XERS Xeris Biopharma Holdings Inc

Q1 2024 Total Revenue of $40.6M – up 22% over Q1 2023

Tightening full-year 2024 total revenue guidance to $175M-$200M

Ended Q1 with $87.4M in cash, cash equivalents, and short-term investments, lowered borrowing rate of Hayfin debt by 2.05%

Entered into a worldwide license agreement for XeriJect® formulation of teprotumumab

Announced an exclusive worldwide agreement with Beta Bionics for development of a new XeriSol™ formulation of glucagon for bi-hormonal pumps and pump systems

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 first quarter ended March 31, 2024 and recent events.

“We grew total product revenue 25% in the first quarter compared to last year, despite an estimated $3 million negative impact to Gvoke revenue from the Change Healthcare cyberattack. This strong growth was driven by impressive momentum in Recorlev sales, Keveyis’ resilience in the marketplace, and Gvoke’s growing market share,” said Paul R. Edick, Xeris’ Chairman and CEO. “With these results, a strong start to the second quarter, along with our new technology partnership with Beta Bionics, we are confident in tightening our 2024 total revenue guidance to $175 million to $200 million.”

First Quarter 2024 Highlights

 

Three months ended March 31,

 

Change

 

2024

 

2023

 

$

%

Product revenue (in thousands):

 

 

 

 

 

 

 

 

Gvoke

$

16,579

 

 

$

15,033

 

 

$

1,546

 

10.3

 

Keveyis

 

13,085

 

 

 

12,755

 

 

 

330

 

2.6

 

Recorlev

 

10,599

 

 

 

4,477

 

 

 

6,122

 

136.7

 

Product revenue, net

 

40,263

 

 

 

32,265

 

 

 

7,998

 

24.8

 

Royalty, contract and other revenue

 

375

 

 

 

931

 

 

 

(556

)

(59.7

)

Total revenue

$

40,638

 

 

$

33,196

 

 

$

7,442

 

22.4

 

Commercial Products

• Gvoke®: First quarter net revenue was $16.6 million as compared to $15.0 million in the first quarter of 2023 – an increase of approximately 10%. Gvoke’s market share of the retail TRx glucagon market grew to over 36% through late April and weekly Gvoke TRxs broke the 5,000 level in late April.
• Keveyis®: First quarter net revenue remained very strong at $13.1 million – an increase of approximately 3% compared to the same period in 2023. Keveyis patient referrals remained strong with considerably lower patient loss in the quarter than anticipated.
• Recorlev®: First quarter net revenue was $10.6 million – an increase of $6.1 million compared to the same period in 2023. The average number of patients on Recorlev increased 139% from the same period in 2023 and 18% compared to the fourth quarter 2023.

Pipeline Program

• XeriSol™ levothyroxine (XP-8121): Successfully completed the Phase 2 clinical study. Data from the Phase 2 study will be available mid-2024.

Technology Partnerships

• XeriSol™: In May, Xeris entered into an exclusive worldwide collaboration and license agreement with Beta Bionics for the development and commercialization of a new and unique formulation of liquid stable glucagon for use in a bi-hormonal pump and pump systems.
• XeriJect®: In January, Xeris entered into an exclusive worldwide license agreement for Amgen to develop, manufacture, and commercialize a subcutaneous formulation of teprotumumab using Xeris’ XeriJect® technology in Thyroid Eye Disease (TED). Under the terms of the License Agreement, Xeris has the potential to receive $75 million in development, regulatory, and sales-based milestones, as well as escalating single-digit royalties based on future sales of TEPEZZA® using the XeriJect ® technology.

Cost of goods sold increased by $0.7 million for the three months ended March 31, 2024 compared to the same period ended in 2023. This increase was mainly attributable to higher product sales.

Research and development expenses increased by $3.0 million for the three months ended March 31, 2024 compared to the same period in 2023, driven by strategic investments in our pipeline, notably XP-8121, and our emerging technology partnership business as well as higher personnel costs.

Selling, general and administrative expenses increased by $4.8 million for the three ended March 31, 2024 compared to the same period in 2023, due to higher personnel costs and rent expenses related to our headquarter lease, which commenced in April 2023.

