Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | May 15, 2023 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Document Period End Date | Mar. 31, 2023 | |
Entity File Number | 001-36714 | |
Entity Registrant Name | JAGUAR HEALTH, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 46-2956775 | |
Entity Address, Address Line One | 200 Pine Street, Suite 400 | |
Entity Address, City or Town | San Francisco | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 94104 | |
City Area Code | 415 | |
Local Phone Number | 371-8300 | |
Title of 12(b) Security | Common Stock, Par Value $0.0001 Per Share | |
Trading Symbol | JAGX | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001585608 | |
Amendment Flag | false | |
Common stock - voting | ||
Document and Entity Information | ||
Entity Common Stock, Shares Outstanding | 19,105,622 | |
Common stock - non-voting | ||
Document and Entity Information | ||
Entity Common Stock, Shares Outstanding | 9 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash | $ 14,367 | $ 5,469 |
Accounts receivable | 987 | 1,879 |
Other receivable | 457 | 588 |
Inventory | 8,684 | 7,024 |
Prepaid expenses and other current assets | 7,866 | 7,361 |
Total current assets | 32,361 | 22,321 |
Property and equipment, net | 541 | 557 |
Operating lease - right-of-use asset | 1,062 | 1,140 |
Intangible assets, net | 21,951 | 22,439 |
Other assets | 1,012 | 995 |
Total assets | 56,927 | 47,452 |
Current liabilities: | ||
Accounts payable | 5,692 | 5,808 |
Accrued liabilities | 9,280 | 8,165 |
Operating lease liability, current | 503 | 483 |
Notes payable, current | 15,621 | 15,883 |
Total current liabilities | 31,096 | 30,339 |
Operating lease liability, net of current portion | 627 | 725 |
Notes payable, net of discount, net of current portion (includes hybrid instrument designated at Fair Value Option amounting to $8.2 million as of March 31, 2023 and $7.8 million December 31, 2022, respectively) | 17,544 | 17,744 |
Total liabilities | 49,267 | 48,808 |
Commitments and contingencies (See Note 5) | ||
Stockholders' equity (deficit) | ||
Additional paid-in capital | 287,383 | 266,971 |
Noncontrolling interest | 310 | (699) |
Accumulated deficit | (279,150) | (266,948) |
Accumulated other comprehensive loss | (884) | (680) |
Total Stockholders' equity (deficit) | 7,660 | (1,356) |
Total liabilities and Stockholders' equity (deficit) | 56,927 | 47,452 |
Series B-2 Preferred Stock | ||
Stockholders' equity (deficit) | ||
Preferred stock value | ||
Series C perpetual preferred stock | ||
Stockholders' equity (deficit) | ||
Preferred stock value | ||
Series E perpetual preferred stock | ||
Stockholders' equity (deficit) | ||
Preferred stock value | ||
Common stock - voting | ||
Stockholders' equity (deficit) | ||
Common stock value | 1 | |
Common stock - non-voting | ||
Stockholders' equity (deficit) | ||
Common stock value |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Preferred stock, shares authorized | 5,496,239 | 5,496,239 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Notes payable, net of current portion (includes hybrid instrument designated at Fair Value Option) | $ 8,198 | $ 7,800 |
Series B-2 Preferred Stock | ||
Convertible preferred stock, shares authorized | 10,165 | 10,165 |
Convertible preferred stock, shares issued | 0 | 0 |
Convertible preferred stock, shares outstanding | 0 | 0 |
Preferred stock, shares authorized | 10,165 | 10,165 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Series C perpetual preferred stock | ||
Preferred stock, shares authorized | 1,011,000 | 1,011,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Series E perpetual preferred stock | ||
Preferred stock, shares authorized | 4,475,074 | 4,475,074 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common Stock | Common stock - voting | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 298,000,000 | 298,000,000 |
Common stock, shares issued | 14,175,741 | 2,182,084 |
Common stock, shares outstanding | 14,175,741 | 2,182,084 |
Common Stock | Common stock - non-voting | ||
Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 2,120,786 | 2,120,786 |
Common stock, shares outstanding | 2,120,786 | 2,120,786 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Operating expenses | ||
Cost of product revenue | $ 345 | $ 455 |
Research and development | 4,775 | 4,945 |
Sales and marketing | 1,884 | 2,835 |
General and administrative | 4,813 | 6,144 |
Total operating expenses | 11,817 | 14,379 |
Loss from operations | (9,845) | (11,754) |
Interest expense | (2,181) | (4,194) |
Loss on extinguishment of debt | 0 | (2,815) |
Change in fair value of financial instruments and hybrid instrument designated at Fair Value Option | (359) | (233) |
Other income (expense) | (12) | 832 |
Loss before income tax | (12,397) | (18,164) |
Income tax expense | ||
Net loss | (12,397) | (18,164) |
Net loss attributable to noncontrolling interest | (195) | (178) |
Net loss attributable to common stockholders | (12,202) | (17,986) |
Net loss attributable to common shareholders (diluted) | $ (12,202) | $ (17,986) |
Net loss per share, basic | $ (2.39) | $ (23.10) |
Net loss per share, diluted | $ (2.39) | $ (23.10) |
Weighted-average common shares outstanding, basic | 5,109,609 | 778,512 |
Weighted-average common shares outstanding, diluted | 5,109,609 | 778,512 |
Product revenue | ||
Revenue | ||
Total revenue | $ 1,972 | $ 2,625 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSSES - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS | ||
Net loss | $ (12,397) | $ (18,164) |
Other comprehensive loss | (232) | |
Net comprehensive loss | (12,629) | (18,164) |
Common stockholders: | ||
Net loss attributable to common stockholders | (12,202) | (17,986) |
Other comprehensive loss attributable to common stockholders | ||
Translation adjustments | (204) | |
Net loss and comprehensive loss attributable to common stockholders | (12,406) | (17,986) |
Comprehensive Income (Loss), Net of Tax, Attributable to Noncontrolling Interest [Abstract] | ||
Net loss attributable to non-controlling interests | (195) | (178) |
Other comprehensive loss attributable to non-controlling interests | ||
Translation adjustments | (28) | |
Net loss and comprehensive loss attributable to non-controlling interests | $ (223) | $ (178) |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY - USD ($) | At The Market Offering Common Stock Common stock - voting | At The Market Offering Additional paid-in capital | At The Market Offering | Common Stock Common stock - voting Iliad | Common Stock Common stock - voting Irving | Common Stock Common stock - voting | Common Stock Common stock - non-voting | Additional paid-in capital Iliad | Additional paid-in capital Irving | Additional paid-in capital | Noncontrolling Interest | Accumulated deficit | Accumulated other comprehensive loss | Iliad | Irving | Total |
Beginning Balance at Dec. 31, 2021 | $ 231,105,000 | $ 242,000 | $ (219,494,000) | $ 11,853,000 | ||||||||||||
Beginning Balance (in shares) at Dec. 31, 2021 | 644,700 | 2,120,786 | ||||||||||||||
Increase (decrease) in Stockholders' Equity (Deficit) | ||||||||||||||||
Issuance of common stock | $ 9,111,000 | $ 9,111,000 | ||||||||||||||
Issuance of common stock (In shares) | 267,286 | |||||||||||||||
Shares issued to third party for services | 14,000 | 14,000 | ||||||||||||||
Shares issued to third party for services (in shares) | 333 | |||||||||||||||
Shares issued in exchange of notes payable and accrued interest | $ 4,233,000 | $ 4,233,000 | ||||||||||||||
Shares issued in exchange of notes payable and accrued interest (in shares) | 115,333 | |||||||||||||||
Stock-based compensation | 1,063,000 | 1,063,000 | ||||||||||||||
Net loss | (178,000) | (17,986,000) | (18,164,000) | |||||||||||||
Translation Loss | 0 | |||||||||||||||
Ending Balance at Mar. 31, 2022 | 245,526,000 | 64,000 | (237,480,000) | 8,110,000 | ||||||||||||
Ending Balance (in shares) at Mar. 31, 2022 | 1,027,652 | 2,120,786 | ||||||||||||||
Beginning Balance at Dec. 31, 2021 | 231,105,000 | 242,000 | (219,494,000) | 11,853,000 | ||||||||||||
Beginning Balance (in shares) at Dec. 31, 2021 | 644,700 | 2,120,786 | ||||||||||||||
Ending Balance at Dec. 31, 2022 | 266,971,000 | (699,000) | (266,948,000) | $ (680,000) | (1,356,000) | |||||||||||
Ending Balance (in shares) at Dec. 31, 2022 | 2,182,084 | 2,120,786 | ||||||||||||||
Increase (decrease) in Stockholders' Equity (Deficit) | ||||||||||||||||
Issuance of common stock | $ 1,000 | $ 17,864,000 | $ 17,865,000 | |||||||||||||
Issuance of common stock (In shares) | 10,463,983 | |||||||||||||||
Shares issued in exchange of notes payable and accrued interest | $ 1,275,000 | $ 627,000 | $ 1,275,000 | $ 627,000 | ||||||||||||
Shares issued in exchange of notes payable and accrued interest (in shares) | 1,370,005 | 150,000 | ||||||||||||||
Stock Issued During Period, Value, Third Party For Services | 166,000 | 166,000 | ||||||||||||||
Shares issued to other third party for services (in shares) | 9,669 | |||||||||||||||
Shares issued to other third party for services | 166,000 | 166,000 | ||||||||||||||
Additional investments from non-controlling interests | 1,232,000 | 1,232,000 | ||||||||||||||
Stock-based compensation | 480,000 | 480,000 | ||||||||||||||
Net loss | (195,000) | (12,202,000) | (12,397,000) | |||||||||||||
Translation Loss | (28,000) | (204,000) | (232,000) | |||||||||||||
Ending Balance at Mar. 31, 2023 | $ 1,000 | $ 287,383,000 | $ 310,000 | $ (279,150,000) | $ (884,000) | $ 7,660,000 | ||||||||||
Ending Balance (in shares) at Mar. 31, 2023 | 14,175,741 | 2,120,786 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
At The Market Offering | ||
Stock Transactions, Parenthetical Disclosures | ||
Issuance costs | $ 30 | $ 83 |
CONDENSED CONSOLIDATED STATEM_5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net loss and comprehensive loss | $ (12,629,000) | $ (18,164,000) |
Adjustments to reconcile net loss and comprehensive loss to net cash used in operating activities: | ||
Amortization of debt issuance costs, debt discount, and non-cash interest expense | 1,276,000 | 3,429,000 |
Depreciation and amortization expense | 504,000 | 426,000 |
Stock-based compensation, vested and released restricted stock units and exercised stock options | 480,000 | 1,063,000 |
Change in fair value of financial instruments and hybrid instrument designated at Fair Value Option | 359,000 | 233,000 |
Shares issued in exchange for services | 166,000 | 14,000 |
Amortization of operating lease - right-of-use-asset | 47,000 | 29,000 |
Loss on extinguishment of debt | 0 | 2,815,000 |
Equity in loss in joint venture | 31,000 | |
Changes in assets and liabilities | ||
Accounts receivable | 892,000 | (86,000) |
Other receivable | 138,000 | (117,000) |
Inventory | (1,660,000) | 22,000 |
Prepaid expenses and other current assets | (160,000) | 507,000 |
Other assets | (18,000) | (5,000) |
Accounts payable | (134,000) | (1,173,000) |
Accrued liabilities | 816,000 | 3,341,000 |
Operating lease liability | (53,000) | (29,000) |
Total cash used in operating activities | (9,945,000) | (7,695,000) |
Cash flows from investing activity | ||
Purchase of equipment | 0 | |
Costs incurred in software development activities | 0 | |
Total cash used in investing activity | 0 | |
Cash flows from financing activities | ||
Proceeds from issuance of shares in At the Market offering, net of issuance and offering costs of $30 and $83 in 2023 and 2022, respectively | 17,865,000 | 9,110,000 |
Proceeds from notes payable with Streeterville | 0 | (447,000) |
Payment of Tempesta Note | (50,000) | |
Repayment of insurance financing | (236,000) | (335,000) |
Investment from non-controlling interest | 1,232,000 | (178,000) |
Total cash provided by financing activities | 18,811,000 | 8,150,000 |
Effects of foreign exchange rate changes on assets and liabilities | 32,000 | (50,000) |
Net increase in cash | 8,898,000 | 405,000 |
Cash at beginning of the year | 5,469,000 | 17,051,000 |
Cash at end of the year | 14,367,000 | 17,456,000 |
Supplemental schedule of cash flow information | ||
Cash paid for interest | 6,000 | 11,000 |
Supplemental schedule of non-cash financing and investing activities | ||
Recognition of operating lease - right-of-use asset and operating lease liability | 30,000 | 90,000 |
Iliad | ||
Supplemental schedule of non-cash financing and investing activities | ||
Shares issued in exchange of notes payable and accrued interest | 1,275,000 | $ 4,233,000 |
Irving | ||
Supplemental schedule of non-cash financing and investing activities | ||
Shares issued in exchange of notes payable and accrued interest | $ 627,000 |
CONDENSED CONSOLIDATED STATEM_6
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
At The Market Offering | ||
Issuance costs | $ 30 | $ 83 |
Organization and Business
Organization and Business | 3 Months Ended |
Mar. 31, 2023 | |
Organization and Business | |
Organization and Business | 1. Organization and Business Jaguar Health, Inc. (“Jaguar” or the “Company”) was founded in San Francisco, California as a Delaware corporation on June 6, 2013 (inception). The Company was a majority-owned subsidiary of Napo until the close of the Company's initial public offering on May 18, 2015. The Company was formed to develop and commercialize first-in-class prescription and non-prescription products for companion animals. On July 31, 2017, Jaguar completed a merger with Napo pursuant to the Agreement and Plan of Merger dated March 31, 2017, by and among Jaguar, Napo, Napo Acquisition Corporation (“Merger Sub”), and Napo's representative (the “Merger Agreement”). In accordance with the terms of the Merger Agreement, upon the completion of the merger, Merger Sub merged with and into Napo, with Napo surviving as the wholly owned subsidiary (the “Merger” or “Napo Merger”). Immediately following the Merger, Jaguar changed its name from “Jaguar Animal Health, Inc.” to “Jaguar Health, Inc.” Napo now operates as a wholly owned subsidiary of Jaguar focused on human health including the ongoing development of crofelemer and commercialization of Mytesi. On March 15, 2021, Jaguar established Napo EU S.p.A (which changed its name in December 2021 to “Napo Therapeutics”) in Milan, Italy as a subsidiary of Napo. Napo Therapeutics’ core mission is to provide access to crofelemer in Europe to address significant rare/orphan disease indications, including, initially, two key orphan target indications: Short bowel syndrome (“SBS”) with intestinal failure and congenital diarrheal disorders (“CDD”). The Company manages its operations through two segments – human health and animal health – and is headquartered in San Francisco, California. Nasdaq Communication and Compliance Minimum Bid Price Requirement On February 18, 2022, the Company received a letter from the Staff of Nasdaq indicating that the bid price of the Company’s common stock for the last 30 consecutive business days had again closed below the minimum $1.00 per share required for the continued listing under Nasdaq Listing Rule 5550(a)(2). On January 23, 2023, the Company effected a one-for-seventy-five reverse split of the Company’s issued and outstanding shares of common stock, par value $0.0001 per share. As a result of the Reverse Split every seventy-five shares of common stock issued and outstanding were automatically combined into one share of issued and outstanding common stock, without any change in the par value per share. All information related to Common Stock, stock options, restricted stock units, warrants and earnings per share have been retroactively adjusted to give effect to the Reverse Stock Split for all periods presented. On February 7, 2023, the Company received a letter from the Nasdaq Office of General Counsel notifying that the minimum bid price deficiency had been cured and that the Nasdaq had determined to continue listing the Company’s common stock on the Nasdaq Stock Market. Liquidity and Going Concern The Company, since its inception, has incurred recurring operating losses and negative cash flows from operations and has an accumulated deficit of $279.2 million as of March 31, 2023. The Company expects to incur substantial losses and negative cash flows in future periods. Further, the Company’s future operations, which include the satisfaction of current obligations, are dependent on the success of the Company’s ongoing development and commercialization efforts, as well as securing of additional financing and generating positive cash flows from operations. There is no assurance that the Company will have adequate cash balances to maintain its operations. Although the Company plans to finance its operations and cash flow needs through equity and/or debt financing, collaboration arrangements with other entities, license royalty agreements, as well as revenue from future product sales, the Company does not believe its current cash balances are sufficient to fund its operating plan through one year from the issuance of these unaudited condensed consolidated financial statements. The Company has an immediate need to raise cash. There can be no assurance that additional funding will be available to the Company on acceptable terms, or on a timely basis, if at all, or that the Company will generate sufficient cash from operations to adequately fund operating needs. If the Company is unable to obtain an adequate level of financing needed for the long-term development and commercialization of our products, the Company will need to curtail planned activities and reduce costs. Doing so will likely have an adverse effect on our ability to execute our business plan; accordingly, there is substantial doubt about the ability of the Company to continue in existence as a going concern. The accompanying unaudited condensed consolidated financial statements do not include any adjustments that might result from the outcome of these uncertainties. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Annual Report on Form 10-K for the year ended December 31, 2022. The condensed consolidated balance sheet at December 31, 2022 has been derived from the audited consolidated financial statements at that date, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. There has been no material change to the Company's significant accounting policies during the three months ended March 31, 2023, as compared to the significant accounting policies described in Note 2 of the “Notes to Consolidated Financial Statements” in the Company's Annual Report on Form 10-K as of and for the year ended December 31, 2022, which was filed to SEC on March 24, 2023. Except as noted above, the unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to present fairly the financial position as of March 31, 2023, results of operations for the three months ended March 31, 2023, and 2022, changes in convertible preferred stock and stockholders' equity for the three months ended March 31, 2023, and 2022, and cash flows for the three months ended March 31, 2023 and 2022. The interim results are not necessarily indicative of the results for any future interim periods or for the entire year Principles of Consolidation The consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) and include the accounts of the Company and its subsidiaries with controlling interest. All inter-company transactions and balances have been eliminated in consolidation. The reporting currency of the Company is the U.S dollar. Non-controlling interest ended March 31, 2023, an additional investment from a private entity amounting to €1.1 million equivalent to $1.23 million resulted to the increase in non-controlling interest percentage. Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make judgments, assumptions and estimates that affect the amounts reported in its unaudited consolidated financial statements and the accompanying notes. The accounting policies that reflect the Company’s more significant estimates and judgments and that the Company believes are the most critical to aid in fully understanding and evaluating its reported financial results are the valuation of stock options, restricted stock units (“RSUs”), valuation of hybrid instruments designated at fair value option (“FVO”), valuation of warrant liabilities, acquired in-process research and development (“IPR&D”), and useful lives assigned to long-lived assets; impairment assessment of non-financial assets; valuation adjustments for excess and obsolete inventory; allowance for doubtful accounts; deferred taxes and valuation allowances on deferred tax assets; evaluation and measurement of contingencies; and recognition of revenue, including estimates for product returns. Those estimates could change, and as a result, actual results could differ materially from those estimates. In March 2020, the World Health Organization declared the COVID-19 outbreak to be a pandemic. During the year ended December 31, 2022, the Company’s financial results were not significantly affected by the COVID-19 outbreak. The Company has considered all information available as of the date of issuance of these financial statements and the Company is not aware of any specific events or circumstances that would require an update to its estimates or judgments, or a revision to the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information becomes available. The extent to which the COVID-19 outbreak affects the Company’s future financial results and operations will depend on future developments which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the outbreak, and current or future domestic and international actions to contain and treat it. Cash The Company’s cash on deposit may exceed United States federally insured limits at certain times during the year. The Company maintains cash accounts with certain major financial institutions in the United States. The Company does not have cash equivalents as of March 31, 2023 and December 31, 2022. Accounts Receivable Accounts receivable is recorded net of allowances for discounts for prompt payment and credit losses. The Company utilizes a loss rate approach in determining its lifetime expected credit losses on receivables from customers. This method calculates an estimate of credit losses based on historical experience, credit quality, age of the accounts receivable balances, and current and forecasted economic and business conditions that may affect a customer’s ability to pay. In determining the loss rates, the Company evaluates information related to its historical losses, adjusted for existing conditions and further adjusted for the period of time that can reasonably be forecasted. The facts and circumstances as of the balance sheet date are used to adjust the estimate for periods beyond those that can reasonably be forecasted. The past due status of accounts receivable is determined based on the contractual due dates for payments. A receivable is deemed past due when payment hasn’t been received 30 days after the contractual due date. The credit loss allowance was immaterial as of March 31, 2023 and December 31, 2022. The corresponding expense for the credit loss allowance is reflected in general and administrative expenses. Current Expected Credit Losses The Company recognizes an allowance for credit losses for financial assets carried at amortized cost to present the net amount expected to be collected as of the balance sheet date. Such allowance is based on credit losses that are expected to arise over the contractual term of the asset, which includes consideration of historical credit loss information adjusted for current conditions and reasonable and supportable forecasts. Changes in the allowance for credit losses are recorded as provision of (or reversal of) credit loss expense. Assets are written off when the Company determines that such are deemed uncollectible. Write-offs are recognized as a deduction from the allowance for credit losses. Expected recoveries of amounts previously written off, not to exceed the aggregate of the amount previously written off, are included in determining the necessary allowance at the balance sheet date. Concentrations Cash is the financial instrument that potentially subjects the Company to a concentration of credit risk as cash is deposited with a bank and cash balances are generally in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. For the three months ended March 31, 2023, and 2022, substantially all of the Company’s revenue was derived from the sale of Mytesi. In looking at sales by the Company to distributors whose net revenue percentage of total net revenue was equal to or greater than 10%, for fiscal years 2023 and 2022, the Company earned Mytesi revenue primarily from three and one major pharmaceutical distributor(s) located in the United States, respectively. Revenue earned from each major customer as a percentage of total revenue is as follows: Three Months Ended March 31, 2023 2022 (unaudited) Customer 1 25 % 34 % Customer 2 54 % 49 % Customer 3 — 10 % The Company is subject to credit risk from its accounts receivable related to its sales. The Company generally does not perform evaluations of customers' financial condition and generally does not require collateral. Accounts receivable balance of the significant customers as a percentage of total accounts receivable is as follows: March 31, December 31, 2023 2022 (unaudited) Customer 1 38 % 38 % Customer 2 54 % 54 % The Company is subject to concentration risk from its suppliers. The Company sources raw material used to produce the active pharmaceutical ingredient (“API”) in Mytesi from two suppliers and is dependent on a single third-party contract manufacturer for the supply of API in Mytesi and a single third-party contract manufacturer as well for the supply of finished products for commercialization. Other Risks and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to war, rapid technological change, obtaining second source suppliers, regulatory approval from the FDA or other regulatory authorities, the results of clinical trials and the achievement of milestones, market acceptance of the Company’s product candidates, competition from other products and larger companies, protection of proprietary technology, strategic relationships and dependence on key individuals. Recent Global Events Conditions within the Banking Sector First Republic, another U.S. regional bank, also experienced large withdrawals of deposits, raising concerns about its financial stability. On May 1, 2023, First Republic was placed under FDIC receivership and the FDIC entered into a purchase and assumption agreement with JPM Chase Bank, N.A. under which JPM Chase Bank, N.A. will assume all of the deposits and substantially all of the assets of First Republic. Although the U.S. Department of Treasury, the Federal Reserve and the FDIC have taken measures to stabilize the financial system, uncertainty and liquidity concerns in the broader financial services industry remain. As of March 31, 2023, the Company had no cash deposits nor investments within SVB, Signature or First Republic and does not expect any impact from its cash deposits from its financial institutions. Fair Value The Company’s financial instruments include accounts receivable, accounts payable, accrued liabilities, warrant liability, operating lease liability, equity-linked financial instruments, and debt. The recorded carrying amount of accounts receivable, accounts payable and accrued liabilities reflect their fair value due to their short-term nature. Other financial liabilities are initially recorded at fair value, and subsequently measured at either fair value or amortized cost using the effective interest method. See Note 3 for the fair value measurements. Fair Value Option ASC 825-10, Financial Instruments Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. Cost is initially recorded at the invoiced amount of raw materials or API, including the sum of qualified expenditures and charges in bringing the inventory to its existing condition and location. The Company calculates inventory valuation adjustments when conditions indicate that net realizable value is less than cost due to physical deterioration, usage, obsolescence, reductions in estimated future demand or reduction in selling price. Inventory write- downs are measured as the difference between the cost of inventory and net realizable value. The Company does not have allowance for inventory obsolescence as at March 31, 2023, and December 31, 2022. Prelaunch Inventory Property and Equipment Land is stated at cost, reflecting the fair value of the property at July 31, 2017, the date of the Napo merger. Equipment is stated at cost, net of accumulated depreciation. Equipment begins to be depreciated when it is placed into service. Depreciation is calculated using the straight-line method over estimated useful lives ranging between 3 to 10 years. Expenditures for repairs and maintenance of assets are charged to expense as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their estimated useful lives. