"The biotech industry finished the year by giving back over
half the stellar gains earned by its 'blue chip' companies in
2005, a year in which they increased 22%, with the Burrill Biotech
Select Index closing 2006 down 14%," said G. Steven Burrill, CEO,
Burrill & Company, a San Francisco based global leader in life
sciences with principal activities in Venture Capital, Merchant Banking
and Media. "It could have been a lot worse because, by June, the
Index was down approximately 20%," noted Burrill, "but thanks
to product successes and strong third quarter financials, biotech's
leading market cap companies strengthened their share prices and posted
strong monthly performances to claw back some of the earlier reversals.
"Overall, it wasn't a great year for biotech and on
reflection it will finish the year almost as it started, with the
industry's collective market cap at approximately $490 billion.
Interestingly, we saw some stellar gains by individual large cap
companies such as Gilead and Vertex Pharmaceuticals (up 21% and 40%,
respectively year-to-date) that were balanced out by companies that
crashed and burned such as Neurocrine Biosciences (down 85%)," said
Burrill. "Neurocrine is part of the Burrill Biotech Select Index
and it contributed a significant portion to the group's loss in
value.
Although, biotech's blue chip companies were unable to sustain
their momentum in 2006, with Genentech and Amgen down 12% and 11%
year-to-date, it was the mid-cap and small-cap companies that carried
the load. The Burrill Mid-Cap Biotech Index was up 15% and the Burrill
Small-Cap Biotech Index performing almost as well, up 13% and these
increases mirrored the Dow, which was up a respectable 15%, and Nasdaq
up 11% for the year. Leading the way for the mid-caps was Illumina,
Inc., which has been one of Wall Street's "darlings" all
year with its stock value up a massive 186% since January, and New River
Pharmaceuticals Inc. up 115%. "Illumina also led the resurgence in
the technology, tools and genomics companies. We saw Millennium
Pharmaceuticals, Human Genome Sciences, Curagen and Celera Genomics all
post high double digit gains in their share prices year-to-date.
"The transition to a more personalized medicine world is
creating the need for molecular diagnostics, biomarkers, genotyping
assays, etc. and so companies specializing in these areas have received
positive investor attention," continued Burrill. "Sequenom,
for example, a provider of fine mapping genotyping, methylation and gene
expression analysis solutions, has seen its share price rocket 600%
since January.
"It has been that kind of year with interesting side bars but
no blockbuster stories, but stay tuned 2007 is shaping up to be one of
biotech's best if some of the products now near the regulatory goal
line get approved.
"While biotech's performance in the capital markets waxed
and waned throughout the year, at the mercy of prevailing macro-economic
forces, concern for Iraq, elections/politics, and about healthcare cost
increases, it was a big year for biotech/life sciences fund raising.
Financings and partnering deals brought in a record $40 billion for US
companies with over $25 billion through financings and $15 billion in
partnering capital."
"There were some bright spots for biotech during the year ...
and we saw some notable results from the November election," added
Burrill, "with 16 of the 19 Congressional races in which stem cells
were a divisive issue won on the stem cell side, and all of the
gubernatorial races also settled in favor of this issue."
"Most of our predictions for the industry's 2006
performance were accurate," added Burrill, "except our
expectation of a slightly better IPO market during the year, which like
2005 remained lukewarm," added Burrill.
Burrill's Predictions for Biotech in 2007
* Capital markets in the US will be more robust than 2006 and
biotech's elite companies will outperform the DJIA and Nasdaq.
* Biotech IPOs will pick up and improve on their lackluster numbers
during the past two years and over 30 IPOs will be completed in the US
(an increase of 50% over the 2006 number). At 2006 year-end, of the 71
biotech IPOs that completed since the window opened in 2003, 35 of them
were underwater. By the end of 4Q 07, most all will be trading above
their offer price.
* $40+ billion will be raised by the US biotechs; and the
industry's market cap will reach an all time high of $575B (a 15%
year-over- year increase)
* The M&A trends, that have been hot in 2005 and 2006 in
biotech land, will not slow down with pharma desperate to access
pipeline and innovation. Both big pharma and big biotech will be
competing for companies with advanced product pipelines, as well as
important land grabs of technology such as the $1.1B acquisition of
Sirna by Merck announced in November.
