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

Iveric Bio Reports Fourth Quarter and Full Year 2022 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, 2022 and provided a general business update.

"In 2022, we successfully delivered a banner year with avacincaptad pegol (ACP) achieving a statistically significant reduction in the rate of geographic atrophy (GA) progression at the 12-month pre-specified primary endpoint across two Phase 3 clinical trials," stated Glenn P. Sblendorio, Chief Executive Officer of Iveric Bio. "We are excited to begin 2023 with the FDA's acceptance of the filing of our new drug application (NDA) and granting of priority review for ACP for the treatment of GA secondary to age-related macular degeneration (AMD). With the achievement of these important milestones, we move closer to our goal of providing patients with a treatment for GA, a devastating disease that leads to irreversible blindness."

"We are also excited about the new post-hoc analysis highlighting the potential signal of ACP reducing the rate of vision loss by slowing progression of GA at 12 months of treatment," stated Pravin U. Dugel, MD, President of Iveric Bio. "Our commercial leadership team brings extensive experience in launching drugs for retinal diseases with large market potential. We continue to accelerate our commercial plans and expect to have the full U.S. commercial team, including a field based sales force, hired by early April. We believe that we are well-positioned to become a leader in the development and commercialization of treatments for retinal diseases and to create long-term value for our shareholders."

Avacincaptad pegol (ACP): Complement C5 Inhibitor

IC-500: HtrA1 (high temperature requirement A serine peptidase 1 protein) Inhibitor

Gene Therapy Programs in Orphan Inherited Retinal Diseases (IRDs)

Corporate Update

Fourth Quarter and Year Ended 2022 Financial Results

2022 Q4 Financial Highlights

Conference Call/Webcast 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 March 1, 2023, at 8:00 a.m. Eastern Time. To participate in this conference call, dial 1-888-317-6003 (USA) or 1-412-317-6061 (International), passcode 1375589. 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 1-877-344-7529 (USA Toll Free), passcode 4132187.

About Iveric Bio

Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients' lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration. 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 regarding the regulatory pathway for and potential approval of ACP for the treatment of GA secondary to AMD, including its plans to submit MAAs to the European Medicines Agency and the UK Medicines and Healthcare Products Agency, statements regarding the Company's commercial plans and strategy for ACP, the clinical relevance of the clinical data from its GATHER1 and GATHER2 trials of ACP in GA, including from post-hoc analyses that it conducted, its development and regulatory strategy for ACP and its other product candidates, including its plans for the use of ACP in treating patients with intermediate AMD, the timing, progress and results of clinical trials and other research and development activities and regulatory submissions, the potential safety and efficacy and commercial potential of its product candidates, its projected use of cash, cash equivalents, marketable securities and its committed loan facilities and the sufficiency of its cash resources, and statements regarding the Company's business development and hiring plans. 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, expectations for regulatory matters, interpretation of clinical trial results by the scientific and medical community, the initiation, progress and success of research and development programs and clinical trials, reliance on clinical trial sites, contract development and manufacturing organizations and other third parties, developments from the Company's competitors and the marketplace for the Company's products, need for and availability of additional financing, negotiation and consummation of business development transactions, the hiring of personnel 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 may 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.

 
IVERIC bio, Inc.
Selected Financial Data (unaudited)
(in thousands, except per share data)
 

Three Months Ended December 31,

 

Year Ended December 31,

2022

 

2021

 

2022

 

2021

 
Statements of Operations Data:
Operating expenses:
Research and development

$

35,841

 

$

25,096

 

$

117,012

 

$

85,068

 

General and administrative

 

27,130

 

 

8,001

 

 

72,894

 

 

29,689

 

Total operating expenses

 

62,971

 

 

33,097

 

 

189,906

 

 

114,757

 

Loss from operations

 

(62,971

)

 

(33,097

)

 

(189,906

)

 

(114,757

)

Interest income, net

 

1,449

 

 

61

 

 

2,264

 

 

245

 

Gain on sale of IC100 & IC200

 

2,369

 

 

-

 

 

2,369

 

 

-

 

Other income (expense), net

 

92

 

 

3

 

 

62

 

 

(10

)

Loss before income tax benefit

 

(59,061

)

 

(33,033

)

 

(185,211

)

 

(114,522

)

Income tax benefit

 

-

 

 

-

 

 

-

 

 

-

 

Net loss

$

(59,061

)

$

(33,033

)

$

(185,211

)

$

(114,522

)

Net loss per common share:
Basic and diluted

$

(0.47

)

$

(0.29

)

$

(1.53

)

$

(1.12

)

Weighted average common shares outstanding:
Basic and diluted

 

125,367

 

 

115,073

 

 

121,037

 

 

101,866

 

 
December 31, 2022 December 31, 2021
(in thousands)
Balance Sheets Data:
Cash, cash equivalents and marketable securities

$

646,835

 

$

381,749

 

Total assets

$

666,823

 

$

389,358

 

Term loan, net

$

96,568

 

$

-

 

Total liabilities

$

132,166

 

$

28,830

 

Additional paid-in capital

$

1,399,555

 

$

1,040,098

 

Accumulated deficit

$

(864,806

)

$

(679,595

)

Total stockholders' equity

$

534,657

 

$

360,528

 

ISEE-G


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