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GenMark Diagnostics (NASDAQ:GNMK)

Q3 2013 Earnings Call

November 12, 2013 4:30 pm ET

Executives

Nancy Torok

Hany Massarany - Chief Executive Officer, President and Director

Richard B. Slansky - Chief Financial Officer and Principal Accounting Officer

Analysts

David C. Clair - Piper Jaffray Companies, Research Division

Brian Weinstein - William Blair & Company L.L.C., Research Division

Chris Lin - Cowen and Company, LLC, Research Division

Operator

Good day, ladies and gentlemen, and welcome to the GenMark Diagnostics Third Quarter Earnings Conference Call. [Operator Instructions] As a reminder, today's conference is being recorded for replay purposes.

I would now like to turn the conference over to your host today, Ms. Nancy Torok. Ma'am, you may begin.

Nancy Torok

Thanks, Mary, and thank you all very much for joining us this afternoon. Before we begin, I would like to inform you that certain statements made by GenMark during the course of this call may constitute forward-looking statements. Any statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance are forward-looking statements. For example, statements concerning our 2013 financial guidance, the development and commercialization of new products, plans and objectives of management and market trends are all forward-looking statements.

We believe these statements are based on reasonable assumptions. However, these statements are not guarantees of performance and involve known and unknown risks and uncertainties that may cause the actual results to be materially different from any future results expressed or implied by such statements.

Important factors which could cause actual results to differ materially from those in these forward-looking statements are detailed in GenMark's filings with the SEC.

GenMark assumes no obligation and expressly disclaims any duty to update any forward-looking statements to reflect events or circumstances occurring after this call or to reflect the occurrence of unanticipated events.

In addition, our presentation today includes information presented on a non-GAAP basis. We believe these non-GAAP financial measures provide meaningful supplemental information regarding the company's performance by excluding certain expenses and other items that may not be indicative of core business results. We refer you to the press release we issued this afternoon, which is available on our site for a reconciliation of the differences between the non-GAAP presentation and the most directly comparable GAAP measure.

I will now turn the conference call over to Mr. Hany Massarany, President and CEO of GenMark. Hany?

Hany Massarany

Thank you, Nancy, and hello everyone. I'm joined on the call today by our CFO, Richard Slansky. And as usual, we have a few prepared comments, and then we will be happy to respond to any questions that you might have. Our prepared comments will cover the following topics: first, Richard will walk us through our operating results for the third quarter of 2013; then I'll provide an overview of our business progress and update you on our business objectives and milestones.

Before I hand the call over to Richard, I'd like to make some comments in relation to certain aspects of our performance in the third quarter and expectations for the fourth quarter and beyond.

Last month, we were compelled to file a lawsuit against NMTC, seeking the collection of past-due amounts from earlier product sales and for damages resulting from unsatisfied contract purchase commitments. NMTC subsequently filed for Chapter 11 bankruptcy protection. GenMark was listed as NMTC's largest creditor with a disputed $75.7 million claim related to an outstanding receivable balance of $2.7 million and a remaining contract obligation of approximately $73 million.

Accordingly, we made provisions in this quarter's financial statements to account for this development. Richard will shortly provide specific details in relation to these provisions. Furthermore, we removed 50 company-owned XT-8 analyzers from NMTC's facilities. The majority of which were actually placed in 2012.

We did not recognize any revenue from NMTC in the third quarter.

Furthermore, in September, CMS issued their proposed final GAAP fill rates for the new molecular testing codes. As you know, these new codes are specific to genetics and pharmacogenetics testing and do not impact our infectious disease business which, as you already know, is the primary focus of our power NexGen menu. While the recently issued GAAP fill rates have addressed most of the new codes, payment rates were not established for several pharmacogenetics test in our menu, including Warfarin 3A4 and 3A5.

The proposed CMS GAAP fill rates have also not clarified the wide variation in payment levels across the MACs for the covered pharmacogenetics tests like 2C19 and 2D6. Until these rates are finalized and become effective in 2014, we expect continued challenges for the pharmacogenetics testing segment, with customers taking more conservative approaches to business expansion and inventory management.

