5/11/2022

speaker
Operator
Conference Operator

Today's conference is scheduled to begin shortly. Please continue to stand by and thank you for your patience. Thank you. Thank you. Thank you. Good day, and thank you for standing by. Welcome to the Minerva Surgical first quarter 2022 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star zero. I would now like to hand the conference over to your speaker today, Caroline Corner with Investor Relations. Please go ahead.

speaker
Caroline Corner
Investor Relations

Thank you, Operator. Welcome to Minerva's first quarter 2022 earnings call. Joining me on today's call are Dave Clapper, President and Chief Executive Officer, and Joel Young, Chief Financial Officer. This call will provide forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements made on this call that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the markets in which Minerva Surgical operates, trends and expectations for Minerva's products and technology, trends and demands for Minerva's products, Minerva's expected financial performance, expenses, and position in the market and outlook for fiscal year 2022, and the impact of COVID-19 and its variance on Minerva's operations and Minerva's customers' operations. These statements neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause ISOR results, performance, or achievements to differ materially from any results, performance, or achievements expressed or implied by the forward-looking statements. Please review Minerva's most recent filings with SEC. particularly the risk factors described in Minerva's quarterly report on Form 10Q for the quarter ended March 31, 2022, which was filed on May 11, 2022, for additional information. Any forward-looking statements provided during this call, including projections for future performance, are based on management's expectations as of today. Minerva undertakes no obligations to update these statements to reflect events that occur or circumstances that exist after today, except as required by applicable law. Minerva's press release for the first quarter of 2022 results is available on Minerva's website, www.minervasurgical.com, under the Investors section, and includes additional details about Minerva's financial results. Minerva's website also has the latest SEC filings, which you are encouraged to review. A recording of today's call will be available on Minerva's website by 5 p.m. Pacific time today. With that, I will hand the call over to Dave.

