GERMANTOWN, Md., March 1, 2022 /PRNewswire/ -- Precigen, Inc.
(Nasdaq: PGEN), a biopharmaceutical company specializing in the
development of innovative gene and cell therapies to improve the
lives of patients, today announced fourth quarter and full year
2021 financial results.
"In 2021, Precigen was able to demonstrate significant progress
in our core therapeutic platforms with indicators of strong early
efficacy and favorable safety profiles across each of our most
clinically advanced assets," said Helen
Sabzevari, PhD, President and CEO of Precigen. "As we
advance assets with the most promising paths to licensure, we will
continue to focus on strengthening our financial position by
continuing to ensure operational efficiency while seeking strategic
non-dilutive funding opportunities where appropriate."
Key Business Highlights
- Public Offering: In January, Precigen closed a
public offering of 17,250,000 shares of common stock, which
resulted in gross proceeds to Precigen of approximately
$129.4 million before deducting the
underwriting discount and other offering expenses payable by
Precigen;
- PRGN-3006 UltraCAR-T in Acute Myeloid Leukemia
(AML): In 2021, enrollment in the dose escalation phase of
the Phase 1/1b PRGN-3006 UltraCAR-T
clinical trial for the treatment of patients with relapsed or
refractory AML or higher-risk myelodysplastic syndromes (MDS) was
completed for both the lymphodepletion and non-lymphodepletion
cohorts. Interim data for patients treated in Dose Levels 1-3 of
the non-lymphodepletion cohort and Dose Levels 1-2 of the
lymphodepletion cohort were presented at the 63rd American Society
of Hematology (ASH) Annual Meeting and Exposition in December 2021;
- PRGN-3005 UltraCAR-T in Ovarian Cancer: In 2021,
enrollment in the dose escalation phase of the Phase 1/1b clinical trial for the treatment of patients
with advanced, recurrent platinum-resistant ovarian cancer was
completed for both the intraperitoneal (IP) and intravenous (IV)
arms. Interim data for patients treated in Dose Levels 1-3 of the
IP arm were presented at the Company's 2021 research and
development (R&D) Virtual Event in November 2021;
- PRGN-3007 Next Generation UltraCAR-T with Intrinsic
PD-1 Inhibition: In 2021, Precigen received investigational new
drug (IND) application clearance from the US Food and Drug
Administration (FDA) to initiate a Phase 1 study of PRGN-3007
UltraCAR-T in advanced receptor tyrosine kinase-like orphan
receptor 1 positive (ROR1+) hematological tumors, including chronic
lymphocytic leukemia (CLL), mantle cell leukemia (MCL), acute
lymphoblastic leukemia (ALL) and diffuse large B-cell lymphoma
(DLBCL) and solid tumors, including triple negative breast cancer
(TNBC). An abstract highlighting PRGN-3007 preclinical data was
presented as a poster presentation at the 63rd ASH Annual Meeting
and Exposition in December 2021;
- PRGN-2012 AdenoVerse Immunotherapy in Recurrent Respiratory
Papillomatosis (RRP): In 2021, Precigen received IND clearance
from the FDA to initiate a Phase 1 study of PRGN-2012, an
off-the-shelf (OTS) AdenoVerse immunotherapy, in patients with RRP
and began dosing patients in the study. Precigen completed
enrollment in the Phase 1 dose escalation and expansion cohorts.
Interim data for the Phase 1 study were presented at the Company's
2021 R&D Virtual Event in November
2021;
- PRGN-2009 AdenoVerse Immunotherapy in HPV-associated
Cancers: In 2021, Precigen completed enrollment in the
PRGN-2009 Phase 1 monotherapy arm and enrollment is ongoing in the
Phase 1 combination arm of the study. The Phase 2 monotherapy arm
in newly diagnosed oropharyngeal squamous cell carcinoma (OPSCC)
patients is also ongoing. In November
2021, interim data for patients in the Phase 1 monotherapy
and combination arms were presented at the Company's 2021
R&D Virtual Event and Society for Immunotherapy of Cancer
(SITC) 2021 Annual Meeting; and
- AG019 ActoBiotics in Type 1 Diabetes (T1D): In
2021, Precigen completed the Phase 1b/2a AG019 ActoBiotics clinical trial in T1D.
Positive results from the trial were presented at the Federation of
Clinical Immunology Societies (FOCIS) Virtual Annual Meeting in
June 2021 and European Association
for the Study of Diabetes (EASD) 57th Annual Meeting in
October 2021.
