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8-K - FORM 8-K - Cardiogenesis Corp /CA | a54342e8vk.htm |
EX-99.1 - EX-99.1 - Cardiogenesis Corp /CA | a54342exv99w1.htm |
Exhibit 99.2
FINAL TRANSCRIPT
CORPORATE PARTICIPANTS
Paul McCormick
Cardiogenesis Corporation Executive Chairman
Cardiogenesis Corporation Executive Chairman
Bill Abbott
Cardiogenesis Corporation Chief Financial Officer
Cardiogenesis Corporation Chief Financial Officer
CONFERENCE CALL PARTICIPANTS
Jared Cohen
Cohen & Company Analyst
Cohen & Company Analyst
PRESENTATION
Operator
Good day, ladies and gentlemen, and welcome to the third quarter 2009 Cardiogenesis Corporation
earnings conference call. My name is Stacy and I will be your conference moderator for today. At
this time, all participants are in a listen-only mode. We will be facilitating a
question-and-answer session towards the end of this conference.
(Operator Instructions)
As a reminder, this conference call is being recorded for replay purposes. During the course of
this call, the Company will make a number of forward-looking statements which may include, without
limitation, statements regarding the Companys future business development plans and future
results. These statements are subject to risks and uncertainties and actual results may differ
materially from those projected in these forward-looking statements. Those risks and uncertainties
are more fully described in the Companys SEC reports filed under the Securities Exchange Act of
1934, included under the heading of Risk Factors in the Companys Annual Report on Form 10-K. The
Company undertakes no obligation to update the forward-looking statements made today.
In addition, please be aware that if you decide to ask a question on todays call, it will be
included in both the live transmission and may be made available on the Companys website
thereafter. This conference call report is protected by copyright law and international treaties.
Any recording or other use or transmission of the text or audio of todays call is not allowed
without express permission of Cardiogenesis. I would like to turn the presentation over to your
host for todays call, Mr. Paul McCormick, the Executive Chairman of Cardiogenesis. Please
proceed.
Paul McCormick - Cardiogenesis Corporation Executive Chairman
Thank you, Stacy. I am Paul McCormick and, along with Bill Abbott, our CFO, we will be reporting
on the 2009 third quarter results.
Today we reported total revenues of $2,134,000 for the third quarter which was down from the
previous years third quarter. This decrease was primarily driven by a difficult capital equipment
environment with no lasers sold in this past quarter. Total domestic handpiece revenue for the
third quarter was $1,828,000. We continue to make progress focusing our sales force on the
utilization of installed lasers. We are taking the right steps to increase our core TMR business.
We are also making progress to initiate a clinical study for our PHOENIX Combination Delivery
System which permits the intramyocardial delivery of stem cells. I will discuss our plans in
greater detail later in the call but first, Bill will review our third quarter and year-to-date
financial results, Bill
Bill Abbott - Cardiogenesis Corporation Chief Financial Officer
FINAL TRANSCRIPT
Thanks Paul, and thank you all for joining us. As Paul just mentioned, in the third quarter of
2009, we recorded revenues of $2,134,000, a decrease of approximately $484,000 or 18% from revenues
of $2,618,000 in the third quarter of 2008. We did not sell any capital equipment during this
years third quarter, whereas we sold $373,000 in
capital equipment during the third quarter of 2008. Worldwide handpiece revenue declined $151,000
to $1,831,000 in the current year quarter. Service and other revenue totaled $303,000 for the
quarter, a 15% increase over the prior-year third quarter.
For the first nine months of 2009, we recorded sales of $7,222,000, a decrease of approximately
$2,497,000 or 26% from sales of $9,719,000 in the first nine months of 2008. The year-to-date
shortfall results primarily from a decrease of $1,832,000 in capital sales in 2009 as compared to
the first nine months of 2008, and a decline in handpiece revenue of $786,000 from the
corresponding prior-year period.
Reflecting lower sales activity, gross profit decreased by $390,000 to $1,754,000 in this years
third quarter, as compared with $2,144,000 in the third quarter of 2008. Gross margin of 82%
remained flat for the quarter ended September 30, 2009 as compared to the prior-year quarter.
