On October 18, 2022 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2022. "Our third quarter performance demonstrates our continued strength and resilience across all three of our businesses," said Joaquin Duato, Chief Executive Officer (Filing, 8-K, Johnson & Johnson, OCT 18, 2022, View Source [SID1234622132]). "Through the ongoing efforts of our teams around the world, we continue to navigate the dynamic macroeconomic environment and remain focused on delivering transformative healthcare solutions. Looking ahead, I remain confident in our business and ability to continue advancing our innovative portfolio and pipeline."

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OVERALL FINANCIAL RESULTS:
a3q22overallfinancialresula.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Excludes intangible amortization expense and special items
Note: values may have been rounded

REGIONAL SALES RESULTS:
a3q22regionalfinancialresua.jpg

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

SEGMENT SALES RESULTS:
a3q22salesbysegment002a.jpg
1 Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules
2 Excludes the impact of translational currency
3 Excludes the net impact of acquisitions and divestitures and translational currency
4 Certain international OTC products, primarily in China, were reclassified from the Pharmaceutical segment to the Consumer Health segment based on
operational changes
Note: Values may have been rounded

THIRD QUARTER 2022 SEGMENT COMMENTARY:

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Consumer Health

Consumer Health worldwide adjusted operational sales increased 4.8%*. Major contributors to growth include upper respiratory and analgesic products in the over-the-counter franchise, NEUTROGENA and AVEENO in Skin Health/Beauty and Women’s Health products outside the United States.

Pharmaceutical

Pharmaceutical worldwide adjusted operational sales grew 9.2%*, driven by DARZALEX (daratumumab), a biologic for the treatment of multiple myeloma, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, and INVEGA SUSTENNA/XEPLION and INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults. Also contributing to growth were sales of the Janssen COVID-19 Vaccine (Ad26.COV2.S) for the prevention of the SARS-CoV-2 virus. This growth was partially offset by declines in sales of REMICADE (infliximab), a biologic approved for the treatment of several immune-mediated inflammatory diseases and IMBRUVICA (ibrutinib), an oral, once daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer.

MedTech

MedTech worldwide adjusted operational sales grew 8.1%*, driven primarily by electrophysiology products in Interventional Solutions, contact lenses in Vision, Trauma in Orthopaedics and wound closure products in General Surgery.

NOTABLE NEW ANNOUNCEMENTS IN THE QUARTER:

The information contained in this section should be read in conjunction 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 available online in the Investors section of the Company’s website at news releases, as well as
www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LTLManagementInformation.com.

Regulatory Decisions STELARA (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis (Press Release)
European Commission Approves IMBRUVICA (ibrutinib) in a Fixed-Duration Combination Regimen for Adult Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (Press Release)
Janssen Marks First Approval Worldwide for TECVAYLI (teclistamab) with EC Authorisation of First-in-Class Bispecific Antibody for the Treatment of Patients with Multiple Myeloma (Press Release)
U.S. FDA Approves IMBRUVICA (ibrutinib) as First and Only BTKi Treatment for Pediatric Patients with Chronic Graft-Versus-Host Disease (Press Release)
Data Release Janssen Announces New Data Supporting Safety and Efficacy of RYBREVANT and Lazertinib Combination for Patients with Non-Small Cell Lung Cancer and EGFR Mutations (Press Release)
Final Analysis of Phase 2 GRIFFIN Study Presented for DARZALEX (daratumumab)-based Investigational Quadruplet Regimen in Patients with Newly Diagnosed, Transplant-Eligible Multiple Myeloma (Press Release)
TREMFYA (guselkumab) Demonstrates Higher Rates of Complete Skin Clearance with Earlier Treatment in Adults with Moderate to Severe Plaque Psoriasis in Phase 3b GUIDE Study (Press Release)
Results of Novel Clinical Study of Guselkumab and Golimumab Combination Therapy Show Adults with Moderately to Severely Active Ulcerative Colitis Maintained Higher Rates of Clinical, Histologic, and Endoscopic Remission at Week 381
(Press Release)
STELARA (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis1
(Press Release)
Janssen Announces Late-Breaking Data from Two Gene Therapy Programs at the American Academy of Ophthalmology 2022 Annual Meeting (Press Release)
Product Launches Biosense Webster Launches the OCTARAY Mapping Catheter with TRUEref Technology (Press Release)
Johnson & Johnson Vision Introduces All Purpose EDOF, TECNIS Symfony OptiBlue IOL, the Latest PC-IOL Powered by InteliLight Technology (Press Release)
Johnson & Johnson Vision Launches New Contact Lens Innovation to Help Meet the Needs of Digitally Intense Lifestyles: ACUVUE OASYS MAX 1-Day (Press Release)
Biosense Webster Launches HELIOSTAR in Europe, the First Radiofrequency Balloon Ablation Catheter, Enabling Physicians to Perform More Efficient Cardiac Ablations1
(Press Release)
Other Johnson & Johnson Announces $5 Billion Share Repurchase Program (Press Release)
Johnson & Johnson Appoints Larry Merlo as Non-Executive Chair Designate of Planned New Consumer Health Company (Press Release)
Johnson & Johnson Announces Kenvue as the Name for Planned New Consumer Health Company (Press Release)

