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.
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.
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.
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 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 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 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.
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.
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 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.
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.
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 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 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 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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
What to Learn from US FDA Warning Letters and Their Impact on Pharmacovigilan...Covance
Drug safety and pharmacovigilance (PV) are paramount to the development of new drugs and the continued use of approved medications. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Karl-Ludwig Kley, CEO and Marcus Kuhnert, CFO held Merck's annual press conference on March 8, 2016 to report on the company's financial results for 2015. Merck achieved stronger results in 2015 with net sales increasing 7.1% to €12.8 billion and EBITDA pre growing 13% to €3.6 billion. All business segments saw organic sales growth with particularly strong growth in Asia-Pacific, Latin America, and the Middle East and Africa. Merck also successfully integrated the Sigma-Aldrich acquisition which closed in November 2015. Looking ahead, Merck expects continued growth driven by its existing businesses and progress in its pipeline.
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.
Valeant held an investor conference call to discuss its relationship with Philidor RX Services, LLC, a specialty pharmacy. Valeant had a pilot program with Philidor starting in 2012 and obtained an option to acquire Philidor in January 2013. Philidor's network grew substantially since then and represented 6.8% of Valeant's revenue in Q3 2015. However, questions remained around Valeant's diligence, oversight, and control of Philidor as well as Philidor's accounting and disclosure.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
What to Learn from US FDA Warning Letters and Their Impact on Pharmacovigilan...Covance
Drug safety and pharmacovigilance (PV) are paramount to the development of new drugs and the continued use of approved medications. **Disclaimer: This article was previously published. Sciformix is now a Covance company.
Karl-Ludwig Kley, CEO and Marcus Kuhnert, CFO held Merck's annual press conference on March 8, 2016 to report on the company's financial results for 2015. Merck achieved stronger results in 2015 with net sales increasing 7.1% to €12.8 billion and EBITDA pre growing 13% to €3.6 billion. All business segments saw organic sales growth with particularly strong growth in Asia-Pacific, Latin America, and the Middle East and Africa. Merck also successfully integrated the Sigma-Aldrich acquisition which closed in November 2015. Looking ahead, Merck expects continued growth driven by its existing businesses and progress in its pipeline.
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.
Valeant held an investor conference call to discuss its relationship with Philidor RX Services, LLC, a specialty pharmacy. Valeant had a pilot program with Philidor starting in 2012 and obtained an option to acquire Philidor in January 2013. Philidor's network grew substantially since then and represented 6.8% of Valeant's revenue in Q3 2015. However, questions remained around Valeant's diligence, oversight, and control of Philidor as well as Philidor's accounting and disclosure.
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.
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.
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.
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.
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.
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.
- Generic division revenues declined year-over-year due to lower pricing, partially offset by higher volumes. Pricing declines moderated sequentially. The specialty pharmaceutical division saw revenue growth driven by higher product sales.
- 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
Astrazeneca Full year and_q4_2016_results_presentationThe ScientifiK
The document provides an overview of AstraZeneca's full-year and Q4 2016 results presentation. It notes that total revenue was primarily impacted by generic competition for Crestor and the tail-end of Nexium's loss of exclusivity in the US. The "New AstraZeneca" grew by 6% in FY 2016 and Q4, led by growth in Emerging Markets, Symbicort, and Farxiga. EPS was supported by cost management. 2017 guidance forecasts low-to-mid single digit revenue decline and low-to-mid teens decline in core EPS. The presentation highlights pipeline progress including regulatory filings for Tagrisso, Durvalumab and Faslodex.
Merck reported strong financial results for fiscal year 2016. Net sales increased 17% to €15.02 billion, driven by organic growth across all regions and the acquisition of Sigma-Aldrich. EBITDA pre increased 24% to €4.49 billion and EPS pre increased 28% to €6.21, both exceeding guidance. All business sectors achieved organic growth, with particularly strong contributions from the Life Science and Healthcare sectors. Merck also reduced net financial debt by 9% and proposed a dividend of €1.20 per share, a 19% increase over the prior year.
DUPIXENT was approved by the FDA for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The document discusses DUPIXENT's clinical profile, launch strategy focusing on patients with the highest unmet need, pricing responsibly based on the disease burden and clinical benefits, and plans for working with payers and providing patient support to optimize access and treatment. Regeneron and Sanofi are committed to bringing this breakthrough therapy rapidly to patients and minimizing barriers to treatment.