While no single pharmacogenetics customer represents a significant portion of our revenue, as was the case in the past with NMTC, we have several laboratories that use our XT-8 System for these tests and we anticipate headwinds to continue through Q4 and 2014, given the recent developments associated with reimbursement.

Primarily as a result of these changes, we are revising our 2013 revenue guidance to approximately $27 million. Notwithstanding this, our commercial team has delivered another very solid quarter with continued strong growth in our base XT-8 business, which excludes revenues from NMTC. Our FDA-cleared RVP test and research-use only HCV Genotyping Test have been the main drivers of our XT-8 placement and revenue growth.

Based on our robust commercial sales funnels, we expect to maintain healthy XT-8 placements and revenue growth. Our plans to establish our international business are also progressing well. As previously communicated, our international efforts will start with XT-8 in advance of the international launch of our NexGen system scheduled for the second half of 2014.

Finally, our R&D organization remains very focused on completing the development of our NexGen sample-to-answer system, and we are very pleased with the achievements and test performance results to date. We continue to believe we will bring to market the most competitively differentiated multiplexed molecular sample-to-answer system, and we continue to expect development completion in the second quarter of 2014.

In addition, I will outline later in the call a decision we have recently made to further expand our NexGen assay development teams to accelerate menu.

With that, I will now hand over the call to Richard Slansky. Richard?

Richard B. Slansky

Thank you Hany, and good afternoon everyone. We issued our financial results before this conference call, and we will be filing our third quarter Form 10-Q shortly after this call. We have quite a bit to cover today, particularly related to the financial impacts related to NMTC. This includes the reserve of $2.7 million of accounts receivable and $1.5 million of inventory and equipment impairment, which I will speak to in more detail in a moment.

We had another strong quarter of revenue growth from our base business. We are pleased to report for the 3 months ended September 30, 2013, our total revenue from our base business grew 159% from the same 3-month period last year. And our base business for the 9 months ending September 30, 2013, grew 173% from the same 9-month period last year. As Hany indicated, we did not recognize any revenue from NMTC in the third quarter, and at this time, we are not projecting any additional revenue from NMTC going forward.

Our installed base of analyzers increased by 41 net analyzers in the quarter, and after the removal of 50 analyzers from NMTC that Hany mentioned, many of which have been redeployed already in other revenue-generating customer sites. Our installed base now consists of 375 analyzers within a very diverse customer base. None of our current customers represent 10% of our revenue, which we believe speaks to the overall expansion of our customer base and the value proposition delivered by our eSensor technology.

As you no doubt recall, NMTC represented approximately 50% of our revenue in the first half of 2013. Our annuity per analyzer was $48,000 in the quarter, excluding analyzers on site at NMTC, which did not produce any revenue during the current quarter. With the exception of revenue -- with the exception of our revenue discussion, I will address both the reported GAAP results and the published non-GAAP results after adjustment for NMTC.

We're going to make reference in this call to non-GAAP or pro forma results, which excludes the impact of costs associated with NMTC's current situation. We believe that excluding these items and the related effects from our financial results, reflect operating results that are more indicative of our ongoing operating performance while improving comparability to prior periods.

Today, we reported total revenues of $4.6 million for the third quarter of 2013, in line with our expectations despite the lack of revenue contribution from NMTC during the current quarter. This represented a decrease of 12%, or $619,000 compared with the third quarter of 2012, where revenues were $5.2 million, $3.5 million of which was attributable to NMTC.

Total 2013 year-to-date revenues amounted to $21 million, compared to $11 million for the year-to-date revenues for 2012, or a 90% increase.

Our gross margin for the third quarter was $0.5 million, or 11% of revenue, versus $2.2 million, or 42% of revenue in the same quarter last year. As part of the provisions in this quarter's financial statements that Hany mentioned earlier, we created an inventory where excess and obsolete reserve of $900,000 in the quarter related to specific inventory that we manufactured for NMTC. As a result of NMTC's bankruptcy and the recently published CMS reimbursement rate, we expect this inventory will expire before we can sell it.

