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JOHNSON & JOHNSON REPORTS 2019 FOURTH-QUARTER AND FULL YEAR RESULTS

On January 22, 2020 Johnson & Johnson (NYSE: JNJ) reported results for fourth-quarter and full year 2019 (Press release, Johnson & Johnson, JAN 22, 2020, View Source [SID1234553410]). "We delivered strong underlying sales and earnings growth in 2019, driven by the strength of our Pharmaceutical business, accelerating performance in our Medical Devices business and improved profitability in our Consumer business," said Alex Gorsky, Chairman and Chief Executive Officer. "As we enter into 2020 and this next decade, our strategic investments focused on advancing our pipelines and driving innovation across our entire product portfolio, position us well to deliver long-term sustainable growth and value to our shareholders."

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Mr. Gorsky continued, "I am extremely proud of our talented and dedicated colleagues who live Our Credo values each and every day, and are inspired to deliver transformative healthcare solutions that improve the lives of our patients and consumers around the world."
OVERALL FINANCIAL RESULTS:
q4chart1.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

REGIONAL SALES RESULTS:

q4chart2.jpg

q4chart3.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:

q4chart4.jpg

q4chart5.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

FULL-YEAR 2019 SEGMENT COMMENTARY:

Consumer
Consumer worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 1.4%* driven by NEUTROGENA beauty products and over-the-counter products including TYLENOL and MOTRIN analgesics, partially offset by lower sales of baby care products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 5.8%* driven by STELARA (ustekinumab), a biologic for the treatment of a number of immune-mediated inflammatory diseases, DARZALEX (daratumumab), for the treatment of multiple myeloma, IMBRUVICA (ibrutinib), an oral, once-daily therapy approved for use in treating certain B-cell malignancies, a type of blood or lymph node cancer, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, and ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer. This growth was partially offset by biosimilar and generic competition, primarily declines in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, U.S. ZYTIGA (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of metastatic, castration-resistant prostate cancer and international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 3.9%* driven by electrophysiology products in the Interventional Solutions business, international energy and endocutter products in the Advanced Surgery business, and ACUVUE contact lenses in the Vision business.

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.
Regulatory
Approvals

DARZALEX (daratumumab) – European Commission Approves Combination with Bortezomib, Thalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible1
(press release)
SPRAVATO (esketamine) Nasal Spray – Approved in Europe for Adults with Treatment-Resistant Major Depressive Disorder
(press release)
DARZALEX (daratumumab) – European Commission Approves Combination with Lenalidomide and Dexamethasone for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Ineligible
(press release)
STELARA (ustekinumab) – U.S. FDA Approval for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis
(press release)
Regulatory
Submissions
SPRAVATO (esketamine) – Submission of a Type II Variation Application to the European Medicines Agency (EMA) Seeking Expanded Use as a Treatment for Depressive Symptoms in Adults with Major Depressive Disorder Who Have Current Suicidal Ideation with Intent1
(press release)
IMBRUVICA (ibrutinib) – Supplemental NDA Submitted to U.S. FDA and Type II Variation Submitted to EMA1 Seeking Approval of Combination with Rituximab for Previously Untreated Patients with CLL
(press release)
(press release)
Ebola Vaccine Regimen – Submission of MAA to EMA for Prevention of Ebola Virus Disease (EVD) caused by Zaire Ebolavirus Species.
(press release)
TREMFYA (guselkumab) – Submission of a Type II Variation Application to the EMA Seeking to Expand Use in the Treatment of Adults with Active Psoriatic Arthritis
(press release)
Other
Completion of Acquisition of Bermekimab, an investigational compound for multiple dermatological indications, from XBiotech Inc. 1
(press release)
Rilpivirine and Cabotegravir – U.S. FDA issues Complete Response Letter Issued for Investigational Two-Drug Long-Acting HIV Regimen
(press release)
Completion of Acquisition of TARIS Biomedical with Focus on Transforming the Treatment of Bladder Cancer
(press release)
Agreement Announced to Acquire Remaining Stake in Verb Surgical Inc.
(press release)
BCMA CAR-T Therapy Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Relapsed or Refractory Multiple Myeloma
(press release)
J&J Vision Introduces TECNIS Toric II 1-Piece IOL as New Monofocal Option for Cataract Patients with Astigmatism
(press release)
Ethicon Launches VISTASEAL Fibrin Sealant (Human) To Manage Bleeding During Surgery
(press release)
New Cervical Spine System from DePuy Synthes Advances Treatment Options for Patients with Complex Cervical Spine Disorders
(press release)
1 Subsequent to the quarter

FULL-YEAR 2020 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.

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 2020 = $1.11 (Illustrative purposes only)
4 Non-GAAP financial measure; excludes intangible amortization expense and special items

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 8:00 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.

