1) The document contains a "Safe Harbor Statement" noting that statements in the presentation contain forward-looking information and are subject to risks and uncertainties.
2) It discusses Impax Laboratories' positioning for future growth through its generic and branded platforms, established core competencies, and strong financial profile.
3) It provides an overview of Impax's two growth platforms - generics and brands, noting key areas of focus and pipeline products for each.
Deutsche Bank Health Care Conference May 30 2013impax-labs
Impax Laboratories provided a "Safe Harbor" statement noting that statements in the presentation involving the future are forward-looking and actual results could differ. Impax is committed to improving operations by addressing FDA issues, implementing quality enhancements, and moving in the right direction. The company is positioned for future growth through two platforms - generics targeting $25B in U.S. sales and brands focused on central nervous system conditions. Impax has a diversified generic pipeline, established competencies, and financial flexibility to support growth strategies including organic growth, partnerships, and M&A.
UBS Global Healthcare Conference May 22 2013impax-labs
- The document contains forward-looking statements about the company's future performance that involve known and unknown risks and uncertainties.
- The company has submitted responses to recent FDA observations and requested a meeting to ensure regulatory alignment. Significant improvements have been made to quality systems over the past two years.
- The company is committed to improving operations and moving in the right direction.
Jefferies Global Healthcare Conference June 5 2013impax-labs
This document contains a "Safe Harbor" statement regarding forward-looking statements in the presentation. It notes several risks and uncertainties that could cause the company's future results to differ from forward-looking statements, including economic conditions, issues raised by the FDA in warning letters and observations, developing and commercializing pharmaceutical products, reductions in business with significant customers, the impact of competition, and other regulatory, legal and operational risks. It also provides an overview of the company's generic and branded product pipelines and growth strategies focusing on organic growth, partnerships, and M&A.
The document is a presentation from Impax Laboratories' management at the Cowen and Company 34th Annual Health Care Conference on March 3, 2014.
In 3 sentences:
1) Impax Laboratories has leveraged its dual generic and brand business model and significant investments to drive 21% revenue growth over 7 years and create resources for business development and M&A.
2) The company is focused on growing its generic and brand pipelines through internal R&D, partnerships, and M&A, while continuing to implement a quality improvement program and commercialize new products.
3) Impax provided 2014 objectives including resolving its manufacturing warning letter, commercializing potential new generics, resubmitting its RYTARY N
Bank of America Merrill Lynch Healthcare ConferenceImpaxLaboratories
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly for alternative dosage forms, and mergers and acquisitions mainly for alternative dosage forms.
Bank of America Merrill Lynch Health Care Conferene May 16 2013impax-labs
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly in alternative dosage forms, and mergers and acquisitions mainly in alternative dosage forms.
Cowen & co health care conference march 2 2015impax-labs
- Impax provides a presentation summarizing its business, including an overview of its generic and branded pharmaceutical platforms, key areas of focus, and growth opportunities.
- It discusses its recent financial performance and growth, the approval and commercialization plans for its Parkinson's drug RYTARY, and a proposed acquisition of CorePharma that would expand its generic and branded portfolios.
- The presentation includes financial projections for RYTARY sales, pro forma financials assuming the CorePharma acquisition, and reconciliations of GAAP to non-GAAP financial metrics.
Impax Laboratories presented at the Cowen & Co Health Care Conference on March 6, 2013. They discussed their progress in improving quality operations and resolving FDA observations. They are committed to improving operations but have more work to do to fully address issues. Impax also outlined their strategy to create long-term growth through diversifying their generic product mix, building their branded neurology pipeline, and pursuing business development opportunities, supported by their strong financial position with $299 million in cash.
Deutsche Bank Health Care Conference May 30 2013impax-labs
Impax Laboratories provided a "Safe Harbor" statement noting that statements in the presentation involving the future are forward-looking and actual results could differ. Impax is committed to improving operations by addressing FDA issues, implementing quality enhancements, and moving in the right direction. The company is positioned for future growth through two platforms - generics targeting $25B in U.S. sales and brands focused on central nervous system conditions. Impax has a diversified generic pipeline, established competencies, and financial flexibility to support growth strategies including organic growth, partnerships, and M&A.
UBS Global Healthcare Conference May 22 2013impax-labs
- The document contains forward-looking statements about the company's future performance that involve known and unknown risks and uncertainties.
- The company has submitted responses to recent FDA observations and requested a meeting to ensure regulatory alignment. Significant improvements have been made to quality systems over the past two years.
- The company is committed to improving operations and moving in the right direction.
Jefferies Global Healthcare Conference June 5 2013impax-labs
This document contains a "Safe Harbor" statement regarding forward-looking statements in the presentation. It notes several risks and uncertainties that could cause the company's future results to differ from forward-looking statements, including economic conditions, issues raised by the FDA in warning letters and observations, developing and commercializing pharmaceutical products, reductions in business with significant customers, the impact of competition, and other regulatory, legal and operational risks. It also provides an overview of the company's generic and branded product pipelines and growth strategies focusing on organic growth, partnerships, and M&A.
