Conference Call and Webcast Scheduled for 8
a.m. Eastern Time
Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine
company, today reported fourth quarter and full year 2019 financial
results and recent business highlights.
“This quarter marked an important milestone for Sangamo, as we
transitioned to a Phase 3 company following the transfer of the IND
for SB-525 hemophilia A gene therapy to our partner Pfizer, who
plan to commence the registrational study this year. This is a
significant step in our mission to bring our genomic medicines to
patients,” said Sandy Macrae, CEO of Sangamo. “Additionally this
year, we look forward to progressing our wholly owned assets,
ST-920 gene therapy for Fabry disease and TX200 CAR-Treg cell
therapy, in the clinic, and will work closely with our
collaborator, Kite, as they advance KITE-037, an anti-CD19
allogeneic CAR-T therapy into a Phase 1/2 clinical trial. We will
also continue to advance new IND targets in highly prevalent
diseases, as exemplified by the newly announced Biogen
collaboration, and will continue to look for additional synergistic
partnership opportunities to advance our mission to bring
innovative genomic medicines to patients and to create value for
our shareholders.”
Recent Highlights
- Yesterday, announced global collaboration agreement with Biogen
to develop and commercialize gene regulation therapies for
Alzheimer’s, Parkinson’s, neuromuscular and other neurological
diseases. Under the terms of the collaboration, Biogen has
exclusive global rights to ST-501 for tauopathies including
Alzheimer’s disease, ST-502 for synucleinopathies including
Parkinson’s disease, and a third undisclosed neuromuscular disease
target. In addition, Biogen has exclusive rights to nominate up to
nine additional undisclosed targets over a target selection period
of five years. Closing of the transaction is contingent on
completion of review under antitrust laws, including the
Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United
States (HSR).
- Completed the transfer of the investigational new drug
application (IND) for SB-525 gene therapy in hemophilia A to
development partner Pfizer, triggering a $25 million milestone
payment. Pfizer is currently enrolling patients in a 6-month Phase
3 lead-in study, which serves as the foundation of the Phase 3
registrational study.
- Presented updated follow-up of the Phase 1/2 Alta Study
assessing SB-525 in adult patients with severe hemophilia A in
partnership with Pfizer at the 61st American Society of Hematology
(ASH) annual meeting in December 2019. The data showed that SB-525
was generally well tolerated and demonstrated sustained increased
Factor VIII levels following treatment with SB-525 through to 44
weeks, the extent of follow-up for the longest treated patient in
the 3e13 vg/kg dose cohort.
- Received Orphan Drug Designation from the European Medicines
Agency for ST-920, an investigational gene therapy candidate for
Fabry disease. Six US sites are currently active and screening
subjects for the Phase 1/2 STAAR study evaluating ST-920, which
Sangamo is enrolling in 2020.
- Presented preliminary data from the Phase 1/2 THALES Study
assessing ST-400, investigational ex vivo gene-edited cell therapy
in patients with transfusion-dependent beta thalassemia in
partnership with Sanofi at ASH.
- Achieved $7.5 million milestone from Sanofi for the first
patient dosed in their Phase 1/2 PRECIZN-1 trial evaluating
BIVV003, investigational ex vivo gene-edited cell therapy for the
treatment of sickle cell disease.
- Received clinical trial application authorization in the United
Kingdom for the Phase 1/2 STEADFAST clinical study
evaluating the CAR-Treg cell therapy TX200 for kidney
transplantation.
- Hosted R&D Day in New York where Sangamo executives and
scientists provided updates across the Company’s clinical and
preclinical pipeline, as well as an overview of manufacturing
capabilities to support clinical and commercial supply.
- Established new Scientific Advisory Board comprising industry
and academic international thought leaders who will advise Sangamo
on its current and future clinical programs and research and
development strategy.
Fourth Quarter 2019 Financial Results
For the fourth quarter ended December 31, 2019, Sangamo reported
consolidated net income attributable to Sangamo of $4.6 million, or
$0.04 per share, compared to a net loss attributable to Sangamo of
$18.7 million, or $0.18 per share, for the same period in 2018.
