QuidelOrtho Corporation (QDEL)
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Earnings Call: Q3 2019

Oct 30, 2019

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Quidel Corporation third 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. If anyone has difficulty hearing the conference, please press star zero for operator assistance. I'd now like to turn the call over to Mr. Ruben Arreola, Quidel's Director, Investor Relations. Please go ahead.

Ruben Arreola
Director of Investor Relations, Quidel

Thank you, operator. Good afternoon, everyone, and thank you for joining today's call. With me today are our President and Chief Executive Officer, Doug Bryant, and Randy Steward, our Chief Financial Officer. Our third 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 new IR website following the conclusion of this call on October 30, 2019, for a period of 30 days. 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, October 30, 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 September 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. We'll open the call to your questions. I'll now hand the call over to Doug for his comments.

Douglas Bryant
President and CEO, Quidel

Thanks, Ruben Arreola, and good afternoon, everyone. As you saw in the press release, Quidel's third quarter financial performance was solid and in line with our expectations. Total revenue was $126.5 million, up 8% over the prior year quarter. Total Triage revenue at $66.8 million, including Triage MeterPro cardiac and toxicology assays and Triage BNP, was once again in the quarterly range of $64 million-$69 million that we've suggested is appropriate for the business in advance of the impact of new product launches. Total influenza revenue for the quarter, which includes all immunoassay and molecular platforms, grew 36% to $29.3 million, driven mainly by influenza test cartridge sales on existing as well as new Sofia placements. Sofia placements at under 2,000 in Q3 were typical for a non-flu quarter, aided a bit by a couple of hundred or so instruments shipped to new Sofia Lyme customers.

Regarding earnings for the quarter, as Randy will describe in more detail, there were no significant spending surprises. The overall gross margin profile was a little elevated due to the increase in flu sales, and the fall through to EPS was as anticipated, given slightly higher revenue and favorable product and geographic mix. Moving forward, we expect modest traction on the fourth quarter in Europe with high sensitivity troponin as we await the publication of a major study that demonstrates the clinical performance of our point-of-care high sensitivity assay. We also expect to see progress with the launch of the new Triage toxicology panel. Although admittedly, our launch was delayed by about one quarter, and sales in Q4 will not be as we had anticipated.

I have no doubt that we will be as successful with this product as we had planned, but we did have what I would call a self-inflicted wound with the launch of this product, as our commercial organization in the U.S. was simply not ready to execute. They are executing now, however, and I can explain more about this during the Q&A if you like. The big questions for the fourth quarter are when the RSV and flu seasons will start, and will the flu season be early and severe enough to cause distributors to reorder product as they would typically do during the last three weeks of the quarter. At this point, I can't call it. In early October, we saw hints in our Virena data of the approaching respiratory season as test rates began to increase.

The increases in test rates, which were across every region of the U.S., were largely due to RSV and other viruses that mimic influenza and that often precede influenza by six to eight weeks. We have seen increased testing and positivity rates for RSV in Florida, which has reached epidemic levels. To be clear, the volume of RSV test data collected by Virena is not robust enough to be predictive in the way that millions of flu data points are across a season. At this point, we are continuing to model a normal season in terms of influenza revenue for the next two quarters. Shifting gears, I will proudly provide the final update on the status of the integration of the Alere assets. After just two years from the close of the transaction, we have effectively completed our integration process.

On July 1st, we went live with the integration of our warehouse operations at our Summers Ridge facility, moving off Abbott's ordering and distribution system, and realizing $2.6 million in annualized synergies. We also successfully migrated India and Brazil to our ERP on August 1, completing the order-to-cash process for 88 of 89 countries. The Japan, the final country, goes live November 1, which gives us control of 100% of the business. At this point, we are on track to deliver $20.4 million in synergies by year-end, slightly better than we had planned. Let's talk for a couple of minutes about product development and pipeline. Never in my 10 years with this company has the opportunity for revenue growth been as exciting. At last, not only do we hear the wind blowing, but we can see the trees moving.

