Since its invention in
1881, doctors, specialists, researchers, hospitals and pharmaceutical companies have been
utilising the sphygmomanometer. Sph-what? Don't worry it's just the inflatable
cuff that your doctor may have placed around your arm that is used to measure
blood pressure. It's proven to be a very useful device for predicting and
preventing cardiovascular disease, strokes, diabetes, kidney failure, eye
disease etc. However, while it measures the blood pressure in your arm, known
as brachial blood pressure in medical parlance, what we really want to know is
the blood pressure around your heart, or your aortic central blood pressure.
Until recently, the only way to find that out was to use an invasive catheter -
basically a tube they stick into your body to reach the heart - and as such,
this was typically done in a hospital.
|
The SphygmoCor XCEL |
However, in 1992, a
company was co-founded by two clever guys and in 1994 they developed a device called SphygmoCor. It was able
to take your brachial blood pressure (blood pressure in your arm) and
mathematically derive your central blood pressure with a good degree of
accuracy compared to the invasive catheter, in addition to a host of other
useful measurements. The newest iteration of that technology called the SphygmoCor XCEL is in the cuff based form that GPs and patients are used to.
The operator simply presses start, waits 60 seconds and all the data is fed to
a computer.
As you might have
guessed, I'm writing about all this because the device and its 8 patents are
owned by AtCor Medical (ASX:ACG), which designs, manufactures and sells the SphygmoCor products all over the world with the help of distributors. Although
I typically stay away from emerging biotech companies because they are often
too speculative and too hard to understand, the risk/reward appeared compelling
enough for me to buy 14,530 shares at $0.12 yesterday. I've actually been
following this company since June or July last year, when shares traded at
around $0.07 and I was very tempted to dip my toes in and buy some shares. My
more intelligent friend purchased shares but regrettably I didn't, and I
watched as the shares rocketed up to a high of $0.21 in October, before
gradually dropping back to its current level. At a market capitalisation of
$18.9 million, or $21.3 million assuming all options are exercised, I believe
that this business could be significantly undervalued and will try to explain
why.
In the last decade, study
after study has come out showing that central blood pressure provides more
useful information than brachial blood pressure. Even though two people could
have the same brachial blood pressure, their cardiovascular risk as measured by
central blood pressure can differ significantly. Using central blood pressure
helps doctors to diagnose people better, and a study has shown that it improves
treatment too, since the better diagnosis allows them to prescribe fewer drugs
to patients. In addition, pharmaceutical companies are able to develop more
effective drugs with fewer side effects, cardiologists are able to better treat
complex cases of hypertension (high blood pressure), renal physicians can
improve treatment of kidney problems, and researchers are able to draw better
conclusions in their studies. The list goes on.
The body of evidence in
support of using central blood pressure is growing every year, with over 100
new peer reviewed journals being published each year. At the forefront of this
trend is ACG with its SphygmoCor technology, having been mentioned in over 700
per reviewed journals to date. As the first device to measure central blood
pressure through a noninvasive method, it's been subject to a lot of scrutiny,
and has held up quite well. So much so, that new devices are regularly compared
to the SphygmoCor in academic papers to determine accuracy, and the management
of Atcor labels its device the 'gold standard'. I am quite confident that this
technology will eventually replace the old sphygmomanometers that only measure
brachial blood pressure, but what I'm much less sure of is how long it will
take. Some other important measures a SphygmoCor device can take include pulse
wave velocity, heart rate variability and arterial stiffness, but I won't get
into these (mainly because I don't
understand myself).
Reflecting their
usefulness, these machines do not come cheap, and although I am not sure about
the latest figures, I believe they were being sold for $15,000 to $20,000
before. This is obviously why ACG has stunningly high gross margins of over
80%. Assuming they sell for $15,000, that means it only costs ACG $3000 to
manufacture it. However, as a small company, administrative expenses, marketing
and sales expenses, and research and development each away at a large portion
of that gross profit. With a substantial amount of relatively fixed costs, ACG
has a lot of operating leverage, which will supercharge profits when revenue
increases, and vice versa. Only last year AtCor managed to report its first
profit after many years of losses, and has had positive cash flow from
operating activities for the last 6 quarters. Bear in mind however, that ACG
has been receiving financial support from the government through grants and
R&D tax concessions, and this will not continue indefinitely. Recent
performance has meant the balance sheet is in much better shape than it has
been in the past, with cash of $4.1 million and no debt.
