Sat, Oct. 24, 7:50 AM
- “We’re trying to figure out where we are and what we do going forward," a Walgreens Boots Alliance (NASDAQ:WBA) source tells the WSJ. "We need to understand the truth."
- The drugstore chain has "no concrete plans at this stage" to expand its partnership with Theranos beyond the 41 stores in Arizona and California which already include Theranos "wellness centers," reports the Journal. That partnership also includes an equity stake in the startup.
- Walgreens made the move after meeting late this week with top brass at Theranos, including CEO Elizabeth Holmes. Said meeting came about after stories questioning the viability of the startup's technology. Walgreens was also unaware of the FDA's surprise inspection of Theranos facilities in August and September, according to sources.
- Previously: Theranos chief Holmes says technology sound (Oct. 21)
- Related tickers: Abbot Labs (NYSE:ABT), Quest Diagnostics (NYSE:DGX), Lab Corp. (NYSE:LH), Roche Holding (OTCQX:RHHBY)
Thu, Oct. 22, 8:58 AM
- Quest Diagnostics (DGX +0.03%) Q3 results: Revenues: $1,880M (-1.3%); COGS: $1,162M (-1.4%); SG&A: $402M (-9.9%); Operating Income: $631M (+146.5%); Net Income: $342M (+165.1%); EPS: $2.35 (+167.0%); Quick Assets: $123M (-35.9%).
- FY2015 Guidance: Revenue: $7.49B from $7.49B - 7.57B; non-GAAP EPS: $4.75 - 4.80 from $4.70 - 4.85; CF Ops: >$850 (unch); CAPEX: ~$275M from ~$300M.
Thu, Oct. 22, 6:47 AM
Wed, Oct. 21, 5:30 PM
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Wed, Oct. 21, 12:44 PM
- During a technology conference in California hosted by the Wall Street Journal, Theranos CEO Elizabeth Holmes defended her company and its technology against critics who claim things are not what they seem at the high-flying early-stage firm.
- She said the company has moved away from one of its devices only briefly as it proceeds to getting FDA clearance for all of its tests. She also cites her personal involvement in enacting a law in Arizona that allows patients to get blood tests without a doctor's order, saying, "I personally in Arizona worked very hard to change the law. I can't do that without knowing that the tests that are offered are of the highest quality."
- Related tickers: (ABT +1.2%)(OTCQX:RHHBY -1%)(LH -1.2%)(DGX -0.7%)
- Previously: Upstart Theranos has arrived, the ax grinding has begun (Oct. 16)
- Previously: FDA clears upstart Theranos' test system (July 2)
Fri, Oct. 16, 2:00 PM
- Start-ups, especially biotechs, typically enjoy an "image honeymoon" period with stakeholders, constituency groups and the press as they try to pull themselves up from a "little company that could" to establishing themselves as sustainable enterprises and legitimate players in their respective markets. Anyone remotely familiar to the biotech arena knows how extraordinarily difficult it is to pull this off so it is rare to see anything but encouraging references to the upstarts as they pursue their visions of successful disruptions and the monetary rewards that follow. Once the company gets momentum and grows in size and valuation, the situation evolves as insiders position themselves for the big payday and competitors wake up to the potential threat. Those who feel threatened or disadvantaged typically use the press to drum up negative news either as "payback" for being excluded from the money train or to dim the aura of the upstart's halo.
- Palo Alto, CA-base Theranos is a case in point. The medical diagnostics firm, started by a teen-aged Stanford University drop-out in 2003, now sports a $9B market cap based on the disruptive potential of its automated microfluidics-based system to the $50B global diagnostics industry. Founder Elizabeth Holmes is a billionaire at age 31. The enormous amount of money at stake inevitably leads to "haves" and "have-nots."
- An article published in the Wall Street Journal yesterday is a superb example of this dynamic. The reporter based his article on information provided by four former (disgruntled) employees who allege that Theranos' dream is quite a distance from reality, saying, among other things, that most of the tests currently being offered are performed by traditional instruments rather than its proprietary Edison system. Other missteps cited in the article, such as providing an incorrect result, occur every day in the diagnostics industry. The selective use of individual examples paints a very biased view of reality. Some of the information may be true, but it is impossible to determine fact from fiction. No one said being a billionaire was easy.
