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Cubist Pharmaceuticals to Present at May 2008 Investor Conferences
12:09p ET April 28, 2008 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that David McGirr, SVP and CFO, will present on Wednesday, May 14th at 10:40 A.M. CDT, at the RW Baird 2008 Growth Stock Conference being held at the Four Seasons Hotel in Chicago, IL. Mr. McGirr will also present on Wednesday, May 21st at 11:00 A.M. EDT, at the Citigroup Healthcare Conference taking place at the Hilton Hotel, New York, NY. These presentations will include discussion of the company's business activities, financial outlook, and current news.
Live webcasts of the presentations (Citigroup will be audio only) will be accessible through Cubist's website at www.cubist.com in the Investor Relations Conference Calendar section. The webcasts will be available on Cubist's website for a period of 14 days after the presentations.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes DX-88, a recombinant human protein in Phase II clinical trials for the prevention of blood loss during cardiothoracic surgery, and pre-clinical programs that address unmet medical needs in Gram-positive infections, Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections). Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.
SOURCE: Cubist Pharmaceuticals, Inc.
Dyax Corp. and Cubist Pharmaceuticals, Inc. Sign Development and Commercialization Agreement for DX-88 Surgical Indications
7:00a ET April 24, 2008 (Business Wire)
Dyax Corp. (NASDAQ: DYAX) and Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that they have signed an exclusive license and collaboration agreement for the development and commercialization of the intravenous formulation of DX-88 for the prevention of blood loss during surgery in North America and Europe.
Dyax will receive a $15 million upfront payment, an additional $2.5 million milestone payment in 2008 and is eligible to receive up to an additional $214 million in clinical, regulatory and sales-based milestone payments. Dyax is also entitled to receive tiered, double-digit royalties based on sales of DX-88 by Cubist. The agreement provides an option for Dyax to retain certain US co-promotion rights. Going forward, Cubist will be responsible for costs associated with the ongoing DX-88 on-pump cardiothoracic surgery (CTS) Phase 2 trial, known as Kalahari 1, as well as all further development costs associated with DX-88 in the licensed indications in the Cubist territory.
Dyax retains exclusive rights to DX-88 in all other indications, including its hereditary angioedema program, currently in its second Phase 3 trial, as well as for the manufacturing of DX-88. Dyax also plans to develop DX-88 in other angioedemas.
"Cubist brings a wealth of clinical resources and commercial expertise in the development of a hospital-based therapy, which will serve to maximize the potential of DX-88 in the prevention of blood loss during surgery," commented Henry E. Blair, Chairman, President and Chief Executive Officer of Dyax. "Furthermore, this partnership validates DX-88's potential as a multi-indication franchise and underlines the tremendous possibilities of this valuable asset."
"DX-88 immediately leverages our strong acute care clinical development and regulatory capabilities. Assuming approval, it will be an excellent fit with our proven acute care commercial infrastructure as well," commented Mike Bonney, President and CEO of Cubist. "As a potent plasma kallikrein inhibitor, DX-88 has the potential to be a breakthrough therapy in reducing blood loss and inflammation in multiple surgical indications. There is a serious unmet medical need and a large market opportunity for a successful therapy here."
About DX-88 in Surgery
DX-88, a Dyax-discovered potent inhibitor of plasma kallikrein, is being tested in an ongoing Phase 2 clinical trial (Kalahari 1) evaluating DX-88 in the prevention of blood loss during on-pump CTS, which includes coronary artery bypass graft (CABG) and heart valve and replacement procedures. The trial followed the completion of a Phase 1/2 proof-of-concept trial for the prevention of blood loss during high risk CABG surgery.
About Dyax
Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on oncology and inflammatory indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development.
Dyax's lead product candidate is DX-88, a recombinant small protein that is currently in clinical trials for its therapeutic potential in two separate indications. Dyax has completed three Phase 2 trials and a Phase 3 trial of DX-88 for the treatment of hereditary angioedema (HAE). A second Phase 3 trial, known as EDEMA4, is currently being conducted under a Special Protocol Assessment (SPA). DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S. for the treatment of acute attacks of HAE.
Dyax identified DX-88 and other compounds in its pipeline using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents.
Dyax is headquartered in Cambridge, Massachusetts, and has antibody discovery facilities in Liege, Belgium. For online information about Dyax Corp., please visit www.dyax.com.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. As announced today, Cubist is developing DX-88, a clinical stage compound in-licensed from Dyax Corp., as an IV therapy for use in reducing blood loss and inflammation in CTS. The Cubist product pipeline also includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections.) Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com
Cubist Pharmaceuticals Q1 2008 Revenues up 48%; Net Income up 220%: Total Revenues $88.3 Million; Net Product Revenues $87.9 Million
4:03p ET April 17, 2008 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today reported results for the first quarter ended March 31, 2008. Cubist's net revenues from CUBICIN(R) (daptomycin for injection) increased 48% from the prior year, from $59.4 million in the first quarter of 2007 to $87.9 million in the first quarter of 2008. U.S. net product revenue for the first quarter of 2008 was $86.1 million. Cubist's total revenues for the first quarter of 2008 increased 48% over the first quarter of 2007 from $59.5 million in the first quarter of 2007 to $88.3 million in the first quarter of 2008.
Net income for the first quarter ended March 31, 2008, on a GAAP basis was $17.9 million, or $0.32 and $0.26 per basic and diluted share, as compared to net income of $5.6 million, or $0.10 per basic and diluted share for the first quarter of 2007. First quarter 2008 GAAP net income includes $2.8 million, or $0.05 and $0.04 per basic and diluted share, respectively, in stock-based compensation expenses. First quarter 2008 GAAP net income also includes a one-time, non-cash, charge of $2.3 million related to the write off of assets disposed of to build new laboratory space at 65 Hayden Avenue.
Non-GAAP net income for the first quarter ended March 31, 2008, excluding the charges mentioned above, was $23.0 million, or $0.41 and $0.34 per basic and diluted share, respectively.
As of March 31, 2008, Cubist had $331.1 million in cash, cash equivalents and investments. The total number of common shares outstanding at March 31, 2008 was 56,241,087.
Use of Non-GAAP Financial Measures
Cubist adopted FAS 123(R) on January 1, 2006 using the modified prospective method, which resulted in the recognition of stock-based compensation expenses in the statement of operations from 2006 onward without adjusting the prior years. Cubist uses non-GAAP net income (loss) and non-GAAP net income (loss) per share data to improve its analysis of operational results and trends. Cubist's management also uses these non-GAAP figures to make financial and operational decisions as these numbers exclude non-operational activities. These measures should not be considered an alternative to measurements required by GAAP, such as net income (loss) and net income (loss) per share, and should not be considered measures of our liquidity. A reconciliation between non-GAAP financial measures and GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements. CONFERENCE CALL & WEBCAST INFORMATION Cubist will host a conference call and live audio webcast to discuss its first quarter 2008 Financial results, business activities and financial outlook. WHEN: Thursday, April 17, 2008 at 5:00 p.m. EDT LIVE DOMESTIC & CANADA CALL-IN: 877-407-0778 LIVE INTERNATIONAL CALL-IN: 201-689-8565 24-HOUR REPLAY DOMESTIC & CANADA: 877-660-6853 24-HOUR REPLAY INTERNATIONAL: 201-612-7415 REPLAY PASSCODES (BOTH REQUIRED FOR PLAYBACK): ACCOUNT #: 286 CONFERENCE ID #: 274880 CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.cubist.com Replay will be available for 30 days at www.cubist.com
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections.) Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.
CUBIST PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS UNAUDITED (in thousands) March 31, December 31, 2008 2007 --------- ------------ ASSETS Cash, cash equivalents and investments $331,144 $398,184 Accounts receivable, net 35,167 29,075 Inventory 17,622 18,733 Property and equipment, net 51,248 50,150 Other assets 34,696 38,373 --------- ------------ Total assets $469,877 $534,515 ========= ============ LIABILITIES AND STOCKHOLDERS' EQUITY Accounts payable and accrued expenses $ 39,284 $ 65,299 Deferred revenue 18,133 17,816 Debt, capital lease obligations and other long- term liabilities 303,450 352,698 --------- ------------ Total liabilities 360,867 435,813 --------- ------------ Total stockholders' equity 109,010 98,702 --------- ------------ Total liabilities and stockholders' equity $469,877 $534,515 ========= ============
CUBIST PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS UNAUDITED (in thousands, except share and per share data) Three months ended March 31, -------------------------- 2008 2007 ----------- ----------- Revenues: U.S. product revenues, net $ 86,058 $ 57,525 International product revenues 1,804 1,910 Other revenues 423 44 ----------- ----------- Total revenues, net $ 88,285 $ 59,479 Costs and expenses: Cost of product revenues 19,348 16,738 Research and development 22,364 15,870 Sales and marketing 19,983 14,994 General and administrative 11,433 7,720 ----------- ----------- Total costs and expenses 73,128 55,322 Operating income 15,157 4,157 ----------- ----------- Other income, net 3,327 1,610 ----------- ----------- Income before income taxes 18,484 5,767 Provision for income taxes 606 166 ----------- ----------- Net income $ 17,878 $ 5,601 =========== =========== Basic net income per common share $ 0.32 $ 0.10 Diluted net income per common share $ 0.26(a) $ 0.10 Shares used in calculating: Basic net income per share 56,220,709 55,118,813 Diluted net income per share 68,042,120 56,946,557
CUBIST PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS - NON-GAAP UNAUDITED (in thousands, except share and per share data) Three months ended March 31, -------------------------- 2008 2007 ----------- ----------- GAAP net income $ 17,878 $ 5,601 Stock-based compensation expense under SFAS 123(R) 2,764 2,639 Write off of assets disposed of to build new lab space 2,323 - ----------- ----------- Non-GAAP proforma net income $ 22,965 $ 8,240 =========== =========== Non-GAAP basic net income per common share $ 0.41 $ 0.15 Non-GAAP diluted net income per common (a) share $ 0.34 $ 0.14 Shares used in calculating: Non-GAAP basic net income per common share 56,220,709 55,118,813 Non-GAAP diluted net income per common share 68,042,120 56,946,557
SOURCE: Cubist Pharmaceuticals, Inc.