Udit Batra, CEO of Life Science at Merck KGaA, presented at the UBS Global Healthcare Conference in New York on May 23, 2016. Merck KGaA is a leader in the life science industry with a portfolio of three high-tech businesses: Life Science, Performance Materials, and Healthcare. The integration of the Sigma-Aldrich acquisition is on track to deliver cost synergies while maintaining sales momentum in the Life Science business. Merck KGaA expects mid-single digit organic growth in Life Science in 2016, driven primarily by the Process Solutions business unit.
shire-to-acquire-dyax-presentation-final-02-nov-2015Aaron Sato
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3. 3
Well-Positioned for Future Growth
Generic pipeline of 46 products targeting $19B U.S. sales*
Specialty pipeline focused on next generation opportunities
Solid platform on which to build long-term growth
Targeting
Sustainable
Generic and
Specialty
Pharma Markets
Generic and Specialty Pharma commercialization success
Track record of complex formulation and development
Hatch-Waxman expertise and Paragraph IV successes
Established
Core
Competencies
Diversifying and building scale organically and through BD and M&A
Demonstrated ability to integrate product and company acquisitions
Track record of profitability and balance sheet to support growth
Strong and
Flexible
Financial Profile
Investment Considerations
Pipeline data as of Dec. 31, 2015; Source of sales data: IMS Nov. 2015; *U.S. Brand/Generic market sales; BD – Business Development; M&A – Mergers and Acquisition s
4. 4
Dual Platforms for Growth
Impax Generics
Targeting complex solid oral
and alternative dosage form
ANDAs with high revenue
potential
Product Portfolio
60 commercialized
28 pending at FDA
18 under development
Impax Specialty Pharma
Developing products for unmet
needs in the treatment of
Central Nervous System
disorders and other select
specialty segments
Product Portfolio
6 commercialized
1 pending at FDA
1 under development
Pipeline data as of Dec. 31, 2015; ANDA = Abbreviated New Drug Application
5. 5
Strategy to Create Long Term Growth
Focus on Quality and Operations
Maximize Dual Platform
Optimize R&D
Business Development Acceleration
6. 6
1. Focusing on Quality and Operations
• Resolved Warning Letter in
September 2015
• Three generic approvals since
resolution of Warning Letter
• Passed EMA (MHRA) inspection
• GMP license granted
• RYTARY® and NUMIENTTM approved
• Five generic products approved in 2015
• Successfully transferred and closed
central packaging operation
• Successfully transferred distribution to
UPS
Generic product approval data Jan.1, 2015 through Dec. 31, 2015; MHRA – Medicines & Healthcare products Regulatory Agency; GMP – Good Manufacturing Practice
• Continued to enhance structure and personnel
• Ongoing focus on Quality Improvement Programs and Systems
Corporate Quality
Delivered Positive Quality / Compliance Results in 2015
Hayward Middlesex
Taiwan Philadelphia/Chalfont
Facilities
7. 7
Approvals Launches
14
11
2. Maximizing Generic Platform
Data as of Dec. 31, 2015; FTF = First to File
2015 Approvals and Launches
Achieved 2015 Goal of Launching 14 Products
Products Approval Launch
Lamotrigine ODT (Lamictal®) - FTF 1Q15 2Q15
Azelastine Nasal (Astepro®) Re-launch 2Q15
Olopatadine Nasal (Patanase®) AG 2Q15
Oxymorphone IR tablet (Opana®) 4Q14 2Q15
Metaxalone 400mg IR tablet (Skelaxin®) 1Q15 2Q15
Fenofibrate IR tablet (Fenoglide®) AG 2Q15
Cyproheptadine IR tablet (Periactin®) Re-launch 3Q15
Pyridostigmine Bromide ER tablet (Mestinon® Timespan®) 3Q15 4Q15
Pilocarpine IR tablet (Salagen®) Re-launch 4Q15
Methyltestosterone IR Capsule, USP (Testred® C-III) 3Q15 4Q15
Quinine Sulfate IR capsule (Qualaquin®) 3Q15 4Q15
Molindone IR tablet (Moban®) 1Q15 4Q15
Dutasteride IR capsule (Avodart®) 4Q15 4Q15
Divalroex ER tablet (Depakote ER®) Re-launch 4Q15
Methadone IR tablet (Dolophine®) 3Q15 TBD
Glyburide IR tablet (DiaBeta®) 4Q15 TBD
Guanfacine ER tablet (Intuniv®) 4Q15 TBD
