Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 08, 2019 | |
Document and Entity Information | ||
Entity Registrant Name | ROCKWELL MEDICAL, INC. | |
Entity Central Index Key | 0001041024 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2019 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 63,824,584 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
ASSETS | ||
Cash and Cash Equivalents | $ 21,417,159 | $ 22,713,980 |
Investments Available-for -Sale | 13,816,079 | 10,818,059 |
Accounts Receivable, net of a reserve of $27,351 in 2019 and $2,104 in 2018 | 5,388,858 | 6,979,514 |
Insurance Receivable | 371,217 | |
Inventory | 3,972,637 | 4,038,778 |
Prepaid and Other Current Assets | 3,667,605 | 1,903,682 |
Total Current Assets | 48,262,338 | 46,825,230 |
Property and Equipment, net | 2,563,428 | 2,638,293 |
Inventory, Non-Current | 1,445,000 | 1,637,000 |
Right of Use Assets, net | 3,329,481 | |
Goodwill | 920,745 | 920,745 |
Other Non-current Assets | 555,222 | 536,516 |
Total Assets | 57,076,214 | 52,557,784 |
LIABILITIES AND SHAREHOLDERS' EQUITY | ||
Accounts Payable | 4,065,302 | 4,492,071 |
Accrued Liabilities | 4,071,341 | 5,129,761 |
Settlement Payable | 430,000 | 416,668 |
Lease Liability - Current | 1,637,481 | |
Deferred License Revenue - Current | 2,243,256 | 2,252,868 |
Insurance Financing Note Payable | 1,908,554 | |
Customer Deposits | 128,654 | 63,143 |
Other Current Liability - Related Party | 350,000 | 850,000 |
Total Current Liabilities | 14,834,588 | 13,204,511 |
Lease Liability - Long-Term | 1,690,310 | |
Deferred License Revenue - Long-Term | 10,959,577 | 12,076,399 |
Total Liabilities | 27,484,475 | 25,280,910 |
Commitments and Contingencies (See Note 15) | ||
Shareholders' Equity: | ||
Preferred Shares, no par value, no shares issued and outstanding at March 31, 2019 and December 31, 2018 | ||
Common Shares, no par value, 63,3698,704 and 57,034,154 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 320,882,946 | 299,601,960 |
Accumulated Deficit | (291,358,764) | (272,388,234) |
Accumulated Other Comprehensive Income | 67,557 | 63,148 |
Total Shareholders' Equity | 29,591,739 | 27,276,874 |
Total Liabilities And Shareholders' Equity | $ 57,076,214 | $ 52,557,784 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - shares | Jun. 30, 2019 | Apr. 30, 2019 | Dec. 31, 2018 |
CONDENSED CONSOLIDATED BALANCE SHEETS | |||
Preferred Shares, shares issued | 0 | 0 | |
Preferred Shares, shares outstanding | 0 | 0 | |
Common Shares, shares issued | 63,398,704 | 437,043 | 57,034,154 |
Common Shares, shares outstanding | 63,398,704 | 57,034,154 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||
Net Sales | $ 14,845,788 | $ 14,913,363 | $ 30,405,227 | $ 29,861,943 |
Cost of Sales | 14,112,639 | 18,930,371 | 28,661,686 | 34,599,442 |
Gross Profit (Loss) | 733,149 | (4,017,008) | 1,743,541 | (4,737,499) |
Selling and Marketing | 2,218,997 | 164,374 | 5,321,375 | 379,457 |
General and Administrative | 5,496,670 | 5,526,575 | 11,717,169 | 8,643,449 |
Settlement Expense, net of Reimbursement | 430,000 | 1,030,000 | 430,000 | 1,030,000 |
Research and Product Development | 2,958,276 | 1,558,946 | 3,455,552 | 3,225,302 |
Operating Loss | (10,370,794) | (12,296,903) | (19,180,555) | (18,015,707) |
Other Income (Expense) | ||||
Realized Gain (Loss) on Investments | 4,135 | (122,095) | 18,023 | (124,987) |
Interest Income | 74,476 | 188,206 | 192,002 | 360,381 |
Total Other Income (Expense) | 78,611 | 66,111 | 210,025 | 235,394 |
Net Loss | $ (10,292,183) | $ (12,230,792) | $ (18,970,530) | $ (17,780,313) |
Basic and Diluted Net Loss per Share | $ (0.18) | $ (0.24) | $ (0.33) | $ (0.35) |
Basic and Diluted Weighted Average Shares Outstanding (in shares) | 58,216,066 | 51,288,424 | 57,660,947 | 51,288,424 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||||
Net Loss | $ (10,292,183) | $ (12,230,792) | $ (18,970,530) | $ (17,780,313) |
Unrealized Loss on Available-for-Sale Debt Instrument Investments | 11,426 | 142,454 | 4,265 | (47,542) |
Foreign Currency Translation Adjustments | 236 | (4,905) | 144 | (7,389) |
Comprehensive Loss | $ (10,280,521) | $ (12,093,243) | $ (18,966,121) | $ (17,835,244) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) | Public Offering [Member]COMMON SHARES | Public Offering [Member] | At The Market [Member]COMMON SHARES | At The Market [Member] | COMMON SHARES | ACCUMULATED DEFICIT | ACCUMULATED OTHER COMPREHENSIVE INCOME/(LOSS) | Total |
Balance at Dec. 31, 2017 | $ 273,210,907 | $ (240,262,376) | $ (35,383) | $ 32,913,148 | ||||
Balance (in shares) at Dec. 31, 2017 | 51,768,424 | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||
Net Loss | (17,780,313) | (17,780,313) | ||||||
Unrealized Loss on Available-for-Sale Investments | (47,542) | (47,542) | ||||||
Foreign Currency Translation Adjustments | (7,389) | (7,389) | ||||||
Stock-based compensation | $ 1,811,335 | 1,811,335 | ||||||
Balance at Jun. 30, 2018 | $ 275,022,242 | (258,042,689) | (90,314) | 16,889,239 | ||||
Balance (in shares) at Jun. 30, 2018 | 51,768,424 | |||||||
Balance at Mar. 31, 2018 | $ 273,656,910 | (245,811,897) | (227,863) | 27,617,150 | ||||
Balance (in shares) at Mar. 31, 2018 | 51,768,424 | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||
Net Loss | (12,230,792) | (12,230,792) | ||||||
Unrealized Loss on Available-for-Sale Investments | 142,454 | 142,454 | ||||||
Foreign Currency Translation Adjustments | (4,905) | (4,905) | ||||||
Stock-based compensation | $ 1,365,332 | 1,365,332 | ||||||
Balance at Jun. 30, 2018 | $ 275,022,242 | (258,042,689) | (90,314) | 16,889,239 | ||||
Balance (in shares) at Jun. 30, 2018 | 51,768,424 | |||||||
Balance at Dec. 31, 2018 | $ 299,601,960 | (272,388,234) | 63,148 | $ 27,276,874 | ||||
Balance (in shares) at Dec. 31, 2018 | 57,034,154 | 57,034,154 | ||||||
Increase (Decrease) in Shareholders' Equity | ||||||||
Net Loss | (18,970,530) | $ (18,970,530) | ||||||
Unrealized Loss on Available-for-Sale Investments | 4,265 | 4,265 | ||||||
Foreign Currency Translation Adjustments | 144 | 144 | ||||||
Exercise of Employee Stock Option | $ 147,900 | $ 147,900 | ||||||
Exercise of Employee Stock Option (in shares) | 30,000 | 30,000 | ||||||
Delivery of common stock underlying restricted stock units, net of tax | $ (95,429) | $ (95,429) | ||||||
Delivery of common stock underlying restricted stock units, net of tax (in shares) | 64,173 | |||||||
Issuance of Common Shares | $ 16,120,679 | $ 16,120,679 | $ 2,089,208 | $ 2,089,208 | ||||
Issuance of Common Shares (in shares) | 5,833,334 | 437,043 | ||||||
Stock-based compensation | $ 3,018,628 | 3,018,628 | ||||||
Balance at Jun. 30, 2019 | $ 320,882,946 | (291,358,764) | 67,557 | $ 29,591,739 | ||||
Balance (in shares) at Jun. 30, 2019 | 63,398,704 | 63,398,704 | ||||||
Balance at Mar. 31, 2019 | $ 301,171,733 | (281,066,581) | 55,895 | $ 20,161,047 | ||||
Balance (in shares) at Mar. 31, 2019 | 57,128,327 | |||||||
Increase (Decrease) in Shareholders' Equity | ||||||||
Net Loss | (10,292,183) | (10,292,183) | ||||||
Unrealized Loss on Available-for-Sale Investments | 11,426 | 11,426 | ||||||
Foreign Currency Translation Adjustments | 236 | 236 | ||||||
Issuance of Common Shares | $ 16,120,679 | $ 16,120,679 | $ 2,089,208 | $ 2,089,208 | ||||
Issuance of Common Shares (in shares) | 5,833,334 | 437,043 | ||||||
Stock-based compensation | $ 1,501,326 | 1,501,326 | ||||||
Balance at Jun. 30, 2019 | $ 320,882,946 | $ (291,358,764) | $ 67,557 | $ 29,591,739 | ||||
Balance (in shares) at Jun. 30, 2019 | 63,398,704 | 63,398,704 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Cash Flows From Operating Activities: | ||
Net Loss | $ (18,970,530) | $ (17,780,313) |
Adjustments To Reconcile Net Loss To Net Cash Used In Operating Activities: | ||
Depreciation and Amortization | 380,372 | 281,327 |
Stock-based Compensation | 3,018,628 | 1,811,335 |
Increase in Inventory Reserves | 192,000 | 5,927,793 |
Amortization of Right of Use Asset | 975,947 | |
Loss on Disposal of Assets | (300) | 2,483 |
Realized (Gain) Loss on Sale of Investments Available-for-Sale | (18,023) | 124,987 |
Foreign Currency Translation Adjustment | 144 | (7,389) |
Changes in Assets and Liabilities: | ||
Decrease in Accounts Receivable | 1,590,656 | 1,001,160 |
Decrease (Increase) in Insurance Receivable | 371,217 | (500,000) |
Decrease in Inventory | 66,141 | 1,310,702 |
Decrease (Increase) in Other Assets | 125,750 | (691,139) |
Decrease in Accounts Payable | (426,772) | (1,015,539) |
Increase (Decrease) in Settlement Payable | 13,332 | 1,530,000 |
Decrease in Lease Liability | (977,636) | |
Decrease in Other Liabilities | (992,909) | (706,929) |
Decrease in Deferred License Revenue | (1,126,434) | (1,145,418) |
Changes in Assets and Liabilities | (1,356,655) | (217,163) |
Cash Used In Operating Activities | (15,778,417) | (9,856,940) |
Cash Flows From Investing Activities: | ||
Purchase of Investments Available-for-Sale | (21,774,410) | (2,594,349) |
Sale of Investments Available-for-Sale | 18,798,678 | 6,133,307 |
Purchase of Equipment | (305,030) | (340,800) |
Purchase of Research and Development Licenses (Related Party) | (500,000) | |
Cash Provided By (Used In) Investing Activities | (3,780,762) | 3,198,158 |
Cash Flows From Financing Activities: | ||
Proceeds from the Exercise of Employee Stock Options | 147,900 | |
Repurchase of Common Shares to Pay Employee Withholding Taxes | (95,429) | |
Cash Provided By Financing Activities | 18,262,358 | |
Decrease In Cash and Cash Equivalents | (1,296,821) | (6,658,782) |
Cash At Beginning Of Period | 22,713,980 | 8,406,917 |
Cash At End Of Period | 21,417,159 | 1,748,135 |
Supplemental Disclosure of Noncash Investing Activities: | ||
Change in Unrealized Loss on Marketable Securities Available-for-Sale | 4,265 | $ (47,542) |
Insurance Financing Note Payable | 1,908,554 | |
Public Offering [Member] | ||
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Stock | 17,500,002 | |
Offering Costs from the Issuance of Common Stock | (1,379,323) | |
At The Market [Member] | ||
Cash Flows From Financing Activities: | ||
Proceeds from the Issuance of Common Stock | 2,296,235 | |
Offering Costs from the Issuance of Common Stock | $ (207,027) |
Description of Business
Description of Business | 6 Months Ended |
Jun. 30, 2019 | |
Description of Business | |
Description of Business | 1. Description of Business Rockwell Medical, Inc. and subsidiaries (collectively, “we”, “our”, “us”, or the “Company”), is a specialty pharmaceutical company targeting end-stage renal disease and chronic kidney disease with products for the treatment of iron deficiency and hemodialysis. We are also a manufacturer of hemodialysis concentrates for dialysis providers and distributors in the United States and abroad. We supply the domestic market with dialysis concentrates and we also supply dialysis concentrates to distributors serving a number of foreign countries, primarily in the Americas and the Pacific Rim. Substantially, all of our sales have been concentrate products and ancillary items. Our business strategy is developing unique, proprietary renal drug therapies that we can commercialize or out-license, while also expanding our dialysis products business. These renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are designed to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience and outcome. Triferic ® is a registered trademark of Rockwell Medical, Inc. |
Liquidity and Capital Resources
Liquidity and Capital Resources | 6 Months Ended |
Jun. 30, 2019 | |
Liquidity and Capital Resources | |
