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Sunday, 11/08/2015 7:41:35 PM

Sunday, November 08, 2015 7:41:35 PM

Post# of 253
Question-and-Answer Session for Q1 2016

Operator

[Operator Instructions] Our first question comes from the line of Peter Vaid [ph], Individual Investor, please proceed.

Unidentified Analyst

This is Peter Vaid [ph]. My big question is cash on hand and how will you generate more cash without diluting further?

Bob Newell - CFO
The key thing we're doing is accomplishing the milestones we set this before us to continue to expand our effort in Europe with bad centers, to complete our FDA submission and - once we have clearance to get into the U.S. market. We think by doing that will certainly create more value in our company, in terms of cash we have a little less than $22 million in cash and we've reduced our burn rate. So we think that we have adequate cash to pursue our near term goals. We will look for all different alternatives for future financing, including partnering and distribution relationships, and we'll develop an approach that we think is in the best interest of all shareholders.

Unidentified Analyst

Bob, Julian I have one more question and that question is, being a shareholder, I've been in Cardica for over six years and I'm looking forward to a broader launch in Europe. And can you give me a timetable when that will happen?

Julian Nikolchev - President & CEO
It's - we're not prepared to give you a timetable at this time because we are looking at the performance of our devices. We are focused on performance and adoption at this time. For the white-only device and that will, as well as improving and optimizing a supply change. That will give us the ability then to forecast more accurately what is the broader launch of this device. At the same time we are also waiting for approval of the FDA to increase our indications with a white device to vascular use.

Unidentified Analyst

Julian, one last question, the FDA approval, will that happen this calendar year or the vascular indication?

Julian Nikolchev - President & CEO
The FDA - our plans are to submit on-time, in mid-December. And then as you know, it's very difficult to predict when the FDA will respond to us but we would be - we're working with them to - and we are on-schedule to submit the response.

Unidentified Analyst

Okay. Well, I am truly committed to the product and I think that I think you have a great product, but just be aware that there are other competitors that are just lurking underneath your footsteps, sort to speak. So time is always of the essence and I thank you for talking to me.

Julian Nikolchev - President & CEO
Thank you, I really appreciate it.

Operator

Your next question comes from the line of Pablo Hieman [ph]. Please proceed.

Unidentified Analyst

Hi, so I'm following - I'm from a family office and my question is, first of all, why did the Board give such a generous compensation package to Mr. Palermo? And I guess a follow-up question to that would be were the Board members nominated by breaking the line with disposition or was it decided by the long-term Board members?

Bob Newell - CFO
I'm sorry. Your question was about Mr. Palermo?

Unidentified Analyst

Yes, about the compensation package.

Bob Newell - CFO
I don't know of any compensation package for Mr. Palermo that's been public.

Operator

Your next question comes from the line of Todd Mitchell with UBS. Please proceed.

Todd Mitchell - UBS
Thank you. Can you hear me all right?

Julian Nikolchev - President & CEO
Yes.

Todd Mitchell - UBS
First of all, regarding the Japan approval, is there a timing on that when you will hear back from Century Medical regarding the marketing or the potential market for that product?

Julian Nikolchev - President & CEO
We're in contact with them and we will be meeting with them and that's an ongoing discussion. It's something that needs to be done jointly and we're providing data to them and they are considering what they want to do.

Todd Mitchell - UBS
Okay. And along those lines what if they decide to go ahead with the marketing of the XCHANGE 30 with the white cartridge, would it - do you have the manufacturing capability to handle the demand they could have?

Julian Nikolchev - President & CEO
This is a very important part of our task right now, milestones on the near-term is to stabilize and to optimize our supply chain for the white-only device. We have good results in the market from the current version of the device, and we are working very closely to optimize the supply chain, so we can be ready as the device - as we get the FDA approval and the device gets broadly issued in Europe and/or U.S.

Todd Mitchell - UBS
Okay. When you say the product and the XCHANGE 30 which you're using over in Europe right now, give us a little bit if you could, some details how well the product is working and what you're hearing from surgeon?

Julian Nikolchev - President & CEO
At this time I can tell you that we are we are hearing very positive responses from the surgeons and we are receiving very consistent and positive results. We are collecting that information and so we're not prepared yet to give you any more detail but we will be doing that as soon as we can.

Todd Mitchell - UBS
And regarding the generation for product, where are you with that? I mean it sounds like that you're working on that but is there a timeline that we could work with there or something you could share with investors?

Julian Nikolchev - President & CEO
Yes, similarly we are definitely working on it and we think that what we are doing currently with XCHANGE 30, the current generation, as well as the supply chain would be very helpful in that generation four device. So - we're not prepared for a timeframe but we will share that with you as soon as we can.

Todd Mitchell - UBS
Okay. And I've known Bob for a long - many years, I'm a long-term shareholder. And my big concern is that - well first of all, does the company have plans to go out and tell the story to the investment community?

