- 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.