Hologic Q2 2022 Earnings Results & Report

Hologic EPS Results

• Actual EPS: $2.07
• Consensus EPS: $1.55
• Beat/Miss: Beat by +$0.52
• One Year Ago EPS: $2.59
• EPS Beat Rate: 6 of last 8 quarters

Hologic Revenue Results

• Actual Revenue: $1.44 billion
• Expected Revenue: $1.28 billion
• Beat/Miss: Beat by +$160.63 million
• YoY Revenue Growth: N/A

Hologic (NASDAQ:HOLX) (NASDAQ: HOLX) is a global medical technology company specializing in women’s health. Headquartered in Marlborough, Massachusetts, the company develops and manufactures diagnostic products, imaging systems and surgical solutions designed to detect, diagnose and treat diseases with a primary focus on breast and skeletal health, gynecological conditions and molecular diagnostics. Its product portfolio includes digital mammography systems, 3D mammography solutions, bone densitometry equipment and molecular assays for infectious disease and oncology applications.

Since its founding in 1985, Hologic has grown through both internal innovation and strategic acquisitions. A landmark transaction was the 2012 acquisition of Gen-Probe, which expanded the company’s leadership in molecular diagnostics and infectious disease testing. Over the years, Hologic has invested heavily in research and development, bringing advances such as rapid COVID-19 molecular tests and minimally invasive surgical technologies to market.

The company serves customers in more than 100 countries across North America, Europe, Latin America, Asia-Pacific and the Middle East. Its products are distributed to hospitals, diagnostic laboratories, imaging centers and physician offices, supported by manufacturing facilities and regional offices around the world. Through partnerships with health systems and public health agencies, Hologic’s diagnostic platforms play a critical role in early disease detection and population health screening programs.

Hologic is led by President and Chief Executive Officer Jan Verstreken, who has overseen the company’s strategic initiatives since 2022. Under his leadership, Hologic continues to prioritize innovation in women’s health and expand its global footprint, with ongoing efforts to streamline operations, strengthen supply chains and accelerate development of next-generation diagnostic and imaging technologies.

Hologic Q2 2022 Earnings Call Transcript

Key Takeaways

• In Q2, Hologic posted $1.44 billion in total revenue and $2.07 non-GAAP EPS, exceeding guidance by over 12% on the top line and 33% on the bottom line.
• Both the Diagnostics and Surgical divisions delivered organic growth excluding COVID, while Breast Health declined due to a semiconductor chip shortage, though orders and backlog remain strong.
• Hologic placed 123 new Panther instruments in Q2—surpassing pre-pandemic placement averages—and now has over 3,100 Panthers installed worldwide, with a molecular vaginitis panel that nearly doubled year-over-year revenue.
• The Breast Health business faces up to a $50 million headwind in H2 from chip shortages, but an increased allocation received for late in FY 2022 should support revenue recovery in early 2023.
• Acquisitions BioTheranostics and Diagenode are integrating successfully: BioTheranostics quarterly revenue rose to $16.4 million and its BCI test was added to both NCCN and ASCO guidelines, while Diagenode teams advance two viral load assays for transplant testing.

Presentation

[Operator]

Please stand by. Good afternoon, and welcome to the Hologic 2Q22 Earnings Conference Call. My name is Lauren, 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, VP of Investor Relations at Hologic]

Thank you, Lauren. Good afternoon, and thank you for joining Hologic's second 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 second quarter press release is available now on the investor section of our website, along with an updated corporate presentation. We will also post our prepared remarks to our website shortly after we deliver them. A replay of this call will be available through May 27. 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.

[Ryan Simon, VP of Investor Relations at Hologic]

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 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.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Thank you, Ryan, and good afternoon, everyone. We are pleased to discuss our financial results for the second quarter of fiscal 2022. We posted solid results overall and continued our excellent performance. Total revenue was $1.44 billion, and non-GAAP earnings per share were $2.07, exceeding the midpoint of our guidance by over 12% on the top line and over 33% on the bottom. We stated last quarter we continue to deliver in an uncertain business environment. For example, in January, we saw COVID cases spike once again, putting pressure on healthcare utilization and certain elective procedures. Through February and March, the ripple effects of the war in Ukraine added additional uncertainty to a world already facing headwinds from COVID, rising inflation and interest rates, as well as ongoing global supply chain disruptions.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

In these challenging times, we continue to deliver. Our performance is a direct result of the planning and investments we made throughout the pandemic to strategically strengthen our business. We are a stronger Hologic through portfolio diversification, the addition of multiple growth drivers into our franchises, and continued growth in our international businesses. Today, we'd like to provide additional color in three areas. First, we'll discuss Q2 growth in light of the macro environment, including updates on the breast health chip shortage we spoke to in Q1. Second, provide progress on acquisitions turning organic in our third quarter. Third, highlight our additional efforts to lean into ESG and how our purpose, passion, and promise are elevating women's health around the world. In our second quarter, both our diagnostics and surgical divisions delivered organic growth excluding COVID, while, as expected, our breast and skeletal health division declined.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