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in the unaudited condensed consolidated comprehensive loss. Software Developed for Internal Use The Company capitalizes the costs of developing software for internal use. These costs include both purchased software and internally developed software. Costs of developing software are expensed until technological feasibility has been established. Thereafter, all costs are capitalized and are carried at the lower of unamortized cost or net realizable value. Internally developed and purchased software costs are generally amortized over five years. Long-lived Assets The Company regularly reviews the carrying value and estimated lives of all of its long-lived assets, including property and equipment and definite-lived intangible assets, to determine whether indicators of impairment exist that warrant adjustments to carrying values or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and positive cash flow in future periods as well as the strategic significance of the assets to the Company’s business objectives. If the Company determines that an impairment trigger has been met, the Company evaluates the realizability of its long-lived assets (asset group) based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset. Any write-downs (which are measured based on the difference between the fair value and the carrying value of the asset) are treated as permanent reductions in the carrying amount of the assets (asset group). Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company’s long-lived assets were impaired. The Company’s had no impairment of long-lived assets as at March 31, 2023, and 2022. Indefinite-lived Intangible Assets Acquired IPR&D are intangible assets acquired in the July 2017 Napo merger. Under ASC 805, IPR&D are initially recognized at fair value and classified as indefinite-lived assets until the successful completion or abandonment of the associated research and development efforts. During the development period, these assets will not be amortized as charges to earnings; instead, these assets will be tested for impairment on an annual basis or more frequently if impairment indicators are identified. An impairment loss is measured based on the excess of the carrying amount over the asset’s fair value. The Company recorded no impairment for the three months ended March 31, 2023, and 2022. Leases The Company accounts for its leases in accordance with ASC 842, Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. Because the interest rate implicit in lease contracts is typically not readily determinable, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. Research and Development Expense Research and development expense consists of expenses incurred in performing research and development activities including related salaries, clinical trials and related drug and non-drug product costs, contract services and other outside service expenses. Research and development expense is charged to operating expense in the period incurred. Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the costs to be recorded based upon validation with the external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers The Company’s policy typically permits returns if the product is damaged, defective, or otherwise cannot be used when received by the customer if the product has expired. Returns are accepted for product that will expire within three months or that have expired up to one year after their expiration dates. Estimates for expected returns of expired products are based primarily on an ongoing analysis of our historical return patterns. The Company recognizes revenue in accordance with the core principle of ASC 606 or when there is a transfer of control of promised goods or services to customers in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those goods or services. The Company recognizes the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that the Company otherwise would have recognized is one year or less. The Company does not adjust the amount of consideration for the effects of a significant financing component if, at contract inception, the expected period between the transfer of promised goods or services and customer payment is one year or less. The Company has elected to treat shipping and handling activities as fulfillment costs. Additionally, the Company elected to record revenue net of sales and other similar taxes. Contracts and Agreements Effective January 16, 2019, the Company engaged Cardinal Health as its exclusive third-party logistics distribution agent for commercial sales of the Company’s Mytesi product and to perform certain other services which include, without limitation, storage, distribution, returns, customer support, financial support, Electronic Data Interchange (“EDI”) and system access support (the “Exclusive Distribution Agreement”). On September 3, 2021, the Company ended its engagement with Cardinal Health as its exclusive title model customer for commercial sales and fully implemented its limited distribution Specialty Pharmacy model. Cardinal Health continues to provide third-party logistics services for Mytesi. The Company's Canalevia-CA1 and Neonorm products are primarily sold to distributors, who then sell the products to the end customers. Since 2021, the Company has entered into two distribution agreements with established distributors to distribute the Company’s animal health products in the United States. The distribution agreements and the related purchase orders together meet the contract existence criteria under ASC 606 10 25 1. The Company sells directly to its customers without the use of an agent. Performance obligations For animal health products sold by the Company, the single performance obligation identified above is the Company’s promise to transfer the Company’s animal health products to distributors based on specified payment and shipping terms in the arrangement. Product warranties are assurance-type warranties that do not represent a performance obligation. For the Company’s human health product, Mytesi, the single performance obligation identified above is the Company’s promise to transfer Mytesi to specialty pharmacies, based on specified payment and shipping terms as outlined in the Exclusive Distribution Agreement. Transaction price For contracts with Cardinal Health and other distributors, the transaction price is the amount of consideration to which the Company expects to collect in exchange for transferring the promised goods or services. The transaction price of Mytesi is the Wholesaler Acquisition Cost (“WAC”), and the transaction price of Canalevia-CA1 and Neonorm is the manufacturer’s list price, net of discounts, returns, and price adjustments. Allocate transaction price For contracts with Cardinal Health and other distributors, the entire transaction price is allocated to the single performance obligation contained in each contract. Revenue recognition For contracts with Cardinal Health, for the Company, a single performance obligation is satisfied at a point in time, upon the FOB terms of each contract when control, including title and all risks, has transferred to the customer. Disaggregation of Product Revenue Human Sales of Mytesi are recognized as revenue at a point in time when the products are delivered to the wholesaler. Net revenues from the sale of Mytesi were $404,000 and $438,000 for the three months ended March 31, 2023, and 2022, respectively. Animal The Company recognized Canalevia-CA1 products revenues of $27,000 and zero for the three months ended March 31, 2023, and 2022, respectively. Revenues are recognized at a point in time upon shipment, which is when title and control is transferred to the buyer. Sales of Canalevia-CA1, Neonorm Calf and Foal to distributors are made under agreements that may provide distributor price adjustments and rights of return under certain circumstances. Contracts – Specialty Pharmacies Effective October 1, 2020, the Company engaged a private company as an authorized specialty pharmacy provider of the Company’s Mytesi product. Under the Specialty Product Distribution Agreement, the Company shall supply the products to the private company’s specialty pharmacies, through a designated wholesaler, in such amounts as may be ordered. There is no minimum purchase or inventory requirement. The specialty pharmacies were authorized distributors of record for all National Drug Codes (“NDCs”) of Mytesi. Effective April 20, 2021, the Company engaged another private company as an authorized specialty pharmacy provider of Mytesi. Under the Specialty Pharmacy Distribution and Services Agreement, the private company shall sell and dispense the Mytesi directly ordered from the Company at the agreed price to patients within the territories identified in the agreement. The Company has entered into agreements with a total of five different specialty pharmacy chains that are authorized to provide Mytesi to patients. Performance obligations The single performance obligation is the Company’s promise to transfer Mytesi to specialty pharmacies, based on specified payment and shipping terms as outlined in the agreements. Transaction price The transaction price is the amount of consideration to which the Company expects to collect in exchange for transferring the promised goods or services. The transaction price of Mytesi is the WAC, net of estimated discounts, returns, and price adjustments. Allocate transaction price The entire transaction price is allocated to the single performance obligation contained in each contract. Revenue recognition The single performance obligation is satisfied at a point in time, upon the free on board (“FOB”) terms of each contract when control, including title and all risks, has transferred to the customer. Product Revenue Sales of Mytesi are recognized as revenue at a point in time when the products are delivered to the specialty pharmacies. Net revenues from the sale of Mytesi to the specialty pharmacies were $1.5 million and $2.2 million for the months ended March 31, 2023 and 2022, respectively. Collaboration Revenue Revenue recognition for collaboration agreements requires significant judgment. The Company’s assessments and estimates are based on contractual terms, historical experience and general industry practice. Revisions in these values or estimations have the effect of increasing or decreasing collaboration revenue in the period of revision. On September 24, 2018, the Company entered into a Distribution, License and Supply Agreement (“License Agreement”) with Knight Therapeutics ("Knight"). The License Agreement has a term of 15 years (with automatic renewals) and provides Knight with an exclusive right to commercialize current and future Jaguar human health products (including crofelemer, NP-300, and any product containing a proanthocyanidin or with an anti-secretory mechanism) in Canada and Israel. Knight forfeited its right of first negotiation for expansion to Latin America. Under the License Agreement, Knight is responsible for applying for and obtaining necessary regulatory approvals in the territory of Canada and Israel, as well as marketing, sales and distribution of the licensed products. Knight will pay a transfer price for all licensed products, and upon achievement of certain regulatory and sales milestones, the Company may receive payments from Knight in an aggregate amount of up to approximately $18 million payable throughout the initial 15-year term of the agreement. The Company did not have any license revenues for the three months ended March 31, 2023 and 2022. Modifications to Liability-classified Instruments In accounting for debt modifications and exchange transactions, it is the Company’s policy to first determine whether it qualifies as a troubled debt restructuring (“TDR”) pursuant to the guidance provided in ASC 470-60. A debt modification or exchange transaction that is not within the scope of the ASC 470-60 is accounted for under ASC 470-50 to determine if the transaction is a mere modification or an extinguishment. For the three months ended March 31, 2023, the Company entered into another amendment on the terms of its October 2020 and December 2020 Purchase Agreements (see Note 7). Modifications to Equity-classified Instruments In accounting for modifications of equity-classified warrants, it is the Company’s policy to determine the impact by analogy to the share-based compensation guidance of ASC 718, Compensation - Stock Compensation The Company did not modify any equity-classified warrants for the three months ended March 31, 2023, and 2022. In accounting for amendments to preferred stock, it is the Company’s policy to measure the impact by analogy to ASC 470-50 in determining if such an amendment is an extinguishment or a modification. If the amendment results in an extinguishment, the Company follows the SEC staff guidance in ASC 260-10-S99-2 and ASC 470-20. If the amendment results in a modification, the Company follows the model in either ASC 718 or ASC 470-50, depending on the nature of the amendment. The Company did not modify any equity-classified preferred stock for the three months ended March 31, 2023 and 2022. Stock-based Compensation The Company's Stock Incentive Plan (see Note 11) provides for the grant of stock options, restricted stock and restricted stock unit awards. The Company measures stock awards granted to employees, non-employees and directors at estimated fair value on the date of grant and recognizes the corresponding compensation expense of the awards, net of estimated forfeitures, over the requisite service periods, which correspond to the vesting periods of the awards. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company issues stock awards with only service-based vesting conditions, and records compensation expense for these awards using the straight-line method. The Company uses the grant date fair market value of its common stock to determine the grant date fair value of options granted to employees, non-employees and directors. The Company measures and recognizes compensation expense for all stock options and restricted stock units (“RSUs”) granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The fair value is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. The determination of the grant date fair value of options using an option pricing model is affected by the Company’s estimated Common Stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair market value of common stock is based on the closing price of the Company’s common stock as reported on the date of the grant. Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company has adopted the provisions of ASC 740, Income Taxes Related to Uncertain Tax Positions Foreign Currency Remeasurement and Translation The functional currency of Napo Therapeutics is Euro. The Company follows ASC 830, Foreign Currency Matters For certain subsidiaries, translation adjustments result from the process of translating the functional currency of subsidiary financial statements into the U.S. Dollar reporting currency. These translation adjustments are reported separately and accumulated in the unaudited condensed consolidated balance sheets as a component of accumulated other comprehensive loss. Comprehensive Loss The Company follows ASC 220, Comprehensive Income For the months ended March 31, 2023 and 2022, the amount of other comprehensive losses from translation adjustments were $232,000 and zero, respectively. Basic and Diluted Net Loss Per Common Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the year by the weighted-average number of common shares outstanding during the year. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders for the year by the weighted-average number of common shares, including potential dilutive shares of common stock assuming the dilutive effect of potential dilutive securities. For years in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, because their impact would be anti-dilutive to the calculation of net loss per common share. Diluted net loss per common share is the same as basic net loss per common share for the three months ended March 31, 2023 and 2022. Recent Accounting Pronouncements There are no recent accounting pronouncements that are expected to have a material impact on the Company’s financial statem |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Measurements | |
Fair Value Measurements | 3. Fair Value Measurements ASC 820, Fair Value Measurements ● Level 1 – Observable inputs such as quoted prices (unadjusted) for identical instruments in active markets. ● Level 2 – Observable inputs such as quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, or model-derived valuations whose significant inputs are observable. ● Level 3 – Unobservable inputs that reflect the reporting entity’s own assumptions. The following tables set forth the fair value of the Company’s financial instruments that were measured at fair value on a recurring basis as of March 31, 2023 and December 31, 2022. March 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Warrant liability $ — $ — $ — $ — Streeterville note — — 8,198 8,198 Total fair value $ — $ — $ 8,198 $ 8,198 December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Warrant liability $ — $ — $ — $ — Streeterville note $ — $ — $ 7,839 $ 7,839 Total fair value $ — $ — $ 7,839 $ 7,839 The change in the estimated fair value of Level 3 liabilities is summarized below: Three Months Ended March 31, 2023 (in thousands) Warrant liability Streeterville note Beginning fair value of Level 3 liability $ — $ 7,839 Additions — — Exercises — — Change in fair value — 359 Ending fair value of Level 3 liability $ — $ 8,198 Warrant Liability The warrants associated with the Level 3 warrant liability were valued at zero in the Company’s unaudited condensed consolidated balance sheet. Warrants as at March 31, 2023 and December 31, 2022 were computed using the Black-Scholes-Merton pricing model. Streeterville Note The fair value of the Streeterville Note at January 13, 2021, date of issuance and as of March 31, 2023 amounting to $6.0 million and $8.2 million, respectively, were based on the weighted average discounted expected future cash flows representing the terms of the note, discounting them to their present value equivalents. This was classified as Level 3 fair values in the fair value hierarchy due to the use of unobservable inputs, including the Company’s own credit risk. The Company determined and performed the valuations of the Streeterville Note with the assistance of an independent valuation service provider. On a quarterly basis, the Company considers the main Level 3 inputs used derived as follows: ● Discount rate for the Streeterville note which was determined using a comparison of various effective yields on bonds as of the valuation date ● Market indications for vouchers, which affect the Return Bonus from the sale of Tropical Disease Priority Review Voucher (“TDPRV”) ● Weighted probability of cash outflows which was estimated based on the entity's knowledge of the business and how the current economic environment is likely to impact the timing of the cash outflows, attributed to the different repayment features of the note The following table summarizes the quantitative information about the significant unobservable inputs used in Level 3 fair value measurement: Range of Inputs (probability-weighted average) Relationship of unobservable inputs Unobservable Inputs 2023 2022 to fair value Risk Adjusted Discount Rate 11.30%-25.66% (25.66%) 11.53%-26.06% (26.06%) If discount rate is adjusted to total of additional 100 basis points (bps), fair value would have decreased by $319,000. Sales Proceeds: Amount of comparable TDPRV $67.5 million to $350 million ($100 million) $67.5 million to $350 million ($100 million) If expected cash flows by Management considered the lowest amount of market indications for vouchers, FV would have decreased by $1.06 million. Range of Probability for Timing of Cash Flows: 0.42%-47.08% 0.39%-46.55% If expected cash flows by Management considered the Scenario with the least amount of indicated value, FV would have decreased by $394,000. Fair Value Option Beginning January 1, 2021, the Company elected to apply the FVO accounting to selected financial instruments to align the measurement attributes of those instruments under U.S. GAAP and to simplify the accounting model applied to those financial instruments. The Company elected to apply FVO accounting to the entire class of hybrid instruments, including structured notes, of which there are assessed embedded derivatives that would be eligible for bifurcation. Changes in the fair value of FVO assets and liabilities as well as the mark-to-market adjustment on the entire class of hybrid instruments, including derivatives and the net realized gains or losses on these instruments are reported in the change in fair value of financial instruments and hybrid instrument designated at FVO in the unaudited condensed consolidated comprehensive loss. As of March 31, 2023, the Company did not note any fair value movement on FVO liabilities attributable to any instrument-specific credit risk, which should be recorded in other comprehensive income (loss). Hybrid Instruments The Company elected to apply FVO accounting to all of the hybrid instruments issued, including structured notes. The valuation of the hybrid instruments is predominantly driven by the derivative features embedded within the instruments. The Company determined and performed the valuations of the hybrid instruments with the assistance of an independent valuation service provider. The valuation methodology utilized is consistent with the income approach for estimating the fair value of the interest-bearing portion of the instrument and the related derivatives. Cash flows of the hybrid instruments in their entirety, including the embedded derivatives, are discounted at an appropriate rate for the applicable duration of the instrument. Interest on the interest-bearing portion of the instrument that is held to maturity is aggregated as gain (loss) on instruments designated at fair value and related derivatives in the change in fair value of financial instruments and hybrid instruments designated at FVO of the unaudited condensed consolidated comprehensive loss. The following table summarizes the fair value and unpaid principal balance for items the Company accounts for under FVO: (in thousands) Fair value Unpaid Principal Balance Fair Value Over (Under) Unpaid Principal Balance At March 31, 2023 Hybrid Instrument: Streeterville note $ 8,198 $ 6,221 $ 1,977 |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2023 | |
Balance Sheet Components | |
Balance Sheet Components | 4. Balance Sheet Components Inventory Inventory at March 31, 2023 and December 31, 2022 consisted of the following: March 31, December 31, 2023 2022 (in thousands) (unaudited) Raw Material $ 2,128 $ 2,101 Work in Process 5,383 3,599 Finished Goods 1,173 1,324 Inventory $ 8,684 $ 7,024 Prelaunch Inventory Costs capitalized for the Company’s lyophilized drug amounting to zero and $2.4 million as of March 31, 2023, and December 31, 2022 are included in the prepayments and other assets account. As of March 31, 2023, the Company has filed the POC for the lyophilized drug to European FDA and expects approval at the end of the first half of 2023. Upon approval, the prelaunch inventory shall be reclassified as part of the Company’s inventory. Property and Equipment, net Property and equipment at March 31, 2023 and December 31, 2022 consisted of the following: March 31, December 31, 2023 2022 (in thousands) (unaudited) Land $ 396 $ 396 Lab equipment 477 477 Software 63 63 Furniture and fixtures 18 18 Computers and peripherals 7 7 Total property and equipment at cost 961 961 Accumulated depreciation (420) (404) Property and equipment, net $ 541 $ 557 Depreciation and amortization expense was $16,000 and $124,000 for the three months ended March 31, 2023 and 2022, respectively. Intangible Assets, net Intangible assets at March 31, 2023 and December 31, 2022 consisted of the following: March 31, December 31, 2023 2022 (in thousands) (unaudited) Developed technology $ 25,000 $ 25,000 Accumulated developed technology amortization (9,444) (9,028) Developed technology, net 15,556 15,972 In-process research and development 4,800 4,800 In process research and development, net 4,800 4,800 Trademarks 300 300 Accumulated trademark amortization (113) (108) Trademarks, net 187 192 Internal use software costs - registry 1,236 1,236 Accumulated internal use software costs amortization (184) (122) Internal use software costs - registry, net 1,052 1,114 Patents 361 — 361 Accumulated patents amortization (5) — Patents, net 356 361 Total intangible assets, net $ 21,951 $ 22,439 Amortization expense of finite-lived intangible assets was $488,000 and $418,000 for the three months ended March 31, 2023 and 2022. The following table summarized the Company’s estimated future amortization expense of intangible assets with finite lives as of March 31, 2023: (in thousands) Amounts 2023 1,414 2024 1,952 2025 1,952 2026 1,952 2027 1,952 Thereafter 7,929 $ 17,151 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2023 | |
