Emergent BioSolutions Inc. (NYSE: EBS) announced today its financial
results for the full year ended December 31, 2009.
For the full year 2009, total revenues were $234.8 million as compared
to $178.6 million in 2008, and net income was $31.1 million, or $1.02
per share, as compared to $20.7 million, or $0.69 per share, in 2008.
The 2009 performance was primarily driven by sales of BioThrax®
(Anthrax Vaccine Adsorbed), the company’s FDA licensed vaccine for the
prevention of anthrax disease, including $34.0 million related to the
approval of four-year expiry dating for BioThrax®.
For the fourth quarter 2009, total revenues were $53.8 million as
compared to $35.8 million in 2008, and net income was $4.2 million, or
$0.14 per share, as compared to net income of $1.5 million, or $0.05 per
share in 2008.
R. Don Elsey, chief financial officer of Emergent BioSolutions, stated,
"Our 2009 financial performance reflects our continued success in
growing revenue from the sale of BioThrax® under multi-year
procurement contracts with the US government while managing our
expenditures. We expect to continue these trends in the current year, as
evidenced by our forecast for 2010 of total revenues of $235 to $255
million and net income of $20 to $30 million.”
2009 Key Operational Accomplishments
-
Received FDA approval extending shelf life of BioThrax® to
4 years, triggering a $34.0 million payment from HHS;
-
Received FDA approval to amend the BioThrax® license,
providing for an intramuscular route of administration and a reduction
in the dosing schedule to five doses over 18 months—an initiative
supported and funded by the U.S. Centers for Disease Control and
Prevention (CDC);
-
Received market authorization for BioThrax® in India;
-
Commenced what we expect will be the only clinical trial of the
company’s polyclonal anthrax immune globulin (AIG) candidate for
treating anthrax disease;
-
Obtained Fast Track designation and Orphan Drug status from FDA and
Orphan Drug status from EMEA for the company’s AIG candidate;
-
Secured a NIAID grant to fund development of a third-generation
anthrax vaccine candidate, valued at $4.9 million over a two-year
period;
-
Initiated a Phase IIb field efficacy trial in South Africa for the
Company’s advanced TB vaccine candidate, largely funded by The Aeras
Global TB Vaccine Foundation and the Wellcome Trust;
-
Completed a Phase IIb clinical trial of TyphellaTM which
demonstrated additional safety and immunogenicity of this typhoid
vaccine product candidate in healthy subjects in the U.S.;
-
Purchased a 56,000 square foot manufacturing facility in Baltimore,
MD., which houses five independent manufacturing suites flexibly
designed to support the production of both clinical and commercial
materials for the Company's growing product pipeline, for a total
purchase price of $8.2 million;
-
Purchased a 48,000 square foot product development facility in
Gaithersburg, MD., that the Company previously leased, for a total
purchase price of $6.4 million;
-
Resumed scale-up of BioThrax® in the Company’s large-scale
manufacturing facility (Building 55) in Lansing, MI.; and
-
Submitted a proposal to HHS, in response to a request, for funding the
completion of the manufacturing scale-up of BioThrax® in
Building 55.
2009 Key Financial Results
Product Sales
For 2009, product sales were $217.2 million, an increase of $48.0
million, or 28 percent, from $169.1 million in 2008, primarily due to
payments from HHS of approximately $34.0 million related to the approval
of four-year expiry dating for BioThrax®, obtained in June
2009, coupled with an 8 percent increase in doses sold in 2009. Product
sales revenues in 2009 consisted of BioThrax® sales to HHS of
$216.4 million and aggregate international and other sales of $0.7
million.
Contracts and Grants Revenues
For 2009, contracts and grants revenue was $17.6 million, an increase of
$8.2 million, or 87 percent, from $9.4 million in 2008. Contracts and
grants revenue for 2009 primarily consisted of development contract
revenue from NIAID and BARDA.
Cost of Product Sales
For 2009, cost of product sales was $46.3 million, an increase of $12.2
million, or 36 percent, from $34.1 million in 2008. This increase was
attributable to the 8 percent increase in BioThrax® doses
sold and an increase in the average cost per dose sold associated with
reduced production yield in the period during which the doses sold were
produced.
Research and Development
For 2009, research and development expenses were $74.6 million, an
increase of $15.1 million, or 25 percent, from $59.5 million in 2008.
This increase reflects higher contract service costs, and includes
increased expenses of $16.6 million on product candidates in our
biodefense programs, primarily BioThrax® extensions and
enhancements and our other anthrax-related product candidates, decreased
expenses of $7.1 million related to our commercial product candidates,
and increased expenses of $5.7 million in other research and
development, which are in support of technology platforms and central
R&D activities.
Selling, General and Administrative
For 2009, selling, general and administrative expenses were $73.8
million, an increase of $18.7 million, or 34 percent, from $55.1 million
in 2008. This increase includes approximately $5.0 million in increased
litigation services and other professional services, a $7.3 million
non-cash charge associated with our Frederick, Maryland facilities, and
a $1.4 million non-cash charge associated with acquisitions that were in
progress but not completed as of December 31, 2008, as well as increased
personnel costs related to the growth of the Company.
Financial Condition and Liquidity
Cash and cash equivalents at December 31, 2009 was $102.9 million
compared to $91.5 million at December 31, 2008. Additionally, at
December 31, 2009, the accounts receivable balance was $54.9 million,
which is comprised primarily of an unpaid balance consists primarily of
amounts due related to shipments of BioThrax® received and
accepted by the US government in the fourth quarter of 2009.
2010 Forecast
For 2010, the Company is reaffirming its financial forecast of total
revenues of $235 to $255 million and net income of $20 to $30 million.
2010 total revenue is expected to be driven by, among other things:
-
the continuation of deliveries of BioThrax® under the
current multi-year procurement contract with CDC;
-
an increase in the performance of work under development contracts
with the U.S. government with respect to the Company's BioThrax®
related programs, anthrax immune globulin therapeutic candidate, and
anthrax monoclonal antibody candidate;
-
additional sales of BioThrax® to allied foreign
governments; and
-
work performed under an expected development contract with the U.S.
government related to the Company's rPA vaccine candidate.
Conference Call and Webcast
Company management will host a conference call at 5:00 pm Eastern on
March 4, 2010 to discuss the financial results for the full twelve
months of 2009, recent business developments and the forecast for 2010.
The conference call will be accessible by dialing 888/680-0893 or 617/213-4859
(international) and providing passcode 15824424. A webcast of the
conference call will be accessible from the Company’s website at www.emergentbiosolutions.com,
under "Investors”.
A replay of the conference call will be accessible, approximately one
hour following the conclusion of the call, by dialing 888/286-8010 or
617/801-6888 and using the passcode 94837956. The replay will be
available through March 18. The webcast will be archived on the
Company’s website, www.emergentbiosolutions.com,
under "Investors”.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the
development, manufacture and commercialization of vaccines and
therapeutics that assist the body’s immune system to prevent or treat
disease. Emergent’s marketed product, BioThrax® (Anthrax
Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and
Drug Administration for the prevention of anthrax infection. Emergent’s
product pipeline targets infectious diseases and includes programs
focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional
information may be found at www.emergentbiosolutions.com.
Safe Harbor Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Any
statements, other than statements of historical fact, including
statements regarding our strategy, future operations, future financial
position, future revenues, projected costs, prospects, plans and
objectives of management, including any potential future securities
offering, our expected revenue growth and net earnings for 2010, and any
other statements containing the words "believes”, "expects”,
"anticipates”, "plans”, "estimates” and similar expressions, are
forward-looking statements. There are a number of important factors that
could cause the company’s actual results to differ materially from those
indicated by such forward-looking statements, including appropriations
for BioThrax® procurement; our ability to obtain new BioThrax®
sales contracts; our plans to pursue label expansions and improvements
for BioThrax®; our ability to win a development award with
the U.S. government for our recombinant protective antigen anthrax
vaccine candidate; our plans to expand our manufacturing facilities and
capabilities; the rate and degree of market acceptance and clinical
utility of our products; the success of our ongoing and planned
development programs, preclinical studies and clinical trials; our
ability to identify and acquire or in license products and product
candidates that satisfy our selection criteria; the potential benefits
of our existing collaboration agreements and our ability to enter into
selective additional collaboration arrangements; the timing of and our
ability to obtain and maintain regulatory approvals for our other
product candidates; our commercialization, marketing and manufacturing
capabilities and strategy; our estimates regarding expenses, future
revenue, capital requirements and needs for additional financing; and
other factors identified in the company’s Quarterly Report on Form 10-Q
for the quarter ended September 30, 2009 and subsequent reports filed
with the SEC. The company disclaims any intention or obligation to
update any forward-looking statements as a result of developments
occurring after the date of this press release.
Financial Statements Follow
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Emergent BioSolutions Inc. and Subsidiaries
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Consolidated Statements of Operations
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(in thousands, except per share data)
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Year Ended
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December 31,
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2009
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2008
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Revenues:
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Product sales
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$
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217,172
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$
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169,124
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Contracts and grants
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17,614
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9,430
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Total revenues
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234,786
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178,554
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Operating expense:
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Cost of product sales
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46,262
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34,081
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Research and development
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74,588
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59,470
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Selling, general and administrative
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73,786
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55,076
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Income from operations
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40,150
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29,927
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Other income (expense):
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Interest income
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1,418
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1,999
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Interest expense
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(7
|
)
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(47
|
)
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Other income (expense), net
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(50
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)
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134
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Total other income (expense)
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1,361
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2,086
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Income before provision for income taxes
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41,511
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32,013
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Provision for income taxes
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14,966
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12,055
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Net income
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26,545
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19,958
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Net loss attributable to noncontrolling interest
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4,599
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|
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724
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Net income attributable to Emergent BioSolutions Inc.
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$
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31,144
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$
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20,682
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Earnings per share -- basic
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$
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1.02
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$
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0.69
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Earnings per share -- diluted
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$
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0.99
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$
|
0.68
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Weighted-average number of shares -- basic
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30,444
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29,835
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Weighted-average number of shares -- diluted
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31,375
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30,458
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Emergent BioSolutions Inc. and Subsidiaries
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Consolidated Statements of Operations
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(in thousands, except per share data)
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Three Months Ended
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December 31,
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2009
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2008
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(Unaudited)
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Revenues:
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Product sales
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$
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47,160
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$
|
29,816
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Contracts and grants
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6,644
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5,934
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Total revenues
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53,804
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35,750
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Operating expense:
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Cost of product sales
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11,782
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6,870
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Research and development
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19,226
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14,162
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Selling, general and administrative
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18,671
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13,864
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Income from operations
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4,125
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|
854
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|
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Other income (expense):
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Interest income
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387
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|
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|
401
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Interest expense
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7
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|
|
|
(43
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)
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Other income (expense), net
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(22
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)
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(47
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)
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Total other income (expense)
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372
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311
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Income before provision for income taxes
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4,497
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1,165
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Provision for income taxes
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836
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4
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Net income
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3,661
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1,161
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Net loss attributable to noncontrolling interest
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573
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296
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Net income attributable to Emergent BioSolutions Inc.
