Targeted Medical Pharma (OTCQB: TRGM) is a small cap biotechnology company that specializes in manufacturing of medical foods for a vareity of disease states. Innovators in the growing medical food sector, The Company has developed products that improve back pain, sleep disorders, hypertension, peripheral neuropathy, fibromyalgia, PTSD and cognitive dysfunction. The Company has recently launched Clearwayz (www.clearwayz.com), the first in a line of proprietary dietary supplements.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
ISR interviewed 13 experienced Regulatory Affairs professionals at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function. ISR has designed this report to be used as a benchmarking tool for companies to compare their Regulatory Affairs functions to those of other organizations. Key takeaways include:
Identify how your company’s approach to Regulatory Affairs may be different from a typical industry approach and the benefits and drawbacks that may result
Gather information on unique Regulatory Affairs structures and best practices employed by other organizations, which may be used to improve or streamline the function
Compare your company’s Regulatory Affairs department size, structure, resources and approach to those of other companies
Learn more: https://goo.gl/
Amgen Inc. is a biotechnology/pharmaceutical company based in the US that was founded in 1980. The document provides an overview of Amgen's financial performance, acquisitions, competitors including AbbVie, Johnson & Johnson, and Celgene, and recommends Amgen as a moderately safe investment option in the biotech industry.
Diplomat is a specialty pharmacy company that provides concierge services and clinical support to patients. It has experienced strong growth in recent years, with revenues increasing 49% from the second quarter of 2014 to 2015. Diplomat focuses on growing its higher margin specialty infusion and manufacturer services businesses. It also seeks to gain market share in core therapeutic areas like oncology and hepatitis C through new drug approvals and acquisitions of other specialty pharmacies. Diplomat's financial performance has been outstanding, with revenue and adjusted EBITDA growing significantly each year and margins expanding.
Abbott intends to acquire St. Jude Medical to create a premier medical device leader. The transaction values St. Jude Medical at $25 billion. Abbott will pay St. Jude Medical shareholders $46.75 in cash and 0.8708 Abbott shares per St. Jude Medical share. The combination is expected to generate $500 million in annual synergies by 2020 and be accretive to Abbott's earnings per share in the first full year. The transaction is subject to shareholder and regulatory approvals and is expected to close in the fourth quarter of 2016.
Dsp investor deck jp morgan january 2017 final2DiplomatIR
This document discusses Diplomat Pharmacy, a specialty pharmacy company. It provides an overview of the company, including its leadership, growth strategy through acquisitions, financial performance, and outlook. The specialty pharmacy industry is growing significantly due to increasing specialty drug utilization and limited distribution drugs. Diplomat aims to continue taking market share as the largest independent specialty pharmacy through its focus on specialty drugs and services.
Stj 2016 analyst and investor day presentation v2ir_stjude
The document provides an overview of St. Jude Medical's 2016 Analyst and Investor Meeting. Key points include: St. Jude's goals to establish reimbursement for CardioMEMS, successfully integrate the Thoratec acquisition, execute plans to recover in the US CRM market through new product launches. The meeting agenda outlines presentations on driving growth in heart failure, atrial fibrillation, neuromodulation and cardiovascular markets through innovation.
Diplomat is a specialty pharmacy that provides medications and services to patients with complex chronic conditions. It has experienced strong revenue growth of 49% year-over-year through focused expansion in specialty infusion services and by winning contracts for new limited distribution drugs, which comprise 40% of its revenues. Diplomat has a national footprint and diversified revenue streams that make it well positioned for continued growth in the specialty pharmacy market.
NeoStem, Inc. (“NeoStem” or the “Company”), a biopharmaceutical company, is capitalizing on the paradigm shift occurring in medicine by engaging in the development and manufacture of cellular therapies for oncology, immunology, and regenerative medicines in the United States. The Company anticipates that cell therapy will play a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society.
ISR interviewed 13 experienced Regulatory Affairs professionals at 11 of the Top 50 pharmaceutical companies to better understand the Regulatory Affairs function. ISR has designed this report to be used as a benchmarking tool for companies to compare their Regulatory Affairs functions to those of other organizations. Key takeaways include:
Identify how your company’s approach to Regulatory Affairs may be different from a typical industry approach and the benefits and drawbacks that may result
Gather information on unique Regulatory Affairs structures and best practices employed by other organizations, which may be used to improve or streamline the function
Compare your company’s Regulatory Affairs department size, structure, resources and approach to those of other companies
Learn more: https://goo.gl/
Amgen Inc. is a biotechnology/pharmaceutical company based in the US that was founded in 1980. The document provides an overview of Amgen's financial performance, acquisitions, competitors including AbbVie, Johnson & Johnson, and Celgene, and recommends Amgen as a moderately safe investment option in the biotech industry.
Diplomat is a specialty pharmacy company that provides concierge services and clinical support to patients. It has experienced strong growth in recent years, with revenues increasing 49% from the second quarter of 2014 to 2015. Diplomat focuses on growing its higher margin specialty infusion and manufacturer services businesses. It also seeks to gain market share in core therapeutic areas like oncology and hepatitis C through new drug approvals and acquisitions of other specialty pharmacies. Diplomat's financial performance has been outstanding, with revenue and adjusted EBITDA growing significantly each year and margins expanding.
Abbott intends to acquire St. Jude Medical to create a premier medical device leader. The transaction values St. Jude Medical at $25 billion. Abbott will pay St. Jude Medical shareholders $46.75 in cash and 0.8708 Abbott shares per St. Jude Medical share. The combination is expected to generate $500 million in annual synergies by 2020 and be accretive to Abbott's earnings per share in the first full year. The transaction is subject to shareholder and regulatory approvals and is expected to close in the fourth quarter of 2016.
Dsp investor deck jp morgan january 2017 final2DiplomatIR
This document discusses Diplomat Pharmacy, a specialty pharmacy company. It provides an overview of the company, including its leadership, growth strategy through acquisitions, financial performance, and outlook. The specialty pharmacy industry is growing significantly due to increasing specialty drug utilization and limited distribution drugs. Diplomat aims to continue taking market share as the largest independent specialty pharmacy through its focus on specialty drugs and services.
Stj 2016 analyst and investor day presentation v2ir_stjude
The document provides an overview of St. Jude Medical's 2016 Analyst and Investor Meeting. Key points include: St. Jude's goals to establish reimbursement for CardioMEMS, successfully integrate the Thoratec acquisition, execute plans to recover in the US CRM market through new product launches. The meeting agenda outlines presentations on driving growth in heart failure, atrial fibrillation, neuromodulation and cardiovascular markets through innovation.
Diplomat is a specialty pharmacy that provides medications and services to patients with complex chronic conditions. It has experienced strong revenue growth of 49% year-over-year through focused expansion in specialty infusion services and by winning contracts for new limited distribution drugs, which comprise 40% of its revenues. Diplomat has a national footprint and diversified revenue streams that make it well positioned for continued growth in the specialty pharmacy market.
The FOURIER trial investigated whether adding evolocumab to statin therapy reduces cardiovascular events. Over 27,000 patients with a history of cardiovascular disease were randomized to receive evolocumab or placebo injections in addition to statin therapy. The primary objective was to determine if evolocumab lowered the risk of major cardiovascular events such as heart attack, stroke, and cardiovascular death. Secondary objectives were to examine the long-term safety and tolerability of evolocumab and investigate the efficacy and safety of achieving very low LDL-cholesterol levels. Results from this outcomes trial could provide evidence on whether PCSK9 inhibition translates to clinical benefit for high-risk patients.
Prescient is preparing to commence a Phase 1b/2 clinical trial of PTX-200 in acute myeloid leukemia (AML) at prominent cancer research centers in the United States. PTX-200 is a novel inhibitor of the Akt signaling pathway that has shown promise in overcoming chemotherapy resistance and inducing cancer cell death with fewer toxic side effects than other Akt inhibitors. If successful, the upcoming AML trial could increase interest in Prescient and validate PTX-200 as an improved treatment for this disease with high unmet medical need. Prescient has additional clinical-stage oncology programs in breast cancer, ovarian cancer, and multiple myeloma across its pipeline.
