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Fall 2012
                                                                                                                           www.bdo.com



Thought Leadership from the BDO technology and life sciences industry practice




                                                                                                      For more information on BDO USA’s
                                                                                                      service offerings to this industry
                                                                                                      vertical, please contact one of the
                                                                                                      following regional service leaders:


                                                                                                      Contact:
                                                                                                      Todd Berry
                                                                                                      Boston
                                                                                                      617- 239-4125
                                                                                                      tberry@bdo.com

                                                                                                      Tim Clackett
                                                                                                      Los Angeles
                                                                                                      310-557-8201
                                                                                                      tclackett@bdo.com


U.S. Biotechs Investing                                                                               Hank Galligan
                                                                                                      Boston


in R&D
                                                                                                      617-422-7521
                                                                                                      hgalligan@bdo.com

                                                                                                      Paul Heiselmann
                                                                                                      Chicago
                                                                                                      312-233-1876
   The BDO Biotech Briefing examined the most recent 10-K SEC filings of companies listed             pheiselmann@bdo.com
   on the NASDAQ Biotechnology Index. Companies reporting more than $300 million
   in revenue were excluded to ensure findings are representative of the vast majority of             Aftab Jamil
   companies included in the NASDAQ Index. Remaining companies were divided into                      Silicon Valley
   two groups—those with more than $50 million in revenue and those with less than $50                408-352-1999
   million in revenue—to identify trends and key metrics relevant to each group.                      ajamil@bdo.com

   The report has been cited in the following media outlets: Fierce Biotech, Mass High Tech, New      Ryan Starkes
   Jersey Business Journal, Pharma Times, Pharmalot and The Pharma Letter.                            Woodbridge
                                                                                                      732-734-1011
                                                                                                      rstarkes@bdo.com




A
                                                                                                      David Yasukochi
        s drug pipelines slow at the major          Not surprisingly, R&D expenditures in the
                                                                                                      Orange County
        pharma companies, biotech                   biotechnology industry grew five percent in       714-913-2597
        companies are increasingly becoming         2011, bouncing back after a decline the prior     dyasukochi@bdo.com
more relevant as acquisitions and research          year. According to a new study from BDO, on
partnerships are driving innovation.                average, biotech companies spent $50 million
Success for biotechs relies on research             on R&D in 2011, up from just over $47 million
and development (R&D) and the ability to            invested in 2010.
cultivate and commercialize the next big
discovery.


                                                                                         Read more
2     2012 BDO Biotech Briefing




    Aftab Jamil, partner and national director for BDO, told Mass High Tech that there was a great deal of concern
    last year when the industry decreased R&D spending for the first time in many years. This year’s data is evidence
    that the 2010 data may have been just a one-time drop.




The 2012 BDO Biotech Briefing, which
examined the most recent 10-K SEC filings         Biotech R&D Spend and Revenue Trends
of publicly traded companies listed on the
NASDAQ Biotechnology Index, found that            $160,000
the boost in R&D spending coincided with
                                                   140,000
a 24 percent rise in average revenues for
the industry. Average revenues for those           120,000
companies included in the BDO analysis
                                                   100,000
jumped to $76 million in 2011, up from
$62 million the year earlier. Large biotech         80,000
firms—those with revenues greater than $50
                                                    60,000
million—reported a 33 percent increase from
the previous year. Smaller biotech companies,       40,000
however, reported average revenues of $20
                                                    20,000
million, a 12 percent decline from 2010.
                                                         0
Indeed, 55 percent of smaller companies                          2009                            2010                             2011
increased their R&D spending in 2011,
                                                              Average Revenue (< $50M)                  Average R&D Spend (< $50M)
whereas two-thirds had trimmed spending the
                                                              Average Revenue (> $50M)                  Average R&D Spend (> $50M)
previous year. Sixty-six percent of large firms
boosted R&D spending last year. Six-in-ten
(60 percent) of all companies in the study
increased their investments in research and
development in 2011.

