4/1/2022

speaker
Matt
Operator

Good morning, ladies and gentlemen, and welcome to the Milestone Scientific Fiscal 2021 Year-End Business Update Call. At this time, all participants have been placed on a listen-only mode, and we will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Natalia Rudman of Milestone Scientific. Ma'am, the floor is yours.

speaker
Natalia Rudman
Investor Relations / Host

Thank you, Matt. Good morning, and thank you for joining Milestone Scientific's 2021 Year-End Financial Results Conference Call. On the call with us today are Ariane Haberhaus, Chief Executive Officer, and Keisha Harcum, Controller of Moscow Scientific. The company issued a press release today, Friday, April 1st, containing 2021 year-end financial results, which is also posted on the company's website. If you have any questions after the call or would like any additional information about the company, please contact the Shenzhen Communications at 212-671-1020. The company's management will now provide prepared remarks reviewing the financial and operational results for the year ended December 31st, 2021. Before we get started, we would like to remind everyone that during this conference call, we may make forward-looking statements regarding timing and financial impacts of Mopsone's ability to implement its business plan, expected revenues, and future success. These statements involve a number of risks and uncertainties and are based on assumptions involving judgments with respect to future economics, competitive and market conditions, and future business decisions, all of which are difficult or impossible to predict accurately, and many of which are beyond my control. Some of the important factors that could cause actual results to differ materially from those indicated by the forward-looking statements are general economic conditions, failure to achieve expected revenue growth, changes in our operating expenses, adverse patent rulings, FDA or legal development, competitive pressures, changes in customer market requirements and standards, and the risk factors detailed from time to time in Milestone's periodic filings with the Security and Exchange Commission, including without limitation, Milestone's report on 410K for the year ended December 31st, 2021. The forward-looking statements made during this call are based upon management's reasonable belief as of today's date, April 1st, 2022. Milestone undertakes no obligation to revise or update publicly any forward-looking statements for any reason. With that out of the way, we'll now turn the call over to Aryan Haverhal, Chief Executive Officer. Please go ahead, Aryan.

