NanoString Technologies Inc (NSTG) 2014 Q4 法說會逐字稿

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  • Operator

  • Good day, ladies and gentlemen, and welcome to the NanoString 2014 fourth quarter financial results conference call. (Operator Instructions)I would like to turn the call over to your host for today's conference. Leigh Salva, you may begin.

  • Leigh Salva - IR

  • Thank you. On the call with me today is Brad Gray, NanoString President and CEO, and Jim Johnson, CFO. Earlier today NanoString released the financial results for the fourth quarter and year ended December 31, 2014 and a copy of the press release can be found on our website at nanostring.com. During this call we will make a number of statements that are forward looking including statements about financial projections, existing and future collaborations, future business growth, trends and related factors.

  • Interactions with third party payers and the timing at outcome of any related reimbursement decisions, our strategic focus and objectives, and the development, status and anticipated success of additional product offerings. Forward-looking statements are subject to risks and uncertainties, many of which are beyond our control including those described from time to time in our SEC filings. Our results may differ materially from those projected on today's call. We undertake no obligation to publicly update any forward-looking statement.

  • Additionally, non-GAAP financial measures will be referred to during today's call. A reconciliation of these non-GAAP measures is included in today's press release which is available on our website. With that I would like to turn the call over to Brad.

  • Brad Gray - President, CEO

  • Thanks, Leigh. Good afternoon and thank you for joining us today. 2014 was another year of strong growth for NanoString. Our encounter technology emerged as a leading platform for tumor profiling with broad and growing acceptance and both research and clinical markets the validation and impact of our platform was underscored by the rapidly growing body of research generated by our customers which averaged 5 new papers per week and now totals approximately 650 peer review publications, up 70% compared to one year ago. The increasing use of our platform by academic researchers, bio-pharmaceutical companies and clinical laboratories delivered revenue of $47.6 million for the full year, growth of 52% over 2013. The year finished on a high note and we made meaningful progress across all three core areas of our business.

  • Life Sciences, Companion Diagnostics, and Prosigna. Fourth quarter of revenue of $15.6 million set a new record and represented 54% growth. Today's call will have three segments. First, I'll provide Q4 highlights in our three core areas of business, next our CFO Jim Johnson will summarize our financial performance and outlook, and officially I will wrap up by outlining our key strategic objectives for 2015, before opening the call for your questions. In 2014 our core instrumented consumable business remained a primary engine driving our growth as we substantially expanded our install base and nCounter analysis systems while maintaining a high level of consumable pull through. We added both research and clinical lab customers.

  • Growing our install base by 44% year over year, ending the year with a world-wide install base of 264 nCounter analysis systems. Many of the trends we saw throughout the year continue to the fourth quarter. Oncology was the primary driver of new instrument placement accounting for 70% of new nCounter systems placed in the quarter. The popularity of our dual used flex configuration also continued in Q4 as more than half of our instrument placements were for disconfiguration which we believe validates our strategy of combining cancer research and diagnostics on a single platform. During the fourth quarter we continued to penetrate international markets with more than half of the new nCounter systems sold outside of North America.

  • We now have approximately 40% of our installed base located outside the United States. With China representing the second largest market globally. We believe these trends of nCounter adoption and oncology research, clinical laboratories and international markets are durable and will continue in 2015. Turning to consumables, the fourth quarter set a new record for consumable revenue with annualized consumable pull through well above $100,000 per system. A highlight of the quarter was the demand for our panel products which more than doubled year-on-year. This growth driven in large part by the success of our pan-cancer panels which we introduced earlier in the year. Our pan-cancer pathway's panel offers researchers a simple way to investigate the biology of 750 (inaudible) genes in all major cancer pathways. While our pan-cancer immune profiling panel is unique offering targeted toward the dynamic field of immunal oncology.

  • Consumable sales to our biopharma customers and our contract research organizations were robust. Accounting for over 50% of consumable sales during the quarter. This was supported by several large orders from leading biopharma companies running biomarker studies on tissue samples collected during clinical trials for cancer therapeutics.

