>>> Clovis Oncology and Strate Oncology announce an agreement to accelerate pati

Clovis Oncology and Strate Oncology announce an agreement to accelerate patient identification and enrollment for Clovis’ ongoing TRITON clinical trial program (64.80)
Cos announced an agreement to accelerate patient identification and enrollment for Clovis' ongoing TRITON (Trial of Rucaparib in Prostate Indications) clinical trial program, which includes Phase 2 and Phase 3 clinical trials of rucaparib in metastatic castration-resistant prostate cancer, both of which are open for enrollment.
  • Under the terms of the agreement, Strata will exclusively refer BRCA and ATM-mutated advanced prostate cancer patients for consideration of enrollment to Clovis' TRITON2 and TRITON3 clinical trials of rucaparib.

(TechCrunch) EU ready to hang up on mobile roaming fees by mid-June


The abolition of mobile roaming charges across the European Union by the middle of this year looks almost certain now, after the region’s executive body, parliament and representatives of the 28 Member States agreed a deal on wholesale charges.

The date for the start of what the EC is dubbing ‘roam-like-at-home’ is June 15. Although the European Parliament and the Council still need to formally approve today’s agreement via a vote. But that should be a formality given the accord now reached between the various players.

In statement commenting on today’s announcement, the European Commission’s VP for the Digital Single Market, Andrus Ansip, described the agreement as the “last piece of the puzzle”. “This was the last piece of the puzzle. As of 15 June, Europeans will be able to travel in the EU without roaming charges,” he said.

Agreements over wholesale charges (aka the prices mobile operators can charge each other for allowing other networks’ users to roam across their networks) had caused sticking points for the policy before. So it’s unsurprising that the agreement includes a gradually reducing wholesale cap for data — eventually shrinking to €2.5 per GB by 2022.

Regardless, this does not affect EU consumers’ roaming fees for data, which will still end come mid June.

The EU has been trying to end roaming charges for what feels like forever several years — setting out its intention to end the fees in a 2013 reform plan (called the Telecoms Single Market initiative), with the aim of boosting the region’s global competitiveness and fostering digital jobs by reducing market fragmentation.

And prior to that, as far back as 2007, it has been pushing to reduce the amount operators can charge for roaming as it moved towards a final phasing out.

One major sticking point for the policy has been operator concerns that it could be abused by so-called ‘permanent roamers’ — aka people taking out a cheaper mobile contract in one European country in order to use it all the time in another EU country, thereby bypassing more expensive tariffs in their home market.

The Commission notes today that it adopted rules on “fair use policy and sustainability” back in December — limiting how often home subscriptions can be used without roaming charges. So the end to roaming will only benefit periodic travelers, though it notes that cross-border commuters, for example, are covered.

The fair use policy will require a mobile user to be able to show “frequent and substantial presence on the territory of the Member State of the mobile operator, like an employment relationship or following recurring courses at University”, according to an EC Fact Sheet.

The Fact Sheet further notes operators will have leeway to ask customers to provide “proof of residence or of such stable links to the Member State in question”.

Operators will also be able to apply what it dubs “fair, reasonable and proportionate control mechanisms based on objective indicators to detect the risks of abusive or anomalous use of ‘Roam like at Home’ beyond periodic travelling”.

“We have… made sure that operators can continue competing to provide the most attractive offers to their home markets,” said Ansip today.

The agreed wholesale caps are as follows:

3.2 cents per minute of voice call, as of 15 June 2017
1 cent per SMS, as of 15 June 2017
A step by step reduction over 5 years for data caps decreasing from €7.7 per GB (as of 15 June 2017) to €6 per GB (as of 1 January 2018), €4.5 per GB (as of 1 January 2019), €3.5 per GB (as of 1 January 2020), €3 per GB (as of 1 January 2021) and €2.5 per GB (as of 1 January 2022).
The EC notes that if consumers exceed their contract limits when roaming then any additional charges will not be higher than the wholesale roaming caps.

