Q1 2024 Xeris Biopharma Holdings Inc Earnings Call

May 9, 2024

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Operator: Hello everyone, and welcome to the Xeris Biopharma first quarter 2024 financial results conference call and webcast. My name is Seb, and I'll be the operator for your call today. If you would like to ask a question during the Q&A session, you may do so by pressing star 1 on your telephone keypad, or press star 2 if you wish to withdraw your question. I will now hand the floor over to Allison Wey to begin the call. Please go ahead when you're ready.

Speaker Change: Hello, everyone and welcome to the <unk> Biopharma first quarter 2020 full financial results conference call and webcast. My name is <unk> and I'll be the operator for your call today. If you would like to ask a question during the Q&A session. You may do so by pressing star one on your telephone Keypad, Oh Press Star two if you wish to withdraw your question.

Speaker Change: I will now hand, the floor over to Alison wait to begin Nicole. Please go ahead when you're ready.

Speaker Change: Okay.

Allison Wey: Thank you, John. Good morning, and welcome to Xeris's first quarter 2024 Financial Results Conference call and webcast. This morning, we issued our press release, which can be found on our website. We are joined this morning by Paul Edick, Chairman and CEO, and Steve Pieper, our CFO.

Alison: Thank you John Good morning, and welcome to <unk> first quarter 2024 financial results Conference call and webcast. This morning, we issued a press release, which can be found on our website.

Alison: Joined this morning by Paul It is chairman and CEO and Steve Piper our CFO. After our prepared remarks, we will open the lines for questions before we begin I would like to remind you that this call will contain forward looking statements concerning the companys future expectations plans prospects and financial performance.

Allison Wey: After our prepared remarks, we will open the line for questions. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, prospects, and financial performance. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward-looking statements. For more information on such risks, please refer to our earnings press release and risk factors, including in our SEC filings in our annual report on Form 10-K that will be filed following this call.

Allison Wey: After our prepared remarks, we will open the lines for questions. Before we begin, I would like to remind you that this call will contain forward-looking statements concerning the company's future expectations, plans, prospects, and financial performance. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward-looking statements. For more information on such risks, please refer to our earnings press release and risk factors, including in our SEC filings in our annual report on Form 10-K that will be filed following this call.

Allison Wey: Any forward-looking statements in this call represent our views only as of the date of this call and subject to applicable law. We disclaim any obligation to update such statements. I will now turn the call over to Paul.

Alison: Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward looking statements.

Alison: More information on such risks please refer to our earnings press release and risk factors, including in our SEC filings.

Alison: Fuel report on Form 10-K that will be filed following this call.

Alison: Any forward looking statements in this call represent our views only as of the date of this call and subject to applicable law.

Alison: Disclaim any obligations to update such statements I will now turn the call over to Tom.

Paul R. Edick: Thanks Allison. Good morning everyone, and thank you for joining us today. Let me start again by thanking everyone who's contributed in some meaningful way to us delivering an outstanding quarter for the company, including the patients we serve, the health care providers we enable, and the dedicated Xeris team that executes at a high level every day. The headline for today's call is 22% growth in total revenue versus last year, with momentum already building in the second quarter, giving us confidence to tighten our total revenue guidance, raising the bottom line from $170 to $175 million, making for a great start to 2024.

Paul R. Edick: Thanks, Allison. Good morning, everyone, and thank you for joining us today. Let me start again by thanking everyone who's contributed in some meaningful way to us delivering an outstanding quarter for the company, including the patients we serve, the health care providers we enable, and the dedicated Xeris team that executes at a high level every day. The headline for today's call is 22% growth in total revenue versus last year, with momentum already building in the second quarter, giving us confidence to tighten our total revenue guidance, raising the bottom line from $170 to $175 million, making for a great start to 2024.

Tom: Thanks, Alison good morning, everyone and thank you for joining us today.

Tom: Let me start again by thanking everyone, who has contributed in some meaningful way to us delivering an outstanding quarter for the company, including the patients we serve the health care providers, we enable and the dedicated <unk> team that executes at a high level every day.

Tom: The headline for todays call was 22% growth in total revenue versus last year with momentum already building in the second quarter, giving us confidence to tighten our total revenue guidance raising the bottom from $170 million to $175 million, making for a great start to 2024.

Paul R. Edick: At a high level, we have continued our strong commercial performance across all three of our products. Korolev, Jeevoke, and Kiveyas together grew net sales by a combined 25% in the first quarter compared to last year. On Monday, we announced another technology partnership, entering into a new collaboration and license agreement with Betabionics. And you'll recall that in January, we announced Amgen had executed the exclusive worldwide license agreement to develop, manufacture, and commercialize a subcutaneous formulation of Tepeza using our Xerijec technology for thyroid eye disease.

Paul R. Edick: At a high level, we have continued our strong commercial performance across all three of our products. Korolev, Jeevoke, and Kiveyas together grew net sales by a combined 25% in the first quarter compared to last year. On Monday, we announced another technology partnership, entering into a new collaboration and license agreement with Betabionics. And you'll recall that in January, we announced Amgen had executed the exclusive worldwide license agreement to develop, manufacture, and commercialize a subcutaneous formulation of Dopeza using our Xerijec technology for thyroid eye disease.

Tom: At a high level, we have continued our strong commercial performance across all three of our products. The core lab gibeau can convey us together grew net sales by a combined 25% in the first quarter compared to last year on Monday, We announced another technology partnership entering into a new collaboration and license agreement with beta bionics.

Tom: And Youll recall that in January we announced Amgen had executed the exclusive worldwide license agreement to develop manufacture and commercialize a.

Tom: Subcutaneous formulation of <unk>, using our <unk> technology in thyroid eye disease.

Paul R. Edick: I'm excited by the momentum we've already generated, and the continued momentum into April, and I believe we're well positioned to deliver on all fronts in 2024. Let's start with the performance of our commercial products in the first quarter. We're going to start with ReCORLA today. We grew ReCORLA's net sales to $10.6 million in a quarter, a 137% increase compared to last year. We're very excited with Recorla's progress, driving a quarterly record for patient referrals and converting those referrals into new patients on the drug at a record pace.

Paul R. Edick: I'm excited by the momentum we've already generated, and the continued momentum into April, and I believe we're well positioned to deliver on all fronts in 2024. Let's start with the performance of our commercial products in the first quarter. We're going to start with Recorlip today. We grew Recorla's net sales to $10.6 million in the quarter, a 137% increase compared to last year. We're very excited with Recorla's progress, driving a quarterly record for patient referrals and converting those referrals into new patients on the drug at a record pace.

Tom: I am excited by the momentum we've already generated the continued momentum into April and I believe we are well positioned to deliver on all fronts in 2024.

Tom: Let's start with the performance of our commercial products in the first quarter.

Tom: We're going to start with recall of today.

Tom: We grew <unk> of net sales to $10 6 million in the quarter, a 137% increase compared to last year. We're very excited with record lows progress driving a quarterly record of patient for patient referrals and converting those referrals into new new patients on drug at a record pace.

Paul R. Edick: As patient referrals continue to grow, the underlying patient demand has shown increasing growth, with average patients on the drug growing 18% versus the previous quarter and 139% versus first quarter 2023. The number of unique prescribers with referrals also continues to grow.

Tom: As patient referrals continue to grow the underlying patient demand has shown increasing growth with average patients on drug growing 18% versus the previous quarter and 139% versus first quarter 2023.

Tom: The number of unique prescribers with referrals also continues to grow growth in the first quarter was fueled not only by the significant increase in our patient referral pipeline and new patient starts, but importantly by a significant increase in the number of unique prescribers, who recognize the value in treating patients with record low.

Paul R. Edick: Growth in the first quarter was fueled not only by a significant increase in our patient referral pipeline and new patient starts, but importantly, by a significant increase in the number of unique prescribers who recognize the value in treating patients with Recorla. It bears repeating that we see tremendous potential for Recorlab in an increasingly dynamic Cushing's market. The key advantage prescribers recognize with Recoralev versus most other products used in the category is that Recorilov actually treats the underlying conditions in Cushing by normalizing cortisol levels in the body.

Paul R. Edick: Growth in the first quarter was fueled not only by a significant increase in our patient referral pipeline and new patient starts, but importantly, by a significant increase in the number of unique prescribers who recognize the value in treating patients with Recorla. It bears repeating that we see tremendous potential for Recorlab in an increasingly dynamic Cushing's market. The key advantage prescribers recognize with Recorlev versus most other products used in the category is that Recorlev actually treats the underlying conditions in Cushing's by normalizing cortisol levels in the body.

Tom: The bears repeating that we see tremendous potential for korlym in an increasingly dynamic cushings market.

Tom: Key advantages advantage prescribers recognized with <unk> versus most other products used in the category is that record of actually treats the underlying conditions in cushings by normalizing cortisol levels in the body.

Paul R. Edick: Increasingly, prescribers recognize this and that Ricorlav is an ideal therapy for treatment of quick patients with Cushy. Capitalizing on this momentum, we continue to add to our commercial team and patient assistance resources in support of our continued record of growth. Moving to Cuevas.