Liquidity and Capital Resources | 2. Liquidity and Capital Resources As of June 30, 2019, the Company had approximately $21.4 million of cash and cash equivalents, $13.8 million of investments available-for-sale, working capital of $33.4 million and an accumulated deficit of $291.4 million. Net cash used in operating activities for the six months ended June 30, 2019 was approximately $15.8 million. On June 20, 2019, the Company closed a public offering of 5,833,334 shares of common stock at a price of $3.00 per share. The aggregate proceeds from this public offering (net of the underwriters’ commissions and offering expenses) were approximately $16.1 million. On July 9, 2019, the underwriters of the public offering partially exercised their over-allotment option and purchased an additional 425,800 shares of common stock at a price of $3.00 per share, which closed on July 11, 2019. The aggregate proceeds from the exercise of the over-allotment option (net of the underwriters’ discount and offering expenses) were approximately $1.2 million. On March 22, 2019, the Company entered into a sales agreement with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell from time to time shares of the Company’s common stock, no par value, through the Agent up to $40,000,000. We are not required to sell any shares at any time during the term of the facility. Our ability to sell common stock under the facility may be limited by several factors including, among other things, the trading volume of our common stock and certain black-out periods that we may impose upon the facility, among other things. Based on the capital raised from the June 20, 2019 offering and proceeds from the partial exercise of the over-allotment option on July 11, 2019, management believes the Company currently has sufficient funds to meet its operating requirements for at least the next twelve months from the date of the filing of this report. The Company will require additional capital to sustain its operations and make the investments it needs to execute upon its longer-term business plan, including the launch of Dialysate Triferic and I.V. Triferic. If the Company is unable to generate sufficient revenue from its existing long-term business plan, the Company will need to obtain additional equity or debt financing. If the Company attempts to obtain additional debt or equity financing, the Company cannot assume that such financing will be available on favorable terms, if at all. |
Basis of Presentation, Summary
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 6 Months Ended |
Jun. 30, 2019 | |
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | |
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | 3. Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. The results for the condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2019 or for any future interim period. The condensed consolidated balance sheet at June 30, 2019 has been derived from unaudited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet at December 31, 2018 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2018 and notes thereto included in the Company’s annual report on Form 10-K filed on March 18, 2019. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain reclassifications have been made to the 2018 financial statements and notes to conform to the 2019 presentation. Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Significant Accounting Policies With the exception of the adoption of ASU 2016-02 relating to accounting for leases, there have been no material changes in the Company’s significant accounting policies as previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2018. Leases Effective January 1, 2019, the Company accounts for its leases under Accounting Standards Codification (“ASC”) 842, Leases . Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred. In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. The Company continues to account for leases in the prior period financial statements in accordance with ASC Topic 840. Loss Per Share ASC 260, Earnings Per Share, requires dual presentation of basic and diluted earnings per share (“EPS”), with a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. Basic EPS excludes dilution. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that are then sharing in the earnings of the entity. Basic net loss per share of common stock excludes dilution and is computed by dividing the net loss by the weighted average number of shares outstanding during the period. Diluted net loss per share of common stock reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive. The Company has only incurred losses, therefore, basic and diluted net loss per share is the same. Securities that could potentially dilute net income per share in the future that were not included in the computation of diluted loss per share were as follows: As of June 30, 2019 2018 Options to purchase common stock 8,187,161 6,806,001 Unvested restricted stock awards 146,800 480,000 Unvested restricted stock units 1,658,205 - Warrants to purchase common stock 2,770,781 - 12,762,947 7,286,001 Adoption of Recent Accounting Pronouncements The Company continually assesses any new accounting pronouncements to determine their applicability. When it is determined that a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures that there are sufficient controls in place to ascertain that the Company’s consolidated financial statements properly reflect the change. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) , which amended the guidance on accounting for leases. The FASB issued this update to increase transparency and comparability among organizations. This update requires the recognition of lease assets and lease liabilities on the balance sheet and the disclosure of key information about leasing arrangements. The Company adopted this ASU effective January 1, 2019 using the additional (optional) approach by recording a right-of-use asset and a lease liability of approximately $3.5 million. Our adoption of this ASU had no effect on opening retained earnings, and the Company continues to account for leases in the prior period consolidated financial statements under ASC Topic 840. In adopting the new standard, the Company elected to apply the practical expedients regarding identification of leases, lease classification, indirect costs, and the combination of lease and non-lease components. In June 2018, the FASB issued ASU 2018-17, Improvements to Nonemployee Share-Based Payment Accounting, which simplifies the accounting for share-based payments granted to nonemployees for goods and services. Under ASU 2018-17, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. The amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than an entity’s adoption of Topic 606. The Company adopted this new standard on January 1, 2019 and the adoption did not have a material impact on its condensed consolidated financial statements and related disclosures. |
Revenue Recognition
Revenue Recognition | 6 Months Ended |
Jun. 30, 2019 | |
Revenue Recognition | |
Revenue Recognition | 4. Revenue Recognition The Company recognizes revenue under ASC 606, Revenue from Contracts with Customers. The core principle of the new revenue standard is that a company should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. The following five steps are applied to achieve that core principle: · Step 1: Identify the contract with the customer · Step 2: Identify the performance obligations in the contract · Step 3: Determine the transaction price · Step 4: Allocate the transaction price to the performance obligations in the contract · Step 5: Recognize revenue when the company satisfies a performance obligation Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight related to contracts with customers are accounted for as a fulfillment cost and are included in cost of sales when control of the goods transfers to the customer. Nature of goods and services The following is a description of principal activities from which the Company generates its revenue. Product sales – The Company accounts for individual products and services separately if they are distinct (i.e., if a product or service is separately identifiable from other items and if a customer can benefit from it on its own or with other resources that are readily available to the customer). The consideration, including any discounts, is allocated between separate products and services based on their stand-alone selling prices. The stand-alone selling prices are determined based on the cost plus margin approach. Drug and dialysis concentrate products are sold directly to dialysis clinics and to wholesale distributors in both domestic and international markets. Distribution and license agreements for which upfront fees are received are evaluated upon execution or modification of the agreement to determine if the agreement creates a separate performance obligation from the underlying product sales. For all existing distribution and license agreements, the distribution and license agreement is not a distinct performance obligation from the product sales. In instances where regulatory approval of the product has not been established and the Company does not have sufficient experience with the foreign regulatory body to conclude that regulatory approval is probable, the revenue for the performance obligation is recognized over the term of the license agreement (over time recognition). Conversely, when regulatory approval already exists or is probable, revenue is recognized at the point in time that control of the product transfers to the customer. The Company received upfront fees under two distribution and license agreements that have been deferred as a contract liability. The amounts received from Wanbang Biopharmaceuticals Co., Ltd. (“Wanbang”) are recognized as revenue over the estimated term of the distribution and license agreement as regulatory approval was not received and the Company did not have sufficient experience in China to determine that regulatory approval was probable as of the execution of the agreement. The amounts received from Baxter Healthcare Corporation (“Baxter”), are recognized as revenue at the point in time that the estimated product sales under the agreement occur. For the business under the Company’s distribution agreement with Baxter (the “Baxter Agreement”), and for the majority of the Company’s international customers, the Company recognizes revenue at the shipping point, which is generally the Company’s plant or warehouse. For other business, the Company recognizes revenue based on when the customer takes control or receipt of the product. The amount of revenue recognized is based on the purchase order less returns and adjusted for any rebates, discounts, chargebacks or other amounts paid to customers. There were no such adjustments for the periods reported. Customers typically pay for the product based on customary business practices with payment terms averaging 30 days, while distributor payment terms average 45 days. Disaggregation of revenue Revenue is disaggregated by primary geographical market, major product line, and timing of revenue recognition. In thousands of US dollars ($) Three Months Ended June 30, 2019 Six Months Ended June 30, 2019 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 15 $ 15 $ — $ 15 $ 15 $ — License Fee – Over time 68 — 68 136 — 136 Total Drug Products 83 15 68 151 15 136 Concentrate Products Product Sales – Point-in-time 14,268 12,822 1,446 29,264 25,746 3,518 License Fee – Over time 495 495 — 990 990 — Total Concentrate Products 14,763 13,317 1,446 30,254 26,736 3,518 Net Revenue $ 14,846 $ 13,332 $ 1,514 $ 30,405 $ 26,751 $ 3,654 Three Months Ended June 30, 2018 Six Months Ended June 30, 2018 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues License Fee – Over time $ 68 — $ 68 $ 136 — $ 136 Concentrate Products Product Sales – Point-in-time 14,340 12,856 1,484 28,717 25,329 3,388 License Fee – Over time 505 505 — 1,009 1,009 — Total Concentrate Products 14,845 13,361 1,484 29,726 26,338 3,388 Net Revenue $ 14,913 $ 13,361 $ 1,552 $ 29,862 $ 26,338 $ 3,524 Contract balances The following table provides information about receivables, contract assets, and contract liabilities from contracts with customers. In thousands of US dollars ($) June 30, 2019 December 31, 2018 Receivables, which are included in "Trade and other receivables" $ 5,389 $ 6,980 Contract liabilities $ 13,203 $ 14,329 There were no impairment losses recognized related to any receivables arising from the Company’s contracts with customers for the three and six months ended June 30, 2019 and 2018. For the three and six months ended June 30, 2019 and June 30, 2018, the Company did not recognize material bad-debt expense and there were no material contract assets recorded on the condensed consolidated balance sheet as of June 30, 2019 and December 31, 2018. The Company does not generally accept returns of its concentrate products and no reserve for returns of concentrate products was established as of June 30, 2019 or December 31, 2018. The contract liabilities primarily relate to upfront payments and consideration received from customers that are received in advance of the customer assuming control of the related products. Transaction price allocated to remaining performance obligations For the three and six months ended June 30, 2019, revenue recognized from performance obligations related to prior periods was not material. Revenue expected to be recognized in any future year related to remaining performance obligations, excluding revenue pertaining to contracts that have an original expected duration of one year or less, contracts where revenue is recognized as invoiced and contracts with variable consideration related to undelivered performance obligations, totaled $13.2 million as of June 30, 2019. The amount relates primarily to upfront payments and consideration received from customers that are received in advance of the customer assuming control of the related products. The Company applies the practical expedient in paragraph 606-10-50-14 and does not disclose information about remaining performance obligations that have original expected durations of one year or less. The Baxter Agreement includes minimum commitments of product sales over the duration of the agreement. Unfulfilled performance obligations related to the Baxter Agreement are product sales of $10.1 million, which will be amortized through expiration of the agreement on October 2, 2024. |
