On February 22, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Veracyte, FEB 22, 2023, View Source [SID1234627528]).

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"We had an outstanding fourth quarter, driving record revenue and operating cash flows, achieving the best quarter ever for both our Decipher prostate and Afirma thyroid tests," said Marc Stapley, Veracyte’s chief executive officer. "Moreover, throughout 2022, we invested in our long-term growth drivers to deliver on our promise of empowering clinicians with high-value insights to guide and assure patients at pivotal moments in the race to diagnose and treat cancer. Moving into 2023, we have a clear strategy, strong financial position, and significant momentum to advance our vision of transforming cancer care for patients all over the world."

Key Business Highlights:

Grew total test volume to 28,001 in the fourth quarter and 102,524 for the full-year 2022, an increase of 26% and 30%, respectively, compared to the prior year.
Launched an updated Decipher Genomics Resource for Intelligent Discovery (GRID) patient report, providing physicians who order the Decipher Prostate Genomic Classifier with expanded precision-medicine insights, on a Research Use Only basis.
Submitted the Envisia Genomic Classifier to the Notified Body for CE marking in the European Union, ahead of schedule.
Published data in the International Journal of Radiation Oncology, Biology, Physics demonstrating that the Decipher Prostate Genomic Classifier can improve risk stratification among men with clinically high-risk prostate cancer.
Published a meta-analysis of 13 independent studies for the Afirma Genomic Sequencing Classifier in the Journal of Clinical Endocrinology & Metabolism, confirming the test’s strong real-world performance in informing thyroid nodule diagnosis.
Published data in Frontiers in Endocrinology suggesting that insights derived from Veracyte’s comprehensive thyroid nodule database of whole-transcriptome sequencing may help personalize care for patients with thyroid nodules.
Generated $9.7 million in cash from operating activities in the fourth quarter and $7.5 million for the full-year 2022. Ended the fourth quarter of 2022 with cash, cash equivalents and short-term investments of $178.9 million, compared to $177.2 million at the beginning of 2022.
Promoted Annie McGuire to General Counsel and Chief People Officer.
Fourth Quarter 2022 Financial Results

Total revenue for the fourth quarter of 2022 was $80.3 million, an increase of 19% compared to $67.3 million in the fourth quarter of 2021. Testing revenue was $70.3 million, an increase of 32% compared to $53.4 million in the fourth quarter of 2021 driven primarily by the strong performance of our Decipher and Afirma tests. Product revenue was $3.2 million, an increase of 17% compared to $2.8 million in the fourth quarter of 2021. Biopharmaceutical and other revenue was $6.8 million, a decrease of 39% compared to $11.2 million, driven primarily by a milestone payment received in the prior year period.

Total gross margin for the fourth quarter of 2022, including the amortization of acquired intangible assets, was 61%, compared to 59% in the fourth quarter of 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 67% compared to 66% in the fourth quarter of 2021.

Operating expenses, excluding cost of revenue, were $58.9 million, an increase of 4% compared to the fourth quarter of 2021. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, were $51.1 million compared to $46.2 million in the fourth quarter of 2021.

Net loss for the fourth quarter of 2022 was $3.8 million, an improvement of 63% compared to the fourth quarter of 2021. Basic and diluted net loss per common share was $0.05, an improvement of 67% compared to the fourth quarter of 2021.

Full Year 2022 Financial Results

Total revenue for 2022 was $296.5 million, an increase of 35% compared to $219.5 million in 2021. Testing revenue was $250.5 million, an increase of 33% compared to $188.2 million in 2021 driven primarily by the strong performance of our Decipher and Afirma tests. Product revenue was $12.6 million, an increase of 10% compared to $11.5 million in 2021. Biopharmaceutical and other revenue was $33.4 million, an increase of 68% compared to $19.9 million in 2021, driven primarily by the contribution of the HalioDx acquisition.

Total gross margin for the full year 2022, including the amortization of acquired intangible assets, was 59%, compared to 60% in 2021. Non-GAAP gross margin, excluding the amortization of acquired intangible assets and other acquisition related expenses was 66%, flat to 2021.