Paul R. Edick: Increasingly, prescribers recognize this and that Rekorlev is an ideal therapy for treatment of patients with Cushy. Capitalizing on this momentum, we continue to add to our commercial team and patient assistance resources in support of our continued record of growth. Moving to Cavaes.

Tom: Increasingly prescribers recognize recognize this and that <unk> is an ideal therapy for treatment of patients with cushings.

Tom: Capitalizing on this momentum we continue to add to our commercial team and patient assistance resources in support of continued record of growth.

Tom: Moving to convey is the <unk> brand remains incredibly resilient in the face of generic competition.

Paul R. Edick: The Coveus brand remains incredibly resilient in the face of generic competition. We're off to a much stronger start in 2024 than we anticipated, with Coveas growing 3% compared to the first quarter last year. I stated last quarter that we expected to see a decline in Cabeza sales in the first quarter and for the year, driven by generic competition and payer resets. However, this didn't happen as rapidly as we expected.

Paul R. Edick: The Coveas brand remains incredibly resilient in the face of generic competition. We're off to a much stronger start in 2024 than we anticipated, with Coveas growing 3% compared to the first quarter last year. I stated last quarter that we expected to see a decline in Cabeza sales in the first quarter and for the year, driven by generic competition and payer resets. However, this didn't happen as rapidly as we expected.

Tom: We're off to a much stronger start in 2024 than we anticipated with <unk> growing 3% compared to the first quarter last year.

Tom: I stated last quarter that we expected to see a decline in <unk> sales in the first quarter and for the year driven by generic competition and payer resets.

Tom: This didn't happen as rapidly as we expected.

Paul R. Edick: Unpredictably, underlying patient demand for Cavaeus remained stronger in the first quarter than we anticipated, which we believe was driven by our continued ability to find and start new patients, as well as retain existing Cavaeus patients. This resulted in sales that significantly exceeded our expectations for the quarter. And importantly, we're also seeing this momentum carry well into the second quarter. We're committed to the primary periodic paralysis community, and finding new patients continues to be the key to maintaining Coveas' contribution to our commercial portfolio. Moving to G-Vote.

Tom: Unpredictably underlying excuse me underlying patient demand for <unk> remained stronger in the first quarter than we anticipated, which we believe was driven by our continued ability to find and start new patients as well as retain existing <unk> patients.

Tom: This resulted in sales that significantly exceeded our expectations for the quarter and importantly, we're also seeing this momentum carry well into the second quarter.

Tom: We are committed to the primary periodic paralysis community and finding new patients continues to be the key to maintaining <unk> contribution to our commercial portfolio.

Paul R. Edick: GVOAT's net sales increased approximately 10 percent in the quarter compared to the prior year, while GVOAT prescriptions grew 27 percent. This net sales increase was largely driven by GVOC's gain in market share and the continued growth of the glucagon market in January and February. As of the last published weekly figures in April, GVOC's share of total prescriptions was over 36 percent. The total glucagon market started off the year with growth consistent with historical trends as well. For reference, in February, the glucagon market grew a healthy 15% compared to the prior year.

Tom: Moving to <unk> <unk>.

Paul R. Edick: GVOAT's net sales increased approximately 10 percent in the quarter compared to the prior year, while GVOAT prescriptions grew 27 percent. This net sales increase was largely driven by GVox's gain in market share and the continued growth of the glucagon market in January and February. As of the last published weekly figures in April, GVOC's share of total prescriptions was over 36 percent. The total glucagon market started off the year with growth consistent with historical trends as well. For reference, in February, the glucagon market grew a healthy 15% compared to the prior year.

Tom: <unk> net sales increased approximately 10% in the quarter compared to prior year, while <unk> prescriptions grew 27%.

Tom: This net sales increase was largely driven by <unk> gain in market share and the continued growth of the glucagon market in January and February.

Tom: As of the last published weekly figures at April <unk> share of total prescriptions was over 36%.

Tom: The total group glucagon market started off the year with growth consistent with historical trends as well for.

Tom: For reference in February the glucagon market grew a healthy 15% compared to prior year.

Paul R. Edick: However, the glucagon market, our script growth, and importantly, the utilization of our copay assistance program were all negatively impacted in late February and March when Change Healthcare announced their cybersecurity breach and shut down their claims processing system. For those who are less familiar with the situation... Change Healthcare is the largest U.S. clearinghouse that adjudicates prescription claims between pharmacies and payers. This shutdown essentially prevented the adjudication of many prescriptions by many pharmacies, especially certain chains, through normal means starting in February through early April.

Tom: However, the glucagon market, our script growth and importantly, the utilization of our co pay assistance program were all negatively impacted in late February and March when change healthcare announced their cyber cyber security breach and shut down their claims processing systems.

Tom: For those who are less familiar with the situation.

Tom: <unk> healthcare is the largest U S clearinghouse that adjudicated prescription claims between pharmacies and payers.

Tom: This shutdown essentially prevented the adjudication of many prescriptions by many pharmacies.

Tom: Especially certain change through normal means starting in February through early April.

Paul R. Edick: This meant that many of our retail pharmacies struggled to dispense G-Bulk prescriptions, and G-Bulk patients were unable to utilize our co-pay assistance program for several weeks. Not only did this impact prescription processing, but it also resulted in tightening of inventory by wholesalers. We calculate, based on the change in the utilization of our copay card, that the healthcare cybersecurity breach had as much as a $3 million temporary impact on GVOOC net sales in the first quarter.

Paul R. Edick: This meant that many of our retail pharmacies struggled to dispense GVogue prescriptions, and GVote patients were unable to utilize our co-pay assistance program for several weeks. Not only did this impact prescription processing, but it also resulted in tightening of inventory by wholesale. We calculate, based on the change in the utilization of our co-pay card, that the change healthcare cyber security breach had as much as a $3 million temporary impact on G-book net sales in the first quarter.

Tom: This meant that many of our retail pharmacy struggled to dispense diebold prescriptions and <unk> patients were unable to utilize our copay assistance program for several weeks.

Tom: Not only did this impact prescribed prescription processing, but it also resulted in tightening of inventory by wholesalers.

Tom: We calculate based on the change in the Utah.

Tom: Utilization of our.

Tom: Copay card that the change healthcare cyber cyber security breach had as much as a $3 million temporary impact on <unk> net sales in the first quarter.

Paul R. Edick: To be clear, this unprecedented situation did not have a similar impact on Rekor, Love, or Cabeas, as they are dispensed through a single specialty pharmacy that was able to quickly switch to alternate means of prescription adjudication.

Paul R. Edick: To be clear, this unprecedented situation did not have a similar impact on Rekor, Lev, or Cabeas, as they are dispensed through a single specialty pharmacy that was able to quickly switch to alternate means of prescription adjudication. Importantly, in late April and early May, we saw recovery and prescription fulfillment, and wholesaler purchases commensurate with script demand. Based on the most recent week of GVOC new prescription data, the new prescription market share for GVOC has increased to 37%.

Tom: To be clear this unprecedented situation did not have a similar impact on record level because as.

Tom: As they are dispensed through a single specialty pharmacy that was able to quickly switch to alternate means of prescription adjudication.

Paul R. Edick: Importantly, in late April and early May, we have seen recovery and prescription fulfillment and wholesaler purchases commensurate with script demand. Based on the most recent week of GVOC new prescription data, GVOC's new prescription market share for GVOC has increased to 37%. And we believe the total glucagon market will return to historical growth trends by the end of the second quarter. To be very clear, were it not for the changed healthcare situation, we believe we would have exceeded expectations for GVOC and total product revenue in the quarter, moving to our technology platform.

Tom: Importantly in late April and early May we have seen recovery in prescription fulfillment at wholesaler purchases commensurate with script demand.

Tom: Just on the most recent week of <unk>, new prescription data new prescription market share for <unk> has increased to 37% and we believe the total glucagon market will return to historical growth trends by the end of the second quarter.

Paul R. Edick: And we believe the total glucagon market will return to historical growth trends by the end of the second quarter. To be very clear, were it not for the changed healthcare situation, we believe we would have exceeded expectations for GVOC and total product revenue in the quarter, moving to our technology platform. Our Xerisol and Xerijec platform science is a growing and increasingly important part of our overall enterprise development. Not only is our formulation science what has enabled the development of GVOC and our levothyroxine pipeline product, but it's also enabling a growing number of partnerships that could deliver considerable revenue well into the future.

Tom: To be very clear we are were it not for the change healthcare situation. We believe we would've exceeded expectations for <unk> total product revenue in the quarter.

Tom: Moving to our technology platforms.

Paul R. Edick: Our Xerisol and Xerijec platform science is a growing and increasingly important part of our overall enterprise development. Not only is our formulation science what has enabled the development of GVOC and our levothyroxine pipeline product, but it's also enabling a growing number of partnerships that could deliver considerable revenue well into the future. On Monday, we announced that we entered into an exclusive worldwide collaboration and license agreement with Beta Bionics for the development and commercialization of a new and unique Xerosol-based formulation of liquid-stable glucagon for use in bihormonal pumps or pump systems. To be clear, this is not GVOKE.