ACG's head office is
based in Sydney, but it is in their American office that the CEO Duncan Ross
resides. Why? Because for many years ACG has been focusing on driving
penetration in the US market. Rich, developed nations that seek out the best
technology are the perfect target for ACG, and America falls into that
category. In addition, the majority of big pharmaceutical companies are based
in America, and around 60-70% of ACG's sales come from selling devices to these companies for their trials. Astonishingly, as of late 2012, SphygmoCor had a 95% share of the market in this pharmaceutical trials sector
and speaking with management on the phone, it seems Atcor's position may have
even turned into true monopoly. Aside from providing higher quality data, one
of the reasons for this is because ACG adds further value by offering data
management services to pharmaceutical companies, which can be quite a hassle
for these companies if they are running big trials. AtCor's exceptional service
has led to a 100% retention rate in this market. Apparently one pharmaceutical
company tried a competing product, in the end coming to ACG and saying that
they regretted it. Management reckons that the market for selling these devices
to pharmaceutical companies is US$110 million annually. With only single digit
penetration so far, ACG would be hugely successful if it could continue to
maintain that monopoly whilst take up within the industry heads higher, given
its total sales were just $9.1 million last year.
Unfortunately, the
pharmaceutical trials market is quite lumpy, and delays in contracts has led to
ACG's sales dropping 51% in their most recent half (56% on a constant currency
basis), knocking the share price down a fair bit. Nevertheless, I believe that
this is only a temporary hiccup that the market is too impatient to look past. Encouragingly, sales to US clinicians grew 77% in spite of uncertain market conditions. One
major short term risk is that in FY13, $5.3 million out of AtCor's $9.1 million
in sales were from just two customers (which I presume are pharmaceutical
customers). This helps to illustrate how ACG's revenue could easily fall
dramatically, as it did in the first half of FY14. Fortunately, results are
expected to improve in the second half, and the pipeline of potential new
pharmaceutical business is quite strong at more than US$16 million.
The other three markets
that ACG is targeting are the clinical specialists (such as cardiologists,
nephrologists and endocrinologists), researchers (universities and affiliated hospitals), and the
clinical - primary care market (GPs, internists, executive health, wellness
centres). The research market has the smallest potential at US$22 million
annually, followed by clinical specialists at US$100 million, pharmaceutical
trials at US$110 million, and finally the clinical - primary care market at US$268
million. In total, the global market potential is around US$500 million annually.
Penetration in the research market is 11%, while the other three categories are
in the low single digits. As you can imagine, with its current margins, even if
ACG manages to capture even 10% of that $500 million total, shareholders at the
current price will do very well. Driving adoption in the specialists is
particularly important, because general practitioners want to see that the
specialists are using a procedure before they adopt it themselves.
For years ACG has been
trying to get the CPT code I, which means that Medicare in the US will
reimburse clinicians every time they take someone's central blood pressure.
Private payers, such as insurance companies, generally follow Medicare's lead
on what they will reimburse for and how much. While AtCor managed to obtain a CPT
code III for their technology a couple of years ago, this is a temporary code
reserved for emerging technology/processes and is generally not
reimbursed. I was told that the reimbursement rate for ECG, which is
around $50 per test, would be quite a reasonable amount in the event that ACG
gets the CPT I code (keep in mind there are variations based on geographical
regions). At this level, the payback for doctors would be around 6-9 months, while
the device can be expected to last around 4-5 years. I agree with management
that these are very compelling economics, and one could expect sales to
increase quite rapidly if this does eventuate. Although I am no expert on the
approval criteria, it seems to me that success is more likely than not as
almost all of the boxes have been ticked, and for what it's worth, management
has a 'good degree of confidence'. ACG is expecting to file for a CPT I code
later this calendar year with the backing of the Renal Physicians Association
(who also played the same role for the CPT III) but even if it is approved, the
earliest it could come into effect is 1 January 2016, so patience is
required on this front. The existing CPT III code and the CPT I code will only
apply to FDA approved products, of which there are only four, and only products
that utilise the central waveform. Most competing devices that spit out numbers
don't actually use the central waveform and therefore won't be covered by the
CPT code.
At the moment, there is
very little competition in the US for ACG as most of its competitors are based
in Europe and focus on selling their products into European countries, potentially allowing ACG to build up a decent first mover advantage in the US. This is partly due to the regulatory environment in Europe, which has a simpler regulatory regime than the US and therefore has lower barriers to entry. However,
the European market for these devices is more reliant on the government than private
payers, and as we all know, the government budgets for European countries are
generally not too great at the moment. In addition, most of the European sales
are made to researchers, which is the smallest market for central blood
pressure devices. These factors help explain why AtCor hasn't been very profitable in
Europe. Asia doesn't yet have a culture of funding healthcare and new technology, although this is gradually changing as the middle class grows. Recent regulatory approvals in China, Canada, Mexico and Korea should
help boost sales, although are unlikely to be very significant in the short
term. Excluding pharmaceutical sales (which are grouped in the Americas segment even though they are increasingly globalised), sales between Americas, Europe and Asia Pacific are fairly even, with America a little bigger than the other two. Over time, I believe governments will recognise that it is in their
economic and social interests to adopt this technology. As Benjamin Franklin
said, 'An ounce of prevention is worth a pound of cure', and this is very true
of central blood pressure measuring devices. It is cheaper for governments and
insurance companies to prevent people from developing serious complications by
funding these devices than to spend years trying to treat people.
