Milestone Scientific(MLSS) - 2020 Q2 - Quarterly Report

Sales Performance - The total product sales for the six months ended June 30, 2020, were $1,979,060, a decrease from $4,173,759 in the same period of 2019, reflecting a significant decline in demand due to the COVID-19 pandemic[142]. - Domestic sales in the U.S. for devices dropped to $525 in 2020 from $232,205 in 2019, while handpieces sales decreased to $635,490 from $1,597,316[142]. - International sales for devices were $281,904 in 2020 compared to $665,068 in 2019, and handpieces sales fell to $1,018,123 from $1,485,067[142]. - For the three months ended June 30, 2020, net product sales were $167,674, a decrease of 92.57% compared to $2,257,851 in 2019[144]. - For the six months ended June 30, 2020, total net sales were $1,979,060, a decrease of 52.58% from $4,173,759 in 2019[145]. Profit and Loss - Gross profit for the same period was $112,048, down 92.56% from $1,505,668 in 2019[148]. - Gross profit for the six months was $1,363,734, down 51.35% from $2,802,883 in 2019[154]. - The net loss for the three months ended June 30, 2020, was $3,178,202, compared to a net loss of $1,053,243 in 2019[144]. - The total loss from operations for the six months ending June 30, 2020, was approximately $4.7 million, an increase of 148.26% compared to a loss of $1.9 million in the same period of 2019[157]. Expenses - Selling, general and administrative expenses increased to $3,176,768, a rise of 26.16% from $2,517,970 in 2019[149]. - Research and development expenses for the six months increased to $215,650, a significant rise of 111.68% from $101,875 in 2019[156]. Cash Flow - Cash flow from operating activities for the six months ended June 30, 2020, was a net cash used of $4,111,504, compared to $622,279 in 2019[145]. - Negative cash flows from operating activities for the six months ended June 30, 2020, were approximately $4.2 million, compared to $622,000 for the same period in 2019[158]. - The company had cash and cash equivalents of approximately $16.6 million and working capital of approximately $16.5 million as of June 30, 2020, compared to $1.2 million in working capital on December 31, 2019[158]. Impact of COVID-19 - The COVID-19 pandemic has led to a decrease in demand for the company's products, particularly in the dental and medical divisions, with potential long-term impacts on sales and operations[137]. - The company anticipates that revenue for the third and possibly fourth quarters will be materially and adversely affected due to COVID-19[147]. - The company is focusing on the commercialization of the CompuFlo Epidural System, which may be impacted by the ongoing pandemic[147]. Product Development and Market Expansion - The CompuFlo Epidural System achieved a 99% success rate in identifying the epidural space in a clinical trial involving 400 patients, demonstrating its effectiveness in labor and delivery[130]. - The company has expanded its global footprint by granting exclusive marketing and distribution rights for the Wand/STA Instrument to suppliers in various regions, including Asia, Africa, South America, and Europe[125]. - Milestone Scientific is transitioning from a research and development organization to a commercially focused medical device company following successful FDA clearances of its medical devices[123]. - The company has trained up to 25 exclusive product sales specialists to promote the Wand/STA instrument and handpieces in the U.S. market[123]. - The CompuFlo Epidural Trainer was introduced to the medical education market to improve epidural placement success, with distribution agreements signed with American 3B Scientific[133]. - The company is focused on expanding applications for its DPS Dynamic Pressure Sensing technology platform, aiming to establish it as the standard-of-care in drug delivery[123]. - The CompuFlo Epidural System has obtained FDA clearance, allowing the company to establish distribution in the U.S.[161]. - The company plans to restart the 510K application process for the intra-articular device later this year, subject to available internal resources[161]. Financing Activities - In April 2020, the company completed a Common Stock Offering generating gross proceeds of approximately $5.1 million, followed by a second offering in June 2020 generating approximately $14.6 million[159]. - The combined price of shares and warrants in the April offering was $0.95 per share, while in the June offering it was $2.15 per share[159]. - The company is actively pursuing positive cash flows through increased revenue from its dental and medical devices businesses, while considering other strategic plans[160].