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EX-99.1 - EX-99.1 - Cardiogenesis Corp /CA | a58953exv99w1.htm |
8-K - FORM 8-K - Cardiogenesis Corp /CA | a58953e8vk.htm |
Exhibit 99.2
CORPORATE PARTICIPANTS
Paul McCormick
Cardiogenesis Corporation Executive Chairman
Paul McCormick
Cardiogenesis Corporation Executive Chairman
Bill Abbott
Cardiogenesis Corporation CFO
Cardiogenesis Corporation CFO
CONFERENCE CALL PARTICIPANTS
Jared Cohen
JM Cohen & Company. Analyst
Jared Cohen
JM Cohen & Company. Analyst
PRESENTATION
Operator
Good day, ladies and gentlemen, and welcome to the Cardiogenesis Corporation fourth quarter and
full year 2010 Earnings Conference Call. My name is Kathy, and I will be your operator for todays
call. (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 Kathy, I am Paul McCormick, Executive Chairman of Cardiogenesis, and along with Bill
Abbott, our CFO, we will be reporting on the 2010 fourth quarter and year to date results.
Today we report total revenues of approximately $2.9 million for the fourth quarter of 2010, a 9%
decrease from prior year fourth quarter revenue. For the full year 2010, revenue was approximately
$11.3 million, an increase of 9% over revenue of $10.4 million in 2009. Fourth quarter revenues
were negatively impacted by lower capital equipment sales as compared to 2009. In addition the
fourth quarter of 2009 included $218,000 of handpiece revenue previously deferred under accounting
rules. Excluding the impact of that non-recurring, deferred revenue, handpiece revenue actually
increased 13% in fourth quarter 2010 over the prior period. The company posted a solid performance
for both the fourth quarter and full year as our sales organization made the case for TMR and
increased product utilization.
At the same time we made significant progress on our clinical and regulatory objective to begin an
IDE study for our PHOENIX Combination Delivery System. I will discuss that in greater detail
later in the call but first, Bill will review our fourth quarter financial results, Bill.
Bill Abbott Cardiogenesis Corporation CFO
Thanks Paul. As Paul just mentioned, in the fourth quarter of 2010 our revenue totaled $2,864,000,
a decrease of $268,000, or 9%, from revenues of $3,132,000, in the fourth quarter of 2009. We
recognized
an increase in overall handpiece revenue of $38,000, or 2%, to $2,172,000 in the fourth quarter of
2010 from $2,134,000 in last years fourth quarter. Also Paul noted the prior year fourth quarter
includes $218,000 of handpiece revenue previously deferred under accounting rules. Excluding that
impact, handpiece revenue in the fourth quarter of 2010 grew $256,000 or 13% with both average
selling price and unit sales increasing from the prior year quarter. Laser revenue in the fourth
quarter of 2010 was $400,000, a decrease of $287,000 from the fourth quarter of last year. Service
and other revenue for the fourth quarter of 2010 was $292,000, a decrease of approximately $19,000
from last years fourth quarter.
For full year 2010, revenue totaled $11,290,000, an increase of $936,000, or 9%, from sales of
$10,354,000 in the 2009 year. The full year increase in sales as compared to the 2009 period
results from higher average selling prices and higher unit sales of our handpieces, which, at
$8,637,000 for all of 2010, increased $980,000 or 13% over last year.
Our gross margin was 83% of net revenue in the fourth quarter of 2010, a 1 percentage point
decrease from the fourth quarter of 2009. For the full year, our gross margin was 84%, an increase
of 1 percentage point over 2009. In dollars, gross profit decreased by $242,000, or 9%, to
$2,390,000 for the fourth quarter of 2010 as compared with $2,632,000 for the 2009 fourth quarter.
For all of 2010, gross profit increased by $906,000, or 11%, to $9,453,000 from a gross profit of
$8,547,000 in 2009.
Research and development expense was $634,000 in the fourth quarter of 2010 about double the R&D
expense of $318,000 in the 2009 fourth quarter. This increase results primarily from costs
associated with our biocompatibility and large animal safety studies at the Texas Heart Institute
Stem Cell Center which began towards the end of the third quarter and expenses for the feasibility
study of our PHOENIX Combination System. Full year 2010 R&D expense totaled $1,464,000, which was
$133,000, or 10%, above the $1,331,000 of R&D expenditures in 2009.
