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Stereotaxis Inc (NASDAQ:STXS)

Q3 2012 Earnings Call

November 5, 2012 4:30 pm ET

Executives

Jim Byers – SVP MKR Group, Inc.

Mike Kaminski – President, Chief Executive Officer

Sam Duggan – Chief Financial Officer

Analysts

Rosemary Liu – Oppenheimer Securities

Jose Haresco – JMP Securities

Operator

Good afternoon, ladies and gentlemen. Thank you for standing by. Welcome to the Stereotaxis Q3 2012 Results Conference Call. During today’s presentation, all participants will be in a listen-only mode. Following the presentation, the conference will be opened for questions. (Operator Instructions)

At this time, I’d like to turn the conference over to Jim Byers of MKR Group. Please go ahead, sir.

Jim Byers

Thank you, operator, and good afternoon, everyone. Thank you for joining us for the Stereotaxis conference call and webcast to review the financial results for the third quarter, which ended on September 30, 2012.

Before we get started, we’d like to remind you that during the course of this conference call the company may make projections and other forward-looking statements regarding future events or the future financial performance of the company, including, without limitation, statements regarding future operating results, growth opportunities and other statements that reflects 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 the 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, 2011 and the quarterly filings for 2012.

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 purchased 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 commitments may be revised, modified, or canceled either by their express 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 Mike Kaminski, President and Chief Executive Officer of Stereotaxis.

Mike Kaminski

Thank you, Jim. Good afternoon, everyone, and thank you for joining us for our review of our third quarter 2012 performance. With me today is our Chief Financial Officer, Sam Duggan. Following our prepared remarks, we’ll open up the call for your questions.

We’re pleased to report a strong financial quarter and trend for the company. To start, we reduced our operating loss to $900,000, our lowest level since the company’s initial public offering in August 2004 and a 90% improvement over this time a year ago. This near breakeven operating performance was a result of a marked increase in revenue, strong margins and significantly lower expenses. Specifically, third quarter revenue was up 36% and operating expenses were down 40% compared to the same quarter last year.

Through the cost reduction plan that we announced and implemented early in the year, operating expenses in Q3 were down 29% compared to first quarter levels, which is a full quarter ahead of schedule. We have made a company-wide commitment to focus operating spend on key revenue drivers and, as a result, have substantially reduced our cost structure.

As impressive as our financial metrics are for the quarter, the non-financial results are even greater indicators of our momentum. Incoming new capital orders for the quarter were $7.1 million, up 131% sequentially and up 227% compared to a year ago, reaffirming our planned uptick in capital revenue as orders translate to revenue.

Now, let me cover some highlights of the Epoch in the quarter. When we launched Epoch 11 months ago, we anticipated that upgrading the installed base would ignite excitement around the new platform in the broader market and drive capital sales. That’s exactly what is occurring.

As you recall, we generated no new Niobe ES orders in Q1, two Niobe ES orders in the second quarter. In the third quarter, new orders for the ES system increased to four, two of which were second system sales. This is the second consecutive quarter that we’ve experienced second system sales, as hospitals look to advance their robotic research and support of procedure growth with installation of a second Niobe ES. At the same time, we’ve continued to see our pipeline strengthen with mid and late stage customers as market awareness of the value of the platform broadens.

During the quarter, another 13 sites from the installed base upgraded to the new platform bringing the total ES upgrade to 60, or 43% of customers in Europe and North America. We also saw utilization among ES users continue to improve, a result of enhanced customer support and innovative programs to ensure clinical adoption.

In Niobe ES sites, EP procedures grew 26% in the third quarter while all sites grew 9% compared to the same quarter last year. The Epoch Solution represents a fundamental shift in the treatment of complex arrhythmias for the single physician operator and enthusiasm around its capabilities and potential continues to grow in the mainstream commercial markets.

With our robotic suite of Niobe ES, Odyssey and Vdrive procedures are performed safer, simpler and faster. Difficult to reach areas of the heart are assessed more easily and we believe that with the consistency of performance of our robotic platform we can positively impact recurrence rate. In fact, one physician relayed that when asked by a colleague about his strategy to treat – redo AF cases, he realized that none of his patients treated with our Robotic Navigation System had comeback for further treatment. This kind of validation continues to come about with our latest generation technology.

