V-Go is a single-use, fully disposable insulin delivery device that provides basal and bolus insulin. It addresses the needs of the 4.6 million Type 2 diabetes patients in the US who require insulin but are not achieving treatment goals. Extensive clinical data shows V-Go lowers A1C levels and total daily insulin dose. It has established reimbursement through pharmacy benefits, making it cost-neutral for payors and patients compared to insulin pens. Valeritas sees significant growth opportunities by expanding its sales force to reach more prescribers.
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET). Phase 1 and 2 trials show it has a favorable safety profile compared to immediate release anagrelide with fewer adverse events. A pivotal Phase 3 trial is planned for Q2 to initiate comparing GALE-401 to best available therapies in patients who failed or were intolerant to hydroxyurea.
NeuVax is an investigational immunotherapy targeting HER2-positive breast cancer. It contains an immunodominant HER2 peptide that stimulates CD8+ T-cells to destroy tumor cells. Phase 2 trials are ongoing in various breast cancer populations in combination with Hercept
A hematology and oncology focused company has a diversified pipeline with multiple mid-to-late stage clinical trials. Their lead program is GALE-401 for essential thrombocythemia, which is a controlled release formulation of anagrelide in Phase 3 ready. Their immunotherapy programs include NeuVax for HER2-positive breast cancer in multiple Phase 2 trials in combination with Herceptin, and GALE-301/302 targeting folate binding protein in early stage trials.
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET) as a potential third line therapy. Phase 1 and 2 clinical trials showed that GALE-401 maintains platelet lowering effects while reducing peak plasma concentrations and adverse events compared to immediate release anagrelide. The company plans to initiate a Phase 3 trial in Q2 2017 to further evaluate GALE-401 in ET patients who are intolerant or refractory to first and second line therapies such as hydroxyurea and anagrelide.
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
GALE-401 is a controlled release formulation of anagrelide targeting patients who are intolerant to immediate release anagrelide, the current standard of care for third line treatment of essential thrombocythemia. Phase 1 and 2 clinical trials demonstrated GALE-401's improved pharmacokinetic profile with lower Cmax and longer half-life, maintaining platelet lowering effects while showing better tolerability. A Phase 3 trial is planned to initiate in Q2 2017. NeuVax is an immunotherapy targeting HER2-expressing cancers by eliciting a CD8+ T-cell immune response. Current clinical trials are investigating NeuVax in combination with trastuzumab for the treatment of HER2 1+/2+ breast cancer
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET). Phase 1 and 2 trials show it has a favorable safety profile compared to immediate release anagrelide with fewer adverse events. A pivotal Phase 3 trial is planned for Q2 to initiate comparing GALE-401 to best available therapies in patients who failed or were intolerant to hydroxyurea.
NeuVax is an investigational immunotherapy targeting HER2-positive breast cancer. It contains an immunodominant HER2 peptide that stimulates CD8+ T-cells to destroy tumor cells. Phase 2 trials are ongoing in various breast cancer populations in combination with Hercept
A hematology and oncology focused company has a diversified pipeline with multiple mid-to-late stage clinical trials. Their lead program is GALE-401 for essential thrombocythemia, which is a controlled release formulation of anagrelide in Phase 3 ready. Their immunotherapy programs include NeuVax for HER2-positive breast cancer in multiple Phase 2 trials in combination with Herceptin, and GALE-301/302 targeting folate binding protein in early stage trials.
GALE-401 is a proprietary controlled release formulation of anagrelide being developed for the treatment of essential thrombocythemia (ET) as a potential third line therapy. Phase 1 and 2 clinical trials showed that GALE-401 maintains platelet lowering effects while reducing peak plasma concentrations and adverse events compared to immediate release anagrelide. The company plans to initiate a Phase 3 trial in Q2 2017 to further evaluate GALE-401 in ET patients who are intolerant or refractory to first and second line therapies such as hydroxyurea and anagrelide.
This document provides a summary of Galena Biopharma's Q3 2016 financial results and corporate update. It discusses interim results from the Phase 3 PRESENT trial of NeuVax showing a potential delay in disease-free survival and highlights the risk of pseudoprogression in cancer immunotherapy trials. It also reviews the company's immunotherapy development pipeline, including NeuVax programs in breast and gastric cancer and GALE-301/302 programs in ovarian and breast cancer. Finally, it discusses the company's cash position and expected milestones for the remainder of 2016.
GALE-401 is a controlled release formulation of anagrelide targeting patients who are intolerant to immediate release anagrelide, the current standard of care for third line treatment of essential thrombocythemia. Phase 1 and 2 clinical trials demonstrated GALE-401's improved pharmacokinetic profile with lower Cmax and longer half-life, maintaining platelet lowering effects while showing better tolerability. A Phase 3 trial is planned to initiate in Q2 2017. NeuVax is an immunotherapy targeting HER2-expressing cancers by eliciting a CD8+ T-cell immune response. Current clinical trials are investigating NeuVax in combination with trastuzumab for the treatment of HER2 1+/2+ breast cancer
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
This document provides Galena's Q2 2016 financial results and corporate update. It discusses Galena's product pipeline including GALE-401 for essential thrombocythemia, NeuVax for breast cancer and gastric cancer, and GALE-301/302 for ovarian and breast cancer. For GALE-401, it outlines positive preliminary results from a Phase 2 trial and plans for a Phase 2/3 trial. For NeuVax, it describes ongoing Phase 2 trials in breast cancer. For GALE-301/302, it discusses a Phase 1/2a trial showing preliminary efficacy for GALE-301. The document also provides Galena's Q2 2016 financial results and cash position.
Experts from Informa’s Medtrack, Trialtrove and Strategic Transactions teams presented a panel discussion at the recent T3 Conference in Orlando, Florida.
Clinical application of cardiovascular pharmacogeneticsGowhar Shafi
This document discusses the clinical application of cardiovascular pharmacogenetics. It reviews major pharmacogenetic variants associated with commonly used cardiovascular medications such as antiplatelet agents, warfarin, statins, beta-blockers, diuretics, and antiarrhythmic drugs. Three principal classes of pharmacogenetic markers are discussed: 1) pharmacokinetic variants that influence drug metabolism and transport, 2) pharmacodynamic variants that influence drug targets, and 3) variants related to underlying disease mechanisms. For each drug class, specific genetic variants are described and their potential clinical implications are highlighted.
Several drugs failed in clinical trials in 2017, including:
- Brontictuzumab and tarextuzumab, anticancer stem cell antibodies from OncoMed Pharmaceuticals, failed trials for colorectal and small-cell lung cancer respectively.
- CA4P from Mateon Therapeutics failed a phase II/III trial for ovarian cancer.
- Fovista from Opthotech and Novartis failed two phase III trials for wet age-related macular degeneration.
- JCAR015, a CAR-T cancer immunotherapy from Juno Therapeutics, was halted after patient deaths in a phase II trial for leukemia.
- Several other drugs like levosimendan
Oncoceutics leerink global healthcare 2015oncoceutics
- Oncoceutics has discovered a novel class of compounds called ONC201 that shows compelling efficacy against aggressive and refractory tumors in preclinical studies.
- Phase I/II clinical trials are underway at leading cancer centers to evaluate ONC201's safety and efficacy in hematological malignancies and solid tumors.
- ONC201 engages multiple critical cancer pathways without toxicity, demonstrating potential as a first-in-class therapeutic for treatment-resistant cancers.
- The document is a corporate presentation by Roberto Bellini, President and CEO of BELLUS Health Inc., discussing the company's lead product candidate KIACTA for treating AA amyloidosis.
- KIACTA is currently in a Phase 3 confirmatory study expected to report results in mid-2016. It has shown strong results in reducing kidney worsening events in a prior Phase 2/3 study.
- BELLUS has a partnership with Auven Therapeutics to fully fund the KIACTA development program. Auven will fund 100% of costs with proceeds from any future KIACTA deal or commercialization to be shared 50-50.
- BELLUS is also exploring
HIV Alert- Novel Strategies and Agents for HIV Management.2016hivlifeinfo
In this downloadable slideset, Daniel R. Kuritzkes, MD, and Paul E. Sax, MD, review potential future HIV treatment strategies—including long-acting ART, dual-therapy regimens, and investigational agents—and discuss where these strategies might fit into the current therapeutic landscape.
Format: Microsoft PowerPoint (.ppt)
File size: 926 KB
Date posted: 6/21/2016
On February 10, 2020, Clarivate Analytics released the "The 2020 Cortellis Drugs to Watch" annual report, predicting 11 new drugs that will be launched in 2020 and with sales expected to exceed $ 1 billion in 2024. Among these 11 drugs, 2 are anti-tumor drugs. Coincidentally, these 2 drugs are Antibody–Drug Conjugates (ADC).
The document summarizes several key studies presented at the 2016 American Society of Hematology (ASH) Annual Meeting. It discusses results from the GALLIUM and ALCANZA studies showing improved outcomes for obinutuzumab and brentuximab vedotin, respectively, in follicular lymphoma and cutaneous T-cell lymphoma. It also summarizes positive results from maintenance rituximab in mantle cell lymphoma and lenalidomide in high-risk chronic lymphocytic leukemia. Finally, it discusses advances in CAR T-cell therapy and results from studies of pacritinib and transplant approaches in myeloma.
One in 8 U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. Following breast cancer surgery in the adjuvant setting, a HER2/neu 3+ patient typically receives Herceptin® in the first year, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years after surgery. Herceptin® has been shown to reduce recurrence rates from 25% to 12% in the adjuvant setting. In the neoadjuvant setting, a patient receives treatment before surgery and based on the results of a biopsy at surgery, will receive the same or more potent treatment after surgery. Kadcyla® has been shown to reduce recurrence rates from 22% to 11% in the neoadjuvant setting. Accordingly, we believe that GP2 may be used to address the 50% of recurring patients who do not respond to either Herceptin® or Kadcyla®.
This presentation summarizes an oncology focused immunotherapy company. Key points include:
- The company has a pioneering immunotherapy technology that induces, activates and causes proliferation of cytotoxic T-cells to target cancer.
- Clinical development is focused on secondary prevention in cancer survivors to redefine the standard of care with targeted therapies to prevent cancer recurrence.
- The company has two lead programs - NeuVax targeting HER2 positive breast and gastric cancers, and GALE-301/302 targeting folate binding protein in ovarian and endometrial cancers.
