Thank you, Operator. Good afternoon everyone, and thank you for joining today's call.

With me today is our President and Chief Executive Officer, Doug Bryant, and Randy Steward, our Chief Financial Officer. Our second quarter 2020 earnings release is now available on ir.quidel.com, our Investor Relations website.

We will also post our prepared remarks on the Presentations tab of our IR website following the conclusion of this call, on July 30th, for a period of 24 hours. Please note that this conference call will include forward-looking statements within the meaning of Federal securities laws, including our anticipated revenues for Q3 2020.

Forward-looking statements by their nature involve material risks, assumptions and uncertainties. In particular, our expectations and assumptions around the impact of the COVID-19 pandemic on our business, results of operations and financial condition and that of our suppliers, customers and other business partners are uncertain and subject to change.

Many possible events or factors could affect our future financial results and performance, such that our actual results and performance may differ materially from those in the forward-looking statements. For a discussion of such factors, please review Quidel’s most recent annual report on Form 10-K, including the section titled Risk factors, registration statements and subsequent quarterly reports on Form 10-Q, as filed with the SEC.

Furthermore, this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, July 30, 2020. Quidel undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call, except as required by law.

Today, Quidel released financial results for the three and six months ended June 30, 2020. If you have not received our news release, or if you would like to be added to the company's distribution list, please contact me at 858-646-8023.

Following Doug's comments, Randy will briefly discuss our financial results. Then, we’ll open the call to take your questions.

I’ll now hand the call over to Doug for his comments.

Thank you Ruben, and good afternoon everyone. Thank you for joining us today.

I hope that you and your families are well and safe. These times have certainly been challenging for everyone.

Despite the country's efforts to deliver more testing, there is still a considerable backlog for sample processing, especially in central labs, accounting for the long period of time between sample to result, typically taking between 5-7 days. Obviously, getting a COVID-19 test result a week later is not helpful, and not conducive to the test and contact trace process that is needed to flatten the curve and reduce the healthcare burden that we are seeing in hotspots across the country.

And so, we believe that expanding access to affordable, highly accurate and timely diagnostic testing is the key to flattening the curve. At Quidel, we're doing our part to help address the need for COVID-19 testing in four ways: first, using our Lyra and Lyra direct molecular tests to help remove the sample bottlenecks in highly complex laboratories with established testing infrastructure; second, by offering a fast, front-line test with best-in-class accuracy at the point-of-care to our traditional and non-traditional channels; third, by securing our supply chain and scaling up our test manufacturing and distribution for both our molecular and rapid tests by over 100%; and fourth, by developing multi-analyte COVID-19 test panels to help diagnose co-infections, rule-out flu and other illnesses, and increase overall test manufacturing scale.

Before we get into the quarterly results, I'd like to say that we're proud of what we as an organization have accomplished in such a short amount of time. Over the last quarter, our people, a good portion of which are still working from home, have shown the positive, nimble, can-do spirit that is the hallmark of Quidel's culture, and together, we are doing our part to help provide answers to the most vulnerable.

Quidel's second quarter results largely reflect the collective efforts of our people and offer a glimpse of what our company is capable of achieving, even in the midst of a pandemic. Consistent with our pre-announcement, revenue for the second quarter of 2020 was $201.8 million, driven by growth in our Rapid Immunoassay and Molecular categories as a result of higher sales for our COVID-19 products, which totaled $109 million in the quarter.

We saw good demand for our 2 PCR assays, which received EUA in March and May, and very strong demand for our Sofia Antigen rapid point-of-care test, which received EUA in May. Importantly, we were able to satisfy some of the need for RT-PCR testing in highly complex labs by ramping up the manufacture of our Lyra assay to approximately 500,000 tests per week.

As some of you might recall, our Lyra assays can be run on several thermal cycling platforms, including the ABI 7500 Standard, the ABI 7500 Fast, Qiagen’s Rotor-Gene Q, the Roche LC480, and QuantStudio7Pro, which allows us to be very helpful to customers who may prefer sample to-answer methodologies but may not always receive the volume of reagents they require. We expect this trend to continue, seeing increasing demand through the end of the year.

Demand for our Sofia rapid antigen point-of-care test continues to be strong, sustained, and frankly, more than we can satisfy. At the moment, customers are ordering a multiple of what they had expected as the product's outstanding performance is enabling an expansion of use-cases for the product.

Since receiving the first EUA for an antigen test in early May, we have been on allocation, partially fulfilling customer orders even as we continue to ramp up production to the levels we had forecasted. We anticipate continued growth over the coming months and are actively working to increase our manufacturing scale by expanding facilities, hiring additional personnel, and asking more of our supply chain.

