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Hologic Q4 2022 Earnings Call Transcript


Listen to Conference Call View Latest SEC 10-K Filing

Participants

Corporate Executives

  • Ryan Simon
    Vice President, Investor Relations
  • Stephen MacMillan
    Chairman, President and Chief Executive Officer
  • Karleen Oberton
    Chief Financial Officer

Analysts

Presentation

Operator

Good afternoon and welcome to the Hologic Fourth Quarter Fiscal 2022 Earnings Conference Call. My name is Jenny. And I am your operator for today's call. Today's conference is being recorded. All lines have been placed on mute. I would now like to introduce Ryan Simon, Vice President, Investor Relations, to begin the call.

Ryan Simon
Vice President, Investor Relations at Hologic

Thank you, Jenny. Good afternoon and thank you for joining Hologic's Fourth Quarter Fiscal 2022 earnings call. With me today are Steve MacMillan, the company's Chairman, President and Chief Executive Officer and Karleen Oberton, our Chief Financial Officer.

Our fourth quarter press release is available now on the investors section of our website. We will also post our prepared remarks to our website shortly after we deliver them, as well as an updated corporate presentation. And a replay of this call will be available through November 30th.

Before we begin, we would like to inform you that certain statements we make today will be forward-looking. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Such factors include those referenced in the safe harbor statement included in our earnings release and SEC filings.

Also during this call, we will discuss certain non-GAAP financial measures. A reconciliation to GAAP can be found in our earnings release. Two of these non-GAAP measures are, one, organic revenue, which we define as constant currency revenue excluding the divested blood screening business and revenue from acquired businesses owned by Hologic for less than one year. And two, organic revenue excluding COVID-19, which excludes COVID-19 assay revenue, revenue related to COVID-19, and discontinued product sales in Diagnostics.

Finally, any percentage changes we discuss will be on a year-over-year basis, and revenue growth rates will be in constant currency unless otherwise noted.

Now, I'd like to turn the call over to Steve MacMillan, Hologic's CEO.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Thank you, Ryan, and good afternoon, everyone. Happy Halloween. We're pleased to discuss our financial results for the fourth quarter of fiscal 2022 and provide guidance for fiscal '23. It was another dynamic year for Hologic delivering strong performance while navigating macro headwinds. And we closed 2022, once again posting outstanding results for the quarter.

Total revenue was $953.3 million and non-GAAP earnings per share was $0.82, exceeding both our base business and COVID guidance. We also deployed $175 million of capital to buy back 2.5 million shares in the quarter. For those of you keeping score, for the full year, we utilized $542 million of our exceptional cash flow to repurchase 7.7 million shares, reflecting great confidence in our future.

For today's call, we'll first provide a high-level overview of our fourth quarter performance and then reflect on our full year results. In doing so, we'll also share insights into our future outlook as we look forward to 2023.

Overall, make no mistake, our consistent strong performance in these turbulent times is no coincidence. We are a fundamentally different company today than when we entered the COVID pandemic. We also understand that some of you are still trying to ascertain the strength of our core businesses. As we look ahead, each of our core franchises, listen closely here, Diagnostics, Breast, and Surgical, are expected to produce low double-digit top line growth for fiscal 2023.

As we set out to do just over two and a half years ago, we are emerging from the pandemic a much stronger company. We thoughtfully and strategically reinvested our upside earnings into both our business and into our passion to be champions for women's health. Our ability to step up to the plate during the pandemic and address the global demand for COVID testing was an incredible achievement -- but our real homerun was the transformation of Hologic that cannot be ignored.

Through organic and inorganic additions, we now have more growth drivers across our business, in each of our divisions than ever before. These growth drivers, layered on top of our market-leading core franchises, form a solid foundation that anchors our business in these volatile and pivotal times.

Under the intense pressures of the macro-economic landscape, we live in today, all companies will face adversity. That said, because Hologic is a much stronger company today: we -- will -- thrive. As we've said before, you can count on us to deliver on our commitments, even in the face of volatility and uncertainty.

It's equally important to recognize that our revenue is the least capital sensitive it has ever been in our 36-year history. For fiscal '22, given COVID and the impact from chip shortages, only 12% of our revenue was from capital, a percentage we expect will settle well below pre-pandemic levels. A truly astounding change from where we were just a few years ago, and a transformation that makes Hologic a more durable company in the face of a potential recessionary environment.

Our confidence and conviction in our business is underpinned by our unwavering commitment to our purpose-driven business strategy. A strategy that is centered around our purpose -- to enable healthier lives everywhere, every day; our passion -- to become global champions for women's health; and our promise -- the Science of Sure.

We don't see our commitment to our mission and ESG as a trend or fad. Instead, we know that in order to continue to achieve our strong financial results, we must continue on our path to elevate and improve women's health and well-being around the world.

Now let's turn to the quarter results. As expected, our strong performance was driven primarily by both our Molecular Diagnostics and Surgical businesses.

To answer the question we're sure many of you are wondering -- core Panther utilization is strong. Our molecular diagnostics business grew north of 17% in Q4 excluding COVID, driven primarily by more assays being run through our expanded Panther installed base.

