.9

(2.8)

27.1

International

10.5

0.3

8.8

19.1

5.8

9.6

22.7

15.4

Worldwide Medical Devices sales increased 9.9 percent on a reported basis and 12.6 percent on an organic basis in the first quarter.

Sales growth in the quarter was led by 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 Diabetes Care, sales of continuous glucose monitors were $1.7 billion and grew 18.3 percent on a reported basis and 21.6 percent on an organic basis.

ABBOTT’S FINANCIAL GUIDANCE
Abbott projects full-year 2025 organic sales growth to be in the range of 7.5% to 8.5%.

Abbott projects full-year 2025 adjusted operating margin to be 23.5% to 24.0% of sales.

Abbott projects full-year 2025 adjusted diluted earnings per share of $5.05 to $5.25 and second-quarter 2025 adjusted diluted earnings per share of $1.23 to $1.27.

Abbott has not provided the related GAAP financial measures on a forward-looking basis for these forward-looking non-GAAP financial measures because the company is unable to predict with reasonable certainty and without unreasonable effort the timing and impact of certain items such as restructuring and cost reduction initiatives, charges for intangible asset impairments, acquisition-related expenses, and foreign exchange, which could significantly impact Abbott’s results in accordance with GAAP.

ABBOTT DECLARES 405th CONSECUTIVE QUARTERLY DIVIDEND
On Feb. 21, 2025, the board of directors of Abbott declared the company’s quarterly dividend of $0.59 per share. Abbott’s cash dividend is payable May 15, 2025, to shareholders of record at the close of business on April 15, 2025.

Abbott has increased its dividend payout for 53 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 April 16, 2025 Akari Therapeutics, Plc (Nasdaq: AKTX), a biotechnology company developing next-generation precision bi-functional antibody drug conjugates (ADC) for the treatment of cancer, reported its financial results for the fiscal year ended December 31, 2024 and provided a corporate update (Press release, Akari Therapeutics, APR 16, 2025, View Source [SID1234651955]).

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"2024 was a transformational year for Akari with the successful completion of our merger with Peak Bio Inc., and renewed focus on advancing our next-generation precision ADC pipeline candidates," commented Samir R. Patel, M.D., President and Chief Executive Officer of Akari Therapeutics. "Looking ahead, we have made strategic leadership appointments with key skillsets to continue setting the Company up for success. We recently announced the appointment of Abizer Gaslightwala, a seasoned oncology executive with an impressive track record, who will serve as Akari’s President and Chief Executive Officer, effective April 21, 2025. I believe with our innovative platform technology and preclinical data demonstrated to date, Akari is well-positioned to become a key player in the ADC space and capitalize on the significant deal-flow seen in early ADC development. We look forward to an exciting year ahead and remain focused on the successful execution of our capital-efficient development strategies."

Program Highlights

Following the completed merger with Peak Bio, Inc. in November 2024, Akari has focused its efforts on the discovery, research and development of novel anti-cancer payloads with mechanisms of action that differ from currently approved ADC therapies and the application of those payloads against clinically validated targets. Leveraging its platform, the Company is advancing a pipeline of potentially first-in-class, best-in-class ADC candidates that are designed to target and kill cancer cells and stimulate the immune system, or bifunctional ADCs, all while potentially overcoming the limitations inherent in existing therapies.

Lead Candidate: AKTX-101 (TROP2 PH1 ADC) – Novel Payload is a Spliceosome Inhibitor With Multiple Anti-Tumor Mechanisms

•
Potential to overcome shortcomings of current ADCs
•
Immunostimulatory effects
•
Reduced off-target toxicity
•
Overcomes resistance mechanisms
•
Potential for synergy with immunotherapies

•
Significant advantages over current TROP2 ADCs observed in multiple preclinical models:
o
Superior activity
o
Prolonged survival
o
Less resistance
o
Better tolerability
o
Prolonged survival in combination with checkpoint inhibitors (CPI)

Upcoming Expected Value-Driving Milestones

Next-Generation Precision Bi-Functional ADC Platform

•
Present anticipated PH1 Payload preclinical data at scientific conference
•
Complete additional preclinical studies for AKTX-101