Operating expenses, excluding cost of revenue, were $236.0 million, an increase of 4% compared to 2021. Non-GAAP operating expenses, excluding cost of revenue, amortization of acquired intangible assets, other acquisition related expenses and other restructuring costs, were $200.3 million compared to $158.4 million in 2021.

Net loss for the full year 2022 was $36.6 million, an improvement of 52% compared to 2021. Basic and diluted net loss per common share was $0.51, an improvement of 54% compared to 2021. Net cash provided by operating activities in 2022 was $7.5 million, an improvement of $39.2 million compared to 2021.

A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. An explanation of these measures is also included below under the heading "Note Regarding Use of Non-GAAP Financial Measures."

2023 Financial Outlook

Veracyte is initiating 2023 annual total revenue guidance of $325 million to $335 million, assuming currency rates as of February 22, 2023. This range includes mid-teens year-over-year growth of testing and product revenue, and a decline in Biopharmaceutical and other revenue for fiscal 2023 compared to fiscal 2022.

Conference Call and Webcast Details

Veracyte will host a conference call and webcast today at 4:30 p.m. Eastern Time to discuss the company’s financial results and provide a general business update. The conference call will be webcast live from the company’s website and will be available via the following link: View Source The webcast should be accessed 10 minutes prior to the conference call start time. A replay of the webcast will be available for one year following the conclusion of the live broadcast and will be accessible on the company’s website at View Source

The conference call dial-in can be accessed by registering at the following link: https://register.vevent.com/register/BIbe54a1af06be4083968e88a7edfb6679

United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, reported its financial results for the fourth quarter and year ended December 31, 2022 (Press release, United Therapeutics, FEB 22, 2023, View Source [SID1234627527]). Full year total revenues rose to a record $1.94 billion, as U.S. patients being treated with the company’s treprostinil-based therapies reached an all-time high during the fourth quarter of 2022.

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"We’re building momentum for our commercial business with continued double-digit revenue growth for our treprostinil products," said Martine Rothblatt, Ph.D., Chairperson and Chief Executive Officer of United Therapeutics. "In addition, we are marching toward pivotal clinical data for Tyvaso in idiopathic pulmonary fibrosis and ralinepag in pulmonary arterial hypertension."

"We are tremendously proud of reaching our goal of doubling the number of patients on Tyvaso therapy since the Tyvaso PH-ILD approval in early 2021," said Michael Benkowitz, President and Chief Operating Officer of United Therapeutics. "We’re now focused on continued commercial uptake of Tyvaso and Tyvaso DPI in both PAH and PH-ILD to support our long-term goal of doubling our revenue to a $4 billion run rate by the end of 2025."

Fourth Quarter and Full Year 2022 Financial Results

Key financial highlights include (in millions, except per share data):

Three Months Ended
December 31,

Year Ended
December 31,

2022

2021

2022

2021

Total revenues

$

491.5

$

415.2

$

1,936.3

$

1,685.5

Net income

$

132.1

$

112.2

$

727.3

$

475.8

Net income, per basic share

$

2.88

$

2.49

$

15.98

$

10.60

Net income, per diluted share

$

2.67

$

2.35

$

15.00

$

10.06

Revenues

The table below summarizes the components of total revenues (dollars in millions):

Three Months Ended
December 31,

Dollar
Change

Percentage
Change

Year Ended
December 31,

Dollar
Change

Percentage
Change

2022

2021

2022

2021

Net product sales:

Tyvaso(1)

$

242.3

$

166.5

$

75.8

46

%

$

873.0

$

607.5

$

265.5

44

%

Remodulin(2)

122.5

118.3

4.2

4

%

500.2

513.7

(13.5

)

(3

)%

Orenitram

75.8

72.3

3.5

5

%

325.1

306.1

19.0

6

%

Unituxin

36.7

50.0

(13.3

)

(27

)%

182.9

202.3

(19.4

)

(10

)%

Adcirca

10.4

8.1

2.3

28

%

41.3

55.9

(14.6

)

(26

)%

Other

3.8

—

3.8

NM

(3)

13.8

—

13.8

NM

(3)

Total revenues

$

491.5

$

415.2

$

76.3

18

%

$

1,936.3

$

1,685.5

$

250.8

15

%

(1)

Net product sales include both the drug product and the respective inhalation devices for both nebulized Tyvaso Inhalation Solution and the dry powder version known as Tyvaso DPI.

