Earnings Call Transcript - QTRX Q3 2020

Operator, Operator

Good afternoon, ladies and gentlemen. Thank you for standing by and welcome to the Quanterix Corporation Q3 2020 Earnings Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference call may be recorded. I would now like to turn the conference over to your speaker today, Mr. Amol Chaubal, CFO, Quanterix. Please go ahead, sir.

Amol Chaubal, CFO

Thanks, Annie. Good afternoon, everyone, and thanks for joining us today. With me on today’s call is Kevin Hrusovsky, our Chairman and CEO. Before we begin, I would like to remind you about a few things. We had several problems with our press release distribution today, and hence, the earnings release can be found on our website. Today’s call will be recorded and will be available in the Investor Resources section of our website. This call will contain forward-looking statements that are based on management’s beliefs and assumptions and on information available as of the date of this call. We may not actually achieve the plans, intentions, or expectations disclosed in our forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, assumptions and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. The risks and uncertainties that we face are described in our most recent filings with the Securities and Exchange Commission. During today’s conference call, we will discuss some financial measures that are not presented in accordance with U.S. Generally Accepted Accounting Principles or non-GAAP financial measures. In the Q3 earnings release and in the appendix of our presentation, which are available on our website, you will find additional disclosures regarding these non-GAAP measures, including reconciliations of these measures to comparative GAAP measures. We believe that these non-GAAP financial measures provide investors with relevant period-to-period comparisons of our operations. These financial measures are not recognized under GAAP and should not be considered in isolation or as a substitute for a measure of financial performance prepared in accordance with GAAP. With that, I would turn the call over to Kevin.

