Minerva Surgical, Inc. (NASDAQ:UTRS) is a commercial-stage medical technology company focused on developing, manufacturing, and commercializing minimally invasive solutions to meet the distinct uterine healthcare needs of women. The company has established a broad product line of commercially available, minimally invasive alternatives to hysterectomy, which are designed to address the most common causes of abnormal uterine bleeding (AUB) in most uterine anatomies.
Business Overview
Minerva Surgical's product portfolio includes the Minerva ES Endometrial Ablation System, Genesys HTA Endometrial Ablation System, Symphion Operative Hysteroscopy System, and Resectr Tissue Resection Device. These devices are utilized by obstetrician-gynecologists (OB/GYNs) across a variety of medical treatment settings, including hospitals, ambulatory surgical centers (ASCs), and physician offices.
The company's Minerva ES product was cleared by the FDA in 2015, while the Genesys HTA, Symphion, and Resectr products were acquired from Boston Scientific Corporation in 2020. Minerva Surgical markets and sells its products through a direct sales force in the United States, targeting approximately 19,000 OB/GYNs.
Financials
For the full year 2022, Minerva Surgical reported annual revenue of $50,294,000, a net loss of $34,112,000, annual operating cash flow of -$35,567,000, and annual free cash flow of -$35,640,000.
In the third quarter of 2023, the company generated revenue of $11,965,000, a gross margin of 52.0%, and a net loss of $7,181,000. This compares to revenue of $12,588,000, a gross margin of 54.1%, and a net loss of $11,329,000 in the prior year's third quarter.
For the first nine months of 2023, Minerva Surgical reported revenue of $37,889,000, a gross margin of 54.5%, and a net loss of $27,205,000. This compares to revenue of $36,490,000, a gross margin of 54.5%, and a net loss of $27,867,000 in the first nine months of 2022.
The company's revenue decrease in the third quarter of 2023 was primarily due to lower sales of its Minerva ES and Genesys HTA products, partially offset by higher sales of its Symphion product. The consistent gross margin in the first nine months of 2023 compared to the prior year period was due to the offsetting impact of increased sales volume and a change in product mix, as well as a reduction in depreciation expense related to equipment under customer usage agreements.
Liquidity
As of September 30, 2023, Minerva Surgical had cash and cash equivalents of $11,125,000 and $40,000,000 in outstanding debt under its CIBC term loan agreement. The company incurred a net loss of $27,205,000 during the first nine months of 2023 and had an accumulated deficit of $310,718,000 as of September 30, 2023.
Minerva Surgical's current cash and cash equivalents are not expected to be sufficient to fund the company's operations within the next twelve months without additional capital. The company is actively seeking to refinance its CIBC term loan and raise additional capital. However, there is substantial doubt about the company's ability to continue as a going concern if it is unable to obtain adequate financing on acceptable terms.
Risks and Challenges
Minerva Surgical faces several key risks and challenges, including:
1. Dependence on a limited number of products and the need to drive broader market adoption: The company currently derives substantially all of its revenue from sales of its existing products, and its future growth depends on increasing awareness and adoption of its minimally invasive solutions for AUB among physicians and patients.
2. Competitive landscape: The market for AUB treatments is highly competitive, with established players like Hologic, Medtronic, and CooperSurgical offering competing products. Minerva Surgical must continue to innovate and differentiate its offerings to maintain its competitive position.
3. Regulatory environment: As a medical device company, Minerva Surgical's products and operations are subject to extensive government regulation, particularly by the FDA. Failure to comply with applicable regulations could result in significant penalties and harm the company's business.
4. Reliance on third-party suppliers and manufacturers: The company relies heavily on third-party suppliers and contract manufacturers for the production of its products, which exposes it to risks related to supply chain disruptions and quality control.
5. Liquidity and capital requirements: Minerva Surgical's current cash resources are not expected to be sufficient to fund its operations over the next twelve months, and the company's ability to continue as a going concern is dependent on its success in securing additional financing.
Outlook
Minerva Surgical is a commercial-stage medical technology company with a portfolio of minimally invasive solutions for the treatment of AUB. While the company has faced some challenges in driving broader market adoption of its products and maintaining profitability, it continues to work to expand its commercial footprint, improve its financial position, and navigate the competitive and regulatory landscape.
Conclusion
The company's ability to secure additional financing and successfully execute its growth strategy will be critical to its long-term success. Investors should closely monitor Minerva Surgical's progress in addressing its liquidity concerns, expanding its customer base, and developing new innovative products to meet the evolving needs of the AUB treatment market.