Fourth Quarter and Full Year 2021 Financial
Highlights
- Net cash used in operating activities of $55.8 million in 2021 compared to $77.0 million in 2020;
- Net proceeds received from the issuance of common stock in
January 2021 were $121.0 million;
- Cash, cash equivalents, and short-term and long-term
investments totaled $163.7 million as
of December 31, 2021;
- The Company anticipates that its cash, cash equivalents
and short-term and long-term investments as
of December 31, 2021 should enable the Company to
fund operations well into 2023, assuming the Company's programs
advance as currently contemplated; and
- The Company's non-core businesses continued to generate
increased revenues and profitability.
Fourth Quarter 2021 Financial Results Compared to Prior Year
Period
For the quarter ended December
31, 2021, R&D expenses increased $2.3 million, or 22%, from the quarter ended
December 31, 2020. This was primarily
the result of an increase in salaries, benefits, and other
personnel costs of $1.4 million and
an increase in contract research organization costs and lab
supplies of $0.8 million due primarily to the advancement of
the Company's clinical and preclinical programs. Selling, general
and administrative (SG&A) expenses decreased $13.3
million, or 44%, due primarily to a noncash $11.4 million loss on a settlement agreement in
the prior year as well as decreased salary, benefit and other
personnel costs, including noncash share-based compensation
expenses attributable to equity grants made in the first quarter of
2020. Net loss from continuing operations was $25.0 million,
or $(0.13) per share for the quarter ended December 31, 2021, of which $5.0 million was for noncash charges, compared to
net loss from continuing operations in the prior year's fourth
quarter of $39.7 million, or $(0.22) per share, of
which $19.7 million was for noncash
charges in 2020.
Total revenues increased $4.9
million, or 25%, over the quarter ended December 31, 2020. This was primarily the result
of product and service revenues generated by Trans Ova and
Exemplar, which increased $5.8
million. This increase was due to higher customer demand
for Trans Ova's products and services as a result of
stronger beef and dairy industries in the current year and a change
in pricing structure with certain customers, as well as increased
services provided by Exemplar to new and existing customers.
Collaboration and licensing revenues decreased $0.8
million primarily due to a decrease in the recognition of
previously deferred revenue in the current period resulting from
fewer services being performed pursuant to the Company's historical
collaboration agreements.
Full Year 2021 Financial Results Compared to Prior Year
Period
For the year ended December
31, 2021, R&D expenses increased $8.5 million, or 20%, over the prior year. This
was the result of an increase in contract research organization
costs and lab supplies of $6.7
million due primarily to the advancement of the Company's
clinical and preclinical programs. SG&A expenses decreased
$17.6 million, or 19%, from the prior
year due primarily to certain costs incurred in 2020 that were not
recurring in 2021 and a reduction in salary, benefit and other
personnel costs. Costs incurred in 2020 that did not recur in 2021
included $13.9 million for certain
legal settlements. Salaries, benefits, and other personnel costs
decreased $4.9 million in 2021
primarily due (i) to reduced headcount as the Company scaled down
its corporate functions to support a more streamlined organization
and (ii) reduced stock compensation costs for previously granted
awards that became fully vested in early 2021. Net loss from
continuing operations for the year ended December 31, 2021 was $96.8 million, or $(0.49) per share, of which $29.4 million was for noncash charges compared to
net loss from continuing operations of $103.8 million in the prior year, or $(0.62) per share, of which $45.9 million was for noncash charges in
2020.
Total revenues were comparable year-over-year,
with increased revenues generated by Trans Ova and Exemplar being
offset by a decrease in collaboration and licensing revenue as a
result of the Company's changing business. The increase in Trans
Ova and Exemplar revenues was $21.6
million. This increase was primarily due to higher customer
demand for Trans Ova's products and services as a result of
stronger beef and dairy industries in the current year, as well as
increased services provided by Exemplar to new and existing
customers combined with a change in pricing structure with certain
customers for both Trans Ova and Exemplar. Collaboration and
licensing revenues decreased $20.7
million as the Company accelerated the recognition of
previously deferred revenue in the prior period upon the mutual
termination of two of its collaboration agreements in 2020. Gross
margin on products and services improved as a result of the
increased revenues, the change in pricing structure for certain
customers, and operational efficiencies that have been gained
through reductions in workforce and improved inventory
management.
Precigen: Advancing Medicine with
Precision™
Precigen (Nasdaq: PGEN) is a dedicated
discovery and clinical stage biopharmaceutical company advancing
the next generation of gene and cell therapies using precision
technology to target the most urgent and intractable diseases in
our core therapeutic areas of immuno-oncology, autoimmune
disorders, and infectious diseases. Our technologies enable us to
find innovative solutions for affordable biotherapeutics in a
controlled manner. Precigen operates as an innovation engine
progressing a preclinical and clinical pipeline of
well-differentiated therapies toward clinical proof-of-concept and
commercialization. For more information about Precigen, visit
www.precigen.com or follow us on Twitter @Precigen,
LinkedIn or YouTube.
