Eiger BioPharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update

<br /> Eiger BioPharmaceuticals Reports Third Quarter 2021 Financial Results and Provides Business Update<br />

– Phase 3 HDV D-LIVR (Lonafarnib) Enrolled; Topline Data Planned by End of 2022

– Phase 3 HDV LIMT-2 (Peginterferon Lambda) Enrolling

– Company to Host Conference Call Today at 4:30 PM ET

PR Newswire


PALO ALTO, Calif.

,

Nov. 4, 2021

/PRNewswire/ — Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases, today reported its third quarter 2021 financial results and provided a business update.

“The recent completion of enrollment in our Phase 3 HDV

D-LIVR

study of Lonafarnib-based regimens sets up pivotal topline data by the end of 2022,” said

David Cory

, President and CEO.  “Additionally, our Phase 3 HDV

LIMT-2

study of Peginterferon Lambda is now activating sites and screening patients.  Eiger is focused on the development of treatments and a cure for HDV.  We are positioned to be a leader in this space with two first-in-class therapies for HDV, offering hope for the over 12 million patients around the globe with this devastating disease.”



Program Updates and Upcoming Milestones



HDV Platform



Lonafarnib for HDV

  • First-in-class prenylation inhibitor and only oral agent in development

  • D



    LIVR

    , largest Phase 3 global study conducted in HDV
    • Fully enrolled with over 400 patients
    • Opportunity for approval of two Lonafarnib-based regimens:
      • All-oral and combination with peginterferon alfa
    • Pivotal topline data planned by end of 2022



Peginterferon Lambda for HDV

  • Well-tolerated interferon administered as a weekly subcutaneous injection

  • LIMT-2

    (N=150), pivotal study of Peginterferon Lambda monotherapy
    • Now activating sites and screening patients



Avexitide for Rare Metabolic Disorders

  • Phase 3 studies for post-bariatric hypoglycemia and congenital hyperinsulinism could begin as early as 2022



Zokinvy


®





for Progeria and Processing-Deficient Progeroid Laminopathies

  • MAA is under EMA review, with an opinion from the Committee for Medicinal Products for Human Use (CHMP) expected around end of 2021
  • Cohort ATU program (Temporary Use Authorization) approved in

    France
    • First ATU shipment completed



Peginterferon Lambda for COVID-19

  • Phase 3

    TOGETHER

    study enrolling patients across clinical sites in

    Brazil
  • DSMB interim futility analysis (n=453) recommended study continuation
  • Next interim futility data analysis by end of 2021
  • Positive data could support emergency use authorization package



Corporate

  • Appointed Erik Atkisson General Counsel and Chief Compliance Officer
  • Cash and investments of

    $120.4 million

    at the end of third quarter 2021 expected to fund planned operations into fourth quarter 2023



Third Quarter Financial Results

Net revenues from Zokinvy product sales were

$3.0 million

for third quarter 2021, as compared to

$2.1 million

for second quarter 2021.  The increase was primarily driven by modestly higher inventory on-hand at the specialty pharmacy.  The company commercially launched Zokinvy in the U.S. in

January 2021

and has reported September year-to-date net sales of

$8.8 million

.

Cost of Sales were

$0.3 million

for third quarter 2021 and is related to certain costs associated with Zokinvy that were incurred after FDA approval.

Research and Development expenses were

$18.1 million

for third quarter 2021, as compared to

$9.8 million

for the same period in 2020.  The increase was primarily due to clinical trial related expenses, including contract manufacturing and headcount related expenses, including stock-based compensation expense.

Selling, General and Administrative expenses were

$6.5 million

for the third quarter of 2021, as compared to

$5.0 million

for the same period in 2020.  The increase was primarily due to outside consulting and advisory services and headcount related expenses, including stock-based compensation expense.

Total operating expenses include non-cash expenses of

$3.0 million

for the third quarter of 2021, as compared to

$1.9 million

for the same period in 2020.

Eiger reported a third quarter 2021 net loss of

$22.2 million

, or

$0.65

on a per share basis.  This compares to a net loss of

$15.7 million

, or

$0.52

on a per share basis, for the third quarter of 2020.

Cash, cash equivalents, and investments as of

September 30, 2021

, totaled

$120.4 million

compared to

$139.8 million

as of

June 30, 2021

.

As of

September 30, 2021

, the company had 33,975,800 common shares outstanding.


