Conference Call and Webcast Scheduled for 5:00
p.m. Eastern Time
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine
company, today reported fourth quarter and full year 2020 financial
results and recent business highlights.
“We are very pleased with our execution and the progress we made
in the challenging year of 2020 during the pandemic, where we
advanced our hemophilia A product candidate into a Phase 3 clinical
trial with Pfizer, dosed patients in our Phase 1/2 clinical study
evaluating our wholly owned product candidate treating Fabry
disease, entered into transformational neuroscience collaborations
with Biogen and Novartis, brought in-house AAV manufacturing online
in our Brisbane headquarters, and built a strong cash position,”
said Sandy Macrae, Chief Executive Officer of Sangamo. “In 2021, we
will continue to build on our momentum with a focus on clinical
execution and bringing our in-house cell therapy manufacturing
facilities online.”
Fourth Quarter Updates and Recent Business Highlights
- Presented with collaborator Pfizer updated follow-up data from
the Phase 1/2 Alta study of giroctocogene fitelparvovec, a gene
therapy product candidate to treat hemophilia A, which was
generally well-tolerated and demonstrated sustained Factor VIII
activity levels in the therapeutic range through one year for the
five patients in the highest dose cohort. The data were presented
at the 62nd American Society for Hematology Annual Meeting.
- Announced with Pfizer that the first participant has been dosed
in the registrational Phase 3 AFFINE trial of giroctocogene
fitelparvovec.
- Completed dosing in February 2021 of the third patient in the
Phase 1/2 STAAR study evaluating ST-920 gene therapy for Fabry
disease. This is the first patient in the second dose cohort.
- Brought in-house AAV manufacturing capabilities online in
Sangamo’s Brisbane, California headquarters at the end of
2020.
- Announced global collaboration with Novartis to develop and
commercialize gene regulation therapies to treat three
neurodevelopmental targets, including genes linked to autism
spectrum disorder and intellectual disability.
- Announced global collaboration with Biogen to develop and
commercialize gene regulation therapies for Alzheimer’s,
Parkinson’s, neuromuscular and other neurological diseases.
Fourth Quarter and Full Year 2020 Financial Results
Consolidated net loss for the fourth quarter ended December 31,
2020 was $40.7 million, or $0.29 per share, compared to net income
of $4.5 million, or $0.04 per share, for the same period in 2019.
For the year ended December 31, 2020, consolidated net loss was
$121.1 million, or $0.90 per share, compared to consolidated net
loss of $95.4 million, or $0.85 per share, for the year ended
December 31, 2019.
Revenues
Revenues for the fourth quarter ended December 31, 2020 were
$25.8 million, compared to $54.9 million for the same period in
2019. The decrease in revenue was due primarily to milestones
achieved under our collaboration agreements in the fourth quarter
of 2019, which included $25.0 million from Pfizer for the
completion of the investigational new drug, or IND, transfer for
giroctocogene fitelparvovec and $7.5 million from Sanofi for dosing
of the first patient in our Phase 1/2 clinical study evaluating our
BIVV003 product candidate to treat sickle cell disease.
Revenues were $118.2 million in 2020, compared to $102.4 million
in 2019. The increase in revenues was primarily due to recognition
of upfront license fees under the Biogen and Novartis collaboration
agreements entered into in 2020. This increase was partially offset
by a decrease in revenues from our giroctocogene fitelparvovec
collaboration agreement with Pfizer following the IND transfer in
December 2019.
Operating expenses
Three Months Ended December
31,
Year Ended December 31,
(In millions)
2020
2019
2020
2019
Research and development
$
52.4
$
38.3
$
180.6
$
145.9
General and administrative
16.8
15.1
67.1
61.7
Total operating expenses
69.2
53.4
247.7
207.6
Stock-based compensation expense
(6.6
)
(5.2
)
(25.7
)
(19.3
)
Non-GAAP operating expenses
$
62.6
$
48.2
$
222.0
$
188.3
Total operating expenses for the fourth quarter ended December
31, 2020 were $69.2 million compared to $53.4 million for the same
period in 2019. Stock-based compensation expense for the fourth
quarter ended December 31, 2020 was $6.6 million, compared to $5.2
million for the same period in 2019. Non-GAAP operating expenses,
which exclude stock-based compensation expense, for the fourth
quarter ended December 31, 2020 were $62.6 million, compared to
$48.2 million for the same period in 2019.
Total operating expenses in 2020 were $247.7 million, compared
to $207.6 million in 2019. Stock-based compensation expense in 2020
was $25.7 million, compared to $19.3 million in 2019. Non-GAAP
total operating expenses, which exclude excluding stock-based
compensation expense, were $222.0 million and $188.3 million in
2020 and 2019, respectively.
The increase in operating expenses in the full year and fourth
quarter was due primarily to headcount growth and facilities
expansion to support the advancement of our clinical trials and
manufacturing capabilities. The full year and fourth quarter
increase was partially offset by a decrease in travel and corporate
costs arising from the COVID-19 pandemic.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of December
31, 2020 were $692.0 million, compared to $384.3 million as of
December 31, 2019. The balance as of December 31, 2020 includes a
$30.0 million milestone from Pfizer for the initiation of the
AFFINE trial for giroctocogene fitelparvovec and a $5.0 million
milestone from Pfizer for our C9ORF72 collaboration with
Pfizer.
In August 2020, we entered into an Open Market Sale Agreement
with Jefferies LLC providing for the sale of up to $150.0 million
of our common stock from time to time in ‘at-the-market’ offerings
under our shelf registration statement. Through February 19, 2021,
we sold 1,034,762 shares of our common stock pursuant to this
agreement for net proceeds of approximately $15.7 million.
