Jaguar Health, Inc. (NASDAQ: JAGX) is a natural-products pharmaceuticals company focused on developing and commercializing novel, sustainably derived gastrointestinal products for both human prescription use and animals on a global basis.
Recent Events
September 29, 2017. The company announced the pricing of an underwritten public offering of 21,250,000 shares of voting common stock with a public offering price of $0.20 per share. The Company expects to receive gross proceeds of approximately $4.25 million, before deducting underwriting discounts and commissions and other estimated offering expenses. The offering is expected to close on or about October 3, 2017, subject to customary closing conditions. The Company intends to use the net proceeds from the offering for commercialization of Mytesi®, an FDA-approved human prescription drug product of Jaguar’s wholly-owned subsidiary, Napo Pharmaceuticals, Inc., as well as for general corporate purposes and working capital.
September 28, 2017. The company’s wholly owned subsidiary, Napo Pharmaceuticals, Inc., has filed a Chemistry, Manufacturing, and Controls (CMC) supplement with the U.S. Food & Drug Administration (FDA) for six-tablet bottles of Mytesi®, Napo’s FDA-approved human drug, in preparation for Napo’s planned national sample campaign.
September 25, 2017. Napo Pharmaceuticals, Inc., has entered into a Termination, Asset Transfer, and Transition Agreement with India-based Glenmark Pharmaceuticals Ltd. Glenmark is Napo’s primary manufacturer of crofelemer, the active pharmaceutical ingredient in Mytesi®, Jaguar’s and Napo’s FDA-approved human prescription drug product. The Agreement returns to Napo certain rights which Napo licensed to Glenmark in 2005 related to the development and commercialization of crofelemer for certain specified human indications in India and 140 other countries largely in developing regions.
September 20, 2017. The U.S. Food & Drug Administration’s Center for Veterinary Medicine (CVM) has indicated that the use of Canalevia™ for treatment of exercise-induced diarrhea (EID) in dogs qualifies as a “minor use”, per the requirements of The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act), which means that Canalevia™ is eligible for conditional approval for the indication of EID in dogs.
July 31, 2017. The merger of Jaguar Animal Health, Inc. and Napo Pharmaceuticals, Inc. (Napo) became effective July 31, 2017, at which point Jaguar Animal Health’s name changed to Jaguar Health, Inc. and Napo began operating as a wholly-owned subsidiary of Jaguar focused on human health and the ongoing commercialization of, and development of follow-on indications for, Mytesi®.
Product Pipeline
Mytesi® (crofelemer) is an antidiarrheal indicated for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy (ART). Mytesi® is currently covered by Medicaid in all 50 states. It is also currently covered on 100% of the top 10 commercial insurance plans, representing more than 245 million U.S. lives. Mytesi® is not indicated for the treatment of infectious diarrhea. Rule out infectious etiologies of diarrhea before starting Mytesi®. If infectious etiologies are not considered, there is a risk that patients with infectious etiologies will not receive the appropriate therapy and their disease may worsen. In clinical studies, the most common adverse reactions occurring at a rate greater than placebo were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough (3.5%), flatulence (3.1%), and increased bilirubin (3.1%).
Follow-On Indications Being Planned and/or Developed:
- Chemotherapy-Induced Diarrhea (CID) is a development priority for crofelemer. Based on completed market research with oncologists and oncology nurses, there is an unmet need and opportunity for new treatments for CID given the incidence of diarrhea with chemotherapy drugs/regimens, particularly some of the newer agents.
- Diarrhea-Predominant Irritable Bowel Syndrome (Phase 2)
- Acute Adult Infectious Diarrhea Including Cholera (Phase 2)
- Travelers’ Diarrhea (Phase 2)
- Pediatric Acute Diarrhea (Phase 1)
- difficile-related Diarrhea (Planning stage)
Canalevia™ is a lead prescription drug product candidate for the treatment of various forms of diarrhea in dogs. Canalevia is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree.
Neonorm™ Calf is a non-prescription product to help dairies and beef farms proactively retain fluid in calves; helping the animals avoid debilitating, dangerous levels of dehydration. Neonorm is a botanical extract derived from the Croton lechleri tree.
Equilevia™ is Jaguar’s non-prescription product for total gut health in equine athletes.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a natural-products pharmaceuticals company focused on developing and commercializing novel, sustainably derived gastrointestinal products for both human prescription use and animals on a global basis. Their wholly-owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary human gastrointestinal pharmaceuticals for the global marketplace from plants used traditionally in rainforest areas. Their Mytesi® (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Mytesi® is in development for multiple possible follow-on indications, including chemotherapy-induced diarrhea; orphan-drug indications for infants and children with congenital diarrheal disorders and short bowel syndrome; supportive care for inflammatory bowel disease (IBD); irritable bowel syndrome (IBS); and as a second-generation anti-secretory agent for use in cholera patients. Canalevia™ is their lead animal prescription drug candidate, intended for treatment of various forms of diarrhea in dogs. Equilevia™ is Jaguar’s non-prescription product for total gut health in equine athletes. Canalevia™ and Equilevia™ contain ingredients isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm™ Calf and Neonorm™ Foal are Jaguar’s lead non-prescription animal products. Mytesi®, Canalevia™, Equilevia™ and Neonorm™ are distinct products that act at the same last step in a physiological pathway generally present in mammals.
Q2 Financial Review
Highlights:
Summary numbers: Revenues of $.90 million, Net Earnings of $-1.81 million.
Gross margins widened from 24.64% to 95.56% compared to the same period last year, operating (EBITDA) margins now -260.48% from -14,077.79%.
Year-on-year change in operating cash flow of 68.81% is about the same as the change in earnings, likely no significant movement in accruals or reserves.
Earnings growth from operating margin improvements as well as one-time items.
The company ended Q2 with cash of about $2.7M, and was burning cash at the rate of $3.1M in that quarter. The recent capital raise ($4.25M) may provide the company with cash to get through the near-term.
Stock Influences and Risk Factors
The market for the company’s products is on a growth trajectory;
The recent capital raise of $4.25 million should fund the company in the near-term;
customers and other third-party business partners may seek to terminate and/or renegotiate their relationships with JAGX because of the merger;
the attention of management may be directed toward the completion of the merger and related matters and may be diverted from day-to-day business operations;
current and prospective employees may experience uncertainty regarding their future roles with the combined company, which might adversely affect the ability to retain, recruit and motivate key personnel.
Stock Chart
On Tuesday, October 3, 2017, during intra-day trading shares of Jaguar Health Inc. were at $.23/share. The stock ended the day 50.22% lower at 0.20. The share price has a 52-week trading range of $.17 – $1.53. The company’s shares are currently trading below their 200-day moving average of $.70 and below the stock’s 50-day moving average of $0.45.
On July 11, 2017 Rodman & Renshaw initiated coverage on JAGX with a “buy” recommendation and a target price of $2.00. The shares dropped significantly after the recent announcement of a stock offering. Now that investors have reacted to the dilution (-50%), these shares may be positioned to appreciate.
Disclaimer
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
17B Disclosure
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.