This exceptional growth was once again broad based and fueled by a combination of legacy and newer assays in our robust molecular portfolio. Our legacy STI business contributed growth dollars, while our newer assays including our vaginitis panel, M.gen and our virology portfolio lifted the growth rate.

As for Panther placements, we now have nearly 3,250 Panthers placed around the world. A remarkable achievement considering we exited fiscal 2019 slightly north of 1,700 Panthers in the field.

In Surgical, our business grew nearly 9% organically, and over 11% including the Bolder acquisition. As anticipated, the COVID pressure on our Surgical business abated in the quarter, and we saw procedural volumes return, as well as acceleration from our new business lines. Powering the strong performance in Surgical were the same growth drivers as in Q3, MyoSure, Fluent, and solid contributions from Bolder and Acessa.

In Breast Health, as expected, the business was down 16% driven primarily by the chip shortage adversely impacting our gantry business. Having said that, we have confidence that the worst of the shortage is behind us and that the business will return and accelerate throughout 2023. We will go into more depth on Breast Health later in the call.

Shifting gears, we will now reflect on our full year results and outlook for fiscal 2023. For 2022, Diagnostics grew 10.2%, Surgical grew 6.3%, and Breast and Skeletal Health declined 7.7%, driven primarily by constrained gantry sales as a result of chip shortages. Net, without the chip shortage, it is very clear that each of our businesses would have been solidly at or above our long-term guidance. As a reminder, each of these figures are in constant currency, exclude acquisitions until they annualize, and also exclude COVID assays, as well as COVID related and discontinued products' revenue.

We are extremely proud of where we landed in both Diagnostics and Surgical. And we have high confidence that the concentrated impact on Breast Health will rebound strongly in 2023. Looking forward by division, as mentioned at the onset of this call, each of our businesses, including International, is expected to achieve low double-digit growth in fiscal 2023.

In Diagnostics, powered by our vastly expanded Panther installed base, we expect low double-digit growth from the division in 2023. Bolstering growth for the division, we expect continued strong sequential growth from Biotheranostics, as well as incremental contribution from Mobidiag internationally.

Focusing on molecular diagnostics, our growth thesis centers on more customers running more volume and more menu on our Panther systems. While we are still in the early days of ramping utilization, we are already seeing positive signs today. With our broad menu, we are well positioned to continue double-digit growth in our core molecular Panther business in 2023.

To provide additional color and shed more light on non-COVID Panther utilization, pre-COVID, at the end of our fiscal 2019, about 20% of U.S. customers were running at least four assays on their Panther systems. Fast forward to the close of Q4 -- now, over 33% of U.S. customers are running at least four assays. Nice improvement and still future opportunity ahead.

Moreover, last quarter we spoke to the fact that over 90% of all COVID customers were running at least one other non-COVID assay. Many of you asked, what about new customers acquired during COVID? As of the Q4 close, over 85% of new customers worldwide are running at least one other assay on their Panthers in addition to COVID.

More impressive is that over 55% of these new to Hologic customers are running at least two non-COVID assays on their Panthers, a strong signal of future utilization at new customer sites. While still early, we expect these positive utilization trends to continue in the quarters and years to come.

Now turning to Surgical. We also expect Surgical to deliver low double-digit growth in 2023. Consistent with the last two quarters of 2022, we believe MyoSure and Fluent, plus Acessa and Bolder, will lead the way. We expect the division's revenue to accelerate as we continue to integrate our acquired laparoscopic assets into the business and into the bags of our strong Surgical sales force. Increased physician access and payer coverage for our laparoscopic portfolio should continue to improve over time and be a tailwind for growth.

Longer term, our goal is to build both Acessa and Bolder into $100 million-plus Surgical brands, that will complement our market leading NovaSure and MyoSure products.

In Breast Health, we fully expect to exit 2023 achieving low double-digit top line growth from the supply constrained 2022 comps. We have confidence the worst of the chip shortage is behind us. As chip supply normalizes, as it should over the course of 2023, we expect our gantry business to return to strength. Frankly, as we work down the backlog, we have the opportunity to perform slightly above the historical gantry placement run rate as we exit the fiscal year.

Even with the shortage of gantries we faced in 2022, we maintained our market leading position in the U.S., grew our presence internationally, and have no reason to believe we are giving any ground to the competition. In fact, the backlog for our best-in-class gantries continues to grow and we continue to receive orders at a healthy rate.

We also understand customer capital budgets may face increased pressure given the macro environment. Despite this challenge, we remain confident in our ability to place gantries even if we enter a recession. The reality is that gantries tend to be at the lower price point of hospital capital spend. Gantries also represent both a value driving opportunity for our customers, and more importantly, essential capital equipment for world-class patient care.

Finally, our international business will continue to be a tailwind and powerful lever of growth for each division. In 2022, our international business grew just north of 6% organically excluding COVID, posting strong growth even with the chip headwind and constrained gantry supply. International is now nearly 30% of total revenue and poised to continue its growth trajectory.

