Exelixis reported financial results for Q1 2014 and provided updates on its clinical trials and product pipeline. Key highlights include:
- Net revenue of $4.9M from sales of COMETRIQ for medullary thyroid cancer.
- Two phase 3 trials of cabozantinib in castration-resistant prostate cancer (COMET-1 and COMET-2) continue as planned and are expected to report top-line data in 2014.
- Phase 3 trials of cabozantinib are ongoing or planned in renal cell carcinoma (METEOR), hepatocellular carcinoma (CELESTIAL), and medullary thyroid cancer (EXAM). Top-line data from
Exelixis reported financial results for Q2 2014 and provided updates on their cabozantinib and cobimetinib development programs. COMETRIQ sales increased 34% over Q1 2014. Exelixis expects key data readouts from cabozantinib trials in prostate cancer and renal cell carcinoma in late 2014/2015. Cobimetinib phase 3 data in melanoma presented positive top-line results and Exelixis is preparing for potential co-promotion with Genentech. Exelixis reaffirmed 2014 financial guidance and expects year-end cash over $200 million.
Public Device & Biopharma Ophthalmology Company Showcase - OmerosHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Omeros at OIS@AAO 2016.
Presenter:
Leonard M. Blum, Chief Business & Commercial Officer
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Genetic Technologies is an Australian company focused on developing and commercializing genetic risk assessment tests. The presentation provides an overview of the company's business, including its portfolio of current and upcoming genetic tests, markets and channels to market, and capabilities. Key points include:
- Genetic Technologies aims to offer the most comprehensive suite of genetic risk assessment tests on the market, covering up to 70% of disease risks.
- The company is prioritizing market entry strategies in key regions like Australia, the US, and Asia.
- Tests are marketed through consumer-initiated and medical business-to-business channels.
- An innovative pipeline of new tests for diseases like cancer, heart disease, and diabetes is being
Eleven Biotherapeutics is developing a pipeline of protein therapies targeting inflammatory cytokines for ocular diseases with significant unmet need. Their lead candidate, EBI-005, is a topical IL-1 receptor antagonist in Phase 3 clinical trials for dry eye disease with results expected in Q2 2015. EBI-005 has also shown activity in allergic conjunctivitis and the company plans to begin Phase 3 trials in this indication in the second half of 2015. EBI-031, an anti-IL-6 antibody for diabetic macular edema, has demonstrated extended intravitreal retention and efficacy comparable to standard of care therapies in preclinical studies.
Sutro Biopharma is conducting a Phase 1 clinical trial of STRO-002, an antibody-drug conjugate (ADC) targeting folate receptor alpha (FolRα), in patients with advanced platinum-resistant or refractory epithelial ovarian cancer, fallopian tube or primary peritoneal cancers. Interim data from the trial will be presented at the AACR virtual conference on April 27th. STRO-002 was designed using Sutro's proprietary protein engineering platform, XpressCF, to have improved stability and a widened therapeutic index compared to other FolRα-targeting ADCs. Preclinical studies demonstrated STRO-002's enhanced potency and specificity versus benchmarks. The trial will evaluate
Posterior Segment Company Showcase - Graybug VisionHealthegy
Posterior Segment Company Showcase - Graybug Vision at OIS@AAO 2016.
Presenter:
Jeffrey Cleland, PhD, President & CEO
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Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
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 2021, 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 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.
Exelixis reported financial results for Q2 2014 and provided updates on their cabozantinib and cobimetinib development programs. COMETRIQ sales increased 34% over Q1 2014. Exelixis expects key data readouts from cabozantinib trials in prostate cancer and renal cell carcinoma in late 2014/2015. Cobimetinib phase 3 data in melanoma presented positive top-line results and Exelixis is preparing for potential co-promotion with Genentech. Exelixis reaffirmed 2014 financial guidance and expects year-end cash over $200 million.
Public Device & Biopharma Ophthalmology Company Showcase - OmerosHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - Omeros at OIS@AAO 2016.
Presenter:
Leonard M. Blum, Chief Business & Commercial Officer
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Genetic Technologies is an Australian company focused on developing and commercializing genetic risk assessment tests. The presentation provides an overview of the company's business, including its portfolio of current and upcoming genetic tests, markets and channels to market, and capabilities. Key points include:
- Genetic Technologies aims to offer the most comprehensive suite of genetic risk assessment tests on the market, covering up to 70% of disease risks.
- The company is prioritizing market entry strategies in key regions like Australia, the US, and Asia.
- Tests are marketed through consumer-initiated and medical business-to-business channels.
- An innovative pipeline of new tests for diseases like cancer, heart disease, and diabetes is being
Eleven Biotherapeutics is developing a pipeline of protein therapies targeting inflammatory cytokines for ocular diseases with significant unmet need. Their lead candidate, EBI-005, is a topical IL-1 receptor antagonist in Phase 3 clinical trials for dry eye disease with results expected in Q2 2015. EBI-005 has also shown activity in allergic conjunctivitis and the company plans to begin Phase 3 trials in this indication in the second half of 2015. EBI-031, an anti-IL-6 antibody for diabetic macular edema, has demonstrated extended intravitreal retention and efficacy comparable to standard of care therapies in preclinical studies.
Sutro Biopharma is conducting a Phase 1 clinical trial of STRO-002, an antibody-drug conjugate (ADC) targeting folate receptor alpha (FolRα), in patients with advanced platinum-resistant or refractory epithelial ovarian cancer, fallopian tube or primary peritoneal cancers. Interim data from the trial will be presented at the AACR virtual conference on April 27th. STRO-002 was designed using Sutro's proprietary protein engineering platform, XpressCF, to have improved stability and a widened therapeutic index compared to other FolRα-targeting ADCs. Preclinical studies demonstrated STRO-002's enhanced potency and specificity versus benchmarks. The trial will evaluate
Posterior Segment Company Showcase - Graybug VisionHealthegy
Posterior Segment Company Showcase - Graybug Vision at OIS@AAO 2016.
