>>> Merck receives Breakthrough Therapy Designation from FDA for KEYTRUDA (pembr

Merck receives Breakthrough Therapy Designation from FDA for KEYTRUDA (pembrolizumab) in advanced colorectal cancer

Co announces that the FDA has granted Breakthrough Therapy Designation to KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. This is the third Breakthrough Therapy Designation granted for KEYTRUDA. Merck is conducting a Phase 2 registration study (KEYNOTE-164) to evaluate the efficacy and safety of KEYTRUDA based on microsatellite instability status in patients with previously treated advanced colorectal cancers, and is also planning a Phase 3 study (KEYNOTE-177) in a treatment naïve patient population. Registration-enabling trials of KEYTRUDA are currently enrolling patients in melanoma, NSCLC, head and neck cancer, bladder cancer, gastric cancer, colorectal cancer, esophageal cancer, breast cancer, Hodgkin lymphoma, multiple myeloma and other tumors, with further trials in planning for other cancers.

>>> Uber Pulls Out Of Three German Cities After Court Ban Shrinks Driver Pool

Uber Pulls Out Of Three German Cities After Court Ban Shrinks Driver Pool

Despite raising a warchest of some $8 billion thus far, on-demand ride sharing platform Uber is retrenching its operations in Germany — pulling out of three cities (Frankfurt, Hamburg and Düsseldorf), leaving active operations in just Berlin and Munich.

The move follows a Frankfurt regional court ban on Uber using unlicensed drivers, issued back in March. The court ruled that each violation of the ban would be subject to a €250,000 ($270,000) fine. The legal challenge was driven by German taxi operator group Taxi Deutschland targeting the lower cost UberPop service.

At the time Uber had said it would continue operations in the cities, offering its limousine service and licensed taxi drivers, but has now decided it’s not able to run a reliable service with only those fall-back options because it can’t get enough drivers.

“For many prospective Uber partners the process of registering an independent rental car enterprise has proved as too costly and time consuming,” Uber said in a statement picked up by Reuters on Friday.

Writing in an email sent to Uber driver in Hamburg the company notes it has found the “local conditions difficult to build a reliable switching platform for car rental companies”, saying it has therefore been unable to guarantee both high demand for its service and enough drivers to supply passengers wanting to use Uber in the city.

It goes on to say it has decided to “pause Uber in Hamburg temporarily”, as of November 9, adding that is working “with politicians and local authorities” to try to find a long term solution for its business in Germany.

Although it is continuing to operate in Berlin, the UberPop service has also been banned there — with a Berlin court upholding an ban on the service back in April on passenger safety grounds. So in Berlin Uber runs a service that uses regular licensed taxis to fulfill rides hailed via its app.

In a statement provided to TechCrunch, Uber’s Christian Freese, GM for Germany, added: “We’ve found the requirements, even for licensed services, to be very complex. Uber is increasingly popular in Munich and Berlin so we have decided to focus our efforts there and suspend our operations in Frankfurt, Düsseldorf and Hamburg.

“We know this will be disappointing for riders and our partner drivers in those three cities, so we are looking at how we can support them. Uber remains committed to expanding its services in Germany, and will therefore continue its engagement and dialogue with politicians and regulators.”

The UberPop service has also been banned in multiple other locations in Europe, including France, Belgium, Italy, Spain and the Netherlands (although Uber has continued to operate the service in some markets, flouting court rulings). Meanwhile in the U.K., London’s transport regulatory body is currently consulting on proposed changes to regulations governing private hire vehicles which could result in strict new limits on how Uber can operate in the city next year.