  • We are pleased by the enthusiastic use of our nCounter platform by the biopharma Companies as we believe this sets the stage for more strategic relationships in the future. Moving to our second quarter area of focus and growth, 2014 marked the entry into companion diagnostics. I am proud of results we achieved and our collaboration with cell gene under which our technical work progressed at a rapid pace and our interactions with the FDA went more smoothly and faster than expected. The robust study, a pivotal phase III clinical trial using cell genes (inaudible) to treat DLBCL, opened earlier this quarter with numerous sites now open for patient screening based on their DLBCL sub type as assessed by our invitro diagnostic (inaudible).

  • We anticipate the results of this study, if successful, will be used to support a PMA filing in the US and other international registrations several years in the future. In parallel, to our work with Celgene we have commenced a new initiative to collaborate with biopharma companies on the analysis of clinical trial results using our existing clinical assays Prosigna and the DLBCL sub-typing test. Unlike our Celgene collaboration these translational projects do not commit NanoString to develop a companion diagnostic.

  • Rather, they are designed to allow biopharma partners to explore whether one of our clinical assays could in the future become a companion diagnostics for one of their drugs. During the fourth quarter we entered translational agreements with two undisclosed biopharma companies. One focused on Prosigna, and the other on our DLBCL sub typing test. While these projects of translational projects offer economics that are much lower than our companion diagnostic partnerships such as our Celgene collaboration, we are optimistic they may lead to more substantial companion diagnostic partnerships with these companies in the future. Turning to our Prosigna breast cancer assay, sales in Q4 were modest consistent with the expectation that uptake will remain limited until official reimbursement is secured.

  • Our attention throughout 2014 was on focused primarily on building the install base of Prosigna testing sites and establishing reimbursement. And we made meaningful progress on both objectives. As of today, 37 clinical laboratories across 12 countries have acquired nCounter systems with the intent of offering the Prosigna testing services. Since our last call we have added seven new medical centers across Australia, France, Germany, Italy, Spain, Switzerland and the United States. In US market, nine labs are now offering Prosigna services and another six labs are preparing for launch.

  • Outside US, 11 labs are offering Prosigna services while another 11 labs are preparing to come on line in the months ahead. During 2014 we began establishing reimbursement for Prosigna and have had important lands in the US and Europe. In the US total covered labs Prosigna are now more than 45 million, or 20% of the US patients indicated for Prosigna. In Europe we have coverage in several regions of Spain and the governments of Germany and Switzerland have recently taken important steps to reimbursement of (inaudible) testing for breast cancer for the first time. Inclusion in breast cancer treatment guidelines will be a key catalyst for reimbursement and adoption of Prosigna.

  • Earlier this month the NCCN posted on our website a partial update of their breast cancer treatment guidelines. Prosigna was not specifically addressed in the partial update we look forward to seeing the complete update of the NCCN guidelines when they are available. We expect the positioning of Prosigna in the discuss section of the guidelines will be important to our interactions with the both the (inaudible) team and the largest US private payers.

  • We leave favorable treatment of the discussion section could facilitate positive coverage decisions over the year ahead. In parallel to pursuing guideline inclusion we continue our efforts to build the body of evidence for Prosigna's clinical utility. To that end, two particularly important results were presented during the annual San Antonio breast cancer symposium in December. First, our collaborators in Spain presented positive results from the first Prosigna decision impact study showing physicians in a real world setting used Prosigna to help guide their use of chemotherapy.

  • Second, researchers from the UK presented results from the (inaudible) prelim study which rated Prosigna highly compared to other major breast cancer gene signature tests. As a result, Prosigna has been chosen over other tests for use in a major prospective clinical trial which we expect to be enrolled in the UK beginning later in 2015. Overall we are pleased with our progress on multiple fronts and optimistic about our continued growth. I would like to turn the call over to Jim Johnson to review the financial results and provide financial guidance.

