XERS Xeris Biopharma Holdings Inc

Achieved first quarter total revenue of $33.2M representing 50% growth compared to Q1 2022

Ended Q1 2023 with $95.1M in cash, cash equivalents, and short-term investments

Affirms 2023 guidance: total revenue of $135M-$165M; cash utilization from operating activities of $57M-$77M; year-end cash, cash equivalents, and short-term investments of $45M-$65M

Announced research collaboration and option agreement with Regeneron for XeriJect® formulation®

Ricki Fairley joined Board of Directors

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 patients’ lives by developing and commercializing innovative products across a range of therapies, today announced financial results for the first quarter ended March 31, 2023, and other corporate highlights.

“We had a very strong start to 2023 with record total revenue, strong underlying patient demand in all three commercial products, and the addition of another XeriJect collaboration,” said Paul R. Edick, Chairman and CEO of Xeris Biopharma. “With continued steady and strong execution, we believe that we can achieve our 2023 revenue and year-end cash guidance and achieve cash flow breakeven in the fourth quarter this year.”

First Quarter Highlights and Recent Events

 

Three Months Ended March 31,

 

Change

 

2023

 

2022

 

$

%

Product revenue (in thousands):

 

 

 

 

 

 

Gvoke

$

15,033

 

$

12,452

 

$

2,581

20.7

Keveyis

 

12,755

 

 

9,324

 

 

3,431

36.8

Recorlev

 

4,477

 

 

134

 

 

4,343

nm

Product revenue, net

 

32,265

 

 

21,910

 

 

10,355

47.3

Royalty, contract and other revenue

 

931

 

 

163

 

 

768

nm

Total revenue

$

33,196

 

$

22,073

 

$

11,123

50.4

nm - not meaningful

 

 

 

 

 

 

Commercial Products

• Gvoke®: First quarter net revenue was $15.0 million as compared to $12.5 million in the first quarter of 2022, an increase of approximately 21%. Gvoke prescriptions topped 45,000 for the first time, growing approximately 50% compared to the same period in 2022. Year over year glucagon TRx and NRx market growth was 10% and 9%, respectively. At the end of April, Gvoke’s NRx and TRx market share of the retail glucagon market exceeded 30% and 29%, respectively. In the first quarter, the U.S. Patent and Trademark Office issued US Patent Number 11,590,205, entitled ‘METHODS FOR PRODUCING STABLE THERAPEUTIC GLUCAGON FORMULATIONS IN APROTIC POLAR SOLVENTS.’ The claims in this newly issued patent cover certain pharmaceutical formulations in Xeris’ Gvoke® product line, methods of use of such formulations in treating hypoglycemia, and methods of manufacturing the therapeutic formulations.
• Keveyis®: First quarter net revenue was $12.8 million, an increase of approximately 37% compared to the same period in 2022, driven by higher patient demand.
• Recorlev®: First quarter net revenue was $4.5 million driven primarily by increases in the number of patients on therapy.

Pipeline and Partnership Programs

• XeriSol® levothyroxine (XP-8121): The Phase 2 study is on track to begin enrolling patients in the second quarter.
• XeriJect®: In March, Xeris announced a research collaboration and option agreement with Regeneron to develop an ultra-concentrated, ultra-highly concentrated, ready-to-use, small volume subcutaneous injections of two undisclosed monoclonal antibodies developed by Regeneron. Regeneron has an option to commercially license XeriJect for these molecules and nominate additional molecules for reformulation and potential commercialization.

Corporate Highlights

• In March, Xeris appointed Ricki Fairley to its Board of Directors, increasing the number of members to nine.
• Xeris will hold its Annual Meeting of Stockholders on June 7, 2023.
• Members of Xeris’ senior management will participate in Jefferies Global Healthcare Conference June 7-9, 2023, in New York City.

First Quarter 2023 Other Results

Cost of goods sold was $5.3 million and $6.3 million for the three months ended March 31, 2023 and 2022, respectively. The decrease was attributable to a one-time contract credit and favorable product mix offset by an increase in product sales.

Research and development expenses decreased $1.4 million for the three months ended March 31, 2023 when compared to the same period in 2022. The decrease was primarily driven by lower product development costs in the period.

Selling, general and administrative expenses decreased $2.3 million for the three months ended March 31, 2023 when compared to the same period in 2022. The decrease was primarily driven by lower costs related to the restructuring plan commenced in 2021 and fully expensed by 2022.

Net Loss for the three months ended March 31, 2023, was $16.8 million, or $0.12 per share.

Cash, cash equivalents, and short-term investments at March 31, 2023 was $95.1 million compared to $122.0 million at December 31, 2022. Total shares outstanding at May 1, 2023, were 137,311,468.

