GERMANTOWN, Md., Nov. 12, 2019 /PRNewswire/ -- Intrexon
Corporation (NASDAQ: XON), a leader in the engineering and
industrialization of biology to improve the quality of life and
health of the planet, today announced its third quarter financial
results for 2019.
Recent Business Highlights:
In Intrexon Health:
- Precigen, Inc., a wholly owned subsidiary of Intrexon,
continues to advance its clinical and pre-clinical portfolios.
Details about Precigen accomplishments will be highlighted during a
conference call and webcast today at 11:00
AM ET;
- Triple-Gene LLC, a majority owned subsidiary of Intrexon,
completed patient enrollment and dosing for the second cohort in
its Phase 1 clinical trial of INXN-4001, an investigational new
drug which is the world's first triple effector gene drug candidate
being evaluated for the treatment of heart failure, and expects to
present preliminary data at the American Heart Association
Scientific Sessions November
16-18th in Philadelphia;
- ActoBio Therapeutics, Inc., a wholly owned subsidiary of
Intrexon, received a greenlight from the independent Data and
Safety Monitoring Board to open the randomized part of the adult
combination cohort and the open-label part of the adolescent
combination cohort in its Phase Ib/IIa clinical trial of AG019 for
the treatment of early onset type 1 diabetes. ActoBio's
collaboration partner Oragenics, Inc. (NYSE American: OGEN)
continues patient recruitment in the Phase 2 trial of AG013 for the
treatment of severe oral mucositis and anticipates completion of
enrollment by the end of the fourth quarter 2019;
- Exemplar Genetics, a wholly owned subsidiary of Intrexon,
formed a collaboration with Lovelace Biomedical to continue
development of Exemplar's porcine animal model for sickle cell
disease with support from the National Center for Advancing
Translational Sciences;
- Collaborator PTC Therapeutics, Inc. (NASDAQ: PTCT) announced
its intention to file an Investigational New Drug submission for
its gene therapy candidate for Friedreich ataxia in mid-2020;
and
- With two clinical stage collaboration product candidates,
collaborator Fibrocell Science, Inc. (NASDAQ: FCSC) announced it is
being acquired by Castle Creek Pharmaceutical Holdings, with the
transaction expected to close in Q4, 2019. Proceeds to Intrexon are
due upon the closing.
In Intrexon Bioengineering:
- Intrexon appointed David H.
Witte, formerly of IHS Markit, as Chief Executive Officer of
MBP Titan LLC, a standalone subsidiary company of Intrexon
comprising Intrexon's Methane Bioconversion Platform (MBP) with its
associated technologies, personnel, and facilities. Intrexon
transferred substantially all of its proprietary assets related to
MBP to this new entity and, under Mr. Witte's leadership, MBP will
seek investment to fund its capital needs. Intrexon and Governor
David Dewhurst, Chairman Designate
of MBP Titan, have agreed that Governor Dewhurst will participate
in this financing in lieu of his previous commitment;
- Okanagan Specialty Fruits, a wholly owned subsidiary of
Intrexon, completed the 2019 harvest of Arctic® Goldens
and Arctic® Grannies yielding an estimated 6,800 bins (6
million pounds) of apples, a 3.5-fold increase over 2018;
- Oxitec, Ltd., a wholly owned subsidiary of Intrexon, initiated
a pilot project for releases of its 2nd Generation
Friendly™ Aedes aegypti technology in Indaiatuba,
Brazil. Additionally, the US
Environmental Protection Agency (EPA) closed the comment period on
Oxitec's Experimental Use Permit (EUP) application to conduct pilot
projects on its 2nd generation Friendly™
Aedes aegypti technology in Florida and Texas. Oxitec is coordinating with EPA
leadership on its application and contingent upon regulatory
approval, anticipates mosquito releases would commence in 2020.
Oxitec also received a cash payment from the Bill & Melinda
Gates Foundation for completing certain developmental
milestones;
- Intrexon closed its Animal Sciences Division and Cell
Engineering Unit; and
- Effective October 29, 2019,
Intrexon entered into a stock purchase agreement with TS
AquaCulture, LLC, an affiliate of Third Security, LLC, for the sale
of 8,239,199 shares of AquaBounty Technologies, Inc. (NASDAQ: AQB),
representing all of Intrexon's ownership interests in AquaBounty,
for an aggregate purchase price of approximately $21.6 million.
