false000130525300013052532023-11-092023-11-09

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_________________________________________________
FORM 8-K
_________________________________________________
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): November 9, 2023
_________________________________________________
EIGER BIOPHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
_________________________________________________
Delaware001-3618333-0971591
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
Eiger BioPharmaceuticals, Inc.
2155 Park Blvd.
Palo Alto, California 94306
(Address of principal executive offices, including zip code)
(650) 272-6138
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report.)
_________________________________________________
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange
on which registered
Common Stock, par value $0.001EIGRThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company o
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o


Item 2.02.    Results of Operations and Financial Condition.
On November 9, 2023, Eiger BioPharmaceuticals, Inc. reported its financial results for the quarter ended September 30, 2023. A copy of the press release titled “Eiger BioPharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto and is incorporated herein by reference.
The information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information in this Item 2.02 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Eiger BioPharmaceuticals, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing.
Item 9.01.    Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No.
Description
99.1
104Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Eiger BioPharmaceuticals, Inc.
Dated: November 9, 2023
By:/s/ David Apelian
David Apelian
Chief Executive Officer


image_991a.jpg

Eiger BioPharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Update
•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., November 9, 2023 -- 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

image.jpg




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)
2023202220232022
Product revenue, net
$3,209 $4,024 $11,720 $10,038 
Other revenue— — 250 750 
Total revenue3,209 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,
2023202220232022
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 

v3.23.3
Cover
Nov. 09, 2023
Cover [Abstract]  
Document Type 8-K
Document Period End Date Nov. 09, 2023
Entity Registrant Name EIGER BIOPHARMACEUTICALS, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-36183
Entity Tax Identification Number 33-0971591
Entity Address, Address Line One 2155 Park Blvd.
Entity Address, City or Town Palo Alto
Entity Address, State or Province CA
Entity Address, Postal Zip Code 94306
City Area Code 650
Local Phone Number 272-6138
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001
Trading Symbol EIGR
Security Exchange Name NASDAQ
Entity Emerging Growth Company false
Amendment Flag false
Entity Central Index Key 0001305253
Eiger BioPharmaceuticals (NASDAQ:EIGR)
Gráfico Histórico do Ativo
De Out 2024 até Nov 2024 Click aqui para mais gráficos Eiger BioPharmaceuticals.
Eiger BioPharmaceuticals (NASDAQ:EIGR)
Gráfico Histórico do Ativo
De Nov 2023 até Nov 2024 Click aqui para mais gráficos Eiger BioPharmaceuticals.