Conference Call


At

4:30 PM Eastern Time

today,

November 4, 2021

, Eiger will host a conference call to discuss its financial results and provide a business update.  The live and replayed webcast of the call will be available through the company’s website at

www.eigerbio.com

.  To participate in the live call by phone, dial (844) 743-2495 (U.S.) or (661) 378-9529 (International) and enter conference ID 9874006.  The webcast will be archived and available for replay for at least 90 days after the event.


About Eiger


Eiger is a commercial-stage biopharmaceutical company focused on the development of innovative therapies to treat and cure Hepatitis Delta Virus (HDV) and other serious rare diseases.  The Eiger HDV platform includes two first-in-class therapies in Phase 3 that target critical host processes involved in viral replication.  All five Eiger rare disease programs have been granted FDA Breakthrough Therapy Designation.

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, 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 anticipated significant milestones in 2021 and 2022; the timing of our ongoing and planned clinical development; the sufficiency of our cash, cash equivalents and investments to fund our operations; expectations regarding the timing and availability of topline data from our Phase 3 D-LIVR study in HDV; the ability to activate sites and fully enroll the Phase 3 LIMT-2 study; initiating a Phase 3 study for avexitide in post-bariatric hypoglycemia and congenital hyperinsulinism; the potential approval of Zokinvy in jurisdictions outside of the U.S., including the EU; and the potential of Lambda to be an effective therapy for newly diagnosed outpatients with COVID-19.  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” sections in the Quarterly Report on Form 10-Q for the quarter ended

June 30, 2021

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 and Media:


Sri Ryali


CFO

Email:

[email protected]


Phone: 1-650-272-6138



Eiger BioPharmaceuticals Inc.



Condensed Consolidated Balance Sheets


(in thousands)



September 30,



December 31,



2021



2020


(1)




(unaudited)



ASSETS


Cash and cash equivalents


$                         49,255


$                   28,864


Short-term debt securities


36,051


99,976


Accounts receivable


2,762




Inventories


2,621


93


Prepaid expenses and other current assets


8,397


8,873


Total current assets


99,086


137,806


Long-term debt securities


35,093




Property and equipment, net


581


709


Operating lease right-of-use assets


777


1,176


Other assets


4,740


3,903


Total assets


$                       140,277


$                 143,594



LIABILITIES AND STOCKHOLDERS’ EQUITY


Current liabilities


$                         22,012


$                   16,627


Other liabilities


28,800


31,932


Stockholders’ equity


89,465


95,035


Total liabilities and stockholders’ equity


$                       140,277


$                 143,594



(1)


Derived from the audited financial statements, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020.



Eiger BioPharmaceuticals Inc.



Condensed Consolidated Statements of Operations Financial Data


(in thousands, except per share and share amounts)



Three Months Ended



Nine Months Ended



September 30,



September 30,



(unaudited)



(unaudited)



2021



2020



2021



2020


Product revenue, net


$        3,039


$              —


$        8,782


$              —


Costs and operating expenses:


Cost of sales


318




641




Research and development

(1)


18,106


9,810


46,250


29,045


Selling, general and administrative

(1)


6,466


5,027


17,916


15,141


Total operating expenses


24,890


14,837


64,807


44,186


Loss from operations


(21,851)


(14,837)


(56,025)


(44,186)


Interest expense


(894)


(906)


(2,659)


(2,681)


Interest income


35


76


119


629


Other income (expense), net


503


(13)


46,462


(7)


Income (loss) before provision for taxes


(22,207)


(15,680)


(12,103)


(46,245)


Provision for income taxes


16




46




Net loss


$     (22,223)


$     (15,680)


$     (12,149)


$     (46,245)


Net income (loss) per common share:


Basic and diluted


$         (0.65)


$         (0.52)


$         (0.36)


$         (1.74)


Weighted-average common shares outstanding:


Basic and diluted


33,946,559


29,879,135


33,922,080


26,639,201



(1)


Includes stock-based compensation expense of:



Three Months Ended



Nine Months Ended



September 30,



September 30,



2021



2020



2021



2020


Research and development


$            686


$            367


$        1,627


$        1,154


General and administrative


1,644


1,078


4,310


3,382


Total stock-based compensation expense


$        2,330


$        1,445


$        5,937


$        4,536

Cision
View original content to download multimedia:

https://www.prnewswire.com/news-releases/eiger-biopharmaceuticals-reports-third-quarter-2021-financial-results-and-provides-business-update-301417006.html

SOURCE Eiger BioPharmaceuticals, Inc.