Related Party Transactions | |
Related Party Transactions | 5. Related Party Transactions BOD Cash Compensation The Company makes BOD cash compensation on a quarterly basis based on the Director Compensation Program. For the three months ended March 31, 2023, and 2022, Company paid approximately $68,000 and $35,000 cash compensation to its directors, respectively. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies | |
Commitments and Contingencies | 6. Commitments and Contingencies Commitments Leases On April 6, 2021, the Company entered into an office lease agreement of approximately 10,526 square feet of office space in San Francisco, inclusive of office space covered under the previous sublease agreement. The term of the lease began on September 1, 2021 and will expire on February 28, 2025, unless terminated earlier. The lease had an early occupancy provision which entitled the Company to use a portion of the leased premises on June 1, 2021, free of rent obligation. In addition, the Company has the option to extend the lease for one three-year period after the expiration date. This option was not included as part of the lease term as the Company was not reasonably certain to exercise it, hence the lease term only includes the noncancellable period of three years plus the period of early occupancy. The base rent under the lease were $42,000 monthly for the first 12 months, $43,000 monthly for the next 12 months and $45,000 for the last twelve months. The lease agreement only contained one lease component, that is, the lease of the office space. Non-lease components such as payment of building operating costs and share in real property taxes were accounted for separately and were not considered as part of the total lease payments. The lease was classified as an operating lease. On October 7, 2021, the Company entered into an agreement for the lease of office premises from November 1, 2021 to April 30, 2022, subject to automatic renewal for subsequent periods until terminated by either party. Base rent amounted to €10,000 or approximately $10,500. If the contract is not terminated within 12 months, the lease amount will be increased in line with the index of relevant inflation at each annual expiration of the start date of the contract. The lessor has the right to decline the renewal of the contract. Upon the happening of certain specified events, the lessor may immediately withdraw from the contract. The Company is required leave the occupied spaces immediately in the same condition in which they were found in the event of contract termination or expiry. The Company paid deposit of €20,000 or approximately $21,000 to the lessor. On January 26, 2022, the lease agreement was amended whereby the term was extended by 20 months from May 1, 2022 to December 31, 2023. All other contract provisions remained the same. On October 10, 2021, the Company also entered into a short-term office lease in Milan, Italy. The term of the lease began on November 1, 2021, subject to automatic renewal equal to the present term until terminated by mutual agreement. On January 26, 2022, the lease agreement was amended whereby the term was extended by 20 months from May 1, 2022 to December 31, 2023. The Company recognizes rent expense on a straight-line basis over the non-cancellable lease period. On December 22, 2021, the Company entered into an agreement for the lease of two separate vehicles for 48 months expiring on November 30, 2025. Total monthly lease payment amounted to €2,000 or approximately $2,100 payable in advance. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. The Company also paid a total deposit of €19,000 or approximately $20,000, exclusive of VAT. Early termination of the contracts requires the payment of specified amounts. On January 25, 2022, the Company entered into an agreement for the lease of office premises from March 1, 2022 to December 31, 2023, subject to automatic renewal for subsequent periods until terminated by either party. Base rent amounted to €4,000 or approximately $4,200. A similar agreement was entered with the lessor for the lease of premises to be used as office space from November 1, 2022 to December 31, 2023, subject to automatic renewal for subsequent periods until terminated by either party. Base rent amounted to €3,817 or approximately $4,000. If the contracts are not terminated within 12 months, the lease amounts will be increased in line with the index of relevant inflation at each annual expiration of the start date of the contract. The lessor has the right to decline the renewal of the contracts. Upon the happening of certain specified events, the lessor may immediately withdraw from the contracts. The Company is required leave the occupied spaces immediately in the same conditions in which they were found in the event of contract termination or expiry. The Company paid deposit of €9,000 or approximately $9,500 to the Lessor. In May 2022, the Company entered into an agreement for the lease of one vehicle for 48 months expiring on April 30, 2026. Total monthly lease payment amounted to €833 or approximately $880 payable in advance. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. The Company also paid a total deposit of €21,000 or approximately $22,000, exclusive of VAT. Early termination of the contracts requires the payment of specified amounts. In October 2022, the Company entered into an agreement for the lease of three vehicles for 48 months expiring on September 30, 2026. Total monthly lease payment amounted to €2,094 or approximately $2,200 payable in advance. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. In November 2022, the Company entered into an agreement for the lease of two vehicles for 48 months expiring on October 31, 2026. Total monthly lease payment amounted to €1,459 or approximately $1,500 payable in advance. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. The table below provided additional details of the office space lease presented in the unaudited condensed consolidated balance sheet as of March 31, 2023 and December 31, 2022: March 31, December 31, 2023 2022 (in thousands) (unaudited) Operating lease - right-of-use asset $ 1,062 $ 1,140 Operating lease liability, current 503 483 Operating lease liability, net of current portion 627 725 Total $ 1,130 $ 1,208 Weighted-average remaining life (years) 2.17 2.36 Weighted-average discount rate 17.82% 17.89% Lease cost included in general and administrative expenses in the unaudited consolidated statements of comprehensive loss for the three months ended March 31, 2023 and 2022 was approximately $209,000 and $115,000 . For the three months ended March 31, 2023 and 2022, cash paid for operating lease liabilities recognized under operating cash flows amounted to $53,000 and $105,000, respectively. Non-cash investing and financing activities for the three months ended March 31, 2023, and 2022 include addition to right-of-use asset obtained from new and modified operating liabilities amounting to $30,000 and 90,000, respectively. The following table summarizes the undiscounted cash payment obligations for operating lease liability as of March 31, 2023. March 31, 2023 (in thousands) 2023 495 2024 617 2025 172 2026 41 Total undiscounted operating lease payments 1,325 Imputed interest expenses (195) Total operating lease liability 1,130 Less: Operating lease liability, current 503 Operating lease liability, net of current portion $ 627 Rent and lease expense included in the general and administrative expenses in the unaudited condensed consolidated statements of comprehensive loss the three months ended March 31, 2023 and 2022 was approximately $209,000 and $42,000 , respectively. Purchase Commitment On September 3, 2020, the Company entered into a manufacturing and supply agreement (the “Agreement”) with Glenmark Life Sciences Limited (“Glenmark”), pursuant to which Glenmark will continue to serve as the Company’s manufacturer of crofelemer for use in Mytesi, the Company’s human prescription drug product approved by the U.S. Food and Drug Administration, and for other crofelemer-based products manufactured by the Company or its affiliates for human or animal use. The term of the Agreement is approximately 2.5 years (i.e., until March 31, 2023) and may be extended for successive two-year renewal terms upon mutual agreement between the parties thereto. Pursuant to the terms of the Agreement, Glenmark will supply crofelemer to the Company. The Agreement contains provisions regarding the rights and responsibilities of the parties with respect to manufacturing specifications, forecasting and ordering, delivery arrangements, payment terms, confidentiality and indemnification, as well as other customary provisions. The Agreement includes a commitment for the purchase from Glenmark of a minimum quantity of 300 kilograms of crofelemer per year, pro-rated for partial years, where the Company may be obligated to pay any shortfall. Either party may terminate the Agreement for any reason with 12 months prior written notice to the other party. In addition, either party may terminate the Agreement upon written notice as a result of a material breach of the Agreement that remains uncured for a period of 90 days. If the Company terminates the Agreement as a result of a material breach caused by Glenmark, the Company will not be obligated to pay for any minimum quantity shortfall. As of March 31, 2023, the remaining commitment is 149 kilograms. Master Services Agreement (“MSA”) On October 5, 2020, the Company entered into another MSA for clinical research organization services (the “2020 MSA”) and a service order under such 2020 MSA with Integrium. The service order covers the Company’s planned upcoming pivotal Phase 3 clinical trial for cancer-therapy related diarrhea. As consideration for its services, the Company will pay Integrium a total amount of up to approximately $12.4 million, later reduced to approximately $6.0 million, that will be paid over the term of the engagement and based on the achievement of certain milestones. The 2020 MSA will terminate upon the satisfactory performance of all services to be provided thereunder unless earlier terminated by the parties . For the three months ended March 31, 2023, and 2022, the Company paid Integrium $498,000 and $276,000 , respectively. Asset Transfer and Transition Commitment On September 25, 2017, the Company entered into the Termination, Asset Transfer and Transition Agreement dated September 22, 2017 with Glenmark. As a result of the agreement, the Company now controls commercial rights for Mytesi for all indications, territories and patient populations globally, and also holds commercial rights to the existing regulatory approvals for crofelemer in Brazil, Ecuador, Zimbabwe and Botswana. In exchange, the Company agrees to pay Glenmark 25% of any payment it receives from a third party to whom the Company grants a license or sublicense or with whom the Company partners in respect of, or sells or otherwise transfers any of the transferred assets, subject to certain exclusions, until Glenmark has received a total of $7.0 million. For the three months ended March 31, 2023, and 2022, the Company paid Glenmark $1.9 million and $559,000, respectively. Revenue Sharing Commitment Update On December 14, 2017, the Company announced its entry into a collaboration agreement with Seed Mena Businessmen Services LLC (“SEED”) for Equilevia™, the Company's non-prescription, personalized, premium product for total gut health in equine athletes. According to the terms of the Agreement, the Company will pay SEED 15% of total revenue generated from any clients or partners introduced to the Company by SEED in the form of fees, commissions, payments or revenue received by the Company or its business associates or partners, and the agreed-upon revenue percentage increases to 20% after the first million dollars of revenue. In return, SEED will provide the Company access to its existing United Arab Emirates (“UAE”) network and contacts and assist the Company with any legal or financial requirements. The agreement became effective on December 13, 2017 and will continue indefinitely until terminated by either party pursuant to the terms of the Agreement. No payments have been made to date. Joint Venture - Magdalena Biosciences, Inc. In January 2023, Jaguar and Filament Health (“Filament”), with Funding from One Small Planet, formed the U.S.-based joint venture Magdalena Biosciences, Inc. (“Magdalena”). Magdalena’s focus is on the development of novel, natural prescription medicines derived from plants for mental health indications including, initially, attention-deficit/hyperactivity disorder (“ADHD”) in adults. The goal of the collaboration is to extend the botanical drug development capabilities of Jaguar and Filament in order to develop pharmaceutical-grade, standardized drug candidates for mental health disorders, and to partner with a potential future licensee to develop and commercialize these novel plant-based drugs. This new venture aligns with Jaguar's mental health Entheogen Therapeutics Initiative (“ETI”) and Filament's corporate mission to develop novel, natural prescription medicines from plants. Magdalena will leverage Jaguar's proprietary medicinal plant library and Filament's proprietary drug development technology. Jaguar’s library of 2,300 highly characterized medicinal plants and 3,500 plant extracts, all from firsthand ethnobotanical investigation by Jaguar and members of the ETI Scientific Strategy Team, is a key asset we have generated over 30 years that bridges the knowledge of traditional healers and Western medicine. Magdalena holds an exclusive license to plants and plant extracts in Jaguar's library, not including any sources of crofelemer or NP-300, for specific indications and is in the process of identifying plant candidates in the library that may prove beneficial for addressing indications such as ADHD. The Company accounted for its March 31, 2023 (in thousands) (unaudited) Revenue $ — Operating expenses (77) Loss before income tax (77) Income tax expense — Net loss $ (77) Net loss attributable to the Company $ (31) Contingencies From time to time, the Company maybe a party to various legal actions, both inside and outside the U.S., arising in the ordinary course of its business or otherwise. The Company accrues amounts, to the extent they can be reasonably estimated, that the Company believes will result in a probable loss (including, among other things, probable settlement value), to adequately address any liabilities related to legal proceedings and other loss contingencies. A loss or a range of loss is disclosed when it is reasonably possible that a material loss will incur and can be estimated, or when it is reasonably possible that the amount of a loss, when material, will exceed the recorded provision. The Company did not have any material accruals for any currently active legal action in its unaudited condensed balance sheets as of March 31, 2023, as the Company could not predict the ultimate outcome of these matters, or reasonably estimate the potential exposure. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2023 | |
Debt | |
Debt | 7. Debt Notes payable at March 31, 2023 and December 31, 2022 consisted of the following: March 31, December 31, 2023 2022 (in thousands) (unaudited) Royalty Interest $ 37,037 $ 38,931 Streeterville Note 8,198 7,840 Insurance Financing 83 234 Tempesta Note 200 250 45,518 47,255 Less: unamortized discount and debt issuance costs (12,353) (13,628) Note payable, net of discount $ 33,165 $ 33,627 Notes payable - non-current, net $ 17,544 $ 17,744 Notes payable - current, net $ 15,621 $ 15,883 Future maturities of the notes payable not designated at FVO as of March 31, 2023 are as follows: (in thousands) Amounts Periods ended March 31, 2024 $ 15,621 2025 21,699 2026 8,198 45,518 Less: unamortized discount and debt issuance costs (12,353) Total $ 33,165 Future maturities are based on contractual minimum payments. Timing of maturities may fluctuate based on future revenue. Sale of Future Royalty Interest October 2020 Purchase Agreement On October 8, 2020, the Company entered into another royalty interest purchase agreement (the “October 2020 Purchase Agreement”) with Iliad, pursuant to which the Company sold to Iliad a royalty interest entitling Iliad to receive $12.0 million of future royalties on sales of Mytesi and certain up-front license fees and milestone payments from licensees and/or distributors (the “Royalty Repayment Amount”) for an aggregate purchase price of $6.0 million. Until such time as the Royalty Repayment Amount has been paid in full, the Company will pay Iliad 10% of the Company’s net sales on included products and 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and/or distributors, but specifically excluding licensing fees and/or milestone payments that are reimbursements of clinical trial expenses (the “Royalty Payments”). Beginning on the six-month anniversary of the delivery of the October 2020 Purchase Agreement to the Company (the “Purchase Price Date”) and continuing until the 12-month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $250,000, and (b) the actual Royalty Payment amount Iliad is entitled to for such month. Beginning on the 12-month anniversary of the Purchase Price Date and continuing until 18-month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $400,000 and (b) the actual Royalty Payment amount Iliad is entitled to for such month. Beginning on the 18-month anniversary of the Purchase Price Date and continuing until 24-month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $600,000 and (b) the actual Royalty Payment amount Iliad is entitled to for such month. Beginning on the 24-month anniversary of the Purchase Price Date and continuing until the Royalty Repayment Amount has been paid in full, the monthly Royalty Payment shall be the greater of (a) $750,000, and (b) the actual Royalty Payment amount Iliad is entitled to for such month. The Royalty Interest amount of $12.0 million was classified as debt, net of a $6.0 million discount, at initial recognition. Under ASC 470-10-35-3, royalty payments to Iliad will be amortized under the interest method per ASC 835-30. Because there is no set interest rate, and because the royalty payments are variable, the discount rate is variable. After each royalty payment, the Company will use a prospective method to determine a new discount rate based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 34.51% . Pursuant to the October 2020 Purchase Agreement, if the weekly volume weighted average price (“VWAP”) of the Company’s common stock is not equal or greater than the minimum VWAP of $0.9105 at least twice during each calendar month during the six-month period beginning on November 1, 2020, then the Royalty Repayment Amount will be automatically increased by $6.0 million at the end of such six-month period. During the observation period starting November 1, 2020, the Company’s weekly VWAP failed to reach the minimum VWAP of $0.9105 and on November 13, 2020, the Company concluded that the contingent clause has been met, warranting an additional $6.0 million Royalty Repayment Amount, to be added to the outstanding balance commencing on May 10, 2021 for the purpose of cash interest calculation. The change in the Royalty Repayment Amount was accounted for as a debt modification and resulted in a new discount rate of 45.42%. On April 13, 2021, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $3.0 million from the original outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 7,843 shares of the Company’s common stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. The exchange agreement was accounted for as a modification and resulted in a new discount rate of 77.09%. On February 11, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $2.4 million from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 23,117 shares of the Company’s common stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. On March 2, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $1.1 million from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 32,333 shares of the Company’s common stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. On March 4, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $800,000 from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 26,667 shares of the Company’s common stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. On March 9, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $700,000 from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 24,667 shares of the Company’s common stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. Because the period between the first and last exchanges occurred within a 12-month period and each was individually assessed as a modification, the debt terms that existed prior to the February 13 exchange was used in the application of the 10% test on the cumulative assessment performed. The exchanges were cumulatively accounted for as an extinguishment and resulted to a loss of $2.2 million. On April 14, 2022, the Company entered into amendments (the “Royalty Interest Global Amendments”) to its existing royalty interests including the Royalty Interest in the original principal amount of $12.0 million under the October 2020 Royalty Interest. The amendment grants the Company at its sole discretion, the right to exchange from time to time, all or any portion of the Royalty Interests for shares of the Company’s common stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of date of the applicable exchange. Under the Royalty Interest Global Amendments, the Company’s ability to exchange the Royalty Interests for shares of the Company’s common stock is subject to certain limitations, on which the Company will not have such right and issue any common stock to investors if (a) the issuance of the Company’s common shares would cause investor’s beneficial ownership to exceed 4.99% of Company’s issued and outstanding common stock as of such date; (b) any of the exchange conditions has not been satisfied as of the applicable exchange date; and (c) the total cumulative number of shares of the Company’s common stock issued pursuant to the Royalty Interests would exceed the requirements of The Nasdaq Capital Market (including the rules related to the aggregation of offerings under Nasdaq Listing Rule 5635(d) if applicable) (the “Exchange Cap”), unless stockholder approval is obtained to issue more than the Exchange Cap. The Exchange Cap shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction. On May 13, 2022, the Company entered into an exchange agreement with Iliad, pursuant to which the parties agreed to partition $400,000 from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 15,249 shares of the Company’s common stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. On July 25, 2022, the Company entered into another exchange agreement with Iliad, pursuant to which the parties agreed to partition $750,000 from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 31,546 shares of the Company’s stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. On November 18, 2022, the Company entered into another exchange agreement with Iliad, pursuant to which the parties agreed to partition $715,000 from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 978 shares of the Company’s stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. On March 17 and 23, 2023, the Company entered into another exchange agreement with Iliad, pursuant to which the parties agreed to partition $992,000 and $227,000, respectively from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 14,533 and 3,733 shares, respectively of the Company’s stock. The exchange consisted of Iliad surrendering the partitioned royalty in exchange for the exchange shares. The exchanges that occurred within the 12-month period prior to May 13, 2022 exchange were previously accounted for as extinguishment, therefore, cumulative assessment was not performed anymore. The subsequent exchanges were accounted for as a modification. As of March 31, 2023, the forecasted future revenues changed which resulted to a new discount rate of 42.93%. Interest expense for the three months ended March 31, 2023 and 2022 was $766,000 and $3.1 million, respectively. As of March 31, 2023 and December 31, 2022, the carrying value of the debt is $6.3 million and $7.3 million, respectively. December 2020 Purchase Agreement On December 22, 2020, the Company entered into a royalty interest purchase agreement (the “December 2020 Purchase Agreement”) with Irving Park Capital, LLC (“Irving”), a company affiliated with CVP, pursuant to which the Company sold to Irving a royalty interest entitling Irving to receive $12.0 million of future royalties on sales of Mytesi and certain up-front license fees and milestone payments from licensees and/or distributors (the “Royalty Repayment Amount”) for an aggregate purchase price of $6.0 million. Until such time as the Royalty Repayment Amount has been paid in full, the Company will pay Irving 10% of the Company’s Net Sales on Included Products and 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and/or distributors, but specifically excluding licensing fees and/or milestone payments that are reimbursements of clinical trial expenses (the “Royalty Payments”). Beginning on the payment start date of March 8, 2024 and continuing until the 12-month anniversary of the Purchase Price Date, the monthly Royalty Payment shall be the greater of (a) $750,000, and (b) the actual Royalty Payment amount Irving is entitled to for such month. The Royalty Interest amount of $12.0 million is classified as debt, net of a $6.0 million discount, at initial recognition. Under ASC 470-10-35-3, royalty payments to Irving will be amortized under the interest method per ASC 835-30. Because there is no set interest rate, and because the royalty payments are variable, the discount rate is variable. After each royalty payment, the Company will use a prospective method to determine a new discount rate based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 23.70%. As of March 31, 2023, the forecasted future revenues changed which resulted to a new discount rate of 29.55%. On April 14, 2022, under the Royalty Interest Global Amendments, the Company is granted at its sole discretion, the right to exchange from time to time, all or any of the Royalty Interest under the original principal amount of $12.0 million or any portion of the December 2020 Purchase Agreement for shares of the Company’s common stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of date of the applicable exchange, subject to certain limitations. On February 8, 2023, the Company entered into an exchange agreement with Irving, pursuant to which the parties agreed to partition $675,000 from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 150,000 shares of the Company’s stock. The exchange consisted of Irving surrendering the partitioned royalty in exchange for the exchange shares. The exchange was accounted for as a modification as of March 31, 2023, the forecasted future revenues changed which resulted to a new discount rate of 48%. Interest expense for the three months ended March 31, 2023 and 2022 was $1.1 million and $784,000, respectively. As of March 31, 2023 and December 31, 2022, the carrying value of the debt is $9.4 million and $10.0 million, respectively. March 2021 Purchase Agreement On March 8, 2021, the Company entered into a purchase agreement (the “March 2021 Purchase Agreement”) with Streeterville Capital, LLC (“Streeterville”), a company affiliated with CVP, pursuant to which the Company sold a royalty interest entitling Streeterville to $10.0 million and any interest, fees, and charges as royalty repayment amount for an aggregate purchase price of $5.0 million. Interest will accrue on the royalty repayment amount at a rate of 5% per annum, compounding quarterly, and will increase to 10% per annum, compounding quarterly on the 12-month anniversary of the closing date. The Company will be obligated to make minimum royalty payments on a monthly basis beginning at the earlier of (a) 36 months following the closing date or (b) 30 days following the satisfaction of all existing royalties to Streeterville, and its affiliates namely Iliad and Irving, but not earlier than 18 months following the closing date in an amount equal to the greater of (i) $250,000 beginning on the royalty payment start date and continuing until either the royalty repayment amount has been paid in full or the 6-month anniversary of the royalty payment start date, $400,000 beginning on the 6-month anniversary of the royalty payment start date and continuing until either the royalty repayment amount has been paid in full or the 12-month anniversary of the royalty payment start date, $600,000 beginning on the 12-month anniversary of the royalty payment start date and continuing until either the royalty repayment amount has been paid in full or the 18-month anniversary of the royalty payment start date, $750,000 beginning on the 18-month anniversary of the royalty payment start date and continuing until the royalty repayment amount has been paid in full, and (ii) 10% of the Company’s net sales on included products, 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and/or distributors but specifically excluding licensing fees and/or milestone payments that are reimbursements of clinical trial expenses or associated with the license of Included Products from the Company to Napo EU, including but not limited to the upfront fee payable by Napo EU to Napo for included products and Crofelemer for other indications; and 50% of royalties collected from licenses of the included products to third parties. The Royalty Interest amount of $10.0 million is classified as debt, net of a $5.0 million discount, at initial recognition. Under ASC 470-10-35-3, royalty payments to Streeterville will be amortized under the interest method per ASC 835-30. Because there is no set interest rate, and because the royalty payments are variable, the discount rate is variable. After each royalty payment, the Company will use a prospective method to determine a new discount rate based on the revised estimate of remaining cash flows. The new rate is the discount rate that equates the present value of the revised estimate of remaining cash flows with the carrying amount of the debt, and it will be used to recognize interest expense for the remaining periods. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 19.36%. As of March 31, 2023, the forecasted future revenues changed which resulted to a new discount of 19.14%. On April 14, 2022, under the Royalty Interest Global Amendments, the Company is granted at its sole discretion, the right to exchange from time to time, all or any of the Royalty Interest under the original principal amount of $10.0 million of the March 2021 Purchase Agreement for shares of the Company’s common stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of date of the applicable exchange, subject to certain limitations. On August 17, 2022, the Company entered into an exchange agreement (the “Royalty Interest Exchange Agreement”) with Streeterville to (i) partition a new royalty interest in the royalty repayment amount of $3.4 million (“Partitioned Royalty”) from the royalty interest of the March 2021 Purchase Agreement and then cause the outstanding balance of the royalty interest to be reduced by an amount equal to the initial outstanding balance of the Partitioned Royalty, and (ii) exchange (“Royalty Exchange”) the Partitioned Royalty for 153,333 shares of the Company’s common stock with a par value of $0.0001 in accordance with the term of the Royalty Interest Exchange Agreement. Under the terms of the Royalty Interest Exchange Agreement, the Royalty Exchange will consist of Streeterville surrendering the Partitioned Royalty in exchange for the shares, free of any restrictive securities legend, and Streeterville shall give no consideration of any kind whatsoever to the Company in connection with the Royalty Interest Exchange Agreement. On September 30, 2022, the Company entered into an exchange agreement with Streeterville, pursuant to which the parties agreed to partition $2.0 million from the outstanding balance of the royalty interest. The parties further agreed to exchange the partitioned royalty for 156,863 shares of the Company’s common stock. The exchange consisted of Streeterville surrendering the partitioned royalty in exchange for the exchange shares. The exchange was accounted for as a debt modification and resulted to a reduction in the outstanding balance of the royalty interest amounting to $2.0 million. As of March 31, 2023, the forecasted future revenues changed which resulted to a new discount of 42.0%. Interest expense for the three months ended March 31, 2023 and 2022 was $448,000 and $416,000, respectively. As of March 31, 2023 and December 31, 2022, the carrying value of the debt is $3.4 million and $3.1 million, respectively. August 2022 Purchase Agreement On August 24, 2022, the Company entered into another royalty interest purchase agreement (the “August 2022 Purchase Agreement”) with Streeterville, pursuant to which the Company sold to Streeterville (the entitling “Investor”) a royalty interest to receive $12.0 million of future royalties on sales of Mytesi® (crofelemer) for any indications that could cannibalize crofelemer indications or any other chronic indication and certain up-front license fees and milestone payments from licensees and/or distributors for an aggregate purchase price of $4.0 million (“the Royalty Financing”). The Company will use the proceeds to support the ongoing pivotal phase 3 clinical trial of crofelemer for prophylaxis of diarrhea in adults receiving targeted cancer therapy. Interest will accrue on the Royalty Repayment Amount at a rate of 5% per annum from the closing of the Royalty Financing until the one-year anniversary of such closing and 10% per annum thereafter, simple interest computed on the basis of a 360-day year comprised of twelve 30-day months. The Company will be obligated to make minimum royalty payments on a monthly basis beginning on January 1, 2024 in an amount equal to the greater of (A) $250,000 (which increases to $400,000 beginning 6 months following the closing of the Royalty Financing, $600,000 beginning 12 months following the closing of the Royalty Financing, and $750,000 beginning 18 months following the closing of the Royalty Financing) and (B) the royalty payments to which Investor is entitled, consisting of (1) 10% of the Company’s net sales of crofelemer for any indications that could cannibalize crofelemer indications or any other chronic indication (including any improvements, modifications and follow-on products, collectively referred to as “Included Products”) (2) 10% of worldwide revenues related to upfront licensing fees and milestone payments from licensees and/or distributors, but specifically excluding licensing fees and/or milestone payments that are (A) reimbursements of clinical trial expenses or (B) associated with the license of the of the Included Products from the Company to Napo EU S.p.A. and (3) 50% of royalties collected from licenses of the Included Products to third parties. Pursuant to the terms of the Royalty Interest, the Company has the right to exchange from time to time at the Company’s sole discretion all or any portion of the Royalty Interest for shares of Common Stock at a price per share equal to the Nasdaq Minimum Price (as defined in Nasdaq Listing Rule 5635(d)) as of the date of the applicable exchange. At issuance, based on projected cash outflows from future revenue streams, the discount rate was 55.97%. Interest expense for the three months ended March 31, 2023, and 2022 was $716,000 and zero, respectively. As at March 31, 2023 and December 31, 2022, the carrying value of the debt is $5.6 million and $4.8 million, respectively Streeterville Note On January 13, 2021, the Company issued a secured promissory note to Streeterville in the original principal amount of $6.2 million for an aggregate purchase price of $6.0 million. The Company will use the proceeds to fund development of the Company’s NP-300 drug product candidate for the indication of the symptomatic relief of diarrhea from cholera and general corporate purposes, including the Company’s product pipeline activities. The note is due after four years and bears interest at 3.25% per annum. Interest on the note is payable annually in advance by adding the interest charge for each upcoming year to the outstanding balance on the date each such interest charge is accrued. The Company also paid $25,000 to cover legal fees, accounting costs, due diligence, monitoring and other transaction costs incurred in connection with the issuance of the note. The first year of prepaid interest and the transaction expenses are included in the original principal amount. At any time following the occurrence of a trial failure which refers to any of the following: (i) the Company abandons the clinical trial with NP-300 for an indication for the symptomatic relief of infectious diarrhea for cholera; (ii) the Company fails to start the Phase 1 clinical trial of NP-300 for the symptomatic relief of infectious diarrhea for cholera by July 1, 2022; or (iii) the Company fails to meet all primary endpoints in the pivotal trials of NP-300 for the symptomatic relief if infectious diarrhea for cholera with statistical significance, Streeterville may elect to increase the outstanding balance as of the date of the trial failure by 25% without acceleration (the “Trial Failure Effect”). If Streeterville elects to apply the Trial Failure Effect, it reserves the right to declare the outstanding balance immediately due and payable at any time. As of March 31, 2023, no trial failure occurred. Streeterville is entitled to a maximum of 18% and a minimum of 1% of the gross proceeds received by the Company from the sale of TDPRV (the “Return Bonus”). The Return Bonus percentage is reduced pro rata based on the percentage of the original principal balance of the note that has been repaid as of the date of the sale of the TDPRV. Even if the note has been paid in full at the time of the sale of the TDPRV, the Company is still obliged to pay Streeterville a Return Bonus of 1%. If Streeterville applies the Trial Failure Effect, the Return Bonus will automatically be reduced to 1%. If the TDPRV has not been sold as of the day immediately preceding the maturity date of the note, the Return Bonus percentage will be fixed as of such date. As of March 31, 2023, the Company has not sold any TDPRV. Beginning on the earlier of (a) 6 months after January 2021, and (b) initiation of human trials with NP-300 for symptomatic relief of infectious diarrhea for cholera, the Company may pay all or any portion of the outstanding balance earlier than it is due. In the event the Company elects to prepay all or any portion of the outstanding balance, it shall pay to Streeterville 112.5% of the portion of the outstanding balance the Company elects to prepay. The Company may not prepay the note without the Streeterville’s consent on the date the last patient is enrolled in a pivotal trial. After Streeterville becomes aware of the occurrence of any default, Streeterville may accelerate the note, with the outstanding balance becoming immediately due and payable in cash at the Mandatory Default Amount (i.e., the outstanding balance following the application of the Default Effect). Streeterville reserves the right to declare the outstanding balance immediately due and payable at any time following the default. Default Effect means multiplying the outstanding balance as of the date of default by 5% or 15% for each occurrence of default, capped at an aggregate of 25%, and then adding the resulting product to the outstanding balance. The percentage to be used depends on whether the default is viewed as minor or major as defined in the agreement. Furthermore, interest accrues on the outstanding balance beginning on the date of default at an interest rate equal to the lesser of 18% per annum or the maximum rate permitted under applicable law. As of March 31, 2023, no default has occurred. In connection with the note issuance, the Company has entered into a security agreement with Streeterville, pursuant to which Streeterville will receive a first priority security interest in all existing and future NP-300 technology, and any TDPRV and the sale proceeds therefrom that may be granted to the Company by the FDA in connection with the development of NP-300 for the cholera indication. The Company also agreed, with certain exceptions, not to grant any lien on any of the collateral securing the note and not to grant any license under any of the intellectual property relating to such collateral. The grant of security interest has become effective upon the receipt of the Salix Waiver on April 6, 2021 in observance to the requirement of the settlement agreement previously entered by the Company with Salix Pharmaceuticals, Inc. The Company irrevocably elected to initially and subsequently apply the FVO accounting to the entire note. The fair value at transaction date was equal to the cash proceeds received of Insurance Financing May 2022 First Insurance Financing In May 2022, the Company entered into a premium finance agreement for $752,000 with First Insurance representing the unpaid balance of the total premiums, taxes, and fees of $941,000 with an annual interest rate of 4.3%. The total finance charge was $15,000. Payment of principal and interest is due in equal monthly installments over ten months. Interest expense for the end of March 31, 2023, was $4,000. The financing balance was zero at March 31, 2023. March 2023 First Insurance Financing In March 2023, the Company entered into a premium finance agreement for $98,000 with First Insurance representing the unpaid balance of the total premiums, taxes, and fees of $115,000 with an annual interest rate of 4.6%. The total finance charge was $2,000. Payment of principal and interest is due in equal monthly installments over ten months. Interest expense for the end of March 31, 2023, was zero. The financing balance was $83,000 as at March 31, 2023. 2019 Tempesta Note In October 2019, the Company entered into a License Termination and Settlement Agreement with Dr. Michael Tempesta, pursuant to which certain royalty payment disputes between the Company and Tempesta were settled. Per the terms of the Agreement, Tempesta received $50,000 in cash, an unsecured promissory note issued by the Company in the aggregate principal amount of $550,000 and 13,333 shares of the Company’s common stock in exchange for the cessation of all royalty payments by the Company to Dr. Tempesta under the License Agreements. The $550,000 promissory note bears interest at the rate of 2.5% per annum and matures on March 1, 2025. The promissory note provides for the Company to make semi-annual payments equal to $50,000 plus accrued interest beginning on March 1, 2020 until the Note is paid in full. Interest expense for the three months ended March 31, 2023 and 2022 was $3,000 and $2,000 respectively. At March 31, 2023 and December 31, 2022, the net carrying value of the note was $200,000 and $250,000, respectively. |
Warrants
Warrants | 3 Months Ended |
Mar. 31, 2023 | |
Warrants | |
Warrants | 8. Warrants The following table summarizes information about warrants outstanding and exercisable into shares of the Company’s common stock as of March 31, 2023 and December 31, 2022: March 31, December 31, 2023 2022 (unaudited) Warrants outstanding, beginning balance 7,505 7,513 Issuances — — Exercises — — Expirations and cancelations — (8) Warrants outstanding, ending balance 7,505 7,505 As of March 31, 2023, and 2022, the Company’s outstanding warrants have an exercise price ranging from $1.47 to $157.5 per common share and generally expires prior to December 31, 2024. |
Preferred Stock
Preferred Stock | 3 Months Ended |
Mar. 31, 2023 | |
Preferred Stock. | |
Preferred Stock | 9. Preferred Stock At March 31, 2023 and December 31, 2022, preferred stock consisted of the following: Liquidation ( in thousands, except share and per share data) Shares Issued and Carrying Preference Series Authorized Outstanding Value per Share B-2 10,165 — $ — $ — C 1,011,000 — — — E 4,475,074 — — — Total 5,496,239 — $ — Series C Perpetual Preferred Stock In September 2020, the Company entered into an exchange agreement with Iliad to issue 842,500 shares of the Company's Series C Perpetual Preferred Stock at $0.0001 par value per share, for a non-cash exchange of equity instruments. The exchange agreement was contemporaneously entered with the issuance of Series D Perpetual Preferred shares, in exchange of remaining Series A Convertible Preferred shares totaling 5,524,926 shares, and accreted value of $11.2 million as of the exchange date. An amendment agreement of the Exchange Note 2 was also entered into, with issuance value of $2.3 million and carrying value of $2.6 million as of the exchange date, to extend maturity from December 31, 2020 to December 31, 2021, in consideration of 5% increase in the outstanding balance. The preferred stock has been classified as permanent stockholders' equity in accordance with authoritative guidance for the classification and measurement of perpetual shares without mandatory redemption period because the redemption option was ultimately in the control of the Company. There were no series C Preferred Shares outstanding at March 31, 2023 and 2022. Series E Preferred Stock On August 18, 2022, the Company entered into an agreement (the “Securities Purchase Agreement”) with a third party to issue 10 Series E Preferred Stock with a par value of $0.0001, amounting to $100. In consideration of the Securities Purchase Agreement, the Company and third party agree to amend the existing definition of the term “Service Share Amount” in the License Agreement entered by both parties (See Note 2) and include a subsection for lock-up wherein the third party agrees not to sell, transfer, loan, grant any option of the purchase of, or otherwise dispose of any shares of common stock acquired pursuant to the License Agreement until after the 90-day period following the date of acquisition. On October 4, 2022, the Company redeemed all 10 shares of Series E Preferred Stock in accordance with the terms of such securities. As a result, no shares of Series E Preferred Stock remain outstanding. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity | |
Stockholders' Equity | 10. Stockholders' Equity As of March 31, 2023 and December 31, 2022, the Company had reserved shares of common stock, on an as-if converted basis, for issuance as follows: March 31, December 31, 2023 2022 (unaudited) Options issued and outstanding 26,357 26,533 Inducement options issued and outstanding 1,534 1,546 Options available for grant under stock option plans 120,033 122,978 Restricted stock unit awards issued and outstanding 47,998 44,865 Warrants issued and outstanding 7,505 7,505 Total 203,427 203,427 Common Stock The holders of common stock are entitled to one vote for each share of common stock held. The common stockholders are also entitled to receive dividends whenever funds and assets are legally available and when declared by the Board of Directors. The holders of non-voting common stock are not entitled to vote, except on an as converted basis with respect to any change of control of the Company that is submitted to the stockholders of the Company for approval. Shares of the Company's non-voting common stock have the same rights to dividends and other distributions and are convertible into shares of the Company's common stock on a At a special meeting of stockholders of Jaguar Health, Inc. (the “Company”) held on September 30, 2022 (the “Special Meeting”), the Company’s stockholders approved an amendment (the “Sixth Amendment”) to the Company’s Third Amended and Restated Certificate of Incorporation (the “COI”) to effect an increase in the number of authorized shares of the Company’s voting common stock, par value $0.0001 per share (the “Common Stock”), from 150,000,000 to 298,000,000 shares of Common Stock (the “Authorized Share Increase”) on September 30, 2022. Pursuant to such authority granted by the Company’s stockholders, the Company’s board of directors approved the Authorized Share Increase and the filing of the Sixth Amendment to effectuate the Authorized Share Increase. On September 30, 2022, the Company filed the Sixth Amendment with the Secretary of State of the State of Delaware (the “DE Secretary of State”), and the Authorized Share Increase became effective in accordance with the terms of the Sixth Amendment immediately upon filing with the DE Secretary of State (the “Effective Time”). The Company is now authorized to issue a total number of 352,475,074 shares, of which 298,000,000 shares are common stock, 50,000,000 are non-voting common stock and 4,475,074 are preferred stock. Reverse Stock Split On September 3, 2021, the reverse stock split of the Company’s issued and outstanding voting common stock at a ratio not less than 1 1 three On January 20, 2023, the Company approved a seventh amendment to the Company’s Third Amended and Restated Certificate of Incorporation to effect a 1 seventy-five The reverse stock split reduces the number of shares of common stock issuable upon the conversion of the Company’s outstanding non-voting common stock and the exercise or vesting of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and causes a proportionate increase in the conversion and exercise prices of such non-voting common stock, stock options and warrants. In addition, the number of shares reserved for issuance under the Company’s equity compensation plans immediately prior to the effective time will be reduced proportionately. The reverse stock split did not change the total number of authorized shares of common stock or preferred stock. At the Market Offering (“ATM”) December 2021 ATM Agreement On December 10, 2021, the Company entered into an ATM Agreement (“December 2021 ATM Agreement”) with Ladenburg, pursuant to which the Company may offer and sell, from time to time through Ladenburg, shares of common stock having an aggregate offering price of up to $15.0 million, subject to the terms and conditions of the December 2021 ATM Agreement. The offering will terminate upon the earlier of (i) December 10, 2024 and (ii) termination of the December 2021 ATM Agreement as permitted therein. On February 2, 2022, the Company entered into an amendment to the December 2021 ATM Agreement, pursuant to which, the aggregate offering amount of the shares of the Company’s common stock which the Company may sell and issue through Ladenburg, as the sales agent, was increased from $15.0 million to $75.0 million (the “ATM Upsize”). During the three months ended March 31, 2023, the Company issued an aggregate of 10,463,983 shares under the ATM Agreement for total net proceeds of $17.9 million. Noncontrolling Interest As a result of the merger on November 3, 2021 between Napo EU and Dragon SPAC, the Company assumed a non-controlling interest amounting to $242,000 as of December 31, 2021 which represents noncontrolling interest held by an investor in Napo Therapeutics. During the three months ended March 31, 2023 and 2022, noncontrolling interest increased by $1.0 million and decreased by $178,000, respectively due to the additional investment and share in net comprehensive loss on Napo Therapeutics’ financial performance. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Stock-based Compensation | |
