Posted on July 23, 2008 @ 10:27 am
Pfizer
2Q Revenues: $12.1 billion (+9%)
2Q Earnings: $2.8 billion (+119%)
YTD Revenues: $24.0 billion (+2%)
YTD Earnings: $5.6 billion (+19%)
Comments: Pharmaceutical sales in the quarter were $11.1 billion (+9%) and $22.0 billion YTD (+1%), including exchange rate benefits of $800 million in 1Q08. Lipitor revenues in the quarter were $3.0 billion (+9%). Lyrica revenues in the quarter were $614 million (+52%). Celebrex revenues were $589 million (+23%). Sutent revenues were $211 million (+45%). Chantix (Champix outside the U.S.) revenues in the quarter were $207 million (+3%). U.S. sales were down 35% to $109 million, due to added safety information on the U.S. label, while international sales were $98 million (+197%). R&D expenses were $1.9 billion in the quarter (-8%), excluding $156 million of in-process R&D expenses associated with the acquisitions of Serenex, Inc. and Encysive Pharmaceuticals. Restructuring charges and acquisition-related costs were $569 million in the quarter (-46%). Results were impacted by the loss of U.S. exclusivity for Zyrtec, which Pfizer stopped selling in January 2008, and for Camptosar in February 2008. Zyrtec and Camptosar 2Q08 revenues decreased by $377 million and $104 million, respectively.
Posted on July 23, 2008 @ 10:25 am
Wyeth
2Q Revenues: $5.9 billion (+5%)
2Q Earnings: $1.1 billion (-6%)
YTD Revenues: $11.7 billion (+6%)
YTD Earnings: $2.3 billion (-5%)
Comments: Pharmaceutical sales were $5.0 billion (+5%), due to Effexor, Enbrel, Prevnar, and Zosyn sales, as well as the favorable foreign exchange, offset, in part, by lower sales of Protonix due to generic competition. Effexor sales in the quarter were $1.0 billion (+5%) and $2.0 billion YTD (+9%). Prevnar sales were $691 million (+9%) and $1.4 billion YTD (+12%). Enbrel revenues in the quarter were $976 million and $1.9 billion YTD, which includes sales outside U.S. and Canada (+36% 2Q and YTD) and alliance revenue in the U.S. and Canada (+6% 2Q and 23% YTD). Zosyn/Tazocin sales were $319 million (+14%) in the quarter and $661 million YTD (18%). R&D expenses (excluding impact of foreign exchange) were $836 million in the quarter (+1%) and $1.7 billion YTD (+6%).
Posted on July 23, 2008 @ 10:23 am
Genzyme
2Q Revenues: $1.2 billion (+25%)
2Q Earnings: $69.6 million (-17%)
YTD Revenues: $2.3 billion (+25%)
YTD Earnings: $214.8 million (-11%)
Comments: Myozyme sales were up 65% in the quarter to $77.2 million. The company is still awaiting approval of its Myozyme 2000L-scale facility in the U.S.; the FDA is expected to discuss the BLA in October. Cerezyme sales were up 13% to $319.4 million. Sales of Fabrazyme were up 21% to $126.6 million. Sales of Aldurazyme were up 33% to $38.8 million. Thyrogen sales were $39.4 million (+34%). Renagel and Renvela sales were $168.6 million (+16%). Sales of Thymoglobulin and Lymphoglobuline were up 10% to $45.6 million. R&D expenses were up 92% in the quarter to $381 million and $644.7 million YTD (+77%). Earnings reflect a license fee of $175 million paid in the quarter for mipomersen, a cholesterol-lowering drug in late-stage development, and $70 million in 1Q08 for the purchase of Isis shares.
Posted on July 23, 2008 @ 10:21 am
Bristol-Myers Squibb and
AstraZeneca have submitted an NDA to the FDA and a MAA to the EMEA for Onglyza (saxagliptin) for the treatment of type 2 diabetes.
The submissions are based on data from a clinical program conducted in addition to standard therapies, as well as in treatment naïve patients as a monotherapy. The program included studies that evaluated the drug at doses as high as 80 times therapeutic clinical doses. The six Phase III trials assessed the safety and efficacy of saxagliptin and involved more than 4,000 patients.
