Shockwave Medical Inc (SWAV) ニュース

And that's a wrap. Congrats to all who held at least some thru to the buy out ...or at least made $ on the way .
Kiwi

Thanks, Kiwi...not sure that I have a kidney problem other than a large stone which causes no problem at this point. I was advised to drink lots of water to flush out the contrast...my prepping certainly allowed my body to tolerate the contrast (and I really have no other indication that iodine contrast ever caused my reaction to it many years ago)....I know that iodine itself has no effect on me, so the prep was done for safety purposes as far as I know. After I see the doctor on April 24th, I'll let you know what comes out of it.

I think I have finally shaken off this cold I received one day after my procedure on 3/18....yes, it has taken this long!

Hope you had a Happy Easter!

Best. Steve

Steve I just wanted to forward this on to you if another angiogram or procedure is being considered .
Don't know what your eGFR ( kidney function ) is but this is the latest on reducing kidney injury from the contrast typically used in angiograms .
Maybe forward to your interventionist if appropriate
https://www.practiceupdate.com/c/163795/1/2/?elsca1=emc_enews_expert-insight&elsca2=email&elsca3=practiceupdate_cardio&elsca4=cardiology&elsca5=newsletter&rid=NDE0ODg4MzcyNTk0S0&lid=20845029
Good luck
Kiwi

Hi Steve. I'm spending more time on RZLT now ( been in it for awhile )
So come over to that board if you're interested..
I've had a core position in SWAV since soon after its IPO ...trading around it .
I'll keep that position until buyout ..or if no buyout ...just to follow the Co .
Kiwi

Thanks! We'll see what is suggested and I'll let you know! As you know I only had 300 shs of SWAV and sold for a profit of $25,000 so it was worth it, but I then avoided getting back in, since the takeout by those rumored to be interested seemed to think SWAV wanted too much....it's now up to where I had wanted to set aside....my tough luck!

Steve

Hi Steve , I think IVUS imaging is now considered better then an angiogram but only used so far in about 20% of cases due to reimbursement issues.
IVUS is better at detecting calcification inside arterial walls that may be constricting blood flow and thus enables better use of IVL technology .
I suggest you ask your interventionist / Cardiologist his views on IVUS for imaging and IVL for below the knee applications.
If he doesn't use any of these procedures maybe he could recommend some who does for a second opinion.

Most of the major teaching hospitals ( like UCSF out here ) will be using IVUS for imaging and when appropriate IVL to increase blood flow or to prepare the artery for a drug eluting stent.

Not medical advice ...just my opinion
Best of luck
Kiwi

Kiwi:
I had a chance to view those links: I did not have IVUS or OCT...but rather Angiogram/Angioplasty to lower left leg (below the knee) which later was decided to do both legs..."no intervention" was decided prior to procedure after discussion with doc as to risks, so I will see him and discuss, also mentioning the Shockwave procedure, too...hopefully, he will be impressed, but some doctors only do what they are familiar with...he has been in practice for close to 30 years.
Steve

Thanks, Kiwi!

I value your opinion and will watch these after I get prepared today....best, Steve

