OSUR - NASDAQ

Good afternoon, ladies and gentlemen and welcome to the OraSure Technologies First Quarter Earnings Conference Call. [Operator Instructions] Later, we will conduct a question-and-answer session. I'd now like to introduce your host, Scott Gleason. Mr. Gleason, you may now begin.

Thanks, Paul. Good afternoon and welcome to OraSure Technologies first quarter '22 earnings call. I'm Scott Gleason, the Interim CFO and SVP of Investor Relations and Communications. Presenting with me today for OraSure is Dr. Nancy Gagliano, our Interim President and Chief Executive Officer; Lisa Nibauer, our President of Diagnostics and Cathy Weber, our President of Molecular Solutions. As a reminder, today's webcast is being recorded and the recording along with the slide presentation accompanying the webcast can be found on our Investor Relations 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 and other financial performance, product development performance, shipment and markets, business plans, regulatory filings and approvals, expectations and strategies. Actual results could be significantly different. Factors that could affect our 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 ended December 31st, 2021, its quarterly reports on Form 10-Q and its other SEC filings. Although forward-looking statements help to provide complete information about future prospects, listeners should keep in mind that forward-looking statements are based solely on the 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 Dr. Gagliano.

Good evening. Thank you, Scott and thank you, everyone for joining the call today. OraSure once again delivered record revenue this quarter. Perhaps more importantly, we made substantial progress on our InteliSwab manufacturing scale-up and continue to improve the efficiency of our process. This positions us well for increased InteliSwab revenue throughout the remainder of the year. From a demand perspective, we continue to anticipate robust government demand through the end of the calendar year. And we are working to expand our commercial footprint for the test as well. I also believe it is important to highlight that this quarter, excluding COVID-19 products, both our Diagnostics and our Molecular Solutions businesses grew at a double-digit rate year-over-year, with Diagnostics up 11% year-over-year and Molecular Solutions growing 28% year-over-year. This demonstrates the continued strength of our core business. As most of you know, I was recently appointed as Interim CEO by the Board of Directors to focus on scaling and improving the production process of InteliSwab and to ensure business continuity, as the Board conducts its strategic alternative process in tandem with the search for a permanent CEO. Our permanent CEO search is well underway and we have identified a number of high-quality potential candidates for the role. Regardless of which path the company ends up taking, we remain highly optimistic about our ability to create value and be a market leader in the areas of simple, reliable point of care and home test, as well as innovative and easy-to-use sample collection techniques. Additionally, as an organization, we remain focused on improved execution and driving profitable growth with a number of programs in place to improve our long-term cost structure and margin profile. With that, I'm pleased to turn the call over to Lisa to provide an update on our Diagnostic business unit.

