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Healthcare - Biotechnology - NASDAQ - US
$ 0.051
-15 %
$ 99.5 M
Market Cap
None
P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2021 - Q3
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Operator

Hello, and welcome to the Quantum-Si Q3 2021 Earnings Call. My name is Boben [ph] and I will be coordinating your call today. [Operator Instructions] I will now hand you over to your host, Juan Avendano, from Quantum-Si Investor Relations. Juan, please go ahead. .

Juan Avendano Vice President of Investor Relations

Hello and thank you for joining us today. Yesterday, after market close, Quantum-Si released financial results for the third quarter ended September 30, 2021, and provided a business update. The release is available on the Investors section of the company's website.

Joining me today are Quantum-Si's Chief Executive Officer, John Stark; and Chief Financial Officer, Claudia Drayton. During today's call, we will be making certain forward-looking statements within the meaning of Federal Securities laws.

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated. Additional information regarding these risks and uncertainties appears in the section entitled forward-looking statements of the earnings press release.

For more complete risk and description of risk factors please see the company’s filings made with the Securities and Exchange Commission. The company disclaims any obligation to update any forward-looking statements. During this call will discuss certain financial measures that are not prepared in accordance with U.S.

Generally Accepted Accounting Principles or GAAP. reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the earnings press release. As a reminder, this call is being webcast live and recorded. A replay of the event will be available on the company's website following the call.

I would now like to turn the call over to John..

John Stark

first, attract industry-leading talent to expand all areas of the organization, including product development and commercial operations. Second, solidify our supply chain to secure product inventory and manufacturing scale and profitability over the next several years.

Third, accelerate early access placements to finalize platform configuration, performance and application. And finally, expand utilization of our platform ecosystem through industry and academic collaborations. I would now like to expand on our progress in each of these areas.

Starting with our first objective on organizational expansion, in the quarter, we made strong progress in expanding the team, attracting top talent across the industry. The company now has over 150 employees across established operations in Connecticut and our facility in San Diego, which opened in Q3.

During the quarter, we made critical hires to accelerate commercial readiness within product development and operations.

We are proud to have a number of seasoned individuals join our team, including Gray Williams, Vice President of Global Operations; Matt Anstett, Head of Clinical and Pharma Market Development; and Juan Avendano, Vice President of Investor Relations, all bringing knowledge and expertise in the life science tool space.

In San Diego, we started staffing the facility in September with key leadership, joining the team such as [indiscernible], leading Product Development and key staff members with biomarker development, single molecule and application development expertise. We plan to expand the San Diego facility to over 50 individuals as we head into 2022.

I would also like to thank the four catalyzer [ph] leadership and support organization for allowing Quantum-Si to grow and expand on campus since 2013. In the first half of 2022, we plan to relocate our headquarters to a nearby state-of-the-art campus in New Haven that will allow us to expand and accelerate company-wide efforts.

The combined campuses in California, Connecticut will be the cornerstone of growth for both research and development and commercial operations. Our second objective is to secure our supply chain and product inventory. In relation to this, our operations team has placed advanced orders to secure components for more than 500 platinum systems.

Working with our contract manufacturer, we have purchased materials to support our internal needs and anticipated commercial demand heading in 2023. Pilot manufacturing is complete and commercial builds are in progress. We are confident in our ability to manage instant inventory demand for the foreseeable future.

Taking into a count increased production lead times by some of our vendors, we've also ensured capacity for all chip production phases for internal and commercial demands heading into 2023.

As a result, we have secured the ability to increase our chip production volumes by 50% to over a thousand units per month, heading into 2022 to ensure supply chain requirements are met.

In addition, we are pleased to announce that Quantum-Si has acquired all assets of Majelac Technologies, a provider of semiconductor packaging and integrated circuit assembly services located in Garnet Valley, Pennsylvania.

This is a strategic move by quantum SI to not only secure assembly and packaging capabilities, but also to accelerate our ability to scale up operations for future chip design. We've worked directly with the Majelac team for several years and have always admired their high quality and speed at meeting supply demands for the company.