Presenter:
Jeffrey Cleland, PhD, President & CEO
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For more ophthalmology innovation
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Aridis Pharmaceuticals is a late-stage clinical development company, leading the creation of transformative, first-in-class anti-infectives for life-threatening viral and bacterial respiratory infections. The company’s lead drug candidate for acute pneumonia met all endpoints for its phase 2 clinical trial and the Company is now preparing for a phase 3 study. Its pipeline of novel mechanism antibacterial and antivirals, sprung from its proprietary technology platforms, are designed to combat the growing public health threat of viral pandemics and antimicrobial resistant (AMR) bacteria. Its anti-toxin monoclonal antibody approach is a proven Mechanism of Action and has shown efficacy as a combination therapy in reducing acute pneumonia patients time in ICU as compared to the current standard of care, which is antibiotics. In addition to its phase 3 program, ARDS also has a phase 2 asset for the treatment of Bacteria HAP/VAP LPS 011. It also recently began enrolling for a phase 2 clinical trial for the treatment of Cystic Fibrosis patients with acute pneumonia, a program funded by the Cystic Fibrosis Foundation for $7.5 million. Importantly, ARDS is also preparing to launch a Phase 1/2 clinical trial in the second half of 2021 with its novel inhalation antibody technology for emerging COVID-19 mutated variants. The expansion of COVID virus strain coverage, combined with the product's self-administered, at-home treatment modality, further differentiates the company's AR-712 COVID treatment offering.
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 2021, 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 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.
Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
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For more ophthalmology innovation
Visit us at www.ois.net
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
The document discusses Critical Outcome Technologies Inc. (COTI), a bioinformatics company that uses its proprietary CHEMSAS platform to accelerate drug discovery and reduce costs. The CHEMSAS platform uses artificial intelligence and computational modeling to simulate the drug discovery process in silico, identifying promising compounds faster and cheaper than traditional wet-lab approaches. COTI has multiple collaborations utilizing the platform and an oncology drug candidate, COTI-2, that shows promise for cancers with p53 mutations and is nearing phase 1 clinical trials. The platform also positions COTI for numerous potential licensing deals and revenue streams from drug development milestones and royalties.
- Palisade Bio was formed through the merger of Leading BioSciences and Seneca to focus on developing drugs to restore intestinal barrier health.
- Their lead product, LB1148, is an oral protease inhibitor that has shown in clinical trials to accelerate the return of normal bowel function after surgery by 30%.
- They plan to initiate a Phase 3 trial in 2021 to evaluate LB1148 in improving GI recovery in neonates undergoing cardiac surgery, which could potentially qualify for priority review.
- If successful, LB1148 has the potential to reduce postoperative complications and lower healthcare costs through shorter hospital stays.
HR Compliance & Insurance Benefit Perspectives: What Employers Should Be Awar...Rea & Associates
Guidelines for employees are constantly changing but it’s important that businesses stay on top of mandates and regulations. What risks should organizations be informed about? Is your organization able to have varied insurance premiums for vaccinated vs. non-vaccinated employees?
Join Rea & Associates and Huntington Insurance for a deep dive into best practices for exposures, insurance perspectives, and vaccine mandates and regulations.
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
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This presentation discusses forward-looking statements and risks associated with them. It notes that while management believes expectations in forward-looking statements are reasonable, actual results could differ materially due to known and unknown risks and uncertainties. The presentation also notes that views expressed as of the date may change in the future.
Interpace Diagnostics provides molecular diagnostic tests and pathology services to evaluate cancer risk. The presentation discusses:
1) Interpace's product portfolio including tests that risk-stratify pancreatic cysts, Barrett's esophagus, and thyroid nodules.
2) Clinical evidence and guidelines supporting their tests, and growth in adoption and coverage by payers.
3) Financial highlights including recent funding raises, revenue growth, and progress reducing costs.
4) Drivers for continued growth including expanding sales force and strategic partnerships.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
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®.
Catasys provides a virtual, scalable, and data-driven behavioral health program called OnTrak to help address the high costs of untreated behavioral health conditions like substance abuse, depression, and anxiety. OnTrak uses predictive analytics to identify avoidant patients, engages them in a 52-week outpatient treatment program with care coaching support, and integrates medical and psychosocial care. This approach aims to reduce health plan costs by around 50% while providing full reimbursement. Catasys has signed agreements with several major health insurance companies to provide OnTrak and is seeing growing enrollment.
Advanced Medical Isotope Corporation is developing RadioGel, a brachytherapy device, to treat cancers in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing. It is working towards FDA approval for human cancer indications like skin cancer. RadioGel consists of radioactive yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing revenue. It is led by an experienced management team and advises by world-class medical and scientific boards.
- The document discusses Sanofi's performance at the Cowen Healthcare Conference on March 12, 2018.
- It highlights Sanofi's building of a leadership position in rare blood disorders through recent acquisitions including Bioverativ and planned acquisition of Ablynx.
- Clinical trial results for investigational drugs like caplacizumab for aTTP and fitusiran for hemophilia are presented as enhancing Sanofi's pipeline.
- Growth of Sanofi's immunology franchise including Dupixent is discussed as an emerging driver of specialty care sales.
Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
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- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
American Noble Gas is an oil and gas exploration, development, and production company with a history of operations in Texas, Kansas, Oklahoma, and the Rocky Mountain region of the US. The Company is currently exploring and developing natural gas, helium, and other noble gases and brine minerals contained in the Hugoton Gas Field, a prolific natural gas and helium gas field spanning the states of Kansas, Oklahoma, and Texas, through a 40% participation in a farmout agreement that covers drilling and completion of up to 50 wells. American Noble Gas also owns 60.7143% of GMDOC, LLC, LLC which acquired certain oil and gas leases covering approximately 10,000 acres located in Southern Kansas near the Oklahoma border. The GMDOC leases currently produce approximately 100 barrels of oil and 1.2 million cubic feet of natural gas per day on a gross basis. The Company also owns mineral rights to approximately 11,000 acres in the Otis/Albert Field located on the Kansas Central Uplift.
Unicycive Therapeutics (UNCY) is a developer of residential communities in Northern Baja California with projects are targeted at buyers and investors of primary, vacation, and/or retirement homes. The Company’s projects in Northern Baja – a popular tourism and retirement destination – are strategically located within driving distance of Southern California and are supported by the region’s attractive demographics, large pent-up demand, and persistent housing shortages. With a goal of delivering sustainable and socially responsible solutions, the Company leverages advanced property and construction technologies to provide a seamless and efficient platform that enhances the customer sales experience. A newly added mortgage division, providing previously unattainable financing options to US buyers, is expected to drive accelerate sales growth across UNCY’s projects.
