Silicon Investor - ABMD - Replacement Heart System

[tech101] $ABMD (ABioMed, Inc) Does Impella (from ABMD)Affect Predicted AKI Risk? Study Sh...

tech101 — 11/8/2019 7:24:07 PM

$ABMD (ABioMed, Inc)
Does Impella (from ABMD)Affect Predicted AKI Risk?
Study Shows a 78% Risk Decrease in Overall Incidence of Post-procedural AKI
October 30, 2019
Dr. Michael Flaherty presents a more contemporary analysis of acute kidney injury (AKI) in patients undergoing high-risk PCI with Impella support.
protectedpci.com
The Impella 5.5 with SmartAssist is a minimally invasive, forward flow, fully unloading heart pump designed for surgical use, delivering peak flows of >6 L/min, allowing the heart to rest; enabling heart recovery. This next generation heart pump is designed to improve patient outcomes by using real-time intelligence to optimize positioning, managing and weaning of the Impella device for better patient care. The Impella 5.5 heart pump pulls blood from the left ventricle through an inlet area near the tip and expels blood from the catheter into the ascending aorta. New hemodynamic sensor technology allows for repositioning in the ICU without the need for imaging*; the optical sensor senses aortic pressure while the micro-axial motor senses the blood flow (pressure) between the aorta and the left ventricle. *For ventricularized pumps
Insertion: The Impella 5.5 with SmartAssist can be inserted through the axillary artery or anterior aorta and across the valve and into the left ventricle.
abiomed.com

[tech101] Why Abiomed Stock Is Jumping TodayInvestors liked the medical device maker's Q2 ...

tech101 — 11/1/2019 4:49:57 PM

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.

[tech101] Abiomed Announces Q2 FY 2020 Revenue of $205 Million and 29.4% Operating Margin ...

tech101 — 11/1/2019 4:29:51 PM

Abiomed Announces Q2 FY 2020 Revenue of $205 Million and 29.4% Operating Margin

Business Wire•October 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.

[tech101] If You Like EPS Growth Then Check Out Abiomed (NASDAQ:ABMD) Before It's Too Late...

tech101 — 9/12/2019 4:51:23 PM

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.

[Julius Wong] ABMD: Analyst Ratings & Price Targets tipranks.com

Julius Wong — 10/29/2018 7:53:36 AM

[Lynn] World's Smallest Heart Pump Fuels Red-Hot Medtech Stock ...

Lynn — 9/28/2018 10:10:39 PM

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

[Lynn] :) :) Without looking how my make-me-groan stocks are doing, just reading your r...

Lynn — 9/25/2018 12:17:31 PM

:) :) 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!!

[dominoe] Then you must be feeling great between yesterday and today. Go ABMD!

dominoe — 9/25/2018 12:07:17 PM

[Lynn] Hey, thank you, dominoe. I have been a tad bit gloomy over a few stocks I recent...

Lynn — 9/24/2018 6:11:19 PM

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

[Julius Wong] Data Presented at TCT 2018 Shows Use of Impella and Best Practices Increases Car...

Julius Wong — 9/24/2018 2:57:39 PM

Data Presented at TCT 2018 Shows Use of Impella and Best Practices Increases Cardiogenic Shock Survival

finance.yahoo.com

[dominoe] Dont look now but we are soaring on positive news of our impact on lowering mort...

dominoe — 9/24/2018 12:20:51 PM

Dont look now but we are soaring on positive news of our impact on lowering mortality and morbidity for certain cardiac ailment.

[Lynn] You haven't been around since 2005, Ken, hope you are fine. Looking back at past...

Lynn — 9/14/2018 11:47:16 PM

You haven't been around since 2005, Ken, hope you are fine. Looking back at past postings, this comment you made to Charles [when ABMD looked like it might be a candidate for Chapter 11] made me sigh:

... I am hanging in there indefinitely on Abiomed - I guess the same way lots of people are with Sun ...

SUNW... Talk about a climb into the stratosphere than about-face to the almost ground when ORCL snatched it--for cash rather than stock (groan). I still think about some people on that thread who could not believe it would continue to decline and actually bought more shares when it was in the 90s. Should ABMD start pulling a, "SUNW," I sure hope I am smart enough to bail! SUNW... I could cry. :(

[Lynn] 7 Tech Stocks Sporting Amazon-Like Growth Louis Navellier InvestorPlace Septemb...

Lynn — 9/14/2018 9:13:20 PM

7 Tech Stocks Sporting Amazon-Like Growth

Louis Navellier
InvestorPlace
September 13, 2018

[Only ABMD section copied/pasted]

Tech Stocks to Buy: Abiomed, Inc. (ABMD)

View photos

Tech Stocks to Buy: Abiomed, Inc. (ABMD)

Abiomed, Inc. (NASDAQ: ABMD) makes specific medical devices that assist or replace the pumping function of a failing heart.

What makes ABMD’s devices unique is, implanting them is a relatively easy process, so significant costs or energy isn’t necessary up front.

For example, if someone comes into the Emergency Room with a heart attack, the team can put in an Impella Heart Pump and then, once the patient is stable, figure out what the next steps will be.

And its products are seeing very good results. In late October ABMD reported its FYQ2 numbers; revenue was up 29% and patient utilization was up by 33%.

Those are very big numbers and bode well for Impella’s future, especially because it packs a lot of bang for the buck, which makes health insurance companies very happy.

Up 104% YTD, ABMD is just starting its run.

finance.yahoo.com

[Julius Wong] Analyst Ratings & Price Targets on Abiomed tipranks.com

Julius Wong — 9/9/2018 3:12:15 PM

[Lynn] What Analysts Expect for AbiomedMike Benson Market Realist September 5, 2018 A...

Lynn — 9/8/2018 3:36:43 PM

What Analysts Expect for AbiomedMike Benson

Market Realist
September 5, 2018

Abiomed’s revenues As discussed earlier, Abiomed ( ABMD) reported revenues of $180.0 million in Q1 2019, a 36% increase as compared to revenues of ~$132.5 million in the first quarter of 2018.

The above graph compares the quarterly revenues of Abiomed since the first quarter of 2018.

Q1 2019 performance Abiomed’s top line increased ~35.9% to ~$180.0 million during Q1 2019. The increase was driven by a 37% increase in Impella heart pump sales globally to $173.7 million during Q1 2019 as compared to $127.2 million in the first quarter of 2018.

Impella heart pump sales The revenues for Impella heart pump in the US markets increased by ~32% to $151.7 million during Q1 2019 as compared to $114.7 million in the first quarter of 2018.