Revenues for the fourth quarter ended December 31, 2019 were
$54.9 million, compared to $26.8 million for the same period in
2018. The increase in revenue was primarily attributable to a $25.0
million milestone achieved for the completion of the IND transfer
for SB-525 to Pfizer for hemophilia A, and a $7.5 million milestone
achieved for dosing the first subject in the BIVV003 sickle cell
disease Phase 1/2 clinical trial partnered with Sanofi.
Total operating expenses were $53.4 million for the fourth
quarter ended December 31, 2019, compared to $47.6 million for the
same period in 2018.
Research and development expenses were $38.3 million for the
fourth quarter of 2019, compared to $33.3 million for the same
period in 2018. General and administrative expenses were $15.1
million for the fourth quarter of 2019, compared to $14.4 million
for the same period in 2018.
Full Year 2019 Results
For the year ended December 31, 2019, the consolidated net loss
attributable to Sangamo was $95.2 million, or $0.85 per share,
compared to a net loss attributable to Sangamo of $68.3 million, or
$0.70 per share, for the year ended December 31, 2018.
Revenues were $102.4 million in 2019, compared to $84.5 million
in 2018. The increase in revenues was primarily attributable to
milestones achieved with Sanofi and Pfizer as well as higher
revenues related to our collaboration agreement with Kite, a Gilead
Company.
On a GAAP basis, total operating expenses were $207.6 million in
2019, compared to $161.6 million in 2018. Stock-based compensation
expense included in total operating expenses in 2019 was $19.3
million, compared to $14.7 million in 2018.
Non-GAAP total operating expenses excluding the above
stock-based compensation expense, were $188.3 million and $146.9
million in 2019 and 2018, respectively.
The increase in total operating expenses was primarily related
to the Company’s overall headcount growth and facilities expansion
to support the advancement of Sangamo’s therapeutic pipeline.
Research and development expenses were $145.9 million in 2019,
compared to $114.9 million in 2018. General and administrative
expenses were $61.7 million in 2019, compared to $46.7 million in
2018.
As of December 31, 2019, the Company had cash, cash equivalents,
marketable securities and interest receivable of $385.0
million.
Financial Guidance for 2020
On a GAAP basis, Sangamo expects total operating expenses to be
in the range of $270 to $285 million in 2020, which includes
non-cash stock-based compensation expense of approximately $25
million.
Non-GAAP total operating expenses, excluding expected non-cash
stock-based compensation expense of approximately $26 million, are
expected to be in the range of $245 to $260 million.
Conference Call
Sangamo will host a conference call today, February 28, 2020, at
8:00 a.m. Eastern Time, which will be open to the public. The call
will also be webcast live 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 4609858. 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 4609858.
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, ex vivo gene-edited cell
therapy, and in vivo genome editing and genome regulation. For more
information about Sangamo, visit www.sangamo.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding
Sangamo’s current expectations. These forward-looking statements
include, without limitation, statements regarding the closing of
Sangamo’s recently-announced global collaboration agreement with
Biogen, Pfizer’s plans to commence a registrational study for
SB-525 this year, Sangamo’s expectations of progressing its wholly
owned assets in the clinic, the expected advancement of KITE-037
into a Phase 1/2 clinical trial, Sangamo’s expectation of advancing
new IND targets, potential additional synergistic partnership
opportunities for Sangamo to advance its mission to bring
innovative genomic medicines to patients and to create value for
its stockholders, Sangamo’s 2020 financial guidance related to GAAP
and non-GAAP total operating expenses, and other statements that
are not historical fact. These statements are not guarantees of
future performance and are subject to certain risks, uncertainties
and assumptions that are difficult to predict. Factors that could
cause actual results to differ include, but are not limited to, the
dependence on the success of clinical trials, the lengthy and
uncertain regulatory approval process, risks and uncertainties
related to the initiation, enrollment and completion of clinical
trials, whether the final results from a study will validate and
support interim safety and efficacy data, Sangamo’s reliance on
partners and other third-parties to meet their clinical and
manufacturing obligations, and the ability to maintain strategic
partnerships and collaborations. Further, there can be no assurance
that (i) Sangamo’s global collaboration agreement with Biogen will
become effective and that the transaction will otherwise close,
including as a result of the failure by the parties to clear HSR
review or otherwise satisfy closing conditions or (ii) the
necessary regulatory approvals will be obtained or that Sangamo and
its partners will be able to develop commercially viable product
candidates. Actual results may differ from those projected in
forward-looking statements due to risks and uncertainties that
exist in Sangamo’s operations and business environments. These
risks and uncertainties are described more fully in Sangamo’s
Quarterly Report on Form 10-Q for the quarter ended September 30,
2019 as filed with the Securities and Exchange Commission and
Sangamo’s Annual Report on Form 10-K that it intends to file
shortly. Forward-looking statements contained in this announcement
are made as of this date, and Sangamo undertakes no duty to update
such information except as required under applicable law.
