Sold ABMD

I bought a little bit of ABMD after Saul mentioned it in this board, but just sold it.

I try to make a guess about ABMD’s valuation. I assume the company get 800M revenue in 3 years (about 50% annual growth), 80% gross margin. 320M operation expense (2 times of TTM expense), 40% tax rate. If we give it 25 PE, ABMD’s market cap will be 4.8B. 60% gain in 3 years, not too bad. Of course, it is just a rough estimation. You can change the numbers to get a very wide range.

I read their annual report and a few conference transcripts. They are all good until I watched a documentary on NFLX, The Widowmaker. Part of it calls into questions the practice of stent procedure. I also googled some articles related to stent procedure. It seems there is quite controversy about stent effectiveness and overuse.

I am just not confident enough to hold it as an investment. It is out of my knowledge circle.

Thanks for reading.

ZZ

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thanks for posting, I have made a note to self to watch The Widowmaker.

I bought a little bit of ABMD after Saul mentioned it in this board, but just sold it. - ZZ

Disclosure: Doctors have told me I should consider stents, given that I suffer from atherosclerosis (in my case, it’s genetic - my Father died from coronary heart disease at a young age). Being a biologist possessed of insatiable curiosity, I’ve studied stents extensively. I concluded they’re not for me. Stents have been a great money-maker for a whole lotta cardiologists, but extensive studies have indicated that they’re not all that therapeutic, EXCEPT in critical situations.

That brings us to ABMD. Saul brought this to the Board’s attention. Intrigued, I spent a day or three researching the company and its competitors. I was impressed enough by what I learned to establish an entry position. I also learned enough to know that what ABMD offers are not stents but heart support and recovery products. Big difference. The Impella series of products are essentially mini-pump devices that serve a very specific (e.g., temporary) need in response to necessary interventions. (For those interested, stent evaluations also noted that stents are best used in response to cardiac emergencies). These types of cutting-edge cardiac support systems are relatively new to the market. IMHO, they certainly have a place.

All props to Saul for bringing this company to my attention. Having said that, I’ll note my position is still small. It’s small because I also learned that Edwards Lifesciences (ticker: EW) is also a leader in this sector. EW is a much bigger firm, and is a formidable competitor. It’s gonna take me a while to suss out the better investment.

Meantime, I’m glad Saul brought ABMD to my attention.

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There are some doctors in the house here so you might want to check in with what they have to say…
Ant

Curious about stents.

Maybe some of the reasons they sometimes don’t do much long term are that there are lots of other things to die from, or that if one part of your coronary arteries are blocked the others will also be prone to blockage.

Any experts on that here?

One other heart question. My cardiologist wants to do a stress echocardiogram ? on me, despite my advanced age and no evidence of heart disease except hypertension (controlled) .

My attitude is don’t whip an old horse just to see how fast he can run. Let him take it slow.

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Again please note that I am not a cardiologist, so take my comments with a grain of salt. I do work with stents in the rest of the body (anything below the neck and outside of the heart). I apologize that this will probably be long and rambling, since I’m not sure there was a specific question and haven’t seen the Widow Maker documentary. If there are any specific questions feel free to ask and I’m happy to answer (or defer if I simply don’t know).

I’m not up to date with all the literature regarding stents in the coronary arteries, but from what I remember, there was a lot of data initially suggesting that they are helpful, and more recently (in the past 5-10 years) more literature suggesting maybe they aren’t so helpful after all.

As a background, stents are used to keep open a blood vessel that is narrowed. Originally, they were developed in bigger vessels, and as an adjunct to angioplasty alone (using a small balloon to re-open a blood vessel that has been narrowed or occluded by clot, scar tissue, or calcium). Stents were originally made because after using a balloon, often there is a “recoil” effect where the vessel closes back down partially or completely, like rubber. Stents in general exert a radial force and hold open the vessel.

The problem is that stents are a foreign object and elicit an inflammatory response, which in the body means scar tissue and a chance of clotting. In big vessels this isn’t so much of a problem because it’s just small portion of the diameter (in a big pipe, a little gunk on the side doesn’t block it off). In the coronary arteries, which are only a few millimeters in size to begin with, this can be a big problem. And the biggest concern is that it causes a clot, which can cause a chain reaction, completely closing off the blood vessel. Instant, large or massive heart attack.