Onglyza, under joint development by BMS and AZ, is a DPP-4 inhibitor designed to be a selective, reversible inhibitor of the DPP-4 enzyme, with dual routes of clearance. Additional Phase III data for saxagliptin, including when added to a sulfonylurea, a thiazolidinedione and as initial combination therapy with metformin, are planned for disclosure later this year.
Posted on July 22, 2008 @ 10:18 am
Schering-Plough
2Q Revenues: $4.9 billion (+55%)
2Q Earnings: $436 million (-16%)
YTD Revenues: $9.6 billion (+56%)
YTD Earnings: $726 million (-34%)
Comments: Pharmaceutical sales were $3.7 billion in the quarter (+47%) and $7.3 billion YTD (+48%) driven by Remicade sales ($557 million in the quarter, up 41% and $1.1 billion YTD, up 39%). Nasonex sales were $311 million in the quarter (+6%) and $618 million YTD (+7%). Temodar sales were $251 in the quarter (+16%) and $487 million YTD (+18%). Clarinex sales were $240 million in the quarter (-4%) and flat YTD at $454 million. Pegintron sales were $229 million in the quarter (-2%) and $454 million YTD (+1%). R&D expenses were $906 million in the quarter (+30%) and $1.8 billion YTD (+27%). Results in the quarter and YTD include sales of $1.4 billion and $2.8 billion, respectively, from Organon BioSciences, which was acquired in November 2007. In the quarter, Schering-Plough/Merck Pharmaceuticals terminated its respiratory joint venture, which received a not-approvable letter from the FDA for a fixed combination of Claritin/Singulair in April. Sales of the global cholesterol joint venture with Merck, which include Vytorin and Zetia, were down 9% to $1.1 billion. S-P incurs substantial costs related to the JV, such as selling, general and administrative costs.
Posted on July 22, 2008 @ 10:17 am
Merck
2Q Revenues: $6.1 billion (-1%)
2Q Earnings: $1.8 billion (+5%)
YTD Revenues: $11.9 billion (flat)
YTD Earnings: $5.1 billion (+50%)
Comments: Worldwide sales of Singulair were $1.1 billion in the quarter (-1%). Combined worldwide sales of Zetia and Vytorin, as reported by the Merck/Schering-Plough joint venture, were $1.2 billion (-9%). Worldwide sales of Zetia, marketed as Ezetrol outside the U.S., were $560 million (-3%). Worldwide sales of Vytorin, marketed outside the U.S. as Inegy, were $592 million (-14%). Cozaar and Hyzaar sales were $941 million (+11%). Sales of Fosamax and Fosamax Plus D, marketed as Fosavance in the EU, were $411 million (–48%) due to loss of U.S. marketing exclusivity. Sales Januvia, Janumet and Isentress were $2.0 billion in the quarter (+24%). Worldwide vaccine sales were $995 million (-5%). R&D expenses were $1.2 billion for the quarter (+13%). Restructuring costs, primarily representing employee separation costs associated with the company's global restructuring program, were $102 million in the quarter.
Posted on July 22, 2008 @ 10:15 am
Biogen Idec
2Q Revenues: $993 million (+28%)
2Q Earnings: $207 million (+11%)
YTD Revenues: $1.9 billion (+30%)
YTD Earnings: $369.7 million (+16%)
Comments: Growth in the quarter was driven by Avonex sales up 14% to $527 million, Tysabri sales up 210% to $147 million, and Rituxan revenues from the unconsolidated joint business arrangement up 21% to $279 million. Tysabri revenue comprised $46 million related to product sold through Elan in the U.S. and $101 million related to product sold by Biogen Idec Internationally. Royalties in the quarter were $28 million (+22%). R&D expenses were $252.3 million in the quarter (+16%) and $510.5 million YTD (+25%)
Posted on July 22, 2008 @ 10:13 am
Roche has entered into a definitive agreement to acquire
Mirus Bio Corp. for $125 million. Mirus Bio is a privately owned company based in Madison, WI, focused on the discovery and development of RNAi delivery technologies.
Under the terms of the agreement, Roche will maintain an RNAi research site in Madison. Mirus' transfection reagents business will be divested into a standalone business called Mirus Bio LLC. Employees will be offered a transition into their respective business unit. Closing of the transaction is expected during 2H08.