                                                   In April 2012, the government enacted the Jumpstart Our Business
u elative to Revenue,
 R                                                 Startups (JOBS) Act to encourage funding for small businesses by
Small Firms Splurge on                             easing securities regulations.
R&D                                                The Act is particularly encouraging for emerging biotech companies who can access
Smaller companies’ average R&D expenditure         capital markets with reduced regulatory requirements and can focus more their
of $38 million in 2011 remained virtually flat,    resources on mission critical R&D efforts. In essence, the JOBS Act should create an
showing just a one percent increase over the       easier “on-ramp” for biotech companies to generate funds to bring new drugs and
prior year. However, average R&D spending, as      other products to market faster.
a percentage of revenue, grew to 194 percent
for smaller companies, compared to 168             The JOBS Act also allows for larger corporate fundraising efforts by increasing the
percent a year earlier. As smaller companies       limit for securities offerings exempted under Regulation A from $5 million to $50
reduced their headcounts, the increase in R&D
                                                   million.
spending was even more pronounced. Larger
companies’ expenditures, on the other hand,
remained more consistent with 2010 levels,
falling slightly to 45 percent from 55 percent
the year before.
                                                                                                                                  Read more
2012 BDO Biotech Briefing          3




 Employment Holds
u                                                 Average Number of Employees
Strong at Large Firms
Despite persistently high unemployment                400
rates in the United States, biotech companies
                                                      350
showed a healthy increase in their employee
base, which grew 10 percent in 2011. Again,           300
though, gaps between large and small
                                                      250
companies remained. Larger companies
showed an employment increase of 16                   200
percent, while smaller companies reduced
                                                       150
their workforces by about three percent.
                                                       100

                                                       50
u pending Per Capita
 S                                                      0
Varies by Size                                                      2009                        2010                                2011
While overall R&D spending rose last year,                            Small biotechs (> $50M)               Large biotechs (< $50M)
expenditures per employee decreased by
five percent, to $233,000, for all companies
included in the BDO report. At larger biotech
companies, there was an eight percent decline
in average R&D spending per employee,
indicative of companies’ back-filling of sales,
marketing and administrative positions that
were hit hard over the past few years. In sharp   Average R&D Spend by Employee
contrast, smaller companies saw a 4.5 percent
increase in per-employee spending, another        $400,000
indication of the growing popularity of the
virtual biotech business model at emerging
                                                   300,000
companies.

Smaller companies spent significantly more         200,000
on R&D per employee—$337,000 in 2011—
compared to their larger counterparts, who         100,000
spent $188,000 per employee last year.
Overall, 65 percent of revenues were spent              0
on R&D expenses in 2011, highlighting the                          2009                         2010                                2011
critical nature of investments for innovation
and on the development of new drugs and                      Small biotechs (> $50 million)        Large biotechs (< $50 million)
technologies.




   “There are a lot of experienced people out in the marketplace still and they’re maybe choosing to not join on a
   full-time basis, but rather as a consultant,” Ryan Starkes partner and leader of BDO’s life sciences practice
   noted to NJBiz. “That’s enabling the companies to leverage their experience on a more focused basis.”



