Sangamo Therapeutics Reports Business Highlights and Third Quarter 2020 Financial Results – BioSpace

We are pleased with the clinical execution momentum across our portfolio, including the first patient dosed in the registrational AFFINE study of our investigational hemophilia A gene therapy partnered with Pfizer, as well as dosing of the first two patients in the Phase 1/2 STAAR study evaluating our Fabry disease gene therapy, said Sandy Macrae, CEO of Sangamo. We also continue to advance our research projects, exemplified by the completion of our research activities in our ALS program partnered with Pfizer.

Business Updates

Third Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities were $694.6 million as of September 30, 2020, compared to $384.3 million as of December 31, 2019. The balance at the end of the third quarter includes the previously announced $75.0 million upfront license fee from Novartis. We expect to receive the $35 million in milestone payments from Pfizer in the fourth quarter.

Consolidated net loss attributable to Sangamo for the third quarter ended September 30, 2020 was $1.6 million, or $0.01 per share, compared to a net loss of $27.3 million, or $0.24 per share, for the same period in 2019. Revenues for the third quarter ended September 30, 2020 were $57.8 million, compared to $22.0 million for the same period in 2019.

Three Months Ended September

Nine Months Ended September

2020

2019

2020

2019

$

45.3

$

36.3

$

128.3

$

107.6

16.2

14.9

50.2

46.6

61.5

51.2

178.5

154.2

(6.7

)

(4.7

)

(19.1

)

(14.1

)

$

54.8

$

46.5

$

159.4

$

140.1

Total operating expenses were $61.5 million for the third quarter ended September 30, 2020, compared to $51.2 million for the same period in 2019. Non-GAAP operating expenses, which exclude stock-based compensation expense, were $54.8 million for the third quarter ended September 30, 2020, compared to $46.5 million for the same period in 2019. The increase in operating expenses reflects our headcount growth and facilities expansion to support the advancement of our therapeutic pipeline and manufacturing capabilities. These increases were partially offset by a decrease in clinical and manufacturing supply expenses.

Revised Financial Guidance for 2020

We are revising our full year operating expense guidance initially provided on February 28, 2020 and revised on August 5, 2020 as follows:

(In millions)

Initially Provided February 28, 2020; Reiterated May 11, 2020

Revised on August 5, 2020

Updated on November 4, 2020

Estimated GAAP Operating Expenses

$270 to $285

$235 to $250

$235 to $245

Estimated Non-GAAP Operating Expenses*

$245 to $260

$210 to $225

$210 to $220

*(excludes estimated stock-based compensation of $25 million)

Conference Call

Sangamo will host a conference call today, November 4, 2020, 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 2575067. 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 2575067.

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 http://www.sangamo.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding Sangamos current expectations. These forward-looking statements include, without limitation, statements relating to the potential clinical benefits and long-term durability of SB-525 therapy, anticipated plans and timelines of Sangamo and its collaborators for conducting clinical trials, the potential to receive milestone payments under our collaborations with Pfizer and the timing of such payments, Sangamos financial resources and expectations, Sangamos 2020 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 its collaborators, including the initiation and operation of clinical trials; the research and development process; the uncertain timing and unpredictable results of clinical trials, including whether final clinical trial data will validate the safety and efficacy of product candidates; the regulatory approval process for clinical trials and product candidates; the manufacturing of products and product candidates; the commercialization of approved products; the potential for technological developments that obviate technologies used by Sangamo and its collaborators; the potential for Sangamo or its collaborators to breach or terminate collaboration agreements; the potential for Sangamo to fail to realize its expected benefits of its collaborations; and Sangamos ability to achieve expected future financial performance.

There can be no assurance that Sangamo and its 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 its collaborators. These risks and uncertainties are described more fully in Sangamos Securities and Exchange Commission filings and reports, including in Sangamos Quarterly Report on Form 10-Q for the quarter ended September 30, 2020. 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 Sangamos 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 Sangamos results from period to period and to its forward-looking guidance, and to identify operating trends in Sangamos 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 Sangamos business.

Three months ended

Nine Months Ended

September 30,

See original here:
Sangamo Therapeutics Reports Business Highlights and Third Quarter 2020 Financial Results - BioSpace