Thanks, Nancy. I would first like to provide a quick overview of our core diagnostics business, followed by an update on our progress with InteliSwab. For the first quarter, the overall Diagnostics business unit revenue was $38.3 million and grew 163% versus last year. While most of this growth was driven by the addition of InteliSwab, our global diagnostics business excluding InteliSwab grew 11% versus the prior year. This represents strong growth, especially in light of the Q1 headwinds from our HIV OTC sales to the CDC Let's Stop HIV Together Program and the lapping of the Bill and Melinda Gates subsidy, which was in effect for most -- much of our international HIV business in Q1 of last year. Our core domestic diagnostic business, excluding InteliSwab grew 7% in the quarter due primarily to increased employee drug testing as more people returned to work and gains in our grant revenues from the US government versus Q1 of last year. Our domestic HIV revenue declined year-over-year due solely to the lapping of last year's Q1 CDC Let's Stop HIV Together Program, where our OraQuick In-Home HIV test kits were shipped directly to consumers. In that regard, we are pleased to announce that the CDC recently issued a $33 million grant opportunity notification specifically for the mass mailing of HIV self-test to persons disproportionately affected by HIV in the US. This has an estimated award and start date of September 30th, 2022. Given that OraSure is the only FDA-approved OTC HIV self-test in the United States, we would expect to benefit from this award via the partner's bidding on its execution. We believe this represents a continuation of the successful pilot program from Q1 last year and could lead to several quarters of strong HIV sales in late 2022 and early 2023. We also believe along with the recent COVID-19 testing initiative, this program demonstrate a new potential model for the US government to take a more direct testing role in public health for major diseases by targeting the highest need communities. Outreach testing such as this is an area where OraSure's easy to use tests have a substantial benefit versus other tests. And we believe outreach or direct-to-consumer testing program can also provide strong health economics given the low cost of testing and sizable cost savings of disease prevention. We see this as an area of future opportunity for the diagnostics business for our existing products, as well as other disease and wellness testing opportunities, which could utilize the same model. Outside the US, the international diagnostic business grew 20% versus the prior year quarter and grew even faster on a volume basis given the expiration of the Bill and Melinda Gates subsidy in June of 2021. Excluding the impact of this subsidy, international Diagnostics grew 34% versus prior year. Our strong international growth in the first quarter is partially reflective of our strategy to expand the reach of our product into new international market. As a reminder, in the second half of 2021, we received our Thailand pre-sale certification, which will allow us to register the product in Asian and Latin American countries, regions we were unable to access without this certification from the country of origin. In addition, early in the first quarter of this year, we launched our HIV self-test into six European countries, including the UK, Germany, France, Spain and Portugal, where the test will be available in retail pharmacies. While these initiatives take time to garner traction, we believe they will help contribute to our international growth and importantly increase access for HIV self-testing around the world with our proprietary oral fluid HIV self-test. Now I would like to discuss InteliSwab and our operational progress in the quarter, which was significant. As a reminder, Diagnostics operations was integrated into the business unit under my leadership at the start of this year. As previously announced, we hired an operations consulting firm used by the National Institute of Health RADx program with deep expertise in manufacturing scale of rapid antigen test. This team made significant progress during the quarter, identifying major bottlenecks and areas for efficiency improvements. In Q1, we have resolved all prior scale-up issues for InteliSwab, increased production greater than fourfold between early January and April and reduced scrap from approximately 30% to less than 1% in the quarter. These significant improvements were due to a methodical Lean Six Sigma approach, which entails several key steps. First, we uncovered that the manual handling of our assay strip contained inside the test stick was causing our scale-up challenges. We have since changed procedures and automated our assay card production completely. Second, we mapped and measure the process to determine the rate-limiting step and change settings on our robotic assembly to improve the part per minute output. We then turn to the next limiting step where we optimize setting and vision systems on our automated striping and assay car assembly machines. These changes improved output, while also reducing in-process scrap. We continue to find more opportunities for improvement as we further optimize the manufacturing process. In early government procurement contract and the commercial market, there was significant work that went into these changes and I am exceptionally proud of our team and the NIH RADx team in driving these meaningful improvements. Beyond capacity, we also focused on efficiency and many of the changes listed above reduced our scrap rates and material waste as well. To give you a sense for how significant these changes were in the quarter, our finished goods scrap rates declined from approximately 30% in early January to less than 1% by late March. While we have made significant progress, we continue to believe that there is room for continued improvements in our processes. We have created a detailed cost of goods sold improvement plan, which outlines key areas for profitability improvement, including our packaging redesign, efficiencies through global logistics and shipping, efficiencies associated with further process automation and efficiencies garnered through site optimization and workflow design. In aggregate, we believe we can dramatically reduce our operations cost structure in the coming years and our longer-term vision is to have a highly automated, continuous manufacturing process, utilizing the advantages of our Department of Defense capital equipment contract that will benefit all of our lateral flow products. We view improving our cost structure as strategically important, given gross margin improvement can unlock further investment in R&D and sales and marketing to drive innovative new products and opportunities in new market segments. This quarter, we continued to provide InteliSwab to the Department of Health and Human Services as part of our formerly announced procurement contract. The US government has told us, they plan to continue to buy InteliSwab ongoing through the year as they support several programs, which have the need for ongoing consistent testing. This helps even out demand and enables continued shipments even in lower periods between surges. We are also working to continue to grow our commercial footprint for InteliSwab. Following the Omicron surge this winter, we have seen a reduction in commercial testing and high inventory levels at both customers and distributors. Consequently, we believe the commercial business will remain somewhat tepid until we see another surge in coronavirus infection or until inventory levels come down. We also continue to garner data to support InteliSwab accuracy in the phase of new variants. As required with our emergency use authorization, OraSure initiated studies using live SARS-CoV-2 Omicron virus at the National Institute of Health, Rocky Mountain Lab to evaluate our test ability to detect this variance and all other variants of concern. Importantly, the data indicates that InteliSwab detects the Omicron variant at similar levels of detection as it did with all other variants of concern and the original Wuhan strain. The NIH studies are now published in virus with the limit of detection of InteliSwab against all variants. In conclusion, we made substantial progress this quarter in our manufacturing scale up, have begun to optimize our process to improve efficiency and are highly focused on a multiyear journey to improve our cost structure and profitability. We are excited by the opportunities in front of us and strongly believe that the role for easy-to-use test in point of care and home settings is growing as our health care system evolves to continue to empower patients. With that, I am pleased to turn the call over to Cathy to discuss our Molecular Solutions business unit.