                                                                                                                                    Read more
4      2012 BDO Biotech Briefing




 Larger Companies Rely
u                                                 u maller Firms Show
                                                   S
on Cash, Small Firms                              Losses, but Liquidity
Turn to Capital Markets                           Remains Steady
Just 24 percent of large companies raised         Losses declined slightly in 2011 for biotech
equity financing in 2011, indicating a heavier    companies. Across the board, biotechs
reliance on cash generated from operations        reported an average loss of $32 million for
to fund R&D activities. Smaller companies         2011, compared to $34 million in 2010.
continued to rely on capital markets to help      Virtually all smaller companies in the
fund their R&D efforts, with 64 percent of        survey—90 percent—reported losses in 2011,
smaller biotech firms raising equity financing    in line with last year’s results.
at an average level of $64 million, compared
to $62 million the prior year. Among all firms,   Concurrently, firms maintained financial
those in need of financing chose equity twice     liquidity at levels fairly consistent with those
as often as debt, 40 percent compared to 19       of previous years. On average, companies held
percent, respectively. Companies raised an        2.63 years’ worth of R&D spending in liquid
average of $74 million in equity financing, up    assets in 2011, up slightly from 2.56 years’
significantly from the $68 million raised in      worth in 2010 and 2.23 years’ worth in 2009.
2010.
                                                  Firms continued to show signs of prudence
                                                  in fiscal policy and cash management,
                                                  holding $131 million in cash and short-term
    Financing for Small Biotechs                  investments in 2011, seven percent more
                                                  than they did the previous year. That rate
                                                  was consistent among both small and large
                                                  companies. For biotech companies, the
                                                  ability to fund research and development is a
                                                  mission-critical activity that spans multiple
                                                  years. Cash is a strategic asset and liquidity
          36%                                     is extremely important to support product
                                                  development efforts.

                                 64%
                                                  For many companies, cash generated through
                                                  operations is supplemented through public
                                                  and private equity and debt markets. Biotech
                                                  companies continue to show their remarkable
                                                  ability to attract such equity and debt
                                                  investments.

        Equity Financing

        Debt Financing




     “Funding challenges within the industry force developers to be more creative in terms of trial design, selection
     of secondary endpoints, etc. The days of a shotgun approach to finding out where your drug is most effective
     are gone. To succeed, developers need to take more of a risk sharing approach with contract research
     organizations and other service providers.” Christopher Lowe, Chief Business and Chief Financial Officer at
     Anthera Pharmaceuticals, Inc.
2012 BDO Biotech Briefing   5




   “I think there will be a continued trend of acquisitions of R&D companies. In the economic downturn,
   companies tended to trim back their R&D staff and opt more towards ‘purchased R&D.’” Anthony L. Alfonso,
   Senior Managing Director, BDO Consulting




u irtual Biotech
 V                                                  The concept of virtual biotech companies is
                                                    gaining momentum as well, particularly with
Business Model Gaining                              start-ups in certain biotech clusters. In these
Momentum                                            biotech clusters, such as Silicon Valley, the
Although the firms included in the study are        advent of more and more virtual companies
generally well-established public companies,        is leading to a greater percentage of money
innovative business models are being deployed       spent on R&D, instead of on payroll, which is
to use scarce resources strategically, several      boosting the overall picture.
data points suggest.

Aftab Jamil, partner and national director of
the Technology and Life Sciences Practice
at BDO, told FierceBiotech that younger
companies are relying more on specialized
contractors and consultants, as well as
outsourcing partners, to address specific needs
rather than hiring them on a full-time basis.




  Total Years’ Worth of R&D Spending in Liquid Assets




        2011




        2010




        2009



               2             2.1              2.2               2.3              2.4                  2.5   2.6           2.7
                                                                           Years
About the Technology & Life Sciences Practice at BDO USA, LLP
BDO has been a valued business advisor to technology and life sciences companies for over
100 years. The firm works with a wide variety of technology clients, ranging from multinational
Fortune 500 corporations to more entrepreneurial businesses, on myriad accounting, tax and
other financial issues.

About BDO USA

BDO is the brand name for BDO USA, LLP, a U.S. professional services firm providing assurance,
tax, financial advisory and consulting services to a wide range of publicly traded and privately
held companies. For more than 100 years, BDO has provided quality service through the active
involvement of experienced and committed professionals. The firm serves clients through
more than 40 offices and more than 400 independent alliance firm locations nationwide. As
an independent Member Firm of BDO International Limited, BDO serves multinational clients
through a global network of 1,118 offices in 135 countries.  

