Paul Edick
Analyst · SVB Leerink. Your line is now open
Thanks Allison. Good morning, everyone. 2019 was a transformative year for Xeris. We had a number of major accomplishments and milestones of which the most significant achievement was the FDA approval of our first product, Gvoke, the first and only approved liquid stable glucagon for rescue in severe hypoglycemia in two presentations. The Gvoke pre-filled syringe and the Gvoke HypoPen auto-injector. It is important to note that both presentations were approved in September with the Gvoke pre-filled syringe selling now and the Gvoke HypoPen coming available in July. Since our September 10th approval and throughout the fourth quarter, the focus of our commercial team has been on the critical foundational elements needed for successful launches of both the pre-filled syringe and the HypoPen. First, getting the sales force hired and trained, which we completed in mid-November; second, executing all of our wholesaler agreements to enable distribution of Gvoke PFS now and HypoPen in July; third, verifying Gvoke pre-filled syringe and HypoPen availability in retail computer systems; fourth, confirming that Gvoke PFS and HypoPen are in physician's electronic health record systems as well as establishing Xeris within the endocrinology offices. And fifth, securing and executing on national payer contracts for both Gvoke PFS and HypoPen. In addition, we have distributed in the fourth quarter and to date over 5000 sample units to endocrinology offices, for patients who are not yet covered by insurance or may not have insurance at all, so that that physician can meet their needs. Essentially, the fourth quarter was all about making sure that Gvoke pre-filled syringe was made available, accessible, prescribe able and deliverable, as well as reimbursable for patients. You will note in our financial results that we also saw some modest early prescribing and unit sales and we know that most of the sample units got into the hands of patients. By way of an update, at the end of February we had over 65% of commercial lives covered without restrictions, which is excellent so far. This number should continue to increase as more payers come onboard. Since the introduction of new glucagon products, both us and Lilly last July, we have seen an approximate 25% to 30% increase in prescriptions year-over-year and an increase in the number of units dispensed per prescription from approximately 1.4 for the legacy mix kits to 2.2 for Gvoke through the end of February and even as many of 2.7 units per prescription in a given week. This points to a very underserved market. You might remember on previous calls our analysis suggests fewer than one in five patients that would benefit from having glucagon actually have it today. Adoption of new products, including Gvoke has been seamless, has not been seamless however. Decades-long prescribing habits and payer processes still result in some prescriptions for Gvoke being rejected at the payer level or incorrectly adjudicated. And we've had several reports of pharmacy switching Gvoke prescriptions to immediately available glucagon kits which are already on their shelves rather than ordering Gvoke and stocking it in pharmacies. So what are we doing about that? We're working closely with the payer plans to ensure their systems and their processes are set up correctly to ensure that covered Gvoke prescriptions folds through the system properly. We are working with doctors offices to change their standing orders from legacy kits to Gvoke PFS. We are working with local pharmacies so they know and understand the benefit Gvoke versus the legacy kit and to encourage them to fill prescriptions as written. We are also planning to implement a non-dispensing hub in an effort to ensure that prescriptions written as Gvoke are also filled as Gvoke and this should be up and running in the second quarter. Having worked through all of these processes and hurdles, when the HypoPen launches, which is once again expected in July, it will launch into a fast-growing glucagon market with much better formulary status than the PFS had at its launch a few months ago, with many of the aforementioned issues resolved. Turning to our pipeline, in November we submitted our marketing authorization application to the EU for our ready-to-use glucagon for rescue. Assuming a typical EMA review timeline, we could have a CHMP opinion later this year or early next year. We also have two ongoing Phase 2 ready-to-use glucagon programs, exercise induced hypoglycemia and post bariatric hypoglycemia that will have topline results from the outpatient portions of each study in the first half of this year. Recall that we reported positive results from the in-clinic portion of each study a few months ago. If the outpatient data is positive, we will take the data to the FDA for discussion of a potential regulatory and clinical path forward. Our goal with these glucagon programs is to advance at least one program that will ultimately get us a non-rescue indication for our liquid stable glucagon to the market. Now beyond the reviews glucagon, our Xeris all formulations of diazepam and pramlintide insulin will also have clinical study results in the first half of 2020. If we see positive results, we will assess the next steps and discuss clinical and regulatory path forward with the FDA late in 2020. Once again, 2020 is an important year for Xeris with several catalysts for creating shareholder value. We must continue to execute commercially on the launches of Gvoke PFS and HypoPen by driving awareness in prescriptions and we will determine which of our clinical and preclinical programs should move forward based on study results and regulatory pathways. I'll now turn the call over to Barry, who will review our financial results for the fourth quarter and full year 2019. Barry?