Vdrive contributed $0.5 million to capital revenue on four system sales in the third quarter. During the quarter we released a disposable bundle of consumable products for the Vdrive system to test the economics of a multi-used program and we have seen renewed sales activities and utilization as a result.

We have had extremely positive feedback regarding the clinical value of Vdrive and by addressing the cost per patient we should allow our European customers to significantly improve the cost value equation. We expect the commercial release of the multi-use product line in Europe by the end of this year.

During the quarter, our clinical affairs team began enrolling the patients in the V-Loop human clinical trial. The study compares manual navigation of the circular mapping catheter with the mechanical navigation of Vdrive. We expect a total of 120 patients to participate in the study, which will be conducted at up to five sites in the U.S. and Europe.

We also submitted the first FDA pre-market notification for V-Sono ICE, which enables a remote control of a variety of ultrasound catheters. Approval of either of the Vdrive disposable components, the V-Loop or Sono, will allow us to market the Vdrive universal robotic arm in the U.S. with disposables added as they receive U.S. approval.

In the Odyssey business, we recognized revenue of $1.6 million on eight system sales for the third quarter. Year-to-date, the Odyssey solution has contributed $4.8 million to revenue. During the quarter, we saw traction with Odyssey outside of the Niobe lab through our Biosense Webster commercial agreement.

Given the growing demand for the Epoch Solution, we believe we will accomplish our 2012 Niobe ES milestones by the end of the year. First, achieve 10 new Niobe ES system sales during the year. We shipped one system in October and expect to confirm a second system from backlog. The other two systems are expected to come from our late-stage pipeline.

It is worth noting that we’ve been able to reduce the time from order to shipment for Niobe ES, as evidenced by two orders posted to revenue in the third quarter, which were also received during the quarter. Secondly, upgrade at least 50% of the existing North American and European sites or nine more by year-end.

Also, in addition to releasing the Vdrive disposable multi-use program in Europe, we have set a goal of submitting the Vdrive V-CAS ablation catheter manipulator for FDA clearance before year-end.

V-CAS, which stands for catheter advancement system, is the disposable use to advance and retract a catheter during the Niobe procedures. Approval is anticipated in 2013. The Vdrive product line is an example of the innovations that will continue to define Stereotaxis.

While we are focused on translating the excitement around our robotic technology into capital revenue and higher utilization and are always mindful of cost, we remain dedicated to delivering new product that bring value and change people’s lives.

I’ll now turn the call over to Sam to provide further details on the quarterly results. Sam?

Sam Duggan

Thanks, Mike, and good afternoon, everyone. Revenue in the third quarter was $11.6 million, up from $8.5 million in the 2011 third quarter and $10.5 million in the second quarter 2012. System revenue improved to $5 million from $2 million in the prior year quarter and $3.9 million in the second quarter.

In the third quarter, we recognized revenue of $2.9 million on two Niobe ES systems and upgrades, $0.5 million on four Vdrive systems and $1.6 million in Odyssey sales.

Recurring revenue of $6.5 million was unchanged year-over-year and sequentially. Compared to the prior year period growth in procedures was more than offset by a weakening of the euro and to a lesser extent inventory adjustments at our customers resulting in a slight decline in disposable revenue.

Royalty income was also marginally lower than last year due to a contractually lower royalty rate of 14%, which went into effect on January 1 and compares to a rate of approximately 16% in the prior year period. Utilization in Niobe ES sites increased 26% in the quarter over the same period last year and overall utilization was up 9%. This should positively impact disposable and royalty revenue as we move forward.

Gross margin was $8.1 million or 69.8% of revenue in the third quarter compared to a margin of 68.9% in the year-ago quarter and 69% in the second quarter. The improvement in gross margin was driven by higher production volumes.

Operating expenses in the third quarter were down $5.9 million or 40% year-over-year and down $2.9 million sequentially. The year-over-year decrease was principally related to reduced head count and related travel expenses, lower consulting and discretionary spending, as well as a decline in registration costs in Japan as our products approach the end of clinical trials.