  • Jim Johnson - CFO

  • Thanks, Brad. The Company had a strong fourth quarter. Total revenue of $15.6 million, up 54% versus the fourth quarter of 2013. Instrument revenue for the quarter was $6.3 million, up 20% over a strong comp and fourth quarter of 2013. Consumable revenue was a record $7.2 million, up 69%, and well above the historical benchmark for annualized pull through of $100,000 per system. The growth in consumables reflected more than the typical volume of large orders from biopharma customers.

  • Prosigna test kit revenue remained modest at $156,000. We recorded $1.4 million of collaboration revenue for the quarter. Most of this relates to our Celgene collaboration with modest contribution from an exploratory collaboration with a pharma company involving an ongoing phase two study. During the fourth quarter we received an incremental $1 million milestone from Celgene which brings the total cash received under the collaboration to date to nearly $12 million, with $2.9 million recorded as revenue since inception in March of 2014. Gross margin on product and service revenues for the quarter 53%, compared to 52% a year earlier.

  • R&D expense was $5.4 million, compared to $4.5 million in the fourth quarter of 2013. The increase reflects increased investment in the nCounter technology including the engineering and testing of our next generation system, as well as costs related to diagnostic development including the Celgene collaboration. SG&A expense was $15 million, up from $9.1 million a year ago. The increase versus the prior year reflects the Prosigna launch costs, expansion of our commercial team, and increased administrative cost to address the Company's growth. Stock based compensation expense contributed significantly to the overall growth in operating expenses and totalled $1.3 million for the fourth quarter of 2014, compared to $380,000 a year earlier.

  • Our press release includes a schedule of non-GAAP financial which shows our operating results as if all pre-IPO preferred stock had been converted to common stock. On a non-GAAP basis, our net loss for the quarter was $9.7 million, or $0.53 per share compared to $7.5 million, or $0.51 per share in the fourth quarter of 2013. You should refer to that schedule for a detailed reconciliation of GAAP and non-GAAP results. We ended the year with $72 million of cash investments.

  • Now, I will turn to our financial guidance for 2015. We're currently projecting total revenue of $58 to $61 million for the year which includes collaboration revenue of $2.5 million, primarily from our existing collaboration with Celgene. Potential new companion diagnostic collaborations represent upside to this guidance. Following the announcement of new collaborations we intend to update our guidance to reflect related revenue impact.

  • Total product and service revenue is projected to be $55.5 million to $58.5 million for the year reflecting growth of 25% to 31% over 2014. We expect this growth to accelerate as we progress through the year due to the impact of new product launches and sales personnel hired in late 2014 and early 2015, we expect to reach full productivity in the second half of the year. We have included $2 million of Prosigna revenue in our guidance reflecting an assumption that Prosigna will be positively described in updated NCCN guidelines leading to additional reimbursement wins in the second half of the year. In the interim, however, we expect modest uptick to continue.

  • There are other expected revenue trends I would like to highlight. With respect to instrument revenue we plan to release the new Gen 3 system in mid 2015 and expect initial revenues in the third quarter. As a result, we anticipate instrument revenue growth will moderate in the third quarter while the funnel for the new lower priced system builds. With respect to consumables revenue for the installed base of the current Gen 2 system, for the full year we expect to maintain consumable pull through at or near the $100,000 per system we've generated historically.

  • However, consistent with experience over the past three years, we expect pull through in the first quarter of the year to be somewhat lower on a per system basis than in the other three-quarters. We expect gross margin on product and service revenue in 2015 to continue to fluctuate from quarter to quarter depending on the mix between consumables and instruments. For the year in total we expect overall gross margin to be in the range of 53% to 55%. On a quarterly basis, ignoring the impact of revenue mix, we expect it to move upward over the course of the year consistent with the growing scale of our consumables manufacturing operation.

  • As a reminder, collaboration revenue is excluded from our calculations of gross margin. After making significant investments to grow the business over the past two years we expect operating expense growth to moderate in 2015 and remain relatively consistent with the fourth quarter 2014 run rate.

