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Showing posts with label Medical Tech. Show all posts
Showing posts with label Medical Tech. Show all posts

Wednesday, June 27, 2012

Nanotechnology is to the 21st Century what chemistry was to the 20th Century


June 27th, 2012
by 


The word "nanotechnology" gets thrown around a lot but it still remains a fuzzy concept for most people.

From a self-aware, self-assembling grey goo that takes over the world in a Michael Crichton book, to Apple's (Nasdaq: AAPL) Nano music player or Tata Motor's (NYSE ADR: TTM) Nano car, it's hard to get a clear picture of what nanotech really is.

But as global World Economic Forum member and emerging tech guru Dr. Tim Harper explains, "Nanotechnology is to the 21st Century what chemistry was to the 20th Century."

Like plastics, computers, and the Internet before it, nanotechnology will change the world in ways that we can't even imagine now. That's how powerful the nano-world will become.

That's why every long-term growth investor needs to consider investing in nanotechnology. In terms of scale, the potential for investors is simply enormous.

That's why one company, FEI Co. (Nasdaq: FEIC) is on my list of "buys" as the top "picks and shovels" play.

The Miracle of Nanotechnology

So what exactly is nanotech?

It's a way of working with objects and materials at the atomic level, one molecule at time.

That means that in the near future, we will be able to custom design structures literally from the ground up, molecule by molecule, creating a quantum leap forward in medicine, materials, electronics, food, and fuels - practically everything we know of.

In fact, one of the biggest sectors where nanotech continues to have a huge impact is in drug development and drug delivery.

Recent nanotech developments include: cancer treatments without chemotherapy or radiation, long-dose treatment of diabetes with a single monthly injection, long-release or on-demand blood pressure medications, and textiles to build skin, bone or organs from you own cells.

Developments like these will invariably lead to big money

A recent report by Cientifica, a leading global emerging technology consulting firm predicts:
  • Nanotech-enabled drug delivery therapeutics is set to grow from a current value of $2.3 billion to $136 billion by the year 2021.
  • Global growth in the drug delivery market will be led by Asia with a compound annual growth rate (CAGR) of 32.5% between now and 2021.
  • And the total addressable market for nanotech enabled diagnostics will reach $53.6 billion in 2021 from $2.4 billion in 2011.
But drug delivery is just a small piece of the sector. The truth is nanotech is going to impact every facet of your life someday.

Because if you look into every industrial sector from textiles to materials to electronics to energy to defense to computing to telecommunications to packaging, nanotech is the fulcrum that is moving the world.

Investing in Nanotechnology: The Leading Player in the Game

For investors that opens up a whole new set of opportunities.

And if there is one thing this new field requires, it's the ability to see what's happening to these materials at these elemental levels.

That means high-powered microscopes and scanning equipment are the picks and shovels of today's (and tomorrow's) innovators.

And when it comes to these devices, FEI Co. is one of the leading players in the game.

A five-year price chart of FEIC is a simple story of how integral modern day microscopy is to the new economy. Since cratering around 11 in early 2009, the stock has had a steady rise to around $50 today.


As you can see, even as the world financial system crumbled, the world entered the Great Recession, FEIC kept chugging along.

Part of the reason was healthcare was a pretty stable base for the company as companies poured money into new R&D projects.

But FEIC also has a Natural Resources Business Unit that does imaging for energy companies around the world, including spotting shale reserves.

As cheap oil dwindles and unconventional oil and gas become the norm, FEIC's QEMSCAN imaging system will become even more in demand. In fact, earlier this month the company announced a fee-based agreement with a major oil service company to provide on-site automated surface logging using the QEMSCAN WellSite analysis solution for a U.S. customer.

So there's little doubt this unit will be pumping a lot more revenue into the company as the years progress. It has contracts in every major oil developing country in the world already.

As for business in general, revenue is up, margins are up and net bookings are up-- all in a terrible global economy.

New electronics, new textiles, new materials, new drugs, new energy -- FEIC will be in the middle of it all.

FEIC is a "Buy" up to $50.

Source: Investing in Nanotechnology: FEI Co. (Nasdaq: FEIC) is the Top "Picks and Shovels" Play:

Monday, May 7, 2012

Looking at Small Medtech and Biotech in Canada: Nick Waddell

TICKERS: CVE, GSK, IMRS, MDA.TO, RIM; RIMM, TMD, VPT, VRS, ZMS; W1I; ZMSPF

Source: George S. Mack, The Life Sciences Report  (5/3/12)

Nick Waddell Is there a developing Silicon Valley model in Canada? Not quite yet, but Publisher and Founding Editor Nick Waddell of the Vancouver-based Cantech Letter would like to see that happen. Meanwhile, he's looking for—and finding—exciting small- and micro-cap ideas as potential big returners. In this exclusive interview with The Life Sciences Report, Waddell discusses current favorite healthcare names that will surely surprise people who have not been looking North.

The Life Sciences Report: If you're looking for great technology stories, why limit yourself to Canadian-listed stocks?

Nick Waddell: I would describe it as an invest-in-what-you-know approach. I think many investors, especially newer ones, can be overwhelmed by the sheer size of the equities market, and people end up being intimidated by the sheer amount of data out there. My approach is to divide the market into small sections, whether by geographic region or by sector, and to find value there. That way, instead of examining thousands of different investment vehicles I can narrow the market down and know it like the back of my hand.

TLSR: You are an online publisher. In April two online publications won Pulitzer Prizes. Where does the online format go from here?

NW: It's an interesting question. I've been involved with publishing on the Internet since the early days. I was part of a site called The Canadian Stock Market Reporter back in 1994, which was one of the very first profitable sites on the Internet. I've remained involved and watched it evolve. Now it has become a part of the fabric of our everyday lives. I've written for both print and Internet, and there are advantages to each. But ultimately I think the advantages of the Internet lend themselves well to niche interests and niche sites, and that's how it will continue to evolve. However, that makes me worry a little about general interest publications and where they're going, because I think they're extremely important.

TLSR: You hosted a roundtable on the topic of the Canadian government's role in fostering technology. My impression is that you have a generally negative view of your government's management—or lack of management—of incentives. What are the issues and what might the solutions be?

NW: I wouldn't characterize my view as entirely negative about the government. But I don't want the government's hand in everything. The dangers of large government can be seen in Greece, where the government is triple the size of the Canadian government.

I do believe government should find ways to foster and encourage private industry and technology. Specifically we should be learning from the U.S., where technology, more than any other industry, is being developed in physical clusters. The biggest example is, of course, Silicon Valley. In Canada we don't have a Silicon Valley equivalent, but we've had two tries at it. The first was in Ottawa, where the entire thing blew up with the demise of Nortel Networks Corp. (NRTLQ:OTCPK). We have gotten a second chance with Research In Motion, which has fostered a Silicon Valley-style culture around the Kitchener/Waterloo area in Ontario, especially now with the arrival of Google Inc. (GOOG:NASDAQ) and Microsoft Corporation (MSFT:NASDAQ).

TLSR: What should government be doing?