Looking forward to 2023, we are confident our international business excluding the impact of COVID will return to double-digit top line growth and sustain the momentum created by our strong response to COVID and from our groundbreaking initiatives like the Hologic Global Women's Health Index and our Global Access Initiative.

To conclude, at Hologic we know we must center on our purpose to achieve our strong financial results. From our strong results we will continue to drive patient education and access initiatives, and continue to invest in our business. From our strategic investments we will continue to deliver innovative, life-changing technologies. These technologies will power our perpetual cycle of reaching and helping more patients, all while delivering value and strong financial results for our shareholders.

Before turning the call over to Karleen, let me close by saying that we are incredibly excited about where we have been and even more excited about where we're headed.

And finally, from me personally and the rest of our global leadership team, we would like to thank and congratulate each and every one of our nearly 7,000 employees all around the world for their dedication to our purpose and another incredible year at Hologic.

With that, let me hand the call over to Karleen.

Karleen Oberton
Chief Financial Officer at Hologic

Thank you, Steve, and good afternoon everyone.

We are very pleased to share our fourth quarter financial performance; capping off the end to an excellent fiscal year. These results highlight our current position of strength, as well as tremendous opportunities that lie ahead.

Growth in the period was powered by our core Diagnostics and Surgical businesses, as both franchises posted strong growth to close 2022. For a second quarter in a row, these businesses each showcased multiple growth catalysts. And as we look towards our fiscal 2023, we are excited to drive this momentum forward.

In Breast Health, we are proud of the resilience of our teams. Although our chip allocations are still constrained, we believe that the worst of the division's supply chain problems are in the rearview. As I will highlight in more detail when discussing our guidance for next year, we should see continuous improvement in our chip supply and thus gantry revenue throughout fiscal 2023.

Finally, before moving on to our divisional results, it is important to reiterate that our balance sheet is a key point of strength as we head into fiscal 2023. Our leverage rate remains far below our target range and our capital structure is pristine, providing our business incredible confidence and flexibility given the increasingly uncertain macro environment.

Moving on, I will now provide more color on our financial results. In the fourth quarter, revenue and profitability once again significantly exceeded our estimates, as total revenue came in at $953.3 million. This result was nearly $100 million higher than the mid-point of our guidance, despite a greater than anticipated FX headwind of approximately $27 million in the quarter. And non-GAAP EPS was 82 cents, roughly 20 cents higher than the mid-point of our prior guide.

Turning to our business results, in Diagnostics, global revenue of $520.9 million declined 35.6% compared to the prior year. However, it is important to note that COVID testing revenue was elevated in our fiscal fourth quarter of 2021 due to the onset of the Delta variant. Therefore, a more accurate depiction of the state of the Diagnostics business is to exclude COVID assay revenue, related ancillaries, and a small amount of revenue from discontinued products. When making these adjustments, we see that worldwide organic Diagnostics revenue increased 11% in the quarter, a fantastic result.

Within Diagnostics, our Molecular business was again extremely strong, growing more than 17% in the fourth quarter when excluding the impact of COVID-19. Growth in Molecular was broad based, driven by solid performance in our legacy STI portfolio, as well as the continued success of both our vaginitis panel and our virology menu. These results -- in conjunction with the exceptional performance of our molecular business last quarter -- highlight strong traction in our base Panther business.

As it relates to our COVID results, we generated $151 million of COVID assay revenue in the quarter, well exceeding our previous guidance.

In terms of the COVID assay revenue split by geography, domestic demand outpaced our expectations, with U.S. COVID assay revenue representing nearly 70% of total COVID testing revenue in the period. As expected, international demand continued to moderate.

Rounding out Diagnostics, our cytology and perinatal businesses increased 1.5% compared to the prior year.

In Breast Health, global revenue of $275.1 million was down 16%, as expected, primarily driven by chip supply shortages. For Q4, the impact to revenue from the chip supply shortage was in-line with our prior guidance.

In Surgical, fourth quarter revenue of $133.3 million grew more than 11%. And excluding the Bolder acquisition, the business grew nearly 9%. We are very encouraged by another strong quarter from our Surgical franchise, as the momentum we saw in our fiscal third quarter continued into our fiscal fourth quarter. The division's results were again led by MyoSure and Fluent with contributions from recent acquisitions.

Lastly, in our Skeletal business, revenue of $24.0 million increased approximately 4% compared to the prior year period.

Now let's move on to the rest of the non-GAAP P&L for the fourth quarter. Gross margin of 62.5% was ahead of our forecast, driven by higher-than-expected COVID-19 testing volume and strong results in our base business in the period.

Total operating expenses of $329.9 million in the fourth quarter decreased 6.6% compared to the prior year period. This decrease was driven by less spend within G&A and Sales, partially offset by higher marketing and R&D expense.

Below operating income, Other Income was an expense of $3.1 million, less than anticipated, primarily due to gains associated with our foreign exchange hedging activities. Finally, our tax rate in Q4 was 21%, as expected.

Putting these pieces together, operating margin for Q4 came in at 27.9%, and net margin was 21.8%, both ahead of our previous estimates. Non-GAAP net income finished at $207.5 million, and non-GAAP EPS was 82 cents.

