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MarketScreener Homepage  >  Equities  >  Nasdaq  >  OpGen, Inc.    OPGN

OPGEN, INC.

(OPGN)
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OPGEN : Management's Discussion and Analysis of Financial Condition and Results of Operations (form 10-K)

03/24/2020 | 05:07am EST

The following Management's Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with our audited consolidated financial statements and the accompanying notes thereto included elsewhere in this Annual Report. This discussion contains forward-looking statements, based on current expectations and related to future events and our future financial performance, that involve risks and uncertainties. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of many important factors, including those set forth in the section titled "Risk Factors" included under Part I, Item 1A of this Annual Report.

Overview

OpGen was incorporated in Delaware in 2001. On July 14, 2015, OpGen completed the Merger with AdvanDx. Pursuant to the terms of a Merger Agreement, Velox Acquisition Corp., OpGen's wholly-owned subsidiary formed for the express purpose of effecting the Merger, merged with and into AdvanDx with AdvanDx surviving as OpGen's wholly-owned subsidiary. OpGen and AdvanDx are collectively referred to hereinafter as the "Company." The Company's headquarters and principal operations are in Gaithersburg, Maryland. The Company also has operations in Copenhagen, Denmark, and Bogota, Colombia. The Company operates in one business segment.

OpGen is a precision medicine company using molecular diagnostics and informatics to help combat infectious disease. The Company is developing molecular information products and services for global healthcare settings, helping to guide clinicians with more rapid and actionable information about life threatening infections, improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. The Company's proprietary DNA tests and informatics address the rising threat of antibiotic resistance by helping physicians and other healthcare providers optimize care decisions for patients with acute infections.

The Company's molecular diagnostics and informatics products, product candidates and services combine its Acuitas molecular diagnostics and Acuitas Lighthouse informatics platform for use with its proprietary, curated MDRO knowledgebase. The Company is working to deliver products and services, some in development, to a global network of customers and partners.

      •     The Company's molecular diagnostic tests provide rapid microbial
            identification and antibiotic resistance gene information. These
            products include its Acuitas antimicrobial resistance, or AMR, Gene
            Panel (Urine) test in development for patients at risk for complicated
            urinary tract infections, or cUTI, its Acuitas AMR Gene Panel
            (Isolates) test in development for testing bacterial isolates, and its
            QuickFISH and PNA FISH FDA-cleared and CE-marked diagnostics used to
            rapidly detect pathogens in positive blood cultures. Each of its
            Acuitas AMR Gene Panel tests is available for sale for research use
            only, or RUO.


      •     The Company's Acuitas Lighthouse informatics systems are cloud-based
            HIPAA compliant informatics offerings that combine clinical lab test
            results with patient and hospital information to provide analytics and
            actionable insights to help manage MDROs in the hospital and patient
            care environment. Components of the informatics systems include the
            Acuitas Lighthouse Knowledgebase and the Acuitas Lighthouse Software.
            The Acuitas Lighthouse Knowledgebase is a relational database
            management system and a proprietary data warehouse of genomic data
            matched with antibiotic susceptibility information for bacterial
            pathogens. The Acuitas Lighthouse Software system includes the Acuitas
            Lighthouse Portal, a suite of web applications and dashboards, the
            Acuitas Lighthouse Prediction Engine, which is a data analysis
            software, and other supporting software components. The Acuitas
            Lighthouse Software can be customized and made specific to a
            healthcare facility or collaborator, such as a pharmaceutical company.
            The Acuitas Lighthouse Software is not distributed commercially for
            antibiotic resistance prediction and is not for use in diagnostic
            procedures.

In July 2019, it received an Additional Information, or AI, Request from the FDA detailing a number of questions related to the submission. At the time, questions from the FDA focused on the intended use of the test including the correlation between marker detection and antibiotic resistance, the level of evidence to support resistance marker/organism claims, whole genome sequencing, or WGS, test validation and use as a comparator method, clinical performance of the test compared to WGS and further analysis of individual study results, in silico analysis to support test evaluations, further analysis of analytical study results, additional information regarding instrumentation for use with the test, and test reporting and labeling. On January 6, 2020, OpGen filed a formal response to the FDA'sJuly 2019 AI Request. Subsequently, the FDA issued a second AI Request on January 17, 2020 to formalize additional questions and remaining requests for information from the earlier July 2019 AI Request. The issuance of the January 2020 AI letter effectively placed the Acuitas AMR Gene Panel (Isolates) 510(k) submission on hold until OpGen provided a formal response to the questions posed or a 180-day hold period ends, after which the Acuitas AMR Gene Panel (Isolates) 510(k) submission may be considered withdrawn and a second submission required. OpGen is continuing to work interactively with the FDA to finalize its formal response to the January 2020 AI letter to provide the required responses as well as answering additional questions that arose through this second interactive response review process. OpGen is continuing to work with the FDA to address additional questions that have arisen during the interactive review process. The FDA shared with OpGen a working plan to complete the FDA's review of