Cubist Pharmaceuticals, Inc. Eileen C. McIntyre, 781-860-8533 Senior Director, Corporate Communications eileen.mcintyre@cubist.com or Fleishman-Hillard, Inc. Jonathan R. Potter, 212-453-2406 potterj@fleishman.com
Cubist Pharmaceuticals to Announce First Quarter 2008 Financial Results on Thursday, April 17, 2008
Conference Call to be Held at 5:00 p.m. EDT
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) will issue its first quarter 2008 financial results at 4:00 p.m. EDT on Thursday, April 17th, 2008. In connection with this announcement, Cubist will host a conference call and live audio webcast (with slides) at 5:00 p.m. EDT that same day to discuss its first quarter financial results, business activities and financial outlook.
As always, the quarterly earnings call will be available via phone and webcast. The phone call dial-in information is listed below. To access the webcast, please log on to the Cubist website at www.cubist.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
A replay of the webcast and teleconference will be available on Cubist’s website beginning approximately three hours after the call.
**************CONFERENCE CALL & WEBCAST INFORMATION**************
Cubist will host a conference call and live audio webcast to discuss its first quarter 2008
financial results, business activities and financial outlook.
WHEN: Thursday, April 17, 2008 at 5:00 p.m. EDT
LIVE DOMESTIC & CANADA CALL-IN: 877-407-0778
LIVE INTERNATIONAL CALL-IN: 201-689-8565
24-HOUR REPLAY DOMESTIC & CANADA: 877-660-6853
24-HOUR REPLAY INTERNATIONAL: 201-612-7415
REPLAY PASSCODES (BOTH REQUIRED FOR PLAYBACK):
ACCOUNT #: 286 CONFERENCE ID #: 274880
CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.cubist.com
Replay will be available for 30 days at www.cubist.com
********************************************************************
Standard & Poor's Announces Change to U.S. Index
NEW YORK, March 10 /PRNewswire/ -- Cubist Pharmaceuticals Inc. (Nasdaq: CBST) will replace AMIS Holdings Inc. (Nasdaq: AMIS) in the S&P SmallCap 600 after the close of trading on a date to be announced. AMIS is being acquired by ON Semiconductor Corp. in a deal that is still pending final approvals.
Standard & Poor's will monitor this transaction, and post any relevant updates on its website: www.standardandpoors.com.
Cubist Pharmaceuticals researches, develops and commercializes novel antimicrobial drugs to combat serious and life-threatening bacterial and fungal infections. Headquartered in Lexington, MA, the company will be added to the S&P SmallCap 600 GICS (Global Industry Classification Standard) Biotechnology Sub-Industry index.
Following is a summary of the change:
S&P SMALLCAP 600 INDEX -- TBA
COMPANY GICS ECONOMIC SECTOR GICS SUB-INDUSTRY
ADDED Cubist Pharmaceuticals Health Care Biotechnology
DELETED AMIS Holdings Information Technology Semiconductors
Additions to and deletions from an S&P equity index do not in any way reflect an opinion on the investment merits of the companies concerned.
About Standard & Poor's
Standard & Poor's, a division of The McGraw-Hill Companies (NYSE: MHP), is the world's foremost provider of financial market intelligence, including independent credit ratings, indices, risk evaluation, investment research and data. With approximately 7,500 employees, including wholly-owned affiliates, located in 21 countries, Standard & Poor's is an essential part of the world's financial infrastructure, and has played a leading role for more than 140 years in providing investors with the independent benchmarks they need to feel more confident about their investment and financial decisions. For more information, visit http://www.standardandpoors.com.
About The McGraw-Hill Companies
Research and Markets: Get a Complete and Comprehensive Analysis of Cubist Pharmaceuticals
5:44a ET February 22, 2008 (Business Wire)
Research and Markets (http://www.researchandmarkets.com/reports/c83706) has announced the addition of "Analysis of Cubist Pharmaceuticals" to their offering.
We present Analysis of Cubist Pharmaceuticals. A complete and comprehensive analysis of Cubist Pharmaceuticals, includes an overview of the industry the company operates in, a PEST Framework Analysis of the industry, and then moves on to analyzing the company itself.
Company analysis includes a history of Cubist Pharmaceuticals, a business segment analysis of the segments Cubist Pharmaceuticals operates through, a look at the organization structure of the company, a geographical operating segments analysis, an analysis of the company's major competitors.
A financial analysis of Cubist Pharmaceuticals is presented in the report which includes a ratio analysis, basic profit and loss analysis, presentation of the company balance sheet, and much more.
A SWOT Framework Analysis of Cubist Pharmaceuticals completes this in-depth company analysis.
Topics Covered: - Executive Summary - Looking at the Industry - Industry Definition - Brief Profile of the Industry - Impacts on the Industry - Challenges Facing the Industry - Future Perspective - Industry PEST Framework Analysis - Political Aspects - Economic Aspects - Social Aspects - Technological Aspects - Looking at the Company - Company Profile - History of the Company - Ownership Pattern in the Company - Corporate Hierarchy - Organizational Divisions - Profiling the Key Executives - Products & Services - Recently in the News - Looking at Business - Business Segments - Geographical Segments - Company Subsidiaries - SWOT Framework Analysis - Strengths to Build Upon - Weaknesses to Overcome - Opportunities to Exploit - Threats to Overcome - Profiling the Competition - Abraxis BioScience, Inc. - Pfizer Inc. - Financial Analysis of the Company - Current Financials - H.2 Balance Sheet - Profit & Loss Statement - Ratio Analysis - Future Perspective - Appendix - Glossary of Terms Companies Mentioned: Cubist Pharmaceuticals Abraxis BioScience, Inc. Pfizer Inc.
For more information, visit http://www.researchandmarkets.com/reports/c83706.
SOURCE: Research and Markets Ltd.
Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com Fax: +353 1 4100 980
Cubist Pharmaceuticals Names Steven C. Gilman, Ph.D., as Senior Vice President, Discovery and Non-Clinical Development and Chief Scientific Officer
7:30a ET February 12, 2008 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that Dr. Steven Gilman has joined Cubist as Senior Vice President, Discovery and Non-clinical Development and Chief Scientific Officer, a newly created position. Dr. Gilman will be a member of the company's Executive Team. In this new position, Dr. Gilman will oversee all areas of drug discovery for Cubist. These areas had reported to Michael Bonney, President and CEO of Cubist.
Dr. Gilman has more than 25 years of drug research and development experience. Most recently, he was Chairman of the Board and Chief Executive Officer of ActivBiotics, Inc. While at ActivBiotics, Dr. Gilman led the transition of the organization from early research/academic stage to focus on advanced product development/commercialization. Dr. Gilman's positions prior to his most recent role at ActivBiotics included President, Chief Executive Officer of ActivBiotics and Vice President and General Manager, Inflammation Franchise, Millenium Pharmaceuticals, Inc. Earlier in his career, Dr. Gilman was responsible for pharmaceutical research units at Pfizer, Sterling Winthrop, Cytogen Corporation and Wyeth Laboratories in areas including chronic inflammatory diseases, transplant rejection, autoimmune diseases and bacterial infections. Dr. Gilman has a Ph.D. in Microbiology from Pennsylvania State University and did post doctoral work in the Department of Immunopathology at Scripps Clinic and Research Foundation in La Jolla, CA.
Cubist recently has announced that it expects to file two Investigative New Drug Applications (INDs) in 2008. Compounds advancing towards IND include potential new therapies for the treatment of infections caused by the Hepatitis C virus (HCV) and for Clostridium difficile-associated diarrhea (CDAD). The company also is progressing lead compounds in preclinical development for the treatment of infections caused by Gram-negative bacteria. As Senior Vice President, Discovery and Non-clinical Development, Dr. Gilman will oversee these and other existing internal discovery programs. Dr. Gilman also will pursue innovative approaches to identify new molecules with medical and commercial potential in the acute care arena, including but not limited to Cubist's current focus on antinfectives.
Cubist developed and commercializes CUBICIN(R) (daptomycin for injection) which, since its launch in 2003, continues to track as the most successful IV antibiotic in U.S. history in dollar terms
Cubist Pharmaceuticals Announces Fourth Quarter 2007 U.S. Net Product Revenues of $83.9 Million and Full Year 2007 U.S. Net Product Revenues of $285.1 Million
8:44a ET January 7, 2008 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today reported U.S. net product revenues of $83.9 million (unaudited) for the fourth quarter of 2007 for its antibiotic product CUBICIN(R) (daptomycin for injection). This result represents an increase of 49%, or $27.6 million, from fourth quarter 2006 U.S. net product revenues. Full year 2007 U.S. net product revenues were $285.1 million (unaudited). This result represents an increase of 50%, or $95.5 million, from full year 2006 U.S. net product revenues. Full year 2007 international net product revenues were $5.3 million (unaudited). This represents an increase of $4.5 million from full year 2006 international product revenues.
Mike Bonney, President and CEO of Cubist said, "CUBICIN continues to deliver historic performance four years after its launch as an important and much needed therapy for the treatment of serious, often life-threatening infections caused by multi-drug resistant Staphylococcus aureus, or MRSA. These results reflect successful execution by our acute care commercial organization and the dedication of Cubist scientists in response to this significant public health problem."
Cubist will issue its full earnings release and host its fourth quarter and full year 2007 earnings conference call and webcast with slides on Wednesday, January 23rd. The webcast presentation will also include a discussion of the company's business activities, financial outlook, and current news. Details are provided below. **************CONFERENCE CALL & WEBCAST INFORMATION************** Cubist will host a conference call and live audio webcast to discuss its fourth quarter and full year 2007 financial results, business activities and financial outlook. WHEN: Wednesday, January 23, 2008 at 5:00 p.m. ET LIVE DOMESTIC & CANADA CALL-IN: 877-407-0778 LIVE INTERNATIONAL CALL-IN: 201-689-8565 24-HOUR REPLAY DOMESTIC & CANADA: 877-660-6853 24-HOUR REPLAY INTERNATIONAL: 201-612-7415 REPLAY PASSCODES (BOTH REQUIRED FOR PLAYBACK): ACCOUNT #: 286 , CONFERENCE ID #: 260424 CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.cubist.com Replay will be available for 30 days via the Internet ******************************************************************
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R)(daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, CDAD (Clostridium difficile-associated diarrhea), and HCV (Hepatitis C infections.) Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com
Cubist Pharmaceuticals Acquires Illumigen Biosciences
9:15a ET December 26, 2007 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) and Illumigen Biosciences, Inc. announced today that Cubist has acquired Illumigen pursuant to a definitive agreement and plan of merger entered into on December 24, 2007. Illumigen's lead compound is IB657, a protein therapeutic in pre-clinical development for the treatment of Hepatitis C Virus (HCV) infections. Cubist expects that an IND for IB657 will be filed in 2008.
