Ladies and gentlemen, thank you for standing by. Welcome to the Quidel Corporation Second Quarter 2019 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, instructions will be given for the question-and-answer session. [Operator Instructions] I’d now like to turn the call over to Mr. Ruben Argueta, Quidel’s Director of Investor Relations. Please go ahead.

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 2019 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 August 8, 2019, for a period of 24 hours. Please note that this conference call will include forward-looking statements within the meaning of federal securities laws. It is possible that actual results and performance could differ significantly from these stated expectations. For a discussion of risk factors, please review Quidel’s Annual Report on Form 10-K, 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, August 8, 2019. 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 months ended June 30, 2019. 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 your questions. I’ll now hand the call over to Doug for his comments.

Thank you, Ruben, and good afternoon, everyone. For today’s call I’ll cover three topics, our financial performance for the second quarter, the status of products in development, and very briefly, as we’ve done in previous quarters, the status of the Danaher litigation. And as always, I’m happy to answer your questions as well, following Randy’s remarks. Regarding our financial performance, I’ll begin by saying that we had a solid, profitable quarter. We met our expectations. Total revenue was $108.3 million on a reported basis, up 5% over last year’s Q2. On a constant currency basis, total revenue was up 7% versus last year. Randy will walk you through the specifics on each of the businesses in a moment. I’ll just comment briefly on a couple of the key revenue drivers in the quarter. Clearly the prolonged influenza season was a tailwind. Many of you had asked what our expectation was for influenza test revenue in Q2. We said publicly that we certainly expected to exceed last year’s Q2 influenza revenue, which was $5.5 million, and thought that $6 to $10 million seemed like the right range, given our experiences in previous years. Total influenza revenue for the quarter was $13.1 million, driven mainly by influenza test sales on existing and new Sofia instrument placements. Our forecast was a bit off as we may have misunderstood the impact that the new Sofia placements would have. The other revenue driver I will comment on is the Triage Cardiac and Toxicology business. We had said that we were expecting $276 million in revenue for the year, not considering FX, which would mean an overall growth rate of just under 4%, driven by introductions in the back half of the year of the new toxicology panel globally and high sensitivity Troponin in Europe. We…

Thank you, Doug. Good afternoon, everyone. As Doug mentioned earlier today we reported total revenues for the second quarter of 2019 at $108.3 million. This compares to $103.2 million in the second quarter of 2018, an increase of 5%, and on a constant-currency basis, revenue increased a solid 7%. Rapid immunoassay revenue increased 30% from the second quarter of 2018 due to strong results from our Sofia franchise, which experienced growth across virtually all products. The largest rapid immunoassay dollar growth came from the Influenza category, up $6.2 million. Flu revenues for the rapid category was $9.3 million, while Strep A declined 9% and RSV increased 6%. The Strep A revenue decline was purely driven by fluctuation in distribution inventory levels. Rapid Immunoassay inventory and distribution is down 41% from the second quarter of last year and down 44% sequentially. More granularly, Influenza inventories and distribution are down 56% versus last year second quarter, and Strep A inventories are down 33% versus the second quarter of last year. For the second quarter, Sofia revenue was $11.6 million. This compares to $5.1 million in Q2 of the prior year. And QuickVue revenue was $8.9 million, compares to $10.1 million in Q2 of 2018. In the Cardiac Immunoassay category, revenue totaled $68 million in the quarter. This compares to $69.9 million in the same period last year. On a constant-currency basis, revenue was in line with last year. Within the category, Triage revenue was $36.8 million, a decline of 4% from the second quarter of 2018. Regionally, Triage saw revenue declines in the U.S. and to a lesser extent, Latin America and Asia Pacific, and this is partially offset by a 16% growth in China. On a constant-currency basis, Triage revenue was down 1% versus last year. On the Beckman BNP side,…

[Operator Instructions] Your first question comes from the line of Jack Meehan with Barclays. You’re now live.

Thank you, good afternoon.

Hi, Jack.

Doug, I was curious – I was wondering if you could – as you think about some of the new products you’ve rolled out, wanted to start with Lyme. I was wondering if you could parse out how much that contributed in the quarter. And can you talk about any success you’re having in cross-selling and utilization of other products as you push that?

