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Xeris Biopharma Reports Third Quarter 2023 Financial Results

Achieved record revenue of $48.3M – a 27% increase from prior quarter, and a 63% increase from same period prior year

Tightens full-year 2023 revenue guidance from $155M-$165M to $160M-$165M

Ended Q3 with $66.0M in cash, cash equivalents and short-term investments and remains on track to achieve cash flow breakeven in the fourth quarter

Extended maturity of approximately two-thirds of 2025 Convertible Senior Notes to 2028

Successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA®

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 third quarter and nine months ended September 30, 2023 and corporate highlights.

“We continue to demonstrate record revenue growth as we execute on our strategy. Because of this strong performance, we are further tightening our full year 2023 revenue guidance from $155 million - $165 million to $160 million - $165 million, which is at the high end of our original range,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “Due to continued disciplined expense management coupled with our strong revenue growth we are confident we will achieve cash flow breakeven in the fourth quarter.”

Third Quarter 2023 Highlights

 

Three months ended

September 30,

 

Change

 

2023

 

2022

 

$

%

Product revenue (in thousands):

 

 

 

 

 

 

Gvoke

$

17,735

 

$

13,663

 

$

4,072

29.8

Keveyis

 

15,865

 

 

13,371

 

2,494

18.7

Recorlev

 

8,097

 

 

2,520

 

5,577

nm

Product revenue, net

 

41,697

 

 

29,554

 

12,143

41.1

Royalty, contract and other revenue

 

6,623

 

 

171

 

6,452

nm

Total revenue

$

48,320

 

$

29,725

 

$

18,595

62.6

 

nm - not meaningful

Commercial Products

  • Gvoke®: Third quarter 2023 net revenue was $17.7 million as compared to $13.7 million in the third quarter of 2022 – an increase of approximately 30%. Gvoke prescriptions topped 58,000 for the first time, growing 52% compared to the same period in 2022. Gvoke’s market share of the retail TRx glucagon market grew to over 31% through late October.
  • Keveyis®: Third quarter net revenue was $15.9 million – an increase of approximately 19% compared to the same period in 2022. The average number of patients on Keveyis increased approximately 5% from the same period in 2022.
  • Recorlev®: Third quarter net revenue was $8.1 million – an increase of $5.6 million compared to the same period of 2022. The average number of patients on Recorlev increased over 203% from the same period in 2022.

Pipeline Program

  • XeriSol® levothyroxine (XP-8121): The Phase 2 clinical study is over 85% enrolled, and the study should be completed in the first half of 2024 based on the current enrollment rate.

Technology Partnerships

  • Horizon/Amgen: Xeris successfully formulated the prespecified target product profile of the XeriJect™ formulation of TEPEZZA® which triggered revenue of $6.0 million in the third quarter from a milestone payment under the research collaboration and option agreement with Horizon (subsequently acquired by Amgen) that was signed in November 2022. The payment was subsequently received in the fourth quarter. Amgen has the option to license the XeriJect technology to further the development of an ultra-concentrated, ready-to-use, subcutaneous injection of TEPEZZA®.

Year-to-Date 2023 Financial Results

 

Nine Months Ended September 30,

 

Change

 

2023

 

2022

 

$

%

Product revenue (in thousands):

 

 

 

 

 

 

Gvoke

$

48,406

 

$

37,595

 

$

10,811

28.8

Keveyis

 

42,708

 

 

35,506

 

 

7,202

20.3

Recorlev

 

19,741

 

 

3,623

 

 

16,118

nm

Product revenue, net

 

110,855

 

 

76,724

 

 

34,131

44.5

Royalty, contract and other revenue

 

8,669

 

 

380

 

 

8,289

nm

Total revenue

$

119,524

 

$

77,104

 

$

42,420

55.0

 

nm - not meaningful

  • Gvoke®: Net revenue was $48.4 million for the nine months ended September 30, 2023, a 29% increase compared to prior year. Gvoke prescriptions for the first three quarters of 2023 were over 156,000 TRx’s, growing 51% compared to the same period in 2022. The growth in product demand was partially offset by a decrease in net pricing.
  • Keveyis®: Net revenue was $42.7 million for the nine months ended September 30, 2023, a 20% increase from last year. This increase was driven by higher patient demand and an increase in net pricing.
  • Recorlev®: Net revenue was $19.7 million for the nine months ended September 30,2023, a $16.1 million increase from last year, driven primarily by increases in the number of patients on therapy.

Cost of goods sold increased by $2.9 million for the three months ended September 30, 2023 compared to the same period ended September 30, 2022. The increase was mainly attributable to higher product sales. Cost of goods sold increased by $4.7 million for the nine months ended September 30, 2023 compared to the same period ended September 30, 2022. The increase was mainly attributable to higher product sales partially offset by the product mix and a one-time contract credit in the first quarter of 2023.

Research and development expenses decreased by $1.0 million for the three months ended September 30, 2023 compared to the same period ended September 30, 2022 driven by lower product development costs. Research and development expenses were flat in the nine months ended September 30, 2023 compared to the same period ended September 30, 2022.

Selling, general and administrative expenses increased by $2.8 million and $5.1 million for the three and nine months ended 2023, respectively, compared to the same periods ended September 30, 2022, due to higher personnel costs and rent expenses related to the new lease commenced in April 2023.

