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JOHNSON & JOHNSON REPORTS 2019 THIRD-QUARTER RESULTS

On October 15, 2019 Johnson & Johnson (NYSE: JNJ) reported results for third-quarter 2019. "Our third-quarter results represent strong performance, driven by competitive underlying growth in Pharmaceuticals and Medical Devices, as well as continued optimization in our Consumer business," said Alex Gorsky, Chairman and Chief Executive Officer (Press release, Johnson & Johnson, OCT 15, 2019, View Source [SID1234542253]). "As we look ahead, we remain confident in the strength of our broad-based business model, which is fueled by our disciplined portfolio management, focus on transformational innovation and dedicated employees around the world who position us for success today and well into the future."

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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

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
Consumer worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 1.3%* driven by NEUTROGENA beauty products and over-the-counter products including TYLENOL analgesics, international upper respiratory products and digestive health products, partially offset by lower sales of baby care products due to prior year U.S. re-launch activities.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 6.4%* 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, SIMPONI/SIMPONI ARIA (golimumab), biologics 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, UPTRAVI (selexipag), an oral prostacyclin receptor agonist used to treat pulmonary arterial hypertension and reduce hospitalization and OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, 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
Worldwide Medical Devices operational sales, excluding the net impact of acquisitions and divestitures grew 5.3%* driven by the growth of electrophysiology products in the Interventional Solutions business, ACUVUE contact lenses in the Vision business, international energy products in the Advanced Surgery business, wound closure products in the General Surgery business and trauma products in the Orthopaedics 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.
Pipeline Updates
Regulatory Approvals
XARELTO (rivaroxaban) – U.S. FDA Approves to Help Prevent Blood Clots in Acutely Ill Medical Patients (U.S.)1

(press release)
INVOKANA (canagliflozin) – U.S. FDA Approves for Treatment of Diabetic Kidney Disease (U.S.)1
(press release)

DARZALEX (daratumumab) – U.S. FDA Approves Combination Regimen for Newly Diagnosed, Transplant-eligible Patients with Multiple Myeloma (U.S.)

(press release)

ERLEADA (apalutamide) – U.S. FDA Approves Supplemental New Drug Application for the Treatment of Metastatic Castration-Sensitive Prostate Cancer (U.S.)

(press release)

STELARA (ustekinumab) – EU Commission Approves Extended Use for the Treatment of Moderately to Severely Active Ulcerative Colitis (EU)
(press release)

IMBRUVICA (ibrutinib) – EU Commission Approves Expanded Use in Combination with Obinutuzumab in Adult Patients with Previously Untreated Chronic Lymphocytic Leukemia and in Combination with Rituximab in Waldenström’s Macroglobulinemia (EU)
(press release)
Regulatory Submissions
SPRAVATO (esketamine) CIII Nasal Spray – Janssen Submits Supplemental New Drug Application to U.S. FDA for the Rapid Reduction of Depressive Symptoms in Adults with Major Depressive Disorder Who Have Active Suicidal Ideation with Intent (U.S.)1

(press release)
STELARA (ustekinumab) – Janssen Submits Application to U.S. FDA for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis (U.S.)1

(press release)

TREMFYA (guselkumab) – Janssen Submits Application to U.S. FDA for Treatment of Adults with Active Psoriatic Arthritis (U.S.)

(press release)
Rilpivirine and Cabotegravir – Janssen Submits Application to EMA for Monthly, Injectable, Two Drug Regimen for Treatment of HIV (EU)

(press release)
DARZALEX (daratumumab) – Janssen Submits Application to EMA for Novel Subcutaneous Formulation (EU)

(press release)
Other
Niraparib – Breakthrough Therapy Designation for the Treatment of Metastatic Castration-Resistant Prostate Cancer (U.S.)1

(press release)

Launch of ECHELON CIRCULAR, the Industry’s First Powered Circular Stapler

(press release)

Launch of ATTUNE Cementless Knee in a Rotating Platform Option

(press release)

Investigational Prophylactic Vaccine – Breakthrough Therapy Designation for Prevention of Respiratory Syncytial Virus in Older Adults (U.S.)

(press release)

1 Subsequent to the quarter

FULL YEAR 2019 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: October 2019 = $1.12; Euro Average Rate: July 2019 = $1.12 (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.

Immutep Reports Positive Final Efficacy Data from TACTI-mel Trial in Melanoma

On October 15, 2019 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel immunotherapy treatments for cancer and autoimmune diseases, reported mature positive efficacy data from its TACTI-mel Phase I clinical study combining its lead product candidate, eftilagimod alpha ("efti" or "IMP321") with KEYTRUDA (pembrolizumab) in metastatic melanoma (Press release, Immutep, OCT 15, 2019, View Source [SID1234542252]).