During the quarter, we also made good progress with our product pipeline, especially as it relates to diagnosing COVID-19. Currently under development is our Sofia Serology assay that we believe could provide better clinical utility than the current tests in-market.

Also under development is our Sofia Influenza A+B and SARS Antigen rapid point-of-care combination test, which will provide healthcare workers with all three results. Because the assay uses the same manufacturing lines as our Sofia flu and Sofia Antigen tests, the combo test can potentially increase our manufacturing capacity, especially as we enter into the crucial winter months, when the potential for co-circulating SARS-CoV-2 and influenza could further strain our healthcare system.

Additionally, we are collaborating with BARDA to develop a 4-analyte Sofia rapid point-of-care test that includes Influenza A+B, SARS Antigen, and Respiratory Syncytial Virus (RSV) that we believe could help in addressing the nation's testing shortage at the point-of-care. All key non-COVID product development projects have remained ontrack.

We plan on submitting 510(k) packages for Sofia Strep98 and C. Difficile to the FDA in the fall.

With respect to TroponinTru, our hstroponin product, we continue our discussions with the FDA, and are designing a clinical strategy for our clinical trial, which we expect to start before year-end. Regarding Savanna, work continues on the instrument, with the first trial planned for early next year.

Regarding the Savanna cartridge, we plan to complete a high-volume cartridge evaluation in mid-August, using the six assays that are part of the near launch menu. Goal of the study is to receive final proof that the performance of the cartridge with integrated assays is optimal.

Industrial design for user interface cartridge features is to be completed by end of August. On the manufacturing side, cartridge high-throughput production and assembly automation lines are under development, with the first automated modular manufacturing and assembly lines expected to be operational by November 2020.

With regard to the Savanna instrument, we're assembling 19 prototype builds that will very closely resemble the commercial instrument by means of functionality, performance, size and appearance. Once the instrument performance is evaluated, minor refinements will lead to the prototype version, which will be used during the clinical trials.

So in summary, the Savanna instrument and cartridge development activities are continuing according to schedule. In summary, Q2 was another typically productive quarter for us, augmented by significant demand for our COVID products, which is terrific in terms of our financial performance, but at the same time, we recognize the difficulty all this growth is creating for analysts trying to model revenue and EBITDA over the next few quarters.

Historically, we've not provided quarterly or annual guidance, but the variability in forecasts and expectations suggests that a revenue floor that reflects a high confidence of achievement might be useful. Therefore, based on the current demand for our antigen test, good visibility in our ordering patterns for our Lyra SARS-CoV-2 assays, and assuming minimal supply chain disruptions, we are confident that third quarter revenue will be at least $375 million.

In all, we had a strong quarter, and are confident in our business outlook. Through the hard work and perseverance of our 1,300 people across the globe, a good number of which are still working from home, we are well-positioned to change lives for the better by access to highly accurate, affordable diagnostic testing to our communities.

We are proud of what we've accomplished thus far, and look forward to contributing to the re-opening of our country Randy?

Thank you, Doug. Good afternoon everyone.

As Doug stated, we had a very strong quarter that exceeded even our own key performance metrics. We will continue to keep focused on servicing our customers, ramping up our production capacity as diligently as possible, investing in future product development while continuing to utilize our cash wisely.

As we reported earlier today, total revenues for the second quarter of 2020 were $201.8 million, as compared to $108.3 million in the second quarter of 2019. The 86% increase in revenue was driven by significant demand for our products that diagnose COVID-19.

This revenue growth was partially offset by declines in demand for the Cardiometabolic and Specialized Diagnostic Solutions product categories. Foreign currency impact was minimal, at $0.6 million in the quarter.

Rapid Immunoassay product revenues increased $58.8 million to $80.6 million in the second quarter of 2020. Within this category, Sofia products grew $63.6 million to $75.2 million due to $56.3 million in Sofia SARS Antigen sales.

QuickVue product revenues decreased $3.9 million to $5.0 million. For the total Rapids business, 70% growth in Influenza was offset by reduced demand for Strep A, down 60%, and pregnancy products, down 48%, due to decreased office visits associated with the COVID-19 pandemic.

The Influenza Rapid Immunoassay revenue was $15.8 million, with approximately 86% of that revenue derived from the Sofia platform. For the Cardiometabolic Immunoassay business, revenue was $54.2 million, a 20% decrease versus the second quarter of 2019.

In constant currency, the decrease was 19%. Of the $54.2 million in Cardiometabolic revenue, $28.2 million were derived from the Triage business, and $26.0 million from the Beckman BNP business.

