Post by icemandios on Aug 10, 2022 12:24:44 GMT
Xeris Biopharma Reports Second Quarter Financial Results and Upcoming Events
Achieved record net product revenue of $25.3M – a 15% increase from Q1 ’22, and a 34% increase from same period prior year on a pro forma basis
Ended Q2 with $111.6M in cash, cash equivalents and short-term investments
Reaffirms full-year total net product revenue of $105M-$120M; $50M in synergies by year-end, 2022 year-end cash balance of $90M-$110M, and cash flow breakeven by year-end 2023
Hosting conference call and webcast today at 8:30 a.m. ET
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the second quarter and six months ended June 30, 2022 and upcoming events.
“We continue to execute our growth strategy and are pleased to have posted record net revenue in the second quarter. Demand for Gvoke HypoPen remains strong and its market share continues to outpace the overall glucagon market; Keveyis reported its best quarter to date; and newly launched Recorlev is off to a great start,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “We continue to drive education and awareness of all three products and remain confident in the long-term growth opportunity of each. Our strong performance year-to-date and expectations for the remainder of the year gives us confidence that we will achieve our guidance of net product revenue to $105 million to $120 million for the full year 2022, year-end cash balance of $90 million-$110 million and cash flow breakeven by year-end 2023.”
Second Quarter Highlights and Upcoming Events
Commercial Products
Gvoke® : Second quarter 2022 net revenue was $11.5 million as compared to $8.8 million in the second quarter of 2021 – an increase of approximately 30%. Gvoke prescriptions topped 34,000 for the first time, growing more than 60% compared to the same period in 2021. Gvoke’s market share of the retail TRx glucagon market grew to approximately 22% at the end of July.
Keveyis® : Second quarter net revenue was $12.8 million – an increase of 28% compared to the same period in 2021 on a pro forma basis. The number of patients on Keveyis increased 5% from the same period in 2021.
Recorlev® : Second quarter net revenue was $1.0 million. Xeris launched Recorlev in February 2022 and is experiencing a steady increase of physicians’ referrals and patients’ starts.
Commercial Partner Update
Ogluo®: On August 4, 2022, Arecor Therapeutics completed the acquisition of Tetris Pharma, Xeris’ commercial partner for Ogluo in the UK and EU. Tetris Pharma is now a subsidiary of Arecor Therapeutics and continues to commercialize Ogluo in the UK and EU.
Upcoming Events
XeriSol® levothyroxine (XP-8121) : The third and final cohort was successfully dosed during the second quarter. The Company anticipates reporting topline data from a range of doses and dose proportionality early in the fourth quarter.
Xeris will participate at the H. C. Wainwright’s 24th Annual Global Investment Conference, September 12-14, in New York City.
Second Quarter and Year-to-Date 2022 Financial Results
Gvoke ®: Net revenue was $23.9 million for the six months ended June 30, 2022, a 42% increase compared to prior year. Gvoke prescriptions for YTD 2022 were over 65,000 TRx’s, growing more than 73% compared to the same period in 2021. The growth in product demand was partially offset by a decrease in net pricing.
Keveyis ®: Net revenue was $22.1 million for the six months ended June 30, 2022, a 20% increase from last year on a pro forma basis. This increase was driven by an 11% increase in sales volume and an increase in net pricing.
Recorlev ®: Net revenue was $1.1 million since its launch in February 2022.
Cost of goods sold were $4.8 million and $11.1 million for the three and six months ended June 30, 2022, respectively, a $1.4 million and a $5.9 million increase compared to the same periods last year. The increases were primarily attributable to increases in sales as well as product mix and increased costs.
Research and development expenses decreased $1.7 million or 30.9% and increased $0.6 million or 5.9% for the three and six months ended June 30, 2022, respectively, compared to the same periods last year. The quarter-to-date decrease was primarily driven by reduced spend on clinical and product development. The year-to-date increase was primarily driven by higher personnel related costs, offset by lower product development costs.
Selling, general and administrative expenses increased $7.1 million or 27.2% and $23.9 million or 53.1% for the three and six months ended June 30, 2022, respectively, compared to the same periods last year. The quarter-to-date increase was mainly attributable to a $9.7 million of increased personnel-related costs due to the build out of our sales force to support our three commercial products. These were offset by $3.8 million decreased expenses related to the acquisition of Strongbridge. The year-to-date increase was mainly attributable to a $19.6 million increase in personnel-related costs due to the buildout of the sales force to support our three commercial products. We also had a $2.5 million increase in marketing expenses to primarily support the launch of Recorlev.
Net Loss for the three months ended June 30, 2022, was $26.2 million, or $0.19 per share, and a net loss of $59.9 million, or $0.44 per share, for the six months ended June 30, 2022.
Cash, cash equivalents, and short-term investments at June 30, 2022 was $111.6 million compared to $102.4 million at December 31, 2021. Total shares outstanding at July 31, 2022 was 135,957,280.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday, August 10, 2022, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: ige.netroadshow.com/registration/q4inc/11152/xeris-biopharma-second-quarter-2022-financial-results-call/ . After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Wednesday, August 24, 2022, at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 562978. In addition, a live audio of the conference call will be available as a webcast. To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com .