Pursuant to the terms of the agreement, which was approved by the Boards of Directors of each company, Cubist will pay to the Illumigen stockholders $9 Million (after adjusting for Illumigen's closing cash balance) in cash and Illumigen has become a wholly-owned subsidiary of Cubist. Cubist will make payments during the development of IB657 as a therapy for HCV infections of up to $75.5 Million upon achieving certain development and regulatory milestones. If Cubist develops Illumigen products for the treatment of viruses other than HCV, development and regulatory milestone payments of up to $117 Million could apply. Assuming that HCV or other Illumigen antiviral products are commercialized, additional milestone payments of up to $140 Million, as well as tiered royalties, could apply.
Mike Bonney, President and CEO of Cubist Pharmaceuticals, said "We are excited about the opportunity of filing an IND for IB657 in the coming year and advancing it into the clinic. An HCV product candidate is an important addition to our pipeline, and leverages our antiinfective development, regulatory, and commercialization expertise."
Donald Elmer, Chairman of Illumigen Biosciences, said "We believe that Cubist is ideally positioned to exploit the immediate opportunity for IB657 against HCV, and potentially for additional viral infections."
No financing will be necessary to complete the acquisition of Illumigen or to fund the development of IB657. The impact of any charges related to purchase accounting, including in-process R&D, will be recorded in Cubist's 2007 full-year results.
About HCV
HCV is a virus that primarily targets the liver, currently causing infection in more than 4 million people in the U.S. and 180 million people worldwide. The virus is difficult to eradicate, with infected patients eventually developing chronic liver infection, and, in some cases, liver cancer. HCV infection is the most common reason for liver transplantation in the U.S. and Western Europe and the leading cause of death from liver disease.
No vaccine is currently available to prevent HCV infection. Current HCV therapy combines a pegylated-interferon with ribavirin for up to 48 weeks of treatment. Current therapy has significant problems with both safety (e.g., significant treatment limiting adverse effects and contraindications) and efficacy (e.g., 80% of HCV infections in the U.S. are due to genotype 1 virus for which the efficacy rate of current therapy is approximately 40 to 50%). The HCV market was $2.2 Billion in 2005 and is projected to double to $4.4 Billion in 2010. This growth will be driven by an increase in the number of patients being treated, uptake of new drugs, and the use of multi-drug treatment regimens.
About IB657
IB657 is a pre-clinical protein therapeutic being developed for treatment of HCV infection. Based on its antiviral activity, IB657 may have therapeutic utility in the treatment of certain other viral diseases. Pre-clinical studies to assess activity against these viruses may occur in parallel with its development for HCV infection.
About Illumigen
Illumigen Biosciences, Inc. was co-founded by Drs. Charles Magness and Shawn Iadonato in 2000 to discover beneficial human genetic mutations that might provide a roadmap for novel therapeutic drug mechanisms. The discovery of IB657 resulted from an investigation into the cause of apparent immunity to HCV infection enjoyed by people with a specific naturally occurring genetic mutation. Prior to founding Illumigen, Drs. Magness and Iadonato both were involved in the Human Genome Project. Illumigen is a Seattle-based, privately held biopharmaceutical company financed by Pacific Horizon Ventures in Seattle, WA. Additional information can be found at Illumigen's web site at www.illumigen.com and www.pacifichorizon.com.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, and CDAD (Clostridium difficile-associated diarrhea). Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com
Cubist Pharmaceuticals Announces Members of Scientific Advisory Board
7:45a ET November 27, 2007 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) named three members to its Scientific Advisory Board (SAB), which was established earlier this year under the leadership of Associate Dean for Research at Virginia Commonwealth University School of Medicine Dr. Gordon Archer.
The SAB will be an ongoing resource to provide Cubist management with additional scientific and medical perspective as the company approaches Go/No Go decision points on its preclinical anti-infective programs, as well as on in-licensing or acquisition drug candidates, and review of clinical development plans. The company also engages experts with specific therapeutic expertise as needed for assessment of certain acute care areas.
Dr. Archer became the Chairman of the SAB in October 2007 which required him to leave Cubist's Board of Directors. In addition to his current position at VCU, he is the director of the school's M.D./Ph.D. program. Dr. Archer has served as professor of medicine and microbiology/immunology at VCU since 1985 and, from 1992 to 2005, served as chairman of the Division of Infectious Diseases at the school. Since 1975, he has held various faculty roles at VCU and began his career as an instructor of medicine in 1974 at the University of Michigan Medical School. He is a previous member and chair of the National Institutes of Health (NIH) Study Section on Bacteriology and Mycology and the NIH Study Section on Drug Discovery and Mechanisms of Resistance to Antimicrobials. Additionally, Dr. Archer was a member of the Food and Drug Administration's Antiinfective Advisory Board and he is currently on the Scientific Advisory Board of MicuRx Pharmaceuticals. He received a B.A. in Pre-med and German from Washington and Lee University in Virginia, and his M.D. from the University of Virginia School of Medicine.
The new members joining Dr. Archer are Dr. Bonnie Bassler, Professor Eric Jacobsen and Dr. Richard White.
Dr. Bonnie Bassler, a member of the National Academy of Sciences and American Academy of Arts and Sciences, is a Howard Hughes Medical Investigator and the Squibb Professor of Molecular Biology at Princeton University. She received a B.S. in Biochemistry from the University of California at Davis, and a Ph.D. in Biochemistry from the Johns Hopkins University. The research in her laboratory is focused on the molecular mechanisms of bacterial intercellular communication. This process is known as quorum sensing. Dr. Bassler was awarded a MacArthur Foundation Fellowship in 2002. She is the 2006 recipient of the American Society for Microbiology's Eli Lilly Investigator Award for fundamental contributions to microbiological research.
Professor Eric Jacobsen is the Sheldon Emery Professor of Chemistry at Harvard University, a position he has held since 2001. He received a B.S. in Chemistry from New York University, and his Ph.D. from the University of California, Berkeley. From 1986 to 1988 he was a National Institutes of Health Postdoctoral Fellow at MIT. Professor Jacobson has been a professor at Harvard University since 1993. Prior to that, he was an assistant professor at the University of Illinois at Champaign-Urbana. He is a member of the American Academy of Arts and Sciences, and he provides consulting services to a number of pharmaceutical companies. Professor Jacobsen serves on the Editorial Board of Advanced Synthesis and Catalysis, and Science of Synthesis, and on the Editorial Advisory Boards of the Journal of Organic Chemistry, Synthesis, Synlett, Organic Letters, the Journal of Combinatorial Chemistry, the Journal of Molecular Catalysis, Current Opinion in Drug Discovery & Development, and Chemistry: An Asian Journal. Professor Jacobsen's research interests are in organic chemistry, and particularly on the discovery and application of new methods for organic synthesis.
Dr. Richard White provides consulting services to the biotechnology sector, offering special expertise in antimicrobial drug discovery and development. He received his B.Sc. in biochemistry from the University of Manchester and his Ph.D. in biochemistry from Oxford. After a post-doctoral fellowship on microbial biochemistry at Oxford, he began a career in infectious disease drug discovery in 1969. The first 25 years were spent in the pharmaceutical industry in positions of increasing responsibility at Lepetit (in Italy), Glaxo (in England), Lederle (in the USA), and finally at Bristol-Myers Squibb in Connecticut, where he was Vice President in charge of Infectious Disease Drug Discovery for 12 years. In 1997 he moved to biotech, taking a position at Versicor in California as Chief Scientific Officer. In the ensuing eight years he played an important role in licensing in Dalbavancin and Anidulafungin, taking Versicor public and merging with Biosearch Italia. The merged entities became Vicuron Pharmaceuticals, which was sold for $1.9 billion to Pfizer in 2005. Dr. White's research interests are on the mechanism of action of and resistance to antibacterial drugs, and the special role that natural products have played in treating infectious diseases.
The average health professional rarely ever sees let alone tyreats a staph MRSA infection. The Infectious disease specialists know abot it very well. As Community Staph MRSA keeps spreading and infecting large numbers it will become as well known as aspirin.
Cubist Pharmaceuticals to Present at the CIBC Healthcare Conference
12:07p ET October 25, 2007 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that David McGirr, SVP and CFO will present on Monday, November 5th, at 9:10 A.M. ET at the CIBC World Markets 18th Annual Healthcare Conference being held at the Waldorf-Astoria Hotel in New York City. This presentation will include a discussion of the company's business activities, financial outlook, and current news.
A live webcast of the presentation will be accessible through Cubist's website at www.cubist.com in the Investor Relations Conference Calendar section. The presentation will be archived there as well and available after the event for a period of 14 days.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, and CDAD (Clostridium difficile-associated diarrhea). Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.
SOURCE: Cubist Pharmaceuticals
Cubist Pharmaceuticals, Inc. Eileen C. McIntyre, 781-860-8533 Senior Director, Corporate Communications eileen.mcintyre@cubist.com
My wife, as a consequence of a total knee replacement surgery several years ago tried a three week course of treatment with Cubicin in a wasted attempt to contain the Staph Epi infection in her knee. Of course Cubicin is for treatment of Stapf MRSA infections. The infectious disiease specialist who prescribed this expensive treatment was also involved in the clinical trials of this drug. I am going to speak with him and see if he can explain the lack of awareness on the part of our media. I'll post result. PS The treatment with cubicin cost $7000 and I administered the intravenous treatment at my home.
It is hard to believe but many health professionals have never heard of Cubicin. A family member is a nurse supervisor over the OR and had not heard of it until I told her.
In the D.C. Metro area the newspapers and TV news are reporting wide spread of Staph infections in area high schools. A number of Staph MRSA cases have surfaced and one student death has been recorded. Could have impact on sales.But surprising to me is that not a single story on this subject has mentioned daptomycin nor cubicin
Thursday's biggest gaining and declining stocks
9:22a ET October 18, 2007 (MarketWatch)
SAN FRANCISCO (MarketWatch) -- Among the companies whose shares are likely to see active trading during Thursday's session are Allstate, Bank of America, Bank of New York Mellon, Continental Air, Cubist, eBay, E-Trade, Fairchild Semi, Knoll, Nordstrom, Stryker and UnitedHealth.
Allstate Corp. said its third-quarter net income fell to $978 million, or $1.70 a share, from $1.16 billion, or $1.83 a share, in the year-ago period. Consolidated revenue rose to $8.99 billion from $8.74 billion last year. Analysts estimated earnings per share of $1.67 on revenue of $8.94 billion.