The revenues for Impella heart pump outside US markets increased by ~75% to $21.9 million during Q1 2019 as compared to $12.5 million during the first quarter of 2018.

Profitability during Q1 2019 Abiomed reported a decrease in gross profit margin to 82.9% during Q1 2019 as compared to a gross profit margin of 83.5% during the first quarter of 2018. The operating margin increased to 26.0% during Q1 2019 as compared to an operating margin of 25.0% during the first quarter of 2018.

The GAAP net income increased by ~141% to $90.1 million in Q1 2019 as compared to the GAAP net income of $37.4 million during the first quarter of 2018.

The iShares US Healthcare ETF ( IYH) holds 0.5% of its total investments in Abiomed ( ABMD), 1.3% in Boston Scientific ( BSX), 3.4% in Medtronic ( MDT), and 9.4% in Johnson & Johnson ( JNJ).

What Analysts Expect for AbiomedBy Mike Benson
Sep 5, 2018 | 1:20 PM

Wall Street analysts’ estimates Wall Street analysts estimate Abiomed ( ABMD) will report 29.9% growth in revenues to ~$771.0 million in 2019 as compared to $593.7 million in 2018. The earnings per share are expected to be $4.66 in 2019. Analysts estimate the net income margin to increase to 27.3% during 2019 as compared to 18.9% during 2018.

The above chart compares changes in analysts’ recommendations for Abiomed since January 2018.

2019 guidance Abiomed estimates revenues to be between $755 million and $770 million during 2019, a 27% to 30% increase in revenues as compared to 2018. The operating margin is expected to be in the range of 28% to 30% in 2019.

Analyst ratings Abiomed’s stock price has increased by nearly 172.3% in the last 12 months and nearly 119.5% in 2018 year-to-date. Analysts estimate the stock might increase by 9.2% over the next 12 months. Wall Street analysts have a 12-month target price of $449.22 per share as compared to the last price of $411.36 per share as of September 4.

As of September 5, 11 analysts are tracking Abiomed. Of these, five analysts recommend a “strong buy,” four analysts recommend a “buy,” and two analysts recommend a “hold.” None of the analysts recommend a “sell.” The consensus rating for Abiomed stands at 1.73, which represents a “strong buy” for long-term growth investors as well as momentum investors. Changes in analysts’ estimates and recommendations are based on changing trends in stock prices and the performance of the company.

The iShares US Medical Devices ETF ( IHI) holds 2.3% of its total investments in Abiomed ( ABMD), 4.7% in Stryker ( SYK), 4.7% in Boston Scientific ( BSX), and 8.8% in Medtronic ( MDT).

finance.yahoo.com

[Lynn] Abiomed Announces Approval in India for the Impella 2.5®, Impella CP® and Impel...

Lynn — 7/26/2018 8:15:00 PM

Abiomed Announces Approval in India for the Impella 2.5®, Impella CP® and Impella 5.0® Heart Pumps and First Indian Patient Treated

DANVERS, Mass., July 26, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. ( NASDAQ:ABMD), a leading provider of breakthrough heart recovery and support technologies, announced the Impella 2.5®, Impella CP® and Impella 5.0® heart pumps received Central Drugs Standard Control Organization (CDSCO) approval in India for use during high-risk percutaneous coronary intervention (PCI), cardiogenic shock, and other reduced left ventricular function conditions. The first patient was treated with the Impella 2.5 heart pump at Fortis Escorts Heart Institute in New Delhi.

Ashok Seth, MD treated the first patient, an 86 year old man who was too high risk for heart surgery and presented with severe, recurrent chest pain and multiple comorbidities. A diagnostic catheterization demonstrated blockages of more than 90% in three left coronary arteries as well as distal disease. Dr. Seth performed a Protected PCI procedure including atherectomy with Impella 2.5 support. The patient was weaned off support and after three days was discharged home with an improved quality of life.

Impella heart pumps stabilize the patient's hemodynamics, unload the left ventricle, perfuse the end organs and promote recovery of the native heart. Heart disease is the number one cause of death in India1 and of those diagnosed with heart failure, 23% die within one year2.

"We are proud to be the first Heart Recovery Program in India," said Ashok Seth, MD, Chairman, Fortis Escorts Heart Institute and Head, Cardiology Council, Fortis Group. "The Impella heart pump unloads the left ventricle and allows the heart to rest and recover so that patients may gain an improved quality of life. We look forward to providing access to protected revascularization to improve their cardiac function and subsequent quality of life for more patients with heart failure, cardiogenic shock or left ventricular dysfunction."

“Abiomed is committed to expanding access to our heart recovery products around the world. We are moving forward to establish Heart Recovery Programs in India, starting with limited centers of excellence in New Delhi and Jaipur,” said Michael R. Minogue, President, Chairman and Chief Executive Officer of Abiomed. “We commend the dedication of Dr. Seth and his team for providing advanced technology to improve outcomes for patients who now have the opportunity for an improved quality of life.”

Data Supporting CDSCO Approval

Data supporting CDSCO approval included the U.S. FDA studies PROTECT I, PROTECT II RCT and RECOVER I for the Impella 5.0. Additional clinical data was submitted from peer-reviewed publications and the cVAD Registry study, which contains nearly 4,000 patient records. The data collection from the registry includes Institutional Review Board (IRB) approval, complete data monitoring and Clinical Events Committee adjudication.

CDSCO approval for Impella 2.5, Impella CP and Impella 5.0:

The Impella 2.5® and Impella CP® (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to five days for the following indications, as well as others: The Impella® 2.5/CP is a circulatory support system for patients with reduced left ventricular function, e.g., post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction, or for myocardial protection after acute myocardial infarction; the Impella 2.5 and Impella CP may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome; support during high risk percutaneous coronary intervention (PCI).

The Impella 5.0 (intracardiac pump for supporting the left ventricle) is intended for clinical use in cardiology and in cardiac surgery for up to 10 days for the following indications, as well as others: The Impella 5.0 is a cardiovascular support system for patients with reduced left ventricular function, e.g. post-cardiotomy, low output syndrome, cardiogenic shock after acute myocardial infarction. The Impella 5.0 may also be used as a cardiovascular support system during coronary bypass surgery on the beating heart, particularly in patients with limited preoperative ejection fraction with a high risk of postoperative low output syndrome, or post PCI.

