CircuLite Boosts HeartWare's Fundamentals But What About Profit?
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Tue, Jan. 14, 5:39 PM
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. 26, 2013, 12:48 PM
- Galena Biopharma (GALE +6.8%) initiated at Outperform at Oppenheimer. Price target is $6.
- Veracyte (VCYT +7%) started at Outperform at Leerink (PT $17), William Blair, and Cowen (PT $16).
- Surgical Care Affiliates (SCAI +2.8%) initiated at Buy at BofA. Price target is $34. Yesterday: Goldman starts SCAI at Neutral.
- Heartware (HTWR +2.3%) started at Buy at CRT Capital. Price target is $109.
- Mallinckrodt (MNK +2%) initiated at Buy at Jefferies. Price target is $60.
- Harvard Bioscience (HBIO +4.4%) upgraded to Buy from Neutral at Sidoti.
- Forest Labs (FRX +1.1%) upgraded to Neutral from Underweight at Piper. Price target hiked to $49 from $33.
- Cardiovascular Systems (CSII +0.9%) cut to Hold at Benchmark. Price target is $35.
Aug. 8, 2013, 1:24 PM
- Heartware International (HTWR -7%) slips after reporting a Q2 EPS loss of $0.79 versus the estimated $0.78, missing by $0.01.
- EPS were Up 51% from the same quarter last year.
- Revenue came in at $50.80M, +75% Y/Y.
- Revenue from international markets, generated through the sale of 288 units, was $25.7M, +4% Y/Y.
- R&D costs rose nearly 25% to $24.2M, primarily due to clinical trial costs related to advancing its pipeline technologies.
Apr. 30, 2013, 9:10 AM
Apr. 29, 2013, 6:19 PMMore on HeartWare International (HTWR): Q1 beats across the board on an 87% jump in total sales. Net losses narrowed on U.S. sales of its implantable heart pumps. The company sold a record 482 HVAD pumps globally in the latest period, up from 298 units in Q112 and surpassing its previous high quarterly total of 345 in Q412. Gross margin widened to 61.9% from 58.9%. Shares +7.7% AH. | Comment!
Apr. 29, 2013, 6:13 PM
Apr. 29, 2013, 5:38 PM
Mar. 12, 2013, 3:15 PMHeartWare International (HTWR -2%) trades lower today after the maker of surgically implanted pumps announced plans to sell 1.5M shares. The company plans to use the new funds for working capital and general corporate purposes, including research and development and expanding its manufacturing facilities. | Comment!
Nov. 21, 2012, 12:28 PMThoratec (THOR +5.3%) trades higher today after Wells Fargo ups the shares to Outperform and raises its valuation by roughly 20%. The move comes a day after the FDA approved rival HeartWare International's (HTWR -5.4%) heart-pumping device, and Wells notes that THOR's competing product showed a lower incidence of stroke in recent trials. | Comment!
Nov. 20, 2012, 3:13 PM
Apr. 26, 2012, 9:25 AMHeartWare's (HTWR) +15.5% premarket on news the company's implantable pump for heart-transplant candidates wins the backing of an FDA advisory panel. If HTWR's Ventricular Assist System also is approved for patients who aren’t eligible for a transplant, the company could split the U.S. market with Thoratec’s (THOR) HeartMate device by 2015, analysts say. | Comment!
Apr. 26, 2012, 9:20 AMPremarket gainers: PATK +26%. HTWR +15%. REGN +14%. NUAN +14%. LOGI +14%. VHC +12%. CTXS +12%. NRGY +10%. EQIX +9%. CRUS +8%. SPPI +8%. INCY +7%. XLNX +7%. WPI +7%. AMRN +5%. EA +7%. MWW +5%. AH +6%. PHM +6%. AIS +5%. AIXG +5%. LSI +4%. TS +3%. UN +3%. ZNGA +3%. FRO +3%. RDS +3%.
Losers: FURX -28%. PCS -15%. HRB -15%. TQNT -14%. ALU -13%. TSPT -12%. AET -9%. PTX -7%. AKAM -6%. AZN -6%. ZMH -5%. DB -5%. HERO -5%. STD -5%. DOW -4%. CELG -4%. CS -4%. CROX -4%. GG -3%. BWA -3%. UNH -3%. LVS -3%. VALE -3%. UPS -3%. POT -3%. | Comment!
Apr. 23, 2012, 10:09 AMHeartWare (HTWR +5.5%) beating strongly after the FDA says the firm's blood pump appears to aid patients with severe heart failure. However, the agency raises safety concerns about clotting rates and stroke, and says the clinical trials may have missing data and are difficult to compare. An FDA advisory panel is due to vote on the device on Wednesday. | Comment!
Feb. 14, 2012, 12:42 PMHeartWare (HTWR +1.9%) moves higher after an FDA panel says it will review the Premarket Approval application for the company's Ventricular Assist System on April 25. Leerink Swann says the overhang in the shares has been removed following the news, and it believes a Q3 approval and launch is likely. | Comment!
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