Sales and marketing expense was $1,448,000 for the 2010 fourth quarter, essentially flat with prior
year fourth quarter expense of $1,454,000. For all of 2010, sales and marketing expenses were
$6,176,000, an increase of $618,000 or 11%, when compared to $5,558,000 of S&M expense for full
year 2009. The increase in S&M expense for the 2010 full year period was a result of higher salary
and related expenses from an increased average headcount, as well as revenue driven increases in
commission and bonus compensation and related expenses.
Fourth quarter 2010 general and administrative expense was $1,041,000, an increase of $640,000 from
$401,000 of G&A expense in the fourth quarter of 2009. Full year 2010 G&A expense totaled
$3,252,000, an increase of $476,000, or 17% from 2009. The increase for both the 2010 fourth
quarter and full year amounts versus the respective prior year periods is primarily the result of
higher legal fees from the Cardiofocus litigation as several depositions were taken during the
fourth quarter and other procedural and corporate matters were required in the fourth quarter of
2010.
For the 2010 fourth quarter, we recorded an operating loss of $733,000 as compared with operating
income of $459,000 in the fourth quarter of 2009. The operating loss for all of 2010 was
$1,439,000 as compared to an operating loss of $1,118,000 for the full year of 2009.
The net loss for this years fourth quarter was $558,000, or $0.01 per basic and diluted share, as
compared with net income of $409,000, or $0.01 per basic and diluted share, in 2009s fourth
quarter.
For the full year, our net loss in 2010 was $1,282,000, or $0.03 per basic and diluted share, as
compared with a net loss of $1,234,000, or $0.03 per basic and diluted share for all of 2009.
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 McCormick Cardiogenesis Corporation Executive Chairman
Thanks, Bill. The company continues to execute on its key objectives to drive utilization of our
high margin disposable handpieces, manage expenses to control our financial destiny, and pursue the
PHOENIX clinical initiative as a platform for future growth.
The PHOENIX combination delivery system combines the intramyocardial injection of stem cells
derived from the patients own bone marrow with the pretreatment of the myocardium with the
companys TMR system. In addressing the feedback from the FDA regarding our IDE submission for the
PHOENIX, we initiated preclinical work with the Texas Heart Stem Cell Center. This included bone
marrow compatibility testing with the PHOENIX as well as a large animal safety study. The
treatment and follow up of the animal study has been completed, the data collection and preliminary
analysis is underway. This is the final item required to update our IDE file with responses to all
of the exceptions detailed by the FDA. We expect to submit our update to the FDA by May. Approval
of our IDE request will enable us to begin enrolling patients at a small number of centers here in
the US under an approved protocol. Accomplishment of this goal is a significant milestone for us
and reflects our focus of becoming a leader in regenerative therapies for the treatment of diffuse
coronary artery disease.
Simultaneously we have initiated a feasibility clinical study outside the U.S with the PHOENIX. In
October we announced the enrollment of the first two patients and in January we completed an
additional two cases at the Bakoulev Institute in Moscow Russia. Our team is preparing to return
to Europe in the next few weeks to support additional cases and to travel to India once we obtain
the required regulatory approval. This activity is providing us with important experience in
preparing for the U.S. pivotal trial
I am also pleased to report continued success with our commercial products. For the full year of
2010 we increased disposable handpiece revenue 13% or $980,000 over 2009 and these products have a
gross margin of 84%. For the full year 2010 we maintained laser sales levels at 2009 levels in
spite of a challenging capital equipment environment. The overall increase in sales revenue of our
commercial products permits us to make the requisite investments and achieve progress in our
advanced product initiatives.
At December 31, 2010, the company had no debt and a cash balance of $1.8 million dollars. We
utilized $758,000 of cash in the full year of 2010 to fund our product development and corporate
initiatives. We are accomplishing our sales growth with a sharp eye on our expenses.
