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These excerpts taken from the ANIK 10-Q filed May 4, 2009. Research and Development
Products in development include next generation joint health related products. Our next generation osteoarthritis products include a single-injection treatment product that uses a non-animal source HA, and is our first osteoarthritis product based on our proprietary crosslinked HA-technology. This product has been branded as MONOVISC. We received Conformité Européene (CE) Mark approval for the MONOVISC product in October 2007 and began sales in Europe during the second quarter of 2008, following a small, post marketing clinical study. In the U.S., we filed an Investigational Device Exemption, or an IDE application, with the FDA, and completed patient enrollment for our U.S. clinical trial in December of 2008. Our second single-injection osteoarthritis product is CINGAL, which is based on the same technology platform used in MONOVISC, with an added active therapeutic molecule to provide broad pain relief for a long period of time. We expect to commence a clinical study and file an application for CE Mark for CINGAL in 2009.
Research &
development. Research and development expenses for the quarter ended March 31, 2009 was
$2,194,308, an increase of $685,968, or 45.5%, compared to $1,508,340 for the
quarter ended March 31, 2008. Research
and development expenses for the three month period ended March 31, 2009 was
primarily related to our U.S.-based clinical trials for MONOVISC, U.S.-based
post-approval clinical trial for ELEVESS, as well as the development of our
next-generation osteoarthritis product, CINGAL.
The increases in research and development expenses for the three month
period ended March 31, 2009 from the same periods in 2008 was primarily
attributable to an increase in clinical trial expenses related to MONOVISC and ELEVESS
products, and development work related to CINGAL. We expect research and development expenses will increase in the future related to
next generation joint health products, ELEVESS line extension products, and
other research and development programs in the pipeline, but to decrease as a
percentage of revenue commencing in 2009.
These excerpts taken from the ANIK 10-K filed Mar 9, 2009. Research and Development Products in development include next generation joint health related products. Our next generation osteoarthritis products include a single-injection treatment product that uses a non-animal source HA, and is our first osteoarthritis product based on our proprietary crosslinked HA-technology. This product has 27 been branded as MONOVISC. We received CE Mark approval for the MONOVISC product in October 2007 and began sales in Europe during the second quarter of 2008, following a small, post marketing clinical study. In the U.S., we filed an investigational device exemption, or an IDE application, with the FDA, and completed patient enrollment for our U.S. clinical trial in December of 2008. Our second single-injection osteoarthritis product is CINGAL, which is based on the same technology platform used in MONOVISC, with an added active therapeutic molecule to provide broad pain relief for a long period of time. We expect to commence a clinical trial and file an application for CE Mark for CINGAL in 2009. Research and Development Products in development include next generation joint health related products. Our next generation osteoarthritis products include a 27 been Research and Development Research and development costs consists primarily of salaries and related expenses for personnel and fees paid to outside consultants and outside service providers, including costs associated with licensing, milestone and contract revenue. Research and development costs are expensed as incurred. Research and Development Research and development costs consists primarily of salaries and related expenses for personnel and fees paid to outside consultants This excerpt taken from the ANIK 10-Q filed Nov 6, 2008. Research &
development. Research and development expenses for the quarter ended September 30,
2008 were $1,801,561, an increase of $675,735, or 60.0%, compared to $1,125,826
for the quarter ended September 30, 2007. For the nine months ended September 30,
2008, research and development expenses were $4,954,520, an increase of
$1,985,302, or 66.9%, compared to $2,969,218 for the same period in 2007. Research
and development expenses for the three and nine month periods ended September 30,
2008 were primarily related to our U.S.-based clinical trials for MONOVISC, and
post-approval clinical studies for MONOVISC and ORTHOVISC mini
in Europe, manufacturing scale-up and related activities for MONOVISC and
ELEVESS, as well as the development of our next-generation osteoarthritis
product, CINGAL. The increases in
research and development expenses for the three and nine month periods ended September 30,
2008 from the same periods in 2007 were primarily attributable to an increase
in clinical trial expenses related to MONOVISC and ORTHOVISC products,
engineering related expenses for the scale up of MONOVISC for commercial sales
and additional headcount. We expect research and development expenses will increase in
the future related to next generation joint health products, ELEVESS line
extensions, and other research and development programs in the pipeline, but to
decrease as a percentage of revenue commencing in 2009.
