On July 17, 2024 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2024 (Press release, Johnson & Johnson, JUL 17, 2024, View Source [SID1234644933]). "Johnson & Johnson’s second quarter performance reflects our relentless focus on advancing the next wave of medical innovation and resulted in strong sales and adjusted operational earnings per share growth," said Joaquin Duato, Chairman and Chief Executive Officer. "With a robust pipeline, upcoming regulatory milestones for RYBREVANT and TREMFYA, the integration of Shockwave, and continued expansion of newly launched products, including ACUVUE OASYS MAX 1-Day contact lenses and our VARIPULSE platform, we have a strong foundation for near and long-term growth."
Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson.

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Overall financial results
Q2
($ in Millions, except EPS) 2024 2023 % Change
Reported Sales $22,447
$ 21,519
4.3%
Net Earnings $4,686 $5,376 (12.8)%
EPS (diluted) $1.93 $2.05 (5.9)%

Q2
Non-GAAP* ($ in Millions, except EPS) 2024 2023 % Change
Operational Sales1,2
6.6%
Adjusted Operational Sales1,3
6.5%
Adjusted Operational Sales ex. COVID-19 Vaccine1,3
7.1%
Adjusted Net Earnings1,4
$6,840 $6,730 1.6%
Adjusted EPS (diluted)1,4
$2.82 $2.56 10.2%

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
4Excludes intangible amortization expense and special items
5Excludes COVID-19 Vaccine
Note: values may have been rounded

Regional sales results
Q2 % Change
($ in Millions) 2024 2023 Reported
Operational1,2
Currency
Adjusted
Operational1,3
U.S. $12,569 $11,657 7.8% 7.8 — 7.6
International 9,878 9,862 0.2 5.1 (4.9) 5.3
Worldwide $22,447 $21,519 4.3% 6.6 (2.3) 6.5

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) 2024 2023 Reported
Operational1,2
Currency
Adjusted
Operational1,3
Innovative Medicine $14,490 $13,731 5.5% 7.8 (2.3) 8.0
MedTech 7,957 7,788 2.2 4.4 (2.2) 4.0
Worldwide $22,447 $21,519 4.3% 6.6 (2.3) 6.5

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 2024 segment commentary:
Operational sales* reflected below excludes the impact of translational currency.
Innovative Medicine
Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 8.8%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), and Other Oncology in Oncology, TREMFYA (guselkumab) and STELARA (ustekinumab) in Immunology, and SPRAVATO (esketamine) in Neuroscience. Growth was partially offset by Other Neuroscience. Including the COVID-19 Vaccine, Innovative Medicine worldwide operational sales grew 7.8%*.

MedTech
MedTech worldwide operational sales grew 4.4%*, with acquisitions and divestitures positively impacting growth by 0.4%. Operational sales growth was driven primarily by electrophysiology products and Abiomed in Cardiovascular, previously referred to as Interventional Solutions, and wound closure products in General Surgery.
Full-year 2024 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.
Johnson & Johnson is updating its 2024 guidance, including adjusted operational EPS guidance, to reflect improved performance and the impact for the recent acquisitions of Shockwave Medical, Proteologix, and NM26 Bispecific Antibody.

Non-GAAP* 2024
April 2024 Adjusted Operational EPS1,2
$10.68
Improved performance outlook $0.05
July 2024 Adjusted Operational EPS1,2 pre-M&A
$10.73
M&A impact ($0.68)
July 2024 Adjusted Operational EPS1,2
$10.05

1Non-GAAP financial measure; excludes the impact of translational currency
2Non-GAAP financial measure; excludes intangible amortization expense and special items
Note: Adjusted operational EPS figures reflect midpoint of issued guidance

($ in Billions, except EPS) July 2024 April 2024
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
5.5% – 6.0% / 5.8% 5.5% – 6.0% / 5.8%
Operational Sales2,5/ Mid-point
Change vs. Prior Year / Mid-point
$89.2B – $89.6B / $89.4B
6.1% – 6.6% / 6.4%
$88.7B – $89.1B / $88.9B
5.5% – 6.0% / 5.8%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$88.0B – $88.4B / $88.2B
4.7% – 5.2% / 5.0%
$88.0B – $88.4B / $88.2B
4.7% – 5.2% / 5.0%
Adjusted Operational EPS (Diluted)2,4/ Mid-point
Change vs. Prior Year / Mid-point
$10.00 – $10.10 / $10.05
0.8% – 1.8% / 1.3%
$10.60 – $10.75 / $10.68
6.9% – 8.4% / 7.7%
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$9.97 – $10.07 / $10.02
0.5% – 1.5% / 1.0%
$10.57 – $10.72 / $10.65
6.6% – 8.1% / 7.4%