Corporate Matters:
- Intrexon continues its discussions and negotiations with
multiple parties concerning the sale or disposition of numerous
business units and assets;
- Randal J. Kirk, Chairman and
Chief Executive Officer of Intrexon, has also made a non-binding
offer to purchase for cash all non-healthcare assets, including
Intrexon Bioengineering, although there is no certainty that any
transaction with Mr. Kirk will be entered into or consummated, and
any such transaction would be subject to negotiation and approval
by an independent committee of Intrexon's Board of Directors;
and
- Intrexon believes that the Company has options available to
allow it to achieve, without the sale of equity, binding
commitments with respect to its yearend cash goal of $175 million, allowing it to begin 2020 with a
tighter focus on Health and especially around Precigen.
There are risks and uncertainties inherent in forecasts of this
nature, including with respect to the challenges in identifying and
negotiating with counterparties, transactions taking longer or
generating lower proceeds than expected, changes in strategic
directions, general market developments, costs and expenses being
higher than anticipated, developments in clinical, market or
competitive data, and other factors of the type generally
applicable to the Company's business, including those discussed
under the Safe Harbor Statement below.
Third Quarter 2019 Financial Highlights:
- Total revenues of $23.0
million;
- Net loss of $53.6 million
attributable to Intrexon, or $(0.35)
per basic share, including non-cash charges of $19.5 million; and
- Cash, cash equivalents, and short-term investments totaled
$89.7 million and the value of common
equity securities totaled $22.8
million at September 30,
2019.
Year-to-Date 2019 Financial Highlights:
- Total revenues of $82.4
million;
- Net loss of $153.1 million
attributable to Intrexon, or $(1.00)
per basic share, including non-cash charges of $47.7 million.
"Intrexon's longstanding focus on Health and, in particular, in
cancer therapeutics may be vindicated as Precigen's clinical
programs further develop," commented Mr. Kirk.
Mr. Kirk concluded, "When I became CEO in 2009, when the company
entered into its first collaboration in 2011, when it IPO'd in 2013
and through last year's reacquisition of the vast majority of its
commercial rights pertaining to its cancer therapeutics programs,
healthcare has been our greatest area of investment and
potential. When Helen Sabzevari joined us in 2017 as
President of Precigen, truly the repository of the original
Intrexon technology as well as its most substantial technology
acquisitions, we saw great potential if these technologies could be
unlocked by a great drug development team. Today we begin to
share with the world what Helen and her team have accomplished and,
equally importantly, to let you hear this formidable pharmaceutical
executive tell you this in her own words."
Third Quarter 2019 Financial Results Compared to Prior Year
Period
Total revenues decreased $9.4
million from the quarter ended September 30, 2018. Collaboration and licensing
revenues decreased $8.1 million, or
57%, from the quarter ended September 30,
2018 primarily due to the reacquisition of rights previously
licensed to some of Intrexon's most significant collaborators in
the second half of 2018 and the result of which eliminated or
substantially reduced revenues previously generated from those
collaborations. Additionally, collaboration and licensing revenues
from collaborations with other collaborators decreased due to lower
demand for research and development services in the current year
period.
Research and development expenses decreased $13.4 million, or 30%. The 2018 amounts include
an $8.7 million expense related to
in-process research and development reacquired as part of an asset
acquisition in September 2018.
Additionally, depreciation and amortization decreased $2.2 million primarily due to intangible assets
that were impaired or abandoned in 2018. Selling, general and
administrative (SG&A) expenses decreased $14.0 million, or 36%, and of this amount,
$11.2 million was primarily
attributable to (i) decreased compensation expenses related to
performance and retention incentives for SG&A employees and
(ii) decreased share-based compensation expense which arose
primarily from the departure of former employees during the first
half of the current year.
Year-to-Date 2019 Financial Results Compared to Prior Year
Period
Total revenues decreased $35.0
million from the nine months ended September 30, 2018. Collaboration and licensing
revenues decreased $30.4 million, or
59%, from the nine months ended September
30, 2018 primarily due to the reacquisition of rights
previously licensed to some of Intrexon's most significant
collaborators in the second half of 2018 and the result of which
eliminated or substantially reduced revenues previously generated
from those collaborations. Product revenues decreased $5.0 million, or 21%, primarily due to lower
customer demand. Gross margin on products also declined in the
current period for the same reason.