Initial Financial Guidance for 2021
On a GAAP basis, we expect total operating expenses in the range
of approximately $285 million to $305 million in 2021, which
includes non-cash stock-based compensation expense.
We expect non-GAAP total operating expenses, excluding estimated
non-cash stock-based compensation expense of approximately $30
million, in the range of approximately $255 million to $275
million.
Conference Call
Sangamo will host a conference call today, February 24, 2021, at
5:00 p.m. Eastern Time, which will be open to the public. The call
will also be webcast with live Q&A and can be accessed via a
link on the Sangamo Therapeutics website in the Investors and Media
section under Events and Presentations.
The conference call dial-in numbers are (877) 377-7553 for
domestic callers and (678) 894-3968 for international callers. The
conference ID number for the call is 1795427. Participants may
access the live webcast via a link on the Sangamo Therapeutics
website in the Investors and Media section under Events and
Presentations. A conference call replay will be available for one
week following the conference call. The conference call replay
numbers for domestic and international callers are (855) 859-2056
and (404) 537-3406, respectively. The conference ID number for the
replay is 1795427.
About Sangamo Therapeutics
Sangamo Therapeutics is committed to translating ground-breaking
science into genomic medicines with the potential to transform
patients’ lives using gene therapy, cell therapy, and genome
engineering. For more information about Sangamo, visit
www.sangamo.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
our current expectations. These forward-looking statements include,
without limitation, statements relating to anticipated plans and
timelines of Sangamo and our collaborators for conducting clinical
trials and bringing in-house manufacturing facilities online, our
financial resources and expectations, our 2021 financial guidance
related to GAAP and non-GAAP total operating expenses and
stock-based compensation and other statements that are not
historical fact. These statements are not guarantees of future
performance and are subject to certain risks and uncertainties that
are difficult to predict. Factors that could cause actual results
to differ include, but are not limited to, risks and uncertainties
related to the effects of the evolving COVID-19 pandemic and the
impacts of the pandemic on the global business environment,
healthcare systems and business and operations of Sangamo and our
collaborators, including the initiation and operation of clinical
trials; the construction, opening and operation of in-house
manufacturing facilities and our ability to achieve expected future
financial performance.
There can be no assurance that we and our collaborators will be
able to develop commercially viable products. Actual results may
differ from those projected in forward-looking statements due to
risks and uncertainties that exist in the operations and business
environments of Sangamo and our collaborators. These risks and
uncertainties are described more fully in our Securities and
Exchange Commission filings and reports, including in our Annual
Report on Form 10-K for the year ended December 31, 2020.
Forward-looking statements contained in this announcement are made
as of this date, and we undertake no duty to update such
information except as required under applicable law.
Non-GAAP Financial Measure
To supplement our financial results and guidance presented in
accordance with GAAP, we present non-GAAP total operating expenses,
which exclude stock-based compensation expense from GAAP total
operating expenses. We believe that this non-GAAP financial
measure, when considered together with our financial information
prepared in accordance with GAAP, can enhance investors’ and
analysts’ ability to meaningfully compare our results from period
to period and to our forward-looking guidance, and to identify
operating trends in our business. We have excluded stock-based
compensation expense because it is a non-cash expense that may vary
significantly from period to period as a result of changes not
directly or immediately related to the operational performance for
the periods presented. This non-GAAP financial measure is in
addition to, not a substitute for, or superior to, measures of
financial performance prepared in accordance with GAAP. We
encourage investors to carefully consider our results under GAAP,
as well as our supplemental non-GAAP financial information, to more
fully understand our business.
SELECTED CONSOLIDATED FINANCIAL DATA (unaudited; in
thousands, except per share data)
Statement of Operations
Data:
Three months ended
Year Ended
December 31,
December 31,
2020
2019
2020
2019
Revenues
$
25,800
$
54,851
$
118,192
$
102,428
Operating expenses: Research and development
52,358
38,329
180,647
145,922
General and administrative
16,874
15,053
67,097
61,686
Total operating expenses
69,232
53,382
247,744
207,608
(Loss) income from operations
(43,432
)
1,469
(129,552
)
(105,180
)
Interest and other income, net
2,865
3,032
8,775
9,761
(Loss) income before income taxes
(40,567
)
4,501
(120,777
)
(95,419
)
Income tax expense
108
-
345
-
Net (loss) income
(40,675
)
4,501
(121,122
)
(95,419
)
Net loss attributable to non-controlling interest
(71
)
(54
)
(126
)
(233
)
Net (loss) income to Sangamo Therapeutics, Inc. stockholders
$
(40,604
)
$
4,555
$
(120,996
)
$
(95,186
)
Basic and diluted net (loss) income per share attributable to
Sangamo Therapeutics, Inc. stockholders
$
(0.29
)
$
0.04
$
(0.90
)
$
(0.85
)
Shares used in computing basic net (loss) income per share
attributable to Sangamo Therapeutics, Inc. stockholders
141,508
115,903
134,449
112,114
Shares used in computing diluted net (loss) income per share
attributable to Sangamo Therapeutics, Inc. stockholders
141,508
126,653
134,449
112,114
Balance Sheet Data: December 31,2020
December 31,2019 Cash, cash equivalents and
marketable securities
$
691,953
$
384,306
Total assets
938,550
637,516
Total stockholders' equity
497,366
432,739
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version on businesswire.com: https://www.businesswire.com/news/home/20210224005277/en/
Investor Relations & Media
Inquiries Aron Feingold 628.252.7494
afeingold@sangamo.com
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