Full Press Release Details
Jaguar Health Provides Company Updates and Reports
2022 First Quarter Financials
Mytesi net revenue of $2.6 million
increased approximately 24% over the fourth quarter of 2021 and increased approximately 112% over Mytesi net revenue in the first quarter
Phase 3 clinical trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD) adding international sites, targeting completion
of enrollment 1H 2023
Targeted completion in 2022 & 2023 of investigator-initiated proof-of-concept studies of crofelemer for short bowel syndrome and
congenital diarrheal disorders, supporting the potential for expanded patient access through programs in Europe in 2023
Ongoing launch of Canalevia -CA1, which is now commercially available for treatment of chemotherapy-induced diarrhea
REMINDER: Jaguar to host investor
webcast Tuesday, May 10th at 8:30 a.m. Eastern regarding first quarter 2022 financials and company updates; Click here
to register for webcast
SAN FRANCISCO, CA / May 10, 2022 / Jaguar Health, Inc.
(NASDAQ: JAGX) ("Jaguar" or the "Company") today provided company updates and reported consolidated first quarter
2022 financial results.
Mytesi net revenue was approximately $2.6 million in the first quarter
of 2022, representing an increase of approximately 24% over Mytesi net revenue in the fourth quarter of 2021, which totaled approximately
$2.1 million, and an increase of approximately 112% over Mytesi net revenue in the first quarter of 2021, which totaled approximately
"These increases in Mytesi revenue largely represent the important
and continuing realization of the benefits - from both a financial perspective and the standpoint of improved patient access -
from the shift Jaguar completed this past January to distributing Mytesi through a closed network of specialty pharmacies (rather than
to wholesalers that resell the product to retail pharmacies). I am also pleased to announce that Canalevia-CA1 (crofelemer), our prescription
product for chemotherapy-induced diarrhea (CID) in dogs, is now commercially available," said Lisa Conte, Jaguar's president and
CEO. "Regarding future commercial opportunities, Jaguar is focused on two important crofelemer pipeline development activities
in the next 12-15 months that are expected to be value-creating: the completion of enrollment for our Phase 3 pivotal OnTarget
trial of our core follow-on indication for crofelemer's novel mechanism of action, prophylaxis of cancer therapy-related diarrhea
(CTD) in humans; and the completion in 2022 and 2023 of investigator-initiated proof-of-concept studies of crofelemer for short bowel
syndrome (SBS) and congenital diarrheal disorders (CDD), supporting the potential for expanded patient access through programs in Europe
in 2023 for these devastating and catastrophic diseases and health situations for these patients, who are often on parenteral nutrition
for as long as 20 hours a day, seven days a week."
2022 MILESTONES, UPDATES & ACCOMPLISHMENTS:
"We look forward to 2022 continuing to be an exciting year, with
continued development initiatives for crofelemer - our pipeline within a product'; continuing efforts to forge license
and business development relationships, such as the recently completed license and distribution deal with Quadri Pharma for the MENA region;
our ongoing Canalevia-CA1 launch, and potential expansion of Canalevia conditional approval to exercise-induced diarrhea (EID) in dogs;
and continued growth in sales of Mytesi, with the successful completion of the shift to our specialty pharmacies distribution and continued
educational and promotional activities in 2022, including the recent launch of our telehealth initiative. 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," Conte said.
2022 FIRST QUARTER COMPANY FINANCIAL RESULTS:
Mytesi net revenue was approximately $2.6 million in the first quarter
of 2022, representing an increase of approximately 24% over Mytesi net revenue in the fourth quarter of 2021, which totaled approximately
$2.1 million, and an increase of approximately 112% over Mytesi net revenue in the first quarter of 2021, which totaled approximately
"Mytesi total prescription volume, the metric we believe to be
the best indicator of patient demand, increased 14.6% in the first quarter of 2022 over the fourth quarter of 2021," said Ian Wendt,
Jaguar's Chief Commercial Officer. "As previously announced, the transition to a closed network of specialty pharmacies has resulted
in a meaningful reduction in Mytesi distribution costs as well as a higher average net price and 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 and SBS. This transition has also allowed us to begin utilizing sales and prescription data directly provided
by our network of specialty pharmacies to more accurately track prescription volume, rather than relying on a third-party provider of
estimated data for this important performance metric."
