Mytesi® net sales and gross sales grew 38% and 44%, respectively, in 2019 compared to 2018
Reminder: Company to host investor call Monday, April 6 at 8:30 a.m. Eastern
SAN FRANCISCO, CA / ACCESSWIRE / April 6, 2020 / Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today reported consolidated financial results for the year ended December 31, 2019 and provided business updates.
“We are very pleased to see strong Mytesi® (crofelemer) sales growth in 2019 over 2018,” Lisa Conte, Jaguar’s president and CEO, commented. “Looking forward, we believe 2020 has the potential to be a transformative year for the Company. Our core goals for the year include forging a regional, ex-US business development deal to bring in non-dilutive dollars to support efforts to move key potential Mytesi pipeline indications into development, commercialization, and access outside the U.S., and completing the roll-out of our new, recently announced patient support program for Mytesi. Subject to additional financing, we are also planning to initiate three clinical trials in the second half of 2020 – a pivotal trial for the indication of prevention and treatment of cancer therapy-related diarrhea (CTD) in adult cancer patients, and two studies for the rare pediatric disease indications of congenital diarrheal disease and short bowel syndrome. For the adult CTD study, we’ve been in active discussions with the FDA, and in meetings with key opinion leaders, and have received their input on the clinical trial and statistical analysis plan. We are revising the clinical protocol to accommodate their input and preparing the requisite documents including the statistical analysis plan, the informed consent and other requirements to initiate this pivotal adult CTD trial under a new IND. The principal investigator is at a major cancer institution in the US. Finally, at a time when the world is grappling with a pandemic, we are pleased to announce that our wholly owned subsidiary, Napo Pharmaceuticals, will receive additional preclinical services from the National Institute of Allergy and Infectious Diseases (“NIAID”) to support development of lechlemer, Napo’s second generation, plant-based anti-secretory drug candidate for treatment of diarrhea associated with the enduring scourge of cholera. Under NIAID’s suite of preclinical services, NIAID-funded contractors will conduct toxicology testing for a 28-day rat study. NIAID is part of the National Institutes of Health.”
2019 Company Financial Results:
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Year-Ended |
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Financial Highlights
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December 31, |
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(in thousands, except per share amounts)
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2019 | 2018 | $ change | % change | |||||||||||||
Net product revenue
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$ | 5,775 | $ | 4,239 | 1,537 | 36 | % | ||||||||||
Loss from operations
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$ | (28,948 | ) | $ | (30,824 | ) | 1,876 | -6 | % | ||||||||
Net loss
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$ | (38,539 | ) | $ | (32,146 | ) | (6,393 | ) | 20 | % | |||||||
Net loss attributable to common shareholders
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$ | (44,726 | ) | $ | (32,146 | ) | (12,580 | ) | 39 | % | |||||||
Net loss per share, basic and diluted
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$ | (9.01 | ) | $ | (153.27 | ) | |||||||||||
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Year-Ended | |||||||
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December 31, | |||||||
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2019 | 2018 | ||||||
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(unaudited) | |||||||
Net loss
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$ | (38,539 | ) | $ | (32,146 | ) | ||
Adjustments:
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||||||||
Interest expense
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5,731 | 2,629 | ||||||
Property and equipment depreciation
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50 | 61 | ||||||
Amortization of intangible assets
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1,687 | 1,687 | ||||||
Share-based compensation expense
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2,989 | 2,024 | ||||||
Income taxes
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(10 | ) | – | |||||
Non-GAAP EBITDA
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(28,092 | ) | (25,745 | ) | ||||
Impairment of goodwill
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– | 5,211 | ||||||
Impairment of indefinite-lived intangible assets
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4,000 | – | ||||||
Loss on extinguishment of debt
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4,941 | 544 | ||||||
Campaign batch cancelation fee
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78 | – | ||||||
Distribution fees from former distributor
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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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$ | (19,035 | ) | $ | (19,990 | ) |
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: April 6, 2020 at 8:30 a.m. Eastern Time
Dial-in (US Toll Free): 888-394-8218
Dial-in (International): 323-701-0225
Conference ID number: 7352525
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: 7352525
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 belief that 2020 has the potential to be a transformative year for the Company, the Company’s goal of forging an ex-US business development deal to bring in non-dilutive dollars to support efforts to move key potential Mytesi pipeline indications into development, commercialization, and access outside the U.S., the Company’s plans to complete the roll-out of its new patient support program for Mytesi, plans to initiate three clinical trials in the second half of 2020, subject to additional financing, the expectation that Napo will receive additional preclinical services from NIAID to support development of lechlemer, and the expectation that the Company will host an investor call on April 6, 2020. 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/583914/Jaguar-Health-Reports-2019-Financial-Results-and-Business-Updates
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