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   Biotech / MedicalABMD - Replacement Heart System


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To: Lynn who wrote (136)9/24/2018 12:20:51 PM
From: dominoe
   of 147
 
Dont look now but we are soaring on positive news of our impact on lowering mortality and morbidity for certain cardiac ailment.

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From: Julius Wong9/24/2018 2:57:39 PM
1 Recommendation   of 147
 
Data Presented at TCT 2018 Shows Use of Impella and Best Practices Increases Cardiogenic Shock Survival

finance.yahoo.com

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To: dominoe who wrote (137)9/24/2018 6:11:19 PM
From: Lynn
   of 147
 
Hey, thank you, dominoe. I have been a tad bit gloomy over a few stocks I recently (past 6 months) picked up. I needed this positive ABMD news/move!

Lynn

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To: Lynn who wrote (139)9/25/2018 12:07:17 PM
From: dominoe
   of 147
 
Then you must be feeling great between yesterday and today.
Go ABMD!

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To: dominoe who wrote (140)9/25/2018 12:17:31 PM
From: Lynn
   of 147
 
:) :) Without looking how my make-me-groan stocks are doing, just reading your reply to me--which made my notebook 'ding,' seeing ABMD is up 6%--YES!! A ray of sunshine. Thanks, dominoe.

S&P 500 Movers: [worst performer removed], ABMDIn early trading on Tuesday, shares of ABIOMED (NASDAQ: ABMD) topped the list of the day's best performing components of the S&P 500 index, trading up 4.4%. Year to date, ABIOMED registers a 133.7% gain.

[snip to end]

marketnewsvideo.com

You are right, Go ABMD!!

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From: Lynn9/28/2018 10:10:39 PM
   of 147
 
World's Smallest Heart Pump Fuels Red-Hot Medtech Stock By
Bailey Lipschultz

September 27, 2018, 7:30 AM EDT Updated on September 27, 2018, 10:37 AM EDT

Abiomed has more than doubled this year as revenue skyrockets

Patents and technology keep potential competitors at bay
It may be hard to justify buying a company that nearly tripled over the past 12 months, but then there’s Abiomed Inc.

With annual sales growth seen at more than 25 percent through 2021, the maker of the world’s smallest heart pump has quickened the pulse of investors, analysts and -- not surprisingly -- its chief executive.



Abiomed Impella

Source: Abiomed
“We’re just getting started,” Michael Minogue, president and CEO, said in an interview at the company’s headquarters earlier this month. Abiomed has spent more than $200 million over the last 10 years developing and improving its Impella devices, he said.

Abiomed’s hot run can be at least partially attributed to the patented technology that provides an almost impenetrable barrier from competitors seeking involvement in the segment. Plus, it has space in the market to grow. The Danvers, Massachusetts-based company estimates it has only reached about a tenth of its addressable market, with more products and patents on the horizon. On top of that, there’s global expansion.

Abiomed’s preparing for a rush. Its recently expanded facilities in Danvers and Aachen, Germany can now produce more than $1 billion in product a year. That compares to fiscal first quarter sales of $180 million, according to data compiled by Bloomberg.

The minimally invasive Impella devices can be inserted via a standard catherization procedure and allow patients to maintain their native heart instead of more invasive surgeries that may require a heart transplant. The tiny pump is slightly less than 5 millimeters in diameter compared to other devices that are more than double the size.



Of course, the rally that’s made it one of the Standard & Poor 500 Index’s hottest stocks this year may also give new investors pause. Shares opened higher on Thursday to extend what was an eight session rally, the longest winning streak in four years, before reversing gains.

Not a Bargain“If there’s one constraint on the company it is the valuation,” Jefferies analyst Raj Denhoy said in a phone interview. “It’s the most expensive stock that we track in medical devices and by a good amount, frankly. But again, it’d be hard to find another company with the characteristics as this company in terms of a sustainable growth story.”



Rapid adoption of Abiomed’s Impella technology, increased appreciation for the company’s competitive moats and pipeline optionality explain the company’s nearly two-year stock surge, according to BNP Paribas portfolio manager Jon Stephenson. And he sees more upside to come.

“A lot of people look at the valuation as mind-boggling, but in Abiomed’s case, the addressable market for the indications in which they’ve already launched are huge,” Stephenson, who helps oversee $450 million in BNP’s World Health Care fund, said by telephone. The company has 321 patents protecting its technology with an additional 338 pending, management noted.

