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Cyberonics (NASDAQ:CYBX)

Q1 2014 Earnings Call

August 22, 2013 9:00 am ET

Executives

Daniel Jeffrey Moore - Chief Executive Officer, President and Executive Director

Gregory H. Browne - Chief Financial Officer, Principal Accounting Officer and Senior Vice President of Finance

Analysts

Brooks E. West - Piper Jaffray Companies, Research Division

Matthew O'Brien - William Blair & Company L.L.C., Research Division

Kyle Rose - Canaccord Genuity, Research Division

James Sidoti - Sidoti & Company, LLC

Charles Haff - Craig-Hallum Capital Group LLC, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the Cyberonics Q1 Fiscal Year 2014 Earnings Conference Call. My name is Kevin, and I'll be your operator for today. [Operator Instructions] As a reminder, this conference is being recorded for replay purposes. I would now like to turn the conference over to your host for today, Mr. Dan Moore, President and Chief Executive Officer. Please proceed.

Daniel Jeffrey Moore

Thank you, Kevin, and welcome to Cyberonics Fiscal 2014 First Quarter Conference Call. Joining me today is Greg Browne, our Chief Financial Officer, who will first summarize the Safe Harbor statement. Greg?

Gregory H. Browne

This presentation and earnings call includes forward-looking statements. Forward-looking statements may be identified by the use of forward-looking terminology including may, believe, will, expect, anticipate, estimate, plan, intend and forecast, or other similar words. Statements in this presentation are based on information presently available to us and assumptions that we believe to be reasonable. Investors are cautioned that all such statements involve risks and uncertainties. Forward-looking statements in this presentation and on this call include statements concerning building stockholder value; achieving consistent sales growth and profitability growth worldwide; achieving clinical, regulatory and product development milestones; evaluating and advancing other medical device and neuroscience opportunities, including the previously announced stock repurchase programs and fiscal guidance for 2014.

Our actual results may differ materially. For a detailed discussion of the factors that may cause our actual results to differ, please refer to our most recent filings with the SEC, including our annual report on Form 10-K for the fiscal year ended April 26, 2013. Dan?

Daniel Jeffrey Moore

Thanks, Greg, and good morning. Cyberonics started fiscal 2014 with solid financial results in several key areas and we also achieved important clinical milestones. The financial and operating highlights included:

Net product sales of $67.4 million, with growth exceeding 12% and reported revenues up $68.9 million.

Record U.S. epilepsy unit sales of 2,448 generators.

Strong international unit growth of 21%, again, led by Europe.

Adjusted operating earnings up $21 million, a 22% increase over the prior year, as adjusted. Note that the reported results for the most recent quarter include $1.5 million of license revenue, compared to $0.4 million included in the comparable quarter of the prior year.

Growth in the U.S. was in line with our Q1 expectations and that growth supports our annual guidance for sales, new patients and replacement activity. The AspireHC represented 26% of sales in the U.S. in Q1.

In addition to strong sales in Germany and the U.K., European growth was enhanced by results from our partners in Eastern Europe. Importantly, other international regions showed growth over the first quarter of the prior year as well.

In the areas of market development and reimbursement, we continue to make good progress in our global efforts. For example, reimbursement for privately-insured patients in Brazil has been recommended and is currently in a public comment period. Florida recently authorized increased funding for VNS Therapy for Medicaid patients and we continue to work to improve reimbursement in several other states. We also continue to sponsor activities to support global peer-to-peer events, and believe these events are important in helping physicians adopt and utilize VNS Therapy as a more foundational part of their practices for patients with refractory epilepsy. At the same time, we have accelerated the addition of more field-based sales representatives and support personnel in the last several months to facilitate further penetration in both the U.S. and European markets.

An update on our product development activities.

In addition to achieving the Q1 sales and financial goals to support our full year guidance, we also made significant progress with our new product pipeline. Let me highlight the key projects.

