On July 16, 2025 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2025 (Press release, Johnson & Johnson, JUL 16, 2025, View Source [SID1234654408]). "Today’s strong results reflect the depth and strength of Johnson & Johnson’s uniquely diversified business operating across both MedTech and Innovative Medicine," said Joaquin Duato, Chairman and Chief Executive Officer, Johnson & Johnson. "Our portfolio and pipeline position us for elevated growth in the second half of the year, with game-changing approvals and submissions anticipated in areas like lung and bladder cancer, major depressive disorder, psoriasis, surgery and cardiovascular, which will extend and improve lives in transformative ways."
Overall financial results
Q2
($ in Millions, except EPS)
2025
2024
% Change
Reported Sales

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

$23,743
$22,447
5.8%
Net Earnings
$5,537
$4,686
18.2%
EPS (diluted)
$2.29
$1.93
18.7%

Q2
Non-GAAP* ($ in Millions, except EPS)
2025
2024
% Change
Operational Sales1,2

4.6%
Adjusted Operational Sales1,3

3.0%
Adjusted Net Earnings1,4
$6,699
$6,840
-2.1%
Adjusted EPS (diluted)1,4
$2.77
$2.82
-1.8%
Free Cash Flow6,7
~$6,200
$7,507

Regional sales results
Q2

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S.
$13,544
$12,569
7.8%
7.8
–
5.0
International
10,199
9,878
3.2
0.6
2.6
0.4
Worldwide
$23,743
$22,447
5.8%
4.6
1.2
3.0

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Segment sales results
Q2

% Change

($ in Millions)
2025
2024
Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine
$15,202
$14,490
4.9%
3.8
1.1
2.4
MedTech
8,541
7,957
7.3
6.1
1.2
4.1
Worldwide
$23,743
$22,447
5.8%
4.6
1.2
3.0

1Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2Excludes the impact of translational currency
3Excludes the net impact of acquisitions and divestitures and translational currency
Note: values may have been rounded

Second-Quarter 2025 segment commentary:

Operational sales* reflected below excludes the impact of translational currency.

Innovative Medicine

Innovative Medicine worldwide operational sales grew 3.8%*, with net acquisitions and divestitures positively impacting growth by 1.4%. Growth was primarily driven by DARZALEX, CARVYKTI, ERLEADA and RYBREVANT/LAZCLUZE in Oncology, TREMFYA and SIMPONI/SIMPONI ARIA in Immunology, and SPRAVATO in Neuroscience. Growth was partially offset by an approximate (1,170) basis points impact from STELARA in Immunology, and an approximate (130) basis points impact from COVID-19 in Infectious Diseases.

MedTech

MedTech worldwide operational sales grew 6.1%*, with net acquisitions and divestitures positively impacting growth by 2.0%. Growth was primarily driven by electrophysiology products and Abiomed in Cardiovascular, as well as wound closure products in General Surgery.

Full-year 2025 guidance:
Johnson & Johnson does not provide GAAP financial measures on a forward-looking basis because the company is unable to predict with reasonable certainty the ultimate outcome of legal proceedings, unusual gains and losses, acquisition-related expenses, and purchase accounting fair value adjustments without unreasonable effort. These items are uncertain, depend on various factors, and could be material to Johnson & Johnson’s results computed in accordance with GAAP.
($ in Billions, except EPS)
July 2025
April 2025
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
3.2% – 3.7% / 3.5%
2.0% – 3.0% / 2.5%
Operational Sales2,5 / Mid-point
Change vs. Prior Year / Mid-point
$92.7B – $93.1B / $92.9B
4.5% – 5.0% / 4.8%
$91.6B – $92.4B / $92.0B
3.3% – 4.3% / 3.8%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$93.2B – $93.6B / $93.4B
5.1% – 5.6% / 5.4%
$91.0B – $91.8B / $91.4B
2.6% – 3.6% / 3.1%
Adjusted Operational EPS (Diluted)2,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.63 – $10.73 / $10.68
6.5% – 7.5% / 7.0%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.80 – $10.90 / $10.85
8.2% – 9.2% / 8.7%
$10.50 – $10.70 / $10.60
5.2% – 7.2% / 6.2%

1Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2Non-GAAP financial measure; excludes the impact of translational currency
3Calculated using Euro Average Rate: July 2025 = $1.13 and April 2025 = $1.10 (Illustrative purposes only)
4Non-GAAP financial measure; excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: percentages may have been rounded
Other modeling considerations will be provided on the webcast
Notable announcements in the quarter:
The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. The reader is also encouraged to review all other news releases and information available in the Investor Relations section of the company’s website at News Releases, as well as Innovative Medicine News Center, MedTech News & Events, and www.factsabouttalc.com.
Regulatory
Supplemental new drug application submitted to U.S.
FDA for CAPLYTA (lumateperone) with data
demonstrating significant schizophrenia relapse prevention compared to placebo1
Press Release
DARZALEX (daratumumab) receives the first positive CHMP opinion for patients with high-risk smouldering multiple myeloma
Press Release
IMBRUVICA (ibrutinib) receives positive CHMP opinion for the treatment of patients with previously untreated mantle cell lymphoma (MCL) who would be eligible for autologous stem cell transplant
Press Release
U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma
Press Release
Johnson & Johnson receives FDA approval for IMAAVY (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)
Press Release

Johnson & Johnson MedTech Announces Completion of First Cases with OTTAVA Robotic Surgical System
Press Release
Data Releases IMAAVY (nipocalimab-aahu) showed greater sustained disease control versus approved FcRn blockers for generalized myasthenia gravis (gMG) at multiple timepoints over 24 weeks in newly published indirect treatment comparison (ITC)
Press Release
Investigational combination of first-in-class bispecifics TALVEY and TECVAYLI shows deep and durable responses in heavily pretreated multiple myeloma patients with extramedullary disease
Press Release
Johnson & Johnson’s dual-targeting CAR T-cell therapy shows encouraging first results in large B-cell lymphoma
Press Release
New results for Johnson & Johnson’s bleximenib demonstrate promising antileukemic activity in combination with venetoclax and azacitidine for acute myeloid leukemia
Press Release
Significant efficacy benefit of IMBRUVICA (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison
Press Release
New data show TREMFYA (guselkumab) is the only IL-23 inhibitor proven to significantly inhibit progression of joint structural damage in active psoriatic arthritis
Press Release
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)-based regimen shows 95 percent progression-free survival at four years in transplant-eligible, newly diagnosed patients with multiple myeloma who achieved sustained MRD negativity
Press Release
Early results from Johnson & Johnson’s trispecific antibody show promising response in heavily pretreated multiple myeloma patients
Press Release
Single infusion of CARVYKTI (ciltacabtagene autoleucel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma
Press Release
Johnson & Johnson leads with first PARP inhibitor combo to improve efficacy in patients with HRR-altered mCSPC
Press Release
Johnson & Johnson unveils first-in-human results for pasritamig, showing early anti-tumor activity in prostate cancer
Press Release
Shockwave Medical Study Confirms Benefit of IVL-First Strategy in Real-World Female Patients with Complex Calcified Lesions in Late-Breaking Data Presentation at EuroPCR 2025
Press Release
Icotrokinra results show significant skin clearance in patients with difficult-to-treat scalp and genital psoriasis
Press Release
TREMFYA (guselkumab) delivers sustained clinical and endoscopic remission in ulcerative colitis through two years
Press Release
TREMFYA (guselkumab) positioned to become the first and only IL-23 inhibitor to offer subcutaneous induction in ulcerative colitis as demonstrated in new data through 24 weeks
Press Release
Johnson & Johnson’s TAR-200 monotherapy achieves high disease-free survival of more than 80 percent in BCG-unresponsive, high-risk papillary NMIBC
Press Release
Johnson & Johnson’s TAR-200 monotherapy demonstrates highest complete response rate with sustained clinical benefits in patients with certain types of bladder cancer
Press Release

Johnson & Johnson MedTech Presents 3-Month Data from Omny-IRE Clinical Trial at 2025 Heart Rhythm Society Annual Meeting
Press Release

Product Launch
Johnson & Johnson Launches First and Only Daily Disposable Multifocal Toric Contact Lens – ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM
Press Release
Johnson & Johnson Launches VOLT Wrist and Proximal Humerus Plating Systems in the U.S.
Press Release
Johnson & Johnson Launches New TECNIS Odyssey Next-Generation Intraocular Lens in Europe, the Middle East, and Canada Offering Cataract Patients Precise Vision at Every Distance in Any Lighting
Press Release
Johnson & Johnson Launches KINCISE 2 System, the Only Automated Surgical Impactor Approved for Knee and Hip Revision Procedures
Press Release
Johnson & Johnson MedTech Launches SOUNDSTAR CRYSTAL in the US, Redefining Image Clarity in 2D Intracardiac Imaging
Press Release

Other
Johnson & Johnson Elects Daniel Pinto, President, JPMorganChase to its Board of Directors
Press Release

Webcast information:
Johnson & Johnson will conduct a conference call with investors to discuss this earnings release today at 8:30 a.m., Eastern Time. A simultaneous webcast of the call for investors and other interested parties may be accessed by visiting the Johnson & Johnson website. A replay and podcast will be available approximately two hours after the live webcast in the Investor Relations section of the company’s website at events-and-presentations.