The document is a presentation from Impax Laboratories' management at the Cowen and Company 34th Annual Health Care Conference on March 3, 2014.
In 3 sentences:
1) Impax Laboratories has leveraged its dual generic and brand business model and significant investments to drive 21% revenue growth over 7 years and create resources for business development and M&A.
2) The company is focused on growing its generic and brand pipelines through internal R&D, partnerships, and M&A, while continuing to implement a quality improvement program and commercialize new products.
3) Impax provided 2014 objectives including resolving its manufacturing warning letter, commercializing potential new generics, resubmitting its RYTARY N
Bank of America Merrill Lynch Healthcare ConferenceImpaxLaboratories
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly for alternative dosage forms, and mergers and acquisitions mainly for alternative dosage forms.
Bank of America Merrill Lynch Health Care Conferene May 16 2013impax-labs
- The document is a presentation by Impax Laboratories at a health care conference discussing its business strategies and outlook.
- Impax has two platforms for growth - generics targeting $25B in US sales and brands focused on central nervous system drugs.
- Its strategies include organic growth of its generic and brand pipelines, strategic partnerships mainly in alternative dosage forms, and mergers and acquisitions mainly in alternative dosage forms.
Cowen & co health care conference march 2 2015impax-labs
- Impax provides a presentation summarizing its business, including an overview of its generic and branded pharmaceutical platforms, key areas of focus, and growth opportunities.
- It discusses its recent financial performance and growth, the approval and commercialization plans for its Parkinson's drug RYTARY, and a proposed acquisition of CorePharma that would expand its generic and branded portfolios.
- The presentation includes financial projections for RYTARY sales, pro forma financials assuming the CorePharma acquisition, and reconciliations of GAAP to non-GAAP financial metrics.
Impax Laboratories presented at the Cowen & Co Health Care Conference on March 6, 2013. They discussed their progress in improving quality operations and resolving FDA observations. They are committed to improving operations but have more work to do to fully address issues. Impax also outlined their strategy to create long-term growth through diversifying their generic product mix, building their branded neurology pipeline, and pursuing business development opportunities, supported by their strong financial position with $299 million in cash.
33rd Annual J.P. Morgan Healthcare Conferenceimpax-labs
This document contains forward-looking statements about Impax Laboratories' presentation at the 33rd Annual J.P. Morgan Healthcare Conference on January 13, 2015. The summary discusses Impax's focus on quality improvements, commercial success in 2014, proposed acquisition of CorePharma, and multiple opportunities to drive growth through their generic pipeline, RYTARY, business development, and a strong balance sheet. The acquisition of CorePharma is highlighted as expanding Impax's generic and branded portfolios and pipeline while growing and diversifying its revenue base.
Impax Laboratories is focused on improving health through developing generic and branded pharmaceutical products. For generics, Impax has a portfolio of 45 applications pending FDA approval and 24 products under development, targeting high value opportunities. For brands, Impax's Parkinson's drug Rytary was filed for approval in 2012 and Phase II trials are underway for restless leg syndrome treatment IPX159. Impax also has drug delivery expertise and manufacturing expansion underway to support its growth initiatives.
Jp morgan 34th annual healthcare conferenceimpax-labs
Impax provides a cautionary statement regarding forward-looking statements in their presentation at the J.P. Morgan Healthcare Conference. They discuss key priorities for 2016 including maintaining quality and compliance across facilities, optimizing existing generic opportunities and launching up to 16 new generics, effectively utilizing an expanded specialty sales force, optimizing R&D through new product development, and pursuing value-enhancing business development opportunities including licensing for NUMIENT outside the US. Impax is well-positioned for future growth through their dual generic and specialty platforms and established core competencies.
Raymond james insitutional investors conference march 7 2016impax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future results.
2) Impax is well-positioned for future growth with a generic pipeline targeting $18B in sales and a specialty pipeline focused on next-generation opportunities.
3) Impax highlights its established competencies in generic and specialty commercialization, complex formulation and development expertise, and profitability to support growth.
Impax laboratories credit suisse conference nov 11 2014impax-labs
Impax provides a summary of its dual generic and branded business model, focusing on resolving FDA issues, maximizing both platforms, optimizing R&D, and accelerating business development. It highlights recent generic and branded product launches contributing over $190 million and the growth of Zomig Nasal Spray sales. Impax also outlines its reorganization of R&D to strengthen infrastructure, leverage internal strengths, improve efficiencies, and prioritize quality initiatives within scientific operations.
Impax provides concise summaries of forward-looking statements and highlights its focus on four key areas:
1) Continued focus on quality to resolve regulatory issues and gain approvals of generic products.
2) Maximization of its generic and specialty pharmaceutical platforms through pipeline of potential launches representing billions in sales.
3) Optimization of its generic research and development pipeline including first-to-file opportunities representing $19 billion in potential sales.
4) Pursuit of business development to accelerate growth including advancement of its next-generation brand pipeline programs.