First, the Aspire generator, specifically the E-36, EU clinical study to support CE Mark submission. We completed enrollment in the clinical study in the first quarter of fiscal 2014. And as a reminder, our objective is to submit AspireSR for European regulatory approval no later than the end of fiscal 2014.

Also, on the topic of AspireSR, our U.S. clinical study, the E-37, our clinical investigators have now implanted by patients in that study. We expect to complete enrollment of the first phase of that trial this fiscal year.

Our ProGuardian system. ProGuardian is our in-home monitoring system that is designed to aid in the detection, recording and notification of seizures accompanied by heart rate variations or movement. Our objective is also to submit the first product of the ProGuardian platform for regulatory approval in Europe by the end of this fiscal year.

Our Relay generator. Development of a wireless-enabled VNS Therapy generator has continued to progress as we strive towards regulatory submissions.

The programming tablets. On the last earnings call, we discussed a transition from the handheld PDA programmer, which is used by patients for -- or used by physicians for patient dosing, to a new tablet computer programmer. First shipments of the new tablet are occurring in the current quarter.

The Neural [ph] Autonomic Regulation Therapy for chronic heart failure. Enrollment and implant activity in the ANTHEM pilot study is now complete. While we are encouraged by the pace of this program, further activities in this area remain contingent on the results from this pilot study, which are expected later this calendar year.

Greg will now take us through a discussion of our financial results and our guidance in more detail.

Gregory H. Browne

Thank you, Dan, and good morning, everyone. As mentioned by Dan earlier, the quarter's results include recognition of the final portion of license revenue from the 2007 agreement, a total of $1.5 million. This amount was included in our full year guidance, although in previous years, the annual amount was recognized at a rate of $374,000 per quarter. Subsequent quarters in fiscal 2014 will not reflect any license revenue from this agreement as all terms have now been met.

With respect to the litigation settlement during the recently completed quarter, we recorded an amount of $7.4 million pre-tax to settle an outstanding legal dispute. This amount includes the legal expenses incurred to date and has been excluded from the adjusted non-GAAP results for the purposes of comparison. Please note that our earnings release and the presentation posted to our website today both contain reconciliations between reported numbers and adjusted non-GAAP numbers.

Product sales in the first quarter of fiscal 2014 was $67.4 million, representing growth of 12.4% over the first quarter of the prior year. U.S. unit sales increased by 6.2% for the quarter, and along with generator ASP growth of 4%, resulted in an increase in U.S. product revenue of 10.8%. International units increased by 21% and revenue by 22% over the fiscal 2013 first quarter with no material currency impact.

U.S. epilepsy unit growth occurred in both generators and leads over the prior year. Variation in lead sales from quarter-to-quarter will occur for a variety of reasons and may not be indicative of underlying activity. For example, we continue to replace some leads each quarter.

For the first quarter of fiscal 2014, U.S. epilepsy lead sales are estimated at 1,234, compared with 1,133 in the previous year, an increase of 8.9%. The trailing 4 quarter growth rate in U.S. leads was 8.5%.

On the last call, we guided growth for U.S. replacements in fiscal 2014 in the mid-single digits, and this is still our expectation for the fiscal year.

Foreign currency movements, when compared to the first quarter of last fiscal year, did not have any material impact on international revenue. As a reminder, our annual guidance is predicated upon an average dollar-euro exchange rate of $1.30 to EUR 1. The average exchange rate for the first quarter of the current fiscal year was $1.26 compared to $1.32 in the first quarter of fiscal '13, although this was largely offset by changes in the U.S. dollar to the pound exchange rate.

The AspireHC accounted for 26% of U.S. unit sales in the most recent quarter, an increase from the 19% in the fourth quarter. Demipulse was 61% of units sales and the Pulse at 13%. This increased market adoption of AspireHC was achieved with a solid price premium to the Demipulse and in line with our annual plan.

The reported gross profit of 90.5% in the first quarter was consistent with the previous quarter and lower by 119 basis points from the first quarter of fiscal 2013, most of which is the result of the inclusion of the full quarter of the medical device tax in cost of goods sold, although there was a 15 basis points favorable impact from the license revenue acceleration.

