generation bio | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|-------|-------|-------|-------| | | | | | | | | | | | | | | | | | | | | NASDAQ: GBIO APRIL 2021 Forward-looking statements 2 Any statements in this presentation about future expectations, plans and prospects for the Company, including statements about the Company's strategic plans or objectives, technology platforms, research and clinical development plans, manufacturing plans and goals, and othe ...

Compliance and Regulatory Costs - The company has incurred increased costs due to operating as a newly public entity, with significant legal, accounting, and compliance expenses expected to rise as it transitions from an Emerging Growth Company (EGC) status [716]. - The Sarbanes-Oxley Act and other regulations impose requirements that will increase legal and financial compliance costs, necessitating the hiring of additional financial and accounting personnel [716]. - The company is required to furnish a report on internal control over financial reporting starting with the Annual Report for the year ended December 31, 2021, which may involve significant costs and challenges [718]. - There is a risk that the company may not conclude that its internal control over financial reporting is effective, which could lead to adverse reactions in the financial markets [718]. Financial Performance and Position - Generation Bio Co. reported total assets of $294.155 million as of December 31, 2020, a significant increase from $42.140 million in 2019, representing a growth of 596% [818]. - The company incurred a net loss of $80.523 million for the year ended December 31, 2020, compared to a net loss of $61.317 million in 2019, reflecting a 31% increase in losses [820]. - Generation Bio Co. reported comprehensive loss of $80.514 million for 2020, compared to a comprehensive loss of $61.308 million in 2019, an increase of 31.2% [820]. - The company’s total operating expenses for 2020 were $81.114 million, up from $62.302 million in 2019, representing a 30.3% increase [820]. - The Company reported a net loss of $80.5 million for the year ended December 31, 2020, with an accumulated deficit of $189.0 million as of the same date [832]. Research and Development - Research and development expenses rose to $58.532 million in 2020, up from $50.134 million in 2019, indicating a 16.7% increase in investment in R&D [820]. - Research and development costs are expensed as incurred, including salaries, stock-based compensation, and external vendor costs [850]. - The Company recorded research and development expenses of less than $0.1 million under its license agreements with NIH and UMass for both 2020 and 2019 [910][916]. Capital and Funding - The company raised $213.900 million from its initial public offering in 2020, contributing to a net cash increase of $47.757 million for the year [826]. - The Company may need to obtain additional funding through public or private equity offerings, debt financings, or collaborations, which may not be on acceptable terms [833]. - As of March 18, 2021, the Company expects its cash, cash equivalents, and marketable securities to be sufficient to fund operating expenses and capital expenditures for at least 12 months [832]. Tax Matters - Changes in tax laws, including a reduction of the corporate tax rate from 35% to 21%, may adversely affect the company's financial condition [724]. - The CARES Act allows for the carryback of Net Operating Losses (NOLs) for up to five years, which could impact the company's tax liabilities [726]. - As of December 31, 2020, the Company had federal net operating loss carryforwards of $177.3 million, which may offset future taxable income [899]. - The Company recorded no income tax benefits for net operating losses incurred for the years ended December 31, 2020 and 2019 due to uncertainty in realizing benefits [897]. - The effective income tax rate for the years ended December 31, 2020 and 2019 was 0.0% [899]. Stockholder and Corporate Governance - The company is subject to various provisions in its corporate charter that may make acquisitions more difficult, potentially affecting stockholder interests [728]. - The company is governed by Delaware law, which includes provisions that could limit stockholder actions and affect the ability to replace management [729]. - The number of shares authorized for issuance under the 2017 Stock Incentive Plan increased from 8,407,405 to 10,275,717 shares in January 2020 [884]. - As of December 31, 2020, 2,500,761 shares remained available for future issuance under the 2020 Stock Incentive Plan, with an increase of 1,878,800 shares effective January 1, 2021 [887]. Operational Risks - The company maintains disaster recovery plans, but natural disasters or catastrophic events could significantly disrupt operations and financial performance [734]. - The Company relies on third-party suppliers for drug substance and product, which poses a risk of supply interruptions affecting its programs [838]. - The Company has incurred recurring losses and expects to continue generating operating losses in the foreseeable future [832]. Lease and Asset Management - The Company expects to recognize a lease liability of approximately $49.7 million and a related right-of-use asset of approximately $33.4 million upon adopting new lease accounting standards [869]. - Future minimum lease payments as of December 31, 2020, total $64,875,000, with the largest payment of $27,570,000 due thereafter [921]. - The total assets measured at fair value on a recurring basis amounted to approximately $263.3 million as of December 31, 2020 [874]. Employee Compensation and Stock Options - The Company recorded stock-based compensation expense of $8.4 million for the year ended December 31, 2020, up from $4.2 million in 2019 [896]. - The total intrinsic value of stock options exercised during the year ended December 31, 2020 was $20.0 million, compared to $0.1 million in 2019 [892]. - The total fair value of restricted common stock vested during the year ended December 31, 2020 was approximately $15.8 million, compared to $7.0 million in 2019 [895]. - The Company has unrecognized compensation cost related to unvested stock-based awards of $27.1 million, expected to be recognized over a weighted average period of 3.2 years [896].

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39319 GENERATION BIO CO. (Exact name of registrant as specified in its charter) Delaware 81-4301284 (State or other ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39319 GENERATION BIO CO. (Exact name of registrant as specified in its charter) Delaware 81-4301284 (State or other jurisdiction of incorpo ...