Moving on from the P&L, cash flow from operations was $168.7 million in the fourth quarter. Based on strong cash conversion, we had $2.3 billion of cash on our balance sheet and our leverage ratio was 0.2 times. Our cash generation continues to be excellent, and our balance sheet remains a pillar of strength. Both positive attributes in any environment, but are especially valuable in periods of macro instability like we face today. And although we have continued to build cash, our M&A teams in each division remain active and our funnel of potential tuck-in opportunities is robust.

As it relates to share repurchases, they remain an integral part of our capital deployment strategy moving forward. In the fourth quarter we repurchased 2.5 million shares for $175 million. Further, on September 22nd our Board of Directors approved a new 5-year share repurchase authorization for up to $1 billion.

Now let's move on to our updated non-GAAP financial guidance for the first quarter and full year fiscal 2023. As a reminder our organic guidance excludes acquisition revenue until each deal annualizes. Therefore, our first quarter guidance only excludes Bolder revenue from our organic base. Bolder becomes organic in our fiscal second quarter of 2023.

In the first quarter of fiscal 2023, we expect strong financial results again, with total revenue in the range of $940 to $990 million. For all of fiscal 2023, we expect total revenue in the range of $3.7 to $3.9 billion, significantly exceeding our pre-pandemic levels. This guidance assumes low double digit organic revenue growth ex. COVID in each division for the full-year fiscal 2023.

To help with your constant currency modeling, we are assuming significant foreign exchange headwinds of slightly more than $30 million in the first quarter of 2023, and approximately $90 million for the full year. Please note, that while we have taken a conservative view when considering the strength of the U.S. dollar, currency markets continue to be very unpredictable.

In terms of our divisions, we expect Breast Health, Surgical and core Diagnostics, excluding the impact of COVID, to grow low double digits for 2023.

In Diagnostics, we expect our molecular business to continue to drive growth. Our Panther continues to deliver incredible benefits for our customers through assay consolidation, scalability, and automation. In this environment where labor remains a scarce resource, our highly automated Panther is a tremendous value proposition. With nearly 20 assays on menu, we are eager to capitalize on this great opportunity to increase utilization on our expanded installed base.

Finally, as Steve mentioned, we now have approximately 3,250 Panther's placed globally, placing more than 350 Panthers in fiscal 2022 and 49 units in Q4. Going forward we will return to reporting Panther placements on an annual cadence.

Moving to Breast Health, we are excited for the year ahead. Our customer base is hungry for our best-in-class mammography instrumentation. We continue to expect chip supply to gradually improve throughout 2023 and therefore the division's revenue should increase throughout the year. And while we only have line of site to allocations impacting revenue about two quarters out, we remain optimistic that the gantry business will exit fiscal 2023 at or near normalized levels.

As it relates to our guidance, we expect Breast Health revenue to be down low double digits in our fiscal first quarter of 2023, given the prior year was not yet impacted by supply chain shortages. However, for the full-year, our guidance assumes that Breast Health will grow low double-digits, reflecting supply recovery as the year progresses.

Finally, in Surgical, we expect more broad-based growth than ever before. We anticipate MyoSure will continue to drive growth, but also expect notable lift from our Fluent Fluid Management System, as well as our laparoscopic portfolio of Acessa and Bolder.

In terms of COVID sales, consistent with prior messaging, we believe COVID could be one of our largest molecular assays over the long-term. Having said that, given how quickly we've seen the pandemic change course, we believe it is still too early to accurately forecast an endemic state. As result, we expect COVID assay sales to be $75 million in the first quarter of 2023, and $150 million for the full year. COVID-related items, inclusive of a small amount of discontinued product revenue, are expected to be approximately $35 million in the first quarter, and $130 million for the full year.

Moving down the P&L, for the full year we forecast our non-GAAP gross margin percentage in the low 60s and our non-GAAP operating margin percentage to be approximately 30%. Please note that we anticipate our COVID revenue, which is margin accretive, will be front-end loaded to the first half of 2023 to coincide with the fall and winter seasons in the U.S. In addition, we have again incorporated elevated inflationary pressures into our guidance as it relates to input costs. We foresee these higher costs persisting throughout 2023.

In terms of operating expenses, we expect spending to be down compared to the prior year. While we will continue to invest in our business, marketing spend will be lower in fiscal 2023, as our fiscal 2022 had several large one-time expense items, such as our Super Bowl Bold [Phonetic] commercial and higher spending for initiatives such as our WTA partnership.

Below operating income, we expect other expenses, net, to be around $20 million a quarter. Our guidance is based on an effective tax rate of approximately 19.0%. And diluted shares outstanding are expected to be approximately 252 million for the full year. All this nets out to expected non-GAAP EPS of $0.80 to $0.90 in the first quarter and $3.30 to $3.60 for the year.

To conclude, let me wrap up by saying that our strong fourth quarter results once again exceeded our guidance despite the various macro headwinds. Performance was driven by exceptional growth in our molecular diagnostics and Surgical businesses, which we expect to continue. And while the future macro-outlook remains uncertain, with a natural hedge to future COVID uncertainties and a fortress balance sheet, we are well positioned to continue to deliver strong results in our fiscal 2023.