For the first quarter of fiscal 2014, adjusted operating income was $21 million or 30.6% of sales, compared with $17.3 million or 28.6% of sales in the first quarter of fiscal 2013.

Operating expenses, as adjusted, were materially unchanged from the fourth quarter. Although as Dan mentioned, we chose to accelerate the planned annual additions to the U.S. and European sales organizations to continue driving growth. Operating expenses are expected to be relatively flat for the remainder of fiscal 2014.

Generating operating leverage has been a key objective over the last 5 years and will continue to be an important focus. However, we have emphasized investment in both market and product development, including related clinical activity.

The significant progress in the clinical studies that Dan referred to earlier, along with other activity in preparing new products for regulatory submission, has resulted in R&D spending of 17.4% for the quarter. This percentage is not expected to increase materially over the remainder of fiscal 2014, and as previously stated, we do not expect research and development spending to exceed 18% of revenue in the future.

Earnings before interest, depreciation, amortization, equity compensation expense and other adjustments, totaled $25.6 million in the first quarter, an increase of 12% over the first quarter of fiscal 2013.

For the first quarter of fiscal year 2014, we had an effective tax rate of 35.8%. This rate reflects some benefit from the domestic manufacturing deduction and the current year and prior year impact of a new Texas state tax research and development credit retroactively enacted in 2013. We continue to expect a tax rate of approximately 32.5% for fiscal 2014, assuming that the federal research and development tax credit is extended beyond December 31 of this year.

The number of shares included for the purposes of diluted earnings per share calculation this quarter of 27.8 million continues to be reduced through repurchases. As stated in our press release, we repurchased 205,000 shares in the first quarter and we expect to complete the remaining authorization of 740,000 shares this fiscal year.

Adjusted earnings per share of $0.48 includes approximately $0.025 per share from the license fee acceleration. Without this inclusion, earnings per share of $0.46 increased by 21%, compared to an adjusted $0.38 per share in the first quarter of the prior fiscal year. Overall day sales outstanding were 54 days, materially unchanged from the end of the prior quarter of fiscal '13.

Our balance sheet remains strong. The stockholders' equity, approximately $235 million. Approximately $131 million in cash and short-term investments, and no interest-bearing debt.

During the first quarter, we invested approximately $6 million relating to the Costa Rican project, as well as Houston facilities and equipment. With respect to our guidance, we've maintained and reaffirmed our guidance for fiscal 2014 with net sales in the range of $279 million to $283 million.

Our assumptions in setting this range are unchanged and include worldwide unit growth of approximately 10%, mid- to high-single-digit growth in new patients, mid-single-digit growth in U.S. replacements, ongoing European growth, and the euro-dollar exchange rate of $1.30. The gross profit margin is still expected to be approximately 89.5% for the full year and adjusted operating income is expected to fall in the range of $85 million to $88 million.

Adjusted net income is anticipated to fall into the range of $53 million and $56 million, and we anticipate that diluted shares outstanding will be approximately 27.5 million in fiscal '14.

With these assumptions, adjusted earnings per share is anticipated to be between $1.93 and $2.01 per diluted share. We'll now open up the call for questions. Operator, first question, please.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from Brooks West of Piper Jaffray.

Brooks E. West - Piper Jaffray Companies, Research Division

Greg, on the guidance, you were a bit cautious on the unit guidance for the year on both U.S. replacements and Europe, and both of those look like they came in reasonably above your cautious tone. Are you seeing anything that would make you more cautious going forward? Or is this just conservatism at the beginning of the year?

Gregory H. Browne

Well, Brooks, thanks. I think the results for the first quarter were pretty much in line. I mean, our worldwide unit growth was 9.8%, approximately 10%. I think our U.S. new patient growth was in the mid to high single-digits. Replacement, actually was -- is measured by leads, was pressed a little less, but on a full-quarter basis, it's in line. And Europe has been good. I think that as far as our guidance is concerned with -- plus one exception. We've not adjusted our guidance every quarter. We do it if necessary and if appropriate, at the end of the second quarter. And -- but we're not seeing any trends that would cause us -- as we guide forward, that would cause us any more caution than we presently [ph] have.

