Thank you, Allison. You can take a breath. Good morning, everyone, and thank you for joining us today. Before I highlight our achievements for the first quarter, I think it’s important that I reiterate what we’re trying to build at Xeris.
Every day, everyone at Xeris is intensely focused on building a substantial, patient-centric, commercially-focused, self-sustaining biopharma enterprise with multiple products — commercial products in multiple therapeutic areas, a highly targeted development pipeline that has significant long-term promise and increasingly a significant value added technology partnership business, literally a three-dimensional enterprise.
What you’ll hear today is that we are continuing to progress very successfully on that journey. We are executing on our vision, as I said, just a few short weeks ago when we reported outstanding 2022 results. Our momentum from 2022 has set us up for a great 2023. First quarter 2023, delivered another Recorlevd of quarterly revenue, strong underlying demand for Gvoke Keveyis and Recorlevlev.
Another potentially very valuable XeriJect partnership and a continued healthy cash position. Here are the headlines. We have achieved first quarter total revenue of $33.2 million, representing 50% growth compared to first quarter of ’22. We ended first quarter 2023 with $95.1 million in cash, cash equivalence and short term investments.
We announced a research collaboration and option agreement with Regeneron for XeriJect formulations and we are reaffirming our 2023 guidance of total revenues of $135 million to $165 million cash utilization from operating activities of between $57 million and $77 million and year-end cash, cash-equivalent and short-term investments of between $45 million and $65 million.
Steve will go into those in greater detail as we progress. Let’s start with the commercial portion of our business, which generated $32 million in the quarter, representing a 47% increase over last year in the first quarter. First Gvoke. Gvoke had another Recorlevd quarter of net revenue and prescriptions just over $15 million in net revenue and a 21% increase compared to first quarter of ’22.
Total prescriptions for the first quarter were just shy of 46,000, growing 50% compared to the same period last year, and a 10% increase from fourth quarter of ’22, which is a very good sign, since the first quarter, market growth is historically flat to the fourth quarter of the prior year.
Since the beginning of the year, market growth is back to double digits with Gvoke continuing to outpace all other products and driving that market growth. At the end of April, Gvoke market share of new and total prescriptions in the glucagon market grew to approximately 30% and 29% respectively.
Ready-to-use glucagon products now represent over 75% of the total new prescription market for glucagon. Gvoke is also off to a good start in the second quarter, having recently topped 4,000 prescriptions per week for the first time and for two consecutive weeks.
I mentioned this on our fourth quarter call in a few weeks ago, but due to the significance, I believe it bears repeating, especially since we’re entering an important conference period. While more and more patients on insulin are getting ready to use glucagon such as Gvoke, there are still over 7 million people on insulin who remain at high risk and don’t have a ready to use Gvoke available just in case.
To address this critical situation and motivate healthcare professionals to do more, The American Diabetes Association, The Endocrine Society, The American Association of Clinical Endocrinology and others, have recently updated their guidelines and algorithms to include an important focus on the incorporation of ready-to-use glucagon into clinical practice.
For example, the Endo Society expanded the definition of those at high risk for severe low blood sugar and strongly recommends that ready to use glucagon should be prescribed for all patients with diabetes who are on daily insulin or sulfonylureas, confirming what we’ve been saying all along.
Onto Recorlevlev, Recorlevlev generated $4.5 billion in net revenue for the first quarter, an increase of approximately 18% from the fourth quarter of ’22. We continue to see a steady increase in referrals, new patients on drug and unique prescribers of Recorlev in the first quarter. For example, we saw an increase in the number of referrals to Recorlev in the first quarter of nearly 30% from the prior quarter.
Interestingly, in the first quarter, more than 30% of patients were prescribed Recorlev as their first drug therapy. This means that healthcare professionals are valuing Recorlev lab as a first-line treatment for Cushing syndrome post-surgery. Overall, Recorlev lab is developing exactly as expected.
