Generation Bio Reports Fourth Quarter and Full Year 2020 Financial Results
March 18 2021 - 8:00AM
Generation Bio Co. (Nasdaq: GBIO), an innovative genetic medicines
company creating a new class of non-viral gene therapy, reported
recent business highlights and fourth quarter and full year 2020
financial results.
“2020 was a foundational year for Generation Bio in which we
strengthened the leadership team, advanced our platform science,
and added substantially to our balance sheet to fund our lead
programs to human data,” said Geoff McDonough, M.D., president and
chief executive officer of Generation Bio. “We entered 2021 with
preclinical data in mice and non-human primates that we believe
demonstrate our platform’s potential to go beyond what is currently
possible with gene therapy for hemophilia A. We expect to announce
additional data throughout the remainder of this year that will
support the rapid expansion of our pipeline and showcase our
differentiated approach to creating a new class of genetic
medicine.”
Recent Business Highlights
- Raised $225.4 million in gross proceeds from follow-on
offering: In January 2021, Generation Bio closed a
public offering of 9,200,000 shares of its common stock at a public
offering price of $24.50 per share, including 1,200,000 additional
shares of common stock issued upon the exercise in full by the
underwriters of their option to purchase additional
shares. The gross proceeds of the offering, before deducting
the underwriting discount and commissions and other offering
expenses payable by Generation Bio, were approximately $225.4
million.
- Appointed Ron Cooper to Board of Directors: In
February 2021, Generation Bio announced the appointment of Ron
Cooper to its Board of Directors. Mr. Cooper is a global
biopharmaceutical executive who currently serves as president,
chief executive officer and board member of Albireo Pharma,
Inc.
- Announced preclinical data
that support development candidate selection for hemophilia A
program: Also in January 2021, the company reported
data from a series of preclinical studies evaluating the expression
of factor VIII in both mice and non-human primates (NHP). Data in
mice showed that a single dose of a closed-ended DNA (ceDNA)
construct delivered via the company’s novel, cell-targeted lipid
nanoparticle (ctLNP) system led to mean human factor VIII
expression levels from 9% to 23% of normal with a dose response
across the three cohorts. In two additional separate studies, a
mean 2:1 species translation ratio from mice to NHPs was observed,
consistent with best-in-class translation ratios seen for other
nucleic acids delivered via LNPs.
Selected Anticipated Company Milestones in
2021
- NHP factor VIII expression data for
hemophilia A development candidate
- NHP factor IX expression, durability
and redosing data
- Initiation of IND-enabling studies
for phenylketonuria (PKU)
- Preclinical data for Gaucher disease
and Wilson disease
- Preclinical data for expression of
therapeutic antibodies
Fourth Quarter and Full Year 2020 Financial
Results
- Cash Position: Cash, cash equivalents and
marketable securities were $262.3 million as
of December 31, 2020, compared with $15.1 million as of
December 31, 2019. Cash at December 31, 2020 does not include the
$211.3 million in net proceeds received from the follow-on public
offering completed in January 2021.
- R&D Expenses: Research and
development (R&D) expenses
were $16.4 million for the quarter ended December
31, 2020 and $58.5 million for the year ended December 31, 2020,
compared to $12.7 million for the quarter ended December 31, 2019
and $50.1 million for the year ended December 31, 2019.
- G&A Expenses: General and
administrative (G&A) expenses
were $8.0 million for the quarter ended December 31,
2020 and $22.6 million for the year ended December 31, 2020,
compared to $3.4 million for the quarter ended December 31, 2019
and $12.2 million for the year ended December 31, 2019.
- Net Loss: Net loss
was $24.2 million, or $0.53 basic and diluted net loss
per share, for the quarter ended December 31, 2020 and $80.5
million, or $2.95 basic and diluted net loss per share, for the
year ended December 31, 2020, compared to a net loss of $16.1
million, or $3.09 basic and diluted net loss per share, for the
quarter ended December 31, 2019 and $61.3 million, or $12.96 basic
and diluted net loss per share, for the year ended December 31,
2019.
About Generation Bio
Generation Bio is an innovative genetic medicines company
focused on creating a new class of non-viral gene therapy to
provide durable, redosable treatments for people living with rare
and prevalent diseases. The company’s non-viral platform
incorporates a proprietary, high-capacity DNA construct called
closed-ended DNA, or ceDNA; a cell-targeted lipid nanoparticle
delivery system, or ctLNP; and an established, scalable capsid-free
manufacturing process. The platform is designed to enable
multi-year durability from a single dose of ceDNA and to allow
titration and redosing if needed. The ctLNP is engineered to
deliver large genetic payloads, including multiple genes, to
specific tissues to address a wide range of indications. The
company’s efficient, scalable manufacturing process supports
Generation Bio’s mission to extend the reach of gene therapy to
more people, living with more diseases, in more places around the
world.
