Jaguar Health, Inc.

expectations, and projections are reasonable in view of the currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward-looking statements and risk factor sections of the company's Form 10-K for the year 2022, which was filed March 24, 2023, and and its other filings with the SEC, which are available on the Investor Relations section of Jaguar's website. Except as required by law, Jaguar undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events, or otherwise. Additionally, please note that the company supplements its condensed consolidated financial statements presented on a GAAP basis by providing non-GAAP EBITDA and non-GAAP recurring EBITDA. 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 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. Today's conference is being recorded. At this time, it's my pleasure to turn the call over to Lisa Conte, Jaguar Health's founder, president, and chief executive officer. Lisa, the floor is yours.

Thank you. Thank you for that very comprehensive, forward-looking statement as well. Thank you all for joining our first quarter 2023 earnings webcast, and welcome to you all. And as you just heard, my name is Lisa Conte, and I am the founder, president, and CEO of Jaguar Health. Well, this is an earnings webcast. Our overreaching theme for this morning's discussion is patient voice and its importance in every aspect of drug development, including labeling and regulatory approval, raising awareness of noninfectious diarrhea, preparation for promotion related to the potential introduction of profilamer for prophylaxis and mitigation of cancer therapy-related diarrhea, and commercialization to provide comfort, and treatments to a meaningful share of the affected population. We are prioritizing learning from and listening to patient voice to bridge from the HIV community to the cancer community. And to refer to Crossing the Chasm, to take a phrase from Jeffrey Moore, if anybody's familiar with that book. We can do better by co-creating awareness with the patient community through education around cophelomers' potential entries to the cancer market to provide a better solution to the comfort, the dignity, and treatment outcomes to cancer patients with chronic diarrhea. We believe this will allow us to best serve these important neglected comorbidities. The potential patient reach is much larger for the cancer community than the HIV community, both in terms of the number of patients affected by non-infectious diarrhea and and of emerging relevance with the paradigm shift in cancer care to long-term targeted treatments that often result in chronic secretory diarrhea. We have two short video interviews, one from an oncologist who is a thought leader in the field and one from a well-recognized patient advocate on this important issue, which we will play for you in a moment and I think you will enjoy and find really important. First, however, I want to address our sales performance for the first quarter of 2023. We have to own this and learn from it. After five consecutive quarters of prescription product net sales growth, we have now seen in Q1 a decrease in prescription product sales compared to the prior quarter and compared to the first quarter of 2022. Let me say it again. This is a learning moment for the organization and likely a wake-up call that we have perhaps lost sight of the depth reach an importance of patient voice to facilitate expansion of the care Crofellimer can provide into the HIV community, the current approved indication. Over the past 18 months or so, as we shifted to a specialty pharmacy distribution model and incorporated other aspects of a patient access program, we've facilitated the difficult process of gaining prior authorization for patient reimbursement And we improved gross to net revenues significantly by decreasing distribution costs and improving our payer mix. The population of adults living with HIV AIDS is an aging population. And according to the National Institutes of Health, nearly 50% of those living with HIV in the United States are age 50 and older and have had the virus in their gut for over 10 years. A trend we have seen over the last two years is a decrease in net sales in the first quarter of the year over the prior quarter due mainly to commercial and Medicare plan deductibles resetting, which results in a much higher out-of-pocket cost to patients during this time period, the first quarter. The Inflation Reduction Act, a specific Medicare provision that starts to take effect in 2024 that will reduce prescription abandonment in the first quarter of the year due to significantly lowered out-of-pocket expenses for patients. We believe the provisions in this legislation should benefit the Mitessi brand and the Q4 to Q1 dip when implemented. We also believe that higher copays in Q1 account for about half of the decrease in net sales in the first quarter of this year over the Q4 2022. To help address the additional shortfall, we at Jaguar are taking diagnostic steps to understand how the voice of the people in the HIV community needs to be incorporated further into our patient access activities. It appears we've lost our reach to some of the patients. The continued learning of how to effectively navigate the HIV market is foundational to our preparations for the potential introduction of profilamer to the much larger U.S. oncology market for our target indication of prophylaxis of cancer therapy-related diarrhea. Much larger here, when I say much larger oncology market, is referring to the estimated 1.8 million patients newly diagnosed with cancer each year in the United States. Additionally, annually in the United States, there are an estimated 1 million cancer patients on targeted therapies chronically with an average rate of non-infectious diarrhea of 80%, the most common side effect. An estimated 40% of patients have their therapeutic dose, their cancer therapeutic dose, reduced or go off their life-saving targeted therapy because of the side effect of diarrhea. With the now fully enrolled phase three on-target trial, we are addressing this paradigm shift of prophylactic treatment of cancer therapy-related diarrhea with cofellinus. And I do want to say that again, fully enrolled on-target trial, which we're very excited about. This is analogous to what already occurs in the supportive care cancer world with chemotherapy-induced nausea and vomiting. It's referred to as CINV. Guidelines and protocols that incorporate prophylaxis for CINV, typically the first three days of cytotoxic chemotherapy. That global market is projected to reach $3.9 billion by 2029, according to a report from iHealthcare Analyst, Inc., and there's a good portion of that market that is addressed with generic products. With targeted cancer therapy, we're talking about chronic diarrhea. for several months to several years in both the metastatic and curative scenarios, and nothing tested or approved specifically for cancer therapy-related diarrhea. Profilamer would be the first entry to this market. We're going to play two short recent videos for you consisting of segments from interviews regarding the neglected comorbidity of cancer treatment-related diarrhea with two amazing women, both of whom are members of Jaguar's Scientific Advisory Board. Dr. Sandy Swain is a professor of medicine at Georgetown University and former president of ASCO, the American Society of Clinical Oncology. She served as the senior investigator of the investigator-initiated HALT-D trial, H-2 trial, evaluating profilamer for preventing cancer. chemotherapy-induced diarrhea in her two positive breast cancer patients, which was published last October in the peer-reviewed journal Breast Cancer Research and Treatment. The other video features Dr. Kelly Shanahan, a metastatic breast cancer patient who's now a full-time independent patient advocate who made a shared decision with her oncologist, regarding chronic targeted therapy specifically to avoid the side effect of chronic diarrhea. And she so eloquently says that she could live, not just exist. Following the videos, Carol Isaac, Jaguars Chief Financial Officer, who's having a little trouble connecting, so hopefully Carol Isaac, Jaguars Chief Financial Officer, will provide a more detailed recap of key financial results for the first quarter of 2023. And we will review the clinical milestones we have coming up in 2023, this year, that we feel will be transformative in terms of value and selection for the company. We'll now move forward with the two videos. And I'll turn that over to... I'm Lisa Conte.

I'm the founder, president, and CEO of Jaguar Health.