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:
- 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
- Total worldwide revenue was
$8.36 million for the fourth quarter of 2009, an increase of 16%
over the same period in 2008
- Total U.S. revenue was $6.10
million, up 3% over the same period in 2008
- Total outside the U.S. (OUS)
revenue was $2.26 million, an increase of 69% over the same period
in 2008
- 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
- 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.
Operating expense for the fourth quarter of 2009 was $6.77
million, compared with $7.05 million for the fourth quarter of
2008. Lower operating expense was primarily due to a significant
reduction in U.S. marketing expense as the Company shifted tactics
to more efficient local marketing programs from national
direct-to-consumer campaigns. Research and development expense was
also lower, as a milestone charge under the Company’s agreement
with DuPont of $0.20 million recorded in Q4 2008 was not incurred
in Q4 2009.
Operating loss for the fourth quarter of 2009 declined
significantly, to $0.49 million from $1.58 million in the same
period of 2008, a drop of 69%.
Foreign exchange gain for the fourth quarter of 2009 was $0.14
million compared with $0.05 million for the same period last year
due to the strengthening of the U.S. dollar against the euro, which
creates a translation benefit for the Company’s euro-denominated
intercompany accounts.
The Company recorded an income tax benefit of $0.05 million in
the fourth quarter of 2009 from the French economic stimulus
program.
The quarterly preferred stock dividend for the fourth quarter of
2009 was $0.15 million, unchanged from the fourth quarter of
2008.
Net loss applicable to common stockholders in the fourth quarter
of 2009 was $0.44 million, or $0.02 per share, improved 74%
compared with a net loss applicable to common stockholders in the
same period last year of $1.68 million, or $0.09 per share.
As of December 31, 2009, BioSphere had cash, cash equivalents
and marketable securities of $18.01 million, compared with $18.24
million as of December 31, 2008. During the fourth quarter of 2009,
BioSphere used only $0.48 million of cash, nearly operating cash
flow break even.
Sales by therapeutic area in the fourth quarter of 2009 were as
follows:
- Worldwide sales of embolics used
in interventional gynecology, or UFE, were $5.74 million, up 4%
over $5.55 million in the fourth quarter of 2008, which includes
U.S. sales of $4.71 million, an increase of 1%, and sales outside
of the U.S. of $1.03 million, an increase of 17%.
- Worldwide sales of embolics used
in interventional oncology rose 68% to $2.23 million compared with
the fourth quarter of 2008, which includes U.S. sales of $1.20
million, an increase of 21%, and sales outside of the U.S. of $1.03
million, an increase of 209%, with the bulk of this increase coming
from the People’s Republic of China, Brazil, and from distributors’
stocking orders in anticipation of a HepaSphere Microsphere price
increase in Europe.
- Worldwide sales of delivery
systems were $0.30 million, compared with $0.23 million in the
fourth quarter of 2008, which includes U.S. sales of $0.18 million
and sales outside of the U.S. of $0.11 million.
For the year ended December 31, 2009, total revenue was $31.44
million, compared with $29.26 million in the prior-year period, an
increase of 7%. Full-year 2008 revenue includes $0.82 million of
phased-out gastric product revenue. Excluding gastric products,
revenue for 2009 increased 11%. Net loss applicable to common
stockholders in 2009 was $3.25 million, or $0.18 per share,
compared with $6.07 million, or $0.34 per share, in 2008.
Conference Call and Webcast
The Company will host a conference call to discuss these results
and answer questions on February 11, 2010 beginning at 8:30 a.m.
Eastern Time. The dial-in number is 1-888-563-6275 (U.S./Canada) or
1-706-643-3137 (International), and the conference ID is 53823025.
The live webcast will be available in the “Investors” section of
BioSphere’s Web site at www.biospheremed.com. A replay of the
webcast will also be available at BioSphere’s Web site.
About BioSphere Medical, Inc.
BioSphere Medical, Inc. seeks to pioneer and commercialize
minimally invasive diagnostic and therapeutic applications based on
proprietary bioengineered microsphere technology. The Company's
core technologies, patented bioengineered polymers and
manufacturing methods, are used to produce microscopic spherical
materials with unique beneficial properties for a variety of
medical applications. BioSphere's principal focus is the use of its
products for the treatment of symptomatic uterine fibroids using a
procedure called uterine fibroid embolization, or UFE. The
Company's products continue to gain acceptance in this rapidly
emerging procedure, as well as in a number of other new and
established medical treatments.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including, without limitation, statements regarding: the size
and growth of the liver cancer market and the related business
opportunity; the Company’s plans and expectations with respect to
its IDE and planned pivotal trial of QuadraSphere Microspheres; and
the Company’s plans and expectations regarding its sales and
marketing strategies for UFE. The Company may use words such as
"plans," "seeks," "projects," "believes," "may," "anticipates,"
"estimates," “expects,” "should," "intends," "looking forward," and
similar expressions to identify these forward-looking statements.
