Boston Scientific says Eluvia was 85% effective as treatment for arterial diseases
Oct. 06, 2021 1:09 PM ETBoston Scientific Corporation (BSX)
By: Dulan Lokuwithana, SA News Editor
Eluvia Drug-Eluting Vascular Stent System (Eluvia stent) has demonstrated superiority over the self-expanding bare metal stents (BMS) in patients with a form of vascular disease, Boston Scientific (NYSE:BSX) says, citing one-year results from its EMINENT trial.
In the trial involving 775 subjects, Eluvia stent has shown ~85% of primary patency rate compared to ~76% for BMS among patients with peripheral artery disease (PAD) and superficial femoral artery (SFA)/ popliteal artery (PPA) lesions (p=0.0077).
Restricting blood flow to limbs, PAD can cause pain in affected individuals. However, a greater portion of patients who were treated with Eluvia stent experienced sustained clinical improvement without interventions (83% for Eluvia compared to ~77% for those treated with BMS at p=0.0450).
Through one year, there were no notable differences in major adverse events or all-cause mortality rates between the two patient groups, the company said.
The data were included in a late-breaking clinical trial presentation at the Vascular InterVentional Advances (VIVA) meeting in Las Vegas.
Developed as a treatment for peripheral artery disease, Eluvia stent was granted the FDA approval in 2018.
Boston Scientific Announces Results For First Quarter 2021
Apr. 28, 2021
MARLBOROUGH, Mass., April 28, 2021 /PRNewswire/ -- Boston Scientific Corporation (BSX) generated net sales of $2.752 billion during the first quarter of 2021. This represents growth of 8.2 percent on a reported basis, 5.6 percent on an operational1 basis and 5.9 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income available to common stockholders of $327 million or $0.23 per share (EPS), compared to GAAP net income of $11 million or $0.01 per share a year ago, and achieved adjusted EPS of $0.37 for the period, compared to $0.28 a year ago.
"We are pleased by the trajectory of our recovery," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "Our global team remains committed to helping patients and our customers by delivering a robust portfolio of innovative solutions, and that commitment will continue to fuel our future growth."
First quarter financial results and recent developments:
Reported net sales of $2.752 billion, representing an increase of 8.2 percent on a reported basis, compared to the company's guidance range of 0 to 6 percent; 5.6 percent on an operational basis; and 5.9 percent on an organic basis, compared to the company's guidance range of (3) to 3 percent, all compared to the prior year period.
Reported GAAP net income available to common stockholders of $0.23 per share compared to the company's guidance range of $0.05 to $0.11 per share. Achieved adjusted EPS of $0.37 compared to the guidance range of $0.28 to $0.34 per share.
Achieved net sales growth in each reportable segment4, compared to the prior year period:
MedSurg: 11.1 percent reported, 8.6 percent operational and 9.5 percent organic
Rhythm and Neuro: 6.8 percent reported, 4.0 percent operational and 1.6 percent organic
Cardiovascular: 10.0 percent reported, 7.4 percent operational and organic
Achieved the following regional5 net sales growth, compared to the prior year period:
U.S.: 8.6 percent reported and operational
EMEA (Europe, Middle East and Africa): 9.4 percent reported and 1.9 percent operational
APAC (Asia-Pacific): 15.6 percent reported and 9.1 percent operational
Emerging Markets3: 16.0 percent reported and 13.2 percent operational
Received U.S. Food and Drug Administration (FDA) approval for the TheraSphere™ Y-90 Glass Microspheres for the treatment of patients with hepatocellular carcinoma, the most common type of primary liver cancer, and secured FDA Breakthrough Device designation for TheraSphere treatment for patients with glioblastoma, a type of brain cancer.6
Received approval for the Ranger™ Drug-Coated Balloon from Japan's Ministry of Health, Labor and Welfare (MHLW) and initiated a full launch in the region.
Launched Vercise Genus™ Deep Brain Stimulation (DBS) System in the U.S. Additionally, the system is being used with the world's first 16-channel directional leads—Cartesia™ X and HX leads—in the eXTend 3D Study in Europe.
Commenced U.S. launch of the WaveWriter Alpha™ portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MR conditional, Bluetooth-enabled devices, new FAST paresthesia-free therapy and all supported by Cognita™ Solutions—a suite of digital tools that helps physicians and patients navigate the pain management journey.
Surpassed 50,000 patients worldwide treated with the SENTINEL™ Cerebral Protection System, the first and only FDA-cleared device to protect patients from stroke risk during transcatheter aortic valve replacement (TAVR) procedures.