Tom: Our <unk> platform science is a growing and increasingly important part of our overall enterprise development.

Tom: Not only is our formulation science what has enabled the development of <unk> and our legal thyroxine pipeline product, but it's also enabling a growing number of partnerships that could deliver considerable revenue well into the future.

Paul R. Edick: On Monday, we announced that we entered into an exclusive worldwide collaboration and license agreement with Beta Bionics for the development and commercialization of a new and unique Xerosol-based formulation of liquid-stable glucagon for use in bihormonal pumps or pump systems. Just to be clear, this is not GVOC. We are formulating a new loop gun specifically for use in a pump.

Tom: And our latest partnership on Monday, we announced that we entered into an exclusive worldwide collaboration and license agreement with beta bionics for the development and commercialization of.

Tom: A new and unique zero cell based formulation of a liquid stable glucagon for use in by hormonal pumps or pump systems just to be clear. This is not <unk>. We are formulating a new <unk> specifically for use in a pump.

Paul R. Edick: We are formulating a new group gun specifically for use in a pump. Through this partnership, we have the potential to receive payments through clinical development and low double-digit royalties on future sales of Xeris Glucagon for pumps and pump systems. Some other notable developments in the quarter include, as we announced in January, Amgen executed the exclusive license agreement to develop, manufacture, and commercialize a subcutaneous formulation of tepratupamab using our Xeriject technology for thyroid eye disease. With Regeneron, we have completed formulation development for both initial molecules.

Paul R. Edick: Through this partnership, we have the potential to receive payments through clinical development and low double-digit royalties on future sales of Xeris Glucagon for pumps and pump systems. Some other notable developments in the quarter include, as we announced in January, Amgen executed the exclusive license agreement to develop, manufacture, and commercialize a subcutaneous formulation of tepratupamab using our Xeriject technology for thyroid eye disease. With Regeneron, we have completed formulation development for both initial molecules.

Tom: Through this partnership we have the potential to receive payments through clinical development and low double digit royalties on future sales of <unk> glucagon for pumps and pump systems.

Tom: Some other notable developments in the quarter as we announced in January Amgen executed the exclusive license agreement to develop manufacture and commercialize a subcutaneous formulation of <unk> using our <unk> technology in cellulite eye disease with Regeneron, we have completed formulation.

Tom: <unk> for both initial molecules.

Paul R. Edick: Regeneron's stability and non-clinical evaluations will take place over the next six months. Assuming continued success, that could lead to their potentially executing a license option for further clinical development and commercialization of any of the molecules in the platform, which would trigger additional one-time milestones. Now on to an update on our Xerosol Levothyroxine Program, a potential once-weekly subcutaneous injection. We successfully completed the phase two clinical study, and data will be available by the end of the second quarter.

Paul R. Edick: Regeneron's stability and non-clinical evaluations will take place over the next six months. Assuming continued success, that could lead to their potentially executing a license option for further clinical development and commercialization of any of the molecules in the platform, which would trigger additional one-time milestones. Now on to an update on our Xerosol Levothyroxine Program, a potential once-weekly subcutaneous injection. We successfully completed the Phase II clinical study, and data will be available by the end of the second quarter.

Tom: <unk> stability of non clinical evaluations will take place over the next six months.

Tom: Assuming continued success that could lead to their potentially executing a license option for further clinical development and commercialization of any of the molecules in the platform, which would trigger additional onetime milestone.

Tom: Now onto an update of our aerosol legal thyroxine program a potential once weekly subcutaneous injection.

Tom: We successfully completed the phase II clinical study and data will be available by the end of the second quarter.

Paul R. Edick: As a reminder, this oral dose conversion data will help inform our proposal to the FDA for a pivotal phase three program. We anticipate requesting an end of phase two meeting later this year. If we gain alignment with FDA on a phase three study design, we can start that study as early as mid-2025. Here is my overriding message today.

Paul R. Edick: As a reminder, this oral dose conversion data will help inform our proposal to the FDA for a pivotal phase three program. We anticipate requesting an end of phase 2 meeting later this year. If we gain alignment with FDA on a phase three study design, we can start that study as early as mid-2025. Here is my overriding message today.

Paul R. Edick: As a reminder, this oral dose conversion data will help inform our proposal to the FDA for a pivotal phase three program. We anticipate requesting an end-of-Phase II meeting later this year. If we gain alignment with FDA on a Phase III study design, we can start that study as early as mid-2025. Here is my overriding message today.

Tom: As a reminder, the oral.

Tom: This oral dose conversion data will help inform our proposal to the FDA for a pivotal phase III program.

Tom: We anticipate requesting an end of phase II meeting later this year, if we gained alignment with FDA on the phase III study design, we can start that study as early as mid 2025.

Tom: Here's my overwriting message today, our commercial product portfolio is generating significant growth and we are adding new meaningful technology partnerships, we continue to meet or exceed expectations across the board. Despite the temporary impact of external uncontrollable events such as change healthcare.

Steven M. Pieper: Our commercial product portfolio is generating significant growth, and we are adding new meaningful technology partnerships. We continue to meet or exceed expectations across the board, despite the temporary impact of external uncontrollable events, such as changing health care. That continued performance and our future outlook is what gives us confidence in tightening our revenue guidance for 2024. We are raising the low end of our total revenue range from $170 to $175 million. Our revised total revenue guidance is now $175 million to $200 million.

Paul R. Edick: Our commercial product portfolio is generating significant growth, and we are adding new meaningful technology partnerships. We continue to meet or exceed expectations across the board, despite the temporary impact of external uncontrollable events, such as healthcare changes. That continued performance and our future outlook is what gives us confidence in tightening our revenue guidance for 2024. We are raising the low end of our total revenue range from $170 to $175 million. Our revised total revenue guidance is now $175 million to $200 million.

Tom: That continued performance and our future outlook is what gives us confidence in tightening our revenue guidance for 2024.

Tom: We are raising the low end of our total revenue range from 170 to $200 million to $175 million.

Tom: Our revised total revenue guidance is now 175 million to $200 million.

Paul R. Edick: Our overall strong business performance is also enabling us to make incremental investments in our commercial business, our technology business, and our internal pipeline while maintaining our cash guidance of $55 to $75 million at year end 20204. We continue to build a healthy, self-sustaining enterprise. I'll now turn the call over to Steve for additional details on our financial performance.

Steven M. Pieper: Our overall strong business performance is also enabling us to make incremental investments in our commercial business, our technology business, and our internal pipeline while maintaining our cash guidance of $55 to $75 million at year-end 2024. We continue to build a healthy, self-sustaining enterprise. I'll now turn the call over to Steve for additional details on our financial performance.

Tom: Our overall strong business performance is also enabling us to make incremental investments in our commercial business, our technology business and our internal pipeline, while maintaining our cash guidance of $55 to $75 million at year end 2024.

Tom: We continue to build a healthy self sustaining enterprise.

Tom: I'll now turn the call over to Steve for additional details on our financial performance.

Steven M. Pieper: Thanks Paul and good morning everyone. As Paul mentioned, we're off to a great start. All three of our commercial products grew revenue in the first quarter compared to last year. We ended the quarter with net product revenue of 40.3 million, a roughly 25% increase compared to last year, and total revenue of 40.6 million, a 22% increase compared to last year. Starting with Recorilev revenue, Recoralov net revenue was 10.6 million for the first quarter, a 137% increase compared to the prior year and an 8% increase from the fourth quarter of 2023. This growth was primarily driven by the average number of patients on Recoraleb increasing 139% from last year and 18% compared to the fourth quarter.

Steven M. Pieper: Thanks, Paul. And good morning, everyone.

Steve: Thanks, Paul and good morning, everyone.

Steve: Paul mentioned, we're off to a great start all three of our commercial products grew revenue in the first quarter compared to last year. We ended the quarter with net product revenue of $43 million, a roughly 25% increase compared to last year and total revenue of $40 6 million a 22.

Steven M. Pieper: As Paul mentioned, we're off to a great start. All three of our commercial products grew revenue in the first quarter compared to last year. We ended the quarter with net product revenue of $40.3 million, a roughly 25 percent increase compared to last year, and total revenue of $40.6 million, a 22 percent increase compared to last year. Starting with Rekorlev, Rekorlev Net Revenue was $10.6 million for the first quarter, a 137% increase compared to the prior year, and an 8% increase from the fourth quarter of 2023.

Steve: <unk> increased compared to last year star.

Steve: Starting with her Korolev revenue <unk> net revenue was $10 6 million for the first quarter, a 137% increase compared to prior year and an 8% increase from the fourth quarter 2023.

Steven M. Pieper: This growth was primarily driven by the average number of patients on Recoraleb increasing 139% from last year and 18% compared to the fourth quarter. We continue to be encouraged by patient demand growth for Recoraleb, which has been fueled by a consistently increasing pipeline of referrals, growing 93% compared to last year and 10% compared to the fourth quarter. Based on the early success of our fourth quarter Record Lab field expansion and a strong start to the second quarter, we will continue to add field and patient support resources this year to drive revenue growth in 2024 and beyond. Moving to Cavalas.