The revenue decline was realized in all three major geographies, as patients with chest pain either would not or could not visit traditional testing centers as a result of the coronavirus pandemic. We believe this downward trend should improve over the next several quarters.

Revenue in the Specialized Diagnostic Solutions category decreased 18% in the second quarter to $11.8 million. Our Molecular Diagnostic Solutions category increased $51.0 million in the quarter to $55.2 million, driven by $52.7 million in sales of our Lyra SARS-CoV-2 product, which was granted EUA by the FDA on March 17th, and our Lyra Direct SARS-CoV-2 product, which was granted EUA on May 18th.

Total Influenza revenue, which includes Rapid Immunoassay, DHI Respiratory and Molecular Diagnostics, grew 44% in the quarter to $18.7 million. Gross Profit in the second quarter of 2020 increased $89.6 million to $148.8 million, driven by the demand for the SARSCoV-2 assays, which drove improved product mix.

In addition, higher volumes contributed to increased manufacturing overhead absorption. Gross profit margin in the second quarter of 2020 improved to 74%.

In the quarter we realized a significant improvement in our profitability profile. Over the short term, we do not incur material variable operating cost increases, thus in quarters where we realize significant revenue and gross profit growth, we see a large portion of the gross profit roll into operating income.

In the second quarter, our total operating expenses measured as a percent of revenue declined by 17 percentage points versus last year to 32% percent of revenues, helping improve our operating income in the quarter to 41% of revenues. We see this trend continuing into the third and fourth quarters as well.

We are increasing our R&D spend this year as we continue to invest in additional covid-19 assays, our Savanna project, new Sofia assays and next generation platforms, such as our internally named project Sniffles. We will also continue to invest in our S&M organization as we expand our customer base and profile.

For the full year, we are currently estimating our R&D spend to be in the range of $70-$75 million. Our G&A spend for the full year should be in the range of $60-$65 million.

As it relates to the provision for income taxes, we recorded $12.5 million in income tax provision in the quarter, and the effective tax rate was 16%. From the federal statutory tax rate of 21%, the difference in the effective tax rate was primarily a result of discrete tax benefits recorded for excess tax benefits of stock-based compensation.

We are currently estimating a full year effective tax rate between 21% and 22% due to the increase in pre-tax income versus prior years. As of the end of June, we had $72.6 million in cash and cash equivalents.

During the second quarter, the company generated almost $60 million in cash flow from operations. This number would have been even larger had it not been for the approximately $43 million investment in Accounts Receivable and Inventory as we accelerate our growth and ramp to support increased production of SARS assays.

In the quarter, the company also invested $7.5 million in capital expenditures. In April, we made the third annual Abbott payment of $48 million, and now have $136.0 million remaining on the deferred and contingent consideration that will be paid over the next 3 years.

Also in the quarter, we repurchased approximately 247,000 shares of Quidel stock for $42.2 million. We have no outstanding balance on our $175 million-Revolving Credit Facility, and only $13 million remaining in Convertible Bond Debt, maturing this December.

In short, we have minimal debt, access to credit, and good cash flow, which places us in a good position to support our future initiatives. Those initiatives include increasing our R&D investment, strengthening and expanding our supply chain, ramping up our manufacturing capacity, and pursuing M&A.

And with that, we conclude our formal comments for today. Operator, we are now ready to open the call for questions.

This is Andrew on for Brian. Maybe we can first start with the guidance for the third quarter.

Hi, Doug. The guidance for the third quarter and the assumption sort of behind the COVID revenue that's built into that.

So first I guess I want to clarify that this floor only includes to two currently approved our EUA products for COVID? And then I guess bigger picture how should we’d be thinking about the build in terms of the production capacity ramp through the quarter any bulk orders you have and then in pricing for those products?

Where do I start?

A lot there, right?

Yes. So what was the first piece of the question, Andrew that was on…

The COVID revenue associated with…

Yes, so we have three EUA products it's a little confusing because two of them are Lyra product here’s the kits that requires extraction and then there's the direct kit and now there is the Sofia SARS antigen. So that the Q3 forecast does not include COVID products beyond that.

In other words, it doesn't include the serology product or the combo product. And then capacity…

Does it –you want to talk about the capacity?

Yes. That’ll be great.

Okay. Well, without revealing things that our competitors would like to know, we said before that our theoretical max capacity with our current plant and equipment is 1.8 million tests per week, about 7.2 million tests per month, managing the supply chain to achieve that up was consistently is the variable and is difficult given the timing of delivery of all components that we need each week.

Therefore, the likelihood of achieving that level on a consistent basis is not super high, of course, at least not at this time. Our output is highly dependent on receiving all components and shipments of certain items have been quite inconsistent.