speaker
Ariane Haberhaus
Chief Executive Officer

Thank you, Natalia, and thanks to everyone for joining us today. We achieved a 90% year-over-year growth in revenue to $10.3 million, surpassing our prior revenue guidance and exceeding pre-pandemic levels. We achieved these results despite of the impact of COVID-19 which indicates that we are successfully navigating the pandemic and remain on a solid growth trajectory. At the same time, we continue to carefully manage our expenses while investing in sales, marketing, and new product development, along with analyzing new areas for our technology. The growth in the dental division reflects the success of our three-year multi-distribution strategy to expand the worldwide global dental market. As a result, we are successfully adding domestic and global distribution partners. As an example, we recently announced an agreement with Endow Medical to distribute the STA single tooth anesthesia system in the United States and Canada. In the United States, we are looking to bring on new strategic channel partners that can help sell through their network of dental customers in specialized areas of dentistry, such as implant dentistry and aesthetics, as well as large dental groups, also known as dental service organizations, or DSOs, and educational partners as they train the current and next generation of dentists. In parallel, we look forward to further expanding our international sales and are working closely with our new global distributors We believe that through this decentralized sales strategy, in combination with our increased marketing efforts, we can further grow the dental business in the coming years. Our dental business continues to generate positive cash flow on a standalone basis. As we continue to grow this business, we expect to benefit from economies of scale due to the recurring nature and high margins on our disposables. At the same time, we have made progress over the past year, advancing our commercial efforts around the CompreFlow epidural instrument and cath check system. In the beginning of 2021, we had some major setbacks due to organizational issues and the pandemic. However, due to the arrival of vaccines and vaccination programs, hospitals started opening up again during the second quarter of last year. that triggered our decision to invest heavily in our new sales force. As of August, when the real medical commercialization began, management decided that 11 salespeople over the first few months would be the correct number in the United States. Irrespective of the individual changes within that group, it is still our goal to maintain 11 full-time experienced sales representatives in the field that are calling on hospitals every day. We are setting high performance standards for our sales team and monitor their performance closely on a daily basis. We will continue to add sales personnel as appropriate. During the second half of 2021, there was a strategic decision to focus additional efforts resources in trade and consumer marketing communications both the medical and dental brands received a soft image refresh to better align with product messaging through the enhanced brand awareness and stronger digital presence new tools and tactics were deployed to aid our sales representatives and drive qualified leads these materials include training and brand videos educational literature digital marketing materials, and consumer media relations, where Milestone Scientific was recently featured on ZDNet, a media outlet with over 8 million monthly users. From a digital marketing perspective, we've had success in our website traffic. As an example, from the first quarter in 2021 to the first quarter this year, our website visitors have increased by 187%. we are deploying an integrated marketing communication strategy that elevates our brand's awareness and targets key audiences. As a result of our combined sales and marketing initiatives, we have begun to sell our disposables to key hospitals, healthcare systems, and pain management clinics, despite a setback related to the pandemic, which I'll discuss in further detail in a moment. Although we are not always allowed to disclose the names in 2021, we announced sales to the following hospitals. First, we signed an agreement and were approved as vendor in a major northeast teaching hospital, which is part of one of the leading health systems in the United States. We introduced our technology at Memorial Regional Hospital, the flagship facility of the Florida Memorial Healthcare System, and one of the largest hospitals in Florida. Additionally, we received approval to eventually supply our CompuFlow epidural and catch-check verification system disposables across Memorial Healthcare System's network of hospitals. We're selling into University of Texas Medical Branch in Galveston and added Health Clear Lake Campus Hospital belonging to the same group, a major academic health science center of global influence. We're selling into a regional medical center, a premier regional healthcare system in South Carolina. And internationally, we are selling into the University Hospital of Würzburg, one of the leading national hospitals in Germany, in particular for the thoracic indication, approved in Europe where the incident rates of mobility are much higher for this indication. In addition, we have expanded our global reach by adding new international distributors in markets such as Austria, Switzerland, Canada, Slovenia, and the United Arab Emirates. We're also in the process of bringing on new distributors in additional markets. Each of these distributors brings relationships within key global markets and proven track records introducing medical devices within their territories. Turning back to our domestic sales initiatives, in December alone, immediately preceding the spike in Omicron cases, we announced the addition of three leading hospitals, all of which belong to large healthcare systems. However, our activities came to an abrupt halt. It is important to note that the pandemic had a significant impact on the labor and delivery departments within hospitals, much more so than other departments. This was due to the fact that many pregnant women have opted out of the vaccine, resulting in stricter restrictions than other departments. As a result, our sales team was unable to enter the operatories, which limited our ability to demo and trial the instruments. With the pandemic and specifically the Omicron variant now waning, The restrictions have begun to ease, and we are resuming activities, although delayed by several months. This doesn't mean that there won't be another variant or spike that could impact our business, but assuming things remain stable, our reps are back in the field and we are picking up where we left off. Our sales pipeline is solid and growing, and we are advancing discussions with a number of hospitals and healthcare institutions. In addition to our growing regional presence, especially in Florida, we're also targeting Tier 1 university teaching hospitals. Some of these hospitals are among the top 20 in the nation. We believe that as we begin to penetrate some of these larger, well-recognized names, that will add greater credibility and reduce the sales cycle with some of the smaller institutions. We also continue to expand sales of our CompuFlow Epidural System within pain clinics across the US. With over 11 million reported epidural procedures each year, the pain market segment is at least twice the size of the labor and delivery market segment. The pain management market not only includes numerous hospitals, but also specialty centers, outpatient centers, and sports medicine centers. We are receiving positive feedback among clinics and physicians based on our ability to achieve better outcomes at lower cost. We recently announced that a leading pain management specialist, Dr. Harsh Govil, has begun using our technology within his practice at Pittman Healthcare. Similarly, Dr. Miguel de la Garza, a recognized leader in pain management and president of the Florida Society of Interventional Pain Physicians, has begun using our technology within his practice. Dr. De La Garza conducts these procedures at Surgery Partners, one of the largest and growing surgical services businesses in the country, which has also approved the CompuFlow epidural instrument for use across the network in pain management As a result of the pandemic and the issues I explained earlier, we've put strong emphasis on the pain clinics in the first quarter of this year. As you can see, these efforts are paying off. Just this week, we announced we commenced sales of the CompuFlow epidural disposables with the Cypress Surgery Center in Santa Maria. California and the Galileo Surgery Center in San Luis Obispo pain management specialist in California. Both of these prominent pain management practices are located in California and owned by pain management specialists. We are now selling our disposables in the first two of pain management specialist three clinics. The third clinic was closed as they shifted resources during the pandemic, but we aim to sell into the third clinic after it reopens. Fortunately, pain clinics have been less impacted than labor and delivery departments following the latest spike in cases, but we believe we have weathered the worst of the storm and are well positioned in both the pain management as well as labor and delivery markets as the pandemic hopefully continues to recede. So to summarize, we remain committed to our goal of establishing the CompreFlow epidural instrument as the new standard of care in epidural anesthesia by providing patients with effective pain relief while reducing the risk of complications. Our CompreFlow epidural system offers objective detection of pressure changes to verify true loss of resistance and confirm epidural space within minutes. The clinical and safety benefits of the CompuFlow Epidural System are backed by extensive published clinical data demonstrating significant reductions in epidural punctures and complication rates, as well as economic benefits for the institutions. At this point, I'd like to turn the call over to our Kisha Harkin, controller, to go over the financials in detail. Please go ahead, Kisha.

Disclaimer

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