In breast, as we discussed on our last call, the semiconductor chip shortage was the primary driver of the division's temporary decline. Encouragingly, underlying demand remains strong, as measured by healthy orders and a growing backlog. As we've seen during the last two years, as COVID testing rises, elective annual exams, screenings, and GYN surgical procedures are often postponed. As COVID testing declines, we see the opposite and our base business returns. We believe what the latest rebound also makes clear is that demand for our products remains strong despite the unpredictability of COVID surges. We are confident in our business, confident in our people, and excited about our positioning heading into the third quarter. For example, in diagnostics, we placed an additional 123 Panthers in the second quarter, surpassing first quarter placements of 119.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Only halfway through the year, we have again exceeded our pre-pandemic average of roughly 225 Panther placements per year. This is a phenomenal result given the rapid global expansion of our Panther installed base during the pandemic. Our Panther installed base is now over 3,100 instruments worldwide, with over 45% placed internationally. Also in diagnostics, our vaginitis panel, BV/CV/TV, continues its growth trajectory. In our Q2 of 2021, this assay generated about $7 million for the quarter. One year later, the panel contributed almost $14 million in worldwide sales, nearly double the year before. BV/CV/TV is now on pace to become a top three women's health assay in our molecular diagnostics portfolio. Now let's provide an update on chip supply and breast health.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Our supply chain service and commercial organizations have been working hard to gain greater visibility and mitigate the impact of the shortage. In Q2, the impact was slightly less than estimated, driven by favorable availability and precise management of chips in circulation within our service inventory. While our teams continue to do a great job navigating the unpredictable supply challenges on chips, the ongoing volatility of supply makes it possible that up to $50 million in additional headwind could surface in the back half of the year. Despite this, we are still materially increasing guidance for the full company, which Karleen will speak to later on. To finish the chip discussion on an upbeat note, we recently received notice of an increased allocation of chips for late in fiscal 2022.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

While this is very encouraging, given production and delivery timing, the benefit from this increase is unlikely to help revenue until early 2023. Said another way, we are optimistic the back half of our fiscal 2022 will prove to be the low watermark in terms of available gantries. Moving on to an update on acquisitions turning organic. In our fiscal third quarter, contributions from both BioTheranostics and Diagenode will be included in the organic growth of our diagnostics division. We will provide an update on both today. First, BioTheranostics. As a reminder, we completed this acquisition in February of 2021. The goal of this acquisition was to enter the high-growth, lab-based oncology market, an adjacent long-time area of interest, and bring our resources and expertise to create an even stronger business.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Based on Breast Cancer Index's earlier than anticipated inclusion in NCCN guidelines in January 2021, the deal is off to a great start. Last year, in its first full quarter post-acquisition, BioTheranostics posted $13 million of revenue, which was more than 30% higher than their best quarter prior to the pandemic. Fast-forward to our most recent quarter. BioTheranostics generated $16.4 million in revenue. This early success comes as a result of outstanding engagement in a successful cross-functional, cross-enterprise integration. As planned, we deployed Hologic resources and expertise and paired this with legacy BioTheranostics capabilities to refine operational efficiency and, most importantly, set a solid foundation for scalable growth. To accelerate BioTheranostics' already strong growth, as an example, we are streamlining the business's ordering process, which we believe will simplify things for the customer.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

We expect this enhancement will greatly improve the customer experience and ultimately result in more orders. We are also excited to share that we are in the process of transferring BioTheranostics operations to our diagnostics headquarters in San Diego. While maintaining required division between CLIA and IVD activities, we believe the move will lead to an even more unified culture, stronger relationships between counterparts, and more collaborative efforts. Finally, and even more encouraging, just last week, the BioTheranostics BCI test was included in the American Society of Clinical Oncology guidelines. Another major step towards increasing utilization and recognition of BCI as the standard of care. BCI is now the only genomic test in both NCCN and ASCO guidelines for predicting benefit of extended endocrine therapy. Moving on. Shortly after we closed the BioTheranostics transaction, we acquired Diagenode, based in Belgium.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

The goal of the acquisition was to accelerate PCR-based assay development for our Panther Fusion and leverage additional R&D capabilities in Europe. So far, we have checked both boxes. Since the close of the acquisition, as planned, we have integrated the Diagenode organization to optimize the speed and efficiency of our global R&D organization, enabling more effective and more efficient cross-border innovation. To date, teams from San Diego and Belgium have worked together closely to improve processes and clearly define a robust product development pipeline. The team is already making meaningful progress towards approval of two viral load assays, which will expand our virology portfolio in the transplant testing space. Overall, for both BioTheranostics and Diagenode, we are pleased with the integration and progress of these two businesses.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

As we look forward, we are excited by the opportunity to unlock more synergies from both and in turn, create more value for our shareholders. Shifting gears, I'd like to close by highlighting two very meaningful and opportunistic marketing efforts from our second quarter. The first being our Super Bowl commercial, which also ran during the Winter Olympics, and the second, our title sponsorship of the Women's Tennis Association tour. As many of you may have seen, our television commercial titled Her Health Is Her Wealth, featured Mary J. Blige. The commercial highlighted that despite her busy life, she makes time in her schedule for her annual health exams. The campaign came at a critical time as an alarming number of women missed annual breast and cervical cancer screenings during the COVID-19 pandemic.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

In January, the inaugural results of our Hologic Global Women's Health Index found that nearly 50% of women ages 16 to 54 had not seen a medical professional in the prior year. The purpose of our message was to encourage women to schedule their annual exams and prioritize their health. Detecting cancer early is critical and can often make the difference between a curable and non-curable prognosis. After two years of the pandemic, with too many women not being screened and our unique relationship with Mary J. Blige, there was no better time and no better stage for us to encourage more women to see their doctors. Our second effort is our landmark title sponsorship of the WTA Tour, announced in early March. This alliance was forged to make significant progress on our shared vision of greater wellness and equality for women.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

The partnership has global reach and will emphasize the importance of preventive care through well-woman visits. We are proud to stand with the WTA as we work together to jointly raise the profile of women and share the importance of early detection and treatment. Before turning the call over to Karleen, let me conclude by saying that the results of this quarter demonstrate our business is both durable and resilient, and the demand for our products is exceptionally strong. Despite multiple macro headwinds, we continue to deliver strong results. We are both excited and confident in our business and see great opportunity to be even stronger in the years ahead. With that, let me turn the call over to Karleen.

