Good day, and welcome to the Accelerate Diagnostics Second Quarter 2022 Earnings Call. All participants will be in listen-only mode. Please note that this event is being recorded. I would like to turn the call over to Ms. Laura Pierson. Please go ahead..

Before we begin, it is important to share that information presented during this call may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.

Forward-looking statements include projections, statements about our future and those that are not historical facts. All forward-looking statements that are made during this conference call are subject to risks, uncertainties and other factors that could cause our actual results to differ materially.

These are discussed in greater detail in our annual report on Form 10-K for the year ended December 31, 2021, and other reports we file with the SEC. It is my pleasure to now introduce the company's President and CEO, Jack Phillips..

Thank you, Laura. Good afternoon, everyone, and welcome to our second quarter 2022 earnings call. On today's call, we will discuss our exciting new partnership with Becton Dickinson, our second quarter financial results and other consequential developments from the quarter of which there are many.

This morning we announced an exclusive global commercial partnership with Becton Dickinson. The combination of BD's leadership position in my microbiology and our innovative products will deliver immediate commercial synergy and strategic value to both companies.

I will detail the terms of this arrangement, our rationale for entering into it, and it's many benefits later in my prepared remarks. The second quarter's financial and product development results were consistent with our expectations.

In addition to strong revenue growth, we made meaningful progress in product development and took another consequential step to improve our balance sheet. Before providing additional detail on our progress during, I would like to hand it over to our Chief Financial Officer, Steve Reichling, to review our second quarter financial results.

Over to your steve..

Thank you Jack, and good afternoon every one. Our net sales were $3.9 million for the quarter and $6.8 million year-to-date. This compares to $2.8 and $5.3 million from the same period of the prior year. This represents growth of 39% and 28% over these periods respectively.

The strong and accelerating growth resulted from steady increases in recurring revenues and positive contribution from capital revenue deals struck in the second quarter. Cost of goods sold were $2.8 million for the quarter and $4.9 million year-to-date resulting in gross margins of 28% for the quarter and year-to-date.

This compares to cost of goods sold of $1.7 million and $3.4 million and gross margins of 38% and 37% respectively during the same periods in the prior year. The decline in gross margins resulted from continued inflation to production costs and other factors.

Selling, general and administrative expenses excluding non-cash stock based compensation expense were $8.9 million for the quarter and $16.5 million year-to-date. This compares to $7.7 million and $15.8 million for the same periods in the prior year.

These increases were the result of higher commercial activity in the quarter, which drove higher costs in areas like travel and commissions. Non-cash stock based compensation expense in SG&A was $3.2 million in the quarter and $5.6 million year-to-date compared with $5.2 million and $11.2 million from the same periods in the prior year.

Research and development costs, excluding non-cash stock based compensation expense were $6.2 million for the quarter and $11.9 million year-to-date. This compares to $4.4 million and $8.6 million for the same periods in the prior year.

These increases were the result of ramping investment in our next generation Pheno development program to finalize and produce instruments for assay development. Non-cash stock based compensation expense in R&D were $500,000 for the quarter and $900,000 year-to-date compared to $1.3 million and $4.1 million for the same periods in the prior year.

Our net loss excluding non-cash stock based compensation expense was $13 million for the quarter and $24.2 million year-to-date. Our GAAP net loss was $17 million for the quarter and $31.2 million year-to-date, resulting in a net loss per share of $0.22 and $0.43 respectively.

Net cash used was $13.6 million for the quarter and $26.8 million year-to-date excluding cash flows from financing. We ended the quarter with cash and investments of $36.8 million. This morning we announced a financing of approximately half of our outstanding debt convertible debt.

This transaction took approximately $50 million of convertible debt that was due in March of 2023 and converted it into a 35 million term loan due in five years. This effectively extinguished 15 million of our debt and pushed the balance of 35 million out for five years.

This term loan has no cash interest due during the term and includes 15% warrant coverage. This leaves approximately $56 million of the original $172 million convertible debt outstanding. We continue to work with our advisors and remaining debt holders on strategies to resolve this debt prior to maturity.

