BioSphere Medical, Inc. (NASDAQ: BSMD) (“BioSphere” or the “Company”) –
the pioneer in the use of bioengineered microspheres to treat uterine
fibroids, hypervascularized tumors and vascular malformations by a
minimally invasive, image-guided medical procedure called embolotherapy
– today reported financial results for the three and 12 months ended
December 31, 2009. Highlights of the fourth quarter of 2009 and
subsequent weeks include:
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Net loss per share was $0.02 for the fourth quarter of 2009, sharply
narrowed from a net loss per share of $0.09 for the fourth quarter of
2008
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Total worldwide revenue was $8.36 million for the fourth quarter of
2009, an increase of 16% over the same period in 2008
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Total U.S. revenue was $6.10 million, up 3% over the same period in
2008
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Total outside the U.S. (OUS) revenue was $2.26 million, an increase of
69% over the same period in 2008
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BioSphere filed an Investigational Device Exemption (IDE) in October
2009 with the U.S. Food and Drug Administration (FDA) and continues to
work with the FDA on finalizing the related clinical study protocol
for a planned pivotal trial of its QuadraSphere® Microspheres loaded
with doxorubicin for the treatment of primary liver cancer
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BioSphere conducted 51 Community Health Talks (CHTs) in partnership
with hospitals and interventional radiologists to raise awareness
among targeted patients of uterine fibroid embolization (UFE) as a
treatment option for women with symptomatic fibroids
Commentary
Richard Faleschini, BioSphere’s president and chief executive officer,
said, “In the fourth quarter of 2009, we saw significant growth in the
sale of our products used by interventional radiologists to treat
primary liver cancer. The 68% worldwide increase in sales was, we
believe, due largely to continued publications and podium presentations
by thought leaders of the results of their independent work in the use
of our embolics, both bland and drug eluting, for the treatment of liver
cancer. We are working closely with the FDA to obtain an approval for
our IDE for a planned pivotal study using QuadraSphere Microspheres
loaded with doxorubicin for the treatment of primary liver cancer. The
worldwide annual incidence of hepatocellular carcinoma, or HCC, is more
than 600,000, half of which cases are in China, and 20,000 of which
occur in the U.S. Based on the current scientific literature, we expect
the incidence of HCC to increase significantly in the next ten years.
The current market size and our expectations of growth in incidence make
the liver cancer market a key opportunity for BioSphere. Assuming FDA
approves our pivotal trial, we expect to treat approximately 200
patients at 16 sites in the U.S., EU, and Brazil, and the study will
compare QuadraSphere Microspheres loaded with doxorubicin with
conventional transarterial chemoembolization with doxorubicin, which is
the current standard of care. If the trial is successful, and we obtain
a premarket approval, or PMA, from the FDA, we expect that QuadraSphere
Microspheres would be the first FDA-approved device to treat
hepatocellular carcinoma using drug-eluting chemoembolization, which we
believe has the potential to be a significant value-creating event for
BioSphere.”
Mr. Faleschini continued, “In the fourth quarter of 2009, we continued
to scale up Community Health Talks (CHTs) in the U.S., which we believe
can increase UFE procedures over time. In the quarter we conducted 51
CHTs, up from 39 in the third quarter. A total of 119 CHTs were held in
2009, 75 of which were conducted after mid September. On average, our
studies indicate that there is a lag of five to eight months between
when a woman attends a CHT and has a UFE procedure done, if she elects
to have a UFE. Thus, UFE sales improved in Q4 compared to Q3, but did
not reach or exceed our high point achieved in Q2. We expect that the
full impact of 2009’s CHTs should be felt more throughout the first half
of this year. We believe CHTs can help to countervail the adverse impact
that the bad economic climate and consequential high rates of
unemployment and lapsing health insurance have had on UFE in the U.S.
Consequently, we plan to more than double the number of CHTs in 2010
compared with 2009, and as we continue to ramp up, they should have a
positive compounding effect going forward, assuming no further
deterioration of the U.S. economy. Moreover, on average, CHTs are cost
effective to run and yield more UFE procedures per dollar spent compared
with other direct-to-patient marketing programs. So, over time our
marketing spend should get more efficient if current metrics hold as we
scale up these activities,” he concluded.
Financial Results
Total worldwide revenue for the fourth quarter of 2009 was $8.36
million, an increase of 16%, compared with $7.24 million for the fourth
quarter of 2008. Worldwide revenue from sales of embolics and delivery
systems for the fourth quarter of 2009 was $8.27 million, up 17% from
$7.10 million in the prior year. Revenue from licensing and the Nippon
Kayaku distribution agreement was $0.09 million, compared to $0.10
million in the same period last year.
U.S. sales of embolics and delivery systems were $6.09 million in the
fourth quarter of 2009, up 5% from $5.79 million in the fourth quarter
of 2008. Revenue from embolics and delivery systems in Europe, the
Middle East and Africa (EMEA) in the fourth quarter of 2009 was $1.49
million, an increase of 39% (24% in local currency), compared with $1.07
million for the same period in 2008. The EMEA results for the fourth
quarter of 2009 include distributor stocking orders of approximately
$0.30 million from the required prenotification in our distributor
agreements of a HepaSphere™ Microsphere price increase, which took
effect in January 2010. In emerging markets outside of the United States
and EMEA, product revenue was up approximately threefold, to $0.69
million for the fourth quarter of 2009, compared with $0.23 million for
the same period in 2008. The People’s Republic of China and Brazil
accounted for much of the increase, with combined revenues of $0.55
million, compared with $0.12 million in the comparable quarter last year.
Gross profit rose to $6.29 million, or 75.2% of revenue, for the fourth
quarter of 2009, compared with gross profit of $5.47 million, or 75.6%
of revenue, for the fourth quarter of 2008. The slight decline in gross
profit margin reflects a mix shift to lower gross margin OUS sales
compared with the same quarter last year.