  • We are expecting total operating expenses of $77 million to $81 million for the year which represents an increase of 6% to 12% over 2014. We expect operating expenses to include approximately $5 million to $6 million of stock based compensation expense for the year. Our operating loss for the year is expected to be in the range of $42 million to $49 million. Interest expense is expected to be approximately $4 million for the year.

  • However, if we decide to borrow any of the incremental $15 million available to us under the existing term loan agreement, interest expense would be higher. Finally, total capital expenditures are expected to be $4 to $5 million for the year, of which approximately half is expected to be funded by our landlord as lease hold improvements. With that, I will turn it back over to Brad to wrap up.

  • Brad Gray - President, CEO

  • Thanks, Jim. We enter 2015 in a position of strength stemming from the continued traction we achieved in our core life sciences business. Our fundamentals are sound with a growing world wide install base and strong consumable pull-through. Our entry into the clinical diagnostics market provides the potential for meaningful upside as our Prosigna launch progresses and the companion diagnostic program matures. I would now like to highlight four strategic objectives we will pursue during 2015. First, we plan to sharpen the focus on oncology where we believe our technology plays a unique role and provides us with a strategic advantage. We will seek to solidify our leadership in tumor profiling while expanding into the field of imuno-oncology.

  • Our commitment to oncology cuts across all three business areas as we aspire to provide best-in-class products (inaudible) biology from tumor samples and yielding new insights and therapies, and improving patients' lives. In recognition of this, we recently restructured from two independent commercial organizations; one for life sciences and another for Prosigna, to a single commercial organization empowered to sell our entire suite of products and targeted primarily toward academic medical centers and biopharma companies. We believe this approach strikes the optimal balance between effectiveness and efficient in reaching the leaders in oncology who are our customers and our partners. (inaudible) is a dynamic field in which we are already engaged via the launch of our pan-cancer immune profiling panel. In 2015 we plan to build on our current momentum and relationships introducing additional assays and collaborating closely with leaders in the field at both academic centers and biopharma companies.

  • We expect immunal oncology to become an important part of our business in the future. Our second strategic objective is to deepen our relationships with biopharma Companies, including building a pipeline of companion diagnostics. In 2014 biopharma customers drove a substantial fraction of our growth in instruments and consumables and today represent over 20% of our installed base. In 2015 we expect to continue growing our product sales to biopharma customers while also evolving our relationships with them to be more strategic and, ultimately, to become a trusted companion diagnostic partner.

  • While we are not factored revenue from the potential new companion diagnostics collaborations into the 2015 guidance, we are optimistic we will have the opportunity to enter into one or more such collaborations this year and that over time companion diagnostic partnerships will become a significant driver of our growth and cash flow.

  • Our optimism stems from our numerous ongoing dialogues with biopharma companies interested in Prosigna, and our DLBCL sub typing tests, as well as the bio market signatures discovered by some of the more than 30 biopharma companies who are currently using our nCounter technology. Our third strategic objective is to further penetrate the clinical laboratory market with the flex configuration of our nCounter system, our Prosigna breast cancer assay and our elements free agents. We plan to increase our focus on working with hospitals and cancer centers where our value proposition of decentralized breast cancer testing resonates most strongly.

  • In addition, we are continuing our effort to demonstrate Prosigna's clinical utility and look forward to presenting the results from several new studies at major meetings later this year. Our fourth strategic objective is to expand our addressable market by launching new products with broad affordability and appeal. Historically, we've offered instruments at a prices that were affordable primarily by labs which shared the equipment across multiple users. As a result, the pace of our installed base growth had been restricted by capital budgets and long sales cycles. In mid 2015, we expect to launch a new lower cost nCounter system designed to meet the needs of individual researchers at a much more affordable price.

  • We expect this launch will increase our addressable market to two to three times what it is today. We are currently in an intensive internal verification and validation phase and once completed should allow us to skip beta testing and go straight to full product launch. In parallel, we plan to introduce an application allowing researchers to simultaneously profile both the gene expression and the pro-gene expression of the sample on a single instrument system. We believe this multi-omic application will broaden the appeal of our technology to researchers who have traditionally focused more on (inaudible), and provide another distinctive capability not generally available from other technology platforms.

