Jaguar Health(JAGX) - 2021 Q1 - Quarterly Report

PART I. — FINANCIAL INFORMATION This part details the company's financial statements, notes, and management's discussion and analysis for the reporting period Item 1. Condensed Consolidated Financial Statements This section presents the company's unaudited condensed consolidated financial statements for Q1 2021, covering balance sheets, operations, equity, cash flows, and explanatory notes Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position at March 31, 2021, and December 31, 2020 Condensed Consolidated Balance Sheets (In thousands) | (In thousands) | March 31, 2021 (unaudited) | December 31, 2020 | | :------------------------------------------ | :-------------------------- | :------------------ | | Assets | | | | Cash | $32,250 | $8,090 | | Accounts receivable | $5,897 | $2,098 | | Inventory | $2,821 | $2,782 | | Total current assets | $44,104 | $17,792 | | Property and equipment, net | $674 | $677 | | Intangible assets, net | $23,916 | $24,337 | | Total assets | $68,713 | $42,843 | | Liabilities, convertible preferred stock and stockholders' equity | | | | Accounts payable | $4,740 | $4,759 | | Accrued liabilities | $6,409 | $4,493 | | Warrant liability | $12 | $179 | | Notes payable, net of discount, current | $1,431 | $3,789 | | Total current liabilities | $12,592 | $13,220 | | Notes payable, net of current portion | $24,230 | $12,421 | | Total liabilities | $36,822 | $25,641 | | Total stockholders' equity | $31,891 | $17,202 | | Total liabilities, convertible preferred stock and stockholders' equity | $68,713 | $42,843 | - Total assets increased by $25.87 million (60.39%) from December 31, 2020, to March 31, 2021, primarily driven by a significant increase in cash from $8.09 million to $32.25 million[6] - Total liabilities increased by $11.18 million (43.68%) over the same period, mainly due to an increase in non-current notes payable[6] - Total stockholders' equity increased by $14.69 million (85.40%), reflecting new equity issuances and changes in accumulated deficit[6] Condensed Consolidated Statements of Operations This section presents the company's financial performance for the three months ended March 31, 2021, and 2020 Condensed Consolidated Statements of Operations (Unaudited, In thousands) | (In thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Product revenue | $1,241 | $869 | | Cost of product revenue | $583 | $676 | | Research and development | $2,414 | $1,582 | | Sales and marketing | $2,139 | $1,469 | | General and administrative | $3,409 | $3,149 | | Series 3 warrants inducement expense | $1,462 | $0 | | Series B convertible preferred stock inducement expense | $0 | $1,647 | | Total operating expenses | $10,007 | $8,523 | | Loss from operations | $(8,766) | $(7,654) | | Interest expense | $(1,901) | $(199) | | Loss on extinguishment of debt | $(753) | $0 | | Change in fair value of financial instruments and hybrid instrument designated at FVO | $(599) | $(1) | | Net loss | $(12,009) | $(7,936) | | Net loss per share, basic and diluted | $(0.10) | $(0.56) | - Product revenue increased by $372,000 (42.8%) from $869,000 in Q1 2020 to $1,241,000 in Q1 2021[8] - Net loss increased by $4.073 million (51.3%) from $(7.936) million in Q1 2020 to $(12.009) million in Q1 2021, primarily due to higher operating expenses, interest expense, and loss on extinguishment of debt[8] - Basic and diluted net loss per share improved from $(0.56) in Q1 2020 to $(0.10) in Q1 2021, despite a higher net loss, due to a significant increase in weighted-average common shares outstanding (from 15.14 million to 125.42 million)[8] Condensed Consolidated Statements of Changes in Convertible Preferred Stock and Stockholders' Equity This section details changes in the company's equity structure for the three months ended March 31, 2021 Changes in Stockholders' Equity (In thousands, except share data) | (In thousands, except share data) | Balances as of January 1, 2021 | Shares issued on exercise of Series 1, Series 2, and 2019 Bridge Note Warrants | Shares issued in PIPE financing | Shares issued in At the Market offering, net | Shares issued in registered public offering, net | Shares issued in extinguishment of Exchange Note 2 | Shares issued on exercise of Series 3 warrants | Stock-based compensation | Net loss | Balances as of March 31, 2021 | | :-------------------------------- | :----------------------------- | :---------------------------------------------------------------- | :------------------------------ | :------------------------------------------- | :----------------------------------------------- | :------------------------------------------------ | :--------------------------------------------- | :----------------------- | :------- | :---------------------------- | | Common Stock - voting (Shares) | 114,022,368 | 4,150,600 | 1,250,000 | 2,009,554 | 4,437,870 | 1,413,606 | 620,750 | — | — | 127,906,558 | | Common Stock - voting (Amount) | $11 | $1 | $0 | $0 | $1 | $0 | $0 | $0 | $0 | $13 | | Additional paid-in capital | $184,090 | $2,033 | $975 | $5,365 | $13,397 | $2,516 | $1,776 | $634 | $0 | $210,786 | | Accumulated deficit | $(166,899) | $0 | $0 | $0 | $0 | $0 | $0 | $0 | $(12,009) | $(178,908) | | Total Stockholders' Equity | $17,202 | $2,034 | $975 | $5,365 | $13,398 | $2,516 | $1,776 | $634 | $(12,009) | $31,891 | - Total stockholders' equity increased from $17.202 million at January 1, 2021, to $31.891 million at March 31, 2021, primarily driven by proceeds from various equity issuances and warrant exercises[11] - Significant increases in common stock outstanding resulted from exercises of Series 1, Series 2, and 2019 Bridge Note Warrants (4.15 million shares), PIPE financing (1.25 million shares), At the Market offering (2.01 million shares), registered public offering (4.44 million shares), extinguishment of Exchange Note 2 (1.41 million shares), and exercise of Series 3 warrants (0.62 million shares)[11] Condensed Consolidated Statements of Cash Flows This section outlines the company's cash inflows and outflows from operating, investing, and financing activities for the reported periods Condensed Consolidated Statements of Cash Flows (Unaudited, In thousands) | (in thousands) | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :------------------------------------------ | :-------------------------------- | :-------------------------------- | | Net loss | $(12,009) | $(7,936) | | Total cash used in operating activities | $(6,708) | $(4,296) | | Total cash used in investing activity | $0 | $(7) | | Total cash provided by financing activities | $30,868 | $2,023 | | Net increase (decrease) in cash and restricted cash | $24,160 | $(2,280) | | Cash and restricted cash at beginning of period | $8,090 | $3,883 | | Cash and restricted cash at end of period | $32,250 | $1,603 | - Net cash used in operating activities increased from $(4.296) million in Q1 2020 to $(6.708) million in Q1 2021, reflecting a larger net loss[18] - Net cash provided by financing activities significantly increased from $2.023 million in Q1 2020 to $30.868 million in Q1 2021, primarily due to proceeds from equity offerings and notes payable[18] - The company experienced a net increase in cash and restricted cash of $24.160 million in Q1 2021, a substantial improvement from a net decrease of $(2.280) million in Q1 2020[18] Notes to Condensed Consolidated Financial Statements This section provides detailed explanations and disclosures supporting the condensed consolidated financial statements 1. Organization and Business This note describes the company's corporate structure, business segments, and operational context - Jaguar Health, Inc. (formerly Jaguar Animal Health, Inc.) was incorporated in Delaware on June 6, 2013, initially focusing on gastrointestinal products for animals[24] - On July 31, 2017, Jaguar merged with Napo Pharmaceuticals, Inc., with Napo becoming a wholly-owned subsidiary focused on human health and the commercialization of Mytesi, an FDA-approved drug for noninfectious diarrhea in HIV/AIDS patients[25] - The company operates through two segments: human health and animal health, and established Napo EU S.p.A in Italy on March 15, 2021, to address inflammatory diarrhea in post-COVID-19 patients in Europe[26][27] - Jaguar regained compliance with Nasdaq's minimum bid price requirement by January 21, 2021, after facing potential delisting notices in 2020[30][31][33] - The company has incurred recurring operating losses and had an accumulated deficit of $178.9 million as of March 31, 2021, but believes its $35.0 million cash balance (as of issuance date) is sufficient for at least 12 months[34][35] 2. Summary of Significant Accounting Policies This note outlines the key accounting principles, estimates, and judgments applied in preparing the financial statements - The unaudited condensed consolidated financial statements are prepared in accordance with U.S. GAAP for interim financial information and reflect normal recurring adjustments[36] - Key accounting estimates and judgments include valuation of stock options, hybrid instruments, warrant liabilities, acquired IPR&D, useful lives of long-lived assets, inventory valuation, allowance for doubtful accounts, deferred taxes, contingencies, and revenue recognition[41] - The COVID-19 pandemic did not significantly affect financial results for the period ended March 31, 