Full Press Release Details
Reports Second Quarter 2024 Financial Results
The combined net Q2 2024 revenue of approximately
$2.72 million for prescription and non-prescription products increased approximately 16% versus net Q1 2024 revenue of $2.35 million and
2.0% versus net Q2 2023 revenue of $2.67 million
Company to complete analysis of full data for
first and second 12-week periods of pivotal phase 3 OnTarget trial of crofelemer for prophylaxis of cancer therapy-related diarrhea
(CTD) in support of FDA discussion; Jaguar to explore possible approval pathway for crofelemer in breast and lung cancer based on phase
Jaguar planning to begin commercial launch
in October 2024 for Gelclair , the company's third prescription product
Import permit for crofelemer granted for independent,
investigator-initiated proof-of-concept trial in Abu Dhabi in pediatric patients for the rare and orphan disease indications of microvillus
inclusion disease (MVID) and short bowel syndrome (SBS) with intestinal failure
REMINDER: Jaguar to host investor
webcast Tuesday, August 13th at 8:30 a.m. Eastern regarding Q2 2024 financials and company updates; Click here
to register for webcast
CA / August 13, 2024 / Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar" or the "Company")
today reported its consolidated second-quarter 2024 financial results and provided Company updates.
The combined net revenue for the Company's crofelemer prescription
products, Mytesi and Canalevia -CA1, and the Company's non-prescription products,
was approximately $2.72 million in the second quarter of 2024, representing an increase of approximately 16% over the combined net revenue
in the first quarter of 2024, which totaled approximately $2.35 million, and 2.0% over the combined net revenue in the second quarter
of 2023, which totaled approximately $2.67 million.
Jaguar, with strong leadership and participation from Jaguar family
companies Napo Pharmaceuticals and Napo Therapeutics, is supporting investigator-initiated proof-of-concept (POC) studies
of crofelemer for the rare disease indications of microvillus inclusion disease (MVID) and short bowel syndrome (SBS) with intestinal
failure in the US, EU, and Middle East/North Africa (MENA) regions, with results expected by the end of 2024 and throughout 2025. The
import permit for crofelemer for Abu Dhabi for the POC study in pediatric patients with MVID or SBS with intestinal failure has been
granted. In accordance with the guidelines of specific EU countries, published data from clinical investigations in such rare diseases
could support early patient access to crofelemer for these debilitating conditions in those countries.
Jaguar's president and CEO, said, "Our paramount near-term activities are our planned October 2024 commercial launch of the FDA-approved
oral mucositis prescription product Gelclair in the U.S., progressing our rare disease development business, and our
ongoing analysis of full data for the first and second 12-week stages of our pivotal phase 3 OnTarget trial of crofelemer
for prophylaxis of cancer therapy-related diarrhea (CTD). As announced, we are collaborating with our clinical and scientific
advisers to evaluate the significance of the clinically meaningful results identified in patients with breast and lung cancer in the
initial data from OnTarget, as we plan to engage in discussions with the FDA to explore the possible pathway of approval to make crofelemer
available to breast and lung cancer patients for CTD."
to the World Health Organization, in 2022 breast cancer was the most common cancer in women in 157 countries out of 185, with 2.3 million
women diagnosed with breast cancer globally.1 Lung cancer is the most common cancer worldwide, with 2,480,675 new cases
of lung cancer in 2022. It is the most common cancer in men and the second most common in women.2
2024 SECOND QUARTER COMPANY FINANCIAL RESULTS:
| Three Months Ended | ||||||||||||||||
| Financial Highlights | June 30, | |||||||||||||||
| (in thousands, except per share amounts) | 2024 | 2023 | $ change | % change | ||||||||||||
| Net product revenue | $ | 2,720 | $ | 2,676 | 44 | 2 | % | |||||||||
| Loss from operations | $ | (7,198 | ) | $ | (8,102 | ) | 904 | -13 | % | |||||||
| Net loss attributable to common shareholders | $ | (9,492 | ) | $ | (12,150 | ) | 2,658 | -28 | % | |||||||
| Net loss per share, basic and diluted | $ | (4.04 | ) | $ | (41.35 | ) | 37 | -924 | % |
| Three Months Ending | ||||||||
| June 30, | ||||||||
| (in thousands) | 2024 | 2023 | ||||||
| (unaudited) | ||||||||
| Net loss attributable to common shareholders: | $ | (9,492 | ) | $ | (12,150 | ) | ||
| Adjustments: | ||||||||
| Interest expense | (108 | ) | 3,453 | |||||
| Property and equipment depreciation | 17 | 20 | ||||||
| Amortization of intangible assets | 430 | 484 | ||||||
| Share-based compensation expense | 387 | 529 | ||||||
| Non-GAAP EBITDA | (8,766 | ) | (7,665 | ) | ||||
| Non-GAAP Recurring EBITDA | $ | (8,766 | ) | (7,665 | ) |
Note Regarding Use of Non-GAAP Measures
The Company supplements its condensed consolidated financial
statements presented on a GAAP basis by providing 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.
The Company defines non-GAAP EBITDA as net loss before interest expense
and other expense, depreciation of 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. 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.
Participation Instructions for Webcast
When: Tuesday, August 13, 2024, at 8:30 AM Eastern
Registration & Access Link: Click Here
Replay Instructions for Webcast
Replay of the webcast on the investor relations
section of Jaguar's website: (click here)
is the only oral FDA-approved prescription drug under botanical guidance. It is plant-based, extracted and purified from the red bark
sap of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals, a Jaguar family company, has established
a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity,
and support for Indigenous communities.
About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals
company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people
and animals with gastrointestinal distress, specifically associated with overactive bowel, which includes symptoms such as chronic debilitating
diarrhea, urgency, bowel incontinence, and cramping pain. Jaguar family company Napo Pharmaceuticals (Napo) focuses on developing and
commercializing human prescription pharmaceuticals for essential supportive care and management of neglected gastrointestinal symptoms
across multiple complicated disease states. Napo's crofelemer is FDA-approved under the brand name Mytesi for the
symptomatic relief of noninfectious diarrhea in adults with HIV/AIDS on antiretroviral therapy. Jaguar family company Napo Therapeutics
is an Italian corporation Jaguar established in Milan, Italy in 2021 focused on expanding crofelemer access in Europe and specifically
for orphan and/or rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a joint venture formed by Jaguar
and Filament Health Corp. that emerged from Jaguar's Entheogen Therapeutics Initiative (ETI), is focused on developing novel prescription
medicines derived from plants for mental health indications.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Magdalena Biosciences, visit magdalenabiosciences.com
Visit the Make Cancer Less Shitty patient advocacy program
at makecancerlessshitty.com and on X, Facebook & Instagram
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.
GELCLAIR has a mechanical action indicated for the
management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies, including
oral mucositis/stomatitis (may be caused by chemotherapy or radiation therapy), irritation due to oral surgery, traumatic ulcers caused
by braces or ill-fitting dentures, or disease. Also, indicated for diffuse aphthous ulcers.
IMPORTANT SAFETY INFORMATION
You are encouraged to report negative side effects of prescription
medical products to the FDA.