ANIK » Topics » Research & development

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


Table of Contents


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
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









HREF="#bg47301a_main_toc">Table of Contents






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

        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 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 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
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 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.

Wikinvest © 2006, 2007, 2008, 2009, 2010, 2011, 2012. Use of this site is subject to express Terms of Service, Privacy Policy, and Disclaimer. By continuing past this page, you agree to abide by these terms. Any information provided by Wikinvest, including but not limited to company data, competitors, business analysis, market share, sales revenues and other operating metrics, earnings call analysis, conference call transcripts, industry information, or price targets should not be construed as research, trading tips or recommendations, or investment advice and is provided with no warrants as to its accuracy. Stock market data, including US and International equity symbols, stock quotes, share prices, earnings ratios, and other fundamental data is provided by data partners. Stock market quotes delayed at least 15 minutes for NASDAQ, 20 mins for NYSE and AMEX. Market data by Xignite. See data providers for more details. Company names, products, services and branding cited herein may be trademarks or registered trademarks of their respective owners. The use of trademarks or service marks of another is not a representation that the other is affiliated with, sponsors, is sponsored by, endorses, or is endorsed by Wikinvest.
Powered by MediaWiki