News Release Details
News Release Details
Jaguar Health Provides Company Updates and Reports 2022 Third Quarter Financials
Prescription product net revenue of approximately
OnTargetPhase 3 clinical trial of crofelemer for prophylaxis of cancer therapy-related diarrhea (CTD) adding international sites, targeting completion of enrollment in Q2 2023
- Publication of Phase 2 IIT study in peer reviewed journal
Breast Cancer Researchand Treatment
- Expected presentation in
December 2022from a third-party investigator, Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City in Abu Dhabi, following initiation of proof-of-concept trial of crofelemer for short bowel syndrome (SBS) and congenital diarrheal disorders (CCD), supporting the potential for expanded patient access through programs in Europein 2023
- Second conditional approval for Canalevia®, for exercise-induced diarrhea (EID), expected in Q1 2023, adding to ongoing commercial activities of Canalevia-CA1 for treatment of chemotherapy-induced diarrhea (CID) in dogs
- Business development activities with nondilutive funding for Jaguar's mental health Entheogen Therapeutics Initiative (ETI) program targeted for Q1 2023
- Jaguar's Canine Cancer: Take C.H.A.R.G.E. Registry honored by the MarCom Awards program with two Platinum awards and one Gold award
REMINDER: Jaguar to host investor webcast
The combined net revenue for Mytesi® and the Company's other prescription product, Canalevia®-CA1, which became commercially available in
"We are very pleased that growth in Mytesi (crofelemer) revenue continued for the fifth quarter in a row in the third quarter of 2022," said
"As I frequently state, what is really powerful about crofelemer is that it is a pipeline within a product, and we are focused on two late-stage clinical events in the next approximately 6 to 9 months that we expect to be transformational in terms of value creation and recognition for the Company. Our key near-term clinical activity is our Phase 3 pivotal
2022 MILESTONES, UPDATES & ACCOMPLISHMENTS:
- Phase 3 clinical trial of crofelemer for cancer therapy-related diarrhea (CTD) in humans: The pivotal
OnTargetPhase 3 clinical trial of crofelemer for prophylaxis of CTD was initiated in October 2020and is ongoing. The Company is in the process of adding additional clinical trial sites - both in the US and outside the US - to accelerate patient enrollment. Further details about the trial can be viewed here on the clinicaltrials.gov website. Is it estimated that 50-80% of chemotherapy patients experience diarrhea,1 and diarrhea has the potential to cause dehydration, potential infections, and non-adherence to treatment in cancer patients. Patients with CTD are 40% more likely to discontinue their chemotherapy or targeted therapy than patients without CTD,2 and the cost of care of CTD patients is estimated to be 2.9 times higher than for patients who are not experiencing CTD.3 European Medicines Agencygrants Orphan Drug Designation for crofelemer for Microvillus Inclusion Disease (MVID), a second rare disease indication: Jaguar and Napo Therapeutics, the Italian corporation established by Jaguar in Italyin 2021 that focuses on development and commercialization of crofelemer in orphan and rare diseases, thus expanding access to crofelemer to patients in Europe, announced on October 17, 2022that the European Commissionadopted the decision to grant Orphan Drug Designation (ODD) for crofelemer for the indication of microvillus inclusion disease (MVID), a rare congenital diarrheal disorder (CDD) condition, in the European Union. This is a very welcome development for crofelemer, a new molecular entity that has been granted two orphan designations by the EMA in less than one year, as crofelemer received ODD for short bowel syndrome (SBS) from the EMA in December 2021(crofelemer received ODD in the U.S.for SBS from the FDA in 2017.) The recognition of ODD in Europefor crofelemer for MVID is a key Napo Therapeutics milestone under the company's exclusive crofelemer license agreement with Jaguar, and receipt of this new ODD supports some specific regulatory pathways for this serious form of CDD, which remains a significant unmet medical need, especially in pediatric patients. December 2022: Presentation by third-party investigator Dr. Mohamad Miqdady, Division Chief of the Pediatric Gastroenterology, Hepatology & Nutrition Division at Sheikh Khalifa Medical City in Abu Dhabiin the United Arab Emirates, following initiation of proof-of-concept trial of crofelemer for short bowel syndrome (SBS) and congenital diarrheal disorders (CCD): Jaguar is currently supporting an investigator-initiated proof-of-concept study of crofelemer in patients with SBS or CDD with intestinal failure, with a planned endpoint of reduction of requirement of weekly volume of parenteral nutrition. The