Shockwave Medical Inc (SWAV)

[Whalatane]

https://www.tctmd.com/news/ai-predicted-play-major-role-cardiac-ct-and-cv-care-coming-decade

Kiwi

[Whalatane]

https://cardiovascularnews.com/turning-extra-pulses-into-pluses/

Kiwi

[Whalatane]

Agree ...maybe they were hoping for higher reimbursement $ ?
General market sell off probably due to Fitch downgrade not helping
Earnings on Monday will be key ...other med tech Co's have reported strong earnings as use in operating rooms now back or above pre Covid levels .
JMO
Kiwi

[sab63090]

Kiwi:
I thought this announcement was bullish, yet the stock continues to go down! I guess I will hold off on buying back in until I meet with my doctor who performed my angioplasty with stents to the lower extremities in September...kind of unusual reaction in my mind!

[sab63090]

Kiwi:
Well, it has come down close to where I last owned shares ($250)....maybe I'll give it a shot again

[Whalatane]

Reposting a comment from Dew on the Biotech Values board .
This comes following the JNJ and ABT med tech earnings report

Re: Whalatane post# 248116
Thursday, July 20, 2023 6:56:50 PM
Post# of 248120
Medical-device companies are doing well because elective-procedure volumes are finally back to their pre-pandemic levels—and are now even higher than those levels in many cases. To the extent that SWAV's procedures can be considered elective, SWAV ought to be a beneficiary of this trend.

[Whalatane]

Yep , I agree

Outpatient revenue in 2022 was $443.3 million, up from $195.7 million in 2021.

I can't see the CMS not reimbursing for out patient services after mid 2024 ...until the new reimbursement code goes into effect mid 2025 .
Co needs to negotiate a " bridge " ...so it raises uncertainty until one is in place
However the stocks only down 5% ...so I guess the market believes it'll get worked out eventually ...or at least before mid 2024.

Kiwi

[sab63090]

Thanks, Kiwi! I don't like the fact that the enhanced pay out to doctor's "runs out"....that is certainly not what I had hoped....Steve
:(

[Whalatane]

IBD's take on the CMS decision

ALLISON GATLIN12:15 PM ET 07/14/2023
Shockwave Medical (SWAV) received mixed reimbursement news from the Centers for Medicare and Medicaid Services, and SWAV stock tumbled Friday.

The company is a leader in intravascular lithotripsy, a method of cracking hardened calcium in blood vessel walls. It rivals an older procedure called atherectomy that relies on a drill for the same purpose.

Late Thursday, CMS published a reimbursement decision that could hamper usage of intravascular lithotripsy for outpatients beginning in the second half of 2024. But the agency also increased the amount of money doctors receive from these procedures, making them more lucrative than traditional atherectomy.

In midday trading on today's stock market, SWAV stock dropped 4.8% near 270.50.

SWAV Stock: Reimbursement Shift In Flux

Under the current rules, CMS pays an additional $4,700 for outpatients who receive intravascular lithotripsy. But that reimbursement rule will expire after June 30, 2024. Shockwave expects CMS to eventually shift to a higher paying code.


But the agency didn't make that shift in the rule changes proposed for next year, Needham analyst Mike Matson said in a note to clients. Instead, it seems CMS will wait for the June 30, 2024, expiration and include the higher reimbursement code in the 2025 proposal.

"Outpatient coronary intravascular lithotripsy would lose the (additional $4,700 payment) and see lower reimbursement in the second half of 2024, which would probably cause decreased outpatient coronary utilization and sales, though it's difficult to quantify this," he said.

But Matson kept his buy rating and 325 price target on SWAV stock.

He noted physician payments for performing intravascular lithotripsy will increase by 25%-30% beginning Jan. 1, 2024. This makes Shockwave's technology more lucrative for doctors that standard procedures like atherectomy.

Shockwave Remains Below A Key Line

Shockwave shares broke out last month and immediately toppled, undercutting their 50-day moving average on July 7. SWAV stock is now trapped under a ceiling at that line, according to MarketSmith.com.