Impax provides an overview of its growth strategy, operations, generic and branded businesses, and 2014 financial outlook. The company's growth strategy focuses on internal and external R&D opportunities, M&A, and business development to drive revenue growth. Key generic products launched in 2013 include oxymorphone ER and authorized generics of Zomig and Trilipix. The branded pipeline includes RYTARY for Parkinson's disease and a bupivacaine patch for postherpetic neuralgia. For 2014, Impax forecasts adjusted gross margins in the low 50% range and expenses of $82-88M for generic R&D and $36-39M for branded R&D.
Impax Announces Agreement to Acquire Generic Products - June 21, 2016impax-labs
Impax announces it has agreed to acquire a portfolio of 18 generic products from an undisclosed party for $586 million in cash. The acquisition expands Impax's portfolio of solid oral, injectable, inhalable, and topical generic drugs. It is expected to add $80 million in revenue and $50 million in EBITDA in the second half of 2016 and be immediately accretive to earnings per share. Impax provides updated 2016 financial guidance incorporating the acquisition, projecting at least 15% revenue growth over 2015 to over $860 million.
This document contains forward-looking statements from Impax Laboratories regarding their financial projections, product pipeline and opportunities for growth. Some of the key points include:
- Impax expects revenue growth from the commercialization of their Parkinson's drug RYTARY, with projections of $275-350M in US sales by 2019.
- Their generics division has 30-48% potential for first-to-file or first-to-market opportunities among pending ANDAs, with expected product launches in 2015 addressing $1.6B in total market sales.
- Following the acquisition of CorePharma, Impax estimates their revenue mix will shift to 75-80% generics and 20-25% branded products, divers
Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014impax-labs
Impax to acquire Tower Holdings Inc. and Lineage Therapeutics Inc. for $700 million in cash. The acquisition adds a portfolio of growing branded and generic products that are expected to generate $215-225 million in revenue and $80-85 million in EBITDA in 2014. The deal provides strategic benefits like diversifying Impax's product portfolio and expanding its manufacturing capabilities. It is also expected to be immediately accretive to Impax's earnings per share.
1) Impax reported financial results for the third quarter of 2016 with generic revenue down 3% year-over-year due to price erosion, partially offset by growth in epinephrine auto-injector and oxymorphone sales.
2) The company provided a business update on growing market share for key generic and brand products through marketing initiatives and new launches, while also facing challenges from industry-wide price declines.
3) Impax discussed its pipeline of generic opportunities and investments in research and development, focusing on expanding its central nervous system franchise and growing products like Rytary, Zomig nasal spray, and Emverm.
Cowen and Company 37th Annual Health Care Conference Presentationimpax-labs
Impax provides a forward-looking statement regarding risks and uncertainties for its business. It discusses various risks including fluctuations in revenues and operating income, reliance on key customers and products, supply chain risks, competition, product development risks, and regulatory risks. Impax also outlines steps it has taken to reduce costs and optimize operations, with estimated annual savings of $40-50 million by 2018. Its priorities for 2017 include focusing on quality, executing specialty product growth, maximizing generics profits, and exploring more efficiencies.
Impax Labs - 35th Annual JP Morgan Healthcare Conferenceimpax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future performance.
2) Impax operates both a generic pharmaceutical division and specialty pharmaceutical division focused on central nervous system disorders.
3) Impax is focusing on growth opportunities including product development and approvals, marketing execution, and business development activities while also improving operations and reducing debt.
Impax reported its fourth quarter and full year 2016 financial results. Revenue declined year-over-year due to continued pricing pressures and volatility in the generic drug market. The company reported a net loss for the year due to non-cash impairment charges related to intangible assets. Looking ahead, Impax expects the challenging market conditions to continue but believes its specialty drug portfolio and generic pipeline can drive growth. Key priorities for 2017 include reducing debt, improving efficiency, and investing in R&D and generic launches.
Bank of america merrill lynch 2014 health care conferenceimpax-labs
This document contains forward-looking statements from Impax Laboratories regarding their business strategies and goals. It discusses leveraging their dual generic and brand business model, with a focus on first-to-file generic opportunities and developing a portfolio of specialty branded products. It outlines their priorities of resolving FDA issues, optimizing brand and generic strategies, analyzing their product pipelines, and pursuing expansion opportunities through partnerships or acquisitions. The overall message is that Impax is positioned for future growth by leveraging their core competencies in generics and specialty brands.
Raymond james 38th annual institutional investor conferenceimpax-labs
Impax provides a summary of its business operations and growth priorities. It discusses its specialty pharmaceutical and generic drug portfolios, highlighting products that delivered strong growth in 2016 such as Rytary, Zomig Nasal Spray, and Albenza. Impax also summarizes its pipeline of generic ANDAs pending approval and in development, which could provide future growth opportunities. It reviews cost optimization efforts undertaken to reduce expenses and debt levels. Priorities for 2017 include focusing on quality, executing specialty product growth plans, maximizing profitability within generics, and continuing to diversify its product portfolio.