Thank you, Lisa. As Nancy mentioned, our core Molecular Solutions business started the year on a strong note, with sales plus 28% versus Q1 '21. Importantly, we saw growth in existing customers, as well as the addition of new customers. Our strong genomics kit growth was driven by our commercial segment, which grew 50%. This growth was driven by a combination of customers resuming their genetic risk testing and population health initiatives, customers supplementing saliva as a sample type for some blood-based test due to the blood tube shortage and some changes to order patterns by key accounts. As we look to the second quarter, we are anticipating some shifts in order timing from our historical quarterly splits with a few of our major customers for our molecular kits business. Additionally, we will be undergoing the IVDR transition for our saliva-based kits in late May, which could introduce additional volatility to second quarter shipment timing. Therefore, we are anticipating that our core molecular kits business could be flattish on a sequential basis this quarter despite typical positive seasonality in the second quarter. For COVID collection, we were pleased to achieve 12% growth versus our Q4 levels, but did see a decline versus our peak COVID sales in Q1 '21. Our sales in Q1 reflected the gain of a new state testing customer, as well as kit sales for several clinical and research studies in the US and Canada, offset by a shift to antigen tests and high kit inventories in some of our existing customers. Looking ahead, we're focused on expanding beyond the US and the broader overall launch in viral surveillance. However, we expect to see continued volatility in COVID collection kit demand over the next several quarters. As Nancy mentioned, we continue to advance the launch of our new collection and service offerings. This quarter, we completed production transfer of our new OMNIgene GUT Dx 510(k) product and will begin shipping this quarter. We began promoting our metatranscriptome service at several microbiome conferences this spring. As part of our commercialization strategy around our new gut metatranscriptome offering, we'll be embarking on a series of marketing activities. These activities will include alumina invited speaker engagements, joint webinars with alumina guest and co-publication with alumina researchers of relevant development and validation work. This quarter we'll also add a few new offerings to our portfolio. These include the OMNIgene Gut RNA DNA kit. This research use only product based on the OMNIgene Gut DNA kit incorporates a newly developed and validated reagent to stabilize microbial DNA and RNA from human fecal samples. As microbiome applications and use cases continue to grow, there is a growing need to study the transcriptome, as well as the microbiome. We're also launching Medigene k9 [ph], a specie-specific curated database to improve the interpretation of the composition and function of the microbiome. Medigene k9 increases the annotation rates, facilitating the identification of relevant microbes and uncovering pathways important in health, nutrition and disease. This quarter, we also were awarded three new patents pertaining to methods for microbiome testing, as well as our microbiome device and chemistry outside the US. Additionally, we filed a method patent pertaining to microbiome analytics. We continue to look for opportunities to expand our intellectual property portfolio for our products and services. Finally, although we enjoy attractive margins across our collection kit products, we have embarked on a COGS management program, targeting a minimum of 10% COGS reduction across our collection kits, despite increasing raw material cost. We look forward to sharing the results of this initiative in future calls. With that, I'm pleased to turn the call back over to Scott.

