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spk04: Greetings and welcome to the ENZO Biochem fourth quarter and full year 2021 financial results and business update. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I'd now like to turn the conference over to your host, Bob Yedit of LifeSite Advisors. Thank you. You may begin.
spk00: Thank you, Melissa, and good morning. Joining us today from the company are Barry Weiner, co-founder and president, and David Bench, chief financial officer. The news release announcing the results and the update was issued this morning and is available on the ENSO website. I will now read the company's safe harbor statement. Except for historical information, the matters discussed in this news release may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 as amended and Section 21E of the Securities and Exchange Act of 1934 as amended. Such statements include declarations regarding the intent, belief, or current expectations of the company and its management, including those related to cash flow, gross margins, revenue, and expenses, which are dependent on a number of factors outside of the control of the company, including the markets for the company's products and services, cost of goods and services, other expenses, government regulations, litigation, and general business conditions. We see the risk factors in the company's Form 10-K for the fiscal year ended July 31, 2021. Investors are cautioned that any forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect results. The company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this conference call. During this conference call, the company may refer to EBITDA, a non-GAAP measure. EBITDA is not and should not be considered an alternative to net income loss, income loss from operations, or any other measure for determining operating performance. The company has provided a reconciliation of the difference to GAAP on its website, www.enzo.com, and its press release issued this morning. I'd like to now turn the call over to Barry Weiner, co-founder and CEO co-founder and president of Enso Biochem. Barry, please go ahead.
spk02: Thank you, Bob. Good morning and thank you for joining us on our full year business and financial update call today. We issued our fourth quarter and fiscal year 2021 financial and operating results earlier this morning. I hope you've been able to review them briefly. At the onset, I am pleased to report ENSO marked fiscal 2021, which ended July 31st, with many significant accomplishments. Fiscal 2021 was a validating and extraordinary year for ENSO as our team proved its strength in meeting the challenges of these unprecedented times. As we reflect on the events of 2020 to present, we are increasingly recognizing that the COVID-19 pandemic will be long-lasting, and remain a healthcare priority for some time. As populations increase their vaccination rates, employees return to offices, travel and leisure increases, and masking enforcement loosens, the need for some level of testing is likely to be ongoing. We at ENSO remain committed and are prepared for this fluid environment. After a bit of slowdown with the variant emergent this summer, testing needs have rebounded. More vaccinations, even with greater vaccine potency, should help moderate the course of the disease, as will greater and more careful adherence to masking and other precautions. The recent increase in infection rates demonstrates a new vigor of this virus and its ability to mutate. We intend to remain ready to introduce cost-efficient, flexible solutions to meet any of these new challenges when they arise. We are also committed to innovation with a go-forward strategy, capitalizing on our inherent demonstrated ability to remain at the forefront of scientific and medical innovation. As the market has evolved, we have focused on targeting new channels, including schools, pharmacies, and business as new venues for testing. We are extending our GenFlex platform that has processed hundreds of thousands of specimens this past year for COVID-19 to other diagnostic areas, such as women's health, upper respiratory infections, gastrointestinal infections, and sexually transmitted diseases. We are in the process of regulatory approvals for a number of additional tests to our GenFlex platform. Our pipeline of tests is available in the 10K released today. The pandemic resulted in vast changes in healthcare for practitioners and patients alike, and the impact is still very fresh in people's lives. While physician office visits are returning and hospital inpatient and outpatient services are operational, test utilization levels can vary greatly depending on geography and demographics. During the past year, we capitalized on our GenFlex molecular platform and developed enhancements and improvements to process hundreds of thousands of COVID-19 specimens. We also now recognize the shift in demand for molecular testing in a more direct and immediate setting, specifically at point-of-care facilities. We are actively involved in the strategic development and future commercialization of testing outside of a central lab, including point-of-care platforms and direct-to-consumer offerings. Point-of-care diagnostics require simple performance