Public Device & Biopharma Ophthalmology Company Showcase - QLTHealthegy
Public Device & Biopharma Ophthalmology Company Showcase - QLT at OIS@AAO 2016.
Presenter:
David Saperstein, MD, Chief Medical Advisor
Powered by:
Healthegy
For more ophthalmology innovation
Visit us at www.ois.net
Virios Therapeutics is a clinical-stage biotechnology company focused on
advancing novel, dual mechanism antiviral therapies to treat conditions
associated with virally triggered or maintained immune responses, such as
Fibromyalgia (“FM”). Immune responses related to the activation of tissue
resident Herpes Simplex Virus-1 (“HSV-1”) have been postulated as a
potential root cause triggering and/or sustaining chronic illnesses such as
FM, irritable bowel disease (“IBS”), and chronic fatigue syndrome, all of
which can be characterized by waxing and waning symptom “flair-ups” with
no obvious etiology. Virios’ lead development candidate (“IMC-1”) is a
novel, proprietary, fixed dose combination of famciclovir and celecoxib
designed to synergistically suppress HSV-1 replication, with the end goal
of reducing virally promoted disease symptoms.
The document discusses Critical Outcome Technologies Inc. (COTI), a bioinformatics company that uses its proprietary CHEMSAS platform to accelerate drug discovery and reduce costs. The CHEMSAS platform uses artificial intelligence and computational modeling to simulate the drug discovery process in silico, identifying promising compounds faster and cheaper than traditional wet-lab approaches. COTI has multiple collaborations utilizing the platform and an oncology drug candidate, COTI-2, that shows promise for cancers with p53 mutations and is nearing phase 1 clinical trials. The platform also positions COTI for numerous potential licensing deals and revenue streams from drug development milestones and royalties.
- Palisade Bio was formed through the merger of Leading BioSciences and Seneca to focus on developing drugs to restore intestinal barrier health.
- Their lead product, LB1148, is an oral protease inhibitor that has shown in clinical trials to accelerate the return of normal bowel function after surgery by 30%.
- They plan to initiate a Phase 3 trial in 2021 to evaluate LB1148 in improving GI recovery in neonates undergoing cardiac surgery, which could potentially qualify for priority review.
- If successful, LB1148 has the potential to reduce postoperative complications and lower healthcare costs through shorter hospital stays.
HR Compliance & Insurance Benefit Perspectives: What Employers Should Be Awar...Rea & Associates
Guidelines for employees are constantly changing but it’s important that businesses stay on top of mandates and regulations. What risks should organizations be informed about? Is your organization able to have varied insurance premiums for vaccinated vs. non-vaccinated employees?
Join Rea & Associates and Huntington Insurance for a deep dive into best practices for exposures, insurance perspectives, and vaccine mandates and regulations.
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnol...Healthegy
Public Device & Biopharma Ophthalmology Company Showcase - Adverum Biotechnologies at OIS@AAO 2016.
Presenter:
Samuel B. Barone, MD SVP, Clinical Development
Powered by:
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For more ophthalmology innovation
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This presentation discusses forward-looking statements and risks associated with them. It notes that while management believes expectations in forward-looking statements are reasonable, actual results could differ materially due to known and unknown risks and uncertainties. The presentation also notes that views expressed as of the date may change in the future.
Interpace Diagnostics provides molecular diagnostic tests and pathology services to evaluate cancer risk. The presentation discusses:
1) Interpace's product portfolio including tests that risk-stratify pancreatic cysts, Barrett's esophagus, and thyroid nodules.
2) Clinical evidence and guidelines supporting their tests, and growth in adoption and coverage by payers.
3) Financial highlights including recent funding raises, revenue growth, and progress reducing costs.
4) Drivers for continued growth including expanding sales force and strategic partnerships.
Immuron Limited is a clinical stage biopharmaceutical company developing oral immunotherapies to treat inflammatory and infectious diseases. It has two lead clinical assets in Phase 2 development for non-alcoholic steatohepatitis (NASH) and Clostridium difficile infection. Immuron's lead candidate, IMM-124E, is being studied in three Phase 2 clinical trials for NASH, alcoholic steatohepatitis, and pediatric non-alcoholic fatty liver disease, with data expected in late 2017 and 2018. IMM-124E works through broad anti-inflammatory effects and has demonstrated a strong anti-fibrotic effect in preclinical models of liver disease.
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®.
Catasys provides a virtual, scalable, and data-driven behavioral health program called OnTrak to help address the high costs of untreated behavioral health conditions like substance abuse, depression, and anxiety. OnTrak uses predictive analytics to identify avoidant patients, engages them in a 52-week outpatient treatment program with care coaching support, and integrates medical and psychosocial care. This approach aims to reduce health plan costs by around 50% while providing full reimbursement. Catasys has signed agreements with several major health insurance companies to provide OnTrak and is seeing growing enrollment.
Advanced Medical Isotope Corporation is developing RadioGel, a brachytherapy device, to treat cancers in humans and animals. The company plans to generate near-term revenue from veterinary clinics and international licensing. It is working towards FDA approval for human cancer indications like skin cancer. RadioGel consists of radioactive yttrium-90 phosphate particles delivered via a hydrogel vehicle that solidifies in the body. The company expects to begin sales to veterinary clinics in early 2018 and obtain international licensing revenue. It is led by an experienced management team and advises by world-class medical and scientific boards.
- The document discusses Sanofi's performance at the Cowen Healthcare Conference on March 12, 2018.
- It highlights Sanofi's building of a leadership position in rare blood disorders through recent acquisitions including Bioverativ and planned acquisition of Ablynx.
- Clinical trial results for investigational drugs like caplacizumab for aTTP and fitusiran for hemophilia are presented as enhancing Sanofi's pipeline.
- Growth of Sanofi's immunology franchise including Dupixent is discussed as an emerging driver of specialty care sales.
Posterior Segment Company Showcase - PanOpticaHealthegy
Posterior Segment Company Showcase - PanOptica at OIS@AAO 2016.
Presenter:
Paul Chaney, Co-Founder, President & CEO
Powered by:
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For more ophthalmology innovation
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- IDXG provides molecular diagnostic tests for cancer risk assessment and prognosis.
- Recent accomplishments include new product launches, reimbursement from Aetna for ThyraMir, and achieving approval in New York State.