NW: The Canadian government is overly focused on oil, gas, minerals, grain and wood, because these industries contribute to the tax base at the present time. I think it should be more concerned with moving Canada up the technology value chain and in leveling the playing field. We have some incentives, like the flow-through shares (FTS) program, which allows startup companies not currently earning taxable income to convey deductable expenses to shareholders. The program is available to mining and other resource industries in Canada, but we don't have it for technology.

Recently, at the World Economic Forum in Davos, Switzerland, there were some encouraging signs when Prime Minister Stephen Harper talked about lagging research and development in Canada and about implementing some of the recommendations from a report called "The Review of Federal Support to Research and Development," which was produced by a group led by Open Text Corp. (OTC:TSX; OTEX:NASDAQ) Chairman Thomas Jenkins. The report concluded that government spending in Canada was outdated, needlessly complex and should be changed to more of a U.S.-style system in which there is direct investment into technology rather than through tax incentives.

TLSR: The U.S. National Institutes of Health (NIH) makes grants to academia and companies. Is that the kind of program you'd suggest?

NW: Yes. More is needed. In the U.S. there is 5–10 times the amount of direct investment per capita into technology than in Canada. We are really lagging in terms of simple direct investment.

TLSR: What about the Canadian government's deep interest and investment in healthcare? Has that translated into innovation in healthcare?

NW: I think it has. But, again, I don't think that has been led by government. The real center for innovation in healthcare in Canada is Québec. It is one of three or four North American centers for healthcare, life sciences and biotech. Every major biotech company in the world has a presence in Québec. I believe the government's role there is to support what private industry has already built, and to find ways to communicate with the industry about what its needs are. Often it comes back to direct investment, rather than tax credits.

TLSR: Do you find Canadian CEOs to be risk averse to development of new business?

NW: That's an interesting question. I would have to defer to the people who've done the studies and surveys. A number of different firms have looked at this. Maybe Canadians are a little bit more risk averse than Americans, and this always comes up in comparisons. There may be a grain of truth in that.

TLSR: A Canadian guest visiting in my home in the U.S. told me that one reason for the business development lag in Canada is the weather. People don't want to go there because of the cold. Does that assertion hold water?

NW: I've heard that. Certainly no one is going to be attracted to Ottawa for the weather. If a similar salary or incentive is being dangled for a job in Menlo Park versus Moose Jaw, that becomes a pretty easy decision if you have no previous links to either place. These are challenges that we have to overcome in Canada. It is what it is.

TLSR: You've written about some interesting Canadian healthcare companies. I would like to hear your thoughts.

NW: I've been made aware of a group of medical device companies nearing commercialization of their products. They are intriguing to people who have an interest in biotech or life sciences but aren't prepared to sit around and wait for clinical trials or U.S. Food and Drug Administration (FDA) clearance.

TLSR: In other words, opportunities where you don't have to wait 10–15 years to get to market.

NW: Exactly. There are three companies in particular that I've met with recently, and three others as well.

I recently met with the management of CRH Medical Corp (CVE:CRM.V). This company is comprised of many of the same people who were part of a very large local success story here in Vancouver called ID Biomedical, which was bought by GlaxoSmithKline (GSK:NYSE) for $1.7 billion (B). ID Biomedical was very successful in developing influenza vaccines. Management took that company through from beginning to end, and nobody is going to have a problem with a $1.7B payday for 10–12 years of work.

In this next effort as a team, the people at CRH Medical specifically looked for something that was ready to go to market, and they acquired the O'Regan System, which is the first patented single-use, 100%-disposable product for hemorrhoids. It is a banding technology invented by laparoscopic surgeon Patrick J. O’Regan. It only takes a minute or less of the physician's time to band a hemorrhoid, and it does not require any advance preparation for the patient. CRH is out of the gate with this, and the company has posted three consecutive profitable quarters already. This is a management team with a history of success and a product that is already in the market and profitable.

TLSR: Single use means recurring revenues. It's interesting from that perspective.

NW: Exactly.

TLSR: What about another company?

NW: I recently met with Verisante Technology (VRS:TSX.V), which has developed a skin cancer detection device called the Aura. It uses Raman spectroscopy to biochemically analyze the skin to detect melanoma, and basal cell or squamous cell carcinomas. This is all done non-invasively, and the results are immediate. It is already approved in Australia, Europe and here in Canada. The company has deep ties to the Department of Dermatology at the University of British Columbia, which is a world leader in skin cancer research. Verisante is rolling the product out in Canada within the next six weeks, and we are right on the cusp of Aura's entrance into this market. The device sells for $60,000 (60K), and revenue could come quite quickly.

TLSR: What's the value proposition for the dermatologist?

NW: The big market for Verisante is Australia, where the incidence of skin cancer is much higher, and the value proposition for dermatologists is very compelling because they can charge $200–500 for a screening. It doesn't take very long to recoup their investments when they're seeing as many as 50 patients a day.

TLSR: That's the way dermatologists like to work, seeing each patient for just a few minutes?

NW: Exactly. This device works in seconds, literally.

TLSR: And a positive screen means an immediate biopsy.

NW: Yes. Of course, the only way to determine with precision that the cells are cancerous is through a biopsy, but if you have 100 moles on your back this will point you to the ones that should be biopsied.

TLSR: Is there another company you could mention?

NW: The next two companies are in a very interesting space that is gaining a foothold right now—robotic surgery. The two companies are completely different. One is IMRIS Inc. (IMRS:NASDAQ) and the other is Titan Medical Inc. (TMD:TSX.V). The market estimates I have for robotic surgery total about $1B now, but it is set to grow by $1B every year for the next five years.

IMRIS is an already established company in the magnetic resonance imaging (MRI) department. The company has 43 patents around MRI systems. The technology is intraoperative fluoroscopy and magnetic resonance used together. IMRIS is just getting into the robotic surgery market, but it is in partnership with a well established Canadian tech company, Macdonald Dettwiler & Associates Ltd. (MDA.TO:TSX). You have IMRIS, a company with an established base market reduced risk and the upside of a market that is growing by leaps and bounds. You also have the comfort of having an established partner like MacDonald Dettwiler.

TLSR: These are operating room suites for intraoperative visualization, correct?

NW: Yes.

TLSR: Can you talk about robotics company Titan Medical?

NW: Titan just listed on the TSX Venture Exchange this year. The company has an exclusive license agreement with Columbia University for its technology. The real upside and benefit of Titan lies in its claim that its robotic surgery system is the world's smallest in terms of required diameter to enter the body, while still maintaining full manipulation capabilities. Its Amadeus Robotic Surgical System is Star Trek-type technology. Surgeons are able to perform surgery remotely and can seamlessly switch between local and long-distance operators.

TLSR: This is still development stage, correct?

NW: It is, yes.

TLSR: Another company?

NW: A lot of people think of Calgary and the rest of Alberta as an oil- and gas-only domain, but there is a lot of technology going on in Calgary. Ventripoint Diagnotics (VPT:TSX.V) is an example of this. It has a 3D diagnostic system for examining the heart, which is an alternative to traditional methods such as MRIs and can increase the speed of diagnosis by as much as 20 times. One of the real benefits of VentriPoint is that it can use existing 2D or 3D imaging equipment that's already found in most hospitals. The system can be added with software and a tracking sensor system. Anatomical information can be identified by connecting dots on the heart to form a more realistic and specific image than existing MRI systems can do.

