Hello, and welcome to today’s Xeris Biopharma’s First Quarter 2022 Financial Results Conference Call and Webcast. My name is Bailey and I will be your moderator for today’s call. All lines will be muted during the presentation portion of the call, with an opportunity for questions-and-answers at the end. [Operator Instructions] I would now like to pass the conference over to Allison Wey, Senior Vice President of Investor Relations and Corporate Communications. Allison, please go ahead.

Thank you, Bailey. Good morning and welcome to Xeris Biopharma's first quarter 2022 financial results and corporate update conference call and webcast. A press release with the company's first quarter 2022 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 Pieper, our CFO. Paul will provide opening remarks, Steve will provide details on our financial results and then, we will open up the call for questions. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning Xeris' business practices, Xeris' future expectations, plans, prospects, clinical approvals, commercialization, corporate strategy, performance, and the impact of COVID-19 on Xeris' business practices, which constitute forward-looking statements for the purposes of the Safe Harbor provision under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements, as a result of various important factors, including the effect of uncertainties related to the COVID-19 pandemic on the U.S. and global markets, Xeris' business, financial condition, operations, clinical trials and third-party suppliers and manufacturers and other risk factors included those discussed in our filings with the SEC. In addition, any forward-looking statements represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligations to update such statements. I'll now turn the call over to Paul.

Thanks, Allison. Good morning to everybody and thanks for joining us today. Our headline for this call is that we had another very good quarter in the first quarter of 2022. We generated approximately $22 million in net product revenue. We continued strong prescription and share growth for Gvoke. We continue to add more patients to all of our products including Gvoke, Recorlev, Keveyis and even overall in the UK and the Gvoke Kit, which became available at the end of the quarter. We also dramatically strengthened our cash position with the addition of a $30 million pipe and the debt refinancing, we finalized with Hayfin, ending the quarter with over $132 million in cash and we continue to advance the Phase 1 study of our levothyroxine product. This first quarter performance gives us great confidence that we are on track for the year. We are therefore affirming our previously announced guidance of $100 million to $120 million in total net product revenue for 2022, realizing $50 million in synergies from the Strongbridge acquisition by year end 2022. Year-end 2022 cash balance of $90 million to $110 million and achieving cash flow breakeven by year-end 2023. I'll go into some specific highlights behind our performance, starting with Gvoke. We continue to see impressive Gvoke prescription growth. In the first quarter, Gvoke prescriptions grew 88% compared to first quarter last year. On a sequential basis, Gvoke grew 5% quarter-over-quarter, while the overall glucagon market declined 1%. So again, there continues to be strong demand for Gvoke and we continue to outpace the market. For those watching prescriptions, April started out, it had flat during the holiday period, but we finished the month strong with over 2,700 prescriptions the last week in April and a 22% market share, which makes us feel…

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…

Thanks, Steve. As you just heard, we are off to a good start for 2022 in the first quarter and we can’t say often enough that we generated approximately $22 million in net product revenue. We continued strong prescription growth in -- share growth for Gvoke. We continue to add more and more patients to all of our products. We continue to advance our pipeline with the Phase 1 study of levothyroxine. And as Steve mentioned, we dramatically strengthened our cash position with the pipe and debt (ph) refinance. Given our [indiscernible] exceptionally strong cash position as a result of cash on hand revenue generated from our three commercial products, the addition of cash and recent private placement in the refinance We would not anticipate needing to raise additional capital in order to fund our ongoing operations. And return to capital markets would be for M&A purposes only. And importantly, we are well positioned to achieve our 2022 guidance of net product revenues of $105 million to $120 million, $50 in synergies from Strongbridge acquisition, year-end cash balance of $90 million to $110 million and cash flow breakeven assuming we're on our guidance by year end 2023. Operator, if you would please open the line for questions.

Thank you. [Operator Instructions] Our first question today comes from David Amsellem from Piper Sandler. David, Please go ahead. Your line is now open.

