Live Earnings Conference Call: QuidelOrtho will host a live Q1 2025 earnings call on May 7, 2025 at 5:00PM ET. Follow this link to get details and listen to QuidelOrtho's Q1 2025 earnings call when it goes live. Get details. NASDAQ:QDEL QuidelOrtho Q3 2024 Earnings Report $25.94 -1.75 (-6.32%) Closing price 05/6/2025 04:00 PM EasternExtended Trading$26.25 +0.31 (+1.20%) As of 05/6/2025 07:56 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast QuidelOrtho EPS ResultsActual EPS$0.85Consensus EPS $0.30Beat/MissBeat by +$0.55One Year Ago EPS$0.90QuidelOrtho Revenue ResultsActual Revenue$727.00 millionExpected Revenue$642.16 millionBeat/MissBeat by +$84.84 millionYoY Revenue Growth-2.30%QuidelOrtho Announcement DetailsQuarterQ3 2024Date11/7/2024TimeAfter Market ClosesConference Call DateThursday, November 7, 2024Conference Call Time5:00PM ETUpcoming EarningsQuidelOrtho's Q1 2025 earnings is scheduled for Wednesday, May 7, 2025, with a conference call scheduled at 5:00 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptSlide DeckPress Release (8-K)Quarterly Report (10-Q)Earnings HistoryCompany ProfileSlide DeckFull Screen Slide DeckPowered by QuidelOrtho Q3 2024 Earnings Call TranscriptProvided by QuartrNovember 7, 2024 ShareLink copied to clipboard.There are 11 speakers on the call. Operator00:00:00Welcome to the Quidel Ortho Third Quarter 20 24 Financial Results Conference Call and Webcast. At this time, all participant lines are in a listen only mode. For those of you participating on the conference call, there will be an opportunity for your questions at the end of today's prepared remarks. Please note this conference call is being recorded. An audio replay of the conference call will be available on the company's website shortly after this call. Operator00:00:23I would now like to turn the call over to Juliet Cunningham, Vice President of Investor Relations. Speaker 100:00:30Thank you. Good afternoon, everyone. Thanks for joining the Quidel Ortho Third Quarter 2024 Financial Results Conference Call. With me today are Brian Blaser, President and Chief Executive Officer and Joe Buskey, Chief Financial Officer. This conference call is being simultaneously webcast on the Investor Relations page of our website. Speaker 100:00:52To aid in the discussion, we posted a supplemental presentation on the Investor Relations page that will be referenced throughout this call. This conference call contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not strictly historical, including the company's expectations, plans, future performance and prospects are forward looking statements that are subject to certain risks, uncertainty, assumptions and other factors. Actual results may vary materially from those expressed or implied in these forward looking statements. Information about potential factors that could affect our actual results is available in our annual report on Form 10 ks for the 2023 fiscal year and subsequent reports filed with the SEC, including the Risk Factors section. Speaker 100:01:54Forward looking statements are made as of today, November 7, 2024, and we assume no obligation to update any forward looking statement except as required by law. In addition, today's call includes discussion of certain non GAAP financial measures. Tables reconciling these non GAAP measures to their most directly comparable GAAP measures are available in our earnings release and the supplemental presentation, which are on the Investor Relations page of our website at quietortho.com. Lastly, unless stated otherwise, all year over year revenue growth rates given on today's call are given on a comparable constant currency basis. And now I'd like to turn the call over to our CEO, Brian Blaser. Speaker 200:02:44Thanks, Juliet. Good afternoon, everyone. I'm pleased to be here with you today and share our Q3 2024 results. We reported 3rd quarter revenue of $727,000,000 adjusted EBITDA of $171,000,000 and adjusted diluted EPS of $0.85 Our results demonstrate solid progress in executing our business improvement initiatives, including our previously communicated $100,000,000 in annualized cost savings that we expect to realize through the first half of twenty twenty five. After my remarks, Joe will cover our detailed quarterly financials as well as provide our full year 2024 financial guidance, which we reinstated today. Speaker 300:03:29I would also like to Speaker 200:03:30highlight the key focus areas where we see the greatest opportunity for improvement in profitability and growth. During my 1st 6 months here at Quidel Ortho, we undertook an extensive review of every part of the business. I continue to be excited by the opportunity to serve our customers across the entire healthcare continuum and meet patients' needs in every care setting and at every step of the journey from prevention to diagnosis, treatment and monitoring. To meet those needs and to do so profitably, we need the right people, the right products, rigorous discipline and a strong cultural mindset that places customers and quality first. With that objective in mind, we strengthened our leadership team with the recent addition of 2 highly experienced industry leaders, Jonathan Segrist as Chief Technology Officer and Lee Bowman as Chief Human Resources Officer. Speaker 200:04:27Jonathan has a proven 15 year track record in molecular diagnostics, microfluidic platforms and biomedical engineering. He most recently was the CTO and Head of Assay Research and Development at Cepheid. Lee brings over 25 years of experience leading teams through transformative initiatives in workforce engagement and leadership development at Edwards Life Sciences, Levi Strauss and Company and Target. Lee's expertise in developing talent in a high performing workplace is critical as we create a winning continuous improvement culture and drive continued growth here at Clyde El Ortho. In addition, we are aligning our leadership structure to be a flatter, more agile organization to increase our customer focus, reduce complexity and improve our efficiency and cost structure. Speaker 200:05:21As part of this effort, Mike Istra, Chief Commercial Officer and Rob Budjarski, Chief Operating Officer will be leaving the company. We're grateful to Mike and Rob for their contributions in leading the Quidel Ortho commercial and operations teams and fostering a culture of collaboration. Going forward, our global regions will be fully aligned with our business units and both the business unit and global regional leaders will report directly to me. The alignment of our leadership team is designed to improve the way we run the business and enable us to achieve consistently improved performance over time. We believe the changes we are making are designed to better leverage the scale of our global commercial team, accelerate cross selling opportunities and continue to build a customer focused organization. Speaker 200:06:09As part of delivering on our customer commitments, we remain steadfast in achieving our product timelines and improving our business efficiency. Under Jonathan's leadership, we're focused on executing our key R and D priorities including increasing our R and D productivity, expanding our menu and advancing critical platforms. While Savanna is only one of our initiatives, we believe Savanna and Molecular in general is an important driver of future profitable revenue growth. We plan to enter clinical trials with our respiratory panel as the respiratory season develops and to be in market in the later part of 2025. To improve our cost structure, we are also in the early phases of implementing cost and process improvement initiatives in procurement, supply chain, manufacturing quality and IT. Speaker 200:07:00We expect these initiatives to enable us to operate more effectively and deliver incremental margin contributions in 20252026. We plan to provide greater detail in the coming quarters as we move ahead. Lastly, I think it bears repeating that we are focused on challenging every aspect of our business to do more for our customers and improve profitable growth. I'm proud to be the leader of Fidel Ortho. I'm excited about the improvements that we're making and I look forward to updating you on our progress next quarter. Speaker 200:07:34With that, I'll hand it over to Joe. Speaker 300:07:37Okay. Thanks, Brian. Let's begin with the details of our Q3 year to date 2024 results on Slides 34 of the earnings presentation, which is posted on our IR website. I will also provide our reinstated full year 2024 financial guidance, and then we will open up the call for questions. Unless stated otherwise, all year over year revenue growth rates on today's call are provided on a comparable constant currency basis. Speaker 300:08:06During the Q3 and the 1st 9 months of 2024, our business performed well, and we continue to see healthy customer demand and momentum. Total reported revenue in the Q3 of 2024 was $727,000,000 which declined by approximately 2% due to higher COVID-nineteen and flu revenue in the prior year period. While foreign currency exchange did not have a material impact on overall 3rd quarter results, we had a negative 100 basis point FX impact in our Labs business, which is our global footprint. Q3 2024 recurring revenue, which we define as revenues from sales of our assays, reagents, consumables and services and excludes instrument revenue, was $598,000,000 as reported with no significant change in constant currency. This figure excludes COVID-nineteen and U. Speaker 300:09:02S. Donor screening revenue. Recurring revenue growth was 1% in Q3. Underlying labs recurring revenue growth was 6% but was offset by a decline in cardiac revenue mainly due to expected order timing between Q3 and Q4 in China. Total reported year to date revenue was $2,100,000,000 and total year to date recurring revenue was $1,740,000,000 or 5% growth compared to the prior year period. Speaker 300:09:35Again, this excludes COVID-nineteen and U. S. Donor screening revenue. From a regional perspective, our Q3 2024 total revenue performance was led by EMEA growth of 12% and 8% growth in our other region, which is comprised of Japan, Asia Pacific and Latin America. North America declined by mid single digits due to higher respiratory revenue in the prior year period and U. Speaker 300:10:02S. Donor screening business wind down. In China, our Labs business grew 5% year over year, but that growth was offset by softness in transfusion medicine and cardiac point of care products. As a result, China revenue declined by 1% year over year. We continue to expect growth in the region to be strong in Q4 and in the high single digits for the full year 2024. Speaker 300:10:32We continue to closely monitor both value based pricing initiatives and the impact of China's anti corruption policies as potential headwinds. We have not been meaningfully impacted by BPB initiatives to date and do not expect significant impact in the near term. As we discussed last quarter, we have seen customer delays in a small number of instrument purchases and installations due to the Chinese government's anti corruption policies. We believe these disruptions will abate in 2025 as customers adjust to these ongoing governmental policies. In addition, there may be some changes to reimbursement on cardiac products in certain Chinese provinces, which could negatively impact our sales of China. Speaker 300:11:18On the positive side, the recently announced economic stimulus planned by the Chinese government could represent the potential future tailwind. China continues to be a complex market that we are monitoring closely, but despite these dynamics, we believe our China business is solid and we see more potential upside than risk at this time. Moving to our non respiratory business, which includes labs, transfusion medicine and cardiac point of care products. 