2021, but future impacts remain uncertain[42] Mytesi Revenue Concentration by Customer | Customer | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--------- | :-------------------------------- | :-------------------------------- | | Customer 1 | 86 % | 96 % | | Customer 2 | 10 % | — % | - Substantially all revenue is derived from Mytesi sales, with significant concentration from two pharmaceutical distributors in the U.S. (86% from Customer 1, 10% from Customer 2 in Q1 2021)[46][47] - The company relies on two suppliers for raw materials and a single third-party contract manufacturer for Mytesi's active pharmaceutical ingredient and finished products, posing concentration risk[48] - Revenue recognition follows ASC 606, with Mytesi sales recognized upon delivery to wholesalers/specialty pharmacies and animal product sales upon shipment[64][79][80][87] - The company adopted ASU 2019-12 (Income Taxes) on January 1, 2021, with no material effect, and is evaluating ASU 2016-13 (Credit Losses) and ASU 2020-06 (Convertible Instruments) for future adoption[103][104][105] 3. Fair Value Measurements This note details the methodologies and categorization of fair value measurements for financial instruments - Fair value measurements are categorized into Level 1 (quoted prices in active markets), Level 2 (observable inputs other than Level 1), and Level 3 (unobservable inputs)[110] Fair Value of Financial Instruments (In thousands) | (in thousands) | March 31, 2021 (unaudited) | December 31, 2020 | | :------------- | :------------------------- | :---------------- | | Warrant liability | $12 | $179 | | Streeterville note | $6,452 | $0 | | Total fair value | $6,464 | $179 | Change in Estimated Fair Value of Level 3 Liabilities (In thousands) | (in thousands) | Warrant liability | Streeterville note | | :------------- | :---------------- | :----------------- | | Beginning fair value of Level 3 liability | $179 | $0 | | Additions | $1,462 | $6,000 | | Exercises | $(1,776) | $0 | | Change in fair value | $147 | $452 | | Ending fair value of Level 3 liability | $12 | $6,452 | - The Streeterville Note, issued January 13, 2021, was valued at $6.452 million at March 31, 2021, based on discounted expected future cash flows, classified as Level 3 due to unobservable inputs like the company's credit risk[116][118] - The company elected the Fair Value Option (FVO) for hybrid instruments starting January 1, 2021, to align measurement attributes and simplify accounting, reporting unrealized gains/losses in earnings[118][119] 4. Balance Sheet Components This note provides a breakdown of specific asset and liability accounts on the balance sheet Inventory (In thousands) | (in thousands) | March 31, 2021 (unaudited) | December 31, 2020 | | :------------- | :------------------------- | :---------------- | | Raw Material | $790 | $1,321 | | Work in Process | $1,478 | $1,026 | | Finished Goods | $553 | $435 | | Inventory | $2,821 | $2,782 | Property and Equipment, net (In thousands) | (in thousands) | March 31, 2021 (unaudited) | December 31, 2020 | | :------------- | :------------------------- | :---------------- | | Land | $396 | $396 | | Lab equipment | $424 | $418 | | Clinical equipment | $65 | $65 | | Software | $63 | $63 | | Total property and equipment at cost | $948 | $942 | | Accumulated depreciation | $(274) | $(265) | | Property and equipment, net | $674 | $677 | Intangible Assets, net (In thousands) | (in thousands) | March 31, 2021 (unaudited) | December 31, 2020 | | :------------- | :------------------------- | :---------------- | | Developed technology | $25,000 | $25,000 | | Accumulated developed technology amortization | $(6,111) | $(5,694) | | Developed technology, net | $18,889 | $19,306 | | In-process research and development | $4,800 | $4,800 | | Trademarks | $300 | $300 | | Accumulated trademark amortization | $(73) | $(69) | | Trademarks, net | $227 | $231 | | Total intangible assets, net | $23,916 | $24,337 | - Inventory increased slightly from $2.782 million to $2.821 million, with a shift from raw materials to work in process[121] - Intangible assets, net, decreased from $24.337 million to $23.916 million, primarily due to amortization of developed technology[123] 5. Related Party Transactions This note discloses transactions and agreements with parties considered to be related to the company - The Management Services Agreement with Sagard Capital was terminated on September 1, 2020, with 2,289,474 shares of common stock issued in lieu of $1.1 million in accrued fees[125] - A letter of credit agreement with Dr. Charles Conte (brother of CEO Lisa Conte) for $475,000 was released in October 2020 upon expiration of the office lease, with a prorated