2016 Global Burden of Disease Report. 15 Sept, 2017. healthdata.org

Lancet Glob Health. Global mortality variations in patients with heart failure: results from the International Congestive Heart Failure (INTER-CHF) prospective cohort study. 2017 Jul;5(7):e665-e672.

ABOUT IMPELLA HEART PUMPS

The Impella 2.5 and Impella CP devices are FDA approved to treat certain advanced heart failure patients undergoing elective and urgent percutaneous coronary interventions (PCI) such as stenting or balloon angioplasty, to re-open blocked coronary arteries. The Impella 2.5®, Impella CP®, Impella CP® with SmartAssist, Impella 5.0® and Impella LD® are FDA approved heart pumps used to treat heart attack or cardiomyopathy patients in cardiogenic shock, and have the unique ability to enable native heart recovery, allowing patients to return home with their own heart. To learn more about the Impella platform of heart pumps, including their approved indications and important safety and risk information associated with the use of the devices, please visit: www.protectedpci.com.

The ABIOMED logo, ABIOMED, Impella, Impella 2.5, Impella 5.0, Impella LD, Impella CP, Impella RP, and Recovering Hearts. Saving Lives. are registered trademarks of ABIOMED, Inc. in the U.S. and in certain foreign countries.

ABOUT ABIOMED
Based in Danvers, Massachusetts, 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.

FORWARD-LOOKING STATEMENTS

This release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities and expected regulatory approvals. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the most recently filed Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this release or to reflect the occurrence of unanticipated events.

**For further information please contact:
Tom Langford
Director, Communications and Public Relations
978-882-8408
tlangford@abiomed.com

Ingrid Goldberg Ward
Director, Investor Relations
978-646-1590
igoldberg@abiomed.com

markets.siliconinvestor.com

[Lynn] Why Abiomed Inc. Stock Is Sinking Today Keith Speights, The Motley Fool July 26...

Lynn — 7/26/2018 4:36:34 PM

Why Abiomed Inc. Stock Is Sinking Today

Keith Speights, The Motley Fool
July 26, 2018

What happened
Shares of Abiomed Inc. (NASDAQ: ABMD) sank 11.3% as of 11:23 a.m. EDT on Thursday. The medical-device company, which primarily markets heart pumps, reported its fiscal year 2019 Q1 results before the market opened. The stock dropped in reaction to this update.

Abiomed's Q1 numbers actually looked great. The company announced revenue of $180 million, up 36% year over year. Earnings per share came in at $1.95, which reflected a jump of nearly 138% over the prior-year period. So what was the problem? There was a twist with that earnings figure.

A big chunk of Abiomed's Q1 EPS -- $1.17 of it -- stemmed from excess tax benefits related to employee share-based compensation awards. Adjusting for this amount, the company's EPS was only $0.78. Wall Street analysts expected Abiomed's adjusted EPS would be $0.82.

Doctor holding hands over hearbeat monitor icon
Image source: Getty Images.

So what
Is missing analysts' estimates by $0.04 a big deal? Not over the long run. In my view, today's decline is a result of a hypersensitive focus on the short term.

Abiomed still appears to be doing quite well. Because of the impact of taxes on the company's bottom line, probably the best way to evaluate Abiomed's performance relative to the prior-year period is to look at earnings before income taxes (EBIT). The company's EBIT soared 43.5% year over year. That shouldn't be troubling to long-term investors; it should be encouraging.

Earnings numbers, though, can be subject to accounting tweaks. Revenue, on the other hand, is harder to manipulate. Although year-over-year revenue growth slowed a little from the 40% reported in the company's 2018 Q4 results, top-line growth was still impressive in Q1.

Now what
Investors would be better served by focusing on Abiomed's prospects, not how close the company came to meeting what Wall Street analysts expected. For now, at least, those prospects look solid.

Abiomed updated its 2019 revenue guidance, increasing the lower end of its range by $15 million. The company now projects full-year revenue between $755 million and $770 million. The midpoint of that range reflects a year-over-year increase of 28.5%.

The company's flagship product, the Impella heart pump, continues to enjoy strong momentum. International markets especially are fueling sales growth. Abiomed also recently received approval for three of its Impella models in India. The company should be on course to keep growing as more international markets open up.

finance.yahoo.com

[Lynn] Abiomed (ABMD) Q1 Earnings Lag Estimates Zacks Equity Research July 26, 2018 A...

Lynn — 7/26/2018 4:31:08 PM

Abiomed (ABMD) Q1 Earnings Lag Estimates

Zacks Equity Research
July 26, 2018

Abiomed (ABMD) just came out with quarterly earnings of $0.78 per share, missing the Zacks Consensus Estimate of $0.80 per share. This compares to earnings of $0.45 per share a year ago. These figures are adjusted for non-recurring items.

This quarterly report represents an earnings surprise of -2.50%. A quarter ago, it was expected that this maker of heart devices would post earnings of $0.64 per share when it actually produced earnings of $0.80, delivering a surprise of 25%.

Over the last four quarters, the company has surpassed consensus EPS estimates three times.

Abiomed, which belongs to the Zacks Medical - Instruments industry, posted revenues of $180.01 million for the quarter ended June 2018, surpassing the Zacks Consensus Estimate by 4.70%. This compares to year-ago revenues of $132.47 million. The company has topped consensus revenue estimates four times over the last four quarters.

The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call.

Abiomed shares have added about 129.8% since the beginning of the year versus the S&P 500's gain of 6.5%.

What's Next for Abiomed?

While Abiomed has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock?

There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately.

Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions.

Ahead of this earnings release, the estimate revisions trend for Abiomed was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #2 (Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.

It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is $0.75 on $172.71 million in revenues for the coming quarter and $3.50 on $765.84 million in revenues for the current fiscal year.

Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Instruments is currently in the top 32% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1.

finance.yahoo.com

[Lynn] Abiomed Announces Q1 FY 2019 Record Revenue of $180 Million, Up 36% Over Prior Y...

Lynn — 7/26/2018 10:54:47 AM

Abiomed Announces Q1 FY 2019 Record Revenue of $180 Million, Up 36% Over Prior Year

DANVERS, Mass., July 26, 2018 (GLOBE NEWSWIRE) -- ABIOMED, Inc. ( NASDAQ:ABMD), a leading provider of breakthrough heart recovery and support technologies, today reported first quarter fiscal 2019 revenue of $180.0 million, an increase of 36% compared to revenue of $132.5 million for the same period of fiscal 2018. First quarter fiscal 2019 GAAP net income was $90.1 million or $1.95 per diluted share, up 141% compared to GAAP net income of $37.4 million or $0.82 per diluted share for the prior year period.