* There will be no slow down in partnering deals and a significant
portion of the $15 billion raised will be directed at gaining access to
technology at an earlier stage in its development as companies
strengthen their product indication franchises.
* We will see US biotechs accessing capital overseas...especially
on the public side...with Euronext and AIM leading the pack...but also
new structures will appear, which allow companies to float in Japan (on
Mothers) and other regional exchanges (Singapore, SWX, etc.).
* On the political front, it will be a tough year. The new Congress
has drug pricing in its cross hairs aiming to add power to Medicare to
negotiate what is pays for drugs. This has significant implications for
both biotech and pharma and drives them towards adding more products to
their pipelines with better economics...thus increasing their appetite
for acquisitions (good for biotechs), but Congress may reduce the
capital gains differential (bad for the capital raising side of the
industry).
* Drug safety will continue to be a major issue in the wake of the
Institute of Medicine's report on the subject. Regulators will take
a more proactive stance that will raise the bar for innovation and drug
approvals and pharmacovigilence will be the story.
* Other issues, which will dominate the 2007 political agenda
include: FDA reauthorization and NIH spending levels. We will see heated
debate on healthcare during the early campaign trail for the 2008
presidential election and this could have negative repercussions on the
industry in general.
* Sales of products will continue to increase and more biotech
companies will become profitable for the first time. In addition,
despite stricter regulatory oversight, we will see more companies bring
products to the marketplace.
* Stem cell progress will continue, with more funding emanating
from both public and private sources. There will be increased activity
at the state level as they encourage stem cell development locally.
* Biosimiliars will become more prevalent in Europe and pressure to
approve biogeneric pharmaceuticals will increase in the US ... and the
industry's protection through the manufacturing process will be
whittled away.
* Progress in biofuels will continue, as will the use of biotech in
industrialized settings, and significantly more capital will be raised
along with more immediate commercialization.
* Biotech will continue to become more global as companies,
particularly in the US, look to India and China for their manufacturing
needs and to conduct clinical trials.
Overall, biotechnology in 2007 will continue to fuel a major
transformation in healthcare -- one that emphasizes earlier disease
detection, more targeted treatments, and adjunctive support through
enhanced nutrition. We will see further progress on the personalized,
predictive, preventative front...with new products targeting the
"individualization" of medicine in the marketplace.
A look back at Burrill's Predictions about 2006
Capital Markets
Prediction: A reasonably robust public equity IPO market with 30+
IPOs completed in the U.S. and an even larger number internationally.
Outcome: The IPO market languished once again with only 18 biotech
IPOs managing to get done in the US in 2006 (so far ... although several
poised on the runway may get done before the end of the year), one more
than in 2005, but collectively raising approximately the same amount as
2005 ($800 million). To get done, almost all the offerings priced at the
low end of their pricing ranges or considerably lower.
Prediction: Biotech stocks in 2006 will continue to out perform
NASDAQ, DJIA and the pharma indices although biotech's performance
will be out of its direct control and in the hands of the macro-markets
(impacted by the price of oil, inflation, the war in Iraq, rising
interest rates, and corporate earnings in the non-biotech sector). This
may retard biotech's growth somewhat because overall the world
economy will not be as strong as it should be.
Outcome: Although biotech overall kept pace with the market, and
the industry's collective market cap finishing the year back to the
record level achieved in 2005, at $490 billion, it failed to outperform
it with the macro- markets taking their toll on investor confidence,
which saw them gravitate away from biotech into other industrial sectors
including energy.
Prediction: The industry will be able to raise over $35 billion in
2006, with approximately $25B from the public equity markets capital and
$10B in partnering.
Outcome: The biotech industry raised an estimated $40 billion in
financing (+$25 billion) and partnering ($15 billion) capital in the
U.S.
Mergers & Acquisitions/Partnering
Prediction: Increased big pharma consolidation, increased biotech
to big pharma consolidation, and increased biotech-to-biotech
consolidation.