Michael Quinn, CEO of Majelac, will be joining Quantum-Si and continue working to scale production capacity in excess of a 100,000 package chips in years to come. We are pleased to welcome the entire Majelac team who are joining Quantum-Si to continue in their previous roles.

As it relates to kitted [ph] reagents, we feel confident about our supply chain and ability to scale. Many of the components in the protein sequencing kits are proprietary to a large degree. And we have de-risked our production efforts by working with multiple vendors, providing chemical synthesis and protein purification capacities.

While Quantum-Si is equipped to assemble and manufacture kits internally, we will be transferring kit packaging externally to a global contract manufacturer in Q1 2022, in order to allocate internal capacity to accelerate development programs. Our third objective is to expand instrument placements, to accelerate commercial readiness.

As we announced a few weeks back, the company has now expanded its early access program to ten external sites. This is a key milestone for the company and critical for expansion and development of applications and workloads for protein analysis.

Over the last several decades, the scientific community has been limited to viewing the proteom at the known protein levels, similar to how genomics advanced from the tens of thousands of known genes to greater than three billion bases.

Single molecule protein sequencing can enable advanced understanding beyond the estimated 20,000 proteo forms, but potentially millions of variants in modifications that play a role in the cause in treatment of disease.

Quantum-Si specifically has engaged key thought leaders across target markets and application areas that represent tremendous growth in future utilization. As outlined, our key target disciplines are biological discovery and research, clinical and therapeutic biomarker development in multi omic applications.

Early access participants quoted in our recent announcement highlight the areas of application of our platinum system. And the problem they're looking to solve are expand understanding.

The goal of Quantum-Si’s commercial strategy over the next several years is to enable the groups to explore new dimensions of biology and partner with us to expand the capabilities of the system. This approach further enables the tens of thousands of users that utilize both traditional proteomic and tools and next generation DNA sequencing platforms.

In parallel to the open platform of pro approach, we are on a path to enable instrumentation, kitted content and analysis tools that allow investigators to routinely monitor essential mechanisms in cell behavior that indicate early onset or recurrence of disease.

Millions of individuals annually are diagnosed with cancer or immunocompromised stage for which we currently have limited ability to assess at early stages. Over the next decade key advancements in detection and therapy are expected to improve general health.

We are committed to working with our partners and end users to provide the tools to advance these efforts. The commercial team has visibility to thousands of potential placements spanning across users of central proteomics scores, next-generation sequencing DNA benchtop users, drug development organizations and future clinical testing labs.

The key capabilities that will drive system placements begins with the accessibility to a benchtop instrument that streamlines both sample workflow and analysis.

This coupled with the power of time domain sequencing, Quantum-Si delivers unprecedented resolution and sensitivity by sequencing single molecules of protein to analyze peptide and direct immune acid changes. As stated, this increases the visibility of the biology that occurs in a cell, which is currently limited to less than 2% of true activity.

Our fourth objective is to expand utilization of the ecosystem enabled by the platform. Our initial focus will be on two areas. The first to develop clinically relevant assays, focused on identification and measurement of post-translational modification.

And second, to optimize content to drive high volume applications and single molecule detection assays. The goal these efforts will be to partner with drug development in clinical research groups to eventually drive the implementation of routine monitoring.

Key external partners had voice that there is a huge demand for technologies that can deliver enhanced accuracy, sensitivity, and time to result. In many cases, such as in the treatment of lung cancer, patients are put on kinase inhibitors that can result in successful treatment initially.

However, future modifications and protein structure can cause the activation of alternatives, key signaling pathways resulting in the recurrence disease. The ability to recognize translation of modifications at low frequency is a potential method for identifying these activated pathways at early onset by routine monitoring post-treatment.

Similar to what drove the routine adoption of next-generation DNA sequencing, we believe that focus content can meet the high-volume routine utilization.

Moving from simple protein identification to individual amino acid sequencing, can unlock advanced content insights, much like targeted panels that are done with genomics in the areas of cancer and inheritable disease.

