icad inc.

and welcome to the ICAD incorporated fourth quarter and full year 2023 earnings conference call. At this time, all participants are on a listen-only mode and 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. Please note, this conference is being recorded. I will now turn the conference over to your host, Mr. Jeremy Bennett. Sir, the floor is yours.

Thank you, Operator. Good afternoon, everyone. Thank you for joining us today for ICAD's fourth quarter and full year 2023 earnings call. On the call today, we have Dana Brown, our President and Chief Executive Officer, and Eric Longquist, our Chief Financial Officer. Before turning the call over to Dana, I would like to remind everyone that we'll be making forward-looking statements on the call today. These forward-looking statements are based on ICAD's current expectations and are subject to uncertainty and changes in circumstances. Actual results may differ materially from these expectations. For a list of factors that could cause actual results to differ, please see today's press release and our filings with the U.S. Security and Exchange Commission. ICAD undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. Also, please note that management will refer to certain non-GAAP financial measures. Management believes that these measures provide meaningful information for investors and reflect the way they view the operating performance of the company. You can find a reconciliation of our GAAP to non-GAAP measures at the end of the earnings release. With that, I'll turn the call over to Dana.

Thank you, Jeremy, and good afternoon, everyone. This week marks one year since I was named president and CEO of ICAD. I had my first earnings call on March 28th of last year, and during that call, I shared my background, why the board and I believe I was uniquely qualified to lead the company, and our confidence in the company's future. As I stated then, and reiterate now, I'm honored to be leading this incredible company. Working alongside our talented team, our board, our clients and partners, I'm committed to uphold our vision to be the world's most pervasive and personalized suite of AI cancer detection solutions, changing lives for patients around the world and creating value for our shareholders and stakeholders. The management team we've assembled is uniquely prepared to leverage their experience and expertise to position this company for future growth. And I hope as you followed our progress over the course of the past year, you see we deliver on what we say we're going to do. Before we get into financials, I want to take a few minutes particularly in light of 2024 being our first year as a company solely focused on AI cancer detection and risk solutions, to recap our solution set and market opportunity. ICAD is a global leader in AI-powered cancer detection solutions. Our mission is to create a world where cancer can't hide, because cancer wins when it hides. Remaining undetected, cancer poses one of the greatest threats to life. With our industry-leading profound breast health suite, cancer has finally met its match. The profound breast health suite enables medical providers and professionals to accurately and reliably identify where cancer may be hiding and when it might make its move. The profound suite offers solutions comprised of four areas. Number one, breast cancer detection. Number two, density assessment. Number three, one or two-year breast cancer risk evaluation, and number four, cardiovascular risk evaluation related to elevated levels of breast arterial calcifications. Powered by the latest innovations in artificial intelligence and built on one of the largest, most demographically and geographically diverse data sets, The PROFOUND suite offers unique 360-degree solutions for cancer detection, density assessment, and personalized risk evaluation, all based on a 2D or 3D mammogram's collection of images. The PROFOUND detection solution scores cases and suspicious lesions, helping radiologists identify and focus on areas of most concern and highest suspicion of cancer. The PROFOUND density assessment standardizes and simplifies breast density reporting, algorithmically examining a woman's breast anatomy from the mammogram image. The profound risk solution provides a near-term probability for developing breast cancer in the next one or two years, making it more actionable and relevant than generalized lifetime risk scores. The profound heart health solution identifies the presence and quantity of breast arterial calcification, which is proven to correlate with calcifications elsewhere in the body, raising concern for cardiovascular or heart health concerns. Used by thousands of providers serving millions of patients, Profound is available in over 50 countries. We estimate that Profound has been used for more than 40 million mammograms worldwide in the last five years alone. With over 25 years of experience in AI cancer detection, ICAD has secured 45 patents, completed over 50 clinical studies, and as I just described, we train our algorithms on one of the largest and most diverse data sets, pulling data regularly from over 100 global locations. ICAD's deep experience and unmatched set of capabilities differentiates ICAD from its competition and positions it as the industry leader with an AI solution that continuously gets better as the company continually refines its algorithm models using its extensive data set and research partners. As outlined during our 2023 third quarter earnings call, ICAD is increasing its leading position as the premier breast AI solution by transitioning into a platform-based, software-as-a-service, data-as-a-service organization by implementing a three-phase transformation. Phase one, realigning our base. Phase two, strengthening our foundation. and phase three, investing in growth initiatives. In 2023, we made good progress executing phases one and two, including stabilize the business through reducing our cash burn. EBITDA, which we view as a relevant metric to indicate operating cash flow, was a loss of 0.4 million in Q4 23 versus a loss of 3.6 million in Q1 of 23. This represents an improvement of nearly $3.2 million per quarter. Reduced cash burn. 2023 cash burn from operating activities of $5 million compared to 2022 cash burn from operating activities of $12.8 million. We