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Jaguar Health Reports 2021 Third Quarter Financial Results Mytesi prescription volume increased 7.6% in Q3 2021 over Q2 2021 Third quarter 2021 Mytesi net and gross sales were approximately $0.6 million and approximately

Key Takeaway: Reports 2021 Third Quarter Financial Results prescription volume increased 7.6% in Q3 2021 over Q2 2021 2021 Mytesi net and gross sales were approximately $0.6 million and approximately $3.2 million to complete transition to selling Mytesi through closed specialty pharmacy net

Full Press Release Details

Reports 2021 Third Quarter Financial Results
prescription volume increased 7.6% in Q3 2021 over Q2 2021
2021 Mytesi net and gross sales were approximately $0.6 million and approximately $3.2 million
to complete transition to selling Mytesi through closed specialty pharmacy network by end of 2021 as part of Company's market access
2021 milestones: Presentation of Phase 2 HALT-D study results at San Antonio Breast Cancer Symposium & launch of Canalevia -CA1
for chemotherapy-induced diarrhea in dogs
Jaguar to host investor webcast today (Wednesday, November 17th) at 8:30 a.m. Eastern regarding third quarter 2021
financials & business updates; Click here to register for webcast
SAN FRANCISCO, CA / November 17,
2021 / Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar" or the "Company") today reported consolidated third
quarter 2021 financial results.
Mytesi (crofelemer) prescription volume,
the metric the Company believes to be the best indicator of patient demand, increased 7.6% in the third quarter of 2021 over the second
quarter of 2021, and new Mytesi prescriptions increased 9.0% during the same period. Mytesi total prescription volume remained the same
in the third quarter of 2021 over the third quarter of 2020 and new Mytesi prescriptions increased by 10.5% during the same period. Prescription
volume differs from invoiced sales volume.
As previously announced, the Company
is in the process of transitioning a substantial amount of Mytesi volume to a closed network of specialty pharmacies (rather than to
wholesalers that resell the product to retail pharmacies) by the end of 2021. This transition results in an underrepresentation of Mytesi
utilization, as revenue related to wholesaler inventory has already been recognized by Jaguar, and that inventory has now been brought
down. A key component of the Company's market access strategy, this initiative is intended to help remove access barriers for patients
receiving Mytesi, and includes services such as a higher level of support for prior authorizations, appeals, adherence counseling, and
home delivery options. While patients often visit retail pharmacies for short-term or uncomplicated medical needs, specialty pharmacies
focus on serving patients with complex and chronic medical conditions like HIV. The transition to a closed network of specialty pharmacies
is expected to result in a meaningful reduction in Mytesi distribution costs and prepares the Company's U.S. commercial distribution
network for future indication expansion of crofelemer to other populations of patients with complex medical needs.
Clinical & Product Development
2021 Third Quarter Company Financial
Three months Ended
Financial Highlights September 30,
(in thousands) 2021 2020 $ change % change
Gross product sales
Mytesi $ 3,184 $ 6,303 $ (3,119 ) -49 %
Neonorm 15 13 2 15 %
Total gross product 3,199 6,316 (3,117 ) -49 %
Medicare rebates (449 ) (588 ) 139 -24 %
Sales discounts (1,599 ) (2,218 ) 619 -28 %
Sales returns (36 ) (107 ) 71 -66 %
Wholesaler fee (485 ) (630 ) 145 -23 %
Net product sales $ 630 $ 2,773 $ (2,143 ) -77 %
Three Months Ended
Financial Highlights September 30,
(in thousands, except per share amounts) 2021 2020 $ change % change
Net product revenue $ 630 $ 2,773 (2,143 ) -77 %
Loss from operations $ (9,529 ) $ (5,375 ) (4,154 ) 77 %
Net loss attributable to common shareholders $ (12,192 ) $ (8,271 ) (3,921 ) 47 %
Net loss per share, basic and diluted $ (0.27 ) (0.62 ) 0.35 -56 %
Three Months Ended
September 30,
(in thousands) 2021 2020
(unaudited)
Net loss $ (12,192 ) $ (7,866 )
Adjustments:
Interest expense 2,078 581
Property and equipment depreciation 8 11
Amortization of intangible assets 422 422
Share-based compensation expense 1,165 675
Income taxes - -
Non-GAAP EBITDA (8,519 ) (6,177 )
Series 3 warrants inducement expense - -
Non-GAAP Recurring EBITDA $ (8,519 ) $ (6,177 )
Note Regarding Use of Non-GAAP Measures