The Commission intends to carry out a review of the wholesale market by the end of 2019 to assess how the measures are working.

What about Brexit? UK mobile users should still be able to enjoy the benefits of reduced roaming fees across the EU in the short term — i.e. during the two-year Article 50 exit period for leaving the EU (due to be triggered by the UK Prime Minister by the end of March).

What happens to UK mobile users roaming fees in the EU after the UK has left the European Union remains to be seen.

Reuters - Siemens shareholders tell CEO to maintain momentum

Siemens shareholders urged Chief Executive Joe Kaeser to press ahead with transforming the engineering group which made its best annual operating profit to date last year and raised its earnings forecasts.

As unknown risks loom from the protectionist policies of new U.S. President Donald Trump, Kaeser cautioned that the German company could not afford to be complacent, while basking in a rare glow of shareholder approval at the group's annual meeting as the company's shares jumped to a 17-year high on Wednesday.

"I admit we don't always succeed in everything. And risks lurk everywhere. But we have noticeably improved," Kaeser said.

Siemens raised its earnings forecasts on Tuesday after its industrial business profit jumped in its fiscal first quarter, lifted by its factory automation unit.

Asked about the risks and opportunities arising from Trump's election, Kaeser sounded clearly more concerned than three months ago when he had urged people to "give Trump a chance".

"The new American president has a style that's different from what we're accustomed to," he told a news conference ahead of the AGM. "It worries us, what we see."

Kaeser has made multi-billion-dollar bets on oil and gas, wind power and industrial software while shedding the last of Siemens' consumer businesses since taking over as CEO of Europe's top engineering group in 2013.

Many of these, especially oil and gas, depend on the United States, Siemens' biggest single market where it makes 21 percent of its revenue and employs 50,000 people.

The former finance chief now plans to list Siemens' healthcare operations.

The chief executive has cemented the power he won in a boardroom coup, seeing off veteran managers such as Siegfried Russwurm -- who gave a hard stare from the stage as Kaeser wished "Siggi" all the best for the future.

In the latest change, Chairman Gerhard Cromme announced he planned to hand over next year to 51-year-old former SAP co-CEO Jim Hagemann Snabe after a decade in office, marking a move to a more software-oriented era.

Kaeser has also banished, at least for now, the huge one-off charges for poor project risk management that plagued Siemens in the past - helping it reach a record operating profit of 8.74 billion euros ($9.43 billion) in its last fiscal year.

"We want the last, strong financial year not to remain an exception but to represent the new normal at Siemens. The old Siemens disease must never break out again," fund manager Ingo Speich of Union Investment, the 12th-largest shareholder in Siemens, told the AGM in Munich.

Speich praised the share-price performance of Siemens, which has risen by a third over the past year, outperforming the German blue-chip DAX as well as rival General Electric - whose shares rose just 5 percent in the same period - although lagging Rockwell Automation's 60 percent leap.

Siemens shares jumped a further 4.9 percent to a 17-year high of 122 euros on Wednesday after the trains-to-turbines group raised its profit forecast.

Siemens' raised profit outlook is still seen by some analysts as conservative, but executives warned that political uncertainty was working against many of its businesses, especially those requiring large, long-term investments.

"Price pressure is intense," Chief Financial Officer Ralf Thomas told journalists of the Power and Gas business, whose orders dropped 40 percent last quarter. "We have to fight for every order."

FT Lex : TalkTalk: reconnecting

TalkTalk: reconnecting

Investors are excited by Charles Dunstone’s return but the outlook is tough

Dido, Queen of Carthage, leapt on a bonfire after her relationship with Roman forefather Aeneas ended. A different flame is being rekindled by Baroness Dido Harding’s impending separation from TalkTalk, where she is chief executive: shareholders’ passion for Sir Charles Dunstone, who becomes executive chairman.

Entrepreneurs usually jump back into companies they have founded for one reason: to re-energise them. A hop in the shares showed that investors believe Sir Charles can do just that at the broadband group.