Tuesday, Shockwave Medical Inc ( SWAV ) shares traded higher following a Wall Street Journal report suggesting Johnson & Johnson ( JNJ ) is reportedly in talks to acquire the company.
Shockwave Medical ( SWAV ) is a cardiovascular medical device.
In 2022, Johnson & Johnson ( JNJ ) acquired heart failure device-focused Abiomed Inc. for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion.
Piper Sandler says it has considered Johnson & Johnson ( JNJ ) a potential buyer due to its interest in expanding into cardiovascular devices and strong financial position.
Additionally, there were reports in May 2023 indicating Johnson & Johnson’s interest in acquiring Shockwave Medical ( SWAV ). However, the Piper analyst writes that Shockwave Medical ( SWAV ) could thrive independently, maintaining the Overweight rating.
Piper’s analysis suggests that acquiring Shockwave Medical ( SWAV ) would likely require a substantial offer due to its profile.
Compared with Johnson & Johnson’s acquisition of Abiomed, which was about 12.5x consensus 2024 revenue without milestones and closer to 13.7x with milestones, it provides a benchmark.
Shockwave Medical ( SWAV ) reportedly sought bids around the mid-$300s per share, Piper notes, citing a StreetInsider report.
While a Johnson & Johnson-Shockwave Medical combination seems suitable, other major players like Medtronic Plc ( MDT ) and Boston Scientific Corporation ( BSX ) , with their focus in interventional cardiology and peripheral vascular, could also be interested.
Both Medtronic ( MDT ) and Boston Scientific ( BSX ) had shown previous interest in acquiring Shockwave Medical ( SWAV ).
The absence of obvious FTC issues suggests regulatory clearance wouldn’t be a major hurdle. A competitive bidding process could emerge, with Johnson & Johnson ( JNJ ) viewed as a strong strategic fit for Shockwave Medical ( SWAV ).
Price Action: SWAV shares closed higher by 2.07% at $322.61 on Wednesday.

Hi Steve .....well the good news is that you were released the same day .
Sounds as tho you had IVUS ( or OCT ) for pictures down to your feet .
Chk out
https://shockwavemedical.com/clinicians/international/peripheral/below-the-knee/

This is assuming calcification in the walls of these arteries
https://shockwavemedical.com/clinicians/international/peripheral/shockwave-s4/
Definitely watch the video on the risks using a balloon in below the knee and why that hasn't been a problem with IVL

I suggest you forward this to your Cardiologist / interventionist and ask them if they use IVL and would it be of any benefit for your situation .
Chk the safety record for IVL below the knee . They have developed a very thin system .

Not medical advice but hope it helps
Kiwi

Hi Kiwi
The surgery was done on 3/18 and my follow up is not until 4/24, so other than what was done, I'm not yet clear on my options. This is my 2nd angiogram/angioplasty since the 1st one gave little improvement to my below the knee problems, so this one was to take pictures down to my feet....it went well with no complications other than me being there from 10am to getting home at 8pm....2 or so hours for the procedure which required "prepping" Dexamethasone, Benadryl, so it was long and then 3 hours lying on my back without moving much! This time I did not have the bruising like the last time with the stents to my illiac area and pain....BUT....I got sick from being in the hospital for so long and I am recovering from some sort of bug (nasal congestion, chest cold, headache, etc...still trying to recover even now! When I see the doctor, I hope to hear about my options considering my diabetic neuropathy, cancer, & whatever....he said that any type of balloon in my lower legs would have risks if it had been done, so he suggested no intervention at this time....BTW, I turn 80 on April 9th...let's hope I'm still kicking for a while.......best, Steve

Hi Steve ...Wow. sorry to hear .
They used the femoral artery I'm assuming ...entered in your groin . I had a coronary angioplasty in 2016 via the femoral and had to lie real still afterwards ...risk of a blood clot.
The good news is that they didn't keep you over night or " send you down for surgery "
As I was laid out on the Cath table , right before inserting the catheter the interventionist leans over and say " If we can't fix this we may need to send you down for surgery "...meaning a bypass.
Gee thx Doc :--)
Can you share the results and does SWAV IVL technology have any role in helping you below the knee .

Just an FYI. RZLT is coming up on P2 2 data in DME in Q2 . Lot of insider buys recently
UNCY ...pivotal data end of Q2 . None of wife's dialysis patients are at serum phosphorous goals . They hate the current pills.
Risk with UNCY ...very powerful phosphorous lowering drug in 1 small pill swallowed with meals ....but are the stomach upsets etc more then what patients want to deal with .

Thx for the update
Good luck
Kiwi

Kiwi
You are really on a roll! VKTX and now SWAV...wow!
Steve
PS had some setbacks in health and saw my vascular doc at hospital for another angiogram to below the kneed....overall took 10 hours at hospital 10 am to 8pm....had to lie still after procedure for 3 hours....it was not fun!