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 counseling, and home delivery options.
| Three Months Ended | ||||||||||||||||
| Financial Highlights (in thousands) | March 31, | |||||||||||||||
| Gross product sales | 2022 | 2021 | $ change | % change | ||||||||||||
| Mytesi | $ | 3,395 | $ | 4,558 | $ | (1,163 | ) | -25.5 | % | |||||||
| Neonorm | 20 | 33 | (13 | ) | -39.4 | % | ||||||||||
| Canalevia | 44 | - | 44 | 100.0 | % | |||||||||||
| Total gross product sales | 3,459 | 4,591 | (1,132 | ) | -24.7 | % | ||||||||||
| Medicare rebates | (504 | ) | (1,097 | ) | 593 | -54.1 | % | |||||||||
| Sales discounts | (320 | ) | (1,732 | ) | 1,412 | -81.5 | % | |||||||||
| Sales returns | (10 | ) | (20 | ) | 10 | -50.0 | % | |||||||||
| Wholesaler fee | - | (501 | ) | 501 | -100.0 | % | ||||||||||
| Net product sales | $ | 2,625 | $ | 1,241 | $ | 1,384 | 111.5 | % |
| Three Months Ended | ||||||||||||||||
| Financial Highlights | March 31, | |||||||||||||||
| (in thousands, except per share amounts) | 2022 | 2021 | $ change | % change | ||||||||||||
| Net product revenue | $ | 2,625 | $ | 1,241 | 1,384 | 111.5 | % | |||||||||
| Loss from operations | $ | (11,754 | ) | $ | (8,766 | ) | (2,988 | ) | 34.1 | % | ||||||
| Net loss attributable to common shareholders | $ | (17,986 | ) | $ | (12,009 | ) | (5,977 | ) | 49.8 | % | ||||||
| Net loss per share, basic and diluted | $ | (0.40 | ) | $ | (0.28 | ) | (0.12 | ) | 42.9 | % |
| Three Months Ending | ||||||||
| March 31, | ||||||||
| (in thousands) | 2022 | 2021 | ||||||
| (unaudited) | ||||||||
| Net loss attributable to common shareholders | $ | (17,986 | ) | $ | (12,009 | ) | ||
| Adjustments: | ||||||||
| Interest expense | 4,194 | 1,901 | ||||||
| Property and equipment depreciation | 131 | 9 | ||||||
| Amortization of intangible assets | 422 | 422 | ||||||
| Share-based compensation expense | 1,063 | 634 | ||||||
| Non-GAAP EBITDA | (12,176 | ) | (9,043 | ) | ||||
| Loss on extinguishment of debt | 2,815 | 753 | ||||||
| Series 3 warrants inducement expense | - | 1,462 | ||||||
| Non-GAAP Recurring EBITDA | $ | (9,361 | ) | $ | (6,828 | ) |
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 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.
Gross sales percentages issued by the Company are based on gross sales
figures that represent Mytesi orders placed by select Specialty Pharmacies with Jaguar's third-party logistics warehouse, less allowances
for rebates 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. 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
specialty pharmacy discounts, Medicare rebates, Medicaid rebates, 340B discounts, ADAP rebates, VA rebates, copay program costs, prompt
pay discounts, and returns based on historical trends to determine net sales.
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: Tuesday, May 10, 2022, at 8:30 AM Eastern
Participant Registration & Access Link: Click
Replay Instructions for Webcast
Replay of the webcast on the investor relations
section of Jaguar's website: (click here)
About Jaguar Health, Jaguar Animal Health, Napo Pharmaceuticals,
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 Animal Health is a tradename of Jaguar Health. 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.
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