505 b 2 strategy and Rx to otc switch market overview = ishan shuklaIshan Shukla
This document discusses regulatory pathways for switching drugs from prescription to over-the-counter status, including submitting an efficacy supplement to an approved NDA for a full switch or an NDA for a partial switch. It lists potential drugs that could be candidates for Rx-to-OTC switches due to upcoming patent expiries, and provides examples of switches that have occurred since 2000 along with their first-year OTC sales figures.
Shire - Jefferies 2014 Global Healthcare ConferenceCompany Spotlight
This document provides an overview of Shire's strategy and performance in Q1 2014. Shire has repositioned itself around four focused business units and an integrated R&D organization to drive sustainable growth. In Q1 2014, Shire delivered strong results including 19% revenue growth, 41% EBITDA growth, and upgraded full-year guidance. Shire has leading positions in attractive therapeutic areas such as Rare Diseases, Neuroscience, and GI, and is pursuing a pipeline of innovative treatments.
Shire - The Path to US$10 Billion in Product Sales by 2020Company Spotlight
Shire outlines a plan to achieve $10 billion in product sales by 2020 through 10% compound annual growth rate. This will be achieved through growth of existing products, pipeline programs currently in development becoming commercialized, and potential additional M&A and licensing deals. Key elements of the plan include simplifying the organizational structure to focus on four commercial business units and one integrated R&D unit, improving operational efficiency through a cost savings program, and acquiring new products like Lifitegrast for dry eye disease and Maribavir for CMV infection in transplant patients. Shire believes this strategy will allow it to maintain leadership in rare diseases and deliver substantial shareholder value through 2020 and beyond.
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
Cowen Co Health Care Conference March 6 2013impax-labs
Impax Laboratories is committed to improving its quality operations and resolving an FDA warning letter. It has made significant improvements over the past two years through changes to quality management and increased quality staffing. However, more work remains to be done to complete its quality improvement program and address recent FDA observations. Impax is also focused on growing its generic and branded drug pipelines to target sustainable markets. It has established competencies in complex drug development and delivery and seeks to diversify its generic portfolio and build its neurology-focused branded pipeline.
The document discusses Impax Laboratories' strategy to grow through both generic and brand drug opportunities. For generics, Impax focuses on developing complex generic drugs that are difficult to formulate and can provide exclusivity opportunities. Impax has 45 generic drug applications pending FDA approval and 24 more in development. For brands, Impax is preparing to launch Rytary for Parkinson's disease in early 2013 and has IPX159 in Phase II trials for restless leg syndrome. Impax also has manufacturing facilities in Taiwan capable of supporting future growth.
33rd Annual J.P. Morgan Healthcare Conferenceimpax-labs
This document contains forward-looking statements about Impax Laboratories' presentation at the 33rd Annual J.P. Morgan Healthcare Conference on January 13, 2015. The summary discusses Impax's focus on quality improvements, commercial success in 2014, proposed acquisition of CorePharma, and multiple opportunities to drive growth through their generic pipeline, RYTARY, business development, and a strong balance sheet. The acquisition of CorePharma is highlighted as expanding Impax's generic and branded portfolios and pipeline while growing and diversifying its revenue base.
Impax Laboratories is focused on improving health through developing generic and branded pharmaceutical products. For generics, Impax has a portfolio of 45 applications pending FDA approval and 24 products under development, targeting high value opportunities. For brands, Impax's Parkinson's drug Rytary was filed for approval in 2012 and Phase II trials are underway for restless leg syndrome treatment IPX159. Impax also has drug delivery expertise and manufacturing expansion underway to support its growth initiatives.
Jp morgan 34th annual healthcare conferenceimpax-labs
Impax provides a cautionary statement regarding forward-looking statements in their presentation at the J.P. Morgan Healthcare Conference. They discuss key priorities for 2016 including maintaining quality and compliance across facilities, optimizing existing generic opportunities and launching up to 16 new generics, effectively utilizing an expanded specialty sales force, optimizing R&D through new product development, and pursuing value-enhancing business development opportunities including licensing for NUMIENT outside the US. Impax is well-positioned for future growth through their dual generic and specialty platforms and established core competencies.
Raymond james insitutional investors conference march 7 2016impax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future results.
2) Impax is well-positioned for future growth with a generic pipeline targeting $18B in sales and a specialty pipeline focused on next-generation opportunities.
3) Impax highlights its established competencies in generic and specialty commercialization, complex formulation and development expertise, and profitability to support growth.
Impax laboratories credit suisse conference nov 11 2014impax-labs
Impax provides a summary of its dual generic and branded business model, focusing on resolving FDA issues, maximizing both platforms, optimizing R&D, and accelerating business development. It highlights recent generic and branded product launches contributing over $190 million and the growth of Zomig Nasal Spray sales. Impax also outlines its reorganization of R&D to strengthen infrastructure, leverage internal strengths, improve efficiencies, and prioritize quality initiatives within scientific operations.