believe cash burn is stabilized and I'm pleased to affirm the company does not need to raise additional funding to pursue current growth initiatives. continued to manage the shift to a subscription-based annual reoccurring revenue cycle. We'll talk more about ARR growth later in this call, but in summary, we had a 36% increase in ARR since the start of the subscription transition. We've achieved 16% compounded annual growth rate in total ARR over the two-year period through the end of Q4 23. We expanded our leadership team with the appointment of our permanent CFO, Eric, and the addition of a COO, Chief Product Officer, Vice President of Marketing, and Vice President of Customer Success. In December, we announced expanding our sales leadership team to accommodate growth. Bill Kyes shifted and expanded his role to Senior Vice President, Global Sales Operations, and Peter Graham joined us as Senior Vice President, North American Sales. We also made good progress in recruiting new board members, and you may have seen the recent announcements on those additions. We upgraded our brand by transitioning from a product focus to patient-centric value proposition, resulting in our new tagline of creating a world where cancer can't hide. You can see more of this brand upgrade in our new investor deck, available for download via the investor section of our website, icadmed.com. announced game-changing collaborations with esteemed partners, exemplifying our company's commitment to creating the world's most pervasive and personalized suite of AI cancer detection solutions. And last but not least, the divestiture of Zot also resulted in a reduction to cash burn and an influx of cash. Completing this divestiture has enabled us to put our focus into scaling the profound suite business, immediately prioritizing expanding our sales and partnership models to grow revenue. The company's next phase of transformation, phase three, has begun in 2024 and includes launching initiatives that strengthen and deepen business with existing accounts and growing through expanding our direct and indirect sales channels, including expanding ICAD's geographic footprint. We believe U.S. sales had declined due in part to a significant reduction in the sales force in fiscal year 2022. As of Q3 2023 in the U.S., we had six sales reps versus 12 in Q3 of 2022. After a thorough analysis of rep performance over the past three years, we believe adding additional sales reps focused on new business, given our large addressable market opportunity, which I'm going to discuss next, and reps focused on large national accounts will lead to revenue growth. Since our Q3 call, we added four new team members to the sales organization. I'll take a few minutes now to outline our large addressable market opportunity. When diagnosing breast cancer, early detection matters. Identified in stage one, cancer is more likely to respond to treatment and can result in greater survival rates. In fact, according to the American Cancer Society, The relative five-year survival rate from breast cancer is 99% when detected early. However, the incidence of breast cancer is growing. According to the World Health Organization, breast cancer is the most common cancer worldwide, recently surpassing lung cancer, with 2.26 million new cases diagnosed worldwide in 2020. One in eight women will get breast cancer in their lifetime, and every 14 seconds, a woman is diagnosed with breast cancer worldwide. Compounding the situation, 59% of women in the U.S. missed their recommended screening mammograms. And for those who regularly screen for breast cancer, 20 to 40% of cancers are missed in mammogram screenings, with up to 50% missed in women with dense breast tissue. Traditional risk assessment models have relied on family history of the disease as a leading risk factor, when in fact, and most surprising, 89% of women diagnosed with breast cancer have no direct family history of the disease, and 90 to 95% are not related to inherited gene mutation. As breast cancer detection is becoming increasingly complex, AI can help radiologists spot cancer faster, with greater accuracy, and save more lives. With the continuing migration from 2D reading systems to 3D, known as DBT or TOMO systems, radiologists are spending two times the amount of time reading hundreds more images per 3D case compared to the four images captured with 2D. This geometric increase in the number of images to read leads to stress. 50% of radiologists are overworked, and burnout is reported to be 49%. her Medscape Radiologist Lifestyle Happiness and Burnout Report 2022. Simultaneously, false positives and unnecessary recalls for suspected cancers have continued at similar rates, while hard-to-detect interval cancers are being missed or diagnoses are delayed. The rise in workload for radiologists is felt by patients too, anxiously waiting weeks for results, or receiving unnecessary recalls and biopsies lead to undue stress and anxiety, not to mention distrust of the healthcare system. On average, only 10% of women recalled back from a routine screening mammogram for a diagnostic workup are ultimately found to have cancer, resulting in the patient being confused and frustrated with the process. Additionally, a significant economic burden is placed upon patients and payors that extends throughout multiple years when a breast cancer diagnosis is missed in its early stages and instead diagnosed at a later, more advanced stage. Beyond associated clinical benefits, finding and treating breast cancer earlier may limit the need for more intensive and expensive treatments, increase patients' health-related quality of life, have a significant impact in managing healthcare costs among cancer patients, and reduce caregiver and societal burden. ICAD calculates if diagnoses were shifted one stage earlier for just 20% of the 280,000 women in the U.S. diagnosed with breast cancer each year would result in a savings of approximately $3.7 billion across two years of patient treatment and healthcare costs. Our AI-powered mammograms are setting a new standard of care in cancer detection, density assessment, and short-term risk evaluation. With ICAD's profound breast health suite, radiologists' reading times may be cut in half with improved accuracy and specificity in finding suspicious cancerous lesions. Radiologists