To combat this problem, patients are put on Aspirin and Plavix, which inhibit thrombosis (clotting). This puts them at risk for bleeding in any minor fall or trauma. Stents cost a lot more than balloons (and are reimbursed more). So you can see that while there are probably some real upsides (keeping a vital blood vessel open) there are also real downsides (cost of stent, risk of complication, cost of medication, risk of bleeding). Also add to the equation that we aren’t always sure the area stented is actually the problem in a heart attack or chest pain. Many doctors will put a stent in a vessel that looks bad on angiogram, even though there are no symptoms.

Bottom line, yes, in my opinion the value of stents is overrated and stents are probably overused. I personally use stents much less frequently than my cardiology and vascular surgery colleagues who perform similar procedures when working with vessels of that size (for me, mostly in the legs). But I do believe that PCI (percutaneous coronary intervention) has great value and is not going away until we have nanobots doing it for us.

ABMD does not make a stent. They make a device that assists the heart in supplying blood to the body during a heart attack, particularly during PCI when a stent might be placed. During a massive heart attack, the heart is often stunned and does not pump as well. This can be exacerbated during PCI when a balloon is used to open a vessel, during which time the vessel is completely blocked off. After the procedure, the Impella device can be left in to continue helping the heart as it recovers. In the past, this was accomplished with an intra-aortic balloon pump, which relied on expanding a balloon in the aorta (the outflow pipe of the heart) to fill space, then deflating the balloon to create a suction effect to suck out blood. This is relatively clunky and can be more traumatic to the aorta, and can block off other blood vessels during expansion and affect other organs, most commonly the kidneys. So whether stents are truly helpful or not it will take a major article clearly showing a detriment for it to stop being used, and even then cardiologists will still perform the same interventions, just not with stents (perhaps by sucking out clot or just ballooning). PCI is here to stay, and ABMD is an adjunct to PCI. I don’t think the risk of stents going defunct is even a question except that it might reduce potential buyouts if that seriously affects the big device makers.

@mauser, in general I believe physicians over-recommend screening tests like the stress echo, which on a population basis is probably not cost effective. But you are less likely to be sued if someone has an unnecessary procedure because of a screening test (hard to prove) than if someone drops dead but you didn’t screen for heart disease. If it were me or a family member, I would suggest that someone who is active and regularly stresses his or her heart and has no problems (chest pain or clearly decreasing tolerance) probably doesn’t need a stress echo. Someone who otherwise isn’t stressing the heart for physical or personal reasons probably should. Also, people with very high risk factors or other evidence of problems (for example calcium in the coronary arteries or carotid arteries on a CT for other reasons) might benefit as well. But please do speak with your doctor about it. I’m frequently asked to do procedures or tests on people who have no idea why they’re doing it, and I don’t think it really needs to be done. Also think about this, if there’s something you could recommend that could simultaneously reduce your chance of getting sued and increase your revenue, what might you be tempted to do?

I heard a rumor that a former president recently got a stress test for no reason other than being old when he was hospitalized for something unrelated. The test showed some questionable defect, resulting in a coronary angiogram, which led to stenting. In my opinion, the state of current medical malpractice lends itself to this kind of medicine.

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There are some doctors in the house here so you might want to check in with what they have to say…

Hi Ant, there were at least two posts by doctors on the board about ABMD in the past couple of weeks. Here they are (shortened perhaps as I’m reposting them from my notes):

A - Current AHA guidelines recommend patients with hemodynamic or electrical instability to urgently / emergently be sent to the cath lab (and really, what else is more unstable than say, a cardiac arrest). Fifty percent of cardiac arrest patients, even those without evidence of an active heart attack on their initial EKG, will have an acute coronary occlusion amenable to stenting. And these patients actually do reasonably well.

Now, this has been in the guidelines since, I believe, 2007, and only now is it becoming fashionable to take them to the cath lab. Though, eventually, I believe we’ll get there. The knowledge translation window for things like this to disseminate and become a part of medical culture is about 12-16 years, so we’re about halfway there.

So why do I mention this? Well, first, the numbers are small, but ABMD analyzed ten consecutive hemodynamically unstable patients that would have otherwise been excluded from Protect-II, and used the Impella system. Compared to what you would expect, they did quite well. This should lead to indication creep whereby, if you were a cardiologist regularly using Impella over an intra-aortic balloon pump, and you know that the Impella in “normal” cases offers a slight advantage, why not use it over the IABP in a higher risk scenario and attempt to improve morbidity and mortality? Once they increase usage of IMPELLA for routine cases, the next step is to push for it as a bridge in the acutely unstable patient (ie, the example discussed above). Now, this wont be a tremendously large patient population, but enough to make a dent in within the next few years in earnings if it becomes standard at every cath facility.