TLSR: This is a noninvasive diagnostic for detection of pulmonary arterial hypertension. Is that right?

NW: Yes.

TLSR: Was there one more you wanted to mention?

NW: Yes. Zecotek Photonics Inc. (ZMS:TSX.V; W1I:FSE; ZMSPF:OTCPK) is a Vancouver company involved in the use of scintillation crystals. It's not a pure medical device play, but the company has developed applications for 3D TVs and creative applications for screening devices in airports. But it can also use these scintillation crystals in medical imaging and industrial applications because the micropixel photodiodes can replace the current vacuum tube-based phototubes in positron emission tomography (PET) scanners. It provides real-time anatomic and metabolic images using enhanced diagnostics. PET scanners, the last time I checked, cost about $1 million (M) per unit. As I said, it's not a pure play medical device story, but it could be very big. There are performance advantages that include making the scanners faster and getting higher resolution.

TLSR: One might think of the PET scan section of the business as a free call option, because you would only pay $34M to buy this company today. A $1M per installation price tag could really move shares.

NW: Steven Palmer of AlphaNorth Asset Management is a fund manager here in Canada. Your readers will be familiar with him from your last interview. Steve's a big proponent of Zecotek because he thinks that the multiple initiatives could each have a significantly positive impact. He believes that the company's 3D technology, which does not require 3D glasses, could be worth $100M, and he believes the laser division could be worth another $100M, but that the upside potential of this company could be much, much higher than the sum of its parts.

TLSR: Palmer is looking at Zecotek as a 10- or 20-bagger.

NW: Exactly. He also thinks the value of the current lawsuits that the company has filed, which defend its technology, could be more than $200M.

TLSR: Nick, I've enjoyed meeting you.

NW: Thank you very much.

Nick Waddell is Founding Editor of Cantech Letter. Founded in 2008, Cantech Letter is an online magazine focusing on Canadian-listed technology stocks. The site has grown into one of the most popular and respected financial sites in Canada, and was recently described by Canadian Business Magazine as "one of Canada's premier technology newsletters." Waddell, who is senior editor, is routinely called on by the mainstream media for perspective on Canadian tech stocks, and has been featured on BNN as well as the CBC program The Lang and O’Leary Exchange.

Want to read more exclusive Life Sciences Report interviews like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see a list of recent interviews with industry analysts and commentators, visit our Exclusive Interviews page.

DISCLOSURE:
1) George Mack of The Life Sciences Report conducted this interview. He personally and/or his family own shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of The Life Sciences Report: Zecotek Photonics Inc. Streetwise Reports does not accept stock in exchange for services.
3) Nick Waddell: I personally and/or my family own shares of the following companies mentioned in this interview: None. I personally and/or my family am paid by the following companies mentioned in this interview: Zecotek Photonics Inc. and Verisante Technology Inc. I was not paid by Streetwise Reports for participating in this story.

Companies Mentioned: CRH Medical Corp - GlaxoSmithKline - IMRIS Inc. - Macdonald Dettwiler & Associates Ltd. - Research In Motion - Titan Medical Inc. - VentriPoint Diagnotics - Verisante Technology - Zecotek Photonics Inc.

Sunday, April 22, 2012

Deep Value Found in Small Medtech: Jason Mills

April 22, 2012
Source: George S. Mack, The Life Sciences Report 

The Life Sciences Report: Do you have a theme currently?

Jason Mills: With medical devices, investors must be cognizant of regulatory and reimbursement themes. Overall that environment has been somewhat arduous over the last couple of years, perhaps even more arduous than in the past. Investors are not surprised by this. In addition, some larger medical device markets are seeing more intense competition and resultant price pressures. They are also seeing declining procedural growth, coming down from historic highs. That's the case in some of the areas I follow in cardiology medtech, such as interventional cardiology, drug-eluting stents, electrophysiology with the implantable cardioverter defibrillators (ICDs) and even in atrial fibrillation.

I think medical devices tend to be a stock picker's environment, in which not all stocks are attractive at any given time. There are some obvious reasons for the trough valuations that we're seeing, but these also create opportunities.

TLSR: Negative headwinds are obvious and baked in, but beyond that do you see some of these stocks trading at deep value?

JM: Yes. The valuations for the medical device sector are at levels we haven't seen for years. Back in the early part of the last decade—2001 and 2002, when the tech stock boom was coming off its highs—we saw valuations in small- and large-cap companies down at trough levels, but we're trading well below those levels today.

TLSR: Given these negative factors, what do you look for in a medical device company?

JM: We believe that the most attractive medical device companies possess a few specific characteristics.

First, we favor growth. Growth is at a premium in medical devices today, given that there are fewer markets where critical mass has been achieved in terms of size and continued good growth prospects. Continued growth must be based on a large underpenetrated patient population in which the clinical data suggests the therapeutic modalities have improved patient care. In our view, few medtech companies have prospects for 15%+ revenue growth over the next couple of years. We use that as a screen in our coverage to identify strong growth companies.

Second, we look for an emerging leadership position. We favor companies that are not just players in hot or potentially hot markets, but that are also set to be market leaders for several years. This status is based on differentiated technologies used to treat conditions that are ubiquitous and for which reliable data shows that they are doing a good job for patients.

Third, we look for a pipeline. In order to maintain a leadership position over a long period of time, a company has to continue to innovate. Having new, innovative products in the pipeline is important to maintaining a competitive advantage in some of the nascent markets over time.

Fourth, as far as being attractive for investors, we look for companies that would fit strategically and synergistically within a larger medical device company. The larger medical device companies are generally growth-starved but cash-rich. They have the wherewithal and propensity to do more acquisitions to augment the growth profile of their large medtech franchises.

TLSR: So, growth via penetration is number one; number two is emerging leadership through innovation; number three is the existence of a deep pipeline; and number four is desirability as an acquisition candidate.

JM: That's right.

TLSR: When doing channel checks, you speak to physicians actually using the new technologies. They are by definition more adventurous, and I wonder how you discern if their experiences might translate to the bread-and-butter interventional cardiologist, cardiovascular surgeon or electrophysiologist?

JM: The Edwards Lifesciences Corp. (EW:NYSE) transcatheter heart valve recently went through a very large clinical trial called PARTNER. The company released some data from one arm of that study, and we saw outcomes for physicians who were involved early on and could be considered experts. Then we saw data from physicians who were relatively new to the technology. What we saw was that newer physicians did just as well in delivering care as the more experienced ones. That's one way to get a sense for whether or not a medical device and therapy are transferrable to physicians out in the field once it becomes commercial.

The other way to discern whether a medical device will ultimately become ubiquitous is by talking to the thought leaders and asking them about the pitfalls and snags they encountered early on in delivering therapy.

TLSR: It always strikes me that these interventional cardiovascular procedures are so technique sensitive that the adoption curve is going to be related to ease of use. Where are you currently seeing vigorous uptake of technology?

JM: In medtech, the most excitement exists in areas where delivery of care is becoming less invasive. If patients can spend less time in the hospital and get an outcome that’s as good as or better than that of a patient receiving a more invasive treatment, that's ideal. It also works from a health economics standpoint because hospital stays are typically the most expensive component of an intervention, whether for a surgical or a less-invasive percutaneous medical device intervention.