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.
Dplo investor presentation credit suisse nov 14DiplomatIR
This document contains a 3-paragraph summary of Diplomat Pharmacy, Inc. presented at the Credit Suisse Healthcare Conference in November 2014:
1) Diplomat is the largest independent specialty pharmacy in the US, with $2 billion in revenue and a diversified customer base including Express Scripts, CVS Health, and Walgreens.
2) Diplomat has a highly experienced management team with extensive pharmacy experience and a proven track record of growing the business through strategic acquisitions and partnerships.
3) Specialty pharmacy is a high growth industry driven by new drug launches and treatments for rare diseases, and Diplomat is well-positioned for growth through exclusive drug distribution agreements and
Diplomat is a specialty pharmacy that provides concise summaries in 3 sentences or less that provide the high level and essential information from the document. The document discusses Diplomat's business, including:
- Diplomat is the largest independent specialty pharmacy in the U.S., with over $2 billion in revenue in 2014 and growing rapidly.
- Diplomat has a diversified business model including specialty pharmacy services, specialty infusion, and pharmaceutical manufacturer services.
- Limited distribution drugs, where Diplomat has exclusive or preferred distribution rights, make up about 40% of Diplomat's revenue and are a significant driver of future growth.
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.
Dplo investor presentation jp morgan 2015 finalDiplomatIR
This document summarizes Diplomat Pharmacy's business and growth opportunities:
- Diplomat is the largest independent specialty pharmacy with a national footprint and over $2 billion in revenue.
- It has a highly experienced management team and differentiated business model focused solely on specialty pharmacy.
- The specialty pharmacy industry is growing rapidly due to new drug launches and a shift to pharmacy benefits, and Diplomat is well-positioned to capitalize on this through its scale and relationships.
- Diplomat has multiple avenues for long-term growth including expanding in oncology/immunology, gaining more exclusive contracts, strategic acquisitions, and operational efficiencies.
1) Marker Therapeutics is developing a multi-tumor associated antigen (MultiTAA) T cell therapy approach that targets multiple tumor antigens to address limitations of current CAR T and TCR therapies such as relapse due to antigen escape.
2) In clinical trials to date involving over 50 lymphoma patients, MultiTAA T cell therapy has shown durable complete responses in over 50% of patients with active lymphoma with no serious adverse events or cytokine release syndrome observed.
3) For patients treated while in remission, over 80% have maintained a continued complete response for durations ranging from 3 to 37 months to date.
Dsp investor deck june 2016 william blairDiplomatIR
Diplomat is a leading national specialty pharmacy focused on providing medications for complex and chronic conditions. It has experienced exceptional growth, with projected 2016 revenue of $4.7 billion, up from $2.2 billion in 2013. Diplomat has a unique position in the specialty pharmacy industry due to its focus, scale, and access to limited distribution drugs which comprise 45% of revenue. It has expanded its capabilities through strategic acquisitions and growing relationships with drug manufacturers.
35th Annual J.P. Morgan Healthcare Conference PresentationCardinal_Health
George S. Barrett, Chairman and CEO of Cardinal Health, gave a presentation at the 35th Annual J.P. Morgan Healthcare Conference on January 9, 2017. In the presentation, Barrett discussed how Cardinal Health is changing healthcare by bringing scaled solutions to help customers navigate a complex industry. He outlined key trends shaping the next five years in healthcare and how Cardinal Health is positioned for growth and success through strategic priorities that align with these trends. Barrett also reviewed Cardinal Health's financial performance and goals over the past five years.
2016 analyst and investor day presentationir_stjude
The document provides an overview of St. Jude Medical's 2016 Analyst and Investor Meeting. Key points include:
- St. Jude Medical aims to drive growth through innovation in heart failure, atrial fibrillation, neuromodulation, and cardiovascular markets.
- Goals for 2016 include establishing reimbursement for CardioMEMS, integrating the Thoratec acquisition, executing a plan for recovery in the US CRM market, and successfully launching new products.
- Upcoming product launches are expected to fill gaps and deliver advances in AF, HF, and CRM, positioning St. Jude Medical competitively for contracting.
1) TapImmune and Marker Therapeutics plan to merge, with TapImmune renaming and relocating its headquarters to Houston.
2) The combined company will have multiple clinical trials underway testing a novel T cell therapy approach that targets multiple tumor antigens without genetic modification of cells.
3) This multi-antigen approach aims to provide durable responses, prevent immune escape, reduce costs and complexity compared to CAR-T and TCR therapies, and has shown a superior toxicity profile in over 50 treated patients so far.
This document outlines St. Jude Medical's growth program for 2015. It discusses catalysts for growth including the full year impact of the CardioMEMS HF monitoring system and new ablation catheters. It also covers returning the neuromodulation business in the US to growth through new product launches. The presentation provides an overview of St. Jude Medical's markets, goals for financial metrics like sales and EPS growth, and focus on returning shareholder value through cash flow, dividends, and share repurchases.
PharmAust is a clinical-stage oncology company focused on drug repurposing. Its lead product PPL-1 (Monepantel-MPL) successfully completed Phase I/II trials and is now Phase II ready. MPL has potential as a new class of targeted anti-cancer therapy. PharmAust also has a profitable specialty chemicals business and options for veterinary cancer applications through partnerships. The company is significantly undervalued given its pipeline and clinical progress.
Raymond James 38 th Annual Institutional Investors ConferenceDiplomatIR
Diplomat is a specialty pharmacy company that provides medications and services to patients. It has a national footprint and focuses on specialty medications, which are high-cost drugs that treat complex, chronic conditions like cancer. Diplomat has experienced exceptional revenue growth in recent years due to the expanding specialty drug market and its focus on specialty medications. It aims to continue growing organically and through strategic acquisitions.
This document provides non-GAAP financial information and reconciliations for Edwards Lifesciences Corporation. It defines non-GAAP measures used by the company such as underlying sales, adjusted net income, and adjusted EPS, which exclude items like currency fluctuations, acquisitions, divestitures, and special charges. It also notes management considers free cash flow an important liquidity measure and provides the company's definition. In addition, the document gives examples of items excluded from non-GAAP measures for specific periods to reconcile to GAAP reporting, such as intellectual property litigation expenses.
This presentation provides an overview of St. Jude Medical's 2014 growth program. Key points include:
- The company expects to resolve FDA warning letters and accelerate new product launches in the US.
- Several new products are expected to drive growth, including Nanostim leadless pacemaker and expanded Portico TAVR sizes.
- The goal is to accelerate sales growth over 2014 and exit the year positioned for mid-to-high single digit growth in 2015.
- St. Jude believes it is well positioned to continue delivering earnings leverage through manufacturing optimization and cost reductions.
The document provides an overview of Pfizer Inc., including its business segments, geographic reach, goals, mission/values, history, strategy, external environment analysis, internal environment analysis, and recommendations. It analyzes Pfizer's pharmaceutical, animal health, and corporate/other business segments. Key points include Pfizer operating in over 150 countries, goals of growing in emerging markets and optimizing its patent-protected portfolio, and an analysis of its competitive environment and internal financial performance compared to rivals. One recommendation is for Pfizer to focus on emerging markets like Asia, China, and India.
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.
2016 analyst and investor meeting presentationir_stjude
The document provides an overview of St. Jude Medical's 2016 Analyst and Investor Meeting. Key points include: St. Jude's goals to establish reimbursement for CardioMEMS, successfully integrate the Thoratec acquisition, execute plans to recover in the US CRM market through new product launches. The meeting agenda outlines presentations on driving growth in heart failure, atrial fibrillation, neuromodulation and cardiovascular markets through innovation.
M.V. Rama Kumar has 3 years of experience in application development using Java and big data technologies like Hadoop. He has 1.6 years of experience using Hadoop components such as HDFS, MapReduce, Pig, Hive, Sqoop, HBase and Oozie. He has extensive experience setting up Hadoop clusters and processing large, structured and unstructured data.