Stock-based Compensation | 11. Stock-based Compensation 2013 Equity Incentive Plan 2014 Stock Incentive Plan Effective May 12, 2015, the Company adopted the Jaguar Health, Inc. 2014 Stock Incentive Plan (“2014 Plan”). The 2014 Plan provides for the grant of options, restricted stock and restricted stock units to eligible employees, directors and consultants to purchase the Company's common stock. The term of an incentive stock option may not exceed 10 years, except that with respect to any participant who owns more than 10% of the voting power of all classes or our outstanding stock, the term must not exceed 5 years. The 2014 Plan that provides for automatic share increases on the first day of each fiscal year in the amount of 2% of the outstanding number of shares of the Company's common stock on the last day of the preceding calendar year. The 2014 Plan replaced the 2013 Plan except that all outstanding options under the 2013 Plan remain outstanding until exercised, canceled or expired. On April 13, 2022, the Board of Directors of the Company approved a Registration Statement to register an additional 2,417,660 shares of the Company’s common stock for issuance pursuant to the awards granted under the 2014 Plan. As of March 31, 2023, there were 26,357 options outstanding and 113,053 options available for grant. As of December 31, 2022, there were 26,533 options outstanding and 116,011 options available for grant. 2020 New Employee Inducement Award Plan Effective June 16, 2020, the Company adopted the Jaguar Health, Inc. New Employee Inducement Award Plan (“2020 Inducement Award Plan”) and, subject to the adjustment provisions of the Inducement Award Plan, reserved 166,666 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Award Plan. The term of an incentive stock option may not exceed 10 years , except that with respect to any participant who owns more than 10% of the voting power of all classes or our outstanding stock, the term must not exceed 5 years . The 2020 Inducement Award Plan provides for the grant of non-statutory stock options, restricted stock units, restricted stock, and performance shares. The 2020 Inducement Award Plan was adopted without stockholder approval pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules. The terms and conditions of the 2020 Inducement Award Plan are substantially similar to the Company’s 2014 Stock Incentive Plan, but with such other terms and conditions intended to comply with the Nasdaq inducement award rules. In accordance with Rule 5635(c)(4) of the Nasdaq Listing Rules, the only persons eligible to receive grants of equity awards under the Inducement Award Plan are individuals who were not previously an employee or director of the Company, or following a bona fide period of non-employment, as an inducement material to such persons entering into employment with the Company. On April 13, 2022, the Board of Directors of the Company approved an amendment to the 2020 Inducement Award Plan to reserve an additional 471,833 shares of the Company’s common stock for issuance pursuant to equity awards granted under the Inducement Award Plan, thereby increasing the number of shares of the Company’s common stock issuable thereunder from 500,000 shares to 971,833 shares. As of March 31, 2023, there were 1,534 options outstanding and 6,979 options available for grant. As of December 31, 2022, there were 1,546 options outstanding and 6,967 options available for grant. The Company authorized an additional 151,079 shares for the stock incentive plans. Stock Options and Restricted Stock Units (“RSUs”) The following table summarizes the incentive plan activity for the three months ended March 31, 2023 and year ended December 31, 2022: Weighted Weighted Average Shares Stock Average Remaining Aggregate Available Options RSUs Stock Option Contractual Life Intrinsic (in thousands, except share and per share data) for Grant Outstanding Outstanding Exercise Price (Years) Value* Outstanding at January 1, 2022 8,417 33,286 6,499 $ 707.97 8.35 $ 3 Additional shares authorized 151,079 — — — — Options granted (44) 44 — 23.46 — Options exercised — — — — — Options canceled 5,251 (5,251) — 418.34 — RSUs granted (41,725) — 41,725 — — RSUs vested and released — — (2,516) — — RSUs cancelled — — (843) — — Outstanding at December 31, 2022 122,978 28,079 44,865 $ 592.73 7.19 $ — Additional shares authorized — — — — — — Options granted — — — — — — Options exercised — — — — — — Options canceled 188 (188) — 330.46 — — RSUs granted (3,133) — 3,133 — — — RSUs vested and released — — — — — — RSUs cancelled — — — — — — Outstanding at March 31, 2023 120,033 27,891 47,998 $ 594.50 6.95 $ — Exercisable at March 31, 2023 26,549 $ 607.19 6.89 $ — Vested and expected to vest at March 31, 2023 27,779 $ 595.49 6.95 $ — *Fair market value of Jaguar stock on March 31, 2023 was $0.69 per share. The intrinsic value is calculated as the difference between the exercise price of the underlying options and the fair market value of the Company's common stock for options that were in-the-money. The number of options exercised during the three months ended March 31, 2023 and year ended December 31, 2022 were zero, respectively. The weighted average grant date fair value of stock options granted was zero and $23.46 per share during the three months ended March 31, 2023, and for the year ended December 31, 2022, respectively. The number of options that vested for the three months ended March 31, 2023 and for the year ended December 31, 2022 was 595 and 7,492, respectively. The grant date weighted average fair value of options that vested for the three months ended March 31, 2023, and for the year ended December 31, 2022 was $209.49 and $304.57, respectively. Stock-Based Compensation The following table summarizes stock-based compensation expense related to stock options, inducement stock options and RSUs for the three months ended March 31, 2023, and 2022, and are included in the unaudited condensed consolidated comprehensive loss as follows: Three Months Ended March 31, (in thousands) 2023 2022 Research and development expense $ 227 $ 348 Sales and marketing expense 49 82 General and administrative expense 204 633 Total $ 480 $ 1,063 As of March 31, 2023, the Company had $377,000 of unrecognized stock-based compensation expense for options, inducement options and restricted stock units outstanding, which is expected to be recognized over a weighted-average period of 1.08 years. The fair value of options granted during the three months ended March 31, 2023, and 2022, respectively, were calculated using the range of assumptions set forth below: March 31, December 31, 2023 2022 (unaudited) Volatility — 164.0% Expected term (years) — 5.0 Risk-free interest rate — 3.2% Expected dividend yield — — 401(k) Plan The Company sponsors a 401(k) defined contribution plan covering all employees. There were no employer contributions to the plan from plan inception through March 31, 2023. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss Per Share | |
Net Loss Per Share | 12. Net Loss Per Share The following table presents the calculation of basic and diluted net loss per share of common stock for the periods indicated: Three Months Ended March 31, (In thousands, except share and per share data) 2023 2022 Net loss attributable to common stockholders (basic and diluted) $ (12,202) $ (17,986) Shares used to compute net loss per common share, basic and diluted 5,109,609 778,512 Net loss per share attributable to common stockholders, basic and diluted $ (2.39) $ (23.10) Basic net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted-average number of common shares and common share equivalents outstanding for the period. Common stock equivalents are only included when their effect is dilutive. The Company's potentially dilutive securities which include stock options, convertible preferred stock, RSUs and common stock warrants have been excluded from the computation of diluted net loss per share as they would be anti-dilutive. For all periods presented, there is no difference in the number of shares used to compute basic and diluted shares outstanding due to the Company's net loss position. The following outstanding common stock equivalents have been excluded from diluted net loss per common share for the three months ended March 31, 2023, and December 31, 2022 because their inclusion would be anti-dilutive. March 31, December 31, 2023 2022 (unaudited) Options issued and outstanding 26,357 26,533 Inducement options issued and outstanding 1,534 1,546 Restricted stock units issued and outstanding 47,998 44,865 Warrants issued and outstanding 7,505 7,505 Total 83,394 80,449 As of March 24, 2023, there were 11,680,245 shares of common stock issued after the balance sheet date. Including these shares will have a material effect on the diluted net loss per common share in future periods. |
Segment Data
Segment Data | 3 Months Ended |
Mar. 31, 2023 | |
Segment Data | |
Segment Data | 13. Segment Data The Company has two reportable segments-human health and animal health. The animal health segment is focused on developing and commercializing prescription and non-prescription products for companion and production animals. The human health segment is focused on developing and commercializing human products and the ongoing commercialization of Mytesi, which the U.S. FDA approves for the symptomatic relief of non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. The Company's reportable segments net revenues and net loss for the three months ended March 31, 2023, and 2022 consisted of the following: Three Months Ended March 31, (in thousands) 2023 2022 Revenue from external customers Human Health $ 1,927 $ 2,605 Animal Health 45 20 Consolidated Totals $ 1,972 $ 2,625 Segment net loss Human Health $ (6,539) $ (9,967) Animal Health (5,858) (8,197) Consolidated Totals $ (12,397) $ (18,164) The Company's reportable segments assets consisted of the following: March 31, December 31, 2023 2022 (in thousands) (unaudited) Segment assets Human Health $ 41,124 $ 40,898 Animal Health 143,904 128,607 Total $ 185,028 $ 169,505 The reconciliation of segments assets to the consolidated assets is as follows: March 31, December 31, (in thousands) 2023 2022 (unaudited) Total assets for reportable segments $ 185,028 $ 169,505 Less: Investment in subsidiary (29,232) (29,232) Less: Intercompany loan (98,869) (92,821) Consolidated Totals $ 56,927 $ 47,452 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events | |
Subsequent Events | 14. Subsequent Events December 2021 ATM Agreement Subsequent to March 31, 2023, the Company has issued an additional 3,019,477 shares under the December 2021 ATM Agreement with total net proceeds of approximately $1.7 million. December 2020 Royalty Interest Exchange Agreement On May 8, 2023, the Company entered into an exchange agreement with Irving to (i) partition a new royalty interest in the royalty repayment amount of $1,073,807 (“Partitioned Royalty”) from the royalty interest of the December 2020 Purchase Agreement and then cause the outstanding balance of the royalty interest to be reduced by an amount equal to the initial outstanding balance of the Partitioned Royalty, and (ii) exchange (“Royalty Exchange”) the Partitioned Royalty for 1,908,651 shares of the Company’s common stock with a par value of $0.0001 in accordance with the term of the December 2020 Royalty Interest Exchange Agreement. Under the terms of the December 2020 Royalty Interest Exchange Agreement, the Royalty Exchange will consist of Irving surrendering the Partitioned Royalty in exchange for the shares, free of any restrictive securities legend, and Irving shall give no consideration of any kind whatsoever to the Company in connection with the December 2020 Royalty Interest Exchange Agreement. PIPE Purchase Agreement On May 8, 2023, the Company entered into a Securities Purchase Agreement (the “PIPE Purchase Agreement”) with certain investors named therein (collectively the “Purchasers”), pursuant to which the Company agreed to issue and sell to the Purchasers in a private placement an aggregate of (i) 137 shares (the “Preferred Shares”) of Series G Convertible Preferred Stock, par value $0.0001 per share, of the Company (“Series G Preferred Stock”) and (ii) warrants to purchase up to 6,850,000 shares of the Company’s common stock, par value $0.0001 per share (“Common Stock”), at an exercise price of $0.48 per share (the “PIPE Warrants”), for an aggregate purchase price of approximately $1.86 million (the “Private Placement”). The Company intends to use the proceeds from the Private Placement for working capital and general corporate purposes. Each share of Series G Preferred Stock is convertible into shares of Common Stock. The Series G Preferred Stock terms are set forth in a Certificate of Designation of Preferences, Rights, and Limitations of Series G Convertible Preferred Stock (the “Certificate of Designation”) filed with the Secretary of State of Delaware and effective on May 9, 2023. The PIPE Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on the later of (i) January 1, 2024, and (ii) the date on which the approval by the Company’s stockholders (the “Stockholder Approval”) to remove both the Voting Cap and the Conversion Cap (both as defined below) is obtained (the “Initial Exercise Date”) and ending on the five-year anniversary of the Initial Exercise Date. On May 10, 2023, the Company issued warrants equivalent to 6,850,000 shares of the Company’s common stock in relation to the PIPE Purchase Agreement. The PIPE Purchase Agreement provides that during the period commencing on the signing of the PIPE Purchase Agreement and ending October 22, 2023, the Company will not effect or enter into any agreement to (i) issue securities in exchange for any securities of the Company issued and outstanding on the date of the PIPE Purchase Agreement pursuant to Section 3(a)(9) of the Securities Act of 1933, as amended (the “Securities Act”), or (ii) effect issuance by the Company of Common Stock or Common Stock Equivalents, subject to certain customary exceptions set forth in the PIPE Purchase Agreement including, among others, issuance of shares of Common Stock pursuant to the At The Market Offering Agreement, dated December 10, 2021, by and between the Company and Ladenburg Thalmann & Co. Inc., as amended (the “Ladenburg Thalmann ATM”), provided that such issuance in the Ladenburg Thalmann ATM has consented. Standstill Agreement On May 8, 2023, the Company and NAPO Pharmaceuticals, Inc., a wholly-owned subsidiary of the Company, entered into a standstill agreement (the “Standstill Agreement”) with Iliad and Streeterville with respect to four outstanding royalty interests issued by the Company to Investor dated October 8, 2020, December 22, 2020, March 8, 2021, and August 24, 2022, respectively (collectively, the “Royalty Interests”). Standstill Agreement provides that for a period beginning on the effective date of the Standstill Agreement (the “Effective Date”) and ending on the earliest of: (1) the date that is Following the expiration or earlier termination of the Standstill Period: (i) the Company shall resume making Royalty Payments in accordance with the terms and conditions of the transaction documents of the Royalty Interests, and (ii) all restrictions applicable to Investor’s buying, selling, or otherwise trading in the Company’s Common Stock shall immediately and automatically terminate with no action required on the part of either Investor or Company. As a material inducement and consideration for Investor’s agreement to enter into the Standstill Agreement, the Company agreed to issue (i) Iliad warrants to purchase up to 826,738 shares of the Common Stock, (ii) Uptown warrants to purchase up to 1,097,756 shares of the Common Stock, and (iii) Streeterville warrants to purchase up to 1,892,808 shares of the Common Stock, at an exercise price of $0.48 per share (the “Standstill Warrants”). The Standstill Warrants may be exercisable for cash or on a cashless basis at any time and from time to time during the period commencing on the later of (i) January 1, 2024 and (ii) the date on which the Stockholder Approval is obtained (the “Standstill Warrant Initial Exercise Date”) and ending on the five-year anniversary of the Standstill Warrant Initial Exercise Date. Minimum Bid Price Requirement On May 10, 2023, the Company received a letter from the Staff of Nasdaq indicating that the bid price for the Company’s common stock for the last 30 consecutive business days had closed below the minimum $1.00 per share required for continued listing under Nasdaq Listing Rule 5550(a)(2). Under Nasdaq Listing Rule 5810(c)(3)(A), the Company has been granted a 180-calendar day grace period, or until November 6, 2023, to regain compliance with the minimum bid price requirement. The continued listing standard will be met if the Company evidences a closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days during the 180 calendar-day grace period. In order for Nasdaq to consider granting the Company additional time beyond November 6, 2023, the Company would be required, among other things, to meet the continued listing requirement for the market value of publicly held shares as well as all other standards for initial listing on Nasdaq, with the exception of the minimum bid price requirement. If measured today, the Company would qualify for Nasdaq’s consideration of an extension because the Company currently has stockholders’ equity of at least $5 million. In the event the Company does not regain compliance with the $1.00 bid price requirement by November 6, 2023, eligibility for Nasdaq’s consideration of a second 180-day The Company is diligently working to evidence compliance with the minimum bid price requirement for continued listing on Nasdaq; however, there can be no assurance that the Company will be able to regain compliance or that Nasdaq will grant the Company a further extension of time to regain compliance, if necessary. If the Company fails to regain compliance with the Nasdaq continued listing standards, its common stock will be subject to delisting from Nasdaq. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and on a basis consistent with the annual consolidated financial statements, and in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the periods presented. These interim financial results are not necessarily indicative of the results to be expected for the year ending December 31, 2023, or for any other future annual or interim period. These unaudited condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Annual Report on Form 10-K for the year ended December 31, 2022. The condensed consolidated balance sheet at December 31, 2022 has been derived from the audited consolidated financial statements at that date, but does not include all disclosures, including notes, required by U.S. GAAP for complete financial statements. There has been no material change to the Company's significant accounting policies during the three months ended March 31, 2023, as compared to the significant accounting policies described in Note 2 of the “Notes to Consolidated Financial Statements” in the Company's Annual Report on Form 10-K as of and for the year ended December 31, 2022, which was filed to SEC on March 24, 2023. Except as noted above, the unaudited condensed consolidated financial statements have been prepared on the same basis as the audited consolidated financial statements and, in the opinion of management, reflect all adjustments of a normal recurring nature considered necessary to present fairly the financial position as of March 31, 2023, results of operations for the three months ended March 31, 2023, and 2022, changes in convertible preferred stock and stockholders' equity for the three months ended March 31, 2023, and 2022, and cash flows for the three months ended March 31, 2023 and 2022. The interim results are not necessarily indicative of the results for any future interim periods or for the entire year |
Principles of Consolidation | Principles of Consolidation The consolidated financial statements have been prepared in accordance with U.S. GAAP and applicable rules and regulations of the Securities and Exchange Commission (“SEC”) and include the accounts of the Company and its subsidiaries with controlling interest. All inter-company transactions and balances have been eliminated in consolidation. The reporting currency of the Company is the U.S dollar. |
Non-controlling interest | Non-controlling interest ended March 31, 2023, an additional investment from a private entity amounting to €1.1 million equivalent to $1.23 million resulted to the increase in non-controlling interest percentage. |
Use of Estimates | Use of Estimates The preparation of the consolidated financial statements in conformity with U.S. GAAP requires the Company’s management to make judgments, assumptions and estimates that affect the amounts reported in its unaudited consolidated financial statements and the accompanying notes. The accounting policies that reflect the Company’s more significant estimates and judgments and that the Company believes are the most critical to aid in fully understanding and evaluating its reported financial results are the valuation of stock options, restricted stock units (“RSUs”), valuation of hybrid instruments designated at fair value option (“FVO”), valuation of warrant liabilities, acquired in-process research and development (“IPR&D”), and useful lives assigned to long-lived assets; impairment assessment of non-financial assets; valuation adjustments for excess and obsolete inventory; allowance for doubtful accounts; deferred taxes and valuation allowances on deferred tax assets; evaluation and measurement of contingencies; and recognition of revenue, including estimates for product returns. Those estimates could change, and as a result, actual results could differ materially from those estimates. In March 2020, the World Health Organization declared the COVID-19 outbreak to be a pandemic. During the year ended December 31, 2022, the Company’s financial results were not significantly affected by the COVID-19 outbreak. The Company has considered all information available as of the date of issuance of these financial statements and the Company is not aware of any specific events or circumstances that would require an update to its estimates or judgments, or a revision to the carrying value of its assets or liabilities. These estimates may change as new events occur and additional information becomes available. The extent to which the COVID-19 outbreak affects the Company’s future financial results and operations will depend on future developments which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of the outbreak, and current or future domestic and international actions to contain and treat it. |
Cash | Cash The Company’s cash on deposit may exceed United States federally insured limits at certain times during the year. The Company maintains cash accounts with certain major financial institutions in the United States. The Company does not have cash equivalents as of March 31, 2023 and December 31, 2022. |
Accounts Receivable | Accounts Receivable Accounts receivable is recorded net of allowances for discounts for prompt payment and credit losses. The Company utilizes a loss rate approach in determining its lifetime expected credit losses on receivables from customers. This method calculates an estimate of credit losses based on historical experience, credit quality, age of the accounts receivable balances, and current and forecasted economic and business conditions that may affect a customer’s ability to pay. In determining the loss rates, the Company evaluates information related to its historical losses, adjusted for existing conditions and further adjusted for the period of time that can reasonably be forecasted. The facts and circumstances as of the balance sheet date are used to adjust the estimate for periods beyond those that can reasonably be forecasted. The past due status of accounts receivable is determined based on the contractual due dates for payments. A receivable is deemed past due when payment hasn’t been received 30 days after the contractual due date. The credit loss allowance was immaterial as of March 31, 2023 and December 31, 2022. The corresponding expense for the credit loss allowance is reflected in general and administrative expenses. |
Current Expected Credit Losses | Current Expected Credit Losses The Company recognizes an allowance for credit losses for financial assets carried at amortized cost to present the net amount expected to be collected as of the balance sheet date. Such allowance is based on credit losses that are expected to arise over the contractual term of the asset, which includes consideration of historical credit loss information adjusted for current conditions and reasonable and supportable forecasts. Changes in the allowance for credit losses are recorded as provision of (or reversal of) credit loss expense. Assets are written off when the Company determines that such are deemed uncollectible. Write-offs are recognized as a deduction from the allowance for credit losses. Expected recoveries of amounts previously written off, not to exceed the aggregate of the amount previously written off, are included in determining the necessary allowance at the balance sheet date. |
Concentrations | Concentrations Cash is the financial instrument that potentially subjects the Company to a concentration of credit risk as cash is deposited with a bank and cash balances are generally in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. For the three months ended March 31, 2023, and 2022, substantially all of the Company’s revenue was derived from the sale of Mytesi. In looking at sales by the Company to distributors whose net revenue percentage of total net revenue was equal to or greater than 10%, for fiscal years 2023 and 2022, the Company earned Mytesi revenue primarily from three and one major pharmaceutical distributor(s) located in the United States, respectively. Revenue earned from each major customer as a percentage of total revenue is as follows: Three Months Ended March 31, 2023 2022 (unaudited) Customer 1 25 % 34 % Customer 2 54 % 49 % Customer 3 — 10 % The Company is subject to credit risk from its accounts receivable related to its sales. The Company generally does not perform evaluations of customers' financial condition and generally does not require collateral. Accounts receivable balance of the significant customers as a percentage of total accounts receivable is as follows: March 31, December 31, 2023 2022 (unaudited) Customer 1 38 % 38 % Customer 2 54 % 54 % The Company is subject to concentration risk from its suppliers. The Company sources raw material used to produce the active pharmaceutical ingredient (“API”) in Mytesi from two suppliers and is dependent on a single third-party contract manufacturer for the supply of API in Mytesi and a single third-party contract manufacturer as well for the supply of finished products for commercialization. |
Other Risks and Uncertainties | Other Risks and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to war, rapid technological change, obtaining second source suppliers, regulatory approval from the FDA or other regulatory authorities, the results of clinical trials and the achievement of milestones, market acceptance of the Company’s product candidates, competition from other products and larger companies, protection of proprietary technology, strategic relationships and dependence on key individuals. Recent Global Events Conditions within the Banking Sector First Republic, another U.S. regional bank, also experienced large withdrawals of deposits, raising concerns about its financial stability. On May 1, 2023, First Republic was placed under FDIC receivership and the FDIC entered into a purchase and assumption agreement with JPM Chase Bank, N.A. under which JPM Chase Bank, N.A. will assume all of the deposits and substantially all of the assets of First Republic. Although the U.S. Department of Treasury, the Federal Reserve and the FDIC have taken measures to stabilize the financial system, uncertainty and liquidity concerns in the broader financial services industry remain. As of March 31, 2023, the Company had no cash deposits nor investments within SVB, Signature or First Republic and does not expect any impact from its cash deposits from its financial institutions. |
Fair Value | Fair Value The Company’s financial instruments include accounts receivable, accounts payable, accrued liabilities, warrant liability, operating lease liability, equity-linked financial instruments, and debt. The recorded carrying amount of accounts receivable, accounts payable and accrued liabilities reflect their fair value due to their short-term nature. Other financial liabilities are initially recorded at fair value, and subsequently measured at either fair value or amortized cost using the effective interest method. See Note 3 for the fair value measurements. |
Fair Value Option | Fair Value Option ASC 825-10, Financial Instruments |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. Cost is initially recorded at the invoiced amount of raw materials or API, including the sum of qualified expenditures and charges in bringing the inventory to its existing condition and location. The Company calculates inventory valuation adjustments when conditions indicate that net realizable value is less than cost due to physical deterioration, usage, obsolescence, reductions in estimated future demand or reduction in selling price. Inventory write- downs are measured as the difference between the cost of inventory and net realizable value. The Company does not have allowance for inventory obsolescence as at March 31, 2023, and December 31, 2022. |