BDO USA, LLP, a Delaware limited liability partnership, is the U.S. member of BDO International
Limited, a UK company limited by guarantee, and forms part of the international BDO network
of independent member firms. BDO is the brand name for the BDO network and for each of the
BDO Member Firms. For more information, please visit: www.bdo.com. 
Material discussed is meant to provide general information and should not be acted on without professional advice
tailored to your firm’s individual needs.

To ensure compliance with Treasury Department regulations, we wish to inform you that any tax advice that may
be contained in this communication (including any attachments) is not intended or written to be used, and cannot
be used, for the purpose of (i) avoiding tax-related penalties under the Internal Revenue Code or applicable state or
local tax or (ii) promoting, marketing or recommending to another party any tax-related matters addressed herein.

© 2012 BDO USA, LLP. All rights reserved. www.bdo.com

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2012 Bdo Biotech Briefing

  • 1. Fall 2012 www.bdo.com Thought Leadership from the BDO technology and life sciences industry practice For more information on BDO USA’s service offerings to this industry vertical, please contact one of the following regional service leaders: Contact: Todd Berry Boston 617- 239-4125 tberry@bdo.com Tim Clackett Los Angeles 310-557-8201 tclackett@bdo.com U.S. Biotechs Investing Hank Galligan Boston in R&D 617-422-7521 hgalligan@bdo.com Paul Heiselmann Chicago 312-233-1876 The BDO Biotech Briefing examined the most recent 10-K SEC filings of companies listed pheiselmann@bdo.com on the NASDAQ Biotechnology Index. Companies reporting more than $300 million in revenue were excluded to ensure findings are representative of the vast majority of Aftab Jamil companies included in the NASDAQ Index. Remaining companies were divided into Silicon Valley two groups—those with more than $50 million in revenue and those with less than $50 408-352-1999 million in revenue—to identify trends and key metrics relevant to each group. ajamil@bdo.com The report has been cited in the following media outlets: Fierce Biotech, Mass High Tech, New Ryan Starkes Jersey Business Journal, Pharma Times, Pharmalot and The Pharma Letter. Woodbridge 732-734-1011 rstarkes@bdo.com A David Yasukochi s drug pipelines slow at the major Not surprisingly, R&D expenditures in the Orange County pharma companies, biotech biotechnology industry grew five percent in 714-913-2597 companies are increasingly becoming 2011, bouncing back after a decline the prior dyasukochi@bdo.com more relevant as acquisitions and research year. According to a new study from BDO, on partnerships are driving innovation. average, biotech companies spent $50 million Success for biotechs relies on research on R&D in 2011, up from just over $47 million and development (R&D) and the ability to invested in 2010. cultivate and commercialize the next big discovery. Read more
  • 2. 2 2012 BDO Biotech Briefing Aftab Jamil, partner and national director for BDO, told Mass High Tech that there was a great deal of concern last year when the industry decreased R&D spending for the first time in many years. This year’s data is evidence that the 2010 data may have been just a one-time drop. The 2012 BDO Biotech Briefing, which examined the most recent 10-K SEC filings Biotech R&D Spend and Revenue Trends of publicly traded companies listed on the NASDAQ Biotechnology Index, found that $160,000 the boost in R&D spending coincided with 140,000 a 24 percent rise in average revenues for the industry. Average revenues for those 120,000 companies included in the BDO analysis 100,000 jumped to $76 million in 2011, up from $62 million the year earlier. Large biotech 80,000 firms—those with revenues greater than $50 60,000 million—reported a 33 percent increase from the previous year. Smaller biotech companies, 40,000 however, reported average revenues of $20 20,000 million, a 12 percent decline from 2010. 