XERS Xeris Biopharma Holdings Inc

Achieved record total revenue of $54.3M including record product revenue of $52.9M

Product revenue increased 27% versus prior year and 14% over the prior quarter

Ended Q3 with $69.4M in cash, cash equivalents and short-term investments

Raises full-year guidance of total net revenue to $198M-$202M and tightens year-end cash to $68M-$72M

Hosting conference call and webcast today at 8:30 a.m. ET

Xeris Biopharma Holdings, Inc. (Nasdaq: XERS), a fast-growing biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the third quarter and nine months ended September 30, 2024.

“We are proud to report our record-breaking quarter with total revenue of our $54 million led by strong demand of Recorlev® and Gvoke®. Our product revenue growth of 27% marks the 12th consecutive quarter of over 20% growth," said John Shannon, CEO of Xeris. "We have made investments in areas that drive growth, notably Recorlev®, and we are seeing the benefits of those investments. Given our exceptional year-to-date performance, we are raising our revenue guidance to $198-$202 million from the previous $190-$200 million. Looking ahead, our focus remains on continuing to drive greater than 20% product revenue growth and advancing our robust pipeline - namely our Phase 3 ready, XP-8121."

“While delivering exceptional revenue growth, we held our total operating expenses relatively flat to last quarter when you exclude non-routine charges,” said Steven Pieper, CFO of Xeris. “We will continue to drive robust revenue growth, maintain our strong margin profile, and diligently manage expenses, which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth.”

Third Quarter 2024 Highlights

 

Three Months Ended September 30,

 

Change

 

2024

 

2023

 

$

%

Product revenue (in thousands):

 

 

 

 

 

 

Gvoke

$

22,942

 

$

17,735

 

$

5,207

 

29.4

 

Recorlev

 

17,726

 

 

8,097

 

 

9,629

 

118.9

 

Keveyis

 

12,193

 

 

15,865

 

 

(3,672

)

(23.1

)

Product revenue, net

 

52,861

 

 

41,697

 

 

11,164

 

26.8

 

Royalty, contract and other revenue

 

1,407

 

 

6,623

 

 

(5,216

)

(78.8

)

Total revenue

$

54,268

 

$

48,320

 

$

5,948

 

12.3

 

Commercial Products

• Gvoke®: Third quarter net revenue was $22.9 million as compared to $17.7 million in the third quarter of 2023 – an increase of approximately 29%. Gvoke prescriptions topped 70,000 for the first time, growing 20% compared to the same period in 2023. Gvoke’s share of the retail TRx glucagon market grew to approximately 36% at the end of October.
• Recorlev®: Third quarter net revenue was $17.7 million – an increase of 119% compared to the third quarter of 2023. This growth was driven by the average number of patients on Recorlev increasing 125% from the same period in 2023. On a sequential basis, Recorlev net revenue increased 33% versus prior quarter.
• Keveyis®: Third quarter net revenue was $12.2 million as compared to $15.9 million in the third quarter of 2023 - a decrease of approximately 23% driven by a reduction in patients on therapy. On a sequential basis, net revenue decreased 7% due to pharmacy reimbursement changes.

Year-to-Date 2024 Financial Results

 

Nine Months Ended September 30,

 

Change

 

2024

 

2023

 

$

%

Product revenue (in thousands):

 

 

 

 

 

 

Gvoke

$

59,567

 

$

48,406

 

$

11,161

 

23.1

 

Recorlev

 

41,663

 

 

19,741

 

 

21,922

 

111.0

 

Keveyis

 

38,406

 

 

42,708

 

 

(4,302

)

(10.1

)

Product revenue, net

 

139,636

 

 

110,855

 

 

28,781

 

26.0

 

Royalty, contract and other revenue

 

3,335

 

 

8,669

 

 

(5,334

)

(61.5

)

Total revenue

$

142,971

 

$

119,524

 

$

23,447

 

19.6

 

• Gvoke®: Net revenue was $59.6 million for the nine months ended September 30, 2024, a 23% increase compared to prior year. Gvoke prescriptions for the nine months were approximately 194,000, growing approximately 24% compared to the same period in 2023.
• Recorlev®: Net revenue was $41.7 million for the nine months ended September 30, 2024, a 111% increase from last year, driven by an increase in the number of patients on therapy.
• Keveyis®: Net revenue was $38.4 million for the nine months ended September 30, 2024, a 10% decrease from last year due to a reduction in patients on therapy.

