GENERATION BIO CO. Management’s Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) – Marketscreener.com

The following discussion and analysis of our financial condition and results ofoperations are meant to provide material information relevant to an assessmentof the financial condition and results of operations of our company, includingan evaluation of the amounts and uncertainties of cash flows from operations andfrom outside resources, so as to allow investors to better view our company frommanagement's perspective. It should be read in conjunction with our condensedconsolidated financial statements and related notes appearing elsewhere in thisQuarterly Report on Form 10-Q, or Quarterly Report, and our consolidatedfinancial statements and related notes appearing in our most recently filedAnnual Report on Form 10-K, or Annual Report, with the Securities and ExchangeCommission, or SEC. Some of the information contained in this discussion andanalysis or set forth elsewhere in this Quarterly Report, including informationwith respect to our plans and strategy for our business, includesforward-looking statements that involve risks and uncertainties. As a result ofmany factors, including those factors set forth in the "Risk Factors" section ofthis Quarterly Report, in our Annual Report and in the other documents filedwith the SEC, our actual results could differ materially from the resultsdescribed in, or implied by, the forward-looking statements contained in thefollowing discussion and analysis.

Overview

Furthermore, we plan to expand our portfolio to include rare and prevalentdiseases of the skeletal muscle, the central nervous system and oncology bydeveloping discrete ctLNPs, each engineered to reach a different tissue.

? obtain, expand, maintain, defend and enforce our intellectual property

portfolio;

? continue our current research programs and conduct additional research

programs;

? expand the capabilities of our proprietary non-viral genetic medicine platform;

add operational, legal, compliance, financial and management information? systems and personnel to support our research, product development, future

commercialization efforts and operations as a public company;

develop our capabilities to manufacture and establish additional commercial? manufacturing sources and secure supply chain capacity sufficient to provide

necessary quantities of any product candidates we may develop for clinical or

commercial use;

? hire additional clinical, regulatory and scientific personnel;

? advance any product candidates we identify into preclinical and clinical

development;

? seek marketing approvals for any product candidates that successfully complete

clinical trials; and

? ultimately establish a sales, marketing and distribution infrastructure to

commercialize any products for which we may obtain marketing approval.

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support product sales, marketing and distribution. Further, we expect tocontinue to incur additional costs associated with operating as a publiccompany.

COVID-19

We expect to continue to take actions as may be required or recommended bygovernment authorities or as we determine are in the best interests of ouremployees and other business partners in light of the pandemic.

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Components of Our Results of Operations

Operating expenses

Research and development expenses

personnel-related costs, including salaries, benefits and stock-based? compensation expense, for employees engaged in research and development

functions;

expenses incurred in connection with our research programs, including under? agreements with third parties, such as consultants, contractors and CROs, and

regulatory agency fees;

the cost of developing and scaling our manufacturing process and capabilities? and manufacturing drug substance and drug product for use in our research and

preclinical studies, including under agreements with third parties, such as

consultants, contractors and CMOs;

? laboratory supplies and research materials;

facilities, depreciation and amortization and other expenses, which include? direct and allocated expenses for rent and maintenance of facilities and

insurance; and

? payments made under third-party licensing agreements.

? the timing and progress of preclinical studies, including investigational new

drug, or IND , -enabling studies;

? the number and scope of preclinical and clinical programs we decide to pursue;

? raising additional funds necessary to complete preclinical and clinical

development of our product candidates;

the timing of the submission and acceptance of IND applications or comparable? foreign applications that allow commencement of future clinical trials for our

product candidates;

? the successful initiation, enrollment and completion of clinical trials,

including under Good Clinical Practices;

our ability to achieve positive results from our future clinical programs that? support a finding of safety and effectiveness and an acceptable risk-benefit

profile in the intended patient populations of any product candidates we may

develop;

? our ability to scale RES to produce clinical and initial commercial supply;

? our ability to establish arrangements with third-party manufacturers for

preclinical and clinical supply;

? the availability of specialty raw materials for use in production of our

product candidates;

? our ability to establish new licensing or collaboration arrangements;

? the receipt and related terms of regulatory approvals from the U.S. Food and

Drug Administration and other applicable regulatory authorities;

our ability to establish, obtain, maintain, enforce and defend patent,? trademark, trade secret protection and other intellectual property rights or

regulatory exclusivity for any product candidates we may develop and our

technology; and

? our ability to maintain a continued acceptable safety, tolerability and

efficacy profile of our product candidates following approval.

General and administrative expenses

Other income and interest income

Other income and interest income consists of interest income earned on ourinvested cash balances and other miscellaneous income unrelated to our coreoperations.

Comparison of the three and six months ended June 30, 2022 and 2021

The following table summarizes our results of operations for the three andsix months ended June 30, 2022 and 2021:

(7,639) (73,825) (56,497) (17,328)Other income:Other income and interest income

Research and development expenses

The following table summarizes our research and development expenses for thethree and six months ended June 30, 2022 and 2021:

5,767 $ 1,656 $ 15,169 $ 11,155 $ 4,014Preclinical and manufacturing

920

Total research and development expenses $ 28,365 $ 22,656 $ 5,709 $ 53,919 $ 41,409 $ 12,510

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General and administrative expenses

The following table summarizes our general and administrative expenses for thethree and six months ended June 30, 2022 and 2021:

2,547

Total general and administrative expenses $ 10,116 $ 8,186 $ 1,930 $ 19,906

4,818

Other income and interest income

Liquidity and Capital Resources

3,593 213,930Net increase in cash, cash equivalents and restricted cash $ (216,880) $ 329,183

Investing activities

Financing activities

? the identification of additional research programs and product candidates;

? the scope, progress, costs and results of preclinical and clinical development

for any product candidates we may develop;

? the costs, timing and outcome of regulatory review of any product candidates we

may develop;

? the cost and timing of clinical and commercial-scale manufacturing activities;

the costs and timing of future commercialization activities, including product

? manufacturing, marketing, sales and distribution, for any product candidates we

may develop for which we receive marketing approval;

? the costs and scope of the continued development of our non-viral genetic

medicine platform;

? the costs of satisfying any post-marketing requirements;

? the revenue, if any, received from commercial sales of product candidates we

may develop for which we receive marketing approval;

Excerpt from:
GENERATION BIO CO. Management's Discussion and Analysis of Financial Condition and Results of Operations. (form 10-Q) - Marketscreener.com