Prelaunch Inventory | Prelaunch Inventory |
Property and Equipment | Property and Equipment Land is stated at cost, reflecting the fair value of the property at July 31, 2017, the date of the Napo merger. Equipment is stated at cost, net of accumulated depreciation. Equipment begins to be depreciated when it is placed into service. Depreciation is calculated using the straight-line method over estimated useful lives ranging between 3 to 10 years. Expenditures for repairs and maintenance of assets are charged to expense as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their estimated useful lives. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in the unaudited condensed consolidated comprehensive loss. |
Software Developed for Internal Use | Software Developed for Internal Use The Company capitalizes the costs of developing software for internal use. These costs include both purchased software and internally developed software. Costs of developing software are expensed until technological feasibility has been established. Thereafter, all costs are capitalized and are carried at the lower of unamortized cost or net realizable value. Internally developed and purchased software costs are generally amortized over five years. |
Long-lived Assets | Long-lived Assets The Company regularly reviews the carrying value and estimated lives of all of its long-lived assets, including property and equipment and definite-lived intangible assets, to determine whether indicators of impairment exist that warrant adjustments to carrying values or estimated useful lives. The determinants used for this evaluation include management’s estimate of the asset’s ability to generate positive income from operations and positive cash flow in future periods as well as the strategic significance of the assets to the Company’s business objectives. If the Company determines that an impairment trigger has been met, the Company evaluates the realizability of its long-lived assets (asset group) based on a comparison of projected undiscounted cash flows from use and eventual disposition with the carrying value of the related asset. Any write-downs (which are measured based on the difference between the fair value and the carrying value of the asset) are treated as permanent reductions in the carrying amount of the assets (asset group). Based on this evaluation, the Company believes that, as of each of the balance sheet dates presented, none of the Company’s long-lived assets were impaired. The Company’s had no impairment of long-lived assets as at March 31, 2023, and 2022. |
Indefinite-lived Intangible Assets | Indefinite-lived Intangible Assets Acquired IPR&D are intangible assets acquired in the July 2017 Napo merger. Under ASC 805, IPR&D are initially recognized at fair value and classified as indefinite-lived assets until the successful completion or abandonment of the associated research and development efforts. During the development period, these assets will not be amortized as charges to earnings; instead, these assets will be tested for impairment on an annual basis or more frequently if impairment indicators are identified. An impairment loss is measured based on the excess of the carrying amount over the asset’s fair value. The Company recorded no impairment for the three months ended March 31, 2023, and 2022. |
Leases | Leases The Company accounts for its leases in accordance with ASC 842, Leases At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. Because the interest rate implicit in lease contracts is typically not readily determinable, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use asset may be required for items such as initial direct costs paid or incentives received. The Company elected to include both the lease and non-lease components as a single component and account for it as a lease. |
Research and Development Expense | Research and Development Expense Research and development expense consists of expenses incurred in performing research and development activities including related salaries, clinical trials and related drug and non-drug product costs, contract services and other outside service expenses. Research and development expense is charged to operating expense in the period incurred. |
Clinical Trial Accruals | Clinical Trial Accruals Clinical trial costs are a component of research and development expenses. The Company accrues and expenses clinical trial activities performed by third parties based upon actual work completed in accordance with agreements established with clinical research organizations and clinical sites. The Company determines the costs to be recorded based upon validation with the external service providers as to the progress or stage of completion of trials or services and the agreed-upon fee to be paid for such services. |
Revenue Recognition | Revenue Recognition The Company recognizes revenue in accordance with ASC 606, Revenue from Contracts with Customers The Company’s policy typically permits returns if the product is damaged, defective, or otherwise cannot be used when received by the customer if the product has expired. Returns are accepted for product that will expire within three months or that have expired up to one year after their expiration dates. Estimates for expected returns of expired products are based primarily on an ongoing analysis of our historical return patterns. The Company recognizes revenue in accordance with the core principle of ASC 606 or when there is a transfer of control of promised goods or services to customers in an amount that reflects the consideration that the Company expects to be entitled to in exchange for those goods or services. The Company recognizes the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that the Company otherwise would have recognized is one year or less. The Company does not adjust the amount of consideration for the effects of a significant financing component if, at contract inception, the expected period between the transfer of promised goods or services and customer payment is one year or less. The Company has elected to treat shipping and handling activities as fulfillment costs. Additionally, the Company elected to record revenue net of sales and other similar taxes. Contracts and Agreements Effective January 16, 2019, the Company engaged Cardinal Health as its exclusive third-party logistics distribution agent for commercial sales of the Company’s Mytesi product and to perform certain other services which include, without limitation, storage, distribution, returns, customer support, financial support, Electronic Data Interchange (“EDI”) and system access support (the “Exclusive Distribution Agreement”). On September 3, 2021, the Company ended its engagement with Cardinal Health as its exclusive title model customer for commercial sales and fully implemented its limited distribution Specialty Pharmacy model. Cardinal Health continues to provide third-party logistics services for Mytesi. The Company's Canalevia-CA1 and Neonorm products are primarily sold to distributors, who then sell the products to the end customers. Since 2021, the Company has entered into two distribution agreements with established distributors to distribute the Company’s animal health products in the United States. The distribution agreements and the related purchase orders together meet the contract existence criteria under ASC 606 10 25 1. The Company sells directly to its customers without the use of an agent. Performance obligations For animal health products sold by the Company, the single performance obligation identified above is the Company’s promise to transfer the Company’s animal health products to distributors based on specified payment and shipping terms in the arrangement. Product warranties are assurance-type warranties that do not represent a performance obligation. For the Company’s human health product, Mytesi, the single performance obligation identified above is the Company’s promise to transfer Mytesi to specialty pharmacies, based on specified payment and shipping terms as outlined in the Exclusive Distribution Agreement. Transaction price For contracts with Cardinal Health and other distributors, the transaction price is the amount of consideration to which the Company expects to collect in exchange for transferring the promised goods or services. The transaction price of Mytesi is the Wholesaler Acquisition Cost (“WAC”), and the transaction price of Canalevia-CA1 and Neonorm is the manufacturer’s list price, net of discounts, returns, and price adjustments. Allocate transaction price For contracts with Cardinal Health and other distributors, the entire transaction price is allocated to the single performance obligation contained in each contract. Revenue recognition For contracts with Cardinal Health, for the Company, a single performance obligation is satisfied at a point in time, upon the FOB terms of each contract when control, including title and all risks, has transferred to the customer. Disaggregation of Product Revenue Human Sales of Mytesi are recognized as revenue at a point in time when the products are delivered to the wholesaler. Net revenues from the sale of Mytesi were $404,000 and $438,000 for the three months ended March 31, 2023, and 2022, respectively. Animal The Company recognized Canalevia-CA1 products revenues of $27,000 and zero for the three months ended March 31, 2023, and 2022, respectively. Revenues are recognized at a point in time upon shipment, which is when title and control is transferred to the buyer. Sales of Canalevia-CA1, Neonorm Calf and Foal to distributors are made under agreements that may provide distributor price adjustments and rights of return under certain circumstances. Contracts – Specialty Pharmacies Effective October 1, 2020, the Company engaged a private company as an authorized specialty pharmacy provider of the Company’s Mytesi product. Under the Specialty Product Distribution Agreement, the Company shall supply the products to the private company’s specialty pharmacies, through a designated wholesaler, in such amounts as may be ordered. There is no minimum purchase or inventory requirement. The specialty pharmacies were authorized distributors of record for all National Drug Codes (“NDCs”) of Mytesi. Effective April 20, 2021, the Company engaged another private company as an authorized specialty pharmacy provider of Mytesi. Under the Specialty Pharmacy Distribution and Services Agreement, the private company shall sell and dispense the Mytesi directly ordered from the Company at the agreed price to patients within the territories identified in the agreement. The Company has entered into agreements with a total of five different specialty pharmacy chains that are authorized to provide Mytesi to patients. Performance obligations The single performance obligation is the Company’s promise to transfer Mytesi to specialty pharmacies, based on specified payment and shipping terms as outlined in the agreements. Transaction price The transaction price is the amount of consideration to which the Company expects to collect in exchange for transferring the promised goods or services. The transaction price of Mytesi is the WAC, net of estimated discounts, returns, and price adjustments. Allocate transaction price The entire transaction price is allocated to the single performance obligation contained in each contract. Revenue recognition The single performance obligation is satisfied at a point in time, upon the free on board (“FOB”) terms of each contract when control, including title and all risks, has transferred to the customer. Product Revenue Sales of Mytesi are recognized as revenue at a point in time when the products are delivered to the specialty pharmacies. Net revenues from the sale of Mytesi to the specialty pharmacies were $1.5 million and $2.2 million for the months ended March 31, 2023 and 2022, respectively. |
Collaboration Revenue | Collaboration Revenue Revenue recognition for collaboration agreements requires significant judgment. The Company’s assessments and estimates are based on contractual terms, historical experience and general industry practice. Revisions in these values or estimations have the effect of increasing or decreasing collaboration revenue in the period of revision. On September 24, 2018, the Company entered into a Distribution, License and Supply Agreement (“License Agreement”) with Knight Therapeutics ("Knight"). The License Agreement has a term of 15 years (with automatic renewals) and provides Knight with an exclusive right to commercialize current and future Jaguar human health products (including crofelemer, NP-300, and any product containing a proanthocyanidin or with an anti-secretory mechanism) in Canada and Israel. Knight forfeited its right of first negotiation for expansion to Latin America. Under the License Agreement, Knight is responsible for applying for and obtaining necessary regulatory approvals in the territory of Canada and Israel, as well as marketing, sales and distribution of the licensed products. Knight will pay a transfer price for all licensed products, and upon achievement of certain regulatory and sales milestones, the Company may receive payments from Knight in an aggregate amount of up to approximately $18 million payable throughout the initial 15-year term of the agreement. The Company did not have any license revenues for the three months ended March 31, 2023 and 2022. |
Modifications to Liability-classified Instruments | Modifications to Liability-classified Instruments In accounting for debt modifications and exchange transactions, it is the Company’s policy to first determine whether it qualifies as a troubled debt restructuring (“TDR”) pursuant to the guidance provided in ASC 470-60. A debt modification or exchange transaction that is not within the scope of the ASC 470-60 is accounted for under ASC 470-50 to determine if the transaction is a mere modification or an extinguishment. For the three months ended March 31, 2023, the Company entered into another amendment on the terms of its October 2020 and December 2020 Purchase Agreements (see Note 7). |
Modifications to Equity-classified Instruments | Modifications to Equity-classified Instruments In accounting for modifications of equity-classified warrants, it is the Company’s policy to determine the impact by analogy to the share-based compensation guidance of ASC 718, Compensation - Stock Compensation The Company did not modify any equity-classified warrants for the three months ended March 31, 2023, and 2022. In accounting for amendments to preferred stock, it is the Company’s policy to measure the impact by analogy to ASC 470-50 in determining if such an amendment is an extinguishment or a modification. If the amendment results in an extinguishment, the Company follows the SEC staff guidance in ASC 260-10-S99-2 and ASC 470-20. If the amendment results in a modification, the Company follows the model in either ASC 718 or ASC 470-50, depending on the nature of the amendment. The Company did not modify any equity-classified preferred stock for the three months ended March 31, 2023 and 2022. |
Stock-based Compensation | Stock-based Compensation The Company's Stock Incentive Plan (see Note 11) provides for the grant of stock options, restricted stock and restricted stock unit awards. The Company measures stock awards granted to employees, non-employees and directors at estimated fair value on the date of grant and recognizes the corresponding compensation expense of the awards, net of estimated forfeitures, over the requisite service periods, which correspond to the vesting periods of the awards. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company issues stock awards with only service-based vesting conditions, and records compensation expense for these awards using the straight-line method. The Company uses the grant date fair market value of its common stock to determine the grant date fair value of options granted to employees, non-employees and directors. The Company measures and recognizes compensation expense for all stock options and restricted stock units (“RSUs”) granted to its employees and directors based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes valuation model to estimate the fair value of stock option awards. The fair value is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis. The Company believes that the fair value of stock options granted to non-employees is more reliably measured than the fair value of the services received. The determination of the grant date fair value of options using an option pricing model is affected by the Company’s estimated Common Stock fair value and requires management to make a number of assumptions including the expected life of the option, the volatility of the underlying stock, the risk-free interest rate and expected dividends. The Company estimates the fair value of stock options using the Black-Scholes option valuation model. The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair market value of common stock is based on the closing price of the Company’s common stock as reported on the date of the grant. |
Income Taxes | Income Taxes The Company uses the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the differences between the financial reporting and the tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will not be realized. The Company has adopted the provisions of ASC 740, Income Taxes Related to Uncertain Tax Positions |
Foreign Currency Remeasurement and Translation | Foreign Currency Remeasurement and Translation The functional currency of Napo Therapeutics is Euro. The Company follows ASC 830, Foreign Currency Matters For certain subsidiaries, translation adjustments result from the process of translating the functional currency of subsidiary financial statements into the U.S. Dollar reporting currency. These translation adjustments are reported separately and accumulated in the unaudited condensed consolidated balance sheets as a component of accumulated other comprehensive loss. |
Comprehensive Loss | Comprehensive Loss The Company follows ASC 220, Comprehensive Income For the months ended March 31, 2023 and 2022, the amount of other comprehensive losses from translation adjustments were $232,000 and zero, respectively. |
Basic and Diluted Net Loss Per Common Share | Basic and Diluted Net Loss Per Common Share Basic net loss per common share is computed by dividing net loss attributable to common stockholders for the year by the weighted-average number of common shares outstanding during the year. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders for the year by the weighted-average number of common shares, including potential dilutive shares of common stock assuming the dilutive effect of potential dilutive securities. For years in which the Company reports a net loss, diluted net loss per common share is the same as basic net loss per common share, because their impact would be anti-dilutive to the calculation of net loss per common share. Diluted net loss per common share is the same as basic net loss per common share for the three months ended March 31, 2023 and 2022. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements There are no recent accounting pronouncements that are expected to have a material impact on the Company’s financial statements and related disclosures as at March 31, 2023. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) - Customer risk | 3 Months Ended |
Mar. 31, 2023 | |
Total net revenue | |
Schedule of concentration risk | Three Months Ended March 31, 2023 2022 (unaudited) Customer 1 25 % 34 % Customer 2 54 % 49 % Customer 3 — 10 % |
Total accounts receivable | |
Schedule of concentration risk | March 31, December 31, 2023 2022 (unaudited) Customer 1 38 % 38 % Customer 2 54 % 54 % |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Measurements | |
Summary of information about the company's financial instruments that were measured at fair value on a recurring basis | March 31, 2023 (in thousands) Level 1 Level 2 Level 3 Total Warrant liability $ — $ — $ — $ — Streeterville note — — 8,198 8,198 Total fair value $ — $ — $ 8,198 $ 8,198 December 31, 2022 (in thousands) Level 1 Level 2 Level 3 Total Warrant liability $ — $ — $ — $ — Streeterville note $ — $ — $ 7,839 $ 7,839 Total fair value $ — $ — $ 7,839 $ 7,839 |
Summary of change in the estimated fair value of level 3 liabilities | Three Months Ended March 31, 2023 (in thousands) Warrant liability Streeterville note Beginning fair value of Level 3 liability $ — $ 7,839 Additions — — Exercises — — Change in fair value — 359 Ending fair value of Level 3 liability $ — $ 8,198 |
Summary of information about the significant unobservable inputs used in level 3 fair value measurements | Range of Inputs (probability-weighted average) Relationship of unobservable inputs Unobservable Inputs 2023 2022 to fair value Risk Adjusted Discount Rate 11.30%-25.66% (25.66%) 11.53%-26.06% (26.06%) If discount rate is adjusted to total of additional 100 basis points (bps), fair value would have decreased by $319,000. Sales Proceeds: Amount of comparable TDPRV $67.5 million to $350 million ($100 million) $67.5 million to $350 million ($100 million) If expected cash flows by Management considered the lowest amount of market indications for vouchers, FV would have decreased by $1.06 million. Range of Probability for Timing of Cash Flows: 0.42%-47.08% 0.39%-46.55% If expected cash flows by Management considered the Scenario with the least amount of indicated value, FV would have decreased by $394,000. |
Summary of the fair value and unpaid principal balance for items the Company accounts for under FVO | (in thousands) Fair value Unpaid Principal Balance Fair Value Over (Under) Unpaid Principal Balance At March 31, 2023 Hybrid Instrument: Streeterville note $ 8,198 $ 6,221 $ 1,977 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Balance Sheet Components | |
Schedule of inventory | March 31, December 31, 2023 2022 (in thousands) (unaudited) Raw Material $ 2,128 $ 2,101 Work in Process 5,383 3,599 Finished Goods 1,173 1,324 Inventory $ 8,684 $ 7,024 |
Schedule of property and equipment | March 31, December 31, 2023 2022 (in thousands) (unaudited) Land $ 396 $ 396 Lab equipment 477 477 Software 63 63 Furniture and fixtures 18 18 Computers and peripherals 7 7 Total property and equipment at cost 961 961 Accumulated depreciation (420) (404) Property and equipment, net $ 541 $ 557 |
Schedule of intangible assets | March 31, December 31, 2023 2022 (in thousands) (unaudited) Developed technology $ 25,000 $ 25,000 Accumulated developed technology amortization (9,444) (9,028) Developed technology, net 15,556 15,972 In-process research and development 4,800 4,800 In process research and development, net 4,800 4,800 Trademarks 300 300 Accumulated trademark amortization (113) (108) Trademarks, net 187 192 Internal use software costs - registry 1,236 1,236 Accumulated internal use software costs amortization (184) (122) Internal use software costs - registry, net 1,052 1,114 Patents 361 — 361 Accumulated patents amortization (5) — Patents, net 356 361 Total intangible assets, net $ 21,951 $ 22,439 |
Schedule of estimated future amortization expense of intangible assets with finite lives | (in thousands) Amounts 2023 1,414 2024 1,952 2025 1,952 2026 1,952 2027 1,952 Thereafter 7,929 $ 17,151 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies | |
Schedule of additional details of office space lease | March 31, December 31, 2023 2022 (in thousands) (unaudited) Operating lease - right-of-use asset $ 1,062 $ 1,140 Operating lease liability, current 503 483 Operating lease liability, net of current portion 627 725 Total $ 1,130 $ 1,208 Weighted-average remaining life (years) 2.17 2.36 Weighted-average discount rate 17.82% 17.89% |
Schedule of undiscounted cash payment obligations | March 31, 2023 (in thousands) 2023 495 2024 617 2025 172 2026 41 Total undiscounted operating lease payments 1,325 Imputed interest expenses (195) Total operating lease liability 1,130 Less: Operating lease liability, current 503 Operating lease liability, net of current portion $ 627 |
Schedule of summarized income statement information using equity method | March 31, 2023 (in thousands) (unaudited) Revenue $ — Operating expenses (77) Loss before income tax (77) Income tax expense — Net loss $ (77) Net loss attributable to the Company $ (31) |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Debt | |
Schedule of notes payable | March 31, December 31, 2023 2022 (in thousands) (unaudited) Royalty Interest $ 37,037 $ 38,931 Streeterville Note 8,198 7,840 Insurance Financing 83 234 Tempesta Note 200 250 45,518 47,255 Less: unamortized discount and debt issuance costs (12,353) (13,628) Note payable, net of discount $ 33,165 $ 33,627 Notes payable - non-current, net $ 17,544 $ 17,744 Notes payable - current, net $ 15,621 $ 15,883 |
Schedule of future maturities of notes payable | (in thousands) Amounts Periods ended March 31, 2024 $ 15,621 2025 21,699 2026 8,198 45,518 Less: unamortized discount and debt issuance costs (12,353) Total $ 33,165 |
Warrants (Tables)
Warrants (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Warrants | |
Summary of warrant activity | March 31, December 31, 2023 2022 (unaudited) Warrants outstanding, beginning balance 7,505 7,513 Issuances — — Exercises — — Expirations and cancelations — (8) Warrants outstanding, ending balance 7,505 7,505 |
Preferred Stock (Tables)
Preferred Stock (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Preferred Stock. | |
Schedule of convertible preferred stock | Liquidation ( in thousands, except share and per share data) Shares Issued and Carrying Preference Series Authorized Outstanding Value per Share B-2 10,165 — $ — $ — C 1,011,000 — — — E 4,475,074 — — — Total 5,496,239 — $ — |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity | |
Schedule of common reserved shares of common stock for issuance | March 31, December 31, 2023 2022 (unaudited) Options issued and outstanding 26,357 26,533 Inducement options issued and outstanding 1,534 1,546 Options available for grant under stock option plans 120,033 122,978 Restricted stock unit awards issued and outstanding 47,998 44,865 Warrants issued and outstanding 7,505 7,505 Total 203,427 203,427 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Stock-based Compensation | |