Felbamate IR tablet, USP (Felbatol®) 4Q15 TBD
8. 8
2. Maximizing Generic Platform
Source of sales data: IMS Nov. 2015; Pipeline data as of Dec. 31, 2015; *List is in order of filing date – earliest to latest
Approved Not
Launched/Re-introduction
Pending Approval
9
7
Current U.S. Brand/Generic market sales of $5.6B
Potential Launches Targeted
in 2016
Targeting Up to 16 Potential Launches in 2016
28 Pending ANDAs at FDA
Disclosed Pending ANDAs Include*:
Mixed Amphetamine Salts ER capsule (Adderall XR®)
Sevelamer Carbonate IR tablet (Renvela®)
Colesevelam IR tablet (Welchol®)
Fenofibric Acid DR capsule (Trilipix®)
Ezetimibe Simvastatin IR tablet (Vytorin®)
Oxycodone ER tablet (new formulation) (Oxycontin®)
Dutasteride/Tamsulosin IR capsule (Jalyn®)
Fentanyl Buccal IR tablet (Fentora®)
Oxymorphone ER tablet (new formulation) (Opana ER®)
Risedronate Sodium DR tablet (Atelvia®)
Methylphenidate HCl ER capsule (Metadate CD®)
9. 9
• Growth tracking to long range plan
• 82% of all Rx’s have been Payer approved
• 2% share of carbidopa/ levodopa segment
2. Maximizing Specialty Pharma Platform
Source TRx: IMS; Source % of Rx’s approved: Symphony
CDLD - Carbidopa and Levodopa
0.0%
0.3%
0.6%
0.9%
1.2%
1.5%
1.8%
2.1%
2.4%
0
2,000
4,000
6,000
8,000
10,000
Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15
Monthly TRx and Share of National CDLD TRx Since Launch
RYTARY TRx Share
Successfully Launched RYTARY® in 2015
10. 10
Period
Total
Revenue
Growth
Compounded
Quarterly
Growth Rate
2Q 2012 to 3Q 2015 141% 8%
2. Maximizing Specialty Pharma Platform
Source TRx: IMS
Nasal Spray
Product
Nasal Triptan
National Segment
Prescription Share
TRx Growth
Since
Impax
PromotionApr. 2012 Nov. 2015
Zomig® 23% 33% 83%
Imitrex® 5% 7% 15%
gSumatriptan 72% 60% 2%
Significant Growth Since Initiating Promotional Activity in 2Q 2012
11. 11
Promoting
√ √ √
√ √
2. Maximizing Specialty Pharma Platform
• Builds scale to support organic growth
• Provides increased geographic reach
and frequency
• Strong interest in RYTARY® results in
enhanced physician office access
• Recruitment initiated in 1Q16 and
sales force currently expected to be
completed by mid March
Expanding and Internalizing Sales Force in 2016
2014 2015 2016
66
77
Approximately
120
# of CNS Sales Reps
CNS = Central Nervous System
12. 12
2. Maximizing Specialty Pharma Platform
Choose RYTARY®
Sales force expansion
HCP campaign and
amplification
Educational speaker
programs / webinars
Direct-to-Patient
initiatives
Improve Patient
Experience
Patient advocacy
education
Patient Support Service
Center
Sample direction kit
Direct-to-Patient
initiatives
Medical Affairs support
Patient campaign
Optimize Access
Coverage Support
Service Center
Payer contracting
Patient advocacy
education
Patient financial
assistance
2016 RYTARY® Tactical Plan
13. 13
3. Optimizing Generic R&D
8
2
12
6
Internal External
20
8
Other SOD Controlled-Release SOD Alternative Dosage Form
Current U.S. Brand/Generic Market - $9B
29% Potential/Confirmed FTF or FTM
Source of sales data: IMS Nov. 2015; Pipeline data as of Dec. 31, 2015
FTF = First-to-File; FTM = First-to-Market; SOD = Solid Oral Dosage Form
2 2
6
1
7
Internal External
9 9
Current U.S. Brand/Generic Market - $10B
50% Potential FTF or FTM
Abbreviated New Drug Applications (ANDAs)
28 Products Pending at FDA 18 Products Under Development
Multiple Product Opportunities to Drive Future Growth
14. 14
3. Optimizing Specialty Pharma R&D
Refocused Pipeline on Next Generation / Late-Stage Opportunities
Received European Commission Marketing Authorization Nov. 2015
28 member states of European Union, as well as Iceland, Liechtenstein and Norway
Centralized procedure submission with “Therapeutic Innovation” designation
10-year marketing exclusivity eligibility
Partnering activities ongoing
NUMIENTTM
(IPX066/RYTARY®
ex-US)
Existing product – 200 mg immediate release tablet
Received approval on 200 mg chewable tablet in June 2015 – not launched