Amylin Pharmaceuticals Inc.'s third-quarter loss narrowed to $39.8 million, or 30 cents a share, from a year-earlier loss of $46.1 million, or 36 cents a share. The biopharmaceutical company said revenue rose 29% to $190 million from $147 million. Analysts expected a loss of 42 cents a share on revenue of $198 million.
AptarGroup Inc. reported a third-quarter net profit of $39.4 million, or 56 cents a share, compared with $28.2 million, or 40 cents a share, in the year-earlier period. The supplier of dispensing systems said revenue rose to $485.7 million from $404.9 million a year ago. Analysts were expecting a profit of 50 cents a share on revenue of $463 million. Aptar expects earnings for the fourth quarter to range from 43 cents to 46 cents a share.
Arena Pharmaceuticals Inc. reported a third quarter net loss of $32.3 million compared with $19.6 million in the year-earlier period. The company posted a net loss allocable to common stockholders of $32.8 million, or 54 cents a share, compared with a loss of $20.1 million, or 43 a share. The San Diego-based company said revenue rose to $5 million in the quarter from $4.4 million in third quarter 2006. Analysts had estimated a loss of 71 cents a share on $6 million in revenue.
Bank of America Corp.'s third-quarter earnings slid 32% to $3.7 billion, or 82 cents a share, from $5.42 billion, or $1.18 a share, a year earlier, hurt in part by a decline in global corporate and investment banking revenue. The Charlotte, N.C., commercial bank's net interest income rose to $8.62 billion from $8.59 billion, while its provision for credit losses increased to $2.03 billion from $1.17 billion a year ago. Total average assets at Sept. 30 rose to $1.58 trillion from $1.5 trillion at Sept. 30, 2006.
Bank of New York Mellon Corp. reported third-quarter net income rose 82% on 24% higher revenue, reflecting internal growth and "the positive impact of market volatility on our securities servicing businesses."
Boston Scientific Corp. will restructure business units and undertake other initiatives to reduce operating expenses by 12% to 13% in 2008. The medical products company expects to reduce its operating expenses, excluding amortization and royalty expenses, by $475 million to $525 million in 2008 and another $25 million to $50 million in 2009. Boston Scientific will cut about 2,300 jobs, or 13% of its worldwide work force, beginning this month. Boston Scientific expects to book about $450 million to $475 million, or 20 to 22 cents a share, in pretax charges on the reductions. About $275 million to $300 million of those charges will be recorded in the fourth quarter, with the rest throughout 2008 and 2009. See full story.
Callaway Golf Co. said it expects third-quarter earnings of break-even to 2 cents a share. The estimates are based on projected revenue of about $236 million, a 22% increase over last year. Callaway also raised its adjusted earnings per share estimate for the year to between 85 cents and 89 cents, on revenue of $1.1 billion to $1.11 billion, from a previous forecast of 78 cents to 84 cents a share on revenue of $1.07 billion to $1.08 billion.
Citrix Systems Inc.'s third-quarter net income rose to $60.7 million, or 33 cents a share, compared to $43.7 million, or 23 cents a share in the same period a year earlier. Meanwhile revenue rose to $350 million from $278 million. Excluding certain items, Citrix said earnings for the quarter were 41 cents a share. Analysts had anticipated earnings of 38 cents a share, on $340 million in revenue.
City National Corp.'s third-quarter net income rose 2% to $60 million, or $1.22 a share, from $59 million, or $1.20 cents a share, a year earlier. Analysts polled by Thomson Financial expected earnings of $1.23 a share. The bank holding company and parent of City National Bank said net interest income for the quarter rose 3% to $153.8 million from $148.9 million in the prior year. City National sees earnings per share growth from 3% to 5% in 2007.
Continental Airlines third-quarter net income rose 1.7% to $241 million, or $2.15 a share. Excluding a $12 million charge related to pilot pension plan settlements, net income rose 73% to $253 million, or $2.25 a share. Analysts had been expecting the airline to report earnings of $2.17 a share, according to data compiled by Thomson Financial. "The high cost of fuel continues to pose challenges for us, but we'll keep working those costs we can control," said Jeff Misner, the firm's chief financial officer. Continental also said that it's close to signing supplier cost reduction agreements that are expected to lead to cost savings of around $100 million a year. Operating revenue rose 8.6% to $3.8 billion, after strong international growth, the firm added.
Countrywide Financial Corp.: The Securities and Exchange Commission has opened an informal investigation into stock sales by Countrywide's chief executive officer, The Wall Street Journal reported on its Website late Wednesday. See full story.
Cubist Pharmaceuticals Inc.'s third-quarter net income nearly quadrupled to $20 million, or 32 cents a share, from $5.18 million, or 9 cents a share. Excluding certain stock-based compensation charges, earnings were $22.6 million, or 36 cents a share. The biopharmaceutical company's revenue increased 58% to $79.9 million from $50.4 million a year earlier. Analysts expected earnings of 25 cents a share, including stock-based compensation, on revenue of $76 million
Cubist Pharmaceuticals Reports Third Quarter 2007 Results: Total Revenues $79.8 Million; Net Product Revenues $76.3 Million, +52% vs. Q3 2006
4:01p ET October 17, 2007 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today reported results for the third quarter ended September 30, 2007. Total net product revenues for CUBICIN(R) (daptomycin for injection) increased 52% from the prior year, from $50.3 million in the third quarter of 2006 to $76.3 million in the third quarter of 2007. U.S. net sales of CUBICIN were $75.4 million. Total revenues for the third quarter of 2007 increased 58% over the third quarter of 2006 from $50.4 million in the third quarter of 2006 to $79.8 million in the third quarter of 2007.
Net income for the third quarter ended September 30, 2007 on a GAAP basis was $20.0 million, or $0.36 and $0.32 per basic and diluted share, respectively, as compared to net income of $5.2 million, or $0.09 per basic and diluted share for the third quarter of 2006. Third quarter 2007 GAAP net income includes $2.6 million, or $0.05 and $0.04 per basic and diluted share, respectively, in stock-based compensation expenses as a result of our adoption on January 1, 2006 of Financial Accounting Standards No. 123(R) ("FAS 123(R)").
Non-GAAP net income for the third quarter ended September 30, 2007, excluding the charges mentioned above, was $22.6 million, or $0.41 and $0.36 per basic and diluted share, respectively.
As of September 30, 2007, Cubist had $368.0 million in cash, cash equivalents and investments. The total number of common shares outstanding at September 30, 2007 was 55,862,692.
Use of Non-GAAP Financial Measures
Cubist adopted FAS 123(R) on January 1, 2006 using the modified prospective method, which resulted in the recognition of stock-based compensation expenses in the statement of operations from 2006 onward without adjusting the prior years. Cubist uses non-GAAP net income (loss) and non-GAAP net income (loss) per share data to improve its analysis of operational results and trends. Cubist's management also uses these non-GAAP figures to make financial and operational decisions as these numbers exclude non-operational activities and because management believes these measures are useful to investors because they provide greater transparency regarding Cubist's operating performance. These measures should not be considered an alternative to measurements required by GAAP, such as net income (loss) and net income (loss) per share, and should not be considered measures of our liquidity. In addition, these non-GAAP measures are unlikely to be comparable with non-GAAP information provided by other companies. A reconciliation between non-GAAP financial measures and GAAP financial measures are included in the tables accompanying this press release after the unaudited condensed consolidated financial statements. ****************CONFERENCE CALL & WEBCAST INFORMATION**************** Cubist will host a conference call and live audio webcast to discuss its third quarter 2007 financial results, business activities and financial outlook. WHEN: Wednesday, October 17, 2007 at 5:00 p.m. EDT LIVE DOMESTIC & CANADA CALL-IN: 877-407-0778 LIVE INTERNATIONAL CALL-IN: 201-689-8565 24-HOUR REPLAY DOMESTIC & CANADA: 877-660-6853 24-HOUR REPLAY INTERNATIONAL: 201-612-7415 REPLAY PASSCODES (BOTH REQUIRED FOR PLAYBACK): ACCOUNT #: 286 CONFERENCE ID #: 252157 CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.cubist.com Replay will be available for 30 days at www.cubist.com *********************************************************************
About Cubist
Cubist Pharmaceuticals Inc. Announces Exclusive Option to Acquire Illumigen Biosciences
Tuesday October 16, 4:17 pm ET
Lead Compound IB657 Would Address Unmet Medical Need in HCV Infections;
Cubist Will Pay $4.7 Million for Option and Will Fund the Pivotal IND Enabling Study
LEXINGTON, Mass. & SEATTLE--(BUSINESS WIRE)--Cubist Pharmaceuticals, Inc. (NASDAQ: CBST ) and Illumigen Biosciences, Inc. announced today that they have signed an agreement under which Cubist has an exclusive option to acquire Illumigen on terms that have been agreed to by the parties. For the option, Cubist will pay $4.7 Million and also will pay approximately $1 Million for an IND-enabling study of Illumigen's lead compound, IB657, and for Illumigen's operating costs during the option period. IB657 is a protein therapeutic in late-stage pre-clinical development as an interferon replacement product for the treatment of Hepatitis C virus (HCV) infections.
Mike Bonney, President and CEO of Cubist, said "This option provides us with an opportunity to immediately leverage our antiinfective development and regulatory expertise. The unmet medical need which IB657 would address represents a substantial market opportunity. If we exercise our option, adding an HCV compound will be an important step as we develop a pipeline behind our successful IV antibiotic CUBICIN."
Donald Elmer, Chairman of Illumigen, said "IB657 holds great promise as a therapy that may offer improved safety and efficacy when compared with current standard of care. We believe Cubist is ideally positioned to move the IB657 program forward."
If Cubist exercises its option to acquire Illumigen, Cubist will pay Illumigen shareholders $9 Million upfront and up to $75.5 Million in HCV development and regulatory milestones. If Cubist develops an Illumigen product for the treatment of viral infections other than HCV, additional development and regulatory milestone payments of up to $117 Million would apply. If Illumigen product(s) are commercialized, sales milestones of up to $140 Million as well as tiered royalties would apply.
