OpGen(US:OPGN)2019-11-07 03:36Financial Data and Key Metrics Changes - Total revenue for the first nine months of 2019 increased by 22% to $2.7 million compared to $2.2 million in 2018 [7] - Third quarter revenue was $648,000, a 17% increase from $552,000 in the prior year period [7] - Net loss for the third quarter of 2019 was $3.5 million, or $3.95 per share, compared to a net loss of $3.3 million, or $10.67 per share in the third quarter of 2018 [20] - Total operating expenses for the nine months ended September 30, 2019, were $12.4 million, up from $11.7 million in the same period of 2018 [21] Business Line Data and Key Metrics Changes - Revenue from RUO Acuitas AMR Gene Panel and Acuitas Lighthouse related products represented 43% of total revenue, amounting to $1.2 million, up from less than 5% in the comparable 2018 period [18] - R&D expenses for the first nine months of 2019 were $4.1 million, up from $3.8 million in 2018 [22] - G&A expenses were $4.9 million, down from $5.4 million in 2018 [22] Market Data and Key Metrics Changes - Curetis has a portfolio of five CE marked in vitro diagnostic products marketed through distribution partners in Europe, the Middle East, and some Asian markets [9] - The combined company is expected to have a pro forma 2019 revenue in the range of $5 million to $6 million, with anticipated growth to $10 million to $15 million in 2020 [27] Company Strategy and Development Direction - The strategic focus includes gaining regulatory clearances, establishing market positions for proprietary molecular diagnostic testing platforms, and leveraging global commercial capabilities [13] - The combination with Curetis aims to create a market leader in infectious disease and antimicrobial resistance detection, enhancing operational efficiencies and financial discipline [34][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the completion of the business combination with Curetis, expecting it to close by late January or early February 2020 [26] - The company is committed to improving shareholder value and capturing financial synergies associated with the merger [31][32] Other Important Information - The company closed the public offering of 4.7 million units at $2 per unit, raising gross proceeds of $9.4 million [23] - The company regained compliance with NASDAQ's shareholder equity requirement and minimum bid price rule [24] Q&A Session Summary Question: Timing for commercialization of Acuitas AMR Gene Panel after 510(k) clearance - Management indicated that commercialization would likely start one to two months after clearance, aligning with the merger with Curetis [46] Question: Timeframe for completion of clinical studies for urine panel - Management expects to complete the urine trial phases by early 2020 [48] Question: Financial runway for the combined company post-merger - The combined company is expected to have a financial runway reaching into Q2 of the following year [54] Question: Conditions for closing the transaction with Acuitas - Key conditions include completing financing and gaining shareholder approvals, with optimism for successful closure [55][56] Question: Expected R&D spending trends - R&D spending is expected to increase modestly in Q4 and ramp up significantly in Q1 of the following year [66]