But Shockwave stock also has a strong Composite Rating of 95, IBD Digital shows. This means SWAV stock ranks in the top 5% of all stocks in terms of fundamental and technical performance.

------------------
Kiwi

[Whalatane]

Dive Brief:

The Centers for Medicare and Medicaid Services is set to propose outpatient reimbursement that will increase sales of Shockwave Medical’s heart disease device, Morgan Stanley analysts wrote in a note to investors.
Shockwave sells a coronary intravascular lithotripsy (IVL) catheter for opening calcified arteries before stent implantation. The analysts expect CMS to propose improved IVL reimbursement in the coming week, with terms rising around $4,300 for inpatients and $2,400 for outpatients.. ( my emphasis )
Based on the anticipated reimbursement terms, the analysts think growth expectations for the company are too low and have set their earnings estimate for next year 15% above the average of their peers.
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Dive Insight:

The Morgan Stanley analysts cited what happened when Shockwave’s U.S. reimbursement for above-the-knee arteries reached parity with atherectomy as evidence that a coverage expansion for the coronary device will benefit the business. After the earlier reimbursement change, adoption of the above-the-knee procedure accelerated.

“Despite there being clear history of faster adoption on better surgery economics, consensus actually has a sequential slowdown in coronary IVL penetration in 2024 which we don’t think makes sense,” the analysts wrote.

The analysts found other evidence to support their argument that Shockwave will outperform revenue expectations in the coming years. Shockwave has 60 open sales rep positions, they noted. The hiring represents “a material expansion” to the sales team and suggests “a more aggressive ramp,” they wrote.

Physician channel checks also persuaded the analysts that “the cap on penetration may be higher than the market expects, with positive feedback on accelerated adoption post CMS reimbursement clarity.”

The Morgan Stanley team expects Shockwave to be the main beneficiary of improved reimbursement in the coming years. Abbott is planning to enter the IVL space, but the analysts think it is unlikely to bring a product to market before 2026. Shockwave’s position in a growing cardiovascular market has reportedly caught the attention of Boston Scientific, which was said to be exploring an acquisition earlier this year.
-----------------------

Kiwi

[sab63090]

Thanks, Kiwi
Glad to see this,
btw...I worked at MS for 26 years in addition to other Wall St. Firms

Best, Steve

[Whalatane]

ShockWave Medical Upgraded by Morgan Stanley to Overweight From Equalweight, Boosts Price Target to $335 From $291
7:11 AM ET, 07/10/2023 - MT Newswires
07:11 AM EDT, 07/10/2023 (MT Newswires) -- ShockWave Medical (SWAV) received an investment rating upgrade on Monday to overweight from equalweight from Morgan Stanley, which said it expects a "solid improvement in reimbursement" for the medical technology company's intravascular lithotripsy treatment of atherosclerotic cardiovascular disease to result in Street growth expectations for 2024-2025 being "too low."

Morgan Stanley also raised its price target on ShockWave Medical's shares to $335 each from $291. This moves the target farther above the stock's Friday closing price of $261.77.

The upgrade comes as Morgan Stanley expects the US Centers for Medicare & Medicaid Services to propose "better outpatient reimbursement in the coming week ( my emphasis )" for ShockWave Medical's intravascular lithotripsy, or IVL. This technology uses sonic pressure waves to disrupt challenging calcified plaque.

Improved outpatient reimbursement would drive "a potential acceleration in penetration of SWAV's coronary IVL catheter and upside to Street expectations," Morgan Stanley's analysts said in a Monday note to clients.

Morgan Stanley also sees ShockWave Medical's short-term numbers as "encouraging," and highlighted that competition doesn't appear to be coming "anytime soon." Abbott (ABT) is also working on intravascular lithotripsy but Morgan Stanley's analysts noted Abbott's first-in-human trials have yet to begin and there are "no other clear peers in the market," the analysts noted.

ShockWave Medical has an average investment rating of outperform among analysts polled by Capital IQ, with price targets ranging from $165 to $335.

