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Nanosphere, Inc. (NASDAQ:NSPH)

Q4 2013 Results Earnings Conference Call

February 12, 2014 10:00 AM ET

Executives

Michael McGarrity - President and CEO

Roger Moody - CFO

Analysts

Shaun Rodriguez - Cowen & Company

Brandon Couillard - Jefferies

Jeff Frelick - Canaccord

Chris Lewis - Roth Capital Partners

David Clair - Piper Jaffray

Operator

Good morning and thank you for attending the Nanosphere, Inc. Fourth Quarter Financial Results Conference Call. We appreciate your continued interest in the company. Today from Nanosphere are Michael McGarrity, President and CEO and Roger Moody, Chief Financial Officer.

Before we begin I’d like to remind everyone that various remarks about future expectations, plans and prospects constitute forward-looking statements for purposes of Safe Harbor Provisions under the Private Securities Litigation Reform Act of 1995. Nanosphere cautions that these forward-looking statements are subject to risks and uncertainties that may cause our actual results to vary materially from those indicated.

Among the factors that could cause our actual results to differ materially, include but are not limited to Nanosphere's ability to develop commercially viable products, Nanosphere's ability to achieve profitability, Nanosphere's ability to produce and market its products, Nanosphere's ability to obtain regulatory approval of its products, Nanosphere's ability to protect its intellectual property, competition and alternative technologies and Nanosphere's ability to obtain additional financing to support its operations and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission.

Any forward looking statements made on this conference call speak only as of today's date, Wednesday, February 12, 2014, and Nanosphere does not intend to update any of these forward-looking statements to reflect events or circumstances that occur after today's date. This conference call is being recorded for audio rebroadcast on Nanosphere's website www.nanosphere.us.

All participants on this call will be listen-only mode. The call will be followed by a brief Q&A session. I’ll now turn the call over to Michael McGarrity, President and CEO of Nanosphere, Inc.

Michael McGarrity

Thanks, Travis and thank you all for joining us for our Q4 and full year 2013 results call. With me today is Roger Moody, Chief Financial Officer of the company. And we continue to make progress in building our leadership position in the molecular microbiology market enabled by our Verigene System. We have a number of positive milestones to report that serve as evidence of this progress. First we achieved 35 new customer placements in Q4 and a total of 161 new customer placements for the full year 2013.

Revenue for Q4 totaled $3.4 million and 2013 total revenue was $10 million. In addition, we advanced our menu offering with the recent clearance of our Gram-Negative Blood Culture Assay and submission of our Enteric panel to the FDA. These tests provide significant operating leverage to our customer base and revenue growth.

With that strength in menu coupled with the gold standard performance of our Gram-Positive Blood Culture Assay already proven in the market we can confidently expect to accelerate our growth in both placements and revenue in 2014. This visibility is the basis for our 2014 guidance of approximately 200 new customer placements and $19 million to $20 million in revenue. Our U.S. microbiology business serves as the basis and foundation for this guidance. We continue to move customers through the validation and implementation process for our Gram-Positive Blood Culture Assay. The majority of these customers also planned to validate our Gram-Negative Test now that it is cleared.

And in addition many of our installed-base and new customer pipeline plan to bring up the Enteric Assay which we recently submitted to the FDA. This pipeline of menu adoption from our current customer base and new customer placement pipeline affords us the leverage in our P&L to deliver continued revenue growth and margin improvement.

We have made significant progress in the education of the market and the value of our offering from both the patient care and healthcare economics standpoint. While this value is intuitively understood that earlier diagnosis and treatment leads to better outcomes and cost savings, our customer experience recent publications on that experience and the superior performance of our test to any other methodology is the basis for our continued growth. While we believe our international partners are making progress in the market development and customer pipeline, our guidance is based largely on our U.S. microbiology installed base.

Now let me turn the call over to Roger to provide some additional perspective on guidance after a review of our operating results for Q4 and 2013.

Roger Moody

Thanks Mike. This morning I will summarize Nanosphere’s fourth quarter and full year 2013 financial results. For additional information please refer to our related news release and 8-K both of which are available on our website www.nonosphere.us. Before reviewing the numbers I will summarize our progress.