For the first nine months of 2009, gross margin was 82% of net revenue, as compared to 84% for the
first nine months of 2008. Gross profit in absolute dollars decreased by $2,215,000 to $5,915,000
for the nine months ended September 30, 2009, as compared with $8,130,000 for the nine-month period
in 2008. I should also note that our gross profit in the 2008 year-to-date period included
recognition of $234,000 of deferred revenue for which there was no underlying cost of goods sold.
The lower gross margin for the first nine months of 2009 as compared to the 2008 period is
primarily attributable to lower capital equipment sales in the current year period, which generally
have a higher margin than handpiece sales.
Research and development costs were $379,000 in the third quarter of 2009, as compared with
$165,000 in the 2008 third quarter, an increase of $214,000 or 130%. Year-to-date, R&D expenses of
$1,013,000 were $380,000 or 60% above the prior-year period of $633,000. The increase for both the
three-month and nine-month periods is primarily attributable to regulatory expenses which we have
incurred for FDA submissions.
Sales and marketing expenses totaled $1,363,000 in this years third quarter, a decrease of
$173,000 or 11% when compared with $1,536,000 for the 2008 third quarter. For the first nine
months of 2009, S&M expenditures totaled $4,104,000, a decrease of $754,000 or 16% versus the
$4,858,000 of S&M expense in the first nine months of 2008. The decrease in sales and marketing
expenses for both the third quarter and the nine months ended September 30, 2009, as compared to
the corresponding prior year periods is primarily due to lower commissions and related employee
expenses.
General and administrative expenditures for the 2009 third quarter totaled $730,000, a decrease of
$23,000 or 3%, as compared to $753,000 in the third quarter of 2008. G&A expense in the prior-year
quarter included certain legal costs which did not recur in the current year. For the year-to-date
period, G&A totaled $2,375,000, which is slightly below the nine months ended September 30, 2008.
For the 2009 third quarter, we generated an operating loss of $718,000, as compared with an
operating loss of $310,000 in the prior year third quarter. For the first nine months of 2009, the
year to date operating loss is $1,577,000 versus operating income of $235,000 for the corresponding
prior year period.
Net loss for the 2009 third quarter totaled $739,000, or $0.02 per basic and diluted share, as
compared with a net loss of $308,000, or $0.01 per basic and diluted share, in the 2008 third
quarter. Net loss for the nine months totaled $1,643,000, or $0.04 per basic and diluted share, as
compared with net income of $258,000, or $0.01 per basic and diluted share, in the first nine
months of 2008.
Now Id like to turn the call back to Paul for an update, and then we will be happy to answer any
questions you may have. Paul.
FINAL TRANSCRIPT
Paul McCormick - Cardiogenesis Corporation Executive Chairman
Thanks Bill. As I mentioned on our last call, we are confident we can increase our core business
of interoperative TMR by focusing our sales force on making the clinical case for TMR and increase
utilization of our installed lasers. Over the past quarter we added three new sales professionals, two of which were replacement hires.
We now have 12 sales representatives and two field managers in the U.S.
One of our internal training metrics is to compare the sales of handpieces in the trailing six
months with the sales in the six months preceding that period. For the first time since September
2008, that metric turned positive in August and increased in September. It suggests progress. In
addition, over the past few weeks, Hahnemann Hospital in Philadelphia and St. Michaels Hospital in
Newark, New Jersey successfully performed their first da Vinci robotic TMR cases. Although
anecdotal, it does reinforce that high profile cardiovascular programs are finding a clinical role
for our technology.
We continue to engage the cardiologists that play a key role in patient referral. In September we
sponsored a symposium at the TCT meeting titled Opportunities in Refractory Angina, which was
well attended. The takeaway message for the attendees was that:
| Due to greater longevity, many patients are outliving the effectiveness of prior interventions and surgery; | ||
| There is a growing population of symptomatic patients with few clinical options, and; | ||
| Cardiologists need to more effectively focus on these patients with a graduated treatment regimen from lifestyle changes through technologies such as TMR. |
From our perspective, as this growing population becomes more centrally managed, it makes
identification and access to patients that may benefit by our technology more manageable for us.
Our plan is clear, but not without its challenges. We may have a few choppy quarters as we focus
our efforts on utilization, but we will continue to measure success by our ability to increase
domestic revenue from our disposable products.