  • Later this week, data from this new multi-omic application will be showcased at the AGBT meeting in Marco Island, Florida. We look forward to a beta launch of our first multi-omic application at the (inaudible) meeting in April. Together we expect the launch of our lower cost nCounter and multi-omic applications to broaden the addressable market, further differentiate our technology and build our strategic advantage in the field of tumor profiling. In conclusion, these four strategic initiatives are designed to solidify the role of our Company and technology at the center of cancer research and diagnostics.

  • We believe that successful achievement of these objectives will drive growth and value creation, not just in 2015 but over the long-term. We look forward to updating you on our progress against these initiatives in future calls. I would now like to open the line for questions.

  • Operator

  • (Operator Instructions). First question is from Tycho Peterson, of JPMorgan. Your line is open.

  • Patrick Donnelly - Analyst

  • Thanks, it's Patrick Donnelly in for Tycho. Brad, for you, on the NCCN update, can you give us a feel on your confidence level for being included in the next update and then, best idea on timing? Are you thinking mid-March around that?

  • Brad Gray - President, CEO

  • I wish I could provide more visibility into the NCCN process than I can. As you know the NCCN guidelines are developed in a closed process by a committee of breast cancer experts and once NanoString submitted its application last summer, we have very little visibility into the ongoing proceedings. It is hard to speak to the level of confidence about whether it will be described and how in the discussion section.

  • That being said as we said many times we believe our submission was a strong one. It included FDA clearance, numerous peer reviewed publications including head to head study against tests already in the guidelines. We believe it is a strong package that the guidelines committee should be compelled to speak to in their discussion. In terms of timing, what we understand is that traditionally the full guideline updates for best cancer have appeared at about the same time that is the JNCCN, the NCCN journal, issued, its annual breast cancer issue.

  • According to the JNCCN editorial calendar, the April issue is meant to be dedicated to breast cancer. If that continues according to plan, we would expect that the full guidelines would be released around that time or as early as mid-April, I'm sorry, mid-March, when the electronic copy of that issue would appear online.

  • Patrick Donnelly - Analyst

  • Okay. So, the confidence level hasn't changed. We shouldn't read into the fact that you are including some revenues assuming the approval is happening? Your confidence is the same as it was five or six months ago?

  • Brad Gray - President, CEO

  • Correct.

  • Patrick Donnelly - Analyst

  • On the nCounter next Gen system, I appreciate the color, your going to skip the beta launch. What possible hiccups could happen with the internal review and what is the confidence level on that mid-year target for launch?

  • Brad Gray - President, CEO

  • Our confidence level is high. The program is going very well so far. We have received manufacturing pilots and we've been putting those pilots through their paces. We will be receiving more manufactured pilots and inventory over the weeks and months ahead. That being said, the reason we put an instrument through the tests is to discover any bug that may be there before its released to market. There always a modest risk that something would turn up. Thus far, we haven't seen any kind of show stoppers and we remain on track.

  • Patrick Donnelly - Analyst

  • Last one. I guess on the revenue guidance. You said there is no future companion diagnostic partnerships included. If you got one of those, how much up side could it add in terms of revenue for 2015?

  • Brad Gray - President, CEO

  • It is obviously very hard to say in the abstract. These structures, you know, collaborations can be structured in numerous different ways which have important implications for revenue recognition. I wouldn't hazard a guess about what the revenue contribution in 2015 from a new deal would be. The one benchmark we have is the Celgene deal from 2014 which contributed $3 million in end-year revenue but it is hard to say whether the next accounting treatment of the next collaboration would be similar.

  • Patrick Donnelly - Analyst

  • OK. That is fair. Thank you.

  • Operator

  • Next question from Steve Beuchaw from Morgan Stanley. Your line is open.

