Steve Pieper
Analyst · Mizuho Securities. Vamil, please go ahead. Your line is now open
Thanks, Paul. Good morning, everyone. I will focus my remarks on a few of the key financial results, the details of which are in the press release issued this morning. Total net product revenue was $21.9 million for the first quarter, representing a 33% increase over pro forma first quarter 2021 revenue. Net product revenue was driven by strong underlying patient demand for both Gvoke and Keveyis. While we did recognize Recorlev revenue in the first quarter, it was immaterial to the overall results as we had just launched Recorlev well into Q1. Gvoke continued its strong momentum in the first quarter growing total prescriptions more than 88% from Q1 of 2021 and toping 30,000 prescriptions in the first quarter. Gvoke quarter-over-quarter prescription growth was 5% despite the overall glucagon market total prescriptions declining by 1%, which is in line with historical trends in the first quarter relative to Q4. In Q1, Gvoke continued to capture share of the glucagon market. At the end of March, Gvoke achieved approximately 22% NRx share and the most recent weekly data ending April 29th would suggest Gvoke has now achieved approximately 24% NRx share. In the first quarter, we also made an adjustment to our returns reserve based on actual returns. As our Gvoke product is still in launch mode and we don't have a significant history of product returns. We estimate product returns based on various factors. We will continue to monitor and adjust our returns reserve as necessary. Keveyis also had a solid quarter from a patient on drug perspective, as we grew patients on drug by 12% relative to the first quarter of 2021. Just to wrap up my comments on revenue performance in the first quarter and looking ahead of it, we had a solid quarter and we continue to feel confident based on the underlying fundamentals driving the growth of the business that we will furnish within the range of $105 million to $120 million for full year 2022 net product revenue. Moving down to P&L. Cost of goods sold was $6.3 million for the three months ended March 31, ’22, an increase of approximately $4.4 million compared to the same period in 2021. This increase was primarily driven by increased sales of our products. Research and development expenses increased by approximately $2.2 million in the first quarter to $6.3 million compared to the same period in 2021. These increases were primarily driven by higher pharmaceutical process development and clinical costs across multiple programs. Relative to the fourth quarter 2021, research and development expenses decreased by approximately $3.8 million. This decrease was driven by lower clinical service and pharmaceutical process development costs also across key pipeline programs relative to the fourth quarter. Selling, general and administrative expenses increased by $16.8 million, or 88% for the three months ended March 31, ‘22 compared to the same period in 2021. We incurred $11.5 million of increased commercial related cost, including an increase to our sales force and increased commercial support for Gvoke, Keveyis and the launch of Recorlev. In addition, approximately $2 million of the increase was related to the acquisition of Strongbridge, primarily restructuring and related employee costs. The remaining change was due to an increase in general expenses given the growth of the company. Let me provide some important context to these increases relative to the first quarter 2021 as well as some context on sequential quarter-over-quarter changes. I had mentioned on our year-end earnings call in March that with the acquisition of Strongbridge, we would absorb the Keveyis commercial infrastructure and other key personnel, which prior to the fourth quarter of ‘21 did not exist in Xeris’ financial results. In addition to Strongbridge related infrastructure, we had also expanded our endocrinology commercial team in mid-2021 and this expansion is also driving some of the increase relative to the first quarter of 2021. This is an important context in terms of the increases to SG&A relative to first quarter ’21 expenses. On a quarter-over-quarter basis, SG&A expenses actually decreased by approximately $18 million in the first quarter relative to the fourth quarter. The fourth quarter included approximately $18 million of costs associated with the acquisition of Strongbridge and in the first quarter, we only incurred approximately $2 million of expenses associated with the acquisition of Strongbridge. We had mentioned that Strongbridge acquisition costs would materially decrease in 2022. Therefore, we are seeing a net decline of SG&A expenses on a quarter-over-quarter basis, even though we incurred costs associated with the launch of Recorlev in the first quarter. As a reminder and consistent with previous guidance, we believe that we are on track to realize $50 million in Strongbridge acquisition related synergies approximately equally split between cost reductions and cost avoidance by the end of 2022. From a cash perspective, as of March 31, 2022, Xeris had total cash, cash equivalents and short-term investments of $132.1 million compared to $102.4 million at December 31, 2021. Our balance sheet was strengthened by both the $30 million pipe financing in January and the debt refinancing we finalized with Hayfin in March. Our net operating investing cash burn for the quarter was approximately $42 million, which was driven by our net loss in Q1, coupled with changes in working capital, primarily related to an increase to accounts receivable from higher sales and a decline in accrued liabilities from year end 2021. You will also see in our quarterly filing that Xeris today entered into a sales agreement with Jefferies for a new ATM. You will recall that we had an ATM in place previously, but with the Strongbridge acquisition and the establishment of a new corporate parent, the ATM was effectively terminated. We do not have a need currently for additional equity financing, but are doing this as a matter of good financial housekeeping should need to rise in the future. As we announced in March, we entered into a senior secured term loan agreement with funds managed by Hayfin to provide us with up to a total of $150 million of capital. We drew $100 million on the closing date in March and we repaid our previous debt facility of $43.5 million with Oxford Finance and Silicon Valley Bank. The net proceeds will provide additional working capital to fund our business plan, an additional $50 million is available to Xeris at our election until March 2023. Based upon our current operating plan, we would expect we will draw the remaining $50 million by the end of this year. This capital base and the additional $50 million from the debt facility provides the company with significant operating flexibility to drive our rapidly growing commercial business is currently constructed to cash flow breakeven by year end 2023 and thereafter produce increasing operating cash flow. As a reminder from our last call in March, we project the rate of cash burn to improve over the course of 2022 as our revenue base continues to grow and we see a decline in obligations associated with the Strongbridge acquisition related costs. With the revenue growth from our three marketed products combined with our current cash position, the cash received from the recent pipe financing and the debt restructuring with Hayfin. We believe that we will finish 2022 with approximately $90 million to $110 million and further can achieve cash flow breakeven by year end 2023. To summarize, our commercial products are off to a strong start and we are excited about the very early returns on Recorlev. We are affirming our full year 2022 net product revenue range of $105 million to $120 million. We have integrated Strongbridge quickly in Xeris and we will achieve $50 million in synergies by the end of 2022. And we are in a solid position from a cash perspective to drive growth of Gvoke, Keveyis and Recorlev and fund our R&D pipeline. I will now turn the call back to Paul.