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.
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.
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.
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.
Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013impax-labs
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.
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.
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
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.
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.
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.
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.
Impax Laboratories Credit Suisse 2013 Healthcare Conference November 14, 2013impax-labs
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.
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.
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
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.
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.
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 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 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.
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.
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.
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 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.
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.
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.
Short-term financing options include negotiated financing, money market loans, spontaneous financing, accounts payable, accrued expenses, bank overdrafts, trade credit, and leasing. The types can have disadvantages like poor financial health perceptions and insufficient funds for long-term goals. Beximco Pharmaceuticals is an emerging generic drug player committed to affordable medicines. It has state-of-the-art facilities and consistently expands its product portfolio, currently producing over 500 medicines and differentiating itself. The company's short-term borrowings and accrued expenses increased from 2010 to 2015. Its current liabilities are higher than industry averages according to recent financial statements.
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.
This document provides an overview of the human resource practices and policies of Beximco Pharmaceuticals Limited, a leading pharmaceutical company in Bangladesh. It discusses Beximco's mission, vision, core values, organizational structure, departments, recruitment process, performance appraisals, training programs, compensation policies, and employee relations practices. The summary highlights that Beximco has over 500 pharmaceutical products and 2800 employees across 12 departments. It also outlines Beximco's focus on quality, customer satisfaction, and developing its people as reflected in its human resources policies and practices.
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.
This document discusses how pharmaceutical companies can improve clinical development and manufacturing processes through product lifecycle management (PLM). It identifies 7 key business processes for transforming R&D operations: 1) drug development program management, 2) regulatory archive management, 3) clinical trial management, 4) scale-up and commercial manufacturing, 5) quality management, 6) packaging and marketing asset management, and 7) global product registration. Implementing PLM using Oracle's solutions can deliver ROI by improving productivity, reducing time to market, and lowering development costs.
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.
This document provides a strategic analysis of Pfizer, a major bio-pharmaceutical company. It begins with a brief history of Pfizer, founded in 1849, and its evolution from producing food ingredients and medicines during the Civil War to developing antibiotics like penicillin and pharmaceutical drugs. The document discusses Pfizer's current leadership and top competitors like Novartis, Merck, and AstraZeneca. It analyzes Pfizer's mission and vision statements according to best practices. Finally, it presents an external factor evaluation matrix to examine opportunities and threats in Pfizer's external environment, identifying technology advancement as a key external factor for the company.
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 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.
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.
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 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 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.
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.
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.
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 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.
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.
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.
Short-term financing options include negotiated financing, money market loans, spontaneous financing, accounts payable, accrued expenses, bank overdrafts, trade credit, and leasing. The types can have disadvantages like poor financial health perceptions and insufficient funds for long-term goals. Beximco Pharmaceuticals is an emerging generic drug player committed to affordable medicines. It has state-of-the-art facilities and consistently expands its product portfolio, currently producing over 500 medicines and differentiating itself. The company's short-term borrowings and accrued expenses increased from 2010 to 2015. Its current liabilities are higher than industry averages according to recent financial statements.
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.
This document provides an overview of the human resource practices and policies of Beximco Pharmaceuticals Limited, a leading pharmaceutical company in Bangladesh. It discusses Beximco's mission, vision, core values, organizational structure, departments, recruitment process, performance appraisals, training programs, compensation policies, and employee relations practices. The summary highlights that Beximco has over 500 pharmaceutical products and 2800 employees across 12 departments. It also outlines Beximco's focus on quality, customer satisfaction, and developing its people as reflected in its human resources policies and practices.
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.
This document discusses how pharmaceutical companies can improve clinical development and manufacturing processes through product lifecycle management (PLM). It identifies 7 key business processes for transforming R&D operations: 1) drug development program management, 2) regulatory archive management, 3) clinical trial management, 4) scale-up and commercial manufacturing, 5) quality management, 6) packaging and marketing asset management, and 7) global product registration. Implementing PLM using Oracle's solutions can deliver ROI by improving productivity, reducing time to market, and lowering development costs.
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.
This document provides a strategic analysis of Pfizer, a major bio-pharmaceutical company. It begins with a brief history of Pfizer, founded in 1849, and its evolution from producing food ingredients and medicines during the Civil War to developing antibiotics like penicillin and pharmaceutical drugs. The document discusses Pfizer's current leadership and top competitors like Novartis, Merck, and AstraZeneca. It analyzes Pfizer's mission and vision statements according to best practices. Finally, it presents an external factor evaluation matrix to examine opportunities and threats in Pfizer's external environment, identifying technology advancement as a key external factor for the company.