With that, we ask the operator to open the call for questions.


Questions and Answers

Operator

Thank you. [Operator Instructions] We ask that you please limit yourself to one question with one follow-up. And we will go to our first question from Patrick Donnelly with Citi.

Patrick Donnelly
Analyst at Citi Group

Hey, guys. Thank you for taking the question.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Hey Patrick.

Patrick Donnelly
Analyst at Citi Group

Hey, how are you? Maybe one for you on the Breast Health side. It sounds like the gantry backlog continues to build good order pace can you just talk, I guess, about the visibility into that chip improvement? Obviously, again the guidance kind of implies as the year goes, you guys talked about the exit rate. I think it improved kind of mid-year. But yeah, I mean just talking about the visibility there again on the order side, are you seeing any share shift or kind of customers staying with you guys through this and then similarly, just on kind of staying on the gantry you mentioned even in a recession feel pretty good about what the -- what the order growth would look like. What gives you that confidence? A lot of questions about hospital capex obviously this maybe just focus on the gantries [Indecipherable] I would appreciate it.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Sure, Pat. I think what we feel great about is over time, and we haven't built the market share in the installed base in the United States and really around the world, especially in the U.S. without people really buying into the superiority of our products from a labeling, from a workflow standpoint, from a clinical efficacy published data everything else that we're doing to both detect earlier stage cancers sooner also reducing the false positives and avoiding needless callbacks, people have really seen that. So when it comes down to a hospital system is looking to meet a few new gantries for their system. They're not going to want to go away from us because they've made that decision to come into us. So they're much more willing to wait until we're back in business plus the other reality is this is an across-the-board industry issue.

So it's not like we are short and others can provide. So we really have two things going for us, which is call it the micro our products and the incredible products we're offering and the macro that what we're dealing with the chip issues being felt by everybody else. So I think our customers understand that I think anybody who's in purchasing or work for hospital they all understand the supply chains and their own personal lives. Right. You need a dishwasher fixed and the parts taking months to get those kinds of things that are playing out in everybody's like. I think everybody understands okay, is going to be a little while. So we feel great about customers continuing to want our products and feeling better and better about our visibility into as we've been working with all the chip vendors right down to every single SKU and how many ships go into every one of our machines feeling better and better about where we'll go.

Patrick Donnelly
Analyst at Citi Group

Okay, that's helpful and then maybe on the back of that you mentioned in terms the op [Phonetic] margins COVID is going to be heavier in the first half, which is margin accretive but at the same time as we just talked through their receive the Breast Health recoveries be more second half that's been a drag on margins. How should we think about the op margin cadence throughout the year. I know you talked about 30% for the year, but maybe just talk about how that rolls through given the moving pieces to COVID Breast Health. Thank you.

Karleen Oberton
Chief Financial Officer at Hologic

Yeah, I mean I would think the 30% is probably pretty consistent throughout the quarters of the year. As you said the dynamics kind of change first half versus back half. So I think that 30% plus or minus in any quarter pointed to, I think, I think you're right on.

Operator

And we'll go to our next question from Tejas Savant with Morgan Stanley.

Tejas Savant
Analyst at Morgan Stanley

Hey guys, good afternoon. Karleen just following up on that margin question here a little bit, can you just call out specifically in terms of the COVID contribution assumptions you're baking in here, remind us of what the gross and operating margin assumptions are for that piece versus the rest of the business?

Karleen Oberton
Chief Financial Officer at Hologic

Yeah, Tejas why don't we just say that -- what we've noted in the prepared remarks is that COVID is accretive to the corporate averages, but we haven't disclosed that specifically. And I'd also add on that when you think about in this macro environment in our initial guidance for the full year to say that our margins, operating margins going to be at 30%, which are pretty rich compared to the industry is pretty strong results and we're really proud of that and actually even if you look at our net margin, prior to pre-pandemic levels, which were around 20% our guide would imply that the roughly 22% to 23% really reinforcing our earnings power.

Tejas Savant
Analyst at Morgan Stanley

Got it. That's helpful and then just a quick follow-up there in terms of the ranges you've baked into the guide Karleen, can you just walk us through what's assumed for the Breast Health recovery at the high end of the guide, are you assuming essentially a return to normalcy by the fourth quarter or is there still some possibility of the recovery taking a little bit longer.

Karleen Oberton
Chief Financial Officer at Hologic

Yeah, I think the guidance would imply that we're approaching normalized levels as we exit the year. I would also say that part of the recovery, even if we did get incremental gantry chips than anticipated this resource limitations as our field service engineers who maintains the installed base also do the actual installs in any quarter. So there will be a balance through this recovery, but in general, think about a gradual sequential recovery throughout the course of the year and exiting close to normal levels.

Tejas Savant
Analyst at Morgan Stanley

Got it. Thank you.

Operator

And we'll go to our next question from Anthony Petrone with Mizuho.

