OraSure Technologies, Inc. (NASDAQ:OSUR) Q4 2022 Earnings Call Transcript

OraSure Technologies, Inc. (NASDAQ:OSUR) Q4 2022 Earnings Call Transcript February 14, 2023

Operator: Good day, and thank you pray. Welcome to the OraSure Technologies 2022 Fourth Quarter Earnings Conference Call. . I would now like to hand the conference over to your speaker today, Scott Gleason, Head of Investor Relations. Please go ahead.

Scott Gleason: Thanks, Victor. Good afternoon, and welcome to OraSure Technologies Fourth Quarter ’22 Earnings Call. I’m Scott Gleason, the SVP of Investor Relations and Communications. And presenting with me today for OraSure is Carrie Manner, our President and Chief Executive Officer; and Ken McGrath, our Chief Financial Officer. As a reminder, today’s webcast is being recorded, and the recording can be found on the Investor Relations section of our website. Before we begin, you should know that this call may contain certain forward-looking statements, including statements with respect to revenues, expenses, profitability, earnings or loss per share, other financial performance, product development, performance, shipments and markets, business plans, regulatory filings, approvals, expectations and strategies.

Actual results could differ significantly, factors that could affect results are discussed more fully in the company’s SEC filings, including its registration statements, its Annual Report on Form 10-K for the year ending December 31, 2021, its quarterly reports on Form 10-Q and its other SEC filings. Although forward-looking statements help to provide complete information about our future prospects, listeners should keep in mind that forward-looking statements are based solely on information available to management as of today. The company undertakes no obligation to update any forward-looking statements to reflect events or circumstances after this call. With that, I’m pleased to turn the call over to Carrie.

Carrie Manner: Thanks, Scott, and thank you to everyone for joining us today. In the fourth quarter, we once again delivered strong top line results, which exceeded our prior financial guidance, generated cash of $9 million in the quarter and made further progress in our strategic transformation journey. As we look to important aspects of how we are transforming, we have predominantly been focused on strengthening our foundation, expanding our cost reduction programs. Today, we announced a reduction in our nonproduction workforce of 11%. These changes better align our organizational structure with the realities of our business. We believe the restructuring allows us to utilize our COVID-19 cash generation to support incremental growth investments, while targeting to achieve cash flow breakeven for the core business, that is non InteliSwab revenue by end of 2024.

In 2023, we are focused on elevating growth across our core portfolio, increasing the reach of our current products, expanding segments and further enhancing our enterprise capabilities to drive business efficiency and growth. As an early proof point in our strategy, we signed a deal with Quest Diagnostics to serve as the preferred provider of saliva collection kits for Quest’s Genomic Sequencing Services Group test offerings. We also have several co-clearances of sample collection devices underway with partner companies for their novel assays, similar to our recent Grifols announcement. As we gain momentum across our business, we’ll also look for opportunities to further accelerate growth through our own innovation pipeline, along with enhanced strategic partnerships, as well as potential acquisitions.

In order to provide more detail on our strategic progress, I’ll begin with our organizational restructuring and efforts to drive core business profitability. First, we consolidated our 2 business units into 1 OraSure and have just announced the reduction of our nonproduction workforce by 11%. Streamlining our organization makes sense for our size and for the potential to unlock significant efficiencies, enhanced collaboration while simplifying our leadership structure, increased revenue synergy opportunities and improved resource allocation across the company. It will also allow us to leverage our enterprise functions such as manufacturing operations, R&D, quality and regulatory, along with our digital IT assets enterprise-wide. We anticipate the restructuring, along with other process improvements and cost reductions, will deliver operating expense savings of approximately $15 million per year, when fully implemented at the end of the first quarter.

As we lay the groundwork here for long-term cash generation, we have also made announcements — sorry, and we’ve also made enhancements to our enterprise capabilities and manufacturing operations. I am pleased to announce that our new packaging and labeling configuration for InteliSwab has been authorized by the U.S. Food and Drug Administration, and we expect this new configuration to begin shipping by the end of this March. These changes have been a major undertaking by our team, and will drive per test cost savings of approximately $0.40. This includes the impact from lower shipping costs based upon the smaller packaging configuration, which will reduce total truckloads by approximately 50%. Furthermore, it will reduce our environmental impact, since these changes will save on the order of 90 tons of plastic and 1,500 tons of paper from entering the waste stream.

