Full Press Release Details
Provides Company Updates and
Reports 2021 Financials
Core 2022 development initiatives:
operation of Company's OnTarget Phase 3 clinical trial of crofelemer for prophylaxis
of cancer therapy-related diarrhea (CTD)
and completion in 2H 2022 of investigator-initiated proof-of-concept study of
crofelemer for short bowel syndrome with intestinal failure
FDA conditional approval of Canalevia -CA1
for treatment of chemotherapy-induced diarrhea (CID) in
Fourth quarter 2021 Mytesi net revenue was approximately
$2.1 million versus approximately $0.6
million in the third quarter of 2021, an increase of 230%
Jaguar to host investor webcast Monday, March 14th at 8:30 a.m. Eastern regarding 2021
financials and company updates;
Click here to register for webcast
FRANCISCO, CA / March 11, 2022 / Jaguar Health, Inc. (NASDAQ: JAGX) ("Jaguar" or the "Company")
today provided company updates and reported consolidated financial results for the year ended December 31, 2021.
"2021 was a year of transition and progress for Jaguar's
plant-based drug pipeline for human health," said Lisa Conte, the Company's president and CEO, "as we continued enrollment
in our OnTarget Phase 3 clinical trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD) and advanced this key pipeline
initiative with the presentation at December's San Antonio Breast Cancer Symposium of Phase 2 crofelemer data for prophylaxis in chemotherapy-related
diarrhea; received Orphan Drug Designation in the European Union for crofelemer for short bowel syndrome; formed Napo Therapeutics in
Milan, Italy, which was subsequently funded as a result of the merger of Napo Therapeutics with Milan-based Dragon SPAC S.p.A. and
for which Jaguar Health is the majority shareholder; and completed a license agreement with Napo Therapeutics for exclusive rights to
crofelemer and lechlemer in Europe. In December we also excitingly and importantly received FDA conditional approval for Canalevia-CA1
(crofelemer) for treatment of chemotherapy-induced diarrhea (CID) in dogs."
2022 UPDATES, YEAR-TO-DATE ACCOMPLISHMENTS, AND MILESTONES:
"We look forward to 2022 being an exciting year with the continued
development of crofelemer - our pipeline within a product'; continuing efforts to forge license and business development
relationships; our continuing Canalevia-CA1 launch and continued sales of Mytesi ; and, most importantly, providing relief
with a novel first-in-class mechanism of action to patients in need - including patients for whom no alternative therapeutic options
Core 2022 Initiatives & Milestones:
"As of March 11, 2022, the filing date of Jaguar's
annual report on Form 10-K for the year 2021, the Company's cash position was approximately $18.5 million, and the Company
had a public float exceeding $75 million. Therefore, the Company remains "shelf eligible," said Conte. "There are benefits
of having a shelf registration statement on Form S-3 in place, rather than a registration statement on S-1. At present, we have continuing
flexibility to issue registered shares quickly and opportunistically, including in connection with potential future business transactions
such as asset acquisitions, purchases of product, payments for services, and license deals, and we are pleased with the flexibility the
ATM financing program provides."
COMPANY FINANCIAL RESULTS FOR THE YEAR ENDED DECEMBER 31, 2021:
"Fourth quarter 2021 Mytesi net revenue was approximately $2.1
million versus approximately $0.6 million in the third quarter of 2021. This increase of 230%, or $1.5 million, largely represents the
important realization of the benefits - from both a financial perspective and the standpoint of improved patient access -
from Jaguar's shift to distributing Mytesi through a closed network of specialty pharmacies," said Conte. "The process
of transitioning to a closed network of specialty pharmacies resulted in a one-time, short-term underrepresentation of Mytesi utilization.
As anticipated, Mytesi revenue, primarily in the third and fourth quarters of 2021, was impacted by this transition as wholesalers in
the retail distribution channel drew down their inventory of typically more than two-month's volume. Our closed network of specialty
pharmacies typically orders on a just-in-time inventory business model."
am pleased to report that the Company completed the process of transitioning its Mytesi volume to a closed network of specialty pharmacies
(rather than to wholesalers that resell the product to retail pharmacies) this past January," said Ian Wendt, Jaguar's
Chief Commercial Officer, "and that no significant Mytesi inventory is left in the retail distribution channel. Mytesi new prescription
volume, the metric we believe to be the best indicator of growth in patient demand, increased 10.4% in the fourth quarter of 2021 over
the third quarter of 2021, and increased by 2.1% in the year 2021 over the year 2020. The transition to a closed network of specialty
pharmacies has resulted in a meaningful reduction in Mytesi distribution costs and 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."
| Year Ended | ||||||||||||||||
| December 31, | ||||||||||||||||
| Financial Highlights (in thousands) | 2021 | 2020 | $ change | % change | ||||||||||||
| Gross product sales | ||||||||||||||||
| Mytesi | $ | 15,657 | $ | 20,434 | $ | (4,777 | ) | -23.4 | % | |||||||
| Neonorm | 62 | 77 | (15 | ) | -19.5 | % | ||||||||||
| Total gross product sales | 15,719 | 20,511 | (4,792 | ) | -23.4 | % | ||||||||||
| Medicare rebates | (3,484 | ) | (1,738 | ) | (1,746 | ) | 100.5 | % | ||||||||
| Sales discounts | (6,268 | ) | (7,046 | ) | 778 | -11.0 | % | |||||||||
| Sales returns | (104 | ) | (273 | ) | 169 | -61.9 | % | |||||||||
| Wholesaler fee | (1,528 | ) | (2,069 | ) | 541 | -26.1 | % | |||||||||
| Net product sales | $ | 4,335 | $ | 9,385 | $ | (5,050 | ) | -53.8 | % |
| Year Ended | ||||||||||||||||
| Financial Highlights | December 31, | |||||||||||||||
| (in thousands, except per share amounts) | 2021 | 2020 | $ change | % change | ||||||||||||
| Net product revenue | $ | 4,335 | $ | 9,385 | (5,050 | ) | -53.8 | % | ||||||||
| Loss from operations | $ | (40,708 | ) | $ | (26,647 | ) | (14,061 | ) | 52.8 | % | ||||||
| Net loss | $ | (52,600 | ) | $ | (33,809 | ) | (18,791 | ) | 55.6 | % | ||||||
| Net loss per share, basic and diluted | $ | (1.18 | ) | $ | (3.00 | ) | 2 | -60.7 | % |
| Year Ended | ||||||||
| December 31, | ||||||||
| (in thousands) | 2021 | 2020 | ||||||
| (unaudited) | ||||||||
| Net loss | $ | (52,595 | ) | $ | (33,809 | ) | ||
| Adjustments: | ||||||||
| Interest expense | 8,421 | 2,792 | ||||||
| Property and equipment depreciation | 40 | 41 | ||||||
| Amortization of intangible assets | 1,687 | 1,687 | ||||||
| Share-based compensation expense | 3,974 | 2,824 | ||||||
| Income taxes | - | - | ||||||
| Non-GAAP EBITDA | (38,473 | ) | (26,465 | ) | ||||
| Impairment of indefinite-lived intangible assets | - | 78 | ||||||
| Warrant inducement expense | 172 | |||||||
| Loss on extinguishment of debt | 753 | 1,864 | ||||||
| Distribution fees from former distributor | - | 227 | ||||||
| Non-GAAP recurring EBITDA | $ | (37,548 | ) | $ | (24,296 | ) |
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.
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 sales.
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, March 14, 2022, at 8:30 AM
Registration & Access Link: Click Here
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. For more information about Napo Therapeutics, visit www.napotherapeutics.com.