Recent financial and operating highlights include:

Worldwide Impella® heart pump revenue for the quarter totaled $173.7 million, an increase of 37% compared to revenue of $127.2 million during the same period of the prior fiscal year.

U.S. Impella heart pump revenue for the quarter totaled $151.7 million, an increase of 32% compared to revenue of $114.7 million during the same period in the prior fiscal year with U.S. patient usage of the Impella heart pumps up 30%.

Outside the U.S., Impella heart pump revenue for the quarter totaled $21.9 million, an increase of 75% compared to revenue of $12.5 million during the same period in the prior fiscal year.

Gross margin for first quarter 2019 was 82.9% compared to 83.5% during the same period in the prior fiscal year.

Operating income for the first quarter was $46.7 million, or 26.0% operating margin, compared to $33.1 million, or 25.0% operating margin in the prior fiscal year.

First quarter fiscal 2019 GAAP net income was $90.1 million, or $1.95 per diluted share, which benefited from $53.8 million, or $1.17 per diluted share, of excess tax benefits related to employee share-based compensation awards recorded as a reduction of income tax expense. This compared to GAAP net income of $37.4 million or $0.82 per diluted share for the prior fiscal year, which benefited from $16.8 million, or $0.37 per diluted share, of excess tax benefits.

The Company’s cash and marketable securities balance as of June 30, 2018 was $367.4 million. The Company currently has no debt.

In June 2018, the Company completed enrollment for its STEMI DTU safety and feasibility study and 30-day follow-up.

In June 2018, the Company received approval in India for Impella 2.5®, Impella CP® and Impella 5.0® and treated the first patient at Fortis Escorts Heart Institute in New Delhi.

On June 22, 2018, the Company held the inaugural Women’s Initiative for Heart Recovery Physician Advisory Board meeting. Physicians collaborated to raise awareness of the expanded FDA indications for Impella for patients with peripartum and postpartum cardiomyopathy (PPCM) and spontaneous coronary artery dissection (SCAD).

“Abiomed reported a strong start to our fiscal year 2019,” said Michael R. Minogue, Chairman, President and Chief Executive Officer, ABIOMED, Inc. “Abiomed is committed to sustainable growth and improving patient outcomes each quarter. We do this through advanced training, product enhancements and sharing of best practices derived from real world experience.”

FISCAL YEAR 2019 OUTLOOK
The Company is increasing the lower end of its fiscal year 2019 revenue guidance by $15 million to a new range of $755 million to $770 million, an increase of 27% to 30% over the prior fiscal year. The Company is maintaining its fiscal year 2019 guidance for GAAP operating margin in the range of 28% to 30%.

EARNINGS CONFERENCE CALL DETAILS
The Company will host a conference call to discuss the results at 8 a.m. ET on Thursday, July 26, 2018. 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 investor.abiomed.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 a.m. ET July 26, 2018 through 11:00 a.m. ET on August 2, 2018. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 295-7159.

The ABIOMED logo, ABIOMED, IMPELLA, IMPELLA 2.5, IMPELLA 5.0, IMPELLA LD, IMPELLA CP, IMPELLA RP, IMPELLA BTR, IMPELLA 5.5, and IMPELLA ECP are registered marks or trademarks of ABIOMED, Inc., and are registered in the U.S. and certain foreign countries. AB5000 and cVAD REGISTRY, Recovering hearts. Saving lives. are trademarks of ABIOMED, Inc.

ABOUT ABIOMED
Based in Danvers, Massachusetts, 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

markets.siliconinvestor.com

[Lynn] Will Flagship Impella Drive Abiomed's (ABMD) Q1 Earnings? Zacks Equity Research...

Lynn — 7/11/2018 2:15:40 PM

Will Flagship Impella Drive Abiomed's (ABMD) Q1 Earnings?

Zacks Equity Research
July 10, 2018

Abiomed’s ABMD first-quarter fiscal 2019 earnings are scheduled to release on Jul 26, before the market opens.

We believe that the company is set to gain from its flagship Impella product line. An impressive guidance for fiscal 2019 and a recent upgrade to the coveted S&P 500 benchmark are other tailwinds.

In the last reported quarter, Abiomed posted adjusted earnings per share of 80 cents, which beat the Zacks Consensus Estimate by 25%. Earnings also skyrocketed 142.4% from the year-ago quarter’s figure.

For the quarter to be reported, the Zacks Consensus Estimate for revenues is pegged at $171.9 million, reflecting year-over-year rise of 29.8%. The Zacks Consensus Estimate for adjusted earnings per share is pegged at 80 cents, indicating a significant climb of 77.8%.

ABIOMED, Inc. Price and EPS Surprise

View photos

ABIOMED, Inc. Price and EPS Surprise | ABIOMED, Inc. Quote

Solid Impella Product Line Likely to Drive Q1

Impella, which is the world's smallest heart pump and Abiomed’s flagship product line, has continued to be a growth driver for the company.

Recently, the Impella 5.5 heart pump received CE marking approval in Europe. Notably, the first patient was successfully treated at the University Heart Center in Hamburg, Germany. This latest acceptance further enhances Abiomed’s product portfolio. (Read more: Abiomed’s Impella 5.5 Receives CE Mark in Europe)

Management awaits an approval for Impella 5.5 in the United States, which is expected to help Abiomed to significantly advance in the field of heart recovery.

Moreover, the company’s Impella CP heart pump with SmartAssist also received the U.S. FDA Pre-Market Approval (PMA). Additionally, Abiomed has already received CE marking approval from the European Union to market Impella CP with SmartAssist.

In the last reported quarter, the company witnessed the strong adoption of the Impella product line in the United States, Germany and Japan. Management anticipates 25,000 and 50,000 patients to adopt the product line in Germany and Japan, respectively.

Other Factors at Play

View Impressive

For fiscal 2019, the company expects total revenues of $740-$770 million, reflecting an increase of 25-30% over the prior fiscal. Notably, the Zacks Consensus Estimate for revenues is pegged at $765.8 million, which lies within the projected range.

