- Continued progress on '5x'25' strategy to advance five AAV
Therapeutics from REGENXBIO's internal pipeline and licensed
programs into pivotal-stage or commercial products by 2025
- RGX-314 program for the treatment of wet AMD and diabetic
retinopathy, being developed in collaboration with AbbVie
-
- Enrollment ongoing in the pivotal ATMOSPHERE® and
ASCENT™ clinical trials using subretinal delivery, expected to
support BLA filing in 2024
- Recently announced interim data from the Phase II
pharmacodynamic study supports use of NAVXpress™ platform process
in future commercialization plans
- Recently announced cohort expansions in AAVIATE®
and ALTITUDE® suprachoroidal clinical trials on track to
be completed in the first half of 2023; expected interim trial
updates in the second half of 2023
- AFFINITY DUCHENNE™ Phase I/II trial of RGX-202 is active and
recruiting patients; anticipated to report initial trial data in
the second half of 2023
- CAMPSIITE™ clinical trial of RGX-121 for the treatment of
MPS II on track to complete pivotal program enrollment in the first
half of 2023; recent updates continue to support plan to
file BLA in 2024 using the accelerated approval pathway
- $565 million in cash, cash
equivalents and marketable securities as of December 31, 2022; operational runway into
2025
- Conference call Tuesday, February
28th at 4:30 p.m.
ET
ROCKVILLE, Md., Feb. 28,
2023 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX)
today announced financial results for the fourth quarter and
full-year ended December 31, 2022,
and recent operational highlights.
"REGENXBIO enters the year with a strong pipeline of AAV
Therapeutics. One year ago, we introduced our '5x'25' strategy and
I remain confident that we will achieve this goal," said
Kenneth T. Mills, President and
Chief Executive Officer of REGENXBIO. "Our lead candidate, RGX-314,
is being developed in partnership with AbbVie for the treatment of
wet AMD and diabetic retinopathy, which present opportunities to
make an impact in eye care for millions of patients. In 2022, we
made meaningful progress with our RGX-314 trial enrollment
objectives and geographic expansion planning. We also established
in-house manufacturing to meet global clinical and commercial
regulatory standards. We remain committed to developing treatments
for rare diseases and made significant advancements with our
pipeline of treatments for diseases such as Batten, Duchenne,
Hurler and Hunter Syndrome, the latter of which we expect will
support a second BLA filing using the accelerated approval pathway.
Our history, science, resources, people and values combine to make
us an industry leader in gene therapy and in the development of
potentially ground-breaking therapies. We look forward to providing
additional updates about our progress in 2023."
Program Highlights and Milestones
RGX-314: RGX-314 is an investigational one-time AAV
Therapeutic being developed in collaboration with AbbVie for the
treatment of wet age-related macular degeneration (wet AMD),
diabetic retinopathy (DR) and other additional chronic retinal
conditions. RGX-314 uses the NAV® AAV8 vector to deliver
a gene encoding a therapeutic antibody fragment to inhibit vascular
endothelial growth factor (VEGF).
- RGX-314 Subretinal Delivery for the Treatment of Wet AMD
-
- Enrollment is ongoing in ATMOSPHERE® and ASCENT™,
two pivotal clinical trials to evaluate the efficacy and safety of
RGX-314 in patients with wet AMD using the subretinal delivery
approach. Material from REGENXBIO's NAVXpress™ platform process has
been incorporated in the pivotal trials and is expected to be
produced at REGENXBIO's Manufacturing Innovation Center for future
commercialization of RGX-314. The pivotal trials are expected to
support a Biologics License Application (BLA) submission in
2024.
- In February 2023, REGENXBIO
announced data from the Phase II pharmacodynamic study,
demonstrating that RGX-314 produced by the NAVXpress platform
process was well tolerated and exhibited a similar clinical profile
to the initial adherent cell culture process used in the Phase
I/IIa trial. The Phase II pharmacodynamic study is designed to
evaluate the same dose levels being used in the two pivotal
trials.
- In October 2022, REGENXBIO
announced data from the Phase I/IIa Long-term Follow-up study
demonstrating that RGX-314 continued to be generally well-tolerated
and showed a long-term, durable treatment effect in Cohort 3 up to
four years and in Cohort 4 up to three years. Doses similar to
those used in Cohort 3 and Cohort 4 of the Phase I/IIa trial were
advanced into the pivotal trials.
