On January 23, 2024 Leap Therapeutics presented its corporate presentation (Presentation, Leap Therapeutics, JAN 23, 2024, View Source [SID1234639432]).

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 January 23, 2024 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2023. "Johnson & Johnson’s full year 2023 results reflect the breadth and competitiveness of our business and our relentless focus on delivering for patients," said Joaquin Duato, Chairman and Chief Executive Officer (Press release, Johnson & Johnson, JAN 23, 2024, View Source [SID1234639431]). "We have entered 2024 from a position of strength, and I am confident in our ability to lead the next wave of health innovation."

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!

Unless otherwise noted, the financial results and earnings guidance included below reflect the continuing operations of Johnson & Johnson.

Overall Financial Results
a4q23overallresults.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
5 Excludes COVID-19 Vaccine
Note: values may have been rounded

Regional Sales Results
a4q23regionalsalesresultsv2.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
a4q23segmentsalesperforman.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: The Innovative Medicine segment was previously referred to as the Pharmaceutical segment
Values may have been rounded

Full Year 2023 Segment Commentary:
Operational sales* reflected below excludes the impact of translational currency. Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Innovative Medicine
Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 7.2%*. Growth was driven by DARZALEX (daratumumab), ERLEADA (apalutamide), TECVAYLI (teclistamab-cqyv) in Other Oncology, and CARVYKTI (ciltacabtagene autoleucel) in Oncology, STELARA (ustekinumab) and TREMFYA (guselkumab) in Immunology, and SPRAVATO (esketamine) in Neuroscience. Growth was partially offset by ZYTIGA (abiraterone acetate) and IMBRUVICA (ibrutinib) in Oncology, and REMICADE (infliximab) in Immunology. Including the COVID-19 Vaccine, Innovative Medicine worldwide operational sales grew 4.8%*.

MedTech
MedTech worldwide operational sales grew 12.4%*, with the acquisition of Abiomed contributing 4.7%. MedTech worldwide adjusted operational sales grew 7.8%*, driven primarily by electrophysiology products in Interventional Solutions, contact lenses in Vision, wound closure products in General Surgery, and biosurgery in Advanced Surgery.

Notable New 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, MedTech, www.factsabouttalc.com, www.factsaboutourprescriptionopioids.com, and www.LLTManagementInformation.com.

Regulatory
U.S. Food and Drug Administration Grants Full Approval for BALVERSA to Treat Locally
Advanced or Metastatic Bladder Cancer with Select Genetic Alterations1
Press Release
Biosense Webster Announces Regulatory Approval of VARIPULSE Pulsed Field Ablation (PFA) Platform in Japan1
Press Release
Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Lazertinib, in combination with RYBREVANT (amivantamab), for the First-Line Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer Press Release
Johnson & Johnson Submits Supplemental Biologics License Application and New Drug Application to U.S. FDA Seeking Approval of RYBREVANT (amivantamab-vmjw) Plus Lazertinib for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer (NSCLC) Press Release
Johnson & Johnson’s Investigational TAR-200 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of High-Risk Non-Muscle-Invasive Bladder Cancer Press Release
Janssen Submits Application to the European Medicines Agency for RYBREVANT (amivantamab) in Combination with Chemotherapy for the Treatment of Adult Patients with Advanced EGFR-Mutated Non-Small Cell Lung Cancer After Failure of Prior Therapy Press Release
Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of RYBREVANT (amivantamab-vmjw) Plus Chemotherapy for the Treatment of Patients with EGFR-Mutated Non-Small Cell Lung Cancer Who Progressed on or after Osimertinib Press Release
MONARCH Platform for Bronchoscopy Receives Regulatory License for China Press Release
Data Release Johnson & Johnson highlights its preeminent leadership in hematology through differentiated blood cancer portfolio and pipeline with new clinical and real-world data at ASH (Free ASH Whitepaper) Press Release
New Real-World Data Show TREMFYA (guselkumab) Was Associated With Clinically Meaningful Improvements in Patient-Reported Outcomes for Adults Living With Active Psoriatic Arthritis Press Release
Phase 2 Nipocalimab Data Establish Proof of Mechanism in Adults Living with Moderate to Severe Rheumatoid Arthritis, Supporting its Progression into a Combination Study Press Release
New Biosense Webster QDOT MICRO Catheter Data Demonstrate Very High-Power, Short-Duration Ablations Improved Quality of Life and Reduced Healthcare Utilization for AFib Patients Press Release
New Phase 3 TREMFYA (guselkumab) Results in Ulcerative Colitis Show a 77 Percent Overall Clinical Response Rate and Early Symptom Improvement Press Release
Janssen Aims to Define New Standards of Care in the Treatment of Solid Tumor Cancers with Transformative Data Planned for Presentation at ESMO (Free ESMO Whitepaper) Press Release

