Le Lézard
Classified in: Health, Science and technology, Business
Subjects: EARNINGS, Product/Service, Conference Call, Webcast

IVERIC bio Reports Fourth Quarter and Year End 2019 Operational Highlights and Financial Results


IVERIC bio, Inc. (Nasdaq: ISEE) today announced financial and operating results for the fourth quarter and full year ended December 31, 2019 and provided a general business update.

"We made tremendous progress last year as we build a diversified portfolio in retinal diseases that includes both therapeutics and gene therapy, setting the stage for IVERIC bio to be a leader in developing transformative therapies to treat retinal diseases," stated Glenn P. Sblendorio, Chief Executive Officer and President of IVERIC bio. "We achieved a major milestone with our positive Zimura pivotal clinical trial results in geographic atrophy secondary to dry AMD. Our goal is to continue to build on this momentum. Following the positive data, our team quickly started working on our second Zimura pivotal clinical trial in GA with plans to enroll the first patient next month. Our lead gene therapy programs in rhodopsin mediated adRP and BEST1 related retinal diseases continue to advance towards Phase 1/2 clinical trials and we expect to identify our lead minigene construct for LCA10 later in the year."

Therapeutics Programs

Zimura® (avacincaptad pegol): Complement C5 Inhibitor

HtrA1 Inhibitor

Gene Therapy Programs in Orphan Inherited Retinal Diseases

Corporate Update

In December 2019, the Company completed an underwritten public offering in which it sold 7,750,000 shares of its common stock at a price of $4.00 per share, and it also sold to certain investors pre-funded warrants to purchase 3,750,000 shares of its common stock at a price of $3.999 per share underlying each warrant. The Company raised approximately $42.6 million in net proceeds from this offering.

During the fourth quarter of 2019, IVERIC bio appointed Guangping Gao, PhD as Chief Strategist, Gene Therapy, and Abraham Scaria, PhD as Chief Scientific Officer.

Fourth Quarter and Year End 2019 Financial Results and 2020 Cash Guidance

As of December 31, 2019, the Company had $125.7 million in cash and cash equivalents. The Company estimates that its year-end 2020 cash and cash equivalents will range between $60 million and $70 million. The Company also estimates that its cash and cash equivalents will be sufficient to fund its operations and capital expenditure requirements as currently planned into the beginning of 2022. These estimates are based on the Company's current business plan, including initiation of the Zimura ISEE2008 trial and the continuation of the Company's other on-going research and development programs. These estimates do not reflect any additional expenditures, including associated development costs, in the event the Company in-licenses or acquires any new product candidates or commences any new sponsored research programs.

2019 Financial Highlights

Conference Call/Web Cast Information

IVERIC bio will host a conference call/webcast to discuss the Company's financial and operating results and provide a business update. The call is scheduled for February 27, 2020 at 8:00 a.m. Eastern Time. To participate in this conference call, dial 800-458-4121 (USA) or 323-794-2598 (International), passcode 6010573. A live, listen-only audio webcast of the conference call can be accessed on the Investors section of the IVERIC bio website at www.ivericbio.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 6010573.

About IVERIC bio

IVERIC bio is a biopharmaceutical company focused on the discovery and development of novel treatment options for retinal diseases with significant unmet medical needs. Vision is Our Mission. For more information on the Company please visit www.ivericbio.com.

Forward-looking Statements

Any statements in this press release about the Company's future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company's strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words "anticipate," "believe," "estimate," "expect," "intend", "goal," "may", "might," "plan," "predict," "project," "seek," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. In this press release, the Company's forward looking statements include statements about its expectations to use its previously announced clinical trial of Zimura for the treatment of geographic atrophy as a pivotal trial, its development strategy for Zimura, including its plans and expectations regarding a second, pivotal clinical trial evaluating Zimura for the treatment of geographic atrophy, the implementation of its business plan, the projected use of cash and cash balances, the timing, progress and results of clinical trials and other research and development activities, the potential utility of its product candidates, and the potential for its business development strategy. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company's development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and the progress of research and development programs and clinical trials, availability of data from these programs, reliance on university collaborators and other third parties, establishment of manufacturing capabilities, expectations for regulatory matters, need for additional financing and negotiation and consummation of business development transactions and other factors discussed in the "Risk Factors" section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company's views only as of the date of this press release. The Company anticipates that subsequent events and developments will cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

ISEE-G

 
IVERIC bio, Inc.
Selected Financial Data (unaudited)
(in thousands, except per share data)
 
 Three Months Ended December 31,   Year Ended December 31,  

 

2019

 

 

2018

 

 

2019

 

 

2018

 

 
Statements of Operations Data:                
Operating expenses:
Research and development  

 $

                          11,567

 

 

 $

                          16,128

 

 

 $

                          39,644

 

 

 $

                          41,737

 

General and administrative

 

                               6,275

 

 

                               5,667

 

 

                             21,628

 

 

                             23,612

 

Total operating expenses  

 

                             17,842

 

 

 

                             21,795

 

 

 

                             61,272

 

 

 

                             65,349

 

Loss from operations

 

                           (17,842

)

 

                           (21,795

)

 

                           (61,272

)

 

                           (65,349

)

Interest income  

 

                                  369

 

 

 

                                  677

 

 

 

                               2,151

 

 

 

                               2,389

 

Gain on extinguishment of Royalty Purchase Liability

 

                                     -  

 

 

                           125,000

 

 

                                     -  

 

 

                           125,000

 

Other income (expense)  

 

                                     -  

 

 

 

                                      1

 

 

 

                                  151

 

 

 

                                  (16

)

Income (loss) before income tax provision (benefit)

 

                           (17,473

)

 

                           103,883

 

 

                           (58,970

)

 

                             62,024

 

Income tax provision (benefit)  

 

                                      5

 

 

 

                                (231

)

 

 

                                (111

)

 

 

                             (1,063

)

Net Income (loss)

 $

                        (17,478

)

 $

                        104,114

 

 $

                        (58,859

)

 $

                          63,087

 

Net loss per common share:                
Basic 

 $

                            (0.39

)

 $

                              2.62

 

 $

                            (1.39

)

 $

                              1.70

 

Diluted  

 $

                            (0.39

)

 

 $

                              2.62

 

 

 $

                            (1.39

)

 

 $

                              1.70

 

Weighted average common shares outstanding:
Basic   

 $

                          44,413

 

 

 $

                          39,673

 

 

 $

                          42,224

 

 

 $

                          37,061

 

Diluted

 

                             44,413

 

 

                             39,687

 

 

                             42,224

 

 

                             37,088

 

 

December 31, 2019

December 31, 2018

(in thousands)
Balance Sheets Data:          
Cash and cash equivalents

 $

                        125,699

 

 $

                        131,201

 

Total assets  

 

                           130,187

 

 

 

                           137,165

 

 
Total liabilities

 

                             12,984

 

 

                             13,206

 

 
Additional paid-in capital  

 

                           597,679

 

 

 

                           545,585

 

 
Accumulated deficit

 

                         (480,526

)

 

                         (421,667

)

Total stockholders' equity  

 $

                        117,203

 

 

 $

                        123,959

 

 
 

 


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