...About IB657
IB657 is a late-stage pre-clinical protein therapeutic being developed as an interferon replacement. IB657 activates a key antiviral pathway downstream from the point of interferon activation. This pathway is responsible for much of the antiviral activity of interferon. IB657 does not activate the broad range of cellular functions induced by interferon. IB657 is therefore predicted to produce the antiviral activity of interferon but to have fewer side effects. The primary clinical indication targeted for IB657 is treatment of HCV infection. However, based on the proposed mechanism of action, IB657 may have therapeutic utility in the treatment of certain other viral diseases. Pre-clinical studies to assess activity against these viruses may occur in parallel with its development for HCV infection.
About Illumigen
Illumigen Biosciences, Inc. was co-founded by Drs. Charles Magness and Shawn Iadonato in 2000 to discover beneficial human genetic mutations that might provide a roadmap for novel therapeutic drug mechanisms. The discovery of IB-657 resulted from an investigation into the cause of apparent immunity to HCV infection enjoyed by people with a specific naturally occurring genetic mutation. Prior to founding Illumigen, Drs. Magness and Iadonato both were involved in the Human Genome Project. Illumigen is a privately held biopharmaceutical company based in Seattle, WA. Additional information can be found at Illumigen's web site at www.illumigen.com.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN® (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, and CDAD (Clostridium difficile-associated diarrhea). Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.
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Zacks Earnings Preview: Allstate, Citigroup, Continental Airlines, Cubist Pharmaceuticals and Intel
10:18a ET October 15, 2007 (Business Wire)
Zacks.com releases the list of companies likely to issue earnings surprises. This week's list includes Allstate (NYSE: ALL), Continental Airlines (NYSE: CAL), Cubist Pharmaceuticals (Nasdaq: CBST) and Intel (Nasdaq: INTC). To see more earnings analysis, visit http://at.zacks.com/?id=3207.
Earnings Preview is written by Charles Rotblut, CFA, Senior Market Analyst for Zacks.com.
Calling for new record highs seems rather trivial these days with the Dow holding above 14,000, but it is very possible that the blue-chip average's ascent could continue.
The third full week of October will be highlighted by reports from 12 Dow components.
At least one brokerage analyst has raised his quarterly profit forecast within the past week on five of the 12 companies. In addition, nine out of the 12 companies topped second-quarter expectations. Finally, although expectations have been worsening for Citigroup (NYSE: C), it is possible that the market could withstand a weak report and downbeat conference call from the financial conglomerate.
Of course, there will be more than just these 12 Dow members reporting. In total, we have confirmed earnings reports from 268 companies, 83 of which are S&P 500 members. Large-cap stocks will dominate the earnings calendar for the next 14 days, followed by multiple reports from mid- and small-cap companies.
Friday is an options expiration day. It is also the anniversary of the 1987 crash.
The New York Fed's manufacturing index, published on Monday, will be the week's first economic report. Tuesday features September industrial production and capacity utilization and the National Association of Homebuilders' October housing index. September CPI and housing starts will be released on Wednesday. Thursday will bring the Conference Board's September Leading Indicators index and the October Phili Fed survey. No economic reports are scheduled for Friday.
Third-Quarter Earnings Performance
As of Thursday evening, 75 companies within the S&P 1500 (S&P 500, S&P Midcap 400 and S&P SmallCap 600) had reported earnings. This is hardly a large enough sample to draw any conclusions from, but for those of who are curious, positive surprises are leading negative surprises by a margin of 1.6:1. Median company growth is running at 9.5%. The growth rate is within the range I would expect for the entire earnings season, though I do expect a higher proportion of positive surprises as earnings season goes on. (The ratio could temporarily worsen over the next week given that multiple banks are scheduled to report.)
Companies That Could Issue Positive Earnings Surprises during the Week of Oct 15 - 19
As I discussed in last Wednesday's Industry Rank Analysis column, brokerage analysts have been raising forecasts on multiple property and casualty insurers recently, including Allstate (NYSE: ALL). The lack of a major hurricane striking the U.S. this year, the rebound in the financial markets and higher premiums are all likely behind the bullishness. In the specific case of ALL, roughly one-third of the covering analysts have raised their third-quarter profit projections during the past two weeks. The revisions have resulted in a 11-cent increase in the consensus estimate to $1.65 per share. The most accurate estimate is even more bullish at $1.75 per share. Investors should be aware, however, that over the past four quarters, this insurer has missed expectations two times and topped expectations two times. Allstate is scheduled to report on Thursday, Oct 18, before the start of trading.
Despite the adverse affect of high fuel prices, Continental Airlines (NYSE: CAL) is expected to report good third-quarter earnings. The airline achieved record load factors in September and estimates that it achieved an increase in consolidated revenue per available seat mile of between 4.5% and 5.5%. (Load factor measures how full a plane is; the higher the load factor is, the more likely the plane is going to feel cramped.) The bullish September numbers caused three of the 10 covering brokerage analysts to raise their third-quarter forecasts. The consensus earnings estimate of $2.12 per share is 10 cents above the average forecast of a month ago. The most accurate estimate is more bullish at $2.16 per share. CAL has topped expectations for four consecutive quarters. Continental Airlines is scheduled to report on Thursday, Oct 18, before the start of trading.
Cubist Pharmaceuticals (Nasdaq: CBST) has topped expectations three times during the past four quarters. Ahead of the company's third-quarter report, one of the covering brokerage analysts raised his profit forecast. Although the revision was not significant enough to move the consensus estimate from 25 cents per share, it did result in a most accurate estimate of 29 cents per share. Cubist Pharmaceutical is scheduled to report on Wednesday, Oct 17, after the close of trading.
Although the aggregate outlook for semiconductor earnings is not too bright this quarter, Intel (Nasdaq: INTC) is likely to be a notable standout. The company is projected to have earned 31 cents per share versus 21 cents a year ago. The third-quarter consensus estimate has risen by a penny during the past four weeks, reflecting positive revisions by five brokerage analysts. The leading chipmaker has topped expectations twice during the past four quarters and matched expectations twice. Intel is scheduled to report on Tuesday, Oct 16, after the close of trading.
Want to turn earnings surprises into quick profits? Learn how by visiting http://at.zacks.com/?id=3206.
About the Zacks Rank
Cubist Pharmaceuticals to Announce Third Quarter 2007 Financial Results on Wednesday, October 17, 2007
9:10a ET October 3, 2007 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) will issue its third quarter 2007 financial results at 4:00 p.m. EDT on Wednesday, October 17, 2007. In connection with this announcement, Cubist will host a conference call and live audio webcast (with slides) at 5:00 p.m. EDT that same day to discuss its third quarter financial results, business activities and financial outlook.
As always, the quarterly earnings call will be available via phone and webcast. The phone call dial-in information is listed below. To access the webcast, please log on to the Cubist website at www.cubist.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
A replay of the webcast and teleconference will be available on Cubist's website beginning approximately three hours after the call. **********CONFERENCE CALL & WEBCAST INFORMATION********** Cubist will host a conference call and live audio webcast to discuss its third quarter 2007 financial results, business activities and financial outlook. WHEN: Wednesday, October 17, 2007 at 5:00 p.m. EDT LIVE DOMESTIC & CANADA CALL-IN: 877-407-0778 LIVE INTERNATIONAL CALL-IN: 201-689-8565 24-HOUR REPLAY DOMESTIC & CANADA: 877-660-6853 24-HOUR REPLAY INTERNATIONAL: 201-612-7415 REPLAY PASSCODES (BOTH REQUIRED FOR PLAYBACK): ACCOUNT #: 286 CONFERENCE ID #: 252157 CALL WILL ALSO BE BROADCAST LIVE, LISTEN ONLY, VIA THE WEB AT: www.cubist.com Replay will be available for 30 days at www.cubist.com *****************************************************************
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, and CDAD (Clostridium difficile-associated diarrhea). Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com.
Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.
SOURCE: Cubist Pharmaceuticals, Inc.
Cubist Pharmaceuticals, Inc. Eileen C. McIntyre, 781-860-8533 Senior Director, Corporate Communications eileen.mcintyre@cubist.com
IV Antibiotic CUBICIN Approved for Marketing in Canada
7:30a ET September 25, 2007 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that CUBICIN(R) (daptomycin for injection) is now approved for marketing in Canada. The approval was granted on Monday by Health Canada. Oryx Pharmaceuticals, Inc. (Oryx) has licensed CUBICIN for the Canadian market from Cubist. The approved label includes both complicated skin and skin structure infections caused by certain Gram positive infections, at an approved dose of 4 mg/kg, and bloodstream infections, including right-sided infective endocarditis, caused by Staphylococcus aureus, at an approved dose of 6 mg/kg.
Oryx President Doug Reynolds said, "There is a great need in Canada for new approved therapies to treat serious, sometimes life-threatening infections, particularly those caused by methicillin-resistant Staphylococcus aureus. We look forward to our commercial launch of the drug, and expect that CUBICIN will quickly become an essential part of the infectious disease armamentarium in Canada." Cubist President and CEO Michael Bonney said, "We congratulate the entire Oryx organization on this very important accomplishment, and wish them well with the upcoming launch."
Oryx expects to formally launch CUBICIN in Canada by late November. While undergoing the regulatory review process, CUBICIN has been available to Canadian healthcare institutions, when requested, through Health Canada's Special Access Programme (SAP) which provides access to non-marketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. The SAP will remain active until Canadian inventory is in stock in the Oryx distribution system.
CUBICIN, originally introduced in the U.S. in 2003 and approved for an expanded U.S. label in 2006, already has been used to treat more than an estimated 370,000 patients in the U.S. Other international markets where CUBICIN has received regulatory approval for multiple indications include the EU, Switzerland, Taiwan, South Korea, and Israel. Cubist markets CUBICIN in the U.S. through its own commercial organization and has licensed the drug for marketing in all other parts of the world.
About Oryx:
Oryx (www.oryxpharma.com) is a Canadian specialty pharmaceutical company that commercializes prescription pharmaceutical products in the antiinfective, cardiovascular, CNS, and urology areas.
About CUBICIN
CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). CUBICIN is also approved in the U.S. as therapy for bloodstream infections (bacteremia), including right-sided endocarditis, caused by S. aureus. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.cubicin.com.
About Cubist
CBST reported 2nd quarter 2007 earnings of $0.24 per share on July 18, 2007. This beat the $0.16 consensus of the 9 analysts covering the company.
The next earnings announcement from CBST is expected the week of October 17, 2007.