Summary of incentive plan activity | Weighted Weighted Average Shares Stock Average Remaining Aggregate Available Options RSUs Stock Option Contractual Life Intrinsic (in thousands, except share and per share data) for Grant Outstanding Outstanding Exercise Price (Years) Value* Outstanding at January 1, 2022 8,417 33,286 6,499 $ 707.97 8.35 $ 3 Additional shares authorized 151,079 — — — — Options granted (44) 44 — 23.46 — Options exercised — — — — — Options canceled 5,251 (5,251) — 418.34 — RSUs granted (41,725) — 41,725 — — RSUs vested and released — — (2,516) — — RSUs cancelled — — (843) — — Outstanding at December 31, 2022 122,978 28,079 44,865 $ 592.73 7.19 $ — Additional shares authorized — — — — — — Options granted — — — — — — Options exercised — — — — — — Options canceled 188 (188) — 330.46 — — RSUs granted (3,133) — 3,133 — — — RSUs vested and released — — — — — — RSUs cancelled — — — — — — Outstanding at March 31, 2023 120,033 27,891 47,998 $ 594.50 6.95 $ — Exercisable at March 31, 2023 26,549 $ 607.19 6.89 $ — Vested and expected to vest at March 31, 2023 27,779 $ 595.49 6.95 $ — *Fair market value of Jaguar stock on March 31, 2023 was $0.69 per share. |
Summary of stock-based compensation expense | Three Months Ended March 31, (in thousands) 2023 2022 Research and development expense $ 227 $ 348 Sales and marketing expense 49 82 General and administrative expense 204 633 Total $ 480 $ 1,063 |
Employee stock options | |
Stock-based Compensation | |
Schedule of estimated grant-date fair value of stock options calculated using the Black-Scholes option-pricing model | March 31, December 31, 2023 2022 (unaudited) Volatility — 164.0% Expected term (years) — 5.0 Risk-free interest rate — 3.2% Expected dividend yield — — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Net Loss Per Share | |
Schedule of calculation of basic and diluted net loss per common share | Three Months Ended March 31, (In thousands, except share and per share data) 2023 2022 Net loss attributable to common stockholders (basic and diluted) $ (12,202) $ (17,986) Shares used to compute net loss per common share, basic and diluted 5,109,609 778,512 Net loss per share attributable to common stockholders, basic and diluted $ (2.39) $ (23.10) |
Schedule of common stock equivalents excluded from the calculation of diluted net loss per common share | March 31, December 31, 2023 2022 (unaudited) Options issued and outstanding 26,357 26,533 Inducement options issued and outstanding 1,534 1,546 Restricted stock units issued and outstanding 47,998 44,865 Warrants issued and outstanding 7,505 7,505 Total 83,394 80,449 |
Segment Data (Tables)
Segment Data (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Segment Data | |
Schedule of reportable segments net revenue and net loss | Three Months Ended March 31, (in thousands) 2023 2022 Revenue from external customers Human Health $ 1,927 $ 2,605 Animal Health 45 20 Consolidated Totals $ 1,972 $ 2,625 Segment net loss Human Health $ (6,539) $ (9,967) Animal Health (5,858) (8,197) Consolidated Totals $ (12,397) $ (18,164) |
Schedule of reportable segments assets | March 31, December 31, 2023 2022 (in thousands) (unaudited) Segment assets Human Health $ 41,124 $ 40,898 Animal Health 143,904 128,607 Total $ 185,028 $ 169,505 |
Schedule of reconciliation of segments assets to the consolidated assets | March 31, December 31, (in thousands) 2023 2022 (unaudited) Total assets for reportable segments $ 185,028 $ 169,505 Less: Investment in subsidiary (29,232) (29,232) Less: Intercompany loan (98,869) (92,821) Consolidated Totals $ 56,927 $ 47,452 |
Organization and Business (Deta
Organization and Business (Details) | 3 Months Ended |
Mar. 31, 2023 segment | |
Organization and Business | |
Number of operations segments | 2 |
Organization and Business - Nas
Organization and Business - Nasdaq Communication and Compliance (Details) | May 10, 2023 $ / shares | Jan. 23, 2023 $ / shares | Feb. 18, 2022 $ / shares | Sep. 03, 2021 |
Consecutive business days | 30 days | |||
Reverse stock split ratio | 0.0133 | 0.33 | ||
Common stock, par value (in dollars per share) | $ 0.0001 | |||
Minimum | ||||
Share Price | $ 1 | |||
Reverse stock split ratio | 0.5 | |||
Maximum | ||||
Reverse stock split ratio | 0.05 | |||
Subsequent event | ||||
Consecutive business days | 30 days | |||
Share Price | $ 1 |
Organization and Business - Liq
Organization and Business - Liquidity and Going Concern (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Organization and Business | ||
Accumulated deficit | $ (279,150) | $ (266,948) |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Accounts receivable and Concentrations (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 Distributor item | Mar. 31, 2022 Distributor | Dec. 31, 2022 | |
Supplier risk | |||
Concentrations | |||
Number of suppliers | item | 2 | ||
Total net revenue | Customer risk | One major pharmaceutical distributors | |||
Concentrations | |||
Number of major distributors | 1 | ||
Total net revenue | Customer risk | Customer 1 | |||
Concentrations | |||
Concentration risk (as a percentage) | 25% | 34% | |
Total net revenue | Customer risk | Customer 2 | |||
Concentrations | |||
Concentration risk (as a percentage) | 54% | 49% | |
Total net revenue | Customer risk | Customer 3 | |||
Concentrations | |||
Concentration risk (as a percentage) | 10% | ||
Total net revenue | Customer risk | Three major pharmaceutical distributors | |||
Concentrations | |||
Number of major distributors | 3 | ||
Total net revenue | Customer risk | Minimum | |||
Concentrations | |||
Threshold for calculating concentration risk percentage | 10% | 10% | |
Total accounts receivable | Customer risk | Customer 1 | |||
Concentrations | |||
Concentration risk (as a percentage) | 38% | 38% | |
Total accounts receivable | Customer risk | Customer 2 | |||
Concentrations | |||
Concentration risk (as a percentage) | 54% | 54% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Non-Controlling Interest (Details) $ in Thousands, € in Millions | 3 Months Ended | ||
Mar. 31, 2023 EUR (€) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 | |
Increase in non-controlling interest due to additional investment from outsiders | € 1.1 | $ 1,230 | |
Napo Therapeutics | |||
Percentage of ownership interest by parent | 88% | 88% | 90% |
Private Investors | |||
Percentage of ownership interest by non-controlling owners | 12% | 12% | 10% |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Other Risks and Uncertainties (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
SVB, Signature or First Republic | |
Interest-Bearing Deposits | $ 0 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Summary of Significant Accounting Policies | ||
Allowance for inventory obsolescence | $ 0 | $ 0 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Property and Equipment and Indefinite-lived Intangible Assets (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Goodwill impairment charges | ||
Impairment of long-lived assets | $ 0 | $ 0 |
Impairment of indefinite-lived intangible assets | $ 0 | $ 0 |
Internal use software costs - registry | ||
Goodwill | ||
Intangible asset amortization period | 5 years | |
Napo Member | Equipment | Minimum | ||
Goodwill | ||
Estimated useful lives | 3 years | |
Napo Member | Equipment | Maximum | ||
Goodwill | ||
Estimated useful lives | 10 years |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Revenue Recognition (Details) | 3 Months Ended | |
Mar. 31, 2023 USD ($) item agreement | Mar. 31, 2022 USD ($) | |
Disaggregation of Product Revenue | ||
Number of contracts | agreement | 2 | |
Mytesi | ||
Disaggregation of Product Revenue | ||
Product revenue | $ 404,000 | $ 438,000 |
Number of specialty pharmacies. | item | 5 | |
Mytesi | Specialty Pharmacies | ||
Disaggregation of Product Revenue | ||
Product revenue | $ 1,500,000 | 2,200,000 |
Canalevia-CA1 | ||
Disaggregation of Product Revenue | ||
Product revenue | $ 27,000 | $ 0 |
Summary of Significant Accou_10
Summary of Significant Accounting Policies - Revenue Recognition - Collaboration Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Sep. 24, 2018 | Mar. 31, 2023 | Mar. 31, 2022 | |
Stockholders' Equity | |||
Collaboration revenue | $ 0 | $ 0 | |
Knight | |||
Stockholders' Equity | |||
License agreement term (in years) | 15 years | ||
Transfer price receivable upon achievement of certain regulatory and sales milestones | $ 18,000 |
Summary of Significant Accou_11
Summary of Significant Accounting Policies - Comprehensive Loss (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Summary of Significant Accounting Policies | ||
Translation Loss | $ (232,000) | $ 0 |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value of Liabilities Measured on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Jan. 13, 2021 |
Fair value of liabilities measured on a recurring basis | |||
Fair value | $ 8,198 | $ 7,800 | |
Total fair value | 8,198 | 7,839 | |
Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Total fair value | 8,198 | 7,839 | |
Streeterville Note | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | 8,198 | 7,839 | $ 6,000 |
Streeterville Note | Level 3 | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | $ 8,198 | $ 7,839 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated fair value of Level 3 (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Warrant liability | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning fair value of Level 3 liability | $ 0 |
Ending fair value of level 3 liability | 0 |
Level 3 | Recurring | Streeterville Note | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | |
Beginning fair value of Level 3 liability | 7,839 |
Change in fair value | 359 |
Ending fair value of level 3 liability | $ 8,198 |
Fair Value Measurements - Est_2
Fair Value Measurements - Estimated Fair Value of Warrant Liability (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Warrant liability | ||
Fair Value Assumptions and Methodology for Assets and Liabilities | ||
Fair value of warrant | $ 0 | $ 0 |
Fair Value Measurements - Stree
Fair Value Measurements - Streeterville Note (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Jan. 13, 2021 |
Fair value of liabilities measured on a recurring basis | |||
Fair value | $ 8,198 | $ 7,800 | |
Streeterville Note | |||
Fair value of liabilities measured on a recurring basis | |||
Fair value | $ 8,198 | $ 7,839 | $ 6,000 |
Fair Value Measurements - Quant
Fair Value Measurements - Quantitative information about the significant unobservable inputs (Details) - Level 3 | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Discount rate | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability (as a percent) | 11.30 | 11.53 |
Basis point for adjustment of discount rate | 1 | |
Fair value increase (decrease) | $ (319,000) | |
Discount rate | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability (as a percent) | 25.66 | 26.06 |
Basis point for adjustment of discount rate | 1 | |
Fair value increase (decrease) | $ 319,000 | |
Discount rate | Weighted average | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability (as a percent) | (25.66) | (26.06) |
Sale Proceeds | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Amount of comparable TDPRV | $ 67,500,000 | $ 67,500,000 |
Fair value increase (decrease) | (1,060,000) | |
Sale Proceeds | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Amount of comparable TDPRV | 350,000,000 | 350,000,000 |
Fair value increase (decrease) | 8,180,000 | |
Sale Proceeds | Weighted average | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Amount of comparable TDPRV | $ 100,000,000 | $ 100,000,000 |
Timing of Cash Flows | Minimum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability (as a percent) | 0.42 | 0.39 |
Fair value increase (decrease) | $ (394,000) | |
Timing of Cash Flows | Maximum | ||
Fair Value Measurement Inputs and Valuation Techniques [Line Items] | ||
Probability (as a percent) | 47.08 | 46.55 |
Fair value increase (decrease) | $ 2,650,000 |
Fair Value Measurements - Fai_2
Fair Value Measurements - Fair Value Option - Hybrid Instruments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value Measurements | ||
Fair value | $ 8,198 | $ 7,800 |
Unpaid Principal Balance | 6,221 | |
Fair Value Over (Under) Unpaid Prepaid Balance | $ 1,977 |
Balance Sheet Components - Inve
Balance Sheet Components - Inventory and Prelaunch Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory | ||
Raw Material | $ 2,128 | $ 2,101 |
Work in Process | 5,383 | 3,599 |
Finished Goods | 1,173 | 1,324 |
Inventory | 8,684 | 7,024 |
Prepaid expenses and other current assets | ||
Inventory | ||
Capitalized costs | $ 0 | $ 2,400 |
Balance Sheet Components - Prop
Balance Sheet Components - Property and Equipment (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Land, Property and Equipment | |||
Total property and equipment at cost | $ 961,000 | $ 961,000 | |
Accumulated depreciation | (420,000) | (404,000) | |
Property and equipment, net | 541,000 | 557,000 | |
Depreciation and amortization expense | 16,000 | $ 124,000 | |
Land | |||
Land, Property and Equipment | |||
Total property and equipment at cost | 396,000 | 396,000 | |
Lab equipment | |||
Land, Property and Equipment | |||
Total property and equipment at cost | 477,000 | 477,000 | |
Software | |||
Land, Property and Equipment | |||
Total property and equipment at cost | 63,000 | 63,000 | |
Furniture and fixtures | |||
Land, Property and Equipment | |||
Total property and equipment at cost | 18,000 | 18,000 | |
Computers and peripherals | |||
Land, Property and Equipment | |||
Total property and equipment at cost | $ 7,000 | $ 7,000 |
Balance Sheet Components - Inta
Balance Sheet Components - Intangible assets (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Intangible assets | ||
Finite-lived intangible assets, net | $ 17,151 | |
Total intangible assets, net | 21,951 | $ 22,439 |
Developed technology | ||
Intangible assets | ||
Total intangible assets | 25,000 | 25,000 |
Accumulated amortization | (9,444) | (9,028) |
Finite-lived intangible assets, net | 15,556 | 15,972 |
In process research and development | ||
Intangible assets | ||
Total intangible assets | 4,800 | 4,800 |
Finite-lived intangible assets, net | 4,800 | 4,800 |
Trademarks | ||
Intangible assets | ||
Total intangible assets | 300 | 300 |
Accumulated amortization | (113) | (108) |
Total intangible assets, net | 187 | 192 |
Internal use software costs - registry | ||
Intangible assets | ||
Total intangible assets | 1,236 | 1,236 |
Accumulated amortization | (184) | (122) |
Finite-lived intangible assets, net | 1,052 | 1,114 |
Patents | ||
Intangible assets | ||
Total intangible assets | 361 | 361 |
Accumulated amortization | (5) | |
Finite-lived intangible assets, net | $ 356 | $ 361 |
Balance Sheet Components - Amor
Balance Sheet Components - Amortization (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Balance Sheet Components | ||
Amortization expense | $ 488,000 | $ 418,000 |
Balance Sheet Components - Esti
Balance Sheet Components - Estimated future amortization expense (Details) $ in Thousands | Mar. 31, 2023 USD ($) |
Balance Sheet Components | |
2023 | $ 1,414 |
2024 | 1,952 |
2025 | 1,952 |
2026 | 1,952 |
2027 | 1,952 |
Thereafter | 7,929 |
Finite-lived intangible assets, net | $ 17,151 |
Related Party Transactions - Ca
Related Party Transactions - Cash compensation (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Board of directors | ||
Related party Transactions | ||
Payment of compensation | $ 68,000 | $ 35,000 |
Commitments and Contingencies -
Commitments and Contingencies - Commitments (Details) | 1 Months Ended | 3 Months Ended | ||||||||||||||
Jan. 25, 2022 USD ($) | Jan. 25, 2022 EUR (€) | Dec. 22, 2021 USD ($) item | Dec. 22, 2021 EUR (€) item | Oct. 07, 2021 USD ($) | Oct. 07, 2021 EUR (€) | Apr. 06, 2021 USD ($) ft² | Nov. 30, 2022 USD ($) item | Nov. 30, 2022 EUR (€) item | Oct. 31, 2022 USD ($) item | Oct. 31, 2022 EUR (€) item | May 31, 2022 USD ($) item | May 31, 2022 EUR (€) item | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Jan. 26, 2022 | |
Commitments and Contingencies | ||||||||||||||||
Lease expense under non-cancelable operating lease | $ 4,200 | € 4,000 | ||||||||||||||
Total deposit paid | 9,500 | 9,000 | ||||||||||||||
Cash paid for operating lease liabilities recognized under operating cash flows | $ 53,000 | $ 105,000 | ||||||||||||||
Recognition of operating lease - right-of-use asset and operating lease liability | 30,000 | 90,000 | ||||||||||||||
General and administrative expense | ||||||||||||||||
Commitments and Contingencies | ||||||||||||||||
Lease expense under non-cancelable operating lease | 42,000 | |||||||||||||||
Lease cost | $ 209,000 | $ 115,000 | ||||||||||||||
If contracts are terminated within 12 months | ||||||||||||||||
Commitments and Contingencies | ||||||||||||||||
Lease expense under non-cancelable operating lease | $ 4,000 | € 3,817 | ||||||||||||||
Office space sub lease | ||||||||||||||||
Commitments and Contingencies | ||||||||||||||||
Area (in square feet) | ft² | 10,526 | |||||||||||||||
Extension period | 3 years | |||||||||||||||
Lease term | 3 years | |||||||||||||||
Monthly base rent for first twelve months | $ 42,000 | |||||||||||||||
Monthly base rent for subsequent twelve months | 43,000 | |||||||||||||||
Monthly base rent for final 12 months | $ 45,000 | |||||||||||||||
Leased office premises | ||||||||||||||||
Commitments and Contingencies | ||||||||||||||||
Extension period | 20 months | |||||||||||||||
Leased vehicle | ||||||||||||||||
Commitments and Contingencies | ||||||||||||||||
Lease term | 48 months | 48 months | 48 months | 48 months | ||||||||||||
Number of vehicles on lease | item | 2 | 2 | 3 | 3 | ||||||||||||
Monthly base rent | $ 1,500 | € 1,459 | $ 2,200 | € 2,094 | ||||||||||||
Copernico Centrale agreement | Leased office premises | ||||||||||||||||
Commitments and Contingencies | ||||||||||||||||
Extension period | 20 months | |||||||||||||||
Lease expense under non-cancelable operating lease | $ 10,500 | € 10,000 | ||||||||||||||
Total deposit paid | $ 21,000 | € 20,000 | ||||||||||||||
Arval Service Lease Italia Spa agreement | Leased vehicle | ||||||||||||||||
Commitments and Contingencies | ||||||||||||||||
Lease term | 48 months | 48 months | ||||||||||||||
Lease expense under non-cancelable operating lease | $ 2,100 | € 2,000 | ||||||||||||||
Total deposit paid | $ 20,000 | € 19,000 | ||||||||||||||
Number of vehicles on lease | item | 2 | 2 | ||||||||||||||
ALD Automative Italia S.r.l | Leased vehicle | ||||||||||||||||
Commitments and Contingencies | ||||||||||||||||
Lease term | 48 months | 48 months | ||||||||||||||
Lease expense under non-cancelable operating lease | $ 880 | € 833 | ||||||||||||||
Total deposit paid | $ 22,000 | € 21,000 | ||||||||||||||
Number of vehicles on lease | item | 1 | 1 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional details of office space lease (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies | ||
Operating lease - right-of-use asset | $ 1,062 | $ 1,140 |
Operating lease liability, current | 503 | 483 |
Operating lease liability, net of current portion | 627 | 725 |
Total operating lease liability | $ 1,130 | $ 1,208 |
Weighted-average remaining life (years) | 2 years 2 months 1 day | 2 years 4 months 9 days |
Weighted-average discount rate | 17.82% | 17.89% |
Commitments and Contingencies_3
Commitments and Contingencies - Undiscounted cash payment obligation (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Commitments and Contingencies | ||
2023 | $ 495 | |
2024 | 617 | |
2025 | 172 | |
2026 | 41 | |
Total undiscounted operating lease payments | 1,325 | |
Imputed interest expenses | (195) | |
Total operating lease liability | 1,130 | $ 1,208 |
Less: Operating lease liability, current | 503 | 483 |
Operating lease liability, net of current portion | $ 627 | $ 725 |
Commitments and Contingencies_4
Commitments and Contingencies - Purchase Commitment (Details) - Manufacturing and Supply Agreement with Glenmark Life Sciences Limited [Member] - kg | 3 Months Ended | |
Sep. 03, 2020 | Mar. 31, 2023 | |
Purchase Commitment | ||
License agreement term (in years) | 2 years 6 months | |
Agreement extension term | 2 years | |
License termination term option | 12 months | |
License termination activated upon written notice of material breach of Agreement | 90 days | |
Number of remaining commitments of kilograms | 149 | |
Minimum | ||
Purchase Commitment | ||
Number of kilograms of crofelemer per year per agreement | 300 |
Commitments and Contingencies_5
Commitments and Contingencies - Master Services Agreement (Details) - USD ($) | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Oct. 05, 2020 |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Lease liabilities | $ 1,130,000 | $ 1,208,000 | ||
Master Services Agreement With Integrium LLC, 2020 | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Reduced paid service for achievement of certain milestones | $ 6,000,000 | |||
Lease liabilities | $ 498,000 | $ 276,000 | ||
Master Services Agreement With Integrium LLC, 2020 | Maximum | ||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||
Consideration payable on achievement of milestones | $ 12,400,000 |
Commitments and Contingencies_6
Commitments and Contingencies - Asset Transfer and Transition Commitment Update (Details) - USD ($) | 3 Months Ended | ||
Sep. 25, 2017 | Mar. 31, 2023 | Mar. 31, 2022 | |
Commitments and Contingencies | |||
Percentage of amount received to be paid to Glenmark | 25% | ||
Maximum amount to be received by Glenmark | $ 7,000,000 | ||
Payments to Glenmark | $ 1,900,000 | $ 559,000 |
Commitments and Contingencies_7
Commitments and Contingencies - Revenue Sharing Commitment Update, Joint Venture and Legal Proceedings (Details) | 1 Months Ended | 3 Months Ended | |
Dec. 14, 2017 | Jan. 31, 2023 Plant | Mar. 31, 2023 USD ($) | |
Long-term Purchase Commitment [Line Items] | |||
Number of highly characterized medicinal plants | 2,300 | ||
Number of plant extracts | 3,500 | ||
Magdalena Biosciences, Inc. [Member] | |||
Long-term Purchase Commitment [Line Items] | |||
Percentage of equity method investment | 40% | ||
SEED | |||
Long-term Purchase Commitment [Line Items] | |||
Percentage of revenue sharing commitment | 15% | ||
Percentage of revenue sharing commitment after first million dollars of revenue | 20% | ||
Payments made to date to SEED | $ | $ 0 |
Commitments and Contingencies_8
Commitments and Contingencies - Joint Venture - Income Statement Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Long-term Purchase Commitment [Line Items] | ||
Loss before income tax | $ (12,397) | $ (18,164) |
Income Tax Expense (Benefit) | ||
Net loss | (12,397) | (18,164) |
Net Income (Loss) Attributable to Parent | (12,202) | $ (17,986) |
Magdalena Biosciences, Inc. [Member] | ||
Long-term Purchase Commitment [Line Items] | ||
Operating expense | (77) | |
Loss before income tax | (77) | |
Net loss | (77) | |
Net Income (Loss) Attributable to Parent | $ (31) |
Debt - Notes Payable (Details)
Debt - Notes Payable (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Notes payable | ||
Notes payable - non-current, net | $ 17,544 | $ 17,744 |
Notes payable - current, net | 15,621 | 15,883 |
Notes payable | ||
Notes payable | ||
Principal amount of debt | 45,518 | 47,255 |
Less: unamortized discount and debt issuance costs | (12,353) | (13,628) |
Notes payable, net of discount | 33,165 | 33,627 |
Notes payable - non-current, net | 17,544 | 17,744 |
Notes payable - current, net | 15,621 | 15,883 |
Royalty Interest | Notes payable | ||
Notes payable | ||
Principal amount of debt | 37,037 | 38,931 |
Streeterville Note | Notes payable | ||
Notes payable | ||
Principal amount of debt | 8,198 | 7,840 |
Insurance Financing | Notes payable | ||
Notes payable | ||
Principal amount of debt | 83 | 234 |
Tempesta Note | Notes payable | ||
Notes payable | ||
Principal amount of debt | $ 200 | $ 250 |
Debt - Notes Payable - Future M
Debt - Notes Payable - Future Maturities (Details) - Future maturities of the notes payable not designated at FVO $ in Thousands | Mar. 31, 2023 USD ($) |
As of March 31, | |
2025 | $ 15,621 |
2026 | 21,699 |
2026 | 8,198 |
Total | 45,518 |
Less: unamortized discount and debt issuance costs | (12,353) |
Notes payable, net of discount | $ 33,165 |
Debt - Sale of Future Royalty I
Debt - Sale of Future Royalty Interest (Details) - USD ($) | 3 Months Ended | ||||||||||||||||||||||||
Mar. 23, 2023 | Mar. 17, 2023 | Feb. 08, 2023 | Nov. 18, 2022 | Sep. 30, 2022 | Aug. 24, 2022 | Aug. 17, 2022 | Jul. 25, 2022 | May 13, 2022 | Apr. 14, 2022 | Mar. 09, 2022 | Mar. 04, 2022 | Mar. 02, 2022 | Feb. 11, 2022 | Apr. 13, 2021 | Mar. 08, 2021 | Dec. 22, 2020 | Nov. 13, 2020 | Oct. 31, 2020 | Oct. 08, 2020 | Mar. 31, 2023 | Mar. 31, 2022 | Jan. 23, 2023 | Dec. 31, 2022 | Nov. 01, 2020 | |
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||||||||||||||||||||||
Loss on extinguishment of debt | $ 0 | $ (2,815,000) | |||||||||||||||||||||||
Iliad | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Royalties incurred | $ 227,000 | $ 992,000 | $ 715,000 | $ 750,000 | $ 400,000 | $ 700,000 | $ 800,000 | $ 1,100,000 | $ 2,400,000 | $ 3,000,000 | |||||||||||||||
Issuance of common stock (In shares) | 3,733 | 14,533 | 978 | 31,546 | 15,249 | 24,667 | 26,667 | 32,333 | 23,117 | 7,843 | |||||||||||||||
Beginning on March 2021 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Shortfall restoration period | 30 days | ||||||||||||||||||||||||
Beginning on March 2021 | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Royalty discount rate | 42% | ||||||||||||||||||||||||
October 2020 Purchase Agreement | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Payments for royalties | $ 12,000,000 | ||||||||||||||||||||||||
Aggregate purchase price | $ 6,000,000 | ||||||||||||||||||||||||
Percentage of net sales | 10% | ||||||||||||||||||||||||
Percentage of worldwide revenues | 10% | ||||||||||||||||||||||||
Royalty interest | $ 12,000,000 | ||||||||||||||||||||||||
Royalty discount | $ 6,000,000 | ||||||||||||||||||||||||
Royalty discount rate | 77.09% | 45.42% | 34.51% | 42.93% | |||||||||||||||||||||
Minimum volume weighted average price of stock | $ 0.9105 | $ 0.9105 | |||||||||||||||||||||||
Additional royalty financings committed | $ 6,000,000 | ||||||||||||||||||||||||
Loss on extinguishment of debt | $ (2,200,000) | ||||||||||||||||||||||||
Interest expense | $ 766,000 | 3,100,000 | |||||||||||||||||||||||
Carrying value of notes | $ 6,300,000 | $ 7,300,000 | |||||||||||||||||||||||
Increase In Royalty Repayment Amount | $ 6,000,000 | ||||||||||||||||||||||||
October 2020 Purchase Agreement | Iliad | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Principal amount | $ 12,000,000 | ||||||||||||||||||||||||
October 2020 Purchase Agreement | Iliad | Minimum | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Percentage of shares issued and outstanding | 4.99% | ||||||||||||||||||||||||
October 2020 Purchase Agreement | Beginning On April 2021 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 250,000 | ||||||||||||||||||||||||
October 2020 Purchase Agreement | Beginning On October 2021 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | 400,000 | ||||||||||||||||||||||||
October 2020 Purchase Agreement | Beginning On April 2022 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | 600,000 | ||||||||||||||||||||||||