We are looking to apply these learnings to other portfolio products as well, such as our HIV self-test, and we believe we can unlock additional savings through further standardization and process enhancements. Contributing to our continuous process improvements, I’m pleased to share the addition of Trace Custer to our executive team leading quality and regulatory. Trace is a highly experienced life sciences industry veteran with leadership experience across numerous healthcare companies. Having joined us in Q4, Trace has now helped us implement a number of improvements to help lead in our restructuring and is evaluating further areas for efficiency, such as within our recent implementation of an electronic quality management system. On systems, I would also highlight that we have now fully launched Salesforce.com across our commercial team.

Using a standard CRM enables better monitoring and improvement of our sales KPIs, including in areas like pipeline growth and conversion success. I am a strong believer in operating rigor and every one of our teams at OraSure now has established sets of leading and lagging key performance indicators to drive visibility and accelerate our success, each of which along with those we roll up across the enterprise, we believe will drive results and deliver shareholder value. As I’ve mentioned repeatedly, our organization has strengthened our foundation and is increasingly focused now on elevating our core growth and our strategic transformation. This quarter, we established some early proof points, that we believe helps set the tone for our longer-term roadmap, as we look to establish the company as a leader in self-testing and point-of-care diagnostics, as well as an effortless sample collection and services.

First, within our Diagnostics segment, we are working to expand our respiratory assay portfolio, building on our success with COVID-19 lateral flow testing. We believe that InteliSwab will transition to become part of our core and combination influenza tests will become an important diagnostic for 2 of the most widespread clinically actionable and serious respiratory viruses. As such, we are working internally and in partnership externally to address this healthcare need around the flu. While we are not yet prepared to share details, we do believe in the important role of this test, as a part of the commercial expansion of our respiratory portfolio. Also in InteliSwab this quarter, we won 2 additional contracts from the U.S. federal government.

On the first contract, the U.S. Defense Logistics Agency agreed to purchase an estimated 18 million tests of InteliSwab COVID-19, with a maximum award of 36 million tests and a guaranteed minimum award of 3.6 million tests. The contract runs from November 2022 through November 2023. Additionally, we were notified by the government of an incremental award of 3.2 million tests in December. Fulfillment of both of these awards has been running concurrently with our existing government contract, that is supporting the school testing program. Under our federal government contracts, we have shipped approximately 46 million tests as of the end of the fourth quarter and have up to 64 million additional tests, which can be purchased, assuming the government orders the target number of tests under our second RFP win.

Additionally, in December, we were one of a group of companies awarded a tender for the state government of Connecticut, which also allows us to compete for up to 6 million additional tests. As we think about growth drivers for diagnostics in 2023, we’ve also been notified that we will receive our first orders from Emory University supporting outreach testing under the Let’s Stop HIV Together initiative. Furthermore, our OraQuick In-Home HIV test is now offered on amazon.com directly, with prime fulfillment. While our online sales via Amazon are relatively small, they are increasing as we fulfill more customer orders and have moved up in terms of search algorithm. We are also encouraged by recent U.S. government funding and future potential funding, focused on healthcare conditions we serve.

Moving to our molecular tips business; the headwinds we’ve discussed have continued, as some of our key customers have taken a more cautious stance on their near-term business outlook. That said, we believe the fundamental backdrop supporting genetic sample collection remains very attractive, as the number of applications continues to expand, and precision health is key to the future of healthcare. Examples of these trends include the increase in high-value diagnostic and precision therapeutics, along with clinical laboratories increasingly working to reach patients in lower acuity settings, such as in-home and retail. and like the deal I mentioned with Quest. As we think about expanding our collection kits business, we would also highlight progress with Colli-Pee.

This quarter, we launched 4 new CE IVD products in women’s health and beyond. Additionally, we have multiple clinical research and commercial co-clearance collaborations kicked off, in an effort to continue establishing first void volumetric urine as a validated sample type for HPV screening, women’s health therapeutics and the detection of oncology biomarkers. Finally, I would point out, the recent FDA approval of the first microbiome-based therapeutic to prevent C. difficile in adults with recent data showing that these therapeutics improve health outcomes. This approval paves the way for other biotherapeutics, and we believe will serve as a positive catalyst for microbiome-based investment in new research studies. In conclusion, we have made significant progress strengthening our foundation, by resetting our cost structure and operating rigor.