This presentation sets out how to use data collection and player analytics in online games to create better experiences and environments for players. The Games Industry can use data and analytics to create pro-active Player Relationship Management and increase revenues and engagements.
The FOURIER trial investigated whether adding evolocumab to statin therapy reduces cardiovascular events. Over 27,000 patients with a history of cardiovascular disease were randomized to receive evolocumab or placebo injections in addition to statin therapy. The primary objective was to determine if evolocumab lowered the risk of major cardiovascular events such as heart attack, stroke, and cardiovascular death. Secondary objectives were to examine the long-term safety and tolerability of evolocumab and investigate the efficacy and safety of achieving very low LDL-cholesterol levels. Results from this outcomes trial could provide evidence on whether PCSK9 inhibition translates to clinical benefit for high-risk patients.
Prescient is preparing to commence a Phase 1b/2 clinical trial of PTX-200 in acute myeloid leukemia (AML) at prominent cancer research centers in the United States. PTX-200 is a novel inhibitor of the Akt signaling pathway that has shown promise in overcoming chemotherapy resistance and inducing cancer cell death with fewer toxic side effects than other Akt inhibitors. If successful, the upcoming AML trial could increase interest in Prescient and validate PTX-200 as an improved treatment for this disease with high unmet medical need. Prescient has additional clinical-stage oncology programs in breast cancer, ovarian cancer, and multiple myeloma across its pipeline.
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.
Dplo investor presentation credit suisse nov 14DiplomatIR
This document contains a 3-paragraph summary of Diplomat Pharmacy, Inc. presented at the Credit Suisse Healthcare Conference in November 2014:
1) Diplomat is the largest independent specialty pharmacy in the US, with $2 billion in revenue and a diversified customer base including Express Scripts, CVS Health, and Walgreens.
2) Diplomat has a highly experienced management team with extensive pharmacy experience and a proven track record of growing the business through strategic acquisitions and partnerships.
3) Specialty pharmacy is a high growth industry driven by new drug launches and treatments for rare diseases, and Diplomat is well-positioned for growth through exclusive drug distribution agreements and
Diplomat is a specialty pharmacy that provides concise summaries in 3 sentences or less that provide the high level and essential information from the document. The document discusses Diplomat's business, including:
- Diplomat is the largest independent specialty pharmacy in the U.S., with over $2 billion in revenue in 2014 and growing rapidly.
- Diplomat has a diversified business model including specialty pharmacy services, specialty infusion, and pharmaceutical manufacturer services.
- Limited distribution drugs, where Diplomat has exclusive or preferred distribution rights, make up about 40% of Diplomat's revenue and are a significant driver of future growth.
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.
Dplo investor presentation jp morgan 2015 finalDiplomatIR
This document summarizes Diplomat Pharmacy's business and growth opportunities:
- Diplomat is the largest independent specialty pharmacy with a national footprint and over $2 billion in revenue.
- It has a highly experienced management team and differentiated business model focused solely on specialty pharmacy.
- The specialty pharmacy industry is growing rapidly due to new drug launches and a shift to pharmacy benefits, and Diplomat is well-positioned to capitalize on this through its scale and relationships.
- Diplomat has multiple avenues for long-term growth including expanding in oncology/immunology, gaining more exclusive contracts, strategic acquisitions, and operational efficiencies.
1) Marker Therapeutics is developing a multi-tumor associated antigen (MultiTAA) T cell therapy approach that targets multiple tumor antigens to address limitations of current CAR T and TCR therapies such as relapse due to antigen escape.
2) In clinical trials to date involving over 50 lymphoma patients, MultiTAA T cell therapy has shown durable complete responses in over 50% of patients with active lymphoma with no serious adverse events or cytokine release syndrome observed.
3) For patients treated while in remission, over 80% have maintained a continued complete response for durations ranging from 3 to 37 months to date.
Dsp investor deck june 2016 william blairDiplomatIR
Diplomat is a leading national specialty pharmacy focused on providing medications for complex and chronic conditions. It has experienced exceptional growth, with projected 2016 revenue of $4.7 billion, up from $2.2 billion in 2013. Diplomat has a unique position in the specialty pharmacy industry due to its focus, scale, and access to limited distribution drugs which comprise 45% of revenue. It has expanded its capabilities through strategic acquisitions and growing relationships with drug manufacturers.
35th Annual J.P. Morgan Healthcare Conference PresentationCardinal_Health
George S. Barrett, Chairman and CEO of Cardinal Health, gave a presentation at the 35th Annual J.P. Morgan Healthcare Conference on January 9, 2017. In the presentation, Barrett discussed how Cardinal Health is changing healthcare by bringing scaled solutions to help customers navigate a complex industry. He outlined key trends shaping the next five years in healthcare and how Cardinal Health is positioned for growth and success through strategic priorities that align with these trends. Barrett also reviewed Cardinal Health's financial performance and goals over the past five years.
2016 analyst and investor day presentationir_stjude
The document provides an overview of St. Jude Medical's 2016 Analyst and Investor Meeting. Key points include:
- St. Jude Medical aims to drive growth through innovation in heart failure, atrial fibrillation, neuromodulation, and cardiovascular markets.
- Goals for 2016 include establishing reimbursement for CardioMEMS, integrating the Thoratec acquisition, executing a plan for recovery in the US CRM market, and successfully launching new products.
- Upcoming product launches are expected to fill gaps and deliver advances in AF, HF, and CRM, positioning St. Jude Medical competitively for contracting.
1) TapImmune and Marker Therapeutics plan to merge, with TapImmune renaming and relocating its headquarters to Houston.
2) The combined company will have multiple clinical trials underway testing a novel T cell therapy approach that targets multiple tumor antigens without genetic modification of cells.
3) This multi-antigen approach aims to provide durable responses, prevent immune escape, reduce costs and complexity compared to CAR-T and TCR therapies, and has shown a superior toxicity profile in over 50 treated patients so far.
This document outlines St. Jude Medical's growth program for 2015. It discusses catalysts for growth including the full year impact of the CardioMEMS HF monitoring system and new ablation catheters. It also covers returning the neuromodulation business in the US to growth through new product launches. The presentation provides an overview of St. Jude Medical's markets, goals for financial metrics like sales and EPS growth, and focus on returning shareholder value through cash flow, dividends, and share repurchases.
PharmAust is a clinical-stage oncology company focused on drug repurposing. Its lead product PPL-1 (Monepantel-MPL) successfully completed Phase I/II trials and is now Phase II ready. MPL has potential as a new class of targeted anti-cancer therapy. PharmAust also has a profitable specialty chemicals business and options for veterinary cancer applications through partnerships. The company is significantly undervalued given its pipeline and clinical progress.
Raymond James 38 th Annual Institutional Investors ConferenceDiplomatIR
Diplomat is a specialty pharmacy company that provides medications and services to patients. It has a national footprint and focuses on specialty medications, which are high-cost drugs that treat complex, chronic conditions like cancer. Diplomat has experienced exceptional revenue growth in recent years due to the expanding specialty drug market and its focus on specialty medications. It aims to continue growing organically and through strategic acquisitions.
This document provides non-GAAP financial information and reconciliations for Edwards Lifesciences Corporation. It defines non-GAAP measures used by the company such as underlying sales, adjusted net income, and adjusted EPS, which exclude items like currency fluctuations, acquisitions, divestitures, and special charges. It also notes management considers free cash flow an important liquidity measure and provides the company's definition. In addition, the document gives examples of items excluded from non-GAAP measures for specific periods to reconcile to GAAP reporting, such as intellectual property litigation expenses.
This presentation provides an overview of St. Jude Medical's 2014 growth program. Key points include:
- The company expects to resolve FDA warning letters and accelerate new product launches in the US.
- Several new products are expected to drive growth, including Nanostim leadless pacemaker and expanded Portico TAVR sizes.
- The goal is to accelerate sales growth over 2014 and exit the year positioned for mid-to-high single digit growth in 2015.
- St. Jude believes it is well positioned to continue delivering earnings leverage through manufacturing optimization and cost reductions.