First we are continuing to see a steady build of customers adopting our blood culture gram-positive test. Next most of our U.S. microbiology customers plan to adopt blood culture gram-negative tests. We expect that most of these customers will also adopt our Enteric Assay once FDA clearance is secured. Finally our expanding customer base and test menu will service catalysts for continued revenue acceleration.

Now I will take you through the fourth quarter and full year 2013 results. Placements in the fourth quarter were 35 resulting in 161 new customers for the year. Revenue in the fourth quarter was $3.4 million compared to $1.6 million in the fourth quarter of 2012 and $2.4 million in the third quarter of 2013. This increase was driven predominantly by test and instrument sales to U.S. microbiology customers.

Fourth quarter 2013 revenue increased year-over-year by 118% and sequentially by 44%. Test revenue grew slightly faster in 2013 than instrument revenues. Full year 2013 revenue was $10 million nearly double the $5.1 million in 2012. Gross profit in 2013 was $3.6 million as compared to $1.5 million in the prior year driven primarily by increased sales.

Gross margin increased to 36% in 2013 from 30% in 2012. The margin improvement was driven primarily by reduction in our substrate costs. Investments we are making in higher cavity count plastic moulding and automation should drive further margin improvements in 2014 and beyond.

R&D expense during 2013 was $18.6 million down from $19.7 million in 2012. This reduction was driven primarily by reduced materials spending on development projects and the capitalization of certain raw material inventory items that were expensed in the previous year.

Sales, general and administrative expenses increased to $18.7 million in 2013 from $14.7 million in 2012. The $4.4 million expense increase was driven primarily by expansion of our sales and customer support teams.

Net loss for 2013 was $34.6 million or $0.56 per share as compared to $32.9 million or $0.67 per share in 2012.

Cash used in operations during 2013 was $34 million. Fourth quarter 2013 total cash flow was negative $7.8 million. We finished 2013 with $41.5 million in cash.

Turning to guidance for 2014, we want to reiterate that our guidance of approximately 200 placements and $19 million to $21 million in revenue is based primarily on U.S. microbiology customer adoptions for which we are gaining increased visibility. Customer validations have begun for our gram-negative blood culture assay that was cleared by the FDA in January. These validations should begin to contribute to our revenues by midyear. The Enteric Test we filed with the FDA is likely to be a key placement driver in 2014 and a key revenue driver in 2015 and beyond.

Summing up, we are pleased to see the growth in our U.S. microbiology franchise. Our expanding menu should continue to accelerate our top line growth this year. And finally the investments we're making in new products, our U.S. direct salesforce and international markets will drive sustainable growth beyond 2014.

Now, let me turn the call back over to Mike.

Michael McGarrity

Thanks Roger. Our progress in 2013 coupled with our focus on execution in all operating disciplines within Nanosphere provides us with the confidence and conviction that we are building a sustainable customer and revenue base. We have strived to develop menu that provides clear and compelling value to our laboratory customer, the patients and the healthcare system.

An example of that approach is our recent clear gram-negative blood culture test. Gram-negative organisms account for approximately 30% to 35% of blood stream infections in the U.S. annually. Our 14 target panel provides coverage and gold standards sensitivity for detection of over 95% of all gram-negative organisms.

In addition, it determines resistance to commonly used prophylactic antibiotics up to two to three days faster than conventional methods. Among the critical genetic markers of antibiotic resistance identified by our test, our five genes which identified Carbapenem-resistant organisms or so called superbugs that are resistant to nearly all commonly used antibiotics.

In a recent landmark report the Centers for Disease Control and Prevention assigned them urgent hazard level for these infections, indicating they pose an immediate public health threat and require urgent and aggressive action. We now offer the only broad multiplex panel capable of rapid resistance protection of these critical life-threatening infections, potentially allowing for earlier targeted therapy, prevention of last line therapies, [increase] mortality and significant cost savings to the healthcare system.

Similarly, our Verigene Enteric pathogens test, which we have submitted to the FDA for a review is designed to help hospitals more efficiently and cost effectively diagnose patients with severe diarrhoea.

