Avinger(US:AVGR)2019-11-05 21:46Financial Performance - The company generated revenues of $7.9 million for the year ended December 31, 2018, compared to $9.9 million in 2017, reflecting a decrease of approximately 20.2%[121] - The net loss for the year ended December 31, 2018, was $27.6 million, down from a net loss of $48.7 million in 2017, indicating an improvement of approximately 43.4%[121] - Revenues increased by 19% to $2.4 million for the three months ended September 30, 2019, compared to $2.0 million for the same period in 2018, primarily due to increased sales of the Pantheris product[145] - For the nine months ended September 30, 2019, revenues rose 12% to $6.6 million compared to $5.9 million for the same period in 2018, attributed to additional sales of the Pantheris Next-Generation device and the Pantheris SV device[151] - Net cash used in operating activities for the nine months ended September 30, 2019 was $13.7 million, consisting primarily of a net loss of $14.3 million[170] Financial Position - As of September 30, 2019, the company's accumulated deficit was $343.2 million, highlighting ongoing financial challenges since inception[121] - As of September 30, 2019, the company had cash and cash equivalents of $14.5 million and an accumulated deficit of $343.2 million, compared to $16.4 million and $328.9 million as of December 31, 2018[158] - The total CRG Loan amount as of September 30, 2019 is $8.6 million, which includes future interest to be accrued but not paid in cash[176] - The company has contractual obligations totaling $21.9 million, including $13.7 million under the CRG Loan and $6.1 million in operating lease obligations[176] Operational Developments - The company received FDA 510(k) clearance for its Pantheris SV device in April 2019, which is designed for use in smaller vessels[116] - The company plans to submit a 510(k) application to expand the indication for Pantheris to include in-stent restenosis following the completion of the INSIGHT clinical trial[118] - The company’s Pantheris product line qualifies for existing reimbursement codes, facilitating adoption by hospitals and medical centers[120] - The company aims to enhance the value proposition of its products by designing future offerings compatible with its Lumivascular platform[119] Cost Management - Cost of revenues decreased by 9% to $4.6 million for the nine months ended September 30, 2019, compared to $5.1 million in the same period of 2018, mainly due to lower charges for inventory excess and obsolescence[152] - Research and development expenses decreased by 5% to $4.1 million for the nine months ended September 30, 2019, compared to $4.3 million for the same period in 2018, reflecting lower project-related expenses[154] - Selling, general and administrative expenses decreased by 9% to $12.2 million for the nine months ended September 30, 2019, compared to $13.4 million in the same period of 2018, primarily due to lower personnel-related expenses[155] Financing Activities - The company completed a public offering of 17,979 shares of Series B preferred stock, raising net proceeds of approximately $15.5 million[128] - The company completed a public offering of 728,500 shares of common stock and 8,586 shares of Series C convertible preferred stock on November 1, 2018, receiving net proceeds of approximately $10.2 million[165] - The company raised net proceeds of approximately $15.5 million from the public offering of Series B preferred stock and warrants in February 2018[163] - Net cash provided by financing activities for the nine months ended September 30, 2019 was $11.9 million, primarily from proceeds of $8.0 million from warrant exercises and $3.8 million from a public offering[173] Future Outlook - The company expects gross margin to increase over the long term as production volume increases and fixed manufacturing overhead costs are spread over a larger number of units[138] - The company anticipates SG&A expenses to rise compared to the prior year due to the expansion of sales and marketing efforts[140] - The company expects to incur losses for the foreseeable future and believes its current cash and expected revenues will fund operations through at least Q2 2020[158] Risk Management - The company does not expect foreign currency transactions to materially affect its financial results, estimating that a 10% adverse change in Euro exchange rates would not significantly impact monetary assets[183] - Interest rate risk associated with cash equivalents is limited, with an immediate 100 basis point change in interest rates not expected to materially affect their fair value[180] - The company does not currently use or plan to use financial derivatives in its investment portfolio[180] Internal Controls - There were no changes in internal controls over financial reporting during the third quarter of 2019 that materially affected the company's internal control[186] - The company maintains effective disclosure controls and procedures as of September 30, 2019, ensuring timely and accurate reporting[185]