Cost of goods sold increased $5.4 million and $6.3 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. These increases were primarily due to a $3.6 million write-off of Gvoke components resulting from manufacturing process changes required to support ongoing Gvoke capacity expansion efforts.

Research and development (R&D) expenses increased slightly by $0.9 million and $3.5 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023. R&D increased primarily due to higher spending for pipeline and personnel related expenses.

Selling, general and administrative (SG&A) expenses increased by $7.7 million and $14.8 million for the three and nine months ended September 30, 2024 compared to the same periods ended September 30, 2023, primarily due to the costs associated with the CEO succession plan and related restructuring ($6.1 million) as well as higher costs related to the Recorlev expansions, partially offset by lower external spending.

Net Loss for the three months ended September 30, 2024, was $15.7 million, or ($0.11) per share, and $49.7 million, or ($0.34) per share, for the nine months ended September 30, 2024. Excluding the impact of the CEO succession plan and related restructuring costs of $6.1 million, earnings per share was ($0.06) for the quarter or ($0.30) for the year-to-date.

Cash, cash equivalents, and short-term investments at September 30, 2024 was $69.4 million, compared to $72.5 million at December 31, 2023. Total shares outstanding at October 31, 2024 was 149,081,461.

Conference Call and Webcast Details

Xeris will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the Company’s financial and operational results.

To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=6c5018a9&confId=72180 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 Friday, November 22, 2024 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: 906920

To join the webcast, please visit “Events” on investor relations page of the Company’s website at www.xerispharma.com or use this link: https://events.q4inc.com/attendee/232807470

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®, a proven 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.

Xeris Biopharma Holdings is headquartered in Chicago, IL. For more information, visit www.xerispharma.com, or follow us on X, LinkedIn, or Instagram.

Forward-Looking Statements

Any statements in this press release other than statements of historical fact are forward-looking statements. Forward-looking statements include, but are not limited to, statements about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2024, projections regarding year-end 2024 cash estimates and total revenue, the potential for growth of revenue, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, the advancement of its pipeline (including XP-8121), and other statements containing the words “will,” “would,” “continue,” “expect,” “should,” “anticipate” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on numerous assumptions and assessments made in light of Xeris’ experience and perception of historical trends, current conditions, business strategies, operating environment, future developments, geopolitical factors and other factors it believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. The various factors that could cause Xeris’ actual results, performance or achievements, industry results and developments to differ materially from those expressed in or implied by such forward-looking statements, include, but are not limited to, its financial position and need for financing, including to fund its product development programs or commercialization efforts, whether its products will achieve and maintain market acceptance in a competitive business environment, its reliance on third-party suppliers, including single-source suppliers, its reliance on third parties to conduct clinical trials, the ability of its product candidates to compete successfully with existing and new drugs, and its and collaborators’ ability to protect its intellectual property and proprietary technology. No assurance can be given that such expectations will be realized and persons reading this communication are, therefore, cautioned not to place undue reliance on these forward-looking statements. Additional risks and information about potential impacts of financial, operational, economic, competitive, regulatory, governmental, technological, and other factors that may affect Xeris can be found in Xeris’ filings, including its most recently filed Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, the contents of which are not incorporated by reference into, nor do they form part of, this communication. Forward-looking statements in this communication are based on information available to us, as of the date of this communication and, while we believe our assumptions are reasonable, actual results may differ materially. Subject to any obligations under applicable law, we do not undertake any obligation to update any forward-looking statement whether as a result of new information, future developments or otherwise, or to conform any forward-looking statement to actual results, future events, or to changes in expectations.