(2)

Net product sales include sales of infusion devices, such as the Remunity Pump.

(3)

Calculation is not meaningful.

Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by $83.5 million, or 23%, in the fourth quarter of 2022 compared to the fourth quarter of 2021. The growth in Tyvaso revenues primarily resulted from an increase in quantities sold, which was driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in the number of patients following the PH-ILD label expansion in March 2021. The decrease in Unituxin revenues primarily resulted from a decrease in quantities sold.

Net product sales from our treprostinil-based products (Tyvaso, Remodulin, and Orenitram) grew by $271.0 million, or 19%, in 2022 compared to 2021. The growth in Tyvaso revenues primarily resulted from an increase in quantities sold and, to a lesser extent, the impact of a price increase and lower gross-to-net deductions. The increase in quantities sold was driven by the commercial launch of Tyvaso DPI in June 2022 and continued growth in the number of patients following the PH-ILD label expansion in March 2021. The decrease in Remodulin revenues resulted from a decrease in U.S. Remodulin revenues of $15.9 million, partially offset by an increase in international Remodulin revenues of $2.4 million. The decrease in U.S. Remodulin revenues was primarily due to a decrease in quantities sold, partially offset by lower gross-to-net deductions. The growth in Orenitram revenues primarily resulted from a price increase and lower gross-to-net deductions. The decrease in Unituxin revenues primarily resulted from a decrease in quantities sold, partially offset by a price increase. The decrease in Adcirca revenues resulted from a decrease in quantities sold as a result of generic competition for Adcirca and higher gross-to-net deductions.

Expenses

Cost of sales. The table below summarizes cost of sales by major category (dollars in millions):

Three Months Ended
December 31,

Dollar
Change

Percentage
Change

Year Ended
December 31,

Dollar
Change

Percentage
Change

2022

2021

2022

2021

Category:

Cost of sales

$

55.9

$

32.8

$

23.1

70

%

$

146.7

$

116.7

$

30.0

26

%

Share-based compensation expense(1)

2.9

1.8

1.1

61

%

4.9

5.8

(0.9

)

(16

)%

Total cost of sales

$

58.8

$

34.6

$

24.2

70

%

$

151.6

$

122.5

$

29.1

24

%

(1)

Refer to Share-based compensation below.

Cost of sales, excluding share-based compensation. The increase in cost of sales for the quarter and year ended December 31, 2022, as compared to the same periods in 2021, was primarily due to an increase in royalty expense and product costs for Tyvaso DPI following the commercial launch of the product in June 2022.

Research and development expense. The table below summarizes the nature of research and development expense by major expense category (dollars in millions):

Three Months Ended
December 31,

Dollar
Change

Percentage
Change

Year Ended
December 31,

Dollar
Change

Percentage
Change

2022

2021

2022

2021

Category:

External research and development(1)

$

46.7

$

42.4

$

4.3

10

%

$

168.8

$

156.7

$

12.1

8

%

Internal research and development(2)

35.4

30.1

5.3

18

%

131.4

117.2

14.2

12

%

Share-based compensation expense(3)

11.0

7.4

3.6

49

%

23.8

24.4

(0.6

)

(2

)%

Impairments(4)

—

—

—

NM

(6)

—

130.0

(130.0

)

(100

)%

Other(5)

0.8

3.0

(2.2

)

(73

)%

(1.1

)

111.8

(112.9

)

(101

)%

Total research and development expense

$

93.9

$

82.9

$

11.0

13

%

$

322.9

$

540.1

$

(217.2

)

(40

)%

(1)

External research and development primarily includes fees paid to third parties (such as clinical trial sites, contract research organizations, and contract laboratories) for preclinical and clinical studies and payments to third-party contract manufacturers before FDA approval of the relevant product.

