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Eiger BioPharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results and Provides Business Update

PALO ALTO, Calif., March 14, 2019 /PRNewswire/ -- Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases, today reported financial results for the three months and year ended December 31, 2018 and provided a business update.

"We expect 2019 to be a transformative year for Eiger as we plan to file the first-ever NDA and MAA for Progeria and Progeroid Laminopathies and to enroll the first-ever international Phase 3 study in Hepatitis Delta Virus infection," said David Cory, Eiger President and Chief Executive Officer. "Eiger is poised for significant growth by delivering first-in-class therapies to patients with serious rare and ultra-rare diseases."

Recent Highlights

Hepatitis D Virus (HDV) Program
Lonafarnib in HDV

  • Lonafarnib+Ritonavir patent portfolio expanded to include US, Europe and Japan
  • Breakthrough Therapy designation granted by FDA
  • PRIME designation granted by EMA
  • First site initiated in Phase 3 D-LIVR study

Lambda in HDV

  • Phase 2 LIMT (mono therapy) end of study results selected as a late-breaker oral presentation at The International Liver Congress™ 2019
  • Phase 2 LIFT (combo therapy with lonafarnib) dosing at NIH (N=26)

Lonafarnib in Progeria and Progeroid Laminopathies Program

  • Breakthrough Therapy designation granted by FDA

Avexitide in Post-Bariatric Hypoglycemia (PBH) Program

  • Positive Phase 2 PREVENT 28-day study data (N=18)

Corporate Activity

  • Sri Ryali, MBA, appointed Eiger Chief Financial Officer
  • Stephana Patton, PhD, JD, pharma industry veteran, appointed Eiger as General Counsel, Corporate Secretary and Chief Compliance Officer
  • Christine Murray, MS, RAC, industry veteran and Senior Vice President of Global Regulatory Affairs at Ultragenyx Pharmaceutical, Inc., appointed to Board
  • R&D Day held on December 11, 2018 in NYC
  • October underwritten public offering raised $47.7 million in net proceeds

Anticipated 2019 Milestones

  • Phase 3 D-LIVR study (N=400) complete enrollment in HDV planned by year-end
  • Phase 2 LIMT end-of-study study results in HDV oral presentation at EASL
  • Phase 2 LIFT end-of-treatment study results in HDV planned at AASLD
  • NDA and MAA filings in Progeria and Progeroid Laminopathies planned
  • Phase 2 PREVENT end-of-study results in PBH oral presentation at ENDO
  • End of Phase 2 meeting for avexitide in PBH with regulators planned

Fourth Quarter and Full Year 2018 Financial Results
Cash, cash equivalents, and short-term investments as of December 31, 2018 totaled $100.4 million compared to $41.8 million at December 31, 2017, an increase of $58.6 million

The Company reported net losses of $16.5 million, or $0.92 per share, and $52.4 million, or $3.82 per share, for the fourth quarter and full year 2018, respectively, as compared to $10.9 million, or $1.11 per share, and $42.4 million, or $4.86 per share, for the same periods in 2017.

Research and Development expenses were $12.0 million and $37.1 million for the fourth quarter and full year 2018, respectively, as compared to $7.8 million and $29.5 million for the same periods in 2017. The increases in fourth quarter and full year 2018 were primarily due to costs associated with clinical programs, including drug supply costs.

General and Administrative expenses were $4.1 million and $14.0 million for the fourth quarter and full year 2018, respectively, as compared to $2.8 million and $12.0 million for the same periods in 2017. The increases in fourth quarter and full year 2018 were primarily due to increases in employee-related costs, including stock-based compensation, from increased headcount.

Total operating expenses include total non-cash expenses of $1.6 million and $5.7 million for the fourth quarter and full year 2018, respectively, as compared to $1.1 million and $4.4 million for the same periods in 2017.

In October, 2018, Eiger announced the closing of its underwritten public offering of 4,830,918 shares of its common stock at a price to the public of $10.35 per share. The offering was made under Eiger's effective shelf registration statement and resulted in net proceeds to the company of approximately $47.7 million, after deducting underwriting discounts and commissions and offering expenses.

As of December 31, 2018, the company had 19.2 million of common shares outstanding.

