1stOncology™: Cancer Intelligence Service – Page 11308 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

JOHNSON & JOHNSON REPORTS 2020 FIRST-QUARTER RESULTS

On April 14, 2020 Johnson & Johnson (NYSE: JNJ) reported results for first-quarter 2020 (Press release, Johnson & Johnson, APR 14, 2020, View Source [SID1234556307]). The Company also announced earlier today that its Board of Directors declared a 6.3% increase in the quarterly dividend rate, from $0.95 per share to $1.01 per share . At the new rate, the indicated dividend on an annual basis is $4.04 per share compared to the previous rate of $3.80 per share.

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!

"With Johnson & Johnson’s century-plus history of leading in times of great challenge, we are mobilizing our resources across the Company in the fight against the COVID-19 pandemic," said Alex Gorsky, Chairman and Chief Executive Officer. "Johnson & Johnson is built for times like this, and we are leveraging our scientific expertise, operational scale and financial strength in the effort to advance the work on our lead COVID-19 vaccine candidate. We are committed to beginning production at risk imminently and bringing an affordable and accessible vaccine to the public on a not-for-profit basis for emergency pandemic use."

Mr. Gorsky continued, "I am both proud and amazed at the level of dedication that I have witnessed from our more than 132,000 employees as we have focused on delivering on our commitments and responsibilities to the patients and consumers we serve. Our strong performance in the first quarter reflects the efforts of our teams around the world and the sustainability of our business model. Today, our Board of Directors approved an increase in our quarterly dividend for the 58th consecutive year, underscoring our commitment to delivering value for our shareholders and the confidence we have in our business now and in the future."

OVERALL FINANCIAL RESULTS:
q1chart1.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:

regionalsales005.jpg

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:

a2020q1segments.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 COMMENTARY:

Consumer Health
Consumer Health worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 11.0%* driven primarily by over-the-counter products including TYLENOL and MOTRIN analgesics; upper respiratory products including ZYRTEC; digestive health products and ZARBEE’S NATURALS. Other contributors to growth were LISTERINE mouthwash in oral care products; NEUTROGENA and AVEENO in skin health/beauty products, as well as STAYFREE and o.b. in international women’s health. Consumer Health results across the majority of franchises were positively impacted by the increased demand related to the COVID-19 pandemic.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 10.2%* 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, INVEGA SUSTENNA/XEPLION/INVEGA TRINZA/TREVICTA (paliperidone palmitate), long-acting, injectable atypical antipsychotics for the treatment of schizophrenia in adults, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with prostate cancer, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, and PREZISTA/PREZCOBIX/REZOLSTA/SYMTUZA for the treatment of human immunodeficiency virus type 1 (HIV-1) infection. This growth was partially offset by biosimilar and generic competition, with declines primarily in international VELCADE (bortezomib), a proteasome inhibitor for the treatment of multiple myeloma, REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and PROCRIT (epoetin alfa), a treatment for chemotherapy-induced anemia and patients with chronic kidney disease.

Medical Devices
Medical Devices worldwide operational sales, excluding the net impact of acquisitions and divestitures, declined by 4.8%* driven by the estimated net negative impact of the COVID-19 pandemic and the associated deferral of medical procedures to our Surgery, Orthopaedics, Interventional Solutions and Vision businesses.

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

ERLEADA (apalutamide) – European Commission (EC) Approves Expanded Use for Treatment of Patients with Metastatic Hormone-Sensitive Prostate Cancer
(press release)
STELARA (ustekinumab) – EC Approves Expanded Use for Treatment of Pediatric Patients With Moderate To Severe Plaque Psoriasis

(press release)
Regulatory
Submissions
Ponesimod – Submission of New Drug Applications to the U.S. Food and Drug Administration (FDA) and European Marketing Authorization for Treatment of Adults with Relapsing Multiple Sclerosis

(press release)
DARZALEX (daratumumab) – Submission to U.S. FDA for Combination with carfilzomib and dexamethasone (DKd) For Patients with Relapsed/Refractory Multiple Myeloma

Other
Lead Vaccine Candidate for COVID-19; Landmark New Partnership with U.S. Department of Health & Human Services; and Commitment to Supply One Billion Vaccines Worldwide for Emergency Pandemic Use; Announced

