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Stereotaxis, Inc. (NASDAQ:STXS)

Q4 2013 Earnings Conference Call

February 25, 2014 4:30 PM ET

Executives

Jim Byers – IR

William Mills – Chairman and CEO

Martin Stammer – CFO

Analysts

Jeffrey Cohen – Ladenburg Thalmann & Co.

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Stereotaxis Fourth Quarter and Full Year 2013 Financial Results Conference Call.

During today’s presentation all participants will be in a listen-only mode. Following the presentation the conference will be open for questions. (Operator Instructions). This conference is being recorded today. And at this time I would now like to turn the conference over to Mr. Jim Byers of MKR Group. Please go ahead, sir.

Jim Byers

Thank you, operator, and good afternoon, everyone. Thank you for joining us this afternoon for the Stereotaxis conference call and webcast to review the financial results for its 2013 fourth quarter and full year ended on December 31, 2013.

Before we get started we’d like to remind you that during the course of this conference call the company might make projections and other forward-looking statements regarding future events or the future financial performance of the company. These include without limitation statements regarding future operating results, growth opportunities and other statements that reflect Stereotaxis’ plans, prospects, expectations, strategies, intentions and beliefs.

These statements are subject to many risks and uncertainties that could cause actual results to differ materially from expectations. For a detailed discussion of the risks and uncertainties that affect the company’s business and that qualify to be forward-looking statements made on this call we refer you to the company’s periodic and other public filings filed with the SEC, including the Form 10-K for the fiscal year ended December 31, 2012 and the quarterly Form 10-Q filings and the Form 8-K filed today.

The company’s projections and forward-looking statements are based on factors that are subject to change and therefore these statements speak only as of the date they are given. The company assumes no obligation to update any projections or forward-looking statements.

In addition, regarding orders and backlog there can be no assurance that the company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the company’s control. In addition these orders and comments may be revised, modified or canceled, either by their expressed terms as a result of negotiations or by project changes or delays.

Now with that said, I’d like to turn the call over to William Mills, Chairman and CEO of Stereotaxis.

William Mills

Thank you, Jim. Good afternoon, everyone, and thank you for joining us for a review of Stereotaxis’ fourth quarter and full year 2013 performance. Joining me today is our CFO, Marty Stammer. Following our prepared comments we will open up the call to your questions.

Before we begin I would like to take a moment to express how very pleased I am to assume the reins of Stereotaxis as we enter a new phase of development. 14 years ago I was fascinated by the innovative concepts being generated by the company and from my first days on the Board I have been a true believer in the power of our robotic platform to change interventional medicine and positively impact patients’ lives.

Furthermore, serving as interim CEO for the past 10 months I have witnessed first time the level of perseverance and personal dedication every Stereotaxis’ employee has to the success of our long-term vision. I am excited to work alongside some of the most talented people in the industry and to capitalize on the significant opportunities ahead.

One of these opportunities is the entry of our Niobe technology in Japan. As you will recall we received Shonin, or regulatory, approval of our Niobe system in Japan last March and in October received an interim reimbursement rate which we expect to be finalized as part of the 2014 biannual cycle. Today we are pleased to announce that we have completed an agreement with Medix, Japan and Hokushin Medical, the final step to begin full commercialization of our magnetic platform in Japan.

Hokushin Medical, one of the largest distributors of EP products in Japan will market, sell and distribute our Niobe system to Japanese customers as well as provide clinical training and support. Medix, Japan has been selling medical devices in Japan for nearly 40 years and brings a wealth of experience in complying with regulatory and quality standards for highly regulated medical products. Their parent company, Kamachi Group is a diversified conglomerate with approximately $100 billion in annual sales which also owns and operates 17 hospitals.

Medix Japan will lead completion of the government’s required post-marketing surveillance project and be responsible for securing market authorization of our Vdrive and Odyssey systems in the coming months, ensuring the availability of the full Epoch platform for the Japanese electrophysiology or EP community. Both companies bring great passion for Stereotaxis’ technology and an innovative spirit in addition to deep understanding of healthcare industry and key providers in Japan.