This excerpt taken from the ANIK 10-Q filed Aug 8, 2008. Research & development. Research and development
expenses for the quarter ended June 30, 2008 were $1,644,619, an increase
of $648,568, or 65.1%, compared to $996,051 for the quarter ended June 30,
2007. For the six months ended June 30, 2008, research and development
expenses were $3,152,959, an increase of $1,309,567, or 71.0%, compared to
$1,843,392 for the same period in 2007. Research and development expenses for the three and
six month periods ended June 30, 2008 were primarily related to the
development of our next-generation osteoarthritis product, CINGAL; our
U.S.-based clinical trials for MONOVISC, and post-approval clinical studies for
MONOVISC and ORTHOVISC mini in Europe;
as well as manufacturing scale-up and related activities for MONOVISC and
ELEVESS. The increases in research and
development expenses for the three and six month periods ended June 30,
2008 from the same periods in 2007 were primarily attributable to an increase
in clinical trial expenses related to MONOVISC and ORTHOVISC products,
engineering related expenses for the scale up of MONOVISC for commercial sales
and additional headcount. We expect research and development expenses will increase in
the future related to next generation ORTHOVISC products, ELEVESS line
extensions, and other research and development programs in the pipeline.
This excerpt taken from the ANIK 10-Q filed May 7, 2008. Research &
development. Research and development
expenses for the quarter ended March 31, 2008 was $1,508,340, an increase
of $660,999, or 78.0%, compared to $847,341 for the quarter ended March 31,
2007. Research and development expenses include those costs associated with our
development of ELEVESS line extensions and next generation osteoarthritis
products, the costs of clinical trials and studies, manufacturing process
improvements, and the preparation and processing of applications for regulatory
approvals of current and developmental stage products. The increase in research
and development expenses during the first quarter of 2008 was primarily
attributable to an increase in clinical trial expenses related to ORTHOVISC
Mini and Monovisc products, engineering related expenses for the scale up of
Monovisc for commercial sales and additional headcount compared to 2007. We expect research and development expenses will increase in the future
related to next generation ORTHOVISC products, ELEVESS line extensions, and
other research and development programs in the pipeline.
These excerpts taken from the ANIK 10-K filed Mar 12, 2008. Research and Development Research and development costs consists primarily of salaries and related expenses for personnel and fees paid to outside consultants and outside service providers, including costs associated with licensing, milestone and contract revenue. Research and development costs are expensed as incurred. Research and Development Research and development costs consists primarily of salaries and related expenses for personnel and fees paid to outside consultants and outside service This excerpt taken from the ANIK 10-Q filed Nov 9, 2007. Research &
development. Research and
development expenses for the quarter ended September 30, 2007 was
$1,125,826, an increase of $220,537, or 24.4%, compared to $905,289 for the
quarter ended September 30, 2006. For the nine months ended
September 30, 2007, research and development expenses was $2,969,218, a
decrease of $142,740, or 4.6%, compared to $3,111,958 for the nine months ended
September 30, 2006. Research and development expenses include costs
associated with our development efforts for new products, the costs of animal
and biocompatibility studies, clinical trials, manufacturing process improvements,
and the preparation, filing and follow-up of applications for regulatory
approvals at various relevant stages of development. For the first nine months
of 2007, Research and development spending was focused on finalizing the long
term follow-up of our European trial for our ELEVESS product, finalizing
scale-up of ELEVESS manufacturing for commercial supply, as well as the
development of second-generation osteoarthritis products. The increase in
research and development expenses for the three months ended September 30,
2007 was primarily related to regulatory activities surrounding our second-generation
osteoarthritis products and development activities related to ELEVESS
manufacturing scale-up. The decrease in research and development expenses for
the nine months ended September 30, 2007 was primarily attributable to
modest spending on clinical trial expenses in the nine month period of 2007
compared to 2006. We expect increases in
21
research and development costs going forward related to the Company’s next generation osteoarthritis products, ELEVESS line extensions and other research and development programs in the pipeline.