Gastrointestinal infections are associated with 3.7 million emergency department visits, $1.3 million inpatient hospitalizations and more than $6 billion in healthcare costs per year in the U.S. Since symptoms are lot and often not sufficient to make treatment decisions, rapid and accurate identification of infection or more importantly rule out of infection approximately 90% of these patients can lead to pure hospital admissions reduced use of inappropriate or unnecessary antibiotics and workflow benefits to leverage AR.

Our growing customer base is comprised of the full range of institutions from community-based hospitals to academic medical centers, signaling the appetite for broad market adoption. In addition, we have begun efforts to incorporate product improvements on our Verigene System. These improvements and menu expansion have been directed in closed collaboration with our customers to ensure sound market driven strategic direction that will expand our addressable market and provide compelling and sustainable growth in the future.

We look forward to providing additional commentary on this division for our growth at an upcoming Investor Day we planned to host on March 20, 2014 in New York. We’re very excited about our prospects for continued growth in 2014 and look forward to delivering value to our customers, patients and shareholders. Again I would like to thank all of you for your interest in and support of Nanosphere.

And now I’ll turn the call back over to Travis for questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). Our first question comes from Shaun Rodriguez with Cowen & Company.

Shaun Rodriguez - Cowen & Company

Guys, good morning. So, first really just looking for an update on the gram-positive test, I think on the last call in November you said you had at about 200 U.S. micro labs with about 90 to 100 validated and maybe 50 or so live. So, are you willing to provide an update on where we stand on these metrics?

Michael McGarrity

Yes [Brandon], we have 83 that we reported live in our November call and we have close to 100 live at the end of 2014, I am sorry Shaun, at the end of 2013. And that’s over 200 customer base.

Shaun Rodriguez - Cowen & Company

Okay. Thank you. And so, how much of the call it roughly 10 million incremental increase in 2014 guidance is from new customers versus customers basically with a system entering the year. You noted that the majority of your current gram-positive customers are going to be adding the new panels; I am just trying to get a feel for the potential that exist within the existing customer base and how much of that is reflected in guidance?

Michael McGarrity

Yes Shaun, we have commented on the time to validation go live implementation for our customers. We are investing resources both human in the field from a standpoint of supporting our customers to contract that timeline. Although we are not building a contraction into our plans for 2014 guidance, we expect to deliver that and we’ll comment on that as we see it. But that would say that the majority of the growth in 2014 is coming largely from our current installed base and initial placements with our gram-negative going into 2014.

Shaun Rodriguez - Cowen & Company

Okay, great. And then just lastly, I was just curious for an update on the Hitachi collaboration. I know you said you had a good amount of ground work to lay there in addition to meeting the regulatory requirements. Really just looking for an update on how this is progressing, as well as potential for other similar deals to address China, which I think you’ve alluded to in the past? Thank you.

Michael McGarrity

Yes Shaun, we feel good about the relationship with Hitachi, they are making progress both from a strategic marketing aspect, as well as helping us direct through the regulatory process, which we are making progress there and is a significant effort, which we really count on them to guide us through. And as far as China or other areas, we’ll comment on those if they develop, we have efforts underway in China, we’ll have more news coming here in 2014 regarding our opportunities there and our potential partnerships.

Shaun Rodriguez - Cowen & Company

Thank you.

Operator

Our next question comes from Brandon Couillard with Jefferies.

Brandon Couillard - Jefferies

Hey, good morning. Roger or Mike, could you comment just on the general strength of the flu season that you experienced and as well as give us an update on the expanded flu test that’s in the pipeline for development right now, do you think that will be available by the ‘14, ‘15 flu seasons at the end of the year?

Michael McGarrity

Yes, first part of your question, Brandon, we have seen flu season begin to develop, it’s quite too early to characterize that from the standpoint of comparative strength. Usually as we have discussed you see an uptick in the rapid test and then the molecular methods usually follow, I think that’s the trend we are seeing how broad and/or steep the decline is like last year will be determined.

So, we’ll get better visibility of that obviously as we go through Q1 and report. As far as our development efforts on our expanded panel, we are working towards development and submission to the FDA that would allow us to have that available for next season and we'll continue to update as we get closer to our clinical study completion and submission as we go through the year.