3rd quarter 2024 revenue grew 1% in constant currency year over year. Labs revenue achieved expected growth of 5% compared to the prior year period. Speaker 300:11:57Within our Labs installed base, integrated and automated analyzers grew 7% 17%, respectively, compared to the prior year period. The growth in integrated and automated analyzers continues to show that our commercial go to market strategy is working, and we continue to expect mid single digit revenue growth in this business. Moving to Transfusion Medicine, I want to highlight that we are now breaking out immunohematology and donor screening as separate line items to provide greater transparency to the impact of largely winding down the U. S. Donor screening business by the end of 2025. Speaker 300:12:38Immunohematology revenue grew 3% and donor screening declined by 20% in the quarter as expected. The respiratory side of the business performed well versus our expectations during the Q3 with strong performance from our Sofia flu COVID-nineteen combo test, and we had $72,000,000 in COVID-nineteen revenue in the quarter. On a year over year basis, total Q3 respiratory revenue was down $20,000,000 or 11% due to higher COVID-nineteen and flu revenue in the prior year period. In addition, our distributors began their normal ordering patterns for flu RSV Strep products ahead of the 4th quarter, which points to a typical flu season. I'd also note that distributor respiratory inventories were at expected levels, which were slightly down compared to the prior year period. Speaker 300:13:34Now moving down the P and L, Slide 5 shows Q3 2024 adjusted gross profit margin of 49.2% versus 50.5% in the prior year period. The 130 basis point decrease was expected and primarily driven by higher COVID-nineteen and flu sales in the prior year period. Non GAAP operating expenses of $232,000,000 including SG and A and R and D decreased by $17,000,000 compared to the prior year period and was down sequentially by $4,000,000 We continue to expect a benefit of at least $50,000,000 in the second half of twenty twenty four due to the cost actions we have already taken. And looking ahead to Q4 on a sequential basis, we expect our realized cost savings and total OpEx to be offset by timing of selling and marketing costs in Q4. As a result, we expect total OpEx to be relatively flat to Q3. Speaker 300:14:36Adjusted EBITDA was $171,000,000 compared to 100 and $69,000,000 in the prior year period. Adjusted EBITDA margin was 23.5%, which represents a year over year improvement of 80 basis points due to the cost savings actions we have taken, offset by lower revenue for respiratory tests, which are high margin contributors. Notably, Q3 2024 was the Q1 in 9 quarters to achieve growth in both adjusted EBITDA dollars and margin since the pandemic. Adjusted diluted earnings per share was $0.85 compared to adjusted diluted EPS of $0.90 in the prior year period. This year over year change was primarily due to the higher respiratory revenue in the prior year period and higher interest expense in the current period, offset by our cost savings initiatives. Speaker 300:15:33Our 3rd quarter effective adjusted income tax rate was 23.7 percent, which is in line with our full year expectations. Turning now to the balance sheet on Slide 6. We finished the quarter with $144,000,000 of cash. As of the end of Q3, we had $230,000,000 in borrowings on our $800,000,000 revolver. This is a decrease of $23,000,000 from the 2nd quarter as we begin to pay down the revolver. Speaker 300:16:04Keep in mind, our first capital allocation priority continues to be debt pay down. Q3 2024 recurring adjusted free cash flow was $120,000,000 which represents 70% of adjusted EBITDA. We continue to expect adjusted free cash flow to be positive in the Q4 and for the full year 2024. In addition, we expect adjusted recurring free cash flow in the second half of 'twenty four to exceed 50 percent of our second half adjusted EBITDA. During the Q3 of 'twenty four, our consolidated leverage ratio from the base of the financials is 4.1 times and 3.3 times including pro form a EBITDA adjustments as permitted and defined under our credit agreement. Speaker 300:16:53Based on our current projections, we expect our consolidated leverage ratio to remain relatively flat to current levels at year end. Lastly, on Slide 7, following the business review that Brian conducted upon joining the company as well as the increased visibility we have after executing some of our cost savings initiatives, I will now provide our full year 2024 guidance. I note that our guidance is in line with the comments we made earlier in the year. We expect full year 2024 total reported revenues of between $2,750,000,000 $2,801,000,000 adjusted EBITDA of between $530,000,000 $550,000,000 which equates to a range of 19.3% to 19.6 percent adjusted EBITDA margin and adjusted diluted EPS of between $1.69 1.91 These expectations are based on a set of assumptions that follow. We assume Q4 2024 non respiratory revenue will be in line with the commentary we shared earlier this year, including labs, business growth expected in the mid single digits and transfusion medicine excluding U. Speaker 300:18:21S. Donor screening expected to grow in the low single digits. Now for respiratory revenue, we assume a typical flu season this year with a $50,000,000 to $55,000,000 test market, similar market share to 2023 and greater than 50% of flu product revenue coming from our combo test. Note that we are not changing our full year assumptions on the respiratory season from earlier this year. In our view, the higher respiratory revenue we saw in Q3 is timing related and not expected to increase our full year 2024 outlook. Speaker 300:18:59In addition, we assume full year 2024 COVID-nineteen revenue will be in the range of 100 and $60,000,000 to $170,000,000 which includes about $17,000,000 in government contracts in 2024. We assume cost savings of at least $50,000,000 in the second half of twenty twenty four as part of our $100,000,000 annualized target. And note that in Q4, we also assume a year over year increase of $25,000,000 to $30,000,000 in SG and A expense related to expected bonus accruals that were not included in the prior year period since we did not meet our performance targets last year. We assume second half and full year 2024 positive adjusted free cash flow to exceed 50% of adjusted EBITDA, including expected full year interest expense of $160,000,000 to $165,000,000 and we assume CapEx of approximately $170,000,000 excluding reagent rentals. Plan to provide our detailed 2025 financial guidance when we report our full year 2024 results in February. Speaker 300:20:15But directionally in 2025, we are expecting top line growth in the mid single digits, excluding COVID-nineteen and U. S. Donor screening revenue, which we expect to be $40,000,000 to $50,000,000 as that business winds down expected labs growth in the mid single digits and transfusion medicine growth, excluding U. S. Donor screening, in the low single digits increased cross selling efforts of legacy Quidel products outside of the U. Speaker 300:20:43S. More to come on 2025 respiratory expectations as we exit this year, but we expect to use the same forecast methodologies we used this year, which includes the number of flu tests per year, our market share and product mix. We expect COVID-nineteen revenue to decrease year over year by at least $17,000,000 which is related to the 2024 government contract that is not expected to repeat. And importantly, we expect to realize the remaining benefit of our previously announced $100,000,000 in annualized cost savings in the first half of twenty twenty five. We expect these initiatives, among other things, we expect to deliver adjusted EBITDA margin improvement of approximately 100 to 200 basis points compared to the 2024 year end exit rate depending on the timing of the 2024 year end, 2025 respiratory season. Speaker 300:21:41All right, now wrapping up. We believe our solid Q3 performance demonstrates progress as we remain focused on our top priorities and execute on our cost savings and business efficiency initiatives. Based on the progress we are making, we are pleased to reinstate our 2024 financial guidance and provide an initial outlook for 2025. We are optimistic about the path ahead and look forward to providing further updates in future quarters. And with that, I will now ask the operator to please open up the line for questions. Operator00:22:13Absolutely. We will now begin the Q and A session. The first comes from Andrew Brackmann with William Blair. You may proceed. Speaker 400:22:39Hi, guys. Good afternoon. Speaker 500:22:40Thanks for taking the question. Speaker 400:22:42Maybe I can pick up where you left off there, Joe, related to 2025 and the adjusted EBITDA margin target that you sort of laid out there. I think it was 100 to 200 basis points compared to the 24 exit rates. So by my math, I think that means, call it, somewhere in the low 20s, for adjusted EBITDA margin for next year. Can you maybe just sort of talk about high level the building blocks that get you there? How does that $100,000,000 in annualized cost savings roll in throughout the year? Speaker 400:23:09And any other thing cost saving initiatives that we should be penciling in here? Thanks. Speaker 300:23:15Sure. So and by the way, thanks, Andrew. So yes, here's how I put together the more significant building blocks of that 100 to 200 basis points of margin improvement of the exit rate of this year's margin. First, we'll have the roughly $50,000,000 of cost savings that relate to the first $100,000,000 of actions that