We are confident that they will serve our interest well in an exciting new market. This day has been a long time in the making and we are thrilled to begin providing our one-of-a-kind solutions to a country that is behind only the U.S. in the application of medical devices and expected to experience 10% annual growth in EP procedures through 2018.

Now let’s talk about the progress we made in 2013. The most appropriate word I can use to describe our financial position today compared to a year ago is transformed. Over the course of 2013 we secured $21.9 million in new permanent capital through a series of warrant exercises as well as a successful write offering. This allowed us to extinguish our subordinated convertible debentures and renegotiate a credit agreement with Silicon Valley Bank which terminated our guaranteed advances and term loan effectively eliminating all of short-term debt obligations.

By year-end we had reduced the principal of our total debt by $17.1 million. Moreover in November we filed the universal shelf registration with the SEC, now effective, that allows us to raise an additional $75 million through future offerings of securities. Each of these efforts was hard thought and we are committed to managing our improved working capital in the most intelligent efficient manner just as we have been under tighter resource constrains.

In 2013 we continued to manage operating expenses to a prudent level, $35.9 million for the year and we reported cash burn of $6.3 million for the year, a 48% reduction from the previous year and our lowest annual cash burn since our IPO in 2004. We also reported our lowest full year operating loss of $8.8 million. With a stronger financial footing and proven capital stewardship, we can return our full attention to advancing our clinical platform and achieving targeted commercial results.

During 2013 we were challenged to grow the top line experiencing a year-over-year revenue decrease of 18% and procedural volume decline of 11%. Specifically, system revenue was $12.7 million on nine Niobe ES systems, down from $19.7 million in 2012 and procedures fell from 10,600 completed in 2012 to 9,400 in 2013. However looking forward, we have notable growth potential with our market entry of Niobe platform in Japan and the introduction of our Vdrive with VSono system in the U.S.

Additionally, while not immediately reflected we have made substantial progress in re-engaging customers in several key markets as well as effectively positioning new sites for long-term success through very strategic individualized plans carried out by cross functional teams. Peer-to-peer interaction, mentoring and clinical case observations of Niobe ES continue to be our most effective tools in reigniting inactive sites and inspiring new users.

For example, a critical first step in re-engaging the German market once a high production region with previous Niobe generations was connecting the German physicians with experienced Niobe ES users elsewhere through site visits and live cases transmissions. A November user meeting in China brought together top Niobe users and prospective customers for an effective discussion on system benefits and best practices. We have seen a 47% growth in procedures in Asia-Pacific region since 2012.

Finally, at the annual AF symposium in Orlando last month Stereotaxis hosted a product theater for physician-to-physician information exchange on our clinical solutions which attracted more than 80 participants and highlighted the improvements in EP, procedure safety, accuracy and efficiency that physicians have achieved with our magnetic navigation platform. This exchange of methodologies, procedure techniques and product benefits is especially vital as we seek to build further adoption of our Vdrive system in the U.S.

In the January issue of EP Lab Digest, Dr. Bill Spear of Advocate Christ Medical Center in Chicago described his Epoch system which now includes the VSono ICE catheter manipulator as a core game changer in the way he now approaches complex ablations.

Throughout 2014 we will be focused on leveraging the distinctive value of the Vdrive system in the EP lab to expand Vdrive usage in the US and to ignite new interest in the Epoch platform. We will also be working to secure FDA clearance of the Vdrive with V-Loop circular catheter manipulator and in January we announced the completion of a 120-patient clinical trial of V-Loop which will be included in the 510(k) we intend to submit in the first quarter.

The V-Loop circular catheter manipulator already part of the clinical routine of several European EP labs is indicated for remotely controlling the advancement, retraction, rotation, tip deflection and loop size of the compatible LASSO catheter. In conjunction with the Niobe ES the V-Loop device can improve efficiency and accuracy of catheter management, loop catheter management during EP procedures. In the US, an estimated 60,000 loop catheters are used each year in complex EP procedures.