Bob Newell - CFO
Very much Todd. We have the JPMorgan Conference coming up in January, as you probably know many people are there, it will be a good time for Julian to meet with a number of investors, both existing investors and potential new investors, we're going to take advantage of that. We have the STS meeting coming up, the Society of Thoracic Surgery coming up at the end of January in Phoenix, we'll meet with analysts and some investors there. And then we'll be attending a Med-Tech conference by another investment bank in February which will provide for a number of one-on-one meetings. So I'm very anxious for Julian to meet our investors and to meet new perspective investors. We have been on the phone with a number of our investors as well, so we certainly want to get out over the next few months pretty aggressively.

Todd Mitchell - UBS
And my big issue here is that, it deals with building shareholder value and conviction which takes time because of the reset that we have here but we've had a series of resets over the years but we have a twenty - we have less - we are trading, the IP is valued less than the cash on the books. And I think as an investor, and a long-term investor with this company, I think that somebody needs to evaluate, really does the IP really have value here? And if so, how is that going to be shared with investors? I really think that's - I mean, that's something management is aware of or thinking about?

Julian Nikolchev - President & CEO
Of course we're all disappointed at the stock price and - very disappointed. However, we've just had two very seasons senior medical device executives join the company, one as CEO, one as COO. Both of whom I can assure you had numerous opportunities to look at other things and chose to come here because of the opportunity at Cardica, because of the technology we have, the proprietary position, we have substantial cash, and we have the opportunity we think to create a lot of value. Obviously, it's not being recognized yet in the market but I think as we accomplish these milestones we've set out for the next several months will change the momentum of the company.

Todd Mitchell - UBS
Okay. I'll get back in the queue. Thank you Bob, thank you guys.

Bob Newell - CFO
Thank you, Todd.

Operator

Your next question comes from the line of Peter Mariah [ph], Individual Investor. Please proceed.

Unidentified Analyst

Yes, hi. Can you clarify the FDA clearance, so is that for the current Version 3 with the white cartridge? And if you do receive your clearance in December will you market that in the U.S. or are you waiting for your Version 4 and will Version 4 require an FDA clearance?

Julian Nikolchev - President & CEO
Our FDA clearances is for the Version 3 and it is with the white cartridge.

Unidentified Analyst

Okay, thank you.

Julian Nikolchev - President & CEO
And it's in submission, it's not in clearance yet.

Unidentified Analyst

Right. And you said you completed that and it will be ready for submission in December?

Julian Nikolchev - President & CEO
We are in the process of completing it and will be submitting in mid-December, yes.

Unidentified Analyst

Okay, thank you.

Julian Nikolchev - President & CEO
Thank you.

Operator

Your next question comes from the line of Ernest Pataki [ph], Private Investor. Please proceed.

Unidentified Analyst

Hi, Bob, how are you?

Bob Newell - CFO
Dr. Pataki, how are you?

Unidentified Analyst

Fine, thank you very much. During the conference call and I want to hi and welcome to Julian.

Julian Nikolchev - President & CEO
Thank you.

Unidentified Analyst

I have a couple of questions. One is related to a question though I heard on the conference call which is the why the board, investor got it wrong, I think I got it right. Why the Board gave the CEO such a generous package above and beyond what is required. I mean this is why a few would filing. And the second question is, why such a delay in the shareholders meeting? What was the reason behind - existing reason behind - I think that we have the money to post, we have the technology, and I was complaining that the execution of your devices has been so slow, burning rate is not - money burning rate is not what really, really I told you it would be - which is would be a $3 million a quarter.

Then another question is, the stock price is going to be delisted from NASDAQ because it's already below value, even though we're going to appeal are you considering our reverse plead? I mean if the market coupled, this company went from $80 million, $90 million to $17 million, $18 million. It's absurd, I mean I have to look forward but we have the best markets in the history of the United States Dow Jones; biotechnology, instrumentation, so look at where we are, I mean does shareholders have to hold for? I mean you management, new technology, then you have the issue which I mentioned to Bob - broken capital that is continued misunderstanding, the Directors with Directors, and the only thing that this does is put people on hold.

I mean imagine $19.50, $20 a share I mean, it's something unheard off. And it's not about the price of the stock, it's about looking forward. I mean if nobody wants to buy the $0.20 may be a $0.10 or $0.12, I mean, and I'm sorry for asking too many questions, that I apologize but…

Bob Newell - CFO
Let me answer this. I think the most important question you asked which was the first one. The Board was unanimous in their choice of Julian to come and be CEO of this company, and the compensation package that was proposed to him was a market-based compensation package that the Board felt was totally appropriate to attract someone of Julian's capability and track record to help Cardica get o-track and to produce value for shareholders. I think that all shareholders will be very thankful over the over the months and quarters they had that Julian was decided to come to Cardica and will help us achieve what were the potential that we have. So I don't blame you Dr. Pataki for being frustrated and disappointed. All I can do is assure you that our team here is working very hard to accomplish our near-term goals. And that as we accomplish those goals, we'll create more value for all of us.