. 1 Subsequent to the quarter

FULL-YEAR 2022 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) October 2022 July 2022
Adjusted Operational Sales1,2,5
Change vs. Prior Year
6.7% – 7.2% 6.5% – 7.5%
Operational Sales2,5/ Mid-point2,5
Change vs. Prior Year / Mid-point
$97.5B – $98.0B / $97.8B
6.7% – 7.2% / 7.0% $97.3B – $98.3B / $97.8B
6.5% – 7.5% / 7.0%
Estimated Reported Sales3,5/ Mid-point3,5
Change vs. Prior Year / Mid-point
$93.0B – $93.5B / $93.3B
1.8% – 2.3% / 2.1% $93.3B – $94.3B / $93.8B
2.1% – 3.1% / 2.6%
Adjusted Operational EPS (Diluted)2,4/ Mid-point2,4
Change vs. Prior Year / Mid-point
$10.70 – $10.75 / $10.73
9.2% – 9.7% / 9.5% $10.65 – $10.75 / $10.70
8.7% – 9.7% / 9.2%
Adjusted EPS (Diluted)3,4 / Mid-point3,4
Change vs. Prior Year / Mid-point
$10.02 – $10.07 / $10.05
2.3% – 2.8% / 2.6% $10.00 – $10.10 / $10.05
2.1% – 3.1% / 2.6%

1 Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures
2 Non-GAAP financial measure; excludes the impact of translational currency
3 Calculated using Euro Average Rate: October 2022 = $1.04 and July 2022 = $1.05 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
Note: percentages may have been rounded

Other modeling considerations will be provided on the webcast.

On October 18, 2022 Instil Bio, Inc. ("Instil") (Nasdaq: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported that the first patient has been dosed in a Phase 1 dose escalation study of ITIL-306 (NCT05397093 View Source;draw=2&rank=2) for the treatment of multiple solid tumors (Press release, Instil Bio, OCT 18, 2022, View Source [SID1234622130]). ITIL-306 is Instil’s first genetically-engineered Costimulatory Antigen Receptor-TIL (CoStAR-TIL) therapy.

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"The successful initiation of the Phase 1 study of ITIL-306 underscores our commitment to evolving TIL therapy, using strategies to enhance product efficacy and safety, with the goal to achieve durable remissions in patients with treatment-refractory solid tumors," said Bronson Crouch, Chief Executive Officer of Instil Bio.

Instil’s first-in-human Phase 1 study of ITIL-306 is an open-label, multicenter study in patients with non-small cell lung cancer, ovarian cancer, and renal cell carcinoma. Patients in the first dose cohort will receive a target dose of one billion CoStAR-transduced TILs after receiving a reduced intensity lymphodepletion regimen and no post-infusion interleukin-2. The study will evaluate safety of ITIL-306 in addition to efficacy and translational endpoints. The company anticipates reporting initial clinical data from the Phase 1 trial in 2023.