This excerpt taken from the ANIK 10-Q filed Aug 7, 2007. Research &
development. Research
and development expenses for the quarter ended June 30, 2007 was $996,051, a
decrease of $133,826, or 11.8%, compared to $1,129,877 for the quarter ended
June 30, 2006. For the six months ended
June 30, 2007, research and development expenses was $1,843,392, a decrease of
$363,277, or 16.5%, compared to $2,206,669 for the six months ended June 30,
2006. Research and development expenses
include costs associated with our development efforts for new products, the
costs of animal and biocompatibility studies, clinical trials, manufacturing
process improvements, and the preparation, filing and follow-up of applications
for regulatory approvals at various relevant stages of development. Research
and development spending has been focused on finalizing the long term follow-up
of our European trial for our ELEVESS product, as well as the development of
second-generation osteoarthritis products. The decrease in research and
development expenses for the three and six month periods ended June 30, 2007 is
primarily attributable to modest spending on clinical trial expenses in the
three and six month periods of 2007 compared to 2006. We expect increases in research and
development costs going forward related to the Company’s next generation
osteoarthritis products, ELEVESS line extensions and other research and
development programs in the pipeline.
This excerpt taken from the ANIK 10-Q filed May 9, 2007. Research &
development. Research
and development expenses for the quarter ended March 31, 2007 was $847,341, a
decrease of $229,451, or 21.3%, compared to $1,076,792 for the quarter ended
March 31, 2006. Research
18 and development expenses include costs associated with our in-house research and development efforts for the development of new products, the costs of clinical trials and studies, manufacturing process improvements and the preparation and processing of applications for regulatory approvals at various relevant stages of development. Research and development spending has been focused on finalizing the long term follow-up of our European trial for our ELEVESS product, as well as the development of second-generation osteoarthritis products. The decrease in research and development expenses for the first quarter ended March 31, 2007 is primarily attributable to modest spending on clinical trial expenses in the first quarter of 2007 compared to 2006. We expect increases in research and development costs going forward related to the Company’s next generation osteoarthritis products, CD line extensions and other research and development programs in the pipeline. This excerpt taken from the ANIK 10-K filed Mar 13, 2007. Research and Development Research and development costs consists primarily of salaries and related expenses for personnel and fees paid to outside consultants and outside service providers, including costs associated with licensing, milestone and contract revenue. Research and development costs are expensed as incurred. 52 This excerpt taken from the ANIK 10-Q filed Nov 8, 2006. Research &
development. Research and development expenses for the quarter
ended September 30, 2006 was $905,289 a decrease of $73,231, or 7.5%, compared
to $978,520 for the quarter ended September 30, 2005. Research and development expenses for the
nine months ended September 30, 2006 was $3,111,958 a decrease of $525,942 or
14.5%, compared to $3,637,900 for the nine months ended September 30,
2005. Research and development expenses
include costs associated with our in-house research and development efforts for
the development of CTA product enhancements, next generation osteoarthritis
products, the costs of clinical trials, manufacturing process improvements, and
the preparation and processing of applications for regulatory approvals at
various relevant stages of development. The decrease in research and
development expenses for the three and nine months ended September 30, 2006 is
primarily attributable to the completion of the pivotal CTA clinical trial
during the fourth quarter of 2005, partially offset by costs related to a
smaller scale European follow-on CTA study commenced during the first quarter
of 2006, as well as recording of stock-based compensation expense of $61,919
and $183,212 for the three and nine month periods ended September 30, 2006, as
a result of adoption of SFAS 123R effective January 1, 2006. We expect increases in research and development
costs going forward related to the Company’s next generation ORTHOVISC
products.
This excerpt taken from the ANIK 10-Q filed Aug 7, 2006. Research &
development. Research and development expenses for the quarter
ended June 30, 2006 was $1,129,877 a decrease of $330,293, or 22.6%, compared
to $1,460,170 for the quarter ended June 30, 2005. Research and development expenses for the six
months ended June 30, 2006 was $2,206,669 a decrease of $452,710 or 17%,
compared to $2,659,379 for the six months ended June 30, 2005. Research and development expenses include
costs associated with our in-house research and development efforts for the
development of CTA product enhancements and next generation product for our
HA-based technology, the costs of clinical trials, and the preparation and
processing of applications for regulatory approvals at various relevant stages
of development. The decrease in research and development expenses for the three
and six months ended June 30, 2006 is primarily attributable to the completion
of the pivotal CTA clinical trial during the fourth quarter of 2005, partially
offset by costs related to a smaller scale European follow-on CTA trial
commenced during the first quarter of 2006, as well as recording of stock-based
compensation expense of $67,700 and $121,293 for the three and six month
periods ended June 30, 2006, as a result of adoption of SFAS 123R effective
January 1, 2006. We expect
increases in research and development costs going forward related to the
Company’s next generation ORTHOVISC products.