Published positive 12-month results from the PINNACLE FLX clinical trial in Circulation, demonstrating the next-generation WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device is a safe and effective alternative to oral anticoagulation therapy for stroke risk reduction in patients with non-valvular atrial fibrillation and increased risk of bleeding. The trial met its primary safety endpoint with a low adverse event rate of 0.5%, as well as its primary effectiveness endpoint with a 100% rate of LAA closure at 12 months.
Presented five-year outcomes from the EFFORTLESS study, the largest post-market registry of the Subcutaneous Implantable Defibrillator (S-ICD) System, further validating the long-term efficacy of the device. Results demonstrated 98% overall efficacy over five years, consistent with results of previous S-ICD studies and comparable to or higher than many large transvenous ICD studies.
Received FDA approval to modify the design of the ACURATE IDE trial—evaluating the ACURATE neo2™ Aortic Valve System—to an "all-risk" protocol to study patients with severe, symptomatic aortic stenosis who are at low risk of open-heart surgery, in addition to those at intermediate, high and extreme risk.
Initiated the NEwTON AF IDE clinical trial to evaluate the safety and effectiveness of the INTELLANAV STABLEPOINT™ Ablation Catheter enabled with DIRECTSENSE™ Technology in patients with paroxysmal atrial fibrillation.
Named eighth on the Forbes list of America's Best Employers for Diversity 2021, based on a survey of 50,000 Americans working for businesses with at least 1,000 employees.
Completed the acquisition of Preventice Solutions, Inc., a privately-held company which offers a full portfolio of mobile cardiac health solutions and services, for an upfront cash payment of ~$720 million, with up to an additional ~$230 million in a potential commercial milestone payment, given a preexisting 22 percent equity stake.
Completed the sale of the BTG Specialty Pharmaceuticals business to Stark International Lux S.A.R.L. and SERB SAS, affiliates of SERB, for ~$800 million in cash.
Announced a definitive agreement with an affiliate of Baring Private Equity Asia to acquire the global surgical business of Lumenis LTD. (LUME), a privately-held company that develops and commercializes energy-based medical solutions, for an upfront cash payment of ~$1.07 billion, subject to customary closing conditions and adjustments.
Announced plans to host a virtual Investor Day business review meeting for the investment community on Wednesday, September 22, 2021.
1. Operational net sales growth excludes the impact of foreign currency fluctuations.
2. Organic net sales growth excludes the impact of foreign currency fluctuations and net sales from the recent acquisition of Preventice Solutions, Inc. (Preventice). Organic net sales growth rates also exclude the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021.
3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities. Periodically, we assess our list of Emerging Markets countries, and effective January 1, 2021, modified our list to include the following countries: Brazil, Chile, China, Colombia, Czech Republic, India, Indonesia, Malaysia, Mexico, Philippines, Poland, Russia, Saudi Arabia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey and Vietnam. We have revised prior year amounts to conform to the current year's presentation. The revision had an immaterial impact on previously reported Emerging Markets net sales.
4. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices).
5. On March 1, 2021, we completed the sale of the Specialty Pharmaceuticals business. Our consolidated net sales include Specialty Pharmaceuticals up to the date of the closing of the transaction. Specialty Pharmaceuticals net sales were substantially U.S. based and presented as a stand-alone operating segment alongside our Medical Device Reportable segments.
6. Consistent with Section 515B of the FD&C Act, devices designated as Breakthrough Devices will receive prioritized review (Section II.F).
Guidance for Full Year and Second Quarter 2021
The company now estimates net sales growth for the full year 2021, versus the prior year period, to be in a range of approximately 16 to 19 percent on a reported basis, and approximately 15 to 18 percent on an organic basis. Full year organic net sales guidance excludes the impact of foreign currency fluctuations and the acquisition of Preventice Solutions, Inc., with no prior period related net sales, as well as the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021. The company now estimates earnings on a GAAP basis in a range of $0.81 to $0.88 per share and estimates adjusted earnings, excluding certain charges (credits), of $1.53 to $1.60 per share.
The company estimates net sales growth for the second quarter of 2021, versus the prior year period, to be in a range of approximately 46 to 50 percent on a reported basis and approximately 44 to 48 percent on an organic basis. Second quarter organic net sales guidance excludes the impact of foreign currency fluctuations and the acquisition of Preventice, with no prior period related net sales, as well as the intrauterine health franchise, which we divested in Q2 2020 and the Specialty Pharmaceuticals business, which we divested in Q1 2021. The company estimates earnings on a GAAP basis in a range of $0.16 to $0.18 per share and adjusted earnings, excluding certain charges (credits), of $0.36 to $0.38 per share.
