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GenMark Diagnostics Inc (NASDAQ:GNMK)
Q3 2019 Earnings Call
Nov 6, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon ladies and gentlemen and welcome to today's conference call to discuss GenMark Diagnostics Third Quarter 2019 Financial Results. My name is Shane and I will be your operator on this call. [Operator Instructions] Please note that this call is being recorded today Wednesday, November 6, 2019, at 1:30 PM Pacific Time and will be available on the Investors section of GenMark's website at www.genmarkdx.com.

I would now like to turn the meeting over to Leigh Salvo Investor Relations.

Leigh Salvo -- Investor Relations

Thank you, Shane, and thank you all very much for joining us today. 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 plan objectives assumptions or future events or performance are forward-looking statements. For example, statements concerning our 2019 financial and operational guidance the development regulatory clearance commercialization and features of new product 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 that 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.

I'd now like to turn the conference call over to Hany Massarany President and CEO of GenMark. Hany?

Hany Massarany -- President and Chief Executive Officer

Thank you, Leigh and good afternoon everyone. With me today are Scott Mendel our COO; and Johnny Ek our CFO. I'd like to begin today's call with an update on our commercial performance then Scott will discuss operational highlights and Johnny will conclude with the financial details. At that time we will open the call for questions. Our third quarter results reflect continued success in delivering quality placements of our ePlex platform while also driving our operational efficiency and advancing our innovative product pipeline. Our commercial momentum in the quarter was propelled by the recent addition of our three FDA cleared blood culture ID panels as well as continued demand for our respiratory pathogen panel. More specifically starting with top line financial performance we achieved strong third quarter revenues of $20.9 million representing 32% growth over the prior-year period. ePlex sales in the quarter grew by 98% over the prior period accounting for $13.4 million or 64% of total third quarter revenues. Gross margin was consistent with our expectations at 34% and we will remain on track to achieve our 2019 gross margin guidance of 31% to 33% and longer term goal of 60% plus.

Drilling down to our commercial performance we placed 51 net new ePlex analyzers worldwide in Q3 2019 resulting in a global installed base of 489 ePlex analyzers compared to 312 in Q3 2018 an increase of 57%. We are very pleased with the continued strong adoption of our ePlex system by hospitals and reference labs of all sizes both in the U.S. and internationally. Approximately 65% of our U.S. ePlex placements in the quarter were in labs which had an incumbent rapid multiplex molecular platform and we continue to hear from customers that due to the unique benefits of our ePlex system they are now much better equipped to realize the value of near patient rapid syndromic testing which is becoming ever more essential in the effective management of high-risk patients. Our recently launched blood culture ID panels which provide the broadest target coverage available on the market today for the detection of sepsis are significantly bolstering our competitive position enabling us to go both broader and deeper with key accounts and drawing widespread and new customer interest. In the first full quarter of BCID availability in the U.S. revenue contribution from our BCID panels was a meaningful component of overall ePlex revenues.

Importantly BCID is not only driving ePlex revenue and placements but also enabling us to capture additional RP business by offering an expanded solution. While still in early innings of its launch BCID has already contributed to greater than 70% of year-to-date ePlex placement with RP pull through in about 40% of these places. While we do not anticipate providing quarterly metrics at the assay level in the future we wanted to highlight how the addition of BCID is already contributing to our competitive positioning. A key tool for demonstrating the value proposition and clinical impact of our BCID solution to customers is conducting retrospective reviews of their own lab's positive blood culture data for the prior 12-month period. In this real world analysis, we are consistently able to show 10% to 20% broader pathogen coverage compared to competitive alternatives. These reviews also demonstrate the clinical impact cost savings and antimicrobial stewardship benefits that ePlex BCID provides at the patient provider and hospital system level. Another contributing factor to the market acceptance of our ePlex BCID panel is their unique ability to drive more appropriate use of antimicrobial therapy which is directly aligned with new CMS conditions of participation regulations that required U.S. hospitals to develop and implement antibiotic stewardship programs.