ImmunoGen Announces Proposed Public Offering of Common Stock

On January 22, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that it intends to offer and sell, subject to market and other conditions, shares of its common stock in an underwritten public offering (Press release, ImmunoGen, JAN 22, 2020, View Source [SID1234553409]). ImmunoGen also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the number of shares of common stock offered in the public offering. All of the shares of common stock to be sold in the offering are to be offered by ImmunoGen.

ImmunoGen intends to use the net proceeds of the offering, together with its existing capital, to fund its operations, including, but not limited to, clinical trial activities, supply of drug substance and drug product, pre-commercialization activities, capital expenditures, and working capital.

Jefferies, Cowen and William Blair are acting as joint book-running managers for the proposed offering.

The securities described above are being offered by ImmunoGen pursuant to a shelf registration statement that was previously filed with the Securities and Exchange Commission (SEC) and became effective upon filing. This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this offering, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement, when available, may also be obtained by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by e-mail at [email protected] or by telephone at (877) 821-7388; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attention: Prospectus Department, or by telephone at (631) 274-2806; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, IL 60606, by e-mail at [email protected] or by telephone at (800) 621-0687.

GW Cancer Center Expands Clinical Trial Offerings for Patients with High Risk Cutaneous Squamous Cell Carcinoma

On January 22, 2020 The Cutaneous Oncology Program at the George Washington University (GW) Cancer Center reported that it was selected as the first global site for a clinical trial for patients with high-risk cutaneous squamous cell carcinoma (Press release, The George Washington University, JAN 22, 2020, View Source [SID1234553408]). This designation highlights the GW Cancer Center’s growing regional and global reputation for treating patients with advanced squamous cell carcinoma, the second most common form of skin cancer behind basal cell carcinoma. The study, sponsored by Regeneron, will examine outcomes for patients treated with Libtayo (cemiplimab) — an immunotherapy treatment — prior to surgery and radiation therapy.

In June 2019, the GW Cancer Center was selected as the first global site for a related clinical trial on the effectiveness of Libtayo given after primary surgery and radiation therapy. This new study will focus on the impact of Libtayo on tumors prior to surgery, with the goal to help shrink the tumor and potentially prevent the cancer from returning or metastasizing. Preliminary results from a similar trial at MD Anderson Cancer Center showed promising responses to pre-surgical checkpoint inhibitors in patients with advanced cutaneous squamous cell carcinoma of the head and neck.

"By being selected as the first global site for not one, but two clinical trials in 2019, we are continuing to grow our reputation as one of the most innovative programs for patients with advanced cutaneous squamous cell carcinoma," said Vishal A. Patel, MD, FAAD, FACMS, director of the Cutaneous Oncology Program at the GW Cancer Center and principal investigator of the study. "Our growth means even more patients in our region will have access to the latest potentially promising treatments and therapies."

The phase II trial is intended to investigate the safety and effectiveness of Libtayo in helping reduce the size of tumors and prevent recurrence in high risk cutaneous squamous cell carcinoma, particularly when given early. The study, currently only available at the GW Cancer Center, is estimated to enroll over 75 participants.

"This clinical trial fits clearly within our mission to drive transformational research and personalized therapy," said Eduardo M. Sotomayor, MD, Dr. Cyrus Katzen Family Director of the GW Cancer Center and professor of medicine at the GW School of Medicine and Health Sciences. "Our role as an academic cancer center means we are uniquely positioned to get the latest therapies from bench to bedside, and expanding our clinical trial offerings highlights our commitment to advancing both cancer research and patient care."

Libtayo was approved by the U.S. Food and Drug Administration in September 2018 as cemiplimab-rwlc to treat patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The immunotherapy treatment is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 (programmed cell death protein-1) and was the first treatment approved and available in advanced cutaneous squamous cell carcinoma in the U.S. Current treatment options for the disease include surgery, such as Mohs micrographic surgery, radiation therapy, and systemic chemotherapy for metastatic disease. Libtayo is being jointly developed by Regeneron and Sanofi under a global collaboration agreement.

"Clinical investigations like this one are critical to expanding the treatment options available to patients," said Mitchell Smith, MD, PhD, associate center director for clinical investigations at the GW Cancer Center. "By examining neoadjuvant applications of immunotherapy drugs like Libtayo, the hope is that patients will be able to be treated with less invasive surgeries or avoid surgery altogether."

The Cutaneous Oncology Program at the GW Cancer Center brings together dermatologists; dermatologic surgeons; medical, surgical, and radiation oncologists; and dermato-pathologists to provide comprehensive and personalized skin cancer care to patients. The program also houses the Supportive Oncodermatology and Cutaneous T-Cell Lymphoma multidisciplinary clinics.
The potential use of Libtayo in neoadjuvant cutaneous squamous cell carcinoma is investigational, and its safety and efficacy have not been evaluated by any regulatory authority for this use.

Genialis, Oncologie Form Partnership on Gastric Cancer Biomarker Prediction

On January 22, 2020 Genialis and Oncologie reported that they have formed a partnership to evaluate and predict biomarkers for gastric cancer (Press release, Oncologie, JAN 22, 2020, View Source [SID1234553407]).