Now I would like to turn the call over to Marty to provide more specifics on our quarterly and full year results.

Martin Stammer

Thanks, Bill and good afternoon everyone. Revenue in the fourth quarter was $9.1 million, down from $12.2 million in the year-ago quarter. System revenue of $2.7 million compares to $5.6 million in the prior-year quarter.

In the fourth quarter we recognized revenue of $2.3 million on three Niobe ES systems and one upgrade, $100,000 on one Vdrive system and $300,000 in Odyssey sales. Note that one of the Niobe ES systems were sold at lower selling price to replace the hospital’s existing Niobe 1 system. During the quarter we generated new catheter orders of $3.9 million including three Niobe ES systems and one upgrade, three Vdrive orders and three Odyssey system orders. At quarter-end the proactive backlog was $6.8 million.

Recurring revenue of $6.3 million in the quarter compares to $6.6 million in the 2012 fourth quarter. Utilization declined 11% from the year-ago quarter but improved 5% sequentially. For the full year 2013 revenue was $38 million compared to $46.6 million in the 12-month ended December 31, 2012. System revenue was $12.7 million on nine Niobe ES systems sales in 2013 which compares to $19.7 million in 2012. The decline was primarily a result of performing more ES upgrades during the initial product rollout in 2012 as well as lower Odyssey sales in 2013 compared to 2012.

Recurring revenue was $25.3 million for the full year 2013 and $26.9 million for 2012. Utilization companywide fell 11% year-over-year. In the fourth quarter of 2013 gross margin was $6.2 million or 68.7% of revenue compared to 65% in the year-ago quarter. For the full year gross margin was $27 million or 71% of revenue versus $31.8 million or 68% of revenue in 2012.

Operating expenses in the fourth quarter were $8.7 million compared to $8.8 million in the year-ago period. In 2013 we managed operating expenses to $35.9 million for the full year, a 15% reduction from 2012. Operating loss in the fourth quarter was $2.4 million compared to $900,000 in the fourth quarter of 2012. For the full year 2013 we reported our lowest operating loss, $8.8 million since our initial public offering in 2004 which also represents a 16.8% improvement from the prior year.

Interest expense declined to $900,000 in the 2013 fourth quarter from $2 million in 2012 fourth quarter due to the extinguishment of our convertible debentures. Interest expense in full year 2013 increased to $12.6 million compared to $6.9 million for the full year 2012, primarily related to a one-time non-cash expense incurred in the third quarter of 2013 as a result of extinguishing our convertible debt.

Net loss for the fourth quarter of 2013 was $4 million or $0.23 per share compared to a net loss of $4.3 million or $0.55 per share reported for the fourth quarter of 2012. Weighted average diluted shares outstanding for the fourth quarters of 2013 and 2012 totaled $17.2 million and $7.8 million respectively. Excluding mark to market warrant revaluation and amortization of convertible debt discount the fourth quarter 2013 adjusted net loss would have been $3.3 million or $0.19 per share and the fourth quarter 2012 adjusted net loss would have been $2.3 million or $0.29 per share.

For the full year 2013 our net loss was $68.8 million or $5.95 per share. This includes $54 million of charges reported as other expense and interest expense related to the non-cash mark-to-market adjustment and amortization of convertible debt discount as a result of transactions with convertible note holders and other equity investors. Excluding these charges the net loss would have been $14.9 million or $1.29 per share. This compares to 2012 net loss of $16.5 million or $2.28 per share when excluding a mark-to-market revaluation and amortization of convertible debt discount related to the May of 2012 financing.

In the fourth quarter cash burn was $1.4 million compared to $100,000 in the prior year quarter. For the full year 2013 cash burn was $6.3 million, a 48% reduction from 2012 and our lowest annual reported cash burn since we went public.

