On October 19, 2021 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2021 (Press release, Johnson & Johnson, OCT 19, 2021, View Source [SID1234591524]). "Our third-quarter results demonstrate solid performance across Johnson & Johnson, driven by robust above-market results in Pharmaceuticals, ongoing recovery in Medical Devices, and strong growth in Consumer Health," said Alex Gorsky, Chairman and Chief Executive Officer. "In the face of evolving marketplace dynamics resulting from the effects of COVID-19 and other global trends, we have continued to demonstrate the responsiveness and agility required to meet the needs of our stakeholders, while also successfully investing in a pipeline of innovation and key commercial platforms to drive our future growth. I am incredibly proud of our Company’s transformative growth over the last decade. As I prepare to transition the role of CEO to Joaquin Duato in January, I want to extend my deepest gratitude to our colleagues around the globe who work tirelessly to deliver solutions to address the world’s most urgent and unmet healthcare challenges."

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OVERALL FINANCIAL RESULTS

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Excludes intangible amortization expense and special items

REGIONAL SALES RESULTS

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Non-GAAP financial measure; refer to reconciliations of non-GAAP financial measures included in accompanying schedules

Excludes the impact of translational currency

Excludes the net impact of acquisitions and divestitures and translational currency

Note: values may have been rounded

THIRD QUARTER 2021 SEGMENT COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, increased 5.7%* primarily driven by over-the-counter (OTC) products. Major contributors to growth were TYLENOL and MOTRIN analgesics, upper respiratory products, and digestive health in OTC, and AVEENO in Skin Health / Beauty.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 13.8%* driven by DARZALEX (daratumumab), for the treatment of multiple myeloma, STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and for adults with active psoriatic arthritis, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, and OPSUMIT (macitentan) an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression. Also contributing to growth was sales of the not-for-profit COVID-19 Vaccine (Ad26.COV2.S) for the treatment of the SARS-CoV-2 virus. This growth was partially offset by declines in U.S. sales of REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and INVOKANA (canagliflozin) for the treatment of adults with type 2 diabetes.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 7.6%*, driven by electrophysiology products in Interventional Solutions, wound closure products in General Surgery, surgical vision products and contact lenses in Vision, trauma, hips, and knees in Orthopaedics, and energy, endocutters, and biosurgicals in Advanced Surgery. Growth was partially offset by Spine, Sports & Other.

NOTABLE NEW ANNOUCEMENTS 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.

Regulatory
Decisions

INVEGA HAFYERA (paliperidone palmitate) Receives FDA Approval For First and Only Twice-Yearly Treatment for Adults with Schizophrenia

(press release)

XARELTO (rivaroxaban) Plus Aspirin Receives FDA Approval For Expanded Peripheral Artery Disease (PAD) Indication to Include Patients After Lower-Extremity Revascularization (LER)

(press release)

UPTRAVI (selexipag) Receives FDA Approval For Intravenous Use in Adult Patients with Pulmonary Arterial Hypertension (PAH)

(press release)

Regulatory
Submissions

Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine 1

(press release)

Janssen Submits Application Seeking U.S. FDA Approval of STELARA (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis 1

(press release)

Other

Alex Gorsky to Transition Role of Chief Executive Officer of Johnson & Johnson to Joaquin Duato, Effective January 3, 2022

(press release)

Dr. Paul Stoffels, Vice Chairman of the Executive Committee and Chief Scientific Officer of Johnson & Johnson to Retire, Effective December 31, 2021 1

(press release)

Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.

(press release)

Johnson & Johnson Issues Statement on Nationwide Opioid Settlement Agreement

(press release)

DePuy Synthes Announces Introduction of the INHANCE Shoulder System, a First-to-Market, Fully Integrated Shoulder Arthroplasty System

(press release)

Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults

(press release)

Janssen Receives Positive CHMP Opinion for BYANNLI (six-monthly paliperidone palmitate) for the Maintenance Treatment of Schizophrenia in Adults

(press release)

Ethicon Announces ECHELON CIRCULAR Powered Stapler Associated with Major Reduction in Serious Complications Following Colorectal Surgery

(press release)

Johnson & Johnson Takes Steps to Equitably Resolve All Current and Future Talc Claims 1

(press release)

Janssen Receives Positive CHMP Opinion for RYBREVANT (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy 1

(press release)

Johnson & Johnson COVID-19 Vaccine Booster Shot Unanimously Recommended for Emergency Use Authorization by U.S. FDA Advisory Committee 1

(press release)

1Subsequent to the quarter

FULL-YEAR 2021 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.