we've already executed. That will come in the first half of the year. Speaker 300:23:46And then there are additional cost savings initiatives that Brian hinted at in his prepared remarks that we haven't really framed out yet, but these are all in progress. And these are going to be in really all the areas that Brian laid out, I think procurement, IT, really across all the areas. And I would say that this org structure, the flattening of the org structure is probably a good example of what that will be and what types of things that will be in that second tranche of cost savings that's over and above the $100,000,000 that we've already executed on. The third thing is there are some bad guys that I need to call out and this is not shouldn't be surprising. There's going to be a roughly 3% merit increase for our employees, which will have a negative impact, which will have to build in. Speaker 300:24:44And then, of course, there's going to be what I call normal inflation within the business of roughly 1% to 2% that will be a downside in the margin calculation. And then the last thing I'll mention, which was in the script, but just to reiterate it, where or I should say, when the 24, 25 respiratory season starts and ends, which we don't really know at this point, will likely or could, I should say, could have an impact on where the margins eventually land for this year and next year. Speaker 400:25:22Great. Thanks. And then if I could ask just on the Labs business, it sounds like you had some nice placements there in the quarter. You're also seeing some nice sort of recurring revenue growth in that business as well. Can you maybe just sort of remind us your visibility into the underlying demand for the consumables for that business? Speaker 400:25:38And how should we be thinking about that for the balance of Q4, but also into 2025? Thanks guys. Speaker 300:25:45Yes. I would say, Andrew, for the non respiratory business, particularly the labs business and the immunohematology business, there's really good visibility because as you know, most of these contracts we have with our customers are 5 to 7 year contracts and there's very predictable ordering patterns that we have with these customers. And so the non respiratory side of the business, specifically labs, which is your question, is very predictable. So we have good visibility into Q4 and even into next year, I would say. There's always the variability caused by timing that may slip between 1 quarter to the next, but generally, we've got pretty good visibility there. Operator00:26:43Thank you. The next question comes from Jack Meehan with Nephron Research. You may proceed. Speaker 600:26:50Thank you. Good afternoon. I wanted to ask a little bit more on the respiratory season, just checking my math, the guide, the $160,000,000 $170,000,000 of, I guess, COVID, I think that implies $20,000,000 to $30,000,000 in the Q4. I guess, just would love to hear like, what how you went about thinking about what might have been pull forward versus actual demand. It's been like unusual respiratory season given the summer spike, but just, is that I guess just any comments on that would be great. Speaker 300:27:26Jack, this is Joe. Thanks for the question. So if you look at the guide that we just put out, it is true that that the variability or the range that we put out is predominantly in the respiratory space. As I just said to the previous question, the non respiratory side of the business is fairly predictable. So there's not a lot of range in the guide for non respiratory. Speaker 300:27:54It's really all in the respiratory space. The flu season began early last year and we really haven't seen it tick up to that level yet. The ILI, which everyone knows is a public metric that we can all look at, is just beginning to start to tick up. Last time I looked at it, it was like 2% or 3%. And you're right, the midpoint of our guide has respiratory down about 30% year over year. Speaker 300:28:29So based on the data we're seeing from the Southern Hemisphere, there is a chance that volumes overall may be higher than the average flu season, but we are being somewhat prudent on the timing to account for the risk that some of the revenues could land in Q1 'twenty five versus Q4 this year. So going back to Q3 last year, we had a strong Q3 with both flu and COVID. And last year, we expected that trend to continue into Q4 of last year, but it didn't. And so as a result, we all recall respiratory and we missed the quarter last year Q4. So we just really don't intend to do that again. Speaker 300:29:20So we've in the guide this year, we have as I said, we've planned that the COVID numbers have come down to about the range that you just quoted. I think that's a fair number. And that flu would come down slightly as well versus prior year. Speaker 600:29:39Okay. Got it. And then wanted to follow-up on your China comments. Is it possible to frame up on the cardiac side just the potential magnitude of sales that could be exposed there? I'm not sure if that's related to the Yangtze province, the VBP, but just any color would be great. Speaker 600:29:58Thanks. Speaker 300:30:01Yes. There are proposed decreases for certain cardiac marker, specifically I guess BNP reimbursement changes in various provinces. And again, this is different than BPB. Just want to make sure that's clear. We're still assessing the potential impact, Jack, but at this point, we believe it'll be 1% or less of 2025 China revenue. Speaker 300:30:30Got it. Excellent. Thank you. Operator00:30:36Thank you. The next question comes from Bill Bonia with Craig Hallum. You may proceed. Speaker 700:30:43Hey, guys. Thanks a lot. So two questions, one financial, one not. First of all, thanks for providing the assumptions underlying the guidance. It's really helpful and very much appreciate the prudence. Speaker 700:30:57I am hoping you might be able to help me connect the dots a little bit between those assumptions and what sort of the implicit Q4 EBITDA outlook. It seems like if I'm doing my math right at the midpoint, it looks like EBITDA would be down maybe 2.50 basis points or so. That's down about $23,000,000 on $27,000,000 decline in revenue. I'm just sort of trying to understand, okay, which of the assumptions sort of accounts for that and maybe whether or not there was anything any unusual benefit this quarter, it sounds like maybe there's some uptick in sales and marketing costs next quarter and maybe it's that simple. Speaker 300:31:50Yes. Hey, Bill, this is Joe. Good question. And so let's I'll break it down this way. For the year Q4 and again assuming the midpoint of the guide as we just went through on the previous question about the respiratory season, we are assuming a roughly 30% drop in respiratory revenue year over year Q4 to Q4. Speaker 300:32:19And so that GP or adjusted EBITDA impact, the dropping down from that decline in respiratory revenue will be the majority of what you're referring to as the EBITDA drop year over year. But the other big piece there's 2 other pieces, I would say. One, we will have some incremental cost savings in Q4, which is a good guy. But then there's another bad guy offsetting that is the bonus accrual that I mentioned in the prepared remarks. So we did not have a bonus accrual in the previous year Q4 because we missed our performance targets. Speaker 300:33:03This year, we are tracking towards those performance targets and we do have a bonus accrual. And so that dynamic is causing a roughly $25,000,000 to $30,000,000 increase in SG and A year over year in Q4. That's a big part of the story. Speaker 700:33:21Okay. That's super helpful. And I'm glad you have a bonus accrual this year. And then just not financial, but Speaker 300:33:31can you talk to us a Speaker 700:33:32little bit more about the organizational changes that you're making and what you announced? Maybe the rationale for the changes? And then just also how we might think about the risk of disruption and what you're doing to mitigate that risk? Speaker 200:33:53Sure, Bill. This is Brian. Thanks for the question. And really the decision to eliminate our Chief Commercial Officer and COO roles was all about flattening our organization, improving our speed, efficiency and getting closer to our customers. Mike and Rob did a great job for the business, had a really significant impact on our team, especially as we went through the CEO transition earlier in the year. Speaker 200:34:28At the customer level, this really has no impact. All of these changes are kind of at the top of our organization. We've got very strong business unit, regional, commercial and functional leaders in place who are now going to report to me. So I'm excited about this organization and what it means in terms of our ability to operate more effectively and bring more value to our customers. Speaker 700:35:01And just in terms of the commercial organization, I mean, is there a change sort of in the way the sales force is organized? And are you anticipating any other kinds of change in the sales force structure? Or will it be relatively transparent to the sales team? Speaker 200:35:22Yes. This will be, Bill, relatively transparent to the sales team at the customer interface level. We've consolidated our regional structure. So again at the top of the organization from 5 regions to 3 and we've consolidated our business units from 4 to 2. And in doing that have affected a lot of the top of our business but really again our customer facing impact here is nonexistent. Speaker 200:35:58There really isn't any change at all. Speaker 700:36:02Okay. Thank you very much. Operator00:36:07Thank you. The next question comes from Lou Li with UBS. You may proceed. Speaker 800:36:14Great. Thank you so much for taking my questions. I wanted to go back to the China part. I think you mentioned the cardiac reimbursement pressure is not VBP related. Do you think that the other categories could be impacted as well or it just really just the cardiac biomarkers? Speaker 300:36:38Yes. I believe based on what we're hearing now and the research we've done, we believe that it is cardiac only. However, as I said in the remarks, China is a complex environment and we'll continue to monitor and watch it closely. But right now, we believe it's going to be limited to cardiac. Speaker 200:37:05And our business there we're heavily weighted in clinical chemistry and utilize a dry slide technology, which so far the VBP actions have not been focused on. They've been more focused on immunoassay testing and wet chemistry testing in the region. Speaker 800:37:29Got it. And then, do you have any update on the Savanna platform and then also the menu kind of approval timeline? Any color would be great. Speaker 200:37:43Yes. So on