The third quarter also realized $0.8 million in positive adjustments, primarily related to non-cash stock compensation and bad debt expense. As Mike mentioned, we also reduced our operating expenses by 29% from first quarter levels to an aggressive reduction in expenses not impacting top line growth, more focused R&D spending and reliance on our clinical sales team to drive capital sales.

Operating expenses are expected to be higher on a sequential basis in the fourth quarter, as the $0.8 million in positive adjustments are not expected to reoccur and the V-Loop clinical trial ramps up. However, we expect expenses will remain 15% to 20% below first quarter levels in the first quarter.

Operating loss in the quarter was reduced to $0.9 million compared to $9.1 million in the prior year quarter and $4.6 million, sequentially. This represents a 90% improvement over the prior year quarter and our lowest reported operating loss as a publicly traded company. Even excluding the $0.8 million in positive operating expense adjustments, we still realized our lowest operating loss since August 2004.

Interest expense increased to $1.6 million in the third quarter, compared to $0.8 million in the prior year quarter. The rise is primarily related to the Cowen Healthcare Royalty Partners financing in November 2011, an additional $2.5 million in Cowen borrowings in August, 2012 and issuance of $8.5 million in subordinated convertible debentures in May, 2012.

Interest expense includes the amortization of the debt discount on the subordinated converted debentures, totaling $0.2 million in the 2012 third quarter. This amortization is expected to grow to $0.4 million in the fourth quarter of 2012.

Other income for the 2012 third quarter included a $0.6 million gain primarily related to mark-to-market conversion features of the warrants and subordinated convertible debt associated with the $18.5 million financing in May of 2012. Third quarter 2011 results included a $2.6 million gain in other income related to the change in market value of certain warrants issued in December, 2008.

Net loss for the third quarter was $1.9 million, or $0.25 per share, compared to a net loss of $7.3 million, or $1.33 per share, reported for the third quarter of 2011. The weighted average shares outstanding for the third quarter of 2012 and 2011 totaled 7.7 million and 5.5 million respectively. Excluding the mark-to-market gains included in other income, the third quarter of 2012 adjusted net loss would have been $2.5 million, or $0.33 per adjusted share, and the 2011 third quarter adjusted net loss would have been $9.9 million, or $1.80 per adjusted share.

At quarter end, we valued our active backlog at $13 million compared to $12 million at the beginning of the quarter. During the quarter, we added $7.1 million in new orders and converted $5 million in revenue, consisting principally of $2.9 million for two Niobe ES sales and upgrades, $1.6 million in Odyssey sales, and 0.5 million in Vdrive. We removed one project from backlog valued at $1.1 million. The project was put in backlog in 2010 and removed due to a construction delay, but it’s still in our sales pipeline.

In the third quarter, cash burn was $3.6 million compared to $6.4 million in the prior-year quarter and $4.2 million in the 2012 second quarter. The cash burn in the 2012 third quarter was composed nearly equally between cash losses and higher working capital. As we look forward to the fourth quarter of 2012, we expect our cash burn to continue to decline through higher revenues and controlling costs.

At September 30, 2012, we had cash and cash equivalents of $9.9 million compared to $12.1 million at June 30. Outstanding debt was $30.9 million, including $16.4 million related to Cowen debt. On August 8, we borrowed an additional $2.5 million from Cowen upon completion of our first milestone of six Niobe ES sales in the nine months ending June 30, 2012. We will receive another $2.5 million in the first quarter of 2013 with the sale of 10 Niobe ES systems for the 2012 fiscal year.

While we remain focused on continuing the positive operating and financial trends of the quarter, we also recognize the need to strengthen our balance sheet. In that spirit, we have engaged an independent financial advisor to assist management and the board of directors in reviewing all possible strategic and financing alternatives, including the sale of non-core assets or distribution rights in geographic partnerships.

There can be no assurance as to whether any particular strategic or financing alternative will be recommended by the board, and we do not intend to disclose information on the progress of this evaluation until such time as deemed appropriate by the board.