Product Launch Ethicon Introduces ETHIZIA Hemostatic Sealing Patch, Clinically Proven to Stop Disruptive Bleeding Press Release
Other
Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to Transform the Treatment of Cancer1
Press Release
Johnson & Johnson Announces Key Drivers for Long-Term Competitive Growth at Enterprise Business Review Press Release
Johnson & Johnson Names Eugene A. Woods, Chief Executive Officer of Advocate Health, to its Board of Directors Press Release
Johnson & Johnson MedTech Acquires Laminar, Inc. Press Release
Johnson & Johnson MedTech Provides Details and Timeline for General Surgery Robot Press Release
Johnson & Johnson Announces Departure of Ashley McEvoy, Tim Schmid Named Executive Vice President, Worldwide Chairman of MedTech Press Release

1 Subsequent to the quarter

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.

($ in Billions, except EPS)
January 2024
December 2023
Adjusted Operational Sales1,2,5
Change vs. Prior Year / Mid-point
5.0% – 6.0% / 5.5%
Operational Sales2,5/ Mid-point
Change vs. Prior Year / Mid-point
$88.2B – $89.0B / $88.6B
5.0% – 6.0% / 5.5% 5.0% – 6.0% / 5.5%
Estimated Reported Sales3,5/ Mid-point
Change vs. Prior Year / Mid-point
$87.8B – $88.6B / $88.2B
4.5% – 5.5% / 5.0%
Adjusted Operational EPS (Diluted)2,4/ Mid-point
Change vs. Prior Year / Mid-point
$10.55 – $10.75 / $10.65
6.4% – 8.4% / 7.4% $10.55 – $10.75 / $10.65
7.3% Mid-point
Adjusted EPS (Diluted)3,4 / Mid-point
Change vs. Prior Year / Mid-point
$10.55 – $10.75 / $10.65
6.4% – 8.4% / 7.4%
Average Shares Outstanding (Diluted)6
~2,435 million

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: January 2024 = $1.09 and December 2023 = $1.09 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items
5 Excludes COVID-19 Vaccine
6 Full Year 2024 Projected Average Shares Outstanding (Diluted) reflects impact from the Kenvue exchange offer
Note: percentages may have been rounded

Other modeling considerations will be provided on the webcast.

On January 23, 2024 Inhibrx, Inc. (Nasdaq: INBX) ("Inhibrx," or the "Company") and Sanofi (Nasdaq: SNY) ("Sanofi") reported that the companies have entered into a definitive agreement under which Aventis Inc., a Pennsylvania corporation (a subsidiary of Sanofi) will acquire all the assets and liabilities associated with INBRX-101, an optimized, recombinant alpha-1 antitrypsin ("AAT") augmentation therapy currently in a registrational trial for the treatment of patients with alpha-1 antitrypsin deficiency ("AATD") (Press release, Inhibrx, JAN 23, 2024, View Source [SID1234639430]). Immediately prior to the closing of the merger, all non-101 assets and liabilities, including INBRX-105, INBRX-106, INBRX-109, Inhibrx’s non-101 discovery pipeline and its corporate infrastructure, will be spun out from the Company into a new publicly traded company, Inhibrx Biosciences, Inc. ("New Inhibrx").

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!