Anthony Petrone
Analyst at Mizuho

Thanks and congratulations on a strong finish to the year-end and good to see at least some visibility into calendar '23, just given the headwinds. I guess I'm going to start on COVID testing and just the guidance that was issued here and then a follow-up on broader diagnostics, understanding that it's still tough to forecast pandemic ebbs and flows. But maybe perhaps one of the things that is sort of becoming evident here is the tender patterns, whether it be from large lab entities or even governmental contracts. And so when you think into 2023, is there any incremental visibility that you can point to as it relates to just larger tenders, whether it'd be U.S. OUS [Phonetic] at the hospital level or at the government level and then I'll have a follow-up on broader diagnostics. Thanks.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Yeah, I wouldn't say we've got any more visibility. We've been very close to our customers all along, Anthony. In terms of both international from the Ministry of Health deciding things right down to the regional authorities within various countries and the same within every one of our customers in the U.S., both the main labs as well as the hospitals. So I think we continue to stay close and feel very good about our position and the way we continue to think about COVID is we're going to deliver whatever the marketplace needs. We're not going to get over our skis in terms of forecasting it financially.

Anthony Petrone
Analyst at Mizuho

And then in terms of just quick follow-up on COVID. I mean, as we think of it as a consistent cash flow driver we even look ahead maybe beyond 2023 what point do testing providers really look at this as a relatively consistent cash flow business that reliably again there's going to be a contributor going forward. So just kind of the broader views on the consistency of COVID. And then lastly, diagnostics, when you think it's testing intensity a lot of new Panther users are. How do you think that plays out [Technical Issues], just beyond the point we are here at the end of this fiscal year. Thanks again.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Thanks. We didn't fully hear the second part of that question, because you were cutting in and out on the first part, as it relates to the first part of the follow-up in terms of consistency on COVID, I think the way we've approached this all along has been, you can't predict this has never been consistent. It has been volatile by region and by timeframe and at any 8-week period, people have been way off probably trying to predict what was about to happen. So again, what we have said at the beginning, however, was we thought that this long-term would create a new Assay for us that would be far more enduring than I think anybody ever thought it would be back in 2020 back to what people thought when everybody thought this was going to go away in a hurry, or it was going to go away as soon as vaccines arrive, or molecular testing was going to go away as soon as antigen tests came along.

Right, what we've learned is this thing is going to be around. And frankly, as long as countries like China, are still trying zero COVID approach and everything else and the fact that this thing, we always said in the beginning, this is a respiratory virus that will mutate. Herd immunity was never going to be achieved. And we thought we would end up with an enduring business. Whether that enduring business ends up being $150 million or $200 million, we really don't know, but we feel really good that we're in that business. Thank you.

Anthony Petrone
Analyst at Mizuho

Thank you. I'll hop back in.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Right.

Operator

And we'll go next to Jack Meehan of Nephron Research.

Jack Meehan
Analyst at Nephron Research

Thank you. Good afternoon.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Jack [Indecipherable]. All right. [Indecipherable].

Jack Meehan
Analyst at Nephron Research

I have a couple of questions on molecular testing. Before I go, trick or treating. The first is on the COVID sales. So I think, based on your disclosures, it sounds like the U.S. Assay sales were about $105 million, which was pretty stable sequentially and I look at the government PCR data volumes were down 27% quarter-over-quarter. So I just curious on the COVID side, if you could talk about either share dynamic or was there any end-of-quarter ordering into the respiratory season? Any color on that would be great.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

It's hard for us to fully know. On the share stuff because of the various pieces. I would say, there were no unusual ordering patterns at quarter end. So none of this was stocking up for fourth quarter. We generally -- our business is very diversified. And I think one of the things we did, as you well know early in the pandemic is we went out to a very broad customer base. And I think that has helped insulate and provide a little more enduring nature to our business. It's also helped our pricing hold up reasonably well. So I think we feel pretty good, but we just continues to go and regions and spikes and this it does feel like U.S. testing is kind of settling in for the first time to a more normalized pattern and we're still -- we're starting to see that certainly in our own business, but no unusual spikes.

Jack Meehan
Analyst at Nephron Research

Of course [Phonetic] and then is my second question. So I appreciate the commentary about the new customers 85% earning more than one, 55% more than two. Is there any color you can share on like what are they running is this beyond respiratory testing and I don't know if you have the stats handy, but how large is the Virology business, if I look at the full year, how large is the vaginitis business, any updates on those would be great.

Karleen Oberton
Chief Financial Officer at Hologic

Yes, I think we stopped disclosing the actual number on that, but very strong growth year-over-year in that business continues to have a nice trajectory. I would say that it's diverse on the other assays, but probably leaning towards the core women's health assays primarily. Thank you, Karleen.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Let's do a trick or treat.

Jack Meehan
Analyst at Nephron Research

Appreciate it.

Operator

And we'll move to our next question from Puneet Souda of SCB Securities.

Puneet Souda
Analyst at SCB Securities

Yeah, hi Karleen. And thanks for taking the question. So I'm just a bit on the sort of the longer-term, I mean you've talked about 5% to 7% you're saying low double-digits here obviously businesses are recovering low capital expense, but more of the recurring revenue that your customers are sending your ways to sort of just talk to us about how should we think about that and is that now a more of a conservative number. And just talk to us about how you think about 5% to 7% longer-term?