Steve: This growth was primarily driven by the average number of patients on <unk>, increasing 139% from last year and 18% compared to the fourth quarter. We continue to be encouraged by the patient demand growth for core lab, which has been fueled by a consistently increasing pipeline of referrals.

Steven M. Pieper: We continue to be encouraged by patient demand growth for Recoraleb, which has been fueled by a consistently increasing pipeline of referrals, growing 93% compared to last year and 10% compared to the fourth quarter. Based on the early success of our fourth quarter Recorelev field expansion and a strong start to the second quarter, we will continue to add field and patient support resources this year to drive revenue growth in 2024 and beyond. Moving to Kavayas.

Steve: Rowing, 93% compared to last year, and 10% compared to the fourth quarter.

Steve: Based off the early success of our fourth quarter record of love field expansion and a strong start to the second quarter, we will continue to add field and patient support resources. This year to drive revenue growth in 2024 and beyond.

Steven M. Pieper: Cabeza's net revenue for the quarter was $13.1 million, representing a 3% increase compared to the same period last year. Kiveyas continues to be resilient and actually beat our internal estimate in the first quarter. Our strategy to invest in Kiveyas and defend the brand continues to be successful.

Steve: Moving to <unk>.

Steven M. Pieper: Kaveas net revenue for the quarter was 13.1 million representing a 3% increase compared to the same period last year. Kiveyas continues to be resilient and actually beat our internal estimate in the first quarter. Our strategy to invest in Kiveyas and defend brand continues to be successful.

Steve: <unk> net revenue for the quarter was $13 1 million, representing a 3% increase compared to the same period last year.

Steve: <unk> continues to be resilient and actually beat our internal estimate in the first quarter.

Steve: Our strategy to invest in <unk> and defend brand continues to be successful starting in the fourth quarter and continuing into the first quarter. We saw a slight decrease in patient demand due to generic pressure. However, this decrease was lower than we anticipated and was offset by an increase.

Steven M. Pieper: Starting in the fourth quarter and continuing into the first quarter, we saw a slight decrease in patient demand due to generic pressure. However, this decrease was lower than we anticipated and was offset by an increase in price. Our patient referrals increased 27% compared to the prior year and 35% compared to the fourth quarter. This performance continues to reinforce the strength of the Cabeus brand, including Xeris Care Connections, which offers the best-in-class therapy and support for primary periodic paralysis patients. Moving to G-Vote.

Steve: And pricing.

Steve: Our patient referrals increased 27% compared to prior year and 35% compared to the fourth quarter. This performance continues to reinforce the strength of the <unk> brand, including <unk> care connections, which offers the best in class therapy and support for primary periodic.

Steve: Paralysis patients.

Steve: Moving to <unk>.

Steven M. Pieper: GVOC net revenue was $16.6 million for the first quarter, representing a 10% increase compared to the same period last year. Importantly, in the first quarter, GVOC prescriptions grew 27% compared to the same period last year, and GVOC ended the quarter with a market share of 33%, a 5% share increase from the same period last year. As Paul mentioned, we believe that GVOC's growth and net revenue were negatively impacted by the changed healthcare cybersecurity breach, which we estimate had as much as a $3 million temporary impact on GVOC net sales in the first quarter.

Steve: <unk> net revenue was $16 6 million for the first quarter.

Steve: Representing a 10% increase compared to the same period last year importantly in the first quarter <unk> prescriptions grew 27% compared to the same period last year and <unk> ended the quarter with market share of 33%, a 5% share increase from the same period last year.

Steve: As Paul mentioned, we believe that <unk> growth and net revenue was negatively impacted by the change healthcare cyber security breach, which we estimate had as much as a $3 million temporary impact on <unk> net sales in the first quarter.

Steven M. Pieper: Looking ahead to the second quarter, we are seeing strong demand for GVOC and underlying patient prescriptions, which exceeded 5,000 in the most recent weekly data, as well as increased orders from our wholesalers. We believe that the temporary effects of the Change Healthcare cybersecurity breach will be largely resolved by the end of the second quarter.

Steve: Looking ahead to the second quarter.

Steve: We are seeing strong demand for <unk> underlying patient prescriptions, which exceeded 5000 in the most recent weekly data as well as increased orders from our wholesalers. We believe that the temporary effects of the change healthcare cyber security breach impacts will be largely resolved by the end of the second quarter.

Steven M. Pieper: Looking ahead to the full year, we are tightening our total revenue guidance by raising the low end of the range, with revised guidance going to $175 to $200 million from the original guidance of $170 to $200 million. We are tightening our guidance to reflect the strong performance of Recoraleb, the continued resilience of Kiveyas, and the expected contributions from our technology partnerships. Moving down the P&L, cost of goods sold in the fourth quarter was $6 million, a 12% increase compared to the same quarter last year.

Steve: Looking ahead to the full year, we are tightening our total revenue guidance by raising the low end of the range with revised guidance going to 175 million to $200 million from the original guidance of $170 million to $200 million, we're tightening our guidance to reflect the strong performance of our core lab. The continued resilience of <unk>.

Steve: <unk> and the expected contributions from our technology partnerships.

Steven M. Pieper: This increase was driven by higher product sales. Research and development expenses were $7.8 million for the quarter, an increase of $3 million compared to the same period last year. Consistent with my remarks in March, we continue to make strategic investments in our pipeline, notably Levothyroxine and our Emerging Technology Partnership business, which has and will result in an increase in our R&D costs this year. Selling general and administrative expenses were $38.4 million for the quarter, an increase of $4.8 million compared to the same period last year.

Steve: Moving down the P&L cost of goods sold in the fourth quarter was $6 million.

Steve: 12% increase compared to the same quarter last year. This increase was driven by higher product sales.

Steve: Research and development expenses were $7 8 million for the quarter, an increase of $3 million compared to the same period last year.

Steve: Consistent with my remarks in March we continue to make strategic investments in our pipeline, notably Levo thyroxine in our emerging technology partnership business, which has and will result in an increase in our R&D cost this year.

Steve: Selling general and administrative expenses were $38 4 million for the quarter, an increase of $4 8 million compared to the same period last year. This increase was driven by rent expense related to our headquarter lease which commenced in April 2023, and a higher personnel costs, primarily driven by a modest field.

Steven M. Pieper: This increase was driven by rent expense related to our headquarter lease, which commenced in April 2023, and higher personnel costs primarily driven by a modest field expansion in the fourth quarter. Looking ahead for the full year, we are projecting a modest increase in SG&A this year, which includes the impact of the incremental investment we are making in the RecorLib business to drive growth in 2024 and beyond. Moving to cash, we ended the quarter with $87.4 million in cash, which included net proceeds from the Hafen term loan refinancing of approximately $35 million.

Steve: Pension in the fourth quarter looks.

Steve: Looking ahead for the full year, we are projecting a modest increase to SG&A. This year, which includes the impact of the incremental investment we're making in the record core lab business to drive growth in 2024 and beyond.

Steve: Moving to cash we ended the quarter with $87 $4 million in cash which included net proceeds from the <unk> term loan refinancing of approximately $35 million from.

Steven M. Pieper: From a cash guidance perspective, we continue to maintain our previous guidance of $55 to $75 million, which considers our revised revenue guidance, as well as the additional investments we are making in the RecorLib business. We are able to make these investments as a result of strong revenue growth combined with continued disciplined expense management of our enterprises. Xeris is off to a great start in 2024, and we look forward to continuing to build on this moment. With that, Operator, please open the lines for questions.

Steve: From a cash guidance perspective, we continue to maintain our previous guidance of $55 to $75 million, which considers our revised revenue guidance as well as the additional investments, we're making in the <unk> business.

Steven M. Pieper: We are able to make these investments as a result of strong revenue growth combined with continued disciplined expense management of our enterprise.

Steven M. Pieper: <unk> is off to a great start in 2024, and we look forward to continuing to build on this momentum.

Steven M. Pieper: With that operator, please open the lines for questions.

Speaker Change: Thank you if you would like to ask a question. Please press star one on the telephone keypad or press star two if you would like to withdraw your question. The first question comes from our enlist <unk> from H C. Wainwright. Please go ahead.

Operator: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad, or press star 2 if you would like to withdraw your question. The first question comes from Oren Livnat from HC Wainwright. Please go ahead.

Oren Gabriel Livnat: Thanks, I have a couple. First, on the guidance, can you just clarify tightening up the bottom end, you know, is that essentially maintaining your conservative assumptions on conveyance, you know, tightening up the bottom as an outperforming Q1, but essentially continuing to assume a significant decline going forward from generic impact, and I follow.

Oren Gabriel Livnat: Uh, thanks, I have a couple of questions. First, on the guidance, can you just clarify tightening up the bottom end, you know, is that essentially maintaining your conservative assumptions on conveyance, you know, tightening up the bottom as an outperforming Q1, but essentially continuing to assume that I don't see a significant decline going forward from generic impact, and I follow.

Speaker Change: Thanks, So I got a couple.