These programs are designed specifically to reduce microbial resistance and decrease the spread of infections caused by multidrug-resistant organisms. ePlex BCID helps address these goals by delivering broad pathogen and resistance gene coverage and perhaps more importantly is the only solution that offers an integrated templated comments ID module to make the diagnostic results immediately actionable in alignment with local practice guidelines and pharmacy formularies. Overall awareness for BCID continues to grow through our marketing efforts and the support of key opinion leaders globally. Several studies were presented during ID Week last month which highlighted both the laboratory benefits as well as the patient management impact of ePlex BCID. One study presented had two infectious disease pharmacists make blinded decisions regarding antibiotic selection based on rapid diagnostic test results. The comparison favored our ePlex BCID panel. We scored higher in both gram-negative and gram-positive organisms versus competing panels. Another laboratory director from a major academic medical center in the Northeast shared her early experience with ePlex BCID highlighting its potential to significantly streamline blood culture diagnostic workflows by eliminating numerous other tests that are collectively required to achieve comparable inclusivity.

Finally, we are pleased to announce that our gram-positive clinical study manuscript is under review for publication in the Journal of Clinical Microbiology and we expect papers summarizing the gram-negative and fungal studies to be submitted for a review before the end of the year. These and planned future studies enable us to partner with some of the leading institutions and investigators in the country including a major U.S. cancer center who participated in our fungal study and recently went live with all three BCID panels. I'd now like to comment briefly on recent updates to the reimbursement landscape and GenMark's status. As a reminder, late last year and earlier this year sales in Medicare administrative contractors used local coverage determinations which restrict coverage of large respiratory testing panels to certain patients most commonly in the outpatient setting. While these more restrictive coverage policies have had only a modest impact on our RP business to date in certain cases they have resulted in confusion among our customers and reduced access to a high clinical value test for high-risk patients such as the elderly and the immunocompromised. In response to this, we worked collaboratively with various stakeholders to provide clarity about how ePlex RP Panel would be covered and paid for during the 2019 2020 respiratory season.

And to that end, we are pleased to share that a Proprietary Laboratory Analysis or PLA code has recently been assigned to ePlex RP by the AMA and published in the draft 2020 clinical lab fee schedule. With a preliminary recommendation by CMS to crosswalk this ePlex RP PLA code to the existing CPT code for respiratory panel testing. Based on our discussion with the relevant stakeholders we are optimistic that the ePlex PLA code will be reimbursed for the upcoming flu season ensuring access for Medicare and Medicaid patients to be in their relevant geographic model. We are grateful to those at the AMA MolDX and CMS who have constructively engaged with us on this important topic. In summary, as we enter the final quarter of 2019 I'm very encouraged by the momentum that our company continues to gain. With a highly differentiated menu and a superior testing efficiency, ePlex is increasingly being recognized in the molecular multiplexing market as the best-in-class platform for delivering high quality patient center care. I'm also confident that our strong commercial team and consistent operational execution along with the ongoing advancement of our R&D priorities will continue to drive our performance and growth in this very attractive and rapidly growing market.

At this point, I'll turn the call over to Scott for his operational update. Scott?

Scott Mendel -- Chief Operating Officer

Thank you, Hany. From an operational perspective, our teams are primarily focused on three priorities. The first is supplying our customers with ePlex consumables. The second is investing in continuous improvement efforts that are critical to achieve our state of gross margin targets and the third is menu expansion. My comments today will be mainly focused on our plans to drive continued gross margin improvement which is an important company priority as well as important to our shareholders. During the third quarter, we invested significant resources and manufacturing capacity to drive gross margin improvements. Our engineering and manufacturing teams tackled many projects during the third quarter given the typically lighter production volumes that result from a respiratory business seasonality. More than half of these projects are focused on improving manufacturing processes to reduce variability and increase yield. The remainder of the project were split between implementing quality control procedures and working with our suppliers to reduce costs and incoming material variability. In the fourth quarter, we expect significantly higher volumes coupled with our team's improvement efforts to be key contributors to ePlex gross margin.