This progress will facilitate future growth investments and sets the stage for us to achieve cash flow breakeven by the end of 2024. As we look forward here in 2023, we are increasingly focused on elevating core business and increasing our innovation pipeline to accelerate profitable growth. With that, I am pleased to turn the call over to Ken to discuss our financial results and guidance.

Kenneth McGrath: Thanks, Carrie. I’m pleased to discuss our financial results for the fourth quarter and provide updates on the financial outlook. First, from a top line perspective, we delivered total revenue of $123.1 million in the fourth quarter, which was another new record for the company, representing year-over-year growth of 94%. Our Diagnostics business unit delivered total revenue of $107.3 million in the quarter, growing 228% versus last year. The majority of this growth was driven by IntelliSwab, which increased almost sixfold year-over-year and our core diagnostics business was up 3% in the quarter. Core growth was negatively impacted by the timing of international orders, which were down on a year-over-year basis.

However, many orders were pushed out until the first quarter of 2023, and consequently, we expect a strong first quarter for our international diagnostics business. Additionally, as Carrie mentioned, we will begin seeing our first orders under the Let’s Stop HIV Together program in the first quarter, bolstering our domestic HIV business. Our Molecular Solutions business unit delivered revenue in the quarter of $15.8 million, declining 49% relative to the fourth quarter of last year. Excluding COVID-19 revenue, the business declined 32%. While we continue to add new accounts, 2 of our large consumer-oriented customers, and one large clinical lab ordered significantly less product when compared to Q4 of 2021. We believe this was due to a work down of excessive inventory within these accounts, as they respond to macroeconomic factors impacting the segments in which they compete.

We also cycled against a significant research study purchased in 2021, that despite ongoing needs, did not repeat in Q4 of 2022. Going forward, we expect to see continued volatility in this segment, as some of our largest customers continue to deal with these macroeconomic factors. Despite this expected volatility, we remain optimistic about the potential to expand genetic testing through partnerships, such as the deal with Quest Diagnostics and to support novel diagnostic assays, while we also onboard new customers. From a gross margin perspective, our non-GAAP gross margins in the quarter were 40.7% compared to 40.0% last quarter and showing meaningful positive progress on a sequential basis. The sizable mix shift in revenue towards our diagnostic business unit continued to create some margin headwinds, with 87% of the revenue in the quarter coming from diagnostics versus 84% last quarter.

We continue to make plans to boost our longer-term gross margin profile, including opportunities for further packaging improvements, plus standardization across products, moving our legacy test automation, as well as site consolidation based upon future volume contingencies. As Carrie mentioned earlier in the call, we plan to transition to our new packaging configuration for InteliSwab late in the first quarter of 2023, which we believe will save approximately $0.40 per InteliSwab test and have a meaningful impact on our gross margins. However, it is important to remember that given lower pricing under the new RFPs, we expect to have some pricing headwinds in the first quarter. Therefore, we anticipate some pressure on gross margins in the first quarter, followed by improvements throughout the year, as mix and manufacturing efficiencies improve our cost structure.

Moving on to our operating expenses; our non-GAAP operating expense in the quarter of $31.8 million decreased by $3.5 million relative to the third quarter. The decline in operating expenses is attributable to timing and lower bad debt, along with our focus on cost controls. Looking forward, we believe to expect — we believe the expected $15 million in annualized operating expense savings highlighted by Carrie, will be fully recognized beginning in the third quarter of 2023. As part of achieving these savings from our workforce reductions, we expect to recognize onetime severance expense of $2 million in the first quarter. In anticipation of InteliSwab tapering in the second half of 2023, we will deliver further cost reductions in manufacturing operations.

Across all of our cost reduction efforts, we are targeting to achieve cash flow breakeven in our base business, excluding InteliSwab revenue by the end of 2024. Our operating expense savings will allow us to make targeted investments with attractive returns, utilizing the significant cash we generated from InteliSwab in coming quarters. From a cash perspective, we ended the quarter with total cash and cash equivalents of $111 million, a $9 million increase from last quarter. Working capital increased significantly in the quarter, which the company believes will convert to cash as InteliSwab revenues taper in the future. We also continue to expect to generate positive cash flow from our $109 million Department of Defense contract to build out our InteliSwab capacity.