  • Steve Beuchaw - Analyst

  • Good afternoon. Thank you for taking the question. I actually just have a couple of clarification questions on the guidance of 2015 and at risk of being uncreative I will follow up on Patrick's questions on Gen three and Prosigna. First, let's go to Prosigna. You guide for I believe you said $2 million in contribution in 2015. That is a fairly substantial step up relative to 2014. My question is, what is behind that if the visibility on the NCCN process for very understandable reasons is still really low and the (inaudible) visibility is still really low. Are you taking a view that you can get to that level without the NCCN as a function of expanding coverage? Asked another way, if you got the NCCN would it potentially drive upside to that figure? How does that number come about? Thanks.

  • Brad Gray - President, CEO

  • Thank you, Steve. Let's talk about what's in that $2 million guidance number for Prosigna. First it is split about 50/50 between the US market and the ex-US market. That's what represents the revenue split we experienced for Prosigna in 2014. In the US, as Jim stated, we do assume a positive description in the NCCN guidelines. We also assume that it will be updated along the timeframe I just described which would be in the April timeframe and around the time that JNCCN breast cancer issue is expected to appear. We would expect that we would be able to use that guideline update to gain reimbursement in the second half.

  • We don't expect contribution from a major positive (inaudible) decision in 2015. On the other side, outside the US, on the other million dollars, we would assume that we continue our gradual penetration of those regions that we're already operating in. Some of that will be in regions where we have government reimbursement like Spain, and (inaudible) reimbursement in Germany and Switzerland. Others would be private pay business that we have been enjoying since the launch and some could be associated with the clinical study I mentioned in the UK, that would begin in the second half. I think it is a relatively modest number overall.

  • It is a step up certainly from our current run rate. We view it as a continuation of the trends and the assumptions we just described.

  • Steve Beuchaw - Analyst

  • Exactly what we needed. On Gen 3. You mentioned there would be some I want to say volatility although that is over stating it. In the third quarter as the system comes out. You build the funnel and the sales force needs to redirect the efforts to some extent. Can you us a sense for, number one, how much of an impact you are expecting from the Gen 3 launch in the second half. Number two, building on your comment that you expect some acceleration in terms of instrument revenue in the back half, how you think about Gen 3 versus Gen 2 instrument mix as we get to the fourth quarter and beyond. Thanks, guys.

  • Jim Johnson - CFO

  • OK. Thanks, Steve. Basically, after the Gen 3 launch we will have a segmented product line. We think that Gen 2 should still be the choice of many customers. Clinical labs will like the diagnostic capability. Biopharma customers, the FDA clearance and high through put and (inaudible) is also high through put. First of all, we think there is a minority of our instrument purchases who would have bought Gen 2 will opt instead for Gen 3. So, nevertheless, there is going to be a minority fraction of those customers who are going to be looking at the new system. And our launch strategy is sort of hard cut over with the new system as opposed to a slow soft launch. It is going to take time for that pull to build. In the first quarter of launch the dynamic we see is that there will probably not be the rapid up take of the new system and it will take approximately a quarter for that funnel to build. At that point we expect that the increased size of the opportunity for the Gen 3 system to make up for that and to actually result in higher instrument revenue growth percentages.

  • Steve Beuchaw - Analyst

  • OK. Thank you so much.

  • Operator

  • Next question from Jeff Elliott from R.W. Baird. Your line is now open.

  • Jeff Elliott - Analyst

  • Good evening. Thank you for the question. First, on next Gen. Any update on the list price or pull through that you expect on that instrument?

  • Brad Gray - President, CEO

  • Not at this time, Jeff. We will plan to provide more update on that obviously at the time of launch.

  • Jeff Elliott - Analyst

  • That is fair. Jim, looking at guidance what do you assume for FX? I think it's pretty relevant this year given the growing international (inaudible). What are your assumptions for revenue on the margin side for FX?

  • Jim Johnson - CFO

  • I know that is a question that is on the tips of people's minds these days. For us fluctuations in foreign ex change rates had a negligible direct impact on the revenue. Historically less than 10% has been billed in foreign currency. When we look at guiding for 2015 we didn't make any specific assumptions for FX changes on our 2015 revenue guidance. Indirectly, of course, continued strengthening of the US dollar could indirectly impact demand for products and discounting the products in foreign markets. I think that is implicit in our guidance.