Although I will say that it's getting better due largely to our activities to vertically integrate a number of those components. And that's all I can say about that without teaching future competitors what they should be worried about.

And did have another after that, Andrew?

Yes. And it was just on pricing, whether that really being relatively in line with your expectations?

And is that what's factored in moving forward?

Pricing is consistent with the prior quarter. So, we have one price in the marketplace for our search engine product.

And that we believe enables an affordable product price as well and the reimbursement and also is a significant deterrent to shipping product ex-U.S. We do not believe that it is appropriate for us to price less than that ex-U.S.

So therefore, we have one price for US customers and very little product that has been shipped to ex-U.S.

And then, I guess maybe switching to the demand side of things and you gave some commentary on this in your prepared remarks, but maybe I guess can you be a little bit more specific in terms of what you're seeing for the underlying demand of the Antigen product. I guess what I'm trying to get to is really the idea of, if you weren't constrained by any sort of production capacity, what do you think your average weekly volume demand would be for the antigen product going into different channels?

Well, we've talked before about ramping up to our max opacity. We're in the process of doing that.

These last several weeks have been fine and have been closer to what we would have said before that we have hoped to be at this time. So we're in good shape from a manufacturing perspective of the pouch itself which contains the cartridge.

There are other elements to go on the kit and generally those are the elements that might cause durability from week to week. So as you can imagine, one week we can have super high amount of products were shipping out of the factory here and then next week, we could be slightly lower depending on the arrival of certain elements that need to go into the kit.

At the same time, we are manufacturing at a very high level, the actual kit set itself. So the kit set itself is the not that constrained, is the all the other elements that actually go into the kit.

Customer. Customer demand.

Yes. Customer demand.

At one point in time we had orders that were five times our capacity and, that softened a little bit, but we entered the market thinking that we were going to preferentially ship our customers who either already had Sofia or we felt that could use Sofia most efficiently and their practice in order to get testing them for healthcare providers and first responders. In other words people who knew had batch product and people run hire volumes that's where we started we went to those customers early on and less customers frankly had very little idea about how many tests that they actually were going to need.

So, these customers signed up volume of X and then very shortly after that ordered four times X. And so we had to ramp up to meet that.

So most of the products that we have shipping today is to our traditional customer base and some of those customers are new to us, but it's still in the same category. I would say if you're looking for a single area where it really has accelerate I would say in the Urgent Care segment in particular has gotten you know whilst if you will.

So, right now we don't have any inventory, Andrew. At the end of every day there is not, there is not a box, there isn't a kit on the antigen product.

On the Lyra side we have a little bit more flexibility and we have been trying to go a little bit of inventory although I would say that the commercial organization recently has been signing up a number of customers that are larger than our former customer and that disagreeing over the variability in terms of what we keeping inventory. Right now, we do have a little bit of inventory at the SARS for the Lyra products, but again that's not likely to last very long either.

So, the demand at this point if you added up what we’re able to do was our other competitor in the market says that you’re going to be able to do. And then you think that Abbott would be coming on board at some point in time soon, potentially by August or September.

I'm just making that assumption. And let's assume that their scale is better than ours because of the size of the company.

We had all three of us together, and we compare that with what the admiral says that they would like to have ship in September, and we still walk to demand. So, that's the current state.

And then last one if I can sneak in. FDA seems to be considering at-home testing a little bit more willingly right now.

So I guess the question for you guys is, can you play into that market via QuickVue? And if so, how should we be thinking about your market potential there considering the capacity?

Thanks.

Yes. I think what you're referring to, Andrew, is at-home collection then to be sent to - that’s I think what the FDA would be comfortable with based on what I'm reading.

Therefore, QuickVue would not be an appropriate product for that segment, because you're thinking that people are actually going to run the tests at home. The other factor we’re considering is that earlier on, we saw a pretty significant difference in terms of analytical sensitivity between Sofia chemistry.

In other words, fluorescence immunoassay. Andso the difference between those two products in terms of analytical sensitivity is about 2 logs in other words, Sofia relative to QuickVue on an analytic basis as to about 100 times more sense either.

And so therefore, we don't plan to enter the space where the colorimetric assay. We don't think that is, what we should be doing and we've determined that we will not be using QuickVue at this time and even ex-U.S.

I don't see why we would ship a product that we know is not as sensitive as the Sofia product.

Just kind of following up on Andrew's capacity question, do you that have control if you wanted to get through that 1.8 million test per week max capacity? The reason I ask is, it sounds like you're really constrained by outside factors here, but Becton, Dickinson just announced couple months ago, they just got $24 million by the US government to expand their capacity.