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the Acuitas AMR Gene Panel (Isolates) 510(k) submission. However, we anticipate delays to the planned timeline as a result of the ongoing coronavirus pandemic. Consequently, the anticipated timeline for the remainder of the second interactive response review, and ultimately the clearance of the Acuitas AMR Gene Panel (Isolates) diagnostic test is currently unknown, although we anticipate that the extensive review process is nearing completion.

The Company's operations are subject to certain risks and uncertainties. The risks include rapid technology changes, the need to manage growth, the need to retain key personnel, the need to protect intellectual property and the need to raise additional capital financing on terms acceptable to the Company. The Company's success depends, in part, on its ability to develop and commercialize its proprietary technology as well as raise additional capital.

Following receipt of approval from stockholders at a special meeting of stockholders held on August 22, 2019, the Company filed an amendment to its Amended and Restated Certificate of Incorporation to effect a reverse stock split of the issued and outstanding shares of common stock, at a ratio of one share for twenty shares. All share amounts and per share prices in this Annual Report have been adjusted to reflect the reverse stock split.

2019 Financing Transactions

Since inception, the Company has incurred, and continues to incur, significant losses from operations. The Company has funded its operations primarily through external investor financing arrangements. The following financing transactions took place during 2019:

   •  On October 28, 2019, the Company closed the October 2019 Public Offering of
      2,590,170 units at $2.00 per unit and 2,109,830 pre-funded units at $1.99
      per pre-funded unit, raising gross proceeds of approximately $9.4 million
      and net proceeds of approximately $8.3 million. Each unit included one share
      of common stock and one common warrant to purchase one share of common stock
      at an exercise price of $2.00 per share. Each pre-funded unit included one
      pre-funded warrant to purchase one share of common stock for an exercise
      price of $0.01 per share, and one common warrant to purchase one share of
      common stock at an exercise price of $2.00 per share. The common warrants
      are exercisable immediately and have a five-year term from the date of
      issuance. As of December 31, 2019, all 2,109,830 pre-funded warrants issued
      in the October 2019 Public Offering have been exercised.


   •  On March 29, 2019, the Company closed the March 2019 Public Offering of
      450,000 shares of its common stock at a public offering price of $12.00 per
      share. The offering raised gross proceeds of $5.4 million and net proceeds
      of approximately $4.8 million.





Results of Operations for the Years Ended December 31, 2019 and 2018

Revenues



                                          Years Ended December 31,
                                            2019             2018
                Revenue
                Product sales           $   2,168,179$ 2,395,626
                Laboratory services             5,435          34,665
                Collaboration revenue       1,325,000         516,016
                Total revenue           $   3,498,614$ 2,946,307

Our total revenue for the year ended December 31, 2019 increased 19%, to $3.5 million from $2.9 million, when compared to the same period in 2018. This increase is primarily attributable to:

   •  Product Sales: the decrease in revenue of 9% in 2019 as compared to 2018 is
      primarily attributable to a reduction in the sale of our rapid pathogen ID
      testing products (QuickFISH and PNA FISH);


   •  Laboratory Services: the decrease in revenue of 84% in 2019 as compared to
      2018 is a result of decreases in sales of our Acuitas test products; and


   •  Collaboration Revenue: the increase in collaboration revenue of 157% in 2019
      as compared to 2018 is primarily the result of increased Acuitas revenue
      associated with our NYSDOH contract.