And we feel very positive as we've discussed about our offering there from the standpoint of providing customer with the flexibility to target a panel within our multiplex substrate. So, it allows them to select or deselect targets that will provide both the short panel for ABRSV and an expanded panel for patients that clinicians provide.

So, we see hospitals where they'll have two systems a short panel for potentially outpatient, ABRSV or pediatric patients and then offer a broader panel for inpatient or immunocompromised patients. We’ll be able to provide flexibility in a single panel to address both of those patient populations. And that's really directed and driven by AR capabilities with our customer -- communication and feedback with our customers.

Brandon Couillard - Jefferies

That's helpful. And then what are you baking into the guidance in terms of the expected conversion cycle for gram-negative, what's factored into that outlook? And then could you elaborate just on your visibility, give us a little more detail on your comments that you expect the majority of the existing gram-positive base to adopt enteric and gram-negative, is that survey work, just look at the feedback that you got into around that dynamic?

Roger Moody

Hi Brandon, it's Roger. On both of those points, on gram-negative, we assume that our existing customer base is going to start validating this quarter and we assume that it will take about four months to work through the validation process and implementation, which leads us to a mid-year that will start to see some revenues contributing in. We think we've heard from most of our customers who are running gram-positive or adapting gram-positive that they have an interest in gram-negative.

When we model and what we baked in the guidance was a bit more conservative than what our customer base has told us. And we’ll obviously just as we see experience. But thus far, almost every one of our gram-positive customers have provided feedback to our sales team that they are interested in also running the gram-negative.

Brandon Couillard - Jefferies

Thanks. And then one more Roger, did you restate any R&D and SG&A expenses in the quarter, and could you give us a sense of sort of the cash burn outlook for ‘14?

Roger Moody

Sure. We did actually -- we had in the past reported clinical trials under sales and marketing and that was a bit of an anomaly. And we moved it over since to R&D where I think most companies in the industry reported. So that it was a restatement that would -- there was no restatement, but it was actually a reclassification on the income statement that we’ll further detail when we file our 10-K.

And in terms of going forward cash burn, I would not expect it to change dramatically. We’re continuing to see an increased investment and spend in our field sales force but we’re also seeing an increased contribution from gross profit and R&D is remaining essentially flat. I would expect that the cash flow for 2014 to be somewhat in line with if not slightly higher in terms of burn in the 2013 cash consumption but not dramatically different.

Brandon Couillard - Jefferies

Super. Thank you.

Operator

Our next question comes from Jeff Frelick with Canaccord.

Jeff Frelick - Canaccord

Yes, good morning guys. Hey Mike, should we think about enteric as really expanding the install base or do you see that more kind of leveraging the existing install base and then bringing enteric into complement blood stream infections?

Mike McGarrity

Yes Jeff, we see both. I think that as Roger commented, the majority of our customers that we have currently are buying gram-positive or validating gram-positive are intending to bring up gram-negative and we see a significant number of those that are also planning to bring up enteric. As we also commented, we see enteric also as the catalyst for additional placements here as we move through clearance into the back half of 2014.

So, I think that’s where we really believe we have leverage in our current customer base from a revenue standpoint as we come into the year with average menu with the gram-positive of $50,000 per customer per year and that assumption is holding in fact our range it goes up significantly higher than that. And the gram-negative average customer pull-through is targeted at $30,000 and we see our enteric at $50,000 to $60,000 per customer per year.

So, the leverage we see in our customer base coming into the year with approximately $50,000 just with those three tests and coming out of the year with triple or more of that and if you factor in respiratory and some C. diff business, we feel that’s the real leverage we have in our current install base as well as the catalyst replacement that the expanded menu and the enteric in particular provides.

Jeff Frelick - Canaccord

Okay. That’s helpful. And then with respect to enteric, how should we think about the selling cycle versus that with blood stream infections?