These statements are subject to risks and uncertainties and are
based upon the Company's beliefs and assumptions. There are a
number of important factors that may affect the Company's actual
performance and results and the accuracy of its forward-looking
statements, many of which are beyond the Company's control and are
difficult to predict, including, without limitation, risks relating
to:
- the failure of the Company to
successfully develop, commercialize and achieve widespread market
acceptance of its products;
- the failure of the Company to
increase the rate of UFE procedures, and concomitant use of its
products for UFE, with its sales and marketing strategies;
- the failure of the Company to
achieve or maintain necessary regulatory approvals, either in the
United States or internationally, with respect to the development,
commercialization, manufacture and sale of its products and product
candidates, including, without limitation, the risk that the
Company will not gain necessary regulatory approvals to market and
sell its products in Japan through its agreement with Nippon
Kayaku, and risks related to the Company’s ability to successfully
obtain approval for and complete its planned pivotal clinical trial
of QuadraSphere Microspheres loaded with doxorubicin for the
treatment of primary liver cancer;
- delays and/or adverse results in
the Company’s planned QuadraSphere Microspheres clinical
trial;
- the Company’s ability to obtain
and maintain patent and other proprietary protection for its
products and product candidates;
- the absence of, or delays or
cancellations of, product orders;
- delays, difficulties or
unanticipated costs in the introduction of new products;
- competitive pressures;
- the risk of adverse outcomes in
product liability claims against the Company;
- the inability of the Company to
successfully execute on its plans and strategies for future growth,
including its plans to grow its business in both the UFE and
interventional oncology fields and its plans for international
growth;
- the inability of the Company to
raise additional funds in the near term to finance the development,
marketing, and sales of its products;
- general economic and market
conditions, both domestic and abroad; and
- risk factors described in the
section titled "Risk Factors" in the Company's Annual Report on
Form 10-K for the year ended December 31, 2008, and the Form 10-Q
for the quarter ended September 30, 2009, each as filed by the
Company with the Securities and Exchange Commission, and described
in other filings made by the Company from time to time with the
Securities and Exchange Commission.
In addition, the forward-looking statements included in this
press release represent the Company’s estimates as of the date of
this release. The Company anticipates that subsequent events and
developments may cause its forward-looking statements to change.
The Company specifically disclaims any obligation or intention to
update or revise these forward-looking statements as a result of
changed events or circumstances after the date of this press
release.
BioSphere Medical, Inc. SELECTED FINANCIAL
INFORMATION CONSOLIDATED
CONDENSED BALANCE SHEETS As of December 31, 2009 and
2008 (in thousands, unaudited) December
31, December 31, 2009 2008 ASSETS Cash,
cash equivalents and investments $ 18,088 $ 18,239 Accounts
receivable, net 5,183 4,729 Inventories 3,713 3,762 Prepaid
expenses and other current assets 639 663 Property and equipment,
net 829 989 Goodwill 1,443 1,443 Other assets 552 403
Total assets $ 30,447 $ 30,228 LIABILITIES AND
STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $ 6,028
$ 5,402 Deferred revenue 764 63 Capital lease obligations 8 17
Stockholders' equity 23,647 24,746 Total
liabilities and stockholders' equity $ 30,447 $ 30,228
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS For the
three and twelve months ended December 31, 2009 and 2008 (in
thousands, except per share amounts, unaudited)
Three Months Ended
Twelve Months Ended December 31, December 31,
2009 2008 2009 2008 Revenues $
8,362 $ 7,235 $ 31,443 $ 29,258 Costs and expenses: Cost of
revenues 2,076 1,764 7,682 7,686 Research and development 961 1,066
3,415 3,305 Sales 2,798 2,611 10,636 10,374 Marketing 1,132 1,642
5,243 6,514 General and administrative 1,677 1,582 7,058 6,499
Patent 205 152 781
705 Total costs and expenses 8,849
8,817 34,815 35,083
Loss from operations (487 ) (1,582 ) (3,372 ) (5,825 ) Other
income and expenses, net 141 50
40 462
Net loss before income
taxes (346 ) (1,532 ) (3,332 ) (5,363 ) Income tax
(provision) benefit 53 - 658
(129 ) Net Loss (293 ) (1,532 ) (2,674 ) (5,492 )
Preferred stock dividends (145 ) (145 ) (578 )
(578 ) Net loss applicable to common stockholders $
(438 ) $ (1,677 ) $ (3,252 ) $ (6,070 ) Net loss per common
share
Basic and diluted
$ (0.02 ) $ (0.09 ) $ (0.18 ) $ (0.34 ) Weighted average
common shares outstanding Basic and diluted 18,071
18,002 18,044 17,983
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