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 of 2021
Core initiatives:
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
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 $1.2 million.
"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.
Ongoing business development initiatives in 2022:
Updates about recent and currently active investigator-initiated trials of crofelemer:
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 $1.2 million.
"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 Time
Participant 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, & Napo Therapeutics
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.
About Mytesi®
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.
Important Safety Information About Canalevia®-CA1
For oral use in dogs only. Not for use in humans. Keep Canalevia-CA1 (crofelemer delayed-release tablets) in a secure location out of reach of children and other animals. Consult a physician in case of accidental ingestion by humans. Do not use in dogs that have a known hypersensitivity to crofelemer. Prior to using Canalevia-CA1, rule out infectious etiologies of diarrhea. Canalevia-CA1 is a conditionally approved drug indicated for the treatment of chemotherapy-induced diarrhea in dogs. The most common adverse reactions included decreased appetite, decreased activity, dehydration, abdominal pain, and vomiting.
Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Use only as directed. It is a violation of Federal law to use this product other than as directed in the labeling. Conditionally approved by FDA pending a full demonstration of effectiveness under application number 141-552.
See full Prescribing Information at Canalevia.com.
Forward-Looking Statements
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the Company's expectation that investigator-initiated proof-of-concept studies of crofelemer for SBS and CDD will be completed in 2022 and 2023, supporting the potential for expanded patient access through programs in Europe in 2023, Jaguar's expectation that these SBS- and CDD-related activities, as well as completion of enrollment for the Phase 3 pivotal OnTarget trial in the U.S., will be value-creating in the next 12-15 months, the Company's expectation that Canalevia may receive conditional approval for treatment of EID in dogs in the fourth quarter of 2022, the Company's expectation that growth in sales of Mytesi will continue, Jaguar's expectation that ODD status in the EU for crofelemer for SBS will support Napo Therapeutics' plans to make crofelemer available through Early Access Programs in the EU for SBS and that participation in Early Access Programs will provide a potential opportunity for meaningful revenue generation in addition to the ability to impact important morbidity, mortality, and the cost of care for chronically ill patients, Jaguar's expectation that the Company will file an IND application with the FDA for lechlemer in mid-2022 in support of the initiation of a Phase 1 lechlemer study in 2H 2022 for the symptomatic relief of diarrhea from cholera, the Company's plans to pursue a tropical disease priority review voucher from the FDA for lechlemer for the symptomatic relief of diarrhea from cholera, the expectation that Jaguar will exhibit at the June 2022 ACVIM Forum in Austin, the expectation that a special media event and performance event will be held in New York City on May 23 , 2022 to celebrate the launch of the Jaguar Health Canine Cancer: Take C.H.A.R.G.E. initiative, the expectation that data from the Take C.H.A.R.G.E. initiative may provide insights to help better understand cancer in humans and the importance of managing side effects in human cancer therapy, the expectation that the full results of the HALT-D trial will be submitted to a medical journal in 2022 for consideration for publication, and the expectation that Jaguar will host an investor webcast on May 10, 2022. 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 "continue" or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar's control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
1 Pablo C. Okhuysen, M.D., The impact of cancer-related diarrhea on changes in cancer therapy patterns: Real world evidence
2 Eric Roeland, M.D., FAAHPM, Healthcare utilization and costs associated with cancer-related diarrhea
4 http://www.pharmabiz.com/NewsDetails.aspx?aid=84221&sid=2
Contact:
Peter Hodge
Jaguar Health, Inc.
This email address is being protected from spambots. You need JavaScript enabled to view it.
Jaguar-JAGX
Last Trade: | US$0.96 |
Daily Change: | 0.09 9.95 |
Daily Volume: | 556,029 |
Market Cap: | US$11.330M |
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