Impax provides concise summaries of forward-looking statements and highlights its focus on four key areas:
1) Continued focus on quality to resolve regulatory issues and gain approvals of generic products.
2) Maximization of its generic and specialty pharmaceutical platforms through pipeline of potential launches representing billions in sales.
3) Optimization of its generic research and development pipeline including first-to-file opportunities representing $19 billion in potential sales.
4) Pursuit of business development to accelerate growth including advancement of its next-generation brand pipeline programs.
Impax provides an overview of its growth strategy, operations, generic and branded businesses, and 2014 financial outlook. The company's growth strategy focuses on internal and external R&D opportunities, M&A, and business development to drive revenue growth. Key generic products launched in 2013 include oxymorphone ER and authorized generics of Zomig and Trilipix. The branded pipeline includes RYTARY for Parkinson's disease and a bupivacaine patch for postherpetic neuralgia. For 2014, Impax forecasts adjusted gross margins in the low 50% range and expenses of $82-88M for generic R&D and $36-39M for branded R&D.
Impax Announces Agreement to Acquire Generic Products - June 21, 2016impax-labs
Impax announces it has agreed to acquire a portfolio of 18 generic products from an undisclosed party for $586 million in cash. The acquisition expands Impax's portfolio of solid oral, injectable, inhalable, and topical generic drugs. It is expected to add $80 million in revenue and $50 million in EBITDA in the second half of 2016 and be immediately accretive to earnings per share. Impax provides updated 2016 financial guidance incorporating the acquisition, projecting at least 15% revenue growth over 2015 to over $860 million.
This document contains forward-looking statements from Impax Laboratories regarding their financial projections, product pipeline and opportunities for growth. Some of the key points include:
- Impax expects revenue growth from the commercialization of their Parkinson's drug RYTARY, with projections of $275-350M in US sales by 2019.
- Their generics division has 30-48% potential for first-to-file or first-to-market opportunities among pending ANDAs, with expected product launches in 2015 addressing $1.6B in total market sales.
- Following the acquisition of CorePharma, Impax estimates their revenue mix will shift to 75-80% generics and 20-25% branded products, divers
Impax acquires tower holdings inc and lineage therapeutics inc oct 9 2014impax-labs
Impax to acquire Tower Holdings Inc. and Lineage Therapeutics Inc. for $700 million in cash. The acquisition adds a portfolio of growing branded and generic products that are expected to generate $215-225 million in revenue and $80-85 million in EBITDA in 2014. The deal provides strategic benefits like diversifying Impax's product portfolio and expanding its manufacturing capabilities. It is also expected to be immediately accretive to Impax's earnings per share.
1) Impax reported financial results for the third quarter of 2016 with generic revenue down 3% year-over-year due to price erosion, partially offset by growth in epinephrine auto-injector and oxymorphone sales.
2) The company provided a business update on growing market share for key generic and brand products through marketing initiatives and new launches, while also facing challenges from industry-wide price declines.
3) Impax discussed its pipeline of generic opportunities and investments in research and development, focusing on expanding its central nervous system franchise and growing products like Rytary, Zomig nasal spray, and Emverm.
Cowen and Company 37th Annual Health Care Conference Presentationimpax-labs
Impax provides a forward-looking statement regarding risks and uncertainties for its business. It discusses various risks including fluctuations in revenues and operating income, reliance on key customers and products, supply chain risks, competition, product development risks, and regulatory risks. Impax also outlines steps it has taken to reduce costs and optimize operations, with estimated annual savings of $40-50 million by 2018. Its priorities for 2017 include focusing on quality, executing specialty product growth, maximizing generics profits, and exploring more efficiencies.
Impax Labs - 35th Annual JP Morgan Healthcare Conferenceimpax-labs
1) Impax provides a forward-looking statement regarding risks and uncertainties that could impact future performance.
2) Impax operates both a generic pharmaceutical division and specialty pharmaceutical division focused on central nervous system disorders.
3) Impax is focusing on growth opportunities including product development and approvals, marketing execution, and business development activities while also improving operations and reducing debt.
Impax reported its fourth quarter and full year 2016 financial results. Revenue declined year-over-year due to continued pricing pressures and volatility in the generic drug market. The company reported a net loss for the year due to non-cash impairment charges related to intangible assets. Looking ahead, Impax expects the challenging market conditions to continue but believes its specialty drug portfolio and generic pipeline can drive growth. Key priorities for 2017 include reducing debt, improving efficiency, and investing in R&D and generic launches.
Bank of america merrill lynch 2014 health care conferenceimpax-labs
This document contains forward-looking statements from Impax Laboratories regarding their business strategies and goals. It discusses leveraging their dual generic and brand business model, with a focus on first-to-file generic opportunities and developing a portfolio of specialty branded products. It outlines their priorities of resolving FDA issues, optimizing brand and generic strategies, analyzing their product pipelines, and pursuing expansion opportunities through partnerships or acquisitions. The overall message is that Impax is positioned for future growth by leveraging their core competencies in generics and specialty brands.
Raymond james 38th annual institutional investor conferenceimpax-labs
Impax provides a summary of its business operations and growth priorities. It discusses its specialty pharmaceutical and generic drug portfolios, highlighting products that delivered strong growth in 2016 such as Rytary, Zomig Nasal Spray, and Albenza. Impax also summarizes its pipeline of generic ANDAs pending approval and in development, which could provide future growth opportunities. It reviews cost optimization efforts undertaken to reduce expenses and debt levels. Priorities for 2017 include focusing on quality, executing specialty product growth plans, maximizing profitability within generics, and continuing to diversify its product portfolio.
505 b 2 strategy and Rx to otc switch market overview = ishan shuklaIshan Shukla
This document discusses regulatory pathways for switching drugs from prescription to over-the-counter status, including submitting an efficacy supplement to an approved NDA for a full switch or an NDA for a partial switch. It lists potential drugs that could be candidates for Rx-to-OTC switches due to upcoming patent expiries, and provides examples of switches that have occurred since 2000 along with their first-year OTC sales figures.
Shire - Jefferies 2014 Global Healthcare ConferenceCompany Spotlight
This document provides an overview of Shire's strategy and performance in Q1 2014. Shire has repositioned itself around four focused business units and an integrated R&D organization to drive sustainable growth. In Q1 2014, Shire delivered strong results including 19% revenue growth, 41% EBITDA growth, and upgraded full-year guidance. Shire has leading positions in attractive therapeutic areas such as Rare Diseases, Neuroscience, and GI, and is pursuing a pipeline of innovative treatments.
Shire - The Path to US$10 Billion in Product Sales by 2020Company Spotlight
Shire outlines a plan to achieve $10 billion in product sales by 2020 through 10% compound annual growth rate. This will be achieved through growth of existing products, pipeline programs currently in development becoming commercialized, and potential additional M&A and licensing deals. Key elements of the plan include simplifying the organizational structure to focus on four commercial business units and one integrated R&D unit, improving operational efficiency through a cost savings program, and acquiring new products like Lifitegrast for dry eye disease and Maribavir for CMV infection in transplant patients. Shire believes this strategy will allow it to maintain leadership in rare diseases and deliver substantial shareholder value through 2020 and beyond.
Regulatory Affairs Excellence: Staffing and Performance in Medical Device Com...Best Practices
Regulatory affairs group ensure that medical device companies comply with volatile regulatory environment pertaining to developing and marketing medical device products. These specialized groups rely on their own internal effectiveness and efficiencies for enhanced performance under stringent compliance norms. Also, optimal resourcing and staffing helps Regulatory Affairs groups in the medical device industry prioritize roles and responsibilities that will be most beneficial to growth.
Best Practices, LLC conducted this benchmarking study to establish meaningful metrics and insights around the structure, activities, roles and responsibilities of Regulatory Affairs groups at medical device companies. The study also provides recent spend and staffing trends of regulatory affairs in medical device sector, including the use of outsourcing and off-shoring.
Medical device regulatory leaders can use this study to align their staff as per strategies of best in class companies for an increased performance delivery.
Cowen Co Health Care Conference March 6 2013impax-labs
Impax Laboratories is committed to improving its quality operations and resolving an FDA warning letter. It has made significant improvements over the past two years through changes to quality management and increased quality staffing. However, more work remains to be done to complete its quality improvement program and address recent FDA observations. Impax is also focused on growing its generic and branded drug pipelines to target sustainable markets. It has established competencies in complex drug development and delivery and seeks to diversify its generic portfolio and build its neurology-focused branded pipeline.
The document discusses Impax Laboratories' strategy to grow through both generic and brand drug opportunities. For generics, Impax focuses on developing complex generic drugs that are difficult to formulate and can provide exclusivity opportunities. Impax has 45 generic drug applications pending FDA approval and 24 more in development. For brands, Impax is preparing to launch Rytary for Parkinson's disease in early 2013 and has IPX159 in Phase II trials for restless leg syndrome. Impax also has manufacturing facilities in Taiwan capable of supporting future growth.
Cowen & company health care conference march 7 2017 presentationimpax-labs
Impax provides a summary of its business operations and priorities for 2017. The company operates both specialty pharmaceutical and generic drug divisions. For its specialty division, Impax focuses on growing its Parkinson's drug Rytary and developing a next generation version. Its generic division has a diversified portfolio of 72 approved products and a pipeline of 43 potential products, including several opportunities for first-to-file or first-to-market generics. For 2017, Impax priorities include executing on specialty growth, maximizing generic profits, launching new generics, finding cost savings, and diversifying its portfolio.
Impax provides a summary of its business and priorities for 2017. It has a specialty pharmaceutical division focused on branded CNS products including Rytary for Parkinson's disease. Its generics division has a diversified portfolio of 72 commercial products. For 2017, Impax aims to focus on quality, execute growth initiatives for specialty products, maximize profits from generics, launch new generics, and further diversify and reduce expenses.