- RGX-314 Suprachoroidal Delivery for the Treatment of Wet
AMD
-
- The Phase II AAVIATE® trial continues to
enroll patients in Cohort 6 at the third dose level with
short-course prophylactic ocular steroids following RGX-314
administration to evaluate the ability to prevent or reduce the
occurrence of the mild to moderate intraocular inflammation seen in
previous cohorts. Patients are enrolled in Cohort 6 regardless of
neutralizing antibody (NAb) status. REGENXBIO expects to complete
enrollment of Cohort 6 in the first half of 2023 and report
additional interim trial data, including initial data from Cohort
6, in the second half of 2023.
- In October 2022, REGENXBIO
announced new interim data from the Phase II AAVIATE trial,
demonstrating that RGX-314 using suprachoroidal delivery was well
tolerated across 85 patients. Meaningful reduction in treatment
burden at six months was observed across all dose levels, and no
meaningful differences in outcomes were observed at six months for
patients who are NAb positive. Some patients had mild to moderate
intraocular inflammation, all of which resolved with topical
corticosteroids.
- RGX-314 Suprachoroidal Delivery for the Treatment of DR
-
- The Phase II ALTITUDE® trial continues to enroll
patients in two new cohorts at a higher third dose level, with
patients stratified by Early Treatment Diabetic Retinopathy
Study-Diabetic Retinopathy Severity Scale (DRSS) levels and all
receiving short-course prophylactic ocular steroids following
RGX-314 administration. REGENXBIO expects to complete enrollment of
both cohorts from the higher third dose level in the first half of
2023 and report additional interim trial data, including initial
data from the third dose level, in the second half of 2023.
- In November 2022, REGENXBIO
announced new data from the Phase II ALTITUDE trial demonstrating
that RGX-314 was well tolerated across 50 patients and BCVA
remained stable through six months. Patients treated with RGX-314
demonstrated clinically meaningful improvements in disease severity
and less disease worsening versus observation control at six months
as measured by DRSS. No meaningful differences in safety outcomes
were observed for patients who are NAb positive. Some patients had
mild intraocular inflammation, all of which resolved with topical
corticosteroids.
RGX-202: RGX-202 is an investigational one-time AAV
Therapeutic for the treatment of Duchenne Muscular Dystrophy
(Duchenne), using the NAV AAV8 vector to deliver a transgene for a
novel microdystrophin that includes the functional elements of the
C-Terminal (CT) domain as well as a muscle specific promoter to
support a targeted therapy for improved resistance to muscle damage
associated with Duchenne.
- The Phase I/II AFFINITY DUCHENNE™ trial is active and
recruiting patients. REGENXBIO plans to use commercial-scale cGMP
material from the REGENXBIO Manufacturing Innovation Center in the
clinical trial. REGENXBIO expects to report initial data from the
trial in the second half of 2023.
- Additionally, REGENXBIO is recruiting patients in the AFFINITY
BEYOND™ trial, an observational screening study to evaluate the
prevalence of AAV8 antibodies in patients with Duchenne up to 12
years of age. Information collected in this study may be used to
identify potential participants for the AFFINITY DUCHENNE trial and
potential future trials of RGX-202.
RGX-121: RGX-121 is an investigational one-time AAV
Therapeutic for the treatment of Mucopolysaccharidosis Type II (MPS
II), also known as Hunter Syndrome, using the NAV AAV9 vector to
deliver the gene that encodes the iduronate-2-sulfatase (I2S)
enzyme.
- The Phase I/II/III CAMPSIITE™ trial is ongoing, and is expected
to incorporate material from the NAVXpress platform process
manufactured at the REGENXBIO Manufacturing Innovation Center to
support the future commercialization of RGX-121. CAMPSIITE is
expected to complete enrollment of 10 MPS II patients in the first
half of 2023 to support a BLA filing in 2024 using the accelerated
approval pathway.
- In February 2023, REGENXBIO
announced additional interim data from the Phase I/II part of the
CAMPSIITE trial, demonstrating that RGX-121 continued to be
well-tolerated across 15 patients. Patients receiving the pivotal
program dose level continued to demonstrate the largest reductions
in CSF GAGs and continued to approach normal levels at 48 weeks.
CSF GAGs have the potential to be considered a surrogate biomarker
that is reasonably likely to predict clinical benefit in MPS II
disease under the accelerated approval pathway, as buildup of GAGs
in the CSF of MPS II patients correlates with clinical
manifestations, including neurodevelopmental deficits. Longer-term
clinical measures demonstrated continued improvement in
neurodevelopmental and daily activity skill acquisition up to three
years after RGX-121 administration.