From an investor's standpoint, what we typically look for is a new device that is at least as good as the competitive, older-generation technology. Does it address a larger patient population? Can you deliver a superior result to the patient? Those are some of the issues you look at, but minimally invasive technologies have been, in general, an area that folks look to invest in.

TLSR: Jason, can we talk about some examples of successful innovation and vigorous uptake?

JM: Yes. The first would be transcatheter heart valves. If a patient's aortic valve is not functioning properly, you have a very symptomatic condition that is not only life-threatening but also affects quality of life. Typically the condition has been treated with a very invasive, open surgical procedure—and it still is treated that way very effectively. However, Edwards Lifesciences and others are developing a percutaneous valve that can be delivered much less invasively and has proven in clinical trials to be superior in treating some patients, especially those who are too old, too sick or too weak to be surgical patients.

Another example is mechanical circulatory support for very sick, end-stage heart failure patients. These left ventricular assist devices (LVADs) have really been miniaturized. Thoratec Corporation (THOR:NASDAQ) and HeartWare Int. (HTWR:NASDAQ) have done a good job of reducing the size of LVADs and making them significantly more durable. We are talking about a very invasive surgical procedure here, but it has been made much easier and has resulted in fewer hospital stays and improved outcomes for those patients.

Peripheral artery disease (PAD) is another area in which we're seeing growth. Treatment involves the use of percutaneous devices to clear out arteries encumbered by plaque and calcium-containing thrombi, and all the other nasty stuff that can build up in leg arteries. Innovative devices are being developed, including new atherectomy catheters, or new drug-coated balloons, that really tackle the issue of PAD and, more specifically, the bad outcome of amputations, of which there are still a couple hundred thousand done annually in this country alone.

TLSR: Can we speak about some of your specific ideas for investors?

JM: I like Edwards Lifesciences, the leader in the transcatheter heart valve segment; HeartWare, which is one of the emerging companies in the LVAD heart-failure segment; and Spectranectics Corp. (SPNC:NASDAQ), which is an emerging company delivering technology for excimer laser energy to treat PAD. STAAR Surgical Company (NAS:STAA) is in the ophthalmology field and is at an inflection point right now with a technology called the implantable Collamer lens (ICL). Some like to refer to it as the implantable contact lens, which gives you the context. It is an emerging competitor to laser-assisted in situ keratectomy (LASIK) eye procedures, which have complications. ICL is an interesting technology that has been around for a while but is now being positioned as a really solid, first-line alternative to patients who want a permanent fix for refractive error.

TLSR: We've discussed Edwards, but tell me the growth story.

JM: The growth story for Edwards is driven by its leadership position in the transcatheter aortic valve replacement market. We think that market will grow to $1.5–2B worldwide, with Edwards leading over the next half-decade. We're modeling its earnings growth over the next couple of years to reflect its penetration of this market. We're looking for its transcatheter valve franchise to grow 40–50% over the next two years and really drive that earnings growth. We think that could be a catalyst for the stock.

TLSR: I keep hearing that the transcatheter heart valve market is really "hot." Has there been any overhype in the amount of the growth that could occur in this realm?

JM: I don't know that I would call it overhype. I think it's been well debated. There are solid arguments on both sides. I don't think anyone argues that the transcatheter valve market treats patients who don't otherwise have options. For those patients, it can never be overhyped.

TLSR: The second company you mentioned is HeartWare International. What is the growth story there?

JM: It starts with our bullish stance on technologies that can be advantageous to an ever-increasing percentage of end-stage heart failure patients. Thoratec, which I cover as well, has done a fantastic job of developing the market. HeartWare is following in Thoratec's footsteps. We expect U.S. Food and Drug Administration (FDA) approval for HeartWare's HVAD left ventricular assist device to come later this year, likely in September. That would put it into competition with Thoratec in the U.S. market. We see market growth for these devices being faster than in most medtech markets over the next several years because the patient population is so severely underpenetrated. We estimate that there are about 40,000 (40K) applicable patients for LVADs in this country, with less than 10% penetration to date. We think the penetration level can rise to as much as 30–40% before we should start to worry about growth decelerating markedly. We have a long way to go. Both Thoratec and HeartWare should compete successfully in this market, but HeartWare is going to grow from very little share right now.

TLSR: What percentage of LVAD candidates are awaiting heart transplants?

JM: Theoretically all of them, but donor hearts are not available. Heart transplants would be ideal, but there are somewhere between 2–3K hearts, at the very most, available at any given time. The likelihood of getting a donor heart is very low. The LVAD companies are working on improving the therapy to make it less invasive and more effective.

TLSR: HeartWare recently announced an agreement to acquire WorldHeart Corp. (WHRT:NASDAQ) for $8 million. The company's shares had been beaten down hard. What does HeartWare get out of this? Is it basically just intellectual property?

JM: This deal triples HeartWare's intellectual property portfolio. It is getting technology in the magnetic levitation (mag lev) field, which is one way to move blood. It previously did not have specific technology on the mag lev side prior to the acquisition. It's another arrow in the quiver of its armamentaria. Whether or not anything comes of it, who knows? But at the valuation it acquired WorldHeart, it seems to be worth the money spent.

TLSR: What is your growth theory on Spectranetics?

JM: The PAD market remains underpenetrated. The end market for procedures to treat PAD is still growing nicely—we think over 10%—which makes it one of the better growth markets in medtech. Spectranetics has a litany of devices based on its excimer laser and catheter technology to provide therapy. It has what could be a "killer app" for treating peripheral in-stent restenosis, which is the bane of interventional cardiology. There aren't too many good options for this problem. The excimer laser catheter from Spectranetics could prove to be a nice option for clinicians treating that condition. We think that kind of application drives the vascular intervention business over the long term.

On the lead management side, Spectranetics has a frontline technology to extract expired leads. Many thousands of ICDs and pacemakers have been implanted over time. Some good quality clinical data proves that taking the leads out, especially when they're infected, improves a patient's survival rates markedly. Spectranetics has seen positive tailwinds in that business. We think both of those areas are primed for accelerating growth over time.

TLSR: This question applies to both Spectranetics and Volcano Corp. (VOLC:NASDAQ). Are either of these companies developing diagnostic or therapeutic tools for vulnerable plaques?

JM: Volcano has been very active in the area of detecting vulnerable plaques. Spectranetics, to my knowledge, has not been involved in the diagnosis of vulnerable plaques.

TLSR: Do you have a story on Volcano, which is in the invasive intravascular imaging and precision guidance market?

JM: We have a Hold rating on the stock. We've been on the sidelines given the general sluggishness in the underlying growth of percutaneous coronary interventions (PCI). The company has done a phenomenal job of outgrowing the underlying trend in the PCI market, which has been weighed down by reports of overutilization of stents. But Volcano has risen above the fray. There has been underpenetration in the use of intravascular imaging, and the company has done a phenomenal job of developing that market. It has an emerging leadership position in fractional flow reserve (FFR), which is another intravascular imaging diagnostic that has proven in clinical trials to be very advantageous. This market is growing, and we anticipate the company growing in the low- to mid-teens for the next couple of years. I think it's one of the best-managed medtech companies in my universe. But we see it as being near full valuation right now, so we're looking for a better entry point for our investors.