Finally, we've become a product development company of significance, one with the potential for revenue and margin growth, driven in large part by the introduction of numerous new products. In the first half of 2020, we expect to introduce several new Sofia assays for C. diff toxins, Lyme Tier 2, a single 4-plex Sofia cartridge for flu, RSV, and human metapneumoviruses, and simpler, faster bioassays for TSI and TBI, assays for Graves' and Hashimoto's diseases. In the middle of the year, we plan to launch five more Sofia assays for lactoferrin, H. pylori, parasites, Shiga toxin, and Campylobacter. Before year-end, we expect to introduce Sofia Strep 98, which has demonstrated superb analytical performance in studies thus far, and Sofia assays for the two commonly seen community-acquired pneumonia infectious agents, Strep Pneumo and Legionella.

We'll head into 2021 anticipating the launch of Savanna, which could be the most important product introduction in our history. There's still more in the pipeline to come. Overall, it was a solid quarter, both financially and operationally. Although Q4 will provide the usual challenges we face every year, we'll end the year in good shape, very well-positioned for 2020 and 2021. Randy?

Randall J. Steward
CFO, Quidel

Thank you, Doug. Good afternoon, everyone. As we reported earlier today, revenues for the third quarter of 2019 were $126.5 million. This compares to $117.4 million in the third quarter of 2018, an increase of 8%. On a constant currency basis, revenue growth was also 8%, reflecting the minimal negative impact of foreign exchange of $500,000 in the quarter. Rapid immunoassay revenue increased 20% to $42.5 million from the third quarter of 2018 due to strong results from our Sofia franchise, which grew 35%. Flu revenue for the rapid category was $26.6 million, an increase of 37%, while Strep A increased 6% and RSV increased 10%. For the third quarter, Sofia revenue was $28.7 million, compared to $21.2 million in Q3 of the prior year, and QuickVue revenue was $12.7 million as compared to $13.1 million in Q3 of 2018.

Rapid immunoassay inventory at distribution is up 7% from the third quarter of last year. More specifically, influenza inventories at distribution are up 28% versus last year's third quarter and up 12% versus Q3 of 2017. In the cardiac immunoassay category, revenue totaled $66.8 million in the quarter versus $65.3 million in the same period last year, a 2% increase. On a constant currency basis, cardiac revenue for the third quarter was up 3%. Within the category, Triage revenue was $33.8 million, a decline of 2% from the third quarter of 2018. On a constant currency basis, Triage revenue was down 1% versus last year. As reported, on a geographic basis, Triage realized 6% revenue growth in North America, growth in Asia Pacific and Latin America, which was offset by declines in China and Europe, Middle East, Africa.

On the Beckman BNP side, revenue increased 7% over the third quarter of 2018 to $33 million. On a constant currency basis, BNP was up 8%. Geographically, revenue growth for the Beckman business was realized in all geographies except for North America, which was down slightly by 2%. Revenue in the specialized diagnostic solutions category increased 1% in the third quarter to $12.5 million as our cell culture business declined by 2% and our MicroVue bone health and complement business grew a combined 17% in the quarter. Our molecular diagnostic solutions category increased 5% to $4.7 million, driven by 20% growth from Solana assay revenue. AmpliVue revenue declined 25% in the quarter as we continue to migrate the C. difficile and HSV customers over to the Solana platform.

Gross profit in the quarter of 2019 increased $6.2 million to $75.9 million and was driven by higher sales volumes, improved product mix, and lower scrap, partially offset by lower overhead factory absorption and a negative FX impact. Gross margin in the third quarter of 2019 was approximately 60%, compared to 59% in the third quarter of 2018. The increase was due to the factors described within the net gross profit improvement. Based on product mix and the prevalence of influenza, we estimate our Q4 gross margin to be in the range of 61%-62%. R&D expense decreased by $1.1 million in the third quarter as compared to the same period last year.

This decrease was due primarily to lower spending on projects related to cardiovascular and Solana platforms, as they were largely completed in the quarter, primarily due to increased facility costs from the expansion required to integrate the acquired cardiovascular business and professional service fees incurred in the period, partially offset by lower transition service fees. Acquisition and integration costs in the third quarter were $4.5 million, up from $2.5 million in the third quarter last year, primarily due to the non-cash impairment loss recorded for a facility lease as we move our company headquarters over to our Summers Ridge facility in November, as well as increase in professional service fees. Interest expense for the quarter was $3.2 million and includes $300,000 related to the convertible senior notes, $300,000 related to the senior credit facility, and $1.9 million related to the deferred consideration associated with the purchase of the BNP business.