The document provides an overview of Pfizer Inc., including its business segments, geographic reach, goals, mission/values, history, strategy, external environment analysis, internal environment analysis, and recommendations. It analyzes Pfizer's pharmaceutical, animal health, and corporate/other business segments. Key points include Pfizer operating in over 150 countries, goals of growing in emerging markets and optimizing its patent-protected portfolio, and an analysis of its competitive environment and internal financial performance compared to rivals. One recommendation is for Pfizer to focus on emerging markets like Asia, China, and India.
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.
2016 analyst and investor meeting presentationir_stjude
The document provides an overview of St. Jude Medical's 2016 Analyst and Investor Meeting. Key points include: St. Jude's goals to establish reimbursement for CardioMEMS, successfully integrate the Thoratec acquisition, execute plans to recover in the US CRM market through new product launches. The meeting agenda outlines presentations on driving growth in heart failure, atrial fibrillation, neuromodulation and cardiovascular markets through innovation.
M.V. Rama Kumar has 3 years of experience in application development using Java and big data technologies like Hadoop. He has 1.6 years of experience using Hadoop components such as HDFS, MapReduce, Pig, Hive, Sqoop, HBase and Oozie. He has extensive experience setting up Hadoop clusters and processing large, structured and unstructured data.
This presentation sets out how to use data collection and player analytics in online games to create better experiences and environments for players. The Games Industry can use data and analytics to create pro-active Player Relationship Management and increase revenues and engagements.
Community engagement in the extractive industries in mongoliaAmjiltcom Mongolia
The document discusses community engagement perspectives from the World Bank regarding Mongolia's extractive industries sector. It notes Mongolia's transition to democracy and booming mineral sector. It defines community engagement as building civil society capacity and spaces for community participation. Currently in Mongolia, there is a lack of trust and collaboration between communities and companies/government. The World Bank supports various activities to strengthen community engagement, including forums, reporting, dispute resolution, and grants for civil society organizations.
There many occasions need wearing party dresses, like prom, homecoming, Christmas and so on. This summer, neon dress become a hot pick for girls. How about your summer party dress?
The document describes the evolution of beehive designs over thousands of years, from ancient Egyptian and Israeli beehives made of cylindrical pipes and found in rows, to modern top bar hives with wooden bars and Langstroth hives, the most common design today with 4 sides, a roof, and floor. Log hives from Poland were vertical rather than horizontal structures for housing bee colonies.
Percura, Improve Pain and Numbness Associated with Peripheral NeuropathyTargeted Medical Pharma
Percura capsules by oral administration. A specially formulated Medical Food product, consisting of a proprietary blend of amino acids in specific proportions, for the dietary management of the metabolic processes associated with pain, inflammation and loss of sensation due to peripheral neuropathy. Must be administered under physician supervision.
Percura is a proprietary formulation of amino acids and other dietary factors to support induction, maintenance, and enhancement of the specific neurotransmitter activity involved in the physiology of neuropathic pain. The formulation consists of nonessential and essential amino acids L-Arginine HCL, L-Histidine HCL, L-Glutamine, L-Serine, L-Lysine, L-Ornithine, Acetyl L-Carnitine, L-Tyrosine, the nonstandard amino acid Gamma Aminobutyric Acid, Choline Bitartrate, Glucose, Inositol, Griffonia Extract griffonia simplicifolia (95% 5-HTP) , and Creatine. These ingredients fall into the classification of Generally Recognized as Safe (GRAS) as defined by the Food and Drug Administration (FDA) (Sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act). A GRAS substance is distinguished from a food additive on the basis of the common knowledge about the safety of the substance for its intended use. The standard for an ingredient to achieve GRAS status requires not only technical demonstration of non-toxicity and safety, but also general recognition of safety through widespread usage and agreement of that safety by experts in the field. Many ingredients have been determined by the FDA to be GRAS, and are listed as such by regulation, in Volume 21 Code of Federal Regulations (CFR) Sections 182, 184, and 186.
Susan Nunan's article argues that grammar should be taught as tools rather than rules. She realized she needed to change her views on grammar teaching in order for students to learn and apply the concepts. Historically, prescriptive grammarians determined correct English usage and viewed improper usage as a sign of low morality. However, research shows these views still influence perceptions today. The most important reason to teach grammar, according to Nunan, is to give students tools to think more deeply and express ideas in new ways. Associating grammar with everyday life can help students see it in a new light. Effective grammar tools can help students develop stronger writing and communication skills.
Consult.me is an online marketplace that allows users to buy and sell subject matter expertise. The founders conducted a survey to assess interest. Most respondents said they would pay for the service, with prices ranging from under $50 to $400 depending on need. Topics of most interest included technology, lifestyle, leadership, and finance. Respondents expected to pay experts $50-500 per hour for their time and expertise.
The document describes using bread to create wearable art. Bread can be found worldwide and is inexpensive. Rather than just eating bread in sandwiches, the authors suggest transforming bread into sculptures and clothing by shredding, mixing, kneading and molding it into shapes, which can then be decorated. This process turns humble bread into haute couture artwork. Creativity is the only limiting factor.
AppTrim® is a medical food manufactured in a cGMP certified facility in the United States, that is specially formulated to manage the increased nutritional requirements of obesity. AppTrim provides the specific amino acids and nutrients required by the body to stimulate the production of key neurotransmitters responsible for controlling appetite, hunger and satiety. AppTrim is clinically proven to reduce appetite, carbohydrate cravings and weight when used in addition to a daily exercise and nutrition plan
The Clearwayz formula provides the respiratory system, nasal and sinus cavities with a balance of nutrients, amino acids and polyphenols required to support anti-inflammatory processes and support autonomic nervous system function.
The use of Clearwayz for acute sinus and respiratory support can result in balanced mucous production, improved immune function, and improved nasal breathing during times of congestion.
As a daily supplement the patented Clearwayz formula provides the body with the natural tools it needs to safely manage inflammation in the respiratory system, nasal and sinus cavities.
The fundamental principle of Clearwayz is to support healthy airflow in the nasal and sinus cavities through anti-inflammatory mediators and nervous system support.
Medical Affairs Resources, Structures, & Trends Report SummaryBest Practices, LLC
This survey summarizes research on resources, structures, and trends in medical affairs organizations. The survey collected data from 26 medical affairs leaders at 25 pharmaceutical companies. Key findings include that medical affairs groups typically have a centralized structure reporting to executives, focus over a third of their budget on clinical operations, and have experienced few decreases in resources despite some companies citing economic or product reasons. The research was conducted by Best Practices, LLC to benchmark medical affairs organizations.
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum's current drug pipeline includes indications in orphan diseases, infectious diseases, and metabolic diseases. The Company launched two new clinical trials in 2021. Aptorum’s Smart-ACT™ platform is designed to bring an average of three drug candidates for orphan diseases to clinical trials every 12-18 months. The Company is now preparing to launch a dietary supplement for women undergoing menopause and experiencing related symptoms, including osteoporosis. Targeting a global woman’s health supplement market that is expected to reach $17 billion in 2025, Aptorum is expected to generate near-term revenue with significant long-term growth potential.
Strategies for Conducting New Product Scientific Assessment - Yavuz SILAY - D...Yavuz Silay
Strategies for Conducting New Product Scientific Assessment - Due Diligence - New Strategies for Successful Licensing Acquisitions , DIA , Session Panel, June 22 2008,
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to developing and commercializing novel therapeutics to tackle unmet medical needs. Aptorum's current drug pipeline includes indications in orphan diseases, infectious diseases, and metabolic diseases. The Company launched two new clinical trials in 2021. Aptorum’s Smart-ACT™ platform is designed to bring an average of three drug candidates for orphan diseases to clinical trials every 12-18 months. The Company is now preparing to launch a dietary supplement for women undergoing menopause and experiencing related symptoms, including osteoporosis. Targeting a global woman’s health supplement market that is expected to reach $17 billion in 2025, Aptorum is expected to generate near-term revenue with significant long-term growth potential.