As Bill mentioned earlier, R&D expenditures for the quarter were up 130% and up 60% for the year
compared to the corresponding periods in 2008. This was in support of our efforts to initiate a
U.S. trial for our PHOENIX Combination Delivery System. On October 21st, we met with the
FDA to discuss our pre-IDE submission. Based on the feedback from that meeting, we are collecting
the requisite data and expect to make our IDE submission before the end of the year. The
submission will be to initiate a 15-patient three-center safety and feasibility trial utilizing the
PHOENIX system combining intramyocardial tissue stimulation with the injection of autologous bone
marrow aspirate to treat patients with refractory angina. We identified and initiated discussions
with a handful of investigators and three clinical sites have begun preliminary contract review. We
want to minimize the time from an IDE study approval to patient enrollment.
Upon a successful completion of this safety trial, we would expect to begin a pivotal trial of the
PHOENIX system. This will be the first IDE study of its kind combining myocardial stimulation with
the injection of stem cells.
Earlier this year, the results of our preliminary study of the PHOENIX system utilizing bone marrow
aspirate was published in the European Journal of Cardiothoracic Surgery. The authors treated 14
patients. At a mean follow up of seven months, there were no deaths and average angina class was
significantly improved. All of the patients experienced at least a two class reduction and half
were angina free. The authors concluded that the use of the PHOENIX system seemed to be safe and
effective for treating unmanageable angina. The significance of this early series is that our IDE
study will essentially mimic the patient population and product use from this European study. It is
very much a template for our proposed US study.
We have been working diligently on this initiative and we believe that the intramyocardial tissue
stimulation and injection of stem cells represents an exciting growth opportunity for us. Should
tissue
FINAL TRANSCRIPT
stimulation prove to be synergistic to stem cell delivery, we believe our PHOENIX technology
can become the standard of care for intramyocardial delivery of stem cells.
In summary, we need to increase our efforts to educate cardiologists on the benefits of
interoperative TMR, obtain agreement on its utility as well as obtain referrals for trained
surgeons. We will measure our success by increasing domestic revenue from our disposables.
We must also begin enrollment in a human clinical trial of the PHOENIX system here in the U.S. The
early published work for combination therapy is promising and we are committed to achieving a
leadership position in this space.
With that, I would like to open the line for questions. Operator.
QUESTIONS AND ANSWERS
Operator
(Operator Instructions)
(Operator Instructions)
Paul McCormick - Cardiogenesis Corporation Executive Chairman
While Im waiting for the first question, let me tell those listening that we will be supporting a
satellite symposium sponsored by the Minneapolis Heart Institute at the American Heart Association
meeting this Sunday in Orlando, Florida. The title of the symposium is, Can We Really Grow New
Blood Vessels? Dr. Christopher White, Chairman of the Cardiovascular Disease Section at Ochsner
Clinic will be sharing his insights on the topic, Transmyocardial Revascularization and Stem Cell
Therapy for Refractory Angina. Operator, I am ready for the first question.
Operator
Your first question comes from Jared Cohen with J.M. Cohen & Company. Please proceed.
Jared Cohen - J.M. Cohen & Company Analyst
Just a few questions. One, I dont know if you mentioned it, but how many handpieces were sold
this quarter versus last year?
Paul McCormick - Cardiogenesis Corporation Executive Chairman
We dont report handpieces we will report the revenues. This past quarter, domestically it was
$1,828,000.
Jared Cohen - J.M. Cohen & Company Analyst
Okay, youre not going to give the number of handpieces?
Paul McCormick - Cardiogenesis Corporation Executive Chairman
Right.
Jared Cohen - J.M. Cohen & Company Analyst
All right. I know you had your symposium in San Francisco this past September. I was curious,
what type of questions got asked by or what type of presentations did you make to the
cardiologists and what type of questions did the cardiologists ask you and what was their general
feeling from the symposium?