About Eiger
Eiger is a late stage biopharmaceutical company focused on the development and commercialization of targeted therapies for serious rare and ultra-rare diseases. We innovate by developing well-characterized drugs in newly identified or novel targets in rare diseases.  Our mission is to systematically reduce the time and cost of the drug development process to more rapidly deliver important medicines to patients. 

The company's lead program is in Phase 3, developing lonafarnib, a first-in-class prenylation inhibitor for the treatment of Hepatitis Delta Virus (HDV) infection. Eiger is also preparing an NDA and MAA for lonafarnib to treat Hutchinson-Gilford Progeria Syndrome (HGPS or Progeria) and Progeroid Laminopathies with plans to file in 2019.  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 that involve substantial risks and uncertainties. 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.  These forward-looking statements include terminology such as "believe," "will," "may," "estimate," "continue," "anticipate," "contemplate," "intend," "target," "project," "should," "plan," "expect," "predict," "could," "potentially" or the negative of these terms. Forward looking statements are our current statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ongoing and planned clinical development, including plans to complete enrollment of our D-LIVR study by the end of 2019, submit an NDA and MAA for Progeria and progeroid laminopathies in 2019, timing of end of treatment data in our LIFT study and progress our Phase 3 study in HDV; our ability to transition into a commercial stage biopharmaceutical company; our ability to finance the continued advancement of our development pipeline products; and the potential for success of any of our product candidates.

Various important factors could cause actual results or events to differ materially from the forward-looking statements that Eiger makes, including the risks described in the "Risk Factors" sections in the Annual Report on Form 10-K for the year ended December 31, 2018 to be filed on March 14, 2019 and Eiger's periodic reports filed with the SEC. Eiger does not assume any obligation to update any forward-looking statements, except as required by law.

Investors: Ingrid Choong, PhD
Email: ichoong@eigerbio.com
Phone: 1-650-619-6115

Sriram Ryali
Email: sryali@eigerbio.com
Phone: 1-650-272-6138

 

Eiger BioPharmaceuticals Inc.




Condensed Consolidated Balance Sheets




(in thousands)











Year Ended











December 31,











2018(1)


2017(1)








ASSETS












Cash and cash equivalents


$          61,262


$         32,035








Debt securities, available-for-sale


39,091


9,744








Prepaid expenses and other current assets


1,492


712








Total current assets


101,845


42,491








Property and equipment, net


167


79








Other assets


436


312








Total assets


$        102,448


$         42,882





















LIABILITIES AND STOCKHOLDERS' EQUITY












Current liabilities


$          10,024


$           7,269








Other liabilities


25,832


13,091








Stockholders' equity


66,592


22,522








Total liabilities and stockholders' equity


$        102,448


$         42,882


































(1)Derived from the audited financial statements, included in the Company's Annual Report on Form 10-K for the years ended December 31, 2018 and 2017.


 

Eiger BioPharmaceuticals Inc.

Condensed Consolidated Statements of Operations Financial Data

(in thousands, except per share and share amounts)


















Three Months Ended


Year Ended








December 31, 


December 31, 








(unaudited)












2018


2017


2018


2017





Operating expenses:













Research and development(1)

$      12,011


$        7,779


$         37,091


$         29,519






General and administrative(1)

4,082


2,806


13,956


12,001







Total operating expenses

16,093


10,585


51,047


41,520





Loss from operations

(16,093)


(10,585)


(51,047)


(41,520)





Interest expense

(755)


(395)


(2,329)


(1,524)





Interest income


343


89


997


410





Other (expense) income, net

4


(2)


(12)


186





Net loss



$     (16,501)


$     (10,893)


$       (52,391)


$       (42,448)



















Net loss per common share:













Basic and diluted

$         (0.92)


$         (1.11)


$            (3.82)


$            (4.86)





Shares used to compute net loss per common share:













Basic and diluted

17,926,315


9,799,328


13,711,034


8,727,935



















               (1)

Includes stock-based compensation expense of:





























Three Months Ended


Year Ended








December 31, 


December 31, 








2018


2017


2018


2017





Research and development

$            362


$            443


$           1,500


$           1,214





General and administrative

1,149


577


3,507


3,029







Total stock-based compensation expense

$        1,511


$        1,020


$           5,007


$           4,243





 

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SOURCE Eiger BioPharmaceuticals, Inc.