Science 37 Holdings, Inc.

Good morning, ladies and gentlemen, and welcome to Science 37's earnings conference call for the quarter ended March 31, 2022. At this time, all participants are on a listen-only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Caroline Paul of Investor Relations for a few introductory comments.

Thank you, and thank you all for participating in today's call. Joining me are David Komen, Chief Executive Officer, and Mike Zoranek, Chief Financial Officer. Earlier today, Science 37 released financial results for the quarter ended March 31, 2022. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities laws, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based upon our current estimates and various assumptions and involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. We encourage you to review our filings made with the Securities and Exchange Commission for discussion of these risk factors, including our quarterly report on Form 10-Q for the quarter ended March 31st, 2022, which was filed earlier today. You are cautioned not to place undue reliance on these forward-looking statements, which we speak only as of today, and the company disclaims any obligation to update such statements for new information. We believe that certain non-GAAP metrics are useful in evaluating our operational performance. We use these non-GAAP measures to evaluate our ongoing operations and for internal planning and forecasting purposes. Information about non-GAAP financial measures referenced, including a reconciliation of those measures to the most comparable GAAP measures, can be found in our SEC filings and the earnings materials available on the investor relations portion of our website at investors.science37.com. I would now like to turn the call over to David Coleman. David Coleman Thanks, Caroline.

Good morning, everyone, and thank you for joining us. We started the year with strong financial and operational results, which reflect the continuing demand we're seeing for the Science 37 operating system. We're particularly pleased with our revenue for the first quarter, which reached $18.7 million, a 50 percent increase year over year, despite having pulled $2.3 million out of the first quarter and into 2021, given our ability to over-deliver operationally, in addition to the impact of the two large COVID cancellations that we discussed in detail last quarter. Mike will drill into the rest of the financial KPIs in more detail. I'd like to start today by discussing the broader market context, which is creating some terrific tailwinds for our business. In the last several months, there have been a number of third-party market research reports that have spoken to the significant increase in demand for decentralizing clinical research. Our own research corroborates these findings. According to more than 125 senior clinical research executives who are assessing their portfolio of new clinical trial starts over the next 12 months, demand for clinical trials that include components of decentralization now outpaces demand for fully traditional clinical trials. From a regulatory perspective, the FDA released new draft guidance last month requiring race and ethnicity diversity plans to be submitted by sponsors with specific measures to enroll underrepresented racial and ethnic populations. This is a widespread industry problem given biases derived as a result of a limited number of traditional clinical trial sites that are geographically constrained to recruit from their existing patient populations. This issue is naturally resolved with the Science 37 operating system, which enables us to recruit just about any patient anywhere, regardless of location, and has enabled Science 37 to recruit three times the proportion of diverse patient populations across trials we've conducted to date. while the FDA has written more than 70 papers since the beginning of COVID encouraging the use of decentralization. The NHS in the United Kingdom is taking this one step further with their new advertising campaign that reads, why should I drive miles, pay eight pounds for parking, and sit outside a waiting area for hours to be seen for 15 minutes when I could do this in the comfort of my living room? Not only does the Science 37 model make it significantly more convenient for the patient and attract a more representative patient population, but it's also faster, much faster. According to the Tufts Center for Study of Drug Development, the process of selecting clinical trial sites and launching studies takes more than 30 weeks on average. Our startup time averages less than 12 weeks, taking months out of the process because we're essentially a virtual site with only one contract required. We've said from the beginning that we also enroll patients up to 15 times faster. In two recently completed studies, we enrolled patients 19 and 21 times faster than the parallel site network. By enrolling faster, we can dramatically save on duration, which enables sponsors to get their drug to market faster. by conservatively shaving three months off the startup process and another three to six months off the enrollment timelines on a phase three trial. The Science37 model can dramatically reduce cash burn for sponsors and also give them six to nine months of additional commercialization time for their drug, which represents, for a product at peak revenue of $200 million, about $100 to $150 million in additional revenue for the sponsor. Now translating market dynamics and our value proposition into the strategic priorities we outlined during our fourth quarter earnings call, we continue to make significant strides on enhancing our commercial efforts, extending our leadership position through investments in our operating system, and positioning the company for long-term profitability without the need to raise additional capital. With respect to our commercial efforts, We're happy to report that as we exited the first quarter, our total pipeline was again at record levels, representing significant year-over-year growth. This is as a result of the investments we've made to expand our commercial presence and leverage our CRO partnerships. We saw an increase in RFP dollar volume across each of our main customer cohorts, including large pharma, mid-sized pharma, and emerging growth companies. We recently strengthened our commitment to our most prevalent therapeutic area, oncology, with the addition of Dr. Shalon Begg, a renowned investigator and former medical director of the Clinical Research Office at UT Southwestern Medical Center. With his wealth of clinical trial expertise, it will help us to identify, design, and close more oncology clinical trial opportunities, while helping to accelerate our active oncology trials as a primary investigator. Regarding investments in our operating system, tomorrow we will be formally launching our next generation technology platform. Unlike many of the point solutions being introduced to enable components of decentralization, we believe our unified end-to-end technology solution is the most comprehensive platform available to fully orchestrate study conduct across all stakeholders unifying the stakeholder journey, increasing compliance, and generating high-quality data for decentralized clinical trials and agile trial designs that require both remote and on-premise management. Commercially, we have had two beta enterprise customers already who have been intimately involved in the product design to ensure success and traction in the market. It's also important to note that the new platform is built on a new infrastructure to facilitate speed, flexibility, and scale. Operating this new product will require fewer resources to enable us to initiate and manage clinical trials going forward, which will have a positive impact on our future cost of revenue and margins. In addition to this exciting technology release, we will also be announcing rapid deployment solutions for lightweight virtual site designs that will enable the Science 37 metasite to be deployed in less than a month as a rescue option for poorly performing studies or a risk mitigation option for new studies where Science 37 will benefit from an in-study land and expand approach. Finally, In regard to positioning Science 37 for long-term profitability, we've been aggressively taking expenses out of the business, which will be reflected modestly in our first quarter results and more significantly in our full-year guidance as we strive to become EBITDA positive and cash flow neutral by the end of 2024 without the need to raise additional capital. Now with that, I will turn the call over to Mike Zoranek, our Chief Financial Officer.