Minerva Surgical, Inc.

Good day, and thank you for standing by, and welcome to the Minerva Surgical, Inc., fourth quarter and full year 2021 earnings call. At this time, all participants are on 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'll need to press star 1 on your telephone. Please be advised this call is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your host today, Caroline Corner, Investor Relations, you may begin.

Thank you, operator. Welcome to Minerva's fourth quarter and full year 2021 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 include 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 variants on Minerva's operations and Minerva's customers' operations. These statements are neither promises nor guarantees and involve known and unknown risks and uncertainties that could cause actual 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 the SEC, particularly the risk factors described in Minerva's annual report on Form 10-K for the year ended December 31, 2021, which will be filed later this month 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 obligation 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 of fourth quarter and full year 2021 results is available on Minerva's website, www.minervasurgical.com, under the investor section and includes additional details about Minerva's financial results. Minerva's website also has the latest SEC filings, which you're 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.

Thank you, Caroline, and thanks to all of you for joining us on our first earnings call as a public company. Since many of you are new to our story, I'd like to begin with a brief overview of our company before we move into 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 product line of four products is the treatment of abnormal uterine bleeding, or AUB. Abnormal uterine bleeding is caused by either a dysfunctional lining of the uterus called the endometrium or by uterine tissue structures called fibroids and polyps. we now have a complete product line 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. This equates to 18 million women in the U.S. between 25 and 50 years old. And sadly, AUB is the leading cause of hysterectomies. Next to C-sections, hysterectomy is the highest volume women's surgical procedure with approximately 500,000 hysterectomies performed in the U.S. every 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. Minerva Surgical was founded in 2008 with the mission to eliminate the unnecessary hysterectomies performed for abnormal uterine bleeding. Our flagship product, the Minerva Endometrial Ablation product, received FDA premarket approval, or PMA, in July 2015 and is indicated for women with abnormal uterine bleeding for whom childbearing is complete. The Minerva product ablates the endometrium, the lining of the uterine cavity, to significantly reduce or eliminate heavy menstrual bleeding. In our clinical study for FDA approval, the FDA determined that the Minerva treatment yielded statistically significant greater efficacy than the Objective Performance Criteria Group, or OPC, to which Minerva was compared for approval. This OPC group was comprised of the FDA clinical study data from the five previously FDA approved endometrial ablation products at the time, including our leading competitor's market leading product. In that trial, the Minerva treatment was successful in reducing bleeding at the one year follow up to a normal or less level in 93% of the patients and totally eliminated bleeding in 72% of patients. This very favorably compares to our competitor's treatment success rate of just 77.7% and its total bleeding elimination rate of just 36%. Plus, through three years of follow-up, less than 1% of the Minerva-treated patients had a hysterectomy. This compares with a 6.8% hysterectomy rate in our competitor product clinical study for FDA approval. Prior to May 2020, the Minerva Endometrial Ablation product was the only product that we had to sell. In May 2020, we acquired three additional products from Boston Scientific to expand our product offering in uterine health. The most sought-after product acquired was the Symphion tissue resection product for removing uterine fibroids and polyps. This is the only product on the market today that both cuts and coagulates uterine tissue with the same device to reduce bleeding. And it is the only product on the market today that eliminates the possibility of dangerous patient fluid overload occurring during the procedure. we believe we now have the best products available for both endometrial ablation and uterine tissue resection. Similar to other companies selling medical devices used in elective surgery, COVID has had a significant impact on operations over the past two years and will likely be one of the biggest variables affecting our success in the short term. And the situation is changing every month. Overall, the business environment is reported to be improving, but we are still far from being back to a normal pre-COVID environment. A leading gynecology society, the AAGL, recently reported that January was very negatively affected by the Omicron variant, but things appear to be picking back up. Our daily sales averages are increasing, so we are cautiously optimistic that our growth will respond accordingly. In spite of the challenging macro environment due to COVID, I'm proud to tell you that in 2021, we treated over 40,000 women and over 12,000 in Q4 alone. In addition, we added over 250 new accounts in 2021, that ordered the Minerva endometrial ablation device or the Symphion tissue resection device for the very first time. And we saw positive results with our cross-selling strategy in 2021, as we were able to sell Symphion into 120 established Minerva accounts. Let's turn now to some other performance updates for the fourth quarter. We logged revenues of over $52 million for 2021, with $13.6 million in Q4, and saw double-digit annual growth versus 2020 in both the Minerva Endometrial Ablation and Symphion product lines. As a single-product company, prior to the acquisition of the additional products from Boston Scientific in mid-2020, the absence of account contracts has been a rate-limiting step in our ability to go after many hospitals. In short, we were locked out of doing business with many hospitals who choose not to do business with a single product company. Now, with the full and complete product lineup, hospitals are expressing interest to enter into contracts with us. In fact, in 2021, we signed contracts with three group purchasing organizations, or GPOs, and 18 independent delivery networks, or IDNs, that represent over 500 new accounts under contract for us. We will continue pursuing our national accounts contract strategy as only 37% of our current business is under contract. With our full product line, we are seeing some solid early success with cross-selling, the Symphion tissue resection product into our existing Minerva accounts. While Minerva is sold on superior clinical outcome data and efficacy to all currently marketed products, Symphion is sold on readily observable features and benefits in the surgeon's hands. With regard to expanding our sales force, we are closing in on our target of 80 field sales representatives. We feel that 80 is the right size for now, but this may change mid-year. It takes a new representative between three to six months to get up to speed and become productive, so we'll be monitoring sales rep productivity and expanding where appropriate. We are also very excited to report that this month we will be holding our first in-person national sales meeting in over two years. We're looking forward to getting the team together so we're all on the same page as we come out of COVID. As many of you may know, we are test marketing a direct-to-consumer, or DTC, marketing initiative to build awareness of AUB and our products. This is a pilot, and we expect results to build over the coming 12 months. Educating patients on their AUB treatment options and the advantages of Minerva treatments versus others is very compelling. Our goal is to respond to the over 36,000 U.S. Internet searches per month that utilize AUB symptom keywords. The results to date are encouraging as reflected in the significant increase in Minerva website traffic that we are seeing. For example, in January 2022, we had over 6,000 website visitors compared to 1,000 just a year ago. Of those 6,000 visitors this January, over 5,000 were new first-time visitors to our aubandme.com and minervasurgical.com websites. While we are still seeing the effects of the pandemic, and the impact on our procedures, we are not sitting on our hands waiting for COVID to subside. Instead, we are keenly focused on building the foundation for new business by executing across our key initiatives as follows. Expanding our sales and marketing team. Signing complete product line contracts with GPOs and IDNs. Increasing our installed base of controllers in both new and existing accounts, driving disposable sales growth in both established accounts, and continuing our DTC marketing pilot to increase overall awareness of our less invasive procedures versus hysterectomies. I'll finish up by thanking our investors who supported us at our October IPO. We're excited to deploy the net IPO proceeds of approximately $67 million for market share growth and market expansion by bringing our products to more patients and driving top-line revenue. In a nutshell, we are very excited about our future, and we appreciate your support. With that, I'll hand things over to Joel Young for the financial results. Joel?