Net Loss was $12.2 million, or $0.09 per share, for the three months ended September 30, 2023 and a net loss of $48.9 million, or $0.36 per share, for the nine months ended September 30, 2023.

Cash, cash equivalents, and short-term investments at September 30, 2023 was $66.0 million compared to $122.0 million at December 31, 2022.

Shares outstanding at October 31, 2023 was 138,124,595.

Upcoming Events

Xeris will participate in the following investor conferences:

  • Jefferies London Healthcare Conference, November 14-16, 2023
  • 14th Annual Craig-Hallum Alpha Select Conference, November 16, 2023 (1x1s only)
  • 35th Annual Piper Sandler Healthcare Conference, November 28-30, 2023

Details of each event will be available on Xeris’ website. Contact the respective sponsor to request a 1x1 meeting.

Third Quarter Conference Call and Webcast Details

Xeris will host a conference call and webcast on Thursday, November 9, 2023 at 8:30 a.m. Eastern Time. To pre-register for the conference call, please use the following link: https://www.netroadshow.com/events/login?show=59946218&confId=55658. 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 Thursday, November 23, 2023 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: 328140.

In addition, a live audio of the conference call will be available as a webcast. To join the webcast, please visit “Events” on the investor relations page of the Company’s website at www.xerispharma.com or use the following link: https://events.q4inc.com/attendee/482975153.

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.

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 2023, including projections that the company will achieve cash flow breakeven in the fourth quarter and revenue guidance, the market and therapeutic potential of its products and product candidates, the timing of clinical studies and trials, including advancement of its levothyroxine clinical program and expected Phase 2 study completion in the first half of 2024, the potential utility of its formulation platforms, cash management, 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,

 

2023

 

2022

 

2023

 

2022

Product revenue, net

$

41,697

 

$

29,554

 

$

110,855

 

$

76,724

Royalty, contract and other revenue

 

6,623

 

 

171

 

 

8,669

 

 

380

Total revenue

 

48,320

 

 

29,725

 

 

119,524

 

 

77,104

Costs and expenses:

 

 

 

 

 

 

 

Cost of goods sold

 

8,201

 

 

5,260

 

 

21,075

 

 

16,343

Research and development

 

5,034

 

 

6,043

 

 

15,959

 

 

16,011

Selling, general and administrative

 

37,287

 

 

34,491

 

 

108,527

 

 

103,388

Amortization of intangible assets

 

2,711

 

 

2,711

 

 

8,132

 

 

8,132

Total costs and expenses

 

53,233

 

 

48,505

 

 

153,693

 

 

143,874

Loss from operations

 

(4,913)

 

 

(18,780)

 

 

(34,169)

 

 

(66,770)

Other expense

 

(7,614)

 

 

(3,390)

 

 

(15,709)

 

 

(16,046)

Net loss before benefit from income taxes

 

(12,527)

 

 

(22,170)

 

 

(49,878)

 

 

(82,816)

Benefit from income taxes

 

338

 

 

339

 

 

1,013

 

 

1,086

Net loss

$

(12,189)

 

$

(21,831)

 

$

(48,865)

 

$

(81,730)

 

 

 

 

 

 

 

 

Net loss per common share - basic and diluted

$

(0.09)

 

$

(0.16)

 

$

(0.36)

 

$

(0.60)

 

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

138,059,781

 

 

135,951,761

 

 

137,523,202

 

 

135,508,203

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

September 30, 2023

 

December 31, 2022

 

(unaudited)

 

 

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

46,143

 

$

121,966

Short-term investments

 

19,832

 

 

Trade accounts receivable, net

 

45,966

 

 

30,830

Inventory

 

38,143

 

 

24,735

Prepaid expenses and other current assets

 

7,967

 

 

9,287

Total current assets

 

158,051

 

 

186,818

Property and equipment, net

 

6,185

 

 

5,516

Intangible assets, net

 

112,475

 

 

120,607

Goodwill

 

22,859

 

 

22,859

Operating lease right-of-use assets

 

23,407

 

 

3,992

Other assets

 

4,807

 

 

4,730

Total assets

$

327,784

 

$

344,522

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

12,078

 

$

4,606

Current operating lease liabilities

 

2,366

 

 

1,580

Other accrued liabilities

 

19,073

 

 

36,786

Accrued trade discounts and rebates

 

21,554

 

 

16,818

Accrued returns reserve

 

13,328

 

 

11,173

Current portion of contingent value rights

 

17,517

 

 

Other current liabilities

 

1,123

 

 

2,658

Total current liabilities

 

87,039

 

 

73,621

Long-term debt, net of unamortized debt issuance costs

 

190,423

 

 

187,075

Non-current contingent value rights

 

5,099

 

 

25,688

Non-current operating lease liabilities

 

35,154

 

 

9,402

Deferred tax liabilities

 

2,504

 

 

3,518

Other liabilities

 

3,700

 

 

31

Total liabilities

 

323,919

 

 

299,335

Total stockholders’ equity

 

3,865

 

 

45,187

Total liabilities and stockholders’ equity

$

327,784

 

$

344,522

 

Contacts

Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

awey@xerispharma.com

312-736-1237

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