In the quarter, I think the Lyme launch helped a lot with placements in Sofia. Right now, it looks like, on the contracts that we have in place, a little over 80% of the contracts include the Other Products Flu/Strep/RSV. So that’s been somewhat helpful, and we did see some sales of Flu/Strep/RSV in the quarter as I suggested earlier. But the real incremental growth will come as both patients and physicians become aware that the product is available. It is the world’s first CLIA-waived Lyme test. So it’s a big program that we have in place to create that awareness in order to stimulate the volume. We are getting contracts signed, but we need to get patients pushed to the places where there are Sofia 2s. We have had some success with urgent cares partnering there. We’re spending a bit of time, effort and money on our word-of-mouth marketing campaign in the Northeast. That’s taking off pretty nicely. We’ve also partnered with one of our key distribution partners in the Northeast to run a growth program as well. So I think we have both the physician side covered with our distribution partner and our salespeople, and then I think we’ll see increasing pull-through from a patient perspective as we create word-of-mouth over the next several quarters. So we’re not converting a market. We’re creating a market. So I’m trying to be a little bit patient, but we are seeing traction.

Great. Maybe moving to Savanna. Appreciate the updates and the confidence in the cartridge design. Just confirm, is the design officially frozen? What’s the timing for starting some of the clinical trials? And is that what’s assumed in your R&D, kind of step-up in the back half of the year relative to the first half?

Yes. The step-up is due to development on the instrument side, as well as clinical trials. So yes, we’re pretty confident. We’re down to a decision to be made very shortly on the final cartridge design. And from there, we’ll begin the process of increasing the number of cartridges that we’ll be making in advance of the clinical trial.

Do you think the trials start in the third quarter or more likely in the fourth quarter?

Fourth quarter, first quarter, yes.

Fourth and first. I think the important thing is the assays will definitely be ready to as long as we can get the instruments made and the cartridges made in sufficient quantities. We’ll be in good shape.

Great. And if you don’t mind one more. Can you talk about the initial demand with the toxicology launch and what commercial resources you’re putting behind that?

Well, I would have to say, since we’re shipping product this week, it’s -- that’s a great question but perhaps a little premature. But I can tell you that when I was at the AACC, where actually you and I saw each other, we did, I’m told, from our folks there in the booth, see a bit of traffic and interest in toxicology. As I mentioned on the call previously that we do think we have pent-up demand. We have a customer list. We know that, at least the initial way, we know where to go and who’s going to want the product. So I think it should go fairly according to our plan, and that’s important because there’s a number of drivers to the back half of 2019. That’s one of them. Obviously, I’d just add quickly the T2 launch in Europe, it’s important, continuing with Lyme. And obviously, we’ll see some pull-through with Flu/Strep in the fourth quarter, and that’s pretty important, too. So those are really the drivers of the back half back of the year.

All right, thank you.

Sure.

Your next question comes from the line of Brian Weinstein with William Blair. You’re now live.

Hi guys, good afternoon. This is actually Andrew Brackmann on for Brian. Before I get into my question, just one quick housekeeping one as it relates to the guide. Maybe I missed this. But Randy, did you confirm that $535 million target for the full year and then the $276 million for the Cardiac business?

Yes. I can answer that and then Randy will jump in with further detail if he would like to. But there’s no reason to change the forecast at this stage on the $535 million. The reason I say that is because it’s dependent on the new products. And we don’t have anything to either -- we certainly don’t have anything which tells we can’t do it. We’re just not shipping toxicology. And as I expressed before, we have a limited launch going on in Europe. In the fall, we expect the publication of that big study that I told everybody about called APACE. Remember, we had initiated the study with 2,000 patients, 6,000 samples. And in that study, we had hoped to demonstrate the fact that TriageTrue Troponin was actually a high-sensitivity troponin I product that performed comparably to the bigger boxes. So when we see that published in the fall, I would hope that that will stimulate even further growth. So I’ve got TOX, the growth -- and again, I don’t really know anything more about the fourth quarter at this stage in terms of Influenza. If we assume normal, then there’s no reason to adjust the $535 million forecast at this time. Same with the $276 million on a constant-currency basis, we’re pretty comfortable, but it can vary, depends on the TOX launch and troponin in Europe. So internally, we’re not changing our forecast.

Okay. Thanks for that. And then as it relates to the quarter on the Triage business, the U.S. still seemed to be a little bit soft and China a little bit faster. Anything that you can point to that specifically might be driving that? Thanks.

No. It’s not unexpected. As the customers run more and more BNP, often, they switch to a laboratory-based product. And so we expected some erosion in the U.S. And as we said before, we expected though to solidify that with the introduction of the new product, the toxicology product. Not really commenting yet on whether we think we can do -- that we can succeed with the introduction of T2 in the United States. That will clearly be upside. So that’s what’s going on there. And then of course, it’s being completely offset by what we’re doing in China.

Anything specifically that you can point to in China that might be driving that? Thanks.