Unidentified Analyst

I want to say something else also, I mean I welcome Julian, I mean maybe the - I think the current shareholders and the future of shareholders would change with the new direction of the company in the north give assurance to manage the company. I mean, I cannot agree more than that but let's see how we go to the next quarter and after the next quarter and the formation that we're going to get from you guys. I just wish you luck, I mean I wish you luck in - I'm still on, I haven't sold one stock, one share. I'm looking forward to do to prove myself the contrary that the decision that I made to invest in this company because of the technology, the videos that you send me, the consultation I make with some physicians were fine. I mean the management plays a big role in the success of a company and I still believe in it. But anyway, I want to thank you - we would mean it, you know I talk with you quite often. I want to thank you really for being so kind and so exclusive with me, and its fine. I mean you have changed direction with the new management and has accomplished what we didn't do in the last two years, that's all.

Julian Nikolchev - President & CEO
Thank you, Dr. Pataki. I appreciate your comments on that end and I can also say what - repeat what Bob is saying that the team here - and that was part of my decision, the team here is very solid. There is a lot of very good technical know-how and loyal, I mean the team has been around for a while, that was a big part of the decision that - for me and for Tom to come on Board. So we are now focused on our near-term objectives and we are - and that's where everybody is working towards that. So we hope we can share the results of that with you in the near future.

Unidentified Analyst

Thank you very much for your time and thank you again for taking my call.

Bob Newell - CFO
Thank you.

Julian Nikolchev - President & CEO
Thanks.

Operator

Your next question comes from the line of Mark Rosenker, Cray Crown Capital [ph]. Please proceed.

Unidentified Analyst

Hi, guys this is Mark in for Charles. First off, welcome Julian, good to have you aboard.

Julian Nikolchev - President & CEO
Thank you.

Unidentified Analyst

I was wondering if maybe you could talk a little more. Last quarter you saw some initial good traction in European customers with the MicroCutter XCHANGE 30. Could you reiterate that number you had this quarter and then kind of discuss where you see that ramp going forward in the next 6 or 12 months?

Julian Nikolchev - President & CEO
Yes, the MicroCutter - as you know, primarily sold in Europe and U.S. but primarily in Europe because of the focus on the VAT procedures and we're using the white device, the white cartridge. We had approximately $155,000 of sales in the fourth quarter of last year which ended in June and $185,000 this quarter, again, primarily in Europe. More important than the absolute dollar value of the sales is the focus on the VATS centers and we're really seeking to get clinical adoption in the VAT centers and in terms of sales growth that will come more from once we get U.S. a clearance and once we get launched in Japan. Then I think you will see more significant sales growth. In the meantime though, we think there is real value in showing that we can target VAT centers and gain clinical adoption in the centers that we target, and then transfer that into new markets.

Unidentified Analyst

Okay, great. So how - could you give maybe just a little color on how you're going about targeting these VATS?

Julian Nikolchev - President & CEO
There are key centers, primarily in the U.K. and Germany that do these procedures, Visually Assisted Thoracic Surgery procedures. They are well identified and the surgeons there we're in contact with and getting them to try the device getting some that have tried have started re-ordering have clinically adopted. And then we'll expand that to other markets.

Bob Newell - CFO
We think of them as strategically in terms of the volume that they are performing, as well as the quality of the - and the benefit of working with the specific surgeons, when we identify them.

Unidentified Analyst

Okay, thanks. Just one more if you wouldn't mind, you're on pace for the mid-December submission to the FDA with the animal trial. Is there anything on your end that could perhaps delay this in the next year. I know as soon as you get the ball the record could it's a varying timeframe but is there any risk at all in terms of one that's submitted or do you feel pretty comfortable with that December timeframe?

Julian Nikolchev - President & CEO
We feel comfortable with the submission timeframe. Of course, in terms of how the FDA will respond we can't we can't really predict or comment on that.

Unidentified Analyst

Sure. I'll certainly understand, we'll appreciate the time guys.

Julian Nikolchev - President & CEO
Thank you.

Bob Newell - CFO
Thank you.

Operator

That concludes our Q&A. I'll now turn the call over to Julian Nikolchev for closing remarks.

Julian Nikolchev - President & CEO
Thank you. And thank you all for joining us - our call today. We hope to see you in the annual meeting of the Society of Thoracic Surgeon in Phoenix in January. Thanks very much and we will terminate the call.

Operator

Ladies and gentlemen, that concludes today's conference. Thank you for your participation. You may now disconnect. Have a great day.

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