Savanna, we continue to be on track with our RPV4X panel to enter clinical trials during the start of this year's respiratory season with the objective being that we'll have approval for that assay in the later part of 2025. We're not expecting any sort of significant revenue impact from that panel in 2025. Most of the ramp up will be in 2026 and 2027. Speaker 800:38:23Thank Speaker 500:38:27you. Operator00:38:35The following comes from Patrick Donnelly with Citi. You may proceed. Speaker 300:38:41Hey, guys. Thank you for taking the questions. Speaker 500:38:44Brian and I'm sure Joe you can jump in as well. Just on the EBITDA side, when you guys think about the path to that mid to high 20s that you talked about, it sounds like next year, nice 200 bps expansion. What are the key levers beyond this next $100,000,000 leg when you look at the organization? Where do you see opportunities? Where do you see those additional levers to continue that margin story towards the mid to high 20s? Speaker 200:39:12Yes. So as Joe mentioned earlier, we're really looking at a number of cost and business process improvement initiatives kind of across the P and L, whether it's in direct costs for our products, which includes everything from instrument components to plastics, biologics, chemicals to a lot of the indirect costs, travel and entertainment, distribution, freight, logistics, seeing what more we can do to be more efficient in R and D, etcetera. So there's a lot of work that we're doing on the just sort of the basic blocking and tackling cost side of the P and L. Speaker 300:39:59In Speaker 200:39:59addition, we're doing more with our commercial organization to focus our teams on the most attractive, most profitable and fastest growing segments where we have competitive differentiation and a right to win. And by doing that, we not only improve our competitive win rate, but we also improve our profitability in doing that. So those are really our key areas of focus across the business. And as we get further into the implementation of some of these programs, we'll be providing additional visibility of those as we move forward. Speaker 900:40:46Okay. Speaker 500:40:47That's helpful. And then another one on China, I noticed you talked about some of the variables, cardiac, EVP. I guess when you think about just that setup for 2025, what are you layering in for China? And then maybe just longer term, how you think about that geography on the growth side would be helpful. Thank you, guys. Speaker 300:41:07Yes. Hey, Patrick, it's Joe. So yes, I mean, we take the same opinion I think most in our space do that it's definitely a complex environment and we're watching very closely all of these moving pieces that you mentioned as well as the Internet corruption policies. But we still believe that given all that's going on, we still believe this year is going to be high single digit growth in China. And for next year, I would probably frame it as somewhere between mid single digit to high single digit and more to come on that as we frame out our 2025 operating plan and then we'll talk more about it as we report on 2024 results in February. Speaker 300:41:56But we still as I said before, we still see that there's more opportunity than risks and we business there is pretty solid. Speaker 500:42:06Sounds good. Thanks, Joe. Sure. Operator00:42:11Thank you. The next question comes from Andrew Cooper with Raymond James. Your line is open. Speaker 1000:42:19Hey, everybody. Thanks for the question. A lot has already been asked and you covered a lot in the prepared remarks. So maybe just one quick one for me. You talked about plans for increasing the cross selling efforts on the legacy Quidel side. Speaker 1000:42:31I mean, we can go back to 2018 and the Triage deal and trying to do that internationally with Sofia and QuickVue. How do you operationalize that? Like I said, it's been a long time where we haven't really seen that play out. So maybe just give us a sense for how you refocus the sales force on that? How you incentivize it? Speaker 1000:42:49And what you think it can contribute in terms of growth either in 2025 or over the longer term? Speaker 200:42:58Yes. My observation on that, thank you for the question Andrew, is that I think we've made some progress there, but we're in relatively early innings with cross selling. I think we probably do more there with our triage product line than anything else. And so we are looking at how we can more effectively approach the market with that strategy. Again, focusing more utilizing our direct commercial force as opposed to reliance on distributors which largely our Sofia business is heavily dependent on. Speaker 200:43:43So the opportunity there is to maybe shift more from that channel to the direct channel. And we're trying to understand how we can do that and incent our teams to effectively compete that way. Speaker 1000:43:59Okay. I'll stop there and let others ask. Thanks. Operator00:44:08Thank you. The following comes from Connor McNamara with RBC Capital Markets. You may proceed. Speaker 900:44:23Good evening. This is Ricardo Moreno for Connor. Speaker 500:44:26Thank you for taking the question. Just wanted to ask what were some of the insights you have about current opportunities within the funnel that coincide with the $28,000,000,000 China stimulus for equipment as it starts rolling into 2025? Speaker 300:44:42Is this as related to China? Stimulus. Speaker 900:44:46Yes. As it relates to China. Speaker 200:44:49Yes. I mean, we see potential headwinds in terms of the value based pricing initiatives and the anti corruption policies that are being implemented. The stimulus could be a potential tailwind, but I think it's still a little early for us to understand how that's really going to play out in our market. And so we're still just in the early stages of monitoring that and the impact on our business. Speaker 900:45:23Thank you. And then just one more on the immuno business. A lot of those contracts are been 5 to 7 years, in particular those instruments replaced during COVID in 2020. Where do you see the dynamics of the equipment replacement cycle happening starting now going into 2025? Speaker 200:45:48Generally speaking, whether it's our labs business or our point of care business, we do have longer contract cycles. We have very high retention rates on our existing placements and we have a positive win loss ratio on new business. So I think the overall dynamic there really supports the stability of our underlying business model and that sort of mid single digit growth rate, especially for our Labs business. Speaker 500:46:26Thank you so much. Good job on the quarter. Operator00:46:30Thank you. Thank you. The final question comes from Casey Woodring with JPMorgan. You may proceed. Speaker 500:46:39Great. Thank you for taking my questions. Maybe to piggyback on Patrick's question a little bit earlier. That second tranche of cost savings you mentioned on top of that $100,000,000 run rate in savings here in that first tranche, would you realize those in 2025? And would those help bridge kind of the gap in 2026 and 2027 between below 20s EBITDA margin in 2025 and that kind of mid to high 20s margin in the outer years that target is maintained? Speaker 500:47:06Or would you see would you need to see more kind of cost savings and execution to reach that? Speaker 300:47:17Hey, KC, it's Joe. Yes, I think that this second tranche that was mentioned in Brian's prepared remarks would have an impact into 2025 and 2026. It's not all 2025. And again, we'll try to provide more visibility into sizing that up on the next quarterly call as we get through it. And I think just keep in mind that we are going to be moving to what I would call a continuous improvement culture of looking for cost savings and efficiency. Speaker 300:47:52So there certainly will be more to come. The other area I'd call out as a tailwind, if you will, from the margin improvement is going to be the exit of the donor screening business. That's a dilutive business as you know. And as we exit that at the end of next year, that's going to provide a tailwind to the margins as well. Speaker 500:48:23Okay. Got it. So that the low 20s and 25s assumes cost savings that you haven't identified yet? Is that kind of a particular? Speaker 300:48:32Well, I would say it a different way. I would say that we haven't fully communicated to you yet into The Street, but we have a majority of it fleshed out. And again, a good example is the flattening of the organization that Brian mentioned today. Speaker 500:48:50Okay, got it. Helpful. And maybe just one last one quickly. Your respiratory framework, can you just give us an updated picture on what the competitive landscape looks like there? And you noted that we should expect similar market share to 2023. Speaker 500:49:06Can you just remind us kind of where you saw that last year and what it looks like now? I know that there's a number of players in that space that have been talking about solid growth in their own respiratory panels. So just kind of curious on the updated picture of the share. Thank you. Speaker 300:49:23Sure. Yes. So we are the leader in the respiratory space. I think the other large players are going to be Abbott and DD and then there's some smaller players. And we've got a decent track record of the last couple of years post pandemic of taking market share. Speaker 300:49:43And as I said in the guidance that we have provided, we've assumed similar market share to last year. But obviously internally, we are working very hard to increase our market share and beat that target. So more to come again as we finalize in this respiratory season. When we talk to you guys in February, we can report on what that looks like.