We remain committed to achieving our 2019 overall gross margin range of 31% to 33% as well as exiting 2019 with ePlex gross margin of approximately 30% which not only represents a significant improvement over 2018 but also is an important step toward achieving our longer-term gross margin goals. Looking beyond 2019 we have a multiyear funnel of opportunities to drive additional gross margin improvement by reducing direct material costs of our ePlex consumable. We have prioritized this funnel based upon implementation time technical assessment and return on investment. As a result of this prioritization process, most of the opportunities that we are currently working on will provide direct material savings in 2020. Beyond direct material, our engineering resources have similarly developed a list of manufacturing process improvement opportunities. These improvements will increase manufacturing yield by reducing process variability and eliminating waste as well as driving direct labor efficiency. Our initial process improvement priorities are focused on the preparation and processing of our PCB which is the backbone of our proprietary eSensor detection technology as well as the preparation and application of our reagents that are critical to our detection process.

In addition to our efforts on direct material and direct labor productivity, we expect to capitalize on our rapidly increasing production volumes thereby driving gross margin expansion through additional overhead absorption. Our teams have a track record of driving gross margin improvements as demonstrated by our success with the XT-8 product line. We are balancing our desire to rapidly achieve our stated gross margin goals with a rigorous and methodical validation process so that we can ensure the ongoing supply of our FDA cleared panels for our customers. In addition, our research and development teams also made strong progress on the future menu. The GI development team has now moved into the project phase that focuses on dialing in the optimal settings of various parameters before then moving on to analytical and clinical studies.

While GI is our top development priority we have additional resources focused on advancing our pipeline of panels as well as other technology and software innovations. Our funnel of opportunities spend several years and we expect these technology and software investments to drive the long-term growth of our business beyond traditional menu expansion. We look forward to sharing more details on the advancement of our development pipeline as important milestones are achieved. Our teams are focused on delivering a strong fourth quarter laying the groundwork for continued gross margin expansion in 2020 and beyond as well as making significant process on our GI panel and technology pipeline.

I'd now, like to turn the call over to Johnny for a review of our financial results for the third quarter.

Thank you, Scott. I'll now provide details on our third quarter 2019 financials. As previously mentioned third quarter 2019 revenue was $20.9 million up 32% versus the third quarter of 2018 with year-over-year ePlex revenue growth of 98%.Sales to U.S. customers continue to account for the vast majority of our revenue. The average annuity for ePlex placement in the third quarter was $106000 consistent with our expectations outside of flu season and represented an increase of 20% over the third quarter of 2018. We continue to expect the average annual revenue per ePlex placement will be in the $135000 to $145000 range for the year. Third quarter gross profit was $7.1 million or 34% of revenue versus $5.6 million or 36% of revenue in the third quarter of 2018 which highlights the continued shift to higher ePlex product sales relative to XT-8. As Scott mentioned in his remarks our focus on manufacturing improvement initiatives is driving higher ePlex gross margins through the year. Total operating expenses were $17.3 million for the quarter representing an increase of $1.1 million compared to the third quarter of 2018.

The increase over prior year is the result of our investment in the launch of our BCID panels and the cost associated with the validation and go-live of the systems placed for BCID use. Our net loss per share for the third quarter of 2019 was $0.20 a share consistent with our loss per share in the third quarter of 2018. From a balance sheet perspective, we ended the quarter with $33.2 million in cash and investments. We used approximately $10 million of cash in operations during the third quarter of 2019 versus $12.5 million in 2018 driven by favorable working capital results. In the third quarter of 2019 cash usage increased over the second quarter by $2.5 million primarily due to increases in accounts receivable of $3.7 million and inventory of $2.7 million that will be readily converted to cash in the short term. We drove global DSO of 37 days DPO 41 days and DSI of 75 days for the quarter. Additionally, we added $2.4 million in cash to our balance sheet during the quarter from a sale of shares through an ATM.

As a reminder our current credit facility allows us to draw an additional $15 million later this year subject to achievement of certain milestones. For the remainder of 2019, we continue to expect total revenue in the range of $85 million to $90 million ePlex placements of 170 to 190 analyzers with an expectation closer to the midpoint and an average annuity per analyzer in the $135000 to $145000 range. As mentioned we anticipate gross margin for the year to be between 31% and 33% and we continue to see our operating expenses between $65 million and $70 million for the year. We expect cash usage to be at the high-end of our range of $25 million to $30 million depending on the timing of orders and revenues through the fourth quarter.