procedures and rapid, mostly within a half hour, of affordable and accurate results. Using ENSO proprietary capabilities, we have internally generated proof-of-concept strategies that open the path for future development, validation, and commercialization of these types of systems. In addition to our molecular diagnostic opportunities, our novel loop RNA technology targeting use for the study of gene structure potentially allows for better medical interpretation, accelerated drug development, and improved research capabilities. Earlier this year, ENSO's loop RNA probe was featured in an independent publication of work derived from our scientific collaborators in conjunction with ENSO scientists. The publication details improvements in in situ hybridization, reflecting higher sensitivity and lower background noise when compared to leading commercially available products and services. ENZO's probes uniquely identify a single genetic sequence within a cell without destroying the cell structure. This scientific advance allows for better medical interpretation, accelerated drug development, and improved research capabilities. It also may reduce the risk of false positives and false negatives for earlier detection on RNA-based infections such as human papillomavirus. We intend to provide updates on our Loop RNA technology in the coming months. During fiscal 2021, we further validated the strength of our strategy to transition to a more vertically integrated diagnostics company, supporting a new industry paradigm. Our scientific approach has enabled us to carve out a growing and important niche as an innovator with an eye on efficiencies, effectiveness, and affordability. Looking briefly at the ENSO financial summary, our fourth quarter and fiscal year financials, which David Bench, our CFO, will discuss in detail shortly, represented a period of solid execution, both operationally and financially. Quickly, I'd like to point to a few highlights. Our total revenue for the quarter was $24.8 million, an increase of 27% year over year. Fiscal year 2021 revenues were $117.7 million. This is up 55% year over year from the $76 million the year prior. We achieved impressive revenue growth in both the services and product segments this year, which were growth of 81% and 16% respectively. We also continue to focus on cost savings initiatives, and we were able to generate approximately 10 million in efficiencies throughout the full year. These results support the trend we have reported for several quarters, and we are extremely proud of the team's continued success. Looking briefly at the highlights of the fourth quarter and full year, In July, ENSO received an expansion of its emergency use authorization for the company's rapid extraction method on its proprietary test system for the detection of coronavirus SARS-CoV-2, including the genetic variants. The EUA enables laboratories to immediately use ENSO's faster extraction process to reduce the running time by over one hour. or more than 25%, enabling more test runs on a single instrument. Our success in winning the expanded EUA is another example of the differentiation that separates ENSO from many MeToo testing companies and keeps our products and services on the cutting edge of diagnostic technology. Our core focus remains on the development and application of high-value opportunities which we anticipate will provide meaningful long-term benefit to customers as headwinds remain in the reimbursement environment. The higher margins achieved by the vertically integrated model of our COVID-19 testing are being expanded to a spectrum of molecular and other tests. This is key to our 2022 and 2023 strategy. In June, ENSA performed a new collaboration with CLX Health, a developer of cloud-based solutions to provide rapid access to testing locations in New York and New Jersey for COVID-19 PCR tests that are required for international travel. Using this online service, travelers can schedule PCR tests immediately and receive results in advance of travel by using CLX Health's TrustAssure global testing platform. which includes COVID-19 testing partners in more than 81 countries. From a business development standpoint, we remain engaged regarding business partnerships and seek fresh opportunities for our proprietary products and services to add value across the broader testing market. These include possible tuck-in acquisitions that we can scale and will complement existing activities as part of our growth blueprint. Logistically, and from a manufacturing point of view, we have consolidated ENSO's campus to include GMP manufacturing, CLIA clinical laboratory services, R&D, sales, and marketing capabilities, all within four adjacent buildings on our Farmingdale campus. This integration includes the complete transfer of our Ann Arbor, Michigan manufacturing facility, which was finalized this summer as well. We expect to see the efficiencies of this initiative begin to be accretive in the second half of 2022. Now turning to the full year highlights. In April, ENSA received FDA clearance for our Ampi sample collection kit, which is now manufactured under GMP, for distribution under the emergency use authorization. The Ampi sample collection kit is now available for sample collection for COVID-19 