I see additional benefits to IMPELLA in the future, and wouldnt be at all surprised if ABMD got scooped up by a larger player (St Jude?)

B - I am not a cardiologist, but I do work with catheters and the same techniques since I’m an interventional radiologist. I got interested in this company after hearing some cardiologists discussung it. I did start a position because I think the device is still in its infancy and will continue to grow for a while.

The main differentiator in the Impella products is that they were designed primarily as catheter based systems, rather than a catheter implementation of a surgical device (which is what the intra-aortic balloon pumps look like). I think they can continue to make them smaller and with that the downsides to putting one in drop significantly. If they can get down to an 8F sheath size most closure devices will be compatible, and really it would be an added 10-15 minutes of procedure time to place and remove an Impella (it should only take that long to access the artery, place and position the catheter, then remove the catheter and place an arterial closure device). Being easy to use goes a long way in adoption in cardiology.

I think it may even go the other way, where cardiologists stretch the high risk definition to include more routine patients just for a bit of added protection. With a smaller catheter size, the downsides to putting one in are reduced such that the potential benefits can be lower and still outweigh the risks.

I can also see in the future extension of the catheter to a biventricular assist by running the motor in reverse in the right atrium across the pulmonic valve. Also, some will probably use it for longer term ventricular assist than the currently documented 6 hours, possibly as a bridge to a transplant.

In the end, the reality is that the success or failure of medical devices has as much to do with regulatory issues (they already got their approval) and physician preference as actual medical benefit. A cardiologist would just say to the patient that they use this device, it protects their body during intervention and shortly thereafter, and patients will just agree.

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Thanks for gathering that in Saul and crediting where credit’s due. I really valued the input from IRdoc and Fuma102 who I haven’t come across before - much appreciated both of you.

I know that Gatorswamp and alevine have been invaluable on other medical investing matters, (such as surgical robotics) and I could have sworn I have seen them on this board - I hope they find this thread and are able to contribute too.

Cheers
Ant

I’m really glad you posted this information. I am not a cardiologist so I was not sure if I should post on the subject. My background is engineering and manufacturing. I did a bit of research on the company as well. It seems like most of the customers are hospitals that are doing corrective surgeries that use the ABMD equipment as a temporary pump to keep things moving while they are doing the surgery.

Thanks much, Brian

P.S. I did buy a very small position and am considering getting some more.

Thanks Ant,
I saw this las

Whoops,
Not sure what happened there!
I saw this last night and thought to post but the main thing I was going to say is this company has nothing to do with stents. I do know some things about stents but not more than what has been posted already. I believe the main gist or critique of stents is a difficulty in proving improved survival with or without. I know for a while we needed stress tests on literally everyone with cardiac risk factors and in last few years, maybe five, this has gone down a lot. I can, as a surgeon, figure out who needs referral or not using simple history evaluations such as exercise tolerance, etc.
So, the stent argument is a side show for this company.
Now, the perfusion aspect, done as a catheter based system has many appeals. Certainly there is a market for this although this is not at all what I do, so will leave it at that!
I am interested, this to me is a small company with great financials and is SMALL. So a million great things can happen to it. That is what I made a small investment in.
I hope this helps.

Gator

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Disclosure- I’m an ER Physician Assistant. I am happy to review evidence for what I’m about to talk about with whomever requests in detail if requested.

Now, to address the issue ZZ brings up.

They are all good until I watched a documentary on NFLX, The Widowmaker. Part of it calls into questions the practice of stent procedure. I also googled some articles related to stent procedure. It seems there is quite controversy about stent effectiveness and overuse.

A sampling of things that dont work, that we know havent worked for years (but we still keep doing them since they bring in BILLIONS.)

-TPA for strokes (aka “clot busters”). Most trials have mostly been negative, yet genentech has parlayed an emotional family time to pressure them into a drug that has never been to be effective in a non-industry sponsored trial. And the sole positive trial (not coincidentally industry sponsored) has never been reproduced in two decades.

-Robotic surgery has never proven better than traditional surgical procedures for any reasonable measure - hospital length of stay, morbidity, or mortality.