[Karleen Oberton, CFO at Hologic]

Thank you, Steve, and good afternoon, everyone. We are very pleased to share second quarter results that significantly exceeded our guidance for both revenue and EPS. Our second quarter performance once again highlights the strength of our diverse business. While the Omicron variant negatively impacted our base businesses early in the quarter, our COVID testing upside more than offset this headwind. It is also important to understand that our balance sheet is stronger than ever, providing key strategic flexibility in this uncertain macro environment. Further, we continue to generate very healthy free cash flow, funding our debt and capital deployment priorities. In the second quarter, we generated significant operating cash flow and executed $200 million of share repurchase, both of which I'll touch on in more detail shortly. Before we do that, we will provide color on our consolidated and divisional results for the second quarter.

[Karleen Oberton, CFO at Hologic]

As a reminder, revenue in our fiscal second quarter is typically seasonally lower compared to our first quarter, which benefits from increased patient activity before calendar year-end. In the quarter, total revenue of over $1.4 billion was very strong and came in more than $150 million higher than the midpoint of our previous guidance. In addition, EPS of $2.07 in the second quarter far exceeded our guidance range of $1.50-$1.60. Turning to our divisional results. In diagnostics, global revenue of $987.1 million declined 5.6% compared to the prior year. However, excluding COVID, worldwide organic diagnostics revenue increased 4%. As discussed, the division's results early in Q2 were negatively impacted by the Omicron COVID-19 variant.

[Karleen Oberton, CFO at Hologic]

Our base diagnostics business is inversely correlated to spikes in the pandemic, as women tend to postpone office visits when COVID cases surge. However, we were encouraged by improving trends throughout March as COVID cases declined. This gives us great confidence in the underlying health of our base diagnostics franchise. Moving specifically to our molecular diagnostics business, we will again exclude the impact of COVID. Making these adjustments, base molecular revenue grew about 7% organically in the second quarter. This growth was driven by strong uptake in newer assays such as our vaginitis panel and menu within our virology product line. As it relates to our COVID results, we generated $584 million of COVID assay revenue, far exceeding our guidance of $400 million. We shipped about 28.5 million tests to customers as ASPs held steady around $20 per test globally.

[Karleen Oberton, CFO at Hologic]

The United States represented about 60% of total COVID assay revenue. However, testing demand was strong in international markets as well. Rounding out diagnostics, our cytology and perinatal businesses were essentially flat compared to the prior year, as these segments were also impacted by COVID-19's influence on women's wellness visits. In breast health, global revenue of $310.4 million was down approximately 7% as expected, primarily driven by the chip shortages that we have discussed. In our interventional business, incremental supply chain pressure of a few million dollars surfaced during the quarter, specific to our disposable biopsy needles. As a result, our interventional business was down slightly less than 1% in the period. While supply chain challenges persist, demand for our best-in-class breast health products remains strong. As Steve commented, we expect to see improvement in 2023.

[Karleen Oberton, CFO at Hologic]

In surgical, second quarter revenue of $117.3 million grew 3.5%. As we foreshadowed during our first quarter call, the Omicron variant caused a pullback in elective procedures in the first half of the quarter. This trend improved later in the period as COVID cases declined. Furthermore, we saw nice resilience from several of our newer products, such as the Fluent Fluid Management System and solid co-contributions from Bolder's CoolSeal devices. Lastly, in our skeletal business, revenue of $20.9 million decreased 6% compared to the prior year period. Now let's move on to the rest of the non-GAAP P&L for the second quarter. Gross margin of 71% was well ahead of our forecast, driven by higher than expected COVID-19 testing volumes in the period.

[Karleen Oberton, CFO at Hologic]

Total operating expenses of $338.2 million increased 22% in the second quarter. As we have done throughout the pandemic, given the benefit from COVID-19 profitability, we took the opportunity to reinvest in our base businesses. We also allocated spend to key marketing initiatives to help drive awareness for women's health. For example, second quarter operating expenses included our Super Bowl and Olympic commercials, as well as expenses associated with our WTA partnership. The combined total of these initiatives contribute slightly more than $25 million to operating expenses in the quarter. In addition, within operating expenses, recent acquisitions added slightly less than $35 million in the quarter, about $25 million higher than the prior year period. Finally, our tax rate in Q2 was 20.5%, marginally lower than our expectations, given the higher COVID-19 revenue outside the United States.

[Karleen Oberton, CFO at Hologic]

Putting these pieces together, operating margin for Q2 came in well above our forecast at 47.4%, and net margin was very strong at 36.5%. Non-GAAP net income finished at $524.2 million, and non-GAAP earnings per share was $2.07, nearly 35 above the midpoint of our prior guidance. Moving on from the P&L, cash flow from operations was $1.06 billion in the second quarter, inclusive of tax refunds totaling approximately $418 million related to the sale of our previously held medical aesthetics business in 2020. When normalizing for these refunds, cash generation for the quarter was still exceptional. These robust cash flows continue to provide tremendous financial and strategic flexibility.

[Karleen Oberton, CFO at Hologic]

For example, as referred to earlier, we repurchased 2.9 million shares of our stock for $200 million in the quarter. We continue to view our ongoing share repurchase program as a lever to drive value for our shareholders. Further, we continue to diligently pursue M&A opportunities in each one of our divisions. Based on our strong operational performance, we had $2.3 billion of cash on our balance sheet at the end of the second quarter, and our leverage ratio was 0.3x. Our capital structure is fortified, and while we ended the quarter with an elevated cash balance, we continue to be thorough and exercise discipline as we evaluate opportunities. Given the macro environment, we have comfort with our elevated cash balance and the ability to be patient as we identify high-quality opportunities.