TLSR: Any other company that you would like to comment on?

JM: Another big medical device growth area is atrial fibrillation. I follow AtriCure Inc. (ATRC:NASDAQ), which just received FDA approval for a surgical medical device to treat the problem. I think AtriCure has some fantastic prospects over the longer term. It is trying to put its training and education initiatives in place to develop the market, which is challenging for any company, let alone a small company. But I think it will get there. I think it is very well managed with tremendous prospects for growth given that the market presents a big frontier for medical devices and remains underpenetrated.

TLSR: Does AtriCure get a bad rap because of the U.S. Department of Justice issues that it faced?

JM: No. I think that is largely behind the company. The stock experienced a big impact from that, but the management team was open with the Justice Department and answered all its questions. ArtiCure paid a small fine and is now moving forward as a better, stronger, quality-controlled company.

TLSR: Many thanks to you. I've enjoyed this.

JM: I appreciate it.

Jason R. Mills joined Canaccord Genuity after leaving First Albany Capital, where he was managing director and senior analyst covering the medical devices sector, with a specific focus on the areas of cardiovascular health, ophthalmology and sleep disorders. Mills previously served as a vice president and senior research analyst with Thomas Weisel Partners, where he covered companies in the ophthalmology and sports medicine/arthroscopy sectors. Mills holds a master's degree in sports administration from Ohio University and a bachelor's degree in economics from Yale University.

Want to read more exclusive Life Sciences Report interviews like this? Sign up for our free e-newsletter, and you'll learn when new articles have been published. To see a list of recent interviews with industry analysts and commentators, visit our Exclusive Interviews page.

DISCLOSURE:
1) George S. Mack of The Life Sciences Report conducted this interview. He personally and/or his family own shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of The Life Sciences Report: None. Edwards Lifesciences Corp. is not affiliated with Streetwise Reports. Streetwise Reports does not accept stock in exchange for services.
3) Jason Mills: I personally and/or my family own shares of the following companies mentioned in this interview: None. I personally and/or my family am paid by the following companies mentioned in this interview: None.

( Companies Mentioned: ATRC:NASDAQ, EW:NYSE, HTWR:NASDAQ, SPNC:NASDAQ,
NAS:STAA, THOR:NASDAQ, VOLC:NASDAQ)

Source: The Life Sciences Report

Sunday, April 8, 2012

Know Your Medtech Growth Drivers: Joanne Wuensch

TICKERS: ARTC, CAH, CFN, COV, MDT, RMD, STJ
Joanne Wuensch Medical technology has been stalled in a quagmire of regulation, lowered usage and a more tight-fisted health insurance environment, but Analyst and Managing Director Joanne Wuensch of BMO Capital Markets has identified a few ground-breaking technologies that will drive increasing cash flows in particular companies. In this exclusive interview with The Life Sciences Report, Wuensch delivers the names that will provide essential diversification while they return growth for investors.

The Life Sciences Report: Medical technology (medtech) stocks have taken a breather since the beginning of February, but they had quite a run-up between mid-December and early February. I'm wondering if this has been a response to an improving economy or does it mean medtech is in a secular uptrend?

Joanne Wuensch: I think that the group was generally oversold in Q411. Multiples were meaningfully compressed. There was some positive commentary about increased or improving utilization from management at Johnson & Johnson (JNJ:NYSE) on its Q4 call, and from one of the lab companies. It then became sort of a self-fulfilling prophecy whereby depressed stocks reacted and we saw a lot of short covering and a lot of money chasing money. So, we had some very nice price performance in the first eight weeks of the year.

TLSR: So, if medtech is not in a secular uptrend, is this a response to an improving economy?

JW: I think that in many ways the fundamentals are no different today than they were in November. The only thing that has changed is that multiples have become a little bit more normalized and not as depressed. And, as we look at 2012 guidance, a lot of these companies are not assuming a recovery in the second half of the year, which means that estimates are largely achievable for 2012. And that's a relief.

TLSR: You've written rather extensively about more rigorous U.S. Food and Drug Administration (FDA) regulation around medical device development. It has slowed approvals. How significant is this issue?

JW: Well, it's significant because this industry is driven by technology innovation. So, whether you slow down innovation by slowing down approvals or by increasing hurdles required to bring new technology to market, it is more difficult. We are seeing the need for clinical data for 510(k) premarket notifications that were previously accomplished without clinical studies. [Note: Under the 510(k) process of the Federal Food, Drug and Cosmetic Act, if a device is substantially equivalent in safety and its activity or effectiveness, clinical trials are not required]. Sometimes companies run a clinical trial according to specifications from the FDA, and then the FDA sort of sits on the approval process until further notice. We have also seen increased need for economic data from the FDA.

TLSR: How much of this is attributable to increasing complexity in the medtech field?

JW: Some of it is increasing complexity. Some of it has to do with some very high profile problems, such as concerns about metal-on-metal hips, things like that. A new brand of hips was approved by FDA with limited clinical data, and it was a little bit of a black eye on the FDA.

TLSR: What are the other headwind issues you are seeing?

JW: Well, the most basic one is decreased utilization, and that is somewhat driven by the economy. Also, the delivery of healthcare has changed over the last 24 months with the advent of higher co-payments and annual deductibles. Overall, price pressure is higher. Hospitals are more conscious of cost. Administrators have even changed the way products are stocked to save money. Physicians who used to be independent are now working for hospitals, who are managing their expenses. Also, payers are requiring more clinical data to reimburse for a product, and patients have to pay a higher percentage of the surgical and product cost. All of these things have changed healthcare.

TLSR: I can't help but wonder if all of this additional FDA diligence going into development might help when going to Centers for Medicare & Medicaid Services (CMS) to request approval for reimbursement?

JW: In theory, if you have more economic data, it would help when going to CMS for reimbursement.

TLSR: Are these extended approval times driving medtech companies to sell products in emerging and international markets?

JW: Sadly, yes. There's a push for product sales outside the United States because you don't have to go through the FDA hoops, and you don't have to go through the CMS gauntlet. There is also a push into emerging markets because they are largely untapped. It used to be that a company would get a product approved first in Europe, then here in the U.S. and then in Japan. There was zero discussion of emerging markets. The amount of time between approvals from one region to another was one year, maybe two years, but not an extreme period. Now you have products, like transcatheter heart valves (TCHV), that are approved in Europe four years before they're approved in the United States. And, then there's another 18-month, maybe 24-month gap before it is approved in Japan. That's for a high technology product. Now, even for a lower technology product, companies are talking about emerging markets on every single conference call. Going into emerging markets may mean opening a manufacturing facility in China. It may mean increasing your selling, general and administrative expense (SG&A) or redirecting your SG&A to hire feet on the street in those markets. Or in a more subtle or direct way, a company might create a product that is particularly attuned to the emerging markets.

TLSR: Can those data from markets outside the U.S. be used at the FDA?

JW: Well, can they be submitted? By all means submit it. How much the FDA uses that to come to a conclusion on approvability is still, in my opinion, in question. If you run a U.S. clinical trial and you have data from outside the U.S., I don't know if it matters a hill of beans versus a U.S.-run clinical trial and making a decision toward approvability.