investigator is targeting a presentation in December 2022at the World Congress of Gastroenterology- a global GI conference in Dubai. Additional investigator-initiated requests and trials and clinical data are expected to come throughout 2023. In accordance with the guidelines of specific EU countries, published data from these trials could support early patient access of crofelemer for SBS or CDD with intestinal failure by mid-2023 through programs in Europefor these devastating diseases for which there is a significant unmet medical need. Participation in Early Access Programs provides 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 for whom no good therapeutic options exist. SBS affects approximately 10,000 to 20,000 people in the U.S.,4 according to the Crohn's & Colitis Foundation, and it is estimated that the population of SBS patients in Europeis approximately the same size.5 Despite limited treatment options, the global SBS market exceeded $568 millionin 2019 and is expected to reach $4.6 billionby 2027, according to a report by Vision Research Reports. September 29, 2022: Jaguar subsidiary Napo Pharmaceuticalsannounced activation by FDA of Investigational New Drug (IND) application for NP-300, a novel drug candidate for the symptomatic relief and treatment of diarrhea from cholera and other pathogens: The Company was very pleased to hear from the FDA that they have completed their review of this IND application and concluded that Napo Pharmaceuticalsmay proceed with its proposed phase 1 clinical trial for the drug. Following the completion of the phase 1 trial, the Company will be positioned to initiate the next stage of its clinical development program for cholera-related diarrhea when the Company's development team has the requisite resources and bandwidth to initiate the additional required trials. Jaguarand Napo Pharmaceuticalsare grateful for the partial financial support from the National Institute of Allergy and Infectious Diseases(NIAID) to support the NP-300 preclinical program. NP-300 is a novel oral botanical drug product that is sustainably derived from the Croton lechleri tree, the same source as that for crofelemer, and is planned to be developed under the FDA'sBotanical Guidance. As stated on the FDA'swebsite, crofelemer is currently one of only two drugs that have been approved under the FDA'sBotanical Guidance definition of a botanical drug product. Upon completion of the requisite development activities to support the New Drug Application (NDA) and subsequent approval of NP-300 by the FDA for the symptomatic relief and treatment of diarrhea from cholera, the Company intends to pursue a Tropical Disease Priority Review Voucher to develop NP-300 for this indication under the FDA'sfinancial incentive program. Priority review vouchers are transferable, and in past transactions by other companies have sold for values ranging from $67 millionto $350 million, which provides for a potential immediate return on investment upon approval of NP-300 for the cholera-related diarrhea indication.
- 2022, Jaguar's Year of the Dog: Launch activities remain underway for Canalevia-CA1 in the
U.S.veterinary market for the treatment of chemotherapy-induced diarrhea (CID) in dogs. Dogs, as with humans, discontinue their disease modifying chemotherapy approximately 40% of the time due to diarrhea, and dogs are a predictive model of the human situation. Jaguar expects that Canalevia could additionally receive FDA conditional approval, under the name Canalevia®-CA2, for the treatment of exercise-induced diarrhea (EID) in dogs in the first quarter of 2023. Jaguar Animal Healthsponsored the October 26, 2022episode of dvm360 Live!™, a web-based, magazine-style talk show for veterinary professionals hosted by Adam Christman, DVM, MBA, to drive awareness of Canalevia-CA1 and encourage veterinary clinics to contribute canine cancer records to the Take C.H.A.R.G.E. initiative. Dr. Sue Ettinger, DVM, DACVIM (Oncology), also known as Dr Sue Cancer Vet®, appeared on the dvm360 Live! episode to discuss Canalevia-CA1. She was joined on the show by one of her canine patients, a Labradormix undergoing chemotherapy for sarcoma, and the dog's owner, who discussed his pet's experience with Canalevia-CA1. Dr. Ettingeris also a member of the Take C.H.A.R.G.E. Scientific Advisory Board.
November 2022, the MarCom Awards program, which celebrates excellence in marketing and communication, honored Take C.H.A.R.G.E. with two Platinum awards and one Gold award, which drives awareness of and therefore value to the Registry. The Take C.H.A.R.G.E. campaign was developed by TogoRun, which is Jaguar's PR firm and one of the financial co-sponsors of Take C.H.A.R.G.E. TogoRun'sefforts have led to more than 80 million media impressions generated to date for Take C.H.A.R.G.E., with more to come.