[Karleen Oberton, CFO at Hologic]

Now, let's move on to our updated guidance for the third quarter and full year fiscal 2022. In the third quarter, we expect to continue our track record of delivering strong financial results with total revenue in the range of $875 million-$915 million. For the full year fiscal 2022, we expect total revenue in the range of $4.6 billion-$4.7 billion, significantly exceeding our prior full year guidance by $175 million at the midpoint. We are raising guidance once again in the face of an uncertain macro backdrop, highlighting our confidence in our business. Given the continued strength of the US dollar and to aid with constant currency modeling, we are assuming foreign exchange headwinds of approximately $20 million in the third quarter of 2022 and $65 million for the full year.

[Karleen Oberton, CFO at Hologic]

This FX unfavorability to revenue is higher than our guidance from last quarter. In diagnostics, we expect Molecular to continue to drive growth based on our Panther install base of over 3,100 instruments globally, over 80% larger than the start of the pandemic. We are also seeing encouraging uptake of our newer assays like our vaginitis panel, virals, and MGen, as well as the tremendous international expansion opportunities. In terms of COVID sales, we expect COVID assay sales to be at least $100 million in the third quarter of 2022 and approximately $1.25 billion 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 third quarter and $215 million for the full year.

[Karleen Oberton, CFO at Hologic]

In breast health, our organic and inorganic investments continue to perform well and highlight the diversity of the division's revenue streams. For example, Brevera had another great result, growing mid-teens in the last quarter. In addition, recurring service revenue represented more than 40% of total sales in Q2. In terms of the breast health chip shortage announced last quarter, given significant uncertainty still exists in the chip market, the possibility of an incremental $50 million headwind in the back half of 2022 exists, and we have incorporated this into our guidance. While we are seeing early signs of improvement in chip supply, we are forecasting conservatively. To reemphasize, this headwind is purely a supply issue and not one of underlying demand, which remains strong. Finally, in surgical, we feel great about the trajectory of our business as COVID trends improve.

[Karleen Oberton, CFO at Hologic]

MyoSure and related organic products such as Fluent continue to drive near-term growth, and we expect meaningful contribution from both Acessa and Bolder over the next several years. As a reminder, our organic guidance backs out of revenue from acquisitions until the first full quarter after a deal annualizes, as well as revenue from our divested blood screening business. In terms of the deal, BioTheranostics and Diagenode will become part of our organic revenue in Q3 2022. Therefore, the organic revenue adjustments for Q3 include Mobidiag and Bolder, and for Q4, Bolder only. Moving down the P&L, for the full year, we forecast our non-GAAP gross margin percentage to be in the mid- to high-60s% and our non-GAAP operating margin percentage to be in the high-30s%. Both estimates are higher than our guidance last quarter.

[Karleen Oberton, CFO at Hologic]

Further, our second half guidance incorporates the margin impact from our breast health supply chain revenue shortfall. As a reminder, Gantry gross margin is accretive to the consolidated averages, and we have maintained operating spend in order to be in a position to move quickly once we receive chips. In addition, we have again incorporated inflationary supply chain costs into our guidance as it relates to electronics, plastics, and logistics. Despite these headwinds, for the full year, we expect both growth and operating margins to be above pre-pandemic levels. In terms of operating expenses, we expect spending to be up compared to 2021 but be lower in the second half of 2022 compared to the first half. As we have continued to highlight, in quarters with higher COVID testing revenue, we will take the opportunity to invest for future growth.

[Karleen Oberton, CFO at Hologic]

Below operating income, we expect other expenses net to be a little less than $25 million a quarter for the remainder of the year. Our guidance is based on effective tax rate of 21% and diluted shares outstanding of around 255 million for the full year. All this nets out to expected EPS of $0.67-$0.72 in the third quarter and $5.45-$5.65 for the full year, 10% above our prior guidance at the midpoint. As you update your forecasts, let me remind you that macro uncertainty due to the pandemic, related supply chain challenges, and geopolitical conflicts remain high. We would therefore encourage you to model at the middle of our ranges, which incorporates both potential upsides and downsides.

[Karleen Oberton, CFO at Hologic]

Let me wrap up by saying that Hologic posted very strong second quarter results that far exceeded expectations and guidance. We are also raising our financial guidance for the year, even as we are increasing anticipated supply chain headwinds, highlighting the multiple growth drivers we have added to each of our franchises and benefits from COVID testing. With a strong balance sheet and best-in-class cash flow generation, we are well positioned. With that, we ask the operator to open the call for questions.

[Operator]

Thank you. If you would like to ask a question, please signal by pressing star one on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. We ask that you please limit yourself to one question plus one follow-up. Again, that is star one to ask a question. We'll take our first question from Jack Meehan with Nephron Research.

[Jack Meehan, Equity Research Analyst at Nephron Research]

Thank you, and good afternoon.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Hey, Jack.

[Jack Meehan, Equity Research Analyst at Nephron Research]

My first question is on breast health and the semiconductors. You know, last quarter, the, you know, up to $200 million you talked about, I thought, you know, was fully de-risking the gantry exposure. Then the quarter actually came in a little better than you were thinking. I'm just trying to square this commentary with the additional $50 million you're building in from here. Can you just maybe help me through that? Kind of second off that, just can you give us a little bit more color on the order book and just your confidence that you're not losing, you know, share given some of the supply chain shortages there?

[Karleen Oberton, CFO at Hologic]

Yeah. Jack, it's Karleen. I'll start off on kind of the evolution of the number. You know, first, let's recognize in this quarter we did a little better, and that was really a lot of efforts between our service and supply chain folks really prioritizing and remanufacturing chips for the service needs, which allowed us to sell more new gantries. Great effort there. I think when we think about the additional possibility of an additional $50 million, it has a little more to do with timing. We are pleased that we got a higher allocation of chips than we had thought, than we had originally expected. But the timing of that is such that it won't come in until 2023.