(2)

Internal research and development primarily includes salary-related expenses for research and development functions, internal costs to manufacture product candidates before FDA approval, and internal facilities-related expenses, including depreciation, related to research and development activities.

(3)

Refer to Share-based compensation below.

(4)

Impairments primarily includes impairment charges to write-down the carrying value of in-process research and development (IPR&D) and of certain property, plant, and equipment as a result of research and development activities.

(5)

Other primarily includes upfront fees and milestone payments to third parties under license agreements related to development-stage products, adjustments to the fair value of our contingent consideration obligations, and a one-time expense associated with the redemption of a pediatric disease priority review voucher in 2021.

(6)

Calculation is not meaningful.

Research and development, excluding share-based compensation. The decrease in research and development expense for the year ended December 31, 2022, as compared to the same period in 2021, was due to: (1) a $107.3 million IPR&D impairment charge related to our March 2021 decision to discontinue the U.S. development of Trevyent; (2) a $105.0 million purchase of a pediatric disease priority review voucher in January 2021, which we redeemed upon submission of our NDA for Tyvaso DPI; and (3) impairment charges related to property, plant, and equipment during 2021.

Selling, general, and administrative expense. The table below summarizes selling, general, and administrative expense by major category (dollars in millions):

Three Months Ended
December 31,

Dollar
Change

Percentage
Change

Year Ended
December 31,

Dollar
Change

Percentage
Change

2022

2021

2022

2021

Category:

General and administrative

$

89.3

$

76.0

$

13.3

18

%

$

333.2

$

294.3

$

38.9

13

%

Sales and marketing

23.0

16.4

6.6

40

%

70.8

64.4

6.4

10

%

Share-based compensation expense(1)

50.9

35.5

15.4

43

%

78.1

108.3

(30.2

)

(28

)%

Total selling, general, and administrative expense

$

163.2

$

127.9

$

35.3

28

%

$

482.1

$

467.0

$

15.1

3

%

(1)

Refer to Share-based compensation below.

General and administrative, excluding share-based compensation. The increase in general and administrative expense for the quarter and year ended December 31, 2022, as compared to the same periods in 2021, was primarily due to: (1) an increase in branded prescription drug fee expense associated with sales of Tyvaso; and (2) impairment charges related to property, plant, and equipment. The branded prescription drug fee is a required fee imposed under the Patient Protection and Affordable Care Act of 2010, which became applicable to Tyvaso in 2021, and is now applicable to Tyvaso DPI, as a result of their approval for treatment of PH-ILD, an indication that currently does not have orphan designation from the FDA.

Share-based compensation. The table below summarizes share-based compensation expense by major category (dollars in millions):

Three Months Ended
December 31,

Dollar
Change

Percentage
Change

Year Ended
December 31,

Dollar
Change

Percentage
Change

2022

2021

2022

2021

Category:

Stock options

$

5.8

$

5.6

$

0.2

4

%

$

22.6

$

25.4

$

(2.8

)

(11

)%

Restricted stock units

12.1

6.3

5.8

92

%

35.7

24.7

11.0

45

%

Share tracking awards plan (STAP)

46.5

32.3

14.2

44

%

46.7

86.6

(39.9

)

(46

)%

Employee stock purchase plan

0.4

0.5

(0.1

)

(20

)%

1.8

1.8

—

—

%

Total share-based compensation expense

$

64.8

$

44.7

$

20.1

45

%

$

106.8

$

138.5

$

(31.7

)

(23

)%

The increase in share-based compensation expense for the quarter ended December 31, 2022, as compared to the same period in 2021, was primarily due to: (1) an increase in STAP expense driven by a 33 percent increase in our stock price during the quarter ended December 31, 2022, as compared to a 17 percent increase in our stock price for the same period in 2021; and (2) an increase in restricted stock unit expense. The decrease in share-based compensation expense for the year ended December 31, 2022, as compared to the same period in 2021, was primarily due to: (1) a decrease in STAP expense driven by a 29 percent increase in our stock price during 2022, as compared to a 42 percent increase in our stock price during 2021; and (2) a decrease in stock option expense due to fewer awards granted and remaining outstanding in 2022, as compared to the same period in 2021, partially offset by an increase in restricted stock unit expense.