- Ongoing business development initiatives in 2022:
- In June of this year, as announced,
Jaguarand Filament Health signed a letter of intent to enter a collaboration agreement to develop botanical prescription drugs for specific psychoactive target indications in the U.S. Filament Healthhas the laboratories, manufacturing, and IP capability for natural and plant-based products that Jaguar, as a company focused on later-stage clinical development, no longer has. Jaguar brings to the table the ethnobotany expertise, the expertise of how to do drug development under FDA Botanical Guidance, which is the approval the Company has for Mytesi. The two companies together are seeking partnerships with well-funded entities to pursue regulatory approval and ultimately commercialization for novel, pharmaceutical-grade, plant-based, standardized drug candidates in the mental health space. Jaguarand Filament Health are far along in discussions, and the Company expects that a formalized business development collaboration will be established within the next several months that involves bringing in nondilutive funding to help mobilize and leverage Jaguar's proprietary library of 2,300 plants and 3,500 plant extracts for the very important initial target markets of ADHD and social anxiety disorder, two markets that have understandably expanded because of the pandemic.
June 2022, as announced, Jaguar entered an exclusive license and services agreement with Ontario, Canada-based SynWorld Technologies Corporation(SynWorld) for the treatment of diarrhea in dogs in the Chinamarket with Jaguar's Canalevia drug product. Per the terms of the agreement, Jaguar engaged SynWorld as a service provider to obtain regulatory approval of the product for Jaguar in Chinaand granted SynWorld a license to commercialize and sell this product following such approval in China. As consideration for the license, Jaguar is entitled to receive 60% of any profits from sales of the product in China. If Jaguar reimburses SynWorld for the direct expense of obtaining regulatory approval in China, the profit sharing will be 80% and 20%, respectively, for Jaguar and SynWorld.
- As announced, the Company and
Quadri Pharmaceuticals Store LLC(Quadri Pharma) executed an exclusive crofelemer distribution and license agreement for multiple target indications in Middle Eastmarkets on March 31, 2022. The agreement grants Quadri Pharma exclusive promotional, commercialization, and distribution rights for specified human indications of crofelemer in Bahrain, Kuwait, Qatar, Saudi Arabia, the United Arab Emirates, and Omanfollowing regulatory approval to market crofelemer in these countries for the specified indications, including the indication currently approved in the U.S.for HIV-related diarrhea, and cancer therapy-related diarrhea. In addition, the agreement grants Quadri Pharma exclusive rights to distribute crofelemer in these countries in the future under Named Patient Programs.
- Jaguar is continuing efforts to forge additional license and business development relationships in key markets around the globe.
- Updates about recent and currently active investigator-initiated trials of crofelemer:
- Investigator-initiated HALT-D trial evaluating crofelemer for preventing chemotherapy-induced diarrhea (CID) in HER2-positive breast cancer patients: As announced, the full results of this study, which were presented at the
December 2021San Antonio Breast Cancer Symposium (SABCS 2021), were published in October 2022in the peer reviewed journal Breast Cancer Researchand Treatment.
- Chronic idiopathic diarrhea in non-HIV adult patients
Name: Yield of Diagnostic Tests and Management of Crofelemer for Chronic Idiopathic Diarrhea in Non-HIV Patients: A Pilot Study
University of Texas Health Science Center at Houston
- Functional diarrhea in non-HIV adult patients
Name: A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and efficacy of crofelemer in subjects with functional diarrhea
Beth Israel Deaconess Medical Center, a Harvard Medical Schoolinstitution in Boston
2022 THIRD QUARTER COMPANY FINANCIAL RESULTS:
Prescription product net revenue was approximately
"Mytesi total prescription volume increased approximately 3% in the third quarter of 2022 over the second quarter of 2022," said
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, counseling, and home delivery options.
- Mytesi Prescription Volume: As stated above, Mytesi prescription volume increased approximately 3% in the third quarter of 2022 over the second quarter of 2022. Prescription volume differs from invoiced sales volume, which reflects, among other factors, varying buying patterns among specialty pharmacies in the closed network as they manage their inventory levels.
