Merck’s Keytruda meets endpoint in breast cancer study

Merck (NYSE:MRK) announces that a Phase 3 clinical trial, KEYNOTE-355, evaluating the combination of Keytruda (pembrolizumab) and chemo in patients with metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score at least 10) met one of the dual primary endpoints, progression-free survival (PFS).

In a first-line setting, treatment with the Keytruda combo resulted in a statistically significant increase in PFS compared to chemo alone.

The trial will continue unchanged in order to assess the other primary endpoint of overall survival (OS).

Detailed data will be submitted for presentation at a future medical conference and reviewed with regulatory authorities.

https://seekingalpha.com/news/3540935-mercks-keytruda-meets-pfs-endpoint-in-tnbc-study

Teva Q4 earnings up 104% as turnaround continues

Teva Pharmaceutical Industries (NYSE:TEVA) Q4 results:

Revenues:$4,468M (+1%); North America: $2,373M (+6%); Generics: $2,497M (+2%), Copaxone: $387M (-22%).

Net income: $110M (+104%); non-GAAP net income: $683M (+26%); EPS: ($0.91); non-GAAP EPS: $0.10 (+104%).

Consensus was non-GAAP EPS of $0.61 on revenues of $4.35B.

Cash flow ops (full year): $748M (-69%). Decrease mainly due to the working capital adjustment with Allergan and the Rimsa settlement in 2018 and lower profits in North America in 2019.

Cash flow ops in Q4: $538M (+47%).

All components of 2019 outlook met, including spend base reduction target of $3B.

2020 guidance: Revenues: $16.6B – 17.0B; Copaxone sales: ~$1.2B; Austedo sales: ~$650M; AJOVY sales: ~$250M; non-GAAP EPS: $2.30 – 2.55; free cash flow: $1.8B – 2.2B.

https://seekingalpha.com/news/3540971-teva-q4-earnings-up-104-turnaround-continues

FDA clears Baxter metabolic monitoring device

Baxter International (NYSE:BAX) and licensor COSMED announce FDA clearance of Q-NRG+, a portable metabolic monitoring device based on indirect calorimetry technology. It is used to measure resting energy expenditure in spontaneously breathing and ventilated patients in a healthcare facility setting.

Market launch will commence at the ASPEN 2020 Nutrition Science & Practice Conference in Tampa, FL, March 28-31.

https://seekingalpha.com/news/3541011-fda-clears-baxter-metabolic-monitoring-device

Vir Biotech IDs coronavirus-binding antibodies

Vir Biotechnology (NASDAQ:VIR) perks up 4% premarket on light volume in reaction to its announcement that it has identified two monoclonal antibodies that bind the coronavirus causing the current outbreak, COVID-19 (formerly 2019-nCov).

The company says it is assessing neutralization with a pseudo-virus and is working with international partners to assess neutralization with the live virus.

https://seekingalpha.com/news/3541033-vir-biotech-ids-coronavirus-binding-antibodies-shares-up-4-premarket

Kamada slips after Q4 report

Kamada (KMDA) Q4 results:

Revenues: $32.1M (-33.4%); Revenues from proprietary products: $25.2M (-41.5%); Revenues from distribution: $6.9M (+35.3%).

Net Income: $5.4M (-69.5%); EPS: $0.13 (-70.5%).

CF Ops: $27.6M (+162.9%).

2020 Guidance: Total Revenues: $132M – 137M.

Previously: Kamada EPS in-line, beats on revenue (Feb. 12)

https://seekingalpha.com/news/3541040-kamada-slips-4-premarket-after-q4-report

Medtronic recalls MiniMed pumps over safety issue

Medtronic (MDT -2%) is recalling certain lots of its MiniMed 600 Series Insulin Pumps due to a missing or broken retainer ring that helps lock the insulin cartridge in place in the reservoir compartment.

The company says it has received 26,421 complaints about the issue. It is aware of 2,175 injuries and one death.

https://seekingalpha.com/news/3541078-medtronic-recalls-minimed-pumps-over-safety-issue-shares-down-2

CVS Q4 beat buoys health insurers

CVS Health’s better-than-expected Q4 results, including a healthy jump in cash flow from operations (+45%), has stoked buying in other health insurers.

Selected tickers: Health Insurance Innovations (HIIQ +1.8%), WellCare Health Plans (WCG), UnitedHealth Group (UNH +4.2%), Molina Healthcare (MOH +1.3%), Humana (HUM +4.2%), Cigna (CI +3.8%), Centene (CNC +3.9%), Anthem (ANTM +4.5%)

https://seekingalpha.com/news/3541128-cvs-q4-beat-buoys-health-insurers