Jaguar Health(JAGX) - 2021 Q4 - Annual Report

Part I Item 1. Business Jaguar Health is a commercial-stage pharmaceutical company developing plant-based gastrointestinal medicines, with Mytesi for human HIV/AIDS diarrhea and Canalevia-CA1 for canine chemotherapy-induced diarrhea, and a pipeline for new indications - The company's core business revolves around its plant-based drug, crofelemer, commercialized as Mytesi for human use (HIV-related diarrhea) and Canalevia-CA1 for animal use (chemotherapy-induced diarrhea in dogs)[14][15] - A pivotal Phase 3 clinical trial (OnTarget) for crofelemer for the prophylaxis of diarrhea in adult cancer patients receiving targeted therapy was initiated in October 2020[47][75] - The company established Napo Therapeutics in Italy to expand crofelemer access in Europe, focusing on rare/orphan diseases such as Short Bowel Syndrome (SBS) and Congenital Diarrheal Disorders (CDD), with crofelemer receiving Orphan Drug Designation for SBS in both the U.S. and the E.U.[19][20] - In 2021, the company transitioned Mytesi distribution to a closed network of specialty pharmacies, causing a temporary, one-time reduction in reported sales as wholesalers depleted their existing inventory[29][31][498] Human Product Pipeline Overview | Product Candidate | Indication | Current Phase | Anticipated Milestones | | :--- | :--- | :--- | :--- | | Mytesi | Cancer Therapy-Related Diarrhea (CTD) | Phase 3 | Enrollment ongoing | | Novel crofelemer | Rare disease (SBS & CDD) | Phase 2 | Initiate Phase 2 POC study in 2022 | | Mytesi | Irritable Bowel Syndrome-Diarrhea (IBS-D) | Phase 2 | Potential business development opportunities | | Mytesi | Chronic idiopathic diarrhea | Phase 2 | Top line results of UTH trial expected in 2022 | | NP-300 (lechlemer) | Infectious diarrhea (e.g., cholera) | Pre-IND | Initiate Phase 1 trial in H2 2022 | Item 1A. Risk Factors The company faces significant risks including a history of net losses, going concern doubts, dependence on Mytesi and Canalevia, regulatory hurdles, supply chain reliance, intense competition, and potential Nasdaq delisting - The company has a history of losses, with a net loss of $52.6 million in 2021, and has substantial doubt about its ability to continue as a going concern without raising additional capital[288][289] - The business is substantially dependent on the success of its lead products, Mytesi and Canalevia-CA1, for both current and future follow-on indications[302] - The company is dependent on two suppliers for the raw material (CPL) and third-party contract manufacturers (Glenmark, Indena, Patheon) for the API and finished products, posing a supply chain risk[337][338] - The company received a notice from Nasdaq on February 17, 2022, for failing to maintain the minimum $1.00 bid price requirement, posing a risk of delisting if compliance is not regained[426] - The COVID-19 pandemic could adversely impact the business, including its supply chain, clinical trials, and commercialization efforts for Mytesi and Canalevia[373] Item 1B. Unresolved Staff Comments The company reports no unresolved staff comments from the SEC - There are no unresolved staff comments[454] Item 2. Properties The company's corporate headquarters are located at 200 Pine Street, Suite 400, San Francisco, California - The company's corporate headquarters are located in San Francisco, California[455] Item 3. Legal Proceedings The company addresses a May 2020 Mytesi price inquiry from the U.S. House Committee and a July 2017 class action lawsuit related to the Napo merger, which was settled for $2.6 million - A 2017 class action lawsuit related to the Napo merger was settled for $2.6 million, with the entire amount paid by the company's director and officer liability insurance carrier, receiving final court approval on May 27, 2021[460][461] - In May 2020, the company received an inquiry from the U.S. House of Representatives' Committee on Oversight and Reform concerning a price adjustment for Mytesi, with which the company has cooperated[456][457] Item 4. Mine Safety Disclosure This item is not applicable to the company - Mine safety disclosures are not applicable[463] Part II Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities The company's common stock trades on Nasdaq under 'JAGX', with approximately 28 stockholders, and has never paid cash dividends, intending to retain earnings for business development - The company's common stock trades on The Nasdaq Capital Market under the symbol "JAGX"[466] - The company has never paid cash dividends and does not anticipate doing so for at least the next five years[467] Item 6. Selected Financial Data This item is not applicable as the company is a smaller reporting company - Selected Financial Data is not applicable[470] Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations In FY2021, net product revenue decreased by 53.8% to $4.3 million due to a distribution model transition, operating expenses increased by 25.0% to $45.0 million, resulting in a $52.6 million net loss and substantial doubt about going concern FY2021 vs FY2020 Financial Performance (in thousands) | Metric | 2021 | 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Net Product Revenue | $4,335 | $9,385 | ($5,050) | (53.8)% | | Cost of Product Revenue | $2,333 | $3,280 | ($947) | (28.9)% | | Research & Development | $15,079 | $6,413 | $8,666 | 135.1% | | Sales & Marketing | $8,894 | $6,609 | $2,285 | 34.6% | | General & Administrative | $17,103 | $14,387 | $2,716 | 