- NeuVax is in a Phase 3 clinical trial (PRESENT) in breast cancer and other trials are ongoing or planned in breast and gastric cancers. GALE-
The KEYNOTE-052 study evaluated pembrolizumab monotherapy in the first-line treatment of advanced urothelial carcinoma in patients ineligible for cisplatin-based chemotherapy. In the planned interim analysis of the first 100 patients, the objective response rate was 24%, including a complete response in 6% of patients. Fifteen percent of patients experienced stable disease as their best response. The study aims to determine the optimal PD-L1 expression cut point for predicting response to pembrolizumab.
Big Data and Analytic Strategy for Clinical ResearchBBCR Consulting
This document discusses how big data and analytics can help simplify clinical research and make trials more cost-effective. It begins by providing context on how Henry Ford revolutionized car manufacturing using specialized machinery and standardized processes. Similarly, big data is creating a radical shift in how research is conducted by enabling the analysis of large and complex datasets. The rest of the document outlines opportunities in areas like personalized medicine, challenges like dealing with diverse and fast-changing data, and how innovation in clinical research design can help address these challenges to develop more targeted treatments.
An oncology-focused immunotherapy company is conducting a Phase 3 clinical trial of its lead product, NeuVax, for the prevention of breast cancer recurrence in early-stage, node-positive patients. The trial is fully enrolled with 758 participants and is evaluating NeuVax compared to placebo on disease-free survival. NeuVax targets the HER2 protein and consists of an HLA-A2/A3-restricted peptide that elicits CD8+ T-cell responses. Previous clinical trials demonstrated NeuVax has a positive safety profile and signals of efficacy in reducing recurrence rates. An interim analysis is upcoming in mid-2016, with final results expected in 2018.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay
1) The company has a diversified pipeline including hematology and immunotherapy programs with multiple clinical trials in mid to late stages.
2) Their lead hematology candidate, GALE-401, is a controlled release formulation of anagrelide for the treatment of essential thrombocythemia that has demonstrated an improved safety profile over immediate release formulations in clinical trials to date.
3) Their immunotherapy programs include NeuVax for HER2-positive breast cancer, which has shown strong CD8+ T-cell responses in clinical trials both as a single agent and in combination with trastuzumab.
The document summarizes the annual meeting of WD-40 Company stockholders held on December 13, 2016. It provides an overview of WD-40 Company, which markets maintenance products under brands like WD-40, 3-IN-ONE, and GT85, as well as homecare and cleaning products. The document discusses WD-40 Company's origins, brands, culture and values, strategic focus areas within its circle of competence, and strategic initiatives to drive growth over the next several years. Key goals include doubling WD-40 Multi-Use Product sales and growing the WD-40 Specialist line to $125 million in sales by 2025.
This document is an investor presentation by CB&I that provides an overview of the company. CB&I is a leading provider of technology and infrastructure for the energy industry, focusing on LNG, petrochemicals, refining, and natural gas power. It has over $18.5 billion in backlog and generated $802 million in operating cash flow in 2016. The presentation outlines CB&I's competitive advantages in experience, global reach, vertically integrated project execution, and technology portfolio. It also announces plans to divest its Capital Services business and use the proceeds to reduce debt, in order to focus on its core E&C, fabrication, and technology capabilities. CB&I provides 2017 guidance for revenue between $
Vulcan Materials Company presented at a management meeting on September 29, 2016. The presentation discussed Vulcan's strategy of empowering strong local leadership, highlighted ongoing commitment to safety, customers, communities, and shareholders, and outlined expectations for a multi-year construction recovery ahead. While pre-construction project pipelines have strengthened, recent lags in construction starts and ongoing capacity constraints in the construction sector are slowing the pace of growth in the near term. Vulcan believes underlying demand drivers remain firmly in place to support a sustained recovery over the longer term.
Oshkosh Corporation reported financial results for the first quarter of fiscal year 2017. Net sales declined 3.2% to $1.21 billion due to lower sales in access equipment and defense, though this was partially offset by higher sales in fire and emergency. Earnings per share increased to $0.26 from $0.19 in the prior year. The company also announced plans to restructure operations in Europe and North America to reduce costs in the access equipment segment by $20-25 million annually. Oshkosh reaffirmed its outlook for fiscal year 2017 adjusted earnings per share of $3.00 to $3.40.
Connecticut Water Service, Inc. 2016 Annual Investor-Analyst Callctwater
This document provides an overview of Connecticut Water Service, Inc.'s 2nd Annual Investor/Analyst Presentation on December 13, 2016. It discusses Connecticut Water's forward-looking statements, market data including total enterprise value and market capitalization, regulated and non-regulated revenues, dividend yield, and credit rating. The presentation also summarizes Connecticut Water's value proposition as a regulated water utility focused on infrastructure investment and acquisitions, its growth strategy, building blocks of environmental stewardship, customers, employees, and shareholders. It provides details on the company's regulated operations, constructive regulatory environment, acquisition track record, pending acquisitions, and commitments to environmental, social and governance practices. Financial charts are also included showing historical revenues
Experts from Informa’s Medtrack, Trialtrove and Strategic Transactions teams presented a panel discussion at the recent T3 Conference in Orlando, Florida.
Clinical application of cardiovascular pharmacogeneticsGowhar Shafi
This document discusses the clinical application of cardiovascular pharmacogenetics. It reviews major pharmacogenetic variants associated with commonly used cardiovascular medications such as antiplatelet agents, warfarin, statins, beta-blockers, diuretics, and antiarrhythmic drugs. Three principal classes of pharmacogenetic markers are discussed: 1) pharmacokinetic variants that influence drug metabolism and transport, 2) pharmacodynamic variants that influence drug targets, and 3) variants related to underlying disease mechanisms. For each drug class, specific genetic variants are described and their potential clinical implications are highlighted.
Several drugs failed in clinical trials in 2017, including:
- Brontictuzumab and tarextuzumab, anticancer stem cell antibodies from OncoMed Pharmaceuticals, failed trials for colorectal and small-cell lung cancer respectively.
- CA4P from Mateon Therapeutics failed a phase II/III trial for ovarian cancer.
- Fovista from Opthotech and Novartis failed two phase III trials for wet age-related macular degeneration.
- JCAR015, a CAR-T cancer immunotherapy from Juno Therapeutics, was halted after patient deaths in a phase II trial for leukemia.
- Several other drugs like levosimendan
Oncoceutics leerink global healthcare 2015oncoceutics
- Oncoceutics has discovered a novel class of compounds called ONC201 that shows compelling efficacy against aggressive and refractory tumors in preclinical studies.
- Phase I/II clinical trials are underway at leading cancer centers to evaluate ONC201's safety and efficacy in hematological malignancies and solid tumors.
- ONC201 engages multiple critical cancer pathways without toxicity, demonstrating potential as a first-in-class therapeutic for treatment-resistant cancers.
- The document is a corporate presentation by Roberto Bellini, President and CEO of BELLUS Health Inc., discussing the company's lead product candidate KIACTA for treating AA amyloidosis.
- KIACTA is currently in a Phase 3 confirmatory study expected to report results in mid-2016. It has shown strong results in reducing kidney worsening events in a prior Phase 2/3 study.
- BELLUS has a partnership with Auven Therapeutics to fully fund the KIACTA development program. Auven will fund 100% of costs with proceeds from any future KIACTA deal or commercialization to be shared 50-50.
- BELLUS is also exploring
HIV Alert- Novel Strategies and Agents for HIV Management.2016hivlifeinfo
In this downloadable slideset, Daniel R. Kuritzkes, MD, and Paul E. Sax, MD, review potential future HIV treatment strategies—including long-acting ART, dual-therapy regimens, and investigational agents—and discuss where these strategies might fit into the current therapeutic landscape.
Format: Microsoft PowerPoint (.ppt)
File size: 926 KB
Date posted: 6/21/2016
On February 10, 2020, Clarivate Analytics released the "The 2020 Cortellis Drugs to Watch" annual report, predicting 11 new drugs that will be launched in 2020 and with sales expected to exceed $ 1 billion in 2024. Among these 11 drugs, 2 are anti-tumor drugs. Coincidentally, these 2 drugs are Antibody–Drug Conjugates (ADC).
The document summarizes several key studies presented at the 2016 American Society of Hematology (ASH) Annual Meeting. It discusses results from the GALLIUM and ALCANZA studies showing improved outcomes for obinutuzumab and brentuximab vedotin, respectively, in follicular lymphoma and cutaneous T-cell lymphoma. It also summarizes positive results from maintenance rituximab in mantle cell lymphoma and lenalidomide in high-risk chronic lymphocytic leukemia. Finally, it discusses advances in CAR T-cell therapy and results from studies of pacritinib and transplant approaches in myeloma.
One in 8 U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. Following breast cancer surgery in the adjuvant setting, a HER2/neu 3+ patient typically receives Herceptin® in the first year, with the hope that their breast cancer will not recur, and with the odds of recurrence slowly decreasing over the first 5 years after surgery. Herceptin® has been shown to reduce recurrence rates from 25% to 12% in the adjuvant setting. In the neoadjuvant setting, a patient receives treatment before surgery and based on the results of a biopsy at surgery, will receive the same or more potent treatment after surgery. Kadcyla® has been shown to reduce recurrence rates from 22% to 11% in the neoadjuvant setting. Accordingly, we believe that GP2 may be used to address the 50% of recurring patients who do not respond to either Herceptin® or Kadcyla®.
This presentation summarizes an oncology focused immunotherapy company. Key points include:
- The company has a pioneering immunotherapy technology that induces, activates and causes proliferation of cytotoxic T-cells to target cancer.
- Clinical development is focused on secondary prevention in cancer survivors to redefine the standard of care with targeted therapies to prevent cancer recurrence.
- The company has two lead programs - NeuVax targeting HER2 positive breast and gastric cancers, and GALE-301/302 targeting folate binding protein in ovarian and endometrial cancers.
- NeuVax is in a Phase 3 clinical trial (PRESENT) in breast cancer and other trials are ongoing or planned in breast and gastric cancers. GALE-
The KEYNOTE-052 study evaluated pembrolizumab monotherapy in the first-line treatment of advanced urothelial carcinoma in patients ineligible for cisplatin-based chemotherapy. In the planned interim analysis of the first 100 patients, the objective response rate was 24%, including a complete response in 6% of patients. Fifteen percent of patients experienced stable disease as their best response. The study aims to determine the optimal PD-L1 expression cut point for predicting response to pembrolizumab.