[Karleen Oberton, CFO at Hologic]

I think we thought if there was an additional allocation, we might get that benefit in 2022, but it's looking like it's 2023. On the second part of your question on demand, you know, again, we see our backlog growing in our breast health business. It's super strong. We're working really strategically with customers to make sure that we're not losing any business because of this, and that, you know, I think our intelligence would be that, you know, our competitors are probably in the same position as us.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

I think the reps feel good.

[Jack Meehan, Equity Research Analyst at Nephron Research]

Okay. Yeah, that makes sense on the timing. Very helpful. As an unrelated follow-up, you know, obviously in molecular, big focus on kind of share shifts in the diagnostics industry with COVID. I was wondering if you could talk about your relationship with the national labs and just with the larger customers, whether you think you're gaining or losing share as we transition eventually into an endemic environment.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah, Jack. By the way, I'd also clarify that we're not gonna use the cash on the balance sheet to buy the Eagles. I know you were, but,

[Jack Meehan, Equity Research Analyst at Nephron Research]

Hopefully, they make some good picks tomorrow.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah, exactly. Hey, in terms of our relationship with the national labs, I probably couldn't be more proud of our teams. Even we've always had good relationships, but when you think about the way we responded, and particularly if you look at the two big major labs in the United States, but even, you know, a number of the other big ones right below the top two, you know, when they were really under the gun, and you think back to the April, May, June timeframe of 2020, when the evening news around the world, around the country was always about the eight-day turnaround times for PCR tests and, you know, all of the problems with molecular testing. You know, that's when we dispatched and our teams went round the clock to put Panthers in all over the place.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

We really worked so well to, you know, help both of those customers dramatically reduce the turnaround times. I think we've used both the relationship in coming to, you know, their aid during that time, as well as frankly, I think they increasingly understand that we're building markets. You know, when it comes to how we approach the women's health market, we're also working the reimbursements, we're working the physician recommendations, we're working the guideline developments. All of that is helping to grow the market, which by definition is growing them. I would tell you, I feel like it's more of a partnership that is valued than just a traditional vendor, you know, vendee relationship.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

you know, I think our teams have worked so hard to have, you know, many good relationships throughout, you know, all levels, both operationally within their marketing teams and we like where we're positioned. We really do.

[Jack Meehan, Equity Research Analyst at Nephron Research]

Thank you, Steve.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Great. Thanks.

[Operator]

Our next question comes from Vijay Kumar with Evercore ISI.

[Vijay Kumar, Senior Managing Director and Equity Research Analyst at Evercore ISI]

Hey, guys. Thanks for taking my question. Steve, maybe one big picture for you. I'm looking at the base business here, the segments. It looks like it was light across the board. Breast imaging, perhaps it's understandable given the chip shortage, but it looks like underlying diagnostics came in below Street models. GYN, a similar trend. How much of this was a utilization impact due to Omicron? The reason I ask is, we're seeing other device companies coming up with improved procedure trends. I'm curious, was there any one-off items that impacted you know, Hologic in the Q?

[Steve MacMillan, Chairman, President, and CEO at Hologic]

You know, I think, Vijay, part of it on the surgical business is probably as some of the hospitals came back up post Omicron, they tended to prioritize some of the cardiovascular procedures and some of the more immediate procedures, whereas our GYN surge is viewed as a little more elective. I think there was a little bit of that probably in the quarter that we think shakes out, you know, completely over time as the women's health issues come back. I think, you know, our base molecular diagnostics business was up 7%, not too shabby in a period where a lot of our machines ended up running a lot of, you know, additional COVID tests. You know, nothing that we are concerned about.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

You know, I think as we continue to look all of these quarters, you know, there's variability and there's puts and takes, and we keep managing our business overall that as one part goes up. You know, the reality is we do see trade-offs. You know, we did sell $584 million of COVID in the quarter. There is a bit of a trade-off on our base business with that. As that goes back, I think we're very optimistic about where the base business comes here as that COVID testing really does, you know, probably really subside here.

[Vijay Kumar, Senior Managing Director and Equity Research Analyst at Evercore ISI]

That's helpful perspective, Steve. Maybe one related, there's been a lot of debate on The Street on what is the underlying base margin, base earnings power for Hologic? I know what The Street is trying to do. We're trying to do a COVID P&L and a base business P&L, and in reality, that may not be how corporates think about their businesses. How much of reinvestment is going on in the business, do you? Because the reason I ask is, if I look at the implied Q4 EPS guide, I think it's, you know, $0.60-$0.65. So that's annualizing at $2.50. I'm assuming Q4 has very minimal COVID testing, but also it has some impact from breast imaging, the chip shortage, right?

[Vijay Kumar, Senior Managing Director and Equity Research Analyst at Evercore ISI]

What is the underlying earnings power here for Hologic that we should be thinking about?

[Karleen Oberton, CFO at Hologic]

Yeah, Vijay, it's Karleen. I'll take you through it. If we look at the second half of 2022, you're right, that is the worst impact of the breast health chip shortage. Don't think of the back half earnings power and the math you just did on the Q4 as what we call our base business earnings power. There's definitely an impact there, significant impact, with pretty minimal COVID revenue in the fourth quarter. The other thing I would point to is that, you know, if we look at the back half, we have, you know, a higher operating expenses and simply dilutive operating margins from our acquisitions, which actually will be a tailwind as we move forward into 2023 and beyond. We do have some incremental investments in both Q3 and Q4.

[Karleen Oberton, CFO at Hologic]

Those investments will either not occur in 2023 or be significantly lower. To reiterate, the back half earnings power is not reflective of the base business, because of the one-time items, I'll call them, that we have there.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah. Vijay, back to even building on the comment on the base business, I'd remind you in a couple of simple things here. We've not only passed through the full beat on top line and bottom line through the balance of the year. The second half is every bit as intact as what it was prior, despite more headwinds, all of which should underscore the confidence that we have in our base business. To Karleen's point, that is, you know, the fourth quarter is not the ongoing run rate.