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallQuidelOrtho Q3 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsSlide DeckPress Release(8-K)Quarterly report(10-Q) QuidelOrtho Earnings HeadlinesQ1 EPS Estimates for QuidelOrtho Reduced by William BlairMay 3, 2025 | americanbankingnews.comQuidelOrtho Corporation (QDEL): Among Billionaire David Harding’s Stock Picks with Huge Upside PotentialMay 1, 2025 | insidermonkey.comURGENT: Someone's Moving Gold Out of London...People who don’t understand the gold market are about to lose a lot of money. Unfortunately, most so-called “gold analysts” have it all wrong… They tell you to invest in gold ETFs - because the popular mining ETFs will someday catch fire and close the price gap with spot gold. May 7, 2025 | Golden Portfolio (Ad)QuidelOrtho to Report First Quarter 2025 Financial Results | QDEL Stock NewsApril 23, 2025 | gurufocus.comQuidelOrtho to Report First Quarter 2025 Financial ResultsApril 23, 2025 | businesswire.comJ.P. Morgan Keeps Their Sell Rating on QuidelOrtho (QDEL)April 19, 2025 | markets.businessinsider.comSee More QuidelOrtho Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like QuidelOrtho? Sign up for Earnings360's daily newsletter to receive timely earnings updates on QuidelOrtho and other key companies, straight to your email. Email Address About QuidelOrthoQuidelOrtho (NASDAQ:QDEL) provides diagnostic testing solutions. The company operates through Labs, Transfusion Medicine, Point-of-Care, and Molecular Diagnostics business units. The Labs business unit provides clinical chemistry laboratory instruments and tests that measure target chemicals in bodily fluids for the evaluation of health and the clinical management of patients; immunoassay laboratory instruments and tests, which measure proteins as they act as antigens in the spread of disease, antibodies in the immune response spurred by disease, or markers of proper organ function and health; testing products to detect and monitor disease progression across a spectrum of therapeutic areas; and specialized diagnostic solutions. The Transfusion Medicine business unit offers immunohematology instruments and tests used for blood typing to ensure patient-donor compatibility in blood transfusions; and donor screening instruments and tests used for blood and plasma screening for infectious diseases. The Point-of-Care business unit provides instruments and tests to provide rapid results across a continuum of point-of-care settings. The Molecular Diagnostics business unit offers polymerase chain reaction thermocyclers; amplification systems; and sample-to-result molecular instruments and tests for syndromic infectious disease diagnostics. The company sells its products directly to end users through a direct sales force; and through a network of distributors for professional use in physician offices, hospitals, clinical laboratories, reference laboratories, urgent care clinics, universities, retail clinics, pharmacies, wellness screening centers, blood banks, and donor centers, as well as for individual, non-professional, and over-the-counter use. It operates in North America, Europe, the Middle East, Africa, China, and internationally. 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There are 11 speakers on the call. Operator00:00:00Welcome to the Quidel Ortho Third Quarter 20 24 Financial Results Conference Call and Webcast. At this time, all participant lines are in a listen only mode. For those of you participating on the conference call, there will be an opportunity for your questions at the end of today's prepared remarks. Please note this conference call is being recorded. An audio replay of the conference call will be available on the company's website shortly after this call. Operator00:00:23I would now like to turn the call over to Juliet Cunningham, Vice President of Investor Relations. Speaker 100:00:30Thank you. Good afternoon, everyone. Thanks for joining the Quidel Ortho Third Quarter 2024 Financial Results Conference Call. With me today are Brian Blaser, President and Chief Executive Officer and Joe Buskey, Chief Financial Officer. This conference call is being simultaneously webcast on the Investor Relations page of our website. Speaker 100:00:52To aid in the discussion, we posted a supplemental presentation on the Investor Relations page that will be referenced throughout this call. This conference call contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not strictly historical, including the company's expectations, plans, future performance and prospects are forward looking statements that are subject to certain risks, uncertainty, assumptions and other factors. Actual results may vary materially from those expressed or implied in these forward looking statements. Information about potential factors that could affect our actual results is available in our annual report on Form 10 ks for the 2023 fiscal year and subsequent reports filed with the SEC, including the Risk Factors section. Speaker 100:01:54Forward looking statements are made as of today, November 7, 2024, and we assume no obligation to update any forward looking statement except as required by law. In addition, today's call includes discussion of certain non GAAP financial measures. Tables reconciling these non GAAP measures to their most directly comparable GAAP measures are available in our earnings release and the supplemental presentation, which are on the Investor Relations page of our website at quietortho.com. Lastly, unless stated otherwise, all year over year revenue growth rates given on today's call are given on a comparable constant currency basis. And now I'd like to turn the call over to our CEO, Brian Blaser. Speaker 200:02:44Thanks, Juliet. Good afternoon, everyone. I'm pleased to be here with you today and share our Q3 2024 results. We reported 3rd quarter revenue of $727,000,000 adjusted EBITDA of $171,000,000 and adjusted diluted EPS of $0.85 Our results demonstrate solid progress in executing our business improvement initiatives, including our previously communicated $100,000,000 in annualized cost savings that we expect to realize through the first half of twenty twenty five. After my remarks, Joe will cover our detailed quarterly financials as well as provide our full year 2024 financial guidance, which we reinstated today. Speaker 300:03:29I would also like to Speaker 200:03:30highlight the key focus areas where we see the greatest opportunity for improvement in profitability and growth. During my 1st 6 months here at Quidel Ortho, we undertook an extensive review of every part of the business. I continue to be excited by the opportunity to serve our customers across the entire healthcare continuum and meet patients' needs in every care setting and at every step of the journey from prevention to diagnosis, treatment and monitoring. To meet those needs and to do so profitably, we need the right people, the right products, rigorous discipline and a strong cultural mindset that places customers and quality first. With that objective in mind, we strengthened our leadership team with the recent addition of 2 highly experienced industry leaders, Jonathan Segrist as Chief Technology Officer and Lee Bowman as Chief Human Resources Officer. Speaker 200:04:27Jonathan has a proven 15 year track record in molecular diagnostics, microfluidic platforms and biomedical engineering. He most recently was the CTO and Head of Assay Research and Development at Cepheid. Lee brings over 25 years of experience leading teams through transformative initiatives in workforce engagement and leadership development at Edwards Life Sciences, Levi Strauss and Company and Target. Lee's expertise in developing talent in a high performing workplace is critical as we create a winning continuous improvement culture and drive continued growth here at Clyde El Ortho. In addition, we are aligning our leadership structure to be a flatter, more agile organization to increase our customer focus, reduce complexity and improve our efficiency and cost structure. Speaker 200:05:21As part of this effort, Mike Istra, Chief Commercial Officer and Rob Budjarski, Chief Operating Officer will be leaving the company. We're grateful to Mike and Rob for their contributions in leading the Quidel Ortho commercial and operations teams and fostering a culture of collaboration. Going forward, our global regions will be fully aligned with our business units and both the business unit and global regional leaders will report directly to me. The alignment of our leadership team is designed to improve the way we run the business and enable us to achieve consistently improved performance over time. We believe the changes we are making are designed to better leverage the scale of our global commercial team, accelerate cross selling opportunities and continue to build a customer focused organization. Speaker 200:06:09As part of delivering on our customer commitments, we remain steadfast in achieving our product timelines and improving our business efficiency. Under Jonathan's leadership, we're focused on executing our key R and D priorities including increasing our R and D productivity, expanding our menu and advancing critical platforms. While Savanna is only one of our initiatives, we believe Savanna and Molecular in general is an important driver of future profitable revenue growth. We plan to enter clinical trials with our respiratory panel as the respiratory season develops and to be in market in the later part of 2025. To improve our cost structure, we are also in the early phases of implementing cost and process improvement initiatives in procurement, supply chain, manufacturing quality and IT. Speaker 200:07:00We expect these initiatives to enable us to operate more effectively and deliver incremental margin contributions in 20252026. We plan to provide greater detail in the coming quarters as we move ahead. Lastly, I think it bears repeating that we are focused on challenging every aspect of our business to do more for our customers and improve profitable growth. I'm proud to be the leader of Fidel Ortho. I'm excited about the improvements that we're making and I look forward to updating you on our progress next quarter. Speaker 200:07:34With that, I'll hand it over to Joe. Speaker 300:07:37Okay. Thanks, Brian. Let's begin with the details of our Q3 year to date 2024 results on Slides 34 of the earnings presentation, which is posted on our IR website. I will also provide our reinstated full year 2024 financial guidance, and then we will open up the call for questions. Unless stated otherwise, all year over year revenue growth rates on today's call are provided on a comparable constant currency basis. Speaker 300:08:06During the Q3 and the 1st 9 months of 2024, our business performed well, and we continue to see healthy customer demand and momentum. Total reported revenue in the Q3 of 2024 was $727,000,000 which declined by approximately 2% due to higher COVID-nineteen and flu revenue in the prior year period. While foreign currency exchange did not have a material impact on overall 3rd quarter results, we had a negative 100 basis point FX impact in our Labs business, which is our global footprint. Q3 2024 recurring revenue, which we define as revenues from sales of our assays, reagents, consumables and services and excludes instrument revenue, was $598,000,000 as reported with no significant change in constant currency. This figure excludes COVID-nineteen and U. Speaker 300:09:02S. Donor screening revenue. Recurring revenue growth was 1% in Q3. Underlying labs recurring revenue growth was 6% but was offset by a decline in cardiac revenue mainly due to expected order timing between Q3 and Q4 in China. Total reported year to date revenue was $2,100,000,000 and total year to date recurring revenue was $1,740,000,000 or 5% growth compared to the prior year period. Speaker 300:09:35Again, this excludes COVID-nineteen and U. S. Donor screening revenue. From a regional perspective, our Q3 2024 total revenue performance was led by EMEA growth of 12% and 8% growth in our other region, which is comprised of Japan, Asia Pacific and Latin America. North America declined by mid single digits due to higher respiratory revenue in the prior year period and U. Speaker 300:10:02S. Donor screening business wind down. In China, our Labs business grew 5% year over year, but that growth was offset by softness in transfusion medicine and cardiac point of care products. As a result, China revenue declined by 1% year over year. We continue to expect growth in the region to be strong in Q4 and in the high single digits for the full year 2024. Speaker 300:10:32We continue to closely monitor both value based pricing initiatives and the impact of China's anti corruption policies as potential headwinds. We have not been meaningfully impacted by BPB initiatives to date and do not expect significant impact in the near term. As we discussed last quarter, we have seen customer delays in a small number of instrument purchases and installations due to the Chinese government's anti corruption policies. We believe these disruptions will abate in 2025 as customers adjust to these ongoing governmental policies. In addition, there may be some changes to reimbursement on cardiac products in certain Chinese provinces, which could negatively impact our sales of China. Speaker 300:11:18On the positive side, the recently announced economic stimulus planned by the Chinese government could represent the potential future tailwind. China continues to be a complex market that we are monitoring closely, but despite these dynamics, we believe our China business is solid and we see more potential upside than risk at this time. Moving to our non respiratory business, which includes labs, transfusion medicine and cardiac point of care products. 3rd quarter 2024 revenue grew 1% in constant currency year over year. Labs revenue achieved expected growth of 5% compared to the prior year period. Speaker 300:11:57Within our Labs installed base, integrated and automated analyzers grew 7% 17%, respectively, compared to the prior year period. The growth in integrated and automated analyzers continues to show that our commercial go to market strategy is working, and we continue to expect mid single digit revenue growth in this business. Moving to Transfusion Medicine, I want to highlight that we are now breaking out immunohematology and donor screening as separate line items to provide greater transparency to the impact of largely winding down the U. S. Donor screening business by the end of 2025. Speaker 300:12:38Immunohematology revenue grew 3% and donor screening declined by 20% in the quarter as expected. The respiratory side of the business performed well versus our expectations during the Q3 with strong performance from our Sofia flu COVID-nineteen combo test, and we had $72,000,000 in COVID-nineteen revenue in the quarter. On a year over year basis, total Q3 respiratory revenue was down $20,000,000 or 11% due to higher COVID-nineteen and flu revenue in the prior year period. In addition, our distributors began their normal ordering patterns for flu RSV Strep products ahead of the 4th quarter, which points to a typical flu season. I'd also note that distributor respiratory inventories were at expected levels, which were slightly down compared to the prior year period. Speaker 300:13:34Now moving down the P and L, Slide 5 shows Q3 2024 adjusted gross profit margin of 49.2% versus 50.5% in the prior year period. The 130 basis point decrease was expected and primarily driven by higher COVID-nineteen and flu sales in the prior year period. Non GAAP operating expenses of $232,000,000 including SG and A and R and D decreased by $17,000,000 compared to the prior year period and was down sequentially by $4,000,000 We continue to expect a benefit of at least $50,000,000 in the second half of twenty twenty four due to the cost actions we have already taken. And looking ahead to Q4 on a sequential basis, we expect our realized cost savings and total OpEx to be offset by timing of selling and marketing costs in Q4. As a result, we expect total OpEx to be relatively flat to Q3. Speaker 300:14:36Adjusted EBITDA was $171,000,000 compared to 100 and $69,000,000 in the prior year period. Adjusted EBITDA margin was 23.5%, which represents a year over year improvement of 80 basis points due to the cost savings actions we have taken, offset by lower revenue for respiratory tests, which are high margin contributors. Notably, Q3 2024 was the Q1 in 9 quarters to achieve growth in both adjusted EBITDA dollars and margin since the pandemic. Adjusted diluted earnings per share was $0.85 compared to adjusted diluted EPS of $0.90 in the prior year period. This year over year change was primarily due to the higher respiratory revenue in the prior year period and higher interest expense in the current period, offset by our cost savings initiatives. Speaker 300:15:33Our 3rd quarter effective adjusted income tax rate was 23.7 percent, which is in line with our full year expectations. Turning now to the balance sheet on Slide 6. We finished the quarter with $144,000,000 of cash. As of the end of Q3, we had $230,000,000 in borrowings on our $800,000,000 revolver. This is a decrease of $23,000,000 from the 2nd quarter as we begin to pay down the revolver. Speaker 300:16:04Keep in mind, our first capital allocation priority continues to be debt pay down. Q3 2024 recurring adjusted free cash flow was $120,000,000 which represents 70% of adjusted EBITDA. We continue to expect adjusted free cash flow to be positive in the Q4 and for the full year 2024. In addition, we expect adjusted recurring free cash flow in the second half of 'twenty four to exceed 50 percent of our second half adjusted EBITDA. During the Q3 of 'twenty four, our consolidated leverage ratio from the base of the financials is 4.1 times and 3.3 times including pro form a EBITDA adjustments as permitted and defined under our credit agreement. Speaker 300:16:53Based on our current projections, we expect our consolidated leverage ratio to remain relatively flat to current levels at year end. Lastly, on Slide 7, following the business review that Brian conducted upon joining the company as well as the increased visibility we have after executing some of our cost savings initiatives, I will now provide our full year 2024 guidance. I note that our guidance is in line with the comments we made earlier in the year. We expect full year 2024 total reported revenues of between $2,750,000,000 $2,801,000,000 adjusted EBITDA of between $530,000,000 $550,000,000 which equates to a range of 19.3% to 19.6 percent adjusted EBITDA margin and adjusted diluted EPS of between $1.69 1.91 These expectations are based on a set of assumptions that follow. We assume Q4 2024 non respiratory revenue will be in line with the commentary we shared earlier this year, including labs, business growth expected in the mid single digits and transfusion medicine excluding U. Speaker 300:18:21S. Donor screening expected to grow in the low single digits. Now for respiratory revenue, we assume a typical flu season this year with a $50,000,000 to $55,000,000 test market, similar market share to 2023 and greater than 50% of flu product revenue coming from our combo test. Note that we are not changing our full year assumptions on the respiratory season from earlier this year. In our view, the higher respiratory revenue we saw in Q3 is timing related and not expected to increase our full year 2024 outlook. Speaker 300:18:59In addition, we assume full year 2024 COVID-nineteen revenue will be in the range of 100 and $60,000,000 to $170,000,000 which includes about $17,000,000 in government contracts in 2024. We assume cost savings of at least $50,000,000 in the second half of twenty twenty four as part of our $100,000,000 annualized target. And note that in Q4, we also assume a year over year increase of $25,000,000 to $30,000,000 in SG and A expense related to expected bonus accruals that were not included in the prior year period since we did not meet our performance targets last year. We assume second half and full year 2024 positive adjusted free cash flow to exceed 50% of adjusted EBITDA, including expected full year interest expense of $160,000,000 to $165,000,000 and we assume CapEx of approximately $170,000,000 excluding reagent rentals. Plan to provide our detailed 2025 financial guidance when we report our full year 2024 results in February. Speaker 300:20:15But directionally in 2025, we are expecting top line growth in the mid single digits, excluding COVID-nineteen and U. S. Donor screening revenue, which we expect to be $40,000,000 to $50,000,000 as that business winds down expected labs growth in the mid single digits and transfusion medicine growth, excluding U. S. Donor screening, in the low single digits increased cross selling efforts of legacy Quidel products outside of the U. Speaker 300:20:43S. More to come on 2025 respiratory expectations as we exit this year, but we expect to use the same forecast methodologies we used this year, which includes the number of flu tests per year, our market share and product mix. We expect COVID-nineteen revenue to decrease year over year by at least $17,000,000 which is related to the 2024 government contract that is not expected to repeat. And importantly, we expect to realize the remaining benefit of our previously announced $100,000,000 in annualized cost savings in the first half of twenty twenty five. We expect these initiatives, among other things, we expect to deliver adjusted EBITDA margin improvement of approximately 100 to 200 basis points compared to the 2024 year end exit rate depending on the timing of the 2024 year end, 2025 respiratory season. Speaker 300:21:41All right, now wrapping up. We believe our solid Q3 performance demonstrates progress as we remain focused on our top priorities and execute on our cost savings and business efficiency initiatives. Based on the progress we are making, we are pleased to reinstate our 2024 financial guidance and provide an initial outlook for 2025. We are optimistic about the path ahead and look forward to providing further updates in future quarters. And with that, I will now ask the operator to please open up the line for questions. Operator00:22:13Absolutely. We will now begin the Q and A session. The first comes from Andrew Brackmann with William Blair. You may proceed. Speaker 400:22:39Hi, guys. Good afternoon. Speaker 