Not to say that Abiomed’s completely protected from rivals. Abbott Laboratories’ HeartMate PHP is a device currently being studied to take on the Impella and its incarnations. That said, early results from a study underwhelmed analysts at the Transcatheter Cardiovascular Therapeutics meeting in San Diego over the weekend.

The updates showed Abiomed “will be without meaningful competition to Impella for several more years at least,” Jefferies’ Denhoy wrote in a note to clients. In the interim, there’s plenty of demand. The company has five approved pumps that qualify for reimbursement from the Centers for Medicare and Medicaid Services and major insurers, CEO Minogue said. The device maker could bring three more products to market over the next few years that could lead to increased adoption.



Current indications conservatively show a market potential of close to 200,000 to 300,000 cases in the U.S., Denhoy said. A successful trial could add “another couple hundred thousand patients,” he said.

The next key catalyst for investors, outside of second-quarter results expected in late October, will be the highly-anticipated presentation of its 50-patient STEMI door-to-unloading safety and feasibility study in November.



— With assistance by Javon Thompson

(Updates with details on the pump in the sixth paragraph, shares in seventh paragraph.)

finance.yahoo.com

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From: Julius Wong10/29/2018 7:53:36 AM
   of 147
 
ABMD: Analyst Ratings & Price Targets

tipranks.com

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From: tech1019/12/2019 4:51:23 PM
   of 147
 
If You Like EPS Growth Then Check Out Abiomed (NASDAQ:ABMD) Before It's Too Late



Simply Wall St

Simply Wall St.September 9, 2019



View photos

Some have more dollars than sense, they say, so even companies that have no revenue, no profit, and a record of falling short, can easily find investors. But as Peter Lynch said in One Up On Wall Street, 'Long shots almost never pay off.'

So if you're like me, you might be more interested in profitable, growing companies, like Abiomed ( NASDAQ:ABMD). While profit is not necessarily a social good, it's easy to admire a business than can consistently produce it. Loss-making companies are always racing against time to reach financial sustainability, but time is often a friend of the profitable company, especially if it is growing.

Check out our latest analysis for Abiomed

How Fast Is Abiomed Growing Its Earnings Per Share?In the last three years Abiomed's earnings per share took off like a rocket; fast, and from a low base. So the actual rate of growth doesn't tell us much. As a result, I'll zoom in on growth over the last year, instead. Like a wedge-tailed eagle on the wind, Abiomed's EPS soared from US$3.72 to US$5.72, in just one year. That's a commendable gain of 54%.

I like to see top-line growth as an indication that growth is sustainable, and I look for a high earnings before interest and taxation (EBIT) margin to point to a competitive moat (though some companies with low margins also have moats). The good news is that Abiomed is growing revenues, and EBIT margins improved by 3.1 percentage points to 30%, over the last year. Ticking those two boxes is a good sign of growth, in my book.

In the chart below, you can see how the company has grown earnings, and revenue, over time. Click on the chart to see the exact numbers.



NasdaqGS:ABMD Income Statement, September 9th 2019
More

In investing, as in life, the future matters more than the past. So why not check out this free interactive visualization of Abiomed's forecast profits?

Are Abiomed Insiders Aligned With All Shareholders?Since Abiomed has a market capitalization of US$8.6b, we wouldn't expect insiders to hold a large percentage of shares. But we do take comfort from the fact that they are investors in the company. Indeed, they have a glittering mountain of wealth invested in it, currently valued at US$179m. This suggests to me that leadership will be very mindful of shareholders' interests when making decisions!

Should You Add Abiomed To Your Watchlist?You can't deny that Abiomed has grown its earnings per share at a very impressive rate. That's attractive. Further, the high level of insider buying impresses me, and suggests that I'm not the only one who appreciates the EPS growth. So this is very likely the kind of business that I like to spend time researching, with a view to discerning its true value. Now, you could try to make up your mind on Abiomed by focusing on just these factors, or you could also consider how its price-to-earnings ratio compares to other companies in its industry.

Although Abiomed certainly looks good to me, I would like it more if insiders were buying up shares. If you like to see insider buying, too, then this free list of growing companies that insiders are buying, could be exactly what you're looking for.

Please note the insider transactions discussed in this article refer to reportable transactions in the relevant jurisdiction

We aim to bring you long-term focused research analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material.

If you spot an error that warrants correction, please contact the editor at editorial-team@simplywallst.com. This article by Simply Wall St is general in nature. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. Simply Wall St has no position in the stocks mentioned. Thank you for reading.

