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Jaguar Health Reports 2022 Financial Results - Prescription Revenues up 179% to $11.9 Million Prescription product net revenue was approximately $11.9 million for the year ended

Key Takeaway: Jaguar Health, Inc. reported significant growth in prescription revenues for the year ended December 31, 2022, with an increase of approximately 178.7% compared to the previous year, totaling around $11.9 million. Patient enrollment in the Phase 3 OnTarget trial of crofelemer reached 80%, with completion expected in the second quarter of 2023. The company is also planning to launch proof-of-concept studies for crofelemer in 2023 targeting short bowel syndrome and congenital diarrheal disorders. However, total prescription volume for Mytesi slightly decreased, and the company reported a net loss of $48.4 million for the year.

Market Sentiment Analysis

POSITIVE FACTORS

  • Prescription revenues increased by 178.7% in 2022, reaching approximately $11.9 million.
  • Positive patient enrollment progress in the Phase 3 OnTarget trial for crofelemer.
  • Jaguar is planning additional proof-of-concept studies for crofelemer in 2023 for short bowel syndrome and congenital diarrheal disorders.

CONCERNS & RISKS

  • Despite increased revenue, Mytesi's total prescription volume slightly decreased by approximately 2% in the most recent quarter.
  • The company reported a net loss of $48.4 million in 2022, although this was an improvement from 2021.