Big Data and Analytic Strategy for Clinical ResearchBBCR Consulting
This document discusses how big data and analytics can help simplify clinical research and make trials more cost-effective. It begins by providing context on how Henry Ford revolutionized car manufacturing using specialized machinery and standardized processes. Similarly, big data is creating a radical shift in how research is conducted by enabling the analysis of large and complex datasets. The rest of the document outlines opportunities in areas like personalized medicine, challenges like dealing with diverse and fast-changing data, and how innovation in clinical research design can help address these challenges to develop more targeted treatments.
An oncology-focused immunotherapy company is conducting a Phase 3 clinical trial of its lead product, NeuVax, for the prevention of breast cancer recurrence in early-stage, node-positive patients. The trial is fully enrolled with 758 participants and is evaluating NeuVax compared to placebo on disease-free survival. NeuVax targets the HER2 protein and consists of an HLA-A2/A3-restricted peptide that elicits CD8+ T-cell responses. Previous clinical trials demonstrated NeuVax has a positive safety profile and signals of efficacy in reducing recurrence rates. An interim analysis is upcoming in mid-2016, with final results expected in 2018.
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
All manuscripts are subject to rapid peer review. Those of high quality (not previously published and not under consideration for publication in another journal) will be published without delay
1) The company has a diversified pipeline including hematology and immunotherapy programs with multiple clinical trials in mid to late stages.
2) Their lead hematology candidate, GALE-401, is a controlled release formulation of anagrelide for the treatment of essential thrombocythemia that has demonstrated an improved safety profile over immediate release formulations in clinical trials to date.
3) Their immunotherapy programs include NeuVax for HER2-positive breast cancer, which has shown strong CD8+ T-cell responses in clinical trials both as a single agent and in combination with trastuzumab.
The document summarizes the annual meeting of WD-40 Company stockholders held on December 13, 2016. It provides an overview of WD-40 Company, which markets maintenance products under brands like WD-40, 3-IN-ONE, and GT85, as well as homecare and cleaning products. The document discusses WD-40 Company's origins, brands, culture and values, strategic focus areas within its circle of competence, and strategic initiatives to drive growth over the next several years. Key goals include doubling WD-40 Multi-Use Product sales and growing the WD-40 Specialist line to $125 million in sales by 2025.
This document is an investor presentation by CB&I that provides an overview of the company. CB&I is a leading provider of technology and infrastructure for the energy industry, focusing on LNG, petrochemicals, refining, and natural gas power. It has over $18.5 billion in backlog and generated $802 million in operating cash flow in 2016. The presentation outlines CB&I's competitive advantages in experience, global reach, vertically integrated project execution, and technology portfolio. It also announces plans to divest its Capital Services business and use the proceeds to reduce debt, in order to focus on its core E&C, fabrication, and technology capabilities. CB&I provides 2017 guidance for revenue between $
Vulcan Materials Company presented at a management meeting on September 29, 2016. The presentation discussed Vulcan's strategy of empowering strong local leadership, highlighted ongoing commitment to safety, customers, communities, and shareholders, and outlined expectations for a multi-year construction recovery ahead. While pre-construction project pipelines have strengthened, recent lags in construction starts and ongoing capacity constraints in the construction sector are slowing the pace of growth in the near term. Vulcan believes underlying demand drivers remain firmly in place to support a sustained recovery over the longer term.
Oshkosh Corporation reported financial results for the first quarter of fiscal year 2017. Net sales declined 3.2% to $1.21 billion due to lower sales in access equipment and defense, though this was partially offset by higher sales in fire and emergency. Earnings per share increased to $0.26 from $0.19 in the prior year. The company also announced plans to restructure operations in Europe and North America to reduce costs in the access equipment segment by $20-25 million annually. Oshkosh reaffirmed its outlook for fiscal year 2017 adjusted earnings per share of $3.00 to $3.40.
Connecticut Water Service, Inc. 2016 Annual Investor-Analyst Callctwater
This document provides an overview of Connecticut Water Service, Inc.'s 2nd Annual Investor/Analyst Presentation on December 13, 2016. It discusses Connecticut Water's forward-looking statements, market data including total enterprise value and market capitalization, regulated and non-regulated revenues, dividend yield, and credit rating. The presentation also summarizes Connecticut Water's value proposition as a regulated water utility focused on infrastructure investment and acquisitions, its growth strategy, building blocks of environmental stewardship, customers, employees, and shareholders. It provides details on the company's regulated operations, constructive regulatory environment, acquisition track record, pending acquisitions, and commitments to environmental, social and governance practices. Financial charts are also included showing historical revenues
Rockwell Automation is a global company dedicated to industrial automation and information. It has over 22,000 employees, $5.9 billion in fiscal 2016 sales, and serves customers in over 80 countries. The company provides a broad range of industrial automation products and solutions, including control systems, software, industrial networks, safety systems, and more. It focuses on innovation and domain expertise to help customers achieve faster time to market, improved asset utilization, lower total cost of ownership, and enterprise risk management.
Celp investor presentation march 2017 finalCypressEnergy
Cypress Energy Partners provides pipeline inspection and integrity services as well as water and environmental services to midstream energy customers. Over 85% of its customers are investment grade companies. It inspects over 46,000 miles of pipelines annually using in-line inspection tools to identify anomalies, and performs over 12,000 excavations for further inspection or maintenance. Regulations require pipeline operators to inspect lines every 5-7 years, providing a recurring need for Cypress' inspection services over the 40-60 year lifespan of pipelines.
This document provides an investor presentation for Cobre del Mayo, a Mexican mining company that operates the Piedras Verdes open-pit copper mine. It summarizes Cobre del Mayo's operations, financial performance, cost reduction strategies, mineral reserves, and an outlook for future copper prices. Declining copper prices since 2014 have significantly impacted Cobre del Mayo's sales, though cost reductions have lowered cash costs. An updated resource report estimates reserves sufficient for a 14-year mine life. Analysis of future copper demand and the incentive price needed for new production suggests prices will rise to incentivize supply.
This document provides an overview and update of First Quantum Minerals for 2017. It begins with cautionary notes about forward-looking statements. It then summarizes that First Quantum is a leading copper producer that has seen unrivaled growth in copper production through projects like Sentinel mine and Cobre Panama. Cobre Panama remains on track for phased commissioning beginning in 2018. First Quantum also had a strong 2016 with record production and sales, lower costs, and strengthened financial position. Guidance is given for 2017-2019 production volumes and costs. Capital expenditure plans include continuing investment in Cobre Panama.
Discover reported financial results for full year 2016 and 4Q16. Key highlights include:
- 2016 diluted EPS grew 12% to $5.77 driven by loan growth and lower expenses.
- 4Q16 diluted EPS increased 23% to $1.40 due to higher net interest income and lower expenses.
- Loan balances and credit card sales volumes increased year-over-year for both periods. However, provision for loan losses grew due to higher net charge-offs from loan growth and seasoning.
The document provides an operations report for February 14, 2017. It includes forward-looking statements about guidance, projections, and objectives that involve risks and uncertainties. It also discusses non-GAAP financial measures used by the company such as adjusted EBITDA and distributable cash flow. For 2016, the company delivered on its financial and operational priorities by outperforming its adjusted EBITDA guidance, meeting its capital expenditure targets, and achieving distribution coverage above 1.0x. ENLC also met its cash available for distribution guidance and distribution coverage targets for 2016.
February 2017 Investor Relations Q4 2016 PresentationXOGroup
XO Group Inc. presented its Q4 2016 financial results and business update. Key highlights included:
- Revenue for Q4 increased 7% year-over-year to $41.0 million. Transaction revenue grew 55% year-over-year.
- Adjusted EBITDA for Q4 was $9.2 million, up from $7.9 million in the prior year.
- The company ended 2016 with $106 million in cash and cash equivalents after repurchasing $4.0 million of stock.
- XO's family of brands saw continued growth in monthly unique visitors across its wedding and baby platforms.
The document discusses the results of a study on the impact of climate change on global wheat production. Researchers found that rising temperatures will significantly reduce wheat yields across different regions of the world by the end of the century. Under a high emissions scenario, wheat production is projected to decrease between 6-27% globally depending on the region, posing substantial risks to global food security.
Valeritas Investor Presentation August 2016valeritasir
This document provides an investor presentation for Valeritas Holdings, Inc. discussing their V-Go disposable insulin delivery device. It highlights the large market opportunity in the Type 2 diabetes market, the clinical benefits shown to improve A1C and quality of life, and the established reimbursement and commercial infrastructure. The presentation provides an overview of the company's commercialization progress and strategy to expand adoption and sales of V-Go as a simple, discreet, cost-effective basal-bolus insulin delivery option.
AIS Investor presentation.pw. february 2011rymankoly
This document summarizes Antares Pharma's business and product pipeline. It highlights the company's growing revenues, deep product pipeline including late stage programs like Anturol for overactive bladder and partnerships with Teva and BioSante. Antares has a strong cash position of over $10 million and is reducing its cash burn rate while advancing multiple proprietary and partnered programs toward commercialization and significant news flow.
The document provides an overview of Pyxis Tankers Inc., a maritime transportation company that operates a fleet of six tankers. It summarizes the company's strategy of focusing on medium range tankers, maintaining a diversified chartering approach and competitive cost structure. It also provides context on the product tanker market, including evolving trade routes creating more demand, declining orderbooks, and new environmental regulations expected to increase scrapping of older vessels in the fleet.
Level 3 Communications provides a presentation on its business and financial overview. Key points include:
- Level 3 has over $8 billion in annual revenue and provides connectivity to over 60 countries globally.
- The company focuses on enterprise customers and expanding its network to capture more market share.
- Financially, Level 3 has improved its credit ratings and reduced leverage over time through prudent management.
- CenturyLink plans to acquire Level 3 to create a leading global communications provider with increased scale.
- The document provides an overview of AuRico Metals' Kemess Underground development project and royalty portfolio.
- Kemess Underground is an advanced-stage gold and copper project in British Columbia with over 12 million ounces of gold equivalent resources across all categories. It benefits from $1 billion of existing infrastructure.
- AuRico also holds a portfolio of high-quality royalty interests focused on Canada and Australia, which are expected to generate $8-8.4 million in royalty revenue in 2017.
- The presentation is for a company that owns and operates medium range product tankers.
- The company has a young, eco-friendly fleet of 6 tankers with an average age of 5.8 years. It employs a mixed chartering strategy of both time charters and spot market exposure.