Steven M. Pieper: First on the guidance can you just clarify tightening up the bottom end.

Steven M. Pieper: Is that essentially maintaining our conservative assumptions on covance tightening up the bottom as it outperformed in Q1, but essentially.

Steven M. Pieper: To assume.

Steven M. Pieper: The significant decline going forward from generic impact.

Steven M. Pieper: My follow ups.

Paul R. Edick: Actually, Oren, it's Paul. Raising the bottom is being less conservative on Cabeas. We're pretty excited about what happened in the first quarter. It exceeded what we anticipated. And contrary to what we guided previously, we had said that we'd get a hit in the first quarter and some decline thereafter. But the first quarter hit wasn't even close to what we thought. Therefore, the decline will be a little bit less than we thought. Still, there's some softening there. But we're very pleased with and a little bit surprised. But no matter how resilient Cabeas is.

Steven M. Pieper: Actually our and as Paul.

Steven M. Pieper: The raising the bottom is being less conservative on <unk>, we're pretty excited about what happened in the first quarter. It exceeded what we anticipated and contrary to what we guided previously we had said that we thought we'd get a get hit in the first quarter and some declines thereafter, the first quarter. It wasn't even close to what we thought therefore.

Steven M. Pieper: The decline will be a little bit less than what we thought still there is some softening there but.

Steven M. Pieper: We're very pleased with a little bit surprised.

Steven M. Pieper: How resilient today it is.

Steven M. Pieper: Yeah, I would just add to that, Oren, that we're seeing that momentum really continue into Q2 as well across all of our brands. Yeah. And that gives us confidence to raise the bottom of it.

Steven M. Pieper: Yeah, I would just add to that, Oren, that we're seeing that momentum really continue into Q2 as well, across all of our brands. And that gives us confidence to raise the bottom end.

Speaker Change: Yes, I would just add to that or in that.

Steven M. Pieper: We're seeing that momentum really continue into Q2 as well.

Steven M. Pieper: Across all of our brands.

Steven M. Pieper: And that gives us confidence to raise the bottom end.

Steven M. Pieper: Yes.

Oren Gabriel Livnat: Great. And on Levo, I think you said that you successfully completed phase two, and I guess we're still waiting for a couple months to see more data. Can you just remind us, you know, what you need to see? What is it, what does success entail? And Is there any delay in, I guess, us seeing this data? Is there anything to work through still at this point, or is it just a matter of data crunching?

Steven M. Pieper: Great and on.

Steven M. Pieper: Levo.

Steven M. Pieper: You said that you successfully completed phase two and I guess, we're still waiting for a couple of months to see more data can you just remind us.

Steven M. Pieper: What you need to see what is what is success and tail and.

Steven M. Pieper: Is there any delay and I guess I was seeing this data is there anything to add.

Steven M. Pieper: Work to sell at this point or is it just a matter of data crunch.

Paul R. Edick: It's just a matter of data crunching. Last patient, last visit, successful completion is when we hit the number of patients we needed. We've gotten everybody through the study. We have all the patient records. Now it's a matter of just crunching through all the data. If you recall, the purpose of the study was to confirm the conversion ratio from oral to liquid. In our phase one healthy volunteer study, that was a 4X. This study is designed to confirm whether that is still the case when we do it at multiple doses or multiple different dosage levels in real life. I hope I've got it right, Chase.

Paul R. Edick: It's just a matter of data crunching. We've got the last patient, the last visit, successful completion is, we hit the number of patients we needed, we've gotten everybody through the study, we've got all the patient records, now it's just a matter of just crunching through all the data. If you recall, the purpose of the study was to confirm the conversion ratio from oral to liquid. In our phase one healthy volunteer study, that was a four X conversion. This study is designed to confirm whether that is still the case when we do it at multiple doses or multiple different dosage levels in real life. I hope I've got it right, Chase.

Steven M. Pieper: It's just a matter of data Crunch, we've last patient last visit successful completion as we hit the number of patients we needed we've gotten everybody through the study.

Steven M. Pieper: Got all of the patient.

Steven M. Pieper: Records now it's a matter of just crunching through all the data if you recall the purpose of this study was to confirm the conversion ratio from oral to liquid.

Paul R. Edick: Can you say if there is any difference between healthies and thyroid patients at this point?

Steven M. Pieper: In our phase one healthy volunteer study that was a four X conversion.

Steven M. Pieper: This study is designed to confirm whether that is still the case when we do it at multiple doses and multiple different dosage levels in actual.

Steven M. Pieper: Sure.

Speaker Change: Hi, folks I rotations.

Steven M. Pieper: Yes.

Paul R. Edick: Can you say if there is any difference between healthies and thyroid patients at this point?

Steven M. Pieper: Can you say if there was any difference.

Steven M. Pieper: Between healthy and toric patients at this point.

Steven M. Pieper: Yeah.

Paul R. Edick: We have not gotten the top line data yet.

Steven M. Pieper: We have not gotten the top line data yet.

Oren Gabriel Livnat: All right, great. And just lastly, on GVOC, thanks for quantifying that impact. I know you had already expected a little de-stocking this quarter, and it sounds like this cyber attack caused additional headwinds. Can you just say, was that $3 million impact inclusive of normal seasonal de-stocking? Is that all in the sort of net impact of everything versus what the underlying demand sales would have been, that $3 million?

Steven M. Pieper: Alright, great and.

Steven M. Pieper: And just lastly.

Steven M. Pieper: <unk>. Thanks for quantifying that impact I know you had already expected a little destocking this quarter and it sounds like the cyber attack caused.

Steven M. Pieper: Additional headwinds can you just say what that $3 million impact inclusive of normal seasonal destocking is that all in the sort of net impact is everything versus what the underlying demand sales would've been.

Steven M. Pieper: That $3 million.

Steven M. Pieper: It's all in. Yeah, so it's the underlying demand, which you would see in scripts as well as wholesaler de-stocking, which was significantly more pronounced than we've historically seen. And the timing of it was pretty directly correlated with the timing of the cyber attacks.

Paul R. Edick: It's all in. Yeah, so it's the underlying demand, which you would see in scripts as well as wholesaler de-stocking, which was significantly more pronounced than we've historically seen. And the timing of it was pretty directly correlated with the timing of the cyber attacks.

Steven M. Pieper: It's all in yeah, so the underlying demand, which you would see in scripts as well as.

Steven M. Pieper: Wholesaler Destocking, which.

Steven M. Pieper: Was.

Steven M. Pieper: Significantly more pronounced than we will.

Steven M. Pieper: Historically seen.

Steven M. Pieper: And the timing of it was pretty directly correlated with the timing of the cyber attack.

Oren Gabriel Livnat: So going forward, I mean, obviously, the scripts look great. On top of that, should we expect some rebound and maybe stock up in 2Q? And is there any hangover from a net unit economics perspective in general? Like, do you have to do additional or different patient assistance than you would normally be doing in 2Q to salvage patients that you might have lost or otherwise right to ship?

Steven M. Pieper: So going forward.

Steven M. Pieper: Obviously, the scripts look great.

Steven M. Pieper: On top of that should we expect some rebound and maybe stock in Q2 and is there any hangover from.

Steven M. Pieper: Net unit economics perspective in general like do you have to do additional or different patient assistance than you would normally be doing in the <unk>. The salvage patients that you might have.

Steven M. Pieper: Lost or otherwise right the ship.

Steven M. Pieper: Yeah, we don't have to do anything extra; we don't believe it. The copay card is a pretty good barometer of what's going on with patients, and, you know, we're already starting to see it rebound. Whether or not we get back those prescriptions that may have been stacking up in the pharmacies, we'll see. We believe we'll get some of them, but there may be a period of a little bit of increased abandonment. But if there was a prescription written for a patient, even if they don't pick up that one, they're probably going to get another one written, so we'll still get those patients.

Paul R. Edick: Yeah, we don't have to do anything extra; we don't believe it. The copay card is a pretty good barometer of what's going on with patients, and, you know, we're already starting to see it rebound. Whether or not we get back those prescriptions that may have been stacking up in the pharmacies, we'll see. We believe we'll get some of them, but there may be a period of a little bit of increased abandonment. But if there was a prescription written for a patient, even if they don't pick up that one, they're probably going to get another one written, so we'll still get those patients.

Steven M. Pieper: Yes.

Steven M. Pieper: Don't have to do anything extra we don't believe the copay card.

Steven M. Pieper: Good barometer of what's going on with patients and we're already starting to see it rebound.

Steven M. Pieper: Whether or not weak.

Steven M. Pieper: We get back those prescriptions that may have been stacking up the pharmacies, we will see we believe we'll get we'll get some of them, but there may be a period of a little bit of increased abandonment, but.

Steven M. Pieper: If there was a prescription written for a patient even if they don't pick up that one they are probably going to get another one Ricky so we'll still get those patients.

Steven M. Pieper: Yeah, and what I would say, Oren, to your first question around wholesaler inventory levels, I would say that, in total, our wholesalers are running at historically low inventory levels. Whether or not they build, you know, inventory up remains to be seen. We don't anticipate it going any lower, so no downside there, but if anything, potential for upside, but that really remains to be seen.

