CVRx(US:CVRX)2023-05-10 16:00Financial Performance - Revenue for the three months ended March 31, 2023, was $7,979,000, a 96.5% increase from $4,076,000 in the same period of 2022 [91]. - Gross profit for the same period was $6,651,000, compared to $3,127,000 in the prior year, reflecting a gross margin improvement [91]. - The net loss for the three months ended March 31, 2023, was $11,374,000, compared to a net loss of $9,991,000 for the same period in 2022, representing a 13.9% increase in losses [91]. - The company reported a loss from operations of $12,162,000 for the three months ended March 31, 2023, compared to a loss of $9,908,000 in the same period of 2022 [91]. - The net loss for the three months ended March 31, 2023, was $11.374 million, compared to a net loss of $9.991 million for the same period in 2022, resulting in a net loss per share of $(0.55) compared to $(0.49) in 2022 [147]. - The company expects operating losses and negative cash flows from operations to continue in the foreseeable future [72]. - The company expects to continue incurring net losses for the next several years, which may require additional funding through equity and debt financing [185]. Cash and Assets - Net cash provided by financing activities for Q1 2023 was $7.6 million, primarily from a Loan Agreement and stock options [9]. - As of March 31, 2023, total current assets decreased to $120.582 million from $122.878 million as of December 31, 2022 [62]. - Cash and cash equivalents were reported at $103.276 million, a slight decrease from $106.194 million [62]. - Cash and cash equivalents at the end of the period were $103,276,000, down from $131,177,000 at the end of March 2022 [96]. - The Company has a Loan Agreement allowing for borrowing up to $50 million, with $15 million drawn as of March 31, 2023, and a requirement for trailing three months revenue of $5.75 million to access additional funds [110]. - The Company’s accrued expenses totaled $5,961,000 as of March 31, 2023, a decrease from $6,369,000 on December 31, 2022, representing a decline of 6.4% [132]. Liabilities and Equity - Total liabilities increased significantly to $23.049 million from $15.757 million, primarily due to an increase in long-term debt from $6.747 million to $14.218 million [62]. - The accumulated deficit grew to $(447.556) million from $(436.182) million, indicating ongoing financial challenges [62]. - Total stockholders' equity decreased to $99.642 million from $109.180 million, reflecting a decline in overall financial health [62]. Regulatory and Compliance - The company anticipates making a regulatory submission to the FDA for expanded labeling based on additional analyses from the BeAT-HF pivotal trial, although timing is uncertain [35]. - The company has submitted an application for Barostim to comply with EU Medical Devices Regulation, currently under review [22]. - The company has elected to use an extended transition period under the JOBS Act for compliance with new accounting standards [15]. - The company is subject to extensive governmental regulations, particularly in foreign jurisdictions, which could impact business operations [60]. Operational Challenges - The company continues to face significant risks, including a history of losses and dependence on a single product, Barostim [50]. - Future product approvals and clinical trial results remain uncertain, influenced by various regulatory and market factors [59]. - The ongoing impact of the COVID-19 pandemic on clinical trials and market acceptance of Barostim is still being assessed [59]. - Inflationary factors may adversely affect operating results, but the company does not believe inflation has materially impacted its financial position to date [19]. Research and Development - Total operating expenses increased to $18,813,000 from $13,035,000, primarily driven by higher research and development costs of $3,416,000, up from $2,258,000 [91]. - Research and development expenses for the three months ended March 31, 2023, were $3.4 million, a 51% increase compared to the same period in 2022 [198]. - Research and development expenses for the three months ended March 31, 2023, were $0.508 million, up from $0.102 million in the same period of 2022 [144]. Market Expansion - The company is focused on expanding the market for its medical device, Barostim, in the U.S. and Europe [98]. - The company plans to continue expanding its U.S. commercial infrastructure by investing in and training its sales force to promote the Barostim device [156]. - The company plans to expand its direct sales force and increase awareness of Barostim among payors, physicians, and patients to drive future revenue growth [182]. - U.S. HF revenue totaled $6.8 million for the three months ended March 31, 2023, reflecting a 132% increase over the prior year, driven by expansion into new sales territories and increased awareness of Barostim [200]. - Revenue generated in Europe was $1.0 million for the three months ended March 31, 2023, a 2% increase from the previous year, with total revenue units rising to 52 [201]. Stock and Options - The Company has 1,832,425 shares available for future issuance under the 2021 Equity Incentive Plan as of March 31, 2023 [118]. - The company’s stock options outstanding as of March 31, 2023, totaled 4,426,605, with a weighted average exercise price of $9.44 [167]. - The weighted-average common shares used to compute net loss per share were 20,711,068 for the three months ended March 31, 2023 [82]. - The weighted average fair value of options granted to non-officer employees was $10.72, with expected volatility ranging from 77.6% to 79.2% [122]. - The expected volatility for stock options granted was 84.6% for the three months ended March 31, 2023, compared to 51.3% for the same period in 2022 [143].