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$
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4,234
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|
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$
|
1,457
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Earnings per share -- basic
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$
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0.14
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$
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0.05
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Earnings per share -- diluted
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$
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0.13
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$
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0.05
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Weighted-average number of shares -- basic
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30,808
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30,006
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Weighted-average number of shares -- diluted
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31,555
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31,375
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Emergent BioSolutions Inc. and Subsidiaries
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Consolidated Balance Sheets
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(in thousands, except share and per share data)
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December 31,
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December 31,
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2009
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2008
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
|
102,924
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$
|
91,473
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Accounts receivable
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54,872
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24,855
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Inventories
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13,521
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18,325
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|
Note receivable
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|
10,000
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|
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|
10,000
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Deferred tax assets, net
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|
1,870
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-
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Income tax receivable, net
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2,574
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-
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Restricted cash
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|
215
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|
|
208
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Prepaid expenses and other current assets
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7,838
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8,026
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Total current assets
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193,814
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|
152,887
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|
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Property, plant and equipment, net
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131,834
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124,656
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Assets held for sale
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13,960
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|
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|
-
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Deferred tax assets, net
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|
3,894
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|
|
|
12,073
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Other assets
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|
|
|
1,187
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|
|
|
1,172
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|
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Total assets
|
|
|
$
|
344,689
|
|
|
$
|
290,788
|
|
|
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LIABILITIES AND STOCKHOLDERS' EQUITY
|
|
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Current liabilities:
|
|
|
|
|
|
|
Accounts payable
|
|
|
$
|
17,159
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|
|
$
|
18,254
|
|
|
Accrued expenses and other current liabilities
|
|
|
|
1,570
|
|
|
|
1,399
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|
|
Accrued compensation
|
|
|
|
14,926
|
|
|
|
11,380
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|
|
Indebtedness under line of credit
|
|
|
|
15,000
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|
|
|
15,000
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|
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Long-term indebtedness, current portion
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|
|
|
5,791
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|
|
|
6,248
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|
|
Income taxes payable
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|
|
|
-
|
|