- The product tanker market is positioned for improvement due to increasing global oil trade driven by changes in refinery capacity and trade routes. Tighter environmental regulations will also reduce the fleet size.
Valeritas provides a corporate presentation on their V-Go insulin delivery device. Key points include:
- V-Go is a single-use, fully disposable insulin delivery device worn like a patch that provides 24-hour basal and bolus insulin delivery with no programming.
- It is designed to simplify insulin delivery for patients with type 2 diabetes compared to multiple daily injections, improving adherence and health outcomes.
- With over 4.5 million patients in the US with type 2 diabetes taking insulin but not at glucose goals, V-Go represents a significant market opportunity of over $1 billion if it captures 15% market share.
- Clinical studies show V-Go lowers A1C, improves quality of
Art 1236 rev a-valeritas investor deck 2.0 final_031218bvaleritasir
Valeritas is a medical technology company focused on improving health and simplifying life for people with diabetes. Their flagship product, V-Go, is a wearable insulin delivery device that provides both basal and bolus insulin through a single-use, disposable patch. V-Go aims to help the millions of type 2 diabetes patients in the US who take insulin but struggle with adherence to multiple daily injections. Valeritas believes V-Go can become the preferred insulin delivery method for these patients by eliminating the need for injections. They are currently growing revenue quarter-over-quarter and targeting a $1.6 billion market opportunity by achieving a 15% share of the type 2 diabetes patients in the US who are not reaching their
Art 1236 rev a-valeritas investor deck 2.0 final_031218bvaleritasir
Valeritas is a medical technology company focused on improving health and simplifying life for people with diabetes. Their flagship product, V-Go, is a wearable insulin delivery device that provides both basal and bolus insulin through a single-use, disposable patch. V-Go aims to help the millions of type 2 diabetes patients in the US who take insulin but struggle with adherence to multiple daily injections. Valeritas believes V-Go can become the preferred insulin delivery method for these patients by eliminating the need for injections. They are currently growing revenue quarter-over-quarter and targeting a $1.6 billion market opportunity by achieving a 15% share of the type 2 diabetes patients in the US who are not reaching their
Valeritas is presenting their V-Go insulin delivery device to investors. The device addresses unmet needs for the 4.6 million type 2 diabetes patients in the US who require basal and bolus insulin but are not achieving optimal blood sugar control. Extensive clinical studies show that switching to V-Go significantly reduces A1C levels and total daily insulin dose compared to multiple daily injections, improving health outcomes and quality of life. Valeritas has commercialized V-Go in the US and aims to capitalize on the large $15 billion market opportunity for these patients through a focused commercial strategy and efficient manufacturing model.
Art 920 rev-d-valeritas investor presentation_final_04.03.17valeritasir
Valeritas is an investor presentation for NASDAQ: VLRX discussing their V-Go wearable insulin delivery device. In 3 sentences:
Valeritas provides a simple, discreet and easy-to-use insulin delivery device called V-Go that has strong clinical data showing reductions in A1C levels. V-Go has established reimbursement and is a cost-effective option for both patients and payors. The presentation outlines Valeritas' commercial strategy and financial profile, demonstrating potential for revenue growth while reducing operating expenses and cash burn.
1) The document provides confidential information about Valeritas, Inc. to shareholders, including an overview of their V-Go insulin delivery device, clinical data demonstrating its effectiveness at lowering A1C levels and daily insulin doses, and the experience and focus of the leadership team.
2) Valeritas believes V-Go is well-positioned for success due to its ability to address unmet needs in the large type 2 diabetes market, its demonstrated commercial traction, established reimbursement, and capital efficient strategy.
3) Clinical studies show patients experienced statistically significant improvements in A1C levels and reductions in daily insulin needs after switching to V-Go from multiple daily injections.
Art 1236 rev c-valeritas investor deck 2.0_final_080618 web versionvaleritasir
Valeritas is a medical technology company focused on improving health and simplifying life for people with diabetes. Their flagship product, V-Go, is a wearable insulin delivery device for patients with type 2 diabetes. The presentation discusses Valeritas' significant market opportunity in the global diabetes pandemic, validates their new high-touch sales model which is driving accelerating revenue growth, and presents their attractive financial profile and path to profitability. Key risks to their projections include reliance on V-Go for revenue, ability to retain customers and achieve market acceptance, and manufacturing risks.
Art 920 rev-g-valeritas-investor-presentation_final_11.03.17valeritasir
V-Go is a wearable insulin delivery device that addresses unmet needs for the 4.5 million patients in the US with type 2 diabetes on insulin who are not achieving their A1C goals. It provides both basal and bolus insulin delivery in a discreet, easy-to-use device to improve poor adherence commonly seen with multiple daily injections. Clinical data shows patients achieve better glycemic control and report high satisfaction with V-Go's convenience and ability to fit their lifestyle.
Dsp investor deck william blair june 2015DiplomatIR
Diplomat Pharmacy provides concise summaries in 3 sentences or less that provide the high level and essential information from the document. The document discusses Diplomat Pharmacy's strengths in specialty pharmacy, growth opportunities, and competitive positioning. It highlights Diplomat's focus on growing specialty infusion and pursuing strategic acquisitions to expand in high margin businesses. Diplomat also gains share in core therapeutic areas like oncology and immunology through new limited distribution drug contracts.
This document discusses Diplomat Pharmacy's business and financial performance. It summarizes Diplomat's growth strategies, including expanding into high-margin businesses like specialty infusion, growing key therapeutic areas in oncology and immunology, and pursuing strategic partnerships and acquisitions. The document also outlines Diplomat's competitive advantages in the specialty pharmacy market and its multiple avenues for continued strong growth and financial performance.
Valeant provides revised guidance for Q4 2015 and full year 2015 due to impacts from separating from Philidor and transitioning to a new partnership with Walgreens, estimating a $250M revenue impact from Philidor separation and $150M from the Walgreens transition. Valeant also provides initial guidance for 2016, estimating $12.5-12.7B in revenue and $13.25-13.75 per share in adjusted EPS, representing over 20% growth compared to updated 2015 guidance.
This document summarizes Diplomat Pharmacy's business and growth strategy. It discusses Diplomat's position as the largest independent specialty pharmacy in the U.S., with a focus on oncology and limited distribution drugs. It highlights Diplomat's diversified revenue streams including specialty pharmacy, infusion, and pharmaceutical manufacturer services. The document also outlines Diplomat's financial performance with strong revenue and adjusted EBITDA growth. Finally, it discusses Diplomat's M&A strategy and criteria for expanding into new therapies, geographies, and services.
Glaukos investor presentation for q2 2017 for website and 8_kglaukos
This document discusses Glaukos Corporation and its glaucoma treatment technologies. It contains the following key points:
- Glaukos is transforming glaucoma therapy with micro-scale injectable treatments that restore eye's natural drainage and reduce intraocular pressure, the only proven treatment for glaucoma.
- Their flagship product, iStent, is a single-use micro-bypass stent that has demonstrated long-term IOP reduction and medication reduction when used with cataract surgery based on multiple clinical studies.
- New products in development include iStent Inject for combination cataract/glaucoma procedures, iStent Supra to access a secondary drainage pathway, and iDose for targeted
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.
Glaukos investor presentation q2 2016 for website 08032016glaukos
Glaukos Corporation is a medical technology company transforming glaucoma treatment. Their solution portfolio includes micro-scale injectable therapies to restore and enhance aqueous outflow including the iStent, iStent Inject, and iStent Supra. Clinical trials show the iStent reduces intraocular pressure and medication use when used with cataract surgery or as a standalone procedure. Glaukos has established global commercial operations and seized the first mover opportunity in key markets since US FDA approval of the iStent.
Diplomat is a specialty pharmacy company that has experienced strong growth through expansion into new therapeutic areas and services. It focuses on specialty drugs like oncology that require complex care management. Diplomat has a unique limited distribution model that gives it exclusive access to certain specialty drugs, fueling its ability to gain market share. The company plans to continue its growth strategy through organic growth, acquisitions, and expanding relationships with drug manufacturers and payors.
This document provides a summary of key information from a Glaukos Corporation presentation:
- Glaukos is transforming glaucoma therapy through micro-scale injectable therapies like iStent that restore and enhance the eye's natural drainage system.
- Clinical trials show iStent used with cataract surgery significantly lowers intraocular pressure up to 3 years while reducing medication needs by over 80%.
- US retrospective studies of over 100 eyes found iStent with cataract surgery lowered pressure 22% and medications 56% at 2 years.
- An international study demonstrated iStent's pressure lowering ability increases with 1, 2, or 3 stents implanted as a standalone procedure.
Glaukos Corporation is an ophthalmic medical technology company transforming glaucoma treatment. Their minimally-invasive micro-scale injectable therapies, including the iStent, provide more effective treatment options compared to eye drops and traditional surgeries. Clinical trials demonstrate the iStent used with cataract surgery significantly lowers intraocular pressure up to 3 years post-op while reducing medication use. Additional studies show promise for combination treatments and sustained efficacy of micro-scale injectable therapies.
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.
The document discusses Diplomat Pharmacy as a specialty pharmacy company that has experienced significant growth through acquisitions and expanding its services across the specialty pharmacy ecosystem, noting its portfolio includes over 100 limited distribution drugs and it aims to take advantage of continued growth in the specialty pharmacy market through both organic growth and strategic acquisitions. Diplomat generates revenue from multiple sources including traditional specialty pharmacy, specialty infusion, pharmaceutical manufacturer services, and other services to minimize risks from payors and price inflation.
Similar to Art 923 rev-c-updating investor presentation on valeritas website_final_12.05.16 (20)
Cleades Robinson, a respected leader in Philadelphia's police force, is known for his diplomatic and tactful approach, fostering a strong community rapport.
Methanex is the world's largest producer and supplier of methanol. We create value through our leadership in the global production, marketing and delivery of methanol to customers. View our latest Investor Presentation for more details.
ZKsync airdrop of 3.6 billion ZK tokens is scheduled by ZKsync for next week.pdfSOFTTECHHUB
The world of blockchain and decentralized technologies is about to witness a groundbreaking event. ZKsync, the pioneering Ethereum Layer 2 network, has announced the highly anticipated airdrop of its native token, ZK. This move marks a significant milestone in the protocol's journey, empowering the community to take the reins and shape the future of this revolutionary ecosystem.
UnityNet World Environment Day Abraham Project 2024 Press ReleaseLHelferty
June 12, 2024 UnityNet International (#UNI) World Environment Day Abraham Project 2024 Press Release from Markham / Mississauga, Ontario in the, Greater Tkaronto Bioregion, Canada in the North American Great Lakes Watersheds of North America (Turtle Island).