[Operator]

We'll take our next question from Patrick Donnelly with Citi.

[Patrick Donnelly, Managing Director and Equity Research Analyst at Citi]

Hey, guys. Thanks for taking the questions. Maybe a similar follow-up on that. I mean, just on in terms of the breast health ramp back up as we get into the beginning of 2023, what's the visibility into the supply chain normalizing there? I mean, the confidence level that kind of corrects itself as we get into 2023. Should we think of it as more kind of slowly ramping back up and being a bit of a drag on revenue margins to start 2023 as the expenses come to Karleen's point, those are intact, growth is going to catch up. What's the right way to think about that as we look out to the start of 2023?

[Karleen Oberton, CFO at Hologic]

I would say that I would expect it not to be we will see benefit from increased supply early in 2023, but I think we'll see, to your point, a normalization throughout the year is what I would think would happen. Because even though we have building backlog, it's going to take multiple quarters to work through it as these installs of this equipment is highly scheduled with hospitals and breast centers because they typically have to take the rooms down, it's construction, as well as the install takes, you know, almost a week. It's going to take several quarters to work through that. I would say a normalization over the course of the year.

[Patrick Donnelly, Managing Director and Equity Research Analyst at Citi]

Okay, that's helpful. Steve, you know, on the capital allocation side, what's the right way to think about it? Obviously, you guys, you know, have done some share repos, you've done some deals. How do you balance the priorities there? You know, obviously, the market is volatile and presents opportunities here and there. What's the internal thinking? How large will you go on the deal side? What's the pipeline look like? Just an update there would be helpful.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah, I think the biggest thought we should leave you with is we're comfortable being patient right now. You know what? Just because we have a very strong, you know, amount of cash on the balance sheet doesn't mean we feel a pressure to go do it, you know, in the next quarter or two. We know that deals will present themselves in the quarters or years ahead. You know, I was showing Karleen an old headline from, you know, the late 2008 timeframe at Stryker, where we were sitting on a pile of cash, and at the time, I was being criticized for being too conservative. You know, opportunities presented themselves over the next few years.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

I think we feel very confident and frankly should feel great in an uncertain world to be sitting with the balance sheet that we have relative to what we had, you know, 8 or 10 years ago in this company. It just gives us the ability to be patient and therefore, you know, make great deals and continue to do a combination, you know, some buybacks. But we still ultimately are looking and think there will be some good deals that'll present themselves. You know, we're not going to get into the specific size, but we've got a fair amount on the balance sheet right now, and it doesn't mean we're, you know, ready to go blow it all at once or anything else.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

I think we've been, you know, shown over the last five years or so we're being very disciplined and rigorous.

[Operator]

We'll take our next question from Puneet Souda with SVB Securities.

[Puneet Souda, Senior Research Analyst at SVB Securities]

Yeah. Hi, Steve, Karleen. Thanks for taking the question. Maybe just the first one, on some of the Panthers that you highlighted, the recent sales. Are those still going into a demand for COVID, or was that still a function of, you know, demand pull-through in January from COVID? Or are customers now looking at the broader menu and saying, you know, looking at Panther purchases from a broader menu perspective? You know, could you update us on any utilization trends? I know this is a major question in terms of the utilization of, you know, COVID conversion into other tests. Maybe just walk us through sort of what's happening as we somewhat emerge out of pandemic into this endemic situation.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah. The placements are really going for both COVID and new business. I think the magic for us is we've been able to expose Panther to so many new customers around the world, and they've seen the benefits both in COVID, and it's also given us the chance to talk about the menu and the expanded menu. We're really getting them in, you know, on both fronts. I think every time we start to see customers getting ready to port some of the newer assays onto their machines, we have yet another spike. You know, candidly, we would have expected more base business growth this quarter, and then lo and behold, we did another 28.5 million, you know, COVID tests.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

As a reminder, you know, that's as much as we were doing, you know, practically globally, you know, more than what we were doing globally pre-pandemic on all of our businesses combined. It's, you know, I think people have become dulled to the numbers, but that has an impact in terms of our customers being able to adopt the other parts of the menu when again, they just got thrown back into huge testing. Now, I think as it plays out here in the coming quarters, you know, we're assuming a much stronger and prolonged ramp down here in the COVID testing. That's going to really, we believe, allow the underlying strength of our core menu to start to shine through, and you'll start to see it in these quarters.

[Puneet Souda, Senior Research Analyst at SVB Securities]

Okay, that's helpful. Just one-off question that we've been getting from investors given the China shutdowns. Anything that you're baking from that side into the guide? Maybe just could you if you could remind us your exposure there, both in terms of the revenue and impact to the supply chain. Thank you.

[Karleen Oberton, CFO at Hologic]

Yes. It's Karleen Oberton. I'll answer that. You know, less than 3% of our revenue comes from China, so we have pretty minimal exposure. We do think there is some impact that is factored into our guide. We really don't have any manufacturing presence within China. I think what we're dealing with is the kind of global supply chain chip issue related to China. From a revenue perspective, it's pretty immaterial.

[Operator]

We'll take our next question from Brian Weinstein with William Blair.

[Patrick Griffin, Equity Research Associate at William Blair]

Good afternoon. This is Griffin on for Brian. Thanks for the questions. Just to start, you know, continuing to talk about that OUS strength, I guess specifically in diagnostics. You know, historically, those markets have had some less favorable reimbursement and just lower testing volumes with less screenings. You know, are you seeing any change in either of those dynamics, as you think about the OUS outlook?