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Operating expenses



                                                Years Ended December 31,
                                                  2019             2018
           Cost of products sold              $    911,565$  1,222,919
           Cost of services                        720,156          625,516
           Research and development              5,121,168        5,677,243
           General and administrative            6,252,442        7,069,315
           Sales and marketing                   1,464,721        1,531,556
           Transaction costs                       779,048                -
           Impairment of right-of-use asset        520,759                -
           Total operating expenses           $ 15,769,859$ 16,126,549

The Company's total operating expenses for the year ended December 31, 2019 decreased 2%, to $15.8 million from $16.1 million, when compared to the same period in 2018. This decrease is primarily attributable to:

   •  Costs of products sold: expenses for the year ended December 31, 2019
      decreased approximately 25% when compared to the same period in 2018. The
      change in costs of products sold is primarily attributable to a reduction in
      the sale of our rapid pathogen ID testing products;


   •  Costs of services: expenses for the year ended December 31, 2019 increased
      approximately 15% when compared to the same period in 2018. The change in
      costs of services is primarily attributable to increased costs of services
      associated with our NYSDOH contract;


   •  Research and development: expenses for the year ended December 31, 2019
      decreased approximately 10% when compared to the same period in 2018,
      primarily due to a decrease in expenses related to our 510(k) submission for
      the Acuitas AMR Gene Panel for use with bacterial isolates;


   •  General and administrative: expenses for the year ended December 31, 2019
      decreased approximately 12% when compared to the same period in 2018,
      primarily due to decreased payroll and outside service costs; and


   •  Sales and marketing: expenses for the year ended December 31, 2019 decreased
      approximately 4% when compared to the same period in 2018, primarily due to
      reduced marketing related costs.






Other income (expense)



                                                        Years Ended December 31,
                                                        2019                 2018
Interest expense                                   $      (187,549 )$     (191,195 )
Foreign currency transaction gains/(losses)                  2,410             (10,431 )
Change in fair value of derivative financial
instruments                                                     67               8,386
Interest and other income                                    9,859               5,384
Total other expense                                $      (175,213 )$     (187,856 )

Other expense for the year ended December 31, 2019 decreased to a net expense of $175,213 from a net expense of $187,856 in the same period of 2018. The decrease was primarily a result of a decrease in foreign currency losses and interest income recognized in 2019.

Liquidity and capital resources

At December 31, 2019, the Company had cash and cash equivalents of $2.7 million, compared to $4.6 million at December 31, 2018. The Company has funded its operations primarily through external investor financing arrangements and has raised significant funds in 2019 and 2018, including:

On October 28, 2019, the Company closed the October 2019 Public Offering of 2,590,170 units at $2.00 per unit and 2,109,830 pre-funded units at $1.99 per pre-funded unit. The offering raised gross proceeds of approximately $9.4 million and net proceeds of approximately $8.3 million.

On March 29, 2019, the Company closed the March 2019 Public Offering of 450,000 shares of its common stock at a public offering price of $12.00 per share. The offering raised gross proceeds of $5.4 million and net proceeds of approximately $4.8 million.




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On October 22, 2018, the Company closed its October 2018 Public Offering of 110,000 shares of its common stock at a public offering price of $1.45 per share. The offering raised gross proceeds of approximately $3.2 million and net proceeds of approximately $2.8 million.

On June 11, 2018, the Company executed an Allonge to its Second Amended and Restated Senior Secured Promissory Note, dated June 28, 2017, with a principal amount of $1,000,000 issued to MGHIF The Allonge provided that accrued and unpaid interest of $285,512 due as of July 14, 2018, the original maturity date, will be paid through the issuance of shares of OpGen's common stock in a private placement transaction. In addition, the Allonge revised and extended the maturity date for payment of the Note to six semi-annual payments of $166,667 plus accrued and unpaid interest beginning on January 2, 2019 and ending on July 1, 2021. On July 30, 2018, the Company issued 7,212 shares of common stock to MGHIF in a private placement transaction for $285,512 of accrued and unpaid interest due as of July 14, 2018 under the MGHIF Note.

On February 6, 2018, the Company closed its February 2018 Public Offering of 2,841,152 units at $3.25 per unit, and 851,155 pre-funded units at $3.24 per pre-funded unit, raising gross proceeds of approximately $12 million and net proceeds of approximately $10.7 million. Each unit included one twentieth of a share of common stock and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. Each pre-funded unit included one pre-funded warrant to purchase one twentieth of a share of common stock for an exercise price of $0.20 per share, and one common warrant to purchase one fortieth of a share of common stock at an exercise price of $65.00 per share. The common warrants are exercisable immediately and have a five-year term from the date of issuance.

During the year ended December 31, 2018, the Company sold 15,912 shares of its common stock under its at the market offering resulting in aggregate net proceeds to the Company of approximately $0.6 million, and gross proceeds of $0.6 million. In connection with the October 2018 Public Offering, the Company terminated the at the market offering.