Research and development expenses decreased $25.0 million, or 20%. The 2018 amounts include
(i) an $8.7 million expense related
to in-process research and development reacquired as part of an
asset acquisition in September 2018
and (ii) $5.3 million of one-time
costs associated with closing one of Oxitec's research and
development facilities as the Company decentralized operations
previously conducted in this facility. Additionally, depreciation
and amortization decreased $6.5
million primarily due to intangible assets that were
impaired or abandoned in 2018. SG&A expenses decreased
$33.1 million, or 29%, and of this
amount, $26.7 million was primarily
attributable to (i) decreased share-based compensation expense
which arose primarily from the departure of former employees as
well as a result of certain stock option grants becoming fully
vested in 2018 and (ii) decreased compensation expenses related to
performance and retention incentives for SG&A employees.
Conference Call and Webcast
Precigen, Inc., a biopharmaceutical company specializing in the
development of innovative gene and cellular therapies to improve
the lives of patients and a wholly owned subsidiary of Intrexon,
will host a conference call today Tuesday,
November 12th at 11:00 AM
ET to provide Precigen business and pipeline updates.
The conference call may be accessed by dialing 1-888-317-6003
(Domestic US), 1-866-284-3684 (Canada), and 1‑412-317-6061 (International)
and providing the number 4454504 to join the Precigen Business and
Pipeline Update Call. Participants may also access the live
webcast through Intrexon's website in the Investors section at
http://investors.dna.com/events or Precigen's website in the
Presentations section at
https://precigen.com/media/#id-presentations.
About Intrexon Corporation
Intrexon Corporation (NASDAQ: XON) is Powering the Bioindustrial
Revolution with Better DNA® to create
biologically-based products that improve the quality of life and
the health of the planet through two operating units – Intrexon
Health and Intrexon Bioengineering. Intrexon Health is
focused on addressing unmet medical needs through a diverse
spectrum of therapeutic modalities, including gene and cell
therapies, microbial bioproduction, and regenerative
medicine. Intrexon Bioengineering seeks to address global
challenges across food, agriculture, environmental, energy, and
industrial fields by advancing biologically engineered solutions to
improve sustainability and efficiency. Our integrated technology
suite provides industrial-scale design and development of complex
biological systems delivering unprecedented control, quality,
function, and performance of living cells. We call our synthetic
biology approach Better DNA®, and we invite you to
discover more at www.dna.com or follow us on Twitter at
@Intrexon, on Facebook, and LinkedIn.
Trademarks
Intrexon, UltraCAR-T, Arctic, Friendly, Powering the
Bioindustrial Revolution with Better DNA, and Better DNA are
trademarks of Intrexon and/or its affiliates. Other names may be
trademarks of their respective owners.
Safe Harbor Statement
Some of the statements made in this press release are
forward-looking statements that involve a number of risks and
uncertainties and are made pursuant to the Safe Harbor Provisions
of the Private Securities Litigation Reform Act of
1995. Forward-looking statements made in this press release
include, but are not limited to, statements regarding clinical and
pre-clinical development activities by Intrexon and its
collaborators, commercial and business development plans and the
submission of regulatory filings. These forward-looking statements
are based upon Intrexon's current expectations and projections
about future events and generally relate to Intrexon's plans,
objectives and expectations for the development of Intrexon's
business. 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 and actual future results may be materially
different from the plans, objectives and expectations expressed in
this press release. These risks and uncertainties include, but are
not limited to, (i) Intrexon's strategy and overall approach to its
business model, its efforts to realign its business, and its
ability to exercise more control and ownership over the development
process and commercialization path; (ii) Intrexon's ability to
successfully enter new markets or develop additional products,
including the expected timing and results of investigational
studies and preclinical and clinical trials, whether with its
collaborators or independently; (iii) Intrexon's ability to
successfully enter into optimal strategic relationships with its
subsidiaries and operating companies that it may form in the
future; (iv) Intrexon's ability to hold or generate significant
operating capital, including through partnering, asset sales and
operating cost reductions; (v) actual or anticipated variations in
Intrexon's operating results; (vi) actual or anticipated
fluctuations in Intrexon's competitors' or its collaborators'
operating results or changes in their respective growth rates;
(vii) Intrexon's cash position; (viii) market conditions in
Intrexon's industry; (ix) the volatility of Intrexon's stock price;
(x) Intrexon's ability, and the ability of its collaborators, to
protect Intrexon's intellectual property and other proprietary
rights and technologies; (xi) Intrexon's ability, and the ability
of its collaborators, to adapt to changes in laws or regulations
and policies; (xii) the outcomes of pending and future litigation;
(xiii) the rate and degree of market acceptance of any products
developed by Intrexon, its subsidiaries, collaborations or joint
ventures; (xiv) Intrexon's ability to retain and recruit key
personnel; (xv) Intrexon's expectations related to the use of
proceeds from its public offerings and other financing efforts;
(xvi) Intrexon's estimates regarding expenses, future revenue,
capital requirements and needs for additional financing; (xvii) the
successful formation of a stand-alone company for our Methane
Bioconversion Platform; and (xviii) the successful completion of
certain anticipated transactions. For a discussion of other risks
and uncertainties, and other important factors, any of which could
cause Intrexon's actual results to differ from those contained in
the forward-looking statements, see the section entitled "Risk
Factors" in Intrexon's Annual Report on Form 10-K for the fiscal
year ended December 31, 2018 and
subsequent reports filed with the Securities and Exchange
Commission. All information in this presentation is as of the date
of the release, and Intrexon undertakes no duty to update this
information unless required by law.