Given this, we are related to be working with key opinions leaders to define and prioritize actionable content and performance specifications in areas such as immunocompromised states.

In parallel to our internal development programs, we're also accelerating our efforts to create an application ecosystem around our platform through external partnerships.

Few specific examples I would like to highlight are, ESPCI in Paris was recently able to self-install platinum instrument and quickly generate data, validating our protein sequencing technology. Our development teams have been working closely with ESPCI in the University of Wollongong, to create new proprietary and scalable barcoding approaches.

Similar to the barcodes utilized in sample multiplexing or single-cell tagging, this novel barcoding approach utilizes kinetics as oppose to biologically attached oligo strands, and has the potential to enable applications such as single-cell proteomics. In September, we announced the development partnership with Protein Evolution, Inc.

a private company utilizing proprietary technology in the field of proteomics. In this collaboration, we intend to create new classes of affinity reagents for use on the platform to support the development of focused content and assays.

Much like an antibody these affinity reagents will serve as the front end to our sample preparation workflow to enrich key proteins of interest. Our ultimate goal is to enable customers to develop custom panels for their own targets and to commercialize high throughput content from the monitoring and characterization.

Quantum-Si will continue to drive novel applications targeting high growth markets and leveraging our unique time domain sequencing approach in collaboration with our partners. We're very grateful for the active engagement of our early access program thus far, and look forward to updating you on progress over the next quarter.

I will now turn the call over to Claudia to review our financial results.

Claudia?.

Claudia Drayton

Thank you, John. Hello everyone. Let's discuss now the details of our Q3 financial performance, including a high-level spending outlook for the next few quarters. Total operating expenses in the third quarter of 2021 were $25.2 million, an increase of $16.6 million from $8.6 million in the third quarter of 2020.

Operating expenses decreased sequentially in Q3 from Q2 levels. Recall that in Q2, we recorded one-time transaction expenses related to our merger with HighCape. Research and development expenses for the third quarter of 2021 were $11.1 million compared to $6.7 million in Q3 of 2020.

As John mentioned earlier, we are continuing to hire employees in all areas including R&D. In addition, our spending also reflects important investments we're making with our suppliers.

Sales and marketing expenses were $1.1 million for the quarter, compared to $0.3 million in the third quarter of last year, while general and administrative expenses for the third quarter of 2021 were $13 million compared to $1.6 million in the same period last year.

The increase in expenses is driven by higher headcount as we continue to build our team and extend this related to being a publicly traded company. Net loss for the quarter was $18.1 million compared to a net loss of $8.6 million during the same timeframe in 2020.

Adjusted EBITDA was a loss of $17.5 million in the third quarter of 2021, compared with a loss of $7.8 million in Q3 of 2020. We have provided tables to reconcile adjusted EBITDA to GAAP net loss in the earliest press release. We had $500.2 million in cash, cash equivalent in marketable securities as of September 30, 2021.

We have a strong cash position that allows us to continue investing in our business and to prepare for commercialization. In the next few quarters, we expect to continue investing in hiring personnel.

Hires will be mainly in R&D and sales and marketing as we continue to advance our technology and to scale for our anticipated full commercial launch in 2022. Accordingly, we expect operational spending to continue to grow sequentially in the next few quarters.

In summary, in as John highlighted in his prepared remarks, our early access program is off to a strong start as reflected by the higher-than-expected number of partnerships we have executed so far.

We are also encouraged by our progress in ramping up operations and proactively executing supply chain initiatives to support our manufacturing and commercial readiness. As a result, we reiterate our key milestones in long-term financial targets.

We anticipate commercial launch of our system in 2022 and expect a combined carbon and platinum installed base of over 5,000 instruments by 2025, with an average selling price of about $50,000 and annual consumables pull-through of over $45,000 per unit in a long-term gross margin target of over 70%.

With that, I will now like to turn the call back over to John for closing remarks.

John?.

