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Description of Business, Basis of Presentation and Principles of Consolidation
9 Months Ended
Sep. 30, 2019
Accounting Policies [Abstract]  
Description of Business, Basis of Presentation and Principles of Consolidation

Note 1. Description of Business, Basis of Presentation and Principles of Consolidation

HTG Molecular Diagnostics, Inc. (the “Company”) is a provider of instruments, reagents and services for RNA-based molecular profiling applications. The Company derives revenue from sales of its HTG EdgeSeq instrument system and integrated research use only (“RUO”) and molecular diagnostic (“MDx”) next-generation sequencing-based (“NGS-based”) HTG EdgeSeq assays, from research services including sample processing and custom assay development and from collaborative development services.

 

The Company operates in one segment and its customers are located primarily in the United States and Europe. For the three and nine months ended September 30, 2019 approximately 29% and 31%, respectively, of the Company’s revenue was generated from sales originated by customers located outside of the United States, compared with 79% and 77% for the three and nine months ended September 30, 2018, respectively. Sales to customers located outside of the United States resulted primarily from collaborative development services revenue generated from the Master Assay Development, Commercialization and Manufacturing Agreement (the “Governing Agreement”) with QIAGEN Manchester Limited (“QML”) (see Note 9), which accounted for 70% and 68% of sales to customers located outside of the United States for the three and nine months ended September 30, 2019, respectively, compared to 92% and 82% for the three and nine months ended September 30, 2018, respectively.

Basis of Presentation

The accompanying condensed consolidated financial statements have been prepared by the Company pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and reflect the accounts of the Company as of September 30, 2019 and for the three and nine months ended September 30, 2019 and 2018. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America (“US GAAP”) for complete financial statements. The accompanying condensed consolidated financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and the results of its operations and cash flows, as of and for the periods presented. The accompanying condensed consolidated balance sheets at December 31, 2018 have been derived from the audited consolidated financial statements at that date but do not include all of the information and disclosures required by US GAAP for annual financial statements. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the full year. These condensed consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements and notes thereto for the year ended December 31, 2018, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 7, 2019.

 

Reclassifications

Certain prior year amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations.

Liquidity

In September 2019, the Company successfully completed an underwritten public offering of 29,298,537 shares of its common stock, including 3,821,548 shares sold pursuant to the full exercise of the underwriter’s option to purchase additional shares, at a price of $0.65 per share (see Note 13). The aggregate net proceeds from the offering were approximately $17.6 million, after deducting underwriting discounts and commissions and offering expenses. In addition, the Company sold, in a concurrent private placement transaction an aggregate of 5,411,687 pre-funded warrants, exercisable for up to an aggregate of 5,411,687 shares of common stock, for aggregate net proceeds of approximately $3.1 million, after deducting the placement agent fee and offering expenses.

 

The Company believes that its existing resources will be sufficient to fund its planned operations and expenditures for at least the next 12 months from the issuance of these condensed consolidated financial statements. However, the Company will need to raise additional capital to fund its operations and service its near and long-term debt obligations until its revenue reaches a level sufficient to provide for self-sustaining cash flows. There can be no assurance that additional capital will be available on acceptable terms, or at all, or that the Company’s revenue will reach a level sufficient to provide for self-sustaining cash flows. If sufficient additional capital is not available as and when needed, the Company may have to delay, scale back or discontinue one or more product development programs, curtail its commercialization activities, significantly reduce expenses, sell assets (potentially at a discount to their fair value or carrying value), enter into relationships with third parties to develop or commercialize products or technologies that the Company otherwise would have sought to develop or commercialize independently, cease operations altogether, pursue a sale of the Company at a price that may result in up to a total loss on investment for its stockholders, file for bankruptcy or seek other protection from creditors, or liquidate all assets. In addition, if the Company defaults under its term loan agreement, its lenders could foreclose on its assets, including substantially all of its cash and cash equivalents which are held in accounts with its lenders.  

Principles of Consolidation

The Company formed a French subsidiary, HTG Molecular Diagnostics France SARL (“HTG France”), in November 2018. The accompanying condensed consolidated financial statements include the accounts of the Company and this wholly owned subsidiary after elimination of all intercompany transactions.

Concentration Risks

Financial instruments that potentially subject the Company to credit risk consist principally of cash and cash equivalents, restricted cash, available-for-sale debt securities and uncollateralized accounts receivable. The Company maintains the majority of its cash and restricted cash balances in the form of cash deposits in bank checking and money market accounts in amounts in excess of federally insured limits. Management believes, based upon the quality of the financial institution, that the credit risk with regard to these deposits is not significant.

 

The Company sells its instrument, related consumables, sample processing services, custom RUO assay design and collaborative development services primarily to biopharmaceutical companies, academic institutions and molecular labs. The Company routinely assesses the financial strength of its customers and credit losses have been minimal to date.

 

The Company’s top two customers accounted for 39% and 20% of the Company’s total revenue for the three months ended September 30, 2019, compared with the Company’s top two customers accounting for 72% and 10% of the Company’s total revenue for the three months ended September 30, 2018. The top three customers accounted for 23%, 22% and 21% of the Company’s total revenue for the nine months ended September 30, 2019 compared to the Company’s top two customers which accounted for 63% and 10% for the nine months ended September 30, 2018.

 

The Company’s top two customers accounted for approximately 43% and 30% of the Company’s accounts receivable as of September 30, 2019. The Company’s top four customers accounted for approximately 44%, 27% and two customers accounting for 11% each as of December 31, 2018.

 

The Company currently relies on a single supplier to supply a subcomponent used in the HTG EdgeSeq processors. A loss of this supplier could significantly delay the delivery of processors, which in turn could materially affect the Company’s ability to generate revenue.