Other (expense) income, net. The changes in other (expense) income, net for the quarter and year ended December 31, 2022, as compared to the same periods in 2021, were primarily due to net unrealized and realized gains and losses on equity securities.

Income tax expense. Income tax expense was $223.3 million for the year ended December 31, 2022, as compared to $118.1 million for the same period in 2021. For the years ended December 31, 2022 and 2021, our effective income tax rates (ETR) were approximately 23 percent and 20 percent, respectively. Our ETR for the year ended December 31, 2022 increased, as compared to our ETR for the year ended December 31, 2021, primarily due to an increase in valuation allowance in the current year compared to a decrease in the prior year, and an increase in the reserve for uncertain tax positions, partially offset by an increase in excess tax benefits from share-based compensation.

Webcast

We will host a webcast to discuss our fourth quarter and full year 2022 financial results on Wednesday, February 22, 2023, at 9:00 a.m. Eastern Time. The webcast can be accessed live via our website at View Source A replay of the webcast will also be available at the same location on our website.

On February 22, 2023 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicines company, reported recent business highlights and fourth quarter and full year 2022 financial results (Press release, Sangamo Therapeutics, FEB 22, 2023, View Source [SID1234627525]).

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"2022 was a year of important clinical and non-clinical milestones across our pipeline. We strengthened that momentum today by releasing compelling data from our Phase 1/2 Fabry disease study, supporting a potential best-in-class product profile," said Sandy Macrae, Chief Executive Officer of Sangamo. "In 2023, wise resource allocation is our top priority, as we focus on advancing our wholly owned Fabry program, CAR-Treg portfolio and epigenetic regulation programs in the central nervous system, alongside progression of our Zinc Finger platform and AAV delivery capabilities. We look forward to sharing additional pipeline and delivery milestones in 2023 as we continue to strive to deliver for patients in need."
Fourth Quarter Updates and Recent Business Highlights

Fabry disease – Reported compelling updated preliminary Phase 1/2 data showing extended clinical benefit; reported kidney biopsy data demonstrating 78% globotriaosylceramide (Gb3) substrate clearance at 6-months; Phase 3 trial anticipated to start by end of 2023.
•Presented updated preliminary data as of the October 20, 2022 cutoff date from the Phase 1/2 STAAR study evaluating isaralgagene civaparvovec, our wholly owned gene therapy product candidate for the treatment of Fabry disease at the 19th Annual WORLDSymposium.
•Sustained, elevated expression of alpha-galactosidase A (α-Gal A) activity observed in 13 patients for over two years for the longest treated patient as of the November 15, 2022 supplemental cutoff date.
•No prophylactic corticosteroids or other immune modulating agents have been administered.
•All five patients who began the dose escalation phase on enzyme replacement therapy (ERT) had been successfully withdrawn from ERT and remain off ERT today.
•Announced first available kidney biopsy data demonstrating 78% Gb3 substrate clearance at 6-months and 77% reduction in urine podocyte loss in a treated patient with high baseline plasma globotriaosylsphingosine (lyso-Gb3) levels.
•Reported a clinically meaningful and statistically significant increase in mean general health scores measured across all patients treated in dose escalation phase, as measured by the SF-36 General Health Survey.
•As of the October 20, 2022 cutoff date, naïve and pseudo-naïve patients treated in the dose expansion and escalation phases with baseline lyso-Gb3 levels above 80 ng/mL experienced a 40-65% reduction. For the first time, and at the highest dose, a 54% reduction in lyso-Gb3 levels was observed where baseline levels started below 25 ng/mL.
•As of the October 20, 2022 cutoff date, isaralgagene civaparvovec remained generally well tolerated with no treatment-related adverse events greater than Grade 2 and no treatment-related serious adverse events.
•Since the October 20, 2022 cutoff date, four additional patients have been dosed in the expansion phase to achieve a total of 17, and a further two patients have been withdrawn from ERT.
•Dosing of remaining patients in the expansion phase of the Phase 1/2 STAAR study is ongoing, with a total of 20 sites active and recruiting. We expect dosing to conclude by the end of 2023.
•Preparations for a potential Phase 3 trial actively progress, with a trial start anticipated by the end of 2023, depending on regulatory interactions. Dosing of the first patient is expected to start as early as the first part of 2024.