Moving to Keveyis. First quarter revenue for Keveyis was approximately $13 million, which represents an increase of 37% compared to the first quarter of ’22. Since the first generic was approved in late December, it has not had a material impact on kavas to date in 2023. In fact, our referral rates and patients on drug remain very steady. That isn’t to say there won’t be an impact. However, this is a challenging marketplace that requires significant work to identify, initiate, and maintain patients on therapy.
We have so far only seen glimpses of how generics may impact that process and the market as a whole. We’ll see how the, how it plays out over the course of the year. That said, given the market dynamics historically, we are continuing to invest Keveyis, despite the entrance of a generic and believe we can maintain a considerable portion of the business we’ve worked so hard to build, on behalf of the PPP patient community and we continue to monitor the landscape.
Xeris is committed to ensuring everyone who needs access to Recorlev and Keveyis will receive it. Our dedicated Xeris care connections team, patient advocates and mentors, support patients and healthcare providers through the product initiation, reimbursement, and titration process, and we will continue that effort.
Let’s turn to our pipeline and partnered programs. As you know, we are focused on advancing our XeriSol Levothyroxine development program to eventual Xeris commercialization. We recently began recruiting patients in the Phase 2 study and hope to dose the first patient before the end of the second quarter.
The primary objectives of this Phase 2 study are to determine a target dose conversion factor for oral Le — from oral levothyroxine to our liquid ready-to-use subcutaneous levothyroxine, one week injection, and to assess the safety and tolerability of our XeriSol levothyroxine after once weekly subcutaneous injections, in subjects with hypothyroidism. The study will also gather insight on each subject’s thyroxine or T4 and thyroid stimulating hormone or TSH levels over the course of the study.
Data from this Phase 2 study will help inform our proposal to the FDA for a pivotal Phase 3 program. Oral levothyroxine has been the standard of care for treatment of hypothyroidism for many years, and it is one of the most prescribed medicines in the United States generating more than 100 million prescriptions per year.
However, 47% of patients have some GI issue or combined GI condition with impacting oral absorption. 21% report taking concomitant medications that interfere with absorption and 17% of patients admit to compliance issues with the daily oral regimen, many of whom may be the same patient.
As a result, we believe that our once weekly subcutaneous levothyroxine, if approved, will compete in a potential $2 billion to $3 billion market segment. Now on to our growers — growing Xeris partnership business; in March, we announced the XeriJect platform partnership, this one with Regeneron, to enable subcutaneous delivery of potentially several monoclonal antibodies.
Under the terms of this collaboration and option agreement, Xeris will use our XeriJect formulation to develop ultra-highly concentrated ready-to-use small volume subcutaneous injections of two undisclosed monoclonal antibodies developed by Regeneron.
Regeneron has an option to license clinical development commercial rights to XeriJect for these molecules and to nominate additional molecules for formulation and potential development and commercialization. This is our third recently disclosed Xeris technology partnership following collaborations with Merck and Horizon, which highlights the unique value proposition of XeriJect, as well as the investment and progress Xeris has been making in advancing XeriJect into clinical GMP readiness.
So, where are we with Merck and Horizon programs? For Merck we have completed the XeriJect formulation stability assessment of the molecule, and at this point Merck is evaluating the product for further clinical development and commercialization with the Horizon partnership.
We’re currently in the initial stages of formulation of TEPEZZA in our XeriJect delivery system. Once we meet the agreed upon product profile, we will receive the previously disclosed $6 million from Horizon. If they sign the licensing agreement, giving them exclusive rights in the category, Xeris would be entitled to future development, regulatory and sales-based milestones, as well as royalties on future sales.
With a great first quarter behind us and from where we stand today, I want to reiterate that we are affirming our total revenue guidance of $135 to $165 million, cash utilization of $57 million to $75 million, a year-end cash position in the range of $45 to $65 million and achieving cash flow breakeven in the fourth quarter, without the need for additional capital to fund our operations.
I will now turn the call over to Steve for additional details on our first quarter performance.