Sees FY free cash flow $1.4B-$1.6B, effective tax rate 21%-22%, CapEx about $300M. Comments taken from slides being presented on the Q1 earnings conference call.
https://thefly.com/landingPageNews.php?id=2856829
Thursday, January 31, 2019
Intercept initiated at Credit Suisse
Intercept initiated with an Outperform at Credit Suisse. Credit Suisse analyst Michael Morabito started coverage of Intercept with an Outperform rating and $167 price target. The analyst notes that the company’s lead asset Ocaliva is preparing to enter a large and lucrative market to treat nonalcoholic steatohepatitis. Morabito expects the NASH market to exceed $20B by 2030 in the U.S. alone, with Ocaliva likely to be the first FDA-approved therapy. He forecasts about $4B in peak sales for Ocaliva from NASH.
https://thefly.com/landingPageNews.php?id=2856835
https://thefly.com/landingPageNews.php?id=2856835
US prisons are reportedly creating ‘voice print’ databases
Prisons across the United States are reportedly building biometric databases that include voice recordings of incarcerated people, according to The Intercept. The report cites contracting documents for the state of New York’s prison system, as well as statements from officials in Texas, Florida, Arkansas and Arizona confirming that prisons are actively using voice recognition technology that can extract and digitize voices to create unique and identifiable biometric signatures known as voice prints.
According to the prisons, the systems are being used to improve security in the facilities and to combat fraud. Prisons can use the biometric identifier to track phone calls and find past communications that match the voice print of a particular person. The systems can also flag calls deemed to be suspicious to allow investigators to review the communications. According to The Intercept, the voice printing technologies were developed with grant money from the Department of Defense as a way to identify calls made by terrorists and other suspected criminals. The services have since been marketed to prisons to build databases of incarcerated people.
According to the report, some of the recordings taking place at prisons are made without the consent of the incarcerated. In one instance, The Intercept recounts the story of a prison in New York’s Sing Sing prison who was told by a corrections counselor to read a set of phrases that would be recorded to create a voice print. If he refused, he was told he would lose phone access entirely and no longer be able to contact his family.
The voice printing technology, which is not discernibly different from the technology that enables consumer voice assistants to recognize voices, may not just be invading the privacy of people being kept behind bars. According to the report, officials from New York and Texas confirmed that agencies hold on to voice prints after the incarcerated are out of prison. Some counties also confirmed they could identify the voices of outside callers, meaning people who have not been accused of or committed a crime may still have their voice print recorded by the systems.
How Huawei planned international robot espionage via email
It’s 1 percent James Bond, 99 percent Mr. Bean.
Huawei began building its own phone-testing system, xDeviceRobot, in early 2012. The Chinese company hoped to improve the quality of its mobile hardware, which tended to fail far more often than competitors’ devices in third-party trials. In May 2012, Huawei China asked T-Mobile if it could license or flat-out buy the company’s phone-testing robot, Tappy, which served as a standard for much of the industry. T-Mobile said no.So, Huawei decided to steal Tappy.
After installing a handful of employees at T-Mobile’s headquarters in Bellevue, Washington, federal prosecutors claim Huawei USA and China employees attempted to illegally collect information on Tappy in a year-long espionage campaign that culminated in actual theft. Huawei was found guilty of misappropriating T-Mobile’s Tappy intellectual property in a 2014 civil lawsuit, and federal prosecutors in Seattle this week unsealed an indictment that brings new, criminal charges against the Chinese company.
The following activities and email exchanges were compiled from the indictment signed on January 16th, 2019 (unsealed on January 28th). All bolded messages presented below are direct quotes from Huawei emails, as described in the indictment, while the supporting text has been compiled from the document’s surrounding information.
What follows is a real-life, bumbling, corporate-tinged, international spy drama that played out over internal Huawei emails between 2012 and 2013, as related by US prosecutors:
Asked about licensing or purchasing Tappy, but TMO said no. They have no plans to sell the robot system to any phone manufacturer, including Huawei.