S&P 500 Benchmark

Recently, this Massachusetts-based developer of medical products replaced Wyndham Worldwide Corp. to join the distinguished S&P 500 index. With a portfolio of 500 leading companies that have approximately 80% coverage of the available market capitalization, the S&P 500 index is an important metric for the U.S. equities. Hence, Abiomed’s recent development is a proof of the company’s solid prospects. (Read More: Abiomed to Replace Wyndham in the S&P 500 Benchmark)

Cutthroat Competition

Competition among the treatment providers for heart-related diseases is intense. Abiomed’s products compete with a temporary cardiac assist device by Throated. The company also faces stiff competition from organizations, developing permanent heart assist products like Thoratec, Teleflex, HeartWare, Jarvik Heart and MicroMed Technology.

What Our Model Predicts

Our quantitative model does not predict an earnings beat for Abiomed this quarter.

This is because a stock needs to have a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) to be able to beat estimates. This has been illustrated below:

Earnings ESP: Abiomed has an Earnings ESP of -3.92%. You can uncover the best stocks to buy or sell before they’re reported with our Earnings ESP Filter.

Zacks Rank: Abiomed currently carries a Zacks Rank #2.

finance.yahoo.com

[Lynn] Newbie Abiomed edges out Netflix as S&P 500’s top YTD gainer [graphic] Jessica...

Lynn — 7/2/2018 2:47:11 PM

Newbie Abiomed edges out Netflix as S&P 500’s top YTD gainer

Jessica Dye in New York
Financial Times
June 29, 2018

Abiomed — which was moved from the S&P MidCap 400 to replace Wyndham Worldwide in the benchmark S&P 500 starting May 31 — has risen 120 per cent in the first six months of the year, according to Thomson Reuters data. Among analysts, Abiomed has five “strong buy” ratings, four “buy”, two “hold” and no sells, with a mean price target of $418.33, according to Thomson Reuters data.

[One has to subscribe to read the rest of the article]

finance.yahoo.com

[Lynn] Call it wishful thinking, but I think the ABMD BOD has a 2:1 stock split in mind...

Lynn — 6/26/2018 2:13:42 PM

Call it wishful thinking, but I think the ABMD BOD has a 2:1 stock split in mind due to a proposal on the annual meeting [8 August] voting Proxy I just received (e-mail) to increase the shares:

"Amend and restate the ABIOMED, Inc. Amended and Restated 2015 Omnibus Incentive Plan to, among other things, increase the number of shares of common stock available for the issuance thereunder by 1,725,000 shares to 4,985,000 shares"

[Lynn] I shall post the entire article after this, but the article says some fund manag...

Lynn — 6/7/2018 2:09:09 PM

I shall post the entire article after this, but the article says some fund managers are going with ABMD (and BABA) because they are better values than AMZN.

"Some fund managers are avoiding Amazon as it leads U.S. market"
7 June 2018

NEW YORK (Reuters) - For most U.S. fund managers, beating the market this year has come down to one decision: whether or not to own shares of Amazon.com Inc ( AMZN.O).

More than 70 percent of the actively-managed U.S. large-cap funds that are beating the 3.5-percent gain in the benchmark S&P 500 own shares of the Seattle-based e-commerce giant, according to Lipper data. Shares of the company are up nearly 45 percent for the year-to-date, and account for nearly 40 percent of the S&P 500’s gain for the year, according to S&P Global.

Those gains have left even investors like Warren Buffett, who has never invested in Amazon, kicking themselves for missing out on the company’s growth.

“I was too dumb to realize what was going to happen,” Buffett said at Berkshire Hathaway Inc’s ( BRKa.N) annual shareholder meeting in early May.

Amazon has benefited this year from continued growth of e-commerce and is a business that seems largely immune from the threat of a global trade wars.

Yet with volatility in the stock market expected to continue through the U.S. midterm elections in the fall, Amazon’s pricy valuation and high level of fund ownership may leave the stock more vulnerable to a steep decline, analysts warn.

As a result, some outperforming fund managers who have so far avoided Amazon are branching out into companies ranging from Asian e-commerce company Alibaba Group Holdings Ltd ( BABA.N) to medical device maker Abiomed Inc ( ABMD.O), all in an effort to find better values.

“Not owning Amazon has obviously hurt us this year, but we’ve been fortunate to own names that have made up the difference,” said Bob Doll, portfolio manager of the Nuveen Growth fund.

Doll has avoided Amazon because of its trailing price-to-earnings ratio of 267, a valuation more than ten times that of the broad S&P 500. Instead, he has benefited from positions in MasterCard Inc ( MA.N), Red Hat Inc ( RHT.N), and Intuit Inc ( INTU.O), all of which are up more than 30 percent for the year and trade at less than a third of Amazon’s valuation.

“These stocks aren’t exactly cheap, they’re cheap compared to a concept stock like Amazon where the valuation is so full,” he said.

Amazon.com Inc1683.8

AMZN.ONasdaq
-11.95(-0.70%)

AMZN.OBRKa.NBABA.NABMD.OMA.N

Scott Goginsky, a portfolio manager at the Biondo Growth Fund, said that his fund has been increasing its position in Alibaba instead of owning Amazon because he sees it as a cheaper way to invest in the growth of e-commerce.

“Would we have liked to be in Amazon 5 years ago? Yes. But in last year maybe Alibaba is the way to play it, because you’re getting the same growth profile without the same multiple.”

Shares of Alibaba are up 21 percent for the year and trade at a trailing price to earnings ratio of 54.3.

Fund manager concentration in Amazon may leave the company more vulnerable to sell off if the volatility in the broad market increases this fall ahead of the mid-term elections, said Todd Rosenbluth, director of mutual fund research at CFRA Research.

“We’re of the belief that there will be greater market volatility for the duration of 2018 and while in theory that gives active managers a chance to buy in on whatever they have missed out on, that volatility could hit the better performers first,” he said.

The outsized gain in Amazon relative to other stocks in the S&P 500 suggests that growth is hard to come by in the U.S. market and should benefit more concentrated portfolios, said Daniel Davidowitz, a portfolio manager of the $2.1-billion Polen Growth Fund.

Davidowitz, whose fund holds only 20 stocks, said he has avoided Amazon because of its high valuation and stretched balance sheet and has instead moved into stocks like Invisalign braces-maker Align Technology Inc ( ALGN.O) and Adobe Systems Inc ( ADBE.O), both of which are up more than 40 percent year-to-date.

“The average U.S. company is not growing that much. Earnings may be up a lot but a big slug of that is from the benefits of the Trump tax cut,” he said. “The only way to outperform is to find companies that are creating their own theme.”

Reporting by David Randall; Editing by Jennifer Ablan and Nick Zieminski

reuters.com

[Lynn] I am doing a copy/paste of the entire article in IBD, not just the section on AB...