(Reuters) -Johnson & Johnson is in talks to buy medical device maker Shockwave Medical, the Wall Street Journal reported on Tuesday, with a deal likely to help the healthcare giant expand its presence in cardiovascular devices.

Shockwave, a company that makes devices to treat heart disease, has a market capitalization of around $11 billion, according to LSEG data.

A deal could be finalized in the coming weeks, assuming talks don't fall apart, and it is also possible another suitor could emerge, the report said, citing people familiar with the matter.


Kiwi

The presence of coronary artery calcification (CAC) remains one of the main challenges in the percutaneous treatment of coronary stenosis.
Several factors, such as age, diabetes, dyslipidemia, hypertension, smoking, and impaired renal function, have been linked to CAC development.
Its presence is associated with unfavorable outcomes in both the general population and patients undergoing revascularization.1
CAC hinders percutaneous coronary interventions (PCI) by impeding device crossing, leading to procedural failure and increased complications.2
Calcification can cause substantial surface damage to the stent polymer or drug coating by scratching and scraping against the arterial wall

Kiwi

https://www.jacc.org/doi/10.1016/j.jcin.2023.12.018

Kiwi

Hey we're human. I owned IOVA and sold on FDA approval ...now up 30% plus after hrs :--(
Hope U are well
Kiwi

Yes, did not intend to stay short, only to make a quick buck.
Interesting about CR facility going in. I wonder if they will occupy
part of the old Intel facility.

Earnings were a shocker, Kiwi....I never bought back in....my bad........Steve

Just as well you didn't stay short .
Key pts from the earnings report
Strong demand for their products except in China where a corruption investigation in health care is ongoing
The Aetna prior approval issue is abating and has not been followed by other insurers ( slowed / delayed use of IVL )
Costa Rica manufacturing facility on schedule and will make a difference in 2025 by lowering cost of manufacturing.
Will have revenue close to $1B in 2024

Glad I kept my core position
Kiwi

Covered and profited. Will buy in when the dust settles a bit.

thanks for the info and perspective.

Re insider selling. Probably means a buyout is really off the table. These were 10b filings I think ...preplanned and they have a ton of options that will vest overtime. .
Co has new codes approved for reimbursement but I think there is an issue with one code that expires mid 2024 and is not renewed to early 2025 ( from memory ) .
Their new catheter is popular ( more pulses ) and below the knee applications are increasingly important in reducing toe / foot amputations .
Not a Co I would short
I still maintain a small position but have largely moved on to EWTX, VERA, VKTX and others
Kiwi

Insiders just unloaded a boat load. Going short.

I think this is the JPM conference presentation
https://ir.shockwavemedical.com/static-files/84cb0382-3ad6-435e-a6de-1a132160ff68

Kiwi

Thanks, Kiwi...best wishes for:

A Merry Christmas and Happy New Year ! Steve

https://cardiovascularbusiness.com/topics/clinical/interventional-cardiology/ivl-safe-effective-across-all-calcium-morphologies?utm_source=newsletter&utm_medium=cvb_interventional_cardiology

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Kiwi

And now the good news ... new higher reimbursement rates
https://cardiovascularbusiness.com/topics/clinical/interventional-cardiology/ivl-gains-higher-level-reimbursement-one-biggest-coding-updates-pci-decades?utm_source=newsletter&utm_medium=cvb_weekend

kiwi

Reduced use of stents probably means less use of Shockwaves tech
https://lownhospitalsindex.org/avoiding-coronary-stent-overuse/

Kiwi

Kiwi
I saw that! Not good...I saw somewhere a post about $NARI which is also in this space...comment was that it offers great upside....(I don't follow)....glad I decided to wait this out....best, Steve

New prior authorization requests from Aetna for PAD applications and anti corruption probes of medical facilities in China ......torpedo and otherwise great earnings report .
UGH
Kiwi

SWAV seemed to get dragged down today in the NVO Ozempic initiated med tech sell off.
Ozempic may have a real effect on dialysis related stocks as it appears to slow decline of kidney function but seems rather distant to current treatment of calcium deposits in coronary arteries etc .
Kiwi

Kiwi:
I hope you are getting better now!