Net Loss was $19.0 million, or $0.14 per share, for the three months ended March 31, 2024.

Cash, cash equivalents, and short-term investments at March 31, 2024 was $87.4 million compared to $72.5 million at December 31, 2023.

Shares outstanding at April 30, 2024 was 148,255,663.

First Quarter Conference Call and Webcast Details

Xeris will host a conference call and webcast on Thursday, May 9, 2024 at 8:30 a.m. Eastern Time.

To pre-register for the call, please go to the following link: https://www.netroadshow.com/events/login?show=7144015a&confId=62782. 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, May 23, 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: 952508

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/702822810

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 total revenue guidance for 2024, Xeris’ potential to receive milestones and royalties under a license agreement with Amgen, the expansion of collaboration partnerships such as with Beta Bionics, the impact of the Change Healthcare cyberattack, the timing of the availability of clinical study data, the market and therapeutic potential of its products and product candidates, the potential utility of its formulation platforms, 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 March 31,

 

 

2024

 

 

 

2023

 

Product revenue, net

$

40,263

 

 

$

32,265

 

Royalty, contract and other revenue

 

375

 

 

 

931

 

Total revenue

 

40,638

 

 

 

33,196

 

Costs and expenses:

 

 

 

Cost of goods sold

 

5,971

 

 

 

5,319

 

Research and development

 

7,821

 

 

 

4,838

 

Selling, general and administrative

 

38,380

 

 

 

33,605

 

Amortization of intangible assets

 

2,711

 

 

 

2,711

 

Total costs and expenses

 

54,883

 

 

 

46,473

 

Loss from operations

 

(14,245

)

 

 

(13,277

)

Other expense

 

(4,428

)

 

 

(3,557

)

Net loss before benefit from income taxes

 

(18,673

)

 

 

(16,834

)

Income tax (expense) benefit

 

(307

)

 

 

—

 

Net loss

$

(18,980

)

 

$

(16,834

)

 

 

 

 

Net loss per common share - basic and diluted

$

(0.14

)

 

$

(0.12

)

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

140,513,907

 

 

 

137,142,565

 

 

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

March 31, 2024

 

December 31, 2023

 

(unaudited)

 

 

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

62,690

 

 

$

67,449

 

Short-term investments

 

24,662

 

 

 

5,002

 

Trade accounts receivable, net

 

37,414

 

 

 

39,197

 

Inventory

 

40,878

 

 

 

38,838

 

Prepaid expenses and other current assets

 

7,636

 

 

 

5,778

 

Total current assets

 

173,280

 

 

 

156,264

 

Property and equipment, net

 

5,783

 

 

 

5,971

 

Intangible assets, net

 

107,053

 

 

 

109,764

 

Goodwill

 

22,859

 

 

 

22,859

 

Operating lease right-of-use assets

 

23,027

 

 

 

23,204

 

Other assets

 

4,614

 

 

 

4,540

 

Total assets

$

336,616

 

 

$

322,602

 

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

7,094

 

 

$

11,565

 

Current operating lease liabilities

 

4,624

 

 

 

3,495

 

Other accrued liabilities

 

22,391

 

 

 

23,510

 

Accrued trade discounts and rebates

 

22,560

 

 

 

22,149

 

Accrued returns reserve

 

14,593

 

 

 

14,198

 

Current portion of contingent value rights

 

1,021

 

 

 

19,109

 

Other current liabilities

 

801

 

 

 

1,167

 

Total current liabilities

 

73,084

 

 

 

95,193

 

Long-term debt, net of unamortized debt issuance costs

 

229,674

 

 

 

190,932

 

Non-current contingent value rights

 

—

 

 

 

1,379

 

Non-current operating lease liabilities

 

34,397

 

 

 

34,764

 

Deferred tax liabilities

 

2,575

 

 

 

2,268

 

Other liabilities

 

6,064

 

 

 

4,848

 

Total liabilities

 

345,794

 

 

 

329,384

 

Total stockholders’ equity (deficit)

 

(9,178

)

 

 

(6,782

)

Total liabilities and stockholders’ equity (deficit)

$

336,616

 

 

$

322,602

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20240509287355/en/

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