Despite the high-toned titles of bosses, TalkTalk occupies crowded territory at the value end of the UK telecoms industry. Here, it is exposed to incursions from the likes of BT Group and Sky. Price competition is fierce and customer churn is high. Earnings before interest, tax, depreciation and amortisation have bounced between £200m and £300m since 2010, according to S&P Global.

Analysts at Jefferies forecast a figure of £300m in the year to March, too. That compares with £260m last time, when TalkTalk bore heavy — some would say unnecessary — expenses for a small data breach. The business has since rejigged contracts in a bid to hold on to more of its 4m customers.

Price investment will have to be iterative. TalkTalk has little scope to finance this with debt. Bond covenants caps leverage at three times. The likely year-end figure is 2.5 times, at which level free cash flow may be negligible.

Lower dividends may therefore be on Sir Charles’s agenda when he takes control in May. Usually, that would be bad news. However, shares that had fallen 38 per cent since May rose 7 per cent on Wednesday because investors admire Sir Charles’s ability. The merger of retailers Carphone Warehouse and Dixons, in which he was involved, was a notable success.

The collapse of two competitors helped. That boost is unlikely to assist TalkTalk. Instead, Sir Charles and new chief executive Tristia Harrison will have to grind out improvements in small, hard-won increments. As Aeneas may have remarked as he turned his back on Carthage, Rome is not built in a day.

The Economist : Printed human body parts could soon be available for transplant

Printed human body parts could soon be available for transplant
How to build organs from scratch
EVERY year about 120,000 organs, mostly kidneys, are transplanted from one human being to another. Sometimes the donor is a living volunteer. Usually, though, he or she is the victim of an accident, stroke, heart attack or similar sudden event that has terminated the life of an otherwise healthy individual. But a lack of suitable donors, particularly as cars get safer and first-aid becomes more effective, means the supply of such organs is limited. Many people therefore die waiting for a transplant. That has led researchers to study the question of how to build organs from scratch.

One promising approach is to print them. Lots of things are made these days by three-dimensional printing, and there seems no reason why body parts should not be among them. As yet, such “bioprinting” remains largely experimental. But bioprinted tissue is already being sold for drug testing, and the first transplantable tissues are expected to be ready for use in a few years’ time.

Just press “print”
Bioprinting originated in the early 2000s, when it was discovered that living cells could be sprayed through the nozzles of inkjet printers without damaging them. Today, using multiple print heads to squirt out different cell types, along with polymers that help keep the structure in shape, it is possible to deposit layer upon layer of cells that will bind together and grow into living, functional tissue. Researchers in various places are tinkering with kidney and liver tissue, skin, bones and cartilage, as well as the networks of blood vessels needed to keep body parts alive. They have implanted printed ears, bones and muscles into animals, and watched these integrate properly with their hosts. Last year a group at Northwestern University, in Chicago, even printed working prosthetic ovaries for mice. The recipients were able to conceive and give birth with the aid of these artificial organs.

No one is yet talking of printing gonads for people. But blood vessels are a different matter. Sichuan Revotek, a biotechnology company based in Chengdu, China, has successfully implanted a printed section of artery into a monkey. This is the first step in trials of a technique intended for use in humans. Similarly, Organovo, a firm in San Diego, announced in December that it had transplanted printed human-liver tissue into mice, and that this tissue had survived and worked. Organovo hopes, within three to five years, to develop this procedure into a treatment for chronic liver failure and for inborn errors of metabolism in young children. The market for such treatments in America alone, the firm estimates, is worth more than $3bn a year.

Johnson & Johnson, a large American health-care company, is so convinced that bioprinting will transform parts of medical practice that it has formed several alliances with interested academics and biotechnology firms. One of these alliances, with Tissue Regeneration Systems, a firm in Michigan, is intended to develop implants for the treatment of defects in broken bones. Another, with Aspect, a biotechnology company in Canada, is trying to work out how to print parts of the human knee known as the meniscuses. These are crescent-shaped cartilage pads that separate the femur from the tibia, and act as shock absorbers between these two bones—a role that causes huge wear and tear, which sometimes requires surgical intervention.