So if there isn't enough swabs or whatnot how could anyone really increased capacity on their own? I mean, aren't you pretty much dependent on outside suppliers at this point?

Well, if you're speaking about swabs specifically, we are looking at manufacturing our own and we have secured alternative suppliers and many - much of that volume is coming online this month. So we are taking things under our own hands.

One of the antibodies that we had been securing externally, we are manufacturing now and we'll do - we will have our own manufacturing, which will ensure that we do not have a shortage on that critical supply. So if we look at the things that are really important, which is - which are the things that are required in the cartridge, all of those things we have a great deal of control over.

The swabs were a concern because you had - we use a nasal Bond swab, we don't use the FOX swab that other people do. And so we were constrained by the amount that we were getting from one individual manufacturer.

We now have at least a couple of different avenues and looking at all that. So that - that really your question is, to my comment about vertically integrating key components.

Because we're not interested in just getting to the 1.8 per week, Alex, we're interested in line, seven, eight, nine and 10 which would give us another 200 million tests that we could manufacture by the middle of next year, right? And that's going to require a lot more swabs than we're ordering today.

So I'm not worried about getting the 1.8. I'm worried about getting $200 million a year.

And that's what we're working on. That's the game plan

That we're looking at. So short term, did we have some issues with swabs last month, yes, we did.

And we had kits waiting for swabs to be put in the kits. But then we were able to ship all that out and that was somewhat of a short-term fix.

I'm not worried about - again, I'll just say, this is redundant and I apologize, but we're not worried about getting to 1.8. We are worried about what happens when we go online with the next four automated manufacturing lines.

I got to feed that. That's what I'm worried about.

And then just head into the flu season here. Can you elaborate on the company's plans for distributing the combined COVID and flu test?

Is the plan really to switch over all the flu testing to a combined panel and then, just with the conversations you're having directly with HHS, more people within the U.S. government, and then also your distributors and providers.

Can you just elaborate how the U.S. government is really getting positioned to manage this upcoming flu season, because if they don't manage it properly I think we all know what the result is going to be.

Yes. First, I'll talk about the combo assay.

We've built a number of flu kits and I think that we have the ability for flu only if we want to, to ship millions of tests over the next couple of quarters for influenza. We are in reasonably good shape.

Now, if we had a very large flu season though, is what we worried about. Would we have the ability to supply the market in the event that anybody with flu-like symptoms is getting tested for both flu and SARS?

We worried about that event. So, having the combo assay enables us to reduce the incremental demand that we would have on flu product.

So again, we have inventory now of influenza only and of course, we're not building influenza right now, we're building SARS antigen kits. But we will, we hope - depending on clearance by the FDA, we will have the ability to flex to a combo product and because the ability to move in and out of products is reasonably quick, we think that we can react to whatever the market will require.

There is some speculating that the flu season will be light because of what we've seen in the southern hemisphere. May be, and if that's the case maybe the inventory that we have on hand already takes care of that, which is great because then we just manufacture SARS and we have no decrease in SARS antigen manufacturing.

In the event that I'm wrong and it's a bigger season then - then we still have the ability and we would ask customers to buy the combination product because we more than likely would not have much flu volume left, right? So that - that's sort of the game plan.

And because of the way we manufacturer, we have extraordinary flexibility.

Okay, got it. And then, just last question…

But you had a question about HHS. Right?

And…

Yes, if you don't mind, Doug.

Yes. I haven't had any conversation yet with anybody from HHS regarding influenza other than we did receive comment that they like the idea of having a combination product.

Okay, understood. Thank you.

And then just last question, just on the potential for retail partnerships either with grocery stores or pharmacies. I think we both think that it could be a good way of expanding tests out there, so people can get it quickly.

Can you elaborate on if these contracts, negotiations are taking place and really, what is the limiting factor to seeing an announcement? Is it a function of having enough inventory to launch the deals or is it more of a discussion around pricing and - and how they think about the economics in there, in that particular grocery store pharmacy?

Just any color there would be really helpful

Yeah. Early on, we had a new - a number of conversations with the folks that you're talking about and we would like to be able to shift the number of instruments that they would require in order to do what they want to do.

We've been on allocation, pretty much from the start of this process and we focused initially on making sure that in this first year of our traditional market segments, that we supply those customers first. So the folks that we have been working with understand that we because of instrument availability would not be able to meet their needs until the September time frame.

So all those customers, or are those potential customers still be around at that time, maybe so. There really hasn't been a discussions out your pricing question about price, I don't think it's - the price is actually the obstacle.

I think your reimbursement is appropriate to max of signed up for that, for that national limit at $45.23. Our products is priced well below that and I think it's affordable and appropriate.