Mike McGarrity

We’ll wait till we get the actual experience there but we would expect it to be more straight forward than our initial gram-positive customers. For the reason that this looks to be more of a traditional laboratory validation method comparison and implementation and not as broad of a stakeholder implementation across many different disciplines within the hospital. So, the fact that approximately 90% of these samples are negative, we have received feedback from our target customers in our pipeline that based on our sensitively and specificity that we provide that they will not actually culture out negatives which will provide significant work flow benefits to the laboratory as well as obvious cost savings. So, we think that the validation, the cost justification can be done largely in the laboratory setting with obviously approval from administration and we see that being straight forward. So, we don’t expect the eight month time that we have experienced here in the back half of 2013 with gram-positive, we would expect it to be somewhere closer to the 90 day and 120 day traditional laboratory validation time lines. But as we get closer and get more experience, there we will guide that little closer.

Jeff Frelick - Canaccord

Okay. And then last question Mike, you have talked about the range of hospital labs that are placing Verigene into, just are you seeing any multiple system placements at the IDNs or larger healthcare systems? Thanks.

Mike McGarrity

Yes, we are Jeff, in fact we’ve had data published from similar customer sites that are part of three or four hospital IDNs and the other positive aspect of that is that usually one site serves as the pilot for adoption, validation, mutation, value proposition, and therefore we expect that also contribute to some contracted validation timelines as the additional hospitals bring up the gram-positive, gram-negative tests as part of their protocol.

We are very encouraged by the distribution of our customer base from as I commented on the full range which we believe is a really positive indicator of that broader market adoption. Jeff?

Jeff Frelick - Canaccord

Okay, thanks Mike. All set.

Operator

(Operator Instructions). We will take our next question from Chris Lewis with Roth Capital Partners.

Chris Lewis - Roth Capital Partners

Hey, good morning guys. Thanks for taking the questions here. First off I guess for the guidance for 2014, I was hoping you could talk about the methodology you used to determine that outlook and perhaps how that compares and differs from the approach you took when you provided your initial 2013 guidance a year ago?

Mike McGarrity

Yeah, Chris, I think what we have going into this year that we didn’t have last year is experience and visibility to the process particularly with the gram-positive blood culture assay which is a real standard changing approach to the way hospitals diagnose and treat these patients. And we as we've discussed under estimated, some of the complexity of the implementation with that in 2013 as we moved our customers to the process. We have clear visibility to that process. We understand how hospitals implement. We have a blueprint based on our hospital to hospital experience that helps guide customers with that process. We have invested in field supports to drive that. And finally, we have customer experience published data that provides evidence of the value proposition that is empirically or intuitively understood through the stakeholders of laboratory, pharmacy infectious disease and administration.

I would point to a couple of the key publications we had this year from Banner Health that shows deescalation from vancomycin to methicillin going from 30% to 90% with rapid reporting of our results as well as the cost savings benefit of 22 days reduction length of stay, $60,000 cost savings per patient and the significant healthcare economic value.

So, what we're basing our guidance on is our current installed base, our projected customer placement pipeline and incorporating the times to go live and implementation that we have experienced while continuing to drive efforts to contract those timelines which will update as we get visibility to that -- those efforts as we go through the year.

Chris Lewis - Roth Capital Partners

Okay, great. Thanks for the detail there. And then you mentioned that building customer placement pipeline, I was hoping you could expand on that a bit and perhaps quantify the pipeline of those customers?

Mike McGarrity

Yes, first quantifying the pipeline we build our customer pipeline rep by rep with our sales managers and we go through a process where we establish more and more rigor as we understand how our customers go to through the process, their timing. Some of the adoption timelines can be impacted by a couple of things. Just to remember that we’re bringing in with blood culture at least, we’re bringing in a capital equipment system with additional testing cost that they are not currently experiencing and/or that they have not budgeted for.

So, that's a lot of the timing aspects that drive not only the implementation timeline, but also the time, projecting the time where it will actually bring a system in under a validation agreement.

We've also seen customers begin to purchase our system at the initial transaction, which we believe is a sign of again broader market adoption where they are going through their entire approval process all the way up to a purchase or at least (inaudible) being signed as the catalyst for a system going in the hospital.

We view that as another signal of that adoption. And so, that can be some of the challenge and opportunity as we build experience to project when customers are going to bring a system in. The difference was over the last couple of quarters between the 35 and 45 placements, we don’t view as a significant indicator of adoption, but rather probably more illustrate of these timing variation between customer to customer.