Yes, I may have mentioned that I did have COVID during this past Christmas while on a family trip; and, for me, it was also a very bad sickness and took more than 2 months to get better. My son-in-law had covid but was able to recover quickly with Paxlovid. prior to my illness...I had to wait until I returned home, so it is necessary to get Pax treatment quickly. I have had some biotech stocks in the past....SRPT, Elan, and even Dendreon...all wound up to be profitable...but I mostly have invested in bigger name companies (HD, WMT, and COST)....I worked for MS for a long time and still own a large position in it....I do own a relative smaller position in AVXL which I am down on; I have earmarked for my grand kids...if it works out. I have held quite a few "legal situations" over the years, but no longer have the patience to wait for them to resolve...I owned RMBS and took a large loss on it when they lost the big Anti Trust Lawsuit in San Francisco.

Hi Steve Yes SWAV has been a tough hold over the past 2 months but this coming ER CC should provide some insight on spend going forward.
Good to see them doing an investor day .
Re Covid ...sickest I've been in many many years . If you have never had covid , get the latest booster , have tests on hand and as soon as you test positive go to your doctor or the ER and try and get Paxlovid .
Any other biotechs you follow ?
My biggest win recently was SLNO . Biggest loss ( today ) ETNB
ARDX has a PDUFA date Oct 17th and UNCY is awaiting FDA guidance on their competing drug . I have positions in both
Hope U are well
Kiwi

Kiwi:
Thanks, still follow but no position....best, Steve
Hope you have shaken off covid

SANTA CLARA, Calif., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development and commercialization of transformational technologies for the treatment of cardiovascular disease, will host an Investor Innovation Day on Monday, October 23, 2023, from 1:00 p.m to 4:00 p.m. Pacific Time.

The Shockwave Investor Innovation Day will be held in hybrid format, in person in San Francisco and online as a simultaneous live webcast. Investors and other interested parties may register for the webcast by visiting the news and events section on the company's investor website at https://ir.shockwavemedical.com.

A replay and summary materials from the presentations will also be available online on the company website.
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Lower $ also helps EU sales
Kiwi

From Cardiovascular Mag

Shockwave Medical (SWAV)


Despite Shockwave Medical’s (NASDAQ:SWAV) decline since May 11, it’s one of my top healthcare stock picks. After the stock rallied in April on speculation about a possible Boston Scientific (NYSE:BSX) acquisition, it has come crashing down back to earth.

In July, the Centers for Medicare & Medicaid Services decided not to increase the Medicare reimbursement rate for Shockwave products. The negative news led to a stock selloff.

Despite the setback, Shockwave is in a prime position for growth. It offers intravascular lithotripsy (IVL) technology to treat calcified cardiovascular disease. Its devices help address hardened calcified plaque in arteries for patients with various heart conditions. Its technology helps to alleviate symptoms and sometimes avoid invasive interventions.

These products improve cardiovascular patient outcomes, and the company is increasing its product range and expanding globally. Furthermore, its IVL solution faces limited competition with Abbott Laboratories (NYSE:ABT) products, not expected until 2026.

That is why SWAV stock is a must-own healthcare stock. The adoption of IVL technology is driving growth, and the 49% year-over-year (YoY) revenue growth in the second quarter highlighted the robust demand. The fiscal year 2023 guidance forecasting 48% to 49% growth was equally impressive.

Besides, the recent Neovasc acquisition enables Shockwave to expand into the refractory angina market. Currently, the Neovasc Reducer System is in trials for patients with coronary obstructive refractory angina.