So there's not been any discussion about price. The main thing is how many instruments can you get me and how quickly can you get them here.

We've had people ask us for 700 instruments, we've had people asking us for 350 instruments, 270 instruments

I saw an email a couple of days ago. That's - those are big commitments.

And then on top of that HHS, of course, asked us for 2,000. So our main constraint right now in terms of expanding beyond our current traditional customer is mainly the instrument.

So, maybe just first a modeling question. The third quarter forecast, looking for over $375 million of sales, can you just give us a sense for what that assumes for COVID sales, for Sofia and Lyra?

Sure. It assumes that we ship everything that we make for SARS antigen and it assumes that we begin to ship some of these larger customers that Rob Bujarski and the team are signing up.

So if you're manufacturing, you know, if it's a million Sofia tests per week at 20 bucks, I can use 250 million for a Sofia?

Yes. That's directionally - directionally good.

And then, I was curious just to build on this concept of the multiplex test. What commentary has the FDA and BARDA given you around what they're looking for in terms of performance for the flu AB, COVID, RSV, and does that - is that going to require a trial to bring that to market in the fall?

We are running studies currently and expect to be submitting sometime soon on that particular product. What we're seeing is product performance on the flu side almost identical, is what we saw in our standalone products and we see equally on the SARS side, we are seeing equivalent performance as well.

So assuming that we can find the samples reasonably quickly and get the numbers that are required, I don't see what difficulty we would have in getting an EUA. And I do think that not just our company but for others as well that the FDA would be receptive to the notion of combining some of these assays up to and including RSV as well.

So first we'll do a combo product including flu only A plus B plus the corona virus

And then later this year, we'll be moving forward with the assay that includes RSV as well.

You guys have a pretty high-class problem right now with all the cash generation from the COVID sales. So, I was curious if you could just walk us through your philosophy around how you're planning to reinvest that and thoughts around potential and likelihood of an appetite to do some M&A?

Well, first priority is of course increasing our capacity to manufacture, which will also include, by the way, an additional distribution center which Randy is in the process of negotiating currently. And that's the number one priority for cash.

Of course, we owe Abbott a payment every year as well, as we have said before, and then you're right, there is still a lot of cash left and we still have access to capital. So we do have the things in mind, we think that the world is going to change slightly moving forward.

How people access health care is likely to change and we're trying to think about what sort of acquisitions we would do that would help us learn more moving forward, and how we might take what we do very well and how that blends into a different world where - we have Telehealth, Healthcare IT, etc., and we're looking at some of those opportunities. Some of the other things that we were looking at before may be actionable as well.

But suddenly, although one or two of them looked quite good to us, they don't necessarily represent something as strategic as what I'm thinking about in terms of - what the healthcare world looks like moving forward. So we're trying to be thoughtful in our approach, we're not - the money is not burning a hole in my pocket, as my mother would say, and so we're going to do something that's - that's obvious and appropriate and we're not in a hurry.

If I can squeeze in one more on the new product side, this concept of home testing, Sniffles, would work pretty well right now. So if you could just give us a little bit more of an update around timelines for that and how the progress is going?

That would be great.

Yes, that is a great question and really, when you think of a - diagnostic testing at home, can you rely on the fact that the patient can actually do the whole thing by themselves. You know, with diabetes testing pricking a finger you're taking the sample, pretty straightforward.

But with infectious disease testing, it's not always so straightforward, I've got to get a good sample collection and then I've got to run the test properly and even though it's CLIA-waived is it really ready to be at home and tested in that manner? I think it might be.

I don't know that the FDA would agree with me, and the FDA is really concerned, I would guess, about in a low prevalence situation, can I run the test and what does a positive test results mean, etc. So here's my thought, that the first step has to be that we launch in a world where the physician is involved somehow, either in directing the patients to collect the sample, to have potentially front-end devices that make it almost impossible not to do the test properly.

So this is what we're thinking about, those are the investments that we're thinking about making. is how do you make it so the average person is not going to make a mistake and that they're going to get good advice from a physician.

So I just don't think it's going to be the world where I'm going to take a diabetes meter home and I'm going to test myself every day. I just, I don't think we're there yet.

That's my view, I could be wrong. So that's why we're thinking about what are the right strategic moves for us, what are the right things for us to be thinking about, so that we operate in this world where maybe there's something between - there's something between where we're at today and somebody buying something off-the-counter, taking it home, running it themselves.

So just my view, of course you asked, so I get to say it.

And just - Sniffles, where that stands, in terms of development.

Well, technically by the end of the year, we're going to have a product, the question is how long does the regulatory process take so that - so we'll begin studies early next year. I do think the guys would really like to start studies during this upcoming respiratory season, that - that's the goal.