On a trailing 12-month basis, as compared to the prior period, we realized an $11.6 million reduction in interest expense due to the reduction in debt of approximately $168.4 million. We paid down our revolving credit facility by $75 million, reduced our convertible note by $45.4 million, and paid $48 million on the deferred and contingent consideration. In the quarter, we recorded $1.3 million in an income tax provision. The expense for the quarter was favorably impacted by excess tax benefits from stock-based compensation. We believe our effective tax rate for full year 2019 should be within the range of 18%-20% of pre-tax income before consideration for discrete tax items. We continue to strengthen our balance sheet. In the quarter, we generated $6.4 million in free cash flow after spending $6.9 million in capital expenditures.

We used a portion of the cash to pay down another $10 million on the revolving credit facility. The remaining $8.2 million balance of the revolving credit facility was paid in full in October 2019. In the quarter, we had depreciation of $4.8 million and amortization of $7.0 million. As of September 30, the company had $28.9 million in cash on the balance sheet and $13.1 million in principal amount outstanding related to the convertible notes. The outstanding principal balance on deferred and contingent consideration for the acquired cardiac assets remains at approximately $184 million. With that, we conclude our formal comments for today. Operator, we're now ready to open the call for questions.

Operator

As a reminder, to ask a question, you will need to press star one on your telephone. To withdraw your question, press the pound or hash key. Please stand by while we compile the Q&A roster. Your first question comes from Brian Weinstein with William Blair. Your line is open.

Brian Weinstein
Analyst, William Blair

Hey, guys. Thanks for taking the question. I guess, Doug, I'll take you up on the opportunity to follow up on the comments related to the delay on tox. If you can just give us a little bit more on the self-inflicted wounds and what's going on there and how you're dealing with those. I'll ask a second question in a second.

Douglas Bryant
President and CEO, Quidel

Sure. Of course. This is pretty straightforward, Brian. We trained the sales organization on toxicology very early in the year. Due to the delay in the product launch, we made a commercial decision to train ourselves one more time. Instead of launching in the third quarter as we normally would with a new product, some of the guys were working on other things and waited till after their training to actually send their reps out to the field. I would say that's a pretty good definition of a self-inflicted wound. The reason I mention it is because with all the 2020 products that we have queued up, we can't launch products like that. We can't have guys waiting for a couple of months to be trained in order to go out and start talking to customers.

Pretty lengthy couple days meetings where we discussed all that, and I think we have a pretty good understanding how we're going to get that done. I don't know how many product launches. I didn't count them up, but I think it's at least five or six that we're going to do next year. Obviously, we can't wait to have an all-hands-on-deck sort of sales training before we go out and start talking to customers. It's pretty straightforward, Brian.

Brian Weinstein
Analyst, William Blair

Got it. Okay. With respect to influenza and the levels of distribution, Randy, I think you gave some numbers that indicated that it was meaningfully higher at this point versus last year and even 2017. How should we think about what that might mean for the fourth quarter? The flu numbers were obviously a little bit stronger than we thought here. Should we be taking some out of the fourth quarter and still thinking about the overall season roughly the same? Any thoughts on that would be appreciated.

Douglas Bryant
President and CEO, Quidel

I'll have Randy chime in as well if he likes, but as we exited the second quarter, we had fairly low, I don't know if it's the lowest ever, but fairly low distributor inventory. It was natural that they order some, but I think some distributors ordered more product than they normally would, anticipating a large season. There was a lot of rumors about flu in Australia, et cetera. I do think that there's at least a couple million dollar swing in any quarter that can move from one quarter to another. I think what we have in this case is probably a couple of million more in Q3 than we might normally have. Although when you look year-over-year, it's only about 8% more versus Q3 last year that was ordered in.

Randall J. Steward
CFO, Quidel

Yeah.