(MT Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https://www.mtnewswires.com/contact-us)

Price: 270.21, Change: +8.44, Percent Change: +3.22
--------------------
Kiwi

[sab63090]

Kiwi:

Just the luck, she flies again!....similar to when I bought @ 250 and sold @ 279...only to be followed with $300....at least there is progress and time for me to watch for "developments" at Medicare (CMS code approval for this enhanced treatment) !!! best, Steve

[Whalatane]

Steve. I remembered an earlier post you made .

I'm interested in this for myself...lower extremities of hard calcium build up.

These new IVL catheters might help ...note my earlier link today .

Dr. Briggs: I am a big proponent of optimizing lower extremity arterial inflow by treating the aortoiliac and common femoral segment.
Some of the happiest patients I see back in clinic after an intervention are typically those in whom I have restored flow through this segment.
That said, up until a few months ago, there was a subset of these patients in whom I would alter my treatment paradigm.
These were patients with severe calcification of the common iliac arteries (CIAs), regardless of TransAtlantic Inter-Society Consensus (TASC) II classification.
Severe calcification presents several challenges to endovascular intervention.
For one, severe calcification is largely unresponsive to balloon angioplasty.

Kiwi

[Whalatane]

https://evtoday.com/articles/2023-may/the-new-shockwave-lsup6sup-peripheral-intravascular-lithotripsy-ivl-catheter?twclid=26b52jkpljhj4r5ub0mka2i7n

New IVL catheters now available
Kiwi

[sab63090]

Glad you decided to exit $VKTX...there was someone on Dew's board who seemed very bullish prior to and after the good news and was carrying a large position, too....

I think I will pass on those other 2 stocks for now, got my hands fulll your wife is most likely best qualified to comment on those!

RA Capital is a very informed health science group, but I had some problems with them several years ago when he did some violations in a stock I was carrying....he settled a lawsuit with the company after reporting a large 10% holding while he was actually liquidating it.

Steve

[Whalatane]

Hi Steve ...sold VKTX as soon as I saw the Lily data . Think I still made $ on it over all.

If you have time , take a look at my ARDX and UNCY posts on IHUB and let me know your opinion.
My wife has dialysis patients and wants to get them on either of these treatments as soon as approved
RA Capital just disclosed a position in UNCY ...which had been hit due to FDA wanting more info

Kiwi

[sab63090]

Kiwi,
Glad you did that for yourself! As I mentioned, I stepped away at $279, but did enjoy the profit from $250...you have made a lot more & happy for you. As far as my knee is concerned, it's slowly improving and saw my ortho doc who said it might take longer (appx 1 month), but I am really stiff in the morning and it gets better as I move around a little. Still wearing the brace for several hours a day.

Appreciate the update on "potential" CMS code acceptance....guess I will wait for that & I see my vascular surgeon September 7th...I will question him then about it's potential.

Best, Steve

Sorry about $VKTX....

[Whalatane]

Hope your knee is doing better.

Got stopped out of half of my SWAV position in the mid $260's ( risk mgt ) .
Sell off seems to be around concern over new CMS pricing ...decision expected in July .
From the last CC

After the CPT panel last year voted in favor of a Category I CPT code for IVL, the next step in the process that the RUC committee then goes and surveys physicians to determine what the RVUs are when they sort of -- basically how much work do they do when they do a Shockwave case and that will feed back into the system and determine what physicians will get paid incremental to that stent procedure.

And we will know what is proposed here in the next few months, sort of July timeframe, we should have both the proposed rule for outpatient and the proposed rule for CPT, both of which would affect 2024. And we would be speculating if we said what we thought -- where we thought we would the physician payment would land.