As Bill discussed during 2013 we significantly improved our balance sheet. By December 31, 2013 we had cash and cash equivalents of $13.8 million. This compares to $7.8 million at the end of 2012. During the fourth quarter of 2013 we received gross proceeds of approximately $10.2 million from a subscription rights offering we conducted in November.

Our capitalization efforts throughout the year allowed us to pay down all short term debt reducing the principal on our total debt by $17.1 million. At year-end total debt was $18.5 million related to Healthcare Royalty Partner’s debt which matures in December of 2018. Our 2014 priorities from a financial standpoint are to continue to control cost at every level of the company in order to best leverage our improved capital position for growth opportunities and product innovations. Additionally we’ll be discussing with our commercial banking partner, Silicon Valley Bank the renewal of our credit facility which matures on March 31st.

With that I’ll turn the call back to Bill.

William Mills

Thanks, Marty. In closing I would like to speak briefly to our technology. For more than a decade we have reengineered and refined our Niobe platform into today’s most architecturally advanced, versatile and clinically validated robotic technology for catheter ablation treatment of arrhythmias and coronary disease. In a market trending toward automation we are well ahead of the curve and the clear leader in offering greater safety, convenience, operator efficiencies in the cath lab.

However, along the way our product innovation became more focused on the individual customer preferences and operational workflow than guided by our first priority, to deliver the highest quality patient outcomes possible. With the significant progress we have made in strengthening our financial position we now have the opportunity to realize the full promise of our technology to improve the cure rates achieved in complex ablations. This is our ultimate goal in our guiding principal as we recommit to innovating for the future of cardiac therapies.

We’ll now open the call to questions.

Question-and-Answer Session

Operator

Thank you, sir. (Operator Instructions). Our first question from the line of Jeffrey Cohen, Ladenburg Thalmann. Please go ahead.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Hi, Bill and Marty. Thanks for taking my questions.

William Mills

You bet Jeff. Good afternoon.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Good afternoon. So could you talk a little bit about this V-Loop circular catheter manipulator, is this something that you are manufacturing?

William Mills

We are manufacturing the device which manipulates the catheter, not the catheter itself. So we take off-the-shelf catheters and they are connected with our device which effectively becomes a mechanical pair of hands to remotely manipulate that catheter from the control room.

So this is an important adjunct in our quest for the perfect work flow in the cath lab, Jeff. It’s another reason why interventionist can remain in the control room and not have to return to the cath lab to manipulate what I would term a secondary catheter, a catheter used in addition to the primary ablation catheter that the procedure centers around. So this like the ICE catheter manipulator is a device intended to automate that auxiliary or secondary catheter movement and placement.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay. So I guess it begs the question then what are the ASPs on it and what percent of procedures would you hypothesize are going to be used with it?

William Mills

With regard to the percent of procedures I think that’s – it’s probably a little early for us to speculate what that percentage might be in our environment. It’s going to I can tell you in advance though it’s going to vary considerably amongst practitioners, people, practitioners, electro-physiologists will have various preferences for the way they conduct their procedures. Some of them will lean more heavily on certain tools than others will.

So I am quite sure I can say that we will see a full spectrum of variation of utilization between sites and between operators for that matter within the sites. But Martin do you want to comment on the ASPs for.

Martin Stammer

Sure. So we get couple of different products with a catheter product that will actually hold the V-loop manipulator. The catheter product is going to have an ASP of about $200,000 and then each of the disposable devices that actually clamp on to the LASSO catheter will be I would say in the neighborhood of a $1,000.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay. Got it. I was unsure with the Niobe approval and launch with your partner, does that include also the Vdrive or not?

William Mills

We hope that it will, Jeff in the coming months but it does not yet include the Vdrive component tray.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay.

William Mills

That process now will be I think very substantially aided by our partners there who will be picking up the oak in the effort to complete those regulatory approvals. But as yet, no, Vdrive is not part of the complex of products that will be available for marketing now.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay. And you anticipate that the regulatory process for the Vdrive addition will not be the same time frame as for the Niobe itself?