Douglas Bryant
President and CEO, Quidel

You want to add something, Randy?

Randall J. Steward
CFO, Quidel

No, I think that's right.

Douglas Bryant
President and CEO, Quidel

That's kind of where we're at.

Randall J. Steward
CFO, Quidel

Yeah

Douglas Bryant
President and CEO, Quidel

you never know going into the last three weeks of the year whether all that inventory will be depleted, which would necessitate an order from particularly the bigger distributors. I shouldn't say fingers crossed we're hoping for more flu, but if we don't see an acceleration of flu, which sometimes happens, I could see how we might be $1 million or so heavy in fourth quarter.

Brian Weinstein
Analyst, William Blair

Okay, sounds great. We'll let someone else jump in. Thank you.

Douglas Bryant
President and CEO, Quidel

Sure.

Randall J. Steward
CFO, Quidel

Thanks, Brian.

Operator

Your next question comes from Bill Quirk with Piper Jaffray. Your line is open.

Speaker 11

Hi, this is Rachel in for Bill. Thanks for taking the questions. Do you have any thoughts on the potential?

Douglas Bryant
President and CEO, Quidel

Hi, Rachel.

Speaker 11

Hi. Do you have any thoughts on the potential antigen mismatch between the vaccines and possible strains this year? We've seen a few press stories as of late about it, just wondering your thoughts on that. I have a follow-up.

Douglas Bryant
President and CEO, Quidel

Even in the best year, immunologists would tell you the effectivity of the flu vaccine is only about 30%. It's not that I would not recommend that everybody get a flu vaccination. I certainly got mine. I think there is a concept of herd immunity that's helpful. Please get your vaccination. Whether we call the strains right or not doesn't seem to have a great deal of impact really, although there's a lot written about it. You certainly heard about the mismatch last year on one of the strains. That's probably not super helpful, Rachel, but that's the reality, is that the vaccination rates and how precise the vaccine is against the viruses that are circulating doesn't seem to have a real big impact on severity of the season or on the volume of testing.

Speaker 11

No, that's helpful. Last question, can you just give us an update on the Beckman Coulter litigation and where you guys are at with that and any next steps that you foresee?

Douglas Bryant
President and CEO, Quidel

Sure. Regarding the Beckman litigation matter, I'll just provide a quick update, and then probably will not take, well, not probably, I won't be taking follow-up questions. Where we are is the Court of Appeal issued a written order regarding our writ petition, Quidel's writ petition on August 29th of this year, ruling in our favor. Beckman petitioned for rehearing by the same court, and that petition was denied on September 13th. Beckman filed a petition for review with the California Supreme Court, challenging the Court of Appeal's order that granted Quidel's writ petition. Quidel has filed its answer, and we expect the court to decide whether to take the case by the end of the year.

Because of certain developments in another case regarding the same business law, we understand that there is a significant possibility the court will grant review to clarify the law in this area. If that happens, we remain confident that we will prevail. If the court, on the other hand, does not grant the review, we will return to the trial court, where we also are highly confident that we will prevail.

Speaker 11

Great. Thank you.

Douglas Bryant
President and CEO, Quidel

You're welcome.

Operator

Your next question comes from Jack Meehan with Barclays. Your line is open.

Jack Meehan
Analyst, Barclays

Thank you. Good afternoon.

Douglas Bryant
President and CEO, Quidel

Hi, Jack.

Jack Meehan
Analyst, Barclays

Doug, appreciate all the excitement on the new product development. Was wondering if you could give us a mark to market on the Savanna cartridge design and when you expect to start clinical trials.

Douglas Bryant
President and CEO, Quidel

Yeah, we're in great shape with Savanna now. I'm happy to report we have seven assay panels that are in development and are well on their way. Many are close to being ready to move into the cartridge. We do have a cartridge design that we are highly confident we can manufacture in millions of tests at very high yields. Now we're in the process of moving through the instrument development phase. We should have instrument and at least 1 or more cartridge types ready for submission toward the end of next year, just as we previously had said, and we still anticipate being in the market in the United States in 2021. Compared with last quarter, I would say our confidence level has gone up significantly.