- Prescription Product Net Revenue: Prescription product net revenue during the third quarter of 2022 was approximately
$3.1 millionand approximately $2.9 millionin the second quarter of 2022, an increase of approximately $0.2 million, or 8.2%, quarter over quarter, and an increase of approximately 412% over prescription product net revenue in the third quarter of 2021, which totaled approximately $0.6 million. The transition to a limited distribution network of specialty pharmacies, which was completed this past January, resulted in a meaningful reduction in Mytesi distribution costs and a higher average net price. As part of the process of transitioning to the closed specialty pharmacy network, the third and fourth quarters of 2021 were significantly impacted by the inventory draw-down of approximately 1,300 bottles of Mytesi across the Company's third-party logistics warehouse, wholesalers, distributors, and retail stores.
- Neonorm™: Revenues for the non-prescription Neonorm products and Jaguar's
Animal Healthbusiness unit were minimal for the third quarters of 2022 and 2021, in accordance with the Company's primary focus on human health and prescription products.
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(in thousands, except per share amounts)
|2022||2021||$ change||% change|
Net product revenue
Loss from operations
Net loss per share, basic and diluted
- Cost of Product Revenue: Total cost of product revenue for the quarter ended
September 30, 2022was the same amount at $0.6 millionfor the quarter ended September 30, 2021.
- Research and Development: The R&D expense increased by
$2.6 million, from $3.3 millionfor the quarter ended September 30, 2021to $5.9 millionduring the same quarter in 2022 primarily due to the phase 3 clinical trial of crofelemer for CTD.
- Sales and Marketing: The Sales and Marketing expense decreased by approximately
$0.2 million, from $2.3 millionfor the quarter ended September 30, 2021to $2.1 millionduring the same quarter in 2022. Though direct marketing fees and expenses increased due to increased patient access programs and other Mytesi marketing initiatives, personnel and related benefits decreased.
- General and Administrative: The G&A expense increased by
$0.4 million, from $4.0 millionfor the quarter ended September 30, 2021, to $4.4during the same quarter in 2022. The increase of $0.4 millionwas largely due to an aggregate increase of $1.1 millionin personnel and related benefits, public company expenses, legal and consulting costs, offset by an aggregate decrease of $0.7 millionin stock-based compensation, rent, travel and other expenses.
- Loss from Operations: Loss from operations increased by
$0.4 million, from $9.5 millionin the quarter ended September 30, 2021to $9.9 millionduring the same period in 2022.
- Net Loss: Net loss attributable to common shareholders increased by approximately
$0.3 million, from $12.2 millionin the quarter ended September 30, 2021to $12.5 millionin the same period in 2022. In addition to the loss from operations:
- Interest expense increased by
$0.6 millionfrom $2.1 millionin the quarter ended September 30, 2021to $2.7 millionfor the same period in 2022 primarily due to interest from the royalty and note agreements.
- Change in fair value of financial instrument and hybrid instrument designated at Fair Value Option ("FVO") increased
$0.7 millionfrom a loss of approximately $0.6 millionin the three months ended September 30, 2021to a gain of about $0.2 millionfor the same period in 2022 primarily due to fair value adjustments in liability classified warrants and notes payable designated at FVO.
- Other expenses increased by about
$0.1 millionfrom $20,000in the quarter ended September 30, 2021to approximately $0.2 millionfor the same period in 2022 largely due to foreign currency transactions.
- Non-GAAP EBITDA: Non-GAAP EBITDA for the third quarter of 2022 and the third quarter of 2021 were a net loss of
$8.5 millioneach, respectively.
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Property and equipment depreciation
Amortization of intangible assets
Share-based compensation expense
Non-GAAP Recurring EBITDA
Note Regarding Use of Non-GAAP Measures
The Company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA, which are considered non-GAAP under applicable
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.
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For more information about
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.
Certain statements in this press release constitute "forward-looking statements." These include statements regarding the Company's expectation that enrollment in the OnTarget Phase 3 clinical trial will complete in Q2 2023, the Company's expectation that the third-party investigator of the proof-of-concept trial of crofelemer for SBS and CCD will conduct a presentation about this trial at the
1 Gibson RJ and Stringer AM. Chemotherapy-induced diarrhoea. Curr Opin Support Palliat Care 2009; 3: 31-35