Paul McCormick - Cardiogenesis Corporation Executive Chairman
FINAL TRANSCRIPT
At the TCT in the prior year we focused more on the stem cell therapy and where the technology was
heading. This one was more focused on what are the current opportunities for patients with
refractory angina. One of the key speakers there was Tim Henry from the Minneapolis Heart
Institute. They probably run the largest refractory angina clinic. And the whole purpose of this
meeting was to introduce the cardiologists really to manage these patients in a more focused
fashion. Because right now patients with refractory angina who have already had prior
intervention, prior cabbage, are being managed by heart failure physicians, clinical cardiologists,
GPs, some are not even being
seen by physicians. And the fact of the matter is that these patients require care for the rest of
their lives. Often times staged and tiered therapies, lifestyle changes all the way through things
such as TMR. And so it was to provide some visibility to the cardiologists that there are
alternatives for that. Dr. Bates from the Ochsner Clinic, a surgeon, presented series on robotic
use of TMR. Out of this program we did see surgeons from Abbott Northwestern go off and get
trained on the da Vinci robot. Marv Slepian just talked about the overall history and prevalence
of the disease. I mean this is a serious problem thats really not being managed in a central
fashion. And so I think it was a very good meeting.
There were a number of cardiologists that we spoke to afterwards that were going to go back and
consult with their surgeons and try to determine what was the best approach in finding alternatives
for these patients. So it was a very good program.
Jared Cohen - J.M. Cohen & Company Analyst
Okay, because Ill just bring up something just doing a random search, because I thought this
had already been answered. Im not talking about you or the Company, but by the medical community
already, just I randomly found this on a well known university website who had TMR, if a patient
wanted it, the fact that with surgery that it could possibly one of the answers for TMR, whether it
created new blood flow through the heart or whether it just killed off nerve cells. I thought that
had already been answered medically speaking. I found it amusing and I wonder if you still got the
skepticism from cardiologists or you didnt find that within your symposium.
Paul McCormick - Cardiogenesis Corporation Executive Chairman
From cardiologists perspective, its much more an education process of sharing with them the long
term data of interoperative TMR versus the failed approaches to do this percutaneously or from an
endocardial approach. There is still some discussion about what is the mechanism of action. But I
think the prevailing thought is that there is a certain amount of denervation within the first 30
to 60 days which provides angina relief. But that wouldnt be long-lasting and that couldnt
explain long term reduction of angina. And the animal work and other approaches have really
focused more on angiogenesis, the creation of improved flow of blood flow to that target tissue.
Jared Cohen - J.M. Cohen & Company Analyst
Okay. You mentioned the two hospitals that did the surgery using the da Vinci robot. What,
medically speaking, is the benefit of doing it that way versus doing it the typical way, TMR
surgery? Is it obviously a cardiologist is able to do it versus a thoracic surgeon? Is that the
main benefit?
Paul McCormick - Cardiogenesis Corporation Executive Chairman
No, even with the da Vinci, it is not the cardiologist. It is still the surgeon. And so the
perception, and it may be a reality, is that utilizing the da Vinci robot is less invasive than
through a mini thoracotomy.
Jared Cohen - J.M. Cohen & Company Analyst
Okay, and is the patient relief sooner? Or is that its still or is the patient, is there
anything else or not really?
Paul McCormick - Cardiogenesis Corporation Executive Chairman
FINAL TRANSCRIPT
Its probably, Jared.
Jared Cohen - J.M. Cohen & Company Analyst
Too soon to say?
Paul McCormick - Cardiogenesis Corporation Executive Chairman
Close. Our own data was very positive when we got the approval for the Pearl. For some physicians
it may be a perception that a robotic approach and using ports is more acceptable. Keep in mind
that these patients who have refractory angina and have failed medical management or are having a
tough time with it and cannot go under conventional revascularization either by intervention or
surgery, theres a threshold of morbidity and mortality that they have to accept. And as the
perceived and maybe real reduction of that threshold by da Vinci becomes more well known, it can
potentially be more acceptable. But there has not been any randomized, controlled trials looking
at the application of this via da Vinci versus a mini thoracotomy.
Jared Cohen - J.M. Cohen & Company Analyst
All right, thank you very much.
All right, thank you very much.
Operator
(Operator Instructions)
(Operator Instructions)
At this time Id like to turn the call back over to Mr. McCormick for closing remarks.
Paul McCormick - Cardiogenesis Corporation Executive Chairman
Thanks very much, Operator. Bill and I want to thank you for your interest and participating on the
call. We appreciate the continued support of our shareholders and the efforts of our dedicated
employees. We look forward to updating you on our progress both with the IDE and our FDA submission
that we expect later in this year and when we get to discuss fourth quarter 2009 results. Please
feel free to contact Bill or me with any additional questions. Thank you.
Operator
We thank you for your participation in todays conference. This concludes the presentation. You
may now disconnect and have a great day.