- The presentation provides financial information, with revenue growing but losses continuing from investments in sales, R&D and administrative expenses.
American Noble Gas is an oil and gas exploration, development, and production company with a history of operations in Texas, Kansas, Oklahoma, and the Rocky Mountain region of the US. The Company is currently exploring and developing natural gas, helium, and other noble gases and brine minerals contained in the Hugoton Gas Field, a prolific natural gas and helium gas field spanning the states of Kansas, Oklahoma, and Texas, through a 40% participation in a farmout agreement that covers drilling and completion of up to 50 wells. American Noble Gas also owns 60.7143% of GMDOC, LLC, LLC which acquired certain oil and gas leases covering approximately 10,000 acres located in Southern Kansas near the Oklahoma border. The GMDOC leases currently produce approximately 100 barrels of oil and 1.2 million cubic feet of natural gas per day on a gross basis. The Company also owns mineral rights to approximately 11,000 acres in the Otis/Albert Field located on the Kansas Central Uplift.
Unicycive Therapeutics (UNCY) is a developer of residential communities in Northern Baja California with projects are targeted at buyers and investors of primary, vacation, and/or retirement homes. The Company’s projects in Northern Baja – a popular tourism and retirement destination – are strategically located within driving distance of Southern California and are supported by the region’s attractive demographics, large pent-up demand, and persistent housing shortages. With a goal of delivering sustainable and socially responsible solutions, the Company leverages advanced property and construction technologies to provide a seamless and efficient platform that enhances the customer sales experience. A newly added mortgage division, providing previously unattainable financing options to US buyers, is expected to drive accelerate sales growth across UNCY’s projects.
This presentation provides an overview of a cancer genetics laboratory company. Key points include:
- The company has experienced strong and consistent revenue and test volume growth through strategic partnerships and an expanding test menu. An upcoming acquisition is expected to more than double revenue and more than triple adjusted EBITDA.
- The management team has extensive experience in large cap clinical laboratories.
- The company addresses a $5 billion clinical cancer testing market and has opportunities for further growth through innovation, such as liquid biopsy tests and partnerships with oncologists.
- Recent acquisitions and an expanding test menu have contributed to accelerating same store sales growth.
Presentation from OIS@ASCRS 2016
Amar Sawhney, PhD, President, CEO & Chairman
Video Presentation:
https://www.youtube.com/watch?v=nGQzo6czij0&list=PL1dmdBNnPTZJBhQxPOp0vdNg3s3wtN2yw&index=31
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on being a leading cancer genetics testing provider, experience in consolidating the industry, a comprehensive testing menu, and strategic partnerships with pathologists and oncologists.
- Financial projections estimate the combined company will generate around $247 million in revenue and $35-40 million in adjusted EBITDA in 2016 following the acquisition.
- The company provides an overview presentation of its business operations, growth strategy, and recent acquisition of Clarient, which is expected to more than double its revenue and more than triple its adjusted EBITDA in 2016.
- Key highlights include its focus on cancer genetics testing, strategic partnerships with pathologists and oncologists, a comprehensive testing menu, and experienced management team.
- Financial projections estimate combined pro forma revenue of $242-252 million and adjusted EBITDA of $35-40 million in 2016 following the acquisition of Clarient. Synergies from the acquisition are expected to provide $20-30 million in annual cost savings.
This presentation provides an overview of the company and its recent acquisition of Clarient. It summarizes that the acquisition is expected to more than double the company's revenue and more than triple its adjusted EBITDA in 2016. The company operates a fast-growing cancer genetics laboratory and sees significant opportunity in consolidating the dynamic and consolidating industry. The acquisition combines the companies' complementary assets and geographic footprints to create a leader in hematological and solid tumor cancer testing with synergies of $20-30 million annually.
- The company provides an overview presentation of its business operations as a fast growing cancer genetics laboratory.
- Key highlights include strategic client partnerships through its "tech-only" model, an industry-leading growth rate in revenue and test volume, and the most comprehensive cancer testing menu in the industry.
- The acquisition of Clarient is expected to more than double the company's revenue and more than triple adjusted EBITDA for 2016.
This presentation provides an overview of the company and its recent acquisition of Clarient. It summarizes that the acquisition is expected to more than double the company's revenue and more than triple its adjusted EBITDA in 2016. The company provides cancer genetic testing services and sees significant opportunity for growth and consolidation in the dynamic and expanding industry. The acquisition combines the companies' complementary assets and is expected to generate $20-30 million in annual synergies within 3-5 years.
This presentation provides an overview of NeoGenomics' proposed acquisition of Clarient, which would more than double NeoGenomics' revenue. The strategic rationale is that the combined company would have greater scale and a more balanced oncology product portfolio, allowing it to be a lower-cost provider. It would also gain a larger clinical trials business and enhanced geographic coverage. Synergies of $20-30 million annually are projected from consolidating laboratories, purchasing, cross-selling and other areas. The acquisition supports NeoGenomics' strategy of using M&A to accelerate its vision of becoming a leading cancer testing and information company.
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.
- NeoGenomics is acquiring Clarient, which should more than double NeoGenomics' revenue in 2016.
- The acquisition creates a leading cancer testing and information company with expanded geographic coverage and a more comprehensive product menu.
- Synergies of $20-30 million per year are expected from cost savings and cross-selling opportunities between the two companies.
This document summarizes Sanofi's Sustaining Innovation Analyst Day held on December 13, 2017 in Paris. It outlines Sanofi's strategic focus on sustaining innovation in R&D through developing high-value projects, improving launch pipeline and portfolio prioritization processes. Sanofi's R&D model focuses on key disease areas like immunology, oncology, rare diseases, diabetes and vaccines. The presentation highlights 9 potential product submissions in the next 18 months and over 10 new pivotal trials expected to start in the next 12 months. Sanofi aims to financially discipline its R&D investments based on rigorous project prioritization methodology.
- Sanofi is building a leading rare blood disorder franchise through the acquisitions of Bioverativ and Ablynx which expand their portfolio of therapies for rare diseases like hemophilia and acquired thrombotic thrombocytopenic purpura (aTTP).
- Bioverativ strengthens Sanofi's position in hemophilia with therapies like Eloctate and Alprolix and the investigational fitusiran. Caplacizumab shows strong results for aTTP and was filed for approval in the EU and U.S.