payment of $7,000[126] 6. Commitments and Contingencies This note outlines the company's contractual obligations and potential liabilities - The company's office sublease in San Francisco, California, began August 31, 2020, at $15,000 per month and expires May 31, 2021; a new lease for larger office space begins September 1, 2021[128][129][313] - A manufacturing and supply agreement with Glenmark Life Sciences Limited commits the company to purchase a minimum of 300 kilograms of crofelemer per year until March 31, 2023[129][130] - Remaining commitments under Master Services Agreements with Integrium, LLC for clinical research organization services total $86,000 for a microbiome study and $11.8 million for a planned Phase 3 clinical trial for cancer-therapy related diarrhea[132][133] - A putative class action lawsuit related to the 2017 merger was preliminarily settled for $2.6 million, expected to be covered entirely by the company's director and officer liability insurance carrier[139][140] 7. Debt This note provides detailed information on the company's various debt instruments and their terms Notes Payable (In thousands) | (in thousands) | March 31, 2021 (unaudited) | December 31, 2020 | | :------------- | :------------------------- | :---------------- | | Royalty Interest | $40,000 | $30,000 | | Streeterville Note | $6,452 | $0 | | Tempesta Note | $400 | $450 | | Umbrella Insurance Financing | $98 | $0 | | Oasis Secured Borrowing | $0 | $1,822 | | Exchange Note 2 | $0 | $1,525 | | Insurance Premium Financing | $0 | $95 | | Total | $46,950 | $33,892 | | Less: unamortized discount and debt issuance costs | $(21,289) | $(17,682) | | Note payable, net of discount | $25,661 | $16,210 | | Notes payable - non-current, net | $24,230 | $12,421 | | Notes payable - current, net | $1,431 | $3,789 | - Total notes payable, net of discount, increased from $16.210 million at December 31, 2020, to $25.661 million at March 31, 2021, primarily due to new royalty interest agreements and the Streeterville Note[145] - The company entered into a March 2021 Purchase Agreement with Streeterville Capital, LLC, selling a royalty interest for $5.0 million, entitling Streeterville to $10.0 million in future royalties, classified as debt with a $5.0 million discount[165][166][169] - On January 13, 2021, the company issued a secured promissory note to Streeterville for $6.0 million, with a principal amount of $6.2 million, bearing 3.25% annual interest, to fund development of NP-300 (lechlemer) and for general corporate purposes[171] - The Exchange Note 2 was fully extinguished in January 2021 by issuing 1,413,606 shares of common stock for the remaining $1.8 million outstanding balance, resulting in a $753,000 loss on extinguishment[205] 8. Warrants This note details the company's outstanding warrants, including issuances, exercises, and expirations Warrants Outstanding and Exercisable (Shares) | | March 31, 2021 (unaudited) | December 31, 2020 | | :----------------------------- | :------------------------- | :---------------- | | Warrants outstanding, beginning balance | 7,205,454 | 19,421,892 | | Issuances | 406,250 | 22,048,278 | | Exercises | (6,021,350) | (34,264,393) | | Expirations and cancelations | — | (323) | | Warrants outstanding, ending balance | 1,590,354 | 7,205,454 | - Total warrants outstanding decreased significantly from 7,205,454 at December 31, 2020, to 1,590,354 at March 31, 2021, primarily due to exercises[207] - During Q1 2021, 620,750 Series 3 Warrants were exercised for common shares via an Alternate Cashless Exercise, with an aggregate fair value of $1.8 million[214] - All December 2019 PIPE Financing Warrants were exercised by January 2021, resulting in 1,250,000 common shares issued for $975,000[244] 9. Preferred Stock This note describes the company's preferred stock issuances, conversions, and outstanding balances Preferred Stock (In thousands, except share and per share data) | Series | Authorized | Issued and Outstanding | Carrying Value | Liquidation Preference per Share | | :----- | :--------- | :--------------------- | :------------- | :------------------------------- | | B-2 | 10,165 | — | $0 | $0 | | C | 1,011,000 | — | $0 | $8.00 | | Total | 1,021,165 | — | $0 | | - As of March 31, 2021, there were no Series A, Series B, Series B-2, or Series C Convertible/Perpetual Preferred shares outstanding, as all have been retired, cancelled, or converted into common stock[248][256][263][272] - In September 2020, Series A Convertible Preferred shares were exchanged for Series C and Series D Perpetual Preferred shares, which were subsequently exchanged for common stock by December 2020[247][271] - In March 2020, the conversion price of Series