The Company supplements its condensed
consolidated financial statements presented on a GAAP basis by providing gross sales, 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 reflets 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.
Gross sales percentages issued by the
Company are based on gross sales figures that represent Mytesi orders placed by wholesalers with Jaguar's third-party logistics
warehouse, less allowances for rebates, chargebacks, and discounts, which generate the cash flows for Napo Pharmaceuticals, Inc. ("Napo"),
Jaguar's wholly owned subsidiary. Gross sales are used internally by management as an indicator of and to monitor operating performance,
including sales performance of Mytesi, salesperson performance, and product growth or declines. The Company believes that the presentation
of gross sales provides a closer to real-time useful measure of our operating performance. Gross sales are not a measure that is recognized
under accounting principles generally accepted in the United States of America ("GAAP") and should not be considered as an
alternative to net sales, which is determined in accordance with GAAP, and should not be used alone as an indicator of operating performance
in place of net sales. Additionally, gross sales may not be comparable to similarly titled measures used by other companies, as gross
sales have been defined by the Company's internal reporting practices. In addition, gross sales may not be realized in the form
of cash receipts as promotional payments and allowances may be deducted from payments received from certain customers. Mytesi gross sales
are reduced by Medicare, ADAP 340B chargebacks, returns, and wholesale distribution fees based on historical trends to determine net
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 Today's
When: Wednesday, November 17, 2021,
at 8:30 AM Eastern Time
Participant Registration & Access
Replay Instructions for Webcast
Replay of the webcast on the investor
relations section of Jaguar's website: (click here)
About Jaguar Health, Inc., Napo Pharmaceuticals,
Inc. & Napo EU S.p.A.
Jaguar Health, Inc. is a commercial
stage pharmaceuticals company focused on developing novel, plant-based, non-opioid, and sustainably derived prescription medicines for
GI distress, specifically chronic, debilitating diarrhea. Our wholly owned subsidiary, Napo Pharmaceuticals, Inc., focuses on developing
and commercializing proprietary plant-based human gastrointestinal pharmaceuticals from plants harvested responsibly from rainforest
areas. Our Mytesi (crofelemer) product is approved by the U.S. FDA for the symptomatic relief of noninfectious diarrhea
in adults with HIV/AIDS on antiretroviral therapy and the only oral plant-based prescription medicine approved under FDA Botanical Guidance.
Crofelemer 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. Napo EU S.p.A., the majority owned Italian subsidiary of Napo Pharmaceuticals, focuses on expanding
crofelemer access in Europe.
For more information about Jaguar, please
visit https://jaguar.health. For more information about Napo Pharmaceuticals, visit www.napopharma.com. For more information about Napo
EU, visit www.napoeu.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.
Forward-Looking Statements
Certain statements in this press
release constitute "forward-looking statements." These include statements regarding the Company's expectation that
essentially a full transition to Mytesi prescriptions being dispensed through specialty pharmacies will be complete by the end of
2021, the expectation that results of the Phase 2 HALT-D study will be presented at the San Antonio Breast Cancer Symposium in
December 2021, the Company's expectation that the conditional approval and launch of Canalevia -CA1 for CID
in dogs will take place in late-December 2021, the expectation that a final decision about ODD for crofelemer for SBS in the EU may
occur within the next 30 days, the expectation that Jaguar will host an investor webcast on November 17, 2021, the Company's
expectation that the transition to a closed network of specialty pharmacies will result in a meaningful reduction in Mytesi
distribution costs, and the Company's plans to grow the Napo EU team in Italy. In some cases, you can identify forward-looking
statements by terms such as "may," "will," "should," "expect," "plan,"
"aim," "anticipate," "could," "intend," "target," "project,"
"contemplate," "believe," "estimate," "predict," "potential" or
Last updated: Nov 17, 2021