OpGen Reports Third Quarter 2022 Financial Results and Provides Business Update
- Completes first two commercial customer installations for
Acuitas AMR Gene Panel OpGensubsidiary, Curetis, signed collaboration agreement with BioVersys AGand R&D collaboration agreement with FIND for the Unyvero A30 RQ platform
Yvonne Schlaeppias new, independent non-executive director to the board
- Management conference call scheduled for
November 10, 2022, at 4:30 p.m. EST
Third Quarter 2022 Financial Results of
- Total revenue for the third quarter of 2022 was approximately
$0.4 million, compared with approximately $1.2 millionin the third quarter of 2021. Total revenue for the nine months ended September 30, 2022was approximately $1.9 million, compared with approximately $2.9 millionfor the nine months ended September 30, 2021.
- Operating expenses for the third quarter of 2022 were approximately
$14.0 million, compared with approximately $6.3 millionin the third quarter of 2021. Operating expenses for the nine months ended September 30, 2022were approximately $26.5 million, compared with approximately $20.4 millionfor the nine months ended September 30, 2021.
- The net loss available to common stockholders for the third quarter of 2022 was approximately
$14.1 million, or $0.30per share, compared with approximately $6.1 million, or $0.16per share, in the third quarter of 2021. Net loss for the nine months ended September 30, 2022was approximately $26.7 million, compared with approximately $28.0 millionfor the nine months ended September 30, 2021.
- Cash and cash equivalents were approximately
$10.3 millionas of September 30, 2022, compared with $36.1 millionas of December 31, 2021.
In the third quarter and year to date, the Company reached the following key milestones:
OpGensubsidiary, Ares Genetics, signed a research collaboration agreement with the Belgian National Reference Center (BNRC) for invasive Streptococcus pneumoniae at the University Hospital Leuven. OpGensubsidiary, Ares Genetics, launched the ARESiss isolate sequencing service in the U.S. OpGencompleted enrollment of over 1,800 patient samples for the prospective multicenter clinical trial in the U.S.for the Unyvero UTI Panelon the Unyvero A50 platform. OpGensubsidiary, Curetis, signed an R&D collaboration agreement with FIND for the Unyvero A30 RQ platform. OpGensigned an additional commercial contract for the Acuitas AMR Gene Paneland initiated the first two customer sites in the U.S.with installations, trainings and delivery of Acuitas kits. OpGensubsidiary, Curetis, signed a collaboration agreement with BioVersys AGfrom Switzerlandto use the Unyvero platform in BioVersys’ upcoming Phase II clinical trial. OpGenreceived an update from Beijing Clear Biotech’s regulatory advisors about feedback from China’s NMPA regarding the Unyvero A50 pneumonia product and the need to resubmit our filing under a new electronic filing regime that NMPA has recently implemented.
- Nasdaq granted
OpGenan extension until February 27, 2023to meet Nasdaq’s minimum bid price requirement.
- This week,
OpGen'sboard elected Yvonne Schlaeppias a new, independent non-executive member of the Company’s board of directors. Ms. Schlaeppibrings legal, governance, life sciences and international experience to the board. Since 2011, Ms. Schlaeppihas served as a Managing Partner of Stratevise LLC, an international strategic advisory firm that she co-founded. Prior to founding Stratevise, Ms. Schlaeppiserved as General Counsel at Global Enterprise Technologies, Passport & ID, a high-security document printing solutions provider and systems integrator, from 2007 to 2011, and as Executive Vice President, General Counsel and Corporate IP Officer at Organon BioSciences, a global pharmaceutical, animal health and biotech group based in the Netherlands, from 2006 until its sale in 2007. Prior to that, Ms. Schlaeppiwas a partner at the Boston-based law firm of Palmer & Dodge LLP, where she served as Chairperson of that firm’s International Practice Group. Ms. Schlaeppihas been recognized by the National Association of Corporate Directorsas Directorship Certified®, has served on the board of directors of several public companies and currently is a member of the board of AstroNova, Inc.
In terms of guidance, the Company anticipates:
- The unblinding of data from the Unyvero UTI trial around year-end and subsequent FDA submission in 2023;
- To enter into new commercial contracts in the coming months across Unyvero and Acuitas products, which contracts could have the potential to drive revenue growth for 2023;
- Further developing ARES services and progressing strategic collaborations and partnerships with
U.S.key accounts and leading organizations; and
- Overall, 2022 revenue in a range of approximately
$2.5to $3 millionfrom products and services as well as collaboration business globally. OpGenwill be holding a special meeting of stockholders on November 30, 2022to vote on the proposal for a potential reverse stock split.