Lastly, in addition to the solid growth, Shockwave is highly profitable, achieving 86% gross margins in the second quarter. Despite heavy investments in its sales force expansion and growth opportunities, net income was also positive.
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Kiwi

Thanks for your update, Kiwi! I had the same problem by testing positive after 7 days, then it disappeared, but the long term effects were not great and it really took me about 2 mos to totally "bounce back"....saw my vascular surgeon and had both ultra sound and abi's prior to my meeting with him. Mentioned Shockwave IVL and he was aware of it even though I brought more information for him to review. At this point, my aorta is "patent" and the abi's are around 84% which he said is not great but considering my age and other problems can be dealt with...."without intervention"....so I will just keep on trucking along! Best wishes for a speedy recovery......Steve

Thx. 9 days in and still testing + ve .....altho just fatigue main symptom now.

Thought SWAV's presentation yesterday was great .
Strong demand for their products . With new codes pricing push back from Cath lab administrators less of an issue .
China only slow area . Japan , Germany strong
No competition until late 2024 into 2025
Analyst day in Oct ( 23rd ? )
Hope alls well with you

Kiwi

Kiwi:
Hope you improve quickly! Also, noted that Jill Biden has it, too....Best....Steve

Kiwi
For me it's best to wait especially after what happened yesterday with the market leader: Nvidia....up big on super earnings beat and then hardly higher end of day....month end trading normally has a tendency to stay weak.
Best....Steve

$203 not low enough to tempt you back in :--)
Ceo filed to sell 10,000 shares . He owns 34 m shares I think !!!!!
Lose roughly 1/3rd in about 8 wks ... with no real long term negatives that I can see, besides any buyout deal speculation being erased .
Kiwi

Kiwi:
These investors own the convertible bonds which apparently has been increased to $650 Mil....so when the price makes a move UP, they put on short positions & then cover on the drop; these are professionals and have a great sense of highs and lows.

Convertible bonds issued puts them in control...a little hard to explain other than it will hamper the upside to the stock...overall my experience just suggests that it's not great for shareholders other than a capital raise for the corporation...they collect interest on the converts along the way and get to play the price as to when they sell.

I don't know much about this area . Are the institutions effectively shorting against the box ?

While it was popular in the past, the short sell against the box has increasingly become a restricted practice after an SEC and FINRA crackdown.

Kiwi

Kiwi, normally convertible bonds are not good for the share price since institutional investors short shares against their long cvt bond position from time to time and cap any advance that they want to...I wonder what they are thinking?

Motley fools take on the earnings report
In the end, I'm not particularly concerned about Shockwave's slight earnings miss, as those rising expenses are necessary to continue driving outsized growth while the company chases its large total addressable market.
As it continues to scale the business and expand its global presence, increased operating leverage should begin to take hold with commensurate earnings growth to follow -- and Shockwave's share price should eventually respond in kind.
As such, this drop could prove to be a fantastic chance for patient, long-term investors to open or add to a position.

Kiwi

Hi Steve. This is Schwabs technical view Momentum for SWAV is strongly bearish. The 14-period Slow Stochastic oscillator is below 20, the level which many analysts call oversold. This means that investors have been actively selling shares and driving the price lower.

I was stopped out of a third of my position around $270....adding back in now at around $220

I think net profit will be better in early 2024 as many of the expenses they are now reporting are not likely to persist ...eg the severance they paid to discontinue their EU co marketing agreement in the 2nd qt.
So its largely a waiting game till 2024 .
BO unfortunately , looks off the table ...at least for now

Good to read you have improved blood flow to your feet .

Kiwi

Thanks, Kiwi...my new foot doctor has also given me some exercises to increase blood flow to my feet and they have helped, too....so with the knee getting much better I can hope for my upcoming visit with my vascular guy to show improvements in my ABIs...stay well and keep me informed with your more pertinent observations on $SWAV....I will certainly pay attention and sorry to see this decline now getting more serious, but approaching the 200 day SMA for support and a gap slightly below that level. The RSI is also below a "30" reading...which sets up a low.
Best, Steve

Glad to hear your knee is better .
Let me know how it goes with your vascular surgeon
Kiwi

That is a big problem and the 10-b-5 selling for huge profits with key people just points to the get option pricing they have in their back pocket.