Brooks E. West - Piper Jaffray Companies, Research Division

Okay. Just 2 more. Dan, the growth in the field force that you outlined, is that a shift in the strategy, hunting versus gathering? Or are you seeing a specific opportunity? And then I get a lot of questions, just on when we're going to hear about the data from the various trials. Are you targeting a medical meeting? Are you still thinking of having an Analyst Day this year? Answers to that would be very helpful.

Daniel Jeffrey Moore

Yes. On the first part, the growth of the global sales force. We look weekly in staff meetings. We have regular staff meetings here weekly. We do quarterly off-site. And we're constantly assessing the opportunity to grow our sales force in a productive way. So the only difference is, at times, instead of uniformly adding throughout the year, if we see the opportunity and a need, we will pull forward some additions, and that's what we're talking about. But over the last 12 months or so, we've increased the size of the U.S. and European sales forces collectively by about 10%. So we're just opportunistic there. On your second question, as far as reporting of clinical results, we're working on potentially having an Investor Day coming up on the same kind of timing that we've had in the past and we will look for scientific venues to be able to report the results of some of these trials. The investigators get involved and one of the things that they get out of it are the ability to publish and the ability to go to meetings and speak about their results. So as much as we can, we try to align ourselves with those wishes.

Operator

Our next question comes from Matthew O'Brien with William Blair.

Matthew O'Brien - William Blair & Company L.L.C., Research Division

I was hoping we could start off on the international side of things. I'm assuming that Japan wasn't much of a contributor to the performance this quarter, I'm not really sure what you're saying with the other international territories being stronger than expected. And then within there, you're facing some pretty difficult comparisons going forward given the performance over the last several quarters. Just how can we think about growth internationally from here?

Daniel Jeffrey Moore

Well, as much as we could always think about difficult comparators going all the way back to 5 or 6 years ago, it's not the way we tend to think. We tend to think about an underserved patient population, and that's in the U.S., that's in Europe, that's in all of our international regions. So we have an expectation of continuing to grow, and that -- all of that's reflected in our guidance. So I think we remain bullish and we'll continue to try to grow in every region we're in. Japan has been slow and steady, but over the last quarter, I think they've made -- Nihon Kohden has made some changes to their sales structure that we think, over time, will pay dividends. So we continue to be optimistic, cautiously optimistic, about what can happen in Japan.

Matthew O'Brien - William Blair & Company L.L.C., Research Division

Okay. But the improvement in Japan that you're seeing is probably more like a fiscal '15 event than really this year?

Daniel Jeffrey Moore

Yes, it's been slow and steady, but more like '15.

Matthew O'Brien - William Blair & Company L.L.C., Research Division

Okay. And then Dan, you talked about this penetration opportunity and you've got a number of products in the Q here with SR, Relay, ProGuardian, so on. But just within the existing patient population that you're going after right now, and I know that doesn't include ProGuardian. But how far can you go from a penetration perspective with the existing portfolio, versus then when you layer on Relay, SR? And just how can we think about that trajectory of penetration in the U.S. with those products?

Daniel Jeffrey Moore

The way I think about it is, 6 years ago, the hypothesis for coming into the company was this was a significantly under-penetrated patient population globally, less than 20%. And here we are, despite 6 years of pretty good financial results overall, we're still less than 20% penetrated in just about everywhere in the world. So we tend to keep focusing on the 80% of the patients that we're not getting to and building plans around getting to those patients. I don't look at it and say, there's going to be a big inflection point at any time. I think it'll continue to be slow, steady growth.