Jack Meehan
Analyst, Barclays

Mm-hmm. Do you still expect-

Douglas Bryant
President and CEO, Quidel

We haven't baked the cake yet, but Pardon?

Jack Meehan
Analyst, Barclays

Do you still expect clinical trials to start by the end of the year, beginning of next year?

Douglas Bryant
President and CEO, Quidel

This year?

Jack Meehan
Analyst, Barclays

Yes.

Douglas Bryant
President and CEO, Quidel

No. We will be ready with a cartridge and the instrument toward the end of next year. Yeah.

Jack Meehan
Analyst, Barclays

Sorry, I was referring to clinical trial.

Douglas Bryant
President and CEO, Quidel

Well, the instrument's not developed yet. We won't be in clinical trials until the end of 2020.

Jack Meehan
Analyst, Barclays

Okay. I was wondering if you could maybe just give us a review of the Lyme season and how much that contributed to Sofia and what that was doing in terms of placement rates over the summer.

Douglas Bryant
President and CEO, Quidel

Well, just overall, I would say where we're at with Lyme is we're busy growing and developing a physician office segment that doesn't exist today, to include the urgent care space for a tier 1 assay. I believe we'll get even more help with the introduction of the tier 2 assay, which would be effectively a confirmatory assay and also a replacement for western blot, all of which could be done in the physician's office while the patient waits. We think that that will add some value. We did ship a couple hundred Sofias in Q3 to Lyme customers, 70% of which included flu and RSV on their contracts. We have hundreds of contracts right now, mainly in the Northeast, but we're in the hundreds, not the thousands yet. It's still early days. Didn't really think it was going to be an instant market.

I knew we'd have to spend some time developing the market. We have allocated several million dollars towards a number of marketing campaigns designed to create awareness in those areas of the country that have some level of prevalence. So far, I'd say we're reasonably pleased with what's going on, although it's back to the wind blowing and the trees moving. We hear the wind blowing, but the trees, Jack, are not moving yet at this point.

Jack Meehan
Analyst, Barclays

Sounds good. Thanks, Doug.

Douglas Bryant
President and CEO, Quidel

Sure.

Operator

Your next question comes from Mark Massaro with Canaccord Genuity. Your line is open.

Mark Massaro
Analyst, Canaccord Genuity

Hey, thanks guys for the questions. Looking back at what I would call the mother of all flu seasons, this is 2017 into 2018, and then looking back at other flu seasons in the last, call it seven years, typically Q4 has flu revenue of at least $5 million-$10 million of revenue above the Q3 level, just on a sequential basis. You just reported a pretty big beat on flu here in Q3. I guess the simple question is, do you expect a sequential increase in flu revenue in Q4, and do you think it can be similar to that range of estimates I just mentioned?

Douglas Bryant
President and CEO, Quidel

The short answer, Mark, it depends. I'll let Randy chime in in a second, but let me give you a snapshot as of today, of our Virena data. We look across the nation right now and we're running less than 15% positivity virtually every region, except for the Southeast and Louisiana and parts of Texas. If you were to go on map.quidel.com, you'll actually see the flu map, and you can see where things are happening. It has started, and what you see is a pretty good beginning of a flu season there in Florida. Miami right now, reporting positivity rates of 24%. Miami actually is in a flu season now. Tampa's at 19%, they're just about right on the cusp of being in epidemic range as well. Louisiana actually has spots as well as the two big markets in Texas.

I don't know what's going to happen. It's got to go more than that, obviously, but when it does go, it'll ramp up quickly. If it does ramp up before the last three weeks of the year. Again, those distributors are going to reorder. We've had years where 70%-80% of the quarter were in the last three weeks of December, and we've had years where that was absolutely not the case. I get how you're trying to model going from one quarter and sequentially going to the next. I would say normally you would be right, Mark. I'm not telling you something different, I'm just telling you what we see so far. We do see flu. We see it ramping up to epidemic proportions in a small number of areas.