Speaker Change: Yeah, and what I would say orange to your first question around wholesaler inventory levels I would say that.

Steven M. Pieper: On.

Steven M. Pieper: In total our wholesalers are running at historically low inventory levels.

Steven M. Pieper: Whether or not they build inventory.

Steven M. Pieper: Inventory up.

Oren Gabriel Livnat: All right, thanks, and I will get back and QT.hug the time. Thanks.

Operator: Our next question comes from Roanna Ruiz from Lerink Partners. Please go ahead.

Roanna Clarissa H. Ruiz: Great morning, everyone. So I wanted to ask about the collaboration with Betabionics. So what is the approximate timeline to possible commercialization of this glucagon pump? And how big do you think that market opportunity could be?

Paul R. Edick: Well, I think that is a little bit more of a question for beta bionics at the end of the day. What we've done is, beta bionics, obviously, they've been in the process of developing a bi-hormonal pump that would provide, with an algorithm, that detects your insulin and detects your glucose and can give you a little bit of each as necessary. It really has been something that has been a pursuit in glycemic control for decades.

Steven M. Pieper: It detects your insulin that detects your glucose and can give you a little bit of each as necessary.

Steven M. Pieper: It's really has been something that has been a pursuit in the control of glace.

Steven M. Pieper: <unk> control for decades.

Paul R. Edick: They have perfected the pump, and they have it on the market with one hormone, being the insulin component. Our deal will facilitate the second hormone. So we have glucagon that is liquid stable glucagon that can be put in the pump to facilitate further clinical development, phase two, phase three of the pump with both hormones. At some point, hopefully in the next few years, with approval, it could be an important part of glycemic control for a lot of patients.

Steven M. Pieper: They have perfected the pump and they have it on the market with one hormone being the insulin component.

Steven M. Pieper: Our deal will facilitate the second hormone. So we have the glucagon that is liquid stable glucagon that can be put in the pump to facilitate further clinical development phase two phase III of the pump with both hormones.

Steven M. Pieper: At some point hopefully in the next few years with approval it could be an important part of <unk> control for a lot of patients anybody that's on a pump today could very well want to have a closed loop system with two hormones included so for US it's an important partnership because it could mean for significant sales of our.

Paul R. Edick: Anybody that's on a pump today could very well want to have a closed-loop system with two hormones included. So for us, it's an important partnership because it could mean significant sales of our new, different formulation of glucagon in the future.

Steven M. Pieper: New different formulation of glucagon in the future.

Roanna Clarissa H. Ruiz: Got it. That helps. And the second question on RecorLev.

Speaker Change: Got it that helps and second question on <unk> It seems to be showing some really great traction could you talk about weekly growth trends that you saw in patient referrals in the recent quarter and if you're seeing anything going into second quarter and what you expect for the rest of the year.

Paul R. Edick: It seems to be showing some really great traction. Could you talk about the weekly growth trends that you saw in patient referrals in the recent quarter? And if you're seeing anything going into the second quarter and what you expect for the rest of the year? Yeah, so I don't

Paul R. Edick: Yeah, so... I don't have the weekly data right here in front of me. We track it like a hawk, as you can imagine. But the growth of referrals has been outstanding. And April has been, even, even more encouraging. We're not going to preview what April did. But if you if, Sitting here today, April for both Rekorlev and Coveas, and Givoke for that matter, are all looking great.

Paul R. Edick: Yeah, so... I don't have the weekly data right here in front of me. We track it like a hawk, as you can imagine. But the growth of referrals has been outstanding. And April has been, even, even more encouraging. We're not going to preview what April did. But if you look at it sitting here today, April for both Rekorlev and Coveas, and Givoke, for that matter, are all looking

Speaker Change: Yeah. So.

Speaker Change: I don't have the weekly data right here in front of me, we track it like like a hawk as you can imagine.

Steven M. Pieper: But the the growth referrals has been outstanding and.

Steven M. Pieper: April has been.

Steven M. Pieper: Even even more encouraging.

Steven M. Pieper: We're not going to preview what April did but if sitting here today.

Steven M. Pieper: April for both <unk> and <unk> and <unk> for that matter are all looking great.

Speaker Change: Great. Thanks.

Operator: Our next question comes from David Amsellem from Pieper Sandler. Please go ahead.

Steven M. Pieper: Our next question comes from David <unk> from Piper Sandler. Please go ahead.

David A. Amsellem: Hi, this is Skylar speaking on behalf of David. First, on the correlates, can you talk more about the patient footprint, just what you're seeing from treatment naive versus experience and thoughts on the trajectory, and just overall how you're thinking about the addressable patient population in light of the catalyst study data that shows the prevalence of Cushing's might be much higher than previously understood?

Steven M. Pieper: Hi, This is Carolyn for David first <unk> can you talk more about the patient footprint is what you're saying.

Steven M. Pieper: First experience and that's on the trajectory and just overall higher thinking about the intractable patient population in light of the study data shows the prevalent cushings might be much higher than previously understood.

Paul R. Edick: Yeah, great questions. We believe that the addressable patient population is much larger than the way this category has been viewed historically, without question. So we see that as a tremendous opportunity. To the first part of your question, we're getting patients who have been on other products. There's quite a bit of churn in this category, as you would expect. These are ill people. They have a lot going on.

Speaker Change: Yeah, great questions.

Steven M. Pieper: We believe that the patient of the addressable patient population is much larger than it has been the way. This category has been viewed historically without question.

Steven M. Pieper: So that we see that is a tremendous opportunity to the first part of your question we're getting paid.

Steven M. Pieper: Patients who have been on other products, there's quite a bit of churn in this category as you as you would expect.

Steven M. Pieper: These are these are <unk>.

Steven M. Pieper: People they have a lot of lot going on.

Paul R. Edick: We're getting quite a few patients from Coraline simply because our product... normalizes cortisol. We don't just treat symptoms. So that, we believe, gives us an advantage. But, in essence, we're getting patients from across the board. And interestingly, physicians who've tried Recoralev are starting to use it first-line. So we're getting drug-naive patients, which is early in the lifespan of a product in this kind of category, in this kind of rare disease, to already be treating first-line patients. So we're very encouraged by that, and I think that's what's driving the referral pipeline to a large extent...

Steven M. Pieper: We are getting quite a few patients from corwin simply because our <unk>.

Steven M. Pieper: Product.

Steven M. Pieper: Normalized cortisol, we don't just treat symptomatically. So that we believe gives us an advantage, but in essence, we're getting patients from across the board and interestingly physicians who've tried <unk> are starting to use it first line. So we're getting we're getting drug naive patients which is early in the lifespan of.

Steven M. Pieper: Product in this kind of category in this kind of a rare disease to already beginning first line patients. So we're very encouraged by that and I think that's what's driving the referral pipeline to a large degree.

Paul R. Edick: Great, that is helpful. And then just one more question: how are you thinking about the overall growth of the glucagon rescue category, the underlying opportunity there? And what do you think would be some talent that would increase the penetration of the overall market?

Steven M. Pieper: Great that a couple and then just one more how are you thinking about the overall growth.

Steven M. Pieper: Glucagon rescue category.

Steven M. Pieper: Opportunity there and what do you think would be some talent increased penetration at the overall market.

David A. Amsellem: The rescue category in glucagon. I didn't hear the first part of your question.

Steven M. Pieper: The rescue category and glucagon I didn't hear the first part of your question.

David A. Amsellem: Yes, just the overall opportunity there and what you think will increase the penetration of that market. Yeah, I mean, if you look at what's going on, you see...

Steven M. Pieper: Yeah, it's just the overall opportunity there and what you think will increase penetration of that market.

Paul R. Edick: Yeah, I mean, if you look at what's going on, we've seen some fluctuation in the growth rate of the total market over time, but we fully expect to get back to double-digit growth. Pre-pandemic, it was growing 25-30 percent, so there's good momentum there. What's even more important is regardless of the potential growth or the rate of growth of the overall market, of which we drive the majority of that growth, our share of new prescriptions is increasing dramatically.

Speaker Change: Yeah, I mean, if you if you look at what's going on we've seen some fluctuation in the growth rate of the total market over time.

Steven M. Pieper: But we fully expect it to get back to double digit growth pre pandemic. It was grown 25, 30%.

Steven M. Pieper: So there's good momentum there, what's even more important is regardless of the potential growth or the rate of growth of the overall market, which were driving the majority of that growth our share of new prescriptions is increasing dramatically. If you look at it it's grown five or 6% in the last few months, so as the market as the market growth.

Paul R. Edick: If you look at it, it's grown, you know, five or six percent in the last few months. So as the market increases, our share is increasing, so that all bodes really well for the future for GVO. And there are, you know, 15 million people out there who need a rescue device, and only a million actually have one. So there's tremendous opportunity.

Steven M. Pieper: Increases our share is increasing so that all bodes really well for the future for Djibo.

Steven M. Pieper: And.

Steven M. Pieper: The 50 million people out there who need a rescue device and only 1 million actually have one so there is tremendous opportunity.