Conference Call and Webcast Details

Xeris will host a conference call and webcast today, Tuesday, May 9, 2023 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=148ea405&confId=49077

After registering, a confirmation email will be sent, including dial-in details and a unique code for entry. The Company recommends registering at least ten minutes before the call starts. Following the conference call, a replay will be available until Thursday, June 8, 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: 104892

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/964102801

About Xeris

Xeris (Nasdaq: XERS) is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing differentiated and 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 has a diverse pipeline of development and partnered programs using its formulation sciences, XeriSol™ and XeriJect™, to support 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 Twitter, LinkedIn, or Instagram.

Forward-Looking Statements

Any statements in this press release about future expectations, plans and prospects for Xeris Biopharma Holdings, Inc. including statements regarding the financial outlook for 2023, including projections regarding year-end 2023 cash estimates and total revenue, the Company’s expectations regarding its cash flow breakeven timeline, the market and therapeutic potential of its products and product candidates, continued growth of Gvoke, Keveyis and Recorlev, continued use of Xeris’ formulation sciences in development and partnered programs, potentially new partnerships and collaborations, expectations regarding clinical data or results from planned clinical trials, the timing of clinical trials, including advancement of its levothyroxine clinical program and a related Phase 2 study in mid-2023, the potential utility of its formulation platforms, cash management, becoming a self-sustaining enterprise, and other statements containing the words “will,” “would,” “continue,” “expect,” “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 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 information about potential impacts of COVID-19, 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 Annual Report on Form 10-K 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 believed to be 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,

 

 

2023

 

2022

Product revenue, net

 

$

32,265

 

 

$

21,910

 

Royalty, contract and other revenue

 

 

931

 

 

 

163

 

Total revenue

 

 

33,196

 

 

 

22,073

 

Costs and expenses:

 

 

 

 

Cost of goods sold

 

 

5,319

 

 

 

6,273

 

Research and development

 

 

4,838

 

 

 

6,250

 

Selling, general and administrative

 

 

33,605

 

 

 

35,913

 

Amortization of intangible assets

 

 

2,711

 

 

 

2,711

 

Total costs and expenses

 

 

46,473

 

 

 

51,147

 

Loss from operations

 

 

(13,277

)

 

 

(29,074

)

Other expense

 

 

(3,557

)

 

 

(5,048

)

Net loss before benefit from income taxes

 

 

(16,834

)

 

 

(34,122

)

Benefit from income taxes

 

 

—

 

 

 

408

 

Net loss

 

$

(16,834

)

 

$

(33,714

)

 

 

 

 

 

Net loss per common share - basic and diluted

 

$

(0.12

)

 

$

(0.25

)

 

 

 

 

 

Weighted average common shares outstanding - basic and diluted

 

 

137,142,565

 

 

 

135,032,782

 

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

March 31, 2023

 

December 31, 2022

 

(unaudited)

 

 

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

50,984

 

$

121,966

Short-term investments

 

44,118

 

 

—

Trade accounts receivable, net

 

30,860

 

 

30,830

Inventory

 

29,039

 

 

24,735

Prepaid expenses and other current assets

 

10,512

 

 

9,287

Total current assets

 

165,513

 

 

186,818

Property and equipment, net

 

6,477

 

 

5,516

Goodwill

 

117,896

 

 

120,607

Operating lease right-of-use assets

 

22,859

 

 

22,859

Intangible assets, net

 

3,886

 

 

3,992

Other assets

 

4,729

 

 

4,730

Total assets

$

321,360

 

$

344,522

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

$

11,983

 

$

4,606

Current operating lease liabilities

 

1,448

 

 

1,580

Other accrued liabilities

 

20,149

 

 

36,786

Accrued trade discounts and rebates

 

16,874

 

 

16,818

Accrued returns reserve

 

13,254

 

 

11,173

Current portion of contingent value rights

 

14,958

 

 

—

Other current liabilities

 

2,757

 

 

2,658

Total current liabilities

 

81,423

 

 

73,621

Long-term debt, net of unamortized debt issuance costs

 

187,623

 

 

187,075

Contingent value rights

 

9,371

 

 

25,688

Non-current operating lease liabilities

 

9,346

 

 

9,402

Deferred tax liabilities

 

3,518

 

 

3,518

Other liabilities

 

31

 

 

31

Total liabilities

 

291,312

 

 

299,335

Total stockholders’ equity

 

30,048

 

 

45,187

Total liabilities and stockholders’ equity

$

321,360

 

$

344,522

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20230509005324/en/

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