The majority of the cash tied to this expansion has now been spent, and we will see positive cash flow, as we complete milestones under the contract going forward. Given the continued volatility with InteliSwab, we are only providing quarterly guidance for the fiscal year. In the first quarter of 2023, we are guiding to revenues of $125 million to $130 million, representing year-over-year growth of 85% to 92%. Regarding the cadence of revenue throughout the year, we are expecting continued strength in InteliSwab revenues in the first half of the year, while we deliver on our government contracts, followed by significantly more modest InteliSwab revenue in the third and fourth quarters. As Carrie mentioned, we are focused on driving momentum in our core business as we exit the year, by implementing our planned cost savings and looking for opportunities to drive core growth throughout 2023.

With that, I am pleased to turn the call back over to Carrie for concluding remarks.

Carrie Manner: Thanks, Ken. We continue to make meaningful progress on our transformation journey this quarter, as the company focuses on innovating and operating with disciplined execution and accountability. We have now firmly positioned the company on a strong financial footing and expect to see our balance sheet improve through 2023, creating the opportunity for future growth investments. As we look forward, core growth is our predominant focus as an organization, and our team is motivated to deliver this year. We continue to believe that our capabilities can help power, where healthcare delivery is going, meeting people, patients where they are, providing innovation and care at the lowest possible level of acuity. Therefore, we are excited about the opportunities in front of us. And with that, I’m pleased to turn the call back over to Scott for Q&A.

Scott Gleason: Thanks, Carrie. Operator, we are now ready to begin the Q&A portion of the call. We would ask that you limit your questions to one question and one follow-up to ensure broad participation.

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Q&A Session

Operator: . Our first question will come from the line of Vijay Kumar from Evercore ISI.

Vijay Kumar: Just on the base business here, share all the color. Is the base business now at a place where it should grow, or are we still looking at ’23 as a transition year? And any color — I know you spoke about the consumer genomics market macro, but you’ve also signed some new partnerships. So maybe just help us understand ex-COVID what the base business revenue trajectory should look like?

Kenneth McGrath: No, great question, and thank you for that. Our guidance of $125 million to $130 million for Q1, what we’re guiding towards is that the InteliSwab revenue will be roughly the same — roughly flat or a little bit up quarter over prior quarter. So implied in that is that our core business is roughly flat versus Q4.

Carrie Manner: And I’d add on molecular. While we don’t expect a snap recovery on the first half of 2023, we do remain optimistic about the long-term fundamentals of that segment. And that — we shared some positive signals like the deal with Quest, it really is about those end segments. We are adding customers, and we are staying closely connected with them. So while, again, I’d just reiterate, we don’t expect sort of the snap recovery, we do expect the strength in the long-term growth in that attractive market, which we continue to meet the needs of.

Vijay Kumar: Understood. And then maybe my follow-up here, one on gross margins and free cash flows. Gross margin, a slight improvement sequential from 3Q levels. But again, I think long term, we were looking at 50% plus as the gross margins of the business. Any comments on what the gross margin trajectory should look like? And you’ve also mentioned free cash for base business — hitting free cash positive by end of fiscal ’24, is the cash balance that you have on hand right now, that 80-plus, is that enough for you to achieve that free cash positivity?

Scott Gleason: Hey Vijay, thanks for the question there. A couple of things as we think about the margin profile of the business. Obviously, we’ve seen a very significant mix shift from molecular to diagnostics over the last 12 months. Eventually, we’re going to get to the point where we would expect to see InteliSwab starts to taper some. We obviously made the comments in the press release, where we talked about we expected the first half of the year to have a much higher weighting towards InteliSwab than the second half. As that mix transition occurs, you will start to see some margin benefits, because the molecular business has a higher underlying margin structure to it. The other things that Ken mentioned that we’re focused on, is when you look at the manufacturing side, we still have some significant changes that we’re looking at in terms of site consolidation, standardization across products and then also looking at things like some of the learnings from InteliSwab, transferring that to the additional tests, which we think will drive margin improvements over time.

And so it’s something we’re focused on. We kind of see this as a marathon, not as something that’s going to happen in any single quarter. And so it’s something where we’re going to make continual process improvements. But we have a new Director of operation — or a new SVP of Operations, Zach Wert, who is highly focused on driving efficiencies across our business and it’s something we’re going to keep working on throughout the year here.