- The global hemophilia market is approximately $10 billion and growing at 7% annually, driven by reliable extended half-life factor therapies and broader
March 2017 Company Overview Presentation by NeoGenomics, (Nasdaq: NEO) a fast...Hawk Associates, Inc.
NeoGenomics, Inc. is a high-complexity CLIA-certified clinical laboratory and pharma services company that specializes in cancer genetics diagnostic testing, the fastest growing segment of the laboratory industry. The company's testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, anatomic pathology, and molecular genetics. Headquartered in Fort Myers, FL, NeoGenomics maintains a network of testing facilities across the US. NeoGenomics services the needs of pathologists, oncologists, urologists and other physician specialists, academic institutions, and the pharmaceutical industry.
The company’s acquisition of Clarient at the end of 2015 significantly transformed the company in terms of reach and capabilities. It more than doubled the size of the company overnight and puts the company on a strong path to achieve its vision of becoming the world’s leading cancer testing and information company.
The company has aggressively accelerated its pace of innovation adding new cancer tests. The company’s targeted tumor-specific multimodality NeoTYPE profiles, which combine molecular, FISH and IHC testing, are gaining acceptance by pathologists and clinicians. The new Liquid Biopsy NeoLAB family of tests now includes 16 different liquid biopsy test. Clarient’s expertise in PDL1 testing has further broadened the company’s cancer testing menu.
- Sanofi's CEO Olivier Brandicourt presented at a healthcare conference on September 14, 2018.
- He discussed Sanofi's continued progress on its strategic transformation including acquiring new assets, driving simplification through restructuring, reshaping its portfolio, and executing new product launches.
- Brandicourt highlighted several potentially significant drug approvals and trial results for new drugs and indications expected over the next 12 months that could further advance Sanofi's growth.
- He concluded that while Sanofi saw impacts from recent drug losses of exclusivity in the first half of 2018, performance was otherwise in line with expectations and several factors position Sanofi for a new growth phase in the second half of
This presentation provides an overview of the company. Key points include:
- The company is a fast growing cancer genetics lab serving oncologists, pathologists, and hospitals.
- Recent acquisition of Clarient is expected to more than double revenue and more than triple adjusted EBITDA in 2016.
- The company has a large addressable market of $5 billion for clinical cancer testing and an experienced management team.
- Financial results show strong revenue and test volume growth as well as expanding adjusted EBITDA margins.
This presentation provides an overview of the company and its acquisition of Clarient. It summarizes that the acquisition will more than double the company's revenue and more than triple its adjusted EBITDA. The acquisition provides key benefits like synergies of $20-30 million annually within 3-5 years, a combined leadership in cancer testing, and expanded geographic coverage across the United States with field sales representatives.
Can-Fite BioPharma Ltd. (NYSE American: CANF) is an advanced clinical stage drug development company with a platform technology that addresses multi-billion-dollar markets in the treatment of autoimmune inflammatory diseases including Psoriasis, and liver diseases including advanced liver cancer and NASH. Can-Fite’s drugs have an excellent safety profile with experience in over 1,000 patients. Can-Fite’s intellectual property portfolio consists of 13 patent families issued and pending. Piclidenoson and Namodenoson have been out-licensed in select territories with approximately $18 million received to date. Piclidenoson received approval for COVID-19 clinical trial in Israel in April 2020 and is expected to file its IND in the US in the near-term.
Similar to Exelixis Q1 2014 Financial Results (20)
Presentation Clayton Valley, NevadaFrom Drilling to PEA in under 2 YearsCompany Spotlight
The document summarizes Cypress Development Corp's Clayton Valley lithium project in Nevada. Key points include:
- A Preliminary Economic Assessment shows promising economics including a 32.7% IRR and $1.45 billion NPV.
- Measured and indicated resources total 8.9 million tonnes LCE with additional inferred resources.
- The project has the potential for low-cost production due to favorable geology and metallurgy.
- Upcoming catalysts in 2019 include a metallurgical study and prefeasibility study to further de-risk the project.
Aben Resources has made a new high-grade gold discovery at its flagship Forrest Kerr project in BC's Golden Triangle region. The region is known for major gold deposits and saw $100 million in exploration spending in 2017. Recent improvements have made the Forrest Kerr project more accessible via new roads. Aben's technical team has reinterpreted historical data and identified additional exploration targets. The project covers over 23,000 hectares of prospective geology along the Forrest Kerr fault zone that is similar to other major deposits in the Golden Triangle.
Aben Resources has discovered high-grade gold zones at its Forrest Kerr project in British Columbia's Golden Triangle. The first hole of the 2018 drill program intersected four separate high-grade gold zones within 190 metres, including 331.0 g/t Au over 1.0 metre. Aben plans to expand drilling at the Boundary North Zone and test other gold anomalies identified through soil sampling. The company also holds the Justin project in Yukon and Chico project in Saskatchewan near recent discoveries.
Cypress Development Corp. owns lithium claims in Clayton Valley, Nevada near Albemarle's Silver Peak lithium mine. A preliminary economic assessment found the project could have a 32.7% IRR and $1.45 billion NPV. The project would extract lithium from claystone using leaching and have average annual production of 24,042 tonnes of lithium carbonate over 40 years. Capital costs are estimated at $482 million to build a 15,000 tonne per day operation.
The document discusses Aben Resources Ltd., a gold exploration company with projects in British Columbia's Golden Triangle region and other areas of Western Canada. It provides an overview of Aben's management team and directors, flagship Forrest Kerr project, recent drilling results showing new high-grade gold discoveries, and its strategy to advance exploration through 2018. The document also briefly outlines Aben's other projects including the Chico gold project in Saskatchewan and Justin gold project in Yukon.
Cypress Development Corp. owns the Clayton Valley lithium project in Nevada. Drilling in 2017 intersected lithium-bearing claystone averaging 921 ppm Li over 77 meters thick. A maiden resource estimate calculated 3.287 million tonnes of lithium carbonate equivalent in the indicated category and 2.916 million tonnes LCE in inferred. Metallurgical tests show the claystone is acid leachable and able to recover over 80% of the lithium. Cypress plans additional drilling, engineering studies, and permitting to advance the project towards production.
- Aben Resources has three highly prospective gold projects in Western Canada including its flagship Forrest Kerr Project in BC's Golden Triangle region, which had recent drilling success expanding the Boundary North Zone.