0 Indeed, 55 percent of smaller companies 2009 2010 2011 increased their R&D spending in 2011, Average Revenue (< $50M) Average R&D Spend (< $50M) whereas two-thirds had trimmed spending the Average Revenue (> $50M) Average R&D Spend (> $50M) previous year. Sixty-six percent of large firms boosted R&D spending last year. Six-in-ten (60 percent) of all companies in the study increased their investments in research and development in 2011. In April 2012, the government enacted the Jumpstart Our Business u elative to Revenue, R Startups (JOBS) Act to encourage funding for small businesses by Small Firms Splurge on easing securities regulations. R&D The Act is particularly encouraging for emerging biotech companies who can access Smaller companies’ average R&D expenditure capital markets with reduced regulatory requirements and can focus more their of $38 million in 2011 remained virtually flat, resources on mission critical R&D efforts. In essence, the JOBS Act should create an showing just a one percent increase over the easier “on-ramp” for biotech companies to generate funds to bring new drugs and prior year. However, average R&D spending, as other products to market faster. a percentage of revenue, grew to 194 percent for smaller companies, compared to 168 The JOBS Act also allows for larger corporate fundraising efforts by increasing the percent a year earlier. As smaller companies limit for securities offerings exempted under Regulation A from $5 million to $50 reduced their headcounts, the increase in R&D million. spending was even more pronounced. Larger companies’ expenditures, on the other hand, remained more consistent with 2010 levels, falling slightly to 45 percent from 55 percent the year before. Read more
  • 3. 2012 BDO Biotech Briefing 3 Employment Holds u  Average Number of Employees Strong at Large Firms Despite persistently high unemployment 400 rates in the United States, biotech companies 350 showed a healthy increase in their employee base, which grew 10 percent in 2011. Again, 300 though, gaps between large and small 250 companies remained. Larger companies showed an employment increase of 16 200 percent, while smaller companies reduced 150 their workforces by about three percent. 100 50 u pending Per Capita S 0 Varies by Size 2009 2010 2011 While overall R&D spending rose last year, Small biotechs (> $50M) Large biotechs (< $50M) expenditures per employee decreased by five percent, to $233,000, for all companies included in the BDO report. At larger biotech companies, there was an eight percent decline in average R&D spending per employee, indicative of companies’ back-filling of sales, marketing and administrative positions that were hit hard over the past few years. In sharp Average R&D Spend by Employee contrast, smaller companies saw a 4.5 percent increase in per-employee spending, another $400,000 indication of the growing popularity of the virtual biotech business model at emerging 300,000 companies. Smaller companies spent significantly more 200,000 on R&D per employee—$337,000 in 2011— compared to their larger counterparts, who 100,000 spent $188,000 per employee last year. Overall, 65 percent of revenues were spent 0 on R&D expenses in 2011, highlighting the 2009 2010 2011 critical nature of investments for innovation and on the development of new drugs and Small biotechs (> $50 million) Large biotechs (< $50 million) technologies. “There are a lot of experienced people out in the marketplace still and they’re maybe choosing to not join on a full-time basis, but rather as a consultant,” Ryan Starkes partner and leader of BDO’s life sciences practice noted to NJBiz. “That’s enabling the companies to leverage their experience on a more focused basis.” Read more
  • 4. 4 2012 BDO Biotech Briefing Larger Companies Rely u  u maller Firms Show S on Cash, Small Firms Losses, but Liquidity Turn to Capital Markets Remains Steady Just 24 percent of large companies raised Losses declined slightly in 2011 for biotech equity financing in 2011, indicating a heavier companies. Across the board, biotechs reliance on cash generated from operations reported an average loss of $32 million for to fund R&D activities. Smaller companies 2011, compared to $34 million in 2010. continued to rely on capital markets to help Virtually all smaller companies in the fund their R&D efforts, with 64 percent of survey—90 percent—reported losses in 2011, smaller biotech firms raising equity financing in line with last year’s results. at an average level of $64 million, compared to $62 million the prior year. Among all firms, Concurrently, firms maintained financial those in need of financing chose equity twice liquidity at levels fairly consistent with those as often as debt, 40 percent compared to 19 of previous years. On average, companies held percent, respectively. Companies raised an 2.63 years’ worth of R&D spending in liquid average of $74 million in equity financing, up assets in 2011, up slightly from 2.56 years’ significantly from the $68 million raised in worth in 2010 and 2.23 years’ worth in 2009. 