>>> Estee Lauder beats by $0.12, beats on revs; guides Q2 EPS below consensus; r

Estee Lauder beats by $0.12, beats on revs; guides Q2 EPS below consensus; reaffirms FY16 guidance

  • Reports Q1 (Sep) earnings of $0.82 per share, $0.12 better than the Capital IQ Consensus of $0.70; revenues rose 7.7% year/year to $2.83 bln vs the $2.78 bln Capital IQ Consensus.
    • Adjusting for the impact of the accelerated orders, net sales and diluted earnings per common share in constant currency for the quarter ended September 30, 2015 would have increased 8% and 16%, respectively.
  • Co issues downside guidance for Q2, sees EPS of $1.04-1.08 vs. $1.20 Capital IQ Consensus Estimate.
    • Net sales are forecasted to increase between 6% and 7% in constant currency. Reflecting the strength of the U.S. dollar, foreign currency translation is expected to negatively impact sales by ~5% to 6% versus the prior-year period. The acquisitions the Company made beginning in the second quarter of fiscal 2015 are forecast to contribute ~70 basis points to the Company's overall sales growth in its fiscal 2016 second quarter. Acquisitions are estimated to dilute earnings per share by ~$.01.
  • Co reaffirms guidance for FY16, sees EPS of $3.10-3.17 vs. $3.17 Capital IQ Consensus Estimate.
    • Net sales are forecasted to grow between 8% and 10% in constant currency. Reflecting the strength of the U.S. dollar, foreign currency translation is expected to negatively impact sales by ~4% to 5% versus the prior-year period. The accelerated retailer orders will affect the comparison between the fiscal 2016 and fiscal 2015 full year sales by ~2%. Net sales adjusting for the effect of the accelerated retailer orders are forecasted to grow between 6% and 8% in constant currency.

>>> Cooper Tire beats by $0.12, beats on revs

Cooper Tire beats by $0.12, beats on revs

  • Reports Q3 (Sep) earnings of $0.93 per share, $0.12 better than the Capital IQ Consensus of $0.81; revenues fell 15.0% year/year to $782 mln vs the $763.4 mln Capital IQ Consensus.
    • Net sales rose 2 percent excluding the impact of CCT, the company's former joint venture in China that contributed sales of $150 million in the third quarter a year ago (net of company eliminations). CCT was divested by Cooper in the fourth quarter of 2014.
    • Third quarter results included higher unit volume of $50 million excluding CCT, with unit volume increases in both the Americas and International segments. The unit volume increase was partially offset by unfavorable price and mix of $32 million, primarily due to pricing and promotion actions related to raw material costs, and negative currency impact of $6 million.

>>> Visa misses by $0.01, reports revs in-line; authorizes a new $5.0 billion re

Visa misses by $0.01, reports revs in-line; authorizes a new $5.0 billion repurchase program; sees annual net revenue growth in a high single-digit to low double-digit range
  • Reports Q4 (Sep) earnings of $0.62 per share, $0.01 worse than the Capital IQ Consensus of $0.63; revenues rose 10.6% year/year to $3.57 bln vs the $3.56 bln Capital IQ Consensus.
  • Q3 Payments volume growth, on a constant dollar basis was 11% over the prior year at $1.3 trln.
  • Co authorized a new $5.0 bln repurchase program, in addition to the previously announced 17% quarterly per share dividend increase.
  • Guidance: Annual net revenue growth: High single-digit to low double-digit range on a constant dollar basis, with an expectation of about three percentage points of negative foreign currency impact; Client incentives as a percent of gross revenues: 17.5% to 18.5% range. Annual operating margin: Mid 60s. Annual adjusted diluted class A common stock earnings per share growth: Low-end of the mid-teens range on a constant dollar basis, with an expectation of about four percentage points of negative foreign currency impact.

>>> Loews Corp misses by $0.06

Loews Corp misses by $0.06
  • Reports Q3 (Sep) earnings from cont ops of $0.50 per share, $0.06 worse than the Capital IQ Consensus of $0.56.
  • Book value per share excluding accumulated other comprehensive income increased to $52.59 at September 30, 2015 from $50.95 at December 31, 2014 and $50.32 at September 30, 2014.

>>> Diamond Offshore beats by $0.39, beats on revs

Diamond Offshore beats by $0.39, beats on revs
  • Reports Q3 (Sep) earnings of $0.99 per share, $0.39 better than the Capital IQ Consensus of $0.60; revenues fell 17.4% year/year to $609.7 mln vs the $594.31 mln Capital IQ Consensus.
    • Diamond Offshore also confirmed the Ocean Guardian was awarded a contract for a one-year term in the UK North Sea beginning in March of 2016 at a rate of $220,000 per day.