B Convertible Preferred Stock was reduced as an inducement, leading to a $1.6 million inducement charge[254][255] 10. Stockholders' Equity This note provides details on the components of stockholders' equity and shares reserved for issuance Common Stock Reserved for Issuance (As of March 31, 2021 and December 31, 2020) | | March 31, 2021 (unaudited) | December 31, 2020 | | :------------------------------------------ | :------------------------- | :---------------- | | Options issued and outstanding | 4,449,398 | 4,456,748 | | Inducement options issued and outstanding | 170,892 | 114,892 | | Options available for grant under stock option plans | 6,355,104 | 596,597 | | Restricted stock unit awards issued and outstanding | 5,613 | 5,613 | | Warrants issued and outstanding | 1,590,354 | 7,205,454 | | Total | 12,571,361 | 12,379,304 | - The company is authorized to issue 204,475,074 shares, including 150,000,000 common stock and 50,000,000 non-voting common stock[276] - A reverse stock split of voting common stock (ratio 1-for-2 to 1-for-20) was approved on December 22, 2020, but not yet effectuated as of March 31, 2021[277] - In Q1 2021, the company issued 4,437,870 shares of common stock in a registered public offering for net proceeds of $13.5 million and 2,009,554 shares under an At the Market (ATM) offering for $5.4 million[293][289] 11. Stock-based Compensation This note outlines the company's stock option and RSU activity and related compensation expense Stock Option and RSU Activity (In thousands, except share and per share data) | (in thousands, except share and per share data) | Outstanding at December 31, 2020 | Options granted | Options canceled | Outstanding at March 31, 2021 | | :---------------------------------------------- | :------------------------------- | :-------------- | :--------------- | :---------------------------- | | Stock Options Outstanding | 4,571,566 | 70,000 | (21,350) | 4,620,216 | | RSUs Outstanding | 5,613 | — | — | 5,613 | | Weighted Average Stock Option Exercise Price | $4.23 | $1.92 | $10.68 | $4.16 | | Weighted Average Remaining Contractual Life (Years) | 8.71 | | | 8.51 | | Aggregate Intrinsic Value* | $364 | | | $1,808 | Stock-Based Compensation Expense (In thousands) | (in thousands) | Three Months Ended March 31, 2021 (unaudited) | Three Months Ended March 31, 2020 | | :------------- | :------------------------------------------ | :-------------------------------- | | Research and development expense | $164 | $202 | | Sales and marketing expense | $52 | $56 | | General and administrative expense | $418 | $502 | | Total | $634 | $760 | - Total stock-based compensation expense decreased from $760,000 in Q1 2020 to $634,000 in Q1 2021[304] - As of March 31, 2021, $2.2 million of unrecognized stock-based compensation expense remains, to be recognized over a weighted-average period of 1.13 years[304] 12. Net Loss Per Share This note explains the calculation of basic and diluted net loss per common share Basic and Diluted Net Loss Per Common Share (In thousands, except share and per share data) | (In thousands, except share and per share data) | Three Months Ended March 31, 2021 (unaudited) | Three Months Ended March 31, 2020 | | :---------------------------------------------- | :------------------------------------------ | :-------------------------------- | | Net loss attributable to common shareholders (basic and diluted) | $(12,009) | $(8,416) | | Shares used to compute net loss per common share, basic and diluted | 125,416,228 | 15,141,906 | | Net loss per share attributable to common shareholders, basic and diluted | $(0.10) | $(0.56) | - Diluted net loss per common share is the same as basic net loss per common share due to the company's net loss position, making potential dilutive securities anti-dilutive[307][308] Anti-Dilutive Common Stock Equivalents Excluded from Diluted EPS (Shares) | | Three Months Ended March 31, 2021 (unaudited) | Three Months Ended March 31, 2020 | | :------------------------------------------ | :------------------------------------------ | :-------------------------------- | | Options issued and outstanding | 4,449,398 | 4,508,021 | | Inducement options issued and outstanding | 170,892 | 74 | | Restricted stock units issued and outstanding | 5,613 | 5,613 | | Warrants issued and outstanding | 1,590,354 | 17,622,930 | | Series A convertible preferred stock | — | 473,565 | | Series B convertible preferred stock | — | 4,423,250 | | Series B-2 convertible preferred stock | — | 1,431,460 | | Total | 6,216,257 | 28,464,913 | 13. Segment Information This note presents financial data broken down by the company's human health and animal health segments - The company operates in