- Management has over 100 years of combined experience in Western Canada and a proven track record of success.
- The projects have significant historic work identifying high-grade gold and robust discovery potential remains.
Cypress Development Corp. owns the Clayton Valley lithium project in Nevada. Drilling in 2017 intersected lithium-bearing claystone averaging 921 ppm Li over 77 meters. A maiden resource estimate classified over 1.3 million tonnes of lithium carbonate equivalent as indicated and inferred. Metallurgical testing shows the claystone is leachable with over 80% lithium recovery. Cypress aims to advance the project with engineering studies and further drilling to define resources with the goal of becoming a domestic lithium producer for the growing battery market.
The document provides forward-looking statements and discusses risks associated with such statements. It notes that some statements may be deemed forward-looking and lists factors that could cause actual results to differ from forward-looking statements. The document also identifies the qualified person for the technical information as Cornell McDowell and provides Aben's trading symbols and recent share information.
The document provides an overview of Aben Resources Ltd., a mineral exploration company with gold projects in Western Canada. It summarizes Aben's three key projects - Forrest Kerr in BC's Golden Triangle region with recent drill results discovering the Boundary Zone, Chico in Saskatchewan near producing mines, and Justin in Yukon's White Gold district. It outlines the management team's expertise and provides company details like shares outstanding and trading symbols.
- Cypress Development Corp owns the Clayton Valley lithium project in Nevada located near Albemarle's Silver Peak lithium brine operation.
- Drilling in 2017 encountered lithium mineralization averaging 921 ppm Li over 77 meters in 14 holes drilled.
- Metallurgical tests show the claystone is acid leachable with over 80% lithium extraction possible.
- Cypress aims to define a resource estimate in 2018 and advance the project with feasibility studies to develop a lithium operation.
The document discusses forward-looking statements and provides disclaimers about them. It introduces the qualified person for the technical information presented. It also lists Aben's trading symbols and recent share information including price and market capitalization.
1) Cypress Development Corp owns the Clayton Valley lithium project located next to Albemarle's Silver Peak mine in Nevada. Drilling in 2017 intersected lithium-bearing claystone averaging over 900 ppm Li to a depth of over 100 meters.
2) A maiden resource estimate classified over 1.5 million tonnes of lithium carbonate equivalent as indicated and inferred. Metallurgical testing shows the claystone is acid leachable to extract over 80% of the lithium.
3) The project is located in a strategic location to supply the growing lithium-ion battery market in the US, with lithium demand accelerating due to the increased production of electric vehicles globally.
TerraX Minerals is a Canadian mineral exploration company focused on exploring and developing its 100% owned 772 square km Yellowknife City Gold project located adjacent to the city of Yellowknife, Northwest Territories. The project covers high-grade Archean gold districts and has had multiple high-grade gold discoveries. TerraX has a strong management team with experience discovering and developing gold deposits and low exploration costs due to the project's excellent infrastructure and year-round access near Yellowknife.
This document discusses forward-looking statements and provides information about Aben Resources Ltd., including its stock symbols, shares outstanding, recent share price, market capitalization, and three gold exploration projects in Western Canada. It summarizes the management team's experience and the company's investment highlights. Specifically, it owns the Forrest Kerr gold project in British Columbia's Golden Triangle region, which saw successful drilling results in 2017 that led to a new discovery called the North Boundary zone.
Cypress Development Corp owns lithium claystone deposits in Clayton Valley, Nevada near Albemarle's Silver Peak lithium mine. Drilling in 2017 encountered lithium mineralization averaging 921 ppm Li over 77 meters in 14 holes. Metallurgical tests show the claystone is acid leachable with up to 80% lithium extraction. Cypress plans additional drilling, process engineering, and a preliminary economic assessment in 2018 to advance the project. The company sees potential for the project given growing lithium demand from electric vehicles and batteries.
TerraX Minerals is a Canadian mineral exploration company focused on exploring its 100% owned 772 square km Yellowknife City Gold project located near Yellowknife, Northwest Territories. The project covers high-grade Archean gold districts with known deposits and past producers. TerraX has made multiple high-grade gold discoveries on the property and identified several high-priority targets for further exploration and drilling. The company has a strong management team with experience discovering and developing deposits in the region.
Cypress Development Corp owns lithium claystone deposits in Clayton Valley, Nevada that have the potential to be a significant lithium resource. Drilling in 2017 encountered mineralization averaging 921 ppm lithium over 77 meters thick in 14 drill holes. Metallurgical testing shows the claystone is acid leachable with up to 80% lithium extraction. Cypress plans additional drilling, metallurgical testing, and a preliminary economic assessment in 2018 to further define the resource potential.
Cypress Development Corp owns lithium claystone deposits in Clayton Valley, Nevada near Albemarle's Silver Peak lithium mine. Drilling in 2017 encountered mineralization averaging 921 ppm lithium over 77 meters thick in 14 drill holes. Metallurgical tests show the claystone is acid leachable with up to 80% lithium extraction. Cypress plans additional drilling, metallurgical testing, and a preliminary economic assessment in 2018 to evaluate the project's potential.
Cypress Development Corp is exploring for lithium resources in Clayton Valley, Nevada. Recent drilling has encountered lithium-bearing claystone up to 112 meters below surface, with grades averaging over 800 ppm lithium. Metallurgical testing indicates 80% of the lithium can be extracted using a weak sulfuric acid solution. Cypress plans additional drilling in 2018 and expects to publish a initial lithium resource estimate in Q1 2018 to advance the project towards a preliminary economic assessment. The project is located near existing lithium production and infrastructure to be a potential new supply of lithium for the growing battery market.
Cleades Robinson, a respected leader in Philadelphia's police force, is known for his diplomatic and tactful approach, fostering a strong community rapport.
MUTUAL FUNDS (ICICI Prudential Mutual Fund) BY JAMES RODRIGUESWilliamRodrigues148
Mutual funds are investment vehicles that pool money from multiple investors to purchase a diversified portfolio of stocks, bonds, or other securities. They are managed by professional portfolio managers or investment companies who make investment decisions on behalf of the fund's investors.
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.