- Previously: FDA clears upstart Theranos' test system (July 2)
- Previously: Upstart Theranos receives CLIA waiver for test system clearing the way for rapid diagnostics in Wellness Center setting (July 16)
- Related tickers: (LH +0.7%)(DGX +1.5%)(ABT -0.4%)(OTCQX:RHHBY +1.6%)
Tue, Oct. 6, 1:29 PM
- The FDA issues 510(k) clearance for Quest Diagnostics' (DGX -3%) Simplexa Flu A/B & RSV Direct Kit for the detection of 46 additional influenza A and influenza B strains and seven additional respiratory syncytial virus (RSV) strains. The approval increases the number of flu and RSV strains that Simplexa can detect to 92, the most of any FDA-cleared molecular test kit. The expanded coverage includes 20 avian influenza A and two swine influenza virus strains.
- Simplexa, developed by Quest unit Focus Diagnostics, is a real-time PCR molecular test for the qualitative detection and differentiation of influenza A, B and RSV in nasopharyngeal swabs from symptomatic patients. It was originally approved by the FDA in May 2010.
Fri, Oct. 2, 3:44 PM
- The FDA approves Merck's (MRK +1.1%) Keytruda (pembrolizumab) for the treatment of patients with advanced/metastatic non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and that express a protein called PD-L1 [such as Bristol-Myers Squibb's (BMY +3.2%) Opdivo (nivolumab)].
- The data supporting the sBLA was generated from a subgroup of 61 NSCLC patients within a larger study who progressed following platinum-based chemo and targeted therapies for EGFR/ALK mutations, if present. The subgroup's tumors all expressed PD-L1 as determined by the 22C3 pharmDx companion diagnostic test. Participants received 10 mg/kg of Keytruda every two to three weeks. The results showed that treatment with Keytruda shrank tumors in 41% of patients with the effect lasting as long as 9.1 months.
- The FDA designated Keytruda a Breakthrough Therapy for this indication.
- Reference labs Quest Diagnostics (DGX +2%) and LabCorp (LH +1.9%) will offer the 22C3 pharmDx test as a service. The kit was developed by Agilent's (A +2.7%) Dako unit.
Tue, Aug. 18, 8:27 AM
Thu, Jul. 23, 9:43 AM
- Quest Diagnostics (DGX +1.6%) Q2 results: Revenues: $1,925M (+1.2%); COGS: $1,182M (+0.7%); SG&A: $429M (-2.5%); Operating Income: $301M (+14.9%); Net Income: $118M (-11.3%); EPS: $0.81 (-12.0%); Quick Assets: $150M (-21.9%); CF Ops: $327M (-10.2%).
- FY2015 Guidance: Revenue: $7.49B - 7.57B; non-GAAP EPS: $4.70 - 4.85 (unch); CF Ops: >$850; CAPEX: ~$300M (unch).
Thu, Jul. 23, 7:02 AM
Wed, Jul. 22, 5:30 PM
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Thu, Jul. 16, 8:04 AM
- The FDA grants a Clinical Laboratory Improvement Amendments (CLIA) Waiver to privately-held Theranos for its diagnostic test system. The waiver allows the testing to be performed in non-traditional locations such as Theranos Wellness Centers, currently 42 in Arizona, one in Palo Alto, CA and one in Harrisburg, PA.
- The automated system the company has developed utilizes microfluidics to perform a wide array of tests on small volume blood samples, including those from a finger stick. Some observers believe Theranos will upend the clinical diagnostics industry with its modest costs. The company's herpes test, for example, will sell for only $9.07 compared to ~$175 from leading reference labs.
- Theranos founder and CEO Elizabeth Holmes is one the newest celebrity entrepreneurs. Based on the company's current valuation, she is the youngest self-made female billionaire in U.S. history.
- Related tickers: (NYSE:ABT) (OTCQX:RHHBY) (NYSE:TMO) (NYSE:DGX) (NASDAQ:BRLI) (NYSE:LH)
Tue, Jun. 16, 5:52 PM
- Lab Corp of America (NYSE:LH) initiated with Overweight rating and $143 (19% upside) price target by KeyBanc.
- Quest Diagnostics (NYSE:DGX) initiated with Sector Weight rating by KeyBanc.
- Community Healthcare (Pending:CHCT) initiated with Buy rating and $22 (16% upside) price target by Janney Capital.
- Idera Pharmaceuticals (NASDAQ:IDRA) initiated with Overweight rating and $6 (68% upside) price target by JP Morgan.
- Tonix Pharmaceuticals (NASDAQ:TNXP) initiated with Outperform rating and $18 (82% upside) price target by Oppenheimer.
Fri, May 22, 10:46 AM
Fri, May 15, 10:10 AM
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