- The Company will continue to explore additional strategic and tactical equity and debt financing opportunities as well as potential strategic alternative options throughout the remainder of the year and into 2023 to possibly further strengthen its cash position.
Conference Call Information
OpGen’s management will host a conference call today,
|Conference Call Details
|International Dial-in Number:||1-201-389-0920|
Following the conclusion of the conference call, a replay will be available through
A replay of the webcast will be available following the conclusion of the call and will be archived on the Company’s website for 90 days. Replay access information is below:
|International Dial-in Number:||1-412-317-6671|
For more information, please visit www.opgen.com.
This press release includes statements regarding OpGen’s third quarter 2022 financial results and the current business of
|Consolidated Balance Sheets|
|Cash and cash equivalents||$||10,275,654||$||36,080,392|
|Accounts receivable, net||665,313||1,172,396|
|Prepaid expenses and other current assets||1,678,729||1,250,331|
|Total current assets||13,391,560||39,742,575|
|Property and equipment, net||3,054,990||4,011,748|
|Finance lease right-of-use assets, net||4,347||90,467|
|Operating lease right-of-use assets||1,472,934||1,814,396|
|Intangible assets, net||12,001,036||14,530,209|
|Strategic inventory, net||2,614,805||3,472,337|
|Other noncurrent assets||419,495||551,794|
|Liabilities and Stockholders’ Equity|
|Accrued compensation and benefits||1,391,145||1,621,788|
|Short-term notes payable||8,342,715||14,519,113|
|Short-term finance lease liabilities||6,748||43,150|
|Short-term operating lease liabilities||346,629||459,792|
|Total current liabilities||12,011,654||19,916,769|
|Long-term finance lease liabilities||1,121||3,644|
|Long-term operating lease liabilities||2,631,957||2,977,402|
|Other long term liabilities||121,496||146,798|
|Additional paid-in capital||277,406,700||275,708,490|
|Accumulated other comprehensive (loss)/income||(1,662,123||)||585,626|
|Total stockholders’ equity||13,938,311||41,217,080|
|Total liabilities and stockholders’ equity||$||32,959,167||$||71,666,533|
|Consolidated Statements of Operations and Comprehensive Loss|
|Three Months Ended
||Nine Months Ended
|Cost of products sold||1,886,191||648,298||2,824,577||1,544,932|
|Cost of services||17,239||203,314||63,450||446,232|
|Research and development, net||2,031,113||2,382,303||6,621,310||8,055,384|
|General and administrative||2,020,452||2,088,226||6,779,773||7,444,138|
|Sales and marketing||1,031,496||1,003,577||3,252,277||2,705,378|
|Impairment of right-of-use asset||—||—||—||170,714|
|Total operating expenses||13,962,011||6,325,718||26,516,907||20,366,778|
|Gain on extinguishment of debt||—||—||—||259,353|
|Warrant inducement expense||—||—||—||(7,755,541||)|
|Interest and other income, net||11,174||31,844||28,147||41,471|
|Foreign currency transaction gains||(51,547||)||229,074||419,160||655,774|
|Change in fair value of derivative financial instruments||18,995||(8,161||)||54,623||(122,572||)|
|Total other expense||(590,684||)||(970,110||)||(2,116,869||)||(10,507,533||)|
|Loss before income taxes||(14,103,982||)||(6,056,696||)||(26,748,113||)||(27,993,848||)|
|Provision for income taxes||—||—||—||—|
|Net loss available to common stockholders||$||(14,103,982||)||$||(6,056,696||)||$||(26,748,113||)||$||(27,993,848||)|
|Basic and diluted net loss per share attributable to common stockholders||$||(0.30||)||$||(0.16||)||$||(0.57||)||$||(0.79||)|
|Weighted average shares outstanding - basic and diluted||47,656,972||38,270,250||46,915,880||35,373,397|
|Other comprehensive loss - foreign currency translation||(536,758||)||(597,527||)||(2,247,749||)||(1,146,355||)|
President and CEO
OpGen Press Contact:
FischTank Marketing and PR
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Source: OpGen, Inc.