Randall J. Steward
CFO, Quidel

Just to add onto that, Mark, consistently Q4 and Q1 have been somewhere between 65%-75% of a full flu season. As you know, it can shift a little bit between Q4 and Q1 as well. Certainly for the last five Q3s, the flu revenue has been $20 million or north in any event. We're kind of aligning the same way we have in several of the other previous years.

Mark Massaro
Analyst, Canaccord Genuity

Thank you. That's helpful.

Douglas Bryant
President and CEO, Quidel

If it were normal, Mark, and we're saying normal, if it were normal, it's going to be sequentially higher, yes.

Mark Massaro
Analyst, Canaccord Genuity

Okay. A question on the guidance. I don't think you addressed it, but earlier in the year, you talked about a constant currency basis revenue guide for the year of $535 million. With what you've discussed with the toxicology delay, are you still on track to hit that?

Douglas Bryant
President and CEO, Quidel

No, That was about $4 million in the fourth quarter. We're short there.

Mark Massaro
Analyst, Canaccord Genuity

Okay.

Douglas Bryant
President and CEO, Quidel

We've got obviously some FX headwinds, you're allowing me to not count that by your question, asking for constant currency. We've got what we said we would do minus FX, minus that toxicology delay.

Mark Massaro
Analyst, Canaccord Genuity

Okay, maybe on a reported basis, would that look something similar to $530 million?

Douglas Bryant
President and CEO, Quidel

Got about $5 million in FX.

Mark Massaro
Analyst, Canaccord Genuity

Okay. I want to go back to the question that Brian asked about just the rationale for the delay. Based on my understanding of your comments, Doug, you talked about how you did two trainings. You trained them early in the year, then you trained them again. I could maybe use some clarification as to why they were trained a second time and why they didn't go out the first time.

Douglas Bryant
President and CEO, Quidel

Because of the delay, there was too much time between the training and when we launched. I was actually at arguably our best region of the country and one that I'm expecting to perform at a very high level. I went to their meeting. They were trained at that meeting, and they hadn't started making calls yet. I was a little bit, what's the right word? Disappointed? No, that doesn't sound strong enough, does it? I was not happy. That shouldn't happen. We were trained once. I do understand, let's have a big splash and all that, but at the same time, there was so much going on in Q3 that these people pushed back their meetings to when they could get it done and et cetera.

I share with you all that detail because it's easily fixable, and I don't expect it to affect the longer-term prospects for the product, but it was definitely a self-inflicted wound.

Mark Massaro
Analyst, Canaccord Genuity

Okay. Just one last one for me. You talked a lot about the trees moving. Can you speak whether or not the trees are moving on the M&A fronts? You've recently talked about three to five targets potentially on your plate, with a goal of acquiring $150 million-$250 million of revenue. Should we think about achieving that potentially with one or two deals, or do you see a larger number of smaller deals?

Douglas Bryant
President and CEO, Quidel

It's certainly easier to do deals that would have bigger chunks of that 150. The integration of a smaller company is not any easier than a larger one. I would say a smaller number would be preferred, Mark.

Mark Massaro
Analyst, Canaccord Genuity

Okay. Thank you.

Douglas Bryant
President and CEO, Quidel

It takes a lot of tiny ones to get there.

Operator

Again, if you would like to ask a question, press star one on your telephone. Your next question comes from Alex Nowak with Craig-Hallum Capital. Your line is open.

Alex Nowak
Analyst, Craig-Hallum Capital

Great. Good afternoon, everyone.

Douglas Bryant
President and CEO, Quidel

Yeah

Alex Nowak
Analyst, Craig-Hallum Capital

Just kind of following up on that. With toxicology being delayed to next year, can you kind of ballpark what the contribution here could be from new products, including tox, Lyme, troponin, plus all the new Sofia assays that you mentioned, what sort of contribution those can have in 2020?

Douglas Bryant
President and CEO, Quidel

That's a terrific question. We have done a first pass of our 2020 plan, but we're still modeling and forecasting. We'll present to our board here in a few weeks. Probably would be bad form if I gave you a number now before I ran it by my board. Certainly we will be prepared to discuss the impact of those new products when we present at J.P. Morgan in January.