Lynn — 6/4/2018 9:25:27 PM

I am doing a copy/paste of the entire article in IBD, not just the section on ABMD, in case other stocks held by the mutual fund are of interest to others (AMZN, NFLX, BABA). For anyone just interested in ABMD, though, I am copying it before the entire article:

"Abiomed is in the dynamic growth bucket. The stock replaced leisure-lodging stock Wyndham Worldwide ( WYN) in the S&P 500 index. Many funds, especially index funds, will add Abiomed to their portfolios just because it is now part of the popular benchmark. "Abiomed has had the biggest innovation in cardiac surgery in years by having a balloon pump to help patients extend the life of their hearts during cardiac arrest," lead manager Kelly said. "It works substantially better than all preceding technologies."

The company's market opportunity is about 10 times what its market is today, Kelly says, as its technology grabs market share over the next five to 10 years."

Growth Stocks Like Abiomed And Alibaba Drive This MainStay Fund's Outperformance

PAUL KATZEFF

6/01/2018
How hot is $12.5 billion MainStay Large Cap Growth Fund (MLAAX) right now? Very! Driven by leading growth stocks like Abiomed ( ABMD), Alibaba ( BABA), Amazon.com ( AMZN) and Netflix ( NFLX), the MainStay fund is up 13.37% this year going into Thursday.

That tops 95% of rival large-cap funds focused on growth stocks that are tracked by Morningstar. And it dwarfs the S&P 500's 2.7%.

Abiomed, which was added to the S&P 500 on Thursday, has grown earnings per share at a triple-digit pace in the past three quarters. The maker of cardiac pumping devices is up 103% so far this year.

As of Thursday, Alibaba was up 15% this year. Amazon had climbed 39%. Netflix had notched an 83% gain.

As the fund explains to investors considering buying shares, the managers look "to diversify holdings across three distinct, yet complementary, types of earnings growth to participate in different market cycles."

In addition, the fund sticks to subadvisor Winslow Capital's "no preferred habitat" approach. That means broad diversification with an eye to managing risk by not being overexposed to any one area of the market.

MainStay fund managers Justin Kelly and Patrick Burton cope with different market environments by adjusting their allocations among three types, or buckets, of growth stocks.

One bucket holds stocks that Kelly and Burton think will be able to sustain earnings growth for long periods. The second bucket holds dynamic growth stocks — stocks in newer industries with rapid growth. The third bucket holds cyclical growth stocks. Operating in more economically sensitive sectors, they may be more volatile.

Leading Growth Stocks Abiomed is in the dynamic growth bucket. The stock replaced leisure-lodging stock Wyndham Worldwide ( WYN) in the S&P 500 index. Many funds, especially index funds, will add Abiomed to their portfolios just because it is now part of the popular benchmark.

"Abiomed has had the biggest innovation in cardiac surgery in years by having a balloon pump to help patients extend the life of their hearts during cardiac arrest," lead manager Kelly said. "It works substantially better than all preceding technologies."

The company's market opportunity is about 10 times what its market is today, Kelly says, as its technology grabs market share over the next five to 10 years.

Alibaba's Four Markets Alibaba is another dynamic growth holding. It is the leading e-commerce platform in China, and its share is growing.

"Alibaba is pursuing four markets that are extremely large," Burton said. "The first is its traditional e-commerce business in China. The second is digital advertising. As the company adds e-commerce customers, it boosts its advertising business. The third is its cloud computing business. As it builds its online infrastructure, it can sell that service to other companies. And the fourth is its emerging retail business. It is taking its e-commerce and logistics expertise and applying them to grocery and food delivery, where there is a massive total available market opportunity."

Alibaba is a member of the IBD 50 roster of growth stocks. So are Netflix and Abiomed.

Amazon, which is on IBD's Leaderboard, is in the fund's consistent growers bucket. The stock barely paused when it recently took heat amid news that one of the company's Echo smart-speaker devices recorded a couple's private conversation in their home and sent it to someone on their contact list without their knowledge.

"Amazon is our largest holding," Kelly said. "We're still excited about their two main businesses. The first is retail, which still has a tremendous runway to go. They have 5% of total retail transactions in the U.S., but they get 20% of the total growth. That indicates that they will get to 20% of the total market, so the opportunity is four times what it is today."

Amazon Web Services is the second business that Kelly and Burton like. "We think it is in the early stages of moving corporate work flows from on-premises software to the cloud. Their technology for doing this is in the front of the industry, so they should remain the leader, with Microsoft ( MSFT) number two, and that's why Microsoft is our second largest holding."

Other Growth Stocks Among other holdings, ASML ( ASML) is in the fund's cyclical growth bucket. The Dutch-based company is a manufacturer of lithography systems used to manufacture integrated circuits. Its shares are up 15% this year.

"ASML has two key drivers," Burton said. "First is global demand for semiconductor chips, which is expanding at two-plus times the growth rate of global GDP. It's driven by growth in cloud computing and mobile communications."

Burton likes ASML's EUV technology. "It stands for extreme ultraviolet, and it helps makers of chips. ASML is the only company in the world with this technology."
[huge chart for fund cut out--see article via link if interested in the mutual fund]

investors.com

[Lynn] Abiomed's Shares Doubled. What Happens Next? The size of...

Lynn — 6/2/2018 10:04:37 PM

Abiomed's Shares Doubled. What Happens Next? The size of this medical device company's market might surprise you.

Motley Fool Staff

Jun 1, 2018 at 9:00AM

Open-heart surgery in patients that have suffered major cardiovascular events is risky, but it could be getting less so thanks to temporary heart pumps sold by Abiomed ( NASDAQ:ABMD), a $17 billion market-cap medical devices company. Is Abiomed a stock worth including in your portfolio?

In this clip from Industry Focus: Healthcare, analyst Kristine Harjes and Motley Fool contributor Todd Campbell discuss why Abiomed's shares have doubled this year and what investors should know about this company's market opportunity.

A full transcript follows the video recorded on 30 May 2018 [which I have not included--click the URL at the bottom to watch the video].

Kristine Harjes: Today, we're going to talk about Abiomed, which is a $17 billion market cap company whose stock has doubled since just January of this year. Both of these companies, Loxo Oncology in the front half of the show, and now Abiomed, have been very, very high performers, but they're both kind of under the radar.

Abiomed's flagship product line is the Impella heart pump, which is the world's smallest heart pump. Revenue has been growing very swiftly with seemingly no end in sight. Todd, what's your take on Abiomed?