UnityNet World Environment Day Abraham Project 2024 Press Release
Art 923 rev-c-updating investor presentation on valeritas website_final_12.05.16
1. CONFIDENTIAL – AUTHORIZED USE ONLY
D E L I V E R I N G Q U A L I T Y O F L I F E
Investor Presentation
OTCQB: VLRX
John Timberlake, President & CEO
November 30, 2016
2. 2
Forward Looking Statements
Thispresentationshallnotbe deemedan offerto sellsecuritiesnor a solicitationofan offerto purchasesecurities. Anysale bythe
companyshallbe madepursuantto a definitivepurchaseagreement.Unlessotherwisestatedin this presentation,referencesto
“Valeritas,”“we,”“us,”“our”or “ourcompany”referto ValeritasHoldings,Inc.and its subsidiaries.
Thispresentationcontainsestimates,projectionsand forward-lookingstatements.Our estimates,projectionsandforward-looking
statementsare basedon our management’scurrentassumptionsand expectationsof futureeventsandtrends,whichaffector may
affectour business,strategy,operationsor financialperformance.Althoughwe believethat theseestimates,projectionsandforward-
lookingstatementsare baseduponreasonableassumptionsand expectations,theyare subjectto numerousknownand unknownrisks
and uncertaintiesandare madein lightof informationcurrentlyavailableto us.Manyimportantfactorsmay adverselyand materially
affectour resultsas indicatedin forward-lookingstatements.All statementsotherthan statementsof historicalfact are forward-looking
statements.Thewords“believe,”“may,”“might,”“could,“would”,” “will,”“aim,”“estimate,”“continue,”“anticipate,”“intend,”
“expect,”“plan”and similarwordsare intendedto identifyestimates,projectionsandforward-lookingstatements.Estimates,
projectionsand forward-lookingstatementsspeakonlyas of the date theyare made,and,exceptto the extentrequiredbylaw,we
undertakeno obligationto updateor reviewany estimate,projectionor forward-lookingstatementbecauseof newinformation,future
eventsor otherfactors.
Our estimates,projectionsandforward-lookingstatementsmay be influencedbyoneor more of the followingfactors:
▫ ourhistoryof operatinglossesand uncertaintyregardingour abilityto achieveprofitability;
▫ ourrelianceon V-Go®DisposableInsulinDeliverydevice,or V-Go,to generateall of our revenue;
▫ ourinabilityto retaina high percentageof our patientcustomerbaseor our significantwholesalecustomers;
▫ the failureof V-Goto achieveandmaintainmarketacceptance;
▫ ourinabilityto operatein a highlycompetitiveindustryandto competesuccessfullyagainstcompetitorswithgreaterresources;
▫ competitiveproductsand othertechnologicalbreakthroughsthat may renderV-Goobsoleteor lessdesirable;
▫ ourinabilityto maintainor expandoursalesand marketinginfrastructure;
▫ anyinaccuraciesin ourassumptionsaboutthe insulin-dependentdiabetesmarket;
▫ manufacturingrisks,includingrisksrelatedto manufacturingin SouthernChina,damageto facilitiesor equipmentand failureto
efficientlyincreaseproductionto meetdemand;
▫ ourdependenceon limitedsourcesuppliersand our inabilityto obtaincomponentsfor ourproduct;
▫ ourfailureto secureor retain adequatecoverageor reimbursementfor V-Goby third-partypayers;
▫ ourinabilityto enhanceand broadenour productoffering,includingthroughthe successfulcommercializationof the pre-fillV-Go;
▫ ourinabilityto protectourintellectualpropertyand proprietarytechnology;
▫ ourfailureto complywith theapplicablegovernmentalregulationsto whichour productand operationsare subject;
▫ ourabilityto operateas a goingconcern;and
▫ ourliquidity.
3. 3
▫ Significantly de-risked commercial stage company
– ~$20M revenue & 35% Gross Margins
– > 10 million V-Go’s dispensed to patients
– Substantial growth opportunities
▫ Addressing needs of 4.6M patients with Type 2 diabetes on
insulin not at goal
▫ Established reimbursement
– commercial and Medicare (under Medicare Part D)
– primarily distributed at retail pharmacy
– cost neutral vs. insulin pens to patients & payors
▫ Robust clinical data: V-Go® delivers clinically-relevant A1C
reductions with less insulin
▫ Capital-efficient commercial strategy gaining traction
Valeritas with V-Go® Disposable Insulin Delivery device
Compelling Opportunity in Type 2 Diabetes Market
4. 4
John Timberlake
President & Chief Executive Officer
26 / 10
Erick Lucera
Chief FinancialOfficer
21 / <1
Matt Nguyen
SVP Commercial
21 / 10
Geoffrey Jenkins
EVP Manufacturing,Operations,R&D
30 / 7
The Valeritas Leadership Team
Proven Track Record of Success in Diabetes and Device Manufacturing
Years of Experience
Industry / Valeritas
Rodney
Altman, M.D.
Katherine
Crothall, Ph.D.
Peter Devlin Luke Düster Joe Mandato Brian Roberts
Spindletop
Capital, Team
Health, CMEA
Aspire Bariatrics,
Animas, Liberty
Venture, Luxar,
Insulet, Abbott
Diabetes
CRG Healthcare
Investment Mgt.
DeNovo Ventures
Guidant Corporation
Gynecare, Ioptex Research
Insulet, ViewRay,
Avedro
Majority independent Board of Directors with executive operational experience in medical technology companies
5. 5
V-Go® Disposable Insulin Delivery device:
The Ideal Insulin Delivery Device For Patients with Type 2 Diabetes
▫ Only FDA-cleared single-use, fully disposable insulin delivery
device with basal (background) and bolus (meal time)
capability commercially available on the market in the US
▫ Specifically designed to address unmet needs in Type 2
diabetes market
▫ Small, discreet, wearable, disposable and easy-to-use
▫ Convenient drug-like distribution model
▫ Reimbursed at the pharmacy –
where patients with Type 2 diabetes go
6. 6
V-Go® : Combines Simplicity and Physiologic Insulin in
Patient Friendly and Easy to Use Wearable Device
Preset basal
rates of
insulin
delivered at a
constant rate
On-demand insulin for mealtime coverage in 2 units/click
Bolus
DeliveryButton
Activate Bolus Ready Button Deliver Insulin Repeat as Necessary
BolusReadyButton
Bolus
DeliveryButton
Bolus
Step
1
Bolus
Step
2
Bolus
Step
3
Robust IP with 70 patents issued and 51 pending
7. 7
(1) Based on V-Go® Wholesale Acquisition Price (WAC) of $306.70 per month x 12 months x 4.6 M Type 2 Patients on Insulin not at goal.
WAC price is the gross price sold to wholesalers. The Company’s net price is WAC less fees, discounts and rebates.
(2) Holman RR et al. N Engl J Med. 2009;361(18):1736-1747
$16 Billion
Annual
Opportunity (1)
Addresses Key Unmet Needs for Type 2 Patients on Insulin
The 4.6 Million Patients in the U.S. V-Go® can Benefit Represent a $16 Billion Market
Figures approximate. 2012 US Roper Diabetes Patient Market Study provided by GfK Customer Research LLC
Grabner M, Chen Y, Nguyen M, Abbott SD, Quimbo R. Using observational data to inform the design of a prospective effectiveness study for a novel insulin delivery device. Clinicoecon Outcomes
Res. 2013 Sep 23;5:471-9.
ProgrammablePump
Basal
Basal+1
or
Premix
>95% of Type 2
Patients on
Insulin
IntensiveTherapy
VGO
*A1C refers to a blood test that correlates with a person’s
average blood glucose level over a span of three months.
1.4
4.6
0
1
2
3
4
5
6
U.S. Type 2 Patients
on Insulin (millions)
Type 2 Patients not
at A1C Goal
Type 2 Patients at
A1C Goal 82% of Patients with Type 2 Diabetes Initiated on Basal-Only Insulin
Regimens Required Mealtime Insulin to Achieve and Maintain A1C Goal(2)*
Complex
Physiologic
Simple
Nonphysiologic
8. 8
Complexity and Lack of Discretion Can Result in Non-Compliance
Simplicity Ease-of-use Discretion
V -Go® SOLV ES UNMET PAT I ENT NEEDS:
Data from U.S. Roper Diabetes Patient Market study provided by GfK Custom Research LLC and distributed only with express written permission of GfK
Custom Research LLC. This study is an annual survey of over 2,000 diabetes patients (n=2,104 in 2011; 692 who use insulin) via telephone and internet.
72% Patients prescribed ≥ 3 shots/day reported
they do not inject insulin away from home
V-Go allows patients to easily and discreetly delivery additional insulin at meal time
or when they have a snack in public without anyone knowing
9. 9
Significant Growth Opportunity With Disciplined
Sales Force Expansion
Prescribers Supported by only
Inside Sales
Significant Potential
for Future V-Go®
Growth
Figures approximate. The Company has field based sales professionals located in these states. Sales Territories are based in a local geography within a state.
No sales professional is responsible for an entire state.
Valeritas is Focused on Generating Share Within our Current Targets
14,000
U.S. High Insulin Volume
Prescribers*
Current Sales Representative
Targeted Prescriber Coverage
1,000
* These 14,000 prescribers
generate 40% of All U.S.
Annual Insulin TRx’s per
Symphony Health Solutions.
Estimated 2017 Target Expansion
Field Sales Professionals
1 32
Number of Sales
Representatives
** Prescribers who are called on opportunistically by Rep or are in an office of Targeted Prescriber
**
**
10. 10
V-Go® is Accessible at Retail Pharmacy
Where Patients with Type 2 Go!
• Enhanced Patient Convenience for
patients who frequent pharmacy
• Traditional Co-pay at Pharmacy
~90% Distribution
Through Wholesalers
Sold at Pharmacy / Retail Outlets
V-Go for Type 2 Diabetes
V-Go
Durable Medical
Equipment
Type 1 Durable Pump
Type 1 Pump Maker
• Requires Medical Necessity
• Annual Medical Deductibles
• Monthly Medical Co-
insurance
11. 11
Established Reimbursement with Pharmacy Benefit
164 M Pharmacy Lives*
Diabetes Prevalence >20 Yrs. old: 12.3%
34 M TotalLives*
Diabetes Prevalence >65 Yrs. old: 18.9%
• Over 90% of V-Go Prescriptions Filled at Retail Pharmacies since Launch
• TRICARE & State Medicaid Cover V-Go Under Pharmacy and/or Medical Benefit
All Access figures as of December 2014. Prevalence data : ADA 2013 Fact Sheet and the CDC Diabetes Report Card 2012.
* Commercial Pharmacy Lives: Health Leaders InterStudy 2013: Decision Resources, Medicare Part D Lives: Pathfinder Rx Database 2/1/15.
60%+ Medicare Part D Access70%+ Commercial Access
< 30%
of Lives
Not Covered
or Restricted
Access
70%+
of Lives
V-Go Covered
Under
Insurance
< 40%
of Lives
Not on
Formulary–
Accessthrough
Medical
Exception
60%+
of Lives
V-Go Covered
Under
Pharmacy
Insurance
12. 12
Established Reimbursement
V-Go® is Cost-effective for both Payors & Patients
V-Go® Therapy
Basal/Bolus Pen Therapy
Neutral Cost to Payors
(~$18/day) between Regimens(1)
(1) What a Payor Pays (Net of Rebates & Co-pays
when V-Go Contracted in Preferred Position)
$31
co-pay
$31
co-pay
$11
co-pay
$31
co-pay
$31 or $53
co-pay1
$73
co-pay
$62 or $84
co-pay(2)
(2) Avg. Nat’l Tier 2 or Tier 3 Co-pay for commercial plans is $31 and $53, respectively, The Kaiser Family
Foundation and Health Research & Education Trust Employer Health Benefits 2014 Annual Survey.
Neutral Cost to Patients (+/- $11)
*V-Go has been studied with
both Humalog® and NovoLog®
*
13. 13
(1) Rosenfeld CR, et al. Endocr Pract. 2012; 18 (5):660-667; (2) Grunberger, G, et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 985-P; (3) Omer, A. et
al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 980-P; (4) Lajara, et al. Drugs-Real World Outcomes [First online 02 June 2016]; (5) Lajara R, et al.
Diabetes Ther. 2015;6 (4):531-545 ; (6) Lajara R et al. Endocr Pract. 2016 June; 22 (6): 726-725.
Strong and Extensive Data Supports Broad Adoption
Statistically Significant
Improvements in A1C(1-6)
Improved Quality of Life(1)
Lowered Total Daily Insulin Dose
(Prescribed / Administered)(1-6)
Demonstrated Cost Reductions(4)
11
Published
Clinical
Papers
37
Posters at
Medical
Meetings
~750*
patients studied
*Excludes 169 V-Go patients in completed but not yet presented study
14. 14
Robust Clinical Data Validates V-Go®’s Ability to Deliver
Clinically Relevant Reductions in A1C Levels
-1.0
-2.0
-2.4
-1.2
-1.9
-1.2
-2.0
-1.8
-1.5
-1.6
ChangeinA1C
BL= Baseline
(1) Grunberger G, et al. Poster presented at: AACE 23rd Annual Scientific and Clinical Congress. May 14-18, 2014; Las Vegas, NV.
(2) Lajara R, Davidson JA, et al. Endocr Pract. 2016 June; 22 (6): 726-725.
(3) Omer A, et al. Poster presented at 73rd Scientific Sessions of the ADA; June 21-25, 2013; Chicago, IL.
(4) Rosenfeld CR, et al. Endocr Pract. 2012; 18 (5):660-667.
(5) Sandberg M, et al. Practical Diabetology. 2013;32(3): 6–22.
(6) Lajara R, et al. Practical Diabetology. 2016;36(5): 10-15.
(7) Lajara R, et al. Diabetes Ther. 2015;6 (4):531-545.
(8) Sutton D, et al. Poster presented at 76th Scientific Sessions of the ADA; June 10-14, 2013; New Orleans, LA.
N’s=SIMPLE-59, DAVsMDI-56, UMASS-14, UPP-23,EAP-16,DAMDI-70,DABasal-47,DAT2- 175, DAT1/LADA-29, NEFEDA-83. AllpatientsforDA-204
Clinically Relevant (-0.5%)
SIMPLE(1)
Basal Cohort
BL: 8.7%
9 Months
DA(2)
Vs. MDI
BL: 9.5%
~7 Months
UMASS(3)
All Cohorts
BL: 10.7%
3 Months
UPP(4)
All Cohorts
BL: 8.8%
3 Months
EAP(5)
All Cohorts
BL: 9.3%
3 Months
DA(6)
MDI Cohort
BL: 9.3%
7 Months
DA(6)
Basal Cohort
BL: 9.5%
7 Months
DA(7)
T1/LADA Cohort
BL: 9.5%
~7 Months
DA(7)
T2 Cohort
BL: 9.7%
~7 Months
NEFEDA(8)
All Cohorts
BL: 9.7%
~6 Months
Patients naive to insulin
reduced A1C by 3.4%7
15. 15
$0
$50
$100
$150
$200
$250
$217.16
$118.84
Insulin costs include both the insulin and associated delivery method. The costs of insulin were normalized by calculating a 30 day insulin requirement based on the total
prescribed daily insulin dose for each insulin and multiplying the monthly dose in units by the unit cost. Only branded antihyperglycemic agents were included in total
therapy costs. All pricing based on published wholesale acquisition costs in 2015 U.S. dollars as of 9/1/2015.
†P-value calculated using the cost inferential per 1% reduction using least squares mean A1C reductions at 27 weeks.
V-Go® is a More Cost-Effective Therapy vs. MDI
Lajara R, Davidson JA, et al. Endocr Pract. 2016 June; 22 (6): 726-725.
V-Go Reduced Direct Pharmacy Costs by 45% per 1% Reduction in A1C
† P=0.013
MDI V-Go
DirectPharmacyCostPerMonth
Per1%reductioninA1C
16. 16
Extensive Patient Experience With Proven Quality
V-Go® product quality demonstrated with > 10M devices dispensed to patients
Source: Symphony Health Solutions (Retail and Mail Order).
V-Go adherence & persistency better than most Type 2 regimens (injections or pills)
6 Million
4 Million
1 Million
10 Million
8 Million
17. 17HCP – Healthcare Professionals, which include Prescribers, Physician office staff and retail pharmacies.
Higher Touch
Med-Tech
S&M Model
Target High
Insulin
Volume
Prescribers
Increase
Frequency
of Office
Contact
Execute
Multichannel
Marketing
Greater
Support for
Prescriber
& Patient
Activate
Patients to
Seek & Ask
for V-Go
Current Sales & Marketing Model
Focused, Integrated and Capital Efficient
Estimated 8%
growth in 2016
revenue with
< 50% of the Sales
representatives vs.
2015
Sales rep target list
changed from ~60
doctors to ~30
Instead of ~15
minutes at each
doctor’s office 2x
per month, Now
spending ~40 min
3-4x per month at
each doctor’s
office
18. 18
Target List Refined By:
• Rep relationships
• Access to other
prescribers in office
• Academic or other “no-
rep see” facilities
• Reimbursement
coverage
• Rapid Acting insulin
prescribers
• Physicians that have
expressed intent to Rx
Current Sales Targeting Model —
Actual Example Territory
Current Targets
BLINDED SPECIALTY
INSULIN
DECILE
TOTAL_INSULIN_
TRX_CNT
Q4
TARGET
Dr 1 ENDOCRINOLOGY 10 7,084 Y
Dr 3 ENDOCRINOLOGY 10 4,615 Y
Dr 5 ENDOCRINOLOGY 10 3,663 Y
Dr 6 ENDOCRINOLOGY 10 3,629 Y
Dr 8 ENDOCRINOLOGY 10 3,387 Y
Dr 11 ENDOCRINOLOGY 10 3,102 Y
Dr 13 ENDOCRINOLOGY 10 2,925 Y
Dr 14 ENDOCRINOLOGY 10 2,853 Y
Dr 17 FAMILY MEDICINE 9 2,586 Y
Dr 21 ENDOCRINOLOGY 9 2,233 Y
Dr 22 ENDOCRINOLOGY 9 2,145 Y
Dr 23 UNKNOWN 9 2,119 Y
Dr 24 ENDOCRINOLOGY 9 2,075 Y
Dr 25 ENDOCRINOLOGY 9 2,068 Y
Dr 26 ENDOCRINOLOGY 9 1,930 Y
Dr 30 UNKNOWN 9 1,755 Y
Dr 33 ENDOCRINOLOGY 9 1,548 Y
Dr 36 ENDOCRINOLOGY 8 1,421 Y
Dr 48 GENERAL PRACTICE 8 941 Y
Dr 51 FAMILY MEDICINE 8 904 Y
Dr 52 INTERNAL MEDICINE 8 897 Y
Dr 56 ENDOCRINOLOGY 8 838 Y
Dr 83 INTERNAL MEDICINE 7 652 Y
Dr 93 INTERNAL MEDICINE 7 624 Y
Dr 104 INTERNAL MEDICINE 7 594 Y
Top ~30 Sales Target List
BLINDED SPECIALTY
INSULIN
DECILE
TOTAL_INSULIN
_TRX_CNT
Dr 1 ENDOCRINOLOGY 10 7,084
Dr 2 ENDOCRINOLOGY 10 5,488
Dr 3 ENDOCRINOLOGY 10 4,615
Dr 4 UNKNOWN 10 4,528
Dr 5 ENDOCRINOLOGY 10 3,663
Dr 6 ENDOCRINOLOGY 10 3,629
Dr 7 UNKNOWN 10 3,446
Dr 8 ENDOCRINOLOGY 10 3,387
Dr 9 ENDOCRINOLOGY 10 3,275
Dr 10 ENDOCRINOLOGY 10 3,178
Dr 11 ENDOCRINOLOGY 10 3,102
Dr 12 ENDOCRINOLOGY 10 3,049
Dr 13 ENDOCRINOLOGY 10 2,925
Dr 14 ENDOCRINOLOGY 10 2,853
Dr 15 INTERNAL MEDICINE 10 2,846
Dr 16 UNKNOWN 10 2,681
Dr 17 FAMILY MEDICINE 9 2,586
Dr 18 UNKNOWN 9 2,445
Dr 19 ENDOCRINOLOGY 9 2,426
Dr 20 UNKNOWN 9 2,269
Dr 21 ENDOCRINOLOGY 9 2,233
Dr 22 ENDOCRINOLOGY 9 2,145
Dr 23 UNKNOWN 9 2,119
Dr 24 ENDOCRINOLOGY 9 2,075
Dr 25 ENDOCRINOLOGY 9 2,068
Dr 26 ENDOCRINOLOGY 9 1,930
Dr 27 ENDOCRINOLOGY 9 1,919
Dr 28 ENDOCRINOLOGY 9 1,915
Dr 29 DIABETES 9 1,867
Dr 30 UNKNOWN 9 1,755
Dr 31 UNKNOWN 9 1,745