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.
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.
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
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.
Valeant provided an update on its Q4 2014 operational highlights and guidance. It reported strong organic growth across most business units, with total company organic growth expected to be over 12% for Q4 and over 10% for the full year. It also made progress on its R&D pipeline and completed several business development deals. Valeant maintained its revenue guidance of $2.1-2.3 billion for Q4 but raised its cash EPS guidance to over $2.55 and reiterated its adjusted cash flow from operations guidance of approximately $600 million.
Regulatory affairs professionals ensure public health by controlling the safety and efficacy of products. They keep track of changing legislation and advise their company on legal and scientific requirements. They collect and evaluate scientific data, present registration documents to regulatory agencies, and obtain marketing authorization for products. A good regulatory affairs professional helps maximize resources and serves as the first point of contact between a company and government authorities.
MKT574 v1Strategic Marketing PlanMKT574 v1Page 3 of 10milissaccm
BPI Sports LLC is a nutritional supplement company based in Florida that focuses on products for muscle gain and bodybuilding. The company was established in 2010 and has 51-200 employees. It faces competition in the growing nutritional supplement industry from companies like FitFlex. A SWOT analysis identified strengths like customer loyalty but also weaknesses like a lack of FDA approval and limited brand recognition. The marketing objectives are to develop new products to attract more customers and increase profit margins.
This document provides an overview of Harvard Bioscience, Inc. including its history, global footprint, recent strategic moves, product segments and brands, commercial channels, the life science market, financial performance, guidance, and stock information. Key points include Harvard Bioscience's global operations, realignment to increase efficiencies and reinvest savings, focus on growth through commercial excellence, product development and acquisitions, and financial targets of maintaining 2014 revenue with improved earnings.
The document is a presentation from Impax Laboratories at the J.P. Morgan Healthcare Conference on January 7, 2013. It summarizes Impax's generic and branded drug pipelines targeting over $26 billion in generic sales and central nervous system conditions. It outlines Impax's core competencies in complex formulation and Hatch-Waxman experience. The presentation highlights Impax's financial strength with over $340 million in cash and no debt to support growth through their pipelines, partnerships, and M&A opportunities.
MKT574 v1Strategic Marketing PlanMKT574 v1Page 3 of 10.docxkendalfarrier
MKT/574 v1
Strategic Marketing Plan
MKT/574 v1
Page 3 of 10
Strategic Marketing PlanPart A: Environmental Analysis and SWOT Analysis
(Due in Wk 2)
Company Description
For the environmental and SWOT analysis, I selected BPI Sports LLC before making a strategic marketing plan. It is based in the United States, Hollywood, Florida. The line of products this company works on is nutritional supplements. It not only develops and formulates but also works on marketing nutritional supplements. Its mission is to deliver the highest quality nutritional supplements for muscle gain and bodybuilding to its consumers, which can optimally help them reach their fitness goals (Directory, 2021). The vision statement is based on the phrase "make a difference." They have the vision to formulate the best product to inspire and implement changes in the human physique. The company was established in 2010. It operates with 51 to 200 employees.
Environmental AnalysisCompetitive ForcesThe industry of nutritional supplements, whether it involves mineral/vitamin supplements or protein supplements, is on the rise and incrementing at the rate of 7.1%. This fact has attracted a lot of developers to establish their companies in the market, which has led to an increase in the competition. The main component to survive this completion is to gain the customers' loyalty. This can only be achieved through time. As people become more comfortable and dependent on a specific nutritional supplement, they tend to stay with the same brand instead of choosing another one. FitFlex Company is the biggest competitor of BPI sports in the nutritional supplement industry. BPI Sports is spending more resources to gain customer loyalty which is a beneficial factor as it provides an edge over FitFlex Company. Economic Forces
Economic issues have rendered the sales low, which has led to a low-profit margin for BPI sports. This economic issue was due to the factor of quarantine due to the COVID-19 pandemic. Political ForcesDuring the year 2016, elections were scheduled. It was predicted that the inflation rate would reach 1.7% (The Election’s Effect on Expected Inflation, n.d.). This increment in inflation caused a rise in the cost of manufacturing. Spending more revenue on manufacturing led to narrow profit margins. Legal, Regulatory, and Ethical IssuesThe food and drug administration (FDA) is a regulatory body that monitors the standards of nutritional supplements. It checks not only the manufacturing process but also the ingredients that are added to the supplements. Any issue, whether it is regulatory or ethical, can lead to serious legal charges. Technological ForcesThe technological issues faced by the company in the past have already been resolved involving the use of advanced formulation machinery in the developmental process. For online fitness programs, relevant technical support has also been established to face the pandemic-related issues. Social Forces
The social trend of relyin.