Sources and uses of cash


The following table summarizes the net cash flows provided by (used in)
operating activities, investing activities and financing activities for the
periods indicated:



                                                    Years Ended December 31,
                                                     2019              2018
     Net cash used in operating activities       $ (11,505,439 )$ (11,073,997 )
     Net cash used in investing activities          (2,502,576 )        (137,327 )
     Net cash provided by financing activities      12,168,146        13,845,102



Net cash used in operating activities

Net cash used in operating activities in 2019 consists primarily of our net loss of $12.4 million, reduced by certain non-cash items, including depreciation and amortization expense of $0.9 million, share-based compensation of $0.4 million, partially offset by the net change in operating assets and liabilities of $0.9 million. Net cash used in operating activities for 2018 consists primarily of our net loss of $13.4 million, reduced by certain non-cash items, including depreciation and amortization expense of $0.7 million, share-based compensation expense of $0.9 million, and the net change in operating assets and liabilities of $0.6 million.

Net cash used in investing activities

Net cash used in investing activities in 2019 consisted primarily of funds provided to Curetis GmbH as part of the interim facility. Net cash used in investing activities in 2018 consisted of the purchase of property and equipment offset by proceeds from the sale of equipment.

Net cash provided by financing activities

Net cash provided by financing activities in 2019 of $12.2 million consisted primarily of net proceeds from the October 2019 Public Offering and March 2019 Public Offering. Net cash provided by financing activities in 2018 of $13.8 million consisted primarily of net proceeds from the October 2018 Public Offering, February 2018 Public Offering and the at the market offering.


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Critical accounting policies and use of estimates

This Management's Discussion and Analysis of Financial Condition and Results of Operations is based on our audited consolidated financial statements, which have been prepared in accordance with GAAP. The preparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. In our audited consolidated financial statements, estimates are used for, but not limited to, liquidity assumptions, revenue recognition, stock-based compensation, allowances for doubtful accounts and inventory obsolescence, and valuation of derivative financial instruments measured at fair value on a recurring basis, deferred tax assets and liabilities and related valuation allowance, estimated useful lives of long-lived assets, and the recoverability of long lived assets. Actual results could differ from those estimates.

A summary of our significant accounting policies is included in Note 3 to the accompanying audited consolidated financial statements. Certain of our accounting policies are considered critical, as these policies require significant, difficult or complex judgments by management, often requiring the use of estimates about the effects of matters that are inherently uncertain.

Revenue Recognition

The Company derives revenues from (i) the sale of QuickFISH and PNA FISH diagnostic test products and Acuitas AMR Gene Panel (Urine) RUO test products, (ii) providing laboratory services, and (iii) providing collaboration services including funded software arrangements, and license arrangements.

The Company analyzes contracts to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers, (ii) identification of distinct performance obligations in the contract, (iii) determination of contract transaction price, (iv) allocation of contract transaction price to the performance obligations and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation.

The Company recognizes revenues upon the satisfaction of its performance obligation (upon transfer of control of promised goods or services to our customers) in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services.

The Company defers incremental costs of obtaining a customer contract and amortizes the deferred costs over the period that the goods and services are transferred to the customer. The Company had no material incremental costs to obtain customer contracts in any period presented.

Deferred revenue results from amounts billed in advance to customers or cash received from customers in advance of services being provided.

Impairment of Long-Lived Assets

Property and equipment is reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison of the carrying amount of an asset to future undiscounted net cash flows expected to be generated by the asset. Recoverability measurement and estimating of undiscounted cash flows is done at the lowest possible level for which we can identify assets. If such assets are considered to be impaired, impairment is recognized as the amount by which the carrying amount of assets exceeds the fair value of the assets.

Definite-lived intangible assets include trademarks, developed technology and customer relationships. If any indicators were present, the Company would test for recoverability by comparing the carrying amount of the asset to the net undiscounted cash flows expected to be generated from the asset. If those net undiscounted cash flows do not exceed the carrying amount (i.e., the asset is not recoverable), the Company would perform the next step, which is to determine the fair value of the asset and record an impairment loss, if any.

Goodwill represents the excess of the purchase price for AdvanDx over the fair values of the acquired tangible or intangible assets and assumed liabilities. The Company will conduct an impairment test of goodwill on an annual basis as of December 31 of each year, and will also conduct tests if events occur or circumstances change that would, more likely than not, reduce the Company's fair value below its net equity value.

Share-Based Compensation

Share-based payments to employees, directors and consultants are recognized at fair value. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the option. The estimated fair value of equity


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instruments issued to nonemployees is recorded at fair value on the earlier of the performance commitment date or the date the services required are completed.