Kiwi

[sab63090]

Thanks, Kiwi....I see my vascular surgeon in September and I have already forwarded info to him...hopefully any reimbursement will at least match atherectomy codes providing a better patient experience....we'll see if my ABI's have improved and although my knee is still healing, I'm hoping by then it's much better...best to you.....my "vacation at the beach" was terrible and I found it difficult to walk in the sand with my brace, so I spent most of the time in the house while everyone was enjoying it....going out to eat was the only fun part! Steve

[Whalatane]

Steve TPT I think stands for their Temporary codes for reimbursement .
These will be updated this Qt I think ...question is will these temporary codes become standard or enhanced for higher $ reimbursement .
Currently the reimbursement codes match atherectomy codes I think.
Many ( myself included ) think IVL is superior to atherectomy and should receive a higher reimbursement code
Just my recollection
Kiwi

[sab63090]

Kiwi:
I prefer to listen to buy side analysts, but I don't even know what TPT stands for, nor "up-mapped"; this reads as though their revenue stream will be reduced and not enhanced...maybe you are better at figuring this out than I ever would be! Best, Steve

[Whalatane]

Steve any opinion on this tweet ?

OldKinderhook (@The Kinderhook Analyst) Tweeted: $SWAV C2 catheter unlikely to get up-mapped in CY24 OPPS rule next month. CMS will not let the TPT payment be added on top of the higher APC 5194 rates. The TPT timing problem is not understood by sell-side. $BSX

$SWAV C2 catheter unlikely to get up-mapped in CY24 OPPS rule next month. CMS will not let the TPT payment be added on top of the higher APC 5194 rates. The TPT timing problem is not understood by sell-side. $BSX pic.twitter.com/icMLLWd5aj

— The Kinderhook Analyst (@OldKinderhook) June 28, 2023

Technically ( in my limited understanding of such ) ...chart looks weak as SWAV failed to break out on the upside and is now testing the bottom level of its recent trading range.

I placed a stop in the mid $260's to reduce my overweight .

Kiwi

[Whalatane]

Hi Steve SWAV testing recent highs
Kiwi

[sab63090]

Kiwi: Thanks for those views!

I saw the 8k and what stood out to me is how well Laura Francis placed with the votes! Not so much for Larkin and Sainz...do you have any reasons or thoughts why? The Broker non-votes were small, so with the high institutional investor holdings those were most probably just various passive....so looks like there are "motivated voters" in the activist crowd.....best to you Kiwi, we're off to the beach on Saturday!

Cheers, Steve

PS....My knee is still bothering me even with this costly knee brace being worn for most of the day....darn it!

[Whalatane]

Hi Steve. SWAV receiving a lot of attention this week. First a Slingshot interview with a UCLA med prof ( liked the technology ) , Chart of the day mention ...cup and handle , United Health reporting a lot of discretionary procedures like elective PCI's were now being done ( post Covid ) and the following from IBD

IBD STOCK OF THE DAY
How IBD Stock Of The Day Shockwave Is 'Cracking' The Code To Another Breakout
FacebookTwitterLinkedInShare Licensing
ALLISON GATLIN04:29 PM ET 06/13/2023
Shockwave Medical
SWAV
$ 299.90
$7.96 2.73%
250%
IBD Stock Analysis
SWAV stock has formed a cup-with-handle base with a buy point of 308.09
Has found support at 21-day and 10-week moving average lines
Sports strong IBD Relative Strength Rating of 94 out of 99

Composite Rating


96/99
Industry Group Ranking


46/197
Emerging Pattern


Cup with Handle
* Not real-time data. All data shown was captured at 12:49PM EDT on 06/13/2023.
Shockwave Medical (SWAV) is the IBD Stock Of The Day. With expectations for double-digit growth in the June quarter, SWAV stock is making a run at a breakout.

Shares have surged 42% this year on a bevy of good news. In April, the Centers for Medicare and Medicaid Services announced a new reimbursement rule that could increase the payments the firm receives for its intravascular lithotripsy procedures. These procedures use sonic waves to "crack" hardened calcium in the coronary arteries.

Then, in May, SWAV stock surged again on a big earnings beat as rumors of a Boston Scientific (BSX) buyout emerged and quickly fizzled.

Now, shares are eyeing a buy point at 308.09 out of a cup-with-handle base, IBD MarketSmith charts show. SWAV stock also is finding support at the 21-day line on a daily chart and at the 10-week moving average on a weekly chart.

A move above 300 would offer an early entry. The 300 level also exactly matches a prior buy point.


On the stock market today, SWAV stock rose 1.1% to 291.94.