Per request for photos and technical specs of TMO robot (i.e. component serial numbers, hardware and software details) we were unable to gather relevant information. They say it is because of information security regulations. We were reminded that all Huawei employees signed non-disclosure agreements.
The main point is to figure out the Robot’s specifications and functions. These are the benchmarks of products developed by ourselves.
T-Mobile is not willing to share the detail of robot tech/docs with Huawei or any manufacturers. They refused to provide us the details of robot hardware and software specifications.
This email is just a kindly reminder for the information we need to build our own robot system and kindly feedback the information we need in the attachment…
See message from J.Y.
[…]
Huawei USA engineers have accessed the robot lab… They know how TMO robot work and system info. I asked them to write down the info in detail and then send to Huawei China.
I am sorry we can not get more information from TMO and we can’t finish the whole PowerPoint as we talk about. And as you know, we can take some pictures of test procedure and setting. Hope it is useful to HQ R&D.
Pictures of Tappy robot and software interface attached.
We got not much information from TMO on these questions that you guys asked. Again, TMO won’t want to share any more information about their robot system with us. However, we still try to find more information during our test in TMO robot lab. But it won’t expect any time soon.
We are still working on the Robot system and we had some issues with the system at the moment. More information on Tappy is needed. Are software test strips optimized for each device? What is Tappy’s touch speed? How is the rubbed tip installed? Is there air space in the rubber tip?
See attached photos of Tappy.
We need more technical information, specifically the response time accuracy of TMO’s mechanical arm.
TMO will not give us this information.
Once again, we CAN’T ask TMO any questions about the robot. TMO is VERY angry the questions that we asked. Sorry we can’t deliver any more information to you.
I think a Huawei China engineer should come to Seattle and observe Tappy directly. You will learn a lot in knowledge and experience.
From the results of the recent xDeviceRobot system verification, there is still a definite disparity with T-Mobile.
H.L., can you collect information about the TMO robot arm and tip? We need contact area, hardness and pressure.
Gathering info from TMO is risky. I recommend contacting the robot manufacturer instead. Going through TMO would only backfire, especially after signing a confidentiality agreement at the TMO laboratory, the relevance of this information to us is very sensitive.
We are still not on par with TMO robot. Please send more information about calibration standards, delay calculations and software.
First of all, I am glad that HQ R&D has been continuing to improve the Huawei robot system. Based on the test on TMO’s phone we do see a big difference of test results between TMO robot and Huawei robot. I think we have a lot of work to improve our robot performance. The difference between two is not only the hardware but also (most importantly) the software. TMO has spend much more money on software than hardware.
Once again, we can’t get any further information about TMO robot system from TMO. They have complained to us a lot about this because we asked them too many questions of the robot based on HQ’s request. TMO said to me that if we ask them again such questions, they don’t allow us to use their robot Lab. TMO has set up a security system by putting camera into the robot Lab. I think everyone knows what this means. We can’t provide any further information to HQ because we can’t get anything from TMO.
Once again, I suggested HQ to send an engineer to TMO for a hands-on experience by playing the robot system. I believe this would give HQ robot team a huge benefit in understanding TMO robot system from hardware and software, as well as operation.
Here’s why TMO will not share info with us, as far as I can tell:
TMO is clear that those such as Huawei and Samsung are not only supplying TMO, but are also supplying their competitors such as Verizon, ATT, and other carriers.
- If every Vendor is helped to establish TMO testing environment and standards, it would certainly also improve the product quality, etc. of each Vendor’s competitors, which is equivalent to TMO doing a good deed for the industry.
- TMO took about four years of time and lots of resource optimization to develop the Robot system, and it contains TMO’s intellectual property rights.
- TMO can provide a free testing environment for each Vendor, and it can ensure that this system only services TMO products. This only enhances the competitiveness of TMO.
Access to Tappy by our engineers on the ground is strictly controlled. They are limited to usage of TMO’s robot, and everything else is categorically denied.