This excerpt taken from the ANIK 10-Q filed May 9, 2006. Research &
development. Research and development expenses for the quarter
ended March 31,
19 2006 was $1,076,792 a decrease of $122,417, or 10.2%, compared to $1,199,209 for the quarter ended March 31, 2005. Research and development expenses include costs associated with our in-house research and development efforts for the development of new medical applications for our HA-based technology, the costs of clinical trials, and the preparation and processing of applications for regulatory approvals at various relevant stages of development. The decrease in research and development expenses for the first quarter of 2006 is primarily attributable to the completion of the pivotal CTA clinical trial during the fourth quarter of 2005, partially offset by costs related to a smaller scale European follow-on CTA trial commenced during the first quarter of 2006, as well as recording of stock-based compensation expense of $53,893 as a result of adoption of SFAS 123R effective January 1, 2006. This excerpt taken from the ANIK 10-K filed Mar 9, 2006. Research and Development Research and development costs consists primarily of salaries and related expenses for personnel and fees paid to outside consultants and outside service providers, including costs associated with licensing, milestone and contract revenue. Research and development costs are expensed as incurred. This excerpt taken from the ANIK 10-Q filed Nov 7, 2005. Research & development.
Research and development expense for the quarter ended September 30,
2005 was $979,000 a decrease of $9,000, or 1%, compared to $988,000 for the
quarter ended September 30, 2004.
Research and development expense for the nine months ended September 30,
2005 was $3,638,000 an increase of $618,000, or 20%, compared to $3,020,000 for
the nine months ended September 30, 2004. Research and development expense
includes costs associated with our in-house research and development efforts
for the development of new medical applications for our HA-based technology,
the management of clinical trials, and the preparation and processing of
applications for regulatory approvals at various relevant stages of
development. The decrease for the
quarter was attributable to the winding down of costs in the third quarter
related to the pivotal clinical trial for our CTA product initiated in May
2004. For the nine months ended
September 30, 2005 versus the prior year comparable period, the increase in
research and development expenses is primarily attributable to expenditures
associated with the CTA trial and the pilot study for INCERT-S initiated in
April 2004, as well as engineering and scale-up activities in preparation for
the manufacture of our CTA product. We
expect research and development expenses will increase in the future related to follow on CTA clinical trials, next
generation ORTHOVISC products, and other research and development
programs in the pipeline.
This excerpt taken from the ANIK 10-Q filed Aug 8, 2005. Research
& development.
Research and development expense for the quarter ended June 30, 2005 was
$1,461,000 an increase of $336,000, or 30%, compared to $1,125,000 for the
quarter ended June 30, 2004. Research
and development expense for the six months ended June 30, 2005 was $2,660,000
an increase of $628,000, or 31%, compared to $2,032,000 for the six months
ended June 30, 2004. Research and development expense includes costs associated
with our in-house research and development efforts for the development of new
medical applications for our HA-based technology, the management of clinical
trials, and the preparation and processing of applications for regulatory
approvals at various relevant stages of development. The increase in research and development
expenses for the quarter is primarily attributable to expenditures associated
with the pivotal clinical trial for our product for cosmetic tissue augmentation
initiated in May 2004 and the pilot study for INCERT-S initiated in April
2004. The increase in research and
development expense is also driven by engineering and scale-up activities in
connection the CTA product.
This excerpt taken from the ANIK 10-Q filed May 10, 2005. Research
& development.
Research and development expenses for the quarter ended March 31,
2005 was $1,199,000 an increase of $292,000, or 32.2%, compared to $907,000 for
the quarter ended March 31, 2004.
Research and development expenses include costs associated with our
in-house research and development efforts for the development of new medical
applications for our HA-based technology, the management of clinical trials,
and the preparation and processing of applications for regulatory approvals at
various relevant stages of development.
The increase in research and development expenses for the quarter is
primarily attributable to expenditures associated with the pivotal clinical
trial for our product for cosmetic tissue augmentation initiated in May 2004
and the pilot study for INCERT-S initiated in April 2004. The first quarter of 2004 included initial
costs associated with the start-up of the clinical trials.
This excerpt taken from the ANIK 10-K filed Mar 16, 2005. Research and Development Research and development costs consists primarily of salaries and related expenses for personnel and fees paid to outside consultants and outside service providers. Research and development costs are expensed as incurred. | EXCERPTS ON THIS PAGE: |
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