The document provides an overview of Pfizer Inc., including its business segments, geographic reach, goals, mission/values, history, strategy, external environment analysis, internal environment analysis, and recommendations. It analyzes Pfizer's pharmaceutical, animal health, and corporate/other business segments. Key points include Pfizer operating in over 150 countries, goals of growing in emerging markets and optimizing its patent-protected portfolio, and an analysis of Pfizer's financial performance compared to rivals. One recommendation is for Pfizer to focus on emerging markets like Asia, China, and India.
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.
Assured Pharmacy owns and operates specialty pharmacies that deliver a high level of care, service and compassion for individuals coping with chronic pain.
Dsp Investor deck jan 2016 JP Morgan finalDiplomatIR
Diplomat is a leading independent specialty pharmacy focused on providing exceptional patient care and clinical services. It has experienced strong growth, with revenues increasing over 120% since its IPO and EBITDA growing nearly 400% over the same period. Diplomat has a unique position in the specialty pharmacy industry as it continues to gain exclusive access to limited distribution drugs and expand into complementary service areas, while large PBMs are increasingly excluded from such opportunities. It has strengthened its leadership team through strategic hires and acquisitions to support its diversification and national expansion.
Johnson & Johnson Pharmaceutical Business ReviewDeepa K
The document is an agenda for an investor presentation. It outlines the schedule for the day which includes presentations on the company's enterprise overview, pharmaceutical commercial and R&D strategies, and various therapeutic areas. It also includes notices about forward-looking statements and new molecular entities being discussed. The speakers and locations are listed next to each topic.
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.
Here's what bio-pharma organizations need to know when transforming the promotional material review and approval process from a transactional requirement to a competitive advantage.
The Medical Director oversees all activities of a company's Medical Department and contributes to senior leadership. Their day involves emails and phone calls about clinical trials, regulations, and health economics. They attend internal meetings on research, regulations, reimbursement, and business strategies. External meetings include advising investigators and regulators. As the senior medical advisor, they provide clinical guidance across the company.
Aptorum Group Limited (NASDAQ: APM) is a pharmaceutical company dedicated to
developing and commercializing novel therapeutics to tackle unmet medical needs.
Aptorum's current drug pipeline includes indications in orphan diseases, infectious
diseases, and metabolic diseases. In 2020 the company plans to bring two candidates
to clinical trials. Aptorum’s Smart-ACT™ platform is designed to bring an average of
three drug candidates for orphan diseases to clinical trials every 12-18 months. The
company is now in the process of launching a dietary supplement for women undergoing
menopause and experiencing related symptoms, including osteoporosis. Targeting a
global woman’s health supplement market that is expected to reach $17 billion in 2025,
Aptorum is expected to generate significant revenue in the next 12 months with this
product.
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.
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.
Dsp investor deck march 2016 raymond jamesDiplomatIR
Diplomat is a specialty pharmacy that provides medications to patients with complex and chronic conditions. It has experienced significant growth due to the expanding specialty drug market. Diplomat focuses on specialty areas like oncology and has access to many limited distribution drugs. It aims to continue growing organically and through strategic acquisitions to enhance its service offerings and leverage its competitive positioning in the specialty pharmacy industry.
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.
Forage Hyperfoods produces functional mushroom products and is seeking investor funding. It currently generates revenue through wholesale customers for raw and extracted mushrooms. Forage aims to expand production capacity and inventory to meet increased demand as the functional food market grows. Key milestones for 2021 include launching new product lines, establishing operations in the Caribbean, and formalizing large distribution agreements. Proceeds from funding will be used for operations, sales, increasing inventory, and product expansion. Forage sees potential for significant revenue and market share growth in the functional food and mushroom supplement industries.
Similar to Targeted Medical Pharma Innovating Healthcare for Better Patient Health IP 2014 (20)
STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS E7shruti jagirdar
Unit 4: MRA 103T Regulatory affairs
This guideline is directed principally toward new Molecular Entities that are
likely to have significant use in the elderly, either because the disease intended
to be treated is characteristically a disease of aging ( e.g., Alzheimer's disease) or
because the population to be treated is known to include substantial numbers of
geriatric patients (e.g., hypertension).
Nano-gold for Cancer Therapy chemistry investigatory projectSIVAVINAYAKPK
chemistry investigatory project
The development of nanogold-based cancer therapy could revolutionize oncology by providing a more targeted, less invasive treatment option. This project contributes to the growing body of research aimed at harnessing nanotechnology for medical applications, paving the way for future clinical trials and potential commercial applications.
Cancer remains one of the leading causes of death worldwide, prompting the need for innovative treatment methods. Nanotechnology offers promising new approaches, including the use of gold nanoparticles (nanogold) for targeted cancer therapy. Nanogold particles possess unique physical and chemical properties that make them suitable for drug delivery, imaging, and photothermal therapy.
5-hydroxytryptamine or 5-HT or Serotonin is a neurotransmitter that serves a range of roles in the human body. It is sometimes referred to as the happy chemical since it promotes overall well-being and happiness.
It is mostly found in the brain, intestines, and blood platelets.
5-HT is utilised to transport messages between nerve cells, is known to be involved in smooth muscle contraction, and adds to overall well-being and pleasure, among other benefits. 5-HT regulates the body's sleep-wake cycles and internal clock by acting as a precursor to melatonin.
It is hypothesised to regulate hunger, emotions, motor, cognitive, and autonomic processes.
Summer is a time for fun in the sun, but the heat and humidity can also wreak havoc on your skin. From itchy rashes to unwanted pigmentation, several skin conditions become more prevalent during these warmer months.
Lecture 6 -- Memory 2015.pptlearning occurs when a stimulus (unconditioned st...AyushGadhvi1
learning occurs when a stimulus (unconditioned stimulus) eliciting a response (unconditioned response) • is paired with another stimulus (conditioned stimulus)
Know the difference between Endodontics and Orthodontics.Gokuldas Hospital
Your smile is beautiful.
Let’s be honest. Maintaining that beautiful smile is not an easy task. It is more than brushing and flossing. Sometimes, you might encounter dental issues that need special dental care. These issues can range anywhere from misalignment of the jaw to pain in the root of teeth.
“Psychiatry and the Humanities”: An Innovative Course at the University of Mo...Université de Montréal
“Psychiatry and the Humanities”: An Innovative Course at the University of Montreal Expanding the medical model to embrace the humanities. Link: https://www.psychiatrictimes.com/view/-psychiatry-and-the-humanities-an-innovative-course-at-the-university-of-montreal
Computer in pharmaceutical research and development-Mpharm(Pharmaceutics)MuskanShingari
Statistics- Statistics is the science of collecting, organizing, presenting, analyzing and interpreting numerical data to assist in making more effective decisions.
A statistics is a measure which is used to estimate the population parameter
Parameters-It is used to describe the properties of an entire population.
Examples-Measures of central tendency Dispersion, Variance, Standard Deviation (SD), Absolute Error, Mean Absolute Error (MAE), Eigen Value
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
How to Control Your Asthma Tips by gokuldas hospital.Gokuldas Hospital
Respiratory issues like asthma are the most sensitive issue that is affecting millions worldwide. It hampers the daily activities leaving the body tired and breathless.
The key to a good grip on asthma is proper knowledge and management strategies. Understanding the patient-specific symptoms and carving out an effective treatment likewise is the best way to keep asthma under control.
2. Safe Harbor Statement
This document does not constitute or form part of an invitation or recommendation to subscribe for or purchase any securities of Targeted Medical Pharma, Inc. (“Targeted
Medical Pharma”, “TMP” or “the Company”). This document was prepared exclusively for the benefit and internal use of investors in order to evaluate the feasibility of a
possible transaction or transactions and does not carry any right of publication or disclosure to any other party. This document is incomplete without reference to, and
should be viewed in conjunction with, the oral briefing provided by TMP, the Company’s public filings with the Securities and Exchange Commission (the “SEC”) and press
releases. This presentation may not be used for any other purpose without the prior written consent of Targeted Medical Pharma.
