Aug. 6, 2014, 9:42 PM
- Thoratec (THOR -1.5%) Q2 results: Product Sales: $118.1M (-9.5%); Gross Profit: $83.8M (-6.4%); Operating Expenses: $58.5M (+3.7%); Operating Income: $25.2M (-23.6%); Net Income: $17.4M (-25.0%); EPS: $0.30 (-25.0%); Quick Assets: $291.2M (-4.8%).
- 2014 Guidance: Revenues: $455M - 470M; GAAP EPS: $0.80 - 0.90; non-GAAP EPS: $1.25 - 1.35.
Aug. 6, 2014, 5:41 PM
Aug. 6, 2014, 4:13 PM
Jul. 2, 2014, 4:40 PM
- Thoratec (THOR -2.8%) acquires Irish cardiac device maker Apica Cardiovascular Ltd. for an upfront payment of $35M and up to $40M in clinical and sales milestone payments. The company's product development focus is on implant systems and devices that enable transapical surgical access. It's ASC system received CE Mark clearance in 2013 and is currently in limited commercial launch throughout Europe.
May 6, 2014, 4:23 PM
Mar. 4, 2014, 6:45 PM
- Thoratec (THOR) issues a global Medical Device Correction in order to update its labeling and training materials for its HeartMate II LVAS Pocket System Controller because some patients and caregivers have had difficulty changing from the primary system controller to the backup system controller.
- The difficulties have resulted in four deaths and five cases of unconsciousness and other symptoms of hypoperfusion. Two of the deaths occurred when patients tried to exchange the controllers while alone and without contacting the hospital first per the labeling.
- The company sent the Device Correction Notices to hospitals today.
- The advisory applies to all HeartMate II LVAS Pocket Controllers manufactured and distributed worldwide to date.
- The Pocket Controller has been prescribed to 2,142 patients either at the time of the HeartMate implantation or as a replacement of an older System Controller model. The latter group is at greater risk of having difficulty in the exchange process due to inadequate training on the differences in the models.
- Management has notified the FDA and other competent authorities of this action.
- Investors should expect abnormal volatility in tomorrow's trading.
Feb. 4, 2014, 4:25 PM
Feb. 4, 2014, 12:10 AM
Feb. 3, 2014, 5:35 PM
Dec. 31, 2013, 4:05 PM
- Summer Street is out with its "Alpha List" for 2014. Below are some of the firm's recommendations in the healthcare space.
- NPS Pharmaceuticals (NPSP) and Rockwell Medical (RMTI) are top picks, with the former propelled by Gattex and the latter buoyed by SFP optimism.
- Sunshine Heart (SSH) is a top MedTech play while Abiomed (ABMD), Heartware (HTWR), and Thoratec (THOR) get positive mentions as well, although these names aren't in the firm's coverage universe.
Dec. 17, 2013, 8:12 AM
- Leerink is out with some commentary on the MedTech space.
- Investors should "focus on companies with growth acceleration and/or upside surprise potential independent of (or at least less dependent on) a macroeconomic recovery [or, alternatively,] a higher and increasing percentage of sales derived from end-markets exhibiting above-average growth," Leerink says.
- Not surprisingly, the LVAD device market gets a mention, with Heartware (HTWR) recommended by name (remember, they just snapped up CircuLite which some think can compete with SSH's C-Pulse).
- Other names mentioned by Leerink: Covidien (COV) for neurovascular and energy devices; Stryker (SYK) for neurovascular and robotics; St. Jude's Medical (STJ) and JNJ for atrial fibrillation; Intuitive Surgical (ISRG).
- Thoratec (THOR) gets an LVAD mention as well, which is interesting considering Leerink's recent commentary on the NEJM manuscript which discussed possible thrombus formation with the HeartMate II.
Nov. 29, 2013, 9:17 AM
- Leerink's Danielle Antalffy is out with some commentary on the NEJM manuscript regarding Thoratec's (THOR) HeartMate II device.
- "Wednesday after market close, NEJM published a three-center study highlighting a meaningful increase in thrombus formation in HeartMate II implants performed after March 2011 -- to 8.4% at three months post-implant from 2.2% in the period of 2004- March 2011. This high thrombus rate compares to published HeartMate II clinical trials demonstrating a three-month thrombus rate in the 2%-4% range. While THOR shares could trade down temporarily in reaction to the NEJM article, we continue to believe mid-teens LVAD market growth is sustainable over the next few years, as the study sample is still relatively small and centers are unlikely to dramatically adjust clinical practice on this study alone," said Antalffy.
- "Conversely, HTWR shares could react positively to this study as it seemingly mitigates the concerns around high thrombus rates with LVADs and evens the playing field from a competitive perspective," he added.
- For more, see here.
Nov. 29, 2013, 8:35 AM
- Sunshine Heart (SSH) moves 2.7% higher in premarket trading.
- Investors are likely reacting to the NEJM and JHLT manuscripts which warn of device exchanges linked to thrombus occurring with HeartMate II (THOR) devices.
- SSH's C-Pulse system treats clinical symptoms associated with Class III and ambulatory Class IV heart failure.
- THOR is now -10% premarket
- For more on the journal manuscripts, THOR, and HTWR, see here and here
Nov. 29, 2013, 8:00 AM
- Canaccord isn't overly concerned about the effect two manuscripts published in the NEJM and JHLT are likely to have on the outlook for shares of Thoratec (THOR) and HeartWare (HTWR).
- "Our initial thought is 'we are not surprised,'" writes analyst Jason Mills, who adds that Cannacord "reported on a perceived increase in HM2 device exchanges via thrombus approximately two years ago."
- Mills says he wouldn't be surprised to see near-term weakness in THOR and strength in HTWR but notes that "the totality of data on both of these devices suggest they are both excellent solutions for end-stage heart failure patients in need of LV support relative to the alternatives, of which there are virtually none."
- Finally, Canaccord thinks the manuscripts may help to "offset the negative view of HTWR in some investors’ minds as a result of the higher stroke rates reported in the IFUs for HTWR's HVAD upon the FDA approval in November 2012."
Nov. 28, 2013, 7:23 AM
- Thoratec's (THOR) HeartMate II heart pump has been linked with the formation of potentially fatal blood clots in patients, a study in the New England Journal of Medicine has found.
- Seventy two clots occurred in 66 patients at three institutions where 895 devices were inserted from 2004-2013.
- However, doctors aren't necessarily going to stop using HeartMate II. "I don't think anybody that's in this field is ready to say 'Gee, we have to stop using these,'" says cardiologist Randall Starling. "The alternative isn't good. But we have to better understand their limitations and how to manage them."
Oct. 30, 2013, 4:31 PM
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