Thanks, Kathy. I'm pleased to discuss our financial results for the first quarter and provide updates on our financial outlook. First, from a top line perspective, we delivered total revenue of $67.7 million in the first quarter, which was another new record for the company, representing year-over-year growth of 16%. While InteliSwab was clearly a major growth driver on a year-over-year basis, we would also highlight that our non-COVID-19 products actually grew 21% year-over-year, with double-digit core growth in both our Diagnostics and Molecular Solutions business. Turning to our gross margins. Our gross margin percentage in the first quarter was 36%. Gross margins were significantly impacted by a few items in the quarter and this is not reflective of where we expect our longer-term gross margin structure for the business to be. We experienced very high scrap rates for the first two months of the quarter due to inefficiencies in the InteliSwab production process, along with under absorption as we train new hires. These two items combined led to approximately $7 million in expense in the quarter, having a significant gross margin impact. As we noted in our earnings release, our InteliSwab finished goods scrap rates declined from 30% at the start of the quarter to less than 1% late in the first quarter. We also improved in-process ways significantly and our process that will improve yields at a lower cost. This remarkable turnaround was driven by a number of initiatives implemented through our new leadership structure and our consulting team that had previously supported the NIH RADx program and will support improved gross margins going forward. We also saw some of the impact this quarter from product mix, as well as COVID-19 saliva collection kits were sold and more InteliSwab was sold at lower gross margins. Furthermore, as anticipated, we saw declines in average selling price this quarter since the majority of our volume in the quarter was under the government procurement contract. As a leadership team, we are currently evaluating a number of structural changes to our manufacturing process that we believe can dramatically improve our cost structure. These include changes in our shipping and logistics, further automation initiatives to reduce labor requirements, supply chain optimization, raw material sourcing and changes to our [indiscernible] gene configuration. Some of these changes can be implemented this year, some will take a few years to fully implement. But we see strategic value and improving our overall cost structure, which will allow for further investment in the business and improve profitability. From an expense standpoint, total operating expenses in the quarter were $40 million and increased $3.7 million on a sequential basis. We continue to place a high emphasis on expense control and it's important to note that we had $4.9 million in nonrecurring expenses associated with our CEO transition, our strategic alternative process and other onetime items this quarter. Due to the nonrecurrence of these items, onetime items, we are expecting operating expenses to decline modestly in the second quarter. From a tax perspective, we ended the quarter with $112 million in cash and cash equivalents. As of March 31st, we had approximately $17 million due from the government associated with our $109 million Department of Defense contract to build additional manufacturing capacity. So our pro forma cash position was $129 million. As anticipated, we saw a significant use of cash this quarter from working capital adjustments with receivables and inventories increasing as we scaled InteliSwab. Changes in working capital led to a use of cash of approximately $36 million in the quarter and we expect these working cash flow changes to moderate as we go through the remainder of the year. We are not providing formal financial guidance this quarter given our ongoing strategic alternative process. This quarter, however, we are anticipating continued growth in InteliSwab in the second quarter, but this will be offset to some extent by expected meaningful reduction in our COVID-19 collection kits business, given the decline in laboratory testing in the United States. Additionally, as Kathy indicated in her section, we are expecting some working timing shifts with our molecular kits business. Given these puts and takes, we are expecting modest revenue growth in the second quarter. From a profitability perspective, we are also anticipating improvements in our gross margins, a reduction in total operating loss in the second quarter, coupled with meaningfully lower cash utilization. With that, I'm pleased to turn the call back over to Nancy for concluding remarks.

Thank you, Scott, as well as Lisa and Cathy. As you can see, we've made significant progress this quarter on scaling our InteliSwab production and improving our operational efficiency. We also saw strong growth in our core businesses and launched two new important products in our Molecular Solutions division. Both our leadership team and our Board of Directors are highly focused on strong executing and driving shareholder value. With that, I'd like to turn the call back over to Scott to start our Q&A portion.

Thanks, Nancy. Operator, we're now ready to begin the Q&A portion of our call. We'd ask that you limit your questions to one question and one follow-up to ensure broader participation.

[Operator Instructions] And we have a question from Casey Woodring.

Hi, thanks for taking my question. So you noted that the government plans to continue buying InteliSwab throughout the year. I think the contract that you had for $205 million worth of test. Are these numbers say how we should think about the government InteliSwab revenue for this year? And now that you’ve increased production capacity. And then, I guess how much of that $22 million InteliSwab revenue this quarter went to the government?

Thank you, Casey. We're very pleased to have such a strong relationship with the government. I'm going to turn this over to Lisa to give you some more specifics.

Yes. Thanks, Casey. Yes, we do have the government procurement contract that we had previously announced with a target value of $205 million. We're not providing forward-looking guidance on how much of that contract will be utilized this year and the split of government or non-government. I will say we have ongoing conversations with the government every single week and we have been receiving large consistent orders weekly. They are not at our current installed capacity. As you heard from the prepared remarks, we are currently at that level and demonstrating that installed capacity at this time. So what we're doing is simply matching our production to both the government, as well as non-government demand on an ongoing basis. Importantly, I think we can produce at our installed capacity and we could increase production depending on the needed demand. And given the latest uptick in COVID-19 in this country, we may need to increase production corresponding to that uptick.

Yes, Casey, the only thing I would add is, we did say on the call that the majority of the business this quarter was from the government. That's a little bit different from our fourth quarter where actually the majority of our business was commercial in the fourth quarter.

Got you. And then as we think about -- I think you mentioned that production increased fourfold through the quarter. Can you give us some color as to where that kind of run rate was in January versus where you are now?