Conference Call Information
Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. ET. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.
Boston Scientific EPS beats by $0.06, beats on revenue
Apr. 28, 2021
By: Gaurav Batavia, SA News Editor
Boston Scientific (NYSE:BSX): Q1 Non-GAAP EPS of $0.37 beats by $0.06; GAAP EPS of $0.23 beats by $0.12.
Revenue of $2.75B (+8.3% Y/Y) beats by $130M.
FY21 Guidance: The company now estimates earnings on a GAAP basis in a range of $0.81 to $0.88 per share and estimates adjusted earnings, excluding certain charges (credits), of $1.53 to $1.60 per share vs. $1.54 consensus. The company now estimates net sales growth for the full year 2021, versus the prior year period, to be in a range of approximately 16 to 19 percent on a reported basis, and approximately 15 to 18 percent on an organic basis.
Q2 Guidance: The company estimates earnings on a GAAP basis in a range of $0.16 to $0.18 per share and adjusted earnings, excluding certain charges (credits), of $0.36 to $0.38 per share vs. $0.35 consensus. The company estimates net sales growth for the second quarter of 2021, versus the prior year period, to be in a range of approximately 46 to 50 percent on a reported basis and approximately 44 to 48 percent on an organic basis.
Shares +2.2% PM.
Averaging down on BSX turned out to be smart. Just took a few months as the pandemic lifts and the elective surgeries start up again.
Boston Scientific launches WaveWriter Alpha spinal cord stimulator in the U.S.
Jan. 14, 2021
Boston Scientific (BSX +0.3%) has announced a limited market release of the WaveWriter Alpha portfolio of Spinal Cord Stimulator (SCS) systems.
It includes unified portfolio of four MRI conditional, Bluetooth-enabled rechargeable and non-rechargeable implantable pulse generators, to provide Fast Acting Sub-perception Therapy designed to deliver profound paresthesia-free pain relief in minutes.
The systems are supported by the Cognita Solutions suite of digital tools for patients and physicians.
The WaveWriter Alpha SCS Systems were approved by the FDA in December 2020 and is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with failed back surgery syndrome, Complex Regional Pain Syndrome Types I and II, intractable low back pain and leg pain.
During 2020 BSX’s stock price has faced several headwinds. The medical device industry (typically seen as a secular growth and less cyclical industry) was hit hard by deferrals of more elective procedures due to the COVID-19 pandemic. Sales dropped 20 to 30% in the 2nd quarter as people around the world were locked down. Boston Scientific’s management team, out of an abundance of caution, raised equity in May leaving technical pressure on the stock.
The most recent challenge for BSX was the announcement that the company was shutting down its Lotus Edge heart valve program. The stock dropped 8.3% the day of the announcement. These challenges have resulted in sub-par performance of the stock. At the time of writing, Boston Scientific is down 22.87% YTD, while the S&P is up 17.71% and the S&P 500 Healthcare Sector is up 11.64%.
The pandemic has skewed the growth numbers and shutting down the LOTUS program has lowered the company’s growth prospects, but the story driving growth in EPS and free cash flow still remains intact. Management remains confidence that the business can grow the top-line 6 to 8% organically and expand operating margins 50 to 100bps y/y for the next couple of years (using 2019 as a base year). Based on the assumption that 2022 is a completely normalized year, it is not unreasonable for BSX to do $1.97 in EPS in 2021. A 6% to 8% topline growth rate puts BSX at the top of its peer growth in terms of growth profile which on average trade at ~23x earnings.
Applying a 23x multiple to $1.97 in EPS gets you a $45.30 stock in a year representing a 29.7% return from current trading levels. Your downside is probably around $33, down ~5%.
A month ago we were a $40. So much
For the company doing well. Oh well
Plenty of fish in the sea.
Were Hedge Funds Right About Piling Into Boston Scientific Corporation (BSX)?
Insider Monkey•October 20, 2020
Is Boston Scientific Corporation (NYSE:BSX) a splendid stock to buy now? Money managers were taking a bullish view. The number of bullish hedge fund bets rose by 7 in recent months. Boston Scientific Corporation (NYSE:BSX) was in 66 hedge funds' portfolios at the end of the second quarter of 2020. The all time high for this statistics is 59. This means the bullish number of hedge fund positions in this stock currently sits at its all time high. Our calculations also showed that BSX isn't among the 30 most popular stocks among hedge funds (click for Q2 rankings and see the video for a quick look at the top 5 stocks). Video: Watch our video about the top 5 most popular hedge fund stocks.