benefit from standard, objective, inclusive results measured by an algorithm built upon many millions of images. and patients benefit from receiving timely, personalized results, fact-based assessment of the breast density, and short-term risk assessments that inform their screening plans. As noted above, ICAD's mission is to create a world where cancer can't hide, because when cancer wins, we all lose. For the health of women everywhere and the benefit of their communities, ICAD's AI-powered, image-based solutions help detect cancer faster, earlier and with greater accuracy, as well as evaluate breast cancer and cardiovascular risk from a single mammogram. The Profound Breast Health Suite is cleared by the FDA and has received European CE mark and Health Canada licensing. As I noted earlier, Profound is used by thousands of providers serving millions of patients. Profound is available in over 50 countries. According to a December 2023 report, approximately 40.5 million annual mammograms are conducted in the U.S. across 8,834 certified facilities, as measured by the FDA Mammography Quality Standards Act. Yet, only 37% of facilities are using an AI mammography solution, according to research and markets United States Mammography and Breast Imaging Market Outlook Report 2022-2025, Leaving Room for Growth. Of the 3,268 facilities using AI, ICAD has an active customer base of 1,488, or 46% of the AI market, and 17% of the total U.S. market. In the last five years alone, ICAD estimates reading more than 40 million mammograms worldwide. Based on the number of DBT units relative to the total units left to be converted to DBT and the associated large number of installation opportunities, we believe our profound solutions for 3D may represent a significant growth opportunity in the United States. We also believe that there is a growth opportunity for 2D mammography and DBT AI solutions in international markets, both from the analog to digital conversion, as well as more countries adopt the practice of each exam being read by a single radiologist using AI, rather than the current practice of having two radiologists read each exam. Furthermore, additional Western European countries have already implemented or are planning to implement mammography screening programs, which may increase the number of screening mammograms performed in those countries. Since having released our first FDA-cleared product in 2002, ICAD has remained committed to innovation in artificial intelligence by continuously improving and releasing the highest performing and most widely available solutions in breast care, with FDA clearances, CE marks, and Health Canada licenses. The latest versions of ICAD profound breast health suite solutions are currently under review with the FDA, including version 4.0 of our profound detection solution built on the newest deep learning neural network AI. Per regulatory test data, ICAD has observed detection version 4.0 will deliver significant improvements in specificity, sensitivity, and the highest AUC, or area under the curve, for specificity and sensitivity for breast cancer detection at 92.5%. Along with the new heart health solution, measuring the level of calcification in breast arteries, identifying cardiovascular concerns, and new cloud deployment options, ICAD's overall value and ease of implementation continue to improve. In 2023, we strengthened our market leading partnerships. Recognized as the leader in breast AI powered solutions, ICAD partners with industry leaders across technology, academic research, integration, and advocacy organizations to iterate and improve upon ICAD software and make solutions more accessible to customers. Our solutions are interoperable with more than 50 PACS vendors worldwide. With 22 global distributors and growing, ICAD's market share is on the rise. In 2023, ICAD continued its work with Duke University, Indiana University, University of Pennsylvania, and Karolinska Institute on artificial intelligence advancements and clinical testing. Additionally, ICAD expanded its partnership with Google Health to enhance the company's technology and expand access to millions of women and providers worldwide. ICAD's new 20-year research and development agreement includes co-development, testing, and integration of Google's AI technology with the profound breast health suite for 2D mammography for worldwide commercialization to potentially ease radiologists' workload and reduce healthcare disparities for women. The conventional double-read workflow used by most countries, where mammograms are assessed by two separate radiologists, has become increasingly challenging as there's a global radiologist workforce shortage. Leveraging AI as a viable alternative to current double-reading by introducing ICAD as secondary independent reader can help radiology departments run more efficiently. ICAD solutions more available to customers, we expanded into new platform and channel partners, technology partners, and health system partners. In November of 2023, we announced ICAD is the only breast cancer AI detection solution integrated into GE's new My Breast AI suite, an all-in-one platform made up of three workflow algorithms from ICAD's profound breast health suite. GE has released My Breast AI Suite first in the U.S. and plans to release globally in 2024, simplifying the sales and implementation process for GE and enabling AI use by customers across the globe. Additionally, ICAD developed several new partnerships and integrations with several AI distributors and marketplace aggregators to implement profound AI via cloud options, such as Ferrum, Change Healthcare, Blackford, and have several others currently under negotiation to further expand ICAD's footprint. Looking forward, ICAD is dedicated to serving those in need by establishing free, equitable access to AI-RED mammograms. To start, ICAD will bring profound detection to the countries of Ghana and Guyana in partnership with RAD-AID, a nonprofit entity that works in over 30 countries to improve and optimize access to medical imaging and radiology in low-resource regions of the world. Together, ICAD and RAD-AID plan to improve diagnosis of breast cancer where breast cancer mortality rates are the highest. I'll now turn the call over to Eric for a detailed review of our Q4 and year-end 2023 financials.