Finally, we announced a global commercial partnership with Becton Dickinson. Among other financial benefits that will be discussed later in our prepared remarks, this deal included a $15 million upfront license fee. This fee is to be paid over the term of the agreement with the first $3 million due to us in the third quarter.

We also anticipate closing on a previously announced insider financing round of $4 million in the third quarter. I will now hand it back to Jack to review our second quarter results in greater detail.

Jack?.

Thank you, Steve. I will quickly cover our second quarter commercial and product development results and then turn to our partnership with Becton Dickinson. In the second quarter, we continued to see global conditions for selling our products improve.

This is the result of less pandemic impacts and increasing attention on the growing problem of antimicrobial resistance. This positive trend was evident in the high number of customer meetings and funnel additions during the quarter. We are also starting to see these leading indicators translate into higher rates of contracting and revenues.

That said, hospitals and their laboratory staffing remain affected by the pandemic. Record turnover and resulting high vacancy rates throughout the hospital is negatively impacting our degree of access and relative priority within the hospital.

While we have streamlined the processes for selling and implementing both Pheno and Arc, the involvement of key decision makers, lab staff, and even hospital IT departments is required and remains a hurdle to higher rates of adoption. In the U.S., we contracted eight new Pheno instruments and brought another six Pheno instruments live.

We ended the quarter with revenue generating installed base of 316 Pheno instruments and a backlog of 78 Pheno instruments pending implementation. We also contracted 15 Arc evaluations and advanced our growing sales funnel of prospective Arc customers.

These evaluations span a range of customers, including notable institutions like the Cleveland Clinic and Cedar Sinai. Customer feedback has been quite positive and several of these customers have moved from evaluation to contracting. Lastly, as U.S.

hospital patient mix normalized, we saw recurring revenues rise above pre-pandemic levels, signed several existing customers to long-term contracts, and contracted several new customers to capital revenue deals. In EMEA commercial progress remained steady.

We added several new contracted and clinically live customers and grew our annuity per customer year-on-year. These factors contributed to global revenue growth, which exceeded our internal forecast for the quarter. Our product development teams had a similarly productive second quarter. They achieved all key product development milestones.

This included obtaining regulatory approvals necessary to commercialize Arc outside of the U.S. ahead of schedule. EMEA is a substantial MALDI market and therefore a large opportunity for Arc. Additionally, we continue to make very good progress on our next generation AST platform.

We expect instruments and consumables from our final designs to be available shortly for formal assay development. We anticipate conducting clinical trials in 2023 and are targeting a U.S. launch in 2024. As a reminder, the next generation Pheno will have a total diagnostic solution for all susceptibility testing in a single integrated platform.

This will bring larger instrument annuities at a higher gross margin for Accelerate. Earlier today, we announced the formation of an exclusive global commercial partnership with Becton Dickinson. BD is the global leader in microbiology and continually evaluates important market trends.

A recent market study identified micro labs are looking to process time sensitive samples faster with less resources. As a result, BD ran a competitive process, evaluating several emerging tech technology companies and identified accelerate as the partner of choice. This is a strong validation for our products and capabilities.

Our innovative rapid diagnostic solutions or meaningful additions to BD's diagnostic portfolio. Through Pheno BD is adding their first rapid antimicrobial susceptibility testing capability and through the combination of Arc and Pheno, BD is adding two ways to offer rapid identification testing to its customers.

Either integrated with their MALDI install base through Arc or through ID AST test kit on Pheno. These product additions come at a time when large microbiology players are aligning with innovators in this space.

For example, earlier this year, the number two player of microbiology, BioMérieux acquired a pre-revenue rapid AST company, Specific Diagnostics after their commercial partnership. For Accelerate there are three principle drivers for joining forces with BD. First, to significantly improve our commercial reach, both in the U.S.

and abroad; second, to improve our selling effectiveness by combining offerings with the BD suite of products' and lastly, to collaborate on future innovation. We believe this partnership will translate into greater market penetration resulting in higher sales while lowering spend and leading to an improved balance sheet.

Before I review each of these drivers in detail, a few words on BD. BD has global annual revenues in excess of $1.1 billion in microbiology. They have thousands of customers spanning most countries globally. Nearly every clinical microbiology lab in the world uses at least one of their products.