Investments - Available-for-Sal
Investments - Available-for-Sale | 6 Months Ended |
Jun. 30, 2019 | |
Investments - Available-for-Sale | |
Investments - Available-for-Sale | 5. Investments - Available-for-Sale Investments available-for-sale consisted of the following as of June 30, 2019 and December 31, 2018: June 30, 2019 Amortized Cost Unrealized Gain Unrealized Loss Fair Value Available-for-Sale Securities Bonds $ 13,797,120 $ 21,759 $ (2,800) $ 13,816,079 December 31, 2018 Amortized Cost Unrealized Gain Unrealized Loss Fair Value Available-for-Sale Securities Bonds $ 10,801,836 $ 17,415 $ (1,192) $ 10,818,059 The fair value of investments available-for-sale are determined using quoted market prices from daily exchange-traded markets based on the closing price as of the balance sheet date and are classified as Level 1, as described in Note 3, Fair Value Measurement to our condensed consolidated financial statements. As of June 30, 2019 and December 31, 2018, the amortized cost and estimated fair value of our available-for-sale securities were due in one year or less. |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2019 | |
Inventory | |
Inventory | 6. Inventory Components of inventory, net of reserves as of June 30, 2019 and December 31, 2018 are as follows: June 30, December 31, 2019 2018 Raw Materials $ 3,361,556 $ 3,621,548 Work in Process 244,743 256,129 Finished Goods 1,811,338 1,798,101 Total $ 5,417,637 $ 5,675,778 As of June 30, 20192019, we classified $1.4 million and $1.6 million, respectively, of inventory as non-current, all of which was related to Triferic or the active pharmaceutical ingredient for Triferic. As of June 30, 20192019 we had total Triferic inventory aggregating $3.5 million and $8.0 million respectively, against which we had reserved $1.7 million and $5.8 million respectively. The $1.8 million net value of Triferic inventory consisted of $0.4 million of Dialysate Triferic finished goods with expiration dates ranging from March 2020 to May 2021, and $1.4 million of Triferic API with estimated useful lives extending through 2023. In addition, see subsequent events note 17 for potential risk relating to the inventory valuation. |
Property And Equipment
Property And Equipment | 6 Months Ended |
Jun. 30, 2019 | |
Property and Equipment | |
Property and Equipment | 7. Property and Equipment As of June 30, 2019 and December 31 2018, the Company’s property and equipment consisted of the following: June 30, December 31, 2019 2018 Leasehold Improvements $ 1,105,811 $ 929,849 Machinery and Equipment 4,705,917 4,800,774 Information Technology & Office Equipment 1,720,845 2,459,832 Laboratory Equipment 653,075 668,977 8,185,648 8,859,432 Accumulated Depreciation (5,622,220) (6,221,139) Net Property and Equipment $ 2,563,428 $ 2,638,293 Depreciation expense for the three months ended June 30, 2019 and 2018, totaled $0.2 million and $0.2 million, respectively. Depreciation expense for the six months ended June 30, 2019 and 2018, totaled $0.4 million and $0.3 million, respectively. |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2019 | |
Accrued Liabilities | |
Accrued Liabilities | 8. Accrued Liabilities Accrued liabilities as of June 30, 2019 and December 31, 2018 consisted of the following: June 30, December 31, 2019 2018 Accrued Research & Development Expense $ 101,064 $ 86,820 Accrued Compensation and Benefits 1,095,261 1,525,599 Accrued Legal Expenses 943,642 170,334 Accrued Marketing Expenses 236,793 5,000 Other Accrued Liabilities 1,694,581 3,342,008 Total Accrued Liabilities $ 4,071,341 $ 5,129,761 |
Insurance Financing Note Payabl
Insurance Financing Note Payable | 6 Months Ended |
Jun. 30, 2019 | |
Insurance Financing Note Payable [Abstract] | |
Insurance Financing Note Payable | 9. Insurance Financing Note Payable On June 3, 2019, the Company entered into a short-term note payable for $1.9 million, bearing interest at 4.65% per annum to finance various insurance policies. Principal and interest payments related to this note will begin on July 3, 2019 and are paid on a straight-line amortization over a 10-month period with the final payment due on April 3, 2020. As of June 30, 2019, the Company’s insurance note payable balance was $1.9 million. |
Deferred Revenue
Deferred Revenue | 6 Months Ended |
Jun. 30, 2019 | |
Revenue Recognition | |
Deferred Revenue | 10. Deferred Revenue In October of 2014, the Company entered into a 10 year distribution agreement with Baxter and received an upfront fee of $20 million. The upfront fee was recorded as deferred revenue and is being recognized based on the proportion of product shipments to Baxter in each period, compared with total expected sales volume over the term of the Baxter Agreement. The Company recognized revenue of approximately $0.5 million and $1.0 million during the three and six months ended June 30, 2019 and 2018, respectively. Deferred revenue related to the Baxter Agreement totaled $10.1 million as of June 30, 2019 and $11.1 million as of December 31, 2018. If a “Refund Trigger Event” occurs, we would be obligated to repay a portion of the upfront fee and any paid portion of the facility fee. In the event of a Refund Trigger Event occurring from January 1, 2019 to December 31, 2021, Baxter would be eligible for a 25% refund of the Agreement’s Upfront Payment. In addition, if Baxter terminates the Agreement because Baxter has been enjoined by a court of competent jurisdiction from selling in the United States any product covered by the Baxter Agreement due to a claim of intellectual property infringement or misappropriation relating to such product prior to the end of 2019, Baxter would be eligible for a partial refund of $6.6 million. In no event would more than one refund be required to be paid. During the year ended December 31, 2016, the Company entered into a distribution and license agreement with Wanbang and received an upfront fee of $4.0 million. The upfront fee was recorded as deferred revenue and is being recognized as revenue based on the agreement term. The Company recognized revenue of approximately $0.1 million and $0.2 million during the three and six months ended June 30, 2019 and 2018, respectively. Deferred revenue related to the Wanbang agreement totaled $3.0 million as of June 30, 2019 and $3.2 million as of December 31, 2018. |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2019 | |
Stockholders' Equity | |
Stockholders' Equity | 11. Shareholders’ Equity Preferred Stock As of June 30, 2019 and December 31, 2018, there were 2,000,000 shares of preferred stock authorized and no shares of preferred stock issued or outstanding. Common Stock As of June 30, 2019, the Company’s authorized shares of common stock was 120 million shares. On June 6, 2019, the Company obtained shareholder approval to increase the number of authorized shares of the Company’s common stock by 50 million shares to 170 million shares. On July 30, 2019, the Company amended its Articles of Incorporation to reflect this increase in authorized shares from 120 million to 170 million shares. During the six months ended June 30, 2019, 30,000 vested employee stock options were exercised for cash proceeds of $147,900, at a weighted average exercise price of $4.93. Controlled Equity Offering On March 22, 2019, the Company entered into a sales agreement (the “Sales Agreement”) with Cantor Fitzgerald & Co. (the “Agent”), pursuant to which the Company may offer and sell from time to time shares of the Company’s common stock, no par value, through the Agent. The offering and sale of up to $40,000,000 of the shares has been registered under the Securities Act of 1933, as amended, pursuant to the Company’s registration statement on Form S-3 (File No. 333-227363), which was originally filed with the SEC on September 14, 2018 and declared effective by the SEC on October 1, 2018. The base prospectus contained within the registration statement, and a prospectus supplement that was filed with the SEC on March 22, 2019. Sales of the shares, if any, pursuant to the Sales Agreement, may be made in sales deemed to be a “at the market offering” as defined in Rule 415(a) of the Securities Act, including sales made directly through the Nasdaq Global Market or on any other existing trading market for the Company’s common stock. The Company intends to use the proceeds from the offering for working capital and other general corporate purposes. The Company may suspend or terminate the Sales Agreement at any time. In April 2019, the Company sold 437,043 shares of its common stock pursuant to the Sales Agreement for gross proceeds of $2,296,235, at a weighted average selling price of approximately $5.25. The Company paid $207,027 in commissions and offering fees related to the sale of the common shares. Public Offering of Common Stock On June 17, 2019, the Company entered into a purchase agreement with Piper Jaffray & Co., and Cantor Fitzgerald & Co, pursuant to which the Company agreed to issue and sell up to 6,708,334 shares of common stock, which included 875,000 optional shares that may be sold pursuant to an option granted to the underwriters. On June 20, 2019, the Company closed the sale of 5,833,334 shares of its common stock for gross proceeds of $17,500,002 at the public offering price of $3.00 per share (the “Offering”). The Company paid $1,379,323 in underwriters’ commissions and fees related to the sale of the common shares. The Offering was made pursuant to the Company’s effective registration statement on Form S-3 (File No. 333-227363), which was previously filed with the SEC. On July 9, 2019, the Underwriters exercised their over-allotment option to purchase an additional 425,800 shares of common stock at a price of $3.00 per share, which closed on July 11, 2019. The total proceeds to the Company (net of underwriting commissions and offering fees) from the exercise of the over-allotment option were approximately $1.2 million. Restricted Common Stock During the six months ended June 30, 2019, 98,500 shares of common stock related to fully vested restricted stock units were delivered to an officer of the Company. The Company withheld 34,327 of these common shares at a fair value of $95,429 to cover the officer’s withholding taxes related to the vesting of restricted stock units. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2019 | |
Stock-Based Compensation | |