ITIL-306 is an autologous TIL cell therapy engineered with a novel and proprietary CoStAR molecule that is activated by folate receptor alpha (FRα) to provide robust costimulatory signals within the tumor microenvironment. CoStAR builds on the key advantages of native TILs to enhance the cytokine release, cytolytic activity, and proliferation of TILs in the tumor microenvironment. Previously published preclinical data ( View Source ) demonstrates the ability of CoStAR-T cells to enhance tumor control in vivo in the absence of exogenous IL-2, supporting a treatment regimen free of IL-2 in the Phase 1 study of ITIL-306.

On October 18, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx)TM targeting oncology and immuno-dysregulated diseases, reported that it has approved 4 additional clinical trial sites for IMX-110 clinical trials, complementing existing soft tissue sarcoma lead clinical trial site in California (Press release, Immix Biopharma, OCT 18, 2022, View Source [SID1234622129]). Historically, the lead high-enrolling site has enrolled 2-3 patients per month. Once dosing begins, patients will undergo CT scans every 8 weeks to assess tumor response to IMX-110; results are expected to be released on a rolling basis beginning in Q1 2023.

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"We are excited to select these 4 preeminent oncology sites to join our clinical site consortium from a larger group of interested centers. We are humbled by the enthusiasm from these key opinion leaders to bring IMX-110 to their patients," said Ilya Rachman, MD PhD, CEO of ImmixBio. "These KOLs are excited about both IMX-110 as a monotherapy, and in combination with BeiGene and Novartis’ anti-PD-1, tislelizumab."

About IMX-110

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease designation ("RPDD") for IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma. RPDD qualifies ImmixBio to receive fast track review and a priority review voucher (PRV) at the time of marketing approval of IMX-110. IMX-110 is currently being evaluated in a phase 1b/2a clinical trial in patients with advanced solid tumors. Learn more at www.immixbio.com/iMX-110

On October 18, 2022 Immatics presented its Corporate presentation (Press release, Immatics, OCT 18, 2022, View Source [SID1234622128]).

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On October 18, 2022 Helsinn Group ("Helsinn"), a fully integrated global biopharma company with a diversified pipeline of innovative oncology assets, reported that research from an in vitro study of chlormethine gel has been published in the journal Dermatology and Therapy (Press release, Helsinn, OCT 18, 2022, View Source [SID1234622127]).

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This article, "Chlormethine Gel for the treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing", evaluated part of the mode of action of chlormethine (CL) gel once applied to the skin. In a preliminary, proof-of-concept, in vitro study, the release profile of 0.016% chlormethine gel was evaluated compared to an ointment-based formulation of CL. The absorption profile of the CL gel was also evaluated in ex vivo healthy human skin using in vitro permeation testing (IVPT).

Results from the study indicate that the rate of chlormethine release from the CL gel formulation was statistically higher in comparison to the ointment formulation. In addition, data indicate that only a minimal amount of the CL can pass through the epidermis reaching the dermis, suggesting that most of the applied CL reacted within the epidermal layer. This finding is consistent with the lack of evidence of systemic absorption seen with CL gel(1,2) and further supports the notion that drug-drug interactions are very unlikely.

Details of the publication:

Title: "Chlormethine Gel for the treatment of Mycosis Fungoides Cutaneous T-Cell Lymphoma: In Vitro Release and Permeation Testing."
Authors: Claudio Giuliano, Stefano Frizzarin, Alessandro Alonzi, Virginia Stimamiglio and Pablo L. Ortiz-Romero
Link: View Source
Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.

Dr. Silvia Sebastiani, Group Head of Medical Affairs, commented: "Chlormethine is a well-established and effective topical therapy for treating lesions in patients with MF-CTCL and is available in a variety of formulations. Understanding CL gel’s mode of action and how it permeates through the skin is extremely important for its use in clinical practice."