Their product portfolio spans the entire traditional microbiology workflow from sample collection to clinical decision support solutions. And when compared to other large microbiology players, they have the broadest portfolio of products.

Accelerate considered other partners and determined BD to be the strongest potential collaborator, given their scale reach and the degree to which our products complemented their existing portfolio. The first driver for entering into this agreement is to expand our global commercial reach.

Becton Dickinson has the largest direct sales force in microbiology. In the United States their sales force is 4x the size of Accelerate's. Their broad coverage allows them to call on every microbiology lab in the country.

Under the terms of the partnership, BD will be the exclusive sales agent for Arc and Pheno supported by a focused team of Accelerate product specialists, leading to a much improved sales approach. The new structure will allow us to immediately reduce our sales and marketing costs and transition this large fixed cost into a variable one.

Substantial reductions in sales and marketing spend will be realized starting in the fourth quarter of 2022 with a full year's benefit in 2023. Outside of the U.S., the expansion of global coverage is even more profound. Currently we are in 18 countries in Europe and the Middle East.

BD is a global powerhouse with over 50% of its revenues coming from outside the United States. BD has some 200 direct sales reps in EMEA and a large logistics and distribution network. Given recent regulatory approvals for Arc, BD will have a broad license to sell Arc and Pheno across much of its large global network.

The second driver for entering into this agreement is to improve our commercial effectiveness. Beyond the multiplier effect of having more sales reps selling Pheno and Arc, we anticipate close rates and improved deal economics with BD. Commercial effectiveness will improve throughout better stakeholder access and product synergy.

Looking at improved access, BD has the benefit of a large existing customer base for promoting Pheno and Arc largely to the same stakeholders. In addition, their brand and importance to the hospital lends instant credibility and affords higher levels of priority.

Regarding product synergy, the Pheno and Arc are highly complimentary to BD's existing products. Let me illustrate a couple of practical examples. For Arc, BD manages a very large global install base of MALDI systems. ARC was designed as the perfect companion for MALDI simplifying its existing workflow and dramatically improving its time to result.

With BD's substantial install base of microbiology solutions, the Pheno ID AST can be paired with both Phoenix and back tech to manage clinically sensitive patient samples. Also these bundles of diagnostic tools will become stickier through incorporating our products into the BD Synapsys microbiology information management solution.

Integration with Synapsys will be a priority work stream as part of our broader integration plan. And the third driver for entering this partnership is to collaborate on future product developments. Within the agreement are mechanisms to leverage BD's clinical, marketing, operational, and R&D resources.

The opportunities for mutual benefit here are numerous. With the deal now executed, we are turning our attention to integration plans. We anticipate launching products officially through BD in the U.S. at the start of the fourth quarter of this year. It is expected that launches in EMEA and other ex-U.S. regions will follow in subsequent quarters.

Given this integration timeline, we anticipate positive impacts to contracting and reductions in burn rate to first be seen in the fourth quarter. Benefits leading to higher revenues aren't anticipated until 2023.

Accordingly, we are maintaining our annual revenue guidance of $13 million to $14 million and are expecting to come in below our burn guidance of $44 million to $55 million for the year. We see potential for significantly improved customer contracting, higher revenues and materially reduce cash burn in 2023 and beyond.

In summary, this is a very exciting quarter for Accelerate and certainly one of the most notable in the company's history after two very challenging years where the pandemic had a dramatic impact on the hospital selling environment, we are turning the corner.

Our partnership with Becton Dickinson is a strong validation of our product strategy and comes at a time when the hospital selling environment is improving. We are firing on all cylinders in R&D with new products like Arc-to-cell and our game changing next generation AST platform in the wings.

Our balance sheet position improved with the restructuring of half of our outstanding debt and has the potential to improve further throughout higher revenues and lower costs from the BD partnership. I would now be happy to answer questions from our analysts.

Should others on the call, have questions not addressed we would welcome you to send those questions or request for a follow up meeting to investors@axdx.com. Thank you..

Great. Good afternoon, everyone.

This is Connor on for Alex, first off congrats on the BD agreement, I think that's great and I appreciate all the color, but I guess just starting high level, could you speak a little bit more about the cadence of how the agreement will play out, like more specifics on the current integration activities underway and through the second half of the year, and just kind of what the roadmap looks like for the next six to 12 months? And then just as a second part of that question, could you provide kind of any more granularity on how the economics of the deal work for sales?.