speaker
Dave Clapper
President and Chief Executive Officer

Thank you, Caroline, and thanks to all of you for joining us on our first quarter earnings call. For those of you who are new to our story, I'd like to begin with a brief reminder of who Minerva Surgical is, and then move to our recent updates and plans for the future. Minerva Surgical is one of the few medical device companies that is solely focused on women's uterine health. The indication for our current line of four products is the treatment of abnormal uterine bleeding, or AUB. AUB is caused by either a dysfunctional lining of the uterus called the endometrium or by abnormal intrauterine tissue structures called fibroids and polyps. Minerva has a complete line of products for either the ablation of the endometrium or the resection of fibroids and polyps. AUB, according to the American College of Obstetrics and Gynecology, affects one in three women. which equates to 18 million women in the U.S. between the ages of 25 and 50. And sadly, AUD is the leading cause of hysterectomies. Next to C-sections, hysterectomy is the highest volume women's surgical procedure in the U.S., with approximately 500,000 hysterectomies performed each year. Hysterectomy is a major surgery that in most cases requires general anesthesia, a multiple night stay in the hospital, a four to six week recovery time, and a mortality rate directly attributed to the surgery of up to 1.5 patients per 1,000 hysterectomies. Our mission at Minerva is to eliminate these unnecessary hysterectomies performed for AUB. Our flagship product, the Minerva ES Endometrial Ablation System, received FDA premarket approval in July 2015 and is indicated for women with abnormal uterine bleeding for whom childbearing is complete. In the clinical trial for FDA approval, the efficacy of the Minerva Endometrial Ablation product was judged by the FDA to be statistically significantly greater than the efficacy of the control group, which was comprised of the five previously FDA-approved products. The Minerva ES ablates the endometrium to significantly reduce or eliminate heavy menstrual bleeding. Our Genesis HCA system performs a similar procedure to the Minerva ES, but uses hot saline as the energy source for ablation, providing the gynecologist with an instrument that is better suited for irregular uterine anatomy. Our Synthion uterine tissue resection system is indicated for resecting fibroids and polyps. Fibroids are a significant cause of both pain and excessive bleeding and are a leading cause of hysterectomies. Our Symtheon system is the only product on the market that cuts and simultaneously coagulates tissue to control intrauterine bleeding during and after a fibroid or polyp resection. The Symtheon system also has an exclusive safety feature that employs a pump and filter system that monitors and controls intrauterine pressure while recirculating the saline dissension fluid in a closed-loop system. This system avoids excessive fluid entravization, which could endanger a patient during longer or more complicated procedures. This safety feature is exclusive to the Symphion system and not available with competitive resection devices. And finally, we sell a simple, low-cost manual resection device called Resector for polyp removal. used in office settings to round out our portfolio product. We believe that women should be better informed on their treatment options well before they decide to have a hysterectomy, which is a life-altering organ removal procedure. There are a number of organizations that are focusing on educating women about uterine fibroids, and Minerva is supporting this education effort with our recently launched website, AUB.org. One of these other organizations seeking to raise awareness about uterine fibroids has even suggested that there is a uterine fibroid epidemic. We at Minerva agree that more needs to be done to educate women about this all-too-common condition, and we are bolstering our efforts through our direct-to-consumer marketing campaign via social media outreach for education, community, and advocacy. Now let's turn to some important performance updates for the first quarter. We reported revenues of 10.9 million in the first quarter of 2022 versus 11.8 million in the first quarter of 2021. While we were disappointed with the year-over-year revenue decline, we are very encouraged by recent positive trends in our average daily sales metrics that indicate that the impacts of COVID are improving. We are pleased with the recent sales growth of our Symfion system, which experienced 20% growth over last year's first quarter. We continue to make progress with new account evaluations and trials and believe that as the macro environment improves, we are well positioned to continue this growth. In fact, overall, we have added 238 new accounts during the last 12 months, approximately 40% of which were new Symtheon accounts. In spite of this continuous progress with new accounts, we are still seeing the lingering impact from COVID on both limiting patients who are seeking treatment, as well as hospital staffing challenges and Salesforce access. But we believe we are now seeing light at the end of the tunnel particularly the Symphion. With a full slate of four products, we are making good progress in gaining access to group purchasing organizations and independent delivery networks through new contracts that will allow us to compete in hospitals that we were previously locked out of. We are progressing on our national account strategy, and today 44% of our current business is under contract, And that contracted business is up 17% from the prior quarter. As I previewed on our last call, in March, we held our first in-person national sales meeting since early 2020. It was a pleasure to see the high enthusiasm within the sales team, which is now comprised of 80 sales territories covering all major metropolitan areas. It takes three to six months for a new sales rep to get up to speed, and we are encouraged by our progress and feel well positioned for growth over the coming months. We have begun the test marketing of our direct-to-consumer DTC digital marketing initiative in 10 select markets, and over the next 12 months, we'll be expecting to build awareness of AUB and our products. With this pilot, we are seeking to educate patients on the AUB treatment options and the clinically proven advantages of Minerva treatments versus others, and to correct inaccurate marketing messages from competitors' products. It is our goal to ensure both patients and doctors understand the actual claims as published in FDA-approved labeling. Initial website traffic is very encouraging. showing early signs of success and increasing overall awareness of treatment options for AUB, as well as connecting patients with treating physicians. Our specific goals are to address the over 36,000 U.S. Internet searches per month that utilize AUB symptom keywords. The early results are encouraging, and we are seeing a significant increase in Minerva website traffic. For example, in January of this year, we had approximately 6,000 website visitors to our minervasurgical.com and aubandme.com websites combined. In April of this year, we had over 32,000 visitors to the websites, and of these, over 30,000 were first-time visitors to the websites. As patients began to come back in physician offices, and the economy continues to reopen, we are keenly focused on bolstering the foundation for future growth by executing across several key initiatives. One, completing this year's expansion of our sales and marketing team. Two, signing complete product line contracts with GPOs and IDNs. Three, increasing our installed base of controllers in both new and existing accounts. Four, cross-selling our products to drive new Minerva and Symphion device sales in established accounts. And five, leveraging our DTC marketing efforts to increase awareness of our lesson-based procedures versus hysterectomy and statistically significantly greater clinical results than competitive products for endometrial ablations. I'll finish up by saying that here at Minerva, we're excited about our future and remain keenly focused on helping women realize their best solution for AUB, and we truly appreciate your support. With that, I'll hand things over to Joel for our financial results. Joel?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

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