Hey, thanks. So just had a couple of questions. First, on Recorlev, I know it's early days, Paul, but can you just talk about patient uptake, maybe if you're not in a position to provide patient level metrics, just talk about the extent to which you're growing the patient footprint and also talk about access to the product or are these patients who are getting Recorlev have they been exposed to [indiscernible] or switches from other agents? So I just wanted to get a sense of what adoption looks like in terms of patient specific metrics to the extent you could provide them? That's number one. And then number two is, you mentioned not having to go back to the capital markets unless for M&A purposes, I'm wondering if you could just elaborate on how you're thinking about M&A what kind of assets are you looking at? And would you take on any R&D risk in the context of a potential target -- acquisition target, I should say? Thanks.

Good morning, David. Thanks for the call. Thanks for the questions. Yeah. We're not in a position to give a lot of metrics on Recorlev patients. What we tried to convey in my remarks and I'll reiterate is, we are getting patient referrals. We already have patients on drug. We're managing those patients through the process. We're working with them to clear their prior authorization and get insurance, reimbursement paid for. And we believe relative to our guidance and the degree to which Recorlev is contributing to that guidance. We're well on track -- we're on track for what we set out as our plan. So that's the best I can give you on Recorlev, it's really early. In terms of the return to the capital markets, we want to very strongly and I want strongly reiterate, we have all of the funds necessary to fund our business through the cash flow breakeven, assuming we're on plan and on our guidance. So we’re -- but we did put an ATM in place because it's good financial housekeeping. That being said to your point, we would not want to necessarily add an M&A another company or asset that incurs R&D risk and has a negative impact on a cash position. We're focused on building critical mass and getting to cash flow breakeven. That being said, if there's another Strongbridge out there, it's got a product like Keveyis that's generating good revenue and a product like Recorlev that's on the verge being approved that would be an interesting opportunity for us.

Okay. That's helpful. And if I may just sneak in a follow-up here, just on the sales -- product specific sales disclosures. Can you provide and I apologize if I missed this, just specifics on net sales for Gvoke and Keveyis if at all possible. And, if you're not in a position to do that, maybe just give us a sense of, why you're not providing the products specific sales figures? Thanks.

Yeah. So what we've committed to is guidance for the year on a total product basis. Gvoke is still in launch mode. Recorlev is barely gotten out the door. We're not saying, we'll will never provide product level results, but it's just too early. If you're following Gvoke and you look at IQVIA, you can pretty much do the math. And the balance is Keveyis more or less. In the first quarter, Recorlev didn't contribute much.

Okay. Thank you.

Thank you, David. The next question today comes from Roanna Ruiz from SVB Securities. Roanna, please go ahead. Your line is now open.

Great. Good morning, everyone. So a follow question for Recorlev. I understand you're not able to give three specifics, but I was curious on the physician front. Are you hearing anything anecdotally about real world efficacy or safety about Recorlev and how is awareness growing for the product in your first quarter of launch?

Good morning, Roanna. The receptivity from physicians has been excellent. Their efficacy, we only got a few patients on it so far. We had no concerns about efficacy, the product is working. No safety concerns have been expressed. And awareness is quite high already. We're looking forward to the conference season. We've got AACE 80A (ph) and Endo coming up and we've had great receptivity to the activities we're having at both AACE and Endo and we're all participating. So far, in a few weeks, we're feeling very positive.

Great. And quick questions for Gvoke. I'm curious, what do you think is driving the continued share growth? We did notice that BAQSIMI prescription seem to be stabilizing a bit. So I'm wondering what might be causing some of the slight differences and trends between Gvoke versus BAQSIMI.

Well, I think it's what we've said all from the beginning that they got out to a head start. They had about ten month or ten months plus head start. They also do extremely well during back to school season, which is when they launched the product goes back to school because they've got through their insulin business a very strong position with [indiscernible]. But we've said from the beginning that we would trend upward at a faster rate and we would begin to capture more and more share of the market. To the point, we’re at some point, we see that we very likely could just split to market evenly. And as I've said since day one, we really value the Lilly’s voice in this market in terms of raising the level of the sense of urgency amongst patients and healthcare professionals that if you're on insulin, you should have a prescription for ready-to-use rescue glucagon. If that happens with 7 million people on insulin, we'll get our fair share and Lilly we will get their fair share.