My main concern with
ACG is its competition - if AtCor is unable to differentiate its product, it is quite
likely that its gross margins will get crunched, or sales will simply stall. Regardless of competition, management expects gross margins to contract as clinical sales become more important as clinicians don't require all the extra features that researchers and pharmaceutical companies purchase. The bigger problem is that even though ACG markets itself as the gold standard, and has had its technology
validated through many studies, the competition is catching up and may even be
better than the SphygmoCor technology. Indeed, another listed competitor, Uscom
(ASX:UCM) has recently started calling its central blood pressure
measuring device the gold standard. This was in response to a study that rated
UCM's Cardioscope II product as having more 'clinical applicability' than SphygmoCor. Bearing in mind that this study was only conducted by one
researcher, who acknowledged the ratings were entirely subjective, and who did
not refer to the product comparison at all in the rest of the paper, I was quite
sceptical as to how much reliance should be put on this piece of information.
Nevertheless, I quizzed management about it, who aside from pointing out the
above, said that the main reason why the Cardioscope II and the Centron cBP301 were rated higher was
because unlike the SphygmoCor they do not require a computer for data to be
fed into. The requirement for a PC enables clinicians to keep a patient history and connect to AtCor's proprietary data management system, which is why AtCor believes it is actually an advantage rather than a disadvantage.
Although that study may
not be the best source of information to draw conclusions about the relative
merits of each product, after reading dozens of other academic comparisons, I
get the impression that while AtCor still provides more metrics than its
competitors and has the overall technological edge, the accuracy of the data
that its competitors do measure is quite close to the SphygmoCor. Another issue
is the expiry of patents, some of which AtCor has had for a long time (patents
generally last to a maximum of 20 years). Encouragingly, even though an
important patent - the generalised transfer function (the mathematical model
used to derive central blood pressure) - had expired three years ago,
management says that the competition has so far been unable to fully replicate
it. They also interestingly mentioned that one patent that ACG holds is
unlawfully being used by a Japanese competitor called Omron Corporation, but
since Omron is quite large, ACG has decided not to pursue a costly legal battle
with them at the moment. Fortunately, most of AtCor's competitors are very small
and are in a weak financial state (take a look at Uscom, which had sales of only $387,119 in their most recent half and will be out of cash in the next 6 months if they continue their performance). I was told by management that 'AtCor is well and truly the
largest player', which is a little surprising given ACG is still a very small
company itself.
As you would expect,
ACG isn't resting on its laurels and is developing new versions of its SphygmoCor
technology that is tailored to each market (eg. one for researchers, another
for clinicians etc). In addition, it has formed alliances with three other
companies to either develop new products (one of which is due to be launched in
July this year) or to help market the SphygmoCor XCEL to new segments such as
urologists. AtCor is investigating complementary technologies, such as
optimising pacemakers using central blood pressure and are also working on
applications in cerebral vascular and intensive care medicine. I view all of
these additional opportunities as an extra bonus if they do turn out to be
successful, but in the short to medium term, all eyes will be on how well SphygmoCor goes.
In terms of the people
running the business, I don't have strong views one way or another. Duncan Ross
has been CEO since 2006, when he replaced co-founder Ross Harricks, while the
other co-founder, Dr Michael O'Rourke remains as a non executive director.
Directors and executives hold a modest number of shares, and their compensation
seems sensible to me. While progress since the IPO in 2005 has been slow, I
think management have largely done as good a job as they could have, and am
comfortable with them continuing to manage the business. Peter Manley, the CFO,
was very generous with his time in answering the numerous questions I had by phone and email, so
one might infer that the company's attitude towards shareholders is quite
positive. Either that, or they've got too much time on their hands.
To summarise this post
before it drags on any longer, although there are most certainly substantial
risks to investing in ACG, and it is definitely not a stock for everyone, I
believe that the potential upside more than compensates for the risk. I won't
present any singular valuation because the probabilities of various scenarios
are too difficult to estimate with any reasonable degree of accuracy, but I'm
confident that with even modest success in growing sales, AtCor will be rewarding
shareholders quite handsomely.