John Stark

In Q3, we made significant progress on our core foundational goals and accelerate all phases of commercial efforts. We are encouraged by the enthusiasm within the scientific community as we move from known protein confirmation to resolution at variant and structural level.

In our view, this is what reflects true biological activity within the cell, and what can eventually be leveraged by the clinical community to advance how to detect and treat disease at earlier stages of progression.

We are well-capitalized to fulfill our mission with over $500 million on the current balance sheet and are ready-to-compete for market leadership in the field of single molecule protein sequencing in proteomic analysis. Thank you for your time today, and I will now turn the call over for questions..

Operator

Thank you. It is now time for Q&A. Our first question comes from Kyle Mikson from Canaccord Genuity. Please Kyle, go ahead..

Kyle Mikson

Thanks. Hi, John and Claudia. Hope you guys are doing well? Congrats on the progress so far, really sound encouraging especially the kind of the targets there, I think, you kind of neat over the long-term. I do just want to ask those since we're approaching the year end.

If you could just tell us if the 500 plus system placement number you previously laid out for next year is still the right way to think about the near-term forecast. I know you shored up the inventory sounds honestly on that front, but just given some of these shifts supply shortages will that affect station needs to be reduced? Thanks..

John Stark

Hey Kyle. Good to hear from you. Thank you for joining the call. Just to confirm the 500 platinum systems we have gone in process in placing that order and we're starting to receive instruments as we speak. So that would more than fulfill the 2022 revenue mark for platinum. And as far as chips, I think we addressed that during the call.

Strong relationships with our foundries not only current supply, but development of future chips and obviously with the acquisition of Majelac really gives us control now over the packaging, as well as supply to our customers. So, we're feeling very good about where we're at this point..

Kyle Mikson

Perfect. Thanks for that. And obviously demonstrating reproducibility is obviously a critical end point for this early access program.

From what you've seen during the program with ESPCI et cetera, are you tracking in line with their expectations for this early launch? And I guess what challenges have you seen so far and what – like issues of users faced in the early stages?.

John Stark

Yes. No, another great question. So, first of all, reproducibility is one of the key aspects, actually take a step back.

Really the first focus especially going out to 10 is to make sure that we cannot only deliver install and train 10 sites and that'll all be accomplished at least by the end of the year, if not by the end of this month for those 10 sites. As far as reproducibility, we're very thankful for these sites.

I'd actually be confirming data that we have generated internally just to show equivalent. So that has gone very, very well so far.

As far as are concerned, I mean, what we're facing now in early access programs and why you do them is because now we're looking at specific applications, right? We mentioned quite a few during the press release and during the narrative that we just gave where customers are looking to barcode single cells, right? Not only for interrogation of proteins derived directly from a B-cell, but also in OHS, Oregon Health Science Centers case, they are looking at neurological tissue.

So, one of the things is that where did these customers to actually optimize that approach. Those are some of the challenges and make sure we can specifically interrogate the proteins of interest..

Kyle Mikson

Got it. And as you kind of worked through this, this program and you see the data you being generated. I am just curious what improvements you want to make the Platinum, and I guess Carbon too, before you launch.

I'm thinking like, what needs to be locked down really assay throughput increasing the number of immune acids you want to detect, that'd be helpful to hear it.

And I guess just related to this, how many individuals for the commercial team or the salesforce are you targeting, heading into the launch?.

John Stark

Yes. Sure. So multiple questions there. So, let's start with the last one as far as commercial team. So right now, we've been able to build up the marketing team, which is very focused on voice of customer, as well as application. Obviously, it started hiring specialists that are going to be targeting pharma or the clinically oriented applications.

That's also going to be bringing forward some of the field application specialist. And we'll build that team in the first half of the year and that will be projected in our budgets.

And your first question you asked before that?.

Kyle Mikson

Basically, the improvements to the platform before you launch one needs to be kind of locked down still?.

John Stark

Yes. It really encouraged Kyle, the performance of the Platinum system and the workflow thus far. I mean, I can't say that we were 100% confident that we'd be able to bring sites up in a month. But we've effectively been able to do that in train. So that gives us a lot of confidence in our ability to scale.