Renal Transplant Rejection – Progressed manufacturing and clinical activities ahead of anticipated Q2 dosing; potential dose escalation acceleration scenarios in discussion with regulators.
•Progressed manufacturing and clinical activities in the Phase 1/2 STEADFAST study evaluating TX200, our wholly owned autologous CAR-Treg cell therapy treating patients receiving an HLA-A2 mismatched kidney from a living donor.
•The product candidate continues to be generally well tolerated in both patients dosed to date.
•Completed manufacturing of the dose for the final patient in the first cohort, who recently received a kidney transplant. Dosing is expected early in the second quarter of 2023.
•Progressed clinical and manufacturing activities for the first patient in the second cohort, with dosing expected in the summer of 2023.
•Opportunities to accelerate dose escalation are being explored with regulators.

Sickle cell disease – Presented promising 6-month data for first patient dosed with a product candidate manufactured using improved methods; discontinuing additional material investments in Phase 3 planning in order to prioritize capital allocation; intend to seek a potential collaboration partner.
•Presented promising data from the Phase 1/2 PRECIZN-1 study of BIVV003, a zinc finger nuclease gene-edited cell therapy candidate for the treatment of sickle cell disease at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The first patient to receive a product candidate manufactured using improved methods achieved fetal hemoglobin levels of 45% and total hemoglobin of 12.4 g/dL at week 26.
•Progressed clinical and manufacturing activities for patient 7.
•Agreed on Phase 3 trial design, Chemistry, Manufacturing and Controls (CMC) package and other requirements with the FDA.
•Progressed additional manufacturing improvements which we believe have the potential to further strengthen clinical outcomes and reduce manufacturing costs in a potential Phase 3 trial.
•Announced strategic decision to halt further material investments in the program beyond completion of Phase 1/2 study, to redeploy resources to Fabry and TX200 programs, and to seek a potential collaboration partner to progress this asset to a potential Phase 3 trial.

Hemophilia A – Dosing in Phase 3 AFFINE trial expected to be complete by end of Q1 2023; pivotal data read-out expected in first half of 2024; BLA submission anticipated in second half of 2024.
•Dosing progressed in the Phase 3 AFFINE trial of giroctocogene fitelparvovec, an investigational gene therapy we are developing with Pfizer for patients with moderately severe to severe hemophilia A.
•Dosing to support primary analysis is expected to be complete by the end of Q1 2023.
•A pivotal readout is expected in the first half of 2024, with Pfizer anticipating a BLA submission in the second half of 2024.

Preclinical Programs – Progressed preclinical programs in CAR-Tregs and epigenetic regulation of the central nervous system (CNS), alongside advancements in the zinc finger platform and AAV delivery capabilities.
•By the end of 2023, we expect to announce, and reveal data from, our next wholly owned CNS epigenetic regulation program.
•By the end of 2024, we anticipate submitting two new IND applications from our second wave CAR-Treg and CNS programs.
Fourth Quarter and Full Year 2022 Financial Results
Consolidated net loss for the fourth quarter ended December 31, 2022 was $52.0 million, or $0.32 per share, compared to net loss of $37.5 million, or $0.26 per share, for the same period in 2021. For the year ended December 31, 2022, consolidated net loss was $192.3 million, or $1.25 per share, compared to consolidated net loss of $178.3 million, or $1.23 per share, for the year ended December 31, 2021.

Revenues
Revenues for the fourth quarter ended December 31, 2022 were $27.2 million, compared to $28.0 million for the same period in 2021.
The decrease of $0.8 million in revenues was primarily attributed to decreases of $12.4 million and $1.8 million in revenues related to our collaboration agreements with Biogen and Sanofi, respectively. These decreases were partially offset by increases of $12.6 million and $1.3 million in revenues related to our collaboration agreements with Kite and Novartis, respectively.
Revenues were $111.3 million in 2022, compared to $110.7 million in 2021.
The increase of $0.6 million in revenues was primarily attributed to increases of $13.1 million and $1.8 million in revenues related to our collaboration agreements with Kite and Novartis, respectively. These increases were partially offset by decreases of $13.9 million in revenue related to our collaboration agreement with Biogen.
GAAP and Non-GAAP operating expenses
(In millions)
Three Months Ended
December 31, Year Ended
December 31,
2022 2021 2022 2021
Research and development $ 66.2 $ 51.8 $ 249.9 $ 230.8
General and administrative 16.4 16.1 62.7 63.2
Total operating expenses 82.6 67.9 312.6 294.0
Stock-based compensation expense (8.3) (8.1) (31.7) (33.0)
Non-GAAP operating expenses $ 74.3 $ 59.8 $ 280.9 $ 261.0

Total operating expenses on a GAAP basis for the fourth quarter ended December 31, 2022 were $82.6 million, compared to $67.9 million for the same period in 2021. Non-GAAP operating expenses, which exclude stock-based compensation expense, for the fourth quarter ended December 31, 2022 were $74.3 million, compared to $59.8 million for the same period in 2021.
The increase in total operating expenses on a GAAP basis was primarily attributable to increased spending on our internal infrastructure and external services as we progress our clinical trials coupled with higher headcount related personnel costs, and an adjustment in 2021 related to dissolution of the repayment obligation of a grant from California Institute for Regenerative Medicine with the discontinuation of the ST-400 program. These increases were partially offset by reimbursement of certain research and development expenses by Sanofi under the termination agreement.
Total operating expenses on a GAAP basis in 2022 were $312.6 million compared to $294.0 million in 2021. Non-GAAP operating expenses, which exclude stock-based compensation expense, were $280.9 million and $261.0 million in 2022 and 2021, respectively.
The increase in total operating expenses in the full year on a GAAP basis was primarily driven by increased spending on our internal infrastructure and external services as we progress our clinical trials coupled with higher headcount related personnel costs and our ongoing collaborations, and an adjustment in 2021 related to dissolution of the repayment obligation of a grant from California Institute for Regenerative Medicine with the discontinuation of the ST-400 program. These increases were partially offset by reimbursement of certain research and development expenses by Sanofi under the termination agreement.
Cash, cash equivalents and marketable securities
Cash, cash equivalents and marketable securities as of December 31, 2022 were $307.5 million, compared to $464.7 million as of December 31, 2021. We have raised approximately $90.6 million in net proceeds under our at-the-market offering program since January 1, 2022.
Initial Financial Guidance for 2023
On a GAAP basis, we expect total operating expenses in the range of approximately $310 million to $330 million in 2023, 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 $35 million, in the range of approximately $275 million to $295 million in 2023.

Upcoming Events
Sangamo plans to participate in the following events:
Scientific / Medical Conferences
•19th Annual WORLDSymposium, February 22-24, 2023. Platform presentation taking place Friday February 24, during a session from 8:00-9:00am Eastern Time and poster session 3:00-4:00pm Eastern Time (Poster Ref: 169).
Investor Conferences
•Cowen 43rd Annual Health Care Conference, March 6, 2023
•Barclays Global Healthcare Conference, March 15, 2023
•2023 Bank of America Global Healthcare Conference, May 9-11, 2023
•2023 RBC Global Healthcare Conference, May 16-17, 2023
•Stifel 2023 Tailoring Genes: Genetic Medicines Day, May 30, 2023
Access links for available webcasts for these investor conferences will be available on the Sangamo Therapeutics website in the Investors and Media section under Events. Available materials will be found on the Sangamo Therapeutics website after the event under Presentations.
Conference Call to Discuss Fourth Quarter and Full Year 2022 Results
The Sangamo management team will discuss these results on a conference call today, Wednesday, February 22, 2023, at 4:30 p.m. Eastern Time.
Participants should register for, and access, the call using this link. While not required, it is recommended you join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided or to use the dial-out option to connect their phone instantly.
An updated corporate presentation is available in the Investors and Media section under Presentations.
The link to access the live webcast can also be found on the Sangamo Therapeutics website in the Investors and Media section under Events. A replay will be available following the conference call, accessible at the same link.