This concludes our prepared remarks. So at this time Hany Scott and I would like to open the call up for your questions.

Questions and Answers:

Operator

[Operator Instructions] First question comes from the line of Brian Weinstein of William Blair. Your line is now open.

Casey Preyss -- William Blair -- Analyst

Hi, guys, this is Casey on for Brian. Did you guys talk about the strength of the funnel and how it stands now versus maybe a quarter or even a year ago? And how is it developing? And what kind of time to close you're seeing?

Hany Massarany -- President and Chief Executive Officer

Yes. I'll take it and you guys can add if you have comments. I would say that the funnel is very healthy and continues to strengthen. Certainly since the launch of the FDA cleared BCID panels we are now able to reach many more customers and opportunities to place additional ePlex systems in new accounts but also to work with existing placements going back to the installed base to add a BCID to the menu being utilized. As you will remember for a while we were only selling respiratory panel. And now with BCID, you were able to go back to the existing customers and manage that funnel of opportunity as well as additional placements. So we are very comfortable with the status of the funnel. And like I said it just continues to strengthen and we are very pleased with that.

Casey Preyss -- William Blair -- Analyst

And then one more on how is pricing holding up? And is the market becoming more competitive on price versus menu or system benefits?

Hany Massarany -- President and Chief Executive Officer

Pricing is holding reasonably well. Occasionally we see some aggressive pricing out there but we are always able to differentiate our solution based on the value proposition. And in general, we are able to command and sustain a premium pricing. So again obviously with more options out there and additional competitors coming into the market, we expect that there will be pressure on pricing. But so far it's holding reasonably well.

Casey Preyss -- William Blair -- Analyst

Thanks. That's all for me.

Hany Massarany -- President and Chief Executive Officer

Thank you.

Operator

Next question is from the line of Derik De Bruin Bank of America Merrill Lynch. Your line is now open.

Derik De Bruin -- Bank of America Merrill Lynch -- Analyst

Hi. Good afternoon.

Hany Massarany -- President and Chief Executive Officer

Hi there Derik.

Derik De Bruin -- Bank of America Merrill Lynch -- Analyst

Yes. Hi. Yes, so a couple of questions. So I guess the first one it's like what's the initial look for the flu season? I mean what are your sort of expectations relative to last year?

Hany Massarany -- President and Chief Executive Officer

Well, we are not seeing anything crazy just yet Derik. No sort of major activities. We haven't seen much of it yet. It's difficult to comment on something that's not happening just yet. As you know it was relatively a strong or severe season in the Southern Hemisphere but we are not aware of any credible way of sort of predicting what's going to happen here in the Northern Hemisphere. So at this stage, we haven't seen a lot of activity yet and time will tell.

Derik De Bruin -- Bank of America Merrill Lynch -- Analyst

Great. And you did good progress on the gross margins. I know it's a little bit early to talk about 2020 but can you give us some general sense on how do you see the progression over the next couple of years? How we should think about -- how long it will take us to get to that 60% target?

Scott Mendel -- Chief Operating Officer

Sure Derik. This is Scott. I'll handle that. We continue to think 60% is a two- to three-year goal. The current year's progression was mainly driven by improvement in yield off of the line so that's continues to drive 2019's results. As we look into 2020 although we are not providing explicit guidance right now our expectation would be that the majority of the improvement will come from direct material. As I mentioned on the call we have a multiyear funnel of opportunities to drive direct material costs down and we would expect the improvement in 2020 to come mainly from direct material and then also from just additional production volumes driving absorption of the overhead costs. Again two to three years out that's our goal to hit that 60% plus a gross margin.

Derik De Bruin -- Bank of America Merrill Lynch -- Analyst

Great. And then one final one. You mentioned some competitive wins. Just talk about the nature of the systems that you've displaced; the nature of the customers and what was the driving force behind the wins?

Hany Massarany -- President and Chief Executive Officer

Yes, Derik we have really done well across the Board in smaller and bigger labs in hospital and reference labs. In the quarter approximately 65% of our placements were won against an incumbent that was already in the lab. And BCID was a main driver of our competitive wins. In 40% of the cases, RP came along with it as we expected but certainly, BCID also is generating a lot of interest and traction is really picking up in the field.

Derik De Bruin -- Bank of America Merrill Lynch -- Analyst

Great. Thank you very much.

Hany Massarany -- President and Chief Executive Officer

Thank you.

Operator

We have a question from the line of Mark Massaro Canaccord Genuity. Your line is now open.

Mark Massaro -- Canaccord Genuity -- Analyst

Hey guys congrats on a good quarter. I guess Hany you indicated obviously BCID had a really nice quarter driving a lot of the placements. You talked about how BCID had a meaningful amount of revenue. Is there any way for you to get any more granular than that? And then I'm just -- in my model I have like $2 million so I was just curious how the revenue trended relative to your expectations as well?

Hany Massarany -- President and Chief Executive Officer

All right. Mark, I'd rather not get into more details about the revenue by assay. But OK I'll give you a hint. You were close but it certainly was a good contribution relative to our mid-teens low- to mid-teens of ePlex revenue in total. But again we really don't want to and don't intend to report revenues by assay at this stage.

Scott Mendel -- Chief Operating Officer

And the revenue was in line with our expectations.

Mark Massaro -- Canaccord Genuity -- Analyst

Okay.

Scott Mendel -- Chief Operating Officer

The revenue growth was in line with our expectations Mark from a BCID perspective. And we continue to see implementation times in line with our expectations in that three- to six-month timeframe. So everything operating according to plan thus far from a BCID perspective.

Mark Massaro -- Canaccord Genuity -- Analyst

Great, that's helpful. And then can you give us a sense for the PLA code to the extent of that initiative the new code can help display some of the concerns? Is there any way for you to quantify maybe the percentage of customers that were confused by the prior code?

Hany Massarany -- President and Chief Executive Officer

Well, I'd say not so many. As we said all along this wasn't all that relevant to us since the vast majority of testing on ePlex is an XT-8 for that matter comes from inpatients hospitalized critically ill patients most likely in ICU or immunocompromised and so on and so forth. So it was never a big issue for us and we saw the very minimal impact of the reimbursement issues on our business. But it was important to clarify and take one other sort of objection or issue out of the way. So we are not expecting a material impact based on the PLA code but it is something that just takes that question off the table I guess with respect to Medicare outpatients mostly that's what we are talking about here.

Mark Massaro -- Canaccord Genuity -- Analyst

Okay. And last question from me. Can you just talk about any changes to the competitive marketplace? It seems relatively status quo to me. You guys have done a very nice job with the XT-8 and now certainly with ePlex. But as we think about some of the other systems that have launched can you just give us a sense for competitive dynamics in general?

Hany Massarany -- President and Chief Executive Officer

It's very stable as you said, Mark. We really haven't seen much of the other systems yet. We expect them to come but not yet. So the main players are the same players that you're aware of your familiar with. And I'm pleased to say that we are competing very effectively against them and we are taking a market share and growing our business not just in a white space not just in labs that are new to molecular but also labs that already have an incumbent and were able to displace those as well.

Mark Massaro -- Canaccord Genuity -- Analyst

Very good. That's it from me. Thank you.

Hany Massarany -- President and Chief Executive Officer

Thank you.

Operator

We have from the line of John Hsu from Raymond James.

John Hsu -- Raymond James -- Analyst

Great. Maybe we can just start with the placements. Just given the progress that you're seeing with BCID and the pull through etc. can you just help us think about the comment that you're expecting the placements closer to be the midpoint. I believe that I've seen implies a pretty sizable deceleration from kind of where you've been placing year-to-date. So maybe we could start there.

Hany Massarany -- President and Chief Executive Officer

I'm not sure you're breaking up a little bit John. You're asking about placement and what the expectation needs for the rest of the year. And we still believe that we will be at the midpoint of our range that we guided to. Don't forget that the flu season depending on when it starts and how busy labs may be with the flu season with the routine testing can have an impact on placements because they don't want to bring in necessarily new systems and sort of do their validations and implementations during the busy time. But on the other hand obviously, BCID sepsis is not as a seasonal disease. So we don't expect that would impact placements that are driven by the sepsis. So the net of that is that where we feel good about the range that we provided and we expect to be close to the middle of that range.