Alex Nowak
Analyst, Craig-Hallum Capital

Okay. Got it, understood. Just kind of going back to one of the core tenets here of the Triage acquisition, now two years removed. One of the things was moving legacy Quidel products into the markets outside the U.S. I would say, as you mentioned, all the infrastructure's now in place. You're launching a number of tests here over the next 12 months. How should we be thinking about that potential expansion into new geographies?

Douglas Bryant
President and CEO, Quidel

We just got approval for, what are you whispering to me, Randy?

Randall J. Steward
CFO, Quidel

Yeah, sorry.

Douglas Bryant
President and CEO, Quidel

We, yeah, we just got approval in China for Sofia, for example. We've got a couple of things we're working on in Japan, as another example. We're actually leveraging the infrastructure we've put in place. If you look at China right now, we're up 84% Q3 2019 over Q3 2018 in China with our legacy products, in part because we've got a larger commercial organization representing those products. We've got the infrastructure there. I'm not telling you we're hitting it out of the park yet, but we clearly are taking advantage of the infrastructure that we're putting in place and have put in place across the globe.

Alex Nowak
Analyst, Craig-Hallum Capital

Okay. Got it. Just lastly, can you provide some detail on the Serosep and Tareq Bio deal that was announced a couple of weeks ago? I didn't see a press release from you, looks like you will be commercializing or being distributing their GI assay through your channel. Just curious how that's going to compete with the Sofia GI test, that you're developing.

Douglas Bryant
President and CEO, Quidel

Well, this is a different segment than anything else we do today. It's more in line with how we go to market with our Lyra products, where we're targeted at the larger institution, that has a high complexity lab. The number of facilities out there is fewer, therefore, we're mainly using our molecular sales force, a small team there to represent the product. We do have a model. Obviously, we wouldn't have done the deal without a model. We're using the team now to explore actually what opportunities are out there that are actionable in the 2020 timeframe. We'll be putting those numbers into our plan for 2020. We should have a forecast for that shortly, but I couldn't really speak to the magnitude at this point.

I would say, though, that with each of the ones that I know about, that we've been talking to, the opportunities are fairly significant. The question becomes, which account actually is going to close and when are they going to close in 2020? It should be reasonably easy to model, but it's also reasonably easy to get wrong, if you model some big account and you don't get it. Stand by. We think it's an interesting opportunity. We think it's an interesting segment, and I'm glad we did the deal.

Alex Nowak
Analyst, Craig-Hallum Capital

Okay, understood. Thank you.

Operator

Your next question comes from Tycho Peterson with J.P. Morgan. Your line is open.

Speaker 10

Hi. Thanks. This is Eleni for Tycho. Going back to your questions on Triage, I was wondering, you called out some declines in China, the Middle East, and Africa. Could you talk about the dynamics you're seeing there?

Douglas Bryant
President and CEO, Quidel

Go ahead, Randy.

Randall J. Steward
CFO, Quidel

Yeah. There's nothing significantly different from prior quarters. Again, in China, we're going through 37 different distributors and stuff, so you kind of see quarter to quarter some variances. Overall, I think in China, we're seeing on the Triage business, mid-single digit growth on a year-to-date basis. That continues to be a good growth area for us. Europe, Middle East, Africa, it's been pretty flat for the year. That kind of continues plus or minus one, 2%.

Speaker 10

Okay. That's helpful.

Douglas Bryant
President and CEO, Quidel

If I could just add on China too. The Triage business is what it is, but on the Triage BNP portion, they're actually growing quite rapidly. It's a bit of a mix right now in China.

Speaker 10

Okay, that's helpful. In terms of Sofia placements, you saw strong placements this quarter, you mentioned aided by 100 or so from new Sofia line customers. I was wondering how we should expect the cadence going forward?

Douglas Bryant
President and CEO, Quidel

Well, I'm hoping we get somewhat of a stairstep move when we introduce the product in some of the larger urgent care centers in the Northeast and in the Upper Midwest. I don't see it as sort of a linear progression. I think also with word of mouth, I'm certainly hoping for a big jump in awareness. Instead of going from a couple of hundred in a quarter to maybe double that the next quarter, et cetera, I expect that we'll hit an inflection point and then there'll be thousands. It will go from hundreds to thousands pretty quickly if we're successful. I think that's more in line with what we would expect. We certainly saw it when we introduced Sofia initially. We were, I don't know, moving along quite slowly, then boom, we had awareness and it jumped. I'm hoping we see the same thing, Eleni.