We also impaired $300,000 worth of manufacturing equipment that we procured to support NMTC's previous purchase volumes. Excluding these reserves and adjustments, our non-GAAP gross margin for the third quarter was 36%.

Our year-to-date gross margin was $8.6 million, or 41% of revenue, versus $4.1 million, or 38% of revenue for the same 9-month period last year. Our 9-month inventory reserve was $1.2 million, which reflected a $300,000 reserve in Q2 of 2013 related to specific inventory that we manufactured for NMTC. With the impaired $300,000 worth of manufacturing equipment, the total year-to-date reserve was $1.5 million. Excluding this reserve, our non-GAAP gross margin for the first 9 months of 2013 was 48%.

Our overall operating expenses of $12.8 million for the third quarter of 2013 increased by $4.3 million compared with Q3 of last year, mainly due to an increase in our allowance for doubtful account reserve of $2.5 million related to NMTC and continued expansion of our U.S. sales force ahead of the launch of our NexGen system.

Research and development expenses increased $900,000 due to our continued commitment to develop our NexGen platform and its assay menu. Our non-GAAP basis excluding NMTC-related adjustments -- excuse me, our non-GAAP basis, excluding NMTC-related adjustments, operating expenses for the quarter were $10.3 million. Our total operating expenses year-to-date amounted to $33.2 million, an increase of $11.7 million compared to the same period last year.

Sales and marketing expenses increased by $5.6 million year-over-year mainly due to the increase in our allowance for doubtful accounts reserve of $2.7 million related to NMTC and our sales force expansion.

Research and development expenses increased $6.3 million due to our NexGen platform and assay development efforts. On a non-GAAP basis, operating expenses for the 9 months was $30.5 million.

We reported a loss of $0.30 per share for the quarter with weighted average shares outstanding of 36 million compared with the loss of $0.20 per share for the third quarter of 2012 when our weighted average shares outstanding were $31.8 million. In addition to the NMTC-related adjustments discussed above, the loss per share included a one-time realized gain of $1.4 million from the sale of preferred stock in Advanced Liquid Logic, a private company that was acquired by Illumina in July 2013.

On a non-GAAP adjusted basis, which also excludes the impact of this onetime gain, the loss per share for the quarter ended September 30, 2013 was $0.24. Our 2013 year-to-date loss was $0.69 per share with weighted average shares of $33.3 million, compared to a loss of $0.71 per share with weighted average shares of $24.4 million for the same period in 2012. The loss per share included the same onetime realized gain of $1.4 million from the sale of preferred stocks. On a non-GAAP adjusted basis, also excluding this gain, the loss per share for the 9 months ended September 30, 2013 was $0.60.

We ended the third quarter of 2013 with over $112 million in cash and investments. We plan to continue utilizing our cash balances primarily to support operations by investing in our NexGen product and menu development as well as expanding our commercial organization. Hany will shortly review the progress that we are making across a few strategic areas that we have previously discussed as important in achieving our long-term goal of becoming a global leader in molecular diagnostics.

Before he expands on the opportunity ahead, I want us to spend a brief moment on our 2013 guidance. As we have previously disclosed, our 2012 revenues were $20.5 million, of which $8.8 million came from our base business and $11.7 million came from NMTC. Based on prolonged reimbursement challenges and the recently published CMS rates for the new pharmacogenetics or PGX test codes, we expect emerging PGX sector to experience additional downward pressure in the near term. Primarily, as a result of these changes, we are adjusting our 2013 revenue guidance to approximately $27 million and now expect more modest PGX purchasing patterns in 2014.

With that, I'll now turn the call back over to Hany for our business update. Hany?

Hany Massarany

Thank you, Richard. I would now like to review our accomplishments for the third quarter of 2013. I'll update you on the growth of our current XT-8 business as well as the progress of our NexGen development. I'll also update you on the initiatives we are putting in place to establish our international business. So let's start with the current XT-8 business.