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Yeah, I think long term, we're -- we're sticking with the 5% to 7%, but as we've said all along what sometimes gonna be above, sometimes we'll be a little bit below, I think for where we are right now, we feel very good about delivering certainly above that for next year, but we don't want to get caught up way ahead of ourselves either in saying, we're moving that guidance up by any stretch. It's just that reminder there might be some periods of time where we're a little bit below that and there will be periods were above it. But I think we feel solidly better [Indecipherable] our businesses.

Karleen Oberton
Chief Financial Officer at Hologic

We only gave that range, about 15 months ago. So like we're not, don't need to change it at this point.

Puneet Souda
Analyst at SCB Securities

Okay, got it. And then Steve, a broader question for you. Now in the sort of post-pandemic era and again, might have a long tail to it. Do you see heightened utilization for Flu, RSV, other respiratory just continuing on because the awareness but just overall these viruses and overall the significance of just overall diagnostics and routine primary care settings is such that it's going to be sustained just help us understand, do you see a high utilization just the sustaining here for the respiratory businesses for -- for a long time.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Yeah, it's a great quarter to predict because I think we do see probably higher levels of testing going forth. Right, the Diagnostics industry has been elevated and people's desire to know with more certainty what they have even think about something as simple as RSV that we're talking about here in the last few weeks. I'd argue that 99.9% of the public had never heard of RSV even a month ago. Right. So now we're getting into these levels of granularity that people want to know more about and what they have and we think that will be a positive. It's also, both what we're able to offer on our Fusion platform. Also a big piece that Mobi will bring to us in the future and certainly we're seeing that in our European business right now. So I think we're well poised also for the future

Operator

And we will move on to our next question from Lisa Garcia of UBS.

Lisa Garcia
Analyst at UBS Group

Hi guys, thanks for pulling me in [Phonetic]. Appreciate it. Maybe just to start off on kind of Surgical and tenants expectations there with MyoSure kind of leading the growth for fiscal 2023, can you kind of talk about what kind of gives you confidence. It seems like you have a little bit more optimism about kind of growth expectations for MyoSure in particular, so I'd love to hear kind of what's driving the optimism also kind of -- let's start there.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Yeah, I think with MyoSure we just first off bias because we just came back from our U.S. sales meeting last week with that sales team and hard not to be excited when you've been with them, but I think on a more serious and deeper basis MyoSure has been an outsized grower now for seven or eight years long beyond what anybody thought it could be. And I think what we continue to see is, there is still significant opportunities in the fibroids space, there's still to some degree markets that are under-developed and MyoSure procedure is an amazingly positive procedure with great outcomes. And so I think we just continue to, we're not quite sure what the end market truly is there.

Karleen Oberton
Chief Financial Officer at Hologic

Yeah, International continues to be a bigger piece of that performance as well -- what gives us confidence in that outlook.

Lisa Garcia
Analyst at UBS Group

Great. And then can you just update us where you stand with the biotherapeutics [Phonetic], CLIA lab, going into the San Diego headquarters and you're automation initiatives that you have underway and how we should think about timelines for those. And maybe potential impact there.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Yes, sure. The build-out of the lab in our building here in San Diego has gone well that will be happening in the next couple of quarters and we're adding more automation that will really be kicking in, in terms of, particularly the ordering system really early next calendar year. So that team just as continues to crush it since they've been part of the Hologic team, we were just with all of their salespeople last week and they feeling so supported and excited to be a part Hologic and it's part of that classic thing of what we're trying to do is we bring these technologies in and are they are going to be able [Phonetic] to put additional investment in them to accelerate the growth rate, what we've done with Boulder, what we're doing with Acessa, what we're doing with the Biotheranostics team and just feeling great about these opportunities.

Operator

And we'll hear next from Max Masucci from Cowen and Company.

Max Masucci
Analyst at Cowen and Company

Hey, good afternoon. Congrats on a very strong year. First one, if we just think about the Panther installed base, nearly doubling since pre-pandemic times we have an expanding adoption of non-COVID menu items. Is there a logical range level where the non-COVID Panther gross margins have settled or maybe even in broader terms how they go for molecular diagnostics gross margins have evolved since pre-pandemic times?

Karleen Oberton
Chief Financial Officer at Hologic

Yeah, I mean the gross margins on the molecular business -- we've said all along are accretive to the corporate average, but the dynamics of this business is, as we add more of the newer assays, we typically get those at a higher price higher margin but we give some pricing on the legacy assays. So we'll get as we produce more in our San Diego facility, we will obviously naturally gain more absorption. But I think, think about those holding at higher than corporate averages. But I wouldn't see a significant upward trend anytime.

Max Masucci
Analyst at Cowen and Company

Okay, got it. And then the final one $2.3 billion in cash historically low net leverage ratio -- we are seeing, re-calibrating valuations in the public arena. So could you just give us a peek into the Hologic capital allocation playbook, should we assume that buybacks will remain the priority in a choppy market environment with opportunistic M&A sort of sitting in that number two slot in terms of prioritization?