Speaker 10

Okay. Going back to your comments on contributions from toxicology and troponin in the second half of this year, you had previously mentioned $3 million-$5 million. I know you said because of the delays that will impact, you probably won't see contributions in this range, but I was just wondering, given the pent-up demand and the large customer list you mentioned, for particularly toxicology last quarter, if there is any potential upside there.

Douglas Bryant
President and CEO, Quidel

Sure. There's upside. I suppose we're guilty of being somewhat conservative. I think that's probably our reputation. All things being equal, if we don't see a jump from a couple of very large customers, you might end up being down by about $4 million relative to what we had forecasted. Could we do better than that? Possibly. There's not a lot of time between now and the end of the year.

Speaker 10

Makes sense. Thank you.

Douglas Bryant
President and CEO, Quidel

You're welcome.

Operator

Your next question comes from John Hsu with Raymond James. Your line is open.

John Hsu
Analyst, Raymond James

Good afternoon. Staying on Sofia, can you give us a sense, a snapshot of where you are in terms of placements at this point and maybe just a level set on kind of the annualized annuity per placement?

Douglas Bryant
President and CEO, Quidel

Sure. That's a great question. We were just asking ourselves this morning, where are we going to be at the end of the year? I think we're going to exceed 40,000. You don't have to wait till J.P. Morgan for me to say that. We're going to beat 40,000.

John Hsu
Analyst, Raymond James

Okay, great. On the annuity per placement, I think you said at different times that you're kind of tracking in that $4,000 range or so annualized. Is that the good way to think about where we are now as we level set for next year with all the new menu coming on?

Douglas Bryant
President and CEO, Quidel

It's hard, and I hope you're not modeling by taking the number of boxes times and trying to figure it out, because we can't do it that way. What's happening is we're moving into different segments with different products. Urgent care, you can end up with big numbers, but at the same time realizing that the cost of a Sofia 2 is dramatically less than originally the Sofia 1. We're now moving into smaller accounts that we weren't in before, and those are less than the 4,000. I would say over time, we would hope to have Sofia placements more decentralized, which would mean that on a per unit basis, the pricing would be higher, but it might be lower volume. I would suggest it's probably going to move down from 4,000.

John Hsu
Analyst, Raymond James

Okay, got it. It sounds like the integration is largely complete here with the last country coming on in November. Can you just remind us what's left in cost synergies? I think there's a tail into 2020. Clearly the team's done a very nice job. Are there other projects that you can outline for us as we think about margin expansion from here looking into 2020?

Douglas Bryant
President and CEO, Quidel

Well, what we said was we'd be at $20 million by year three. It's year two, and we're already at $20 million. I know that you're hopeful, but I would suggest that we've gotten to where we thought we were going to be approximately a year earlier, and I'm looking at Randy, and he's saying, "Please don't tell them that there's more.

Randall J. Steward
CFO, Quidel

Sorry, John.

Douglas Bryant
President and CEO, Quidel

I don't know where we would get it. Doesn't mean it's not there. We do have what we call a business transformation group that's looking for lots of different ways that we can improve the way we do things. I'll give you just an example. We're looking at our cost to process an order globally. We think we're a little high, and we think there's things that we can do to get that down. I would say that's more business transformation across the entirety of the business. Now that I've got the infrastructure that did the integration, we're now repurposing those same people to continue to look for other things. That's a very long answer to say, I think there's more to do, but it wouldn't be directly related to that recent acquisition, if that makes sense.

John Hsu
Analyst, Raymond James

Yep. That's great. Thank you so much.

Douglas Bryant
President and CEO, Quidel

Sure.

Operator

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

Douglas Bryant
President and CEO, Quidel

Well, thanks everyone for your support and, of course, your interest in Quidel. Q3 was another solid quarter, and we're in good shape as we finish out the year and head into 2020. Thanks again, everybody.

Operator

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