SWAV Stock: 164% Earnings Growth

Shockwave's technology looks to replace an older method of removing calcium from the arteries called atherectomy. Atherectomy uses a small drill to dig through the calcifications.

In the first quarter, Shockwave's earnings more than doubled, soaring 164% to $1.03 per share. Sales jumped 72% to $161.1 million. Both soundly beat expectations. That followed the launch of its next-generation C2 Plus device outside the U.S. The company finished its international launch last month and is planning the U.S. debut in the fourth quarter.

C2 Plus uses more electrical pulses to accomplish the mission of breaking apart calcifications.

"The extra pulses are most advantageous in areas with the highest burden of calcium, including nodular, eccentric, diffuse and multi-vessel calcium," Dr. Jonathan Hill, a consultant cardiologist at the Royal Brompton Hospital in London, said in a recent news release from Shockwave.

But SWAV stock fell 6% on May 15, the day it announced the international launch of C2 Plus. That was far steeper than a fractional decline for the Medical-Systems/Equipment industry group.

Shockwave also announced it enrolled the first patient in an all-female study called Empower CAD. Women tend to show the symptoms of hardened calcium later in life than men. So, studies of calcium removal tend to have fewer women. Those that do enroll are often frailer than the men.

"This is a major step toward better understanding the optimal strategy for calcium modification in female patients, an underrepresented patient population who frequently are more challenging to treat and often experience suboptimal outcomes," Dr. Margaret McEntegart said in a written statement. McEntegart is the co-principal investigator for the study.

Highly Rated Medical Stock

In addition to forming a cup-with-handle base above its 50-day moving average, SWAV stock has two notably high IBD ratings.

Shares have a Relative Strength Rating of 94 out of a best-possible 99. This puts shares in the top 6% of all stocks when it comes to 12-month performance. SWAV stock also has an IBD Digital Composite Rating of 96. The CR is a 1-99 measure of fundamental and technical measures.

----------------------
Kiwi

[sab63090]

Hi Kiwi,
Now regretting my sale at $279, but at least it was profitable....I'm still a believer like you, but I'm waiting for CMS to pay for this most promising treatment to lower extremity problems like PAD and calcium build-up........best, Steve

[Whalatane]

Symposium on today

Shockwave IVL
@ShockwaveIVL
·
10h
Today at 12:30pm at #LINC2023, join the #ShockwaveIVL lunch symposium ‘Change Compliance to Change the Game in #PAD Treatment’ to hear the expert opinions of Drs
@K_Stavroulakis
, Stefano Fazzini, Dominic Howard & Enrique Alejandre Lafont.

Kiwi

[sab63090]

By that I was implying that the revenues for SWAV will be increased since these procedures are mostly for older patients...
:)

[sab63090]

Hi, Kiwi!

Yes, the ASM is the annual shareholders meeting & I was hoping for this to be updated;

I believed you mentioned that it might be approved in August or September? Those new codes will raise the prices of the procedures for Shockwave Medical...

Stock price keeps trying to break $300...

Best, Steve

[Whalatane]

Hi Steve ...ASM on June 13 th ? Annual shareholders meeting ?
Are you looking for an update on this

Centers for Medicare & Medicaid Services (CMS), as part of the calendar year 2024 Medicare Hospital Inpatient Prospective Payment System (IPPS) proposed rule, proposed three newly introduced MS-DRGs specific to IVL in order to address the higher average costs and generally longer lengths of stay associated with IVL compared with the cases in their previously assigned MS-DRGs.

I thought they expected that later in the year
Kiwi

[sab63090]

SWAV ASM on June 13th 8am Pacific/11am Eastern...hope there is an update or guidance on CMS approval...

.....so far IR (debbie kaster) does not respond to email from me....
:(

[sab63090]

Thanks, Kiwi
I feel that this is most appropriate for those without stents?

I do have (abdominal stents at dual iliacs). I am looking forward to speaking with my vascular surgeon in September about this and have sent him information about this being my hoped for option, but naturally he needs to be educated on Shockwave IVL process.

Shockwavemedical needs to have more marketing and promotional information to spread the word more! With the institutional investors (more than 90% invested), they are aware of it, but it seems many doctors/surgeons are not!