- A Phase I/II trial of RGX-121 for the treatment of pediatric
patients with MPS II over the age of five years old is also
ongoing.
RGX-111: RGX-111 is an investigational one-time AAV
Therapeutic for the treatment of severe Mucopolysaccharidosis Type
I (MPS I), using the NAV AAV9 vector to deliver the α-l-iduronidase
(IDUA) gene.
- A Phase I/II trial of RGX-111 for the treatment of MPS I is
fully enrolled with follow-up ongoing. REGENXBIO is on track to
manufacture commercial-scale cGMP material using the NAVXpress
platform process in the first half of 2023 to support the continued
development of RGX-111. REGENXBIO expects to share additional
updates on program plans in the second half of 2023.
- In February 2023, REGENXBIO
announced additional positive interim data from the Phase I/II
trial demonstrating that RGX-111 was well tolerated in eight
patients. Biomarker and neurodevelopmental assessments indicated an
encouraging CNS profile in patients dosed with RGX-111.
RGX-181: RGX-181 is an investigational one-time AAV
Therapeutic for the treatment of late-infantile neuronal ceroid
lipofuscinosis type 2 (CLN2) disease, a form of Batten disease,
using the NAV AAV9 vector to deliver the TPP1 gene directly to the
central nervous system.
- In December 2022, REGENXBIO
announced that physician investigators in Brazil have dosed the first child with CLN2
disease with RGX-181 in a single-patient, investigator-initiated
study.
RGX-381: RGX-381 is an investigational one-time AAV
Therapeutic for the treatment of the ocular manifestations of CLN2
disease using the NAV AAV9 vector to deliver the TPP1 gene directly
to the retina.
- In December 2022, REGENXBIO
announced a clinical trial application (CTA) has been accepted by
the UK Health Authority to support a first-in-human, open-label,
dose-escalation Phase I/II clinical trial to evaluate the safety
and tolerability, as well as the effect on retinal anatomic and
functional outcomes, of the subretinal delivery of RGX-381 for the
treatment of ocular manifestations of CLN2 disease.
- REGENXBIO continues to expect to initiate the Phase I/II
clinical trial in the first half of 2023.
Operational Updates
- The REGENXBIO Manufacturing Innovation Center in Maryland is fully operational, producing GMP
bulk substance lots to support programs using the NAVXpress™
platform process.
-
- The state-of-the-art cGMP gene therapy manufacturing facility
is designed to meet global clinical and commercial regulatory
standards and enable the Company to efficiently advance its
AAV-based gene therapy pipeline from research and early development
to clinical programs and commercial readiness.
- REGENXBIO is one of only a few gene therapy companies worldwide
with a GMP facility capable of production at scales up to 2,000
liters.
- In 2023, REGENXBIO plans to utilize the facility to continue to
produce commercial-scale cGMP material for its entire clinical
pipeline and performance qualification lots to support planned BLA
filings in 2024 for RGX-314 and RGX-121.
NAV Technology Licensee Program Highlights
As of December 31, 2022,
REGENXBIO's NAV Technology Platform was being applied in one
marketed product and multiple clinical stage partnered programs,
with the potential to impact a broad range of therapeutic areas and
disease indications.
- Zolgensma®, a one-time AAV Therapeutic for the
treatment of spinal muscular atrophy (SMA), is a marketed product
utilizing REGENXBIO's NAV AAV9 vector. In February 2023, Novartis AG reported fourth
quarter and full year 2022 global sales of Zolgensma of
$309 million and $1.37 billion, respectively.
- In January 2023, Rocket
Pharmaceuticals, Inc. announced positive updates from its Phase I
trial of RP-A501 for the treatment of Danon Disease. The Phase II
pivotal trial remains on track for initiation in the second quarter
of 2023 based on ongoing and productive FDA interactions. RP-A501
is being developed as a one-time gene therapy utilizing REGENXBIO's
NAV AAV9 vector.
- In January 2023, Ultragenyx
Pharmaceutical Inc. (Ultragenyx) announced that in the Phase III
study of DTX401 for Glycogen Storage Disease Type Ia (GSDIa), the
last patient has entered the baseline screening period and data
readout is expected in the first half of 2024. Ultragenyx also
expects to initiate the Phase III study of DTX301 for Ornithine
Transcarbamylase (OTC) Deficiency in the first quarter of 2023.
DTX401 and DTX301 are both being developed as one-time gene
therapies utilizing REGENXBIO's NAV AAV8 vector.