Todd Campbell: I'm so excited to be talking about this stock. It's kind of funny, right, when you think about it. We oftentimes tend to expect the biggest returns coming from the biopharma area, not from the medical device area. When you see that return year-to-date, it's like, what?! [laughs] Double my money in a few months in this company? Especially for a company as big as this, right? $17 billion market cap! So, you have to ask yourself, what's the excitement here? What's the reason for excitement at Abiomed? And, what's the potential for this company to continue to grow and deliver for investors?

I think that you did a great job setting the stage here to understand that what they're doing is, through medical devices, they're attacking a very, very big need for devices that can help relieve the stress that gets put on the heart following a heart attack. If you're able to relieve the heart from that stress of pumping on its own, either prior to or during surgery, or in the hours and potentially the days following that surgery, then you can get better outcomes. You can have less of a risk of complications, less of a risk of a readmittance back to the hospital after they've been sent home, and less time overall spent within the hospital, which theoretically can save payers some money there, too.

So, really, what we're talking about is the Impella heart pumps. Those are used temporarily from hours to a few days. They're used in patients who are at a critical risk -- they've had a heart attack and they're also in shock.

Harjes: Yeah, absolutely. This is a very, very large market. Heart disease, as many of our listeners will know, is the leading cause of death in the United States. It kills 875,000 people per year. It costs our healthcare system $555 billion, which is estimated to grow to $1.1 trillion annually by 2035. In that same year, 2035, it's estimated that 45% of the United States population will have heart disease, which is just a frightening and insane statistic.

Abiomed is estimating that about 221,000 U.S. patients per year would benefit from procedures using their Impella product. Despite seeing double-digit growth for revenue for quite a while, they still have a pretty long runway. They're just getting started. They don't seem to have any substantial competitors. They have that first-mover advantage. It looks like it could be early days for this company.

Campbell: Fiscal year 2017, their sales grew 35% to $445 million. In fiscal year 2018, their sales grew, again, by 33%, to $594 million. I think what got people really excited was the fact that that was better than the guidance. The guidance was for 31% growth, $582 million.

The other thing that investors should know is that this has been a profitable company since 2012. They're making money. They had $90 million in operating income in fiscal 2017, and then, that jumped in fiscal 2018, just finished up, to $157 million. So, up 74%. Your operating income grew at a much faster rate than your revenue growth, which suggests to me that as these devices are getting used more frequently, they're able to leverage their fixed costs and really accelerate their profitability for investors. Maybe that's one of the reasons that the company is debt free and its cash stockpile has been growing for three consecutive years.

Harjes: Yeah. The stats that I mentioned were U.S. stats, but they're not even just based in the United States. They're also in Europe, they have approvals there. They launched in Japan in September. They have a presence in Germany. And even though expansion is kind of slow -- and management routinely reminds investors that it has to be slow in order to ensure good outcomes, because you need to be trained to use these pumps, it's not something that you can just drop off and go away -- they have the entire world out there that they're just starting to reach. And when you think about the demographic trends in general across the entire globe of an aging population, I've said it so many times already just in this one segment, but they really do seem like they have a huge runway ahead of them.

Campbell: Well, just to put that into context, in the fiscal fourth quarter, the one that just wrapped up, their overseas sales, their ex-U.S. sales, were only $22 million. So, a very small proportion of their total sales is coming from the international markets right now. And, by the way, that was up 107% year over year, and it was really tied to one country: Germany. So, as Japan starts to accelerate, as other countries start to get more interested in the opportunity to use Impella, I think that, yeah, you could see sales grow substantially. The company, Kristine, estimates this is a $5 billion market opportunity, and they say that they're only about 9% penetrated into it.

Harjes: Yep. And the other thing that's important to realize about the business model is that there's recurring revenue. Their hospital reorder rate stands at over 90%. So, it's sticky. Once you're trained on using these, you're probably not going to move to a competitor. I saw on the fool.com Premium side of things in our Supernova service, an analyst compared this company to Intuitive Surgical, which is the robotic surgery giant. She pointed out that there were similarities in the business model, where you have that recurring revenue, there's a product that will become the standard of care, there's a long growth runway, and really solid financials. I like that comparison a lot.

I think one more thing to add to the list of why these two companies are fairly similar is a nosebleed valuation. This company is definitely not cheap, they're trading at about 30X the last 12 months of sales. Their P/E is several hundred, and that's TTM. It's not even that much better when you look on a forward basis. But, like you said, they have a very strong balance sheet. They've been profitable since fiscal 2012. So, I see a lot of similarity with Intuitive.

Campbell: Yeah. Value investors are not going to be tucking this in a portfolio, similar to what we were talking about last week on the diabetes show. These things are richly valued. But, that's not necessarily a reason to not have a stock like this in your portfolio. You need to take that valuation in the context of where the company's sales could be in five or ten years. You have to take that longer-term look and say, if they're only 9% penetrated into this massive market now, can they grow into that valuation? I'll let someone smarter than me make the answer to that. But, I'm very, very excited by the opportunity to really improve a lot of people's lives. This is a medical device that can save lives. That makes the potential for it to be a must-use device in hospitals, not a nice-to-have device.

Kristine Harjes has no position in any of the stocks mentioned. Todd Campbell has no position in any of the stocks mentioned. His clients may have positions in the companies mentioned. Motley Fool owns shares of and recommends Abiomed and ISRG. The Motley Fool has a disclosure policy

fool.com

[Lynn] ABIOMED Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600 ...

Lynn — 5/29/2018 2:09:05 PM

ABIOMED Set to Join S&P 500; Others to Join S&P MidCap 400 and S&P SmallCap 600

markets.siliconinvestor.com

[Lynn] Abiomed Climbs to Record After Fiscal Q4 EPS, Rervenue Beat Analyst Estimates 12...

Lynn — 5/9/2018 6:13:27 PM

Abiomed Climbs to Record After Fiscal Q4 EPS, Rervenue Beat Analyst Estimates 12:26 PM ET, 05/03/2018 - MT Newswires12:26 PM EDT, 05/03/2018 (MT Newswires) -- Abiomed (ABMD) shares rose 11% to a record after reporting fiscal Q4 EPS of $0.80 compared with $0.33 a year earlier, beating the $0.66 average estimate of analysts in a Capital IQ poll.

The new 52-week range is $123.60 to $338.69.

Revenue was $174.4 million, an increase of 40% from $124.7 million a year earlier. That exceeded the $164.3 million analyst consensus.

