Xeris Biopharma Holdings, Inc.

Hello all and a warm welcome to the Zerries Barrow Farmer Holdings first quarter 2023 financial results call. My name is Louisa and I'll be the operator for today. If you would like to ask a question, you will have the opportunity to do so once we've reached the question and answer portion. Kindly press star followed by one on your telephone keypad should you wish to ask a question. I now have the pleasure of handing over to your host today, Alison Way, Senior Vice President of Investor Relations and Corporate Communications to begin. Alison, please go ahead when you're ready.

Thank you, Louisa. Good morning, and welcome to Therese Biopharma's first quarter financial results conference call and webcast. A press release with the company's financial results was issued earlier this morning and can be found on our website. We are joined this morning by Paul Edick, Chairman and CEO, and Steve Piper, CFO. Paul will provide opening remarks. Steve will provide details on our financial results. Then we will open the call for Q&A. Before we begin, I would like to remind you that this call will contain forward-looking statements which may include, and are now limited to, statements concerning our business practices, future expectations, plans, prospects, clinical approvals, commercialization, corporate strategy, and performance, which constitute forward-looking statements within the meaning of the Private Securities and Litigation Reform Act of 1995. Actual results made different materially from those indicated by the forward-looking statements made during this call. as a result of various factors, including our financial position and need for financing, including to fund our product development programs or commercialization effort, whether our products will achieve and maintain market acceptance in a competitive business environment, our reliance on third-party suppliers, including single-source suppliers, our reliance on third parties to conduct clinical trials, the ability of our product candidates to complete successfully with existing and new drugs, adverse effects of macroeconomic conditions on our business operations and clinical activities, and our and collaborators' ability to protect our intellectual property and proprietary technology, as well as other risk factors set forth in our filings with the Securities and Exchange Commission. Any forward-looking statements in this call represent our views only as to the date of this call and should not be relied upon as representing our views as of any subsequent date. Subject to obligations under applicable law, we disclaim any obligations to update such statements. And I would like to turn the call over to Paul.

Thanks, Alison. You can take a breath. Good morning, everyone. 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 will 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 record of quarterly revenue, strong underlying demand for GVOTE, Coveas, and Rekorolev, another potentially very valuable Zerejec partnership, and a continued healthy cash position. Here are the headlines. We have achieved first quarter total revenue of $33.2 million, representing 50 percent growth compared to first quarter of 22. We ended first quarter 2023 with $95.1 million in cash, cash equivalents and short-term investments. We announced a research collaboration and option agreement with Regeneron for Zerijek 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 and 77 million, and year-end cash, cash equivalents, and short-term investments of between 45 and 65 million dollars. 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 dollars in the quarter, representing a 47 percent increase over last year in the first quarter. First, GVOC. GVOC had another record quarter of net revenue in prescriptions, just over $15 million in net revenue, 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 GVOTE continuing to outpace all other products and driving that market growth. At the end of April, GVOTE 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 percent of the total new prescription market for glucagon. GVOC 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 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 GVOC, there are still over 7 million people on insulin who remain at high risk and don't have a ready-to-use GVOC 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. On to RecorLiv. RecorLiv 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 RecorLiv in the first quarter. For example, we saw an increase in the number of referrals to RecorLiv 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 as a first-line treatment for Cushing syndrome post-surgery. Overall, Recorlev is developing exactly as expected. Moving to Coveas. First quarter revenue for Coveas 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 Cabeas 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 it plays out over the course of the year. That said, given the market dynamics historically, we are continuing to invest in Cabeas, 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 Record11 Cabeas 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. We will continue that effort. Let's turn to our pipeline and partnered programs. As you know, we are focused on advancing our Xerasol levothyroxine development program to eventual commercialization. We recently began recruiting patients in the phase two study and hope to dose the first patient before the end of the second quarter. The primary objectives of this phase two study are to determine a target dose conversion factor from oral levothyroxine to our liquid ready to use subcutaneous levothyroxine, one week injection, and to assess the safety and tolerability of our Xerosol 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, TSH, levels over the course of the study. Data from this phase two study will help inform our proposal to the FDA for a pivotal phase three 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 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 to $3 billion market segment. Now on to our growing Xeris partnership business. In March, we announced the Xeroject 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 Xeroject 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 and commercial rights to Xerogec 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 Xeroject, as well as the investment and progress Xeris has been making in advancing Xeroject into clinical GMP readiness. So where are we with Merck and Horizon programs? For Merck, we have completed the Xeroject 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 TPEZA in our ZERJEC 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, ZERIS 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 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.