In preparing this document we have relied upon and assumed, without independent verification, the accuracy and completeness of all information available from public
sources or which was provided to us or otherwise reviewed by us. The information contained in this document has been taken from sources deemed to be reliable. We do
not represent that such information is accurate or complete and it should not be relied on as such. Any opinions expressed herein reflect our judgment at this date, all of
which are subject to change. We have based the forward-looking statements on our current expectations and projections about future events. These forward-looking
statements are subject to known and unknown risks, uncertainties and assumptions about us and with respect to specific factors identified in this presentation and in the
Company’s filings with the SEC, specifically the reported risk factors, that may cause our actual results, levels of activity, performance or achievements expressed or implied
by such forward-looking statements. Actual results in each case could differ materially from those currently anticipated in such statements.
Non-GAAP Financial Measures
In this presentation, TMP uses the non-GAAP measures adjusted EBITDA and adjusted earnings per share. TMP believes these non-GAAP financial measures are helpful in
understanding its past financial performance and its potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP
measures and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. TMP’s management regularly uses these
supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions.
TMP believes that the use of these non-GAAP measures enhances the ability of investors to compare its results from period to period. Investors should note that adjusted
EBIDTA and adjusted earnings per share, as used by TMP, may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures
used by TMP’ competitors and other companies. The non-GAAP historical financial measures may exclude amortization of intangible assets, share-based
compensation, transaction related costs, non-cash interest expense, loss on extinguishment of debt, and the effect of change in the timing of when certain revenue was
recognized. The non-GAAP 2012 financial guidance may excludes amortization of intangible assets, share-based compensation, transaction and integration costs, purchase
accounting inventory step-up adjustments and the tax effect of these adjustments to GAAP net income.
Trademarks
All products named in this presentation are protected under trademark including those not marked “TM”.
Safe Harbor Statement, Non-GAAP Financial Measures and Trademarks
TARGETED MEDICAL PHARMA (OTCQB:TRGM)2
3. Company Overview
TARGETED MEDICAL PHARMA (OTCQB:TRGM)3
Biotechnology company that develops prescription medical foods for treatment of
chronic disease
Including pain syndromes, sleep , cognitive disorders and obesity
Safe option for treatment without significant side effects
FDA regulated products on the market generating revenue
Does not require FDA pre-approval
Low cost development platform
Robust pipeline and patent portfolio
FDA GRAS/GRAE ingredients (Generally Recognized As Safe and Effective)
Diversified sales/distribution channels
Diversified sources of reimbursement
4. Corporate Profile
TARGETED MEDICAL PHARMA (OTCQB:TRGM)4
Targeted Medical Pharma, Inc. OTC QB: TRGM
Corporate Headquarters Los Angeles, CA
Stock Price (3-28-2014), 52-Week Range $0.84; $0.49 - $5.10
Shares Outstanding 26.3 M
Average Daily Volume (13Wks) 12,459
Market Capitalization (3-28-2014) $22.1M
Debt at 12-31-13 $5.5M
Cash at 12-31-13 $492k
Enterprise Value $26.9M
Revenue/EBITDA (Year Ended 12-31-2013) $9.6M / ($2.7M)
Full-time Employees 57
Fiscal Year Ends December 31st
Accounting Firm Marcum, LLP
5. Key Management
TARGETED MEDICAL PHARMA (OTCQB:TRGM)5
David Silver, M.D.
President and Chief Operating Officer
• University of California Los Angeles - Associate Professor
• Cedars-Sinai Medical Center – Clinical Chief of Rheumatology
and Dir. of Chronic Pain Rehabilitation Program
• Osteoporosis Medical Center - Associate Director
• American College of Rheumatology – Scientific Advisory
Committee Member
• Conducted more then 100 clinical trials
• Nationally-recognized expert on pain, fibromyalgia and PTSD
• Boston University – BA in Medical Sciences with minor in
Economics
• Boston University School of Medicine – M.D.
• Northwestern University – Residency in Internal Medicine
• Cedars Sinai Medical Center – Fellowship in Rheumatology
• Board Certified - Internal Medicine and Rheumatology
William Shell, M.D.
Co-Founder, CEO and Chief Science Officer
• USAF American Soviet Exchange Program – First physician
representative in Moscow
• Keesler Air Force Base –Director of Coronary Case Unit
• Cedars Sinai Medical Center – Dir. of Cardiovascular
Biochemistry Research Laboratories
• Interactive Medical Technologies - Chairman and Chief
Science Officer
• Beverly Glen Medical Systems – Chief Science Officer
• Board Certified - Internal Medicine and Cardiology
• University of California Los Angeles - Associate Professor
• Conducted more than 100 clinical trials
• Dr. Shell’s innovations have led to 16 issues patents and 6 pending
• Published 99 peer-reviewed scientific papers and wrote chapters
in 17 books
• University of Michigan Medical School – M.D.
• National Institutes of Health – Fellow ship under Dr. Eugene
Braunwald and member CK-MB team
William Horne
Chief Financial Officer
• OptimisCorp – Chief Financial Officer
• Patient Safety Technologies (OTCBB:PSTX) – CFO and Interim CEO
• Alaska Wireless Communications - Managing Member and CFO
• Apex Financial Management – CFO and Founding Member
• Phoenix Partners VC – Chief Financial Officer
• Price Waterhouse, LLP – Accountant
• U.S. Marine Corps
• Seattle University – BA Business Administration, Magna Cum
Laude
6. Board of Directors
TARGETED MEDICAL PHARMA (OTCQB:TRGM)6
INDEPENDENT DIRECTORS
Maurice J. DeWald
Chairman of the Board
KPMG - Regional Managing Partner
Serves on the board of director of several healthcare companies
Arthur R. Nemiroff
Chairman of the Audit Committee
BDO USA LLP - Partner
City of Hope Medical Center - Director and Audit Committee Member
Donald J. Webster
Chairman of the Nominating
and Corporate Governance Committee
Chevron Corporation - General Manager of Procurement
Thomas R. Wenkart, M.B.B.S.
Chairman of the Compensation Committee
Macquarie Health Corporation - Chairman
NON-INDEPENDENT DIRECTORS
William Shell, M.D.
CEO and Chief Science Officer
David Silver, M.D.
President and Chief Operating Officer
Kim Giffoni
Co-founder and Executive Vice President
NutraCorp Scientific – President
Giffoni Development Company - CEO
7. Medical foods are FDA-regulated medications intended for the dietary management of a
disease that has distinctive nutritional needs that cannot be met by normal diet alone as
defined in the Food and Drug Administration's 1988 Orphan Drug Act Amendments.