Matthew O'Brien - William Blair & Company L.L.C., Research Division

Okay. And then just 1 more for me, for Greg. You're spending a lot of money right now on R&D and you've got a lot of submissions coming up towards the end of this fiscal year. Should we just think about that R&D spend in fiscal '14 as kind of the high watermark and start to see some leverage from that metric going forward?

Gregory H. Browne

Well, we haven't formulated all of our plans for fiscal '15 as yet, because we only just started fiscal '14. But I think we have said that we're not going to go over 18% of revenue on R&D, and we have been fortunate and planned-for, in fact, to get operating leverage out of the SG&A line over the last 5 years, and that's allowed us to spend more on the R&D. So having said that, I think we are probably getting close to the high watermark and there's more we can do in terms of market development as we go forward. And so I think, in answer to your question is probably close to the high watermark. But having said that, priorities can change over the next 3 quarters or so and we'll take a look at it towards the end of the fiscal year.

Operator

Our next question comes from Bill Plovanic with Canaccord.

Kyle Rose - Canaccord Genuity, Research Division

Great. This is actually Kyle on for Bill. So I wondered if you could just walk us through some of the guidance on the replacement growth, mid-single digits for '14. I just wondered if you could give us a little more color on your expectations there. When should we expect that to pick back up, or is this more of a new reality moving forward?

Daniel Jeffrey Moore

I think we are -- as far as the replacement growth is concerned, we put out estimates on our December 2011 investment Analyst Day, which took us out to fiscal 2015. I think we're generally in line with those estimates. Those estimates did not reflect an acceleration in fiscal 2015. Having said that, we are reviewing our current forecast in anticipation of a possible -- another Investor Day later this year. So at that time, we would've intend to lay out some forecast beyond -- fiscal '15 and beyond as we see it today. But at this stage, I think those estimates still stand, which is around mid-single digits for this year and probably next year.

Kyle Rose - Canaccord Genuity, Research Division

Great. And then just maybe a couple of questions here. I wondered if you could break out the impact of the med tech tax in the quarter?

Gregory H. Browne

Yes. I think I said on the call that it was 119 basis points impact on the cost of goods sold. It was slightly less than $1 million worth of cost plus the $800,000 worth of costs for the quarter.

Kyle Rose - Canaccord Genuity, Research Division

And then lastly, could you just break out new unit sales internationally?

Gregory H. Browne

We generally have not done that. The lead numbers for the international generally run about 65%, if you will, in terms of international units to lead. The international lead sales were $693 million for the quarter, in fact, and that was up from $569 million in the prior year.

Operator

The next question comes from Jim Sidoti with Sidoti & Company.

James Sidoti - Sidoti & Company, LLC

CMS put out some proposed reimbursement rates for '14. Can you just comment, should those rates stay where the proposal level is? What do you think it'll do for your business?

Daniel Jeffrey Moore

Yes, Jim. The rates, we said we're pleased with the proposed rates, which came out around the 4th of July. But as we indicated to people who we've spoken to after that, that these are only proposed rates and there are some new methodologies being applied by CMS to the rates. So we've had some consultants looking at and reviewing the new comprehensive APCs from CMS, which are proposed. This concept involves packaging all of the cost for services on a single claim and across dates of service. So while it doesn't appear that, that will have a material impact on our APCs, the consultants were not able to precisely replicate CMS' methodology. So I think there's a possibility of more than usual change between the proposed rates and the final rates at the end of October. So with that note, of course, I think that obviously, we're encouraged. We've always said that reimburse -- this is not a reimbursement-driven business, but having said that, it probably does help the hospitals to some extent and helps with our pricing, particularly around and on the replacement side.

James Sidoti - Sidoti & Company, LLC

Okay. And then can you just update us on how it's going with the construction in the new facility and when you expect that to be online?

Daniel Jeffrey Moore

Yes. The construction's going well. The -- outer shell -- the land's been procured, the outer shell of the facility is complete. Working on the inside of the facility now, and over the course of this fiscal year, we expect to get into working on regulatory submissions to get this site qualified --

James Sidoti - Sidoti & Company, LLC

So, conservatively, you think by the beginning of fiscal '16, you'll be shipping product from there?

