Avinger(US:AVGR)2024-08-08 21:00Financial Performance - Revenues for the company were $10.1 million in 2021, $8.3 million in 2022, and $7.7 million in 2023, reflecting a decline primarily due to staffing shortages and a competitive market for talent [147]. - The company experienced a net loss of $4.4 million and $9.9 million for the three and six months ended June 30, 2024, respectively, with an accumulated deficit of $430.6 million as of the same date [172]. - Revenues for the three months ended June 30, 2024, decreased by approximately $0.2 million or 10% compared to the same period in 2023, with disposable catheter sales down 9% to $1.7 million [192]. - Revenues for the six months ended June 30, 2024, decreased by approximately $0.2 million or 6% compared to the same period in 2023, with disposable catheter sales down 6% to $3.4 million [200]. - Gross margin for the three months ended June 30, 2024, decreased to 20%, compared to 30% for the same period in 2023, primarily due to decreased production levels and rising material costs [194]. - Gross margin for the six months ended June 30, 2024, decreased to 19%, compared to 32% for the same period in 2023, attributed to decreased production levels and rising material costs [202]. - Net cash used in operating activities for the six months ended June 30, 2024, was $8.3 million, compared to $7.5 million for the same period in 2023 [228][229]. - Net cash provided by financing activities for the six months ended June 30, 2024, was $11.8 million, primarily from the issuance of preferred and common stock [230]. Regulatory and Compliance - The company received 510(k) clearance from the FDA for the Tigereye Spinning Tip in April 2023, with a limited launch initiated in Q2 2023 and full commercial availability expected in Q3 2023 [138]. - In June 2023, the company received FDA clearance for the Pantheris Large Vessel, targeting larger vessels, with a limited launch in Q3 2023 and full availability anticipated in the second half of 2024 [139]. - The company received a Nasdaq delisting notice on April 25, 2023, due to a bid price deficiency, but regained compliance by September 27, 2023 [148][149]. - The company submitted a Compliance Plan to Nasdaq to address stockholders' equity deficiencies and received an extension until November 14, 2023, to regain compliance [150][151]. - The company is required to achieve an aggregate of $10 million in gross revenue within any four consecutive fiscal quarters to trigger an additional investment of $7.5 million from the Purchaser [165]. Capital and Financing - The company undertook actions including converting $11.0 million of debt into equity and completing a public equity offering in June 2024, raising gross proceeds of $6.0 million [153]. - The company anticipates needing to issue additional shares to maintain compliance with Nasdaq's stockholders' equity requirement [156]. - A Securities Purchase Agreement was established with Zylox-Tonbridge for up to $15 million in shares, with an initial closing of $7.5 million on March 5, 2024 [163]. - The company completed a Private Placement for gross proceeds of $7.5 million [181]. - The minimum liquidity requirement of the Loan Agreement was reduced from $3.5 million to $1.5 million for a specified period in 2024 [181]. - The total CRG Loan amount as of June 30, 2024, is $4.0 million, with an obligation of $6.2 million upon maturity in December 2028, including a $2.1 million back-end fee [222]. - The minimum liquidity requirement was reduced from $3.5 million to $1.0 million until April 1, 2024, and then will revert to $3.5 million [223]. Operational Changes - The company undertook a workforce reduction of 17 employees, including a 33% reduction in sales personnel dedicated to the peripheral business, to lower operating expenses [171]. - The lease was extended for one year, obligating the company to pay approximately $1.3 million in base rent payments through November 2025 [169]. - The company has not been profitable since inception and has financed operations primarily through private and public placements of securities and debt financing [172]. - The company has a total lease obligation of approximately $7.1 million in base rent payments through November 2025 [225]. - The weighted average remaining lease term as of June 30, 2024, is 1.4 years [225]. Research and Development - The company has been working on developing CTO crossing devices for the coronary artery disease market, which is highly competitive and requires additional expenses [136]. - Research and development expenses for the three months ended June 30, 2024, decreased by approximately $0.1 million or 9% compared to the same period in 2023, mainly due to the completion of development efforts for Tigereye ST and Pantheris LV [196]. - Research and development expenses for the six months ended June 30, 2024, decreased by approximately $0.4 million or 16% compared to the same period in 2023, primarily due to reduced headcount and completed development efforts [203]. - The company anticipates optimizing inventory levels in light of forecasted demand related to new product introductions, specifically Tigereye ST and Pantheris LV [228]. Market Strategy - The Lumivascular platform is the only technology offering radiation-free, high-definition real-time visualization during PAD treatment, which is expected to improve patient outcomes [141]. - The company focuses its marketing efforts on interventional cardiologists, vascular surgeons, and interventional radiologists, while also developing relationships with key opinion leaders in hospitals [145].