Physician Supervised Medical Foods
TARGETED MEDICAL PHARMA (OTCQB:TRGM)7
Must make a disease claim
Require ongoing physician supervision
Do not require FDA pre-approval
Enteral administration
FDA GRAS/GRAE ingredients (Generally Recognized As Safe and Effective)
Address specific nutritional deficiencies
8. Five-component System for Efficient Uptake and Utilization of Amino Acids
Targeted Cellular Technology®
TARGETED MEDICAL PHARMA (OTCQB:TRGM)8
Reduced
Attenuation
Improved
Efficacy
Milligram
Quantities
Amino Acids Are the
Precursors to Neurotransmitters >>
5 HTP
Choline
Arginine
Tyrosine
GABA
Histidine
Serotonin
Acetylcholine
Nitric Oxide
Catecholamine
GABA
Histamine
The Five Components of TCT:
1. Neurotransmitter precursor
2. Uptake Stimulator
3. Neuron activator
4. Adenosine brake inhibitor
5. Attenuation inhibitor
neurotransmittersneurotransmitters
heldinstorage
synapse
release
binding
changein
potential
Receptorsite
9. Therapeutic Area Product Product Class
% of
Monthly
Doses**
Pain and inflammation Theramine Medical Food 42%
Sleep Disorders Sentra PM / GABAdone Medical Food 24%
Osteoarthritis Trepadone Medical Food 12%
Cognitive Disorders, Fatigue, Vision Sentra AM Medical Food 11%
Metabolic Disorders / Obesity AppTrim and AppTrim-D Medical Food 8%
Hypertension Hypertensa Medical Food 2%
Viral Infection / Impaired Immunity ListerV Medical Food 1%
Neuropathy Percura* Medical Food 1%
Nasal Congestion ClearWayz Oral†
Dietary Supplement < 1%
* First Known Oral Stimulation of Stem Cells
** Cumulative for 2010 to 2012, and including convenience kits
† Direct-to-Consumer
Current Products
TARGETED MEDICAL PHARMA (OTCQB:TRGM)9
10. Product Indication Platform Global
Market
Value*
Expected
Commercialization
ASD-AA Autism Quick Release Wafer $26B+ Q3'2014
AP-113†(New oral deliverysystem) Appetite Suppression Quick Release Wafer $390B+ Q4'2014
ESS-1818*††
ChronicAnemia Capsule $10B+ Q1'2015
PulmonaNew Asthma Capsule $12B+ Q2'2015
Oral IGF1††
Diabetes Capsule $15B+ Q3'2015
Tablet
PARK -AA Parkinson's Disease Capsule $3M+ Q4'2015
ALZ- AA Alzheimer's Disease Capsule $10B+ Q4'2015
† † Enteral alternative to injection therapies
* Estimated global market value
Pipeline Products
TARGETED MEDICAL PHARMA (OTCQB:TRGM)10
11. Often embedded in large pharmaceutical
companies
Mead Johnson--17 billion market
Abbot laboratories-- Abbott Nutrition $6 billion
annual sale
Targeted medical Pharma41% per year revenue
growth rate
Nestlé has entered the medical food space
12
Medical Foods - A large poorly recognized marketplace
TARGETED MEDICAL PHARMA (OTCQB:TRGM)12
12. Purchased Pam labs - Vitamin B12 for pregnancy - $350 million
purchase
Purchased Acerra-- Alzheimer's Disease - $250 million
purchase
Damone Medical Nutrition - offer of $4 Billion
CM&D Pharma: Acquired in 2011, specializes in the
development of products for patients with chronic kidney and
gastrointestinal disease
13
Nestlé Medical Food Entry
TARGETED MEDICAL PHARMA (OTCQB:TRGM)13
13. Low-Cost, Shorter Time to Market
TARGETED MEDICAL PHARMA (OTCQB:TRGM)14
Medical Foods Have a Shorter Time to Market due
to GRAS/GRAE status
Development
and Testing
(1 to 2 yrs)
Database
Registration
(3 to 6 mos)
Revenue and
Post-Marketing
MedWatch
(Milestone)
IND
Submission
(Milestone)
Database
Registration
(3 to 6 mos)
Revenue and
Post-Marketing
MedWatch
(Milestone)
Phase 1 to 3 Trials
(6 to 7 yrs)
Development
and Testing
(1 to 2 yrs)
FDA Review
(1 to 2 yrs)
Medical
Food
1 to 2.5 yrs
Drug
8 to 12 yrs
14. Intellectual Property Highlights
TARGETED MEDICAL PHARMA (OTCQB:TRGM)
1 Targeted Cellular Technology® is a five-component system the stimulates the uptake and
utilization of amino acids. It enables efficacy from microgram quantities of amino acids.
*First Known Oral Stimulation
of Stem Cells
16
Seven Patents Issued Three Patents Pending
4 USPTO neurotransmitter-specific patents covering
Targeted Cellular Technology® (TCT)
1 Japanese patent covering TMP’s Targeted Cellular Technology®
1 USPTO patent covering the convenience pack presentation
1 USPTO Billing methodology for physician dispensing of medication
TAT-related patents:
Stimulation of RBC production*
Oral Insulin / Insulin Resistance*
Neuropathy treatment
15. Reimbursement Channels
TARGETED MEDICAL PHARMA (OTCQB:TRGM)17
Medicare Advantage / Secondary
DOD / VA
Medicaid
Tricare
Cigna
BlueCross/Blue Shield
United Healthcare
Aetna
Health Net
Rx Solutions
Medco
Caremark
Catamaran (Walgreens)
MedImpact
Express Scripts
Workers’ Compensation
Private Insurance
Medicare Secondary Insurance Plans
Top PBMs
Top Medical Plans
Channel Types
Government
Reimbursement
Blue = Current payers
Black = In process
16. Balance Sheet
TARGETED MEDICAL PHARMA (OTCQB:TRGM)19
Balance Sheet as of 9/30/13
ASSETS LIABILITIES
Cash And Equivalents 0.168 Accounts Payable 2.237
Short Term Investments - Accrued Exp. 3.195
Total Cash & ST Investments 0.168 Short-term Borrowings 3.997
Accounts Receivable 0.397 Curr. Income Taxes Payable -
Notes Receivable - Def. Tax Liability, Curr. -
Total Receivables 0.397 Other Current Liabilities 4.593
Inventory 0.604 Total Current Liabilities 14.022
Prepaid Exp. - Long-Term Debt -
Deferred Tax Assets, Curr. - Def. Tax Liability, Non-Curr. -
Other Current Assets 1.276 Other Non-Current Liabilities -
Total Current Assets 2.445 Total Liabilities 14.022
Gross Property, Plant & Equipment - Common Stock 0.024
Accumulated Depreciation - Additional Paid In Capital 14.405
Net Property, Plant & Equipment 0.26 Retained Earnings (23.52)
Treasury Stock -
Other Intangibles 2.226 Comprehensive Inc. and Other -
Accounts Receivable Long-Term - Total Common Equity (9.091)
Deferred Tax Assets, LT - Total Equity (9.091)
Other Long-Term Assets -
Total Assets 4.931 Total Liabilities And Equity 4.931
18. Shipments:
Contract
Receivables
Collections:
Recognized
Revenue
Contract Receivables are amounts due
but not yet recognized as revenue
Monthly collections are approximately
1.5% to 2.0%
Collected amounts impact bottom-line
operating revenue almost directly
Contract receivables are constantly
rejuvenated by additional shipments
$14.8 million as of September 30, 2013
Supported by existing claims.