Kevin Hrusovsky, Chairman and CEO

Thank you very much, Amol. I will start off with a review of the strategic and financial progress the company has made. Starting first with some key advances in Q3, and then ultimately describing the vision and strategy, which continues to evolve very comprehensively. Let me start with Slide 4, where we’re showing publications. As you know, about three to four years ago, we really started a key focus on showing the world how noninvasive early detection could lead to a real game change in health care. We now have nearly 1,000 third-party peer-reviewed publications, and there have been over 368 markers run. On the right-hand side, you can see that Alzheimer’s publications have already surpassed where we were last year. There are some significant developments here. Simoa pTau-181 has been shown to be highly specific for Alzheimer’s, allowing cohorts to be enriched and to eliminate frontotemporal dementia as well. Serum Nf-L levels have revealed symptoms 16 years before dementia in familial patients, showcasing a real early detection opportunity. Additionally, serum Nf-L has shown its evolution in MS disease progression and has even found its way into COVID publications, where scientists have been able to measure associated neuro function with our Nf-L. There’s a lot of excitement right now around aducanumab from Biogen, which is being seen as a key market mover in this evolving landscape of neuro products. The next slide illustrates our continued revenue ascent. As you know, we pivoted to put a lot of focus on our Accelerator to support overall customer activities during this pandemic. We have surpassed significantly last year’s full-year revenue with our third quarter results, running 128 Phase I/II/III drug trials inside the Accelerator. You can also see our instrument placements evolving, mostly focused on neurology, but expansion in oncology is beginning, and we anticipate some movements in infectious disease as well due to COVID-related pivots. You can see that on a total revenue basis, we have surpassed last year’s revenue as a whole. There were onetime large wins incorporated into our third quarter revenue, which we will detail out. Even without significant tailwinds from COVID, we grew 22% in Q3 versus last year’s Q3. So without considerable tailwinds, we are excited that we are offsetting most COVID headwinds with this performance. Significant wins in this past quarter have come from our advances and our focus on neuro and our CAC pivot, which stands for COVID Accelerator China pivot. The momentum in Alzheimer drug trials has picked up, and we launched the pTau-181, also a 4-Plex being used in many Alzheimer trials, advancing our position in this landscape. In the COVID arena, we secured $18.2 million in Q3, having initially won a $2 million grant for feasibility at the end of Q2. We were then rewarded to scale this antigen test further, showing incredible utility and potential to eliminate PPE concerns and enable homecare sampling. We’re really excited that the NIH has seen the potential in this test and invested aggressively in scaling it up, which we believe could also support numerous trials we’re running in both neuro and COVID. We have also begun major IRB studies with one of the largest payers in the U.S. for COVID, running five different IRBs currently inside our Accelerator lab. Additionally, we have recently strengthened our position in China by naming a new General Manager for our Asia Pacific business. The HDX performance continues to evolve and improve, key to our strategy, and we are generating trade-in revenue as well as new system sales. You may have seen a major announcement around Abbott, where we secured a nonexclusive license with them, which is a significant advancement given that Abbott is one of the premier players in the industry, particularly with a major upfront payment. I think it’s a $10 million upfront payment for this license. But longer-term, they will try to deploy Simoa in their instrument platforms. We were also successful in raising $100 million in capital this quarter, marking one of our largest funding rounds yet. Our revenue breakdown shows strong lab Accelerator growth, driven by COVID supply and HD-X transitions for validation work in our customers. While we did experience challenges in Q2, our full-year mix showcases our abilities to grow into our most productive components. Our growth was strongest in Europe, followed closely by North America in Q3. About 60% of our revenue continues to come from pharma and biotech sectors, chiefly in the neuro sector, with growing interest in oncology. Strategically, we strive to transition the life sciences into a digital opportunity for measuring ELISA. Our efforts in digital ELISA have increased sensitivity substantially, which is a big advancement for detecting relevant proteins less invasively. We believe these initial deployments will help drug companies recruit better cohorts of patients and will lead to a more efficient drug approval process. The combination of allowing lower dosing and better toxicity measures leads to a significant improvement in the efficacy of drug trials. As shown, we have rapidly adopted the Simoa technology, significantly increasing our revenues and showing the utility in many pharmaceuticals. We mention earlier Novartis’ new drug approval using our Nf-L. Roche also utilized our technology successfully in MS. For Nf-L, we have strong correlations now in blood for brain health tracking, enabling less invasive sample strategies. The Nf-L protein levels can now be measured with less invasive ways, decreasing the need for painful procedures. This demonstrates a clear shift towards non-invasive early detection, which we believe could lead to significant shifts in medical practices and patient care. The protein we’re measuring captures a lot of environmentally-triggered diseases, paving the way for greater relevance in health care. We’re also excited about the intersection of genomics and proteins, straddling our pipeline into the potential protein revolution. Our total addressable market stands at $1 billion across COVID and neuro channels, supporting our goal of a 30% to 40% CAGR growth moving forward. Lastly, let me turn it back over to Amol to discuss our financials in more detail.

Amol Chaubal, CFO

Thanks, Kevin. I’m going to provide you with additional financial details about our Q3 2020 performance. As Kevin noted, our GAAP revenue for Q3 2020 was $31.4 million, which included $11.2 million linked to our nonexclusive license agreement with Abbott and $1.9 million from our RADx Phase I award. Excluding these nonrecurring items, our non-GAAP Q3 2020 revenue was $18.3 million, representing a 22% increase versus Q3 of the prior year. Instrument revenues rose by 8%, and consumables revenue increased by 9%, even with challenges in accessing customer sites due to COVID-19. As we've discussed previously, we proactively expanded our Accelerator services capacity to support our customers in sustaining their research and clinical trials. This effort drove a 56% increase in service revenue, which totaled $6.6 million. The RADx Phase II contract, which we entered into at the end of Q3, did not influence our Q3 results. Year-to-date total revenues reached $60.2 million. Excluding the previously mentioned nonrecurring items from Q3, our non-GAAP year-to-date total revenues of $47.1 million reflect a 50% increase. We are not issuing revenue guidance at this time, but we anticipate RADx Phase II contract revenue to be about $6 million per quarter, with associated costs around $5 million per quarter over Q4 2020 and the first half of 2021, which we will also continue to exclude from our non-GAAP figures. Throughout Q3, we observed progressive recovery in demand across the U.S. and Europe. However, a second wave of coronavirus could lead to renewed lockdowns, posing challenges such as limited customer site access for installations and decreased consumable utilization due to disruptions in certain laboratories. On a non-GAAP basis, Q3 gross margin was 51.5%, compared to 51.8% in Q3 of the prior year. Q3 2020 gross margin included a 190 basis point negative impact attributable to our HD-1 trade-in program. Our non-GAAP gross margin excludes the effects of the nonrecurring Abbott license agreement and RADx Phase I award as well as non-cash acquisition-related purchase accounting adjustments from the 2019 acquisition of Uman. This gives investors an accurate period-to-period operational comparison. We believe there is significant potential for gross margin expansion as we shift towards higher-margin consumables and Accelerator services, scale our overall business and reduce product costs. On a GAAP basis, our Q3 gross margin was 67.2%, favorably impacted by the Abbott license agreement and RADx grant compared to 47.1% in Q3 last year. Our GAAP operating expenses totaled $18.8 million in Q3 2020, while non-GAAP operating expenses, primarily excluding nonrecurring costs tied to our RADx grant revenue, amounted to $17.5 million. During Q3 2020, we raised $91.4 million in net proceeds through our public offering, and cash usage was restricted to $7 million through proactive working capital measures. Our balance sheet remains robust as of September 30, with approximately $173 million in unrestricted cash. Overall, we are very pleased with our Q3 2020 performance and the progress made on our strategic priorities. We are focused on continuing our recovery towards a strong growth trajectory for the remainder of the year, despite the challenges presented by the ongoing pandemic. With that, I will hand it back to Kevin.

Kevin Hrusovsky, Chairman and CEO

Thank you, Amol. I would like to close on Slide 50 to illustrate that we have an incredible employee group and a robust ecosystem of thought leaders, along with many investors who have supported us in creating demand by working with numerous pharmaceutical companies to help create opportunities for drug approvals in the pipelines of many of our customers. This slide shows that we are primarily a research business today—over 95% of our revenue comes from this research side—which eliminates real regulatory or reimbursement risks. We feel this provides a solid foundation for creating value for investors and a great backstop. However, we have also been calling it an aspirational opportunity to migrate into diagnostics. COVID has provided us with a showcase opportunity, allowing us to help the world, and demonstrates what our technology can accomplish as we expand into various disease sectors. We see a significant market opportunity, as outlined, and believe we are establishing a new category with our sensitivity in proteomics. We have been successfully penetrating this market, projecting a $1 billion TAM today with significant growth potential. We are better connecting DNA and RNA to protein, creating a map of how proteins overlap with disease triggers and environmental factors. Nineteen of the top 20 pharmaceutical companies have now deployed our technology. Thousands of drug trials spanning Phase I, II, and III have been run using our products, with nearly 1,000 peer-reviewed publications validating our technology. As we look at penetration opportunities, we see a significant potential in consumables. We've made substantial investments in our products and aim to continue advancing our sensitivity further. We also have an incredible Board of Directors with a proven track record of commercializing disruptive technology. With that, we’d like to open the floor for any questions.

Operator, Operator

Thank you, sir. We have our first question from Puneet from SVB Leerink. Your line is open. You may ask your question.

Scott Mafale, Analyst

Hi, Kevin, Amol. This is Scott Mafale on for Puneet. Thanks for taking my question.

Kevin Hrusovsky, Chairman and CEO

Sure, Scott.

Scott Mafale, Analyst

Kevin, I’m sure you saw the initial positive stance from the FDA on aducanumab from the recently released briefing documents. I was wondering if you could comment on how this might impact the pace of new trial starts in neurology more broadly and if you believe it will encourage the use of neurology assays such as Nf-L and pTau in these trials?

Kevin Hrusovsky, Chairman and CEO

Yeah, great question, Scott. Obviously, this has been a very challenged landscape for the past 10 years, trying to get an Alzheimer drug across the goal line. When we entered four years ago, we brought the hope of objective markers versus the subjective markers. The FDA created guidance about three years ago under Scott Gottlieb to have biomarker guidance to recruit patients with pre-cognitive impairment. If you could validate that a biomarker was clinically relevant, it could help support your data. I’m intrigued by this advance; it appears that pTau-181 in CSF has shown a nice correlative effect, suggesting that higher doses can reduce pTau-181 in CSF. We see an opportunity for this to create excitement around trials using less invasive measures. We're seeing a more vibrant pharmaceutical base due to this news, offering downstream opportunities for trials. This reveals a moment of potential resurgence for the amyloid thesis. While we can't predict sustainability, if a drug is approved, it could evolve be similar to MS where therapies become more individualized, leading to opportunities for markers such as Nf-L to validate drug efficacy. Overall, this news enhances interest and excitement for our technology.