Next generation immediate release product – pending approval
ALBENZA®
Next generation RYTARY®
Designed to achieve rapid and sustained levodopa concentration, improved motor
benefits and less frequent dosing
Phase II clinical study – Efficacy/PK/PD/Safety in Advanced Parkinson’s disease
First patients enrolled in December 2015
IPX203
15. 15
4. Accelerating Business Development
• Compelling strategic and financial benefits
• Provided a portfolio of growing, high-margin, complex products
› Specialty products including Albenza®
› Generic products including Epinephrine auto-injector
• Generic pipeline with near-term opportunities
• Immediately accretive to adjusted earnings per diluted share
• Diversified and enlarged revenue and earnings base
• $20 million of potential run rate synergies
Completed Acquisition of Tower Holdings*
Achieved BD Acceleration and Improved Capital Structure in 2015
* Impax acquired Tower Holdings, Inc. (including operating subsidiaries CorePharma LLC and Amedra Pharmaceuticals LLC) and Lineage Therapeutics Inc.
(together “Tower”) on March 9, 2015.
• Three product divestiture transactions
worth approximately $60 million
• Two R&D partnership agreements
› One solid oral dosage form product
› One alternative dosage form product
• Issued convertible notes and repaid
higher interest term loan
• Reduced annual interest expense by
approximately $12 million
• Preserved significant borrowing
capacity
Additional BD Activities Improved Capital Structure
16. 16
4. Accelerating Business Development
* As of Sept. 30, 2015; LTM = Last twelve months
• Companies offering complex solid
oral dosage forms with more
sustainable margins
• Alternative dosage form products
beyond existing capabilities
• Product divestitures from industry
consolidation
• Commercialized, Phase III or
Phase III ready assets
• CNS: focused on movement
disorders to utilize infrastructure
• Continue to evaluate other
specialty areas
Generic Specialty Pharma
• Strong balance sheet
› Cash position of $318 million as of September 30, 2015
› Leverage less than 1.5x net debt to LTM adjusted EBITDA* and no senior
secured debt outstanding
Financial Resources and Flexibility to Support Growth
Targeting Strategic Value Creating Opportunities
17. 17
2016 Priorities
• Maintain quality and compliance across all facilities / departments
• Sharpen focus on supply chain and cost efficiencies
• Capture identified Tower acquisition synergies of $10 million for 2016
• Improve conversion costs across global manufacturing network
Focus on Quality and Operations
• Optimize existing generic opportunities including Epinephrine Auto-injector and Oxymorphone
• Launch up to 16 generic products
• Effectively utilize expanded Specialty Pharma sales force to drive growth
Maximize Dual Platform
• Successfully develop and bring to market new products
• Invest in sustainable generic and specialty pharma markets
Optimize R&D
• Execute on value enhancing business development and M&A
• NUMIENT ex-US licensing
• Pursue generic and specialty pharma value creating opportunities
Business Development Acceleration
18. 18
Well-Positioned for Future Growth
Generic pipeline of 46 products targeting $19B U.S. sales*
Specialty pipeline focused on next generation opportunities
Solid platform on which to build long-term growth
Targeting
Sustainable
Generic and
Specialty
Pharma Markets
Generic and Specialty Pharma commercialization success
Track record of complex formulation and development
Hatch-Waxman expertise and Paragraph IV successes
Established
Core
Competencies
Diversifying and building scale organically and through BD and M&A
Demonstrated ability to integrate product and company acquisitions
Track record of profitability and balance sheet to support growth
Strong and
Flexible
Financial Profile
Investment Considerations
Pipeline data as of Dec. 31, 2015; Source of sales data: IMS Nov. 2015; *U.S. Brand/Generic market sales; BD – Business Development; M&A – Mergers and Acquisition