Strategic management - An Outlook on Growth strategyNeha Kalal
Strategic management involves formulating, implementing, and evaluating cross-functional decisions to achieve organizational objectives. The key stages are strategy formulation, implementation, and evaluation. Strategy formulation involves determining the vision, mission, external/internal analysis to identify strengths, weaknesses, opportunities, and threats. Implementation establishes objectives, policies, motivation, and resource allocation. Evaluation assesses performance and makes corrections. Strategic planning provides financial and non-financial benefits but some firms do not plan due to lack of knowledge, poor structures, or overconfidence. Sun Pharma grew through strategic acquisitions of companies and plants from 1996-2015 to expand globally and into new therapy areas.
Novartis announced a new organizational model to power its next phase of innovation, growth, and productivity. Key elements include:
1) Integrating Pharma and Oncology into a single Innovative Medicines business with separate US and International units to increase focus and drive synergies.
2) Combining strategy, portfolio management, and business development into a new Strategy & Growth function to strengthen the pipeline.
3) Forming a single Operations unit and integrating global G&A functions to realize economies of scale and productivity gains.
The changes aim to make Novartis more competitive, enhance operational efficiencies, and deliver high value medicines to support consistent above-peer growth.
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.
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.
3. Significant improvements in the past two years
– Quality first culture
– Management and organization structure changes
– Increased the headcount in quality and quality-related areas
– Initiated an internal Quality Improvement Program
• Identify necessary enhancements to Quality systems beyond
Warning Letter and Form 483 observations
– Implemented corrective actions and enhancements across all sites
– Taiwan inspected in July 2012 with no Form 483 observations
3
Committed to Improving Our Operations
Moving in the Right Direction…
Note: Data as of March 4, 2013.
4. Making significant progress in Quality Improvement Program
– Pre-identified some of the recent Form 483 observations
– Working aggressively to complete key aspects of the Quality
Improvement Program
– Ongoing work to identify and address improvement projects
– Work is in addition to responding to the Form 483 observations
Have the financial means to:
– Properly fund resources needed to resolve Form 483 observations
– Improve our operations globally
– Create a top notch manufacturing and quality operation
Promptly resolving the Warning Letter is our highest priority
4
Committed to Improving Our Operations
…But Have More Work to do
5. 5
Generic pipeline targeting $25B U.S. sales
Brand pipeline focused on Central Nervous System (CNS)
Solid platform on which to build long-term growth
Targeting
Sustainable
Generic and
Specialized
Brand Markets
Track record of complex formulation and development
Established drug delivery capabilities
Hatch-Waxman expertise and Paragraph IV successes
Established
Core
Competencies
Diversifying Generic business product mix
Building a Branded business pipeline
Financial resources and flexibility to support growth
Strong and
Flexible
Financial Profile
Note: All brand/generic product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.
Positioned for Future Growth
6. Two Platforms for Growth
6
Unique targeted ANDAs
• Solid Oral Dosage (SOD)
• Alternative Dosage Form (ADF)
First-to-File/First-to-Market emphasis
Focusing on sustainable products
Partnerships/M&A primarily on ADFs
75 products pending at FDA or
under development
Creating highly valued CNS products
RYTARYTM – NDA pending approval
Commercializing Zomig® in the U.S.
Partnerships/M&A areas
• Neurology
• Psychiatry
Building a strong product pipeline
Developing strong IP positions
Note: Data as of February 8, 2013.