On February 22, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that the Company will participate in the H.C. Wainwright Cell Therapy Virtual Conference taking place February 28, 2023 Precision BioSciences, Inc. (Nasdaq: DTIL) a clinical stage gene editing company developing ARCUS-based ex vivo allogeneic CAR T and in vivo gene editing therapies, reported that the Company will participate in the H.C. Wainwright Cell Therapy Virtual Conference taking place February 28, 2023.

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Details for the virtual fireside chat are as follows:
Date: Tuesday, February 28, 2023
Time: 2:00 PM ET

The fireside chat will be available via a live webcast accessible on Precision’s website in the Investors section under Events & Presentations on February 28, 2023: View Source An archived replay will be available for approximately 30 days following the event..

Details for the virtual fireside chat are as follows:
Date: Tuesday, February 28, 2023
Time: 2:00 PM ET

The fireside chat will be available via a live webcast accessible on Precision’s website in the Investors section under Events & Presentations on February 28, 2023: View Source An archived replay will be available for approximately 30 days following the event.

On February 22, 2023 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a clinical stage biotechnology company whose proprietary INTASYL RNAi platform technology is designed to make immune cells more effective in killing tumor cells, reported that Robert Bitterman has been appointed by the Board of Directors to serve as the Company’s President and Chief Executive Officer, effective as of February 20, 2023 (Press release, Phio Pharmaceuticals, FEB 22, 2023, View Source [SID1234627523]). Mr. Bitterman has served as Interim Chief Executive Officer since September 2022. Mr. Bitterman will continue to serve as Chair of the Board, and as the Company’s principal executive officer and principal financial officer.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"As we considered the next chapter for Phio, the Board undertook a thorough search for a full-time CEO," said Robert Ferrara, Phio’s Lead Independent Director. "We evaluated potential candidates who could effectively lead the Company at this important time in its history, as we ramp up our clinical activities and manage several development programs with our partners. Since taking on the interim CEO role in September 2022, Bob has proven to be a strategic and effective leader of Phio. His extensive leadership experience and existing knowledge of our pipeline make him the most qualified executive to lead Phio forward as we advance our clinical programs and drive shareholder growth. We appreciate his stepping into this role full-time."

"During the last several months, I have seen the passion and dedication of Phio’s team as we continue to make steady progress across several programs in our pipeline and set a clear path for the future. I look forward to continuing to advance our strategy and delivering on several of the preclinical and clinical milestones set for 2023 and 2024," stated Mr. Bitterman.

Mr. Bitterman has served as a member and the Chairman of the Company’s Board since 2012 and as the Interim Executive Chairman of the Company since September 2022. Previously, Mr. Bitterman served as the President and Chief Executive Officer of Cutanea Life Sciences, Inc., a private company he founded in 2005 that focused on developing innovative technologies to treat diseases and disorders of the skin and subcutaneous tissue. He led the company until its acquisition by Biofrontera, Inc., USA in March 2019. Prior to his role at Cutanea Life Sciences, Inc., Mr. Bitterman held the position of President and Chief Executive Officer of Isolagen, Inc., President and General Manager of Dermik Laboratories, and various positions of increasing responsibility in financial and commercial capacities within Aventis S.A. Mr. Bitterman holds an A.B. degree in Economics from The College of the Holy Cross, and a Master of Business Administration degree from Boston University. He also holds a Doctor of Humane Letters (Honoris Causa) from the New York College of Podiatric Medicine.