Stock-Based Compensation | 12. Stock-Based Compensation The Company recognized total stock-based compensation expense during the three and six months ended June 30, 2019 and 2018 as follows: Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Service based awards: Restricted stock awards $ - $ 1,012,171 $ - $ 1,271,902 Restricted stock units 427,472 - 771,823 - Stock option awards 547,139 353,161 1,199,163 539,433 974,611 1,365,332 1,970,986 1,811,335 Performance based awards: Restricted stock units 402,814 - 801,202 - Stock option awards 123,901 - 246,440 - 526,715 - 1,047,642 - Total $ 1,501,326 $ 1,365,332 $ 3,018,628 $ 1,811,335 Restricted Stock A summary of the Company’s restricted stock awards during the six months ended June 30, 2019 is as follows: Weighted Average Grant-Date Number of Shares Fair Value Unvested at December 31, 2018 $ 5.70 Unvested at June 30, 2019 $ 5.70 A summary of the Company’s restricted stock awards during the six months ended June 30, 2018 is as follows: Weighted Average Grant-Date Number of Shares Fair Value Unvested at December 31, 2017 480,000 $ 7.27 Unvested at June 30, 2018 480,000 $ 7.27 The fair value of restricted stock awards are measured based on their fair value on the date of grant and amortized over the vesting period of 20 months. As of June 30, 2019 unvested restricted stock awards of 146,800 were related to performance based awards. Service Based Restricted Stock Units A summary of the Company’s service based restricted stock units during the six months ended June 30, 2019 is as follows: Weighted Average Grant-Date Number of Shares Fair Value Unvested at December 31, 2018 472,959 $ 4.32 Granted 199,938 4.45 Forfeited (3,650) 4.81 Unvested at June 30, 2019 669,247 $ 4.36 The fair value of service based restricted stock units are measured based on their fair value on the date of grant and amortized over the vesting period. The vesting periods range from 1-3 years. Stock-based compensation expense of $0.4 million and $0.8 million was recognized during the three and six months ended June 30, 2019. No stock-based compensation was recognized during the three and six months ended June 30, 2018, since there were no service based restricted stock units outstanding during that period. As of June 30, 2019, the unrecognized stock-based compensation expense was $1.8 million. Performance Based Restricted Stock Units A summary of the Company’s performance based restricted stock units during the six months ended June 30, 2019 is as follows: Weighted Average Grant-Date Number of Shares Fair Value Unvested at December 31, 2018 988,958 $ 4.48 Unvested at June 30, 2019 988,958 $ 4.48 Stock-based compensation expense recognized for performance based restricted stock units was $0.4 million and $0.8 million during the three and six months ended June 30, 2019. No stock-based compensation was recognized during the three and six months ended June 30, 2018, since there were no performance based restricted stock units outstanding during that period. As of June 30, 2019, the unrecognized stock-based compensation expense related to performance based restricted stock units was $1.9 million. In addition, see subsequent events note 17 for potential risk relating to vesting of certain RSU’s granted previously. Service Based Stock Options The fair value of the service based stock options granted for the six months ended June 30, 2019 were based on the following assumptions: June 30, 2019 Exercise price $2.96 - $6.21 Expected stock price volatility 67.5% - 70.3% Risk-free interest rate 1.9% - 2.6% Term (years) 5.5 -6.5 A summary of the Company’s service based stock option activity for the six months ended June 30, 2019 is as follows: Weighted Weighted Average Shares Average Remaining Aggregate Underlying Exercise Contractual Intrinsic Options Price Term Value Outstanding at December 31, 2018 7,856,480 $ 7.50 5.2 $ - Granted 523,105 $ 4.33 9.7 - Exercised (30,000) $ 4.93 - - Forfeited (550,549) 6.67 - - Outstanding at June 30, 2019 7,799,036 $ 7.36 5.4 $ 2,500 Exercisable at June 30, 2019 6,183,193 $ 8.16 4.3 $ - A summary of the Company’s service based stock option activity for the six months ended June 30, 2018 is as follows: Weighted Weighted Average Shares Average Remaining Aggregate Underlying Exercise Contractual Intrinsic Options Price Term Value Outstanding at December 31, 2017 6,906,001 $ 7.92 5.0 $ 976,335 Forfeited (100,000) $ 6.93 - Outstanding at June 30, 2018 6,806,001 $ 7.93 4.6 $ 629,680 Exercisable at June 30, 2018 6,578,161 $ 7.93 4.5 $ 629,680 The aggregate intrinsic value in the table above is calculated as the difference between the closing price of our common stock and the exercise price of the stock options that had strike prices below the closing price. During the six months ended June 30, 2019, the Company granted to certain employee’s stock options to purchase up to 523,105 shares of common stock. During the six months ended June 30, 2019, forfeitures were 550,549. Forfeitures are recorded in the period of occurrence; compensation expense is adjusted accordingly. Stock-based compensation expense recognized for service based stock options was $0.5 million and $1.2 million for the three and six months ended June 30, 2019 and $0.3 million and $0.5 million for the three and six months ended June 30, 2018. As of June 30, 2019, total stock-based compensation expense related to unvested options not yet recognized totaled approximately $2.8 million. Performance Based Stock Options A summary of the performance based stock options for the six months ended June 30, 2019, is as follows: Weighted Average Exercise Number of Shares Price Outstanding at December 31, 2018 388,125 $ 4.70 Outstanding at June 30, 2019 388,125 $ 4.70 Exercisable at June 30, 2019 - $ - Stock-based compensation expense recognized for performance based stock options was $0.1 million and $0.2 million during the three and six months ended June 30, 2019. No stock-based compensation was recognized during the three and six months ended June 30, 2018, since there were no performance based stock options outstanding during that period. As of June 30, 2019, the unrecognized stock-based compensation expense related to performance based stock options was $0.7 million. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2019 | |
Related Party Transactions | |
Related Party Transactions | 13. Related Party Transactions Product License Agreements The Company is a party to an in-license agreement for exclusive worldwide rights to certain patents and information related to our Triferic® product. On October 7, 2018, the Company entered into a Master Services and IP Agreement (the “Charak MSA”) with Charak, LLC and Dr. Ajay Gupta (collectively “Charak”), who serves as Executive Vice President and Chief Scientific Officer of the Company. Pursuant to the MSA, the parties entered into three additional agreements described below related to the license of certain soluble ferric pyrophosphate (“SFP”) intellectual property owned by Charak, as well as the Employment Agreement (defined below). The Charak MSA provides for a payment of $1.0 million to Dr. Gupta, payable in four quarterly installments of $250,000 each on October 15, 2018, January 15, 2019, April 15, 2019 and July 15, 2019, and reimbursement for certain legal fees incurred in connection with the Charak MSA. The Company recorded $1.1 million as Research and Development Expense – License Acquired (Related Party) for the twelve months ended December 31, 2018. As of June 30, 2019, the Company paid three of the quarterly installments totaling $750,000 and accrued $100,000 for the reimbursement of certain legal expenses. As of June 30, 2019 and December 31, 2018, the Company accrued $350,000 and $850,000, respectively, as a related party payable on the condensed consolidated balance sheet. Pursuant to the Charak MSA, the aforementioned parties entered into an Amendment, dated as of October 7, 2018 (the “Charak Amendment”), to the Licensing Agreement between the Company and Charak, dated January 7, 2002, as amended (the “2002 Agreement”), under which Charak granted the Company an exclusive, worldwide, non-transferable license to commercialize SFP for the treatment of patients with renal failure. The Charak Amendment amends the royalty payments due to Charak under the 2002 Agreement such that the Company is liable to pay Charak royalties on net sales by the Company of products developed under the license, which includes the Company’s Triferic® product, at a specified rate until December 31, 2021 and thereafter at a reduced rate from January 1, 2022 until February 1, 2034. Additionally, the Company shall pay Charak a percentage of any sublicense income during the term of the agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sub-licensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and be no less than a lower rate of the net sales of the licensed products by the sub-licensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Commercialization and Technology License Agreement I.V. Triferic®, dated as of October 7, 2018 (the “IV Agreement”), under which Charak granted the Company an exclusive, sublicensable, royalty-bearing license to SFP for the purpose of commercializing certain intravenous-delivered products incorporating SFP for the treatment of iron disorders worldwide for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. The Company is liable to pay Charak royalties on net sales by the Company of products developed under the license at a specified rate until December 31, 2021. From January 1, 2022 until February 1, 2034, the Company is liable to pay Charak a base royalty at a reduced rate on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the IV Agreement, which amount shall not be less than a minimum specified percentage of net sales of the licensed products by the sub-licensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sub-licensee in jurisdictions where there exists no valid claim, on a country-by-country basis. Also pursuant to the Charak MSA, the Company and Charak entered into a Technology License Agreement TPN Triferic®, dated as of October 7, 2018 (the “TPN Agreement”), pursuant to which Charak granted the Company an exclusive, sublicensable, royalty-bearing license to SFP for the purpose of commercializing worldwide certain parenteral nutritional (TPN”) products incorporating SFP. The license grant under the TPN Agreement continues for a term that expires on the later of February 1, 2034 or upon the expiration or termination of a valid claim of a licensed patent. During the term of the TPN Agreement, the Company is liable to pay Charak a base royalty on net sales and an additional royalty on net sales while there exists a valid claim of a licensed patent, on a country-by-country basis. The Company shall also pay to Charak a percentage of any sublicense income received during the term of the TPN Agreement, which amount shall not be less than a minimum royalty on net sales of the licensed products by the sub-licensee in jurisdictions where there exists a valid claim, on a country-by-country basis, and not be less than a lower rate of the net sales of the licensed products by the sub-licensee in jurisdictions where there exists no valid claim, on a country-by-country basis. The transaction was accounted for as an asset acquisition pursuant to ASU 2017-01, Business Combinations (Topic 805), Clarifying the Definition of a Business, as the majority of the fair value of the assets acquired was concentrated in a group of similar assets, and the acquired assets did not have outputs or employees. The assets acquired under the MSA include a license of SFP. Because SFP has not yet received regulatory approval, the $1.1 million purchase price paid and accrued for these assets has been expensed in the Company’s statement of operations for the year ended December 31, 2018. In addition, the potential milestone payments are not yet considered probable, and no milestone payments have been accrued at June 30, 2019. |
Leases
Leases | 6 Months Ended |
Jun. 30, 2019 | |
Leases | |
Leases | 14. Leases We lease our production facilities and administrative offices as well as certain equipment used in our operations including leases on transportation equipment used in the delivery of our products. The lease terms range from monthly to seven years. We occupy a 51,000 square foot facility and a 17,500 square foot facility in Wixom, Michigan under a lease expiring in August 2021. We also occupy two other manufacturing facilities, a 51,000 square foot facility in Grapevine, Texas under a lease expiring in December 2020, and a 57,000 square foot facility in Greer, South Carolina under a lease expiring February 2020. In addition, we occupy a 1,408 square foot office space in Greer, South Carolina under a lease expiring April 2021 and on December 28, 2018 we executed a lease for 4,100 square feet of office space in Hackensack, New Jersey with a lease term commencing in July 2019 and expiring on July 1, 2024. At June 30, 2019, the Company had operating lease liabilities of $3.3 million and right-of-use assets of $3.3 million, which are included in the consolidated balance sheet. The following summarizes quantitative information about the Company’s operating leases: Three Months Ended Six Months Ended June 30, 2019 June 30, 2019 Operating leases Operating lease cost $ 554,921 $ 1,089,888 Variable lease cost 78,237 168,081 Operating lease expense 633,158 1,257,969 Short-term lease rent expense 4,122 8,313 Total rent expense $ 637,280 $ 1,266,282 Other information Operating cash flows from operating leases $ 514,116 $ 1,038,081 Right of use assets exchanged for operating lease liabilities $ 821,195 $ 4,305,428 Weighted-average remaining lease term – operating leases 2.6 2.6 Weighted-average discount rate – operating leases Future minimum rental payments under operating lease agreements are as follows: Six months ended June 30, 2019 $ 944,466 Year ending December 31, 2020 1,394,778 Year ending December 31, 2021 772,616 Year ending December 31, 2022 308,167 Year ending December 31, 2023 174,896 Year ending December 31, 2024 65,119 Total $ 3,660,042 Less present value discount (332,251) Operating lease liabilities $ 3,327,791 |