For all time-vesting awards granted, expense is amortized using the straight-line attribution method. For awards that contain a performance condition, expense is amortized using the accelerated attribution method. Share-based compensation expense recognized is based on the value of the portion of stock-based awards that is ultimately expected to vest during the period. The fair value of share-based payments is estimated, on the date of grant, using the Black-Scholes model. Option valuation models, including the Black-Scholes model, require the input of highly subjective estimates and assumptions, and changes in those estimates and assumptions can materially affect the grant-date fair value of an award. These assumptions include the fair value of the underlying and the expected life of the award.

See additional discussion of the use of estimates relating to share-based compensation, and a discussion of management's methodology for developing each of the assumptions used in such estimates, in Note 3 to the accompanying consolidated financial statements.

Recent accounting pronouncements

On January 1, 2018, the Company adopted Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") 2014-09, Revenue from Contracts with Customers ("ASC 606"), using the modified retrospective method. In adopting the guidance, the Company applied the guidance to all contracts and used available practical expedients including assessing contracts with similar terms and conditions on a "portfolio" basis. The adoption of this new guidance did not have a material impact on the Company's consolidated financial statements. Prior period amounts have not been adjusted in connection with the adoption of this standard.

On January 1, 2018, the Company adopted ASU 2016-18, Statement of Cash Flows: Restricted Cash, using a retrospective transition method and applied to the periods presented on the condensed consolidated statements of cash flows. Restricted cash includes cash and cash equivalents that is restricted through legal contracts, regulations or the Company's intention to use the cash for a specific purpose. The Company's restricted cash primarily related to funds held as collateral for letters of credit.

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) ("ASC 842"), which amended the existing accounting standards for leases. The new standard requires lessees to record a right-of-use ("ROU") asset and a corresponding lease liability on the balance sheet (with the exception of short-term leases), whereas under previous accounting standards, the Company's lease portfolio consisting of operating leases were not recognized on its consolidated balance sheets. The new standard required expanded disclosures regarding leasing arrangements. The new standard was effective for the Company beginning January 1, 2019.

The Company adopted this guidance effective January 1, 2019 using the modified retrospective transition method and the following practical expedients:



   •  The Company did not reassess if any expired or existing contracts are or
      contain leases.


   •  The Company did not reassess the classification of any expired or existing
      leases.



Additionally, the Company made ongoing accounting policy elections whereby the Company (i) does not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12 months or less) and (ii) combines lease and non-lease elements of our operating leases.

Upon adoption of the new guidance on January 1, 2019, the Company recorded an operating lease right of use asset of approximately $2.2 million (net of existing deferred rent) and recognized a lease liability of approximately $2.5 million.

Prior to the adoption of ASC 842, deferred rent was recorded and amortized to the extent the total minimum rental payments allocated to the period on a straight-line basis exceeded or were less than the cash payments required.

In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments ("ASU 2016-13"). ASU 2016-13 requires an entity to measure and recognize expected credit losses for certain financial instruments, including trade receivables, as an allowance that reflects the entity's current estimate of credit losses expected to be incurred. For available-for-sale debt securities with unrealized losses, the standard requires allowances to be recorded through net income instead of directly reducing the amortized cost of the investment under the current other-than-temporary impairment model. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. The Company does not expect the adoption of this standard to have a significant impact on its consolidated financial statements.


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The Company has evaluated all other issued and unadopted ASUs and believes the adoption of these standards will not have a material impact on its results of operations, financial position or cash flows.

Off-Balance Sheet Arrangements

As of December 31, 2019 and 2018, the Company did not have any off-balance sheet arrangements.

JOBS Act

On April 5, 2012, the JOBS Act was enacted. Section 107 of the JOBS Act provides that an "emerging growth company" can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an "emerging growth company" can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The Company has elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This election allows it to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of this election, the Company's financial statements may not be comparable to companies that comply with public company effective dates.

Subject to certain conditions set forth in the JOBS Act, as an "emerging growth company," the Company intends to rely on certain of these exemptions, including without limitation, (i) providing an auditor's attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act of 2002 and (ii) complying with any requirement that may be adopted by the PCAOB regarding mandatory audit firm rotation or a supplement to the auditor's report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. The Company will remain an "emerging growth company" until the earliest of (i) the last day of the fiscal year in which it has total annual gross revenues of $1.07 billion or more? (ii) December 31, 2019? (iii) the date on which the Company has issued more than $1 billion in nonconvertible debt during the previous three years? or (iv) the date on which the Company is deemed to be a large accelerated filer under the rules of the SEC.

© Edgar Online, source Glimpses

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