  • Jeff Elliott - Analyst

  • Let me clarify, Jim. You mean your guidance assumes rates where they are today? Hold constant, or you haven't made any assumptions for any FX change whatsoever?

  • Jim Johnson - CFO

  • Yes. Roughly speaking, roughly unchanged from where they are today.

  • Jeff Elliott - Analyst

  • Okay. Got it. Assuming you don't get the NCCN commentary that you are hoping, which I think is unlikely, but if you don't get that, how should we think about OpEx in that scenario? Would you kind of dial that back for the rest of 2015 if that were to happen?

  • Jim Johnson - CFO

  • I think it is early to discuss what we would do operationally in the scenario where we don't end up in the description of the guidelines. At all times we are looking at the best and highest use of operating expense dollars. We have to think about investment in Prosigna versus other products and within Prosigna, the investment in clinical data versus commercial activity and reimbursement. Today we have focused investment on the activities we think are most important, instrument placement, new Prosigna sites as well as reimbursement activities. Part of the efficiency we sought in the commercial reorganization we described was a more focused effort on those two activities, dialing back some of the straightforward promotional and detailing activities direct to oncologist. We are cognizant of the need to constantly look at the mix of our commercial expense in investment and we won't be specific at this point in time about how we would manage a situation without the guidelines. But we would plan to update you at that time.

  • Jeff Elliott - Analyst

  • Got it. On the 20% (inaudible) that you have for coverage for Prosigna, what level of reimbursement are they covered at?

  • Brad Gray - President, CEO

  • Our understanding is the last who are receiving reimbursement under those policies are receiving at around the same rate that the other tests for breast cancer are being reimbursed which is nearly $4,000 per test.

  • Jeff Elliott - Analyst

  • Thanks, guys.

  • Operator

  • Thank you. Our next question comes from Justin Bowers of (inaudible). Your line is open.

  • Justin Bowers - Analyst

  • Good afternoon. Brad or Jim, thinking about the Gen 3 box differently, what is the contribution maybe as a percentage of instrument growth or revenue growth next year that you have factored in the guidance?

  • Brad Gray - President, CEO

  • This is Brad. We are not currently breaking that out at this point. I think that we were pretty clear on the kind of timing of the launch being midyear and therefore revenue contribution starting in Q3 and Q4 and building in Q4 as the funnel grows. I think you can do a (inaudible) minority of our overall instrument revenue. We are not going to be any more specific than that at this point in time.

  • Justin Bowers - Analyst

  • Then just in terms of the commercial changes you made. Could you talk about maybe just elaborate on the restructuring. Did you add any sales coverage in the fourth quarter?

  • Brad Gray - President, CEO

  • Sure. On the restructuring. What we kind of realized over the past year is that oncology is the primary market we serve. At the same time the lines between the have traditionally demarkated research and clinical testing have really bordered. It is become clear that at this stage of our Prosigna launch, the most critical activities are those geared to establishing new sites and reimbursement. We looked at what we thought would be most efficient and effective commercial channel and decided to move from the two independent channels, one to life sciences and one to diagnostics, to a single one focused on academic centers, clinical labs and biopharma companies. So, that, we think is the right mix for us today.

  • Taking advantage of the power of our technology to decentralize testing into these hospitals and academic centers and forgoing increased investment in detailing to oncologist at the stage in a Prosigna product launch where reimbursement is not yet widespread.

  • Justin Bowers - Analyst

  • Okay. Understood. Thank you.

  • Operator

  • I don't show any further questions at this time. I would like to turn the call over to management for closing remarks.

  • Brad Gray - President, CEO

  • Thank you for taking time this afternoon to hear about our Q4 and full year results. We look forward to seeing you at AGBT and other conferences coming up soon. Thank you.

  • Operator

  • Thank you for participating in today's conference. This concludes the program. Have a good night.