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Jaguar Health Provides Company Updates and Reports 2022 Third Quarter Financials Prescription product net revenue of approximately $3.1 million in Q3 2022 increased 8.2% over Q2 2022 and increased approximately 412% over

Key Takeaway: Jaguar Health Provides Company Updates and Reports 2022 Third Quarter Financials Prescription product net revenue of approximately $3.1 million in Q3 2022 increased 8.2% over Q2 2022 and increased approximately 412% over prescription product net revenue in Q3 2021 Phase 3 cli

Full Press Release Details

Jaguar Health Provides Company Updates and Reports
2022 Third Quarter Financials
Prescription product net revenue of approximately
$3.1 million in Q3 2022 increased 8.2% over Q2 2022 and increased approximately 412% over prescription product net revenue in Q3 2021
Phase 3 clinical trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD) adding international sites,
targeting completion of enrollment in Q2 2023
of Phase 2 IIT study in peer reviewed journal Breast Cancer Research and Treatment
presentation in December 2022 from a third-party investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology,
Hepatology & Nutrition Division at Sheikh Khalifa Medical City in Abu Dhabi, following initiation of proof-of-concept trial of
crofelemer for short bowel syndrome (SBS) and congenital diarrheal disorders (CCD), supporting the potential for expanded patient access
through programs in Europe in 2023
conditional approval for Canalevia , for exercise-induced diarrhea (EID), expected in Q1 2023, adding to ongoing commercial
activities of Canalevia-CA1 for treatment of chemotherapy-induced diarrhea (CID) in dogs
development activities with nondilutive funding for Jaguar's mental health Entheogen Therapeutics Initiative (ETI) program targeted
Canine Cancer: Take C.H.A.R.G.E. Registry honored by the MarCom Awards program with two Platinum awards and one Gold award
REMINDER: Jaguar to host investor
webcast Monday, November 14th at 8:30 a.m. Eastern regarding third quarter 2022 financials and company updates; Click here
to register for webcast
SAN FRANCISCO, CA / November 14, 2022 / Jaguar Health, Inc.
(NASDAQ: JAGX) ("Jaguar" or the "Company") today provided Company updates and reported consolidated third-quarter
2022 financial results.
The combined net revenue for Mytesi and the Company's
other prescription product, Canalevia -CA1, which became commercially available in April 2022, was approximately $3.1
million in the third quarter of 2022, representing an increase of 8.2% over prescription product net revenue in the second quarter of
2022, which totaled approximately $2.9 million, and an increase of approximately 412% over Mytesi net revenue in the third quarter of
2021, which totaled approximately $0.6 million.
"We are very pleased that growth in Mytesi (crofelemer) revenue
continued for the fifth quarter in a row in the third quarter of 2022," said Lisa Conte, Jaguar's president and CEO. "As previously
announced, the transition we completed throughout the end of 2021 and into the beginning of 2022 to a limited distribution network of
specialty pharmacies resulted in a meaningful reduction in Mytesi distribution costs as well as a higher average net price. It is wonderful
to see Mytesi growth continuing following this transition and the other components of our Mytesi patient access program, including our
ongoing educational and promotional activities in 2022 and the launch this past May of our telehealth initiative for Mytesi. Most
importantly, we are pleased with the realization of our mission of providing relief with a novel, plant-based, first-in-class mechanism
of action to patients in need - including patients for whom no alternative therapeutic options exist."
"As I frequently state, what is really powerful about crofelemer
is that it is a pipeline within a product, and we are focused on two late-stage clinical events in the next approximately 6 to 9 months
that we expect to be transformational in terms of value creation and recognition for the Company. Our key near-term clinical activity
is our Phase 3 pivotal OnTarget trial of crofelemer for our core follow-on indication of prophylaxis of cancer therapy-related
diarrhea (CTD). We expect enrollment in this pivotal trial to complete in the second quarter of 2023," Conte said. "Our second