Yes. Understood. And quick one for Keveyis. I was curious, if you have any updates on pursuit of additional patent life for the products as we approach the forefront (ph) exclusivity end?

Yeah. We don't have an update. We continue to prosecute several patents. We're in the appeals process, appeal panel with one or two. We continue to work very hard to try to get patent across the finish line.

Got it. Thanks a lot.

Thank you. The next question today comes from Vamil Divan from Mizuho Securities. Vamil, please go ahead. Your line is now open.

Great. Thanks for taking my question. Maybe following up on a couple of the earlier ones. So one on Keveyis, as you mentioned the IP in terms of secure more patents Can you just give us a sense of what's your sort of base case assumption at this point on potential generic competition there, if at all? And then, Gvoke, you mentioned sort of doing the math to kind of get to the product sales there. It look like from our math that maybe Lilly is doing a little bit of discounting now or more than they were before these with BAQSIMI. I'm just curious if you can share anything on the pricing side and sort of gross to net assumptions we should make, just sort trying back into what the prescriptions actually mean in terms of net sales? Thank you.

Yeah. For Keveyis on the generic front, I think we've said historically, we didn't -- we don't expect, the generic we haven't seen any evidence of the generic. If there is one, we wouldn't expect anything till 2023. We think we're in really good shape for 2022. And we also think that the way Keveyis is, the way PPP patients are identified and put through the process, it takes a great deal of work on the part of the company. We basically do the analysis to help physicians identify patients. So generic is going to have a tough time doing that same amount of work. If you recall, the product was originally launched by a generic company and didn't go terribly well. And that's how Strongbridge ended up buying the product. So -- but we're being very diligent. And as I believe, I've said historically, we have all options open to us up to end including our own authorized Generic. So I think there's a way to protect a significant portion of this business. As far as Gvoke on the gross to net, I think Steve mentioned, thing to probably hit the gross to net that Gvoke are in your math is the return, we added to the returns reserve. You want to talk more.

Yeah. We added to our returns reserve. You'll see it in our financials $1.4 million in the quarter. And again, we take into account various factors when estimating our returns reserve, but primarily driven by actual returns. So I would say that was the impact. We don't comment specifically on gross to net percentage, but in line with industry average for retail product.

And to your question on pricing, there has been no negative impact on pricing. We're still in pretty good shape.

Okay. And then maybe just one quick follow more the financial side with the SG&A. Steve, I call your comments there on the sequential decline. I guess, we're trying to think about forecasting that forward. We were quite a bit higher than. What you guys reported for the quarter, so would you expect things sort of stabilize at these levels or do you expect a little bit more of a decline you're going over at least into the second quarter as you try and think about kind of the progression of your expenses here?

Yes, Good question, Vamil. I would expect that it's basically stabilized, so what you would see and really from an SG&A perspective, what happened in Q1, I think would probably play out for the balance of the year.

Okay. Thank you very much. Thanks.

Thank you. The next question today comes from Robin Garner from Craig-Hallum. Robin, please go ahead. Your line is now open.

Good morning. Can you expand on Tetris and the plan and the timing and perhaps even the order of -- look to further commercialized [indiscernible] into?

I didn't catch the second half, Robin. Welcome to the call, Robin and good morning, but I didn't catch the second half of your question. Anyway, the Tetris launched in the UK. They're beginning to get on all the formularies and there are more formularies in UK that I think than there are payers in the U.S. So it is a difficult process and long process, but they're off to a pretty good start operationally they're doing very well. They're getting patients. They're getting prescriptions, their ordering product. I think they're still on track to launch in Germany and a couple other countries in mid-year and they're going to sequentially go through the rest of -- most of the larger countries Nordic, Scandinavian countries, Italy, France, Spain, all the other likely suspects over the course of 2022 and into 2023. I don't believe that, that business is going to be a huge contributor for us because the pricing they got is equivalent to about $100. We sell it to them at a transfer price and they make whatever they can beyond that.

Thank you for expanding on that.

Yeah. Was there another -- to your question, Robin?