Yes, sure. Just so we can tag team this, I'll take the first part and then have Steve talk a little bit more about the economics, Conner. So I guess first and foremost, this is something, this is a courtship that's been going on for a while. This agreement comes after almost a year of good hard work together by both companies, BD and Accelerate.

And so as a result, I would say that even ahead of this agreement signing we've started working on integration plans together.

We've had several meetings on this very topic and I'm happy to say even like next week, for example, we'll have the senior leadership from BD here in Tucson for a full day and a half of meetings and to really start getting our commercial plan ironed out executed and launched. So I would say overall it's going very, very well.

What to expect over the next six to 12 months, we expect over the next quarter to really come together in finalizing our commercialization plan, getting everyone trained, getting systems in place and effectively launching this partnership. And as I indicated, doing that by Q4 in the U.S.

and hopefully shortly thereafter in other countries outside the U.S. And then, overlooking beyond starting into next year, I mean, we're really excited to see a potential kick up in the amount of activity that we have based on the things that I highlighted access and commercial effectiveness, et cetera.

We expect to see much greater funnel productivity, much more rapid progression through the funnel and then the ability to bring customers live more quickly..

And from a mechanism perspective, the way that we structure this deal with BD is that they, as our principal sales agents in the market will generate leads in new business.

We will have a process to addend those new deals into our contracting system in concert with BD and we will ship product and recognize revenue consistent with our current revenue recognition practices. So therefore all the revenue will flow to Accelerate directly. And then we will pay on a percentage of revenue generated basis, a commission to BD.

Those commissions have a scale. So there is a target level that's established within the agreement and there is a lower rate paid for achievement below that target and then there is a kicker paid for achievement above that target..

Sure. That makes perfect sense. I appreciate the color there.

The next, like I -- could you just give us an overview of Becton, Dickinson’s current microbiology offerings? I know you offered a little bit in the prepared remarks, but it looks like they have an existing ID/AST instrument, cell blood culturing, et cetera, just some more color on how they're expecting to integrate Pheno and or Arc into their pitch?.

Sure, thanks. So first of all Becton, Dickinson's been in microbiology for many, many years and they've earned the number one spot in microbiology for good reason. They have a tremendous portfolio of products, workflow solutions and a fantastic team of sales and support people and provide just tremendous customer experiences and customer satisfaction.

So their portfolio really they're an end-to-end company. I mean, even before microbiology they're a leader in sample collection. They're a leader in blood culture systems.

They're also a very important part of their portfolio is the MALDI portfolio, which they are a distributor for Bruker of, and then they have a very successful business as you mentioned Connor in susceptibility testing. They have very large market share and susceptibility testing..

Kiestra:.

From a front end standpoint in areas like MALDI, where MALDI is one of the best solutions on the market today, it is very, very well established in microbiology, but there's a major drawback and it's very slow for identification of organisms, it takes several days complimenting that very good solution with Arc is really an opportunity to change how MALDI testing is done globally.

With Arc we can produce results in about 72 minutes, spot a MALDI plate and run MALDI to get an identification. It's simply transformative. And then on the back end where BD is well established in susceptibility testing, they still recognize a GAAP in their portfolio, which is rapid susceptibility from positive blood cultures.

That is not something they offer today. And it will be with Pheno, both ID AST and PhenoAST, it will be a tremendous compliment to the Phoenix platform for customers that are looking for addressing those critically time sensitive results more quickly..

Got it. No, that makes perfect sense. Sounds like a great fit for Arc and Pheno just a quick one bouncing off that, I know you said, they have about 4x the amount of reps targeting microbiology labs than Accelerate.

Could you just put a number to that and how many reps do they have calling on the microbiology labs?.

Yes, I don't want to put an exact number to that because I may be off one or two. But it's a, it's again, one of the -- it's one of, if not the largest commercial teams in microbiology. And they have also a well-established corporate accounts team, as you would imagine, a support team and multiple specialists that our team will be integrating with..

Got it, wow makes perfect sense.

