UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March 2, 2018
JAGUAR HEALTH, INC.
(Exact name of registrant as specified in its charter)
Delaware |
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001-36714 |
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46-2956775 |
(State or other jurisdiction of |
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(Commission File Number) |
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(IRS Employer Identification No.) |
201 Mission Street, Suite 2375 |
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94105 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (415) 371-8300
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x\
Item 8.01 Other Events.
On March 2, 2018, Jaguar Health, Inc. (the Company) issued a press release announcing that Napo Pharmaceuticals, Inc., the Companys wholly-owned human health subsidiary, entered into an agreement with specialty pharmaceutical supplier Transition Patient Services to assist Napo in streamlining and expanding nationwide patient access to Mytesi® (crofelemer), Napos FDA-approved, first-in-class anti-secretory human prescription drug. A copy of the press release is furnished as Exhibit 99.1 to this report.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. |
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Description |
99.1 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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JAGUAR HEALTH, INC. | |
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Date: March 2, 2018 |
By: |
/s/ Karen S. Wright |
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Name: |
Karen S. Wright |
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Title: |
Chief Financial Officer |
Jaguar Health Subsidiary Napo Pharmaceuticals Signs Agreement with Pharmacy Services Provider Transition Patient Services to Establish Nationwide Pilot Mytesi Direct Program
San Francisco, CA (March 2, 2018): Jaguar Health, Inc. (NASDAQ: JAGX) (Jaguar or the Company), a commercial stage natural-products pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis, announced today that Napo Pharmaceuticals, Inc. (Napo), Jaguars wholly-owned human health subsidiary, has signed an agreement (the Agreement) with pharmacy services provider Transition Patient Services to help streamline and expand nationwide patient access to Mytesi® (crofelemer), Napos FDA-approved, first-in-class anti-secretory human prescription drug.
Headquartered in Trevose, Pennsylvania, Transition Patient Services (TPS) is a direct-to-patient hub-sevice pharmacy licensed in all 50 states and dedicated to simplifying medication access, increasing patient engagement, reducing prescription abandonment, and enhancing patient outcomes through confirmed medication acquisition and improved adherence.
Under the terms of the Agreement, TPS will operate a nationwide pilot program for Mytesi®, expected to begin this March. The core benefits of the program, named Mytesi Direct, include streamlining prescription fulfillment for Mytesi® in order to ensure that Mytesi® users receive their prescription quickly, coordinating with other Napo programssuch as the Mytesi® Copay Savings Card and the NapoCares Patient Assistance Programto help ensure that patient out-of-pocket expenses for Mytesi® are as low as possible, and improving Mytesi® refill adherence through the transmission of renewal reminders to patients.
Providers, pharmacists and their staff are also able to fill out prior authorization requests electronically for Mytesi® to simplify and streamline the prior authoriziation process.
Were very pleased to have entered into this Agreement with TPS. We expect the Mytesi Direct program to significantly reduce barriers to Mytesi® access, acquisition and adherence in a highly patient-friendly and prescriber-friendly mannerhelping us expand the number of patients able to benefit from the novel, first-in-class anti-secretory mechanism of action of Mytesi®, the only antidiarrheal studied in and U.S. FDA-approved for the symptomatic relief of noninfectious diarrhea in adults living with HIV/AIDS on antiretroviral therapy, Lisa Conte, Jaguars President and CEO, stated.
At Jaguar and Napo, our paramount focus is on driving Mytesi® sales. We remain confident that Mytesi® has the metrics and performance to be a successful, first-in-class entry to gastrointestinal supportive care in the HIV community and the ability to exhibit long-term sales growth, and we currently anticipate that Mytesi® gross sales for the period of January 1, 2017 through March 31, 2018 will total approximately $3.2 million. With the goal of continuing to drive Mytesi® sales and awareness nationwide, our plans for 2018 include new and extensive sales and marketing programs, advertising and promotional activities, a more than 80% expansion in the size of the Mytesi® sales teamwhich was recently increased to eleven highly-trained sales representatives and a national sales manager, direct-to-patient hub-sevice activities, the expected publication of
supplemental data, and an increased focus on patient empowerment and educational programs for the important and neglected comorbidity of diarrhea in people living with HIV.
About Mytesi®
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 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%).
More information and complete Prescribing Information are available at Mytesi.com. Crofelemer, the active ingredient in Mytesi®, is a botanical (plant-based) drug extracted and purified from the red bark sap of the medicinal Croton lechleri tree in the Amazon rainforest. Napo has established a sustainable harvesting program for crofelemer to ensure a high degree of quality and ecological integrity.
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage natural-products pharmaceuticals company focused on developing novel, sustainably derived gastrointestinal products on a global basis. Our 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. Our 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.
For more information about Jaguar, please visit jaguar.health. For more information about Napo, visit napopharma.com.
Forward-Looking Statements
Certain statements in this press release constitute forward-looking statements. These include statements regarding the expectation that the Mytesi Direct program will significantly reduce barriers to Mytesi® access, acquisition and adherence, helping expand the number of patients able to benefit from the novel, first-in-class anti-secretory mechanism of action of Mytesi®, the Companys belief that Mytesi® has the metrics and performance to be a successful, first-in-class entry to gastrointestinal care and the ability to exhibit long-term sales growth, the Companys expectation that Mytesi® gross sales for the period of January 1, 2017 through March 31, 2018 will total approximately $3.2 million, the expected publication of additional data, and the planned expansion by more than 80% in 2018 in the size of the Mytesi® sales team. In some cases, you can identify forward-looking statements by terms such as may, will, should, expect, plan, aim, anticipate, could, intend, target, project, contemplate, believe, estimate, predict, potential or continue or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguars control. Except as required by applicable law,
Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Source: Jaguar Health, Inc.
Contact: |
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Peter Hodge |
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Jaguar Health, Inc. |
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phodge@jaguar.health |
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Jaguar-JAGX |
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