The data will be presented by Dr. Frédéric Triebel, Chief Scientific Officer and Chief Medical Officer of Immutep at the World Immunotherapy Congress as part of the Festival of Biologics 2019 being held in Basel, Switzerland on 15th October 2019.

Commenting on the positive results, Dr. Triebel said, "The combination therapy with efti shows very encouraging efficacy signals of synergy with KEYTRUDA along with a favourable safety profile so far in this high-risk patient population. Patients are responding well to the combination treatment, their tumours are shrinking and not growing back over a long follow up period. In addition, we have seen the complete disappearance of all target tumour lesions for six patients plus one patient with a metabolic complete response on the PET-scan. The efficacy data is now final with a long follow up, the safety assessment is ongoing."

Overview of Trial

TACTI-mel evaluated the combination of efti with anti-PD-1 therapy KEYTRUDA (pembrolizumab) in 24 patients with unresectable or metastatic melanoma. Patients participating in the trial had a very late stage of disease: 75% classified as M1c (associated with lowest probability of survival), 67% had lung metastasis, 50% had liver metastasis, 50% had elevated LDH (poor prognosis marker) and many had either a suboptimal response or disease progression with pembrolizumab treatment as a monotherapy. All patients received subcutaneous injections of efti every two weeks, with a treatment duration of up to either six or 12 months.

TACTI-mel is a multi-centre, open label clinical trial involving four cohorts of six patients per cohort:

Part A includes the first three cohorts testing different dosages of efti (1mg, 6mg and 30mg) in combination with pembrolizumab, with efti treatment given for six months only and commencing at cycle five of pembrolizumab treatment.

Part B includes the remaining cohort testing a 30mg dosage of efti given for 12 months in combination with pembrolizumab, starting at cycle 1, day 1 of pembrolizumab treatment.

The primary endpoint of the trial is safety and tolerability, with the outcome to determine the recommended dose for a Phase II trial. The trial also evaluated efficacy through Overall Response Rate (ORR), tumour shrinkage and Disease Control Rate (DCR).

Key Findings

Efti has a favourable safety profile in combination with pembrolizumab with no dose-limiting toxicities.

The recommended dosage level for a Phase II trial is 30mg of efti, which is the dosage level currently used in the ongoing TACTI-002 Phase II trial.

Deep (with 12 patients (50 %) having a decrease of ³ 75 % in the target lesions) and durable (9 patients (38 %) being treated for ³ 12 months with pembrolizumab ± efti) responses have been observed.

The key efficacy findings from the trial are:

Part A: Combination treatment began at cycle 5 of pembrolizumab treatment with patients having suboptimal response to pembrolizumab monotherapy and included a dose escalation of efti.

Part B: Combination treatment started from cycle 1 day 1 of pembrolizumab.

Part A+B C1D1 analysis: Performed exploratory analysis starting from cycle 1 day 1 of pembrolizumab, including the 4 cycles pembrolizumab monotherapy ("C1/D1 Analysis") and include pts from part B

The full presentation is available on the Company’s website at View Source

About the TACTI-mel clinical trial

The TACTI-mel (Two ACTive Immunotherapies in melanoma) Phase I clinical trial is a multicentre, open-label study evaluating the combination of eftilagimod alpha ("efti") with pembrolizumab, in unresectable or metastatic melanoma patients that have had either a suboptimal response or had disease progression with pembrolizumab monotherapy (clinicaltrials.gov identifier NCT 02676869).

Genmab Announces Net Sales of DARZALEX® (daratumumab) for Third Quarter of 2019

On October 15, 2019 Genmab A/S (Nasdaq: GMAB) reported that worldwide net sales of DARZALEX (daratumumab) as reported by Johnson & Johnson were USD 765 million in the third quarter of 2019 (Press release, Genmab, OCT 15, 2019, View Source [SID1234542250]). Net sales were USD 402 million in the U.S. and USD 363 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 is indicated in Europe 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 therapy. 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 is approved in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adults with relapsed or refractory multiple myeloma and 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. 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

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL. Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

bridgebio pharma terminates merger process with its subsidiary eidos therapeutics

On October 14, 2019 BridgeBio Pharma, Inc. (NASDAQ: BBIO), a clinical-stage biopharmaceutical company focused on genetic diseases, reported that it was unable to come to an agreement with the Special Committee formed by its subsidiary Eidos Therapeutics (NASDAQ: EIDX), a clinical-stage biopharmaceutical company developing AG10 for the treatment of transthyretin amyloidosis (ATTR), to acquire the outstanding common stock of Eidos that BridgeBio does not already own (approximately 34% of Eidos’s outstanding shares) (Press release, BridgeBio, OCT 14, 2019, View Source [SID1234576262]).