And that's why we moved forward with the 500-instrument order from our contract manufacturer going forward into next year..

Kyle Mikson

Perfect. And just move on to biopharma, obviously a powered user of the main proteomics technology is certainly going to be an important partner for you early on.

Just wondering if you could talk about your progress at biopharma so far, just wondering if you are confident in some of those companies will be early adopters, and you could kind of give us any feedback thus far from the end market, they'd be really helpful as well..

John Stark

Yes. And first, I already confirmed that biopharma in industrial accounts will be part of the early access program.

Unfortunately, we don't have the rights to disclose them and typically when you're working with pharma in later stage, say biomarker development, implementation and the clinical research stages, a lot of times that information is kept confidential, but I can confirm that we're already working with them.

There's a number of assays that we are considering at this point in time specifically focusing on content that could be used for inclusion, exclusion trial criteria.

One example that we gave is post-translational modification, right? There's about believe right now, there's about four key thoughts relation events that occur at the amino acid level that could predict 80% of reoccurrence of lung cancer.

This is a high interest to pharma and just a simple assay; with just four markers the reason we can do that so effectively is because we are looking at single molecule resolution and able to detect that at the individual peptides and amino acid level. And that gives you absolute frequency.

So, these are assays that we're going to be working on in partnership with pharma, we will be doing the internal work ourselves..

Kyle Mikson

Okay.

Related to that, have you confirmed her ability to kind of elucidate those PTMs or are you still kind of working on that?.

John Stark

We've shown data in the past where we've been able to demonstrate being able to pick up phosphorylation. I believe some data was disclosed here a few months ago, showing tyrosine – by tyrosine event and then phosphorylated tyrosine event, but that is a dedicated program that we have, right now how about the San Diego..

Kyle Mikson

Okay. Yes. No, that sounds good. Let me just ask one more before I hop off about Protein Evolution. I just wanted to ask if you could kind of walk through the decision to collaborate rather than I guess, merger acquire Protein Evolution.

Just given the fact that PEI is a 4Catalyzer company and just reminded of the merger between high-profile and Liminal, which I still believe it's pending. Generally, there seems to be some solid synergies between you guys and proteomic solutions.

So just wondering if you can kind of walk through why you're so excited and also, and John, I think this is kind of an important question if it's going to – if these reagents will be kind of integrated into carbon..

John Stark

Yes. Great question again. And first of all, the team at Quantum-Si, we have a strong Protein Evolution team, right? Developing recognizers and cutters for our core programs in protein sequencing. What PEI actually brings to the table is expertise I'm working with infinity reagents, which is not something that we're developing necessarily internally.

So, it allows us to really scale our plans as we go out for that expansion of the ecosystem, while the internal team can still focus on the core technologies and the core platforms; so that's how we see it..

Kyle Mikson

Okay.

Will it be integrated into carbon or standalone basically?.

John Stark

We have the opportunity for both. We can use affinity reagents, and again we're not disclosing the actual exact structure, but it can be used for targeted protein assays, which can be incorporated in the carbon, or we can use them for the future development of recognizers..

Kyle Mikson

Got it. Okay. Awesome. Well, thanks so much..

John Stark

Kyle, one thing I do want to stay on that too is there obviously PEI's collaboration that we're very excited about. We obviously have other opportunities to develop out content as well as recognize our development. So, there are other partnerships that we haven't announced at this stage..

Kyle Mikson

Perfect. Sounds promising. Well, congrats guys. Thanks again..

John Stark

Thanks Kyle..

Operator

Thank you, Kyle. [Operator Instructions] Thank you. This concludes our Q&A session. Thank you for joining today's call. I will now pass you back to Juan for closing comments. Thank you..

Juan Avendano Vice President of Investor Relations

Well, thank you all for listening on your participation today. We look forward to updating you on our progress in the next quarterly earnings call. Have a good day..

Operator

Thank you everyone. You may now disconnect your lines..

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