Settlement Agreement
Settlement Agreement | 6 Months Ended |
Jun. 30, 2019 | |
Settlement Agreement | |
Settlement Agreement | 15. Settlement Agreement On August 7, 2018, the Company entered into a confidential settlement agreement and mutual release (the “Settlement Agreement”) with its former CEO, former CFO and a former and then current director. For more details see Note 10 in Form 10-K filed on March 18, 2019. This resulted in a net settlement expense of approximately $1.0 million for the six month ended June 30, 2018. On August 7, 2019, the Company entered into a settlement agreement relating to the class action lawsuits described below. This resulted in a settlement expense of approximately $0.4 million for the six months ended June 30, 2019. See note 16 below for further details. The settlement is subject to court review and approval. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 16. Commitments and Contingencies Litigation SEC Investigation As a follow up to certain prior inquiries, the Company received a subpoena from the SEC during the Company’s quarter ended September 30, 2018 requesting, among other things, certain information and documents relating to the status of the Company’s request to the Centers for Medicare & Medicaid Services (“CMS”) for separate reimbursement status for Dialysate Triferic, the Company’s reserving methodology for expiring Triferic inventory, and the basis for the Board’s termination of the former CEO and CFO. The Company is cooperating with the SEC and is responding to the SEC’s requests for documents and information. Shareholder Class Action Lawsuits On July 27, 2018, Plaintiff Ah Kit Too filed a putative class action lawsuit in the United States District Court in the Eastern District of New York against the Company and former officers, Robert Chioini and Thomas Klema. The complaint is a federal securities class action purportedly brought on behalf of a class consisting of all persons and entities, other than Defendants, who purchased or otherwise acquired the publicly traded securities of the Company between March 16, 2018 and June 26, 2018. The Complaint alleges that the Company and Messrs. Chioini and Klema violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”). Specifically, the Complaint alleges that defendants filed reports with the Securities and Exchange Commission that contained purported inaccurate and misleading statements regarding the potential for the Company’s drug, Triferic, to quality for separate reimbursement status by the Centers for Medicare and Medicaid Services. On September 4, 2018, Plaintiff Robert Spock filed a similar putative class action lawsuit in the United States District Court in the Eastern District of New York against the Company and Messrs. Chioini and Klema. The Spock complaint is a federal securities class action purportedly brought on behalf of a class consisting of persons who purchased the Company’s securities between November 8, 2017 and June 26, 2018. This complaint alleges that the Company and Messrs. Chioini and Klema violated the Exchange Act in that the Company was aware the Centers for Medicare and Medicaid Services would not pursue the Company’s proposal for separate reimbursement for Triferic; misstated reserves in the Company’s quarterly report for the first quarter of 2018; had a material weakness its internal controls over financial reporting, which rendered those controls ineffective; Mr. Chioini withheld material information regarding Triferic from the Company’s auditor, corporate counsel, and independent directors of the Board; and, as a result of these alleged issues, statements about the Company’s business were materially false and misleading. On September 25, 2018, four Company stockholders filed motions to appoint lead plaintiffs, lead counsel, and to consolidate the Ah Kit Too v. Rockwell securities class action with the Spock v. Rockwell securities class action. On October 10, 2018, the court issued an order consolidating the two actions, appointing co-lead plaintiffs and co-lead counsel. On December 10, 2018, lead Plaintiffs filed a consolidated amended complaint, which included the same allegations as the initial complaints and asserted claims on behalf of a putative class consisting of person who purchased the Company’s securities between November 8, 2017 and June 26, 2018, accordingly. On August 7, 2019, all parties to the class action entered into a settlement of the consolidated class action. Pursuant to the terms and conditions of the settlement agreement, the Company will pay the Plaintiffs $3.7 million (the “Settlement Amount’) in exchange for a full release of all liability as to all defendants. Of the Settlement Amount, the Company will be contributing approximately $0.4 million, which represents the remaining retention amount under the Company’s director and officer liability insurance policy. The remainder of the settlement amount will be funded by the Company’s director and officer insurance policy. The settlement is subject to court review and approval. Shareholder Derivative Actions Two verified stockholder derivative complaints (the “Derivative Complaints”) entitled LeClair v Rockwell Medical, Inc., and Post v Rockwell Medical, Inc. were filed in the United States District Court in the Eastern District of New York, purportedly on behalf of the Company (as nominal defendant) and against certain of the Company’s current and former directors (the “Individual Defendants”). The Derivative Complaints assert causes of actions against the Individual Defendants for breach of fiduciary duty, waste of corporate assets, and unjust enrichment. The Derivative Complaints allege the Individual Defendants breached duties by, among other things, permitting alleged misstatements to be made in public filings regarding the status of separate reimbursement for Triferic from CMS, the adequacy of Rockwell’s reserves, and the adequacy of Rockwell’s internal controls. These cases are at an early stage, and the Company anticipates filing a motion to dismiss the action. The Company has tendered the above shareholder derivative actions to its D&O insurance carrier(s) for defense and indemnity under its applicable insurance policies. The Company maintains a $1.0 million self-insured retention under the applicable insurance policies, which will be exhausted upon payment of the Company’s share of the Settlement Amount from the settlement of the class action described above. The Company also has received requests from shareholders to investigate issues relating in part to allegations raised in the securities and derivative lawsuits. The Audit Committee of the Board of Directors engaged independent counsel to investigate these issues. The investigation concluded, among other things that there was no merit to the claims raised in the shareholder requests and the investigation has been concluded. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2019 | |
SUBSEQUENT EVENTS | |
Subsequent Events | 17. Subsequent Events Stock Purchase Agreement On July 9, 2019, the Company issued and sold a total of 425,880 shares of common stock to the underwriters of the Company’s June 17, 2019 underwritten stock offering. The shares sold to the underwriters were issued upon the partial exercise of the underwriters’ overallotment option. The Company received total offering proceeds from the exercise of the over-allotment option (net of underwriting commissions and offering fees) of approximately $1.2 million. I.V. Triferic NDA Acceptance for Filing On August 2, 2019, the Company received notice from the FDA that the Company’s NDA for I.V. Triferic, which was submitted in May, has been accepted for filing, with a Prescription Drug User Fee Act (“PDUFA”) date of March 28, 2020. Amendment to Product Purchase Agreement On August 1, 2019, the Company executed a Products Purchase Agreement (the “Purchase Agreement”) with DaVita Inc. (“DaVita”), with such agreement effective as of July 1, 2019. The Purchase Agreement supersedes and replaces that certain First Amended and Restated Products Purchase Agreement, effective as of May 8, 2013 (as subsequently amended) by and between the Company and DaVita, which agreement expired effective as of July 31, 2019 (the “Prior Agreement”). Pursuant to the Purchase Agreement, the Company will supply certain DaVita dialysis centers with dialysis acid concentrate (i.e., CitraPure® (Liquid and Dry Acid), Dri-Sate® Dry Acid or RenalPure® Liquid Acid) and bicarbonate (i.e., RenalPure® Bicarbonate Powder or Sterilyte® Liquid Bicarbonate) through December 31, 2023 (the “Initial Term”), subject to certain terms and conditions. The Purchase Agreement provides for an increase in the product sale prices relative to the prices charged for these products under the Prior Agreement. If, upon expiration of the Initial Term, the parties have not completed an extension or a new purchase agreement, the Purchase Agreement will continue in effect until terminated by either party with 90 days written notice or until the completion of an extension or new purchase agreement. Centers for Medicare & Medicaid Services (“CMS”) preliminary proposed rule On July 29, 2019, CMS issued a preliminary proposed rule that proposes to update payment policies and rates under the End-Stage Renal Disease (“ESRD”) Prospective Payment System for renal dialysis services furnished to beneficiaries on or after January 1, 2020 (the “Proposed Rules”). The Proposed Rules contain certain proposed revisions to the eligibility requirements for the CMS Transitional Drug Add-on Payment Adjustment (“TDAPA”) program, which has the potential to provide two years of add-on reimbursement for certain qualifying new drugs. Under the proposed revisions to the TDAPA rules, if finalized, ESRD drugs approved by the FDA under the following types of NDAs would be ineligible for TDAPA, effective as of January 1, 2020: (a) NDA Types 3, 5, 7 and 8, (b) NDA Type 3 in combination with NDA Type 2 or NDA Type 4, (c) NDA Type 5 in combination with NDA Type 2, or (d) NDA Type 9, when the “parent NDA” is NDA Type 3, 5, 7 or 8. As previously disclosed, the Company has filed an NDA for the intravenous formulation of Triferic. The FDA has not informed the Company what the classification will be for the I.V. Triferic NDA, although the two prior Triferic NDAs that have been approved were Types 3 and 5. If the I.V. Triferic NDA is classified as either of those Types, or any of the other excluded NDA Types listed in the Proposed Rules, the Company believes that it could be adversely impacted by the Proposed Rules, because it would not be eligible for reimbursement under the Proposed Rules relating to CMS’ TDAPA program. The Company previously disclosed projections for the overall peak Triferic market opportunity in the United States have been based on an assumed market price for I.V. Triferic that is within the CMS reimbursement bundle payment system and not a sustained, higher price based on TDAPA eligibility. CMS is accepting comments on the Proposed Rules through September 27, 2019. Rockwell plans to vigorously oppose this change in the TDAPA eligibility requirements. The Company is currently assessing the impact the Proposed Rules would have on current inventory valuations and stock compensation arrangements if such proposed rule would be finalized and the type of classification for the I.V. Triferic NDA was included. |
Basis of Presentation, Summar_2
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | |
Basis of Presentation | The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. In the opinion of management, the accompanying unaudited condensed consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of such interim results. The results for the condensed consolidated statement of operations are not necessarily indicative of results to be expected for the year ending December 31, 2019 or for any future interim period. The condensed consolidated balance sheet at June 30, 2019 has been derived from unaudited financial statements; however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The condensed consolidated balance sheet at December 31, 2018 has been derived from audited financial statements, however, it does not include all of the information and notes required by U.S. GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended December 31, 2018 and notes thereto included in the Company’s annual report on Form 10-K filed on March 18, 2019. The accompanying condensed consolidated interim financial statements include the accounts of the Company and its subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Certain reclassifications have been made to the 2018 financial statements and notes to conform to the 2019 presentation. |
