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Formation and Business of the Company
6 Months Ended
Jun. 30, 2022
Disclosure Text Block [Abstract]  
Formation and Business of the Company

1. Formation and Business of the Company

The Company

Minerva Surgical, Inc. (the Company, we, us, and our) was incorporated in the state of Delaware on November 3, 2008. The Company's headquarters are in Santa Clara, California. The Company is a medical device company that develops therapeutic devices that treat abnormal uterine bleeding in a minimally invasive manner. The Company commenced commercial introduction of its products in the United States in 2015 following the clearance by the U.S. Food and Drug Administration (FDA).

In May 2020, the Company acquired certain assets from Boston Scientific Corporation (BSC) to broaden its product offerings to its customers. The Company derives all of its revenue from sales to customers in the United States through a direct sales force.

Initial Public Offering

On October 21, 2021, the Company's registration statement on Form S-1 (File No. 333- 259832) relating to its initial public offering (IPO) of common stock became effective. The Company issued and sold 6,250,000 shares of its common stock at a public offering price of $12.00 per share, for aggregate gross proceeds of $75.0 million. The Company received $69.8 million in net proceeds after deducting underwriting discounts and commissions. The total IPO offering costs other than underwriting discounts and commissions were $3.2 million.

In connection with the completion of its IPO, on October 21, 2021, the Company's certificate of incorporation was amended and restated to provide for 100,000,000 authorized shares of common stock with a par value of $0.001 per share and 5,000,000 authorized shares of preferred stock with a par value of $0.001 per share.

Immediately prior to the IPO, $79.2 million in aggregate outstanding principal and accrued interest of the convertible promissory notes converted into 7,006,228 shares of redeemable convertible preferred stock at a conversion price of $11.31 per share. Also, immediately prior to the closing, all outstanding shares of the Company's redeemable convertible preferred stock (including those issued upon conversion of the convertible promissory notes) converted into 19,404,066 shares of common stock which resulted in the reclassification of the carrying value of the preferred stock to common stock and additional paid-in capital.

 

Liquidity

 

In accordance with ASC 205-40, Presentation of Financial Statements – Going Concern, management must evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued. This evaluation initially does not take into consideration the potential mitigating effect of management’s plans that have not been fully implemented as of the date the financial statements are issued. When substantial doubt exists under this methodology, management evaluates whether the mitigating effect of its plans sufficiently alleviates substantial doubt about the Company’s ability to continue as a going concern.

 

The mitigating effect of management’s plans, however, is only considered if both (1) it is probable that the plans will be effectively implemented within one year after the date that the financial statements are issued and (2) it is probable that the plans, when implemented, will mitigate the relevant conditions or events that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued. Generally, to be considered probable of being effectively implemented, the plans must have been approved before the date that the financial statements are issued.

 

The Company’s financial statements have been prepared on a going concern basis, which contemplates the continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. The Company incurred a net loss of $16.5 million during the six months ended June 30, 2022 and had an accumulated deficit of $266.1 million as of June 30, 2022. The Company had cash and cash equivalents of $22.4 million as of June 30, 2022. The Company has prepared an internal forecast that was reviewed with our Board of Directors that includes plans to raise additional capital within the next six to nine months. Should the plan to raise capital within this timeline not be consummated, this forecast presents the possibility of a financial covenant

violation related to the company’s minimum cash position within the twelve-month period from the issuance of these financial statements. A potential financial covenant violation, should it occur, would put the company in technical default per the terms of the CIBC Agreement and provide for remedies to the bank per that agreement.

This potential future covenant violation could impact the Company's ability to fund its current business plan within the twelve-months from the date of issuance of these financial statements. The presence of this condition raises substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the financial statements are issued.

 

The Company is currently in discussions with a number of potential lenders and investors to raise additional capital through debt, equity or a combination financing. Such additional financing may or may not be available to the Company on acceptable terms, or at all. If the Company is unable obtain adequate financing on acceptable terms, the Company may terminate or delay the development of one or more of its products, delay sales and marketing efforts or other activities necessary to commercialize its products, or modify its operations to operate within available resources. Failure to manage discretionary spending or raise additional financing as needed, may adversely impact the Company’s ability to achieve its intended business objectives. While we believe our plans will alleviate the conditions that raise substantial doubt, these plans are not entirely within our control and cannot be assessed as being probable of occurring.

 

Impact of the COVID-19 pandemic

The COVID-19 pandemic and the resulting economic downturn have impacted business conditions in the industry in which the Company operates. Since March 2020, the Company’s net sales were negatively impacted by the COVID-19 pandemic as hospitals and ambulatory surgical centers (ASCs) delayed or canceled elective procedures. In response to the pandemic, many state and local governments in the U.S. issued orders that temporarily precluded elective procedures in order to conserve scarce health system resources. The decrease in hospital and ASCs admission rates and elective surgeries reduced both the number of patients being evaluated for treatment with and demand for elective procedures using the Company's products.

In March 2020, the governor of California, where the Company’s headquarters are located, issued “stay at home” orders limiting non-essential activities, travel, and business operations. Such orders or restrictions have resulted in reduced operations at the Company’s headquarters (including manufacturing facility), work stoppages, slowdowns and delays, travel restrictions and cancellation of events and have restricted the efforts of the Company’s sales representatives, thereby significantly and negatively impacting the Company’s operations. These orders and restrictions have significantly decreased the number of procedures performed using the Company’s products and otherwise negatively impacted sales and operations.

The Company continued to experience a slower than expected revenue growth in the six months ended June 30, 2022, a trend that continued from the second half of 2021. While reinstated hospital and ASC closures for elective procedures due to COVID-19 have been lifted in most hospitals and ASCs in the first six months ended June 30, 2022, a nationwide staffing shortage in the hospital work environment resulted in a negative impact on the numbers of ablation procedures scheduled during that time.

The Company has taken necessary precautions to safeguard its employees, patients, customers, and other stakeholders from the COVID-19 pandemic, while maintaining business continuity to support its patients, customers and employees. The timing, extent and continuation of any increase in procedures, and any corresponding increase in sales of the Company’s products, and whether there could be a future decrease in the current level of procedures as a result of the COVID-19 pandemic or otherwise, remain uncertain and are subject to a variety of factors.

The Company is continuing to monitor the impact of the COVID-19 pandemic on its employees and customers and on the markets in which it operates and will take further actions that the Company considers prudent to address the COVID-19 pandemic, while ensuring that it can support its customers and continue to develop its products.

The ultimate extent of the impact of the COVID-19 pandemic on the Company is highly uncertain and subject to change. This impact may result in a material, adverse impact on liquidity, capital resources, supply chain, operations and revenue and may affect third parties in which the Company relies and could worsen over time. The extent of the continuing resurgence of COVID-19, the efficacy and extent of distribution of vaccines, and the impact of variants of COVID-19 is unpredictable.