Forward-Looking Statements
Any statements in this press release about future expectations,
plans and prospects for the Company, including statements about our
strategic plans or objectives, our technology platforms, our
research and clinical development plans, and other statements
containing the words “believes,” “anticipates,” “plans,” “expects,”
and similar expressions, constitute forward-looking statements
within the meaning of The Private Securities Litigation Reform Act
of 1995. Actual results may differ materially from those indicated
by such forward-looking statements as a result of various important
factors, including: uncertainties inherent in the identification
and development of product candidates, including the conduct of
research activities, the initiation and completion of preclinical
studies and clinical trials and clinical development of the
Company’s product candidates; uncertainties as to the availability
and timing of results from preclinical studies and clinical trials;
whether results from preclinical studies will be predictive of the
results of later preclinical studies and clinical trials;
expectations for regulatory approvals to conduct trials or to
market products; challenges in the manufacture of genetic medicine
products; whether the Company’s cash resources are sufficient to
fund the Company’s operating expenses and capital expenditure
requirements for the period anticipated; the impact of the COVID-19
pandemic on the Company’s business and operations; as well as the
other risks and uncertainties set forth in the “Risk Factors”
section of our most recent quarterly report on Form 10-Q, which is
on file with the Securities and Exchange Commission, and in
subsequent filings the Company may make with the Securities and
Exchange Commission. In addition, the forward-looking statements
included in this press release represent the Company’s views as of
the date hereof. The Company anticipates that subsequent events and
developments will cause the Company’s views to
change. However, 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. These
forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date on which they were made.
Contacts:
InvestorsMaren KillackeyGeneration
Bio541-646-2420mkillackey@generationbio.com
MediaAlicia WebbGeneration
Bio847-254-4275awebb@generationbio.com
Stephanie SimonTen Bridge
Communications617-581-9333stephanie@tenbridgecommunications.com
GENERATION BIO
CO.CONSOLIDATED BALANCE SHEET DATA
(Unaudited)(In thousands)
|
|
December 31, |
|
|
2020 |
|
|
2019 |
|
Cash, cash equivalents and marketable securities |
|
$ |
262,327 |
|
|
$ |
15,076 |
|
Working capital |
|
|
256,515 |
|
|
|
8,998 |
|
Total assets |
|
|
294,155 |
|
|
|
42,140 |
|
Convertible preferred
stock |
|
|
— |
|
|
|
115,593 |
|
Total stockholders’ equity
(deficit) |
|
|
268,013 |
|
|
|
(98,592 |
) |
|
|
|
|
|
|
|
|
|
GENERATION BIO
CO.CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)(in thousands, except share and per share
data)
|
|
|
Three Months Ended December 31, |
|
|
|
Year Ended December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
16,374 |
|
|
$ |
12,731 |
|
|
$ |
58,532 |
|
|
$ |
50,134 |
|
General and administrative |
|
|
7,971 |
|
|
|
3,427 |
|
|
|
22,582 |
|
|
|
12,168 |
|
Total operating expenses |
|
|
24,345 |
|
|
|
16,158 |
|
|
|
81,114 |
|
|
|
62,302 |
|
Loss from operations |
|
|
(24,345 |
) |
|
|
(16,158 |
) |
|
|
(81,114 |
) |
|
|
(62,302 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income and other income (expense), net |
|
|
119 |
|
|
|
95 |
|
|
|
591 |
|
|
|
985 |
|
Net loss and net loss attributable to common stockholders |
|
$ |
(24,226 |
) |
|
$ |
(16,063 |
) |
|
$ |
(80,523 |
) |
|
$ |
(61,317 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
|
$ |
(0.53 |
) |
|
$ |
(3.09 |
) |
|
$ |
(2.95 |
) |
|
$ |
(12.96 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
45,855,896 |
|
|
|
5,205,942 |
|
|
|
27,256,494 |
|
|
|
4,731,519 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(24,226 |
) |
|
$ |
(16,063 |
) |
|
$ |
(80,523 |
) |
|
$ |
(61,317 |
) |
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on marketable securities |
|
|
(17 |
) |
|
|
(2 |
) |
|
|
9 |
|
|
|
9 |
|
Comprehensive loss |
|
$ |
(24,243 |
) |
|
$ |
(16,065 |
) |
|
$ |
(80,514 |
) |
|
$ |
(61,308 |
) |
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