In summary, I am very pleased with our results in increasing sales for our commercial products and
making significant progress towards our goal of beginning a U.S. IDE trial for the PHOENIX
Combination Delivery System in the second half of 2011. Should tissue stimulation by TMR prove to
be synergistic to stem cell delivery, we believe our PHOENIX technology can become the standard of
care for the intramyocardial delivery of stem cells. The PHOENIX may prove to be an important
clinical option for the estimated 200,000 symptomatic patients diagnosed with diffuse coronary
artery disease that are not candidates for traditional therapy of intervention or surgery. We will
continue to update you on our progress via our conference calls.
With that I would now like to open the line for questions...Kathy.
Operator
(Operators instructions)
Paul McCormick Cardiogenesis Corporation Executive Chairman
While I am waiting for the first question, let me share with you that the Company has a poster
presentation at the upcoming American College of Cardiology meeting. Post Approval Studies are
conducted to report on a more current experience for a technology following FDA approval. Greater
device experience and real world patient selection may affect clinical outcomes and influence
opinions to the clinical utility of a given technology. I am pleased to report the results from
our 358 patient TMR Post Approval Study demonstrated improved operative mortality compared to
patients treated by TMR in the original pivotal
trial. This improvement was striking because the patients in the Post Approval Study were older,
had a higher incidence of hypertension, and previous interventions. These new data should reassure
referring cardiologists that TMR is a viable option for the growing number of patients with
refractory angina that are not amenable to traditional revascularization.
Operator I am ready for the first question.
Operator
Thank you sir, the first question comes from the line of Jared Cohen of J.M. Cohen & Company.
Please proceed.
Jared Cohen JM Cohen & Co. Analyst
I was wondering, because Ive noticed Googling the marketplace it seems like more hospitals are
advertising that they are offering TMR, and whether its with you utilizing equipment from someone
like you, your lasers, or equipment from your former competitor. What opportunities that opens up
for you, whether or the overall marketplace in terms of increased utilization of the procedures
and so forth. And then just a follow-on question
Paul McCormick Cardiogenesis Corporation Executive Chairman
Sure. Obviously, when hospitals commit dollars to advertising, its a positive. And I stick with
our comments weve made in the past is that we believe that with the right focus, the right sales
organization, and the right message, that we can in fact grow TMR utilization, and weve couched
that, always saying modestly. And so it becomes its a very solid base of business over which we
can then springboard with the advanced initiatives with stem cells.
Jared Cohen JM Cohen & Co. Analyst
Okay. Also, since the utilization has gone up over the last year or two, particularly within your
own installed base, I wonder if at some point within your own installed base, will they have to go
back and at some point due a change over? Or have they been doing a change over in terms of going
to my English is a little off going to your newer, advanced lasers or so forth?
Paul McCormick Cardiogenesis Corporation Executive Chairman
We may have some upgrades to this as utilization goes up. But our lasers are pretty durable,
frankly. It is still a capital equipment sale, capital equipment environment that is very
difficult. And I think the whole focus of the Company has been to drive utilization on the
handpieces in a more traditional cardiovascular device format.
Having said that, as we move forward with our, the stem cell program, and at some future date with
the potential approval, and this becomes even more broadly utilized, then that probably opens up
the capital equipment space and we can be more aggressive at that point. But I think for the
foreseeable future, Jared, frankly is our focus on our success is going to be driven by growth in
our utilization of the handpieces, with some modest capital equipment sales each year that can be
somewhat erratic from quarter to quarter.
Jared Cohen JM Cohen & Co. Analyst
Okay. All right, thank you very much.
Paul McCormick Cardiogenesis Corporation Executive Chairman
You bet, thank you.
Operator
(Operator Instructions) There are no further questions at this time. I would now like to turn the
conference back over to Mr. Paul McCormick for final remarks. Thank you.
Paul McCormick Cardiogenesis Corporation Executive Chairman
Bill and I thank you for your interest and participating in this call. We appreciate the continued
support of our shareholders, and the efforts of our dedicated employees. We look forward to
providing you an update on our progress when we discuss 1st quarter 2011 results. Please feel free
to contact Bill or me with any additional questions. Thank you.
Operator
Ladies and gentlemen, thank you for your participation in todays conference. This concludes the
presentation. You may now disconnect, and have a great day.