- 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
PALO
ALTO, Calif., Aug. 14,
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 second
quarter 2023 and provided a business update.
"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 $4.6
million in Q2 2023
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
- $53.6 million in cash position as
of June 30, 2023
Second Quarter 2023 Financial Results
Total revenue was $4.6
million for the second quarter of 2023, as compared to
$4.1 million for the same period in
2022. The increase was primarily driven by the product sales
in Germany compared to no such
sales for the same period in 2022. The increase was partially
offset by a decrease of certain upfront payments received under the
terms of the Marketing and Distribution Agreement (MDA) with AnGes,
Inc., which was executed in May 2022,
relating to obtaining regulatory approval for and commercialization
of Zokinvy in Japan.
Cost of sales decreased by $0.5
million in the second quarter 2023 compared to the same
period in 2022. The decrease was primarily due to a reversal of an
inventory accrual related to a nonconforming batch of product.
During the second quarter 2023, the Company was notified by the
vendor that it was no longer obligated to pay for that
nonconforming batch of product.
Research and development expenses were $19.4 million for the second quarter of
2023, as compared to $17.0
million for the same period in 2022. The increase was
primarily due to an increase in clinical and contract manufacturing
expenditures and an increase in compensation and personnel related
expense. The increase was partially offset by a decrease in outside
services across programs, including consulting and advisory
services due to a decline in spending on peginterferon lambda
programs.
Selling, general and administrative expenses were $5.5 million for the second 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
$0.9 million for the second
quarter of 2023, as compared to $4.1
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, a
decrease in loss on early extinguishment of Oxford loan paid off in
June 2022 and a decrease in stock
based compensation expenses.
The Company reported a net loss of $20.7
million, or $0.47 per share
basis for the second quarter of 2023. This compares to a net loss
of $21.9 million, or $0.51 per share basis for the same period in
2022.
Cash, cash equivalents, and short-term debt securities as of
June 30, 2023 totaled $53.6
million, as compared to $98.9
million as of December 31,
2022.
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.
Condensed Consolidated Balance
Sheets
(in thousands)
|
|
|
June
30,
2023
|
|
December 31,
2022(1)
|
|
(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.
Condensed Consolidated Statements
of Operations Financial Data
(in thousands, except per share
and share amounts)
|
|
|
Three Months
Ended
June 30,
(unaudited)
|
|
Six Months
Ended
June 30,
(unaudited)
|
|
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
June 30,
|
|
Six Months Ended
June 30,
|
|
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.