Use of Estimates | Use of Estimates The preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that may affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Actual results could differ from those estimates. |
Leases | Leases Effective January 1, 2019, the Company accounts for its leases under Accounting Standards Codification (“ASC”) 842, Leases . Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the consolidated balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease or the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred. In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. The Company continues to account for leases in the prior period financial statements in accordance with ASC Topic 840. |
Loss Per Share | Loss Per Share ASC 260, Earnings Per Share, requires dual presentation of basic and diluted earnings per share (“EPS”), with a reconciliation of the numerator and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. Basic EPS excludes dilution. Diluted EPS reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that are then sharing in the earnings of the entity. Basic net loss per share of common stock excludes dilution and is computed by dividing the net loss by the weighted average number of shares outstanding during the period. Diluted net loss per share of common stock reflects the potential dilution that could occur if securities or other contracts to issue common stock were exercised or converted into common stock or resulted in the issuance of common stock that then shared in the earnings of the entity unless inclusion of such shares would be anti-dilutive. The Company has only incurred losses, therefore, basic and diluted net loss per share is the same. Securities that could potentially dilute net income per share in the future that were not included in the computation of diluted loss per share were as follows: As of June 30, 2019 2018 Options to purchase common stock 8,187,161 6,806,001 Unvested restricted stock awards 146,800 480,000 Unvested restricted stock units 1,658,205 - Warrants to purchase common stock 2,770,781 - 12,762,947 7,286,001 |
Adoption of Recent Accounting Pronouncements | Adoption of Recent Accounting Pronouncements The Company continually assesses any new accounting pronouncements to determine their applicability. When it is determined that a new accounting pronouncement affects the Company’s financial reporting, the Company undertakes a review to determine the consequences of the change to its consolidated financial statements and assures that there are sufficient controls in place to ascertain that the Company’s consolidated financial statements properly reflect the change. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) , which amended the guidance on accounting for leases. The FASB issued this update to increase transparency and comparability among organizations. This update requires the recognition of lease assets and lease liabilities on the balance sheet and the disclosure of key information about leasing arrangements. The Company adopted this ASU effective January 1, 2019 using the additional (optional) approach by recording a right-of-use asset and a lease liability of approximately $3.5 million. Our adoption of this ASU had no effect on opening retained earnings, and the Company continues to account for leases in the prior period consolidated financial statements under ASC Topic 840. In adopting the new standard, the Company elected to apply the practical expedients regarding identification of leases, lease classification, indirect costs, and the combination of lease and non-lease components. In June 2018, the FASB issued ASU 2018-17, Improvements to Nonemployee Share-Based Payment Accounting, which simplifies the accounting for share-based payments granted to nonemployees for goods and services. Under ASU 2018-17, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. The amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than an entity’s adoption of Topic 606. The Company adopted this new standard on January 1, 2019 and the adoption did not have a material impact on its condensed consolidated financial statements and related disclosures. |
Basis of Presentation, Summar_3
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements | |
Summary of potentially dilutive securities | As of June 30, 2019 2018 Options to purchase common stock 8,187,161 6,806,001 Unvested restricted stock awards 146,800 480,000 Unvested restricted stock units 1,658,205 - Warrants to purchase common stock 2,770,781 - 12,762,947 7,286,001 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Revenue Recognition | |
Disaggregation Of Revenue | In thousands of US dollars ($) Three Months Ended June 30, 2019 Six Months Ended June 30, 2019 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues Product Sales – Point-in-time $ 15 $ 15 $ — $ 15 $ 15 $ — License Fee – Over time 68 — 68 136 — 136 Total Drug Products 83 15 68 151 15 136 Concentrate Products Product Sales – Point-in-time 14,268 12,822 1,446 29,264 25,746 3,518 License Fee – Over time 495 495 — 990 990 — Total Concentrate Products 14,763 13,317 1,446 30,254 26,736 3,518 Net Revenue $ 14,846 $ 13,332 $ 1,514 $ 30,405 $ 26,751 $ 3,654 Three Months Ended June 30, 2018 Six Months Ended June 30, 2018 Products By Geographic Area Total U.S. Rest of World Total U.S. Rest of World Drug Revenues License Fee – Over time $ 68 — $ 68 $ 136 — $ 136 Concentrate Products Product Sales – Point-in-time 14,340 12,856 1,484 28,717 25,329 3,388 License Fee – Over time 505 505 — 1,009 1,009 — Total Concentrate Products 14,845 13,361 1,484 29,726 26,338 3,388 Net Revenue $ 14,913 $ 13,361 $ 1,552 $ 29,862 $ 26,338 $ 3,524 |
Contract Balances | In thousands of US dollars ($) June 30, 2019 December 31, 2018 Receivables, which are included in "Trade and other receivables" $ 5,389 $ 6,980 Contract liabilities $ 13,203 $ 14,329 |
Investments - Available-for-S_2
Investments - Available-for-Sale (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Investments - Available-for-Sale | |
Investments Available for Sale | June 30, 2019 Amortized Cost Unrealized Gain Unrealized Loss Fair Value Available-for-Sale Securities Bonds $ 13,797,120 $ 21,759 $ (2,800) $ 13,816,079 December 31, 2018 Amortized Cost Unrealized Gain Unrealized Loss Fair Value Available-for-Sale Securities Bonds $ 10,801,836 $ 17,415 $ (1,192) $ 10,818,059 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Inventory | |
Schedule components of inventory | June 30, December 31, 2019 2018 Raw Materials $ 3,361,556 $ 3,621,548 Work in Process 244,743 256,129 Finished Goods 1,811,338 1,798,101 Total $ 5,417,637 $ 5,675,778 |
Property And Equipment (Tables)
Property And Equipment (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Property and Equipment | |
Schedule of major classes of property and equipment, stated at cost | June 30, December 31, 2019 2018 Leasehold Improvements $ 1,105,811 $ 929,849 Machinery and Equipment 4,705,917 4,800,774 Information Technology & Office Equipment 1,720,845 2,459,832 Laboratory Equipment 653,075 668,977 8,185,648 8,859,432 Accumulated Depreciation (5,622,220) (6,221,139) Net Property and Equipment $ 2,563,428 $ 2,638,293 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accrued Liabilities | |
Schedule of accrued liabilities | June 30, December 31, 2019 2018 Accrued Research & Development Expense $ 101,064 $ 86,820 Accrued Compensation and Benefits 1,095,261 1,525,599 Accrued Legal Expenses 943,642 170,334 Accrued Marketing Expenses 236,793 5,000 Other Accrued Liabilities 1,694,581 3,342,008 Total Accrued Liabilities $ 4,071,341 $ 5,129,761 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |
Schedule of total stock-based compensation expense | Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Service based awards: Restricted stock awards $ - $ 1,012,171 $ - $ 1,271,902 Restricted stock units 427,472 - 771,823 - Stock option awards 547,139 353,161 1,199,163 539,433 974,611 1,365,332 1,970,986 1,811,335 Performance based awards: Restricted stock units 402,814 - 801,202 - Stock option awards 123,901 - 246,440 - 526,715 - 1,047,642 - Total $ 1,501,326 $ 1,365,332 $ 3,018,628 $ 1,811,335 |
Schedule of restricted stock award | A summary of the Company’s restricted stock awards during the six months ended June 30, 2019 is as follows: Weighted Average Grant-Date Number of Shares Fair Value Unvested at December 31, 2018 $ 5.70 Unvested at June 30, 2019 $ 5.70 A summary of the Company’s restricted stock awards during the six months ended June 30, 2018 is as follows: Weighted Average Grant-Date Number of Shares Fair Value Unvested at December 31, 2017 480,000 $ 7.27 Unvested at June 30, 2018 480,000 $ 7.27 |
Restricted stock units - Service based awards | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |
Schedule of restricted stock award | Weighted Average Grant-Date Number of Shares Fair Value Unvested at December 31, 2018 472,959 $ 4.32 Granted 199,938 4.45 Forfeited (3,650) 4.81 Unvested at June 30, 2019 669,247 $ 4.36 |
Restricted stock units - Performance based awards | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |
Schedule of restricted stock award | Weighted Average Grant-Date Number of Shares Fair Value Unvested at December 31, 2018 988,958 $ 4.48 Unvested at June 30, 2019 988,958 $ 4.48 |
Stock option awards - Service based awards | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |
Schedule of stock options activity | A summary of the Company’s service based stock option activity for the six months ended June 30, 2019 is as follows: Weighted Weighted Average Shares Average Remaining Aggregate Underlying Exercise Contractual Intrinsic Options Price Term Value Outstanding at December 31, 2018 7,856,480 $ 7.50 5.2 $ - Granted 523,105 $ 4.33 9.7 - Exercised (30,000) $ 4.93 - - Forfeited (550,549) 6.67 - - Outstanding at June 30, 2019 7,799,036 $ 7.36 5.4 $ 2,500 Exercisable at June 30, 2019 6,183,193 $ 8.16 4.3 $ - A summary of the Company’s service based stock option activity for the six months ended June 30, 2018 is as follows: Weighted Weighted Average Shares Average Remaining Aggregate Underlying Exercise Contractual Intrinsic Options Price Term Value Outstanding at December 31, 2017 6,906,001 $ 7.92 5.0 $ 976,335 Forfeited (100,000) $ 6.93 - Outstanding at June 30, 2018 6,806,001 $ 7.93 4.6 $ 629,680 Exercisable at June 30, 2018 6,578,161 $ 7.93 4.5 $ 629,680 |
Schedule of Stock Option Assumptions | June 30, 2019 Exercise price $2.96 - $6.21 Expected stock price volatility 67.5% - 70.3% Risk-free interest rate 1.9% - 2.6% Term (years) 5.5 -6.5 |
Stock option awards - Performance based awards | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |
Schedule of stock options activity | Weighted Average Exercise Number of Shares Price Outstanding at December 31, 2018 388,125 $ 4.70 Outstanding at June 30, 2019 388,125 $ 4.70 Exercisable at June 30, 2019 - $ - |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Leases | |
Summary of Operating Leases | Three Months Ended Six Months Ended June 30, 2019 June 30, 2019 Operating leases Operating lease cost $ 554,921 $ 1,089,888 Variable lease cost 78,237 168,081 Operating lease expense 633,158 1,257,969 Short-term lease rent expense 4,122 8,313 Total rent expense $ 637,280 $ 1,266,282 Other information Operating cash flows from operating leases $ 514,116 $ 1,038,081 Right of use assets exchanged for operating lease liabilities $ 821,195 $ 4,305,428 Weighted-average remaining lease term – operating leases 2.6 2.6 Weighted-average discount rate – operating leases |
Future Minimum Rental Payments Under Operating Leases | Six months ended June 30, 2019 $ 944,466 Year ending December 31, 2020 1,394,778 Year ending December 31, 2021 772,616 Year ending December 31, 2022 308,167 Year ending December 31, 2023 174,896 Year ending December 31, 2024 65,119 Total $ 3,660,042 Less present value discount (332,251) Operating lease liabilities $ 3,327,791 |
Liquidity and Capital Resourc_2
Liquidity and Capital Resources (Details) - USD ($) | Jul. 09, 2019 | Jun. 20, 2019 | Jun. 17, 2019 | Mar. 22, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Cash and Cash Equivalents | $ 21,417,159 | $ 1,748,135 | $ 22,713,980 | $ 8,406,917 | ||||
Investments Available-for -Sale | 13,816,079 | 10,818,059 | ||||||
Working Capital Net | 33,400,000 | |||||||