Speaker Change: Helpful. Thank you.

Operator: Our next question comes from Chase Knickerbocker on behalf of Craig Hallam. Please go ahead.

Steven M. Pieper: Our next question comes from at Chase Knickerbocker from Craig Hallum. Please go ahead.

Chase Richard Knickerbocker: Hey, good morning, everyone. This is Connor on for Chase. Thanks for taking my questions.

Steven M. Pieper: Good morning, everyone. This is connor on for chase, Thanks for taking my questions.

Steven M. Pieper: It seems like <unk> continues to hold in there can you give us an update on the treatment from payers. This year are you going to start seeing any force switching to the generic.

Steven M. Pieper: So.

Chase Richard Knickerbocker: It seems like Avaeus continues to hold in there. Can you give us an update on the treatment from payers this year? Are we going to start seeing any force shift to generic?

Steven M. Pieper: We are seeing I mean.

Steven M. Pieper: We're not saying we've had no patient loss, we're seeing some patient loss, but.

Paul R. Edick: We are seeing, I mean, we're not saying we've had no patient loss; we're seeing some patient loss, but... Payers are not forcing that conversion as aggressively as we had anticipated. We figured that with the opportunity with payer insurance resets in the first quarter, payers would take the opportunity to be pretty aggressive about forcing a switch. It's just not happening as rapidly as we would have thought.

Steven M. Pieper: Payers are not forcing that conversion as aggressively as we had anticipated.

Steven M. Pieper: We figured the opportunity with payer insurance resets in the first quarter payers would take the opportunity to be pretty aggressive about forcing switch.

Steven M. Pieper: It's just not happening as rapidly as we would've thought the other thing we're seeing is a reasonably high percentage of patients who are forced to go to a generic are actually coming back.

Paul R. Edick: The other thing we're seeing is that a reasonably high percentage of patients who are forced to go to a generic are actually coming back. And a big part of that is that they don't get the support services that they're used to. They don't have a patient mentor anymore. There's a lot that they're surrounded by when they're on the brand that helps support their sort of re-entry into life that generic

Steven M. Pieper: And a big part of that is they don't get the support services that they're used to they don't have a patient mentor anymore.

Steven M. Pieper: There's a lot that they're surrounded with when they're around the brand that helped support their sort of re entry into life.

Steven M. Pieper: Generic don't provide.

Steven M. Pieper: So yeah, we're losing some but we're getting quite a few of them back and that that is a part of the overall resilience that we're seeing an <unk> performing a lot better than we had.

Paul R. Edick: Yeah, we're losing some, but we're getting quite a few of them back. And that is a part of the overall resilience that we're seeing. And Cabeas is performing a lot better than we had expected. We've been pretty conservative in our 2024 guidance, not knowing what was really going to happen. And, you know, we've been a little surprised, but in a good way.

Steven M. Pieper: We've been pretty conservative and R 2024 guidance not knowing what was really going to happen.

Steven M. Pieper: We've been little surprise, but in a good way.

Chase Richard Knickerbocker: Great. And then maybe can you dive into what else is required for the beta bionics partnership on your end? What do you need to get ready?

Speaker Change: Great and then maybe can you dive into what else is required for the beta bionics partnership on year, and what do you need to get ready.

Paul R. Edick: Our role is pretty simple. We are already starting to formulate the new version of Glucagon, which will be very different than what is in GVOC. It's a pump-specific Glucagon that will be compatible with all of the components of a pump.

Steven M. Pieper: Our role is pretty simple.

Steven M. Pieper: We will we are already starting to formulate the.

Steven M. Pieper: The new version of glucagon, which will be very different than what is in group <unk>.

Steven M. Pieper: Pumped specific glucagon that will be compatible with all of the components of a pump.

Paul R. Edick: We'll formulate that. We expect we can get that done this year. And then, beta bionics will have to do some testing of their own to confirm whatever we give them. And then, they will move into a phase two program for the dual hormone system, and then onto a phase three program, assuming success. That's all 100% beta bionics.

Steven M. Pieper: Will formulate that we figured we expect we can get that done this year and then beta biotics will have to do some testing of their own to make to confirm whatever we give them and then beta biotics will move into a phase two program for the dual hormone system and that onto a phase III program assume.

Steven M. Pieper: <unk> success, that's all 100 per cent beta Biotics, we will support those programs.

Paul R. Edick: We will support those programs through advice and consulting and help them with drug studies and things like that because they're a device company more than they are a drug company. So we'll provide that support and advice in terms of the components of a drug trial. We will manufacture supplies for both phase two and phase three. But beyond that, You know, we get a low double-digit royalty, and we get a markup on supply, and we'll continue to support them well into commercialization.

Steven M. Pieper: Through advice and consulting and helping them with drug studies and things like that because they're a device company more than they are drug company. So we will provide that support and advice in terms of the components of a drug trial.

Steven M. Pieper: We will manufacturer supply for both phase two and phase III.

Steven M. Pieper: But beyond that.

Steven M. Pieper: We get a low double digit royalty and we get a markup on supply.

Steven M. Pieper: And will continue to support them well into commercialization.

Chase Richard Knickerbocker: Great. Thanks for taking my questions.

Speaker Change: Great. Thanks for taking my questions.

Speaker Change: You're welcome.

Operator: Our next question comes from Rohan Matha from Oppenheimer. Please go ahead.

Steven M. Pieper: Our next question comes from <unk> from Oppenheimer. Please go ahead.

Rohan Matha: Hi, thanks for taking my question. This is Rohan Amsellem and Gershel, just a couple from me. When you think about the South Q Levo... opportunity. How are you viewing possible paths forward with respect to either developing the drug in-house or maybe engaging in some form of collaboration?

Speaker Change: Hi, Thanks for taking my question is <unk> just a couple of for me.

Steven M. Pieper: When you think of the lethal.

Paul R. Edick: We're open to both. We have the capabilities to develop it in-house, and we believe that we will have the financial resources in the future, especially as our commercial assets grow and start to deliver more cash to the balance sheet. By the time it's ready for commercialization, our organization will be more than capable of launching it commercially. That doesn't obviate the potential for a partner not to get it done but to make it a bigger drug than we would ourselves.

Steven M. Pieper: Opportunity How're, you feeling possible pets forward this.

Steven M. Pieper: Tither developing the drug in house or maybe engaging in some form of collaboration.

Steven M. Pieper: We are open to both.

Steven M. Pieper: We we have the capabilities to develop it in house and we.

Steven M. Pieper: We believe that we have the financial resources in the future, especially as R. As our commercial assets grow and.

Steven M. Pieper: Start to deliver more cash to the balance sheet.

Steven M. Pieper: We can develop it.

Steven M. Pieper: By the time, it's ready for commercialization, our organization will be more than capable of launching it commercially.

Steven M. Pieper: That doesn't obviate the potential for a partner not to get it done but to make it a bigger drugs and we would ourselves we see the the segment of patients for whom this would be a perfect option those who are not getting good absorption people who have dramatically variable blood.

Paul R. Edick: We see the segment of patients for whom this would be a perfect option, those who are not getting good absorption, people who have dramatically variable blood levels, people who can't tolerate the oral and gastrointestinal tract. We think that's about a 25 percent segment of the overall population, which even at today's prices, regardless of future prices, could be a $2 billion segment. So we think it's a huge opportunity, and if we choose to partner, it would be for the purposes of making it even bigger.

Steven M. Pieper: Blood levels.

Steven M. Pieper: People, who can't tolerate the oral and the gastro intestinal tract, we think that's about a 25% segment of the overall population, which even at today's prices regardless of future prices could be a $2 billion segment. So we think it's a huge opportunity.

Steven M. Pieper: And if we choose to partner it would be for the purposes of making it even bigger.

Paul R. Edick: Got it. And with respect to the Regeneron partnership, should we expect to see any updates this year and maybe anything else on the business development front? We're always active in The Business Division.

Steven M. Pieper: And.

Steven M. Pieper: With respect to the general partnerships should we expect to see any updates this year and maybe anything else on the business development.

Paul R. Edick: We're always active on the business development front. You know, it took us a while to get the beta bionic steel done. We're always talking to people about our technologies, and we're having more and more companies approach us as we do more with that end of the business. Regeneron, as I already said in my comments, over the next six months, they're doing their stability work. I don't expect any announcements this year from that.

Steven M. Pieper: We're always active on the business development front.

Steven M. Pieper: Took us a while to get to the <unk>.

Steven M. Pieper: Data Biotics deal done, we're always talking to people about our technologies and.

Steven M. Pieper: Having more and more companies approach us as we do more with that end of the business.

Steven M. Pieper: Regeneron I think I already said in my comments they are over the next six months, they're doing their stability work.

Steven M. Pieper:

Steven M. Pieper: I don't expect any any announcements this year from that.

Speaker Change: Thank you.

Operator: Our next question is a follow-up from Oren Livnat at HC Wainwright. Please go ahead.

Steven M. Pieper: Our next question is a follow up from our unless not H C.

Speaker Change: See where you might please go ahead.

Steven M. Pieper: [laughter].