Due to answering headquarters’ questions, our employees have had two complaints raised against them, and it was declared that if we inquired again, Huawei’s credentials for using the TMO Robot Laboratory would end. I echo previous suggestions to send an engineer from headquarters to see Tappy in person.
>There are a number of goals for my trip to T-Mobile HQ, but mainly-
I expect to arrive in Washington on May 11.
A.X. has let me into the Tappy laboratory twice over the past few days. Both times we were discovered by a T-Mobile employee and I was asked to leave, since I wasn’t allowed to be there. I observed the robot on both visits and took pictures on the second.
I went once more today to TMO’s mechanical arm testing laboratory and gained an overall understanding of the test environment. I summarized it, please take a look in the attached document and pictures.
TMO has made it clear that I am not allowed to re-enter the robot laboratory. Going forward, A.X. will help you get a deeper understanding of the remaining information.
Due to recent and repeated violations of T-Mobile’s on-site rules, Huawei USA’s access to the Tappy laboratory has been revoked. All Huawei USA employees must return their badges to T-Mobile, with the exception of A.X., who will be the only Huawei USA employee with access to the testing facilities. This is only so Huawei can complete limited testing on in-progress projects.
The engineering team needs more details about the TMO robot:
We’ll certainly help if we can; this period is very sensitive.
In regards to photos and videos, after TMO gives back our badges, I’ll send it back home. No need for home to keep reminding me.
The xDeviceRobot team needs specs on the arm. Specifically, the diameter of the end tip of the conductor stick.
A.X. was able to remove the robot arm from the laboratory without being detected and I took exact measurements. However, TMO quickly discovered the arm was missing and A.X. was forced to return the part the following day. A.X. told them it was taken by mistake. Our access to the lab has been completely revoked and Huawei USA employees are no longer allowed inside the facility unsupervised.
I’ve attached detailed measurements of the arm. See pictures for details.
Can you measure the conductor stick with a caliper device?
F.W. has already sent the pictures home.
The criminal charges lodged against Huawei in the T-Mobile case are just part of the Chinese company’s concerns at the moment. This week, the US filed 23 total charges against Huawei related to trade-secret and sanctions violations.
The 13 sanctions charges stem from the company’s dealings with Iran. Huawei CFO Meng Wanzhou is accused of committing fraud to bypass Iran sanctions and bring US-made technology into the country. She was arrested in Canada last month at the request of US authorities. Though she’s currently out on bail, she faces extradition to the US.
Regarding the T-Mobile situation, Huawei says the case has already been settled. And it has been, in civil court — after hearing the story in 2017, a Seattle jury forced Huawei to pay T-Mobile $4.8 million in damages. However, that was all over breach of contract, not trade-secret violations. The jury said Huawei hadn’t maliciously or willfully misappropriated the data it stole from T-Mobile, and no money was awarded for the trade-secret claim.
A Huawei representative sent the following statement to Engadget this week:
The allegations in the Western District of Washington trade secret indictment were already the subject of a civil suit that was settled by the parties after a Seattle jury found neither damages nor willful and malicious conduct on the trade secret claim.The Company denies that it or its subsidiary or affiliate have committed any of the asserted violations of U.S. law set forth in each of the indictments, is not aware of any wrongdoing by Ms. Meng, and believes the U.S. courts will ultimately reach the same conclusion.
FDA zeroes in on potential causes of blood pressure med contamination
- After months of investigation, the Food and Drug Administration has zeroed in on what it believes to be a contributing cause of potential carcinogenic contaminants recently found in a number of generic blood pressure medications, most notably valsartan.
- Impurities in certain angiotensin II receptor blockers, or ARBs, appear to be generated when certain chemicals and reaction conditions are present during the manufacturing process of the drugs’ active pharmaceutical ingredient. Reuse of materials such as solvents may also play a role, the FDA said in a Jan. 25 statement.
- One challenge confronting the FDA and other regulators has been detection of the impurity in question, N-nitrosodimethylamine (NDMA), which is hard to detect using standard methods. The FDA has since developed new techniques to identify its presence.