October 2020 Purchase Agreement | Beginning On October 2022 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 750,000 | ||||||||||||||||||||||||
December 2020 Purchase Agreement | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Aggregate purchase price | $ 6,000,000 | ||||||||||||||||||||||||
Percentage of net sales | 10% | ||||||||||||||||||||||||
Percentage of worldwide revenues | 10% | ||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 750,000 | ||||||||||||||||||||||||
Royalty interest | 12,000,000 | ||||||||||||||||||||||||
Royalty discount | $ 6,000,000 | ||||||||||||||||||||||||
Royalty discount rate | 48% | 23.70% | 29.55% | ||||||||||||||||||||||
Royalties incurred | $ 675,000 | ||||||||||||||||||||||||
Issuance of common stock (In shares) | 150,000 | ||||||||||||||||||||||||
Interest expense | $ 1,100,000 | 784,000 | |||||||||||||||||||||||
Carrying value of notes | $ 9,400,000 | 10,000,000 | |||||||||||||||||||||||
December 2020 Purchase Agreement | Iliad | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Principal amount | $ 12,000,000 | ||||||||||||||||||||||||
March 2021 Purchase Agreement | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Aggregate purchase price | $ 5,000,000 | ||||||||||||||||||||||||
Percentage of net sales | 10% | ||||||||||||||||||||||||
Percentage of worldwide revenues | 10% | ||||||||||||||||||||||||
Royalty discount rate | 19.36% | 19.14% | |||||||||||||||||||||||
Interest expense | $ 448,000 | 416,000 | |||||||||||||||||||||||
Carrying value of notes | 3,400,000 | 3,100,000 | |||||||||||||||||||||||
Threshold price | $ 10,000,000 | ||||||||||||||||||||||||
Percentage of royalties collected from licenses | 50% | ||||||||||||||||||||||||
March 2021 Purchase Agreement | Iliad | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Principal amount | $ 10,000,000 | ||||||||||||||||||||||||
March 2021 Purchase Agreement | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Aggregate purchase price | $ 3,400,000 | ||||||||||||||||||||||||
Royalty interest | $ 2,000,000 | ||||||||||||||||||||||||
Royalties incurred | $ 2,000,000 | ||||||||||||||||||||||||
Issuance of common stock (In shares) | 156,863 | 153,333 | |||||||||||||||||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | ||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning on March 2021 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Royalty interest | $ 10,000,000 | ||||||||||||||||||||||||
Royalty discount | 5,000,000 | ||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning On April 2021 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 250,000 | ||||||||||||||||||||||||
Increase in royalty repayment, percent | 5% | ||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning On October 2021 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 400,000 | ||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning On April 2022 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Increase in royalty repayment, percent | 10% | ||||||||||||||||||||||||
Royalty instrument, Debt instrument carrying value | $ 600,000 | ||||||||||||||||||||||||
March 2021 Purchase Agreement | Beginning On October 2022 | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 750,000 | ||||||||||||||||||||||||
August 2022 Purchase Agreement | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Aggregate purchase price | $ 4,000,000 | ||||||||||||||||||||||||
Percentage of net sales | 10% | ||||||||||||||||||||||||
Percentage of worldwide revenues | 10% | ||||||||||||||||||||||||
Royalty interest | $ 12,000,000 | ||||||||||||||||||||||||
Royalty discount rate | 55.97% | ||||||||||||||||||||||||
Interest expense | 716,000 | $ 0 | |||||||||||||||||||||||
Carrying value of notes | $ 5,600,000 | $ 4,800,000 | |||||||||||||||||||||||
Percentage of royalties collected from licenses | 50% | ||||||||||||||||||||||||
August 2022 Purchase Agreement | Until One Year Anniversary | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Accrued interest rate on royalty | 5% | ||||||||||||||||||||||||
August 2022 Purchase Agreement | After One Year Anniversary | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Accrued interest rate on royalty | 10% | ||||||||||||||||||||||||
August 2022 Purchase Agreement | Beginning On September 2022 | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 250,000 | ||||||||||||||||||||||||
August 2022 Purchase Agreement | Beginning On March 2023 | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | 400,000 | ||||||||||||||||||||||||
August 2022 Purchase Agreement | Beginning On September 2023 | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | 600,000 | ||||||||||||||||||||||||
August 2022 Purchase Agreement | Beginning On March 2024 | Streeterville | |||||||||||||||||||||||||
Debt Instrument [Line Items] | |||||||||||||||||||||||||
Minimum monthly royalty repayment amount | $ 750,000 |
Debt - Streeterville Note (Deta
Debt - Streeterville Note (Details) | 1 Months Ended | 3 Months Ended | ||
Jan. 13, 2021 USD ($) | Jan. 31, 2021 | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | |
Debt | ||||
Fair value | $ 8,198,000 | $ 7,800,000 | ||
Streeterville Note | ||||
Debt | ||||
Principal amount | $ 6,200,000 | |||
Aggregate purchase price | $ 6,000,000 | |||
Debt term | 4 years | |||
Interest rate (as a percent) | 3.25% | |||
Percentage of return bonus payable | 1 | |||
Percentage of reduction in return bonus | 1 | |||
Term for initiation of human trials | 6 months | |||
Percentage of outstanding balance payable elected to prepay | 112.5 | |||
Capped percentage of aggregate default | 25% | |||
Fair value | $ 6,000,000 | $ 8,200,000 | $ 7,800,000 | |
Transaction expense | $ 25,000 | |||
Decrease in fair value | $ 400,000 | |||
Streeterville Note | Maximum | ||||
Debt | ||||
Interest rate (as a percent) | 18% | |||
Percentage of gross proceeds received from return | 18 | |||
Percentage of default effect | 15% | |||
Streeterville Note | Minimum | ||||
Debt | ||||
Interest rate (as a percent) | 1% | |||
Percentage of default effect | 5% | |||
Accounts Receivable Purchase Agreement | Streeterville Note | ||||
Debt | ||||
Interest rate (as a percent) | 25% | |||
Transaction fee | $ 25,000 |
Debt - Insurance Premium Financ
Debt - Insurance Premium Financing (Details) - USD ($) | 1 Months Ended | 3 Months Ended | ||
Mar. 31, 2023 | May 31, 2022 | Mar. 31, 2023 | Mar. 31, 2022 | |
Short-term Debt [Line Items] | ||||
Financing balance | $ 6,221,000 | $ 6,221,000 | ||
Interest expense | 2,181,000 | $ 4,194,000 | ||
May 2022 First Insurance Financing | ||||
Short-term Debt [Line Items] | ||||
Principal amount | $ 752,000 | |||
Unpaid balance | $ 941,000 | |||
Interest rate (as a percent) | 4.30% | |||
Finance charge | $ 15,000 | |||
Interest expense | 4,000 | |||
Debt term | 10 months | |||
Financing balance | 0 | 0 | ||
March 2023 First Insurance Financing [Member] | ||||
Short-term Debt [Line Items] | ||||
Principal amount | 98,000 | 98,000 | ||
Unpaid balance | $ 115,000 | $ 115,000 | ||
Interest rate (as a percent) | 4.60% | 4.60% | ||
Finance charge | $ 2,000 | |||
Interest expense | $ 0 | |||
Debt term | 10 months | |||
Financing balance | $ 83,000 | $ 83,000 |
Debt - 2019 Tempesta Notes (Det
Debt - 2019 Tempesta Notes (Details) - Tempesta Note - USD ($) | 1 Months Ended | 3 Months Ended | ||
Oct. 31, 2019 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Debt Instrument [Line Items] | ||||
Cash received in the settlement | $ 50,000 | |||
Principal amount | $ 550,000 | |||
Common stock issued in exchange of debt | 13,333 | |||
Interest rate (as a percent) | 2.50% | |||
Semi-annual principal and interest payments | $ 50,000 | |||
Interest expense | $ 3,000 | $ 2,000 | ||
Carrying value of notes | $ 200,000 | $ 250,000 |
Warrants - Warrants outstanding
Warrants - Warrants outstanding and exercisable (Details) - shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Warrants | ||
Warrants outstanding, beginning balance | 7,505 | 7,513 |
Exercises | 0 | 0 |
Expirations and cancelations | (8) | |
Warrants outstanding, ending balance | 7,505 | 7,505 |
Warrants - Additional informati
Warrants - Additional information (Details) - $ / shares | Mar. 31, 2023 | Mar. 31, 2022 |
Maximum | ||
Convertible Promissory Notes and Common Stock Warrants [Line Items] | ||
Exercise price (in dollars per share) | $ 157.5 | $ 157.5 |
Minimum | ||
Convertible Promissory Notes and Common Stock Warrants [Line Items] | ||
Exercise price (in dollars per share) | $ 1.47 | $ 1.47 |
Preferred Stock (Details)
Preferred Stock (Details) - shares | Mar. 31, 2023 | Dec. 31, 2022 |
Class of Stock [Line Items] | ||
Shares Authorized | 5,496,239 | 5,496,239 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series B-2 Preferred Stock | ||
Class of Stock [Line Items] | ||
Shares Authorized | 10,165 | 10,165 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series C perpetual preferred stock | ||
Class of Stock [Line Items] | ||
Shares Authorized | 1,011,000 | 1,011,000 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Series E perpetual preferred stock | ||
Class of Stock [Line Items] | ||
Shares Authorized | 4,475,074 | 4,475,074 |
Issued | 0 | 0 |
Outstanding | 0 | 0 |
Preferred Stock - Series C Perp
Preferred Stock - Series C Perpetual Preferred Stock (Details) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Sep. 30, 2020 | Mar. 31, 2023 | Dec. 31, 2022 | |
Preferred stock, shares outstanding | 0 | 0 | |
Series A | |||
Preferred stock, shares outstanding | 5,524,926 | ||
Series C perpetual preferred stock | |||
Preferred stock, shares outstanding | 0 | 0 | |
Carrying value | |||
Iliad | Series C perpetual preferred stock | |||
Number of shares issued for each convertible preferred stock | 842,500 | ||
Preferred stock, par value (in dollars per share) | $ 0.0001 | ||
Accreted value | $ 11.2 | ||
Gross proceeds from the issuance of common stock | 2.3 | ||
Carrying value | $ 2.6 | ||
Percentage increase in the outstanding balance | 5% |
Preferred Stock - Series E Pref
Preferred Stock - Series E Preferred Stock (Details) - USD ($) | Oct. 04, 2022 | Aug. 18, 2022 | Mar. 31, 2023 | Dec. 31, 2022 |
Preferred stock, shares issued | 0 | 0 | ||
Preferred stock, shares outstanding | 0 | 0 | ||
Series E preferred stock | ||||
Shares redeemed | 10 | |||
Preferred stock, shares outstanding | 0 | |||
SynWorld | Securities Purchase Agreement | Series E preferred stock | ||||
Preferred stock, shares issued | 10 | |||
Preferred stock, par value (in dollars per share) | $ 0.0001 | |||
Aggregate proceeds | $ 100 |
Stockholders' Equity - Reserved
Stockholders' Equity - Reserved shares and Common stock (Details) | 3 Months Ended | |||||
Jan. 23, 2023 $ / shares | Sep. 03, 2021 | Mar. 31, 2023 Vote $ / shares shares | Dec. 31, 2022 $ / shares shares | Sep. 30, 2022 $ / shares shares | Sep. 29, 2022 shares | |
Shares of common stock reserved for issuance | ||||||
Options issued and outstanding | 26,357 | 26,533 | ||||
Options available for grant under stock option plans | 120,033 | 122,978 | ||||
Restricted stock unit awards issued and outstanding | 47,998 | 44,865 | ||||
Warrants issued and outstanding | 7,505 | 7,505 | ||||
Total | 203,427 | 203,427 | ||||
Number of voting rights entitled for each share of common stock held | Vote | 1 | |||||
Reverse stock split ratio | 0.0133 | 0.33 | ||||
Common stock par value (in dollars per share) | $ / shares | $ 0.0001 | |||||
Minimum | ||||||
Shares of common stock reserved for issuance | ||||||
Reverse stock split ratio | 0.5 | |||||
Maximum | ||||||
Shares of common stock reserved for issuance | ||||||
Reverse stock split ratio | 0.05 | |||||
Inducement options issued and outstanding | ||||||
Shares of common stock reserved for issuance | ||||||
Options issued and outstanding | 1,534 | 1,546 | ||||
Common Stock | Common stock - voting | ||||||
Shares of common stock reserved for issuance | ||||||
Common stock par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | $ 0.0001 | |||
Common stock, shares authorized | 298,000,000 | 298,000,000 | 298,000,000 | 150,000,000 | ||
Common Stock | Common stock - non-voting | ||||||
Shares of common stock reserved for issuance | ||||||
Common stock par value (in dollars per share) | $ / shares | $ 0.0001 | $ 0.0001 | ||||
Common stock, shares authorized | 50,000,000 | 50,000,000 | ||||
Convertible non-voting common stock | ||||||
Shares of common stock reserved for issuance | ||||||
Reverse stock split ratio | 1 |
Stockholders' Equity - Reverse
Stockholders' Equity - Reverse Stock Split and ATM (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Jan. 23, 2023 | Dec. 10, 2022 USD ($) | Feb. 02, 2022 USD ($) | Dec. 10, 2021 USD ($) | Sep. 03, 2021 | Mar. 31, 2023 USD ($) shares | Mar. 31, 2022 USD ($) shares | Dec. 31, 2021 shares | Dec. 31, 2022 shares | Sep. 30, 2022 shares | Sep. 29, 2022 shares | |
Total shares authorized | 352,475,074 | ||||||||||
Preferred stock, shares authorized | 5,496,239 | 5,496,239 | |||||||||
Reverse stock split ratio | 0.0133 | 0.33 | |||||||||
Maximum | |||||||||||
Reverse stock split ratio | 0.05 | ||||||||||
Minimum | |||||||||||
Reverse stock split ratio | 0.5 | ||||||||||
At The Market Offering | |||||||||||
Aggregate offering price | $ | $ 17,865 | $ 9,111 | |||||||||
December 2021 ATM Agreement | |||||||||||
Issuance of common stock (In shares) | 10,463,983 | ||||||||||
Proceeds from issuance of Common stock | $ | $ 17,900 | ||||||||||
December 2021 ATM Agreement | Maximum | |||||||||||
Aggregate offering price | $ | $ 15,000 | $ 75,000 | $ 15,000 | ||||||||
Series E perpetual preferred stock | |||||||||||
Preferred stock, shares authorized | 4,475,074 | 4,475,074 | |||||||||
Common Stock | Common stock - voting | |||||||||||
Common stock, shares authorized | 298,000,000 | 298,000,000 | 298,000,000 | 150,000,000 | |||||||
Common Stock | Common stock - voting | At The Market Offering | |||||||||||
Aggregate offering price | $ | $ 1 | ||||||||||
Issuance of common stock (In shares) | 10,463,983 | 267,286 | |||||||||
Common Stock | Common stock - non-voting | |||||||||||
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Stockholders' Equity- Noncontro
Stockholders' Equity- Noncontrolling Interest (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | |
Stockholders' Equity | ||||
Noncontrolling interest | $ 310,000 | $ (699,000) | ||
Increase in noncontrolling interest | $ 1,000,000 | |||
Decrease in noncontrolling interest | $ 178,000 | |||
Napo Member | ||||
Stockholders' Equity | ||||
Noncontrolling interest | $ 242,000 |
Stock-based Compensation - Summ
Stock-based Compensation - Summary of Stock Incentive Plans (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||
Apr. 13, 2022 | Jun. 16, 2020 | May 12, 2015 | Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2013 | Apr. 12, 2022 | |
Stock-based Compensation | ||||||||
Option outstanding | 26,357 | 26,533 | ||||||
Options available for grant under stock option plans | 120,033 | 122,978 | ||||||
Shares Available for Grant | ||||||||
Beginning balance (in shares) | 122,978 | |||||||
Ending balance (in shares) | 120,033 | 122,978 | ||||||
Stock Options Outstanding | ||||||||
Beginning balance (in shares) | 26,533 | |||||||
Ending balance (in shares) | 26,357 | 26,533 | ||||||
RSUs Outstanding | ||||||||
Beginning balance (in shares) | 44,865 | |||||||
Ending balance (in shares) | 47,998 | 44,865 | ||||||
Options vested, exercisable and expected to vest | ||||||||
Weighted average grant date fair value of stock options granted (in dollars per share) | $ 0 | $ 23.46 | ||||||
Number of options vested (in shares) | 595 | 7,492 | ||||||
Weighted average fair value of options vested on grant date | $ 209.49 | $ 304.57 | ||||||
Stock options | ||||||||
Stock-based Compensation | ||||||||
Option outstanding | 27,891 | 28,079 | 33,286 | |||||
Stock Options Outstanding | ||||||||
Beginning balance (in shares) | 28,079 | 33,286 | ||||||
Options granted (in shares) | 44 | |||||||
Options exercised (in shares) | 0 | 0 | ||||||
Options cancelled (in shares) | (188) | (5,251) | ||||||
Ending balance (in shares) | 27,891 | 28,079 | 33,286 | |||||
Weighted Average Stock Option Exercise Price | ||||||||
Beginning balance (in dollars per share) | $ 592.73 | $ 707.97 | ||||||
Options granted (in dollars per share) | 23.46 | |||||||
Options cancelled (in dollars per share) | 330.46 | 418.34 | ||||||
Ending balance (in dollars per share) | $ 594.50 | $ 592.73 | $ 707.97 | |||||
Weighted Average Remaining Contractual Life (Years) | ||||||||
Weighted Average Remaining Contractual Life (Years) | 6 years 11 months 12 days | 7 years 2 months 8 days | 8 years 4 months 6 days | |||||
Options vested, exercisable and expected to vest | ||||||||
Options vested and exercisable (in shares) | 26,549 | |||||||
Options vested and exercisable (in dollars per share) | $ 607.19 | |||||||
Options vested and exercisable (in years) | 6 years 10 months 20 days | |||||||
Options vested and expected to vest (in shares) | 27,779 | |||||||
Options vested and expected to vest (in dollars per share) | $ 595.49 | |||||||
Options vested and expected to vest (in years) | 6 years 11 months 12 days | |||||||
Aggregate Intrinsic Value ,outstanding | $ 3 | |||||||
Options exercised (in shares) | 0 | 0 | ||||||
Stock options and RSUs | ||||||||
Stock-based Compensation | ||||||||
Options available for grant under stock option plans | 120,033 | 122,978 | 8,417 | |||||
Shares Available for Grant | ||||||||
Beginning balance (in shares) | 122,978 | 8,417 | ||||||
Additional shares authorized (in shares) | 151,079 | |||||||
Options granted (in shares) | (44) | |||||||
Options cancelled (in shares) | 188 | 5,251 | ||||||
Ending balance (in shares) | 120,033 | 122,978 | 8,417 | |||||
RSUs Outstanding | ||||||||
RSUs Granted (in shares) | 3,133 | 41,725 | ||||||
Restricted stock units issued and outstanding | ||||||||
Shares Available for Grant | ||||||||
RSUs vested and released (in shares) | (2,516) | |||||||
RSUs Outstanding | ||||||||
Beginning balance (in shares) | 44,865 | 6,499 | ||||||
RSUs Granted (in shares) | 3,133 | 41,725 | ||||||
RSUs vested and released (in shares) | (2,516) | |||||||
RSUs Cancelled (in shares) | (843) | |||||||
Ending balance (in shares) | 47,998 | 44,865 | 6,499 | |||||
2013 Plan | ||||||||
Stock-based Compensation | ||||||||
Option shares outstanding | 0 | 0 | ||||||
2013 Plan | Stock options | ||||||||
Stock Options Outstanding | ||||||||
Options granted (in shares) | 0 | |||||||
2014 Plan | ||||||||
Stock-based Compensation | ||||||||
Incentive stock option term | 10 years | |||||||
Increase in share reserve based on outstanding number of shares (as a percent) | 2% | |||||||
Option outstanding | 26,357 | 26,533 | ||||||
Options available for grant under stock option plans | 113,053 | 116,011 | ||||||
Shares Available for Grant | ||||||||
Beginning balance (in shares) | 116,011 | |||||||
Additional shares authorized (in shares) | 2,417,660 | |||||||
Ending balance (in shares) | 113,053 | 116,011 | ||||||
Stock Options Outstanding | ||||||||
Beginning balance (in shares) | 26,533 | |||||||
Ending balance (in shares) | 26,357 | 26,533 | ||||||
2020 New Employee Inducement Award Plan | ||||||||
Stock-based Compensation | ||||||||
Incentive stock option term | 10 years | |||||||
Option outstanding | 1,534 | 1,546 | ||||||
Options available for grant under stock option plans | 166,666 | 6,979 | 6,967 | |||||
Shares Available for Grant | ||||||||
Beginning balance (in shares) | 6,967 | |||||||
Additional shares authorized (in shares) | 151,079 | |||||||
Ending balance (in shares) | 166,666 | 6,979 | 6,967 | |||||
Stock Options Outstanding | ||||||||
Beginning balance (in shares) | 1,546 | |||||||
Ending balance (in shares) | 1,534 | 1,546 | ||||||
Inducement Award Plan | ||||||||
Stock-based Compensation | ||||||||
Number of shares reserved for issuance | 971,833 | 500,000 | ||||||
Shares Available for Grant | ||||||||
Additional shares authorized (in shares) | 471,833 | |||||||
Common Stock | ||||||||
Options vested, exercisable and expected to vest | ||||||||
Share Price | $ 0.69 | |||||||
Participants Voting Power More than Ten Percent | 2014 Plan | ||||||||
Stock-based Compensation | ||||||||
Incentive stock option term | 5 years | |||||||
Participants Voting Power More than Ten Percent | 2020 New Employee Inducement Award Plan | ||||||||
Stock-based Compensation | ||||||||
Incentive stock option term | 5 years |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-Based Compensation (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Stock-based Compensation | ||
Total stock-based compensation expense | $ 480,000 | $ 1,063,000 |
Research and development expense | ||
Stock-based Compensation | ||
Total stock-based compensation expense | 227,000 | 348,000 |
Sales and marketing expense | ||
Stock-based Compensation | ||
Total stock-based compensation expense | 49,000 | 82,000 |
General and administrative expense | ||
Stock-based Compensation | ||
Total stock-based compensation expense | 204,000 | $ 633,000 |
Stock options and RSUs | ||
Stock-based Compensation | ||
Unrecognized stock-based compensation expense | $ 377,000 | |
Expected weighted average period to be recognized | 1 year 29 days | |
Employee stock options | ||
Estimated grant-date fair value of stock options calculated using the Black-Scholes option-pricing model | ||
Volatility (as a percent) | 164% | |
Expected term (years) | 5 years | |
Risk-free interest rate (as a percent) | 3.20% |
Stock-based Compensation - 401(
Stock-based Compensation - 401(k) Plan (Details) | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Stock-based Compensation | |
Employer contributions to the plan | $ 0 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Net Loss Per Share | ||
Net loss attributable to common shareholders (basic) | $ (12,202) | $ (17,986) |
Net loss attributable to common shareholders (diluted) | $ (12,202) | $ (17,986) |
Shares used to compute net loss per common share, basic | 5,109,609 | 778,512 |
Shares used to compute net loss per common share, diluted | 5,109,609 | 778,512 |
Net loss per share attributable to common shareholders, basic | $ (2.39) | $ (23.10) |
Net loss per share attributable to common shareholders, diluted | $ (2.39) | $ (23.10) |
Net Loss Per Share - Excluded F
Net Loss Per Share - Excluded From Calculation (Details) - shares | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Mar. 24, 2023 | |
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 83,394 | 80,449 | |
Common stock, shares issued | 11,680,245 | ||
Options issued and outstanding | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 26,357 | 26,533 | |
Inducement options issued and outstanding | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 1,534 | 1,546 | |
Restricted stock units issued and outstanding | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 47,998 | 44,865 | |
Warrants issued and outstanding | |||
Outstanding common stock equivalents have been excluded from diluted net loss per common share | |||
Total (in shares) | 7,505 | 7,505 |
Segment Data (Details)
Segment Data (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 USD ($) segment | Mar. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Segment Information | |||
Number of reportable segments | segment | 2 | ||
Net loss | $ (12,397) | $ (18,164) | |
Segment assets | 56,927 | $ 47,452 | |
Less: investment in subsidiary | (29,232) | (29,232) | |
Less: Intercompany loan | (98,869) | (92,821) | |
Human Health | |||
Segment Information | |||
Net loss | (6,539) | (9,967) | |
Segment assets | 41,124 | 40,898 | |
Animal Health | |||
Segment Information | |||
Net loss | (5,858) | (8,197) | |
Segment assets | 143,904 | 128,607 | |
Product revenue | |||
Segment Information | |||
Revenue from external customers | 1,972 | 2,625 | |
Product revenue | Human Health | |||
Segment Information | |||
Revenue from external customers | 1,927 | 2,605 | |
Product revenue | Animal Health | |||
Segment Information | |||
Revenue from external customers | 45 | $ 20 | |
Operating Segments | |||
Segment Information | |||
Segment assets | $ 185,028 | $ 169,505 |
Subsequent Events (Details)
Subsequent Events (Details) | May 10, 2023 USD ($) $ / shares shares | May 08, 2023 USD ($) item $ / shares shares | Apr. 01, 2023 USD ($) shares | Feb. 18, 2022 $ / shares | Mar. 31, 2023 USD ($) $ / shares | Jan. 23, 2023 $ / shares | Dec. 31, 2022 USD ($) | Mar. 31, 2022 $ / shares |
Subsequent Events. | ||||||||
Common stock, par value (in dollars per share) | $ 0.0001 | |||||||
Consecutive business days | 30 days | |||||||
Stockholders' equity | $ | $ 56,927,000 | $ 47,452,000 | ||||||
Minimum | ||||||||
Subsequent Events. | ||||||||
Exercise price (in dollars per share) | $ 1.47 | $ 1.47 | ||||||
Share Price | $ 1 | |||||||
Maximum | ||||||||
Subsequent Events. | ||||||||
Exercise price (in dollars per share) | $ 157.5 | $ 157.5 | ||||||
Subsequent event | ||||||||
Subsequent Events. | ||||||||
Consecutive business days | 30 days | |||||||
Consecutive business days in grace period | 10 days | |||||||
Share Price | $ 1 | |||||||
Grace period | 180 days | |||||||
Subsequent event | Minimum | ||||||||
Subsequent Events. | ||||||||
Stockholders' equity | $ | $ 5,000,000 | |||||||
Subsequent event | December 2020 Royalty Interest Exchange Agreement | ||||||||
Subsequent Events. | ||||||||
Partitioned Royalty | $ | $ 1,073,807 | |||||||
Number of shares to be exchanged | shares | 1,908,651 | |||||||
Common stock, par value (in dollars per share) | $ 0.0001 | |||||||
Consideration for royalty | $ | $ 0 | |||||||
Subsequent event | PIPE Purchase Agreement | ||||||||
Subsequent Events. | ||||||||
Exercise price (in dollars per share) | $ 0.48 | |||||||
Proceeds from Issuance of Private Placement | $ | $ 1.86 | |||||||
Term of warrant | 5 years | |||||||
Subsequent event | PIPE Purchase Agreement | Series G Preferred Stock | ||||||||
Subsequent Events. | ||||||||
Number of shares issued | shares | 137 | |||||||
Common stock, par value (in dollars per share) | $ 0.0001 | |||||||
Warrants to purchase shares of Common stock | shares | 6,850,000 | 6,850,000 | ||||||
Subsequent event | Standstill Agreement | ||||||||
Subsequent Events. | ||||||||
Number of royalty interests issued | item | 4 | |||||||
Agreement term | 6 months | |||||||
Subsequent event | Standstill Agreement | Standstill Warrants | ||||||||
Subsequent Events. | ||||||||
Exercise price (in dollars per share) | $ 0.48 | |||||||
Term of warrant | 5 years | |||||||
Subsequent event | Standstill Agreement | Iliad Warrants | ||||||||
Subsequent Events. | ||||||||
Warrants to purchase shares of Common stock | shares | 826,738 | |||||||
Subsequent event | Standstill Agreement | Uptown Warrants | ||||||||
Subsequent Events. | ||||||||
Warrants to purchase shares of Common stock | shares | 1,097,756 | |||||||
Subsequent event | Standstill Agreement | Streeterville Warrants | ||||||||
Subsequent Events. | ||||||||
Warrants to purchase shares of Common stock | shares | 1,892,808 | |||||||
Subsequent event | December 2021 ATM Agreement | ||||||||
Subsequent Events. | ||||||||
Number of shares issued | shares | 3,019,477 | |||||||
Total net proceeds | $ | $ 1,700,000 |