TLSR: Does dramatic innovation exist in medtech now?

JW: It does. I would say that TCHVs are a dramatic innovation. I would argue that renal denervation is dramatic innovation. Also, patent foramen ovale (PFO) closure type devices, abdominal aortic aneurysm (AAA) devices and neurovascular products still hold a wide-open opportunity. So, I think there is dramatic innovation. There's less of it, but it still exists.

TLSR: What about cardiac rhythm management (CRM), implantable cardioverter defibrillators (ICDs) and coronary artery stents? Would they figure into an aging baby boomer investment theory?

JW: They do figure into an aging baby boomer theory as well as hips and knees obviously.

TLSR: Are you bullish on the cardiovascular segment?

JW: I'm not bullish on ICDs and stents. I'm largely favoring some of the diversified names. I am bullish on two cardiology companies, Medtronic Inc. (MDT:NYSE) and St. Jude Medical Inc. (STJ:NYSE), but for different reasons. I have them both rated Outperform. Medtronic is trading at a discount to the group's 12–13 times multiple. Medtronic has had its problems, particularly in spine, but it's giving a nice dividend of almost 3%. And, I suspect the relatively new CEO Omar Ishrak, who came from GE Healthcare Systems, a unit of the General Electric Company (GE:NYSE), will start to do some company portfolio management, and in the process we anticipate that the gap in the multiple differential will close.

TLSR: You had mentioned AAA as a growing technology. Medtronic is in AAA.

JW: It is absolutely. It has some other higher technology pockets, renal denervation and TCHVs, and the company just launched a new drug-eluting stent in the U.S. But there are some larger portions of its business, such as ICD and particularly its spine franchises, which have been declining. ICD has been bumping along the bottom.

TLSR: These areas you just mentioned are catalysts for Medtronic, right?

JW: Correct.

TLSR: Do you expect market-moving information this year?

JW: Well, the company hasn't had an analyst meeting in almost two years, but as I look out over the next 12 months, Medtronic will have its first analyst meeting under the new CEO in June of this year. As he starts to unveil plans for how he's going to make his mark at the company, the stock should respond in kind.

TLSR: You said you are bullish on St. Jude Medical.

JW: Yes, this is a company that is still heavily devoted to the CRM market. But also similar to Medtronic, it is investing in the higher growth areas, such as atrial fibrillation, TCHVs, renal denervation and PFO closure devices. It has also been steadily taking share in the ICD market, and it received FDA approval in Q411 for a new quadripolar pacing lead, which allowed it to take some market share in Europe. There is a similar expectation here in the U.S.

TLSR: Can we talk about your other Outperform-rated companies?

JW: Sure, let's take them individually. Covidien Ltd. (COV:NYSE) was spun out from Tyco Healthcare Group LP about four years ago. It has done a very good job of rearranging its architecture. It has sold off non-core businesses and actively invested in higher-growth business, and in the process it has expanded operating margins and generated a heck of a lot of cash. It's about to go through another transformation with the sale of its pharmaceutical franchise, and I expect that to happen in H113. It should end up as a company dedicated to medical devices, including some hospital supplies. I expect it to be a high single-digit revenue grower with a low- to mid-20%-type of operating margin.

TLSR: Do you expect a catalyst this year to move the stock?

JW: As the company provides more information and details on the spinout of the pharmaceutical division, I suspect that you'll see returns that continue to outpace over the next 12–18 months.

TLSR: The next Outperfom?

JW: CareFusion Corp. (CFN:NYSE) was spun out of Cardinal Health Inc. (CAH:NYSE) three years ago. A year ago the company got a new CEO, Kieran Gallahue, who came from ResMed Inc. (RMD:NYSE). When he was at ResMed he had a very good eye on expense management, taking several hundred basis points out of SG&A over a two-year period. He moved or expanded manufacturing of ResMed products into Singapore, which is more sheltered from foreign exchange movements than was manufacturing in Australia. I think he's going to bring this approach to market expansion and expense management to CareFusion. Management guidance is up, and by the time CareFusion exits fiscal 2014, the company will be showing operating margins of 20%.

TLSR: Joanne, what are the product lines that will move CareFusion?

JW: This one is less about product lines and more about blocking and tackling to get that operating margin up. The stock will trade as the operating margin moves.

TLSR: What's your next Outperform?

JW: ArthroCare Corporation (ARTC:NASDAQ) is a small-cap name, sub-$1 billion. The company has moved through a lot of legal issues. It has two lawsuits still outstanding that are associated with U.S. Department of Justice inquiries. The older one I expect should be resolved in late spring/early summer. The second one is a new one, and so I do not have any timing for that one. The company is in sports medicine and it is part of our consolidation call on the orthopedic market.

TLSR: So, it's a takeout candidate. Is its low relative strength due to the Justice Department inquiry?

JW: Yes.

TLSR: Assuming the first Justice Department issue is resolved, would another company assume liability of the newer issue and acquire the company, or must both issues be resolved prior to consolidation?

JW: I don't have an answer to that. It's a great question though.

TLSR: Thank you very much. I've enjoyed this.

JW: Thank you.

Joanne Wuensch is a research analyst in BMO Capital Markets' Equity Research Group, covering medical technology companies in the cardiology, ophthalmology, orthopaedic and respiratory sectors. Before joining BMO Capital Markets, she was a research analyst with ABN Amro (ING Barings) covering medical products and was a research associate in the medical technology group at UBS Securities. Her career in financial services began at J.P. Morgan, where, among other positions, she was an associate in municipal finance investment banking in the healthcare and higher education group. Wuensch joined BMO Capital Markets in 2002.

DISCLOSURE:
1) George Mack of The Life Sciences Report conducted this interview. He personally and/or his family own shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of The Life Sciences Report: None.
3) Joanne Wuensch: I personally and/or my family own shares of the following companies mentioned in this interview: None. I personally and/or my family am paid by the following companies mentioned in this interview: None. I was not paid by Streetwise for participating in this story.

Choose Medical Technology Stocks Carefully: William Plovanic

TICKERS: ARTC, DXCM, EXAC, ISRG, MAKO, NUVA, SLTM

William Plovanic The dart board will not help in picking medical technology stocks. Analyst and Managing Director William Plovanic of Canaccord Genuity focuses on the musculoskeletal/orthopedic sector, which is sensitive to factors beyond just the unmet needs of patients. Economic and regulatory dynamics make it difficult to predict growth in medtech, but in this exclusive interview with The Life Sciences Report, veteran analyst Plovanic delivers both ideas and names that could generate excellent returns for investors.


The Life Sciences Report: What is the general feeling of institutional investors? Are they positive on medtech? Are they seeing flows of funds come in from investors?

William Plovanic: I don't think investors are necessarily positive on medical technology, but they are definitely looking for opportunities. Medtech has been difficult from a macro perspective, and therefore investors have not been focused on putting money to work in this space. Over the last year or two it's been challenging, to say the least.

TLSR: We had a bit of a run-up in medtech between mid-December and end of January. My assumption was that this was part of a general market upswing.

WJP: Over the last 12 months, a lot of companies, especially the growth names, have traded in a range after peaking at the end of 2010—early 2011. The stocks that did move in the sectors that I cover were due to company-specific drivers. But as a whole, 2011 was probably more of a consolidation year.