For more information regarding Intrexon Corporation,
contact:
Investor
Contact:
Steven
Harasym
Vice President,
Investor Relations
Tel: +1 (301)
556-9850
investors@dna.com
|
Corporate
Contact:
Marie Rossi,
PhD
Vice President,
Communications
Tel: +1 (301)
556-9850
publicrelations@dna.com
|
Intrexon
Corporation and Subsidiaries
|
Consolidated
Balance Sheets
|
(Unaudited)
|
|
(Amounts in
thousands)
|
|
September 30,
2019
|
|
|
December 31,
2018
|
Assets
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
44,428
|
|
|
$
|
102,768
|
Restricted
cash
|
|
|
—
|
|
|
|
6,987
|
Short-term
investments
|
|
|
45,285
|
|
|
|
119,688
|
Equity
securities
|
|
|
16,320
|
|
|
|
384
|
Receivables
|
|
|
|
|
|
|
|
Trade, net
|
|
|
20,413
|
|
|
|
21,195
|
Related parties,
net
|
|
|
2,588
|
|
|
|
4,129
|
Other, net
|
|
|
1,970
|
|
|
|
2,754
|
Inventory
|
|
|
17,295
|
|
|
|
21,447
|
Prepaid expenses and
other
|
|
|
9,033
|
|
|
|
6,131
|
|
|
|
|
|
|
|
|
Total current
assets
|
|
|
157,332
|
|
|
|
285,483
|
Equity securities,
noncurrent
|
|
|
6,515
|
|
|
|
1,798
|
Property, plant and
equipment, net
|
|
|
122,706
|
|
|
|
128,874
|
Intangible assets,
net
|
|
|
107,141
|
|
|
|
129,291
|
Goodwill
|
|
|
147,949
|
|
|
|
149,585
|
Investments in
affiliates
|
|
|
17,487
|
|
|
|
18,859
|
Right-of-use
assets
|
|
|
43,211
|
|
|
|
—
|
Other
assets
|
|
|
2,564
|
|
|
|
2,287
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
604,905
|
|
|
$
|
716,177
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
7,395
|
|
|
$
|
13,420
|
Accrued compensation
and benefits
|
|
|
9,862
|
|
|
|
10,687
|
Other accrued
liabilities
|
|
|
13,664
|
|
|
|
20,620
|
Deferred
revenue
|
|
|
12,764
|
|
|
|
15,554
|
Lines of
credit
|
|
|
569
|
|
|
|
466
|
Current portion of
long-term debt
|
|
|
31,433
|
|
|
|
559
|
Current portion of
lease liabilities
|
|
|
6,224
|
|
|
|
—
|
Related party
payables
|
|
|
44
|
|
|
|
256
|
|
|
|
|
|
|
|
|
Total current
liabilities
|
|
|
81,955
|
|
|
|
61,562
|
Long-term debt, net
of current portion
|
|
|
184,034
|
|
|
|
211,235
|
Deferred revenue, net
of current portion
|
|
|
66,360
|
|
|
|
54,210
|
Lease liabilities,
net of current portion
|
|
|
38,182
|
|
|
|
—
|
Deferred tax
liabilities, net
|
|
|
5,732
|
|
|
|
7,213
|
Other long-term
liabilities
|
|
|
221
|
|
|
|
3,235
|
|
|
|
|
|
|
|
|
Total
liabilities
|
|
|
376,484
|
|
|
|
337,455
|
|
|
|
|
|
|
|
|
Commitments and
contingencies
|
|
|
|
|
|
|
|
Total
equity
|
|
|
|
|
|
|
|
Common
stock
|
|
|
—
|
|
|
|
—
|
Additional paid-in
capital
|
|
|
1,745,177
|
|
|
|
1,722,012
|
Accumulated
deficit
|
|
|
(1,483,654)
|
|
|
|
(1,330,545)
|
Accumulated other
comprehensive loss
|
|
|
(33,102)
|
|
|
|
(28,612)
|
|
|
|
|
|
|
|
|
Total Intrexon
shareholders' equity
|
|
|
228,421
|
|
|
|
362,855
|
Noncontrolling
interests
|
|
|
—
|
|
|
|
15,867
|
|
|
|
|
|
|