This document discusses ChromaDex's business model and forward-looking statements. It summarizes ChromaDex's goals to lead research in the natural products industry through its standards and analytical services business, gain market intelligence to identify new ingredient technologies, and commercialize novel proprietary ingredients. One such ingredient is pTeroPure, a clinically-studied pterostilbene ingredient from blueberries that ChromaDex has developed and monetized through various partnerships and clinical studies showing its benefits for lowering blood pressure.
Dr. Reddy's Laboratories provided an investor presentation at the Jefferies Global Healthcare Conference in 2016. The presentation contained 3 key sections:
1. An executive summary that outlined Dr. Reddy's strong financial performance over the past decade and optimistic future outlook driven by investments in proprietary products, biologics, and Aurigene.
2. A company overview section that described Dr. Reddy's integrated business model across global generics, pharmaceutical services and active ingredients, and proprietary products. It highlighted the company's industry-leading product development skills and vertically integrated infrastructure.
3. FY17 priorities that focused on accelerating growth in biologics and proprietary products, improving R&D productivity, strengthening
The document discusses ChromaDex's business model, which involves a legacy standards and analytical services business that provides market intelligence used to identify and acquire early-stage ingredient technologies. These technologies are developed and commercialized in multi-billion dollar markets like dietary supplements, food and beverage, cosmeceuticals, and pharmaceuticals. An example case study is provided on ChromaDex's acquisition, development, and commercialization of pterostilbene under the brand name pTeroPure, including a clinical study showing it significantly lowers blood pressure.
Impax third quarter 2017 earnings call presentation impax-labs
Impax reported third quarter 2017 results and provided a business update. Key points include:
- Revenues declined year-over-year due to lower generic pricing, but increased sequentially driven by cost savings initiatives. Adjusted EBITDA and EPS also increased quarter-over-quarter.
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- Phase 2b results for Parkinson's treatment IPX203 showed significant reduction in "off time" compared to an immediate-release competitor, supporting advancement to Phase 3.
- Impax remains on track or ahead of
The document is an investor presentation by Antares Pharma discussing its business and growth strategy. It summarizes that Antares has a diversified revenue mix from proprietary, partner, and development products. It achieved $184 million in revenue in 2021 and guides to $200-220 million in 2022. It is focusing on urology and endocrinology areas with innovative products like XYOSTED and NOCDURNA. XYOSTED is an once weekly testosterone injection that has seen growing prescription trends. The presentation outlines Antares' strategy to expand partnerships and its proprietary product portfolio to drive continued financial growth.
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shire-to-acquire-dyax-presentation-final-02-nov-2015Aaron Sato
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3. Positioned for Future Growth
Targeting
Sustainable
Generic and
Specialized
Brand Markets
Established
Core
Competencies
Strong and
Flexible
Financial Profile
3
Generic pipeline targeting $26B U.S. sales
Brand pipeline focused on Central Nervous System (CNS)
Solid platform on which to build long-term growth
Track record of complex formulation and development
Established drug delivery capabilities
Hatch-Waxman expertise and Paragraph IV successes
Diversifying Generic business product mix
Building a Branded business pipeline
Financial resources and flexibility to support growth
Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.
4. Two Platforms for Growth
Generic Platform
Unique targeted ANDAs
Branded Platform
Creating highly valued CNS products
• Solid Oral Dosage (SOD)
RYTARYTM – NDA pending approval
• Alternative Dosage Form (ADF)
Commercializing Zomig® in the U.S.
First-to-File/First-to-Market emphasis
Partnerships/M&A areas
Focusing on sustainable products
• Neurology
Partnerships/M&A primarily on ADFs
• Psychiatry
69 products pending at FDA or
under development
4
Note: Data as of October 2013.
Building a product pipeline
Developing strong IP positions
5. Strategy to Create Long Term Growth
Revenue Growth
Opportunities
Operational
Improvements
Diversifying Generic
Business product mix
Focusing on improving
quality and compliance
Focusing on building a
Brand pipeline
Right-sizing manufacturing
costs and capacity
Executing business
development and M&A
activities
Enhancing management
team across the company
Supported by financial resources and strong balance sheet:
approximately $437MM cash/cash equivalents and no debt
5
Note: Data as of September 30, 2013,.
6. Committed to Improving Our Operations
• Quality first culture
• Management and organization structure changes
• Initiated an internal Quality Improvement Program (QIP)
• Working aggressively to complete key aspects of the QIP
• Third-party experts continue to assist us with:
– Review of our manufacturing and quality systems
– Enhancing our systems and standards
• Committed to resolving all observations and exceeding
current Good Manufacturing Practice
6
7. Strategic Initiatives for Generic Growth
Focusing on…
Organic Growth
through SOD and
ADF Forms
Organic Growth
Partnership
Both Solid Oral &
Mainly in ADF
Alternative Dosage
Forms (ADF)
7
Strategic Partnerships
Primarily
in ADFs
Strategic M & A
M&A
MainlyPrimarily
in ADF
in ADFs
8. 2013 Generic Product Launches
January
Oxymorphone Hydrochloride ER tablets
5, 7.5, 10, 15, 20, 30 and 40 mg
May
Authorized generic Zomig® tablets
Authorized generic Zomig® Orally Disintegrating Tablets
2.5 and 5 mg
July
Authorized generic Trilipix® Delayed Release Capsules
45 and 135 mg
Shortly…
Solaraze® Gel 3%
8
9. Diversifying Currently Marketed Portfolio
47 Currently Marketed Products
Alternative
Dosage Form
19%
13
9
25
Other Solid Oral
53%
9
Note: Data as of October 2013.