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2. Today’s Agenda
Introduction Susan Hubbard, Investor Relations
Overview Mike Morrissey, President and CEO
Financials Frank Karbe, EVP and CFO
Cabozantinib Gisela Schwab, EVP and CMO
Cobimetinib Peter Lamb, EVP and CSO
Commercial Update Scott Garland, EVP and CCO
Q&A All
2
Press release and webcast (live and archived) available at www.exelixis.com
3. 3
Forward-Looking Statements
This presentation, including any oral presentation accompanying it, contains forward-looking statements, including, without limitation, statements
related to: the continued development and clinical, therapeutic and commercial potential of, and opportunities for, cabozantinib and cobimetinib;
anticipated developments in, and the expected timing of, various trials, including expected top-line results from four pivotal trials in 2014; Exelixis’
strategy for advancing the cabozantinib development program; the designs, plans and goals for ongoing and planned clinical trials of
cabozantinib; future potential regulatory filings; the commercialization of COMETRIQ® (cabozantinib) in the approved medullary thyroid
indications and in new indications if approved for use in such indications; future data presentations; Exelixis’ expectations for revenue growth and
future product sales; Exelixis' financial guidance and outlook for 2014; the length of Exelixis’ financial runway; Exelixis’ goals to bring new
therapies to patients with cancer and build value for investors; and Exelixis’ top priorities for 2014. These statements are based on Exelixis’
current expectations, assumptions, estimates and projections about its business and its industry and involve known and unknown risks,
uncertainties and other factors that may cause Exelixis’ or its industry’s results, levels of activity, performance or achievements to be materially
different from any future results, levels of activity, performance or achievements expressed or implied in, or contemplated by, the forward-looking
statements. Words such as “expect,” “believe,” “anticipate,” “potential,” “will,” “may” “should,” “would,” “could,” “focus,” “build,” “opportunity,”
“continue,” “advance,” “expanding,” “hope,” “look forward,” “plans,” “priorities,” “strategy,” “preparation,” “objective,” “goals,” “progress,” “outlook,”
“guidance,” “remains,” “promising,” “encouraging,” or the negative of such terms or other similar expressions, identify forward-looking statements,
but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to
expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Exelixis’ actual results and
the timing of events may differ significantly from the results discussed in the forward-looking statements. Factors that might cause such a
difference include, without limitation: the availability of data at the expected times; risks related to the potential failure of cabozantinib or
cobimetinib to demonstrate safety and efficacy in clinical testing; the uncertain timing and level of expenses associated with the development of
cabozantinib; Exelixis' ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; Exelixis' dependence on its
relationship with Roche/Genentech for the development of cobimetinib and Exelixis’ ability to maintain its rights under the collaboration; the
uncertainty of regulatory approval processes; the risk that unanticipated developments could adversely affect the commercialization of
COMETRIQ®; the degree of market acceptance of COMETRIQ and the availability of coverage and reimbursement for COMETRIQ; risks and
uncertainties related to Exelixis' compliance with applicable regulatory requirements, including healthcare fraud and abuse laws and post-
marketing requirements; Exelixis' dependence on third-party vendors; the sufficiency of Exelixis' capital and other resources; market competition;
changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” of Exelixis’ quarterly report on Form
10-Q filed with the Securities and Exchange Commission (SEC) on May 1, 2014 and in Exelixis' other filings with the SEC. The forward-looking
statements made in this presentation, including any oral presentation accompanying it, speak only as of the date on which the statements are
made. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking
statements contained herein to reflect any change in Exelixis' expectations with regard thereto or any change in events, conditions or
circumstances on which any such statements are based.
5. Exelixis Q1 2014 Highlights
Key regulatory milestone: E.U. approval for COMETRIQ®
• Indicated for adult patients with progressive, unresectable locally
advanced or metastatic medullary thyroid cancer (MTC)
• Testament to in-house global regulatory capabilities
COMET-1 to proceed to final analysis
• No change to development plans
• Anticipate top-line data from both COMET-1 and -2 this year
Cobimetinib presentations at EADO and ASCO 2014 with data from
phase 1 trial with vemurafenib (BRIM7)
5
7. Q1 2014 Financial Results
(See press release at www.exelixis.com for full details)
Net Revenue: $4.9M, all from COMETRIQ sales
• Decrease of $4.8M vs. Q1’13 due to contract and license revenue of $7.8M
in Q1 last year
• Net revenue from sale of COMETRIQ year-over-year (YoY) increased by
$3M, reflecting launch at end of Jan. 2013
R&D Expenses: $54.8M
• Increase of $22.1M vs. Q1’13 predominantly due to increase in clinical trial
expenses, primarily related to METEOR start-up
SG&A Expenses: $14.7M
• Increase of $4.1M vs. Q1’13 mainly driven by higher personnel expenses
(expansion of sales force, higher stock-based compensation, cobimetinib)
7
8. Q1 2014 Financial Results
(See press release at www.exelixis.com for full details)
Total Costs and Expenses: $69.9M
• Increase of $26.2M vs. Q1’13 reflects increased R&D and SG&A expenses
Other Income (Expense): Net Expense of ($9.6M)
• Decrease of $1.1M vs. Q1’13 associated with mark-to-market valuation of
new Deerfield Warrants issued in Q1 2014
• $7.0M of interest expense reflects non-cash charges
Quarter-End Cash: $408M*
• Includes net proceeds of ~$76M from stock offering in Q1 2014
• Also reflects second and final $10M early debt repayment under Deerfield
notes, as well as $7.5M purchase of comparator drug for METEOR
Financial Guidance for FY2014 unchanged
• Total Costs and Expenses: $250-280M
• Year-end cash >$200M
8
* Includes cash and cash equivalents, short- and long-term investments and short- and long-term
restricted cash and investments
9. Cobimetinib:
Corporate Collaboration with Genentech/Roche
United States: profit-share agreement with multiple tiers
• Entitled to 50% of first $200M in actual sales, decreasing to 30% of
actual sales above $400M
Ex-U.S.: royalties on net sales
• Entitled to low double-digit royalties
Co-promotion: Exelixis entitled to field up to 25% of U.S. sales
force
Exelixis not responsible for any development expenses
9
11. 11
Focused on Expanding the Cabozantinib Opportunity
Phase 3 Pivotal Trials
• COMET-1 (CRPC; OS)
• COMET-2 (CRPC; Pain
Palliation)
• METEOR (RCC)
• CELESTIAL (HCC)
• EXAM (MTC)
EXELIXIS RESOURCES
Phase 1 and 2 Clinical Trials
• National Cancer Institute’s
Cancer Therapy Evaluation
Program (NCI-CTEP)
• Investigator-Sponsored Trial
(IST) Program
PARTNERSHIPS
12. 12
Cabozantinib:
Castration-Resistant Prostate Cancer (CRPC)
Two randomized phase 3 pivotal trials of cabozantinib in CRPC
• COMET-1: vs. prednisone; overall survival (OS) endpoint
• COMET-2: vs. mitoxantrone/prednisone; pain palliation endpoint
• Potential to differentiate cabozantinib from other agents if successful
IDMC recommended COMET-1 proceed to final analysis
• Recommended study continue unchanged; study remains blinded
• Exelixis and CRO partner fully prepared for data read-out in 2014
• Preparations for potential regulatory filings continue as well
Note: Cabozantinib is not approved for use under investigation in these trials.