Scott Mafale, Analyst

That’s very helpful. I want to move my second question on the RADx program. It was great to see you guys move to Phase 2. I was just wondering if you could describe the next steps in the process and any timelines you could provide. Where do you expect the product to fit into the current testing paradigm for COVID-19?

Kevin Hrusovsky, Chairman and CEO

Sure. We feel honored to have been discovered by the NIH, evolving our relationship rapidly. The initial feasibility study showed promising data, leading to an investment to scale our antigen assay capabilities. We're working to improve our ability to run multiple sample types and potentially target asymptomatic cases. Accurate testing is critical, especially for asymptomatic individuals who may carry the virus unknowingly. We're committed to scaling up but will proceed cautiously. The timeline is aggressive, with plans to launch research assays soon which will assist in understanding the status of the virus more accurately. We aim to create endpoints for drug trials and improve overall testing reliability. Our team is dedicated to advancing this as quickly and safely as possible.

Scott Mafale, Analyst

I have one more question. On HD-X, can you update us on the instrument upgrade cycle? Should we expect reacceleration of placements as academic customers return to labs? Do you still aim to convert about 50% of your HD-1 customers?

Kevin Hrusovsky, Chairman and CEO

Absolutely. Q2 posed significant headwinds, and we cannot predict developments with the virus. However, we still foresee strong demand for HD-X, especially as labs adapt post-COVID. We remain focused on new sales in research and potential diagnostic applications. Amol, could you elaborate on trades versus new purchases?

Amol Chaubal, CFO

When we do trade-ins, we offer instruments at a discounted rate, which will drive better reliability and increased utilization over time. While gross margins may temporarily dip during trade-in cycles, it is still an advantageous long-term decision. We anticipate continued interest in trade-ins through Q4 and into the first half of 2021.

Operator, Operator

Thank you, sir. We do have another question from Chris from Cowen. Your line is open. You may ask your question.

Chris Lin, Analyst

Hey, Kevin and Amol, thanks for taking my questions. This is Chris on for Doug today. I apologize if you addressed this during your prepared remarks. We’re juggling about eight earnings calls this afternoon. First, could you follow up on the HD-X? I recall you targeting 75 HD-X and SPR-X systems this year. Is that still the plan? Are there any bottlenecks in terms of instrument shipping and installation?

Kevin Hrusovsky, Chairman and CEO

In general, Q2 presented major challenges, and we're concerned about the potential impact of the virus moving forward. Overall, the targets we outlined pre-COVID seem achievable, given new opportunities that have presented themselves. Amol, do you want to touch on that?

Amol Chaubal, CFO

Yes, Chris, you are correct to note that we projected 75 HD-X and SP-X systems. Those targets remain in our sights and closer to 50% of our installations transitioning to HD-X by year-end, given a stable operational environment.

Chris Lin, Analyst

Great, thanks! Moving on to Abbott, what timelines have you committed to concerning product development and commercialization? How much of that falls in Abbott’s hands versus yours?

Kevin Hrusovsky, Chairman and CEO

While we have not disclosed specific details, Abbott is highly motivated by our Simoa technology's potential. The partnership will lead to deploying this technology in new form factors in the future. Importantly, establishing our foothold in the market validates our approach.

Operator, Operator

Thank you, sir. There are no further questions on the line. I'm turning the call back to Mr. Chaubal. Sir?

Amol Chaubal, CFO

I’ll pass it back to Kevin to close our call.

Kevin Hrusovsky, Chairman and CEO

Sure, thank you so much for your engagement with our team today. We truly appreciate the support from our investor group. We look forward to further discussions about our performance and story. We’re committed to growth and feel honored to help make a difference in this space. Stay safe, and we will talk soon.

Operator, Operator

Ladies and gentlemen, this concludes today’s conference call. You may now disconnect.