Yes, Casey, we're not giving out kind of the specifics around kind of volumes. Obviously, at the beginning of January, we were facing some scale-up challenges and we've scaled up throughout the quarter. We talked about the fact that in early April, we were able to demonstrate production at our installed capacity, which I think we've given that number before. So you guys have an idea of what that is. But -- so obviously, we ramped dramatically over that time frame. But we're not giving out weekly numbers.

Okay. And then if I could just fit one more in. I wanted to dig into the strategic review that was announced in January. Can you give us an update on how that's progressed, when the Board expects to complete the review? And as a follow-up, would management transitions come before the strategic review ends or would the board last a road map in place before when the review is complete, I should say, before a management team is installed? Thank you.

Thank you, Casey. So we're obviously not going to give you details of the exact process. We do expect that the process will be complete by the end of June. The process is active and ongoing as is our CEO search, which we are doing in tandem. However, with this going on, as you can see, we are not stalling all the hard work it takes to run the business and we're staying very focused on our business imperatives.

Thank you. We have a question from Frank Takkinen. Your line is open.

Great, thanks for taking my questions. Wanted to just follow up on the $205 million contract once more. Can you just explain the terms a little bit clear. I hear the $205 million target, so I guess more directly, are they committed to $205 million? Or is that a target amount where they could elect to reduce that amount if the end user demand in there? Just trying to get a little better understanding of the contract terms?

I'll turn that over to Lisa. Why don't you go ahead?

Yes, sure. Yes, so the target amount of $205 million is actually phrased just that in the contract terms. As with any government contract, that's not a firm commitment, but it is indeed what an anticipated amount would be over the period. There could be much higher amount or much lower amount ordered. Again, the bill is a good bit of federal government procurement and supply of rapid antigen test to a number of different settings, particularly those with congregate settings and individuals who need to be tested on a more regular basis. So we're currently seeing good demand from the government consistent on a weekly basis, which is super helpful when COVID goes through the surges and then the peaks in the valley so to speak.

And I'll just add to Lisa saying, we meet with the government on a weekly basis and they share their insights on what their needs are and they have provided only encouragement that the needs will continue. So we have no reason to suspect anything different.

Great. That's really helpful. And then I'll just stick to my one follow-up, Scott. I was hoping you could just clarify when you talk to modest revenue growth, I may have missed it. Was that on a year-over-year basis or a sequential basis?

Yes, Frank, Thanks for the [Technical Difficulty].

Thank you. [Operator Instructions] And we have a question from Andrew Cooper. Your line is open.

Hi, everyone. Thanks for the question. Maybe first sticking with InteliSwab. I think there was a comment in the prepared remarks about inventory in the channel. I was wondering if you could give us a sense for what the inventory looks like in distribution and sort of the commercial channel overall, maybe relative to demand, if you could give kind of days or weeks of inventory in the channel, I think that would be really helpful for our understanding sort of what the commercial side might look like?

Thank you, Andrew. And once again, we have another question for Lisa.

Yes. Thanks, Andrew. We clearly are watching the amount of inventory in the channel in both our distributors, as well as retailers. I think the challenge was that with the Omicron surge, there was clearly not enough supply overall for rapid antigen test. And so as the disease was growing, there weren't enough test to keep up and then all of a sudden, the supply of test became available as the disease was going down. So that's essentially where the direct-to-consumer mailing of these kits, just like they did in the Q1 time period of last year. So the total award is $33 million. The only thing we know on timing is that it supposed to start in -- the awarded and start in September of this year. Most likely, it will go into 2023. It kind of depends on how many kits they buy with that money and how long it takes to distribute all of that. And the $33 million includes both test distribution directly to the consumer, there's follow-up counseling that's involved and some other services that are provided by both a healthcare establishment and a logistics provider. We think it's going to be similar to what happened in Q1 of last year and there was a number of different groups that were involved. So we don't really know which -- what portion of that $33 million will be coming to us in terms of procurement of our kits. But certainly, we will have a portion of that because we are the only approved self-test in this country in the [Technical Difficulty].

Total time toward, some of that, as Lisa said, will go forward to shipment, fulfillment, training and other things. And so only a portion of the award is for the actual test kits and so.

Okay. I'll stop it too as you asked, thanks.

Thank you.

And we have no further questions in queue at this time.

All right. Well, thank you for participating in today's call and for your continued interest in OraSure. Have a great afternoon evening, and stay safe and be well.

Thank you, everybody. We appreciate your time.