Non-GAAP Financial Measures
To supplement Sangamo’s financial results and guidance presented
in accordance with GAAP, Sangamo presents non-GAAP total operating
expenses, which exclude stock-based compensation expense from GAAP
total operating expenses. Sangamo believes that this non-GAAP
financial measure, when considered together with its financial
information prepared in accordance with GAAP, can enhance
investors’ and analysts’ ability to meaningfully compare Sangamo’s
results from period to period and to its forward-looking guidance,
and to identify operating trends in Sangamo’s business. Sangamo has
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. Sangamo encourages investors to carefully
consider its results under GAAP, as well as its supplemental
non-GAAP financial information, to more fully understand Sangamo’s
business.
SELECTED CONSOLIDATED FINANCIAL DATA (unaudited; in
thousands, except per share data)
Statement of
Operations Data: Three months endedDecember 31, Year
endedDecember 31,
2019
2018
2019
2018
Revenues
$
54,851
$
26,837
$
102,428
$
84,452
Operating expenses: Research and development
38,329
33,254
145,922
114,866
General and administrative
15,053
14,355
61,686
46,736
Total operating expenses
53,382
47,609
207,608
161,602
Income (loss) from operations
1,469
(20,772
)
(105,180
)
(77,150
)
Interest and other income, net
3,032
1,553
9,761
8,261
Net income (loss) attributable to Sangamo Therapeutics, Inc.
stockholders
4,501
(19,219
)
(95,419
)
(68,889
)
Net loss attributable to non-controlling interests
(54
)
(555
)
(233
)
(555
)
Net income (loss) attributable to Sangamo Therapeutics, Inc.
stockholders
$
4,555
$
(18,664
)
$
(95,186
)
$
(68,334
)
Basic and diluted net income (loss) per common share attributable
to Sangamo Therapeutics Inc. stockholders
$
0.04
$
(0.18
)
$
(0.85
)
$
(0.70
)
Shares used in computing basic net income (loss) per common share
attributable to Sangamo Therapeutics, Inc. stockholders
115,903
102,057
112,114
96,941
Shares used in computing diluted net income (loss) per common share
attributable to Sangamo Therapeutics, Inc. stockholders
126,653
102,057
112,114
96,941
Balance Sheet Data: December 31, 2019 December
31, 2018 Cash, cash equivalents, marketable
securities and interest receivable
$
384,988
$
400,508
Total assets
637,516
590,395
Total stockholders' equity
432,739
367,257
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version on businesswire.com: https://www.businesswire.com/news/home/20200228005103/en/
Investor Relations – Global McDavid
Stilwell 510-970-6000, x219 mstilwell@sangamo.com
Media Inquiries – Global Aron
Feingold 510-970-6000, x421 afeingold@sangamo.com
Investor Relations and Media Inquiries –
European Union & United Kingdom Caroline Courme 33 4 97
21 27 27 ccourme@sangamo.com
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