Financial Results
Cash Position: Cash, cash equivalents and marketable
securities were $565.2 million as of
December 31, 2022, compared to
$849.3 million as of December 31, 2021. The decrease was primarily
driven by cash used to fund operating activities and capital
expenditures and temporary unrealized losses on marketable debt
securities during the year ended December
31, 2022.
Revenues: Revenues were $31.3
million and $112.7 million for
the three months and year ended December 31,
2022, respectively, compared to $398.7 million and $470.3
million for the three months and year ended December 31, 2021, respectively. The decreases
were primarily attributable to non-recurring revenue of
$370.0 million recognized in the
fourth quarter of 2021 upon the effectiveness of our eye care
collaboration with AbbVie. The decrease in revenues for the year
ended December 31, 2022 was partially
offset by Zolgensma royalty revenues, which increased from
$95.0 million in 2021 to $101.9 million in 2022.
Research and Development Expenses: Research and
development expenses were $62.5
million and $242.5 million for
the three months and year ended December 31,
2022, respectively, compared to $48.0
million and $181.4 million for
the three months and year ended December 31,
2021, respectively. The increases were primarily
attributable to personnel costs as a result of increased headcount,
and costs associated with clinical trials and manufacturing-related
activities for our lead product candidates.
General and Administrative Expenses: General and
administrative expenses were $21.2
million and $85.3 million for
the three months and year ended December 31,
2022, respectively, compared to $22.0
million and $79.3 million for
the three months and year ended December 31,
2021, respectively. The increase in general and
administrative expenses for the year ended December 31, 2022 was primarily attributable to
corporate overhead expenses.
Net Income (Loss): Net loss was $59.9 million, or $1.38 basic and diluted net loss per share, for
the three months ended December 31,
2022, compared to net income of $294.0 million, or $6.87 basic and $6.67 diluted net income per share, for the three
months ended December 31, 2021. Net
loss was $280.3 million, or
$6.50 basic and diluted net loss per
share, for the year ended December 31,
2022, compared to net income of $127.8 million, or $3.01 basic and $2.91 diluted net income per share, for the year
ended December 31, 2021.
Financial Guidance
REGENXBIO expects its balance in cash, cash equivalents and
marketable securities of $565.2
million as of December 31,
2022 to fund its operations into 2025. This cash runway
guidance is based on the Company's current operational plans and
excludes the impact of any payments that may be received from
AbbVie upon the achievement of development or commercial milestones
under our RGX-314 collaboration.
Conference Call
In connection with this announcement, REGENXBIO will host a
conference call and webcast today at 4:30
p.m. ET. Listeners can register for the webcast via this
link. Analysts wishing to participate in the question and answer
session should use this link. A replay of the webcast will be
available via the company's investor website approximately two
hours after the call's conclusion. Those who plan on participating
are advised to join 15 minutes prior to the start time.
About REGENXBIO Inc.
REGENXBIO is a leading clinical-stage biotechnology company
seeking to improve lives through the curative potential of gene
therapy. REGENXBIO's NAV Technology Platform, a proprietary
adeno-associated virus (AAV) gene delivery platform, consists of
exclusive rights to more than 100 novel AAV vectors, including
AAV7, AAV8 and AAV9. REGENXBIO and its third-party NAV Technology
Platform Licensees are applying the NAV Technology Platform in the
development of a broad pipeline of candidates, including late-stage
and commercial programs, in multiple therapeutic areas. REGENXBIO
is committed to a "5x'25" strategy to progress five AAV
Therapeutics from our internal pipeline and licensed programs into
pivotal-stage or commercial products by 2025.
Forward-Looking Statements
This press release includes "forward-looking statements," within
the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as
amended. These statements express a belief, expectation or
intention and are generally accompanied by words that convey
projected future events or outcomes such as "believe," "may,"
"will," "estimate," "continue," "anticipate," "assume," "design,"
"intend," "expect," "could," "plan," "potential," "predict,"
"seek," "should," "would" or by variations of such words or by
similar expressions. The forward-looking statements include
statements relating to, among other things, REGENXBIO's future
operations, clinical trials, costs and cash flow. REGENXBIO has
based these forward-looking statements on its current expectations
and assumptions and analyses made by REGENXBIO in light of its
experience and its perception of historical trends, current
conditions and expected future developments, as well as other
factors REGENXBIO believes are appropriate under the circumstances.