Off-Balance Sheet Asset: Contract Receivables
TARGETED MEDICAL PHARMA (OTCQB:TRGM)21
19. Near-Term Goals
TARGETED MEDICAL PHARMA (OTCQB:TRGM)23
Grow sales to physicians with well-insured (PPO) patients
• A National Sales Manager was hired in March
• A contract was signed to accelerate cash collections
• We are contemplating the acquisition of a distributor network
Begin sales of a dietary supplement product in Q4’2013
Begin sales of first stem-cell product in Q2’2014
• Stimulation of red blood cell production
Grow national sales force
• HI and WA are performing, next are NV and AZ
Bring doctors current on amounts payable to them
• Improving practice management and profitability
20. Targets and Milestones
TARGETED MEDICAL PHARMA (OTCQB:TRGM)24
Revenues - Maintain 40% per year growth rate
Margins
Gross Margin - Continue to grow gross profit by more than 40% per year
EBITDA - Maintain positive EBITDA and net profit growth
Reimbursement - Expand the channels for reimbursement including both private
insurance direct payments for cash and direct to consumer market
Sales Channels - Expand sales channels to include Workers Comp, PPO insurance,
HMO insurance, direct to federal agencies including military, direct to consumer and
direct sales to pharmacies
21. Investment Considerations
PRODUCTS HAVE LOW SIDE-EFFECT PROFILE TARGETED MEDICAL PHARMA (OTCQB:TRGM)25
HIGH DEMAND PRODUCTS ADDRESSING LARGE MARKETS
DIVERSIFIED, GROWING SALES
GROWING ADOPTION OF MEDICAL FOODS
BROAD-REACHING PATENTS AND ROBUST PIPELINE
PROVEN SAFETY AND EFFICACY THROUGH CLINICAL TRIALS
LOW-COST, HIGH-SPEED PRODUCT DEVELOPMENT PLATFORM
TRACK RECORD OF EXCELLENT COST CONTROLS
DIVERSIFIED REIMBURSEMENT SOURCES
SPECIALTY REIMBURSEMENT OPERATIONS
Revenue Growth
Revenue Security
Profitability
Robust Patent Portfolio and Pipeline
“Better health through medical foods”
22. Appendix
TARGETED MEDICAL PHARMA (OTCQB:TRGM)26
Business Team
Key Links
Clearwayz™
Clinical Trial: Sentra PM® and Trazodone (Trazamine®)
Clinical Trial: Theramine® with Ibuprofen (Theraprofen®)
Pain Reduction with Theramine®
Inflammation Reduction with Theramine®
Clinical Trial: Theramine® with Ibuprofen (Theraprofen®)
Disability Reduction with Theramine® and Naproxen (Theraproxen®)
Pharmacoeconomic Analysis of Theramine
Clinical Trial: Sentra PM® and Trazodone (Trazamine®)
Pipeline: Initial Data Indicating ESS-1818 Increases Red Blood Cell Production
Autism Product
Autism Spectral Disorder – Pilot
Appetite Suppression Product
23. Business Team
TARGETED MEDICAL PHARMA (OTCQB:TRGM)27
Legal Counsel Accounting
Investor Relations and Public Relations
FDA
HEALTHCARE
HEALTHCARE
SECURITIES
AUDITORS
INVESTOR
RELATIONS
24. Key Links
TARGETED MEDICAL PHARMA (OTCQB:TRGM)28
Company website: http://www.targetedmedicalpharma.com/
FDA definition of medical food:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation
/MedicalFoods/
Public filings: http://www.sec.gov/cgi-bin/browse-
edgar?action=getcompany&CIK=0001420030&owner=exclude&count=40&hidefilings=0
25. Clearwayz™
TARGETED MEDICAL PHARMA (OTCQB:TRGM)29
Direct to Consumer Market
Rapid inhibition of nasal congestion
with food based pharmaceuticals
26. Clinical Trial: Sentra PM® and Trazodone (Trazamine®)
TARGETED MEDICAL PHARMA (OTCQB:TRGM)30
Source: Shell, et al., “Sentra PM and Trazodone for the management of Sleep Disorders”
Journal of Central Nervous System Disease; 2012:4
2.8
18.9**
-19.3**
-28.4**
-40
-30
-20
-10
0
10
20
30
Time(min)
Less Morning Grogginess
pla/pla pla/tra Sentra PM/pla Sentra PM/tra
**p<0.01
n=111
Change in Visual Analog Scale (VAS) Negative change indicates reduced grogginess
27. Clinical Trial: Theramine® with Ibuprofen (Theraprofen®)
TARGETED MEDICAL PHARMA (OTCQB:TRGM)31
0.09
-6.15
-9.08
-10
-8
-6
-4
-2
0
2
Ibuprofen Theramine Combination
ChangeinVASfrom
Day1today28
Roland Morris Score After 28 Days
n=122
p<(0.01)
-6.2
-9.1
0.1
Source: Shell, et al., “A Double-Blind Controlled Trial of a Single Dose Ibuprofen and an Amino Acid
Medical Food Theramine for the Treatment of Low Back Pain; Publication pending, 2010.
28. Pain Reduction with Theramine®
TARGETED MEDICAL PHARMA (OTCQB:TRGM)32
Source: Shell, et al.,“A Double-Blind Controlled Trial of a Single Dose Naproxen and an Amino Acid Medical
Food Theramine for the Treatment of Low Back Pain”; American Journal of Therapeutics; 2012 108-114
2.95
-44
-65-70
-60
-50
-40
-30
-20
-10
0
10
Percent(%)
Percent Reduction of Roland-Morris Pain Index
Naproxen Theramine Both
* p<0.05
n=126
29. Inflammation Reduction with Theramine®
TARGETED MEDICAL PHARMA (OTCQB:TRGM)33
184.5
-16.7
-78.6-100
-50
0
50
100
150
200
Percent(%)
Change in hsCRP from Baseline at 28 Days
Naproxen Theramine Both
p<0.01
n=126
Source: Shell, et al.,“A Double-Blind Controlled Trial of a Single Dose Naproxen and an Amino Acid Medical
Food Theramine for the Treatment of Low Back Pain”; American Journal of Therapeutics; 2012 108-114
30. Clinical Trial: Theramine® with Ibuprofen (Theraprofen®)
TARGETED MEDICAL PHARMA (OTCQB:TRGM)34
Source: Shell, et al., “A Double-Blind Controlled Trial of a Single Dose Ibuprofen and an Amino Acid
Medical Food Theramine for the Treatment of Low Back Pain; Publication pending, 2010.
31. Disability Reduction with Theramine® and Naproxen (Theraproxen®)
TARGETED MEDICAL PHARMA (OTCQB:TRGM)35
Source: Shell, et al.,“A Double-Blind Controlled Trial of a Single Dose Naproxen and an Amino Acid Medical
Food Theramine for the Treatment of Low Back Pain”; American Journal of Therapeutics; 2012 108-114
-3.4
-32.9
-60.5
-70
-60
-50
-40
-30
-20
-10
0
Percent(%)
Change in Oswestry Disability Index Score at 28 Days
Naproxen Theramine Both
p<0.05
n=126
32. Pharmacoeconomic Analysis of Theramine
TARGETED MEDICAL PHARMA (OTCQB:TRGM)
Theramine NSAID
Product 633,600,000$ 36,000,000$
GI Bleed Treatment - 225,000,000
Protective Medications - 432,000,000
Laboratory Testing 1,000,000 75,000,000
Negative GI Workup - 144,000,000
Total 634,600,000$ 912,000,000$
Estimated Comparative Annual Treatment Cost
Over 45,000,000 capsules administered with no
reported G.I. bleeds or deaths.
Use of Theramine Potentially Reduces the Cost of Care by >30%
36
Sources: Silver DS, et al. Theramine (A Medical Food) Versus Non-Steroidal Anti Inflammatory Agents in Elderly Patients: A Pharmacoeconomic Analysis/
Journal of Pharmacy Research 2012,5(5),2806-2809; and Gaskin DJ, Richardy P. The Economic Costs of Pain in the United States/ The Journal of
Pain, Vol 13, No 8 (August), 2012: pp 715-724
33. Clinical Trial: Sentra PM® and Trazodone (Trazamine®)
TARGETED MEDICAL PHARMA (OTCQB:TRGM)37
1Pittsburgh Sleep Quality Index
Source: Shell, et al., “Sentra PM and Trazodone for the management of Sleep Disorders”
Journal of Central Nervous System Disease; 2012:4
1.0
2.0
3.9**
6.5**
0
1
2
3
4
5
6
7
10-PointScale
Sleep Quality (PSQI1)
Change from Baseline at Day 14
Placebo Trazodone Sentra PM Both
**p<0.01
n=111
34. 1 Effect on one patient in pre-clinical trials. Pre-clinical trials resulted in an 80% response rate.
Pipeline: Initial Data Indicating ESS-1818 Increases Red Blood Cell Production
TARGETED MEDICAL PHARMA (OTCQB:TRGM)38
Source: Initial data from an open label study of an oral amino acid-based erythrocyte
stimulating system (ESS) for the treatment of chronic anemia; 2013.
-
20,000
40,000
60,000
80,000
100,000
120,000
1 2 5 7 17
Increased Reticulocyte Count in Healthy Volunteers1
Treatment
Initiated
Treatment
Discontinued
Primitive
Reticulocytes
(illustration)
35. Autism Product
TARGETED MEDICAL PHARMA (OTCQB:TRGM)39
0
1
2
3
4
5
1 2 3 4 5 6 7 8
Day
Initiation of
Treatment
Number of Events Involving
Anger, Frustration, and Self-Directed Aggressive Behavior
Nutritional Deficiency
Initial Data
Development Status
Distribution Channels
36. Autism Spectral Disorder - Pilot
TARGETED MEDICAL PHARMA (OTCQB:TRGM)40
34 patients aged 7- 21
ASD symptoms including mood disorders, explosive behavior and
social isolation
33 experienced a significant reduction of symptoms
Compared to baseline the average improvement was 83%
The range was 50 to 100 %
Investigator Initiated Observations: