On July 16, 2019 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) reported that Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin, will host a conference call and webcast on Thursday, August 1, at 4:30 p.m. ET to discuss second quarter 2019 financial results and provide a general business update (Press release, BioMarin, JUL 16, 2019, View Source [SID1234537561]).

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!

Dial-in Number
U.S. / Canada Dial-in Number: (866) 502-9859
International Dial-in Number: (574) 990-1362
Conference ID: 6989536

Replay Dial-in Number: (855) 859-2056
Replay International Dial-in Number: (404) 537-3406
Conference ID: 6989536

Interested parties may access a live audio webcast of the conference call via the investor section of the BioMarin website, www.biomarin.com. A replay of the call will be archived on the site for one week following the call.

On July 16, 2019 Johnson & Johnson (NYSE: JNJ) reported results for second-quarter 2019. "We delivered solid second-quarter underlying sales growth and strong earnings growth that enables us to make investments in innovation to accelerate performance in each of our businesses," said Alex Gorsky, Chairman and Chief Executive Officer. "Our pipelines continue to progress with the launch of new products and several regulatory submissions and approvals, which positions us well to deliver the next wave of transformational products and solutions. I am proud of our talented colleagues across Johnson & Johnson who continue to deliver significant healthcare advances to improve the lives of patients and consumers around the world."
SEGMENT COMMENTARY:

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!

Consumer
Consumer worldwide operational sales, excluding the net impact of acquisitions and divestitures, grew 2.3%* driven by NEUTROGENA, AVEENO and OGX beauty products, over-the-counter products including ZYRTEC upper respiratory and MOTRIN analgesic products, international LISTERINE mouthwash in Oral Care products and U.S. Baby Care products.

Pharmaceutical
Pharmaceutical worldwide operational sales, excluding the net impact of acquisitions and divestitures grew 4.4%* 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, 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, TREMFYA (guselkumab), a biologic for the treatment of adults living with moderate to severe plaque psoriasis, OPSUMIT (macitentan), an oral endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension to delay disease progression, ERLEADA (apalutamide), a next-generation androgen receptor inhibitor for the treatment of patients with non-metastatic castration-resistant prostate cancer and PREZISTA/PREZCOBIX/REZOLSTA/ SYMTUZA (D/C/F/TAF) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection, partially offset by declines in REMICADE (infliximab), a biologic approved for the treatment of a number of immune-mediated inflammatory diseases, and 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 due to biosimilar and generic entrants.

Medical Devices
Worldwide Medical Devices operational sales, excluding the net impact of acquisitions and divestitures grew 3.2%* driven by the growth of electrophysiology products in the Interventional Solutions business, endocutters and international energy products in the Advanced Surgery business. As previously disclosed, the divestiture of the ASP business was completed, resulting in an approximate $2.0 billion pretax gain in the quarter.

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
IMBRUVICA (ibrutinib) – CHMP Positive Opinions in combination with obinutuzumab in CLL and in combination with rituximab in WM
(press release)
DARZALEX (daratumumab) – Newly diagnosed patients with Multiple Myeloma in combination with Lenalidomide and Dexamethasone (U.S.)
(press release)
Regulatory Submissions
DARZALEX (daratumumab) – Subcutaneous formulation in multiple myeloma (U.S.)1

(press release)
ERLEADA (apalutamide) – Metastatic Hormone-Sensitive Prostate Cancer (EU)
(press release)
ERLEADA (apalutamide) – Metastatic Castration – Sensitive Prostate Cancer (U.S)
(press release)
Rilpivirine and Cabotegravir – Monthly, Injectable, Two-Drug Regimen for Treatment of HIV
(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.

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 July 16, 2019 Heska Corporation (NASDAQ: HSKA – News; "Heska" or the "Company"), a provider of advanced veterinary diagnostic and specialty products, reported its second quarter 2019 financial performance in a press release on Tuesday, August 6, 2019 before the market opens and to host an earnings call to discuss the results at 9 a.m. MT / 11 a.m. ET on the same day (Press release, Heska, JUL 16, 2019, View Source [SID1234537562]).

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!

To access the conference call:

From within the United States, please dial 1-800-289-0438
From outside of the United States, please dial 1-323-794-2423
Reference Conference ID: 7297179

The earnings call will be webcast live from the Company’s website at View Source

A telephonic replay will be available beginning at 2 p.m. ET August 6 and will continue through 11:59 p.m. ET on Tuesday, August 20, 2019. The webcast will be archived on www.heska.com for 90 days.

To access the replay:

From within the United States, please dial 1-844-512-2921
From outside the United States, please dial 1-412-317-6671
Reference Replay Pin Number: 7297179

On July 16, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI) announced that its licensing partner Knight Therapeutics Inc. (Knight) has received marketing authorization from Health Canada to commercialize NERLYNX (neratinib) in Canada for the extended adjuvant treatment of women with early stage hormone receptor positive, HER2-overexpressed/amplified breast cancer within one year after completion of trastuzumab-based adjuvant therapy (Press release, Puma Biotechnology, JUL 16, 2019, View Source [SID1234537547]).