prioritized clinical program centers around our approved investigator-initiated proof-of-concept trial of crofelemer for short bowel
syndrome (SBS) and congenital diarrheal disorders (CDD). SBS and CDD are devastating and often catastrophic diseases for patients, who
are frequently on parenteral nutrition for as long as 20 hours a day, seven days a week. The third-party investigator is targeting a
presentation following the initiation of this proof-of-concept study at next month's World Congress of Gastroenterology -
a global GI conference in Dubai. Additional investigator-initiated requests and trials and clinical data for SBS and CDD are expected
to come throughout 2023. In accordance with the guidelines of specific European Union countries, publications of proof-of concept data
from these trials could support early patient access to crofelemer for SBS or CDD with intestinal failure within 2023 through programs
in Europe. Early access programs are revenue generating, and reimbursable for participating patients."
2022 MILESTONES, UPDATES & ACCOMPLISHMENTS:
2022 THIRD QUARTER COMPANY FINANCIAL RESULTS:
Prescription product net revenue was approximately $3.1 million in
the third quarter of 2022, representing an increase of 8.2% over prescription product net revenue in the second quarter of 2022, which
totaled approximately $2.9 million, and an increase of approximately 412% over prescription product net revenue in the third quarter of
2021, which totaled approximately $0.6 million.
"Mytesi total prescription volume increased approximately 3%
in the third quarter of 2022 over the second quarter of 2022," said Ian Wendt, Jaguar's Chief Commercial Officer. "As previously
announced, the transition we completed this past January to a limited distribution network of specialty pharmacies resulted in a
meaningful reduction in Mytesi distribution costs as well as a higher average net price. I am very pleased to report that we significantly
outperformed the industry gross-to-net average in the third quarter of 2022 - as we did in the three previous quarters - for
sales of our human prescription product. This improvement in our gross-to-net was largely a result of the efficiencies realized by the
transition to a closed network of specialty pharmacies. This transition assists in the preparation of the Company's U.S. commercial
distribution network for potential future indication expansion of crofelemer to other populations of patients with complex medical needs,
such as CTD, inflammatory bowel disease, and SBS."
The Company believes the availability of Mytesi through specialty pharmacies
represents a significant benefit to patients, as such pharmacies focus on complex and chronic conditions and offer a higher level of support
for prior authorizations, appeals, adherence reminders, counseling, and home delivery options.
Three Months Ended
Financial Highlights September 30,
(in thousands, except per share amounts) 2022 2021 $ change % change
Net product revenue $ 3,150 $ 630 2,520 400 %
Loss from operations $ (9,896 ) $ (9,529 ) (367 ) 4 %
Net loss $ (12,520 ) $ (12,192 ) (328 ) 3 %
Net loss per share, basic and diluted $ (0.12 ) $ (0.27 )
Three Months Ending
September 30,
(in thousands) 2022 2021
(unaudited)
Net loss $ (12,520 ) $ (12,192 )
Adjustments:
Interest expense 2,731 2,078
Property and equipment depreciation 15 8
Amortization of intangible assets 483 422
Share-based compensation expense 745 1,165
Income taxes - -
Non-GAAP EBITDA (8,546 ) (8,519 )
Non-GAAP Recurring EBITDA $ (8,546 ) $ (8,519 )
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: Monday, November 14, 2022, at 8:30
Participant Registration & Access Link:
Replay Instructions for Webcast
Replay of the webcast on the investor relations
section of Jaguar's website: (click here)
About Jaguar Health, Napo Pharmaceuticals, Napo Therapeutics &
Jaguar Animal Health
Jaguar Health, Inc. is a commercial stage pharmaceuticals company
focused on developing novel, plant-based, non-opioid, and 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.
For more information about Jaguar Health, please visit https://jaguar.health.
For more information about Napo Pharmaceuticals, visit www.napopharma.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,
Last updated: Nov 14, 2022