I think they'll be ready, and then we'll have to worry about what the prevalence is out here. If the prevalence for the things we're looking for is high, we'll get through the - the studies quickly.

If not so high, then it will take a while. So I'm hopeful that we can get through all that in this upcoming respiratory season.

So real quick. On the - on the 375 guide, some of your competitors have suggested that there is going to be a bump, assuming return to work, return to school in Q3 and then a potential slowdown in Q4, or step down.

How do you guys think about - how do you guys think about that, do you think it's going to be like that or is it going to be more of a steady demand for your - for your COVID-19 tests?

No, we're seeing steady. Right now, again, I have a multiple of orders beyond what I can make and we're not even in the step up yet so - if there is a step up.

So I see for us that the demand again will far exceed what all of the manufacturers in the rapid antigen space can produce, for at least the next several quarters. And then I would imagine that just as we're thinking about expanding manufacturing, that the other two that I mentioned are doing it as well.

So, even with all of that, it is going to be a while until we can meet that demand. And if their schedule is like mine, that means somewhere during the middle of next year, we would have increased capacity, and then we can figure out do we test all 76 million school kids and how often do we test them.

Is it weekly? I don't know.

Are we going to be able to test for the dental community, right? We're not even going to get to that until we can get through all this other.

And so, in a nutshell.

Yes, okay. No, that makes good sense.

If I look at the categories of testing that could be demanded we're not even going to get to the - we're not going to even get to employee testing until - until sometime next year.

Right, right, yeah, that makes sense. And then - and it's a good problem to have.

On the - I know installed base doesn't really matter because yeah you're already selling as many kits as - and test as you can, but could you just let us know what the installed base for Sofia is because I can - I can imagine once people are at capacity that's going to be a differentiating factor. They have a very large install base there.

So if you could just get an update on Sofia

Yes. There is two factors there too.

It's a really good question. We're going to - we're about 50,000 analyzers right now and then Randy has said before that

We should be doing about 500 a week for a bit, but we're actually running a little bit favorable to that at the moment. So instead of 2,000 a month, we're closer to 2500 a month.

By September, we should be somewhere between 7,500 boxes a month to 10,000, depending again, in the supply chain, we got one element that we're trying to ramp up some people that are making a part of this instrument. If we can get that done we can - we can - we can potentially get to 10,000 faster than we thought.

But there is still to be done there. What was the other part of your question, Steve?

No, that was it. But, yeah, just - just to continue.

Could you just remind us how many RT-PCR instruments are out there, you know, the LightCycler and QuantStudio and ABIs that can run the Lyra?

I wouldn't, I wouldn't even be able to hazard a guess. If you're talking about - the hospital labs I could probably come up with a number, if you want to include public health it's again another tranche.

And then you have got all the folks that have all these instruments for the Life Science Research segment. We do see a little bit of a move of these labs that may have been doing sequencing or something else now acquiring thermocyclers in order to do COVID testing.

So your question is a good one. I don't know that there is anybody that can answer it for you there.

No, I haven't seen any Doug on that.

Okay, no problem. And then my last question real quick.

On the combo panels, do you - have you had discussions with the FDA? Is there a chance that they will have you do a 510(k) given that flu and RSV are already there, and you'd need a 510(k) for those or do you think they would make an exception and if it was a combo?

I think the fact that you've got and EUA product is there, regardless of whether the other assays are cleared or not by definition would make that and EUA. I have to confirm with my regulatory guys to be sure.

But my sense tells me this is and EUA which for most companies would be followed by larger dataset and more testing than was done on the EUA in order to get a 510(k). So this wouldn't be news to anybody.

I don't think there a diagnostic company that would not be thinking they're going to take their EUA product, continue to do testing in order to give us – in order to potentially get a 510(k) clearance, and also to look at other claims. For example, the idea of asymptomatic testing.

These tests when they first came out, were not authorized to be used in individuals who were asymptomatic, they were only in the product claim. In the meantime, the FDA has – in its FAQ a comment on that that says most EUA-authorized SARS coronavirus 2 diagnostic tests have been authorized for use in individual suspected of COVID-19 by their healthcare providers.

Individuals suspected of COVID-19 infection or exposure can be symptomatic, pre-symptomatic, or asymptomatic. Testing of any of these individuals is at the discretion of the healthcare provider ordering the test.

So theoretically, it doesn't matter. However, we're going to continue to do studies, and we are today, on this in order to potentially have a claim for asymptomatic.

So I think that's appropriate. But for a 510(k) we're going to have to have all of that right.