Trademarks
Precigen, UltraCAR-T, ActoBiotics,
AdenoVerse and Advancing Medicine with Precision are trademarks
of Precigen and/or its affiliates. Other names may be
trademarks of their respective owners.
Cautionary Statement Regarding Forward-Looking
Statements
Some of the statements made in this press release
are forward-looking statements. These forward-looking statements
are based upon the Company's current expectations and projections
about future events and generally relate to plans, objectives, and
expectations for the development of the Company's business,
including the timing and progress of preclinical studies, clinical
trials, discovery programs and related milestones, the promise of
the Company's portfolio of therapies, and in particular its CAR-T
and AdenoVerse therapies. Although management believes that the
plans and objectives reflected in or suggested by these
forward-looking statements are reasonable, all forward-looking
statements involve risks and uncertainties, including the
possibility that the timeline for the Company's clinical trials
might be impacted by the COVID-19 pandemic, and actual future
results may be materially different from the plans, objectives and
expectations expressed in this press release. The Company has no
obligation to provide any updates to these forward-looking
statements even if its expectations change. All forward-looking
statements are expressly qualified in their entirety by this
cautionary statement. For further information on potential risks
and uncertainties, and other important factors, any of which could
cause the Company's actual results to differ from those contained
in the forward-looking statements, see the section entitled "Risk
Factors" in the Company's most recent Annual Report on Form 10-K
and subsequent reports filed with the Securities and Exchange
Commission.
Investor Contact:
Steven
Harasym
Vice President, Investor Relations
Tel: +1 (301) 556-9850
investors@precigen.com
Media Contacts:
Donelle M.
Gregory
press@precigen.com
Glenn Silver
Lazar-FINN Partners
glenn.silver@finnpartners.com
Precigen, Inc. and
Subsidiaries
|
Consolidated
Balance Sheets
|
(Unaudited)
|
(Amounts in
thousands)
|
|
December 31,
2021
|
|
|
December 31,
2020
|
Assets
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
42,920
|
|
|
$
|
51,792
|
Short-term
investments
|
|
|
72,240
|
|
|
|
48,325
|
Receivables
|
|
|
|
|
|
|
|
Trade, net
|
|
|
20,832
|
|
|
|
16,487
|
Related parties,
net
|
|
|
73
|
|
|
|
19
|
Notes
|
|
|
—
|
|
|
|
3,689
|
Other
|
|
|
566
|
|
|
|
232
|
Inventory
|
|
|
13,261
|
|
|
|
11,359
|
Prepaid expenses and
other
|
|
|
6,736
|
|
|
|
7,192
|
Current assets held
for sale or abandonment
|
|
|
—
|
|
|
|
9,853
|
Total current
assets
|
|
|
156,628
|
|
|
|
148,948
|
Long-term
investments
|
|
|
48,562
|
|
|
|
—
|
Property, plant and
equipment, net
|
|
|
34,315
|
|
|
|
34,924
|
Intangible assets,
net
|
|
|
54,115
|
|
|
|
65,396
|
Goodwill
|
|
|
54,148
|
|
|
|
54,363
|
Right-of-use
assets
|
|
|
10,900
|
|
|
|
9,353
|
Other
assets
|
|
|
1,188
|
|
|
|
1,603
|
Total
assets
|
|
$
|
359,856
|
|
|
$
|
314,587
|
|
|
|
|
Liabilities and
Shareholders' Equity
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
5,405
|
|
|
$
|
4,598
|
Accrued compensation
and benefits
|
|
|
11,223
|
|
|
|
8,097
|
Other accrued
liabilities
|
|
|
11,595
|
|
|
|
9,549
|
Deferred
revenue
|
|
|
4,442
|
|
|
|
2,800
|
Current portion of
long-term debt
|
|
|
402
|
|
|
|
360
|
Current portion of
lease liabilities
|
|
|
1,551
|
|
|
|
2,657
|
Related party
payables
|
|
|
27
|
|
|
|
19
|
Current liabilities
held for sale or abandonment
|
|
|
—
|
|
|
|
14,047
|
Total current
liabilities
|
|
|
34,645
|
|
|
|
42,127
|
Long-term debt, net