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

2024

 

 

 

2023

 

 

 

2024

 

 

 

2023

 

Product revenue, net

$

52,861

 

 

$

41,697

 

 

$

139,636

 

 

$

110,855

 

Royalty, contract and other revenue

 

1,407

 

 

 

6,623

 

 

 

3,335

 

 

 

8,669

 

Total revenue

 

54,268

 

 

 

48,320

 

 

 

142,971

 

 

 

119,524

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of goods sold

 

13,593

 

 

 

8,201

 

 

 

27,354

 

 

 

21,075

 

Research and development

 

5,888

 

 

 

5,034

 

 

 

19,468

 

 

 

15,959

 

Selling, general and administrative

 

44,969

 

 

 

37,287

 

 

 

123,342

 

 

 

108,527

 

Amortization of intangible assets

 

2,711

 

 

 

2,711

 

 

 

8,132

 

 

 

8,132

 

Total costs and expenses

 

67,161

 

 

 

53,233

 

 

 

178,296

 

 

 

153,693

 

Loss from operations

 

(12,893

)

 

 

(4,913

)

 

 

(35,325

)

 

 

(34,169

)

Other expense

 

(6,169

)

 

 

(7,614

)

 

 

(16,666

)

 

 

(15,709

)

Net loss before benefit from income taxes

 

(19,062

)

 

 

(12,527

)

 

 

(51,991

)

 

 

(49,878

)

Income tax benefit

 

3,324

 

 

 

338

 

 

 

2,268

 

 

 

1,013

 

Net loss

$

(15,738

)

 

$

(12,189

)

 

$

(49,723

)

 

$

(48,865

)

 

 

 

 

 

 

 

 

Net loss per common share - basic and diluted

$

(0.11

)

 

$

(0.09

)

 

$

(0.34

)

 

$

(0.36

)

 

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

148,993,823

 

 

 

138,059,781

 

 

 

145,962,198

 

 

 

137,523,202

 

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

September 30, 2024

 

December 31, 2023

 

(unaudited)

 

 

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

59,232

 

 

$

67,449

 

Short-term investments

 

10,170

 

 

 

5,002

 

Trade accounts receivable, net

 

41,138

 

 

 

39,197

 

Inventory

 

45,119

 

 

 

38,838

 

Prepaid expenses and other current assets

 

7,140

 

 

 

5,778

 

Total current assets

 

162,799

 

 

 

156,264

 

Property and equipment, net

 

5,613

 

 

 

5,971

 

Intangible assets, net

 

101,632

 

 

 

109,764

 

Goodwill

 

22,859

 

 

 

22,859

 

Operating lease right-of-use assets

 

22,758

 

 

 

23,204

 

Other assets

 

5,443

 

 

 

4,540

 

Total assets

$

321,104

 

 

$

322,602

 

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

7,451

 

 

$

11,565

 

Current portion of long-term debt

 

15,057

 

 

 

—

 

Current operating lease liabilities

 

6,042

 

 

 

3,495

 

Other accrued liabilities

 

23,543

 

 

 

23,510

 

Accrued trade discounts and rebates

 

20,519

 

 

 

22,149

 

Accrued returns reserve

 

17,723

 

 

 

14,198

 

Current portion of contingent value rights

 

—

 

 

 

19,109

 

Other current liabilities

 

678

 

 

 

1,167

 

Total current liabilities

 

91,013

 

 

 

95,193

 

Long-term debt, net of unamortized debt issuance costs

 

216,227

 

 

 

190,932

 

Non-current contingent value rights

 

—

 

 

 

1,379

 

Non-current operating lease liabilities

 

33,639

 

 

 

34,764

 

Deferred tax liabilities

 

—

 

 

 

2,268

 

Other liabilities

 

8,548

 

 

 

4,848

 

Total liabilities

 

349,427

 

 

 

329,384

 

Total stockholders’ equity (deficit)

 

(28,323

)

 

 

(6,782

)

Total liabilities and stockholders’ equity (deficit)

$

321,104

 

 

$

322,602

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20241108040671/en/

Investor Contact Allison Wey Senior Vice President, Investor Relations and Corporate Communications awey@xerispharma.com 312-736-1237