two reportable segments: human health (focused on Mytesi and related products) and animal health (focused on prescription and non-prescription products for animals)[310] Segment Net Revenues and Net Loss (In thousands) | (in thousands) | Three Months Ended March 31, 2021 (unaudited) | Three Months Ended March 31, 2020 | | :------------- | :------------------------------------------ | :-------------------------------- | | Revenue from external customers | | | | Human Health | $1,208 | $835 | | Animal Health | $33 | $34 | | Consolidated Totals | $1,241 | $869 | | Segment net loss | | | | Human Health | $(3,941) | $(3,200) |\ | Animal Health | $(8,068) | $(4,736) | | Consolidated Totals | $(12,009) | $(7,936) | - Human Health revenue increased by $373,000 (44.7%) YoY, while Animal Health revenue remained stable[311] - Both segments reported increased net losses, with Human Health loss increasing by $741,000 (23.2%) and Animal Health loss increasing by $3.332 million (70.3%) YoY[311] Segment Assets (In thousands) | (in thousands) | March 31, 2021 (unaudited) | December 31, 2020 | | :------------- | :------------------------- | :---------------- | | Human Health | $37,064 | $34,201 | | Animal Health | $110,052 | $79,760 | | Total | $147,116 | $113,961 | 14. Subsequent Events This note discloses significant events that occurred after the balance sheet date but before the financial statements were issued - On April 6, 2021, the company entered a new office lease agreement in San Francisco, California, for approximately 10,526 square feet, with a term from September 1, 2021, to August 31, 2024, and monthly base rents starting at $42,000[313] - On April 7, 2021, the March 2020 ELOC with Oasis Capital was amended, increasing the purchase price to $3.00 and threshold price to $3.45, and issuing an ELOC Warrant for 100,000 common shares[314] - On April 13, 2021, an exchange agreement with Iliad resulted in a $3.0 million reduction in royalty interest outstanding balance in exchange for 1,764,705 shares of common stock[315] - On April 29, 2021, the company entered a securities purchase agreement to issue and sell 7,647,000 shares of common stock in a registered public offering at $1.41 per share, for gross proceeds of approximately $10.8 million[316][318] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on Jaguar Health, Inc.'s financial condition and results of operations for the three months ended March 31, 2021, compared to the same period in 2020 - Jaguar Health is a commercial-stage pharmaceuticals company focused on novel, sustainably derived gastrointestinal products globally, with its subsidiary Napo Pharmaceuticals focusing on human health and Mytesi[322] - The company continues to incur significant operating losses and negative cash flows, with a net loss of $12.0 million in Q1 2021, up from $7.9 million in Q1 2020[327] - Product revenue increased by 42.8% to $1.241 million in Q1 2021, driven by a 249.5% increase in Mytesi gross product sales due to a 230.0% increase in sales price and a 6.3% increase in bottles sold[373][374][376] - Research and development expenses increased by 52.6% to $2.414 million in Q1 2021, primarily due to increased clinical trial activities for cancer therapy diarrhea and other Mytesi indications, and higher consulting fees[373][382][384] - Sales and marketing expenses rose by 45.6% to $2.139 million in Q1 2021, mainly due to increased patient access programs and Mytesi marketing initiatives[373][383] - General and administrative expenses increased by 8.3% to $3.409 million in Q1 2021, largely due to higher audit, tax, and accounting services fees related to complex debt and equity transactions, and increased D&O liability insurance[373][387][389] - Interest expense surged by 855.3% to $1.901 million in Q1 2021, primarily from royalty interest agreements and Exchange Note 2[373][393] - The company's liquidity is supported by $32.3 million in cash as of March 31, 2021, deemed sufficient for at least 12 months, with significant financing activities in Q1 2021 providing $30.9 million in cash[397][405] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there are no quantitative and qualitative disclosures about market risk applicable to the company for the reported period - The company has no applicable quantitative and qualitative disclosures about market risk for the period[408] Item 4. Controls and Procedures Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2021, due to material weaknesses in internal control over financial reporting - Disclosure controls and procedures were not effective as of March 31, 2021, due to material weaknesses in internal control over financial reporting[410] - Material weaknesses