More immediately, bioprinting can help with the development and testing of other sorts of treatments. Organovo already offers kidney and liver tissue for screening potential drugs for efficacy and safety. If this takes off it will please animal-rights activists, as it should cut down on the number of animal trials. It will please drug companies, too, since the tissue being tested is human, so the results obtained should be more reliable than ones from tests on other species.

With similar motives in mind, L’Oréal, a French cosmetics firm, Procter & Gamble, an American consumer-goods company, and BASF, a German chemical concern, are working on printing human skin. They propose to use it to test their products for adverse reactions. L’Oréal already grows about five square metres of skin a year using older and slower technology. Bioprinting will permit it to grow much more, and also allow different skin types and textures to be printed.

Skin in the game
Printed skin might eventually be employed for grafts—repairing burns and ulcers. Plans are also afoot, as it were, to print skin directly onto the surface of the body. Renovacare, a firm in Pennsylvania, has developed a gun that will spray skin stem cells directly onto the wounds of burns victims. (Stem cells are cells that proliferate to produce all of the cell types that a tissue is composed of.) The suggestion is that the stem cells in question will come from the patient himself, meaning that there is no risk of his immune system rejecting the new tissue.

The real prize of all this effort would be to be able to print entire organs. For kidneys, Roots Analysis, a medical-technology consultancy, reckons that should be possible in about six years’ time. Livers, which have a natural tendency to regenerate anyway, should also arrive reasonably soon. Hearts, with their complex internal geometries, will take longer. In all cases, though, printed organs would mean that those awaiting transplants have to wait neither for the altruism of another nor the death of a stranger to provide the means to save their own lives.

>>> US Early premarket gappers

Early premarket gappers
Gapping up: OSTK +13%, SDRL +9.1%, NSTG +8.8%, XOMA+7.7%, ACXM +6.9%, BDN +5%, AMD +3.5%, AAPL +3.3%,FBHS +3.1%, DRYS +3%, CRH +2.6%, ALGN +2.5%, MT+2.3%, CARB +2.3%, CRUS +2.2%, DB +2.2%, AVY +2.1%,AMGN +1.8%, OKE +1.7%, AVGO +1.5%, SWKS +1.4%, MDT+1.3%, EQR +1.3%, TEVA +1.2%, MYL +1.2%, ALGT +1.2%,CB +1.1%, MU +1%, HSBC +1%, FB +0.9%, OCLR +0.9%,ARNC +0.9%, MTSI +0.9%, NUE +0.7%, ANTM +0.6%,QRVO +0.5%, QCOM +0.5%

Gapping down: CATB -69.3%, CTXS -19.4%, BBOX -13.9%,SGYP -13%, RGSE -9.6%, GALE -9.1%, BOOT -8.8%, MTCH-5.6%, ARAY -4.3%, SN -3.8%, UNVR -3.7%, MBLY -3.6%,TNAV -3.4%, MCRN -3.3%, AGI -3.1%, BBVA -2.8%, MANH-2.5%, KTCC -1.8%, GLW -1.7%, ILMN -1.5%, PMD -1.4%,GFI -1.4%, AKS -1.2%, NEU -1.2%, MSTR -1.1%, CACC-1.1%, TMHC -0.8%, TNP -0.6%, VIAV -0.6%, KYO -0.5%,EA -0.5

>>> Altria beats by $0.01, misses on revs; guides FY17 EPS below consensus (71.