[Steve MacMillan, Chairman, President, and CEO at Hologic]

You know, I think we see opportunities again over time to more directly influence the size of those markets and everything else. I think what we do see in the near term is the ability with a lot of the additional Panthers we've placed to have more menu running through them. Then the second piece will be really helping to grow those markets more significantly over time. I think we feel, you know, very encouraged short term from all the placements and longer term because of the strength that we've put in our teams.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Frankly, the additional access we've gotten to a lot of the health ministers of the world through both COVID time as well as the Hologic Global Women's Health Index to, I think, start to get women's health, you know, moved up the priority list where we will be able to get, you know, more screening guidelines and things put in place in the coming years, particularly in Western Europe.

[Patrick Griffin, Equity Research Associate at William Blair]

Okay. On the CT/NG, you know, to go back to pre-pandemic levels. Any notable changes in how you think about the basis of competition here pre-pandemic versus, you know, endemic state or post-pandemic, particularly with some of the point-of-care molecular entrants in the STI market?

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah. You know, we'll see where that all plays out. You know, we're always very, very cognizant. I think as we continue to think about how women are going to get these tests and the doctors and the reimbursements and everything else, I think we continue to feel very good about our position.

[Karleen Oberton, CFO at Hologic]

I would just emphasize that most of the CT/NG testing is asymptomatic. When you think about at-home testing, it would be generated by a symptom. Most vast majority of the testing is asymptomatic and again, part of that well women's visit.

[Operator]

We'll take our next question from Tejas Savant with Morgan Stanley.

[Tejas Savant, Executive Director and Senior Healthcare Equity Analyst at Morgan Stanley]

Hey guys, good evening. Just a follow-up on some of your earlier comments on the chip shortages on the breast health side, Steve and Karleen. You spoke about, you know, that new allocation that you're expecting to see come through at the end of the second quarter here. How can you quantify that relative to that 20% number that you had spoken of earlier? In terms of seeing the benefit in fiscal 2023, is this largely sort of outside your control, or are there things you can do to accelerate those timelines, perhaps, you know, looking into different suppliers, et cetera?

[Karleen Oberton, CFO at Hologic]

In rough numbers, I think the increased allocation increased our expected unit production by about 20-25% in 2023. You know, I think from that initial, you know, hopefully we'll get. We just don't know. We don't have that visibility to if that allocation gets any higher, but that's what we're planning on right now.

[Tejas Savant, Executive Director and Senior Healthcare Equity Analyst at Morgan Stanley]

Got it. Any comments, Karleen, on the possibility of new suppliers coming in here, or is that sort of all incorporated into your fiscal 2023 recovery commentary?

[Karleen Oberton, CFO at Hologic]

Yeah. What we know is kind of incorporated into the guide and our commentary. I think, you know, you know, to try to bring on new suppliers would take multiple, you know, quarters. You know, I think the issue, the supply issue is not just our suppliers, it's all the suppliers. It doesn't really solve the problem.

[Operator]

Our next question comes from Casey Woodring with J.P. Morgan.

[Casey Woodring, Research Analyst at J.P. Morgan]

Hi, guys. Thanks for taking my question. Can you talk a little bit about breast service and if there's maybe any kind of pull forward you could do there to offset some of the near-term gantry sale headwinds?

[Karleen Oberton, CFO at Hologic]

Yeah. Breast service, we love our breast service revenue. It's, you know, the comment was about 40% of the breast revenue in the quarter. But most of that revenue, the majority is tied to long-term service contracts. It's contracts that are over multiple years where the revenue is basically, you know, amortized over the contract period. Really, it's tied to our install base. You know, if we're not putting out more gantries, it's hard to do more service contracts. That's really more of a stabilizing fact in that division versus this limited ability to pull forward.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah. Nor would we want to pull it forward, to be quite honest. Yeah, I think what we love about that business is it's stable. Candidly, we've got all the additional COVID revenue this year. What we're really looking forward to is people will start to see the underlying strength of our base businesses in 2023. The last thing we'd want to do is mortgage some of that.

[Casey Woodring, Research Analyst at J.P. Morgan]

Gotcha. Just how should we think about the Panther competitive environment in the hospital setting as it relates to some of these smaller benchtop platforms when you think about Cepheid and some of the other instruments out there with overlapping menu? Do hospital customers have both a Panther and a benchtop instrument? Sort of how should we think about this dynamic moving forward given all the COVID placements?

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah, many do, but they're still largely used differently. You know, a lot of the benchtop stuff is really for symptomatic, you know, especially respiratory or other symptomatic stuff, whereas ours is largely asymptomatic and ongoing screening. You know, I think this is gonna be a question of and, not or. You know, there's gonna be meaningful opportunities on all fronts. I do think, you know, we're very well positioned and feel great about where we are with the Panther placement. I think we're very confident you're gonna continue to see that, and that will unfold even more as the COVID revenue goes away.

[Operator]

Our next question comes from Mike Matson with Needham.

[Joseph Conway, Equity Research Associate at Needham]

Hi, guys. This is Joseph calling from Mike. I guess maybe one around gross margin. You know, I guess given the capacity expansion to really meet COVID testing during the surges, and as we start seeing that, you know, the declines, we see the volumes decline. Should we expect some type of gross margin headwind in these next couple of quarters?

[Karleen Oberton, CFO at Hologic]

Well, certainly as COVID revenue comes down, the gross margins will come down from where they have been. From an absorption perspective, you know, our manufacturing of COVID is, you know, fungible with all of our Molecular Diagnostics manufacturing. There's not a separate COVID line where we'll have, you know, to mothball, if you will. I think the other piece of what has happened over the last two years is we have expanded our manufacturing, but that's been substantially funded by the Department of Defense and our contracts with them. There's really no big hit, if you will, for idle capacity. If that was the question.

