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CVRx(CVRX) - 2023 Q2 - Quarterly Report
2023-08-02 16:00
Table of Contents 8 CVRx, Inc. (the "Company") was incorporated in Delaware and is headquartered in Minneapolis, Minnesota. The Company has developed and is marketing a medical device, Barostim, for heart failure ("HF") and resistant hypertension. The Company is focused on the sale of its product in the U.S. and Europe. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. G ...
CVRx(CVRX) - 2023 Q2 - Earnings Call Transcript
2023-07-26 02:08
CVRx, Inc. (NASDAQ:CVRX) Q2 2023 Earnings Conference Call July 25, 2023 5:30 PM ET Company Participants Mike Vallie – Senior Vice President-ICR Westwicke Nadim Yared – President and Chief Executive Officer Jared Oasheim – Chief Financial Officer Conference Call Participants Matthew O’Brien – Piper Sandler Margaret Kaczor – William Blair Bill Plovanic – Canaccord Genuity Alex Nowak – Craig-Hallum Frank Takkinen – Lake Street Capital Markets Operator Greetings, and welcome to the CVRx Q2 2023 Earnings Call. A ...
CVRx(CVRX) - 2023 Q1 - Quarterly Report
2023-05-10 16:00
Financial 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].
CVRx(CVRX) - 2023 Q1 - Earnings Call Transcript
2023-04-30 02:21
CVRx, Inc. (NASDAQ:CVRX) Q1 2023 Earnings Conference Call April 27, 2023 5:00 PM ET Company Participants Michael Vallie - Investor Relations Nadim Yared - President and Chief Executive Officer Jared Oasheim - Chief Financial Officer Conference Call Participants Will Plovanic - Canaccord Genuity Alex Nowak - Craig-Hallum Capital Group Frank Takkinen - Lake Street Capital Markets Operator Greetings, and welcome to the CVRx Q1 2023 Earnings Call. At this time, all participants are in a listen-only-mode. A brie ...
CVRx(CVRX) - 2022 Q4 - Annual Report
2023-02-09 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT For the fiscal year ended December 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40545 CVRx, Inc. (Exact name of registrant as specified in its charter) Delaware 41-1983744 (State or other jurisdiction o ...
CVRx(CVRX) - 2022 Q4 - Earnings Call Transcript
2023-01-27 02:10
CVRx, Inc. (NASDAQ:CVRX) Q4 2022 Earnings Conference Call January 26, 2023 5:30 PM ET Company Participants Mike Vallie - Westwicke, ICR Company Nadim Yared - President and Chief Executive Officer Jared Oasheim - Chief Financial Officer Conference Call Participants Robbie Marcus - JPMorgan Matthew O'Brien - Piper Sandler Margaret Kaczor - William Blair William Plovanic - Canaccord Genuity Alex Nowak - Craig-Hallum Operator Good day and welcome to the CVRx Q4 2022 Earnings Conference Call. At this time, all p ...
CVRx(CVRX) - 2022 Q3 - Quarterly Report
2022-11-03 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |-------------------------------------------------------------------------|------------------------------------------------------------------------ ...
CVRx(CVRX) - 2022 Q3 - Earnings Call Transcript
2022-11-02 00:05
CVRx, Inc. (NASDAQ:CVRX) Q3 2022 Earnings Conference Call November 1, 2022 5:30 PM ET Company Participants Mike Vallie - Westwicke, ICR Company Nadim Yared - President and CEO Jared Oasheim - CFO Conference Call Participants Matthew O'Brien - Piper Sandler Margaret Kaczor - William Blair Bill Plovanic - Canaccord Alex Nowak - Craig-Hallum Operator Good day and thank you for standing by. Welcome to the CVRx Third Quarter 2022 Earnings Conference Call. [Operator Instructions]. Please be advised that today's c ...
CVRx(CVRX) - 2022 Q2 - Quarterly Report
2022-07-31 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | --- | |-----------------------------------------------|--------------------------------------------------------------------------------------|---------------- ...
CVRx(CVRX) - 2022 Q2 - Earnings Call Transcript
2022-07-29 19:07
CVRx, Inc. (NASDAQ:CVRX) Q2 2022 Earnings Conference Call July 28, 2022 5:30 PM ET Company Representatives Nadim Yared - President, Chief Executive Officer Jared Oasheim - Chief Financial Officer Mike Vallie - Westwicke, ICR Company Conference Call Participants Matthew O’Brien - Piper Sandal Margaret Kaczor - William Blair Alex Nowak - Craig-Hallum William Plovanic - Canaccord Operator Good day and thank you for standing by. Welcome to the CVRx Second Quarter 2022 Earnings Conference Call. [Operator Instruc ...