In the financial world there are a large number of tools investors have at their disposal to grade stocks. A pair of the most under-the-radar tools are hedge fund and insider trading indicators. We have shown that, historically, those who follow the top picks of the best fund managers can outperform the broader indices by a solid amount. Insider Monkey's monthly stock picks returned 101% since March 2017 and outperformed the S&P 500 ETFs by more than 56 percentage points. Our short strategy outperformed the S&P 500 short ETFs by 20 percentage points annually (see the details here). That's why we believe hedge fund sentiment is a useful indicator that investors should pay attention to.
At Insider Monkey we scour multiple sources to uncover the next great investment idea. Hedge fund sentiment towards Tesla reached its all time high at the end of 2019 and Tesla shares more than quadrupled this year. We are trying to identify other EV revolution winners, so we are checking out this under-the-radar lithium stock. We go through lists like the 10 most profitable companies in the world to pick the best large-cap stocks to buy. Even though we recommend positions in only a tiny fraction of the companies we analyze, we check out as many stocks as we can. We read hedge fund investor letters and listen to stock pitches at hedge fund conferences. You can subscribe to our free daily newsletter on our website to get excerpts of these letters in your inbox. Keeping this in mind we're going to take a gander at the latest hedge fund action encompassing Boston Scientific Corporation (NYSE:BSX).
What have hedge funds been doing with Boston Scientific Corporation (NYSE:BSX)?
At Q2's end, a total of 66 of the hedge funds tracked by Insider Monkey were long this stock, a change of 12% from the first quarter of 2020. By comparison, 50 hedge funds held shares or bullish call options in BSX a year ago. With the smart money's positions undergoing their usual ebb and flow, there exists an "upper tier" of noteworthy hedge fund managers who were upping their stakes significantly (or already accumulated large positions).
The largest stake in Boston Scientific Corporation (NYSE:BSX) was held by Viking Global, which reported holding $648 million worth of stock at the end of September. It was followed by Steadfast Capital Management with a $325.1 million position. Other investors bullish on the company included OrbiMed Advisors, Marshall Wace LLP, and D E Shaw. In terms of the portfolio weights assigned to each position Parsifal Capital Management allocated the biggest weight to Boston Scientific Corporation (NYSE:BSX), around 6.56% of its 13F portfolio. Blue Whale Capital is also relatively very bullish on the stock, designating 6.07 percent of its 13F equity portfolio to BSX.
As aggregate interest increased, specific money managers were leading the bulls' herd. Bloom Tree Partners, managed by Alok Agrawal, created the most outsized position in Boston Scientific Corporation (NYSE:BSX). Bloom Tree Partners had $41.6 million invested in the company at the end of the quarter. Stephen J. Errico's Locust Wood Capital Advisers also initiated a $37.2 million position during the quarter. The following funds were also among the new BSX investors: Jeremy Green's Redmile Group, Paul Marshall and Ian Wace's Marshall Wace LLP, and Daniel S. Och's OZ Management.
Let's also examine hedge fund activity in other stocks - not necessarily in the same industry as Boston Scientific Corporation (NYSE:BSX) but similarly valued. These stocks are Intercontinental Exchange Inc (NYSE:ICE), The Bank of Nova Scotia (NYSE:BNS), Newmont Corporation (NYSE:NEM), Deere & Company (NYSE:DE), Mercadolibre Inc (NASDAQ:MELI), Kimberly Clark Corporation (NYSE:KMB), and ABB Ltd (NYSE:ABB). All of these stocks' market caps match BSX's market cap.
[table] Ticker, No of HFs with positions, Total Value of HF Positions (x1000), Change in HF Position ICE,60,2754652,-1 BNS,13,252173,1 NEM,55,2418239,12 DE,32,839882,-12 MELI,60,4427510,0 KMB,37,1173794,-9 ABB,10,346451,0 Average,38.1,1744672,-1.3 [/table]
View table here if you experience formatting issues.