And then just you spoke to, kind of the long lasting staffing issues still dealing with them, but any more color there, like, does it seem to be getting any better at all? And I mean, just kind of, what are your expectations on the staffing side in the second half?.

Yes, I think past couple quarters they've continued to improve. They've continued to stabilize, and I would say, I mean, this is all going to stabilize over the future. I mean, this is an area of healthcare and an area of really just work in general that was one of the, the hardest hits area of the pandemic and it's going to recover.

We're starting to see people while they're changing jobs or leaving the industry. New people are being hired. New people are coming in and with that comes the ambition to take on initiatives to improve and transform these critical areas of diagnostics and healthcare.

And so with that, we're seeing actually starting to see, new energy where people are joining new healthcare institutions and methodically going through opportunities to improve microbiology, to improve how critically ill patients are treated and that's where more and more programs are coming into play.

And I would say the other thing that we're seeing is the stewardship programs that were largely disbanded during COVID are also starting to come back and be a big part of health systems, which is very helpful because those have been key stakeholders of ours as we automate with rapid ID and AST..

That's great. That's perfect. Jack, Steve, thanks for the updates and again, congrats on the great quarter here and progress..

Thank you, Conner..

Thank you. Next question will be from Brian Weinstein of William Blair. Please go ahead..

Hey guys. Thanks for taking the questions and congrats as well. You talked a lot about the BD deal.

One thing that wasn't mentioned there was how this impacts the commercialization of Pheno 2.0? What rights do BD have for that product and should we expect them to be marketing that when it comes out or will there need to be some additional considerations when that product gets submitted or becomes available commercially?.

Yes, thank you, Brian. I appreciate the question. And so let me start by saying, first of all Pheno 2 continues to make, we continue to hit major milestones with the program. It's going very well with our partners.

We're on track to have our first alpha units that we'll be able to start full on assay development with here in the coming month and it continues to progress.

The second clear point that I'd like to make is that I'm pretty certain that we would not have a partnership with BD if it wasn't for the fact that Accelerate is thinking beyond Pheno and Arc and really delivering and focused on delivering innovation into the future.

Absolutely Pheno and ID/AST and Arc are absolutely important additions right now for BD and they're excited to start commercializing those products and helping their overall solution to be stronger and be successful with our products as well, but they are very interested in accessing our future innovation.

They will have an opportunity to do that in a number of ways. We will have an innovation council formed immediately that will involve the greatest R&D minds from their company and Accelerate. We will meet regularly to review the progress of Pheno 2 with them.

They will have agreed to provide guidance as appropriate and input as appropriate as they see it as well.

And then as we get closer to launch, as we get through clinical trials next year, and we start that, the opportunity for them to put Pheno 2 in this agreement is absolutely there and one that they're excited about and one that we'll be excited about when the time is right..

Okay, got it.

And then just to follow up on that, when you mentioned product development together in the script in coming together, is that really what you were referring to, or is there the possibility of additional products that you guys theoretically could be kind of working on in the background in trying to come up with is kind of a, I won't say combined entity, but with a common purpose..

Jack Phillips:.

Synapsys:.

Got it.

And, and then you talked a lot about that this deal will be allowing for you guys to be more efficient in your spending here, specifically in sales and marketing, but can you just talk a little bit more about that, any specifics around this? And then maybe with the kind of overall theme of how to be thinking about what this means for guidance, I heard the comment on the revenue side and at the lower end or below the cash flow burn rather, but as we think about kind of the new Accelerate teamed up with BD, how should we be thinking about things in 2023 and beyond, especially given the opportunity for reduced costs on sales and marketing?.

Great..

Yes. You hit on an important point. That was a big part of our modeling around this deal on a prospective basis. One of the things that will help us in the immediate term is to reduce our burn in marketing and sales, by shifting a lot of that to BD.

As Jack mentioned, we will still have a focused team of specialists to work with that team for optimal sales success. But even with that remaining team, we've actually concluded a restructuring already in anticipation of this deal that reduced our sales and marketing spend considerably.

And as we mentioned for lots of points of commercial synergies, so this will lead ideally to higher top lines, but also less spend. And what we've effectively done is turn sales and marketing into a variable cost instead of a fairly sizable fixed cost. So the commission is paid only for revenue generated through the BD channels.