William Mills

No, I would expect a more compact process but I can’t give you specifics at this point.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay. And Marty any commentary on transfer pricing for sales in to Japan?

Martin Stammer

No specific comments there. I would say that we are using distributors in Japan obviously. So I would take that into consideration when looking at what pricing we would obtain. However I would contrast that against the economic opportunity and reimbursement rate that are in each of the individual geographies. So typically we do see considerably lower ASPs in regions where we use distributors but they usually don’t have as advanced medical system as Japan does.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay. And just one more from me. Marty you gave a little bit of metrics on the backlog. Could you just walk through again, the current backlog – the total current backlog of the 6.8 you referenced?

Martin Stammer

Yes. So in the quarter we went in with the – into the quarter with about $5.5 million of backlog. We recognized revenue – system revenue of $2.7 million and added $3.9 million in backlog which brought us up to $6.8 million for the year-end backlog.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay. And the fourth quarter included sales of three Vdrive’s?

Martin Stammer

Yes. It was three Niobe systems, one of which was at a lower selling price because it went to replace a Niobe I system, three Odyssey systems and one Vdrive.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay. Three Niobes, one at a lower ASP, three Odysseys and one Vdrive for the quarter.

Martin Stammer

That’s correct.

Jeffrey Cohen – Ladenburg Thalmann & Co.

Okay. That does it from me. Thanks very much guys.

Martin Stammer

Thanks, Jeff.

William Mills

Thank you, Jeff.

Operator

Thank you. (Operator Instructions). And our next questions from the line of [David Fischer], private investor. Please go ahead.

Unidentified Analyst

Hi, Bill and Marty.

William Mills

Hi, David.

Unidentified Analyst

Hi, I want to ask briefly about the Japanese agreement and your decision to partner with two firms in Japan versus one. How are Hokushin and Medix going to split their work and I guess why split between regulatory versus selling? And if you could give us some color on what is needed now to train the sales force there, what is needed in order to launch properly in Japan?

William Mills

Well, Dave it’s a good question with respect to why two firms rather that one. What we found here in this, I guess you would consider it something of a triangular partnership is that we have two very confident and motivated firms that have each specific expertise componentary that when taken together form a pretty comprehensive and powerful solution to our distribution challenge in Japan.

So certainly there would have been alternatives for us to embrace a single firm with the entirety of the skillsets and appropriate licenses and the like to be a one-stop shop, if you will in that regard. But we were compelled by the vision and the collective capabilities of these two firms who know each other obviously and are comfortable in working in partnership with us to complete this process.

So it’s not necessarily what one would expect as an arrangement but one that we are very enthusiastic about and as I say each of them has their specific expertise. I think in our press release you can read how we’ve reported that these responsibilities will be set out or have been set out between the two parties and what they will each be responsible for. So I would urge you to take a look at that carefully and if that’s not clear we can talk about more about it at some future point.

But I just want to say we are very enthusiastic about the choice of these partners and we think they are going to do a good job for us. We’ve had some time reflect on the options that we have might have – we might be fortunate enough to have in that marketplace and this is what we’ve chosen we’re enthusiastic about our partnership.

Unidentified Analyst

Okay. That sounds great. And then as you said they do have experience working together and so in a way they will know how to share those responsibilities and drive each other?

William Mills

Yes. And I think that’s an important point David. I don’t think that this the type of arrangement that any of us would have proposed putting into place if it were not the case that those two parties had a certain harmony of relationship that we could rely on and they could rely on to avoid those sorts of issues that could creep into an arrangement where the parties were unknown to each other and thrown into a new arrangement like this. So we are comfortable that process is going to work smoothly and we are anxious to begin as we’ve said.

Unidentified Analyst

And as part of the validation of the distributors have they already or you already have discussed with several potential hospital customers, key physicians in Japan?