TLSR: So you have to be selective when you're choosing medtech stocks, is that what you're saying?

WJP: I think you do, but I've also seen the risk trade in high-growth, high-multiple stocks make advances. As money flows back into medtech, it typically goes into that high-growth group.

TLSR: On the outperformers, you think momentum has been the issue there?

WJP: On the growth names, definitely.

TLSR: What has been holding medtech back? Is it macroeconomic, larger co-pays/annual deductibles, regulatory? What is the single biggest factor?

WJP: All of the above. Obviously, these have resulted in a slowdown in procedure volumes, which have changed drastically, and that has negatively impacted these companies. On top of that, we're looking at negative pricing in orthopedics, which used to be a sector that realized positive pricing power, and that's macroeconomic driven as well. Two things have really impacted the sector, volumes and pricing. All of these factors have impacted the growth rates and the bottom line earnings of these companies for the past couple of years and they will likely continue to do so going forward as well.

TLSR: The earth has really shifted under the feet of this sector.

WJP: Right. Also, new technologies are the lifeblood of any industry, and one of the big issues, for med tech as a whole as well as orthopedics, is the regulatory environment. It has become more challenging and more stringent, resulting in fewer new technologies being approved, and that has caused growth rates to slow. That has also been one of the causes of lower pricing. Typically, a new product allows you to gain a premium price. If you don't have innovation and new technologies coming to market, you can't drive price mix.

TLSR: So, companies need to innovate, but the regulatory environment is in the way?

WJP: Companies are trying to innovate, but with more stringent requirements, it pushes out the timelines and increases the cost of innovation. Companies have to become more selective on what technologies they move forward with, based on what they believe the regulatory process may or may not be for any given project.

TLSR: Has the slowdown in regulatory approvals been a factor related to the increasing complexity of the technology, or is there something else going on at the U.S. Food and Drug Administration (FDA)?

WJP: That's a difficult question to answer. Has the complexity of the devices changed drastically in the last four years? No, but it has probably changed over time. Maybe the regulatory process did not keep pace with technology advances over the past few decades, and it's finally making the changes necessary. But we've definitely seen a much more difficult regulatory environment.

TLSR: Bill, do you expect to see consolidation in medtech during 2012?

WJP: We have already seen some consolidation, and given the balance sheets of the larger companies and the lack of innovation, I would expect to continue to see that consolidation in order to drive the top line revenues for those larger companies.

TLSR: I assume that investors want to play the boomer market, and that would mean largely musculoskeletal. Of course it could also be the cardiovascular realm as people live longer.

WJP: It could be orthopedics, cardiovascular, diabetes, obesity or aesthetics. There are many different ways to play that market.

TLSR: Are there decent margins to be had now in orthopedics?

WJP: In the orthopedic companies that I follow, the range of gross margins is typically from 60–80%. There are always some outliers, but that's the range. You don't start falling down to a 50% or below gross margin until you get into truly commoditized product lines.

TLSR: What shifts are you seeing in the orthopedic/spine industry currently?

WJP: For total joints, the discussion has shifted away from materials and squarely onto fit and alignment. That could be achieved via robotic surgery, custom implants or custom cutting guides, but we've definitely moved away from materials as the solution.

There haven't been a lot of new technologies in the spine area, but the one bright spot is artificial discs. I think we'll see the approval of several cervical discs coming over the next 12–24 months. I think that can help drive that market.

With extremities/trauma, it's been the creation of procedure-specific implants. Customization is really a very fast-growing market, and that's driven an increased focus on this segment. Surgeons and companies are coming up with new products that are specifically kitted to solve a problem. If I need a plate for a procedure, it's specifically made for that specific anatomy rather than bending and cutting a standard plate to make it fit. I think we've seen a lot of those types of technology advancements helping to drive that market.

TLSR: Bill, what companies are you talking to investors about today?

WJP: Growth names include MAKO Surgical Corp. (MAKO:NAS) in robotics; I also follow DexCom Inc. (DXCM:NASDAQ) in diabetes with its continuous glucose monitoring sensor; Insulet Corp. (PODD:NASDAQ) with its disposable insulin pumps; and NxStage Medical Inc in the dialysis market. In terms of value names, there's NuVasive, Inc. (NUVA:NASDAQ) in spine; ArthroCare Corp. (ARTC:NASDAQ) in sports medicine. And then there is Solta Medical, Inc. (SLTM:NASDAQ) in the aesthetics space with its non-invasive fat ablation product that it has just started commercializing in the beginning of this year. Of the 21 stocks I cover, those seven names are probably the most discussed on my coverage list today.

TLSR: You have DexCom rated Buy with an $11.50 price target. It's pretty close to that now. Do you expect to raise your target?

WJP: I believe the company is well positioned this year in terms of the guidance it provided and the potential for it to outperform those expectations. As companies beat and raise estimates, the price targets can typically move up. I think the big value driver for this company will be its Gen 4 sensor, which is not due out until the end of this year/early next year. Again, I repeat that stocks tend to perform well in beat-and-raise years.

TLSR: You mentioned NxStage Medical, a growth story. It's about portable home hemodialysis. You raised your target price from $24 to $26. This is the kind of technology that can reduce cost for an insurer, can it not?

WJP: I think the key to NxStage's home hemodialysis is the fact that it's a better therapy for the patient. The economic data showing that it reduces costs to the system will be out the middle of this year. We've seen data from frequent dialysis studies and it tends to point in that direction, but I think what people need to really understand is that when nephrologists and nurses are polled, almost all, like 98–99% of them, would rather patients be on home hemo or peritoneal dialysis rather than in-center. More frequent dialysis allows for lower drug use, better quality of life and quicker recovery times post treatment. It is the right treatment.

TLSR: You say economic data are coming out mid-year. I'm just thinking here, FDA is considering economics along with safety and efficacy in medtech. Why doesn't FDA just defer this to Centers for Medicare & Medicaid Services (CMS) and judge the product on its safety and efficacy?

WJP: Great question.

TLSR: So, do you have a comment on that?

WJP: No.

TLSR: Can NxStage improve predictability for reimbursement purposes?

WJP: That will come over time. CMS will need to do that. One other thing about this industry is that the service providers, the clinics such as DaVita Inc. (DVA:NYSE ) and Fresenius Medical Care (FMS:NYSE ), are the gatekeepers. They're the ones that get reimbursed and they basically control which therapy the patient goes on. So at the end of the day, you get predictability when payers know exactly what the economic model looks like for each type of therapy, and adoption will likely increase. I would say at this point, NxStage, which has more than 5,000 patients on its therapy, has been mostly a word-of-mouth, grassroots campaign.

TLSR: You mentioned the robotics company MAKO Surgical, another of your growth names. This stock is up 35% in the past three months and has almost doubled in the past 12 months. What makes it so interesting?

WJP: I believe it's also the most expensive stock in med tech from an enterprise value:sales multiple. Robotics has been a big value driver. Intuitive Surgical Inc. (ISRG:NASDAQ) was a great success, and I think people point to that company a lot. MAKO has done a phenomenal job in the unicompartmental knee replacement market. Historically, the challenge was surgeons being able to implant the replacements correctly. It was very technique-sensitive. What MAKO did was to make this procedure extremely reproducible in any surgeon's hands. Why replace the whole joint when you can intervene earlier and replace only the diseased part?