Subsequent to an initial offer of 1.3 BridgeBio shares for each Eidos share, the offer was raised twice, resulting in a final offer equivalent to 1.5 BridgeBio shares for each Eidos share with an option for Eidos shareholders to receive a portion of that consideration in cash. Eidos shareholders were to have three options to receive their consideration: all-stock, mixed consideration of cash and stock, or all-cash subject to proration such that the cash portion of the transaction would not exceed approximately $110 million. The cash consideration was to have been funded by BridgeBio with the use of acquisition financing, and was therefore to have had a neutral-to-positive impact upon BridgeBio’s runway post-close.

"We appreciate the hard work of the Eidos Special Committee in evaluating our proposal," said Brian Stephenson, Ph.D., CFA, chief financial officer of BridgeBio. "At BridgeBio, we work hard to balance opportunities for doubling down on attractive pipeline programs with preserving our ability to pursue a diversified pipeline, as the latter characteristic is valued deeply by many of our investors. We continue to believe strongly in AG10, of which we retain approximately 66% ownership, but we feel that beyond our final offer there are superior ways for us to deploy capital, both in and outside of our pipeline, to generate benefits for patients and returns for our investors. Going forward, we will continue to focus on creating value for patients and investors alike by efficiently allocating capital to high-return genetic disease projects where the science supports advancing therapeutic candidates as rapidly as possible."

"With this process now behind us, we will return to operating BridgeBio and Eidos as two companies that share the sole focus of bringing important medicines to patients with genetic disease," said Neil Kumar, Ph.D., founder and chief executive officer of BridgeBio and chief executive officer of Eidos. "BridgeBio will continue to empower Eidos with critical leadership and infrastructure across the commercial, clinical operations, and executive functions, while Eidos will remain laser-focused on getting AG10, our potentially best-in-class stabilizer for ATTR-CM, to patients. I thank the Special Committee for its hard work and look forward to continuing our efforts around the Phase 3 trial for AG10 and the analysis of data from our Phase 2 Open Label Extension. Eidos and AG10 are a significant part of who we are at BridgeBio, having been part of our plan since we founded the company. We remain incredibly excited about the program and its potential for patients with ATTR cardiomyopathy."

ImaginAb signs multi-party collaboration agreement with three global pharmaceutical companies to help further develop company’s CD8 ImmunoPET technology

On October 14, 2019 ImaginAb, Inc., a leading clinical-stage immuno-oncology imaging company, reported the signing of a multi-party collaboration agreement with AstraZeneca (LSE/STO/NYSE: AZN), Pfizer Inc. (NYSE: PFE) and Takeda Pharmaceutical Company Limited (Takeda) focused on furthering the clinical development of ImaginAb’s CD8 ImmunoPET technology (Press release, ImaginAb, OCT 14, 2019, View Source [SID1234554042]). Using its ‘Minibody’ platform, ImaginAb’s technology targets and visualizes CD8+ T cells to provide highly-specific, quantitative assessment of the immunological status of each cancer lesion within a patient, potentially enabling treatment to be tailored quickly and specifically to the needs of that patient.

Under the terms of the agreement, the collaborators will help guide a current ImaginAb-sponsored clinical trial that aims to evaluate the utility and value of CD8 ImmunoPET in immuno-oncology drug development. In return, the collaborators will gain early access to clinical and imaging data and collectively contribute to the post-trial data analysis.

Commenting on the agreement, Ian Wilson, Chief Executive Officer of ImaginAb, said: "One of our key objectives is to streamline the clinical development of next-generation cancer immunotherapies so that ultimately cancer patients have access to the best possible treatments. We believe that working with global leaders in immuno-oncology will help us further develop CD8 ImmunoPET as a pharmacodynamic marker for use in drug development and, in the future, as a diagnostic and predictive test for use in hospitals."

Chris Arendt, Head of the Oncology Drug Discovery Unit at Takeda, said: "We are excited to participate in this pre-competitive alliance, which brings together a rich network of expertise and resources to develop and evaluate an imaging tracer for CD8+ T cells. The ability to track, both spatially and temporally, immune responses associated with novel immuno-oncology therapies and relate these to anti-tumor responses in patients has the potential to deepen our understanding of the cancer immunity cycle and how it can be leveraged for curative intent, which is the primary focus of our oncology research efforts at Takeda."