Oren Gabriel Livnat: Thanks. I just want to follow up on the recall of, you know, it outperformed a bit our expectations for patients and sales, but I'm curious what you're seeing regarding ongoing up titration of dose, you know, those trends over time for, you know, longer-term patients now and new patients. Obviously, that's an important part of the long-term potential of the product. And also, can you expand a bit on the incremental investments you're making this year behind that, are those mostly on the hub and market access services, or are you actually putting more reps in the field to broaden or deepen the field presence? Thanks.

Steven M. Pieper: Thanks.

Steven M. Pieper: I just wanted to follow up on the record left and outperformed our expectations on pay shakes and sales, but I'm curious what you are saying regarding the ongoing up titration dose.

Steven M. Pieper: Trends over time for.

Steven M. Pieper: Longer term patient now and new patients.

Speaker Change: Yeah, it's an important part of the longterm potential products and also could you expand a bit on thank you mentioned incremental investment you're making this year behind that you know are those mostly in the hub and market access services are you actually putting more reps in the field brodner.

Steven M. Pieper: Field preference.

Paul R. Edick: Thanks, Warren. There are about three or four in there.

Steven M. Pieper: So.

Steven M. Pieper: <unk> and there's like about three or four in there.

Steven M. Pieper: The so let me start with dose dose.

Paul R. Edick: Dose titration, so we are seeing up titration on an individual patient basis. However, we're adding new patients so quickly at the low end, at the starting dose, that the average dose per patient is not moving that fast because we're adding so many patients so quickly at the point of entry at the starting dose. Over time, with a larger subset of patients, we'll start to see more impact on the revenue base based on up-titration, but that's a ways off.

Steven M. Pieper: Dose titration.

Steven M. Pieper: So we are seeing uptight creation on an individual patient basis. However, we are adding new patients. So quickly at the low end at the starting dose that the average dose for patient is not moving that fast.

Steven M. Pieper: Because we're adding so many patients so quickly I'm at the point of entry at the at the starting dose over time with a larger subset of patients will start to see more impact on on the.

Steven M. Pieper: The revenue base based on up titration, but that's that's a ways off.

Paul R. Edick: In terms of adding resources, we're adding to the patient support services, and we continue to add a little bit at a time to the field force. We don't want to disrupt the field force, but we will continue to add, you know, 10-15 reps to the field force. We would like, over time, to get up to the 50-60 range because the opportunity is just so big.

Speaker Change: In terms of adding resources, we're adding to the patient support services and we continue to add a little bit at a time to the field for US we don't we don't want to disrupt the field tours.

Steven M. Pieper: But we will continue to add.

Steven M. Pieper: 10, 15 reps to the field for US we would like to overtime get up to 50 60 range to be because of the opportunities are so big.

Steven M. Pieper: [noise] so how many reps you at now sorry.

Paul R. Edick: So how many reps are you at now? I'm sorry.

Steven M. Pieper: [noise] I'm looking at John Shannon to see if I could get this answer 28, I believe we have down here 28 as of today will add.

Paul R. Edick: I'm looking at John Shannon to see if I can get this answer. 28, I believe it is.

Paul R. Edick: We have 28 now. 28 as of today. We'll add, you know, another... 10 to 15. Over time. Yep, okay.

Steven M. Pieper: Another 10 to 1500 yeah.

Steven M. Pieper: Over time.

Oren Gabriel Livnat: Yeah, okay.

Steven M. Pieper: Okay.

Steven M. Pieper: Next couple of quarters.

Steven M. Pieper: Okay.

Speaker Change: I appreciate it.

Speaker Change: [noise] Oh next company. It comes from Kelly <unk> Sorry next question is from the Kelly close Kelly. Please go ahead.

Operator: Our next company comes from Kelly Close. Sorry, the next question is from Kelly Close. Kelly, please go ahead.

Kelly Close: Oh, good morning. Thank you for all of this.

Speaker Change: Oh good morning.

Steven M. Pieper: Thank you for all of this new C. D C data came out.

Kelly Close: New CDC data came out earlier this year from the National Diabetes Statistic Report showing that severe hypo events landing people in the hospital dropped to 200,000 from closer to 240,000 the last time AID as well. I was just wondering if you could talk about, you know, 25% of those people were still admitted to the hospital. It does seem like this number should be zero. Going to the hospital, the BKA numbers have gone up, you know, but what else can be done? You know, what else would you like to see in terms of partnerships, maybe philanthropic, you know, maybe other corporate partnerships? Obviously, people, this number going into the hospital could still change dramatically.

Steven M. Pieper: Earlier this year sailing from the National diabetes statistic report, saying that severe hyper advanced landing people in the hospital had dropped in 200002.

Steven M. Pieper: 240000, and the last time.

Steven M. Pieper: Data, let's get in and so thank you so much you've had a big impact and this is probably.

Speaker Change: D as well I was just wondering if you can talk about 25% of the people were still admitted to the hospital. It does seem like this number should be zero going to the hospital to decay a numbers I'm calling up.

Steven M. Pieper: But what else can be done and what else would you like to see in terms of partnerships maybe philanthropic maybe.

Steven M. Pieper: Maybe at a corporate partnerships obviously people.

Steven M. Pieper: Number going into the hospital could still change dramatically.

Paul R. Edick: Hey Kelly, thanks a lot. We really appreciate the question. And I do believe we're having an impact. I do believe more people with ready-to-use rescue devices such as Jivo and KypoPen are going to have an impact. You're absolutely correct. The most important thing that we're trying to focus on right now and have been for a while is getting the health care professionals to really re-engage. Whenever they write a prescription for insulin or siphon or urea, they should absolutely co-prescribe GVOKE or a ready-to-use rescue product. It should be mandatory. When you look at the allergy category, if you've got a severe allergy and you don't get a hypopen, that would be a rare situation.

Speaker Change: Hey, Kelly Thanks, a lot we really appreciate the question.

Steven M. Pieper: And I do believe we are having an impact I do believe more people with ready to use rescue devices, such as Djibo Hypopen. It's gonna have an impact you are absolutely correct. The most important thing that we're trying to focus on right now and have been for awhile is.

Steven M. Pieper: Getting the healthcare professionals to really reengage whenever they write a prescription for insulin or Savannah urea. They should absolutely co prescribed a G volk or ready views rescue product.

Steven M. Pieper: It should be mandatory.

Steven M. Pieper: When you look at the allergy category, if you've got a severe allergy and you don't get a hypopen.

Steven M. Pieper: That would be a rare situations. This is an equally life threatening situations people are still go into the ER still getting admitted to the hospital.

Paul R. Edick: This is an equally life-threatening situation. People are still going to the ER and still getting admitted to the hospital. There is still mortality associated with this, as you know. It is really the job of the healthcare professional to automatically, or make sure it's standing orders in their office, prescribe a GVOKE hypopen whenever they prescribe insulin. That's number one, and number two, I think the community needs to continue to be motivated to say, you know, that could be me. Even if you've been perfectly managing your condition for decades, it can happen to anybody.

Steven M. Pieper: There are still mortality associated with this as you know.

Steven M. Pieper: It is really the job of the health care professional to to automatically or make sure its standing orders in their office prescribe djibo hypopen whenever they prescribed insulin that's number one and number two I think the community needs to continue to be motivated to to say.

Paul R. Edick: Those are the two things we need to do.

Steven M. Pieper: That could be me.

Steven M. Pieper:

Steven M. Pieper: Even if you've been perfectly managing your condition for decades, it can happen to anybody so.

Steven M. Pieper: Those are the two things we need to do.

Kelly Close: Yeah, thank you so much. I know we're all really grateful to all of the clinicians who are really overworked also. So, you know, all the questions coming from the patient community and so forth, I think, would also be really helpful. And that also seems doable. So thank you very, very much for all of your incredible impact.

Speaker Change: Yeah. Thank you so much I know, we're all just grateful to all of that clinicians who are really overworked also so you know.

Steven M. Pieper: Question is coming from tasting community and so forth I think what else have been really helpful.

Steven M. Pieper: <unk> Sam Thank you very much for all of their incredible impact.

Paul R. Edick: Thank you. We appreciate it.

Speaker Change: Thank you we appreciate it.

Operator: We have no further questions on the call, so I'll hand the floor back to Paul Edick for closing remarks.

Speaker Change: We have no further questions on the call. So I'm, the kind of float back to pull edicts of closing remarks.

Paul R. Edick: Thank you. As you heard, we've delivered another quarter of growth and are very proud of our performance to date. We expect the momentum to continue in the balance of 2024. We've seen a tremendous acceleration in April, and we look forward to another year of growing an enterprise that we can all be very proud of.

Steven M. Pieper: Thank you as you heard we've delivered another growth quarter of growth are very proud of our performance to date, we expect that momentum to continue in the balance of 2024, we've seen a tremendous acceleration in April and we look forward to another year of growing and enterprise, which we can all be very proud of.

Operator: This concludes the conference call. Thank you all very much for joining us.

Speaker Change: This concludes the conference call. Thank you very much for joining.

Steven M. Pieper: [music].

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