13. 13
Cabozantinib:
Castration-Resistant Prostate Cancer (CRPC)
Demonstrable activity in CRPC from phase 2 experience (n=144)
• Median OS of 10.8 months in patient population similar to COMET-1
• Clinical meaningful pain relief in 57% of patients; reduction or
discontinuation of narcotic analgesics in 55%
• Bone scan response in 63%; reduction in measurable disease in 80%
• Most common grade 3/4 AEs: fatigue (22%) and hypertension (14%)
Statistically significant and clinically meaningful improvements in
OS have been seen at the final analysis in other large, randomized
Phase 3 studies
• Of six trials that resulted in approval, only three met endpoint at interim
• Docetaxel (TAX327), sipuleucel-T (IMPACT), cabazitaxel (TROPIC) showed
OS benefit at final analysis and were approved
Note: Cabozantinib is not approved for use under investigation in these trials.
14. Earlier-stage CRPC: combination randomized phase 2 trial with
abiraterone started Q4’13, well underway
CELESTIAL: phase 3 trial in advanced hepatocellular cancer (HCC)
• Versus placebo in 760 patients previously treated with sorafenib; OS endpoint
• Enrolling on multiple continents; top line data expected 2016/17
METEOR: phase 3 pivotal trial in metastatic renal cell cancer (RCC)
• Versus everolimus in 650 patients who have received and progressed on/after
at least one prior VEGFR tyrosine kinase inhibitor; PFS endpoint, OS
secondary endpoint
• Top-line data expected in 2015; ~90% of sites now activated, reflecting a high
level of interest due to early phase data with cabozantinib in RCC, the design
of the phase 3 study, and a limited number of active competitive studies
Other Ongoing Studies of Cabozantinib
14
Note: Cabozantinib is not approved for use under investigation in these trials.
15. 2014 Top-line data from COMET-1 and COMET-2
in CRPC
2015 Top-line data from METEOR in RCC
2016/17 Top-line data from CELESTIAL in HCC
Anticipated Cabozantinib Clinical Trial Milestones
15
Note: Cabozantinib is not approved for use under investigation in these trials.
16. Cabozantinib:
Other Development Updates
MTC: Approval in the European Union
• Indicated for the treatment of adult patients with progressive, unresectable
locally advanced or metastatic MTC
• European Commission maintained orphan drug status for COMETRIQ in
MTC in Europe
Planned presentations at ASCO 2014, Chicago, May 30 – June 3, 2014
• Nine abstracts selected for presentation
• Trials in progress for RCC and HCC studies, plus data from IST and NCI-
CTEP programs
16
18. 18
Competitive Landscape: RAF/MEK Combination in
Metastatic Melanoma (MM), GSK Compounds
January 2014: accelerated approval for dabrafenib (RAF) and trametinib
(MEK) combo in unresectable or MM with BRAF V600 E or K mutation
• Based on phase 1/2 data looking in part at combination vs. dabrafenib alone
• IRC assessed PFS 9.2 mos for combo vs. 7.3 mos dabrafenib alone
• Overall response rate (ORR): 57% for combination versus 46% dabrafenib
• Both agents previously approved as single agents in same population
March 2014: top-line data for phase 3 trial comparing dabrafenib/
trametinib vs. dabrafenib alone in same patient population
• IRC-audited data: PFS 10.1 mos for combo vs. 9.5 mos dabrafenib alone
• ORR: 61% for combination vs. 47% dabrafenib alone
“Dear Healthcare Professional” letter sent to alert physicians to
findings; more detailed data expected at ASCO
19. 19
Cobimetinib Development Program
BRIM7: phase 1b dose escalation study evaluating safety,
tolerability of cobimetinib plus vemurafenib in advanced BRAF-
mutated melanoma
• Cohorts that met criteria for maximum-tolerated dose expanded and
included BRAF inhibitor-naïve and vemurafenib-progressing patients
BRIM7 data presented at ESMO, Fall 2013: ORR of 85% in BRAF
inhibitor-naïve patients; median PFS not reached with median
follow-up of 10 months
• Update on BRIM7 expected at EADO meeting, Vilnius, May 7, 2014
• Updated data also expected during oral presentation at ASCO, Chicago,
June 2, 2014
Genentech guiding top-line data from coBRIM, phase 3 pivotal trial
in previously untreated patients with BRAF-mutated melanoma,
expected this year
21. Commercial Update
Total net COMETRIQ revenues of $4.9M in Q1 2014
• 13% increase vs. Q4’13
• Essentially all sales came from United States: net $4.8M,
11% increase vs. Q4’13
7.5 months ave. treatment duration for active COMETRIQ MTC patients
• Continues to climb month-over-month
• ~25% of patients on drug for one year or longer
• Generally consistent with what was seen in clinical studies
Preparing for E.U. commercial launch with SOBI
• Reimbursement in Europe takes time
• Expect SOBI to purchase a small amount of commercial product in Q2 14
• Will provide quarterly updates on SOBI’s progress in rolling out
Cometriq across the E.U.
Productive conversations with Genentech re: cobimetinib co-promotion
21
23. Top Priorities for Exelixis in 2014
Top-line data readouts from the COMET studies
Preparing for regulatory filings, assuming positive COMET
data
Expediting enrollment in METEOR, phase 3 pivotal trial in
metastatic renal cell carcinoma
Planning commercial build-out supporting prostate cancer in
the U.S. and E.U., pending positive COMET data
23
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