Cubist Pharmaceuticals to Seek Technical Correction in One of Its U.S. CUBICIN Patents
9:06a ET September 12, 2007 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that due to a technical error, one of the CUBICIN(R) (daptomycin for injection) patents listed in the Orange Book (U.S. Patent No. RE39071, originally issued to Eli Lilly, and now owned by Cubist) should be corrected. The Company identified this error as part of its preparations for a potential Paragraph IV filing against its lead product, CUBICIN.
The stereochemistry of one amino acid in the claimed chemical structures is incorrectly identified. As the first step in a process to address this error, on September 11, Cubist asked the Food and Drug Administration (FDA) to de-list the pharmaceutical composition patent from the Orange Book. The company will pursue the appropriate course of action in the US Patent Office to correct this error. If and when the error is corrected, CBST will ask FDA to re-list the corrected patent in the Orange Book
August 1,2007
CUBICIN Approved for S. aureus Bloodstream Infections in South Korea and Taiwan
Successful Filings, by Marketing Partners Kuhnil and TTY, Referenced Cubist’s Landmark SAB/IE Phase 3 trial
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that CUBICIN® (daptomycin for injection) received approvals in July for S. aureus bacteremia, including right-sided infective endocarditis (SAB/RIE), in both South Korea and Taiwan. The recent approval in South Korea includes both complicated skin and skin structure infections (cSSSI) and SAB/RIE. CUBICIN was previously approved in Taiwan (in November of 2006) for cSSSI caused by Gram positive bacteria. The approvals were received by Kuhnil Pharmaceutical Corp. (CUBICIN marketing partner for South Korea) and TTY BioPharm Company, Ltd. (CUBICIN marketing partner for Taiwan.)
Mike Bonney, Cubist President and CEO commented: “I congratulate the regulatory teams at Kuhnil and TTY, as well as the clinical and regulatory teams at Cubist who work closely with our CUBICIN international partners on regulatory filings and reviews. All involved in the development of CUBICIN are proud of the role that this important therapy will continue to play not only in the U.S. but across the globe in the treatment of patients with serious infections, particularly those caused by methicillin-resistant S. aureus (MRSA
Cubist Pharmaceuticals' CUBICIN Approved for Additional Indications in the EU
11:30a ET September 6, 2007 (Business Wire)
Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) said today that its IV antibiotic CUBICIN(R) (daptomycin for injection) is now approved for additional indications in the EU. These remarks were made by Michael W. Bonney, Cubist's President and CEO, during a web cast at the Thomas Weisel Partners Healthcare Conference in Boston. The new EU approval, announced yesterday by Novartis, Cubist's exclusive licensee in the EU and certain other parts of the world for marketing CUBICIN, is based on data from Cubist's landmark Staphylococcus aureus (S. aureus) bacteremia and endocarditis trial.
The two new indications approved for marketing in the EU at 6 mg/kg are right-sided infective endocarditis (RIE) due to S. aureus, and S. aureus bacteremia, when associated with RIE or with complicated skin and soft-tissue infections (cSSTI). CUBICIN was originally approved by the European Commission in January 2006 for use in treating cSSTI infections caused by certain Gram-positive bacteria.
To hear the full remarks from the Thomas Weisel Partners Healthcare Conference, please click the following link for the archive: http://www.veracast.com/webcasts/twp/healthcare07/63206303.cfm. The presentation link will be archived for 30 days, and is also available at our website www.cubist.com in the Investor Relations Conference Calendar tab.
About CUBICIN
CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). CUBICIN is also approved in the U.S. as therapy for bloodstream infections (bacteremia), including right-sided endocarditis, caused by S. aureus. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.cubicin.com.
About Cubist
Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN(R) (daptomycin for injection), the first antibiotic in a new class of anti-infectives called lipopeptides. The Cubist product pipeline includes pre-clinical programs that address unmet medical need in Gram-positive infections, Gram-negative infections, and CDAD (Clostridium difficile-associated diarrhea). Cubist is headquartered in Lexington, MA. Additional information can be found at Cubist's web site at www.cubist.com
News to me
I don't see any news from their research collaboration with Ilypsa to develop a non-antibiotic therapy for Clostridium difficile associated diarrhea (CDAD).
Since they had discontinued the development of HepeX-B, I'm afraid they are still looking for new candidates in preclinical.
If this statement is correct is there any reason status would be reported to SEC???
All I read In the SEC is "The Cubist product pipeline includes our lipopeptide program and our natural products screening program."
They are conducting several more clinical trials with Daptomycin but I don't see any news from their research collaboration with Ilypsa to develop a non-antibiotic therapy for Clostridium difficile associated diarrhea (CDAD).
Since they had discontinued the development of HepeX-B, I'm afraid they are still looking for new candidates in preclinical.
In last SEC filing there was reference to this item. Suggest you read it.
I hope you're right about the pipeline.
Alternatively there is a good chance that the company will be sold for a nice premium.
Daptomycin is unique. No other drug is as effective in its on lable. uses. The pipeline problem is being addressed. One analysts new prediction is for a 55% share price rise within next year. I think he's being ultra concervative. A 10% rise has not impact on me except as an indicator the take off point has arrived and is gaining recognition.
Here we go!!
Ahead of the Bell: Cubist Pharma Rises
Thursday July 19, 8:59 am ET
Cubist Pharmaceuticals Up After 2nd-Quarter Profit and Sales Beat Analyst Estimates
NEW YORK (AP) -- Cubist Pharmaceuticals Inc. shares jumped in premarket electronic trading Thursday after the biotechnology company reported a larger profit than analysts expected on improving sales of its antibiotic Cubicin.
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The Lexington, Mass., company swung to a profit for the quarter, earning 24 cents per share on $69.8 million in revenue. Sales grew 46 percent from the second quarter of 2006.
Analysts had expected a profit of 16 cents per share on $65.1 million in sales.
Jefferies & Co. analyst Eun K. Yang reiterated a "Buy" rating on the stock. Yang's price target of $31 per share implies the stock price will rise 55.1 percent over the next year.
She said Cubist raised its Cubicin sales forecast for the rest of the year, predicting sales in the range of $265 million to $280 million, up from $255 million to $275 million. Cubicin sales totaled $69.5 million in the second quarter, accounting for almost all of the company's revenue.
Yang thinks sales will keep growing, exceeding $500 million in the U.S. in 2010 or 2011.
Lazard Capital Markets analyst Joel Sendek upgraded the stock to "Hold" from "Sell" on Thursday.
The stock gained $2.76, or 13.8 percent, to $22.75 premarket, up from Wednesday's closing price of $19.99.
I think the job should go to Telephonics
[OT] Did the board moderator die? One post (msg #1) and that’s it.
Will you sell today with a 10% pop?
I'm still worried from the thin pipeline.
idit
Cubist Pharma Swings to 2Q Profit
AP via Yahoo! Finance Wed, 18 Jul 2007 2:24 PM PDT
Biotechnology company Cubist Pharmaceuticals Inc. said Wednesday it swung to a second-quarter profit on higher sales of its skin infection treatment Cubicin.
Cubist Pharmaceuticals Reports Second Quarter 2007 Results: Total Revenues $69.8 Million; Net Product Revenues $69.5 ...
Business Wire via Yahoo! Finance Wed, 18 Jul 2007 1:01 PM PDT
LEXINGTON, Mass.----Cubist Pharmaceuticals, Inc. today reported results for the second quarter ended June 30, 2007. Net sales of CUBICIN® increased 52% from the prior year, from $45.7 million in the second quarter of 2006 to $69.5 million in the second quarter of 2007. U.S. net product revenue was $68.3 million.
Cubist
By Brian Lawler
January 29, 2007
2006 was a nice year for Cubist Pharmaceuticals (Nasdaq: CBST), but you wouldn't know that by looking at the company's stock price, which is sitting near 52-week lows. Cubist received approval from the FDA for a market-expanding new use for its antibiotic treatment Cubicin and grew revenues 61% vs. 2005.
Cubist had already pre-released its sales numbers for the fourth quarter three weeks ago, so its sales numbers came as no surprise. Revenue gained 53% to $56.5 million year over year, and gross margins improved 3% to 75%. Earnings were finally in the black at $5 million ($0.10 per share) versus a year-ago loss of almost $7 million, even with higher research and development spending.
Several other stories in the media mentioned Cubist's "lackluster" outlook for the first quarter this year, where sales are expected to be flat versus the fourth quarter. But ever since Cubicin has been on the market, sales have always been sequentially flat in these quarters, so it should come as no surprise that they are flat again this year. 2007's estimates aren't bad at all, though, with Cubist guiding for U.S. net product revenue in the $255 million-$275 million range and earnings of at least $27 million for the year, by my calculations. The only thing holding back earnings next year is the $16 million jump in R&D spending as Cubist initiates more clinical trials to expand Cubicin's label and patent life.
There are some big unknowns that will likely be resolved next year. Besides a possible product acquisition on which Cubist may use its more than $300 million in cash, there is also the resolution of the search for a Japanese partner for Cubicin, which should bring in $10 million-$20 million in up-front payments.
One risk that's worth watching out for -- and which Cubist mentioned -- is the possibility that a paragraph IV filing by a generic company may occur as early as September. Nonetheless, with the FDA's 30-month stay of action on these filings and numerous patents protecting Cubicin, there are many challenges for a generic competitor to overcome before it could begin selling a generic version of the drug. So for the near term at least, investors have nothing to worry about on this front.
Shares of Cubist aren't exactly expensive, with more than $50 million in cash flow expected for next year, sales growing at a rapid clip, and only a $970 million market capitalization. As long as Cubist doesn't make a bad acquisition with that cash hoard, then shares look cheap at today's prices.
ZURICH (AFX) - Novartis AG has a promising product pipeline and expects several key product roll-outs to take place over the course of next year, such as asthma drug Xolair, and Exjade which counters high iron content.
Should all launches go ahead as planned, this would represent the highest number of new launches in a single year for any pharma company, Novarits pharma head Thomas Ebeling said.
In total, the Basel-based drug maker's product pipeline comprises 138 drug candidates in phase I, phase II or phase III as well as regulatory approval stages.
Ebeling also said that Novartis expects anti-inflammatory drug Prexige -- following the recent completion of the EU's mutual recognition procedures -- and Cubicin for the treatment of skin and soft-tissue infections to be launched in 2007 and 2008, he said.
Moreover, Novartis expects first-time approvals, additional indication or regional approvals for blood pressure drug Exforge, cancer treatment Tasigna, and hepatitis B drug Sebivo, postmenopausal osteoporosis drug Aclasta and Alzheimer drug Exelon Patch.