Altria beats by $0.01, misses on revs; guides FY17 EPS below consensus
  • Reports Q4 (Dec) earnings of $0.68 per share, $0.01 better than the Capital IQ Consensus of $0.67; revenues rose 0.1% year/year to $4.73 bln vs the $4.8 bln Capital IQ Consensus. Adj. EPS grew 1.5% to $0.68, primarily driven by a lower effective tax rate on operations, higher adjusted OCI in the smokeable and smokeless products segments and fewer shares outstanding, partially offset by the ABI Timing Lag. Altria's lower fourth-quarter effective tax rate on operations was driven by tax benefits associated with a dividend from AB InBev that was larger than the dividend received from SABMiller in the fourth quarter of 2015.
  • Co issues downside guidance for FY17, sees EPS +7.5-9.5% to $3.26-3.32, excluding non-recurring items, vs. $3.34 Capital IQ Consensus Estimate.

>>> Johnson Controls beats by $0.01, reports revs in-line; guides Q2 EPS below

Johnson Controls beats by $0.01, reports revs in-line; guides Q2 EPS below consensus; reaffirms FY17 EPS guidance (43.98)
  • Reports Q1 (Dec) earnings of $0.53 per share, $0.01 better than the Capital IQ Consensus of $0.52; revenues rose 51.1% year/year to $7.1 bln vs the $7.16 bln Capital IQ Consensus which may not be comparable.
  • Co issues downside guidance for Q2, sees EPS of $0.48-0.50, excluding non-recurring items, vs. $0.53 Capital IQ Consensus Estimate.
  • Co reaffirms guidance for FY17, sees EPS of $2.60-2.75, excluding non-recurring items, vs. $2.68 Capital IQ Consensus Estimate.
  • "First quarter results represent a solid start to the year as we begin executing against our 2017 "Integration activities are well underway and we expect the benefits of the combination will continue to ramp as the year progresses. Our strong first quarter performance, growing backlog in Buildings and continued favorable mix in Power, make us confident in our adjusted EPS guidance range of $2.60 to $2.75 for the year," Molinaroli continued

>>> Marathon Petroleum beats by $0.11, beats on revs; provides details on FY17 c

Marathon Petroleum beats by $0.11, beats on revs; provides details on FY17 capex guidance
  • Reports Q4 (Dec) earnings of $0.43 per share, $0.11 better than the Capital IQ Consensus of $0.32; revenues rose 10.2% year/year to $17.28 bln vs the $16 bln single analyst estimate.
    • Refining & Marketing segment income from operations was $219 mln in the fourth quarter of 2016 and $1.54 bln for full-year 2016, compared with $179 mln and $4.09 bln in the fourth quarter of 2015 and full-year 2015, respectively.
    • Speedway segment income from operations was $165 mln in the fourth quarter of 2016 and $734 mln for full-year 2016, compared with $135 mln in the fourth quarter of 2015 and $673 mln for full-year 2015.
    • Midstream segment income from operations, which includes 100 percent of MPLX's operations as well as other related operations, was $245 mln in the fourth quarter of 2016 and $871 mln for full-year 2016, compared with $94 mln and $380 mln for the fourth quarter and full-year 2015, respectively.
  • MPC's investment plan, excluding MPLX LP (MPLX), totals ~$1.7 bln. The plan includes nearly $1.2 bln for MPC's refining and marketing segment, with approximately $325 mln for margin-enhancing projects and ~$840 mln for sustaining capital, related to regulatory spending including Tier 3 gasoline. It also includes ~$380 mln for MPC's Speedway segment, primarily to build new stores and to remodel and rebuild existing retail locations in its core markets; approximately $90 mln for MPC's midstream segment, excluding MPLX; and approximately $100 mln to support corporate activities.
  • MPLX announced its 2017 capital investment plan, which includes $1.4 bln to $1.7 bln of organic growth capital and approximately $100 mln of maintenance capital. Approximately $1 bln to $1.3 bln of these growth investments are for the development of natural gas and gas liquids infrastructure to support MPLX's producer customers, primarily in the prolific Marcellus Shale.
  • "Moving into 2017, we are executing our strategic plan to unlock the tremendous value in our best-in-class midstream platform for the benefit of all investors," Heminger said. "We are well-positioned across the business to take advantage of strengthening commodity prices, recovering refinery spreads and robust demand for our products."