500:22:40Thanks for taking the question. Speaker 400:22:42Maybe I can pick up where you left off there, Joe, related to 2025 and the adjusted EBITDA margin target that you sort of laid out there. I think it was 100 to 200 basis points compared to the 24 exit rates. So by my math, I think that means, call it, somewhere in the low 20s, for adjusted EBITDA margin for next year. Can you maybe just sort of talk about high level the building blocks that get you there? How does that $100,000,000 in annualized cost savings roll in throughout the year? Speaker 400:23:09And any other thing cost saving initiatives that we should be penciling in here? Thanks. Speaker 300:23:15Sure. So and by the way, thanks, Andrew. So yes, here's how I put together the more significant building blocks of that 100 to 200 basis points of margin improvement of the exit rate of this year's margin. First, we'll have the roughly $50,000,000 of cost savings that relate to the first $100,000,000 of actions that we've already executed. That will come in the first half of the year. Speaker 300:23:46And then there are additional cost savings initiatives that Brian hinted at in his prepared remarks that we haven't really framed out yet, but these are all in progress. And these are going to be in really all the areas that Brian laid out, I think procurement, IT, really across all the areas. And I would say that this org structure, the flattening of the org structure is probably a good example of what that will be and what types of things that will be in that second tranche of cost savings that's over and above the $100,000,000 that we've already executed on. The third thing is there are some bad guys that I need to call out and this is not shouldn't be surprising. There's going to be a roughly 3% merit increase for our employees, which will have a negative impact, which will have to build in. Speaker 300:24:44And then, of course, there's going to be what I call normal inflation within the business of roughly 1% to 2% that will be a downside in the margin calculation. And then the last thing I'll mention, which was in the script, but just to reiterate it, where or I should say, when the 24, 25 respiratory season starts and ends, which we don't really know at this point, will likely or could, I should say, could have an impact on where the margins eventually land for this year and next year. Speaker 400:25:22Great. Thanks. And then if I could ask just on the Labs business, it sounds like you had some nice placements there in the quarter. You're also seeing some nice sort of recurring revenue growth in that business as well. Can you maybe just sort of remind us your visibility into the underlying demand for the consumables for that business? Speaker 400:25:38And how should we be thinking about that for the balance of Q4, but also into 2025? Thanks guys. Speaker 300:25:45Yes. I would say, Andrew, for the non respiratory business, particularly the labs business and the immunohematology business, there's really good visibility because as you know, most of these contracts we have with our customers are 5 to 7 year contracts and there's very predictable ordering patterns that we have with these customers. And so the non respiratory side of the business, specifically labs, which is your question, is very predictable. So we have good visibility into Q4 and even into next year, I would say. There's always the variability caused by timing that may slip between 1 quarter to the next, but generally, we've got pretty good visibility there. Operator00:26:43Thank you. The next question comes from Jack Meehan with Nephron Research. You may proceed. Speaker 600:26:50Thank you. Good afternoon. I wanted to ask a little bit more on the respiratory season, just checking my math, the guide, the $160,000,000 $170,000,000 of, I guess, COVID, I think that implies $20,000,000 to $30,000,000 in the Q4. I guess, just would love to hear like, what how you went about thinking about what might have been pull forward versus actual demand. It's been like unusual respiratory season given the summer spike, but just, is that I guess just any comments on that would be great. Speaker 300:27:26Jack, this is Joe. Thanks for the question. So if you look at the guide that we just put out, it is true that that the variability or the range that we put out is predominantly in the respiratory space. As I just said to the previous question, the non respiratory side of the business is fairly predictable. So there's not a lot of range in the guide for non respiratory. Speaker 300:27:54It's really all in the respiratory space. The flu season began early last year and we really haven't seen it tick up to that level yet. The ILI, which everyone knows is a public metric that we can all look at, is just beginning to start to tick up. Last time I looked at it, it was like 2% or 3%. And you're right, the midpoint of our guide has respiratory down about 30% year over year. Speaker 300:28:29So based on the data we're seeing from the Southern Hemisphere, there is a chance that volumes overall may be higher than the average flu season, but we are being somewhat prudent on the timing to account for the risk that some of the revenues could land in Q1 'twenty five versus Q4 this year. So going back to Q3 last year, we had a strong Q3 with both flu and COVID. And last year, we expected that trend to continue into Q4 of last year, but it didn't. And so as a result, we all recall respiratory and we missed the quarter last year Q4. So we just really don't intend to do that again. Speaker 300:29:20So we've in the guide this year, we have as I said, we've planned that the COVID numbers have come down to about the range that you just quoted. I think that's a fair number. And that flu would come down slightly as well versus prior year. Speaker 600:29:39Okay. Got it. And then wanted to follow-up on your China comments. Is it possible to frame up on the cardiac side just the potential magnitude of sales that could be exposed there? I'm not sure if that's related to the Yangtze province, the VBP, but just any color would be great. Speaker 600:29:58Thanks. Speaker 300:30:01Yes. There are proposed decreases for certain cardiac marker, specifically I guess BNP reimbursement changes in various provinces. And again, this is different than BPB. Just want to make sure that's clear. We're still assessing the potential impact, Jack, but at this point, we believe it'll be 1% or less of 2025 China revenue. Speaker 300:30:30Got it. Excellent. Thank you. Operator00:30:36Thank you. The next question comes from Bill Bonia with Craig Hallum. You may proceed. Speaker 700:30:43Hey, guys. Thanks a lot. So two questions, one financial, one not. First of all, thanks for providing the assumptions underlying the guidance. It's really helpful and very much appreciate the prudence. Speaker 700:30:57I am hoping you might be able to help me connect the dots a little bit between those assumptions and what sort of the implicit Q4 EBITDA outlook. It seems like if I'm doing my math right at the midpoint, it looks like EBITDA would be down maybe 2.50 basis points or so. That's down about $23,000,000 on $27,000,000 decline in revenue. I'm just sort of trying to understand, okay, which of the assumptions sort of accounts for that and maybe whether or not there was anything any unusual benefit this quarter, it sounds like maybe there's some uptick in sales and marketing costs next quarter and maybe it's that simple. Speaker 300:31:50Yes. Hey, Bill, this is Joe. Good question. And so let's I'll break it down this way. For the year Q4 and again assuming the midpoint of the guide as we just went through on the previous question about the respiratory season, we are assuming a roughly 30% drop in respiratory revenue year over year Q4 to Q4. Speaker 300:32:19And so that GP or adjusted EBITDA impact, the dropping down from that decline in respiratory revenue will be the majority of what you're referring to as the EBITDA drop year over year. But the other big piece there's 2 other pieces, I would say. One, we will have some incremental cost savings in Q4, which is a good guy. But then there's another bad guy offsetting that is the bonus accrual that I mentioned in the prepared remarks. So we did not have a bonus accrual in the previous year Q4 because we missed our performance targets. Speaker 300:33:03This year, we are tracking towards those performance targets and we do have a bonus accrual. And so that dynamic is causing a roughly $25,000,000 to $30,000,000 increase in SG and A year over year in Q4. That's a big part of the story. Speaker 700:33:21Okay. That's super helpful. And I'm glad you have a bonus accrual this year. And then just not financial, but Speaker 300:33:31can you talk to us a Speaker 700:33:32little bit more about the organizational changes that you're making and what you announced? Maybe the rationale for the changes? And then just also how we might think about the risk of disruption and what you're doing to mitigate that risk? Speaker 200:33:53Sure, Bill. This is Brian. Thanks for the question. And really the decision to eliminate our Chief Commercial Officer and COO roles was all about flattening our organization, improving our speed, efficiency and getting closer to our customers. Mike and Rob did a great job for the business, had a really significant impact on our team, especially as we went through the CEO transition earlier in the year. Speaker 200:34:28At the customer level, this really has no impact. All of these changes are kind of at the top of our organization. We've got very strong business unit, regional, commercial and functional leaders in place who are now going to report to me. So I'm excited about this organization and what it means in terms of our ability to operate more effectively and bring more value to our customers. Speaker 700:35:01And just in terms of the commercial organization, I mean, is there a change sort of in the way the sales force is organized? And are you anticipating any other kinds of change in the sales force structure? Or will it be relatively transparent to the sales team? Speaker 200:35:22Yes. This will be, Bill, relatively transparent to the sales team at the customer interface level. We've consolidated our regional structure. So again at the top of the organization from 5 regions to 3 and we've consolidated our business units from 4 to 2. And in doing that have affected a lot of the top of our business but really again our customer facing impact here is nonexistent. Speaker 200:35:58There really isn't any change at all. Speaker 700:36:02Okay. Thank you very much. Operator00:36:07Thank you. The next question comes from Lou Li with UBS. You may proceed. Speaker 800:36:14Great. Thank you so much for taking my questions. I