•
Continue to advance pipeline by generating additional validating data on PH1 payload while advancing discovery work on additional novel payloads PH5 and PH6
•
Round out Executive Team with critical hires
•
Seek licensing/strategic partner for AKTX-101 (TROP2 PH1 ADC)

Legacy Pipeline Assets

•
Continue Business Development efforts to secure development partners and provide non-dilutive capital

Summary of Financial Results for Full Year 2024

The net loss from operations for the year ended December 31, 2024 was approximately $21.6 million compared to approximately $16.8 million for the comparable period in 2023. The increase in net loss from operations is primarily attributable to merger related costs of $3.3 million, restructuring costs of $1.7 million and an increase in research and development expenses of $1.5 million which was offset by a reduction in general and administrative expenses of $1.7 million.

The Company reported research and development expenses of $7.0 million for the year ended December 31, 2024 compared to approximately $5.5 million for the comparable period in 2023.

General and administrative expenses were approximately $9.7 million for the year ended December 31, 2024 compared to approximately $11.4 million for the year ended December 31, 2023.

As of December 31, 2024, the Company had cash of approximately $2.6 million. Management anticipates that its cash on hand as of December 31, 2024 including the net proceeds from the private placement of $6.6 million announced in March 2025, is sufficient to fund operations into September 2025.

On April 16, 2025 Ipsen, a global specialty-care biopharmaceutical company, reported sales for the first quarter of 2025 (Press release, Ipsen, APR 16, 2025, View Source [SID1234652994]).

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On April 15, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, reported that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to LYL314 (formerly IMPT-314) for the treatment of adult patients with relapsed and/or refractory large B-cell lymphoma after two or more prior lines of therapy (Press release, Lyell Immunopharma, APR 15, 2025, View Source [SID1234651936]). LYL314 is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR T-cell therapies for the treatment of aggressive large B-cell lymphoma (LBCL).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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RMAT designation provides all the benefits of the Fast Track and Breakthrough Therapy designation programs, including early interactions with the FDA. LYL314’s RMAT designation was granted based on promising early data from the ongoing Phase 1/2 clinical trial.

"The RMAT designation for LYL314, is based on promising clinical data from our ongoing Phase 1/2 trial and highlights the transformative potential of this next-generation CAR T-cell therapy to address the unmet needs of patients with aggressive large B-cell lymphoma," said Lynn Seely, M.D., president and chief executive officer of Lyell. "We believe that by targeting both CD19 and CD20 with equal potency and manufacturing with a process that enriches for more naïve and central memory CAR T cells, LYL314 has the potential to offer patients with aggressive B-cell lymphoma more complete responses and longer duration of response than first-generation CAR T-cell therapies that only target CD19. LYL314 has now received both Fast Track Designation and RMAT designation in the 3rd or later line setting and we look forward to working closely with the FDA as we continue to accelerate this promising CAR T-cell therapy into two pivotal programs for patients."

Initial data from the Phase 1/2 trial of LYL314 were presented at the American Society for Hematology 2024 Annual Meeting in December 2024, including data from 23 patients with relapsed or refractory LBCL in the 3rd or later line setting who received LYL314. The efficacy evaluable population consisted of 17 patients. The overall response rate was 94% (16/17) of patients, with 71% (12/17) of patients achieving a complete response by three months. The median follow up was 6.3 months (range 1.2 – 12.5 months) and 71% of patients were experiencing a response at last follow-up. In the safety evaluable population of 23 patients, no Grade 3 or greater cytokine release syndrome (CRS) was reported. Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) was reported in 13% (3/23) of patients with a median time to ICANS resolution of 5 days, and rapid improvement to Grade 2 or lower with standard therapy.

Additional clinical updates from the Phase 1/2 trial of LYL314 are planned for 2025. The company expects to present more mature data from the ongoing Phase 1/2 trial from patients being treated in the 3rd or later line setting and initial data from patients in the 2nd line setting in mid-2025 and to present more mature data from patients treated in the 2nd line setting in late 2025. Two pivotal programs for LBCL are planned, including one for patients treated in the 3rd or later line setting expected to be initiated in mid-2025 and another for patients treated in the 2nd line setting expected to be initiated by early 2026.