On July 16, 2025 Genmab A/S (Nasdaq: GMAB) reported worldwide net trade sales of DARZALEX (daratumumab), including sales of the subcutaneous (SC) product (daratumumab and hyaluronidase-fihj, sold under the tradename DARZALEX FASPRO in the U.S.), as reported by J&J were USD 3,539 million in the second quarter of 2025 (Press release, Genmab, JUL 16, 2025, View Source [SID1234654407]). Net trade sales were USD 2,017 million in the U.S. and USD 1,521 million in the rest of the world. Genmab receives royalties on the worldwide net sales of DARZALEX, both the intravenous and SC products, under the exclusive worldwide license to J&J to develop, manufacture and commercialize daratumumab.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

On July 16, 2025 Amphista Therapeutics ("the Company" or "Amphista"), a leader in the discovery of next-generation, Targeted Protein Degradation (TPD) medicines, reported the successful achievement of a discovery research milestone under its exclusive research collaboration and licence agreement with Merck (Press release, Amphista Therapeutics, JUL 16, 2025, View Source [SID1234654404]). In conjunction with the milestone achievement, Amphista receives a pre-specified financial payment. The associated target on which the milestone is triggered is currently undisclosed.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"As we continue to build our portfolio of first- and/or best-in-class Targeted Glues, we are delighted to have reached an important milestone in our collaboration with Merck. The progress we have made together speaks to the effective partnership between scientists from both companies, enabling us to focus on advancing high-quality compounds for further development," said Antony Mattessich, Chief Executive Officer at Amphista. "This achievement reinforces the exceptional capabilities of our Eclipsys platform in the rational design of orally bioavailable protein degraders, bringing us a step closer to improving patient outcomes."

Under the agreement, Amphista is responsible for the discovery and early development of small molecule protein degraders using its Eclipsys platform. Merck is granted a global exclusive license to the resulting degrader molecules and will be responsible for further development and commercialisation activities.

On July 16, 2025 MAA Laboratories reported that it has received formal written scientific advice from the Federal Institute for Drugs and Medical Devices (BfArM) in Germany for its Dasatinib Nanoparticle Tablets (Press release, MAA Laboratories, JUL 16, 2025, View Source [SID1234654403]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The advice supports MAA’s ongoing development efforts and provides regulatory clarity for advancing the program in the European Union. Importantly, the feedback from BfArM is consistent with guidance previously received from the U.S. Food and Drug Administration (FDA), further validating the Company’s development strategy and the scientific strength of its NanoCont platform.

"We are grateful for BfArM’s constructive guidance," said Dr. Anjani Jha, CEO of MAA Laboratories. "The alignment between U.S. and EU regulators provides strong validation for our regulatory and clinical approach and reinforces our confidence in the potential of our nanoparticle-based therapies."

MAA Laboratories remains committed to delivering differentiated therapies that improve patient outcomes through enhanced drug delivery, tolerability, and systemic performance. The Company looks forward to initiating clinical studies and advancing its broader pipeline across global markets.

On July 16, 2025 Imugene Limited (ASX:IMU) (Company), a clinical stage immuno-oncology company, reported it has received firm commitments from institutional and sophisticated investors (Placement Subscribers) for a $22.5 million placement of 68.2 million new fully paid ordinary shares (New Shares) in the Company at a price of $0.33 per share (Placement) (Press release, Imugene, JUL 16, 2025, https://mcusercontent.com/e38c43331936a9627acb6427c/files/8f06edf2-4d00-ada9-d455-5d6b87cbf237/Imugene_Completes_225M_Placement_and_c_15M_SPP.pdf [SID1234654399]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The Placement is being followed by an SPP, to raise up to $15 million, for existing eligible shareholders (Eligible Shareholders), with applications up to a maximum of $100,000. The SPP will be made to Eligible Shareholders at the same terms as the Placement and will be subject to shareholder approval.

