Fibrocell
Science, Inc. (NYSE MKT:FCSC), an autologous cell therapy company
primarily focused on developing first-in-class treatments for skin
diseases and conditions, particularly those with high unmet medical
needs, today announced financial results for the third quarter ended
September 30, 2013 and provided an update on recent business
developments.
Third Quarter 2013 Highlights and Recent Business Developments
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In October 2013, completed an underwritten public offering which,
including the exercise of the underwriters’ over-allotment option,
resulted in aggregate net proceeds of approximately $47.4 million, net
of underwriting discounts and commissions and offering expenses
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Expanded the exclusive channel collaboration with Intrexon
Corporation (NYSE:XON) for development of a potentially new class
of therapeutics to include potential treatments based on engineered
autologous fibroblast cells for the localized treatment of autoimmune
and inflammatory disorders including orphan indications morphea
(localized scleroderma) and cutaneous eosinophilias, and moderate to
severe psoriasis
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Awarded a patent from the United States Patent and Trademark Office
covering azficel-T fibroblast suspension, which extends patent
exclusivity in the United States until 2031
Financial Results
Net loss for the three months ended September 30, 2013 was $12.9
million, compared to net income of $11.4 million for the comparable
three-month period in the prior year. The difference is primarily due to
the changes in warrant and derivative revaluation, offset by an increase
in selling, general and administrative expenses and research and
development expenses. In addition, a gain on sale of a discontinued
operation was realized during the third quarter of 2012.
Net loss for the nine months ended September 30, 2013 was $25.0 million,
compared to a net loss of $1.7 million for the comparable nine-month
period. The increase is primarily due to an increase in research and
development expenses and a reduction in warrant and derivative
revaluations, partially offset by the extinguishment of debt that
occurred in 2012. In addition, a deferred tax benefit and a gain on sale
of a discontinued operation were realized in the nine months ending
September 30, 2012.
Research and development expense increased $7.9 million to $8.4 million
for the three months ended September 30, 2013 from $0.4 million for the
three months ended September 30, 2012. Research and development expense
increased $9.5 million to $10.8 million for the nine months ended
September 30, 2013 from $1.3 million for the nine months ended September
30, 2012. The increase is due primarily to research and development
costs incurred in connection with an amendment to the Company’s
exclusive channel collaboration with Intrexon Corporation (NYSE:XON).
Third quarter 2013 research and development costs include a one-time
charge of $6.4 million for the fair value of common stock issued to
Intrexon related to the amended collaboration and stock issuance
agreements. We also recorded $1.4 and $2.4 million for reimbursement of
work performed by Intrexon Corporation for the three and nine months
ended September 30, 2013, respectively. Fibrocell expects research and
development costs to continue to be significant for the foreseeable
future as a result of clinical trials and the collaboration with
Intrexon Corporation.
As of September 30, 2013, the Company had $16.9 million in cash and cash
equivalents, compared to $31.3 million as of December 31, 2012. In
October 2013, subsequent to the end of the 3rd quarter, the
Company received net proceeds of approximately $47.4 million from the
Company’s underwritten public offering.
About Fibrocell Science, Inc.
Fibrocell Science, Inc. (NYSE MKT:FCSC) is an autologous cell therapy
company primarily focused on developing first-in-class treatments for
skin diseases and conditions, particularly those with high unmet medical
needs. Based on its proprietary autologous fibroblast technology,
Fibrocell is pursuing breakthrough medical applications of azficel-T for
restrictive burn scarring and vocal cord scarring. The company’s
collaboration with Intrexon Corporation (NYSE:XON), a leader in
synthetic biology, includes using genetically-modified fibroblasts for
treating orphan skin diseases for which there are no currently approved
products and exploring the localized treatment of the most common
autoimmune skin disease, moderate-to-severe psoriasis. Fibrocell’s
collaboration with UCLA and MIT—focusing on skin-derived stem cells and
more efficient ways to convert skin cells to other cell types—holds
potential for future discovery and development of autologous cellular
therapeutics. For additional information, please visit www.fibrocellscience.com.
About Intrexon Corporation
Intrexon Corporation (NYSE:XON) is a leader in synthetic biology focused
on collaborating with companies in Health, Food, Energy and the
Environment to create biologically-based products that improve the
quality of life and the health of the planet. Through the company's
proprietary UltraVector® platform, Intrexon provides its partners with
industrial-scale design and development of complex biological systems.
The UltraVector® platform delivers unprecedented control over the
quality, function, and performance of living cells. We call our
synthetic biology approach and integrated technologies Better DNA®, and
we invite you to discover more at www.dna.com.