Daniel Jeffrey Moore

Fiscal '16, did you say?

James Sidoti - Sidoti & Company, LLC

Right.

Gregory H. Browne

Yes. We hope to be shipping products prior to that date.

James Sidoti - Sidoti & Company, LLC

Okay, but by this...

Gregory H. Browne

Perhaps the middle of fiscal '15.

James Sidoti - Sidoti & Company, LLC

Middle of '15, okay.

Daniel Jeffrey Moore

We'll be doing stage manufacturing there, though. So when we talk about a product, we'll start at the back end of the production line, which is more the packaging and labeling, and work our way upstream into the manufacturing process over time, and same with product lines.

James Sidoti - Sidoti & Company, LLC

All right. And I assume you'll have both plants running simultaneously, so there might be a little margin pressure during that transition?

Gregory H. Browne

We will be running them simultaneously. We're not anticipating, necessarily, margin pressure at that time. But of course, we do expect to get -- if we do, we hope to more than make that up at the other end of the income statement in terms of an effective tax rate.

Operator

Our next question comes from Charles Haff with Craig Hallum.

Charles Haff - Craig-Hallum Capital Group LLC, Research Division

Most of my questions have been asked and answered. But a couple of housekeeping items here. Any update on the wrongful termination lawsuit that was filed a few months ago, or a request for arbitration there from Hagerty?

Daniel Jeffrey Moore

Nothing new that we're aware of.

Charles Haff - Craig-Hallum Capital Group LLC, Research Division

Okay, great. And then you did the good job of managing inventories this quarter despite the increase in sales. Is there anything that we should be paying attention to there? Any changes that you've made?

Gregory H. Browne

No. I think over the last 5 years, our operations group has done a very good job of managing inventory at all the stages of the process, and that Continued. I mean, we did make a buy about a year or so ago, the new tablets that Dan referred to. We'll start transitioning to those this quarter, so there's nothing -- no changes to the process.

Charles Haff - Craig-Hallum Capital Group LLC, Research Division

Okay, great. And Dan, you mentioned something about Nihon Kohden, that they had made some changes to their sales structure. I was wondering if you could dive a little bit deeper into that. Is that they're calling on psychiatrists now? Or anything, any additional details you can give us on Nihon Kohden there?

Daniel Jeffrey Moore

No. Not calling on psychiatrists. The point here is more focused on our product line, because Nihon Kohden, as you know, is a manufacturer of EEG equipment and they have many EEG equipment salespeople. And what we've been focused on is getting people who are more focused on VNS Therapy and driving those VNS Therapy sales, so that's been the nature of the change.

Charles Haff - Craig-Hallum Capital Group LLC, Research Division

Okay. So I think a couple of years ago, when we were talking about Japan, you were saying they were deploying a tiger team, which would focus on VNS. Is that just additional resources going to those efforts? Or has there been a kind of a change there?

Daniel Jeffrey Moore

It's additional resource. The same concept. You have people who are more marketing and clinically-oriented to supplement that equipment sales team. But now, we're working on getting people who are more sales-oriented as well to supplement the clinical and marketing people. But same kind of tiger team concept.

Operator

And I'm not showing any further questions at this time. I'd like to turn the conference back over to our hosts for closing remarks.

Daniel Jeffrey Moore

Okay. Well, we appreciate all of you participating. The Cyberonics team, as you can see, has very good momentum in early fiscal 2014 and met our revenue and operating income targets. As I've stated before, our products have brought meaningful clinical and quality-of-life benefits, not only to the tens of thousands of people who are experiencing debilitating refractory epilepsy, but also to their families.

Our recently distributed 2013 annual report to shareholders, again, provides examples of how important our products are to people living with epilepsy. Thanks for listening today and your interest in the Cyberonics story, and we'll talk to you again in a quarter. Have a good day.

Operator

Ladies and gentlemen, that concludes today's presentation. You may now disconnect and have a wonderful day.

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