|
|
951
|
|
|
Deferred tax liabilities, net
|
|
|
|
-
|
|
|
|
557
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|
|
Deferred revenue
|
|
|
|
255
|
|
|
|
232
|
|
|
Total current liabilities
|
|
|
|
67,094
|
|
|
|
54,021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term indebtedness, net of current portion
|
|
|
|
44,927
|
|
|
|
35,935
|
|
|
Other liabilities
|
|
|
|
1,246
|
|
|
|
1,483
|
|
|
Total liabilities
|
|
|
|
100,874
|
|
|
|
91,439
|
|
|
|
|
|
|
|
|
|
|
|
|
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Commitments and contingencies
|
|
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|
-
|
|
|
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-
|
|
|
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|
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Stockholders' equity:
|
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|
|
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|
Preferred Stock $0.001 par value; 15,000,000 shares authorized;
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|
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0 shares issued and outstanding at December 31, 2009
|
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|
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|
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|
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and December 31, 2008, respectively
|
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|
|
-
|
|
|
|
-
|
|
|
Common Stock, $0.001 par value; 100,000,000 shares authorized;
|
|
|
|
|
|
|
|
|
30,831,360 and 30,159,546 shares issued and outstanding
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|
|
|
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|
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at December 31, 2009 and December 31, 2008, respectively
|
|
31
|
|
|
|
30
|
|
|
Additional paid-in capital
|
|
|
|
120,492
|
|
|
|
109,170
|
|
|
Accumulated other comprehensive loss
|
|
|
|
(1,476
|
)
|
|
|
(859
|
)
|
|
Retained earnings
|
|
|
|
122,152
|
|
|
|
91,008
|
|
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Total Emergent BioSolutions Inc. stockholders' equity
|
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|
|
241,199
|
|
|
|
199,349
|
|
|
Noncontrolling interest in subsidiary
|
|
|
|
2,616
|
|
|
|
-
|
|
|
Total stockholders' equity
|
|
|
|
243,815
|
|
|
|
199,349
|
|
|
Total liabilities and stockholders' equity
|
|
|
$
|
344,689
|
|
|
$
|
290,788
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Emergent BioSolutions Inc. and Subsidiaries
|
|
|
|
|
|
Consolidated Statements of Cash Flows
|
|
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
Year Ended
|
|
|
|
|
|
|
December 31,
|
|
|
|
|
|
|
2009
|
|
2008
|
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
Net income
|
|
$
|
26,545
|
|
|
$
|
19,958
|
|
|
|
Adjustments to reconcile to net cash provided by
|
|
|
|
|
|
|
operating activities:
|
|
|
|
|
|
|
|
Stock-based compensation expense
|
|
|
5,007
|
|
|
|
2,510
|
|
|
|
|
Depreciation and amortization
|
|
|
4,999
|
|
|
|
4,964
|
|
|
|
|
Deferred income taxes
|
|
|
7,604
|
|
|
|
2,006
|
|
|
|
|
Non-cash development expenses from joint venture
|
|
|
7,215
|
|
|
|
724
|
|
|
|
|
Loss (gain) on disposal of property and equipment
|
|
|
61
|
|
|
|
(135
|
)
|
|
|
|
Provision for impairment of long-lived assets
|
|
|
7,328
|
|
|
|
-
|
|
|
|
|
Excess tax benefits from stock-based compensation
|
|
|
(1,852
|
)
|
|
|
(1,336
|
)
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(30,017
|
)
|
|
|
(6,038
|
)
|
|
|
|
|
Inventories
|
|
|
6,207
|
|
|
|
(1,428
|
)
|
|
|
|
|
Income taxes
|
|
|
(3,525
|
)
|
|
|
(6,714
|
)
|
|
|
|
|
Prepaid expenses and other assets
|
|
|
(1,230
|
)
|
|
|
(4,949
|
)
|
|
|
|
|
Accounts payable
|
|
|
(1,334
|
)
|
|
|
(457
|
)
|
|
|
|
|
Accrued expenses and other liabilities
|
|
|
(66
|
)
|
|
|
(523
|
)
|
|
|
|
|
Accrued compensation
|
|
|
3,546
|
|
|
|
1,878
|
|
|
|
|
|
Deferred revenue
|
|
|
23
|
|
|
|
(3,143
|
)
|
|
|
|
|
Net cash provided by operating activities
|
|
|
30,511
|
|
|
|
7,317
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
Purchases of property, plant and equipment
|
|
|
(33,287
|
)
|
|
|
(20,813
|
)
|
|
|
Issuance of note receivable
|
|
|
-
|
|
|
|
(10,000
|
)
|
|
|
|
|
Net cash used in investing activities
|
|
|
(33,287
|
)
|
|
|
(30,813
|
)
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
Restricted cash release (deposit)
|
|
|
(7
|
)
|
|
|
4,992
|
|
|
|
Proceeds from borrowings on long-term indebtedness and line of credit
|
|
|
57,183
|
|
|
|
60,000
|
|
|
|
Issuance of common stock subject to exercise of stock options
|
|
|
4,464
|
|
|
|
3,391
|
|
|
|
Principal payments on long-term indebtedness and line of credit
|
|
|
(48,648
|
)
|
|
|
(60,751
|
)
|
|
|
Excess tax benefits from stock-based compensation
|
|
|
1,852
|
|
|
|
1,336
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
14,844
|
|
|
|
8,968
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
(617
|
)
|
|
|
271
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
11,451
|
|
|
|
(14,257
|
)
|
|
|
Cash and cash equivalents at beginning of period
|
|
|
91,473
|
|
|
|
105,730
|
|
|
|
Cash and cash equivalents at end of period
|
|
$
|
102,924
|
|
|
$
|
91,473
|
|
|
Supplemental disclosure of cash flow information:
|
|
|
|
|
|
|
Cash paid during the year for interest
|
|
$
|
1,627
|
|
|
$
|
3,216
|
|
|
|
Cash paid during the year for income taxes
|
|
$
|
15,155
|
|
|
$
|
16,788
|
|
|
Supplemental information on non-cash investing and financing
activities
|
|
|
|
|
|
|
Purchases of property, plant and equipment unpaid at year end
|
|
$
|
2,749
|
|
|
$
|
2,510
|
|
|
|
|
|
|
|
|
|
|
|
|