Karleen Oberton
Chief Financial Officer at Hologic

Max. I would actually reverse that to our capital allocation has consistently been to deploy our free cash flow, which as you noted, has grown over the last couple of years, but the priority is the M&A and share repurchases. It has been more of an ongoing activity at a minimum to manage dilution from our equity plans and as we see opportunities disconnects to jump in and we'll get a little more but priority will be M&A, but we'll be disciplined in that in that strategy.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Yes, Max, I could build on that. Obviously, if you're looking at last year, we didn't do as much on the M&A front, the previous year, we did a whole bunch. So sometimes the doctors don't look at any given couple of quarters to say that we've changed our strategy. It's really about the opportunities. The other piece I would reiterate is when you have a healthy base business it's also given us the enormous ability to be very patient in doing deals and I think that's the best part of it all is, when your core business is healthy. There is no need to do deals and we can do the ones that makes sense for us. So clearly to reiterate as Karleen said number one is still on the acquisition front.

Max Masucci
Analyst at Cowen and Company

Thank you.

Operator

And we'll go to our next question from Tim Daley with Wells Fargo.

Timothy Daley
Analyst at Wells Fargo & Company

Great, thanks for the time here. So my first one is around the kind of broader macro environment. So thinking about the guidance range here, is there any specific non-COVID drivers that you could lay out for us that maybe put you guys at the high end of the guidance range at the low-end or COVID that kind of the big -- big delta there.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

COVID is not, this is, we're really talking about our base businesses being strong. All three of them.

Timothy Daley
Analyst at Wells Fargo & Company

Great. And then following up to that are there any concerns that you have around the European geographical footprint particularly relating to some of your third-party OEM partners? Just is that contemplated guidance [Phonetic] any additional details around that would be helpful.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

We certainly worry about the geopolitical and particularly the economic scenarios in Europe and I think particularly as this winter comes in energy and everything else I think having said that, that's all the macro. The micro is our teams and our businesses, are just in great shape and I think are poised regardless of the environment to be able to power and deliver through that, thank you.

Operator

Thank you. We'll move [Technical Issues] with Bank of America.

Unidentified Participant
at Hologic

Good evening. Hope you're doing well.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Hey, all right.

Unidentified Participant
at Hologic

Hey, how are you? So two questions, first of all, the tax rate going from 21% to 19%. But can you tell us what's driving that. And the second question is going to be what are you assuming in pricing I mean how much of your sort of like double-digit organic revenue growth when you're looking at some of the targets for some of the businesses sort of being driven by price and you know are your diagnostic customers in particular, starting to potentially push back on pricing as COVID reimbursement is likely to go away next year -- the higher -- as the public health emergency goes away. Thanks.

Karleen Oberton
Chief Financial Officer at Hologic

Yes. So certainly on the tax rate, we continue to look for opportunities to more effectively leverage our supply chain and our operational footprint looking for our low-cost areas, and so a lot of that work has been happening over the last 24 months, which which is driving that lower tax rate down to 19% for 2023 and I think from one aspect of COVID pricing, I think even when the public health does go away, I do think the pricing certainly much more of our discussion with our customers and it's, and it has been yes.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Yes, [Indecipherable]. We have very little pricing baked into the numbers we have puts and takes frankly across franchises across geographies. And just to give a plug for Karleen [Indecipherable] everybody has always admired, our operating margin piece, but we've been very focused on the net side and our tax team has been working very hard over the last few years and they are doing a great, great job to really kind of show up this year with another opportunity for us to continue to drive that net margin.

Unidentified Participant
at Hologic

And would you use 19% [Phonetic] of the go-forward rate?

Karleen Oberton
Chief Financial Officer at Hologic

Yes. At this point, I would unless there is a change in the federal statutory rate, I think 19% is good to.

Stephen MacMillan
Chairman, President and Chief Executive Officer at Hologic

Thank you, [Indecipherable].

Operator

And we'll go next to Casey Woodring with JP Morgan.

Casey Woodring
Analyst at JP Morgan Cazenove

Hi guys, thanks for fitting me. I guess just so last time we spoke, I think you guys are pointing to a pre-COVID operating margin of 31.5% from 2Q '20. It was just a good place to start for '23 as COVID would maybe balance out some of the supply chain headwinds, so curious just on the 30% number here. Can you maybe quantify what the basis point headwind from the supply chain dynamics on the year and then maybe could you also quantify how much lower, the international business operating margin is in relation to the total company number? Thank you.

Karleen Oberton
Chief Financial Officer at Hologic

Yes. I think from the supply chain from the higher cost is roughly 200 to 250 basis points on the operating margin that yes [Phonetic] we have forecasted would persist through 2023. We have, we have talked about international margins being lower than the US, but we have not disclosed the difference, but I think certainly there is discussions. Our teams are focused on improving their leverage as we move forward.

Operator

And thank you to everyone that concludes today's question-and-answer session. And this now concludes Hologic's Fourth Quarter Fiscal 2020 Earnings Conference Call. Have a good evening.

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