The RMAT designation is a program under the 21st Century Cures Act that is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases or conditions. A regenerative medicine therapy is eligible for RMAT designation if it is intended to treat, modify, reverse or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the regenerative medicine therapy has the potential to address unmet medical needs for such disease or condition.

RMAT designation provides all Breakthrough Therapy designation features, including early interactions to discuss any potential surrogate or intermediate endpoints. RMATs may be eligible for accelerated approval based on previously agreed-upon surrogate or intermediate endpoints that are reasonably likely to predict long-term clinical benefit.

About LYL314

LYL314 is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to the approved CD19‑targeted CAR therapies for the treatment of LBCL. LYL314 is designed as a true CD19/CD20 "OR" logic-gated CAR targeting either CD19 or CD20 with full potency, and the cell therapy product is manufactured with a process that enriches for CD62L+ cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity.

In addition to RMAT, LYL314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of relapsed and/or refractory LBCL in the 3rd or later line setting.

On April 15, 2025 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company, reported that following review of data from its phase 2 ARTISTRY-6 trial in melanoma and previously announced results from the phase 3 ARTISTRY-7 trial in platinum-resistant ovarian cancer, the company is discontinuing all clinical development of nemvaleukin alfa and plans to immediately commence the exploration of strategic alternatives focused on maximizing shareholder value (Press release, Mural Oncology, APR 15, 2025, View Source [SID1234651944]). Mural has engaged Lucid Capital Markets, LLC to act as its financial advisor in connection with the exploration of strategic alternatives. The company had approximately $144.4 million of cash, cash equivalents, and marketable securities as of December 31, 2024. In conjunction with today’s announcement, Mural plans to reduce its workforce by approximately 90%.

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ARTISTRY-6, cohort 2 is a phase 2, single-arm trial evaluating nemvaleukin as a monotherapy in 92 patients with mucosal melanoma with a minimum follow-up of at least six months. A review of the topline data from this cohort showed that the primary endpoint was not achieved. Mural also conducted a review of preliminary data from ARTISTRY-6, cohort 3, evaluating less-frequent intravenous dosing of nemvaleukin in patients with cutaneous melanoma, and did not observe a level of activity that warranted continuation. Based on the totality of these data, together with the interim overall survival results from ARTISTRY-7 as announced on March 25, 2025, Mural will discontinue all clinical development of nemvaleukin.

Mural plans to explore potential strategic alternatives including, but not limited to, an offer for or other acquisition of the company, merger, business combination, or other transaction. While the company has not set a timetable for completion of this process, further updates and developments will be disclosed as appropriate or where necessary under regulatory requirements. There can be no assurance that the exploration of strategic alternatives will result in the company pursuing a transaction or that any acquisition or other transaction involving the company will be completed, nor as to the terms on which any acquisition or other transaction will occur, if at all.

The company confirms that, as at the date of this announcement, it is not in receipt of any approaches and not in active discussions with any potential offeror.

Irish Takeover Rules Considerations

Mural is subject to the Irish Takeover Panel Act, 1997, Irish Takeover Rules 2022 (the "Irish Takeover Rules"), which have certain implications on some of the strategic alternatives to be explored by the company. As the exploration of strategic alternatives is expected to include consideration of potential offers for the company, following the publication of this announcement Mural is now considered to be in an "offer period" as defined in the Irish Takeover Rules and the dealing disclosure requirements of Rule 8 of the Irish Takeover Rules as summarized below will apply.

The Irish Takeover Panel has granted a dispensation from the requirements of Rules 2.4(b) and 2.4(c) of the Irish Takeover Rules such that any potential offeror will not be required to be publicly identified as a result of this announcement for so long as the strategic evaluation is ongoing. Such parties should nonetheless be mindful of their obligations under the Irish Takeover Rules, including in particular with respect to confidentiality under Rule 2.1 and the circumstances in which an announcement may be required under Rule 2.2. If a potential offeror has any doubts about its obligations pursuant to the Irish Takeover Rules, it should contact its financial adviser(s) and, where applicable, it should also consult with the Irish Takeover Panel.

This is an announcement under Rule 2.4 of the Irish Takeover Rules and is not an announcement of a firm intention by any party to make an offer under Rule 2.7 of the Irish Takeover Rules.