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
Financial Tables & Data
Achieved record net product revenue of $25.3M – a 15% increase from Q1 ’22, and a 34% increase from same period prior year on a pro forma basis
Ended Q2 with $111.6M in cash, cash equivalents and short-term investments
Reaffirms full-year total net product revenue of $105M-$120M; $50M in synergies by year-end, 2022 year-end cash balance of $90M-$110M, and cash flow breakeven by year-end 2023
Hosting conference call and webcast today at 8:30 a.m. ET
Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the second quarter and six months ended June 30, 2022 and upcoming events.
“We continue to execute our growth strategy and are pleased to have posted record net revenue in the second quarter. Demand for Gvoke HypoPen remains strong and its market share continues to outpace the overall glucagon market; Keveyis reported its best quarter to date; and newly launched Recorlev is off to a great start,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “We continue to drive education and awareness of all three products and remain confident in the long-term growth opportunity of each. Our strong performance year-to-date and expectations for the remainder of the year gives us confidence that we will achieve our guidance of net product revenue to $105 million to $120 million for the full year 2022, year-end cash balance of $90 million-$110 million and cash flow breakeven by year-end 2023.”
Second Quarter Highlights and Upcoming Events
Commercial Products
Gvoke® : Second quarter 2022 net revenue was $11.5 million as compared to $8.8 million in the second quarter of 2021 – an increase of approximately 30%. Gvoke prescriptions topped 34,000 for the first time, growing more than 60% compared to the same period in 2021. Gvoke’s market share of the retail TRx glucagon market grew to approximately 22% at the end of July.
Keveyis® : Second quarter net revenue was $12.8 million – an increase of 28% compared to the same period in 2021 on a pro forma basis. The number of patients on Keveyis increased 5% from the same period in 2021.
Recorlev® : Second quarter net revenue was $1.0 million. Xeris launched Recorlev in February 2022 and is experiencing a steady increase of physicians’ referrals and patients’ starts.
Commercial Partner Update
Ogluo®: On August 4, 2022, Arecor Therapeutics completed the acquisition of Tetris Pharma, Xeris’ commercial partner for Ogluo in the UK and EU. Tetris Pharma is now a subsidiary of Arecor Therapeutics and continues to commercialize Ogluo in the UK and EU.
Upcoming Events
XeriSol® levothyroxine (XP-8121) : The third and final cohort was successfully dosed during the second quarter. The Company anticipates reporting topline data from a range of doses and dose proportionality early in the fourth quarter.
Xeris will participate at the H. C. Wainwright’s 24th Annual Global Investment Conference, September 12-14, in New York City.
Second Quarter and Year-to-Date 2022 Financial Results
Gvoke ®: Net revenue was $23.9 million for the six months ended June 30, 2022, a 42% increase compared to prior year. Gvoke prescriptions for YTD 2022 were over 65,000 TRx’s, growing more than 73% compared to the same period in 2021. The growth in product demand was partially offset by a decrease in net pricing.
Keveyis ®: Net revenue was $22.1 million for the six months ended June 30, 2022, a 20% increase from last year on a pro forma basis. This increase was driven by an 11% increase in sales volume and an increase in net pricing.
Recorlev ®: Net revenue was $1.1 million since its launch in February 2022.
Cost of goods sold were $4.8 million and $11.1 million for the three and six months ended June 30, 2022, respectively, a $1.4 million and a $5.9 million increase compared to the same periods last year. The increases were primarily attributable to increases in sales as well as product mix and increased costs.
Research and development expenses decreased $1.7 million or 30.9% and increased $0.6 million or 5.9% for the three and six months ended June 30, 2022, respectively, compared to the same periods last year. The quarter-to-date decrease was primarily driven by reduced spend on clinical and product development. The year-to-date increase was primarily driven by higher personnel related costs, offset by lower product development costs.
Selling, general and administrative expenses increased $7.1 million or 27.2% and $23.9 million or 53.1% for the three and six months ended June 30, 2022, respectively, compared to the same periods last year. The quarter-to-date increase was mainly attributable to a $9.7 million of increased personnel-related costs due to the build out of our sales force to support our three commercial products. These were offset by $3.8 million decreased expenses related to the acquisition of Strongbridge. The year-to-date increase was mainly attributable to a $19.6 million increase in personnel-related costs due to the buildout of the sales force to support our three commercial products. We also had a $2.5 million increase in marketing expenses to primarily support the launch of Recorlev.
Net Loss for the three months ended June 30, 2022, was $26.2 million, or $0.19 per share, and a net loss of $59.9 million, or $0.44 per share, for the six months ended June 30, 2022.
Cash, cash equivalents, and short-term investments at June 30, 2022 was $111.6 million compared to $102.4 million at December 31, 2021. Total shares outstanding at July 31, 2022 was 135,957,280.
Conference Call and Webcast Details
Xeris will host a conference call and webcast today, Wednesday, August 10, 2022, at 8:30 a.m. Eastern Time. To pre-register for the conference call please use this link: ige.netroadshow.com/registration/q4inc/11152/xeris-biopharma-second-quarter-2022-financial-results-call/ . After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering a minimum of ten minutes prior to the start of the call. Following the conference call, a replay will be available until Wednesday, August 24, 2022, at US:1 929 458 6194, US Toll Free: 1 866 813 9403, UK: 0204 525 0658, Canada: 1 226 828 7578, or all other locations: +44 204 525 0658 Access Code: 562978. In addition, a live audio of the conference call will be available as a webcast. To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com .
About Xeris
Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
Financial Tables & Data