Reminder: Company to Host Investor Call Today at 9 a.m. Eastern Regarding Interim Analysis of HALT-D Study of Mytesi (Crofelemer) for Prevention of Diarrhea in Breast Cancer Patients, Q3 Financials & Business Updates
SAN FRANCISCO, CA / ACCESSWIRE / November 14, 2019 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today reported third quarter 2019 results and issued the following highlights.
“As we pursue development of pipeline indications for Mytesi, our goal is to optimize efficiency in the commercialization of Mytesi for the current HIV indication. We are pleased with the continued prescribing growth in Q3, in light of the recent approximately 50% decrease in the size of our Mytesi sales force and the recent realignment to focus on what we call ‘super targets’ – family practitioners, general practitioners, internal medicine doctors, nurse practitioners, and physician assistants who were already prescribing anti-motility and anti-retroviral drugs and therefore were already engaging in conversations about diarrhea with their patients living with HIV/AIDS,” Lisa Conte, Jaguar’s president and CEO commented.”
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Three Months Ended | |||||||||||||||
Financial Highlights
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September 30, | |||||||||||||||
(in thousands, except per share amounts)
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2019 | 2018 | $ change | % change | ||||||||||||
Net product revenue
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$ | 973 | $ | 1,132 | (159 | ) | -14 | % | ||||||||
Loss from operations
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$ | (6,727 | ) | $ | (6,506 | ) | (221 | ) | 3 | % | ||||||
Net loss and comprehensive loss
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$ | (7,555 | ) | $ | (6,138 | ) | (1,417 | ) | 23 | % | ||||||
Net loss attributable to common shareholders
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$ | (11,683 | ) | $ | (6,138 | ) | (5,545 | ) | 90 | % | ||||||
Net loss per share, basic and diluted
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$ | (2.00 | ) | $ | (37.77 | ) | ||||||||||
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Three Months Ended | |||||||||||||||
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September 30, | |||||||||||||||
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2019 | 2018 | $ change | % change | ||||||||||||
Net product sales
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$ | 973 | $ | 1,132 | (159 | ) | -14 | % | ||||||||
Adjustment to net product sales due to donations
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337 | – | ||||||||||||||
Net product sales (non-GAAP)
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$ | 1,310 | $ | 1,132 | 178 | 16 | % | |||||||||
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||||||||||||||||
Gross product sales (non-GAAP)
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$ | 1,913 | $ | 1,617 | 296 | 18 | % | |||||||||
2019 Third Quarter Company Financial Results:
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Three Months Ended | |||||||
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September 30, | |||||||
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2019 | 2018 | ||||||
Net loss and comprehensive loss
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$ | (7,555 | ) | $ | (6,138 | ) | ||
Adjustments:
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||||||||
Interest expense and other expense, net
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1,353 | 872 | ||||||
Property and equipment
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10 | 15 | ||||||
Amortization of intangible assets
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422 | 422 | ||||||
Share-based compensation expense
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1,100 | 680 | ||||||
Income Taxes
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10 | – | ||||||
Non-GAAP EBITDA
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$ | (4,660 | ) | $ | (4,149 | ) | ||
Adjustment to gross product revenue due to donations
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337 | – | ||||||
Campaign batch cancelation fee
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161 | – | ||||||
Distribution fees from former distributor (under discussions)
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227 | – | ||||||
Reversal of accrued royalty due to termination of royalty agreement
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(189 | ) | – | |||||
Non-GAAP recurring EBITDA
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$ | (4,124 | ) | $ | (4,149 | ) |
Other Key Updates, as Announced This Week:
Company announcements regarding other third-quarter 2019 pipeline development, commercial, and business development news can be found on the investor relations section of Jaguar’s website.
Note Regarding Use of Non-GAAP Measures
The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing gross sales, non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable SEC rules. Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which Company management assesses and operates the business. These non-GAAP financial measures are not in accordance with GAAP and should not be viewed in isolation or as substitutes for GAAP net sales and GAAP net loss and are not substitutes for, or superior to, measures of financial performance in conformity with GAAP.
Gross sales percentages issued by the Company are based on gross sales figures that represent Mytesi orders placed by wholesalers with Jaguar’s third-party logistics warehouse, which generate invoiced sales and cash flow for Napo. Gross sales is used internally by management as an indicator of and to monitor operating performance, including sales performance of Mytesi, salesperson performance, and product growth or declines. The Company believes that the presentation of gross sales provides a closer to real-time useful measure of our operating performance. Gross sales is not a measure that is recognized under accounting principles generally accepted in the United States of America (“GAAP”) and should not be considered as an alternative to net sales, which is determined in accordance with GAAP, and should not be used alone as an indicator of operating performance in place of net sales. Additionally, gross sales may not be comparable to similarly titled measures used by other companies, as gross sales have been defined by the Company’s internal reporting practices. In addition, gross sales may not be realized in the form of cash receipts as promotional payments and allowances may be deducted from payments received from certain customers. Mytesi gross sales are reduced by Medicare, ADAP 340B chargebacks, returns, and wholesale distribution fees based on historical trends to determine net sales.
The Company defines non-GAAP EBITDA as net loss before interest expense and other expense, property and equipment, amortization of intangible assets, share-based compensation expense and provision for or benefit from income taxes. The Company defines non-GAAP Recurring EBITDA as non-GAAP EBITDA adjusted for certain non-recurring revenues and expenses, such as a non-recurring adjustment related to a donation. Company management believes that non-GAAP EBITDA and non-GAAP Recurring EBITDA are meaningful indicators of Jaguar’s performance and provide useful information to investors regarding the Company’s results of operations and financial condition.
Dial-In Instructions for Conference Call
When: November 14, 2019 at 9 a.m. Eastern Time
Dial-in (US Toll Free): 800-289-0438
Dial-in (International): 323-794-2423
Conference ID number: 3702255
Live webcast on the investor relations section of Jaguar’s website (click here)
Replay Instructions
Dial-in (US Toll Free): 844-512-2921
Dial-in (International): 412-317-6671
Replay Pin Number: 3702255
Replay of the webcast on the investor relations section of Jaguar’s website (click here)
About Jaguar Health, Inc.
Jaguar Health, Inc. is a commercial stage 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.
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%).
See full Prescribing Information 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.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expectation that the Company will host an investor call November 14, 2019. 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 Jaguar’s 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.
Contact:
Peter Hodge
Jaguar Health, Inc.
phodge@jaguar.health
Jaguar-JAGX
SOURCE: Jaguar Health, Inc.
View source version on accesswire.com:
https://www.accesswire.com/566541/Jaguar-Health-Inc-Reports-2019-Third-Quarter-Financial-Results
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