They initially will concentrate on modeling gene expression signatures that might predict potential treatments for the condition. Houston-based Genialis already has begun applying its Expressions software to the clinical and translational expertise of Oncologie in an effort to improve methodologies for patient stratification, according to the companies.

"One of the most encouraging trends in drug development is innovation around integrating and interrogating diverse datasets," Genialis CEO Rafael Rosengarten said in a statement. "Our work in data science requires a great deal of artistry in addition to technology and benefits from hand-in-hand collaboration with biology domain experts, which makes this opportunity with Oncologie so special.

Boston-based Oncologie said that it eventually wants to take its methodologies to expand into other tumor microenvironment phenotypes.

"To be able to better understand the patient’s tumor microenvironment phenotype and how it is related to patient benefit represents a key objective for the future success of our company," Oncologie CEO Laura Benjamin said in a statement.

BioLineRx Completes Recruitment in Triple Combination Arm of COMBAT/KEYNOTE-202 Study in Patients with Second-Line Metastatic Pancreatic Cancer

On January 22, 2020 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, reported the completion of patient recruitment in the triple combination arm of its ongoing Phase 2a COMBAT/KEYNOTE-202 study (Press release, BioLineRx, JAN 22, 2020, View Source [SID1234553404]).

"We are pleased to see the triple combination arm of our Phase 2a pancreatic study advance according to plan," stated Philip Serlin, Chief Executive Officer of BioLineRx. "This follows very promising initial results that were presented last month at the ESMO (Free ESMO Whitepaper) IO conference, demonstrating robust and durable responses to the triple combination treatment. As previously stated, we remain on track to announce progression-free and overall survival data from the triple combination arm in mid-2020."

A total of 40 patients diagnosed with unresectable stage IV metastatic pancreatic adenocarcinoma (PDAC), who have progressed following first-line gemcitabine-based therapy, were enrolled as planned in the triple combination arm focusing on second-line pancreatic cancer patients. Patients receive Motixafortide (BL-8040) monotherapy priming treatment for five days, followed by combination cycles of chemotherapy (Onivyde/5-fluorouracil/leucovorin), KEYTRUDA and Motixafortide until progression. The primary endpoint of the study is the objective response rate (ORR). Secondary endpoints include overall survival, progression free survival, and disease control rate.

Last month, the Company shared preliminary data at the ESMO (Free ESMO Whitepaper) IO conference showing that the triple combination demonstrated a 32% overall response rate (ORR) and a 77% disease control rate (DCR) out of 22 evaluable patients at the time. This compares favorably to the current chemotherapy standard-of-care treatment in second-line patients with ORR of 17% and DCR of 52%. In addition, the median duration of clinical benefit for all 17 patients with disease control (7 partial response and 10 stable disease patients) was 7.8 months, compared to approximately three months of response duration with other treatments for second-line pancreatic cancer.

The COMBAT/KEYNOTE-202 Study
The Phase 2a COMBAT/KEYNOTE-202 study was originally designed as an open-label, multicenter, single-arm trial to evaluate the safety and efficacy of the dual combination of Motixafortide and KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck & Co., Inc., Kenilworth, N.J., USA (known as MSD outside the United States and Canada), in over 30 subjects with metastatic pancreatic adenocarcinoma. The study was primarily designed to evaluate the clinical response, safety and tolerability of the combination of these therapies, and was carried out in the US, Israel and additional territories. The study is being conducted by BioLineRx under a collaboration agreement signed in 2016 between BioLineRx and MSD, through a subsidiary.

In July 2018, the Company announced the expansion of its immuno-oncology collaboration with MSD to include the triple combination arm investigating the safety, tolerability and efficacy of Motixafortide, KEYTRUDA and chemotherapy as part of the Phase 2a COMBAT/KEYNOTE-202 study.

About Motixafortide in Cancer Immunotherapy
Motixafortide is targeting CXCR4, a chemokine receptor and a well validated therapeutic target that is over-expressed in many human cancers including PDAC. CXCR4 plays a key role in tumor growth, invasion, angiogenesis, metastasis and therapeutic resistance, and CXCR4 overexpression has been shown to be correlated with poor prognosis.

Motixafortide is a short synthetic peptide used as a platform for cancer immunotherapy with unique features allowing it to function as a best-in-class antagonist of CXCR4. It shows high-affinity, long receptor occupancy and acts as an inverse agonist.

In a number of clinical and preclinical studies, Motixafortide has been shown to affect multiple modes of action in "cold" tumors, including immune cell trafficking, tumor infiltration by immune effector T cells, and reduction in immunosuppressive cells (such as MDSCs) within the tumor niche, turning "cold" tumors, such as pancreatic cancer, "hot" (i.e., sensitizing them to immune checkpoint inhibitors and chemotherapy).