Under the terms of the agreement, Sanofi will acquire all outstanding shares of Inhibrx through a merger, and in turn, each Inhibrx shareholder will receive: (i) $30.00 per share in cash, (ii) one contingent value right per share, representing the right to receive a contingent payment of $5.00 in cash upon the achievement of a regulatory milestone and (iii) one SEC-registered, publicly listed, share of New Inhibrx per every four shares of Inhibrx common stock held. In addition, in connection with the transaction, Sanofi will assume and retire Inhibrx’s outstanding third party debt and cause New Inhibrx to be funded with $200 million in cash and will retain an equity interest in New Inhibrx of 8%. The boards of directors of both Inhibrx and Sanofi have unanimously approved the transaction.

Combined, the upfront cash portion of the consideration, the potential contingent value payment, if achieved, and the assumption of Inhibrx’s debt, implies an aggregate transaction value of approximately $2.2 billion. Additionally, Inhibrx shareholders will own 92% of New Inhibrx capitalized with $200 million in cash.

Following the closing, New Inhibrx will continue to operate under the "Inhibrx" name and will be led by Mark Lappe as Chairman and CEO, as well as the other members of the current management team of Inhibrx. New Inhibrx will continue to own Inhibrx’s other clinical therapeutic candidates, INBRX-105, INBRX-106, and INBRX-109, as well as its non-101 discovery pipeline and certain corporate infrastructure owned by Inhibrx.

Sanofi expects to finance the transaction with available cash resources.

Sanofi’s acquisition of Inhibrx is subject to the completion of the New Inhibrx spin-off transaction and other customary closing conditions, including receipt of regulatory approvals and approval by Inhibrx’s stockholders. Subject to the satisfaction or waiver of customary closing conditions, Sanofi and Inhibrx expect the transaction to close in the second quarter of 2024.

Advisors

Centerview Partners LLC is acting as exclusive financial advisor to Inhibrx and Paul, Weiss, Rifkind, Wharton and Garrison LLP is serving as legal counsel. Lazard is acting as exclusive financial advisor to Sanofi and Weil, Gotshal & Manges LLP is serving as legal counsel.

On January 23, 2024 HEPHAISTOS-Pharma, a biotechnology company developing next generation immunotherapies against cancer, reported that it has raised a €2 million seed round to finance GMP transfer and advance its lead candidate towards the clinic (Press release, HEPHAISTOS-Pharma, JAN 23, 2024, View Source [SID1234639429]). The round was co-led by xista science ventures and the Foundation Fournier-Majoie, with the participation of Noshaq.

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 Foundation is very pleased to be part of HEPHAISTOS-Pharma thanks to this financing round. The valuable and dedicated team developed a promising TLR4 compound that will be used systemically which will bring to the oncologists a best-in-class product for their cancer patients. We are eager to help the company bring to the clinic this innovative program. » said Jerome Majoie, CEO and Chairman at Fournier- Majoie Foundation.

"We are very proud to be joined by institutional investors" said Frederic CAROFF, CEO, and co-founder of HEPHAISTOS-Pharma. "They bring the necessary funds to match our non-dilutive financing, but also the expertise and network that will help structure the company. They will play a critical role in the success of HEPHAISTOS as we move our platform to the clinic. We are also thankful to our historical investors and new business angels from Angels Santé, who joined the round."

The proceeds from this financing round will enable HEPHAISTOS to industrialize its manufacturing process and prepare for the clinical phases, with the goal of advancing its lead candidate, ONCO-Boost, into clinical development for the treatment of solid tumors with high unmet medical needs, in particular sarcoma. Ingrid Kelly, Partner at xista science ventures, commented that « HEPHAISTOS has an impressive set of preclinical data, showing the high potential of their TLR4 agonist ONCO-Boost to tackle solid tumors, particularly in combination with immunotherapies such as checkpoint inhibitors.

The proceeds will also be used to open a new subsidiary in Liège, Wallonia. The objective will be to leverage local state-of -the-art facilities and expertise to explore additional applications and strengthen HEPHAISTOS’ pipeline. "We are delighted to attract HEPHAISTOS to develop part of its activities in our vibrant local ecosystem. In the midst of a challenging market landscape, Noshaq remains a magnet for innovative companies with a disruptive approach and high-level management" said Eric Brandt, Investment Manager at NOSHAQ.

On January 23, 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 9,744 million in 2023 (Press release, Genmab, JAN 23, 2024, View Source [SID1234639428]). Net trade sales were USD 5,277 million in the U.S. and USD 4,467 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.

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!