John Hsu -- Raymond James -- Analyst

Okay. Great. And then the only other one for me just can you give us an update on maybe how the key accounts initiatives are trending is that starting to bear fruit in the pipeline? And then are you seeing any change to maybe the look on the capital rental mix or ASP as a result of those initiatives?

Scott Mendel -- Chief Operating Officer

The -- our corporate and strategic accounts team is doing a phenomenal job. They've already have got secure several IDN major accounts they continue to manage our relationships that already exist with some of the major IDNs on the East and West coast as well as national reference labs. And we expect to be securing some GPO agreements in the near future that we have been working diligently to secure. So going really was -- I think it was the right thing for us to do. Now with the expanded menu and the traction that we are getting in the marketplace and we haven't seen a shift in the capital reagent rental mix we on average -- I mean if it changes sometimes a quarter-to-quarter. I think this quarter we had more capital than we expected. But that's sort of 70:30 mix is the overall expectations 70% reagent rentals 30% capital in Q3. It was more capital than that.

John Hsu -- Raymond James -- Analyst

Great. That's all from me. Thank you.

Scott Mendel -- Chief Operating Officer

Thanks very much.

Operator

[Operator Instructions] We have a question for Mike Matson of Needham Inc. Your line is now open.

David Saxon -- Needham Inc -- Analyst

Hi, guys, it's David on for Mike. Thanks for taking my questions. First, just with regard to the competitive placements for 65% of the installs in the U.S. can you just talk about how ePlex utilization in those accounts is trending relative to the other portion of placements?

Hany Massarany -- President and Chief Executive Officer

There's no reason to expect this to be any different. I'll just remind you quickly that placements in a quarter don't really start generating revenues until most likely the following quarter. So it takes one to two quarters depending on the lab depending on the menu for the systems to be validated and sort of turned on for routine use. Respiratory takes a little bit less time because labs are more familiar with molecular testing for respiratory disease since those panels have been around for a while. With BCID it's taking a little bit longer but like I said somewhere in the range of one to two quarters. So largely the Q3 placement would be in the process of being validated and implemented in the labs now for future revenue generation and we don't expect that that there will be any different from other placements that we have made in the past.

David Saxon -- Needham Inc -- Analyst

Okay. Thanks. And then I mean I know the U.S. is the main driver but I'm just looking at the international commercialization. Can you talk about how that's going and I think you just got into Southeast Asia and maybe you'll end in America maybe that's this quarter? Can you talk about how those launches are going? Thank you.

Hany Massarany -- President and Chief Executive Officer

Yes. Thanks for the question. Yes. OUS business is going well. Most of the business is coming out of Central and Western Europe. We have a hybrid model as you will remember. So we have a team in Europe working directly with the distributors in Europe and the Middle East and North Africa. We have a lot of stand-alone sort of self-sufficient distributors. I mean obviously, we support them in other parts of the world including the Asia Pacific now many countries in the Middle East and also beginning to place systems in Latin America as well. But with all that said obviously the U.S. still remains the big driver of revenues and the very vast majority of our revenues now and we expect in the future will continue to come from the U.S. market.

David Saxon -- Needham Inc -- Analyst

Okay. Thank you.

Scott Mendel -- Chief Operating Officer

Thank you.

Operator

I'm showing no further questions at this time. I'd like to turn the conference back to Hany Massarany for closing remarks.

Hany Massarany -- President and Chief Executive Officer

All right. Well, thank you all for joining us this afternoon and for your continued support. We look forward to updating you on our progress in the future. Have a good day. Bye-bye.

Operator

[Operator Closing Remarks].

Duration: 41 minutes

Call participants:

Leigh Salvo -- Investor Relations

Hany Massarany -- President and Chief Executive Officer

Scott Mendel -- Chief Operating Officer

Casey Preyss -- William Blair -- Analyst

Derik De Bruin -- Bank of America Merrill Lynch -- Analyst

Mark Massaro -- Canaccord Genuity -- Analyst

John Hsu -- Raymond James -- Analyst

David Saxon -- Needham Inc -- Analyst

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