The company sees total revenue in the 2019 fiscal year to be in the range of $740 million to $770 million, an increase of 25% to 30% over the previous fiscal year. It sees GAAP operating margin in the range of 28% to 30%.

Closing price: 358.16 Change +10.78 (+3.1%)

[Lynn] DANVERS, Mass., April 13, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. ( NASDAQ:ABM...

Lynn — 4/13/2018 2:50:41 PM

DANVERS, Mass., April 13, 2018 (GLOBE NEWSWIRE) -- Abiomed, Inc. ( NASDAQ:ABMD) announced that on Thursday, May 3, 2018, the Company will release financial results for the fourth quarter of fiscal 2018. The Company will host a conference call to discuss the results on Thursday, May 3, 2018, at 8:00 a.m. EDT. Michael R. Minogue, Chairman, President and Chief Executive Officer and Todd Trapp, Vice President and Chief Financial Officer, will host the conference call.

To listen to the call live, please tune into the webcast via investor.abiomed.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 a.m. ET May 3, 2018 through 11:00 a.m. ET on May 10, 2018. The replay phone number is (855) 859-2056; the international number is (404) 537-3406. The replay access code is 448 8806. [snip to end]

markets.siliconinvestor.com

[Lynn] ABMD is one of the top 10 in which at least $100 million was invested as new buy...

Lynn — 4/6/2018 3:41:40 PM

ABMD is one of the top 10 in which at least $100 million was invested as new buys by mutual funds:

New Buys By Best Mutual Funds: From Adobe To Zebra, Who Makes The List? investors.com

[Lynn] Abiomed Receives FDA Approval for Impella CP® with SmartAssist™ and Optical Sens...

Lynn — 4/4/2018 4:08:49 PM

Abiomed Receives FDA Approval for Impella CP® with SmartAssist™ and Optical Sensor

markets.siliconinvestor.com

[Lynn] Abiomed to pay $3.1 mln to settle case over lavish doctor meals Reuters•March 8...

Lynn — 3/8/2018 6:39:57 PM

Abiomed to pay $3.1 mln to settle case over lavish doctor meals

Reuters•March 8, 2018

(Adds comment from Abiomed, further details from lawsuit)

By Nate Raymond

BOSTON, March 8 (Reuters) - Abiomed Inc has agreed to pay $3.1 million to resolve a U.S. probe into allegations that it sought to get doctors to use a line of heart pumps it produced by buying them lavish meals at some of the most expensive restaurants in the United States.

The civil settlement was announced on Thursday by U.S. Attorney Andrew Lelling in Massachusetts and resolves allegations first raised in a whistleblower lawsuit filed by a former Abiomed employee.

The government alleged that Danvers, Massachusetts-based Abiomed from 2012 to 2015 sought to get physicians to use its Impella line of heart pumps by paying for their meals at expensive restaurants, according to the settlement agreement.

The restaurants included Eleven Madison Park in New York, Nobu in Los Angeles, Spago in Beverly Hills, California, and Menton in Boston, Lelling's office said.

Abiomed in a filing with the U.S. Securities and Exchange Commission said it did not admit liability in settling.

Abiomed paid for alcohol at times in amounts inconsistent with legitimate scientific discussion and covered meals the physicians' spouses attended, the government alleged.

Numerous meals cost more than Abiomed's own $150 per person guideline and in one instance cost over $450 per person, the settlement agreement said. In some instances the number of people at a dinner was misrepresented and in other cases attendees were listed with generic names, such as "Mike Anesthesia," the agreement said.

The government contended the meals led to the submission of false claims for payment for Impella heart pumps that cost more than $20,000 each by Medicare, the federal health care program for the elderly and disabled.

"We expect today's settlement with Abiomed to serve as a warning to medical device manufacturers who try to improperly influence the treatment decisions of physicians," Lelling said in a statement.

Abiomed in its SEC filing said the probe revealed that less than 2 percent of the meals it paid for exceeded its internal guidelines.

The deal stemmed from a lawsuit filed by a former Abiomed employee, Max Bennett, under the False Claims Act, which allows whistleblowers to sue companies on the government's behalf to recover taxpayer money paid out based on fraudulent claims.

If successful, whistleblowers receive a percentage of the recovery. The settlement agreement said Bennett will receive $542,500. Abiomed said it will also pay $150,000 to Bennett to cover his attorneys' fees and costs.

Rory Delaney, a lawyer for Bennett, said he was pleased by the settlement. The deal does not resolve claims in Bennett's lawsuit that Abiomed terminated him in 2012 in retaliation for complaining about improper conduct by the company.

The case is U.S. ex rel. Bennett v. Abiomed Inc, U.S. District Court, District of Massachusetts, No. 13-12277. (Reporting by Nate Raymond in Boston Editing by Susan Thomas and Leslie Adler)

finance.yahoo.com

[Lynn] Why Abiomed Soared 14.1% In February [graphic] Brian Feroldi, The Motley Fool,...

Lynn — 3/8/2018 6:34:59 PM

Why Abiomed Soared 14.1% In February

Brian Feroldi, The Motley Fool,
Motley Fool•March 8, 2018

What happened In response to pumping out record quarterly results and sharing a slew of upbeat news announcements with investors, shares of Abiomed (NASDAQ: ABMD), a medical device maker focused on heart recovery, jumped 14.1% in February according to data from S&P Global Market Intelligence.

So whatAbiomed got off to a fast start in February after it reported strong fiscal third-quarter results:

Revenue grew 34% to $154 million.

Adjusted net income more than doubled to $32.2 million.

Adjusted earnings per share of $0.70 were far higher than the $0.51 that Wall Street had expected.

If that wasn't exciting enough, the company also shared two positive regulatory updates with investors later in the month, including:

Winning FDA approval for a label expansion claim for its Impella heart pumps to treat heart failure associated with cardiomyopathy leading to cardiogenic shock.

Gaining FDA approval for a label expansion claim for certain Impella heart pumps to be used during elective and urgent high risk percutaneous coronary intervention (PCI) procedures.

Given the upbeat financial results and label expansion wins, it isn't hard to figure out why Abiomed's shares remain on fire.

A surgeon in the foreground with an operation happening in background.
Image source: Getty Images.

Now whatBetween label expansion claims, product innovations, and international expansion, there are plenty of reasons for investors to believe that Abiomed's days of hyper growth are here to stay. While the company's stock cannot be called cheap right now -- shares are currently trading for more than 22 times sales and 85 times forward earnings -- I still think the long-term potential of this business is so great that the company can continue to put up market-beating results.