Non-GAAP financial measure; excludes the net impact of acquisitions and divestitures

Non-GAAP financial measure; excludes the impact of translational currency

Calculated using Euro Average Rate: July 2021 = $1.19 and October = $1.19 (Illustrative purposes only)

Non-GAAP financial measure; excludes intangible amortization expense and special items

Note: % may have been rounded

Other modeling considerations will be provided on the webcast.

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 Investors section of the company’s website at events-and-presentations.

On October 19, 2021 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a U.S. clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM) (Press release, Cytori Therapeutics, OCT 19, 2021, View Source [SID1234591523]). The Company expects to initiate patient accrual in a Phase 1 dose escalation trial of 186RNL (ReSPECT-LM) in the fourth quarter of 2021.

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"LM is an increasingly common secondary cancer complication, occurring as a result of increasing observed survival rates for a variety of primary solid and hematologic tumors," said Andrew J. Brenner, M.D., Ph.D., Professor of Medicine, Neurology, and Neurosurgery at The University of Texas and ReSPECT-LM Principal Investigator. "Given the excellent safety data thus far using 186RNL in recurrent glioblastoma, and the preclinical efficacy data when used in animal models of LM, we are optimistic about the potential safety and efficacy of 186RNL as a novel treatment option for LM."

The ReSPECT-LM trial is a multicenter, sequential cohort, open-label, single dose, dose escalation Phase 1 study. It will evaluate the maximum tolerated dose, maximum feasible dose, safety, and efficacy of a single administration of 186RNL via intraventricular catheter for LM following standard surgical, radiation, and/or chemotherapy treatment. The primary endpoint of the study is the incidence and severity of adverse events/serious adverse events and dose limiting toxicities. Secondary endpoints include overall response rate, duration or response, progression free survival, and overall survival.

"Leptomeningeal metastasis is a neurologically devastating and fatal complication of cancer," said Marc H. Hedrick M.D., President and Chief Executive Officer of Plus Therapeutics. "Our latest approved IND application is part of a multifaceted plan to expand our radiotherapeutic pipeline with promising, innovative drugs to treat a variety of rare and difficult to treat cancers."

The ReSPECT-LM Phase 1 clinical trial follows preclinical studies in which tolerance to doses of 186RNL as high as 1,075 Gy was shown in animal models with LM with no observed significant toxicity. Treatment led to marked reduction in tumor burden in both C6 and MDA-231 LM models.

About Leptomeningeal Metastases (LM)

LM is a rare complication of cancer in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord. LM occurs in approximately 5% of people with cancer, or 110,000 people in the U.S. each year, and is usually terminal with a median survival of approximately 2-3 months following treatment. LM occurs with cancers that are most likely to spread to the central nervous system. The most common cancers to include the leptomeninges are breast cancer, lung cancer, and melanomas.

On October 19, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), applying innovative diagnostics to transform disease management and improve patient outcomes, reported it has signed a definitive agreement to acquire Cernostics, Inc. (Cernostics), an Illumina Ventures company (Press release, Castle Biosciences, OCT 19, 2021, View Source [SID1234591522]). Cernostics specializes in spatial biology and artificial intelligence-driven image analysis of tissue biopsies. Its TissueCypher Barrett’s Esophagus Assay is the first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE).

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"We are pleased to welcome Cernostics into the Castle family," said Derek Maetzold, president and CEO of Castle Biosciences. "Acquiring the TissueCypher platform is aligned with our commitment to utilizing innovative technology to provide clinically actionable information that guides disease management and improves patient outcomes. The TissueCypher Barrett’s Esophagus Assay addresses an unmet need in BE, as it is designed to objectively and accurately predict progression from non-dysplastic, indefinite for dysplasia and low-grade dysplasia BE to HGD or esophageal adenocarcinoma (EAC). This is critical, as EAC is highly lethal, with five-year survival rates under 20%1, and intervention (ablation) in patients with BE has been proven to reduce progression to EAC. Unfortunately, the incidence of esophageal cancer is increasing at one of the fastest rates of all cancers in the U.S., so we need new clinical tools to reverse this growth trend in the diagnosis of EAC.
"We believe the combined strengths of Castle and Cernostics will position us for continued growth and success as a leader in the diagnostics space, complementing our first-to-market dermatologic franchise. Beginning with a common patient-centric mind-set, our companies are strategically aligned with compatible company cultures and business models that include a strong, ongoing emphasis on growing the body of clinical evidence backing our tests. Together, we have the opportunity to accelerate our impact on patient care and thus drive value creation for shareholders."

