United Therapeutics (NASDAQ:UTHR): Q2 Non-GAAP EPS of $3.63 beats by $0.89; GAAP EPS of $4.66 beats by $2.20.
Revenue of $373.6M (-16.0% Y/Y) beats by $41.34M.
Wednesday, July 31, 2019
LivaNova PLC EPS beats by $0.05, beats on revenue
LivaNova PLC (NASDAQ:LIVN): Q2 Non-GAAP EPS of $0.70 beats by $0.05; GAAP EPS of -$0.61.
Revenue of $277.2M (-3.6% Y/Y) beats by $2.06M.
FDA OKs Bayer Nubeqa for non-metastatic prostate cancer
The U.S. Food and Drug Administration (FDA) today approved Nubeqa® (darolutamide), an androgen receptor inhibitor (ARi), for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1 The FDA approval is based on the Phase III ARAMIS trial evaluating Nubeqa plus androgen deprivation therapy (ADT), which demonstrated a highly significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median of 40.4 months versus 18.4 months for placebo plus ADT (p<0.0001).1 MFS is defined as the time from randomization to the time of first evidence of blinded independent central review (BICR)-confirmed distant metastasis or death from any cause within 33 weeks after the last evaluable scan, whichever occurred first. Nubeqa was approved under the FDA’s Priority Review designation, which is reserved for medicines that may provide significant improvements in the safety or effectiveness of the treatment for serious conditions.
“Patients at this stage of prostate cancer typically don’t have symptoms of the disease. The overarching goals of treatment in this setting are to delay the spread of prostate cancer and limit the burdensome side effects of therapy,” said Matthew Smith, M.D., Ph.D., Director of the Genitourinary Malignancies Program, Massachusetts General Hospital Cancer Center. “This approval marks an important new option for the prostate cancer community.”
In the U.S., over 73,000 men are estimated to be diagnosed with castration-resistant prostate cancer (CRPC) in 2019. About 40 percent of these patients have prostate cancer that has not spread to other parts of the body and is also associated with a rising prostate-specific antigen (PSA) level, despite a castrate testosterone level, which is known as nmCRPC. This is important because about one-third of men with nmCRPC go on to develop metastases within two years. PSA monitoring is important to identify patients and help offset undertreatment in men before the disease spreads.
Smith & Nephew reported revenue increase
Smith & Nephew’s underlying revenue grew 3.5% in the quarter ending 29 June 2019, with emerging markets recording strong mid-teen growth. During the first half of FY 2019, the business’ trading profit margin improved 60bps to 21.4%, while the operating profit margin expanded 150bps to 16.8%. Cash generated from operations grew YoY to $543m from $418m over the same period.
China steered revenue growth in emerging markets, recording more than 30% growth. Factoring in its robust performance, the company upgraded its full-year revenue guidance by 50bps to 4%, but kept the trading profit margin guidance unchanged.
Namal Nawana, CEO of Smith & Nephew, said: “Organic revenue growth has been solid across all three franchises, with strong performance in Emerging Markets and global Sports Medicine. At the same time, we expanded our margin.”
Roche, Spark extend $4.3B takeover again
Roche (OTCQX:RHHBY) and Spark Therapeutics (NASDAQ:ONCE) have announced another extension of the Swiss drugmaker’s $4.3B takeover offer for the U.S. gene therapy specialist as regulatory reviews in the U.S. and Britain continue.
The offer for Spark shares now runs to Sept. 3, Roche said, adding terms and conditions are unchanged.
“The parties remain committed to the transaction and are working cooperatively and expeditiously with the Federal Trade Commission and UK Competition and Markets Authority.”
Takeda Pharmaceutical reports Q1 results
Takeda Pharmaceutical (OTCPK:TKPHF): Q1 Non-GAAP EPS of ¥128.00; GAAP EPS of -¥13.00.
Revenue of ¥849.1B (+88.7% Y/Y)
Indivior PLC ADR reports Q2 results
Indivior PLC ADR (OTCPK:INVVY): Q2 GAAP EPS of $0.10.
Revenue of $215M (-19.8% Y/Y)
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