identified include inadequate policies and procedures for timely, effective review of assumptions used in measuring fair value of certain financial instruments, and insufficient resources with appropriate knowledge and experience for financial reporting[412][413] - Remediation efforts include adding controls to enhance and revise existing designs, establishing policies for timely review by qualified personnel, reassessing internal controls, and hiring permanent accounting personnel and consultants[413][420] PART II. — OTHER INFORMATION This part covers other essential information, including legal proceedings, risk factors, equity sales, and exhibits Item 1. Legal Proceedings This section details ongoing legal proceedings, including a putative class action lawsuit related to the 2017 merger, which has reached a preliminary settlement of $2.6 million, expected to be covered by the company's insurance - A putative class action lawsuit filed in July 2017 concerning the 2017 merger has reached an agreement in principle to settle for $2.6 million, subject to court approval, with the entire settlement expected to be covered by the company's director and officer liability insurance carrier[421][422] - The company received an inquiry from the Committee on Oversight and Reform of the U.S. House of Representatives in May 2020 regarding the list price adjustment of Mytesi, which the company states was decided in December 2019 as part of patient access programs[423][424] Item 1A. Risk Factors This section outlines significant risks that could materially and adversely affect the company's business, financial condition, operating results, and stock price - Obligations to Streeterville are secured by a first priority security interest in all of Napo's lechlemer assets, meaning default could lead to foreclosure and harm development plans[430] - The company is required to make minimum royalty payments totaling $2.3 million in 2021, $6.7 million in 2022, $18.0 million in 2023, $14.0 million in 2024, $7.1 million in 2025, and $3.8 million in 2026, which may strain cash resources even without sufficient product sales[431] - The COVID-19 pandemic could adversely impact the business by disrupting the supply chain, clinical trials, and Mytesi commercialization, including limiting engagement with healthcare providers and patient groups[432][434] - Long-term remote work arrangements may strain business continuity plans, introduce operational risks like cyber-security threats, and impair internal controls over financial reporting[436] - Failure in information technology systems, including cyber attacks, could significantly disrupt operations, lead to legal and financial exposure, and damage reputation[437] - Substantially all revenue for recent periods has been received from a single customer, posing a concentration risk[438] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section reports an unregistered sale of equity securities on April 13, 2021, where the company issued 1,764,705 shares of common stock to a royalty interest holder in exchange for a $3,000,000 reduction in the outstanding balance of the royalty interest - On April 13, 2021, the company issued 1,764,705 shares of common stock to a royalty interest holder in exchange for a $3,000,000 reduction in the outstanding balance of the royalty interest[439] Item 3. Defaults upon senior securities This section states that there were no defaults upon senior securities during the reported period - There were no defaults upon senior securities[441] Item 4. Mine safety disclosures This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[442] Item 5. Other Information This section states that there is no other information to report - No other information to report[443] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including certificates of incorporation, preferred stock designations, secured promissory notes, royalty interests, master services agreements, securities purchase agreements, and certifications - The exhibits include various corporate governance documents (e.g., Certificates of Incorporation, Preferred Stock Designations), financial agreements (e.g., Secured Promissory Note, Royalty Interest, Securities Purchase Agreements), and certifications (e.g., Section 302 and 906 certifications)[444][447] SIGNATURE This section contains the official signature certifying the accuracy and submission of the report SIGNATURE This section contains the signature of the registrant, Jaguar Health, Inc., by its Principal Financial and Accounting Officer, certifying the filing of the report - The report is signed by Carol R. Lizak, Principal Financial and Accounting Officer of Jaguar Health, Inc., on May 17, 2021[450]