Well, the Chinese people will tell you that there a lot of people there, with cardiac issues, and there’s growing awareness that using biomarkers to diagnose cardiac disease is the way to go. So there’s quite a bit of growth. The government’s spending a lot of money on chest pain centers. And so in every community, eventually, there will be a chest pain center where these markers will be performed and that’s another growth category. So just the population, the amount of disease, the government spend on the category are essentially what’s driving sales there, and we have a very competitive product.

And just from an operational perspective, we did cut out a middle tier distribution. So that had somewhat of a pickup on a year-over-year basis as well.

Your next question comes from the line of Bill Quirk with Piper Jaffray. You’re now live.

Great. Thanks, and good afternoon, everybody.

Hi Bill. Bill from Piper Jaffray.

That’s right. That’s right. It’s me. Doug, a quick housekeeping question. With respect to the APACE study, you mentioned that the reference methods would be the kind of typical bigger-box troponins. Could you just remind us specifically what the control is or the reference method is in that study?

The sample set that was used is the same sample set that has been used by all the major manufacturers of big boxes that have clearance in Europe for High-Sensitivity Troponin. So it’s the same patient with the same outcomes, same samples. So it’s -- the competitors actually -- those 2,000 patients and those 6,000 samples and how that performs relative to what all the other guys did, too.

Okay, got it. And then two additional ones for me. First, with respect to the molecular business, I appreciate the put and take as you’re shifting to Solana. But should we continue to think about full-year 2019 as this is a 20% growth business?

You’re asking if Solana is a 20% growth business?

No. No, the overall molecular business, I think…

Overall, yes. Okay, most of the growth obviously, coming from Solana, but yes, the whole category should grow 20%.

Okay, great. And then last one for me, and you’ve certainly heard this a lot in years past, Doug, but it’s the second quarter, so we’re going to ask it again. We’re seeing a pretty significant early flu season going on in the Southern Hemisphere, so would love any and all thoughts on what that might mean for those of us in the Northern Hemisphere. Thanks.

It’s the same question. I think it might be the same answer, Bill. Quite often, there is a correlation, but we don’t -- we certainly don’t know if it’s cause and effect. I think the R squared on the last 25 years, not counting this one because I haven’t looked at it this year. But then I looked at it previously, it was 0.76. So it says there’s a correlation, but does it really mean anything? I don’t know. I certainly think if they were that simple, it would be easy to forecast flu, isn’t it? So I know that you spend a lot of time on this and I think you probably know more about it than I do. So – but that’s my answer. I’ll be curious later to know if that’s the same answer I gave last year. I think it was.

I’ll go back. Thanks, Doug.

Your next question comes from the line of Tycho Peterson with JP Morgan. You’re now live.

Hi. This is Eleni on for Tycho. Thank you for taking our questions. First, on BNP. Last quarter you mentioned some timing issues. You called out some U.S. border delays. And I was just wondering if you saw any reordering dynamics this quarter and if you can quantify how much was recaptured?

No. I think it’s somewhat normalized. I spend some time with one of our key distributors here in the U.S. and saw their out sales? And it’s incredible that they have equally the same variability that we’re experiencing. But I don’t think there was really anything of any significance that was abnormal in this particular quarter. And I would say, Randy mentioned that we did change the way we distribute product in China. That’s obviously made its way through. Also, in Europe, we actually signed up a number of distributors. We also signed up a number of tenders. So I think that’s pretty stable and smooth as well, and we certainly didn’t see anything that would tell us differently in Q2.

Got it, thank you. And then can you give us some more color on what drove the strength in flu? This quarter, you mentioned Sofia placements, but can you compare it what you saw this quarter versus what your expectations were?

The real driver, remember, was the prolonged influenza season. And particularly, we saw A grow into the quarter, which is not normal, and then followed by the continuation of B – flu B, and so – probably halfway through the quarter. And so there’s not a lot more than that. I do though want to say that although we can’t calculate it precisely, we have a lot more new Sofia customers, too. So we were able probably to take full advantage of it just because we had more instruments on the ground.

Okay, great. And then one last one for me. Can you talk about your growth margin progression for the remainder of the year? You’ve reiterated guidance of margin expansion for 2019, but you’ve also decreased it by 100 basis points this quarter. And you mentioned FX, geographic mix and factory absorption of headwinds. So just wondering how you’re thinking about that.

Yes. We – in the comments, I have indicated that we do, for the back half of the year, see gross margin expansion versus 2018. We did see in the first six months our full-year guidance. We did see some headwinds with currency, as well as geographic mix, as you saw a little stronger growth in China versus U.S. on the Cardiac business. But we see pretty much FX less than $1 million impact in the back half of the year, and so we do see margin expansion in the back half of the year versus 2018.

Yes. I think it might be helpful, Randy, to say also, we expect that $1 million, it would be pretty even between Q3 and Q4. So it’s about $0.5 million Q3 FX unfavorable impact and then another $0.5 million in Q4. That’s what we’re forecasting.