With that, I’ll turn the call back to Mike.

Mike Kaminski

Thanks, Sam. When we look ahead to 2013, we have several opportunities that we’re excited about. First, Vdrive’s expected approval in the U.S. should significantly increase its contribution to our top line. The U.S. market is less challenged from a reimbursement standpoint than Europe and we believe physicians will be eager to utilize the unique capabilities of the full robotic suite.

We will also be exploring a possibility of expanding the V arm to a broad number of products, giving customers greater flexibility and allowing us to capture revenue on a greater number of cases.

Secondly, the Japan market will open up with the expected regulatory approval of Niobe in the first half of 2013. Japan currently has approximately 400 hospitals performing ablations with 12% annual procedure growth. AF in particular is a growing problem as 23% of the population is now 65 and older. Japan represents a large untapped market for Stereotaxis with high regard for value added U.S. medical technology. At the same time, we’re committed to continually improve in quarterly financial results.

We continue to see positive uptick in new capital orders, strengthening of our capital pipeline and broadening of our Epoch installed base positively impacting utilization. As a result, we believe we’re positioned to further drive top line growth with strong margins and through diligent control of expenses to demonstrate a stronger bottom line. We believe our vision for the Epoch platform is becoming a reality and leading us on a path to profitability. We are well positioned to penetrate the commercial hospital market with our robotic technology.

Simply put, the EP physician can treat and access all areas of the heart more easily with an Epoch Solution. The idea of robotics in the interventional suite is no longer conceptual, but it is a reality that it’s designed as a practical means to deliver better outcomes through safer more precise and minimally invasive treatment.

In closing, I’d like to recognize our employees for their commitment to the success of Stereotaxis and for stepping up to the challenges of the last couple of years. Thanks to each of you for your continued support.

With that, operator, I would like to open it up for some questions.

Question-and-Answer Session

Operator

Thank you, sir. Ladies and gentlemen, we will now begin the question-and-answer session (Operator Instructions) Our first question comes from the line of Steven Lichtman with Oppenheimer & Company. Please, go ahead.

Rosemary Liu – Oppenheimer & Company

Hi, guys. This is Rosemary in for Steve. Can you hear me okay?

Mike Kaminski

Hi, Rosemary.

Sam Duggan

Hi, Rosemary.

Rosemary Liu – Oppenheimer & Company

Hey. So, congrats on strong Epoch show in the quarter. Obviously, the advantages of the system are definitely generating excitement. I just wanted to see with Epoch now three quarters into its launch, hoping to gain some more color on the dynamics you’re seeing in the field and possible spending appetite and basically how sustainable you expect this growth to be looking forward?

Mike Kaminski

I don’t know if I understood the question. Is the question the sustainability of growth in Epoch? Is that your question, Rosemary?

Rosemary Liu – Oppenheimer & Company

Exactly.

Mike Kaminski

Okay. Yeah. We’re seeing – obviously, we watch the sales pipeline, the prospective customers and look at the growth of that and the excitement around that. We’re beginning to see the Epoch utilization like we talked about. The upgrades drive utilization, which drives a stronger reference base, which builds the excitement in the market. That’s translating to stronger pipeline and now you’re seeing it translate to orders.

So what we’re seeing is the strengthening of the U.S. and Europe. There’s still a fairly untapped market in the Eastern Europe that’s growing in excitement and a lot of that I would call more the innovators and early adopters. And of course, we view – our view is Asia is just this big untapped potential that’s going to open up in 2013. Particularly Japan, which I believe is the third largest EP market. So we’re very bullish on what the Epoch has done and what it can do in the foreseeable future.

Rosemary Liu – Oppenheimer & Company

And that’s definitely very exciting that two of the new capital orders this quarter were second system sales. Could you remind us how many of the original Niobe sites had more than one system? And roughly how many hospitals in your installed base you believe could be potentially interested in more than one system?