Eye care treatment Lucentis, against wet age-related macular degeneration, is expected to be approved in Europe over the next few weeks, following last November's recommendation by the EU's Committee for Medicinal Products for Human Use (CHMP).
Novartis earlier said it remains optimistic it will also receive US Food and Drug Administration (FDA) approval for diabetes treatment Galvus and blood pressure drug Tekturna, after the FDA extended the drugs' review period to assess additional data.
Both treatments are seen as potential blockbusters, with annual sales in excess of 1 bln usd. afx.zurich@afxnews
Show all filings for CUBIST PHARMACEUTICALS INC | Request a Trial to NEW EDGAR Online Pro
Form 8-K for CUBIST PHARMACEUTICALS INC
--------------------------------------------------------------------------------
13-Dec-2006
Change in Directors or Principal Officers
Item 5.02 Departure of Directors or Certain Officers; Election of
Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On December 7, 2006, the Compensation Committee of the Board of Directors of the registrant, Cubist Pharmaceuticals, Inc. ("Cubist"), approved a Short Term Incentive Plan ("STIP") to provide Cubist's employees, including Cubist's Chief Executive Officer ("CEO"), Chief Financial Officer ("CFO"), and its other named executive officers with annual cash awards based on Cubist's achievement of its company goals and the individual employee's achievement of personal goals for 2007. The cash awards under the STIP for 2007 will be paid in 2008.
Cubist's CEO's cash award under the STIP is targeted at 80% of his 2007 salary and is based 100% on Cubist's achievement of its company goals. Cubist's CFO and its other named executive officers' awards are targeted at 40% of each individual's 2007 salary and are based 60% on Cubist's achievement of its company goals and 40% of the individual's achievement of his individual goals. Because the CEO's, CFO's and named executive officers' 2007 salaries have not yet been established, the amounts of these potential awards are not yet known.
A copy of the terms and conditions of the STIP has been filed as an exhibit to this Report on Form 8-K, attached hereto as Exhibit 10.1, and is incorporated herein by reference.
Partner
Smaller drug developers like Cubist Pharmaceuticals (Nasdaq: CBST - News) don't have nearly the level of resources needed to bring their drugs to market and commence sales in the fragmented pharmaceutical marketplace throughout much of the world. The only way for specialty pharmas like Cubist to get their drugs to countries outside the United States or the European Union is by teaming with a much larger pharmaceutical company. Yesterday, Cubist did just that by signing a commercialization agreement with AstraZeneca (NYSE: AZN - News) to help bring to market and sell Cubist's lead drug, the antibiotic Cubicin, in various smaller markets throughout the world.
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In return for getting the rights to market Cubicin in China and certain other Asian countries, as well as places like the Middle East and Africa, Cubist will receive an undisclosed royalty on all sales of the drug. The agreement also gives Cubist $10 million up front and provides for milestone payments upon Cubicin's reaching certain regulatory and sales milestones in various countries.
The best part of the deal is that Cubist retains the rights to Cubicin in Japan, which is by far the biggest market in all of Asia, accounting for almost two-thirds of the approximately $100 billion Asian market for pharmaceuticals. I'd expect an agreement with Pfizer (NYSE: PFE - News) or the Japanese pharmaceutical giant Takeda sometime in the near future to cover Japan, now that the value of Cubicin has been set in the rest of Asia.
When partnering a drug, it's not only the terms of the partnership that are important, but also the quality and clout of the partner. Cubist made a smart decision in choosing AstraZeneca, because it is well represented in Asia and as of 2004 was the ninth largest pharmaceutical company in this rapidly growing market.
Cubicin sales have been growing like crazy in the past year, and opening up sales in these new markets will only hasten the drug's sales trajectory. Cubist is smart to get the long process of bringing Cubicin to market in the individual Asian countries underway sooner rather than later, as the Asia Pacific region accounts for roughly 17% of worldwide pharmaceutical sales. Getting an experienced pharma partner like AstraZeneca to help with the process and provide a generous up-front payment makes this move even better.
Cubist Inks AstraZeneca Licensing Deal
Monday December 4, 10:24 am ET
Cubist, AstraZeneca Sign a Contract to Sell an Antibiotic in Asia, the Middle East and Africa
LEXINGTON, Mass. (AP) -- Drug developer Cubist Pharmaceuticals Inc. on Monday said it signed a $10.3 million licensing agreement with AstraZeneca PLC to market Cubicin antibiotic in China.
The agreement also includes other countries in Asia, the Middle East and Africa not covered by existing agreements, but excludes Japan.
Cubist will receive additional payments from AstraZeneca once the drug reaches certain regulatory and sales milestones. Cubist will also get payments of an undisclosed amount to supply AstraZeneca with Cubicin vials.
Cubicin is a once-daily antibiotic used to treat staph infections of skin and blood.
Shares of Cubist rose 56 cents, or 2.8 percent, to $20.61 in morning trading on the Nasdaq. Shares of AstraZeneca gained 40 cents to $57.53 on the New York Stock Exchange.
Cubist Pharmaceuticals to Present at September Investor Conferences
Wednesday August 30, 9:30 am ET
Presentations at the Thomas Weisel Partners Healthcare Conference, Bear Stearns 19th Annual Healthcare Conference, and the UBS 2006 Global Life Sciences Conference
LEXINGTON, Mass.--(BUSINESS WIRE)--Aug. 30, 2006--Cubist Pharmaceuticals, Inc. (Nasdaq: CBST - News) today announced that senior management will present at three September investor conferences. On Wednesday, September 6th, at 10:55 A.M. ET, David W. J. McGirr, SVP and CFO will present at the Thomas Weisel Partners Healthcare Conference being held at the Four Seasons Hotel in Boston. Michael Bonney, President and CEO will present on Tuesday, September 12th, at 9:00 A.M. ET, at the Bear Stearns 19th Annual Healthcare Conference being held at the Grand Hyatt in New York City. David McGirr will also present at the UBS 2006 Global Life Sciences Conference which will be held at the Park Avenue at Grand Central in New York City on September 25th at 8:00 A.M. ET. Each presentation will include a discussion of the company's business activities, financial outlook, and current news.
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A live webcast of each presentation will be accessible through a link on the front page of Cubist's website at www.cubist.com and also in the Investor Relations Conference Calendar section of the website. The presentations will be archived and available after the event for a period of 30 days.
About Cubist
Cubist Pharmaceuticals (nasdaq: CBST - news - people ) closed the week with a gain of 5% after a rival reported trial data for telavancin, a potential competitor to Cubist's anti-infective Cubicin. Theravance (nasdaq: THRX - news - people ) said late-stage clinical results met the primary goal of the study, but safety data was similar to previous trials, which showed a 5% to 6% increase in kidney toxicity. Morgan Stanley maintained "neutral" rating on Cubist shares. "Toxicity issues have the potential to have a major impact on the commercial viability of the drug, as we see little in these data to compel a formulary committee to choose Telavancin over Cubicin," it said. "These data represent the 'bogey' that we think investors demanded."
Cubist Shares Rise on Allayed Concerns
Wednesday August 23, 4:36 pm ET
Cubist Pharmaceuticals Shares Jump After Theravance Study Results Allay Competitive Concerns
NEW YORK (AP) -- Shares of Cubist Pharmaceuticals Inc. jumped Wednesday after a rival's late-stage drug study results allayed analysts fears the treatment would pose a competitive threat to its Cubicin drug.
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The stock gained $1.67, or 7.5 percent, to close at $23.93 on the Nasdaq, with average trading volume nearly tripling. The shares have traded between $16.69 and $26.77 over the last 52 weeks, and are up 5 percent year-to-date.
On Tuesday, South San Francisco, Calif.-based rival Theravance announced positive results from a late stage clinical trial on its methicillin-resistant Staphylococcus aureus infection drug, but fell short of meeting a secondary goal to treat more complicated infections caused by MRSAs. Better known as "Staph infections," MRSAs are normally limited to a small area of a person's skin but can seriously impact other parts of the body if they enter the bloodstream.
Lexington, Mass-based Cubist, also on Tuesday, filed an 8-K with the Securities and Exchange Commission that referred to results published in the New England Journal of Medicine on its Staph infection drug, Cubicin. That drug was approved in 2003 for complicated skin infections but was given expanded approval May 26 for the treatment of blood stream infections caused by Staph infections.
Cubicin sales totaled $113.5 million in 2005.
Merrill Lynch analyst David Munno released an update to investors, with his assessment that Theravance's drug, called telavancin, would not pose a competitive threat to Cubicin. Instead, he wrote, the future entry of telavancin is likely to expand the market for Cubicin. Also, the drugs will likely both take market share away from companies selling the injectible version of the antibiotic vancomycin.
He reiterated his "Buy" rating and a $35 price target.
"Ultimately, we expect telavancin approval and commercial launch will help both drugs capture market share from vancomycin," he wrote.
In the telavancin study, the drug met its primary endpoint, which was its effectiveness compared with vancomycin. But it missed its co-primary endpoint of superiority in treating Staph infections.
That leaves Cubicin's market in treating infections including endocartis, an infection of the heart, safe. Even so, if telavancin were to cut into Cubicin's market share, Cubist would not be significantly impacted as skin infection drugs make up less than 20 percent of its revenue.
Jefferies & Company Inc. analyst Eun K. Yang reiterated a "Buy" rating with a $30 price target, also citing a diminished threat of competition from telavancin.
In a note to investors, Yang focused more on some of telavancin's side effects, saying they are likely to be focused on by the Food and Drug Administration.
"We believe the toxicity profile to be a focus at the FDA and a key determinant for telavancin's potential," Yang wrote.
Shares of Theravance slid 28 cents to finish at $25 on the Nasdaq.
The New England Journal of Medicine Publishes Results of Cubist's Landmark Study of Staphylococcus Aureus Blood Stream Infections
Wednesday August 16, 5:00 pm ET
Study Results Led to Recent Label Expansion for CUBICIN
LEXINGTON, Mass.--(BUSINESS WIRE)--Aug. 16, 2006--Cubist Pharmaceuticals, Inc. (Nasdaq: CBST - News) today announced that the New England Journal of Medicine (NEJM) has published results from the company's landmark Phase 3 study of CUBICIN® (daptomycin for injection) at 6 mg/kg as monotherapy vs. dual therapy standard of care for the treatment of patients with Staphylococcus aureus (S. aureus) blood stream infections (bacteremia) and infective endocarditis (infection of the heart valves). The study results, which are featured in the August 17, 2006 issue of the NEJM, show that CUBICIN at 6 mg/kg intravenously once daily was as effective as standard-of-care comparator for the treatment of S. aureus bacteremia including right-sided endocarditis. On May 26th, the FDA approved a supplemental New Drug Application (sNDA) to expand the indication for CUBICIN at 6 mg/kg once daily to treat patients with S. aureus blood stream infections including right-sided endocarditis.