[Joseph Conway, Equity Research Associate at Needham]

Yeah. Yeah, absolutely. That's very helpful. I guess maybe one more around the Panther systems. I know you guys have touched on that a lot, but as we're kind of looking towards that capacity utilization and non-COVID assays really going into these systems, I guess maybe, you know, there's been a lot of surges up and down. Obviously, hospitals are very flushed. I guess what are you guys looking for to really, you know, push these forward, whether it be trainings that you guys have to schedule or whether it's just kind of waiting for total COVID cases to really reach a manageable level?

[Steve MacMillan, Chairman, President, and CEO at Hologic]

In terms of the base business, if that's the crux of it's really around having the time to get the new assays up and running on the Panther within each, you know, each hospital and each lab. I will tell you just from having, you know, we're in our strategic plan process right now, where we've been sitting down both with the U.S. diagnostics team, but also our international teams. As we look at the optimism that they have for the underlying growth rates of our Molecular business for the next few years, it gets pretty exciting. We're not ready to give guidance or anything on that front. I think there's, you know, just the additional placements and the additional opportunities.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

You know, don't underestimate in a world where labor constraints and labor costs have become a huge issue. I think people are forgetting one of the massive benefits of the Panther is the workflow automation, the random batch access. This is, you know, the benchmarks that we have. This is a remarkably efficient system that we think is only and that's part of what the customers are seeing and looking forward to the future. I think it's gonna bode very well for us.

[Operator]

We'll take our next question from Derik de Bruin with Bank of America.

[Derik de Bruin, Managing Director and Life Sciences Tools and Diagnostics Analyst at Bank of America]

Hey, good afternoon. Thanks for taking my question. Hey,

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Hey, Derik.

[Derik de Bruin, Managing Director and Life Sciences Tools and Diagnostics Analyst at Bank of America]

Steve, how do you feel about the long-term guide that you've set out? You know, you put out that 5%-7% core growth CAGR through 2025 on the 3Q 2021 call. I'm just wondering, you know, given the chip shortages, given, you know, like that is, I mean, you know, how is your confidence in that? I mean, looking at the results this quarter, I think some people are a little bit nervous. Are you still comfortable with that 5%-7% number?

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Very. You know what? It's a long-term thing. Obviously, we did not anticipate the chip shortage. Having said that, you know what? Think about what those growth rates are gonna be when we index against these quarters, you know, next year. Even on a long-term basis, I think we feel very, very good, you know, about what the growth rates of our base businesses will probably be doing over the next couple of years. You know, we've got a couple of punky quarters here right ahead of us to finish a year that's already a very strong year. You know, it's growth rates as we start to look into 2023, probably looking pretty good.

[Derik de Bruin, Managing Director and Life Sciences Tools and Diagnostics Analyst at Bank of America]

Okay. As a placeholder for COVID for next year, that fourth quarter number, that $40 million-$50 million inflow for COVID testing in Q4, is that a good way to sort of think about it just for now?

[Steve MacMillan, Chairman, President, and CEO at Hologic]

You know, I almost don't even wanna go there, Derik, 'cause the quarterly swing, you know, who knows where it all goes, and I think we're poised either way. You know, I would put in a de minimis number for 2024, and yet I think we'll certainly expect some volume just to continue to be there. Probably not a horrible, you know, estimate, but we're nowhere near being able to give guidance.

[Operator]

We'll take our final question from Ryan Zimmerman with BTIG.

[Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG]

Thanks for squeezing me in. I'll just keep it to one in the interest of time. On the breast health business, Steve or Karleen, we've seen from some of your peers on the equipment side, you know, certainly commentary around softer demand, you know, cost of debt is rising. You had alluded to the fact that, you know, the order book is pretty healthy or the backlog's healthy on the breast side. What do you attribute that to in terms of your capital equipment? Is it a site of service? Is it price points relative to maybe some of the million-dollar-plus robots that are out there? I'd just be curious to understand kinda how you think about the capital equipment demand market at the hospital level.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

Yeah. I think it starts with, you know, always having a superior product. You know, we have not gotten where we've gotten from a market share standpoint, particularly in mammography and especially in 3D, without having a superior product. I think and also superior workflow throughout the whole, you know, throughout the whole gamut. I think, you know, hospitals are seeing what we bring to them in a critically important area. To your second point, I will say, you know, we're not one of the high-ticket items. In a grand scheme, a hospital recapitalizing, you know, a few rooms in mammography or even, you know, several suites is nowhere near the magnitude of some of the bigger iron, the massive, you know, whether it's robots or, you know, MRIs and those kinds of things.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

I think it does allow us to kinda, you know, be in a sweet spot, where even if there's a little bit of, you know, capital contraction that, you know, we think we'll be fine there. I think our team's feeling, you know, very, very good.

[Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG]

Okay. Thank you.

[Steve MacMillan, Chairman, President, and CEO at Hologic]

All right. Thank you. That sounds like it, operator. Lauren?

[Operator]

Yes, sir. That concludes today's question and answer session. This now concludes Hologic's 2Q 2022 earnings conference call. Have a good evening.

Participants

Executives

• Karleen Oberton, CFO
• Ryan Simon, VP of Investor Relations
• Steve MacMillan, Chairman, President, and CEO

Analysts

• Casey Woodring, Research Analyst at J.P. Morgan
• Derik de Bruin, Managing Director and Life Sciences Tools and Diagnostics Analyst at Bank of America
• Jack Meehan, Equity Research Analyst at Nephron Research
• Joseph Conway, Equity Research Associate at Needham
• Patrick Donnelly, Managing Director and Equity Research Analyst at Citi
• Patrick Griffin, Equity Research Associate at William Blair
• Puneet Souda, Senior Research Analyst at SVB Securities
• Ryan Zimmerman, Managing Director and Medical Technology Analyst at BTIG
• Tejas Savant, Executive Director and Senior Healthcare Equity Analyst at Morgan Stanley
• Vijay Kumar, Senior Managing Director and Equity Research Analyst at Evercore ISI