testing protocols in the United States, which we expect to further utilize this winter as testing is expected to increase from Q4 levels. In March, the company showed results that indicate its GenFlex platform met new FDA guidance calling for COVID-19 testing developers to assess the impact of viral mutations on testing results. And in September, the FDA released additional conditions of authorization for certain SARS-CoV-2 tests that have received emergency use authorizations, requiring test makers to update authorized labeling and evaluate the impact of variants on test performance. We realize the importance of updating our tests and the needs to continuously evaluate the impact of these viral mutations on test performance. In January, ENSO received an expansion of its EUA from the FDA, authorizing the use of pooled samples containing up to five individual swab specimens with the AmpiProbe SARS-CoV-2 test system, utilizing these tests on three different platforms, including ENSO's proprietary GenFlex automated high throughput platform. The company received its initial EUA in July 2020, and its proprietary platform for the detection of SARS-CoV-2. In November of 2020, ENSO announced the appointment of two new directors to its board, Dr. Ian B. Walters and Dr. Mary Taglieri. Both are highly respected industry leaders with experience in a range of operational areas, including business development, clinical R&D, as well as regulatory and medical affairs. In October 2020, we announced a major milestone for the company when we launched Go Test Me Now. This online platform enables consumers to directly order physician-authorized lab tests, including COVID-19 molecular and antibody tests. Later this fall, we are planning to expand the Go Test Me platform to offer access to testing for sexually transmitted infections and are planning now for future offerings to include women's health panels, upper respiratory panels, and gastrointestinal panels. We believe that these expanded offerings will be attractive to consumers seeking ease of accessing these tests and reflect an important transition in consumer demand for direct access to testing services. And in October 2020, the company launched an affordable, small portable microprotein reader for use with the company's amino assays. and ultimately molecular diagnostics in providing new opportunities in point-of-care medicine, an area that we deem extremely important in the future. This device enables ENSO to offer a complete solution to academic, CRO, and industrial customers. It has been a very focused and a very busy year. On behalf of the management team, I want to reiterate that we are extremely grateful to all of our employees for their unwavering strength and commitment to ENSO during this time. This has been a challenging year, and we recognize the amazing work they have done today. We are confident in our strategic vision and our ability to execute on it in the year ahead. We have made many important transitions in 2021 and believe the ENSO team has laid the solid foundation from which we have pivoted to a vertically integrated, flexible diagnostics company. Before passing the call over to David, it's important to highlight the company's core objectives, which served us well in fiscal 2021, and remain a focus and discipline of ENSO today. First, we are transforming into an integrated end-to-end diagnostics product and solutions company, focusing on molecular and genomic analysis. Second, we are building out our four key platforms and technologies to address enhanced value in the diagnostic sector. Third, we are building and investing in our infrastructure for growth. And fourth, we continue to implement efficiency measures to better bring in line our cost structure with the market needs. It is critical to stress management's commitment to these objectives, as today I can confidently say We have executed across all four of these pillars. As we've prepared for fiscal 2022 several months ago, the management team with the support of the board have outlined the following core objectives to be the guiding principles in fiscal 2022. First, strategic alignment, partnering with government associations, as we have done with the Suffolk County of Long Island in terms of being a provider of COVID-19 testing to that regionality. associations of other business in nature, as well as key industry leaders to accelerate the commercialization of ENSO's proprietary platforms. Second, we are focusing on product and service expansion, expanding our test menu on the GenFlex platform and expanding cost-efficient platforms for diagnostics purposes and leveraging new business channels. And third, expanded efficiency measures. building on the operational and the financial achievements of 2021. As you can see, we are attacking the future with determination and vigor. The ENSO spirit of innovation is alive and well. The opportunities are numerous, and our optimism about what we have done and what we expect to accomplish we really believe knows no bounds. The year has been a remarkable year on so many fronts. With these insights, I would like to turn the call over to David Bench, our CFO, who will give you a little more detailed review of the fourth quarter and fiscal 2021 financials. Dave.