In mid-2018, the FDA and the European Medicines Agency launched a probe after finding active pharmaceutical ingredient of valsartan made by a Chinese manufacturer to be contaminated with the potential carcinogen NDMA. The investigation spread to other “sartan” drugs, which treat high blood pressure, and eventually found another possible carcinogen, NDEA, to be present.
Investigation by the FDA and others remains ongoing. In the meantime, however, the FDA has taken a number of actions to limit the spread of contaminated API, including placing the Zhejiang Huahai Pharmaceutical facility from which impurities were first spotted on import alert. As a result, API and finished drugs from the company cannot enter the U.S.
The FDA is also maintaining lists of valsartan, losartan and irbesartan lots currently under recall. Torrent Pharmaceuticals and Solco Healthcare are two of the most recent drugmakers to put out voluntary recalls for sartan-based products.
Exposure to NMDA and NDEA, which can be found environmentally, above a certain limit carries carcinogenic risk the FDA has deemed unacceptable. Still, the agency believes the risk to any individual patient taking sartan-based drugs to be relatively small.
If 8,000 people took the highest daily valsartan dose found to contain NDMA for four years, FDA scientists estimate, one additional case of cancer above the average rate may occur.
Because of the role these medicines play, the FDA has sought to balance its containment efforts with maintaining access.
“We remind patients taking these medications or any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option,” said Woodcock and Gottlieb in a statement.
Not all generics of valsartan, losartan and irbesartan contain NDMA or NDEA, so pharmacists may be able to provide other medications, and physicians may prescribe a different medication to treat hypertension.
Recall expanded of baby drops at Walmart, CVS; recalled Family Dollar
Three more lots of pain and fever baby drops sold at CVS and Walmart have been recalled for having elevated ibuprofen concentration.
Tri Pharma, the manufacturer, added these three lots to the three lots it recalled in November of ibuprofen baby drops sold at CVS, Walmart and Family Dollar. The drops are for kids from 6 months to 23 months.
The drops are sold under CVS’ house brand and the Equate brand, which is sold at Walmart. Tri Pharma previously recalled three lots of CVS, Equate and the Family Wellness brand, made for Family Dollar.
“Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle,” the company-written, FDA-posted recall notice says. “There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent (Nonsteroidal anti-inflammatory drug-associated) renal injury.”
Tri Pharma says some of the bottles in the recalled lots have ibuprofen up to 10 percent over the limit, but that’s far below the seven times dosage that’s considered unquestionably dangerous for a baby.
All the recalled products are stated to have a concentration of 50 mg per 1.25 ml.
CVS Health: Infants’ Ibuprofen Concentrated Oral Suspension in half-ounce bottles, lot Nos. 4718, expiring 12/2019, and 00717024A, expiring 8/2019. Lot No. 00717006A, expiring 2/2019, came in 1-ounce bottles.
Equate: Infants’ Ibuprofen Concentrated Oral Suspension in 1-ounce bottles, lot No. 00717005A, expiring 2/2019; and, in half-ounce bottles, lot Nos. 00717009A, 00717015A and 00717024A.
Family Wellness: Ibuprofen Oral Suspension Drops in half-ounce bottles, lot No. 00717024A.
Parents or those providing child care with questions can call Tri Pharma at 732-940-0358, Monday through Friday, 8 a.m. to 8 p.m., Eastern time or email micc_tris@vigilarebp.com.
WuXi AppTec expects 70-86% increase in year net
WuXi AppTec Co., Ltd. (02359) said the realised
net profit attributable to shareholders of the company for the year of 2018 was estimated
to increase by RMB858.97 million to RMB1,055.3 million, representing a year-on-year
increase of 70% to 86%.
The estimated growth is mainly attributable to the continuous increase in revenue and
profit from the principal business of the company and the application of the new
accounting standards in relation to financial instruments, which would result in an
estimated change of the profit or loss for the current period from RMB566.38 million to
RMB664.88 million due to the recognition of change in fair value of financial assets
through profit or loss.
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