Our sales force continues to perform extremely well. In addition to the strong growth in our base business year-over-year, we achieved 41 net new analyzer placements during the quarter. As we already indicated, this excludes the 50 analyzers we removed from NMTC, many of which have been redeployed already in other revenue-generating customer sites. This puts us at a total installed base of 375 analyzers in the field as at the end of September.

Our commercial sales funnels for the remainder of 2013 are very robust. And based on our current trajectory, we expect to place more than 150 analyzers in the field this year.

As previously stated, we did not recognize any revenue from NMTC in the third quarter and as a result, reagent annuity per analyzer was 48,000. Excluding NMTC, this represents 50% growth year-over-year and importantly, excluding NMTC, reagent sales grew by 145% year-over-year. This growth in our base reagents and annuity per analyzer was driven strongly by continued customer adoption and volume growth of our FDA-cleared Respiratory Viral Panel and our RUO HCV Genotyping Test.

Since launching our FDA-cleared RVP and leading into the flu season, we've secured a significant number of very large volume customers in the U.S. market who have continued to provide excellent feedback about this product in terms of its performance and ease-of-use, especially versus the competition. Also, as previously communicated and supported by several studies, our HCV Genotyping Direct Test provides more comprehensive genotyping, direct from blood and plasma samples with greater subtyping precision. Feedback regarding the performance of this product, in terms of detection, accuracy, workflow and turnaround time, continues to be very positive.

Before I move to the NexGen, let me touch briefly on the initiatives we're putting in place to establish our international business. Our plans to establish our ex-U.S. business ahead of the launch of our NexGen system scheduled for the second half of 2014 are advancing well. We're working to establish international distribution channels, including direct operations and highly qualified distributors. We intend to introduce our XT-8 System to key opinion leaders' sites in certain countries as we look to establish our technology and certain tests to these markets in preparation for the launch of NexGen.

We have recently finalized a comprehensive business plan, which outlines the rollout of our international business by country. Now let me review our progress in relation to the development of our NexGen system.

As we've discussed on prior calls, our R&D organization has been exclusively focused on the ongoing development of our NexGen system and its associated test menu. As you also know by now, this is a multiplex molecular sample-to-answer system which will integrate sample preparation steps including extraction and amplification, together with our proprietary eSensor detection technology to enable concurrent detection of multiple molecular targets on a single test cartridge. We are designing the system with all the necessary reagents fully incorporated in self-contained test cartridges and the required fluidic movement enabled by proprietary digital microfluidics technology.

Our R&D organization and partners are well-advanced in the development and integration of our NexGen cartridge instrument software and initial menu of assays, and we are very pleased with the achievements and test performance result to date. In relation to the platform and cartridge development, we are making excellent progress.

As an example, during the third quarter, we achieved assay integration on the cartridge of one of our most complex assays, RVP, and we are very pleased with the performance results that we've accomplished. We are currently optimizing the performance of this and other assays, and we're also very encouraged by preliminary performance data from our Sepsis panels, which compare very favorably with competitor products currently on the market.

Based on these early results, we believe our Sepsis panels will exceed the market requirements with respect to sensitivity and the range of pathogens detected. As mentioned previously, we are also developing an extensive test menu for the NexGen platform with an initial focus on infectious disease.

In addition to the gram-positive and gram-negative Sepsis panels, our initial NexGen assay menu would also include RVP, Gastrointestinal Infection panel, or GI, and HCV Genotyping. Furthermore, based on the excellent progress we've made so far toward the development of our NexGen system and additional market opportunities we've identified, I'm very pleased to let you know that last week, our Board of Directors approved funding for 2 additional assay development teams to accelerate NexGen menu expansion beyond our initial 5 panels.

This week, we intend to unveil an advanced prototype NexGen system and provide customer demonstrations in our exhibition booth at the AMP Meeting in Phoenix. We expect these demonstrations to be well-attended both by current and future customers. And we continue to believe we will bring to market the most competitively differentiated multiplex molecular sample-to-answer system, and we are scheduled to complete its development in the second quarter of 2014.

