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Eiger BioPharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update

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Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) reports Q3 2023 financial results and business update, focusing on avexitide for post-bariatric hypoglycemia and congenital hyperinsulinism, discontinuation of peginterferon lambda study, and cash runway extension. Key financial figures include a total revenue of $3.2 million, a net loss of $18.0 million, and a cash position of $39.4 million as of September 30, 2023.
Positive
  • Avexitide shows potential for post-bariatric hypoglycemia and congenital hyperinsulinism, both rare metabolic diseases, with FDA designations and Phase 3 study alignment.
  • Zokinvy® achieved net revenue of $3.2 million in Q3 2023, demonstrating commercial progress.
  • Cost of sales decreased by $1.1 million in the third quarter of 2023, contributing to improved financial performance.
  • Reduction in workforce and spend related to hepatitis delta program expected to extend cash runway into Q3 2024, ensuring financial stability.
  • Cash, cash equivalents, and short-term debt securities totaled $39.4 million as of September 30, 2023, providing a strong financial position.
Negative
  • Phase 3 LIMT-2 study of peginterferon lambda in chronic hepatitis delta discontinued due to safety findings, indicating potential setbacks in the development pipeline.
  • Total revenue decreased to $3.2 million for Q3 2023, compared to $4.0 million for the same period in 2022, reflecting a decline in U.S. sales.
  • Net loss of $18.0 million reported for the third quarter of 2023, signaling financial challenges.
  • Cash, cash equivalents, and short-term debt securities decreased to $39.4 million as of September 30, 2023, compared to $98.9 million as of December 31, 2022, indicating a significant reduction.
  • Resources prioritized to advance avexitide in hyperinsulinemic hypoglycemia indications
  • Phase 3 LIMT-2 study of peginterferon lambda in chronic hepatitis delta discontinued due to safety findings
  • Company's cash runway expected to extend into the third quarter of 2024

PALO ALTO, Calif., Nov. 9, 2023 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases, today reported financial results for the third quarter 2023 and provided a business update.

"As we disclosed in June 2023, we continue to seek financial resources to advance avexitide in post-bariatric hypoglycemia, or PBH, where we see the highest revenue potential, have demonstrated proof-of-concept in Phase 2 clinical trials, and have FDA alignment on Phase 3 endpoints, sample size, and study design," said David Apelian, MD, PhD, MBA, CEO of Eiger.

Business Highlights

Avexitide for Post-Bariatric Hypoglycemia (PBH)

  • A large orphan disease with a growing population; caused by complications in bariatric surgery
  • Prevalence of approximately 180,000 in the US and approximately half that in the EU
  • Avexitide is the only drug in development for PBH with Breakthrough Therapy designation from FDA
  • FDA alignment on pivotal Phase 3 study endpoints, sample size, and design

Avexitide for Congenital Hyperinsulinism (HI)

  • An ultra-rare, life-threatening, pediatric disorder of persistent hypoglycemia that results in irreversible brain damage in up to 50% of children
  • Breakthrough Therapy designation from FDA
  • Rare Pediatric Disease designation

Zokinvy® (lonafarnib) for Progeria and Processing-Deficient Progeroid Laminopathies

  • Achieved net revenue of $3.2 million in Q3 2023

Corporate

  • 43% reduction in workforce to-date and reductions in out-of-pocket spend related to the Company's hepatitis delta development program are expected to extend the Company's cash runway into the third quarter of 2024

Cash Position

  • $39.4 million in cash, cash equivalents and short-term securities as of September 30, 2023

Third Quarter 2023 Financial Results

Total revenue was $3.2 million for the third quarter of 2023, as compared to $4.0 million for the same period in 2022. The decrease was primarily driven by a decrease in U.S. sales. It was partially offset by an increase in sales in France under the Company's Temporary Authorizations for Use for Zokinvy®, compared to no such sales for the same period in 2022.

Cost of sales decreased by $1.1 million in the third quarter 2023 compared to the same period in 2022. The decrease was primarily due to a non-conforming batch of inventory that was written off during the three months ended September 30, 2022.

Research and development expenses were $14.6 million for the third quarter of 2023, as compared to $22.2 million for the same period in 2022. The decrease was primarily attributed to a decrease in clinical and contract manufacturing expenditures due to a decline in manufacturing costs for peginterferon lambda and avexitide, a decrease in compensation and personnel related expense due to a decrease in headcount, and a decrease in outside services across programs including consulting and advisory services due to a decline in spending on the Company's peginterferon lambda program.

Selling, general and administrative expenses were $5.5 million for the third quarter of 2023, as compared to $7.0 million for the same period in 2022. The decrease was primarily due to a decrease in compensation and personnel related expense, including stock-based compensation, and a decrease in outside services, including consulting, advisory and accounting services.

Total operating expenses include non-cash expenses of $1.4 million for the third quarter of 2023, as compared to $4.0 million for the same period in 2022. The decrease was primarily due to a change in amortization of premiums and discounts on debt securities due to current market and economic conditions and a decrease in compensation and personnel related expense including stock-based compensation, due to a decrease in headcount.

The Company reported a net loss of $18.0 million, or $0.41 per share basis for the third quarter of 2023. This compares to a net loss of $27.1 million, or $0.62 per share basis for the same period in 2022.

Cash, cash equivalents, and short-term debt securities as of September 30, 2023 totaled $39.4 million, as compared to $98.9 million as of December 31, 2022.

As of September 30, 2023, the Company had 44,384,684 common shares outstanding.