-knee “scopes”… new cochrane review essentially says there is no change in pain 1-2 yrs post procedure. A placebo controlled trial in which an actual knee scope was done compared to a “sham” procedure yielded no change in patient outcomes. (surprise! most back surgery for long term pain control is similar!)

-there is scant if any evidence for opiate analgesics for long term pain control after the first week or so of acute pain. Yet, not a shift goes by that I do not see a few patients on “hydros” or “oxy” for several months, if not years.

ZZ, you’re right. there is no evidence that electing cath & stenting improves patient outcomes. But Genentech and ISRG didnt make shareholders happy by letting evidence get in their way. Indication creep is real, and plays on patient emotions to get better, and provider emotions to want to help.

FWIW, I don’t think that my non-pharma holdings are saving the manatees either; it just sucks that Pharma happens to be playing on peoples emotions at vulnerable times.

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Thanks Gator. I took a position too. I have added ABMD to my “Ageing Population” mega theme investing plays.

I just saw some unbelievable data on ageing population growth in JP, Singapore, China and US at the Self Medication conference I’m attending. What was doubly interesting was not the increase in average life expectancy but the gap between the average “healthy life expectancy” and life expectancy. Basically the last 9 years of human life in men and 13 in women are of severe deterioration and as that becomes a focus point, plays like this will become front and center.

Forget about surfing the interweb or Facebook, retired baby boomers will just want the remaining working population to pay their pensions, drive their cruise boats and fix their health and no doubt in western democracies will vote accordingly.

Ant

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Here’s some insights into the industry category…
http://finance.yahoo.com/news/converging-heartthrob-market-1…
Ant

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Hi IRdoc, Chris asked me if the ABMD Impella units are reusable. I always assumed they were used for one patient and discarded, (they are in the patient for from hours to days, after all), and thus represented renewable income. Do you happen to know?

Thanks,

Saul

Do NOT resterilize or reuse the Impella® 5.0 Catheter. It is a disposable device and is intended for single use only. Reuse, reprocessing, or resterilization may compromise the structural integrity of the catheter and/or lead to catheter failure
which, in turn, may result in patient injury, illness, or death.
Retrograde flow will occur across the aortic valve if the Impell

Google search turns up the PDF file on how to do the procedure!

Dr. Google is pretty impressive.

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Thanks Duma, so it’s all recurring income! Appreciate it!

Saul

We had doctor’s here in Nevada reusing single use devices. One went to prison the other was caught and released. Here is a little more info.

The recent advertisement defending Dr. Michael Kaplan – the Las Vegas Valley urologist whose medical license was suspended for reusing single-use needle guides – sheds a faint light on a little-known truth.

Although a medical device is labeled single-use only, it might have been used before.

The ad written by Kaplan’s attorney, Dominic Gentile, in the wake of a joint investigation by the Food and Drug Administration and the Nevada State Board of Medical Examiners, said that FDA guidelines “state that single-use devices can be reused after reprocessing.”

The FDA allows some single-use devices to qualify for reprocessing for reuse. About 100 types of re­processed single-use devices, which often can be bought at half the price of new devices, are marketed in the United States, according to a 2008 Government Accountability Office study.

http://www.reviewjournal.com/life/health/fda-allows-some-rep…

http://lawmedconsultant.com/nevada-hepatitis-c-propofol-cont…

Andy

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I think the question’s been answered but here’s what I know. From what I can tell, the device consists of a central console which hooks up to the catheter. The catheter is sterile, the console is not. The catheters I’m sure are essentially single use (if you left it in a patient after one procedure and the patient had to be taken back to the cath lab, you could continue to use the same device. Most companies will make their money off these catheters, thus revenue is directly tied to the number of procedures done. The catheters cannot be sterilized like surgical components because they need to be mostly plastic (so it doesn’t obscure the image when performing the procedure, done with fluoroscopy/real time x-ray). They typically have a tip that is molded to a specific shape to better fit its use, which would be lost with the high heat used for sterilization. Also most of the time there’s a coating on the catheters to prevent blood clots which could be damaged. So bottom line is the catheters are all recurring revenue.

The central console is probably relatively cheap or free. It’s not like ISRG where you get some revenue from the machine itself and some from each procedure. It would be too much of an impediment to getting the catheters used in smaller hospitals if there was a large up front cost. On the downside, there’s no particular drive to use the devices if you didn’t “invest” in the device itself (as with the da Vinci robot).

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