2010. Firms continued to show signs of prudence in fiscal policy and cash management, holding $131 million in cash and short-term Financing for Small Biotechs investments in 2011, seven percent more than they did the previous year. That rate was consistent among both small and large companies. For biotech companies, the ability to fund research and development is a mission-critical activity that spans multiple years. Cash is a strategic asset and liquidity 36% is extremely important to support product development efforts. 64% For many companies, cash generated through operations is supplemented through public and private equity and debt markets. Biotech companies continue to show their remarkable ability to attract such equity and debt investments. Equity Financing Debt Financing “Funding challenges within the industry force developers to be more creative in terms of trial design, selection of secondary endpoints, etc. The days of a shotgun approach to finding out where your drug is most effective are gone. To succeed, developers need to take more of a risk sharing approach with contract research organizations and other service providers.” Christopher Lowe, Chief Business and Chief Financial Officer at Anthera Pharmaceuticals, Inc.
  • 5. 2012 BDO Biotech Briefing 5 “I think there will be a continued trend of acquisitions of R&D companies. In the economic downturn, companies tended to trim back their R&D staff and opt more towards ‘purchased R&D.’” Anthony L. Alfonso, Senior Managing Director, BDO Consulting u irtual Biotech V The concept of virtual biotech companies is gaining momentum as well, particularly with Business Model Gaining start-ups in certain biotech clusters. In these Momentum biotech clusters, such as Silicon Valley, the Although the firms included in the study are advent of more and more virtual companies generally well-established public companies, is leading to a greater percentage of money innovative business models are being deployed spent on R&D, instead of on payroll, which is to use scarce resources strategically, several boosting the overall picture. data points suggest. Aftab Jamil, partner and national director of the Technology and Life Sciences Practice at BDO, told FierceBiotech that younger companies are relying more on specialized contractors and consultants, as well as outsourcing partners, to address specific needs rather than hiring them on a full-time basis. Total Years’ Worth of R&D Spending in Liquid Assets 2011 2010 2009 2 2.1 2.2 2.3 2.4 2.5 2.6 2.7 Years
  • 6. About the Technology & Life Sciences Practice at BDO USA, LLP BDO has been a valued business advisor to technology and life sciences companies for over 100 years. The firm works with a wide variety of technology clients, ranging from multinational Fortune 500 corporations to more entrepreneurial businesses, on myriad accounting, tax and other financial issues. About BDO USA BDO is the brand name for BDO USA, LLP, a U.S. professional services firm providing assurance, tax, financial advisory and consulting services to a wide range of publicly traded and privately held companies. For more than 100 years, BDO has provided quality service through the active involvement of experienced and committed professionals. The firm serves clients through more than 40 offices and more than 400 independent alliance firm locations nationwide. As an independent Member Firm of BDO International Limited, BDO serves multinational clients through a global network of 1,118 offices in 135 countries.   BDO USA, LLP, a Delaware limited liability partnership, is the U.S. member of BDO International Limited, a UK company limited by guarantee, and forms part of the international BDO network of independent member firms. BDO is the brand name for the BDO network and for each of the BDO Member Firms. For more information, please visit: www.bdo.com.  Material discussed is meant to provide general information and should not be acted on without professional advice tailored to your firm’s individual needs. To ensure compliance with Treasury Department regulations, we wish to inform you that any tax advice that may be contained in this communication (including any attachments) is not intended or written to be used, and cannot be used, for the purpose of (i) avoiding tax-related penalties under the Internal Revenue Code or applicable state or local tax or (ii) promoting, marketing or recommending to another party any tax-related matters addressed herein. © 2012 BDO USA, LLP. All rights reserved. www.bdo.com