About Eiger

Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies for rare metabolic diseases. Eiger's lead product candidate, avexitide, is a well characterized, first-in-class GLP-1 antagonist being developed for the treatment of post-bariatric hypoglycemia (PBH) and congenital hyperinsulinism (HI). Avexitide is the only drug in development for PBH with Breakthrough Therapy designation from the FDA.

For additional information about Eiger and its clinical programs, please visit www.eigerbio.com.

Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts, including statements regarding our future financial condition, timing for and outcomes of clinical results, prospective products, preclinical and clinical pipelines, regulatory objectives, business strategy and plans and objectives for future operations, are forward-looking statements. Forward-looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to secure additional capital, the timing of our ongoing and planned clinical development; our capability to provide sufficient quantities of any of our products or product candidates for studies or to meet anticipated full-scale commercial demands; our ability to identify, pursue and enter into partnering opportunities for our virology assets; the sufficiency of our cash, cash equivalents and investments to fund our operations into the third quarter of 2024, including the scope and impact of any savings from our workforce reduction and cash conservation efforts; the revenue potential of avexitide in post-bariatric hypoglycemia and congenital hyperinsulinism; our ability to finance, independently or through collaborations, the continued advancement of our development pipeline; and the potential for success of any of our products or product candidates. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including additional applicable risks and uncertainties described in the "Risk Factors" section in Eiger's Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 and Eiger's subsequent filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to Eiger and speak only as of the date on which they are made. Eiger does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.

Investors:
Sylvia Wheeler
Wheelhouse Life Science Advisors
swheeler@wheelhouselsa.com 

Media:
Aljanae Reynolds
Wheelhouse Life Science Advisors
areynolds@wheelhouselsa.com 

 

Eiger BioPharmaceuticals Inc.

Condensed Consolidated Balance Sheets

(in thousands)



September 30,
2023


December 31,
2022(1)


(Unaudited)



ASSETS




Cash and cash equivalents

$           27,501


$           25,798

Short-term debt securities

11,920


73,150

Accounts receivable, net

1,321


1,749

Inventories, net

1,105


2,853

Prepaid expenses and other current assets

12,777


13,985

Total current assets

54,624


117,535

Property and equipment, net

677


696

Operating lease right-of-use assets

209


561

Other assets

144


1,347

Total assets

$           55,654


$         120,139

LIABILITIES AND STOCKHOLDERS' (DEFICIT) EQUITY




Current liabilities

16,524


$           25,121

Other liabilities

40,734


39,708

Stockholders' (deficit) equity

(1,604)


55,310

Total liabilities and stockholders'(deficit) equity

$           55,654


$         120,139



(1) 

Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the year ended December 31, 2022.

 

Eiger BioPharmaceuticals Inc.

Condensed Consolidated Statements of Operations Financial Data

(in thousands, except per share and share amounts)



Three Months Ended

September 30,

(unaudited)


Nine Months Ended

September 30,

(unaudited)


2023


2022


2023


2022

Product revenue, net

$              3,209


$              4,024


$           11,720


$           10,038

Other revenue



250


750

Total revenue

3,209


4,024


11,970


10,788

Costs and operating expenses:








Cost of sales

115


1,231


(77)


1,492

Research and development(1)

14,568


22,198


50,717


56,761

Selling, general and administrative(1)

5,454


6,964


20,502


20,804

Total operating expenses

20,137


30,393


71,142


79,057

Loss from operations

(16,928)


(26,369)


(59,172)


(68,269)

Interest expense

(1,412)


(1,092)


(4,040)


(2,912)

Interest income

485


347


1,856


613

Other (expense) income, net

(175)


3


(149)


(1,044)

Loss before provision for taxes

(18,030)


(27,111)


(61,505)


(71,612)

Provision for income taxes



4


26

Net loss

$          (18,030)


$          (27,111)


$          (61,509)


$          (71,638)

Net loss per common share:








Basic and diluted

$              (0.41)


$              (0.62)


$              (1.39)


$              (1.76)

Weighted-average common shares outstanding:          








Basic and diluted

44,320,164


44,010,553


44,254,711


40,806,581


(1) Includes stock-based compensation expense of:



Three Months Ended

September 30,


Nine Months Ended

September 30,


2023


2022


2023


2022

Research and development

$                 650


$                 856


$              2,001


$              2,301

General and administrative

388


1,366


2,324


4,176

Total stock-based compensation expense   

$              1,038


$              2,222


$              4,325


$              6,477

 

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SOURCE Eiger BioPharmaceuticals, Inc.

FAQ

What is Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) focusing on in its business update?

Eiger BioPharmaceuticals, Inc. is prioritizing resources to advance avexitide in post-bariatric hypoglycemia and congenital hyperinsulinism, both rare metabolic diseases.

What are the key financial figures for Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) in Q3 2023?

Eiger BioPharmaceuticals, Inc. reported a total revenue of $3.2 million, a net loss of $18.0 million, and a cash position of $39.4 million as of September 30, 2023.

Why was the Phase 3 LIMT-2 study of peginterferon lambda in chronic hepatitis delta discontinued?

The study was discontinued due to safety findings, leading to the cessation of the development program.

What is the impact of workforce reduction and spend related to the hepatitis delta program on Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR)?

The reduction in workforce and spend is expected to extend the company's cash runway into the third quarter of 2024, ensuring financial stability.

How did the cash position of Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR) change from December 31, 2022, to September 30, 2023?

The cash, cash equivalents, and short-term debt securities decreased to $39.4 million as of September 30, 2023, compared to $98.9 million as of December 31, 2022, indicating a significant reduction.

Eiger BioPharmaceuticals, Inc.

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Biotechnology
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Palo Alto