"We are excited about joining forces with Castle, a leader in the precision diagnostics space with a strong history of commercial success," said Mike Hoerres, chief executive officer of Cernostics. "With our innovative TissueCypher platform, we have the potential to address unmet clinical needs in the gastrointestinal space, starting with BE. We believe the TissueCypher Barrett’s Esophagus Assay is a valuable tool for improving prevention of esophageal cancer, particularly, to help physicians and patients make more informed management decisions based on the unique biology of an individual patient’s esophageal biopsy."
1 Esophageal Cancer Action Network, View Source

There are approximately 4 million patients in the U.S. diagnosed with BE, and annually, approximately 400,000 endoscopies are performed on BE patients. TissueCypher Barrett’s Esophagus Assay is listed in Group 1 of Novitas’ Billing and Coding Article "Molecular Pathology and Genetic Testing" (A58917). The article becomes effective on November 8, 2021.

Transaction Terms and Other Information

Under the terms of the definitive agreement, Cernostics will become a wholly owned subsidiary of Castle Biosciences. At closing, Castle will pay $30 million in initial consideration to Cernostics security holders, which may consist entirely of cash or $20 million in cash and $10 million in common stock of Castle, at Castle’s sole discretion. The purchase price is subject to customary working capital and other adjustments. Further, up to an additional $50 million in cash and/or common stock, at Castle’s sole discretion, is payable in connection with the achievement of certain milestones based on 2022 performance. The transaction is expected to close prior to year-end 2021, subject to the delivery of certain financial statements to the Company, continued employment of certain Cernostics personnel and satisfaction of other customary conditions to closing.

Upon finalization of the transaction, Hoerres and Cernostics’ executive management team and other staff based in Pittsburgh are expected to stay with the Company. Cernostics’ laboratory and operations will remain in Pittsburgh.

Company management will host a conference call and webcast to discuss this transaction at 7:30 a.m. Eastern time today.

Conference Call and Webcast Details

A live webcast of the conference call can be accessed here: View Source or via the webcast link on the Investor Relations page of the Company’s website: View Source Please access the webcast at least 10 minutes before the conference call start time. An archive of the webcast will be available on the Company’s website until Nov. 9, 2021.

To access the live conference call via phone, please dial 1 844 200 6205 from the United States and Canada, or +1 929 526 1599 internationally, at least 10 minutes prior to the start of the call, using the conference ID 781408.

There will be a brief Question & Answer session following management commentary.

About Cernostics and TissueCypher Barrett’s Esophagus Assay

Cernostics applies spatial biology and biologically-aware AI and machine learning to tissue diagnostics, delivering precision diagnostic testing to patients and gastroenterologists. This technology and platform are the core of the TissueCypher Barrett’s Esophagus Assay, the world’s first precision medicine test designed to predict future development of high-grade dysplasia (HGD) and/or esophageal cancer in patients with Barrett’s esophagus (BE). The

TissueCypher Barrett’s Esophagus Assay is indicated for patients with endoscopic biopsy confirmed BE that is graded non-dysplastic, indefinite for dysplasia or low-grade dysplasia. The TissueCypher Barrett’s Esophagus Assay is a proprietary Laboratory Developed Test (LDT) with its own unique CPT PLA code (0108U), available only from Cernostics’ CLIA-certified pathology laboratory. The TissueCypher Barrett’s Esophagus Assay has been on the Medicare Clinical Laboratory Fee Schedule since January 2021.

On October 19, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules, from the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, OCT 19, 2021, View Source [SID1234591521]). With this approval, Dr. Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide Capsules, 2.5 mg and 20 mg.

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In September 2020, Dr. Reddy’s announced a settlement agreement of their litigation with Celgene, the maker of REVLIMID (lenalidomide) Capsules and a wholly-owned subsidiary of Bristol Myers Squibb (NYSE: BMY), relating to patents for the branded drug.

In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr. Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. beginning on a confidential date after March 2022 subject to regulatory approval. The agreed-upon percentages remain confidential. As part of the settlement, Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the U.S. without volume limitation beginning on January 31, 2026.

"We are pleased with the Agency’s approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. "We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients."

On October 19, 2021 Exelixis, Inc. (Nasdaq: EXEL) reported that its third quarter 2021 financial results will be released on Tuesday, November 2, 2021 after the markets close (Press release, Exelixis, OCT 19, 2021, View Source [SID1234591520]). At 5:00 p.m. EDT / 2:00 p.m. PDT, Exelixis management will host a conference call and webcast to discuss the results and provide a general business update . Access to the event is available via the Internet from the company’s website.

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the conference call to ensure adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 855-793-2457 (domestic) or 631-485-4921 (international) and provide the conference call passcode 9563879 to join by phone.

A telephone replay will be available until 8:00 p.m. EDT on November 4, 2021. Access numbers for the telephone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 9563879. A webcast replay will also be archived on www.exelixis.com for one year.