Full Press Release Details

Reports 2022 Financial Results - Prescription Revenues up 179% to $11.9 Million
product net revenue was approximately $11.9 million for the year ended December 31, 2022 versus approximately $4.3 million for the
year ended December 31, 2021, an increase of 178.7%.
product net revenue of approximately $3.3 million in Q4 2022 increased 3.4% over Q3 2022 and increased approximately 57% over prescription
product net revenue in Q4 2021.
2023, the filing date of Jaguar's annual report on Form 10-K for the year 2022, the Company's cash position was approximately
Patient enrollment in OnTarget
Phase 3 clinical trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD) is now at approximately 80% and
expected to complete in Q2 2023.
planning to support investigator-initiated proof-of-concept (POC) studies of crofelemer in 2023 for short bowel syndrome (SBS) with intestinal
failure and congenital diarrheal disorders (CDD). POC targeted for 2H 2023 in support of potential early patient access in Europe, potentially
Company plans to submit an Investigational New Drug (IND) application in Q2 2023 to FDA for crofelemer for microvillus inclusion disease,
a rare CDD condition, for which Orphan Drug Designation has been granted by both the FDA and European Medicines Agency.
Jaguar to host investor webcast Monday, March 27th at 8:00 a.m. Eastern regarding
2022 financials and company updates; Click here to register for webcast.
FRANCISCO, CA / March 27, 2023 / Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar"
or the "Company") today provided Company updates and reported consolidated financial results for the year ended December 31,
combined net revenue for Mytesi and the Company's other crofelemer prescription product, Canalevia -CA1,
which became commercially available in April 2022, was approximately $11.9 million in the year 2022, representing an increase of
178.7% over the combined net revenue in the year 2021, which totaled $4.3 million. The combined net revenue for Mytesi and Canalevia-CA1
was approximately $3.3 million in the fourth quarter of 2022, representing an increase of 3.4% over prescription product net revenue
in the third quarter of 2022, which totaled approximately $3.1 million, and an increase of approximately 57.0% over prescription product
net revenue in the fourth quarter of 2021, which totaled approximately $2.1 million.
"We are very pleased that growth
in Mytesi revenue continued for the sixth quarter in a row in the fourth 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 continuing to grow following this transition and the successful implementation of our Mytesi
patient access programs, including our ongoing disease state education and promotional activities. 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."
I frequently state, what 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 our novel botanical drug, crofelemer, for
our core follow-on indication of prophylaxis of cancer therapy-related diarrhea (CTD). Our efforts over the past year to expand the OnTarget
trial to new U.S. and international sites - with trial sites now active in Eastern Europe - in both Georgia and the Republic
of Serbia - as well as in Argentina and Taiwan - have significantly accelerated patient enrollment. As announced, enrollment
reached approximately 75% one month ago. Enrollment is now at approximately 80%, and target trial enrollment of 256 patients is expected
to complete in the second quarter of 2023, which is just around the corner," Conte said.
The Company's second prioritized
clinical program centers around our approved investigator-initiated proof-of-concept trial of crofelemer for short bowel syndrome with
intestinal failure (SBS-IF) and for microvillus inclusion disease (MVID), a rare congenital diarrheal disorder (CDD). SBS-IF and MVID
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. Jaguar and the company it established in Europe, Napo Therapeutics, are planning to support investigator-initiated
proof-of-concept studies of crofelemer in patients with SBS-IF or MVID, focused on obtaining proof-of-concept (POC) of reduction of requirements
of parenteral support including parenteral nutrition and/or intravenous fluids, in 2023. In accordance with the guidelines of specific
European Union countries, publications of POC data from these trials could support early patient access to crofelemer for SBS-IF or MVID
through programs in Europe. Early access programs are revenue generating, and reimbursable for participating patients.
COMPANY MILESTONES, UPDATES &
COMPANY FINANCIAL RESULTS FOR THE
YEAR ENDED DECEMBER 31, 2022:
"As previously announced, the
transition we completed in January 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," Ian Wendt, Jaguar's Chief Commercial Officer, stated.
"I am very pleased to report that we significantly outperformed the industry gross-to-net average in the fourth quarter of 2022
- as we did in the four 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. While Mytesi net revenue
increased by 3.0% in the fourth quarter of 2022 over the third quarter of 2022, Mytesi total prescription volume decreased slightly by
approximately 2% in this time period. This transition to specialty pharmacy distribution also 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
The transition to a limited
distribution network of specialty pharmacies, which was completed in January 2022, resulted in a meaningful reduction in Mytesi
distribution costs and a higher average net price. As part of the process of transitioning to the closed specialty pharmacy network,
the third and fourth quarters of 2021 were significantly impacted by the inventory draw-down of approximately 1,300 bottles of Mytesi
across the Company's third-party logistics warehouse, wholesalers, distributors, and retail stores.
Year Ended
Financial Highlights (in thousands) December 31,
(in thousands, except per share amounts) 2022 2021 $ change % change
Net product revenue $ 11,956 $ 4,335 7,621 175.8 %
Loss from operations $ (34,415 ) $ (40,708 ) 6,293 -15.5 %
Net loss $ (48,395 ) $ (52,600 ) 4,205 -8.0 %
Net loss per share, basic and diluted $ (36.18 ) $ (88.22 ) 52 -59.0 %
Year Ended
December 31,
(in thousands) 2022 2021
Net loss $ (48,395 ) $ (52,595 )
Adjustments:
Interest expense 12,723 8,421
Property and equipment depreciation 171 40
Amortization of intangible assets 1,687 1,687
Stock based Compensation 3,318 3,974
Warrant Inducement Expense - 172
Non-GAAP EBITDA (30,496 ) (38,301 )
Loss on extinguishment of debt 2,187 753
Non-GAAP Recurring EBITDA $ (28,309 ) $ (37,548 )
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, March 27,
2023, at 8:00 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.

Frequently Asked Questions

What was Jaguar's prescription revenue growth in 2022?

Jaguar's prescription revenues in 2022 grew by 178.7%, reaching approximately $11.9 million.

What is the status of the OnTarget clinical trial?

Enrollment in the OnTarget trial for crofelemer has reached about 80% and is expected to complete by mid-2023.

What supports Jaguar's Mytesi revenue growth?

Mytesi's revenue growth is driven by a transition to specialty pharmacies, enhancing distribution efficiency.

When does Jaguar plan to submit an IND application?

Jaguar plans to submit an IND application for crofelemer in Q2 2023.

What financial challenges did Jaguar face in 2022?

Jaguar reported a net loss of $48.4 million in 2022, a decrease compared to the previous year.

Last updated: Mar 27, 2023