However, the value and the driver of this stock over the last 12 months have been the expectations for the hip market, which it has been slowly launching. MAKO showed the product at the American Academy of Orthopaedic Surgeons' big conference in the spring of 2011, and it started commercializing it at the end of 2011. I think that's what really drove the stock over the last 12 months. I think the jury is still out on how quickly the adoption and penetration rate will be for the hip application and implants.

TLSR: You also mentioned ArthroCare, which has had its issues with the Department of Justice (DOJ). What do you have it rated?

WJP: We have a Buy rating on ArthroCare, and our target is $29.

TLSR: What do you like about it?

WJP: The thesis on ArthroCare is it is a market leader in the two markets where it competes. It started as a platform technology company and created the market-leading position in sports medicine for the use of energy for the cutting/ablating of soft tissue rather than using mechanical tools. It now has 50% of that energy market in sports medicine. It then utilized that beachhead to backfill with other products that would be used in arthroscopic procedures. It also took the technology and moved it into the ear, nose and throat (ENT) market for tonsillectomies where it now has 40% market share. It has also done some backfilling with some other ENT products. It's a company that has great market leadership in the subsegments where it competes. It also has a very high free cash flow yield, floating around 10% right now.

TLSR: But it's had the legal issues.

WJP: The ongoing legal issues have been its biggest challenges over the last three or four years. But it's been going through its checklist one-by-one and ticking them off. It had almost completed that, and then a new one popped up. We'll see how long that one takes to get resolved. This is a company that has great market position and great potential. In terms of acquisition, it would fit well into somebody else's portfolio.

TLSR: So it's a takeout candidate, but now it has the new issue with the DOJ which could put more pressure on the stock.

WJP: It would delay the timing of anything, which therefore puts pressure on the stock. That's why the stock moved from $30 down to where it is.

TLSR: Are the shareholder lawsuits nuisances, or are they material as well?

WJP: Actually it took a charge for the shareholder lawsuits and put the money aside for that. So, that's one of the legal issues that has been resolved.

TLSR: I'm noting that you follow and have a Buy on Exactech Inc. (EXAC:NASDAQ) with a target of $27. Could you speak to that one?

WJP: Exactech is actually the company I've had coverage on the longest, since March 1998.

TLSR: Your target price implies about 80% upside.

WJP: The company trades at a significant discount to the rest of small cap medtech. When it gets some of its new product cycle moving and growing its top line, it will be lifting to a valuation that's closer in line with all of small cap.

TLSR: The company appears diversified in its product lines, and I thought that was interesting considering its small market cap.

WJP: The challenge with these smaller companies is that orthopedics is a capital-intensive business, and they tend to have very low free cash flows. All their money needs to be reinvested into instruments to help grow the business. So orthopedics is definitely a business of scale, and scale could be $1 billion (B) in revenue, but it's difficult to get to that $1B because share shifts very slowly.

TLSR: You mentioned one of your value names, NuVasive, and you have it Buy-rated with a $21 target.

WJP: NuVasive is a stock that we've covered for probably three or four years. We went negative on it with a Hold rating about a year and a half ago. We foresaw a lot of the challenges coming in the spine market, including price and procedure-volume impact. At current valuations, we recently upgraded it. Given the acquisition of the neuromonitoring business, we felt that this stock was finally positioned where it could meet or exceed expectations. We felt that if approval of its cervical disc and the cross-selling efforts with neuromonitoring could come to fruition that it would be all upside to the numbers. Upside tends to drive stock higher. Given the current valuation, which is anywhere between 1–1.5x enterprise value:revenue, that tends to be a bottom for these names. On top of that, NuVasive is the category leader. It created the lateral procedure where it leads the market. It is considered the best player with that technology, and that is a great asset in my opinion.

TLSR: Insulet is one of your growth names. Would you comment on that?

WJP: Insulet is an interesting technology. It is the first player to market with a three-day, disposable insulin pump. It's another company like DexCom that has had challenges with new products coming through the FDA. Its next-generation disposable pump is a very promising technology, and should help more from a profit and loss standpoint than anything else. It's a little smaller, and it might be a little more applicable to a broader patient population as a smaller patient can wear it. But I think this is more of a gross margin story, allowing it to increase from a 50% level to, say a 65–70% gross margin. We have Insulet rated Buy, and the target is $27.

TLSR: You mentioned Solta Medical in the aesthetics space.

WJP: Solta really pioneered fractional laser technology, Fraxel, for skin resurfacing and also the use of radiofrequency energy for skin tightening under the Thermage brand. Solta is different from the rest of the aesthetics pack in that a large component, more than 50% of its business model, is disposables, which is significantly higher than any of its energy device competitors. Those disposables carry ~90% gross margins. The reason we like it that it is literally in the first inning of a new product cycle in a new market with a different technology to be sold to its current customer base. It acquired Liposonix, a noninvasive fat ablation product. It is second to market in this category, and it just began commercializing the product at the end of 2011. We'll see the first significant revenues from this product in Q112. Non-invasive fat ablation is a very fast-growing segment of the market.

TLSR: These procedures are largely non-reimbursable.

WJP: They're all cash out of pocket.

TLSR: Bill, I enjoyed speaking with you.

WJP: Thank you very much.

William Plovanic joined Canaccord in 2007 as managing director, medical technology equity research analyst. He has been a publishing sell-side analyst with coverage of medical devices for over 15 years. Mr. Plovanic's areas of coverage include orthopedics, diabetes, obesity, neuro-technologies, dialysis, aesthetics and general surgery. In 2009, Plovanic was ranked as the #2 Earnings Estimator for Health Care Equipment & Supplies by Starmine. Furthermore, in 2003 and 2004, Mr. Plovanic was selected as a Wall Street Journal "All Star" Analyst in the medical device sector and in 2002 was named the #1 ranked analyst by Starmine for stock picking and performance in the medical technology sector. Mr. Plovanic is a frequent presenter at medical and industry meetings. Prior to Canaccord, Plovanic was a managing director and senior research analyst at First Albany (now Gleacher & Company). Previously, he worked at PMG Capital covering medical devices and products. He also worked as director of research for the capital markets division of LaSalle St. Securities Inc., where he focused on the small-cap healthcare, technology and biotechnology industries. He graduated from Bradley University with a Bachelor of Science in finance and is a chartered financial analyst.

DISCLOSURE:
1) George S. Mack of The Life Sciences Report conducted this interview. He personally and/or his family own shares of the following companies mentioned in this interview: None.
2) The following companies mentioned in the interview are sponsors of The Life Sciences Report: None.
3) Bill Plovanic: I personally and/or my family own shares of the following companies mentioned in this interview: None. I personally and/or my family am paid by the following companies mentioned in this interview: DexCom, Insulet Corp. and TranS1 are investment banking clients of Canaccord Genuity Inc. Additional information, including disclosures regarding all securities under research coverage, is available at Additional information, including disclosures regarding all securities under research coverage, is available at http://www.canaccordgenuity.com/en/ODD/pages/disclosures.aspx. I was not paid by Streetwise for participating in this story.