Full Press Release Details
Reports Second Quarter 2023 Financial Results
Net revenue increased
36% in Q2 2023 versus Q1 2023
expected late October 2023 for company's phase 3 OnTarget trial of crofelemer for preventative treatment of cancer therapy-related
Jaguar is supporting
investigator-initiated proof-of-concept studies of crofelemer for the rare disease indications of short bowel syndrome and microvillus
inclusion disease in the EU and Middle East/North Africa regions, with results expected before the end of 2023 and in 2024
Jaguar to host investor webcast Monday, August 14th at 8:30 a.m. Eastern regarding Q2 2023 financials and company
updates; Click here to register for webcast
SAN FRANCISCO, CA / August 14, 2023
/ Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar" or the "Company") today reported consolidated second-quarter
2023 financial results and provided Company updates.
The combined net revenue for Mytesi (crofelemer) and
the Company's crofelemer prescription product for treatment of chemotherapy-induced diarrhea in dogs, Canalevia -CA1,
which became commercially available in April 2022, was approximately $2.7 million in the second quarter of 2023, representing an increase
of 36% compared to prescription product net revenue in the first quarter of 2023, which totaled approximately $2.0 million, and a decrease
of approximately 8% over prescription product net revenue in the second quarter of 2022, which totaled approximately $2.9 million. The
loss from operations increased by $1.6 million, from $6.4 million in the quarter ended June 30, 2022 to $8.1 million during the same period
Lisa Conte, Jaguar's president and CEO,
said, "Our paramount near-term clinical activity is our Phase 3 pivotal OnTarget trial of Mytesi for the follow-on
indication of the preventative treatment of chemotherapy-induced overactive bowel (CIOB) - which includes symptoms such as chronic
debilitating diarrhea, GI urgency, and GI incontinence. We have completed patient enrollment for OnTarget - a key step on our journey
to making crofelemer available to treat the neglected comorbidity of CIOB - and top line results from this pivotal study are expected
in late October 2023. With success, we expect to expand the indication of Mytesi in 2024."
Jaguar is supporting investigator-initiated and investigator IND proof-of-concept
studies of crofelemer for 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 before the end of 2023 and in 2024. In accordance with the guidelines of
specific EU countries, published data from such clinical investigations could support reimbursed early patient access to crofelemer for
SBS or MVID, potentially in 2024, for these debilitating conditions.
MVID, an ultra-rare pediatric congenital diarrheal disorder (CDD),
and SBS with intestinal failure are Jaguar's two prioritized rare disease investigative indications for a novel formulation of crofelemer.
MVID is a catastrophic medical situation for pediatric patients, and there are currently no approved drug treatments. The Company's
Investigational New Drug application for crofelemer for the treatment of MVID was activated by the U.S. Food and Drug Administration (FDA)
Crofelemer has been granted Orphan Drug
Designation (ODD) by the FDA and the European Medicines Agency (EMA) for both MVID and SBS with intestinal failure. The ODD programs
in the U.S. and European Union qualify sponsors to receive potential incentives to develop therapies for the diagnosis, prevention, or
treatment of rare diseases or conditions.
2023 SECOND QUARTER COMPANY FINANCIAL
| Three Months Ended | ||||||||||||||||
| Financial Highlights | June 30, | |||||||||||||||
| (in thousands, except per share amounts) | 2023 | 2022 | $ change | % change | ||||||||||||
| Net product revenue | $ | 2,676 | $ | 2,921 | (245 | ) | -8 | % | ||||||||
| Loss from operations | $ | (8,102 | ) | $ | (6,479 | ) | (1,623 | ) | 25 | % | ||||||
| Net loss attributable to shareholders | $ | (12,150 | ) | $ | (9,367 | ) | (2,783 | ) | 30 | % | ||||||
| Net loss per share, basic | $ | (0.69 | ) | $ | (0.12 | ) | (0.57 | ) | 475 | % | ||||||
| Net loss per share, diluted | $ | (0.42 | ) | $ | (0.12 | ) | (0.30 | ) | 250 | % |
| Three Months Ending | ||||||||
| June 30, | ||||||||
| (in thousands) | 2023 | 2022 | ||||||
| (unaudited) | ||||||||
| Net loss attributable to common shareholders | $ | (12,150 | ) | $ | (9,367 | ) | ||
| Adjustments: | ||||||||
| Interest expense | 3,453 | 2,536 | ||||||
| Property and equipment depreciation | 20 | 10 | ||||||
| Amortization of intangible assets | 484 | 422 | ||||||
| Share-based compensation expense | 529 | 1,113 | ||||||
| Income taxes | - | - | ||||||
| Non-GAAP EBITDA | (7,665 | ) | (5,286 | ) | ||||
| Impairment of indefinite-lived intangible assets | ||||||||
| Loss on extinguishment of debt | - | - | ||||||
| Non-GAAP Recurring EBITDA | $ | (7,665 | ) | $ | (5,286 | ) |
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
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.
Instructions for Webcast
When: Monday, August
14, 2023, at 8:30 AM Eastern Time
Participant Registration
& Access Link: Click Here
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. Jaguar family company Napo Pharmaceuticals 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
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 GI distress, specifically overactive bowel, which includes symptoms such as chronic debilitating diarrhea,
GI urgency, and GI incontinence. Jaguar family company Napo Pharmaceuticals focuses on developing and commercializing human prescription
pharmaceuticals. Napo Pharmaceuticals' crofelemer drug product candidate is the subject of the OnTarget study, an ongoing
pivotal Phase 3 clinical trial for preventative treatment of chemotherapy-induced overactive bowel (CIOB) in adults with cancer on targeted
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 rare diseases. Jaguar Animal Health is a Jaguar tradename. Magdalena Biosciences, a
joint venture formed by Jaguar and Filament Health Corp., is focused on developing novel prescription medicines derived from plants for
mental health indications.
For more information about Jaguar Health,
please visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more
information about Napo Therapeutics, visit napotherapeutics.com. For more information about Magdalena Biosciences, visit magdalenabiosciences.com.
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.
Important Safety Information About
For oral use in dogs only. Not for use
in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult
a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to
using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment
of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration,
abdominal pain, and vomiting.
Caution: Federal law restricts
this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this
product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application
See full Prescribing Information at