Under the Placement and SPP (together, the Offer), Placement Subscribers and Eligible Shareholders are anticipated to receive three (3) free attaching listed options for every four (4) New Shares subscribed for under the Offer (Attaching Options). The Attaching Options will have an exercise price of $0.43 per option with an expiration of 30 March 2026 and will be subject to shareholder approval. It is intended that the Attaching Options will be quoted on the ASX.

Placement Subscribers and Eligible Shareholders are also anticipated to receive one (1) additional free option for every one (1) Attaching Option exercised prior to 30 March 2026 (Piggyback Option). The Piggyback Options will have an exercise price of $0.86 per option, with an expiration of 30 June 2028, and will be subject to shareholder approval. It is intended that the Piggyback Options will be quoted on the ASX.

The full details of the rights and liabilities attaching to the Attaching Options and Piggyback Options are annexed to this announcement.

The funds raised from the Offer will be used:

 to fund research and development of the azer-cel program through a pivotal clinical trial in CY26;
 extending the funding runway into mid CY27; and
 general administrative and working capital.

Imugene Managing Director and CEO Leslie Chong said: "Following the strong support received in the recent oversubscribed placement, Imugene is pleased to extend this opportunity to existing retail shareholders through a Share Purchase Plan (SPP), enabling participation on the same terms. The placement, together with the SPP and existing cash reserves, places the company in a strong financial position to progress the azer-cel program towards a potential pivotal Phase 2 clinical trial, based on the promising efficacy data reported earlier this week".

About the Placement

Under the terms of the Placement, the Company has secured firm commitments for $22.5 million and proposes to issue up to 68.2 million New Shares to Placement Subscribers at a price of $0.33 per share, representing a discount of:

 22.4% to the last close of $0.4250 on 11 July 2025; and
 19.6% to the five-day VWAP of $0.4107 up to and including 11 July 2025.

The Placement is being conducted under Imugene’s existing placement capacity pursuant to ASX Listing Rule 7.1.

For every four (4) New Shares subscribed for by Placement Subscribers under the Placement, Imugene intends to issue three (3) Attaching Options. The Attaching Options will have an exercise price of $0.43 per option and expiry date of 30 March 2026. For every one (1) Attaching Option exercised prior to the expiry date, Imugene intends to issue one (1) Piggyback Option, with an exercise price of $0.86 and an expiration of 30 June 2028.

The Attaching Options and Piggyback Options (New Options) will be set out in a prospectus (Prospectus). The issuance of the New Options will be subject to shareholder approval at an extraordinary general meeting (EGM) to be convened shortly.

Bell Potter Securities Limited and E&P Capital Pty Ltd acted as Joint Lead Managers and Bookrunners to the Placement and are entitled to the fees as set out In the Appendix 3B lodged today.

About the SPP

The Company will also offer an SPP to Eligible Shareholders at an offer price of $0.33 per share (Offer Price). This is the same price as for the Placement and, as with the Placement, the SPP is currently not underwritten.

Under the SPP, Eligible Shareholders listed on the Imugene register at 7:00pm (Sydney time) on the record date of Tuesday, 15 July 2025 with an address in Australia or New Zealand, will be offered the opportunity to apply for up to $100,000 of New Shares in Imugene, without incurring brokerage fees or other transactions costs, irrespective of their holding size. The SPP will be subject to certain eligibility criteria and other terms and conditions of the SPP which will be out in in the Prospectus and dispatched to eligible shareholders.

The New Shares Issued under the SPP will be subject to shareholder approval at an EGM expected to be held in August 2025.

Notwithstanding the target raise amount of $15 million for the SPP, the Company reserves its right to increase or decrease the amount to be raised under the SPP.

As with the Placement, for every four (4) New Shares subscribed for by Eligible Shareholders under the SPP, Imugene intends to issue three (3) Attaching Options on the same terms as the Placement. For every one (1) Attaching Option exercised by an Eligible Shareholders prior to the expiry date, Imugene intends to issue one (1) Piggyback Option on the same terms as the Placement. The Attaching Options and Piggyback Options are subject to shareholder approval.

Additionally, the Company reserves the right to issue up to 4.4 million options to investors who commit to take-up shortfall of the SPP (subject to the Corporations Act 2001 (Cth) and ASX Listing Rules, including shareholder approval if required).