Got it. That’s helpful. Thank you.

Your next question comes from the line of John Hsu with Raymond James. You’re now live.

Good afternoon. Just a couple for me. Doug, I was wondering if you could comment – appreciate the color there on Lyme and get that it’s still too early. There’s obviously some direct-to-patient work to be done there. But how are you thinking as far as progression on Tier 2 Lyme? I think prior that you would said, that you were hoping to get a product to the FDA and maybe on the market by the second half of 2020. Is that still the right way to think about that opportunity?

Yes. We’re nearing the point where we’re ready to go to clinical trials. We’ve engaged some dialogue with the FDA. I’m going to look it up for you to get the specific quarter, but…

Your next question comes from the line…

Hang on. I’m answering the question. Yes, looks like we’re…

Maybe while you’re looking…

I got it, John. It’s – I just – I knew it was going to be in the fall. Looks like the schedule says September.

Okay. Great. I appreciate that. And then just the only other one I had, maybe an update as far as how the synergies are tracking and perhaps whether, at this point, you think there could be some upside to the total number for this one.

Yes. We’re still confirming the $20 million for 2019 that we had said earlier.

Yes. We’re slightly ahead of schedule of our internal expectations, but we did get – we did convert over our distribution center from Abbott over to our Summers Ridge.

Yes. Why don’t I just – an overall integration update since you’re mentioning the warehousing.

That would be great.

Yes. So during the quarter, we transitioned both India and Brazil, two distribution partners there. That means, at this stage, we’ve migrated 88 of the 89 countries selling Triage to Quidel’s full control, and that represents about 99% – well, over 99% of the revenue. The only remaining migration is Japan, which is well under way and targeted to be completed soon. And Chris and I actually saw in your whiteboard, you had September 1. So that’s pretty specific. So we also achieved a major milestone by eliminating Abbott from the distribution of the Triage products completely. So that’s now done solely by us from our expanded distribution center here in San Diego. Within the first month, we actually shipped over 1,800 instruments. That’s 1,800 instruments from the new warehouse both domestically and internationally. So we’re in very good shape from an integration perspective. We’re nearly done and it’s gone extremely well. Thanks to a number of people here, but a very talented group of people who were able to break that process. So we’re – so hopefully, this is the last quarter that I have to actually talk about integration.

Great. Appreciate all the color. Thank you.

[Operator Instructions] Your next question comes from the line of Alex Nowak with Craig-Hallum. You’re now live.

Great. Good afternoon, everyone. Jumping between a few calls here, so this might have been already asked. But Doug and Randy, what are you thinking about from an M&A perspective? The debt is pretty much paid down. And based on the last answer you had there, it would appear you are ready to layer on some new products onto the existing infrastructure.

That’s a great question and it’s also a question I really can’t answer. I can tell you that we have three to five targets among many that we’ve looked at that we continue to look at. Other than that, I really can’t comment. But you’re right, we have the ability to go get capital if we want it. We certainly have paid down nearly all of our debt. What’s our total debt remaining, like $31 million?

Yes. $31 million, yes. $18 million and…

$18 million and $13 million, yes.

Yes.

So you’re right, we’re – there’s not a whole lot left, and we would be in a position to do something should we want to.

Okay. Got it. And then Randy, regarding the $535 million guide. If you did exclude the new products like Lyme, TOX and Troponin from that guide, what would the number be?

I’m sorry. You’re asking of the $535 million, how much is – how much are the new TOX and Troponin…

How much are new products? That’s right. That’s right.

Yes. We said anywhere in the $3 million to $5 million range in the back half of the year.

For those two. And then also, if you include Lyme, it’s a bit more.

Yes, yes.

Okay, got it. Understood. And then just last question. What is latest on the Danaher/Beckman, call it, their lawsuit. What are we waiting on and what’s the next steps there?

I started the call by saying I wasn’t going to answer questions on the matter, but I did say in the script that oral arguments will be heard on the morning of the 13 of this month.

Okay, understood. Thank you.

[Operator Instructions] That is all the time we have today. Please proceed with your presentation or any closing remarks.

So I’ll just end by saying thanks, everyone, for dialing in. We had another great quarter, and I should have pointed out that this actually was the first profitable Q2 we’ve had since the pandemic 10 years ago. So we’re pretty happy that moving forward, we would expect every single quarter to be profitable, and it’s pretty important milestone for us. So I think we should probably make a cake or something right now. But I think it was a great quarter for us, and we’re just happy that we got everything done that we thought we would. So take care, everybody.

Ladies and gentlemen, we thank you for your participation and ask that you please disconnect your lines. Goodbye.