Mike Kaminski

Yeah. I think you’d have to date back a number of years, but I believe we had a total of five sites, but none of which had two EP systems. I believe they shared one – all five of them had one IC and one EP. So that was back in the early – mid 2005, 2006 time period. This to my knowledge, to my memory, is the first site that we’ve had with multiple EP systems, which is pretty exciting. And I think obviously what you’ll see is physicians have embraced the value of robotics, the consistency of what it can do and the fact that sitting remotely is a better way to treat patients. So as we begin to penetrate that market obviously there’s hospitals out there with multiple EP sites that will begin – we think begin to look at buying second systems.

Rosemary Liu – Oppenheimer & Company

And also, sorry, if I have missed this earlier. But could you remind us what percent of the Epoch sites today have incorporated Odyssey by now?

Mike Kaminski

There are, I think, 70, is that, right, incorporated? Roughly 70 that have incorporated out of the 160.

Sam Duggan

Yeah. I think there’s about 116 Odyssey systems out there at roughly 74 hospitals. I believe that number is correct.

Rosemary Liu – Oppenheimer & Company

Okay. And Mike, last quarter, you had reference to the possibility of seeking other commercial partnership to drive Odyssey footprint. Just wondering if you had any updated thoughts for us on this?

Mike Kaminski

We’re continuing to explore the strategic partnerships and we think that’ll – you’ll see that emerge as the year unfolds and as we go into next year.

Rosemary Liu – Oppenheimer & Company

Okay, fair enough. And just lastly on the Japan launch, obviously, a very exciting market, maybe any early color on your expected rollout process there?

Mike Kaminski

Yeah. So we anticipate a first half approval. There are – we’re getting some exposure. Although, obviously, we’re not approved so we have to be careful about not marketing the product in Japan because as the Japanese physicians come to International Congress is they obviously get exposed to our technology there.

So we believe that by mid-year we should be actively marketing in Japan with the approval and obviously we’ve been fortunate to have our partners support our progress there, so that we should be able to hit the ground running pretty hard. And we’ve – I’ve seen market interest although the – and believe that you should see the resulting impact a little bit in 2013 and then obviously build as the years unfold past that.

Rosemary Liu – Oppenheimer & Company

Okay, great. Thank you so much. That’s it for me.

Mike Kaminski

Thank you.

Sam Duggan

Thank you, Rosemary.

Operator

Thank you. (Operator Instructions) Our next question comes from the line of Jose Haresco, JMP Securities. Please go ahead.

Mike Kaminski

Jose?

Jose Haresco – JMP Securities

Can you hear me?

Mike Kaminski

Yeah.

Jose Haresco – JMP Securities

Okay, here we go. Okay. First of all, good afternoon.

Mike Kaminski

(Inaudible).

Jose Haresco – JMP Securities

Just want to go back to your guidance of being able to install or recognize revenue on 10 systems this year. But can you give us just a little more color on what gives you the confidence you’ll be able to install four more systems by year’s end? I mean that’s essentially a sequential doubling of the installs that you have this quarter.

Mike Kaminski

Yeah. So, Jose, on that one – we’ve already recognized one in October.

Jose Haresco – JMP Securities

Okay.

Mike Kaminski

One is in the process of being confirmed from backlog, which we’re very comfortable will happen. And then two, are in very late stage and actually we’re working more than that, but two we’re very confident will come from late stage pipeline that will convert. And those are – I believe, the construction progress or process has already began. So they’re moving in some cases to try to buy in late stage to match what’s already going on in the hospital. So we’re – although there’s work to do – I mean, by no means is this a slam dunk, we’re confident we can get it done.

Jose Haresco – JMP Securities

Okay. As we start to see or think about 2013 – and I know this is very lumpy business, but is your sense of 2013 that it’ll be more like this year where it’s pretty steady pace of installs throughout the year rather than the typical seasonality that we get in the CapEx businesses? I mean, we’re obviously starting to look at 2013, 2014 numbers now. So what can you tell us about how to think about next year, both from Niobe to – sort of from Epoch down to Odyssey frankly?