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From: tech10111/1/2019 4:29:51 PM
   of 147
 
Abiomed Announces Q2 FY 2020 Revenue of $205 Million and 29.4% Operating Margin



Business WireOctober 31, 2019

DANVERS, Mass.--(BUSINESS WIRE)--

Abiomed, Inc. ( ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported second quarter fiscal 2020 revenue of $205.0 million, an increase of 13% compared to revenue of $181.8 million for the same period of fiscal 2019. Operating income was $60.2 million, up 20%, compared to $50.3 million in the same period of fiscal 2019.

Financial and operating highlights for the second quarter fiscal 2020 include:

  • U.S. revenue totaled $172.0 million, an increase of 9% compared to revenue of $158.2 million during the same period of fiscal 2019 with U.S. patient usage of Impella heart pumps up 14%. In the second quarter, we opened 62 new sites, compared to 135 sites in the prior year, which impacted our U.S. growth rate by $3 million in revenue, or approximately two points of growth.
  • Outside the U.S., revenue totaled $33.0 million, an increase of 40% compared to revenue of $23.5 million during the same period of fiscal 2019. Specifically, Japan revenue was $9.6 million in the quarter, up 135% compared to the same period of fiscal 2019.
  • Gross margin was 83.0% compared to 83.6% during the same period of fiscal 2019.
  • Operating income was $60.2 million, or 29.4% operating margin compared to $50.3 million, or 27.7% operating margin in the same period of fiscal 2019.
  • GAAP net income was $13.1 million, or $0.28 per diluted share, which includes a $34.5 million, or $0.75 per share, unrealized loss from our investment in Shockwave. This compared to GAAP net income of $50.1 million or $1.09 per diluted share for the prior fiscal year, which benefited from $12.9 million, or $0.28 per share, of excess tax benefits.
  • The company generated operating cash flow of $74.3 million in the second quarter and $138.9 million year to date, an increase of 30% versus prior year. As of September 30, 2019, the company had $551.3 million of cash and marketable securities and maintains no debt.
  • On September 23, the company announced that the highest court in Germany, the Federal Court of Justice, ruled in favor of Abiomed in a patent challenge, specifically around the pigtail and design for insertion, filed by Thoratec in 2015, validating the strengths of Abiomed’s Impella-related patents. Abiomed has invested more than $500 million and 20 years of research and development for Impella and owns a robust world-wide portfolio of 715 patents and 622 patents pending, covering all aspects of its existing and future products.
  • On September 25, the company announced that the Impella 5.5 with SmartAssist received U.S. Food and Drug Administration (FDA) pre-market approval (PMA) for safety and efficacy in the therapy of cardiogenic shock for up to 14 days. Impella 5.5 with SmartAssist is a minimally invasive, forward flow, fully unloading heart pump designed for heart surgeons, implanted via axillary artery or direct to the aorta.
  • On September 26, the company announced the results of PROTECT III, the ongoing, prospective, single-arm FDA post-approval study for the PMA approval of Impella 2.5 and Impella CP in high-risk PCI. PROTECT III follows the PROTECT II Randomized Controlled Trial (RCT). The findings of this interim analysis on 898 patients demonstrates a reduction in the primary endpoint of death, stroke, myocardial infarction and repeat procedures at 90 days with Impella-supported Protected PCI, compared to PROTECT II.
  • On September 27, the company announced that data presented from the National Cardiogenic Shock Initiative Study (NCSI) on 250 consecutive AMI cardiogenic shock patients from 49 sites demonstrates 72% survival at discharge with 98% native heart recovery. The patients were treated with the NCSI protocol, which includes placing Abiomed’s Impella heart pump before revascularization via percutaneous coronary intervention (PCI). Investigators also now plan to institute new escalation protocols that will be applied in the cath lab immediately after Impella-supported PCI in order to further increase patient survival and native heart recovery.
  • On October 7, the company announced that the 1,000th patient has been treated with the Impella heart pump in Japan. Procedural outcomes data, available on the first 580 Japanese cases, demonstrates improvements in AMI cardiogenic shock and myocarditis survival rates during the procedure, compared to traditional therapies. The protocols used to introduce Impella in Japan were developed based on best practices learned from the experience treating patients in Europe and the United States, including the National Cardiogenic Shock Initiative, the Impella Quality (IQ) Database and the cVAD Study.
  • On October 25, the company announced that the FDA Post Approval Study demonstrates timely identification of right heart failure and early use of Impella RP leads to higher survival. When physicians followed the FDA’s approved protocol for Impella RP use they achieved 72% patient survival and 88% native heart recovery. These results, from the Impella RP’s post-approval study, match the survival rate in the Impella RP’s pre-approval study.
  • Today, the company announces the first U.S. patients treated with Impella 5.5 with SmartAssist. The first 10 patients were treated at the Cleveland Clinic, Hackensack Meridian Health and Cedars-Sinai Medical Center in Los Angeles. The Impella 5.5 with SmartAssist is being introduced in the U.S. through a controlled rollout at hospitals with established heart recovery protocols.
  • “We are pleased that this quarter demonstrated our ability to leverage best practices and support strategies to improve clinical outcomes overall for high risk PCI, cardiogenic shock and right heart failure,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, Abiomed, Inc. “We have made progress on our key initiatives in the quarter, but we still have more work to do. Our innovation and ability to improve clinical outcomes remains the driver for Impella adoption through a function of training, data and time.”