Dr 32 UNKNOWN 9 1,675
Dr 33 ENDOCRINOLOGY 9 1,548
Dr 34 UNKNOWN 9 1,522
Dr 35 UNKNOWN 9 1,444
Dr 36 ENDOCRINOLOGY 8 1,421
Dr 37 UNKNOWN 8 1,413
Dr 38 FAMILY MEDICINE 8 1,345
Dr 39 INTERNAL MEDICINE 8 1,152
Dr 40 ENDOCRINOLOGY 8 1,051
Dr 41 UNKNOWN 8 1,017
Dr 42 INTERNAL MEDICINE 8 1,012
Dr 43 INTERNAL MEDICINE 8 1,003
Dr 44 FAMILY MEDICINE 8 974
Dr 45 INTERNAL MEDICINE 8 950
Dr 46 INTERNAL MEDICINE 8 948
Dr 47 UNKNOWN 8 946
Dr 48 GENERAL PRACTICE 8 941
Dr 49 FAMILY MEDICINE 8 920
Dr 50 FAMILY MEDICINE 8 908
BLINDED SPECIALTY
INSULIN
DECILE
TOTAL_INSULIN
_TRX_CNT
Dr 51 FAMILY MEDICINE 8 904
Dr 52 INTERNAL MEDICINE 8 897
Dr 53 ENDOCRINOLOGY 8 885
Dr 54 ENDOCRINOLOGY 8 853
Dr 55 UNKNOWN 8 843
Dr 56 ENDOCRINOLOGY 8 838
Dr 57 UNKNOWN 8 831
Dr 58 FAMILY MEDICINE 8 831
Dr 59 INTERNAL MEDICINE 8 793
Dr 60 INTERNAL MEDICINE 8 781
Dr 61 INTERNAL MEDICINE 8 779
Dr 62 INTERNAL MEDICINE 8 763
Dr 63 INTERNAL MEDICINE 8 755
Dr 64 FAMILY MEDICINE 7 738
Dr 65 INTERNAL MEDICINE 7 738
Dr 66 INTERNAL MEDICINE 7 724
Dr 67 FAMILY MEDICINE 7 720
Dr 68 FAMILY MEDICINE 7 714
Dr 69 FAMILY MEDICINE 7 713
Dr 70 ENDOCRINOLOGY 7 703
Dr 71 INTERNAL MEDICINE 7 700
Dr 72 FAMILY MEDICINE 7 698
Dr 73 INTERNAL MEDICINE 7 697
Dr 74 ENDOCRINOLOGY 7 678
Dr 75 ENDOCRINOLOGY 7 676
Dr 76 FAMILY MEDICINE 7 671
Dr 77 ENDOCRINOLOGY 7 665
Dr 78 UNKNOWN 7 664
Dr 79 INTERNAL MEDICINE 7 662
Dr 80 FAMILY MEDICINE 7 659
Dr 81 FAMILY MEDICINE 7 658
Dr 82 FAMILY MEDICINE 7 654
Dr 83 INTERNAL MEDICINE 7 652
Dr 84 FAMILY MEDICINE 7 652
Dr 85 INTERNAL MEDICINE 7 652
Dr 86 FAMILY MEDICINE 7 651
Dr 87 FAMILY MEDICINE 7 646
Dr 88 FAMILY MEDICINE 7 645
Dr 89 FAMILY MEDICINE 7 643
Dr 90 INTERNAL MEDICINE 7 643
Dr 91 INTERNAL MEDICINE 7 631
Dr 92 FAMILY MEDICINE 7 627
Dr 93 INTERNAL MEDICINE 7 624
Dr 94 FAMILY MEDICINE 7 624
Dr 95 INTERNAL MEDICINE 7 622
Dr 96 UNSPECIFIED 7 621
Dr 97 UNKNOWN 7 620
Dr 98 INTERNAL MEDICINE 7 615
Dr 99 FAMILY MEDICINE 7 613
Dr 100 INFECTIOUS DISEASES 7 607
Top Decile Insulin Prescribers – Symphony Data
Source: Symphony Health Solutions
19. 19
Ability to Create and Achieve Sustainable Growth
Moving just prescribers who write
1 NRx per week to 2 NRx per week would
increase Total NRx’s by 26%
BLINDED
INSULIN
DECILE
TOTAL_INSULIN_
TRX_CNT
Q4
TARGET
V-GO SHARE OF
TOTAL RAI
Dr 1 10 7,084 Y 13%
Dr 3 10 4,615 Y 6%
Dr 5 10 3,663 Y 6%
Dr 6 10 3,629 Y 4%
Dr 8 10 3,387 Y 2%
Dr 11 10 3,102 Y 1%
Dr 13 10 2,925 Y 1%
Dr 14 10 2,853 Y 0%
Dr 17 9 2,586 Y 13%
Dr 21 9 2,233 Y 11%
Dr 22 9 2,145 Y 11%
Dr 23 9 2,119 Y 10%
Dr 24 9 2,075 Y 7%
Dr 25 9 2,068 Y 6%
Dr 26 9 1,930 Y 6%
Dr 30 9 1,755 Y 5%
Dr 33 9 1,548 Y 1%
Dr 36 8 1,421 Y 36%
Dr 48 8 941 Y 31%
Dr 51 8 904 Y 23%
Dr 52 8 897 Y 13%
Dr 56 8 838 Y 8%
Dr 83 7 652 Y 28%
Dr 93 7 624 Y 10%
Dr 104 7 594 Y 6%
Target 30 – Expanding Share of Rapid Acting Insulin TRx
14,000
U.S. High
Prescribers*
Current&
2017 Sales
Coverage
I. Increase use & grow share of V-Go within the
current ~ 30 Targeted Offices
II. Gradually call on Add’l High-Volume Prescribers
in Geographic Territory (expand beyond the 30
current targets .... ~ 100 potential)
RAI: Rapid Acting Insulin.
NRx: New Prescription.
III. Increase # of High Volume Prescribers by
Splitting Territory and adding new Rep
IV. Add New Sales Representatives in New
Territories
20. 20
Integrated Marketing Strategy for V-Go
Patient
Activation HCP Prescribing
Reach patients on MDI, educate
on V-Go and motivate to ask their
HCP about V-Go.
• Direct Mail
• E-Mail
• Banner Advertising
• Search Engine Optimization
• In-Office
• In-Pharmacy
Highly targeted media channels
with focused V-Go messaging
Demonstrate the Value of V-Go in
patients on MDI of insulin.
Provide support to enable high
desire to prescribe.
• Direct Sales Representatives
• Multichannel Marketing
• Peer-2-Peer Education
• KOL Advocacy
• In-office Training
• Benefit Verification
Deployment in highest
opportunity markets
Support Patient on V-Go
• V-Go Customer Care
• Education
• Co-Pay Card
• Insurance Assistance
• Pharmacy fulfillment
Patient Interested In
and Educated On V-Go
&
HCP Prepared and
Desiring to Prescribe
V-Go.
HCP: Health Care Provider (Doctor, Nurse, Physician Assistant, Nurse Practitioner or Doctor’s office staff
MDI (multiple daily injection therapy with insulin pens or syringes
KOL: Key Opinion Leader
21. 21
CONVERSION
Paid search / SEO
Display advertising
Email
Direct mail
Context media
Rx Edge Pharmacy
go-vgo.com
V-Go Customer Care
V-Go Life
(enhanced)
Enhanced
starter kit
Patient
advocacy
Patient
Ambassadors
In-office material
Patient Demo units
Patient Activation Strategy
Drive Patients to Ask for and Stay on V-Go®
22. 22
$0.6
$6.2
$13.5
$18.1
2012 2013 2014 2015 2016 est.
~$5~$5~$5~$5
Valeritas: Financial Profile
Poised for Growth and Profitability
Revenue ($ in millions)
Annual Revenue (March 2012 – December 2015)
34%
118%
~ 64 sales
reps
~ 27 sales
reps*
2016
Greater Revenue
with < 50% of
the Sales
Representatives
With a
Significant
Reduction in
Cash Burn
$14.7
YTD
Q3’16
3Q16 Financial Summary ($ in millions) 3Q16 3Q15 Change
Revenue $4.9 $4.7 2.6%
Gross Margin 35.5% 13.1% +224bps
Operating Expenses $9.4 $11.4 (18)%
Net Loss $9.2 $14.5 (37)%
Cash $15.5 $7.5 207%
* The Company completed a restructuring in February 2016 and estimates it will have an average of 27 filled sales territories over the ten months
between March and December 2016.
~ $19.5
~ 64 sales
reps
~ 64 sales
reps
~$5
23. 23
Execute Capital-Efficient U.S. Sales & Market Strategy
Advance V-Go® Next Generation Line Extensions
Expand Sales Force in U.S.
Commercialize V-Go® OUS (Distribution/Licenses)
Launch V-Go® Link
Collaborate with Core Technology
Launch V-Go® Prefill
Focused and Capital Efficient Growth Strategy
Scalable
Business
Model
Short Term TIME Long Term
24. 24
Financial Highlights (at September 30, 2016) (unless otherwise noted)
Common Stock Outstanding 12.7 Million shares
Shares on a fully diluted basis 15.0 Million shares
Share Price (as of 11/30/2016) – range $4.98 ($3.50 to $6.50)
Market Cap (as of 11/30/2016) $63.1M
LTM Net Revenue $19.6M
LTM EBITDA ($34.7M)
Cash & Short-Term Investments $15.5M
Total Debt $57.4M ($52.2 – CRG; $5.2 – WCAS)
NOL Carryforward (12/31/15) $306M
Largest Shareholder CRG – 75%
Cash Burn (12 Mo & 3 Mo ended 9/30/2016) $36.1M / $4.9 M
ADTV – 90 Days (as of 11/30/2016) 1,775 (3,361 30 days)
25. 25
Investment Conclusion
▫ Compelling opportunity creating a new exciting category within the Type
2 diabetes market with the potential to generate sustainable YOY growth
▫ Company Transitioned to a Medical Device Focused & Capital-Efficient
Commercial Strategy
▫ Commercial Operations at Inflection Point
– Positive early results demonstrating potential to generate sustainable YOY growth
▫ Gross Margin Leverage
– ~35% GM on ~$20M revenue with ability to reach 80% at global scale
▫ Company intends to raise capital sufficient to fund operations well
through inflection point and up to CFBE
26. CONFIDENTIAL – AUTHORIZED USE ONLY
D E L I V E R I N G Q U A L I T Y O F L I F E
V-Go® Clinical Summary
27. 27
Better Glycemic Control Improves and Extends Lives
Significant Adverse Health Effects Influenced by Poor Glycemic Control
Stratton IM et al. BMJ. 2000;321:405-412.
