Xeris Pharmaceuticals, Inc. (NASDAQ:XERS) Q2 2020 Earnings Conference Call - Final Transcript

Aug 10, 2020 • 08:30 am ET


Xeris Pharmaceuticals, Inc. (NASDAQ:XERS) Q2 2020 Earnings Conference Call - Final Transcript


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Paul R. Edick

well as our team's commitment to assure access to Gvoke for patients. As you know, towards the end of the first quarter we swiftly moved to a virtual customer engagement model and invested in several programs to ensure that the diabetes community will continue to have easy and convenient ways to access Gvoke Pre-Filled Syringe such as a $0 co-pay and the establishment of a hub to assist our healthcare professional customers. Importantly, achieving very high levels of payer coverage was critical to the start of good prescription growth in both the Gvoke Pre-Filled Syringe and of late the Gvoke HypoPen. Sitting here today, approximately 80% of patients across all types of insurance have unrestricted access to Gvoke. All of these factors combined have contributed to steady growth in weekly prescriptions and has set us up for success with the Gvoke HypoPen launch.

Turning to our pipeline. During the second quarter, we reported positive top line results on four of our clinical programs, the results of which reinforce the value and potential of our XeriSol technology. I will hit some of the highlights of each.

Diazepam, we recently shared complete Phase 1b study results of our ready-to-use diazepam formulation with the FDA at an end-of-Phase 1 meeting. The study results and regulatory feedback from that meeting supported direct to Phase 3 registration study. We believe our novel diazepam formulation is a valuable asset and now with a predictable and expedited development road map, we will search for a suitable partner to continue its development as a critical therapy for the epilepsy community.

PBH or post-bariatric hypoglycemia, the findings from the Phase 2 PBH study show that a mini dose, for example, 300 micrograms, of ready-to-use glucagon was adequate to restore or maintain normal blood glucose levels within 15 minutes of administration after experiencing postprandial hyperglycemia and without the need of an oral glucose tablet. In addition, no rebound hypoglycemia was observed in the ready-to-use glucagon treatment arm.

Exercise-induced hypoglycemia or EIH, results from the Phase 2 study in EIH show that a pre-treatment with a microdose, 150 micrograms of Gvoke ready-to-use Micro significantly prevented EIH during prolonged, moderate-to-high intensity aerobic exercise in a real-world setting with or without adjustment of insulin. Recall that each of these two studies ready-to-use glucagon programs had an in-clinic and an outpatient portion. Results from the PBH and the EIH Phase 2 studies demonstrated the utility of liquid stable ready-to-use glucagon in conditions beyond rescue for severe hypoglycemia, further establishing the safety profile and utility for mini dosing ready-to-use glucagon in a real-world situation that requires self administration by the patient. Keep in mind, there are no approved therapies for either of these conditions. As we said previously -- as we have said previously, our goal with these programs is to advance the use of ready-to-use glucagon for patients that will ultimately get a non-rescue mini dose indication to the market.

Now for some key findings of our XeriSol co-formulation of pramlintide insulin from a