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Cubist Senior Vice President and Chief Scientific Officer, Frank Tally said, "Cubist is proud to have conducted this landmark study of bacteremia and infective endocarditis caused by Staphylococcus aureus, including methicillin-resistant S. aureus or MRSA. CUBICIN is now the only therapy approved for treatment of S. aureus blood stream infections based on a prospective registration trial."
Dr. Vance Fowler, an Assistant Professor at Duke University Medical School and lead author of the paper published today, said, "As stated in this publication, treatment options for S. aureus bacteremia and endocarditis, particularly those caused by MRSA, have been limited. In an era of increasing antimicrobial resistance, and limited antimicrobial development, this study demonstrated that CUBICIN provides a much needed option for the management of S. aureus bacteremia and right-sided endocarditis." Dr. Fowler was one of the five infectious disease specialists who served as members of the Independent External Adjudication Committee (IEAC) which determined outcomes for all patients in this trial.
The study met the pre-specified criteria for the non-inferiority of CUBICIN relative to standard-of-care therapy. Standard-of-care therapy was either semi-synthetic penicillin plus initial gentamicin for infections caused by methicillin-susceptible S. aureus (MSSA), or vancomycin plus initial gentamicin for infections caused by MRSA. In the intent to treat (ITT) analysis, success rates at test of cure (TOC) were 44.2% of 120 CUBICIN-treated patients vs. 41.7% of 115 comparator-treated patients (2.4% difference (95% CI, -10.2%, 15.1%)). Success rates were similar in the patients with complicated bacteremia, and in patients with right-sided endocarditis. A safety analysis showed that the incidence of adverse events in CUBICIN and comparator treatment groups were similar. The most common adverse events occurring at an incidence of greater than or equal to 10% in both groups included anemia, diarrhea, vomiting, constipation, and nausea. Additional adverse events in the comparator group occurring at an incidence of greater than or equal to 10% included hypokalemia, renal impairment, headache, peripheral edema, and arthralgia.
S. aureus is a leading cause of bacteremia and endocarditis. Infections caused by MRSA are a serious and growing problem in the U.S. and other parts of the world. This issue of the NEJM also includes an article by lead author Dr. Gregory Moran from UCLA Medical Center, co-authored by public health experts from the U.S. Centers for Disease Control (CDC) documenting Community-associated MRSA as the most common cause of skin and soft tissue infections in emergency room patients treated in August of 2004 at university-affiliated hospitals in 11 major metropolitan areas across the United States. S. aureus was isolated from 76% of the patients in this analysis. Seventy-eight percent of the S. aureus isolates were methicillin-resistant, giving MRSA an overall prevalence in this study population of 59%.
CUBICIN was originally approved on September 12, 2003, at 4 mg/kg intravenously once daily for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive organisms, including both susceptible and resistant strains of S. aureus (MSSA and MRSA respectively). These newly published findings form the basis of the sNDA filed by Cubist in September 2005 and were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in December 2005 and at an Anti Infective Drugs Advisory Committee meeting convened by the FDA on March 6, 2006. On May 26th, the FDA approved CUBICIN at 6 mg/kg once daily to treat patients with S. aureus blood stream infections including right-sided endocarditis, caused by MSSA and MRSA.
About CUBICIN® (daptomycin for injection)
CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). CUBICIN is also approved in the U.S. as therapy for blood stream infections including right-sided endocarditis, caused by S. aureus. CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.cubicin.com.
About blood stream infections and infective endocarditis caused by S. aureus
Normally the bacteria that live on the body's surfaces are kept in check by the immune system. When bacteria enter the bloodstream, through such means as a post surgical wound, dental work or a catheter, they can cause serious illness. With S. aureus in the bloodstream, patients are at high risk for serious complications, including deep tissue infections and infective endocarditis (IE), an infection of the heart valves. Even with prompt treatment, infective endocarditis caused by S. aureus is associated with significant morbidity and mortality.
About Cubist's landmark S. aureus bacteremia and endocarditis trial
Study DAP-IE-01-02 was an international, multi-center, prospective, randomized, controlled open-label Phase 3 trial of CUBICIN in patients with S. aureus bacteremia and endocarditis. Its end point was non-inferiority versus standard of care in both ITT and per protocol (PP) populations. Enrolled patients with S. aureus bacteremia that was either methicillin-sensitive (MSSA) or methicillin-resistant (MRSA) were randomized to receive a minimum of 2-6 weeks of either CUBICIN 6 mg/kg intravenously (IV) once-daily OR a semi-synthetic penicillin 2 grams IV 6 times per day OR vancomycin (standard doses) IV twice daily depending upon the organism susceptibility. Patients in the comparator arm of the study also received an initial 4 days of IV gentamicin, which is commonly used to reduce the duration of bacteremia. Patients were followed for up to 12 weeks following completion of therapy.
Because of the seriously ill patients involved in the study, and the fact that standard therapy exists for these conditions, this study was designed statistically as a non-inferiority study to compare CUBICIN vs. standard of care. (This is the trial design used for most "registration studies" of antibiotics.) The hurdle was for CUBICIN to be at least as effective as the comparator agents. Success at TOC--42 days following the completion of therapy--was determined by the members of the IEAC who were blinded to therapy.
About
Cubist Pharmaceuticals Appoints Sylvie Gregoire, Pharm. D., to Its Board of Directors
Monday June 12, 12:15 pm ET
LEXINGTON, Mass.--(BUSINESS WIRE)--June 12, 2006--Cubist Pharmaceuticals, Inc. (Nasdaq: CBST - News) today announced the appointment of Sylvie Gregoire, Pharm. D., to its Board of Directors. Dr. Gregoire, who has twenty years of pharmaceutical and biotech industry experience, also serves on the boards of IDM-Pharma, a publicly traded company headquartered in San Diego, CA and Caprion Pharmaceuticals, Inc., a privately-owned biotechnology company in Montreal, Canada
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Dr. Gregoire was President and Chief Executive Officer, as well as Executive Member of the Board of Directors, of GlycoFi, Inc., from October of 2004 to August of 2005. Prior to joining GlycoFi, Dr. Gregoire served as a consultant to the biopharmaceutical industry following nine years with Biogen Idec Inc. both in the United States and, earlier, in France. While in France for Biogen, Dr. Gregoire served as Director of International Regulatory Affairs (1995-1998). Dr. Gregoire then moved to Biogen's headquarters where her responsibilities started in Program Management before she joined the management team as head of Regulatory Affairs and then head of Manufacturing. Immediately prior to leaving Biogen in 2005, Dr. Gregoire was EVP, Technical Operations (2001-2003) and a member of the Executive Management Team. Prior to Biogen, Dr. Gregoire spent eight years with Merck & Co., in various positions in clinical research and in European regulatory affairs in Canada, the US and Europe.
Dr. Gregoire has published papers and presented abstracts in the United States and Canada on pharmacokinetics of pharmaceutical drugs including antibacterials. She received her Doctor of Pharmacy degree from the State University of New York at Buffalo and her pharmacy graduate degree (Bachalaureat en Pharmacie) from the Universite Laval, Quebec City.
Read the latest news release again. Cubist restructured an old debt with 5.5% interest to 2.25% interest. So in effect the new offering is half or less of the total figure. Considering the savings from the difference in debt interest, the offering is in reality much smaller and will finance increased production of Cubicin and increased research for expanding the pipeline.And perhaps most important it provides the resources to defend the company's intellectual property should that need arise.
Smart financial management!
Why are there so few new medicines targeted at resistant bacteria? In the past decade, many big pharmaceutical players, including Wyeth (nyse: WYE - news - people ), Roche and Eli Lilly (nyse: LLY - news - people ), backed off antibiotic research. At the same time, new antibiotics were becoming increasingly difficult to develop. For 30 years--until 2000--there were no new classes of antibiotics approved.
In the past six years, there have been two clear examples: Zyvox, from Pfizer (nyse: PFE - news - people ), and Cubicin, from Cubist Pharmaceuticals (nasdaq: CBST - news - people ). Wyeth's Tygacil and Sanofi-Aventis' (nyse: SNY - news - people ) Ketek have been touted as new classes, and though the distinction can be argued, both were definitely better at fighting resistant bugs.
Drug companies are starting to become interested in antibiotics again. Pfizer, which always kept a presence in developing new germ-killing drugs, saw its Zyvox become a fast-growing drug in recent years. Then it bought antibiotics maker Vicuron last summer; an antifungal medicine from the deal was approved on Feb. 21. Abbott Laboratories' (nyse: ABT - news - people ) Omnicef, an antibiotic pill, saw sales increase 61% to $627 million last year, according to consulting firm IMS Health (nyse: RX - news - people ).
Biotechs are benefiting too. Shares in antibiotic maker Cubist Pharmaceuticals have more than doubled this year based on sales of Cubicin, its injectable treatment for Staphylococcus aureus, one of the bugs topping the IDSA's hit list (see: " A Better Antibiotic?").
But the IDSA authors say the antibiotics in development simply aren't enough. A review of new medicines finds few that work in new ways, meaning that some of the new drugs may hit the market already facing some resistant bugs. And the authors say the drug companies are not developing drugs to treat the organisms that are the biggest health threat. Market forces, they worry, may not take care of the problem.
Click here for a list of the six scariest germs.
Monday, Jun 05, 2006 (generated at 08:05 AM)
CBST: Cubist Pharmaceuticals Announces Underwriters Have Exercised
Option to Purchase Additional $25 Million in 2.25% Convertible
Subordinated Notes Due 2013
- Jun 5 2006 7:30AM (BusinessWire)
- http://www.quote.com/home/news/story.asp?story=58956662
Methicillin-resistant Staphylococcus aureus (MRSA)
Drug-resistant "staph" causes 102,000 hospital infections a year, more than any other. For sick patients, it can be a killer. Recently, S. aureus has escaped the hospital. The number of children infected jumped 28% in three years. Now, athletes are being infected. In 2003, five football players on the St. Louis Rams suffered staph-infected turf burns that resisted multiple antibiotics.
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126
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Created
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01/19/06
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Free
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