|
|
Total
equity
|
|
|
228,421
|
|
|
|
378,722
|
|
|
|
|
|
|
|
|
Total liabilities and
total equity
|
|
$
|
604,905
|
|
|
$
|
716,177
|
Intrexon
Corporation and Subsidiaries
|
Consolidated
Statements of Operations
|
(Unaudited)
|
|
(Amounts in
thousands,
except share and per
share data)
|
|
|
Three months
ended
|
|
|
Nine months
ended
|
|
|
September
30,
|
|
|
September
30,
|
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and
licensing
revenues
|
|
$
|
6,185
|
|
$
|
14,324
|
|
$
|
21,252
|
|
$
|
51,622
|
Product
revenues
|
|
|
5,852
|
|
|
6,829
|
|
|
18,528
|
|
|
23,549
|
Service
revenues
|
|
|
9,924
|
|
|
10,414
|
|
|
39,707
|
|
|
40,379
|
Other
revenues
|
|
|
1,082
|
|
|
881
|
|
|
2,877
|
|
|
1,839
|
Total
revenues
|
|
|
23,043
|
|
|
32,448
|
|
|
82,364
|
|
|
117,389
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of
products
|
|
|
8,263
|
|
|
8,877
|
|
|
25,729
|
|
|
28,046
|
Cost of
services
|
|
|
6,550
|
|
|
6,449
|
|
|
21,860
|
|
|
21,127
|
Research and
development
|
|
|
31,480
|
|
|
44,885
|
|
|
99,060
|
|
|
124,072
|
Selling, general
and
administrative
|
|
|
24,741
|
|
|
38,708
|
|
|
79,818
|
|
|
112,872
|
Impairment
loss
|
|
|
626
|
|
|
—
|
|
|
626
|
|
|
—
|
Total operating
expenses
|
|
|
71,660
|
|
|
98,919
|
|
|
227,093
|
|
|
286,117
|
Operating
loss
|
|
|
(48,617)
|
|
|
(66,471)
|
|
|
(144,729)
|
|
|
(168,728)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other Expense,
Net
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized and
realized
appreciation
(depreciation) in fair value
of equity securities and
preferred stock, net
|
|
|
(3,068)
|
|
|
(7,287)
|
|
|
2,634
|
|
|
(27,565)
|
Interest
expense
|
|
|
(4,471)
|
|
|
(3,999)
|
|
|
(13,140)
|
|
|
(4,240)
|
Interest and
dividend
income
|
|
|
885
|
|
|
6,107
|
|
|
3,280
|
|
|
17,323
|
Other income,
net
|
|
|
2,772
|
|
|
1,452
|
|
|
673
|
|
|
571
|
Total other expense,
net
|
|
|
(3,882)
|
|
|
(3,727)
|
|
|
(6,553)
|
|
|
(13,911)
|
Equity in net loss
of
affiliates
|
|
|
(1,647)
|
|
|
(2,870)
|
|
|
(5,034)
|
|
|
(9,880)
|
Loss before income
taxes
|
|
|
(54,146)
|
|
|
(73,068)
|
|
|
(156,316)
|
|
|
(192,519)
|
Income tax
benefit
|
|
|
512
|
|
|
14,322
|
|
|
1,615
|
|
|
19,535
|
Net loss
|
|
$
|
(53,634)
|
|
$
|
(58,746)
|
|
$
|
(154,701)
|
|
$
|
(172,984)
|
Net loss attributable
to the
noncontrolling interests
|
|
|
—
|
|
|
1,422
|
|
|
1,592
|
|
|
4,113
|
Net loss attributable
to
Intrexon
|
|
$
|
(53,634)
|
|
$
|
(57,324)
|
|
$
|
(153,109)
|
|
$
|
(168,871)
|
Net loss attributable
to
Intrexon per share, basic
and diluted
|
|
$
|
(0.35)
|
|
$
|
(0.44)
|
|
$
|
(1.00)
|
|
$
|
(1.31)
|
Weighted average
shares
outstanding, basic and
diluted
|
|
|
154,596,257
|
|
|
129,518,989
|
|
|
153,770,785
|
|
|
128,843,991
|
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SOURCE Intrexon Corporation