Eiger BioPharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Business Update
- None.
- None.
- Resources prioritized to advance avexitide in hyperinsulinemic hypoglycemia indications
- Active discussions underway with potential partners to advance late-stage virology programs
- Reduction in workforce executed to align with focus on avexitide; extends cash runway into Q4 2024
- David Apelian, MD, PhD, MBA, appointed CEO
"We reported in late June that we are deploying our resources toward recognizing the compelling potential of avexitide in metabolic diseases," said David Apelian, MD, PhD, MBA, CEO of Eiger. "Our initial focus is on post-bariatric hypoglycemia, or PBH, and other forms of hyperinsulinemic hypoglycemia (HH) arising after gastrointestinal surgeries 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. In the future, we also intend to develop avexitide for congenital hyperinsulinism as a second indication."
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
- 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
in Q2 2023$4.6 million
Corporate
25% reduction in workforce, a reduction in out-of-pocket spending related to the Company's hepatitis delta (HDV) development program and the Company's existing term loan are expected to extend the Company's cash runway into the fourth quarter of 2024- David Apelian, MD, PhD, MBA, appointed CEO
Cash Position
in cash position as of June 30, 2023$53.6 million
Second Quarter 2023 Financial Results
Total revenue was
Cost of sales decreased by
Research and development expenses were
Selling, general and administrative expenses were
Total operating expenses include non-cash expenses of
The Company reported a net loss of
Cash, cash equivalents, and short-term debt securities as of June 30, 2023 totaled
As of June 30, 2023, the Company had 44,296,417 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, 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 fourth 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. | |||
June 30, | December 31, | ||
(Unaudited) | |||
ASSETS | |||
Cash and cash equivalents | $ 22,983 | $ 25,798 | |
Short-term debt securities | 30,626 | 73,150 | |
Accounts receivable | 3,715 | 1,749 | |
Inventories | 1,098 | 2,853 | |
Prepaid expenses and other current assets | 12,062 | 13,985 | |
Total current assets | 70,484 | 117,535 | |
Property and equipment, net | 755 | 696 | |
Operating lease right-of-use assets | 329 | 561 | |
Other assets | 790 | 1,347 | |
Total assets | $ 72,358 | $ 120,139 | |
LIABILITIES AND STOCKHOLDERS' EQUITY | |||
Current liabilities | 16,713 | $ 25,121 | |
Other liabilities | 40,350 | 39,708 | |
Stockholders' equity | 15,295 | 55,310 | |
Total liabilities and stockholders' equity | $ 72,358 | $ 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.
| |||||||
Three Months Ended | Six Months Ended | ||||||
2023 | 2022 | 2023 | 2022 | ||||
Product revenue, net | $ 4,393 | $ 3,341 | $ 8,511 | $ 6,014 | |||
Other revenue | 250 | 750 | 250 | 750 | |||
Total revenue | 4,643 | 4,091 | 8,761 | 6,764 | |||
Costs and operating expenses: | |||||||
Cost of sales | (310) | 151 | (192) | 261 | |||
Research and development(1) | 19,401 | 16,993 | 36,149 | 34,563 | |||
Selling, general and administrative(1) | 5,533 | 7,027 | 15,048 | 13,840 | |||
Total operating expenses | 24,624 | 24,171 | 51,005 | 48,664 | |||
Loss from operations | (19,981) | (20,080) | (42,244) | (41,900) | |||
Interest expense | (1,343) | (934) | (2,628) | (1,820) | |||
Interest income | 660 | 221 | 1,371 | 266 | |||
Other income (expense), net | (29) | (1,074) | 26 | (1,047) | |||
Income (loss) before provision for taxes | (20,693) | (21,867) | (43,475) | (44,501) | |||
Provision for income taxes | 2 | 17 | 4 | 26 | |||
Net loss | $ (20,695) | $ (21,884) | $ (43,479) | $ (44,527) | |||
Net income (loss) per common share: | |||||||
Basic and diluted | $ (0.47) | $ (0.51) | $ (0.98) | $ (1.14) | |||
Weighted-average common shares outstanding: | |||||||
Basic and diluted | 44,296,417 | 43,059,809 | 44,221,442 | 39,178,043 |
(1) | Includes stock-based compensation expense of: |
Three Months Ended | Six Months Ended | ||||||
2023 | 2022 | 2023 | 2022 | ||||
Research and development | $ 517 | $ 820 | $ 1,351 | $ 1,445 | |||
General and administrative | 228 | 1,388 | 1,936 | 2,810 | |||
Total stock-based compensation expense | $ 745 | $ 2,208 | $ 3,287 | $ 4,255 |
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SOURCE Eiger BioPharmaceuticals, Inc.
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