18.9% | | Total Operating Expenses | $45,043 | $36,032 | $9,011 | 25.0% | | Loss from Operations | ($40,708) | ($26,647) | ($14,061) | 52.8% | | Net Loss | ($52,600) | ($33,809) | ($18,791) | 55.6% | - The significant decrease in 2021 net product revenue was primarily caused by a one-time inventory draw-down of approximately 1,300 bottles of Mytesi as the company transitioned its distribution model from wholesalers to a closed specialty pharmacy network[498][499] - Research and development expenses increased by $8.7 million (135.1%), largely due to a $4.6 million rise in clinical and contract manufacturing costs related to the start-up of the CTD trial and other indications[506][508] - The company had cash of $17.1 million as of December 31, 2021, but management states there is substantial doubt about the company's ability to continue as a going concern due to recurring losses and the need for additional financing[526][527] Item 7A. Qualitative and Quantitative Disclosures About Market Risk This item is not applicable as the company is a smaller reporting company - Qualitative and Quantitative Disclosures About Market Risk are not applicable[541] Item 8. Financial Statements and Supplementary Data The audited financial statements for FY2021 and FY2020 show a net loss of $52.6 million for 2021, with the independent auditor noting substantial doubt about the company's ability to continue as a going concern - The report from the independent registered public accounting firm explicitly notes that the company's recurring losses and accumulated deficit raise substantial doubt about its ability to continue as a going concern[546] Consolidated Balance Sheet Data (in thousands) | Account | Dec 31, 2021 | Dec 31, 2020 | | :--- | :--- | :--- | | Cash | $17,051 | $8,090 | | Total Current Assets | $28,434 | $17,792 | | Total Assets | $53,265 | $42,843 | | Total Current Liabilities | $15,471 | $13,220 | | Total Liabilities | $41,412 | $25,641 | | Accumulated Deficit | ($219,494) | ($166,899) | | Total Stockholders' Equity | $11,853 | $17,202 | Consolidated Statement of Operations Data (in thousands) | Account | Year Ended Dec 31, 2021 | Year Ended Dec 31, 2020 | | :--- | :--- | :--- | | Product Revenue | $4,335 | $9,385 | | Total Operating Expenses | $45,043 | $36,032 | | Net Loss | ($52,600) | ($33,809) | | Net Loss Per Share | ($1.18) | ($3.00) | Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - There were no changes in or disagreements with accountants on accounting and financial disclosure[932] Item 9A. Controls and Procedures Management concluded that disclosure controls and procedures were effective as of December 31, 2021, having remediated a material weakness related to insufficient internal accounting staff and expertise - Management concluded that disclosure controls and procedures were effective as of December 31, 2021[934] - A material weakness related to accounting staff turnover and inadequate technical expertise, previously reported for fiscal years 2019 and 2020, was remediated as of December 31, 2021[935][936][938] Item 9B. Other Information The company reports no other information under this item - There is no information to report under this item[941] Part III Item 10. Directors, Executive Officers and Corporate Governance The information required for this item, concerning directors, executive officers, and corporate governance, is incorporated by reference from the company's definitive Proxy Statement for the 2022 Annual Meeting of Stockholders - Information is incorporated by reference from the Proxy Statement for the 2022 Annual Meeting of Stockholders[943] Item 11. Executive Compensation The information required for this item, concerning executive compensation, is incorporated by reference from the company's definitive Proxy Statement for the 2022 Annual Meeting of Stockholders - Information is incorporated by reference from the Proxy Statement for the 2022 Annual Meeting of Stockholders[944] Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters The information required for this item, concerning security ownership and related matters, is incorporated by reference from the company's definitive Proxy Statement for the 2022 Annual Meeting of Stockholders - Information is incorporated by reference from the Proxy Statement for the 2022 Annual Meeting of Stockholders[945] Item 13. Certain Relationships and Related Transactions, and Director Independence The information required for this item, concerning related party transactions and director independence, is incorporated by reference from the company's definitive Proxy Statement for the 2022 Annual Meeting of Stockholders - Information is incorporated by reference from the Proxy Statement for the 2022 Annual Meeting of Stockholders[946] Item 14. Principal Accountant Fees and Services The information required for this item, concerning principal accountant fees and services, is incorporated by reference from the company's definitive Proxy Statement for the 2022 Annual Meeting of Stockholders - Information is incorporated by reference from the Proxy Statement for the 2022 Annual Meeting of Stockholders[947] Part IV Item 15. Exhibits, Financial Statement Schedules This section lists all exhibits filed with the annual report, including organizational documents, material contracts, and required CEO/CFO certifications - This section provides a comprehensive list of all exhibits filed with the annual report, including material contracts and required certifications[948][951][956]