Prescription product net revenue of $2.9 million in Q2 2022 increased approximately 12.0% Quarter over Quarter, over Q1 2022; and increased approximately 641% Year over Year, over Mytesi® net revenue in Q2 2021
Core initiatives:
Jaguar Health, Inc. (NASDAQ:JAGX) ("Jaguar" or the "Company") today provided Company updates and reported consolidated second-quarter 2022 financial results.
Prescription product net revenue was approximately $2.9 million in the second quarter of 2022, representing an increase of approximately 12% over Mytesi net revenue in the first quarter of 2022, which totaled approximately $2.6 million, and an increase of approximately 641% over Mytesi net revenue in the second quarter of 2021, which totaled approximately $0.4 million.
"We are very pleased that growth in Mytesi (crofelemer) revenue continued in the second quarter of 2022," said Lisa Conte, Jaguar's president and CEO. "We completed the full shift this past January to a patient access strategy that involves transitioning to a limited distribution network of specialty pharmacies, which reduced our distribution costs and improved our Mytesi gross-to-net ratio dramatically. It is wonderful to see Mytesi growth continuing following this transition and the other components of our Mytesi patient access program, including our ongoing educational and promotional activities in 2022 and the launch this past May of our telehealth initiative for Mytesi. 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."
"Jaguar is focused on two late-stage clinical events in the next approximately 6 to 12 months that we expect to be transformational in terms of value creation and recognition for the Company. We anticipate the completion in 2022 of an investigator-initiated proof-of-concept study of crofelemer for short bowel syndrome (SBS), supporting the potential for expanded patient access to crofelemer in Europe in 2023 for this devastating and often catastrophic disease for these patients, who are frequently on parenteral nutrition for as long as 20 hours a day, seven days a week. The third-party investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City, is targeting the presentation in December 2022 of results from the SBS study at a global GI conference in Dubai. Our second key clinical activity is our Phase 3 pivotal OnTarget trial of crofelemer for our core follow-on indication of prophylaxis of cancer therapy-related diarrhea (CTD). We expect enrollment in this pivotal trial to complete in the first half of 2023," Conte said.
2022 MILESTONES, UPDATES & ACCOMPLISHMENTS:
Ongoing business development initiatives in 2022:
Updates about recent and currently active investigator-initiated trials of crofelemer:
2022 SECOND QUARTER COMPANY FINANCIAL RESULTS:
Prescription product net revenue was approximately $2.9 million in the second quarter of 2022, representing an increase of approximately 12% over Mytesi net revenue in the first quarter of 2022, which totaled approximately $2.6 million, and an increase of approximately 641% over Mytesi net revenue in the second quarter of 2021, which totaled approximately $0.4 million.
"Mytesi total prescription volume increased 8.2% in the second quarter of 2022 over the first quarter of 2022," said Ian Wendt, Jaguar's Chief Commercial Officer. "As previously announced, the transition we completed this past January 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. I am very pleased to report that we significantly outperformed the industry gross-to-net average in the second quarter of 2022 - as we did in both of the two 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. This transition 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. Additionally, the transition has allowed us to begin utilizing sales and prescription data directly provided by our network of specialty pharmacies to more accurately track prescription metrics."
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 and counseling, and home delivery options.