(press release)
XARELTO (rivaroxaban) -Landmark Phase 3 VOYAGER PAD Study of XARELTO Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization
(press release)
Rilpivirine And Cabotegravir Results of Phase 3 FLARE Study Demonstrate the Safety and Efficacy of Long-Acting Injectable HIV Treatment Regimen through 96 Weeks
(press release)
Rilpivirine and Cabotegravir 48-week Results of Phase 3b ATLAS-2M Study Demonstrate the Safety and Efficacy of Long-Acting Injectable HIV Treatment Administered Every Two Months
(press release)
JNJ-6372 Granted U.S. FDA Breakthrough Therapy Designation for the Treatment of Non-Small Cell Lung Cancer
(press release)
RPGR Gene Therapy Granted European Medicines Agency PRIME and Advanced Therapy Medicinal Product Designations for X-Linked Retinitis Pigmentosa
(press release)
HEARTLINE launched, the First-of-its-Kind, Virtual Study Designed to Explore if a New iPhone App and Apple Watch Can Help Reduce the Risk of Stroke1

(press release)
1 iPhone and Apple Watch are trademarks of their respective owners

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.
The impact of COVID-19, inclusive of the related investments the Company is making to combat the pandemic, is included in the guidance below.

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: April 2020 = $1.09 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 8:30 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.

Immunophotonics Receives Swissmedic Approval to Commence Phase 1B/2A Clinical Trial in Switzerland

On April 14, 2020 Immunophotonics reported that it has received Swissmedic approval to commence a new clinical trial entitled "Intratumoral Injection of IP-001 Following Thermal Ablation in Patients With Advanced Solid Tumors (Press release, Immunophotonics, APR 14, 2020, View Source [SID1234556306])." This is a multicenter phase 1B/2A trial with expansion cohorts in melanoma and soft tissue sarcoma patients. The therapeutic approach taken by this trial (SAKK 66/17) is different from those already used in clinical practice and possibly offers patients a therapeutic benefit after failure of standard chemotherapy and immunotherapy.

Patients with laser ablation-accessible solid tumors are treated by thermal ablation followed immediately by an intratumoral injection of IP-001 (1 % N-dihydro-galacto-chitosan, Immunophotonics Inc.) for injection). IP-001 is intended to trigger a tumor-specific systemic immune response when exposed to tumor antigens liberated by thermal ablation. There is strong preclinical and early clinical evidence that combining thermal ablation with IP-001 might be able to turn "cold" tumors into "hot" tumors, inducing a systemic immune response. This may result in shrinkage of the treated tumor, as well as long-term response mediated by the patient’s immunological defense system against any remaining tumor cells (residual primary and metastatic tumor cells) including tumor cells outside or distant from the treated area (also known as abscopal effect).

This trial will provide information on the safety and tolerability of thermal ablation followed immediately by an intratumoral IP-001 injection in patients with laser ablation-accessible solid tumors (6 patients, "all comers," Part 1, safety run in). Further information on safety and tolerability, as well as preliminary antitumor activity, will be evaluated in patients with soft tissue sarcoma (Part 2, Cohort1), whereas in melanoma patients, anti-tumor activity is a primary objective (Part 2, Cohort 2).

Illumina Reports Preliminary Revenue for First Quarter of Fiscal Year 2020

On April 14, 2020 Illumina, Inc. (NASDAQ: ILMN) reported preliminary revenue for the first quarter of fiscal year 2020 and withdrew its 2020 guidance (Press release, Illumina, APR 14, 2020, View Source [SID1234556305]).

Subject to quarter-end closing adjustments, the Company expects to report first quarter revenue of approximately $858 million, compared to $846 million in the first quarter of 2019. Strong sequencing consumable revenue more than offset the impact of COVID-19 including disrupted system sales in the closing weeks of the quarter.

"Our priority in the midst of this global pandemic is the safety of our employees, partners and customers," said Francis deSouza, President and CEO. "We are also committed to ensuring continuity of supply for our customers, many of whom are performing critical clinical testing for patients. We share the commitment of the scientific community to do everything we can to fight COVID-19, and are supporting researchers using sequencing to track transmission, study the evolution of the virus’ genome and how it could impact the effectiveness of diagnostics and therapies, or explore how surveillance could be adopted to reduce the impact of future outbreaks of new infectious diseases."