wanted to go back to the China part. I think you mentioned the cardiac reimbursement pressure is not VBP related. Do you think that the other categories could be impacted as well or it just really just the cardiac biomarkers? Speaker 300:36:38Yes. I believe based on what we're hearing now and the research we've done, we believe that it is cardiac only. However, as I said in the remarks, China is a complex environment and we'll continue to monitor and watch it closely. But right now, we believe it's going to be limited to cardiac. Speaker 200:37:05And our business there we're heavily weighted in clinical chemistry and utilize a dry slide technology, which so far the VBP actions have not been focused on. They've been more focused on immunoassay testing and wet chemistry testing in the region. Speaker 800:37:29Got it. And then, do you have any update on the Savanna platform and then also the menu kind of approval timeline? Any color would be great. Speaker 200:37:43Yes. So on Savanna, we continue to be on track with our RPV4X panel to enter clinical trials during the start of this year's respiratory season with the objective being that we'll have approval for that assay in the later part of 2025. We're not expecting any sort of significant revenue impact from that panel in 2025. Most of the ramp up will be in 2026 and 2027. Speaker 800:38:23Thank Speaker 500:38:27you. Operator00:38:35The following comes from Patrick Donnelly with Citi. You may proceed. Speaker 300:38:41Hey, guys. Thank you for taking the questions. Speaker 500:38:44Brian and I'm sure Joe you can jump in as well. Just on the EBITDA side, when you guys think about the path to that mid to high 20s that you talked about, it sounds like next year, nice 200 bps expansion. What are the key levers beyond this next $100,000,000 leg when you look at the organization? Where do you see opportunities? Where do you see those additional levers to continue that margin story towards the mid to high 20s? Speaker 200:39:12Yes. So as Joe mentioned earlier, we're really looking at a number of cost and business process improvement initiatives kind of across the P and L, whether it's in direct costs for our products, which includes everything from instrument components to plastics, biologics, chemicals to a lot of the indirect costs, travel and entertainment, distribution, freight, logistics, seeing what more we can do to be more efficient in R and D, etcetera. So there's a lot of work that we're doing on the just sort of the basic blocking and tackling cost side of the P and L. Speaker 300:39:59In Speaker 200:39:59addition, we're doing more with our commercial organization to focus our teams on the most attractive, most profitable and fastest growing segments where we have competitive differentiation and a right to win. And by doing that, we not only improve our competitive win rate, but we also improve our profitability in doing that. So those are really our key areas of focus across the business. And as we get further into the implementation of some of these programs, we'll be providing additional visibility of those as we move forward. Speaker 900:40:46Okay. Speaker 500:40:47That's helpful. And then another one on China, I noticed you talked about some of the variables, cardiac, EVP. I guess when you think about just that setup for 2025, what are you layering in for China? And then maybe just longer term, how you think about that geography on the growth side would be helpful. Thank you, guys. Speaker 300:41:07Yes. Hey, Patrick, it's Joe. So yes, I mean, we take the same opinion I think most in our space do that it's definitely a complex environment and we're watching very closely all of these moving pieces that you mentioned as well as the Internet corruption policies. But we still believe that given all that's going on, we still believe this year is going to be high single digit growth in China. And for next year, I would probably frame it as somewhere between mid single digit to high single digit and more to come on that as we frame out our 2025 operating plan and then we'll talk more about it as we report on 2024 results in February. Speaker 300:41:56But we still as I said before, we still see that there's more opportunity than risks and we business there is pretty solid. Speaker 500:42:06Sounds good. Thanks, Joe. Sure. Operator00:42:11Thank you. The next question comes from Andrew Cooper with Raymond James. Your line is open. Speaker 1000:42:19Hey, everybody. Thanks for the question. A lot has already been asked and you covered a lot in the prepared remarks. So maybe just one quick one for me. You talked about plans for increasing the cross selling efforts on the legacy Quidel side. Speaker 1000:42:31I mean, we can go back to 2018 and the Triage deal and trying to do that internationally with Sofia and QuickVue. How do you operationalize that? Like I said, it's been a long time where we haven't really seen that play out. So maybe just give us a sense for how you refocus the sales force on that? How you incentivize it? Speaker 1000:42:49And what you think it can contribute in terms of growth either in 2025 or over the longer term? Speaker 200:42:58Yes. My observation on that, thank you for the question Andrew, is that I think we've made some progress there, but we're in relatively early innings with cross selling. I think we probably do more there with our triage product line than anything else. And so we are looking at how we can more effectively approach the market with that strategy. Again, focusing more utilizing our direct commercial force as opposed to reliance on distributors which largely our Sofia business is heavily dependent on. Speaker 200:43:43So the opportunity there is to maybe shift more from that channel to the direct channel. And we're trying to understand how we can do that and incent our teams to effectively compete that way. Speaker 1000:43:59Okay. I'll stop there and let others ask. Thanks. Operator00:44:08Thank you. The following comes from Connor McNamara with RBC Capital Markets. You may proceed. Speaker 900:44:23Good evening. This is Ricardo Moreno for Connor. Speaker 500:44:26Thank you for taking the question. Just wanted to ask what were some of the insights you have about current opportunities within the funnel that coincide with the $28,000,000,000 China stimulus for equipment as it starts rolling into 2025? Speaker 300:44:42Is this as related to China? Stimulus. Speaker 900:44:46Yes. As it relates to China. Speaker 200:44:49Yes. I mean, we see potential headwinds in terms of the value based pricing initiatives and the anti corruption policies that are being implemented. The stimulus could be a potential tailwind, but I think it's still a little early for us to understand how that's really going to play out in our market. And so we're still just in the early stages of monitoring that and the impact on our business. Speaker 900:45:23Thank you. And then just one more on the immuno business. A lot of those contracts are been 5 to 7 years, in particular those instruments replaced during COVID in 2020. Where do you see the dynamics of the equipment replacement cycle happening starting now going into 2025? Speaker 200:45:48Generally speaking, whether it's our labs business or our point of care business, we do have longer contract cycles. We have very high retention rates on our existing placements and we have a positive win loss ratio on new business. So I think the overall dynamic there really supports the stability of our underlying business model and that sort of mid single digit growth rate, especially for our Labs business. Speaker 500:46:26Thank you so much. Good job on the quarter. Operator00:46:30Thank you. Thank you. The final question comes from Casey Woodring with JPMorgan. You may proceed. Speaker 500:46:39Great. Thank you for taking my questions. Maybe to piggyback on Patrick's question a little bit earlier. That second tranche of cost savings you mentioned on top of that $100,000,000 run rate in savings here in that first tranche, would you realize those in 2025? And would those help bridge kind of the gap in 2026 and 2027 between below 20s EBITDA margin in 2025 and that kind of mid to high 20s margin in the outer years that target is maintained? Speaker 500:47:06Or would you see would you need to see more kind of cost savings and execution to reach that? Speaker 300:47:17Hey, KC, it's Joe. Yes, I think that this second tranche that was mentioned in Brian's prepared remarks would have an impact into 2025 and 2026. It's not all 2025. And again, we'll try to provide more visibility into sizing that up on the next quarterly call as we get through it. And I think just keep in mind that we are going to be moving to what I would call a continuous improvement culture of looking for cost savings and efficiency. Speaker 300:47:52So there certainly will be more to come. The other area I'd call out as a tailwind, if you will, from the margin improvement is going to be the exit of the donor screening business. That's a dilutive business as you know. And as we exit that at the end of next year, that's going to provide a tailwind to the margins as well. Speaker 500:48:23Okay. Got it. So that the low 20s and 25s assumes cost savings that you haven't identified yet? Is that kind of a particular? Speaker 300:48:32Well, I would say it a different way. I would say that we haven't fully communicated to you yet into The Street, but we have a majority of it fleshed out. And again, a good example is the flattening of the organization that Brian mentioned today. Speaker 500:48:50Okay, got it. Helpful. And maybe just one last one quickly. Your respiratory framework, can you just give us an updated picture on what the competitive landscape looks like there? And you noted that we should expect similar market share to 2023. Speaker 500:49:06Can you just remind us kind of where you saw that last year and what it looks like now? I know that there's a number of players in that space that have been talking about solid growth in their own respiratory panels. So just kind of curious on the updated picture of the share. Thank you. Speaker 300:49:23Sure. Yes. So we are the leader in the respiratory space. I think the other large players are going to be Abbott and DD and then there's some smaller players. And we've got a decent track record of the last couple of years post pandemic of taking market share. Speaker 300:49:43And as I said in the guidance that we have provided, we've assumed similar market share to last year. But obviously internally, we are working very hard to increase our market share and beat that target. So more to come again as we finalize in this respiratory season. When we talk to you guys in February, we can report on what that looks like.Read morePowered by