of current portion
|
|
|
182,749
|
|
|
|
171,522
|
Deferred revenue, net
of current portion
|
|
|
23,023
|
|
|
|
23,023
|
Lease liabilities,
net of current portion
|
|
|
9,502
|
|
|
|
7,744
|
Deferred tax
liabilities
|
|
|
2,539
|
|
|
|
2,897
|
Other long-term
liabilities
|
|
|
50
|
|
|
|
100
|
Total
liabilities
|
|
|
252,508
|
|
|
|
247,413
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Shareholders'
equity
|
|
|
|
|
|
|
|
Common
stock
|
|
|
—
|
|
|
|
—
|
Additional paid-in
capital
|
|
|
2,022,701
|
|
|
|
1,886,567
|
Accumulated
deficit
|
|
|
(1,915,556)
|
|
|
|
(1,823,390)
|
Accumulated other
comprehensive income
|
|
|
203
|
|
|
|
3,997
|
Total shareholders'
equity
|
|
|
107,348
|
|
|
|
67,174
|
Total liabilities and
shareholders' equity
|
|
$
|
359,856
|
|
|
$
|
314,587
|
Precigen, Inc. and
Subsidiaries
|
Consolidated
Statements of Operations
|
(Unaudited)
|
(Amounts in
thousands, except share and per
share data)
|
|
|
Three months
ended
|
|
|
Year
ended
|
|
|
|
December
31,
|
|
|
December
31,
|
|
|
|
2021
|
|
|
2020
|
|
|
2021
|
|
|
2020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and
licensing revenues
|
|
$
|
117
|
|
$
|
949
|
|
$
|
506
|
|
$
|
21,208
|
|
Product
revenues
|
|
|
5,282
|
|
|
3,952
|
|
|
27,295
|
|
|
24,349
|
|
Service
revenues
|
|
|
18,719
|
|
|
14,284
|
|
|
75,570
|
|
|
56,899
|
|
Other
revenues
|
|
|
103
|
|
|
148
|
|
|
502
|
|
|
722
|
|
Total
revenues
|
|
|
24,221
|
|
|
19,333
|
|
|
103,873
|
|
|
103,178
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
products
|
|
|
5,663
|
|
|
7,024
|
|
|
24,864
|
|
|
28,550
|
|
Cost of
services
|
|
|
9,263
|
|
|
6,766
|
|
|
33,521
|
|
|
26,963
|
|
Research and
development
|
|
|
13,019
|
|
|
10,671
|
|
|
50,141
|
|
|
41,644
|
|
Selling, general and
administrative
|
|
|
16,763
|
|
|
30,039
|
|
|
74,122
|
|
|
91,704
|
|
Impairment of other
noncurrent assets
|
|
|
—
|
|
|
—
|
|
|
543
|
|
|
920
|
|
Total operating
expenses
|
|
|
44,708
|
|
|
54,500
|
|
|
183,191
|
|
|
189,781
|
|
Operating
loss
|
|
|
(20,487)
|
|
|
(35,167)
|
|
|
(79,318)
|
|
|
(86,603)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
expense
|
|
|
(4,886)
|
|
|
(4,570)
|
|
|
(18,891)
|
|
|
(18,400)
|
|
Interest and dividend
income
|
|
|
312
|
|
|
426
|
|
|
1,617
|
|
|
2,451
|
|
Other income
(expense), net
|
|
|
40
|
|
|
(310)
|
|
|
(330)
|
|
|
(165)
|
|
Total other expense,
net
|
|
|
(4,534)
|
|
|
(4,454)
|
|
|
(17,604)
|
|
|
(16,114)
|
|
Equity in net loss of
affiliates
|
|
|
—
|
|
|
(13)
|
|
|
(3)
|
|
|
(1,138)
|
|
Loss from continuing
operations before income taxes
|
|
|
(25,021)
|
|
|
(39,634)
|
|
|
(96,925)
|
|
|
(103,855)
|
|
Income tax benefit
(expense)
|
|
|
(13)
|
|
|
(48)
|
|
|
160
|
|
|
82
|
|
Loss from continuing
operations
|
|
$
|
(25,034)
|
|
$
|
(39,682)
|
|
$
|
(96,765)
|
|
$
|
(103,773)
|
|
Income (loss) from
discontinued operations, net of income tax benefit
|
|
|
—
|
|
|
(1,979)
|
|
|
4,599
|
|
|
(66,748)
|
|
Net loss
|
|
$
|
(25,034)
|
|
$
|
(41,661)
|
|
$
|
(92,166)
|
|
$
|
(170,521)
|
|
Net Loss per
Share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss from
continuing operations attributable to Precigen per share, basic and
diluted
|
|
$
|
(0.13)
|
|
$
|
(0.22)
|
|
$
|
(0.49)
|
|
$
|
(0.62)
|
|
Net income (loss)
from discontinued operations attributable to Precigen per share,
basic and diluted
|
|
|
—
|
|
|
(0.01)
|
|
|
0.02
|
|
|
(0.40)
|
|
Net loss attributable
to Precigen per share, basic and diluted
|
|
$
|
(0.13)
|
|
$
|
(0.23)
|
|
$
|
(0.47)
|
|
$
|
(1.02)
|
|
Weighted average
shares outstanding, basic and diluted
|
|
|
199,259,802
|
|
|
178,225,571
|
|
|
197,759,900
|
|
|
167,065,539
|
|
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SOURCE Precigen, Inc.