21%
Deaths from Diabetes
14%
Heart Attacks
37%
Microvascular
Complications
43%
Peripheral Vascular
Disease
Each 1% reduction in mean A1C
reduces risk for
28. 28
0%
5%
10%
15%
20%
25%
30%
35%
<7% >7% or <8% >8% or <9% >9%
20.4%
26.5%
20.4%
32.7%
PercentofPatients
OnInsulin
A1C Range
Large Scale Study Validates 80% of Patients on Insulin* are
Not at A1C Goal and are Ideal V-Go® Candidates
ClinicoEconomicsandOutcomesResearch2013:5 471–479
2011 Database analysis of 27,897 adult patients with diabetes on insulin
20% at
Goal
* Insulin: Basal, Basal plus one, Premixed or MDI. Results data from the Health Core Integrated Research Database.
80% of Patients Currently on Insulin Therapy
are V-Go Candidates
29. 29
Many Patients with Type 2 Diabetes Require Basal and
Bolus Insulin Delivery to Maintain Glycemic Control
(1) Adapted from: Riddle. Diabetes Care. 1990;13:676-686
(2) Holman RR et al. N Engl J Med. 2009;361(18):1736-1747
82% of Patients with Type 2 Diabetes Initiated on Basal-Only Insulin Regimens Required
Mealtime Insulin to Achieve and Maintain A1C Goal(2)
PlasmaGlucose(mg/dL)(1)
200
100
0
6AM 12PM 6PM 12AM
Type 2 Diabetes
6AM
150
250
50
Mealtime /Prandial
Hyperglycemia
Normal Basal
Glucose Levels
ElevatedBasal
Glucose Levels
Time of Day
30. 30
Robust Clinical Data Validates V-Go®’s Ability to Deliver
Clinically Relevant Reductions in A1C Levels
-1.0
-2.0
-2.4
-1.2
-1.9
-1.2
-2.0
-1.8
-1.5
-1.6
ChangeinA1C
BL= Baseline
(1) Grunberger G, et al. Poster presented at: AACE 23rd Annual Scientific and Clinical Congress. May 14-18, 2014; Las Vegas, NV.
(2) Lajara R, Davidson JA, et al. Endocr Pract. 2016 June; 22 (6): 726-725.
(3) Omer A, et al. Poster presented at 73rd Scientific Sessions of the ADA; June 21-25, 2013; Chicago, IL.
(4) Rosenfeld CR, et al. Endocr Pract. 2012; 18 (5):660-667.
(5) Sandberg M, et al. Practical Diabetology. 2013;32(3): 6–22.
(6) Lajara R, et al. Practical Diabetology. 2016;36(5): 10-15.
(7) Lajara R, et al. Diabetes Ther. 2015;6 (4):531-545.
(8) Sutton D, et al. Poster presented at 76th Scientific Sessions of the ADA; June 10-14, 2013; New Orleans, LA.
N’s=SIMPLE-59, DAVsMDI-56, UMASS-14, UPP-23,EAP-16,DAMDI-70,DABasal-47,DAT2- 175, DAT1/LADA-29, NEFEDA-83. AllpatientsforDA-204
Clinically Relevant (-0.5%)
SIMPLE(1)
Basal Cohort
BL: 8.7%
9 Months
DA(2)
Vs. MDI
BL: 9.5%
~7 Months
UMASS(3)
All Cohorts
BL: 10.7%
3 Months
UPP(4)
All Cohorts
BL: 8.8%
3 Months
EAP(5)
All Cohorts
BL: 9.3%
3 Months
DA(6)
MDI Cohort
BL: 9.3%
7 Months
DA(6)
Basal Cohort
BL: 9.5%
7 Months
DA(7)
T1/LADA Cohort
BL: 9.5%
~7 Months
DA(7)
T2 Cohort
BL: 9.7%
~7 Months
NEFEDA(8)
All Cohorts
BL: 9.7%
~6 Months
Patients naive to insulin
reduced A1C by 3.4%7
31. 31
Switching to V-Go® Demonstrated Significant Reductions in
Total Daily Insulin Dose (TDD) Across Multiple Studies
-18%
-28%
-46%
-13%
-22%
-41%
-23%
%ChangeinInsulin
(1) Grunberger G, et al. Poster presented at: AACE 23rd Annual Scientific and Clinical Congress. May 14-18, 2014; Las Vegas, NV.
(2) Lajara R, Davidson JA, et al. Endocr Pract. 2016 June; 22 (6): 726-725. Difference in mean insulin TDD at end of study MDI 78 U/day vs V-Go 56 U/day.
(3) Omer A, et al. Poster presented at 73rd Scientific Sessions of the ADA; June 21-25, 2013; Chicago, IL.
(4) Rosenfeld CR, et al. Endocr Pract. 2012; 18 (5):660-667.
(5) Sandberg M, et al. Practical Diabetology. 2013;32(3): 6–22.
(6) Lajara R, et al. Diabetes Ther. 2015;6 (4):531-545. Difference based on patients administering insulin at baseline (N=180) compared to V-Go dose at study end.
(7) Sutton D, et al. Poster presented at 76th Scientific Sessions of the ADA; June 10-14, 2013; New Orleans, LA.. Based on office visit 2.
*Change in basal component of TDD only value available
Diabetes
America(6)
99 U TDDBaseline
UPP(4)
56 U TDD
EAP(5)
Basal Dose*
UMASS(3)
119 U TDD
SIMPLE(1)
62 U TDD
Diabetes
America(2)
78 U TDD
NEFEDA(7)
84 U TDD
32. 32
6.0
7.0
8.0
9.0
10.0
11.0
Pre V-Go On V-Go
10.7
8.3*
A1C(%)
N=14 Average Duration = 88 days
0
20
40
60
80
100
120
140
Pre V-Go On V-Go
119
64†
InsulinTDD(units)
† P=0.01, *P=0.001
Change
-2.4
Change
-55 U
V-Go® Significantly Reduces A1C with Less Insulin
Key Benefit to Both Patients and Payors
(1) Based on Insulin TDD absolute units.
Omer, A. et al. Poster presented at 73rd Scientific Sessions of the ADA; 2013 June 21-25; Chicago, IL. 980-P.
UMASS Study .
Change
-2.4
- 55U
Change
= 46%(1)
- 2.4
33. 33
7.7*
7.6*
8.4*
8.1*
6.5
7.0
7.5
8.0
8.5
9.0
9.5
10.0
Baseline 12 week 27 week
A1C(%)
V-Go: N=56 BL A1C- 9.5% BL TDD - 51 U/day, Starting V-Go TDD- 52 U/day, 12 week TDD- 56 U/day, 27 week TDD- 56 U/day
MDI: N=60 BL A1C- 9.4%, BL TDD- 46 U/day, Starting MDI TDD- 64 U/day, 12 week TDD- 75 U/day, 27 week TDD- 78 U/day
Data are mean (SE)
P=0.02
V-Go® Demonstrates Significant Improvements In
Glycemic Control vs Multiple Daily Injections (MDI)
Lajara R, Davidson JA, et al. Endocr Pract. 2016 June; 22 (6): 726-725.
Better Control with Less Insulin vs MDI
MDI
V-Go
30
40
50
60
70
80
90
51 units 46 units
56
78*
TDD(U/day)at27weeks
Baseline
P<0.0001
MDIV-Go
34. 34
62
143
54†
67*
InsulinTDD(U/day)
V-Go
Baseline
V-Go
Baseline
V-Go
@6 mos.
V-Go
@6 mos.
< 100 U/day at
Baseline
≥ 100 U/day at
Baseline
V-Go® Appropriate For The Vast Majority of Type 2 Patients
V-Go Improved A1C Control in Both the Low and High Prior Insulin Dose Groups
N= 66 patients < 100 U/day at baseline and 38 patients > 100 U/day at baseline
†P<0.05 compared to baseline at 6 months, *P <0.0001 compared to baseline at 6 months
After 6 Months of Using V-Go for Insulin Delivery
Lajara R, Nikkel C. J Diabetes Sci Technol March 2016 10: 476-611, data on file.
Patients on < 100 U
TDD at Baseline
-1.5*
-1.7*
ChangeinA1C
< 100 U/day at
Baseline
≥ 100 U/day at
Baseline
Baseline 9.3% Baseline 9.5%
35. 35
MeanTotalDailyDoseofInsulin
(U/day)
-3.5
-3
-2.5
-2
-1.5
-1
-0.5
0
-3.0*
-3.4*
LSMChangeinA1C
20
40
60
80
100
120
54**
Insulin Naïve Patients Could Represent a Significant
Market Opportunity for V-Go®
Insulin TDD Utilization
Significant A1C
Reduction on V-Go
On V-Go at 27 Weeks 14 Weeks 27 Weeks
Potential for V-Go to be First-Line Insulin Therapy
*p<0.001 comparedtobaselinebasedonLeastSquaresMean(LSM)changeinA1C ** p<0.0001
N= 24,BaselineA1C = 11.3%. Time points represent the mean time elapsed between V-Go initiation and follow-up A1C results for the total population.
Lajara R, et al. Diabetes Ther. 2015;6 (4):531-545
36. 36
28% 27%
10%
53%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
SurveyRespondents
Convenience(1)
Very
Convenient
Somewhat
Convenient
Note: Patients were surveyed prior to starting V-Go and again ~30 days after being on V-Go.
Patients Rate the Convenience of V-Go® and Their
Quality of Life as Superior vs. Previous Therapies
Prior
Therapy
V-Go
Therapy
(1) Data on File (Valeritas Customer Care).
29%
44%
6%
20%
0%
10%
20%
30%
40%
50%
60%
70%
Prior
Therapy
V-Go
TherapySurveyRespondents
Quality of Life(2)
Excellent
Generally
Good
How do you feel physically &
mentally on a typical day?