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 2024 = $1.08 and April 2024 = $1.08 (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, www.factsabouttalc.com, and www.LLTManagementInformation.com.
Regulatory CHMP adopts positive opinion for BALVERSA (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
Press Release
RYBREVANT (amivantamab) in combination with chemotherapy is the first therapy approved by the European Commission for the first-line treatment of patients with advanced non-small cell lung cancer with activating EGFR exon 20 insertion mutations
Press Release
Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA (guselkumab) for the treatment of moderately to severely active Crohn’s disease
Press Release
Subcutaneous amivantamab Biologics License Application submitted to U.S. FDA for patients with EGFR-mutated non-small cell lung cancer
Press Release
DePuy Synthes Receives 510(k) FDA Clearance of the VELYS Robotic-Assisted Solution for Use in Unicompartmental Knee Arthroplasty Procedures
Press Release
Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
Press Release
CARVYKTI (ciltacabtagene autoleucel; cilta-cel) is the first BCMA-targeted treatment approved by the European Commission for patients with relapsed and refractory multiple myeloma who have received at least one prior line of therapy
Press Release

Data Releases
CARVYKTI (ciltacabtagene autoleucel) achieved statistically significant and clinically meaningful improvement in overall survival in landmark CARTITUDE-4 study1
Press Release
Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class for broadest population of myasthenia gravis patients
Press Release
TREMFYA (guselkumab) studies underscore its potential to be the only IL-23 inhibitor to offer both subcutaneous and intravenous induction
Press Release
Johnson & Johnson showcases innovation and leadership in rheumatology at EULAR 2024 Congress
Press Release
Johnson & Johnson pivotal study of seltorexant shows statistically significant and clinically meaningful improvement in depressive symptoms and sleep disturbance outcomes
Press Release
Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper)
Press Release
TREMFYA (guselkumab) demonstrates superiority versus STELARA (ustekinumab) in Phase 3 Crohn’s disease program
Press Release
TREMFYA (guselkumab) QUASAR Maintenance Study in UC met its primary endpoint and all major secondary endpoints, including highly statistically significant rates of endoscopic remission
Press Release
Biosense Webster Presents Late-Breaking Data from admIRE Clinical Trial at the Heart Rhythm Society Annual Meeting
Press Release
TAR-210 results show 90% recurrence-free survival and 90% complete response in patients with high-risk and intermediate-risk non–muscle-invasive bladder cancer, respectively
Press Release
Johnson & Johnson Highlights Commitment to Transform Treatment of Retinal Diseases at ARVO 2024
Press Release
Phase 2 data for ERLEADA (apalutamide) plus androgen deprivation therapy following radical prostatectomy in patients with high-risk localized prostate cancer show 100% biochemical free recurrence rate more than two years post-surgery
Press Release
TAR-200 monotherapy shows greater than 80% complete response rate in patients with high-risk non–muscle-invasive bladder cancer
Press Release
Product Launch Biosense Webster Launches New Version of CARTO 3 Electro-Anatomical Mapping System
Press Release
Other
Johnson & Johnson Strengthens Pipeline to Lead in Atopic Dermatitis With the Completion of the Acquisition of Yellow Jersey Therapeutics, Gaining Ownership of NM261
Press Release
Johnson & Johnson Completes Acquisition of Proteologix, Inc.
Press Release
Johnson & Johnson Completes Acquisition of Shockwave Medical
Press Release
Johnson & Johnson to Obtain Rights to a Clinical-Stage Bispecific Antibody to Address Distinct Patient Needs in Atopic Dermatitis
Press Release
Johnson & Johnson Announces Plan by its Subsidiary, LLT Management LLC, to Resolve All Current and Future Ovarian Cancer Talc Claims Through a Consensual "Prepackaged" Reorganization
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 17, 2024 Genmab A/S (Nasdaq: GMAB) reported that 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 Johnson & Johnson were USD 2,878 million in the second quarter of 2024 (Press release, Genmab, JUL 17, 2024, View Source [SID1234644929]). Net trade sales were USD 1,641 million in the U.S. and USD 1,237 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 Janssen to develop, manufacture and commercialize daratumumab.