Safe Harbor Statement
Some of the statements made in this press release are forward-looking
statements. These forward-looking statements are based upon our current
expectations and projections about future events and generally relate to
our plans, objectives and expectations for the development of our
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.
Accordingly, investors should not place any reliance on forward-looking
statements as a prediction of actual results.
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FIBROCELL SCIENCE, INC.
Consolidated Balance Sheets
(in thousands, except per share and share data)
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Unaudited
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September 30,
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December 31,
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2013
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2012
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Assets
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Current assets:
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Cash and cash equivalents
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$16,875
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$31,346
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Accounts receivable, net of allowance for doubtful accounts of $18
and $25, respectively
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45
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62
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Inventory
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574
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477
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Deferred equity costs
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274
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—
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Prepaid expenses
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1,404
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1,271
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Total current assets
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19,172
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33,156
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Property and equipment, net of accumulated depreciation of $714 and
$434, respectively
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1,540
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1,658
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Other assets
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215
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—
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Intangible assets, net
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5,376
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5,789
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Total assets
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$26,303
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$40,603
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Liabilities and Shareholders' Equity
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Current liabilities:
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Accounts payable
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$1,170
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$921
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Accrued expenses
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1,317
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494
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Deferred revenue
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132
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139
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Total current liabilities
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2,619
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1,554
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Warrant liability
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205
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374
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Other long-term liabilities
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493
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344
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Total liabilities
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3,317
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2,272
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Commitments
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—
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—
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Shareholders' equity:
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Common stock, $0.001 par value; 100,000,000 and 1,100,000,000 shares
authorized at September 30, 2013 and December 31, 2012,
respectively; 27,520,527 and 26,229,909 shares issued and
outstanding at September 30, 2013 and December 31, 2012, respectively
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28
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26
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Common stock-subscription receivable
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—
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(2,004
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Additional paid-in capital
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120,014
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112,384
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Accumulated deficit
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(97,056
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(72,075
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Total shareholders' equity
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22,986
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38,331
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Total liabilities and shareholders’ equity
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$26,303
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$40,603
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FIBROCELL SCIENCE, INC.
Consolidated Statements of Operations
(in thousands, except per share and share data)
(unaudited)
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For the three
months ended
September 30,
2013
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For the three
months ended
September 30,
2012
Restated
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For the nine
months ended
September 30,
2013
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For the nine
months ended
September 30,
2012
Restated
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Revenue from product sales
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$68
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$69
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$156
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$113
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Cost of sales
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1,930
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2,321
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6,523
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5,968
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Gross loss
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(1,862
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(2,252
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(6,367
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(5,855
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)
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Selling, general and administrative expenses
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2,902
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2,632
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7,719
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9,594
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Research and development expenses
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8,357
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426
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10,753
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1,294
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Operating loss
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(13,121
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(5,310
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(24,839
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(16,743
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)
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Other income (expense)
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Warrant income (expense)
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188
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14,545
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(129
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)
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17,192
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Derivative revaluation income (expense)
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—
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1,894
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—
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(23
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Interest expense
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—
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(140
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)
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—
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(586
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Extinguishment of debt
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—
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—
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—
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(4,421
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)
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(Loss) income from continuing operations before income taxes
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(12,933
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10,989
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(24,968
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(4,581
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Deferred tax benefit
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—
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—
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—
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2,500
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(Loss) income from continuing operations
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(12,933
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10,989
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(24,968
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(2,081
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(Loss) income from discontinued operations, net of tax
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(4
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5
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(13
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(1
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Gain on sale of discontinued operations, net of tax
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—
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443
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—
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443
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Net (loss) income
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(12,937
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11,437
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(24,981
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(1,639
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Net loss attributable to noncontrolling interest
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—
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(4
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—
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(24
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Net (loss) income attributable to Fibrocell Science, Inc. common
shareholders.
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$(12,937
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$11,433
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$(24,981
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$(1,663
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Per share information:
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Income (loss) from discontinued operations
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basic
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$—
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$—
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$—
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$—
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diluted
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$—
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$—
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$—
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$—
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Income from deferred tax benefit-basic and diluted
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$—
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$—
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$—
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$0.64
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Gain on sale of discontinued operations, net of tax-basic and diluted
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$—
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$0.11
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$—
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$0.11
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Net (loss) income attributable to common shareholders per
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common share
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basic
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$(0.48
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$2.89
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$(0.94
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$(0.43
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)
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diluted
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$(0.48
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)
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$(1.27
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$(0.94
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)
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$(0.43
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Weighted average number of basic common shares outstanding
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27,158,394
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3,957,231
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26,543,099
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3,887,530
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Weighted average number of diluted common shares outstanding
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27,158,394
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3,957,231
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26,543,099
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3,887,530
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Copyright Business Wire 2013