William Mills

Obviously, nobody’s had discussions before they were entitled to have any discussions and this arrangement is quite hot off the press. So this is not a piece of news that we have been inventorying for distribution at this time. We are reporting it now because it was just completed. So the process is now very young, it’s days old and I think it would probably be premature to comment on the customer contact to-date.

In fact our Senior Vice President of Marketing is in Japan as we speak, in the early stages of the process of unfurling those activities. So it really is a very, very young relationship but again one that we are enthusiastic about and they are enthusiastic to share with you at this point because it’s been a long time coming, as I think was said during the call.

Unidentified Analyst

Okay, great. And if there is anyone else on the line, I am happy to jump off and then come back on later. Otherwise I will keep shooting one more.

William Mills

Why don’t you go ahead and ask, David. I don’t know whether there is or not but why don’t you keep going.

Unidentified Analyst

Okay. Can you talk a little bit about the U.S. sales force spend and then I remember that you had plans to enhance the sales force after some of cuts that were made about a year ago and that those cuts were largely responsible for the decline in sales over the prior year. And so it would be interesting for me to hear about how you are rebuilding the sales force and how that has been going?

William Mills

Well, I don’t think you should think of re-building on this context as re-building in the sense of adding additional OpEx and cost commitments in that regard, because that’s certainly not what we would want people to take away. What we have been doing is really re-deploying and re-charging the duties of the folks that we have in the field so that the things that they are bringing to our customer accounts are more aligned with the kinds of things that we think are needed to both support those accounts as well as to energize them and to bring them to a higher level of understanding of the power in our platform and the ways in which they can use in their procedures.

It is an ongoing effort for us after we sold a Niobe system into a site, the ongoing effort to support and encourage and to be there for the utilization as the operators grow in proficiency and develop their own clinical set of experiences, this is a field functional set of skills and requirements that we are still candidly in the process of defining, but we have now been at this for long enough that I think we feel as though the folks that we have, though not changed in number, are – have been assigned more appropriate duties and targeted them in ways that we hope will prove to be a more efficient and more effective system of encouraging the appropriate level of utilization.

And we are – when we say encourage utilization obviously what we mean by that is to have folks be sure that the operators are understanding of the appropriate opportunities for the use of our system and mindful of its capabilities and use it when it’s appropriate. I think no medical device company should and no company broadly should push the use of its products beyond what would intended or prudent in the individual circumstances and certainly we are not in the business of doing that, but we have to keep these customers that have a very complex piece equipment in a world in which they exist which is otherwise highly complex dynamic.

We have to have a way of keeping an ongoing conversation and level of support with those folks. They are in face positioned to make the best use of the solution that we are offering and indeed the solution that we are evolving because I think as we have indicated over the course of this call, we intend to continue to innovate against the solution that we are offering into this market place.

It will not remain static and that perhaps is our highest priority right now, having established the foundation that we have we’re excited I can tell you personally very excited about the opportunities that we see to do even better and that will require from the sales force an ongoing of support so that the contemporization and further evolution of the products are understood and appreciated by the folks in the field.

Unidentified Analyst

Okay, great. I look forward to obviously a very exciting year.

William Mills

Yes. We are looking forward to talking more about it with you, Dave. Thank you.

Operator

Ladies and gentlemen, at this time, that concludes our question-and-answer session. I would now like to turn the conference back to Mr. Mills for any closing remarks.

William Mills

My closing remarks will be brief and probably what you would expect I really appreciate your – Marty and I both appreciate your joining us today for this call. I think we have reported on some developments which will prove to have been important ones for us as we move forward and we are equally if not more anxious to report to you as the quarters come upon us going forward additional progress against those priorities that we’ve begun to articulate for you during the course of last couple of calls.

So once again, thank you. We appreciate your support and your interest and we are looking forward to being with you in the next quarter’s call. Thank you.

Operator

Thank you, sir. Ladies and gentlemen, this concludes the Stereotaxis fourth quarter and full 2013 financial results conference call. Thank you very much for your participation. You may now disconnect.

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