In conclusion, as I stated in my opening remarks, Q3 was another quarter of exceptional execution and performance for our company, and we are very energized and optimistic about Q4 and beyond. Our commercial team has delivered very strong results in Q3 and boosted by our uniquely differentiated infectious disease panels, we believe we are poised to place many more XT-8 Systems, expand market share and grow revenues going forward.

Plans to establish our international business are progressing well. And in the future, we believe the ex-U.S. markets will make a significant contribution to both our top line revenues and bottom line profits. Our R&D organization is very focused on completing the development of our NexGen's sample-to-answer system. This is where most of our attention will be over the next several quarters, and you can expect to see our investment in R&D continue to increase as we drive to accelerate both the NexGen platform and an increased assay menu during the remainder of this year and beyond.

With continued focus on organizational talent, infrastructure and processes, we are well and truly preparing for significant business growth. We will now open the call to questions. Thank you very much.

Question-and-Answer Session

Operator

[Operator Instructions] Our first question comes from Bill Quirk from Piper Jaffray.

David C. Clair - Piper Jaffray Companies, Research Division

It's actually Dave Clair in for Bill. So first question for me, guys. Just given we're kind of on the cusp of the flu season here, I was wondering what are your RVP expectations that you're including in your -- basically, your 4Q guidance here?

Hany Massarany

Early indications, sort of would suggest that this flu season may be more moderate than expected. So we're certainly not baking into our numbers a severe flu season as we saw last year.

David C. Clair - Piper Jaffray Companies, Research Division

Okay. And in terms of the reimbursement headwinds that you talked about, it sounds like you're expecting those to drag on potentially all the way through 2014? Or how should we think about these?

Hany Massarany

Yes, that's right. As I mentioned and you're aware, of course, that Medicare, sort of, schedules were published very recently in September, and several of these PGX panels, like 2C9, 3A4, 3A5, are no longer reimbursed by Medicare or the reimbursement has not been established for these panels. And then, other panels like 2C19 and 2D6, there's a sort of a little bit of uncertainty in relation to reimbursement levels. And that's sort of the primary reason why we're revising our 2013 number. We don't expect that these issues will be resolved anytime soon.

Operator

Our next question comes from Brian Weinstein from William Blair.

Brian Weinstein - William Blair & Company L.L.C., Research Division

So, my question is around NexGen. Hany, can you be a little bit more specific on the key steps that are still required here to get to the design lockdown? And then, specifically, when do you expect the clinical trials will start outside the U.S.? And will you give us public disclosures as to what those clinical trials are and when will we see the results from that test?

Hany Massarany

All right. Thanks, Brian. Well, let me first say that we are making tremendous progress with our NexGen development program across the board in terms of the platform, the cartridge, the assay development. And as you know, Brian, in sort of prior quarters, our development work sort of concentrated on model systems that demonstrated and optimized functionality of each assay component separately, like sample prep and PCR and detection.

And this quarter, we achieved a very important internal milestone by demonstrating this complete sample-to-answer detection with highly a multiplexed test, our RVP test. And we were able to do that on multiple cartridges, numerous cartridges, using 10 independent standalone instruments. Now, this -- so moving forward, now we are also transitioning other models. So we started already before even integrating RVP on a sample-to-answer cartridge, our R&D team has begun sort of developing each of our NexGen assays using benchtop models of our NexGen system.

And following RVP, we began moving our 2 blood culture assays and our GI panel on to the cartridge. And as I said earlier, I'm very pleased to report that excellent initial results with these assay transfer activities. And in fact, one of these assays is already showing superior performance on the cartridge versus the benchtop. So we have a very comprehensive product development plan with many milestones. We don't intend to sort of outline and sort of disclose all of these milestones. But of course, we will continue to update you on a regular basis as we make progress.

Brian Weinstein - William Blair & Company L.L.C., Research Division

And then on the clinical trials, when do you actually expect to start the clinical trials and will we know which part...

Hany Massarany

We will -- we'll be starting in the second quarter ahead of the completion of development, which is scheduled for the end of the second quarter, the middle of the year next year. We expect that soon after that, that will sort of continue into the third quarter with the CE-marked studies and submissions. And we expect, therefore, soon after that to be launching ex-U.S. in the second half of next year and concurrently, we'll continue with the U.S. IVD studies and submissions into early 2015. And we expect, therefore, U.S. IVD launch in the U.S. in the second half of 2015.