And the last point I would make there is that in our efforts to drive our sales force to sell the full enterprise value throughout the hospital to the additional stakeholders which we know will pay dividends from a standpoint of time to live and secure the placement and the customer ramp is impacting our upfront.

So I’ve commented, we’re complicating it early rather than late in some aspects because we’re getting to those people earlier in the process and that can push or pull our placement in from a quarter-to-quarter. So, that’s the mechanism and the methodology we use to define our customer pipeline and make our projections and we feel it’s based in good sales rep by sales rep data.

Chris Lewis - Roth Capital

Okay, great. And then just one last one for me, on the sales force can you just go through year ended ‘13 both on the direct revenue medical [EAs] on-site and what are your plans to build that sales force in 2014?

Michael McGarrity

Yes, we finished the year with about 20 quarter carrying sales people and we’ve got about 2 or 3 of the medical science leaders currently coming inline and coming online. And as we look at 2014 we’ll continue to expand investment in the commercial organization. And we’ll update as we go quarter-by-quarter, but you’ll probably see a blend of the quarter carrying sales reps in these medical science leaders, our clinical implementation consultants which is really the role they’re playing as the key resource in the field. And Roger and I are working closely with our sales team to define and determine the return on investment and the best allocation of sales people to these implications for people.

We feel very good about our team in the field and the support team that goes along with that from a field service engineering and technical service group. And I think we’re starting to build the reputation in the sales force for that support that we recognize the importance of and pay a lot of attention to.

Chris Lewis - Roth Capital

Okay. Thank you.

Operator

Our next question comes from Bill Quirk with Piper Jaffray.

David Clair - Piper Jaffray

Hi, good morning everybody. It’s actually Dave Clair in for Bill. So just hoping you can give us an update on the competitive environment and do you have any kind of metrics around percentage accounts that you are winning in competitive situations?

Mike McGarrity

Yes. Dave, we continue to believe that we have a very strong competitive position. If you look at the blood culture, obviously which is the major point of discussion and has been the major catalyst for our placement and revenue in 2013 and projecting, it is really only one competitor out there currently in the marketplace. And we feel that a number of factors put us in a position to be strong competitively. But first and the most important is really demonstrated and validated performance of our assay in the customers’ hands from a standpoint of sensitivity and specificity. And the importance of reporting those results that would potentially change therapy for critically ill patient, we’ve demonstrated that now across a significant customer base. So that’s the most important.

I think the second aspect of that is the design of our panels and the price value that we provide the customers from the design of our panels as far as the gram-positive and gram-negative and having that be directed by the gold standard Gram stain, we see customers continue to believe that that’s probably the way they are going to continue to adopt and run the blood cultures. And so while we don’t provide a hit rate, we realize that competitors will get customers, based on their current install base. And we also view some competition as supportive of building the market development and value proposition of a new technology application like this.

So, we’ll more continue to build our customer base. We know that based on our pipeline and based on our proven execution. And we feel confident that we can compete against the current and future competitors and that the building of our installed base is critical to that leverage as we go forward.

David Clair - Piper Jaffray

Okay, thank you. And then in terms of the 200 system adds that you guys are expecting for the year, how should we think about those kind of rolling out throughout the year, is that more one enteric gets proved that should be kind of a spike, or how are you guys thinking about that?

Mike McGarrity

We are not going to provide quarterly guidance just because as from my earlier comment, there are timing aspects to one customer’s bringing in from quarter-over-quarter that we don’t see as material. We know from history and that menu as always the catalyst for adoption and placements, so we will definitely expect the gram-negative and the enteric both contribute to that. And again we set that guidance based on our visibility of our pipeline.

David Clair - Piper Jaffray

Okay, thank you.

Operator

There are no further questions in queue at this time.

Mike McGarrity

Okay Travis, thanks very much. We’d like to thank all of you for joining us. Again, we confirm our 2014 guidance with 200 new customer placements and $19 million to $21 million in revenue. And we look forward to delivering on those expectations and we appreciate your support. Thank you.

Operator

That concludes today’s presentation. Thank you for your participation.

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