spk01: Thank you, Barry. We made important progress in fiscal 2021, though the fourth quarter reflected the impact of what turned out to be a temporary slowdown related to coronavirus testing. As Barry noted, With the emergence of new variants and peaking of vaccination rates, we are once again seeing an uptick in testing demand. In September, we reached over 100,000 accessions in our clinical lab, and this trend is continuing into October. As a point of reference, we reached approximately 235,000 accessions in the fourth quarter versus approximately 183,000 in the year prior period. The closing and transfer of our Ann Arbor facility will prove highly beneficial, providing greater integration of our activities in our now key centralized manufacturing, research, marketing, and administrative campus on Long Island. We are very excited to not only be reporting such a strong fall year performance, but we continue to see indications there are strong results in execution will continue in the year ahead. Here is a review of the financials for the fourth quarter. Total revenue of $24.8 million for the fourth quarter increased 27% from the $19.5 million generated in the year-ago period, but off 24% sequentially, reflecting an initial impact from increasing vaccination rates prior to the spike in Delta variant cases globally. On a divisional basis, clinical service revenue for the fourth quarter was $16.8 million, compared to $12.9 million in the year-ago period, representing an increase of 30%. The year-over-year improvement was driven by increased accession count and a 6% growth in net revenue per accession due to factors related to the COVID-19 pandemic. Product revenue for the fourth quarter was $8.1 million compared to $5.8 million in the year-ago period, an increase of 38% due to the impact of the COVID-19 pandemic, as well as growth in our overall product business. The gross margins for the fourth quarter were 40%, consistent with the 40% gross margin from the year-ago period. Clinical services gross margin was relatively flat at 36% versus 38% from the year-ago period, but lower than the 49% in the third quarter of 2021, primarily due to fewer COVID-19 tests. This was due mainly to increased vaccination rates and seasonally warm weather providing good conditions for people meeting in outdoor environments. And the life science gross margin was 47% compared to 46% in the previous year's quarter and 48% in the sequential third quarter. We continue working to improve gross margin in the coming quarters due to our anticipated mix of products being sold in the marketplace. Research and development expenses decreased 26 percent to $0.9 million, or 3 percent of revenue, from $1.2 million, or 6 percent of total revenue, in the ergo period. The decrease is mostly attributable to lower personnel expense related to platform and pipeline test development. selling general and administrative expenses of $11.8 million increased 18% over the previous year period. The increase was due to investments in sales, incentives, marketing, and client support to promote company growth. However, as a percentage of revenue, SG&A for the fourth quarter equaled 48% compared to 51% a year ago. EBITDA amounted to $3.9 million compared to a year ago EBITDA of negative $2.7 million, an improvement of $6.6 million. GAAP net income was $3.3 million, or 7 cents per share, versus a net loss of $3.3 million, or negative 7 cents per share, in the year-ago period. Cash, cash equivalents, and short-term investments totaled $43.5 million at the end of the fiscal year, and working capital amounted to $44.5 million. Cash, cash equivalents, and short-term investments are slightly lower compared to year-end 2020 due primarily to investment in inventory and capital expenditures. We continue to see tangible results from our ongoing efficiency measures, and we have thus far recognized approximately $10 million, or 100% of our savings targets. We're exploring cost-saving measures within the company's operations and have targeted a goal of an additional $5 million in savings in 2022. We remain committed to investing in key growth areas, most notably our proprietary lab-developed tests and our four proprietary platforms, molecular, immunology, cytology, and immunohistochemistry. We expect this investment to yield significant gross margin improvement in the normalized COVID endemic environment. Now for our fiscal year results. Full year revenue totaled $117.7 million, compared with $76 million, an increase of 55% year over year. Research and development expenses were $3.3 million for the year ended July 31st, 2021, or 3% of total revenue. compared to $4.4 million, or 6% of total revenue, for the same period in 2020. The reduction is due to a shift in personnel and production. Selling general and administrative expenses for fiscal 2021 were $44.9 million, or 38% of total revenue, compared to $43 million, or 56% of total revenue, for fiscal 2020. The increase is primarily due to costs related to our COVID-19 testing business counterbalanced by cost efficiency measures. Legal expenses, including proxy-related costs, amounted to $4.7 million, down from $6.7 million the previous year. EBITDA amounted to positive $10.5 million, compared to a year ago negative EBITDA of $26.2 million. an improvement of $36.7 million. I want to highlight the current ratio improvement to 2.7x from 2.4x during the first nine months of fiscal year 2021. This is indicative of a very clean and improving balance sheet. Additionally, we showed an improvement of $10.2 million in shareholders' equity year over year. Finally, the entire $7 million loan received by Enzo under the PPP program has been forgiven. As of July 31st, 2021, the company had 48.5 million shares outstanding. I will turn the call back over to Barry for closing remarks.