Controlled-Release
Solid Oral
28%
10. Diversifying Generic Product Pipeline
69 Future Opportunities Pending at FDA or Under Development
$26B Current U.S. Brand/Generic Sales
42
4
27
22
15
16
Pending at FDA
19 Total ADF
28% of Pipeline
10
10
2
Under Development
32 Total C-R SO
46% of Pipeline
18 Total Other SO
26% of Pipeline
Note: Date as of October 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.
11. Strategic Initiatives for Brand Growth
Focusing on…
Organic Growth
through SOD and
ADF Forms
Organic Growth
Partnership
Mainly in
Primarily in ADF
Neurology Area
11
Partnerships
Neurology &
Psychiatry Areas
M&A
M&A
Neurology
Mainly in ADF &
Psychiatry Areas
(Products/Companies)
12. Building a Brand Product Pipeline
PROJECT
PHASE I OR POC
PHASE II
IPX232
IPX…
APPROVED
Parkinson’s Disease (carbidopa-levodopa)
RYTARYTM (a)
IPX231
REGISTRATION
Migraine
Zomig®
IPX203
PHASE III
Parkinson’s Disease
Parkinson’s Disease
Migraine
Exploratory Projects
(a) On Jan. 21, 2013, the Company announced the receipt of a complete response letter from the FDA indicating that the FDA required a
satisfactory re-inspection of the Company’s Hayward manufacturing facility before the RYTARY NDA may be approved. On March 4, 2013, the
Company announced the receipt of a Form 483 following an inspection of Hayward that may hold up approval of RYTARYTM, as analytical method
validation and a portion of the stability data were generated at the Hayward facility.
12
13. RYTARYTM (IPX066):
Carbidopa and Levodopa Extended-Release Capsule
PATENT
INFORMATION
DEC.
2011
FEB.
2012
JAN. 21,
2013(a)
THROUGHOUT
2013
RYTARY™ (IPX066) for the Symptomatic Treatment of Parkinson’s Disease
1st Patent Granted
Aug. 2006
Expires May 2022
2nd Patent Granted
Dec. 2008
Expires Dec. 2028
PDUFA Date
FDA
- Received
NDA Acceptance
Complete
of NDA
Filed
Response
Filing
Letter
Pre-launch planning
More than one million people in the U.S., with 50,000-60,000
new cases diagnosed each year in the U.S. alone
13
(a) On Jan. 21, 2013, the Company announced the receipt of a complete response letter from the FDA indicating that the FDA required a
satisfactory re-inspection of the Company’s Hayward manufacturing facility before the RYTARYTM NDA may be approved. On March 4,
2013, the Company announced the receipt of a Form 483 following an inspection of Hayward that may hold up approval of RYTARYTM,
as analytical method validation and a portion of the stability data were generated at the Hayward facility.
Source: National Parkinson’s Foundation. Parkinson’s Disease Overview
14. Continuing Our Commercial Success
Building relationships with neurologists since July 2006
Licensed exclusive U.S. commercialization rights to Zomig®
Began commercializing Zomig® in April 2012
o Tablet and ZMT patents expired May 2013
Continuing commercialization of Zomig® Nasal Spray
o Nasal Spray patent expires May 2021
Since Impax Promotion
April ’12 to Sept. ‘13
Nasal Triptan Market Share, National
80%
Sumatriptan
-5% decrease
70%
60%
50%
Zomig®
+17% increase
40%
30%
Imitrex®
-7% decrease
20%
10%
14
Source: IMS NPA Weekly
Sep-13
Aug-13
Jul-13
Jun-13
May-13
Apr-13
Mar-13
Feb-13
Jan-13
Dec-12
Nov-12
Oct-12
Sep-12
Aug-12
Jul-12
Jun-12
May-12
Apr-12
Mar-12
Feb-12
Jan-12
Dec-11
Nov-11
Oct-11
0%
15. Positioned for Future Growth
Targeting
Sustainable
Generic and
Specialized
Brand Markets
Established
Core
Competencies
Strong and
Flexible
Financial Profile
Generic pipeline targeting $26B U.S. sales
Brand pipeline focused on Central Nervous System (CNS)
Solid platform on which to build long-term growth
Track record of complex formulation and development
Established drug delivery capabilities
Hatch-Waxman expertise and Paragraph IV successes
Diversifying Generic business product mix
Building a Branded business pipeline
Financial resources and flexibility to support growth
15 Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended September 2013.