I actually, that answers the question. One additional question is just around the number of units per patient for Gvoke and if you're seeing that change as your awareness and growth continues in terms of your revenue share?

Yeah. Interesting, right now, it's stabilized right about two units per patient per prescription. It's one of those things where patients might be getting multiple prescriptions in order to get more units, but the average units per prescription is stabilized about two. When we first launched, we did see the average units per prescription creep up to about three. But we're not seeing that now what we're seeing more is patients just get multiple prescriptions.

Okay. Thank you very much.

Thank you. Our next question today comes from Oren Livnat from H.C. Wainwright. Please go ahead. Your line is now open.

Thanks for taking my questions. I have a couple. On Recorlev, I understand it's really early and revenue material at this point, but when we started thinking looking forward, I think on the last call a couple of months ago, you did mention already having some patients on therapy and clearly, I hope you've added more in the meantime. Can you talk about those earliest patients? Do you already have some or all of them through the reimbursement stages to the extent that, you've already got revenue producing patients. Now even if they're, still tight trading up in at lower revenue per patient than they'll eventually get to? And I have a follow up. Thanks.

Yeah. The answer is yes. As you know, all of these patients are going to require a prior authorization until we actually get guidelines with the various payers. But we're clearing insurance. We have patients that are getting reimbursement and we're adding patients every week.

Okay. At some point in the future, do we -- do you think we'll provide besides revenue breakouts hopefully? Any more metrics around this product, obviously, for orphan indications, we're talking about small numbers and small numbers make a big difference. Will you ever talk about patient volumes, added into either the funnel and or on active therapy?

Yeah. I don't think we'll actually be talking about patient volumes because they are such small numbers and they do vary pretty regularly. As we get more history with all of our products. We reassess every quarter on what metrics can we provide that are metrics that we can predict going forward and that are reliable in terms of the data that we're getting. And so as things grow and as things stabilize, we'll continue to look at whether or not we'll provide product level results. We've never said that we never said never.

And I think I've asked you this before but I apologize. I can't remember the answer. Can you just remind us with your, CareConnection process and onboarding process for Recorlev? Do patients who are referred or prescribed the product theoretically get on therapy before the PA is, adjudicated or is anyone who's getting on therapy already through the process end presumably producing revenue?

Yes, The best way for patients to get on therapy such as Recorlev or Keveyis for that matter is to have the physician, the CareConnection patient partner involved and the specialty pharmacy involved where all of that is managed. Insurance is cleared. Patients ready to go, doctors ready to go, a lot of physicians actually request the patients CareConnections patient partner be involved in the consultation when they initiate therapy. So the patients know what's going to happen, how it's going to go, maybe what side effects do expect, how their titration is going to be managed, who's going to be talking to them from the specialty pharmacy, the physician's office and from CareConnections. So by the time a patient is actually initiated on drug, they are in the position to be as successful as possible.

Apologies if I didn't fully understand the answer but I guess just, is drug getting sent to a patient's house before it's necessarily clear just to make this smooth, frictionless transaction is possible for doc’s and patients or does the PA have to be approved before they can get it.

PA has to be cleared. Insurance has to be cleared, then the drug is initiated.

Beautiful. And on Keveyis, sorry for asking a lot of questions. You mentioned 12% year-over-year patient growth. Can you talk a little bit about how that translates to without giving an exact number, ballpark revenue growth just in terms of, I believe there is some price -- material price benefit maybe year-over-year also on top of that? And is that all total patients on therapy added your rear or is there some churn there?

There is some churn in there, right? We do have churn. We do have turnover, right. Discontinuation in there. I would say that if I would generally think that the patient growth translates to revenue growth on a year-over-year basis. I think that's a safest option.

Okay. Thank you for the time.

Thanks, Oren.

Thank you. There are no additional questions waiting at this time. So I'd like to pass the conference over to Paul Edick for closing remarks.

Thanks again to everybody for joining the call and for your continued support, as we execute on our strategy to create critical mass necessary to become a fully capable and profitable pharmaceutical company. Everybody have a really good day.

That concludes the Xeris Biopharma first quarter 2022 financial results conference call and webcast. Thank you for your participation. You may now disconnect your lines.