    FISCAL YEAR 2020 OUTLOOK

    The company is maintaining its fiscal year 2020 guidance for total revenue to be in the range of $885 million to $925 million, an increase of 15% to 20% over the prior year. The company is also maintaining its fiscal year 2020 guidance for GAAP operating margin to be in the range of 28% to 30%.

    EARNINGS CONFERENCE CALL DETAILS

    The company will host a conference call to discuss the results at 8:00 a.m. EDT on Thursday, October 31, 2019. The conference call releasing full quarterly results will be hosted by Michael R. Minogue, Chairman, President and Chief Executive Officer and Todd A. Trapp, Vice President and Chief Financial Officer.

    To listen to the call live, please tune into the webcast via cts.businesswire.com or dial (855) 212-2361; the international number is (678) 809-1538. A replay of this conference call will be available beginning at 11:00 a.m. EDT October 31, 2019 through 11:00 a.m. EST on November 7, 2019. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 7594662.

    ABOUT ABIOMED

    Based in Danvers, Massachusetts, USA, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support. Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart. For additional information, please visit: www.abiomed.com. Abiomed, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Impella Connect are registered trademarks of Abiomed, Inc., and are registered in the U.S. and certain foreign countries. Impella BTR, Impella 5.5, Impella ECP, CVAD Study, and SmartAssist are pending trademarks of Abiomed, Inc.

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    To: tech101 who wrote (145)11/1/2019 4:49:57 PM
    From: tech101
       of 147
     
    Why Abiomed Stock Is Jumping TodayInvestors liked the medical device maker's Q2 results.



    Keith Speights
    (TMFFishBiz)

    Oct 31, 2019 at 11:43AM

    Author Bio

    What happenedShares of Abiomed ( NASDAQ:ABMD) had jumped 11.9% higher as of 11:30 a.m. EDT on Thursday. The heart pump maker announced its fiscal 2019 second-quarter results before the market opened.

    Abiomed reported Q2 revenue of $205 million, up 13% year over year. It posted earnings of $13.1 million, or $0.28 per share, down from the prior-year period net income of $50.1 million or $1.09 per share. The consensus Wall Street estimate was that the company would announce Q2 revenue of $206.5 million and earnings per share of $0.93.

    IMAGE SOURCE: GETTY IMAGES.

    So whatYou might wonder why Abiomed's shares would move higher when the company missed analysts' estimates for both the top and bottom lines. The answer boils down to why Abiomed missed the estimates.

    The company's earnings were weighed down by an unrealized loss of $34.5 million, or $0.75 per share, related to its investment in Shockwave Medical. Without this negative impact, Abiomed would have handily beaten Wall Street's Q2 earnings expectations. This would-be earnings beat trumped any concerns about the company's narrow revenue miss.

    Investors were also probably encouraged because Abiomed stuck by its previous full-year 2019 guidance. The company still anticipates total revenue will be between $885 million and $925 million, which reflects year-over-year growth between 15% and 20%.

    Now whatThe fortunes of healthcare stocks like Abiomed hinge more on their future growth than on how a single quarter goes. Abiomed's future appears to be bright. Investors will especially want to monitor the company's launch of its Impella 5.5 with SmartAssist heart pump. Abiomed received premarket approval from the U.S. Food and Drug Administration for the device on Sept. 25, and it should boost Abiomed's sales.

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