As you can see these stocks had an average of 38.1 hedge funds with bullish positions and the average amount invested in these stocks was $1745 million. That figure was $2313 million in BSX's case. Intercontinental Exchange Inc (NYSE:ICE) is the most popular stock in this table. On the other hand ABB Ltd (NYSE:ABB) is the least popular one with only 10 bullish hedge fund positions. Compared to these stocks Boston Scientific Corporation (NYSE:BSX) is more popular among hedge funds. Our overall hedge fund sentiment score for BSX is 90. Stocks with higher number of hedge fund positions relative to other stocks as well as relative to their historical range receive a higher sentiment score. Our calculations showed that top 10 most popular stocks among hedge funds returned 41.4% in 2019 and outperformed the S&P 500 ETF (SPY) by 10.1 percentage points. These stocks gained 29.2% in 2020 through October 16th and still beat the market by 19.7 percentage points. Unfortunately BSX wasn't nearly as popular as these 10 stocks and hedge funds that were betting on BSX were disappointed as the stock returned 9.5% since the end of the second quarter (through 10/16) and underperformed the market. If you are interested in investing in large cap stocks with huge upside potential, you should check out the top 10 most popular stocks among hedge funds as most of these stocks already outperformed the market in 2020.
Boston Scientific's Acurate Neo valves lacked in comparison to Medtronic’s CoreValve
Oct. 15, 2020 Vandana Singh, SA News Editor
Boston Scientific fell (BSX -4.0%), after reporting that its Scope II trial showed Acurate Neo structural heart valves failed to demonstrate non-inferiority when compared to Medtronic’s CoreValve Evolut. Results were announced during the TCT 2020 Investor Update
Total 796 patients aged 75 years or older with symptomatic severe aortic stenosis and an indication for transfemoral TAVR were recruited.
The trial missed the primary endpoint of composite of all-cause mortality or all stroke at 1 year. The primary efficacy endpoint, powered for superiority, was new permanent pacemaker implantation at 30 days. Secondary endpoints included clinical efficacy and safety endpoints at 30 days and 12 months.
In the intention-to-treat analysis, death or stroke at one year was 15.8% in the Acurate neo group compared to 13.9% in the CoreValve Evolut group, for per-protocol analysis it was 15.3% vs. 14.3%.
Noninferiority of the Acurate neo was not met for the primary endpoint in the intent-to-treat analysis, while it was met in the per-protocol analysis.
Acurate Neo2 estimated approval and U.S. launch is 2024.
Think I’ll get some calls here soon
News: $BSX 3 Top Healthcare Stocks to Buy in August
Though coronavirus-related stocks have been climbing, the path hasn't been smooth for all healthcare companies this year. Many crashed along with the broader market in March, even if their revenue prospects were bright -- and depressed prices mean buying opportunities for the long-term investor....
Find out more BSX - 3 Top Healthcare Stocks to Buy in August
Anyone here know why this stock jumped up 1,00!$$
News: $BSX VICI VENOUS STENT® System Demonstrates Positive Clinical Outcomes in Patients with Deep Venous Blockages
LEIPZIG, Germany and MARLBOROUGH, Mass. , Jan. 22, 2019 /PRNewswire/ -- Today, Boston Scientific (NYSE: BSX) announced positive 12-month data demonstrating that patients who were treated with the VICI VENOUS STENT® System for iliac and femoral vein obstructions exhibited a hig...
Read the whole news https://marketwirenews.com/news-releases/vici-venous-stent-xae-system-demonstrates-positive-clinical-outcomes-in-patients-with-deep-venous-blockages-7409372.html
News: $BSX Boston Scientific, Edwards Lifesciences Agree To Global Litigation Settlement
MARLBOROUGH, Mass. and IRVINE, Calif. , Jan. 15, 2019 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) and Edwards Lifesciences Corporation (NYSE: EW) today announced that the companies have reached an agreement to settle all outstanding patent disputes between the comp...
Find out more https://marketwirenews.com/news-releases/boston-scientific-edwards-lifesciences-agree-to-global-litigation-settlement-6828752.html
approaching its 2 year high, anyone have news on it.
thanks to all
oh yes I see, the SP has been going up. ;<)
That Boston Scientific expose' on Sixty Minutes should give many an investor pause to buy this stock.
There will be fines and jail time coming for some executives.
This Medical Device Stock Just Broke Down
This morning, leading medical device maker, Boston Scientific Corp (NYSE:BSX), is trading lower by 4.1 percent. The negative news for the stock is that the company pulled out of a Piper Jaffray Healthcare Conference today.
Either way, the shares are down and the stock is now trading below its 50 and 100-day moving average. Whenever a stock trades below these critical moving averages it puts the stock in a weak technical position. Traders must now look lower for major chart support. The next major support area would be around the $25.00 level. This area is where the stock broke out in April 2017. Often, when prior break-out levels are tested they will be defended by the institutional money traders. Traders should keep BSX on the radar when it trades around the $25.00 area.