However, whether actual results and developments will conform with
REGENXBIO's expectations and predictions is subject to a number of
risks and uncertainties, including the timing of enrollment,
commencement and completion and the success of clinical trials
conducted by REGENXBIO, its licensees and its partners, the timing
of commencement and completion and the success of preclinical
studies conducted by REGENXBIO and its development partners, the
timely development and launch of new products, the ability to
obtain and maintain regulatory approval of product candidates, the
ability to obtain and maintain intellectual property protection for
product candidates and technology, trends and challenges in the
business and markets in which REGENXBIO operates, the size and
growth of potential markets for product candidates and the ability
to serve those markets, the rate and degree of acceptance of
product candidates, the impact of the COVID-19 pandemic or similar
public health crises on REGENXBIO's business, and other factors,
many of which are beyond the control of REGENXBIO. Refer to the
"Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of
REGENXBIO's Annual Report on Form 10-K for the year ended
December 31, 2022, and comparable
"risk factors" sections of REGENXBIO's Quarterly Reports on Form
10-Q and other filings, which have been filed with the U.S.
Securities and Exchange Commission (SEC) and are available on the
SEC's website at www.sec.gov. All of the forward-looking statements
made in this press release are expressly qualified by the
cautionary statements contained or referred to herein. The actual
results or developments anticipated may not be realized or, even if
substantially realized, they may not have the expected consequences
to or effects on REGENXBIO or its businesses or operations. Such
statements are not guarantees of future performance and actual
results or developments may differ materially from those projected
in the forward-looking statements. Readers are cautioned not to
rely too heavily on the forward-looking statements contained in
this press release. These forward-looking statements speak only as
of the date of this press release. Except as required by law,
REGENXBIO does not undertake any obligation, and specifically
declines any obligation, to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise.
REGENXBIO
INC.
CONSOLIDATED BALANCE
SHEETS
(unaudited)
(in
thousands)
|
|
|
|
December 31,
2022
|
|
|
December 31,
2021
|
|
Assets
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
96,952
|
|
|
$
|
345,209
|
|
Marketable
securities
|
|
|
267,690
|
|
|
|
112,230
|
|
Accounts receivable,
net
|
|
|
28,082
|
|
|
|
32,439
|
|
Prepaid
expenses
|
|
|
13,900
|
|
|
|
18,752
|
|
Other current
assets
|
|
|
9,352
|
|
|
|
10,196
|
|
Total current
assets
|
|
|
415,976
|
|
|
|
518,826
|
|
Marketable
securities
|
|
|
200,560
|
|
|
|
391,907
|
|
Accounts receivable,
net
|
|
|
1,504
|
|
|
|
2,262
|
|
Property and equipment,
net
|
|
|
141,685
|
|
|
|
131,547
|
|
Operating lease
right-of-use assets
|
|
|
65,116
|
|
|
|
60,904
|
|
Restricted
cash
|
|
|
2,030
|
|
|
|
2,030
|
|
Other assets
|
|
|
6,397
|
|
|
|
6,428
|
|
Total
assets
|
|
$
|
833,268
|
|
|
$
|
1,113,904
|
|
Liabilities and
Stockholders' Equity
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
27,213
|
|
|
$
|
11,387
|
|
Accrued expenses and
other current liabilities
|
|
|
46,794
|
|
|
|
76,111
|
|
Deferred
revenue
|
|
|
1,829
|
|
|
|
3,333
|
|
Operating lease
liabilities
|
|
|
5,997
|
|
|
|
1,752
|
|
Liability related to
sale of future royalties
|
|
|
48,601
|
|
|
|
37,889
|
|
Total current
liabilities
|
|
|
130,434
|
|
|
|
130,472
|
|