Mike Kaminski

I think our natural seasonality that we’ve seen in the business is the capital in Q1 is always lighter than the rest of the quarters. And I think that’s true of even our partners, because I believe that a lot happens in the last half of the year and as a result – and this holiday seasons make new construction hard. So it tends to make the first quarter lighter than the rest of the year. And then the summer months are always lighter on utilization because of holidays.

I think that seasonality will always – to my – to the foreseeable future always have – impact the way we look at a year. Obviously the backlog or the building of backlog and the incoming order rate bodes well for what we believe will translate to revenue and capital. All right. So to the extent we get $7.1 million and it grows and we’ve – we got a building pipeline, then we think that’ll translate – should translate on a quarterly basis – if we can consistently do that, to $7 million or more in capital revenue, which is what we anticipate this company can get to and get to breakeven in the not so distant future.

Jose Haresco – JMP Securities

Do you think your pipeline is more predictable now than it was even a year ago?

Mike Kaminski

I think the U.S. and Europe, yes, because I think we’re coming – we have a stronger reference base. I think the rest of the world still probably has some work to do, because we don’t have as many personal touches on the rest of the world, sometimes we’re working through distributors. So we have a little less clarity on that, but I think we’re very comfortable. And the U.S. and Europe are pretty bullish on next year.

Jose Haresco – JMP Securities

Okay, I guess, last question. You’ve done a great job of cutting costs. The down side is how do we – are you going to continue to keep cutting costs into next year, because at some point there’s a diminishing return on that in terms of needing to grow and needing to feed the pipeline and support the systems out there. I mean how low are you intending to take the expense?

Mike Kaminski

Yeah. I’ll let Sam jump in here in a minute, but let me give you a quick view before Sam jumps in is, we’ve done an exceptional job and all employees and all the managers and leaders here of making you sure that we keep an eye on growing the company and innovating the product. So we’ve really looked at all the different areas that we could trim back and improve in order to continue to do that.

And I think as we go into 2013 we can leverage that to continue to grow. So we do believe we’re at a position that we can grow with the cost structure we have. It’s not our intention to cut to prosperity. We’re going to need to grow the company and spread the cost to a higher revenue base so we can get through this breakeven and obviously start generating cash. But I’ll let Sam to put a little color on it?

Sam Duggan

Yeah, Jose, we’ve actually indicated obviously for Q4, we expect the operating expenses to be higher in Q4 than Q3, partly because we had $800,000 in favorable adjustments that will not repeat, partly because the Vdrive trials – excuse me the V-Loop trials are going to be going on and will increase costs. But we would not expect that we’re going to be able to continue to cut cost at the rate we have, because you’re correct we have to continue to grows the business and as the business continues to grows you don’t have the ability to continue to cut those costs.

But we should be able to leverage the operating expenses at this lower level that we’ve been able to achieve to leverage it as then the revenue grows and gross margin grows and have it more naturally flow that down then to the bottom line and help us get to that breakeven level. So we’ve indicated that expenses will likely go up as we said in Q4 and then I think you’re going to kind of see that run rate or potentially a little bit higher next year as we go into 2013. But, obviously, we’re going to continue to focus on controlling those operating expenses and trying to invest those dollars wisely.

Mike Kaminski

Yeah. And Jose let me – as I mentioned in my script, obviously, we think the pipeline bodes well for where we think traction on Niobe will continue to grow in U.S. and Europe and rest of the world. Also Vdrive coming in the U.S. will be additive to the procedures already done in the U.S.

So that we have account managers supporting a case structure within hospitals, by putting Vdrive in there we should get more revenue per case. So it doesn’t increase our cost structure per se, but we should see a nice inflection in revenue per case and the resulting margins too.

Jose Haresco – JMP Securities

Okay, great. Thank you very much.

Mike Kaminski

Thank you.

Sam Duggan

Thank you.

Operator

Thank you. And at this time, I’d like to turn the conference back over to management for any closing remarks.

Mike Kaminski

Well, thank you for joining us on our call. We look forward to talking again in February and reporting an exciting Q4 results at that time. Thank you.

Operator

Thank you, sir. Ladies and gentlemen, this does conclude the Stereotaxis Q3 2012 results conference call. I’d like to thank you all for your participation. You may now disconnect.

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