Let's hope that CMS eventually approves of this procedure, since it will bring on a flood of interest for those who want or need this....those on Medicare and Supplemental Insurance.

Thanks for keeping me informed, Kiwi!

Steve

[Whalatane]

Steve You might find this of interest

Thank you Dr. Juan Pastor-Cervantes for your presentation yesterday at #NCVH2023 on #ShockwaveIVL Below-the-Knee. Great review of the challenges of calcium, the benefits of IVL in #BTK intervention & an impressive #ShockwaveS4 case.

ISI https://t.co/sZ0NdzXNcV @NCVHonline pic.twitter.com/Q3mUO50Bcy

— Shockwave Medical (@ShockwaveIVL) June 2, 2023

Kiwi

[Whalatane]

Hi RMB. yep, rapid growth of use in Cath Labs in the US ( and UK / EU ) ...and now rolling out in Japan and China .

Kiwi

[rosemountbomber]

Thanks for the links Kiwi. Great stuff.

[Whalatane]

https://discover.shockwavemedical.com/hubfs/CathPCI%20IVL%20-%20SCAI%202023%205-18.pdf

Kiwi

[Whalatane]

https://blog.shockwavemedical.com/coronary-ivl-cathpci-analysis-a-paradigm-shift-in-practice

Kiwi

[sab63090]

Kiwi:

Thanks!
I assume you watched this 2 hr presentation and I'll give it a try or skim over it when I get a chance! Best, Steve

[Whalatane]

A lot of interesting detail on how to use OCT for imaging and IVL for vessel prep of calcified areas.... before installing a stent.
I thought the videos to be an impressive marketing tool .
Kiwi

[sab63090]

wow!

over a 2 hour deep dive...need a summary for this! lol

[Whalatane]

https://calciumivleague.com/videos/video-groups/the-calcium-masterclass/

Kiwi

[Whalatane]

https://blog.shockwavemedical.com/drs-spratt-wilson-on-the-ivl-generation

Kiwi

[sab63090]

https://seekingalpha.com/article/4606973-shockwave-medical-multiple-growth-levers-drive-valuation-upside

See if the link above works...

I'm actually right outside of Wash DC, so we have hospitals locally like Georgetown University Hospital where I went to Lombardi Cancer for my chemo...which is even closer to me than John Hopkins...best........Steve

[Whalatane]

Hi Steve Do you have access to the Seeking Alpha article. If so, can you copy and paste it here .
Re SWAV IR ...they probably can't provide anything that resembles medical advice or where to receive it ...just my guess .
I'd be really surprised if Johns Hopkins ( in your area ? ) weren't using IVL . Most "teaching " hospitals seem to be using it
Good luck
Kiwi

[sab63090]

Kiwi:

I always thought NVDA was pretty highly priced and look at it now...wow! but I saw that interview on CNBC with an expert who said it's going to go up, big time....congrats on that one.

I wish that Debbie Kaster (shockwave ir) would have responded to my email about availability in the wash dc metro area for shockwave ivl and cms....but she avoided answering....that's disappointing!

Best, Steve

[Whalatane]

Steve , SWAV is my largest position . NVDA my second largest ...chk the earnings guidance and AH
Time for a glass of fine wine tonight :--)
Kiwi

[sab63090]

Thanks, Kiwi!

I'll check them both out...I do think I might be able to access Seeking Alpha and I never heard about Medstream 360. but will now...Steve

[Whalatane]

$SWAV - Shockwave Medical: Multiple Growth Levers To Drive Valuation Upside

Seeking Alpha article today
Do you have access ?
thx
Also Medstream 360 for live cases using IVL around the world.
Kiwi

[sab63090]

Thanks, Kiwi
My problem with it is that I have blood problems (NHL): low platelets (around 100) and ITP (Thrombocytopenia), so I'm a patient with conflicting & never ending problems....my cardiologist and I were both, at first, impressed with Vascepa & she commented that it was so much more powerful than fish-oil. which thins the blood which is not good for me..appreciate your keeping up on things! best, Steve