Xeris Biopharma Reports Second Quarter Financial Results and Upcoming Events

Xeris Biopharma Reports Second Quarter Financial Results and Upcoming Events




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

CHICAGO–(BUSINESS WIRE)–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.

 

Three Months Ended June 30,

 

 

Change

 

2022

 

2021

 

$

 

%

Product revenue (in thousands):

 

 

 

 

 

 

Gvoke

$

11,479

 

$

8,835

 

$

2,644

 

30%

Keveyis

 

12,812

 

 

 

 

12,812

 

nm

Recorlev

 

969

 

 

 

 

969

 

nm

Product revenue, net

 

25,260

 

 

8,835

 

 

16,425

 

nm

Royalty, contract and other revenue

 

46

 

 

71

 

 

(25

)

-35%

Total revenue

$

25,306

 

$

8,906

 

$

16,400

 

nm

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.

 

Six Months Ended June 30,

 

 

Change

 

2022

 

2021

 

$

 

%

Product revenue (in thousands):

 

 

 

 

 

 

Gvoke

$

23,932

 

$

16,886

 

$

7,046

 

42%

Keveyis

 

22,136

 

 

 

 

22,136

 

nm

Recorlev

 

1,102

 

 

 

 

1,102

 

nm

Product revenue, net

 

47,170

 

 

16,886

 

 

30,284

 

nm

Royalty, contract and other revenue

 

209

 

 

215

 

 

(6

)

-3%

Total revenue

$

47,379

 

$

17,101

 

$

30,278

 

nm

 

 

 

 

 

 

 

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: https://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.

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 the full-year 2022, including projections regarding year-end 2022 cash estimates, the Company’s expectations regarding its cash flow breakeven projection, estimates and projections about the potential synergies in fiscal year 2022 resulting from the Strongbridge Biopharma acquisition, the market and therapeutic potential of its products and product candidates, expectations regarding clinical data or results from planned clinical trials, the timing of clinical trials, the timing or likelihood of regulatory approval and commercialization of its product candidates, the timing or likelihood of expansion into additional markets, the potential utility of its formulation platforms and other statements containing the words “will,” “would,” “continue,” 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, 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 factors described in the context of such forward-looking statements in this communication 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. Although it is believed that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct and persons reading this communication are therefore cautioned not to place undue reliance on these forward-looking statements which speak only as at the date of this communication. Additional information about economic, competitive, governmental, technological, and other factors that may affect Xeris is set forth in the “Risk Factors” section of the 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. Any forward-looking statements in this communication are based upon information available to Xeris, as of the date of this communication and, while believed to be true when made, may ultimately prove to be incorrect. Subject to any obligations under applicable law, Xeris does 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. All subsequent written and oral forward-looking statements attributable to Xeris or any person acting on behalf of any of them are expressly qualified in their entirety by this paragraph.

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 

 

Three Months Ended June 30,

 

Six Months Ended June 30,

 

2022

 

2021

 

2022

 

2021

Product revenue, net

$

25,260

 

 

$

8,835

 

 

$

47,170

 

 

$

16,886

 

Royalty, contract and other revenue

 

46

 

 

 

71

 

 

 

209

 

 

 

215

 

Total revenue

 

25,306

 

 

 

8,906

 

 

 

47,379

 

 

 

17,101

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

Cost of goods sold, excluding amortization of intangible assets

 

4,810

 

 

 

3,383

 

 

 

11,083

 

 

 

5,209

 

Research and development

 

3,718

 

 

 

5,383

 

 

 

9,968

 

 

 

9,415

 

Selling, general and administrative

 

32,984

 

 

 

25,927

 

 

 

68,897

 

 

 

45,004

 

Amortization of intangible assets

 

2,710

 

 

 

 

 

 

5,421

 

 

 

 

Total costs and expenses

 

44,222

 

 

 

34,693

 

 

 

95,369

 

 

 

59,628

 

Loss from operations

 

(18,916

)

 

 

(25,787

)

 

 

(47,990

)

 

 

(42,527

)

Other expense

 

(7,608

)

 

 

(1,728

)

 

 

(12,656

)

 

 

(3,399

)

Net loss before benefit from income taxes

 

(26,524

)

 

 

(27,515

)

 

 

(60,646

)

 

 

(45,926

)

Benefit from income taxes

 

339

 

 

 

 

 

 

747

 

 

 

 

Net loss

$

(26,185

)

 

$

(27,515

)

 

$

(59,899

)

 

$

(45,926

)

 

 

 

 

 

 

 

 

Net loss per common share – basic and diluted

$

(0.19

)

 

$

(0.41

)

 

$

(0.44

)

 

$

(0.72

)

 

 

 

 

 

 

 

 

Weighted average common shares outstanding – basic and diluted

 

135,529,968

 

 

 

66,367,125

 

 

 

135,282,749

 

 

 

63,820,321

 

XERIS BIOPHARMA HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

 

 

June 30, 2022

 

December 31, 2021

 

(unaudited)

 

 

Assets

 

 

 

Current assets:

 

 

 

Cash and cash equivalents

$

95,340

 

$

67,271

Short-term investments

 

16,213

 

 

35,162

Trade accounts receivable, net

 

25,756

 

 

17,456

Inventory

 

17,887

 

 

18,118

Prepaid expenses and other current assets

 

6,010

 

 

4,589

Total current assets

 

161,206

 

 

142,596

Property and equipment, net

 

6,170

 

 

6,627

Goodwill

 

22,859

 

 

22,859

Intangible assets, net

 

126,029

 

 

131,450

Other assets

 

2,352

 

 

829

Total assets

$

318,616

 

$

304,361

Liabilities and Stockholders’ Equity

 

 

 

Current liabilities:

 

 

 

Accounts payable

 

6,631

 

 

8,924

Other accrued liabilities

 

36,945

 

 

49,088

Accrued trade discounts and rebates

 

14,843

 

 

15,041

Accrued returns reserve

 

5,210

 

 

4,000

Other current liabilities

 

916

 

 

1,987

Total current liabilities

 

64,545

 

 

79,040

Long-term debt, net of unamortized debt issuance costs

 

138,068

 

 

88,067

Contingent value rights

 

30,218

 

 

22,531

Supply agreement liability, less current portion

 

 

 

5,991

Deferred rent

 

6,799

 

 

6,883

Deferred tax liabilities

 

4,195

 

 

4,942

Other liabilities

 

848

 

 

1,676

Total liabilities

 

244,673

 

 

209,130

Total stockholders’ equity

 

73,943

 

 

95,231

Total liabilities and stockholders’ equity

$

318,616

 

$

304,361

 

Contacts

Investor Contact
Allison Wey

Senior Vice President, Investor Relations and Corporate Communications

awey@xerispharma.com
312-736-1237