NEW YORK ─ OpGen announced after the close of the market on Thursday a 38 percent year-over-year drop in revenues for the first quarter of 2020.
For the three months ended March 31, OpGen's revenues fell to $617,000 from $1 million in Q1 2019, in line with preliminary revenues reported in April.
The decrease can be attributed to a drop in revenues for its Acuitas AMR Gene Panel and Acuitas Lighthouse revenue, which was approximately $254,000, the firm said. Further, revenues from the company’s rapid FISH products decreased to $363,000, OpGen said.
OpGen noted that its Q1 revenues excluded revenue from Curetis, which it acquired on April 1.
Revenue from Curetis and Ares, OpGen’s wholly owned subsidiaries, was approximately $900,000 for the first quarter, generating pro forma combined unaudited revenue of over $1.5 million, the firm said.
The company logged $366,933 in Q1 product revenue, down 29 percent from $520,177 in Q1 2019. It reported $250,000 in collaboration revenue, down 50 percent from $500,000 a year earlier.
OpGen President and CEO Oliver Schacht said in a statement that OpGen with its subsidiaries "boasts a strong proprietary product portfolio that is extremely agile, flexible, and has elements in place to rapidly identity, develop, and create potential offerings needed to address future infectious disease outbreaks."
Curetis, Ares Genetics, and BGI announced a partnership associated with BGI’s CoV-2 test kit commercialization in Europe, and Curetis began selling the BGI CoV-2 product through its distribution network in Europe, the Middle East, and Africa during Q1 2020.
Schacht said the firm expects its CoV-2 rapid PCR test kit sales in Europe to continue contributing positively to its top-line revenue in Q2 of 2020. Since mid-March 2020, he said, the firm has sold approximately 15,000 CoV-2 tests into its distribution network.
"There are challenges and opportunities from the COVID test kit business," Schacht said on a conference call to discuss the firm's financial results. "We're seeing it making a larger positive impact in the second quarter so far compared to Q1.
Test kits were "extremely hard to come by" because of supply shortages early in March but supply "substantially improved over the month of April and into May," he said.
OpGen is developing its own molecular coronavirus test kit, Schacht said, that it believes will have advantages over others from the standpoint of turnaround times and costs of goods. The test, which the firm anticipates clinically validating in a few weeks, has a proprietary buffer that enables "going straight from the swab specimen to PCR, eliminating the need for RNA preparation," he said.
Removing that step helps the firm circumvent shortages in RNA prep kits, shortens the test turnaround time by about 30 minutes, and reduces the price by $4 to $5 per test. Schacht added that most RT-PCR tests for the coronavirus in Europe are reimbursed by national healthcare systems in the €30 ($32) to €50 range.
He noted that OpGen recently announced a collaboration with Sweden’s Karolinska Institute to test COVID-19 pneumonia patients with the company's Unyvero HPN panel for bacterial co-infections.
OpGen said that clinical trials were initiated during the first quarter of 2020 at nine participating sites for its Acuitas AMR Gene Panel, a urine-based test to identify drug-resistant pathogens. The trial, however, has been suspended due to hospital actions to focus resources on the COVID-19 pandemic.
Further, Acuitas Lighthouse, its cloud-based software to identify, track, and predict antibiotic-resistant infections based on genetic information, was utilized in a research study conducted by the Mayo Clinic to predict phenotypic resistance and antimicrobial susceptibility among clinical isolates.
OpGen said it expects that a submission to the US Food and Drug Administration for clearance of its Acuitas AMR Gene Panel for the detection of antimicrobial resistance genes in bacterial isolates is nearing completion. The firm said it has responded, and is continuing to respond, to the FDA’s additional information requests and now anticipates a clearance decision for the Acuitas AMR Gene Panel for isolates.
"The ball is in the court of the FDA," Schacht said. "We do expect the agency to come back with feedback on some of our earlier responses." However, a fully integrated commercial team from Curetis USA and OpGen is ready to market the test when it launches, he added.
The company also said that it has achieved the last of the first-year milestones in a collaboration with the New York State Department of Health and ILÚM Health Solutions to develop a research program to detect, track, and manage antimicrobial-resistant infections at healthcare institutions statewide.
The firm reported a Q1 net loss of $3.9 million, or $0.53 per share, compared to a net loss of $3.9 million, or $8.25 per share, in the same quarter a year ago. OpGen's Q1 2020 loss per share was calculated using approximately 7.4 million weighted average shares, while its Q1 2019 loss per share was calculated using 467,286 shares.
In October, OpGen raised $9.4 million in a public offering of its stock and warrants to purchase stock.
First quarter R&D expenses fell 33 percent to $1.2 million from $1.8 million, while SG&A costs dropped 5 percent to $2 million from $2.1 million.
At the end of Q1, OpGen had $11.5 million in cash and cash equivalents.