So I don't think there is an IVD manufacturer out there that's not continuing to do studies in order to seek other clients moving forward. Even though, we have this excellent guidance from the FDA on how the test could be used anyway.

Does that help, Steve?

Yes, it does. Yes, thanks, I appreciate all the time.

Thank you.

Thanks for squeezing me in, lot's been covered so maybe just one from me, but just as we think about the comments around vertical integration and bringing some things in-house. Is that an area I guess two things, actually.

One, is there any margin impact that you would call out from doing some of those things, whether immediately or sort of over the longer term? And then two, is that an area when you think about M&A, that you could do something that's maybe a little bit more sizable than what I know you're working on in terms of bringing in antibody production process in-house.

Just anything to help us think about, what you could be thinking about there would be great?

Yes, no thanks for the question, Andrew it's important that I qualify this. The things that we're looking at integrating into our supply chain are not high value items.

And so, the cost differential would not cause me to think I should go buy somebody that does that. Yes so I – it's not really super valuable sort of items that we're talking about here.

So, that would not be on our M&A list I hope that is what you were actually asking.

No, that is, and then I guess – just to add that, is there any sort of margin ramification from bringing some of these things in-house or to your point they are more, some of the almost commoditize-type products where there's not a big cost difference between what you can make it for and it's more about just securing the supply?

Yes, they're not significantly differentiatable. So therefore the cost delta is de minimis.

Yes as you said, it's more of the control of the supply chain, control of our own destiny to a certain degree.

Yes, we want to own it so somebody else can't come buy it.

Hi guys, this is [Casey] on for Tycho. Thanks for squeezing me in as well.

Yes maybe just a quick one on sort of any pushback you've gotten from contract negotiations in terms of quality of antigen testing as a whole. I know we've seen several reports from different places.

There's one specifically in Vermont, where they had I think it was 35 positive antigen test for COVID and when the reflects goes to PCR, only two returned positive? So maybe can you talk about any pushback you've seen and any sort of quality issues regarding antigen testing versus PCR.

And then maybe just a follow-up with that, can you comment at all about how you view reference labs utilizing pooling of samples as potentially being a competitive threat to antigen testing? Thanks.

Sure, first there have been a small number of potential false positives, but not necessarily a pushback. We haven't received any pushback.

What I would say is the number of false positives is very small actually in relation to the millions of tests that have been performed. With each of the customer inquires that we receive, we log them into our quality management system and we begin to work with the customer to determine a root cause.

The situation you're referring to in Vermont I can't quite comment because we haven't got to root cause yet. But even though the number of inquiries has been few in number and it's really not, it's not easy to comment because of the small numbers.

Thus far we have not determined that there are any problems once we've gotten to root cause that are related to the performance of the product. So not only are we in dialogue with the customer.

We are also in dialogue with the FDA. And at this point in time, there are no concerns whatsoever.

Regarding that in terms of pooling, I don't know how that really affects our business at all, because again the number of millions of tests being required is. And point of care segment where people want to test in 15 minutes is the – I don’t have the right word, huge doesn’t sound like a big enough word.

It's unfathomable what the demand looks like right now for a rapid point of care and gen assay that basically performs just like a PCR assay in most situations. So I don't see that the pooling will be an impact at all.

It will potentially help the reference labs though with clearing some of the backlog. I had a friend of mine call me this morning.

He was concerned that I wanted to get test. They were told they couldn't get up for 13 days well and could he find out where he is going to get one faster than that.

And so, I do think the pooling may have an impact, but I will tell you that I think that people are going to be concerned about sensitivity. Any time you take a sample and you dilute it, you are going to be having an impact on sensitivity.

That’s just the fact. So, if I were looking at it, pooling, I would be worried about sensitivity.

And the question is, do low-level positives matter? Does it matter, if you mess a low-level positive?

That's debatable. There are some people that say that those people are not infectious.

But I will have to say, I’ve heard from several others that they are concerned that people are thinking that. And that low-level positives actually matter, which frankly, that's a good thing, if you're a PCR manufacturer because you're saying that sensitivity does matter, right.

So, that's a tough one. That's a tough one, Casey.

Sure. All right I think we're at the end.

I haven't heard the operator say that we have no more time. But I will say thanks everybody for your support and your interest in Quidel.

We obviously had a good quarter. And we're in good shape to achieve our growth objectives over the next few years.

And not only are we working on COVID products and doing obviously quite nicely, but we've got Savanna which, if it weren’t for this, would be the thing that we would be talking about all the time. And we’ve got a number of Sofia products that we’re launching as well.

And then, gosh, what happens if we are the point-of-care assay in the United States with a high-sensitivity troponin. That could be helpful, too.

So, so long everybody.