So that's the first part, great opportunity to improve both top line and bottom line through this partnership. And then while we don't want to get into specific 2023 guidance at this point, we'll certainly be providing more information down the line on that.

We wouldn't have entered into this partnership if be these internal commercial forecast weren't in excess of our internal ones. And so we're expecting, really good things on contracting and revenue generation.

We even have some optimism around improved deal economics with perhaps higher capital rates and that should lead to a healthy guidance for top and bottom line for next year..

Okay. And then last one from me, as you mentioned funnel is growing nicely, obviously BDs going to be taking over significant commercial operations, but it sounds like you're leaving them with or handing over a nice funnel that is sort of built up.

Is there any kind of difference in the type of accounts that you guys were reaching on your own independently and that you are now sort of going to be handing over to BD? Is it just that the, the funnel is expanding nicely or are they bigger accounts? Are they different accounts from what you guys had seen previously? Just any kind of characterization on how that funnel stands as you kind of begin this partnership here?.

Yes, it's I mean, the first thing I would say is, is it's in general Pheno, ID/AST and AST the opportunities are growing there and a big part of that's driven because we launched again the AST kit last year in the height of the pandemic. And, we're just now having the opportunity to really kind of get going with the AST kit.

And so that kit is a better fit in some institutions, Brian, to your question. And so what we're seeing there is a different type of customer mix maybe more academic, larger, et cetera.

And then I would say that Arc is again another as I've talked about, it's a, it is a really fantastic workflow aid and the majority of our funnel, like 90% of our funnel for Arc and the evaluations that we signed, which is about 15 already are in accounts where we have no footprint whatsoever.

It's -- they're not Pheno customers today, they're brand new customers. So and then we'll be working as we go through the commercialization plan. First of all, our sales team will continue to drive these funnel opportunities because we don't want to lose any ground whatsoever.

And then as we get to a point of integration, then we'll start to hand over these opportunities and work together with BD to close them. And then I think lastly, we're real excited about the funnel exponentially expanding in a pretty short period of time based on again, the incredible footprint that BD brings to microbiology..

All right. Well, thanks for all the questions. Congrats on the deal..

Thank you, Brian..

Okay. Thank you, Brian. I think that's it for all the questions today from my side, I just want to thank everybody for the support of Accelerate Diagnostics. I want to thank you for tuning into the call today.

I think in closing just a couple comments from my side, first of all the market we play in has been and continues to be a very sizable undressed market in microbiology. There's about 300 million ID/AST tests performed globally. Most of these tests are performed on legacy platforms of about 20,000 legacy platforms that are out there today.

And very few aside from the Pheno offer an opportunity to really address those critical specimens, those specimens that need answers immediately as soon as possible. And that's what Pheno does. That's what Arc will do in MALDI to bring rapid identification and susceptibility to a very important space.

It's really not a matter of if, but a matter of when this market will be converted. I mentioned there's a lot of other activity in this space. People are paying attention to rapid identification and susceptibility and microbiology because it is an important need to be addressed.

And that's why we have this great partnership, that we're embarking on today with BD.

And then the last thing I would say about BD is as someone that's been in diagnostics for 30 years now, I've known Becton, Dickinson for that long because they've been in business for many, many years, as we know they're an, a company – they're a company with impeccable values.

They're a company that has an incredible culture fit to Accelerate Diagnostics. If you looked at our culture and their culture, it's a tremendous fit. We have a lot of history together as a company based on our work and microbiology, but also our leadership as well.

We have significant leaders with an Accelerate that spent many years at BD and we have a lot of mutual respect and trust already heading into this relationship.

And then I mentioned today about the tremendous synergy of our product portfolio for our customers, the patients that we serve, this is a real opportunity to change the game, to change things up in a very, very positive way that has an opportunity to have dramatic impact on patients, customers and do it in a much quicker fashion.

So with that, thank you very much. As I said in my prepared remarks, we're happy to answer any questions that may not have been addressed today if you connect investors@axdx.com. Thank you very much. Bye-Bye.

Thank you for attending today's conference. The presentation is now over. You may now disconnect..