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!

Health Canada approval was based on the Phase III ExteNET trial, a multicenter, randomized, double-blind, placebo-controlled trial of neratinib following adjuvant trastuzumab treatment. Women (n=2,840) with early stage HER2-positive breast cancer and within two years of completing adjuvant trastuzumab therapy were randomized to receive either neratinib (n=1420) or placebo (n=1420) for one year.

The results of the ExteNET trial demonstrated that after two years of follow-up, for patients with hormone receptor positive, HER2-positive early stage breast cancer patients who were treated within one year after the completion of trastuzumab based adjuvant therapy, invasive disease-free survival (iDFS) was 95.3% in the patients treated with neratinib compared with 90.8% in those receiving placebo (hazard ratio = 0.49; 95% CI: (0.30, 0.78); p=0.002).

The most common adverse reactions (>5%) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, weight loss, and urinary tract infection. The most common adverse reaction leading to discontinuation was diarrhea, which was observed in 16.8% of neratinib-treated patients. Hepatotoxicity or increases in liver transaminases led to drug discontinuation in 1.7% of neratinib-treated patients.

"Health Canada approval marks the first time Canadian women are being presented with an opportunity for extended-adjuvant therapy that will reduce the risk of disease recurrence in patients who would otherwise have had a relapse," said Jonathan Ross Goodman, Chief Executive Officer of Knight.

Puma Biotechnology’s CEO and President Alan H. Auerbach, added, "Reducing the risk of disease recurrence remains a need for patients, despite advances in the treatment of early stage HER2-positive breast cancer. We are pleased that our partner, Knight Therapeutics, will be bringing NERLYNX to patients throughout Canada. Health Canada represents the second international approval of NERLYNX this year and we are committed to supporting our partners to expand NERLYNX commercial accessibility to patients around the world."

About HER2-Positive Breast Cancer

Approximately 20 to 25 percent of breast cancer tumors over-express the HER2 protein. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer returning after surgery, up to 25% of patients treated with trastuzumab experience recurrence.

On July 16, 2019 Melinta Therapeutics, Inc. (NASDAQ: MLNT), a commercial-stage company focused on the development and commercialization of novel antibiotics to treat serious bacterial infections, reported preliminary and unaudited financial results and provided a corporate update for the second quarter ended June 30, 2019 (Press release, Cempra, JUL 16, 2019, View Source [SID1234537564]).

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!

"Melinta’s preliminary second quarter 2019 results demonstrate that the actions taken to improve upon the Company’s operational and financial efficiencies are continuing to drive progress," said John H. Johnson, chief executive officer of Melinta. "As we enter into the third quarter of 2019, we remain focused on driving sales efforts, preparing for the potential Baxdela (delafloxacin) community-acquired bacterial pneumonia (CABP) approval and launch, while also continuing to identify additional ways to reduce expenses. We believe in the strength of our long-term strategy to best position Melinta for future success and remain committed to delivering upon our mission of leading the global fight against antimicrobial resistance and providing antibiotic solutions to patients and healthcare providers."

Preliminary Second Quarter 2019 Financial Results
Melinta anticipates that it will report net product sales of approximately $13.8 million for the second quarter of 2019, which is an increase of 51 percent over the second quarter of 2018 and an increase of 17 percent over the first quarter of 2019.

Melinta also expects to report quarter-end cash and cash equivalents of approximately $90 million, and the Company is targeting to reduce full-year 2019 operating expenses by approximately $70 million.

The figures in the foregoing sentences are all based upon preliminary estimates and remain subject to change as the Company finalizes its results for the second quarter of 2019.
The Company will announce its full second quarter 2019 financial results on August 7, 2019 at 8:30 a.m. ET and plans to host a conference call at that time.

Recent Corporate Updates

On July 10, The World Health Organization (WHO) added Vabomere (meropenem and vaborbactam) to its Essential Medicines List for its ability to target multidrug-resistant infections caused by pathogens deemed a "critical priority" by the WHO, including carbapenem-resistant Enterobacteriaceae

The U.S. Food and Drug Administration (FDA) recently accepted for priority review a supplemental New Drug Application (sNDA) for Baxdela (delafloxacin) seeking to expand the current indication to include adult patients with community-acquired bacterial pneumonia (CABP); the FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date (proposed review deadline) of October 24, 2019

Sixteen scientific presentations and posters of portfolio and pipeline data have been accepted for presentation at the Infectious Diseases Society of America IDWeek 2019 meeting, being held October 1 – 6, 2019 in Washington, D.C. and at the American College of Chest Physicians (ACCP) CHEST Meeting, being held October 19 – 23, 2019 in New Orleans, LA

Second Quarter 2019 Conference Call and Webcast
Melinta’s earnings conference call for the second quarter of 2019 will be broadcast at 8:30 a.m. ET on August 7, 2019. Investors wishing to participate in the call should dial: 877-377-7553 and international investors should dial: 253-237-1151, using the conference ID# 5166674. A live webcast of the call will be available online from the Investor Relations section of the company website at www.melinta.com and will be archived there for 30 days. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference ID# 5166674.