spk02: Thank you, David. While today's call is intended to discuss the company's operations and financial results, I'd like to note a few corporate developments as well. As David highlighted in his report, we strongly believe ENSO is financially and strategically well positioned to capitalize on a segmented market with our differentiated offerings and strong execution. Just six weeks into fiscal 2022, we anticipate benefiting from, among others, increased molecular diagnostic demand, opportunities to expand our product and services menu via partnerships and strategic acquisitions, enhancements to our operations and scale, and most importantly, a tighter control on costs. ENSO successfully navigated what may be one of the most challenging times, considering the COVID-19 activity. And as we have indicated previously, we have already begun implementing our strategy for this new diagnostics environment. Our ability to adapt in the COVID-19 environment is indicative of our team's ability to change with the time. As our team demonstrated at the start of the pandemic, we have remained nimble to reopening timelines for our customers, vendors, and partners as their needs evolve. As we have announced in the previous quarters, the company's strategic initiatives and succession planning are ongoing. The investment banking firm retained earlier this year remains highly engaged with the company, and the executive search within the context of the company's strategic objectives is ongoing. Updates will be provided when appropriate. The company, management, and board are working in unison to translate ENSO's capabilities and resources to benefit all shareholders and enhance and maximize shareholder value. Our fiscal year 2022 focus remains committed to our core objectives based on strategic alignment, product and service expansion, while implementing expanded efficiency measures. We are very excited about the future of ENSO and the many opportunities that have now been presented to us. I would like now to open the call for questions.
spk04: Thank you. At this time, we'll be conducting a question and answer session. If you'd like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. Our first question comes from the line of Paul Norrie with Noble Equity Fund. Please proceed with your question.
spk09: Hey, good morning. Good morning.
spk05: I was wondering in the product segment if most of the growth in the quarter was coming from two of the EUA approvals that you have in sample extraction and processing.
spk09: David, would you like to address that?
spk01: Absolutely. Now, so this quarter actually doesn't have a huge amount from that area. Rather, there was some additional distribution that we were able to push forward on the product side. So it was actually a very good quarter from that perspective. And as you notice, the growth is, you know, especially in the current environment, was pretty impressive on that side. So we do have, you know, obviously sales on that piece, but they didn't represent a huge amount yet.
spk09: Okay. Go ahead, Paul.
spk05: No, go ahead, please. No, I was just going to say, so then most of the product sales was, I don't know, core business and fairly sustainable outside of COVID then?
spk01: Yes. And not only that, but some of our new initiatives, have started to be what I call the razor, razor blade model, such as on the microplate reader, have started to be sold in the quarter, and obviously that's on the amino acid and antibody side. But you can see, you know, that gives you a little bit of color there, and that's with regards to ELISA kits as well as the microplate reader.
spk02: What you have to appreciate, Paul, is during the height of this period, a good percentage of our own production was necessary for internal use for us to be able to sustain the volume commitments in light of the supply chain constraints in the marketplace. So the issue of our vertical integration, which really took a reset of many of our own internal personnel assignments, was focused on production to be able to be able to survive and to thrive in a period when obtaining the necessary components, reagents, and kits was under a very challenging environment.