Accumulated Deficit | (291,358,764) | $ (272,388,234) | ||||||
Net cash used in operating activities | $ (15,778,417) | $ (9,856,940) | ||||||
Common stock, no par value( per share) | $ 0 | |||||||
Sales Agreement, Threshold Sale Of Shares | $ 40,000,000 | |||||||
Maximum | ||||||||
Sales Agreement, Threshold Sale Of Shares | $ 40,000,000 | |||||||
Public Offering [Member] | ||||||||
Number of shares issued | 5,833,334 | |||||||
Price per share | $ 3 | |||||||
Over allotment | ||||||||
Sales Agreement, Threshold Sale Of Shares | $ 875,000 | |||||||
Subsequent event | ||||||||
Number of shares issued | 425,880 | |||||||
Subsequent event | Over allotment | ||||||||
Number of shares issued | 425,800 | |||||||
Price per share | $ 3 |
Basis of Presentation, Summar_4
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Loss Per Share (Details) - shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation | 12,762,947 | 7,286,001 |
Employee stock options | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation | 8,187,161 | 6,806,001 |
Restricted stock awards | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation | 146,800 | 480,000 |
Restricted stock units | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation | 1,658,205 | |
Warrants | ||
Net Earnings per Share | ||
Securities excluded from diluted loss per share calculation | 2,770,781 |
Basis of Presentation, Summar_5
Basis of Presentation, Summary of Significant Accounting Policies and Recent Accounting Pronouncements - Adoption of Recent Accounting Pronouncements (Details) - USD ($) | Jun. 30, 2019 | Jan. 01, 2019 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease Right of use assets | $ 3,329,481 | |
Operating lease liabilities | $ 3,327,791 | |
ASU 2016-02 | ||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||
Operating lease Right of use assets | $ 3,500,000 | |
Operating lease liabilities | $ 3,500,000 |
Revenue Recognition - Nature of
Revenue Recognition - Nature of goods and services (Details) | 6 Months Ended |
Jun. 30, 2019agreement | |
Revenue Recognition | |
Number of distribution and license agreements | 2 |
Customers average payment term | 30 days |
Distributors average payment term | 45 days |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | $ 14,845,788 | $ 14,913,363 | $ 30,405,227 | $ 29,861,943 |
Concentrate Products [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 14,763,000 | 14,845,000 | 30,254,000 | 29,726,000 |
Drug Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 83,000 | 151,000 | ||
Product License Agreements | Drug Revenue [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 68,000 | 68,000 | 136,000 | 136,000 |
Product License Agreements | Concentrate Products [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 495,000 | 505,000 | 990,000 | 1,009,000 |
Product Sales [Member] | Drug Revenue [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 15,000 | 15,000 | ||
Product Sales [Member] | Concentrate Products [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 14,268,000 | 14,340,000 | 29,264,000 | 28,717,000 |
United States | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 13,332,000 | 13,361,000 | 26,751,000 | 26,338,000 |
United States | Concentrate Products [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 13,317,000 | 13,361,000 | 26,736,000 | 26,338,000 |
United States | Drug Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 15,000 | 15,000 | ||
United States | Product License Agreements | Concentrate Products [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 495,000 | 505,000 | 990,000 | 1,009,000 |
United States | Product Sales [Member] | Drug Revenue [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 15,000 | 15,000 | ||
United States | Product Sales [Member] | Concentrate Products [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 12,822,000 | 12,856,000 | 25,746,000 | 25,329,000 |
Rest of World | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 1,514,000 | 1,552,000 | 3,654,000 | 3,524,000 |
Rest of World | Concentrate Products [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 1,446,000 | 1,484,000 | 3,518,000 | 3,388,000 |
Rest of World | Drug Products | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 68,000 | 136,000 | ||
Rest of World | Product License Agreements | Drug Revenue [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | 68,000 | 68,000 | 136,000 | 136,000 |
Rest of World | Product Sales [Member] | Concentrate Products [Member] | ||||
Disaggregation of Revenue [Line Items] | ||||
Net Revenue | $ 1,446,000 | $ 1,484,000 | $ 3,518,000 | $ 3,388,000 |
Revenue Recognition - Contract
Revenue Recognition - Contract Balances (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Revenue Recognition | ||
Other Receivables | $ 5,389 | $ 6,980 |
Contract liabilities | $ 13,203 | $ 14,329 |
Revenue Recognition - Narrative
Revenue Recognition - Narrative (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Revenue Recognition [Line Items] | |||||
Impairment losses | $ 0 | $ 0 | $ 0 | $ 0 | |
Bad-debt expense | 0 | $ 0 | 0 | $ 0 | |
Contract assets | 0 | 0 | $ 0 | ||
Revenue performance obligation | 13,200,000 | $ 13,200,000 | |||
Remaining performance obligation practical expedient | true | ||||
Concentrate Products [Member] | |||||
Revenue Recognition [Line Items] | |||||
Reserve for returns | 0 | $ 0 | $ 0 | ||
Baxter Healthcare Organization | |||||
Revenue Recognition [Line Items] | |||||
Revenue performance obligation | $ 10,100,000 | $ 10,100,000 |
Investments - Available-for-S_3
Investments - Available-for-Sale (Details) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2019 | Dec. 31, 2018 | |
Investments - Available-for-Sale | ||
Investment securities available for sale | $ 13,797,120 | $ 10,801,836 |
Unrealized gains | 21,759 | 17,415 |
Unrealized losses | (2,800) | (1,192) |
Fair value of investments | $ 13,816,079 | $ 10,818,059 |
Inventory (Details)
Inventory (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | |
Inventory [Line Items] | ||
Raw Materials | $ 3,361,556 | $ 3,621,548 |
Work in Process | 244,743 | 256,129 |
Finished Goods | 1,811,338 | 1,798,101 |
Total | 5,417,637 | 5,675,778 |
Inventory, Noncurrent | 1,445,000 | 1,637,000 |
Inventory | 3,972,637 | 4,038,778 |
Triferic Finished Goods | ||
Inventory [Line Items] | ||
Inventory, Noncurrent | 1,400,000 | 1,600,000 |
Inventory | 1,800,000 | |
finished goods sellable through 2020 | 400,000 | |
finished goods sellable through 2023 | 1,400,000 | |
Triferic Finished And Raw Goods [Member] | ||
Inventory [Line Items] | ||
Finished goods inventory | 3,500,000 | 8,000,000 |
Inventory reserve | $ 1,700,000 | $ 5,800,000 |
Property And Equipment (Details
Property And Equipment (Details) - USD ($) | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Property and equipment | |||||
Gross Property and Equipment | $ 8,185,648 | $ 8,185,648 | $ 8,859,432 | ||
Accumulated Depreciation | (5,622,220) | (5,622,220) | (6,221,139) | ||
Property, Plant and Equipment, Net, Total | 2,563,428 | 2,563,428 | 2,638,293 | ||
Depreciation expense | 200,000 | $ 200,000 | 400,000 | $ 300,000 | |
Leasehold Improvements | |||||
Property and equipment | |||||
Gross Property and Equipment | 1,105,811 | 1,105,811 | 929,849 | ||
Machinery and Equipment | |||||
Property and equipment | |||||
Gross Property and Equipment | 4,705,917 | 4,705,917 | 4,800,774 | ||
Information Technology & Office Equipment | |||||
Property and equipment | |||||
Gross Property and Equipment | 1,720,845 | 1,720,845 | 2,459,832 | ||
Laboratory Equipment | |||||
Property and equipment | |||||
Gross Property and Equipment | $ 653,075 | $ 653,075 | $ 668,977 |
Accrued Liabilities (Details)
Accrued Liabilities (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Accrued Liabilities | ||
Accrued Research & Development Expense | $ 101,064 | $ 86,820 |
Accrued Compensation and Benefits | 1,095,261 | 1,525,599 |
Accrued Legal Expenses | 943,642 | 170,334 |
Accrued Marketing Expenses | 236,793 | 5,000 |
Other Accrued Liabilities | 1,694,581 | 3,342,008 |
Total Accrued Liabilities | $ 4,071,341 | $ 5,129,761 |
Insurance Financing Note Paya_2
Insurance Financing Note Payable (Details) - USD ($) | Jul. 03, 2019 | Jun. 30, 2019 | Jun. 03, 2019 |
Subsequent Event [Line Items] | |||
Short-term note payable | $ 1,900,000 | ||
Interest rate per annum | 4.65% | ||
Insurance Financing Note Payable | $ 1,908,554 | ||
Subsequent event | |||
Subsequent Event [Line Items] | |||
Amortization period (in months) | 10 months |
Deferred Revenue (Details)
Deferred Revenue (Details) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Oct. 31, 2014 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2016 | Dec. 31, 2018 | |
Deferred Revenue Arrangement [Line Items] | |||||||
Upfront payment | $ 4 | ||||||
Wanbang Biopharmaceutical | |||||||
Deferred Revenue Arrangement [Line Items] | |||||||
Distribution agreement term | 10 years | ||||||
Recognized deferred revenue | $ 0.1 | $ 0.1 | $ 0.2 | $ 0.2 | |||
Deferred Revenue | 3 | 3 | $ 3.2 | ||||
Baxter Healthcare Organization | |||||||
Deferred Revenue Arrangement [Line Items] | |||||||
Upfront payment | $ 20 | ||||||
Recognized deferred revenue | 0.5 | $ 0.5 | 1 | $ 1 | |||
Deferred Revenue | $ 10.1 | $ 10.1 | $ 11.1 | ||||
Deferred Revenue Benefit Percentage | 25.00% | ||||||
Partial Refund | $ 6.6 |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) | Jul. 09, 2019 | Jun. 20, 2019 | Jun. 17, 2019 | Mar. 22, 2019 | Apr. 30, 2019 | Jun. 30, 2019 | Jun. 30, 2019 | Jul. 30, 2019 | Jun. 25, 2019 | Dec. 31, 2018 |
Preferred Stock | ||||||||||
Preferred stock, Outstanding | 0 | 0 | 0 | |||||||
Preferred stock, Authorized | 2,000,000 | 2,000,000 | 2,000,000 | |||||||
Preferred Stock, Shares Issued | 0 | 0 | 0 | |||||||
Common Stock | ||||||||||
Common stock issued on exercise of stock options (in shares) | 30,000 | |||||||||
Amount of common stock issued on exercise of stock options | $ 147,900 | |||||||||
Exercised (in dollars per share) | $ 5.25 | $ 4.93 | ||||||||
Common shares sold | 437,043 | 63,398,704 | 63,398,704 | 57,034,154 | ||||||
Proceeds from the Issuance of Common Shares | $ 2,296,235 | |||||||||
Common Share Issuance Costs | $ 207,027 | |||||||||
Underwriter and legal fees | $ 1,379,323 | |||||||||
Common Stock, Par or Stated Value Per Share | $ 0 | |||||||||
Sales Agreement, Threshold Sale Of Shares | $ 40,000,000 | |||||||||
Maximum | ||||||||||
Common Stock | ||||||||||
Sales Agreement, Threshold Sale Of Shares | $ 40,000,000 | |||||||||
Restricted stock units | Officer [Member] | ||||||||||
Common Stock | ||||||||||
Vested (in shares) | 98,500 | |||||||||
Withheld common shares (in shares) | 34,327 | |||||||||
Cost of withheld common shares | $ 95,429 | |||||||||
Subsequent event | ||||||||||
Common Stock | ||||||||||
Proceeds from the Issuance of Common Shares | $ 1,200,000 | |||||||||
Issuance of Common Shares (in shares) | 425,880 | |||||||||
Public Offering [Member] | ||||||||||
Common Stock | ||||||||||
Proceeds from the Issuance of Common Shares | $ 17,500,002 | 17,500,002 | ||||||||
Common Share Issuance Costs | 1,379,323 | |||||||||
Share price | $ 3 | |||||||||
Issuance of common stock, net of issuance cost | $ 16,120,679 | $ 16,120,679 | ||||||||
Issuance of Common Shares (in shares) | 5,833,334 | |||||||||
Public Offering [Member] | Maximum | ||||||||||
Common Stock | ||||||||||
Number of common shares authorized | 6,708,334 | |||||||||
Over allotment | ||||||||||
Common Stock | ||||||||||
Sales Agreement, Threshold Sale Of Shares | $ 875,000 | |||||||||
Over allotment | Subsequent event | ||||||||||
Common Stock | ||||||||||
Share price | $ 3 | |||||||||
Issuance of Common Shares (in shares) | 425,800 | |||||||||
COMMON SHARES | ||||||||||
Common Stock | ||||||||||
Number of common shares authorized | 120,000,000 | 120,000,000 | 170,000,000 | |||||||
Increase of common shares authorized | 50,000,000 | |||||||||
Common stock issued on exercise of stock options (in shares) | 30,000 | |||||||||
COMMON SHARES | Subsequent event | ||||||||||
Common Stock | ||||||||||
Number of common shares authorized | 170,000,000 | |||||||||
COMMON SHARES | Public Offering [Member] | ||||||||||
Common Stock | ||||||||||
Issuance of common stock, net of issuance cost | $ 16,120,679 | $ 16,120,679 | ||||||||
Issuance of Common Shares (in shares) | 5,833,334 | 5,833,334 |
Stock-Based Compensation - Shar
Stock-Based Compensation - Share-based compensation expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | $ 1,501,326 | $ 1,365,332 | $ 3,018,628 | $ 1,811,335 |
Service based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 974,611 | 1,365,332 | 1,970,986 | 1,811,335 |