Operating lease
liabilities
|
|
|
88,802
|
|
|
|
84,929
|
|
Liability related to
sale of future royalties
|
|
|
89,005
|
|
|
|
133,460
|
|
Other
liabilities
|
|
|
8,832
|
|
|
|
745
|
|
Total
liabilities
|
|
|
317,073
|
|
|
|
349,606
|
|
Stockholders'
equity
|
|
|
|
|
|
|
Preferred stock; no
shares issued and outstanding
at December 31, 2022 and 2021
|
|
|
—
|
|
|
|
—
|
|
Common stock; 43,299
and 42,831 shares issued and
outstanding at December 31, 2022 and 2021,
respectively
|
|
|
4
|
|
|
|
4
|
|
Additional paid-in
capital
|
|
|
973,145
|
|
|
|
928,095
|
|
Accumulated other
comprehensive loss
|
|
|
(15,401)
|
|
|
|
(2,569)
|
|
Accumulated
deficit
|
|
|
(441,553)
|
|
|
|
(161,232)
|
|
Total stockholders'
equity
|
|
|
516,195
|
|
|
|
764,298
|
|
Total liabilities and
stockholders' equity
|
|
$
|
833,268
|
|
|
$
|
1,113,904
|
|
REGENXBIO
INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS)
(unaudited)
(in thousands,
except per share data)
|
|
|
|
Three
Months
|
|
|
Years
|
|
|
|
Ended December
31,
|
|
|
Ended December
31,
|
|
|
|
2022
|
|
|
2021
|
|
|
2022
|
|
|
2021
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
License and royalty
revenue
|
|
$
|
31,345
|
|
|
$
|
398,655
|
|
|
$
|
112,724
|
|
|
$
|
470,347
|
|
Total
revenues
|
|
|
31,345
|
|
|
|
398,655
|
|
|
|
112,724
|
|
|
|
470,347
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
revenues
|
|
|
12,783
|
|
|
|
23,058
|
|
|
|
54,545
|
|
|
|
51,833
|
|
Research and
development
|
|
|
62,505
|
|
|
|
47,978
|
|
|
|
242,453
|
|
|
|
181,437
|
|
General and
administrative
|
|
|
21,210
|
|
|
|
22,040
|
|
|
|
85,281
|
|
|
|
79,333
|
|
Credit losses
(recoveries)
|
|
|
—
|
|
|
|
(8,102)
|
|
|
|
—
|
|
|
|
(2,569)
|
|
Other operating
expenses (income)
|
|
|
(7,382)
|
|
|
|
85
|
|
|
|
(6,679)
|
|
|
|
333
|
|
Total operating
expenses
|
|
|
89,116
|
|
|
|
85,059
|
|
|
|
375,600
|
|
|
|
310,367
|
|
Income (loss) from
operations
|
|
|
(57,771)
|
|
|
|
313,596
|
|
|
|
(262,876)
|
|
|
|
159,980
|
|
Other Income
(Expense)
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income from
licensing
|
|
|
77
|
|
|
|
19
|
|
|
|
342
|
|
|
|
719
|
|
Investment
income
|
|
|
2,026
|
|
|
|
311
|
|
|
|
5,383
|
|
|
|
6,825
|
|
Interest
expense
|
|
|
(4,310)
|
|
|
|
(6,500)
|
|
|
|
(23,254)
|
|
|
|
(26,277)
|
|
Total other income
(expense)
|
|
|
(2,207)
|
|
|
|
(6,170)
|
|
|
|
(17,529)
|
|
|
|
(18,733)
|
|
Income (loss) before
income taxes
|
|
|
(59,978)
|
|
|
|
307,426
|
|
|
|
(280,405)
|
|
|
|
141,247
|
|
Income Tax Benefit
(Expense)
|
|
|
43
|
|
|
|
(13,403)
|
|
|
|
84
|
|
|
|
(13,407)
|
|
Net income
(loss)
|
|
$
|
(59,935)
|
|
|
$
|
294,023
|
|
|
$
|
(280,321)
|
|
|
$
|
127,840
|
|
Other Comprehensive
Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss)
on available-for-sale securities, net
|
|
|
2,855
|
|
|
|
(1,284)
|
|
|
|
(12,832)
|
|
|
|
(2,209)
|
|
Total other
comprehensive income (loss)
|
|
|
2,855
|
|
|
|
(1,284)
|
|
|
|
(12,832)
|
|
|
|
(2,209)
|
|
Comprehensive income
(loss)
|
|
$
|
(57,080)
|
|
|
$
|
292,739
|
|
|
$
|
(293,153)
|
|
|
$
|
125,631
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(1.38)
|
|
|
$
|
6.87
|
|
|
$
|
(6.50)
|
|
|
$
|
3.01
|
|
Diluted
|
|
$
|
(1.38)
|
|
|
$
|
6.67
|
|
|
$
|
(6.50)
|
|
|
$
|
2.91
|
|
Weighted-average
common shares outstanding:
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
43,296
|
|
|
|
42,774
|
|
|
|
43,152
|
|
|
|
42,438
|
|
Diluted
|
|
|
43,296
|
|
|
|
44,084
|
|
|
|
43,152
|
|
|
|
43,913
|
|
Contacts:
Dana
Cormack
Corporate Communications
dcormack@regenxbio.com
Investors:
Chris Brinzey, ICR Westwicke
339-970-2843
Chris.brinzey@westwicke.com
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SOURCE REGENXBIO Inc.