spk05: And the partnership you have with, I believe it's CLX Laboratories, is that a new partnership? There's not much revenue from that in the current quarter, but maybe something to look forward to in future quarters?
spk01: Yeah, so this is Dave Benz. With regards to the CLX partnership, we looked at that as a very big marketing opportunity for us. You go to some of these major branded airline sites and you're looking for a COVID test to travel internationally. And what they do is they send you to one of their partners, we being one of them. And, you know, obviously they do it based on geography, how close you are to that area. So, for example, RPSCs in Manhattan, you know, that's something which could be close to some of these hotels and other travel areas. So, from a marketing, it represented more, obviously, from a marketing point of view than really from a revenue-generating point of view at this point. But, obviously, there's a huge opportunity going forward, depending on what the testing looks like on international and even domestic travel.
spk05: And would you say that this quarter included a full quarter of benefit from the rationalizing the manufacturing footprint?
spk01: No, I think that we're right now, we actually closed the facility as of September 30th in terms of the Ann Arbor facility. We are, you know, building and a lot of the CapEx obviously is coming up. in terms of expanding our capabilities within our Farmingdale for buildings now. Obviously, one of them being the CLIA Clinical Lab and the other ones related to manufacturing and back office support. Those areas are absolutely starting to ramp up and take the Ann Arbor, you know, manufacturing onsite. Hope that helps.
spk05: Yeah. And then last question. You know, once the integration is complete, what do you see as the run rate for gross margin just in the product side of the business?
spk01: Yeah, we look at 50% as being the sustainable gross margin area, around 50%, you know, give or take one or two percentage in either direction. But with larger orders, we're seeing a higher margin. gross margin capability. And our average product order size has actually been increasing over the last few quarters, so that should benefit us as we move out of the COVID environment.
spk06: All right.
spk05: Thank you both for answering my question.
spk06: No problem.
spk03: Thank you. Ladies and gentlemen, as a reminder, if you'd like to ask a question, please press star 1 on your telephone keypad. We'll pause a moment to allow for other questions. Thank you. Our next question comes from the line of James Wolfe, private investor.
spk04: Please proceed with your question.
spk08: Good morning, everyone. My name is James Wolfe, private investor. My question is, can you comment on the Could you repeat the question again, James? I had trouble hearing it through the connection. You're breaking up on me a bit.
spk07: Could you comment on HoloLogic's new no-load DAG system versus the GenFlex that they've come out with and closed versus new cost and market acceptance and general items? All right.
spk02: Again, technologically, not to get into the details, it's a different system than the high throughput system that the GenFlex represents. The issue here is about cost, cost efficiency. Hologic utilizes a different scientific approach than the GenFlex approach. has been designed to be economically more efficient in terms of cost structure. And it's one that, you know, we focused on very, very extensively. The other key issue here is the concept of an open platform versus closed platform approach. The Enso GenFlex has been built around an open platform technology or architecture. That is to allow parties to be able to acquire reagents from various sources, not just ENSO, even though we do believe one will migrate to ENSO because of the continuity and the economics of our provision. But the open architecture platform will allow them to implement their own testing directions and solutions if they so wish to do so. It's much more flexible, and on an economic level, I believe, will provide higher marginal return to the parties that will be running these tests. Also, you have to look at the flexibility of the approaches in how these systems will be acquired, the footprint of the different platforms, and so forth. So it's a very different approach, a very different technology. I believe the markets that we will be appealing to will be the more middle market of the clinical lab world and physician office-based labs that will give a more efficient and cost-benefit value on running tests. All right.
spk06: Thank you.
spk03: Thank you.
spk04: Ladies and gentlemen, this concludes our question and answer session. I'll now turn the floor back to Mr. Weiner for any final comments.
spk02: Thank you very much for joining us today. While we are extremely proud of the team achievement, our growth, and profitability achieved this year, we remain committed to generating value for our shareholders, and we look forward to discussing the further progress of the company in the Q1 report, which will take place in mid-December. Have a good day. Thank you for joining us.
spk04: Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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