"While our preliminary first quarter results were strong overall, we expect the second quarter to be significantly impacted by COVID-19 related disruption," said Sam Samad, Illumina’s Chief Financial Officer. "We are confident that this is a temporary disruption that in no way alters the long-term trajectory of sequencing adoption and demand. That said, it is not possible at this time to forecast the severity and duration of this outbreak. As a result, we believe it is prudent at this time to withdraw our 2020 revenue and earnings per share guidance."

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Thursday, April 30, 2020. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597, or 1 (647) 689-6853 outside North America, both with conference ID 9492366.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Genmab Announces Net Sales of DARZALEX® (daratumumab) for First Quarter of 2020

On April 14, 2020 Genmab A/S (Nasdaq: GMAB) reported that worldwide net trade sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 937 million in the first quarter of 2020 (Press release, Genmab, APR 14, 2020, View Source [SID1234556304]). Net trade sales were USD 463 million in the U.S. and USD 474 million in the rest of the world. Genmab will receive royalties on the worldwide net sales of DARZALEX under the exclusive worldwide license to Janssen Biotech, Inc. to develop, manufacture and commercialize DARZALEX.

About DARZALEX (daratumumab)

DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.1 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma. DARZALEX intravenous infusion is indicated for the treatment of adult patients in Europe: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy2. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S. In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit www.DARZALEX.com.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a person’s own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).1,2,3,4,5,6

Five Prime Therapeutics Appoints Tom Civik as Chief Executive Officer

On April 14, 2020 Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage biotechnology company focused on developing immune modulators and precision therapies for solid tumor cancers, reported the appointment of Thomas Civik as President and Chief Executive Officer and a member of the Board of Directors of the company (Press release, Five Prime Therapeutics, APR 14, 2020, View Source [SID1234556303]). Mr. Civik joins Five Prime from Foundation Medicine, where he served as Chief Commercial Officer. William Ringo, who has served as interim CEO since September 2019 and as Chairman of the Board, will step down as CEO and will continue as Chairman of the Board of Directors.

"We are delighted to attract an oncology leader of Tom’s stature to propel Five Prime to its next level of achievement," said William Ringo, interim Chief Executive Officer and Chairman of the Board. "Having led teams through the launch, commercialization and lifecycle development of several blockbuster oncology products, including some of the most revolutionary cancer treatments and diagnostics, Tom brings leadership experience to a strong executive team that will enable Five Prime to realize its full potential. I also look forward to my continued work at Five Prime providing important continuity as I work with Tom and the Executive Team in my capacity as Chairman."

Mr. Civik is an industry leader with more than 25 years of commercial and lifecycle management experience in the biotech, biopharma, and diagnostics sectors. At Foundation Medicine, Mr. Civik built a commercial and lifecycle management team that launched FoundationOne CDX, the first FDA approved pan-cancer comprehensive genomic test, and FoundationOne Liquid, a second-generation liquid biopsy test, in addition to expanding the company’s global footprint. Prior to that, Mr. Civik built a distinguished career as an oncology executive at Genentech where he commercialized new and established global brands such as Avastin, Tarceva, Tecentriq, and Alecensa.

"I’m thrilled to join this science-driven organization that has several novel products in the clinic, an impressive portfolio of compounds in preclinical development, and the financial discipline to allocate resources to the most promising opportunities," said Tom Civik. "I consider it an honor to work in the life sciences and I’m excited to contribute to fulfilling the Five Prime mission, which is to fundamentally improve the lives of oncology patients in ways never before possible. I look forward to working with the Five Prime team, our board of directors, our advisors, and our partners to have a meaningful impact on the lives of people with cancer."

Five Prime is focused on advancing its pipeline of proprietary programs in clinical development, novel late-stage research programs and partnered programs. The company remains on track to achieve program milestones and clinical data disclosures in 2020 that will allow the company to prioritize future pipeline investments. The company has also implemented measures in response to the COVID-19 pandemic to protect the health and safety of its employees and their families while still allowing the continued execution of the company’s operations and progress of its programs.