Outcome: Pharma/biotech and biotech/biotech consolidation continued
to be red-hot as pharmas looked increasingly outside for pipeline and
access to innovation ... Major deals in the year included:
Big pharma/pharma: Bayer AG/Schering AG $19.9 billion Merck
KGaA/Serono $12.9 billion UCB/Schwartz Pharma $5.4 billion
Big pharma/biotech: Abbott/Kos $3.7 billion Eli Lilly/Icos $2.1
billion Merck/Sirna $1.1 billion
Biotech/biotech: Gilead/Myogen $2.5 billion Genentech/Tanox $900
million Illumina/Solexa $500 million Genzyme/AnorMED $560 million
Prediction: An improved partnering environment for biotechs with
even larger values attributed to earlier stage compounds (including
pre-clinical). Pharma partners earlier ...
Outcome: The over $15 billion garnered by biotech in 2006 equaled
the record set last year for partnering deals. Although
significant-sized discovery deals are nothing new, pharma focused rather
narrowly on identifying potential therapeutics to a single target or
pathway, rather than on numerous targets.
Challenging Regulatory Environment
Prediction: A more challenging regulatory environment.
Outcome: The industry continued to wrestle with improving its
productivity and ensuring product safety. These issues continued to keep
drug approvals down in 2006, with just 21 NME's and new biologic
license applications approved to date, comparable to the 22 in 2005 ...
and in an effort to improve the situation, the FDA continued to drive
its Critical Path Initiative agenda with personalized medicine firmly on
the radar screen pointing the industry towards an increased use of
pharmacogenomics and theranostics (diagnostics attached to therapeutics
to identify responding patient populations).
Stem cells dominate the technology story
Prediction: Increased progress with stem cells both scientifically
and economically, with more states joining the California focus on
funding stem cell research
Outcome: Subject of stem cells continued to dominate both the
science and the political agenda during 2006. Technology advanced abroad
while US politics served to create a not so ideal environment for
research and investment community domestically. President Bush used his
veto power in September for the first time since taking office, saying
that an embryonic stem-cell research bill "crossed a moral
boundary." The bill, which the Senate passed by a vote of 63-37
would have loosened the restrictions on federal funding for stem-cell
research. However, there was hope of the horizon since in Nancy's
Pelosi's first 100 hours reversal of the President's position
on stem cells is a key issue; although such reversal doesn't appear
to be veto-proof. Some notable results also came from the election with
16 of the 19 Congressional races in which stem cells were considered to
be a divisive issue were won on the stem cell side, and all of the
gubernatorial races also settled in favor of this issue.
Reimbursement - a "hot" issue
Prediction: More pressure from payers (managed care, CMS, various
country health ministries) resulting in more product bundling, more
personalized medicine, less "blockbusterology" (fewer
"one size fits all" drugs).
Outcome: The CMS Medicare part D enacted in November 2005 - brought
the debate on a government price controls system on the drug industry as
a whole into sharp focus. Payers have become more demanding of drug
companies to justify the cost of a drug with true clinical utility. To
the surprise of many, this program is working very well - seniors are
happy, pharma is happy and so is Medicare!
Biogenerics
Prediction: More approval of, and use of generics; the emergence of
biopharmaceutical generics.
Outcome: Many first-generation rDNA proteins are now off-patent,
leaving them open to generic competition. The April approval of
Sandoz's growth hormone somatropin (Omnitrope) in the European
Union and the US in May fueled speculation that there would be a wave of
biosimilar approval. This did not materialize and leading US biotech
company executives believe that it will be probably be many more years
before we see them on the market. The debate continues ... but they are
coming.
Globalization of biotech
Prediction: Increased growth of biotech internationally, especially
in the BRIC countries (Brazil, Russia, India, China), Japan, and
Scandinavia
Outcome: The predicted increase in the growth of biotech
internationally continued to take place in 2006 with China and India
leading the way.
About Burrill & Company
Founded in 1994, Burrill & Company is a San Francisco-based
global leader in life sciences with principal activities in Venture
Capital, Merchant Banking and Media. The company publishes an annual
book on the "State of the Industry" - the 21st Edition,
Biotech 2007-Life Sciences: A Global Transformation, will be available
in March 2006. Burrill also publishes a range of biotechnology/life
science newsletters and reports.
For more information, visit http://www.burrillandco.com or call
415/591-5474.
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