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On July 17, 2024 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell immunotherapy, leveraging its novel allogeneic Epstein-Barr virus (EBV) T-cell platform to develop transformative therapies for patients with cancer and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) has accepted the filing of its Biologics License Application (BLA) for tabelecleucel (tab-cel) indicated as monotherapy for treatment of adult and pediatric patients two years of age and older with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy (Press release, Atara Biotherapeutics, JUL 17, 2024, View Source [SID1234644921]). For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. There are no FDA approved therapies in this treatment setting.

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The BLA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of January 15, 2025.

"The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the U.S.," said Pascal Touchon, President and Chief Executive Officer of Atara. "The FDA’s granting of priority review highlights the high unmet need in EBV+ PTLD, which is a devastating disease with limited treatment options and a poor overall survival rate. We continue to work closely with the Pierre Fabre Laboratories team to help prepare for the potential launch in the U.S. in early 2025, along with the potential label expansion multicohort Phase 2 EBVision trial."

Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy designed to target and eliminate EBV-infected cells. The BLA is supported by pivotal and supportive data covering more than 430 patients treated with tab-cel across multiple life-threatening diseases including the latest pivotal ALLELE study data that demonstrated a statistically significant 48.8% Objective Response Rate (ORR) (p<0.0001) and favorable safety profile consistent with previous analyses.

Tab-cel has been granted Breakthrough Therapy Designation for the treatment of rituximab-refractory EBV-associated lymphoproliferative disease by the U.S. FDA and has orphan drug designation.

In December 2023, Atara announced the closing of the expanded global partnership with Pierre Fabre Laboratories for the U.S. and remaining global commercial markets for tab-cel, building on an initial partnership covering Europe, Middle East, Africa, and other select emerging markets. With the acceptance of the tab-cel BLA, Atara will receive a $20 million milestone payment from Pierre Fabre, with the potential to receive a $60 million milestone payment from Pierre Fabre contingent upon FDA approval of the tab-cel BLA. In addition, Pierre Fabre is reimbursing Atara for expected tab-cel global development costs through the BLA transfer and purchasing tab-cel inventory through the manufacturing transfer date. Atara is also eligible to receive sales milestones and double-digit tiered royalties on net sales of tab-cel in the U.S. and remaining global commercial markets referenced above.

Tab-cel was granted marketing authorization under the brand name Ebvallo in December 2022 by the European Commission. Marketing authorization was also granted by the Medicines and Healthcare Products Regulatory Agency in the United Kingdom in May 2023 and by Swissmedic in Switzerland in May 2024. In all three territories, Ebvallo is indicated as monotherapy for the treatment of adult and pediatric patients two years of age and older with relapsed or refractory EBV+ PTLD who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. Ebvallo was awarded the 2024 Prix Galien International Award for "Best Product for Orphan/Rare Diseases."

On July 17, 2024 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, July 24, 2024 to discuss the company’s second quarter financial results (Press release, Alkermes, JUL 17, 2024, View Source [SID1234644920]).

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. A replay of the webcast will be available approximately two hours after the completion of the event and may be accessed by visiting Alkermes’ website.

On July 17, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that its collaborator, Cleveland Clinic, has received a "Decision to Grant" notice from the Japan Patent Office (JPO) for the patent application titled "Vaccine Adjuvants and Formulations (Press release, Anixa Biosciences, JUL 17, 2024, View Source [SID1234644916])."

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"This new Japanese patent extends the claims for this novel breast cancer vaccine technology to an additional geographic region, beyond the U.S. and European patents previously awarded," stated Anixa Chairman and CEO Dr. Amit Kumar. "As the exclusive worldwide licensee of the technology, we value the additional protection this patent provides as we continue clinical development."

The vaccine is currently being studied in a phase one clinical trial at Cleveland Clinic.

Anixa’s breast cancer vaccine takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in certain breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing.

This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. Cleveland Clinic exclusively licensed this technology to Anixa Biosciences. Dr. Tuohy was entitled to a portion of the commercialization revenues received by Cleveland Clinic and also held equity in Anixa.