|From: 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
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]
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|From: 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.
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
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|From: 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"
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|From: 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
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]
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|From: 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
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
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)
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.
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|From: 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.
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
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|To: Lynn who wrote (129)||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.
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|To: Lynn who wrote (130)||7/26/2018 4:36:34 PM|
|Why Abiomed Inc. Stock Is Sinking Today|
Keith Speights, The Motley Fool
July 26, 2018
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.
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.
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.
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|From: 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.orgLancet 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.
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.
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:
Director, Communications and Public Relations
Ingrid Goldberg Ward
Director, Investor Relations
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|From: Lynn||9/8/2018 3:36:43 PM|
|What Analysts Expect for AbiomedMike Benson|
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).
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