Generic Platform Branded Platform
7. Strategy to Create Long Term Growth
7
Revenue Growth
Opportunities
Diversifying Generic
Business product mix
Focusing on building a
strong Brand pipeline
Executing business
development and M&A
activities
Operational
Improvements
Focusing on improving
quality and compliance
Right-sizing manufacturing
costs and capacity
Enhancing management
team across the company
Supported by financial resources and strong balance sheet:
approximately $299MM cash/cash equivalents and no debt
Note: Data as of December 31, 2012
8. Strategic Initiatives for Generic Growth
Organic Growth
through SOD and
ADF Forms
Partnership
Mainly in ADF
M&A
Mainly in ADF
8
Focusing on…
Organic Growth
Both Solid Oral &
Alternative Dosage
Forms (ADF)
Strategic Partnerships
Primarily
in ADFs
Strategic M & A
Primarily
in ADFs
9. 2008 2009 2010 2011 2012
4 4
20
1
1 5
5
9Currently Marketed
Pending at FDA
Under Development
9
34
Growing Alternative Dosage Form Portfolio
ADF Products Offer Potential Market Sustainability
9
Cumulative Growth of Partnership and Internal/Hybrid ADF Projects
Note: Date as of February 8, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.
5
0
25 Future Opportunities are ADFs
A number of them still FTF/FTM opportunities
$4B Current U.S. Brand/Generic Sales
1
10. Pending at FDA Under Development
19
26
5
5
20
Other Solid Oral Controlled-Release Solid Oral Alternative Dosage Form
10
Diversifying Generic Product Pipeline
75 Future Opportunities Pending at FDA or Under Development
$25B Current U.S. Brand/Generic Sales
50
25
25 Total ADF
33% of Pipeline
31 Total C-R SO
42% of Pipeline
19 Total Other SO
25% of Pipeline
Note: Date as of February 8, 2013. All product sales data included herein are derived from data published by IMS for the 12 months ended January 2013.
11. Strategic Initiatives for Brand Growth
Organic Growth
through SOD and
ADF Forms
Partnership
Mainly in ADF
M&A
Mainly in ADF
11
Focusing on…
Organic Growth
Primarily in
Neurology Area
Partnerships
Neurology &
Psychiatry Areas
M & A
Neurology &
Psychiatry Areas
(Products/Companies)
12. Building a Brand Product Pipeline
Migraine
Parkinson’s Disease (carbidopa-levodopa)
Epilepsy
PHASE I OR POC PHASE II PHASE III REGISTRATION APPROVEDPROJECT
Zomig®
RYTARYTM (a)
IPX218
IPX203
IPX231
IPX232
IPX…
Parkinson’s Disease
Parkinson’s Disease
Migraine
12
(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.
Exploratory Projects
13. RYTARYTM (IPX066): Preparing for Launch
Carbidopa and Levodopa Extended-Release Capsule
13
DEC.
2011
FEB.
2012
THROUGHOUT
2012 - 2013
NDA
Filed
Pre-launch planning
Building sales &
marketing team
Conducting pre-launch
activities
FDA
Acceptance
of NDA
Filing
PDUFA Date
- Received
Complete
Response
Letter
JAN. 21,
2013(a)
1st Patent Granted
Aug. 2006
Expires May 2022
2nd Patent Granted
Dec. 2008
Expires Dec. 2028
PATENT
INFORMATION
(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
More than one million people in the U.S., with 50,000-60,000
new cases diagnosed each year in the U.S. alone
RYTARY™ (IPX066) for the Symptomatic Treatment of Parkinson’s Disease
14. Investments Drove Revenue Growth
2004 2005 2006 2007 2008 2009 2010 2011 2012
$91 $112 $135
$274
$210
$358
$683
$513
$573
Created Significant Resources to Fund Business Development and M&A
Financial Flexibility = $299MM in cash/cash equivalents and NO DEBT
Note: $299MM cash and cash equivalents as of December 31, 2012.
Annual revenues as reported (GAAP) except:
2010 which excludes $196MM due to a change in revenue recognition under the Teva Agreement.
2012 which excludes $9MM due to a change in revenue recognition under the OTC Partner Agreement.14
$ millions
26% 8-Year CAGR
15. 15
Generic pipeline targeting $25B U.S. sales
Brand pipeline focused on Central Nervous System (CNS)
Solid platform on which to build long-term growth
Targeting
Sustainable
Generic and
Specialized
Brand Markets
Track record of complex formulation and development
Established drug delivery capabilities
Hatch-Waxman expertise and Paragraph IV successes
Established
Core
Competencies
Diversifying Generic business product mix
Building a Branded business pipeline
Financial resources and flexibility to support growth
Strong and
Flexible
Financial Profile
Note: All brand/generic product sales data included herein are derived from data published by Wolters Kluwer Health for the 12 months ended October 2012.
Positioned for Future Growth