Full Press Release Details
Reports First Quarter 2023 Financial Results
Net revenue decreased
in Q1 2023 versus Q1 2022
over the same period
has agreed, as described below, not to issue additional equity securities before October 22, 2023
by which point the Company expects to have released top line data for the Phase 3 OnTarget trial
and core near-term milestones:
completed for Phase 3 OnTarget trial
of Investigational New Drug (IND) application planned for Q2 2023 to FDA for crofelemer for microvillus inclusion disease
Jaguar to host investor webcast Monday, May 15th at 8:30 a.m. Eastern regarding
quarter 2023 financials and company updates; Click here to register for webcast
FRANCISCO, CA / May 15, 2023 / Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar"
or the "Company") today reported consolidated first-quarter 2023 financial results and provided Company updates.
The combined net revenue for Mytesi
and the Company's other prescription product, Canalevia -CA1, which became commercially available in April 2022,
was approximately $2.00 million in the first quarter of 2023, representing a decrease of 40% compared to prescription product net revenue
in the fourth quarter of 2022, which totaled approximately $3.3 million, and a decrease of approximately 25% over prescription product
net revenue in the first quarter of 2022, which totaled approximately $2.6 million. The loss from operations decreased by $2.0 million,
from $11.8 million in the quarter ended March 31, 2022 to $9.8 million during the same period in 2023.
"After five consecutive quarters
of prescription product net sales growth, we had a decline in our Q1 2023 net sales. We may have lost sight of the depth, reach and importance
of patient voice in the HIV community to facilitate the expansion of care that Mytesi can provide HIV patients. We are prioritizing learning
from and listening to patient voice and this will be foundational to our preparations for the introduction of crofelemer to the much
larger market for the prophylaxis of cancer therapy-related diarrhea (CTD)," said Lisa Conte, Jaguar's president and CEO. "In
support of this goal, we're very pleased that Dr. Kelly Shanahan has joined our Scientific Advisory Board. As an independent patient
advocate, Dr. Shanahan shares our deep commitment to patient comfort and dignity, especially to the importance of preventing and
ameliorating noninfectious CTD."
is really powerful about crofelemer is that it is a pipeline within a product. Our key near-term clinical activity is our Phase 3 pivotal
OnTarget trial of crofelemer for the follow-on indication of prophylaxis of CTD. We
have completed patient enrollment for OnTarget, which is a key step on our journey to making crofelemer available to treat the neglected
comorbidity of CTD. The top line results from this pivotal study are expected in October 2023," said Conte.
The Company's current cash position
includes gross proceeds from a PIPE (private investment in public equity) transaction of approximately $1.86 million that closed last
week. The PIPE purchase agreement stipulates that during the period commencing on the signing of the agreement and ending on October 22,
2023 (a time period that extends to the expected release date of the primary endpoint for the OnTarget trial), the Company will not effect
or enter into any agreement to (i) issue securities in exchange for any securities of the Company issued and outstanding on the
date of the agreement pursuant to Section 3(a)(9) of the Securities Act of 1933, as amended, including ATM utilization or (ii) effect
issuance by the Company of common stock or common stock equivalents, subject to certain customary carve outs set forth in the agreement
or with the consent of holders of a majority of shares issued in the PIPE.
A new near-term Company development
goal focuses on microvillus inclusion disease-MVID-an ultra-rare pediatric CDD. MVID 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 is planning to submit an Investigational
New Drug application to the FDA for MVID in Q2 2023.
For the European market, MVID and other
CDD patients could potentially participate in revenue generating early access programs targeted for 2024. In accordance with the guidelines
of specific European Union countries, publications of data from proof-of-concept trials could support participation in early patient
access programs for crofelemer for CDD or SBS. Participation in early access programs, which do not exist in the United States, provides
an opportunity for reimbursement while impacting the morbidity and high cost of care for these chronic unmet needs.
2023 FIRST QUARTER COMPANY FINANCIAL
product net revenue was approximately $2.0 million in the first quarter of 2023, representing a decrease of 40% compared to prescription
product net revenue in the fourth quarter of 2022, which totaled approximately $3.3 million, and a decrease of approximately 25% over
prescription product net revenue in the first quarter of 2022, which totaled approximately $2.6 million.
| Three Months Ended | ||||||||||||||||
| Financial Highlights | March 31, | |||||||||||||||
| (in thousands, except per share amounts) | 2023 | 2022 | $ change | % change | ||||||||||||
| Net product revenue | $ | 1,972 | $ | 2,625 | (653 | ) | -25 | % | ||||||||
| Loss from operations | $ | (9,845 | ) | $ | (11,754 | ) | 1,909 | -16 | % | |||||||
| Net loss attributable to common stockholders | $ | (12,202 | ) | $ | (17,986 | ) | 5,784 | -32 | % | |||||||
| Net loss per share, basic and diluted | $ | (2.39 | ) | $ | (23.10 | ) | 21 | -90 | % |
| Three Months Ending | ||||||||
| March 31, | ||||||||
| (in thousands) | 2023 | 2022 | ||||||
| (unaudited) | ||||||||
| Net loss attributable to common stockholders | $ | (12,202 | ) | $ | (17,986 | ) | ||
| Adjustments: | ||||||||
| Interest expense | 2,181 | 4,194 | ||||||
| Property and equipment depreciation | 20 | 131 | ||||||
| Amortization of intangible assets | 484 | 422 | ||||||
| Share-based compensation expense | 480 | 1,063 | ||||||
| Income taxes | - | - | ||||||
| Non-GAAP EBITDA | (9,037 | ) | (12,177 | ) | ||||
| Loss on extinguishment of debt | - | 2,815 | ||||||
| Non-GAAP Recurring EBITDA | $ | (9,037 | ) | $ | (9,362 | ) |
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.
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, May 15,
2023, at 8:30 AM Eastern Time
Registration & Access Link: Click Here
of the webcast on the investor relations section of Jaguar's website: (click here)
is the only oral FDA approved 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, Jaguar Health's wholly owned U.S.
subsidiary, 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 Jaguar Health, Napo Pharmaceuticals,
Napo Therapeutics & Jaguar Animal Health
Health, Inc. is a commercial stage pharmaceuticals company focused on developing novel, plant-based, sustainably derived prescription
medicines for people and animals with GI distress, including chronic, debilitating diarrhea. Jaguar Health's wholly owned subsidiary,
Napo Pharmaceuticals, Inc., focuses on developing and commercializing proprietary plant-based human pharmaceuticals from plants
harvested responsibly from rainforest areas. Our crofelemer drug product candidate is the subject of the OnTarget study,
an ongoing pivotal Phase 3 clinical trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy. Jaguar Health
is the majority shareholder of Napo Therapeutics S.p.A. (f/k/a Napo EU S.p.A.), an Italian corporation established by Jaguar Health in
Milan, Italy in 2021 that focuses on expanding crofelemer access in Europe. Jaguar Animal Health is a tradename of Jaguar Health.
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.
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%).
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