Three Months Ended | ||||||||||||||||
Financial Highlights (in thousands) | June 30, | |||||||||||||||
Gross product sales | 2022 | 2021 | $ change | % change | ||||||||||||
Mytesi | $ | 3,671 | $ | 4,922 | $ | (1,251 | ) | -34 | % | |||||||
Neonorm | 15 | 6 | 9 | 60 | % | |||||||||||
Canalevia | 87 | 87 | 100 | % | ||||||||||||
Total gross product sales | 3,773 | 4,928 | (1,155 | ) | -31 | % | ||||||||||
Sales rebates | (523 | ) | (1,354 | ) | 831 | -159 | % | |||||||||
Sales discounts | (318 | ) | (2,600 | ) | 2,282 | -718 | % | |||||||||
Sales returns | (11 | ) | (48 | ) | 37 | -336 | % | |||||||||
Wholesaler fee | - | (541 | ) | 541 | 0 | % | ||||||||||
Net product sales | $ | 2,921 | $ | 385 | $ | 2,536 | 87 | % | ||||||||
Mytesi Sales: Gross to Net | ||||||||||||||||
Gross sales | $ | 3,671 | $ | 4,922 | $ | (1,251 | ) | -34 | % | |||||||
Sales rebates, discounts and returns | (852 | ) | (4,543 | ) | 3,691 | -433 | % | |||||||||
Net Mytesi Sales | 2,819 | 379 | 2,440 | 87 | % |
Three Months Ended | ||||||||||||||||
Financial Highlights | June 30, | |||||||||||||||
(in thousands, except per share amounts) | 2022 | 2021 | $ change | % change | ||||||||||||
Net product revenue | $ | 2,921 | $ | 385 | 2,536 | 87 | % | |||||||||
Loss from operations | $ | (6,479 | ) | $ | (11,580 | ) | 5,101 | -79 | % | |||||||
Net loss | $ | (9,390 | ) | $ | (14,081 | ) | 4,691 | -50 | % | |||||||
Net loss per share, basic and diluted | $ | (0.12 | ) | $ | (0.31 | ) |
Three Months Ending | ||||||||
June 30, | ||||||||
(in thousands) | 2022 | 2021 | ||||||
(unaudited) | ||||||||
Net loss | $ | (9,390 | ) | $ | (14,081 | ) | ||
Adjustments: | ||||||||
Interest expense | 2,536 | 2,009 | ||||||
Property and equipment depreciation | 10 | 8 | ||||||
Amortization of intangible assets | 422 | 422 | ||||||
Share-based compensation expense | 1,017 | 892 | ||||||
Income taxes | - | - | ||||||
Non-GAAP EBITDA | (5,405 | ) | (10,750 | ) | ||||
Impairment of indefinite-lived intangible assets | - | |||||||
Loss on extinguishment of debt | - | |||||||
Series 3 warrants inducement expense | - | |||||||
Series B convertible preferred stock inducement expense | ||||||||
Non-GAAP Recurring EBITDA | $ | (5,405 | ) | $ | (10,750 | ) |
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: Monday, August 22, 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 Jaguar will host an investor webcast on August 22, 2022, the Company's expectation that the two late-stage clinical events on which the Company is focused in the next approximately 6 to 12 months will be transformational in terms of value creation and recognition for the Company, Jaguar's expectation that an investigator-initiated proof-of-concept study of crofelemer for SBS will be completed in 2022, supporting the potential for expanded patient access to crofelemer in Europe in 2023 for SBS patients, Jaguar's expectation that the third-party investigator for this SBS proof-of-concept study will present the study results in December 2022 at a global GI conference in Dubai, the Company's expectation that enrollment in the OnTarget trial will complete in the first half of 2023, 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, Jaguar's expectation that participation in Early Access Programs in the EU for SBS 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 SBS patients for whom no good therapeutic options exist, the expectation that the global SBS market will reach $4.6 billion by 2027, the Company's expectation that it will pursue a tropical disease priority review voucher under the FDA's financial incentive program to develop drugs for tropical diseases such as cholera, Jaguar's expectation that the Company will exhibit at IVECCS in 2022 and at the 2022 VCS Annual Conference, Jaguar's expectation that Canalevia could receive FDA conditional approval, under the name Canalevia-CA2, for the treatment of EID in dogs in the next 6-8 months, and Jaguar's expectation that patients in Bahrain, Kuwait, Qatar, Saudi Arabia, the United Arab Emirates, and Oman may be able to access crofelemer before the end of 2022 for specified indications once such indications. 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 Gibson RJ and Stringer AM. Chemotherapy-induced diarrhoea. Curr Opin Support Palliat Care 2009; 3: 31-35
2 Pablo C. Okhuysen, M.D., The impact of cancer-related diarrhea on changes in cancer therapy patterns: Real world evidence
3 Eric Roeland, M.D., FAAHPM, Healthcare utilization and costs associated with cancer-related diarrhea
4 http://www.crohnscolitisfoundation.org/sites/default/files/legacy/assets/pdfs/short-bowel-disease-crohns.pdf
5 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$1.09 |
Daily Change: | -0.09 -7.63 |
Daily Volume: | 1,046,998 |
Market Cap: | US$12.860M |
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