Restricted stock awards - Service based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 1,012,171 | 1,271,902 | ||
Restricted stock units - Service based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 427,472 | 771,823 | ||
Stock option awards - Service based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 547,139 | 353,161 | 1,199,163 | 539,433 |
Performance based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 526,715 | 1,047,642 | ||
Restricted stock units - Performance based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | 402,814 | 0 | 801,202 | 0 |
Stock option awards - Performance based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total share-based compensation expense | $ 123,901 | $ 0 | $ 246,440 | $ 0 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Awards (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Weighted Average Grant Date Fair Value | ||||||
Stock based compensation expenses | $ 1,501,326 | $ 1,365,332 | $ 3,018,628 | $ 1,811,335 | ||
Restricted stock awards | ||||||
Number of Shares | ||||||
Unvested, Number of Shares | 146,800 | 146,800 | 146,800 | |||
Weighted Average Grant Date Fair Value | ||||||
Unvested, Weighted Average Grant-Date Fair Value | $ 5.70 | $ 5.70 | $ 5.70 | |||
Vesting period | 20 months | |||||
Restricted stock awards - Performance based | ||||||
Number of Shares | ||||||
Unvested, Number of Shares | 146,800 | 480,000 | 146,800 | 480,000 | 480,000 | |
Weighted Average Grant Date Fair Value | ||||||
Unvested, Weighted Average Grant-Date Fair Value | $ 7.27 | $ 7.27 | $ 7.27 |
Stock-Based Compensation - Serv
Stock-Based Compensation - Service Based Restricted Stock Units (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Weighted Average Grant Date Fair Value | ||||
Stock based compensation expenses | $ 1,501,326 | $ 1,365,332 | $ 3,018,628 | $ 1,811,335 |
Restricted stock units - Service based awards | ||||
Number of Shares | ||||
Outstanding at beginning of period (in shares) | 472,959 | |||
Granted (in shares) | 0 | 0 | ||
Outstanding at end of period (in shares) | 669,247 | 669,247 | ||
Weighted Average Grant Date Fair Value | ||||
Outstanding at beginning of period (in dollars per share) | $ 4.32 | |||
Granted (in dollars per share) | 4.45 | |||
Forfeited (in dollars per share) | 4.81 | |||
Unvested, Weighted Average Grant-Date Fair Value | $ 4.36 | $ 4.32 | ||
Stock based compensation expenses | $ 400,000 | $ 0 | $ 800,000 | $ 0 |
Granted (in shares) | 0 | 0 | ||
Unrecognized stock-based compensation expenses | $ 1,800,000 | |||
Minimum | Restricted stock units - Service based awards | ||||
Weighted Average Grant Date Fair Value | ||||
Vesting period | 1 year | |||
Maximum | Restricted stock units - Service based awards | ||||
Weighted Average Grant Date Fair Value | ||||
Vesting period | 3 years |
Stock-Based Compensation - Perf
Stock-Based Compensation - Performance Based Restricted Stock Units (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Fair value assumptions: | ||||
Stock based compensation expenses | $ 1,501,326 | $ 1,365,332 | $ 3,018,628 | $ 1,811,335 |
Restricted stock units - Performance based awards | ||||
Number of Shares | ||||
Outstanding at beginning of period (in shares) | 988,958 | |||
Granted (in shares) | 0 | 0 | ||
Outstanding at end of period (in shares) | 988,958 | 988,958 | ||
Weighted Average Grant Date Fair Value | ||||
Outstanding at beginning of period (in dollars per share) | $ 4.48 | |||
Outstanding at end of period (in dollars per share) | $ 4.48 | $ 4.48 | ||
Fair value assumptions: | ||||
Stock based compensation expenses | $ 402,814 | $ 0 | $ 801,202 | $ 0 |
Granted (in shares) | 0 | 0 | ||
Unrecognized stock-based compensation expenses | $ 1,900,000 | $ 1,900,000 |
Stock-Based Compensation - Se_2
Stock-Based Compensation - Service Based Stock Options - Fair value assumptions (Details) - Stock option awards - Service based awards | 6 Months Ended |
Jun. 30, 2019$ / shares | |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ 2.96 |
Expected stock price volatility | 67.50% |
Risk-free interest rate | 1.90% |
Term (years) | 5 years 6 months |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Exercise price | $ 6.21 |
Expected stock price volatility | 70.30% |
Risk-free interest rate | 2.60% |
Term (years) | 6 years 6 months |
Stock-Based Compensation - Se_3
Stock-Based Compensation - Service Based Stock Options (Details) - USD ($) | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||
Apr. 30, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Shares Underlying Options | |||||
Granted (in shares) | 199,938 | ||||
Exercised (in shares) | (30,000) | ||||
Forfeited (in shares) | (3,650) | ||||
Weighted Average Exercise Price | |||||
Exercised (in dollars per share) | $ 5.25 | $ 4.93 | |||
Stock option awards - Service based awards | |||||
Shares Underlying Options | |||||
Outstanding at the beginning of the period (in shares) | 7,856,480 | 6,906,001 | 6,906,001 | ||
Granted (in shares) | 523,105 | ||||
Exercised (in shares) | (30,000) | ||||
Forfeited (in shares) | (550,549) | (100,000) | |||
Outstanding at the end of the period (in shares) | 7,799,036 | 6,806,001 | 7,856,480 | 6,906,001 | |
Exercisable, Shares underlying | 6,183,193 | 6,578,161 | |||
Weighted Average Exercise Price | |||||
Outstanding at the beginning of the period (in dollars per share) | $ 7.50 | $ 7.92 | $ 7.92 | ||
Granted (in dollars per share) | 4.33 | ||||
Exercised (in dollars per share) | 4.93 | ||||
Forfeited (in dollars per share) | 6.67 | 6.93 | |||
Outstanding at the end of the period (in dollars per share) | 7.36 | 7.93 | $ 7.50 | $ 7.92 | |
Exercise price (in dollars per share) | $ 8.16 | $ 7.93 | |||
Weighted Average Remaining Contractual Term | |||||
Outstanding, Weighted Average Remaining Contractual Term | 5 years 4 months 24 days | 4 years 7 months 6 days | 5 years 2 months 12 days | 5 years | |
Granted, Weighted Average Remaining Contractual Term | 9 years 8 months 12 days | ||||
Exercisable, Weighted Average Remaining Contractual Term | 4 years 3 months 18 days | 4 years 6 months | |||
Aggregate intrinsic Value | |||||
Outstanding (in dollars) | $ 2,500 | $ 629,680 | $ 976,335 | ||
Intrinsic Value (in dollars) | $ 629,680 |
Stock-Based Compensation - Se_4
Stock-Based Compensation - Service Based Stock Options - Others (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated Share-based Compensation Expense | $ 1,501,326 | $ 1,365,332 | $ 3,018,628 | $ 1,811,335 |
Stock option awards - Service based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Allocated Share-based Compensation Expense | 547,139 | $ 353,161 | 1,199,163 | $ 539,433 |
Unrecognized stock-based compensation expenses | $ 2,800,000 | $ 2,800,000 | ||
Employee stock options | Stock option awards - Service based awards | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Granted (in shares) | 523,105 |
Stock-Based Compensation - Pe_2
Stock-Based Compensation - Performance Based Stock Options (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Number of Shares | ||||
Granted (in shares) | 199,938 | |||
Fair value assumptions: | ||||
Stock based compensation expenses | $ 1,501,326 | $ 1,365,332 | $ 3,018,628 | $ 1,811,335 |
Granted (in shares) | 199,938 | |||
Stock option awards - Performance based awards | ||||
Number of Shares | ||||
Outstanding at the beginning of the period (in shares) | 388,125 | |||
Granted (in shares) | 0 | 0 | ||
Outstanding at the end of the period (in shares) | 388,125 | 388,125 | ||
Weighted Average Exercise Price | ||||
Outstanding at the beginning of the period (in dollars per share) | $ 4.70 | |||
Outstanding at the end of the period (in dollars per share) | $ 4.70 | $ 4.70 | ||
Fair value assumptions: | ||||
Stock based compensation expenses | $ 123,901 | $ 0 | $ 246,440 | $ 0 |
Granted (in shares) | 0 | 0 | ||
Unrecognized stock-based compensation expenses | $ 700,000 | $ 700,000 |
Related Party Transactions (Det
Related Party Transactions (Details) | Oct. 07, 2018USD ($)installmentitem | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2019USD ($) | Jun. 30, 2018USD ($) | Dec. 31, 2018USD ($) | Jul. 15, 2019USD ($) | Apr. 15, 2019USD ($) | Jan. 15, 2019USD ($) | Oct. 15, 2018USD ($) |
Settlement expense | $ 430,000 | $ 1,030,000 | $ 430,000 | $ 1,030,000 | ||||||
Number of additional agreements | item | 3 | |||||||||
Product development and research costs | $ 1,100,000 | |||||||||
Master services and IP agreements | ||||||||||
Payments to acquire assets | 1,100,000 | |||||||||
Milestone payments | 0 | 0 | ||||||||
Executive Vice President and Chief Scientific Officer [Member] | ||||||||||
Total amount due | $ 1,000,000 | 350,000 | 350,000 | $ 850,000 | $ 250,000 | $ 250,000 | $ 250,000 | $ 250,000 | ||
Number of quarterly installment payments | installment | 4 | |||||||||
Installment paid | 750,000 | |||||||||
Related Party Transactions Accrued Reimbursement of Legal Expenses | $ 100,000 | $ 100,000 |
Leases - Narrative (Details)
Leases - Narrative (Details) | Jun. 30, 2019USD ($)ft² |
Lessee, Lease, Description [Line Items] | |
Operating lease liabilities | $ | $ 3,327,791 |
Operating lease Right of use assets | $ | $ 3,329,481 |
Grapevine, Texas | |
Lessee, Lease, Description [Line Items] | |
Facility sqft. | 51,000 |
Hackensack, New Jersey | |
Lessee, Lease, Description [Line Items] | |
Facility sqft. | 4,100 |
Lease Facility One | Wixom, Michigan | |
Lessee, Lease, Description [Line Items] | |
Facility sqft. | 51,000 |
Lease Facility One | Greer, South Carolina | |
Lessee, Lease, Description [Line Items] | |
Facility sqft. | 57,000 |
Lease Facility Two | Wixom, Michigan | |
Lessee, Lease, Description [Line Items] | |
Facility sqft. | 17,500 |
Lease Facility Two | Greer, South Carolina | |
Lessee, Lease, Description [Line Items] | |
Facility sqft. | 1,408 |
Minimum | |
Lessee, Lease, Description [Line Items] | |
Lease Term | 1 month |
Maximum | |
Lessee, Lease, Description [Line Items] | |
Lease Term | 7 years |
Leases - Summary of Operating L
Leases - Summary of Operating Leases (Details) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2019USD ($) | Jun. 30, 2019USD ($) | |
Leases | ||
Operating lease cost | $ 554,921 | $ 1,089,888 |
Variable lease cost | 78,237 | 168,081 |
Operating lease expense | 633,158 | 1,257,969 |
Short-term lease rent expense | 4,122 | 8,313 |
Total rent expense | 637,280 | 1,266,282 |
Operating cash flows from operating leases | 514,116 | 1,038,081 |
Right of use assets exchanged for operating lease liabilities | $ 821,195 | $ 4,305,428 |
Weighted-average remaining lease term – operating leases | 2 years 7 months 6 days | 2 years 7 months 6 days |
Weighted-average discount rate – operating leases | 6.80% | 6.80% |
Leases - Future Minimum Rental
Leases - Future Minimum Rental Payments Under Operating Leases (Details) | Jun. 30, 2019USD ($) |
Leases | |
Six months ended June 30, 2019 | $ 944,466 |
Year ending December 31, 2020 | 1,394,778 |
Year ending December 31, 2021 | 772,616 |
Year ending December 31, 2022 | 308,167 |
Year ending December 31, 2023 | 174,896 |
Year ending December 31, 2023 | 65,119 |
Total | 3,660,042 |
Less present value discount | (332,251) |
Operating lease liabilities | $ 3,327,791 |
Settlement Agreement (Details)
Settlement Agreement (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Loss Contingencies [Line Items] | ||||
Settlement expense | $ 430,000 | $ 1,030,000 | $ 430,000 | $ 1,030,000 |
Confidential Settlement Agreement | ||||
Loss Contingencies [Line Items] | ||||
Litigation settlement amount | $ 1,000,000 | |||
Settlement Agreement with All Parties | ||||
Loss Contingencies [Line Items] | ||||
Settlement expense | $ 400,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) | Aug. 01, 2019 | Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 |
Loss Contingencies [Line Items] | |||||
Settlement expense | $ 430,000 | $ 1,030,000 | $ 430,000 | $ 1,030,000 | |
Self insurance retention | 1,000,000 | ||||
Settlement Agreement with All Parties | |||||
Loss Contingencies [Line Items] | |||||
Settlement expense | $ 400,000 | ||||
Subsequent event | |||||
Loss Contingencies [Line Items] | |||||
Litigation settlement amount | $ 3,700,000 |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | Jul. 09, 2019 | Apr. 30, 2019 |
SUBSEQUENT EVENTS | ||
Proceeds from Issuance of Common Stock | $ 2,296,235 | |
Subsequent event | ||
SUBSEQUENT EVENTS | ||
Number of shares issued | 425,880 | |
Proceeds from Issuance of Common Stock | $ 1,200,000 | |
Over allotment | Subsequent event | ||
SUBSEQUENT EVENTS | ||
Number of shares issued | 425,800 |