Brian Weinstein - William Blair & Company L.L.C., Research Division

And we're still looking at a single cartridge, correct?

Hany Massarany

What do you mean by that, Brian? Fully integrated, you mean, per panel?

Brian Weinstein - William Blair & Company L.L.C., Research Division

What I mean is that a single cartridge design regardless of the sample type, that there's a reason to think you didn't have to have different cartridges for different sample types, correct?

Hany Massarany

Yes, that's correct. So Brian, as you know, we worked very hard to design the right cartridge that can handle the multitude of different types of samples, volumes of samples and therefore, the various panels that we anticipate developing on the same standardized cartridge.

Operator

[Operator Instructions] Our next question comes from Shaun Rodriguez from Cowen and Company.

Chris Lin - Cowen and Company, LLC, Research Division

This is actually Chris Lin on for Shaun today. Just to start off, I think you lowered your guidance by $3 million. Can you just quantify the components of the guidance decrease? I believe you have factored in some NMTC contributions previously. So how much of the $3 million decline is NMTC versus incremental pharmacogenetics headwinds, and understanding that in your prepared remarks, you stated that these 2 were primary drivers. Were there -- just to be clear, were there any other factors baked into guidance?

Hany Massarany

Okay, thank you for the question. Look, we really reduced the Q4 by approximately $2 million compared to consensus at 29 right now. And the vast majority of this is driven by PGX reimbursement reductions and continued uncertainty. So I mentioned, before, the number of different panels that are no longer imbursed or reimbursed or where the level of reimbursement is still uncertain. Now while we don't have a single customer accounting for more than 10% of our revenue, we do have a number of PGX customers who are being impacted by all of this.

And then, furthermore, yes, it is true that we expected very little from NMTC in the third and fourth quarter. But now that they're bankrupt and we removed our XT-8 Systems from their lab, there is no possibility of any further revenue from NMTC regardless of how little that was -- what we expected. And then, finally, I sort of mentioned that based on very early indications, we expect that the flu season may be more modest than originally anticipated. So while PGX reimbursement landscape is, by far, the most significant factor, it's the -- it's an overall combination of all of these factors that led us to reduce our Q4 revenue guidance.

Chris Lin - Cowen and Company, LLC, Research Division

Thank you for that but are you -- I guess, are you able just to quantify each of those components or I guess...

Hany Massarany

No. We're not really prepared to do that, to provide that additional level of granularity at this stage.

Chris Lin - Cowen and Company, LLC, Research Division

Okay. And just lastly, I think it's a little bit hard for us to think about your commentary on the PGX market without knowing the percentage of sales PGX represents. And, I guess, given that the guidance was revised largely due to the segment, I mean, I believe 2014 revenue expectations for PGX were also moderated, can you provide us what percentage of sales is PGX?

Hany Massarany

We haven't provided sort of sales by assay by product in the past, and we're not ready to do that just yet. We did moderate our 2013 number, of course, based on events that took place with NMTC earlier in the year. We have not provided any guidance. It's too early for us to provide guidance in relation to 2014. But I believe that the covering analyst, obviously, sort of factored that into their model. Don't forget that all of these was before the most recent -- and we're talking just a few weeks ago, back in September, when CMS published their schedule. And we certainly had a number of PGX labs, several PGX labs that are being impacted by this development.

Operator

Thank you. I show no further questions and would like to turn the conference back to Mr. Hany Massarany for closing remarks.

Hany Massarany

All right. Well, thank you very much, everyone. And on behalf of our Board of Directors and employees, I want to take this opportunity to thank you for your ongoing support. I look forward to reporting our progress on a quarterly basis going forward. Also, I hope to see many of you at the AMP 2013 annual meeting this week in Phoenix, where we plan to demonstrate the prototype of our NexGen system. Thanks very much for your time, everyone, and have a good day. Bye-bye.

Operator

Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program, and you may all disconnect at this time.

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