RNAi, a natural mechanism the body uses to 'silence' certain genes, represents a potential new class of therapeutics for difficult to treat diseases. The transport of RNAi molecules into the target cell has been the major challenge for this therapy. Mirus' delivery platform provides a new way of getting RNAi therapeutics to specific disease targets.
"The pioneering work in RNAi delivery by the scientists at Mirus, together with our Centre of Excellence for RNAi research in Kulmbach, puts Roche at the forefront of bringing this whole new class of treatment to patients who suffer from difficult to treat diseases," said Lee E. Babiss, global head of Roche Pharma Research. "Our global research team has made great strides in advancing RNAi therapeutics, and with our new colleagues in Madison we will now bolster those efforts. The technology brought by Mirus, together with additional technologies, will bring us closer to creating fully enabled RNAi therapeutics."
Posted on July 22, 2008 @ 10:10 am
MeadWestvaco Corp. and
Bilcare Ltd. have jointly acquired International Labs, a pharmaceutical packaging company based in St. Petersburg, FL. The acquisition will use the companies' capabilities for adherence-promoting pharmaceutical packaging in an effort to streamline the supply chain by eliminating several steps in the distribution channel, according to a Bilcare statement. The goal of the acquisition, which was completed on July 18th, is to make adherence packaging more widely available to consumers through growing low-cost generic and branded drug programs. Terms of the agreement were not disclosed.
The partnership combines MWV’s capabilities in healthcare packaging design (including compliance and injection molded packaging), Bilcare’s research and expertise in materials, products, processes and services for the integration of pharmaceuticals and packaging, and International Labs’ contract packaging services for retail pharmacies, and large generic and branded drug manufacturers.
“The combination of our turnkey capabilities has helped enable the creation of new, highly efficient, consumer-oriented supply chains that are changing the economics of global healthcare and improving patient outcomes,” said Bruce Thomas, senior vice president, global market strategy for MWV. “This acquisition is one component of our healthcare strategy in product innovation, capacity expansion, and other growth investments. We are continuing to work with retailers, including Wal-Mart, and generic and branded pharmaceutical companies to continue to bring our innovative healthcare compliance solutions to serve the fast-growing needs of the global healthcare market.”
Mohan Bhandari, chairman and managing director of Bilcare, commented, “We are excited about the acquisition of International Labs; our partnership with MWV will allow us to combine our global experience, primary and secondary packaging expertise, and research and development capabilities to bring compliance packaging solutions to customers throughout the world.”
Posted on July 21, 2008 @ 09:33 am
Roche has proposed to acquire the outstanding interest in
Genentech for a total of approximately $43.7 billion. Roche acquired a majority in Genentech in 1990 and currently owns 55.9% of the company.
Under the plan, Genentech will operate as an independent research and early development center within Roche from its existing campus in South San Francisco, retaining its employees and approach to discovering and progressing new molecules. Roche's Palo Alto Virology R&D activities will relocate to South San Francisco, while its Palo Alto Inflammation group will become part of Roche's Nutley, NJ R&D organization. Nutley will host two global Disease Biology Areas (Oncology and Inflammation) as well as key functions in Metabolism. Genentech's site in South San Francisco and Roche's NJ campus will represent the biggest R&D centers in the U.S. within the Roche Group.
Roche's Pharma commercial operations in Nutley will be moved to Genentech's site in South San Francisco. The combined company's U.S. commercial operations in pharmaceuticals will use the Genentech name. The existing U.S. sales organizations of both companies will be maintained. Genentech's late stage development and manufacturing operations will be combined with the global operations of Roche. Roche's manufacturing in Nutley will be closed and support functions, such as informatics and finance, will be consolidated.
Severin Schwan, chief executive officer of Roche, said, "We are looking forward to working more closely with our colleagues from Genentech. We have great respect for their achievements and we will take the necessary steps to nurture Genentech's innovative and unique science-driven culture. The Genentech Founders Research Center will operate as an independent unit within the Roche Group to safeguard a diversity of different approaches and to foster the long term flow of novel breakthrough medicines. At the same time, we will be better able to share technologies and expertise in pharmaceuticals and diagnostics across the Group and broaden the mutual access to the external innovation networks of both companies. As Genentech has grown from a research-focused biotech venture into an integrated pharmaceutical organization, the transaction will also unlock synergies by leveraging the scale of the combined operations in the U.S. and improving operational efficiency."
The terms and conditions of the transaction will be determined through negotiations with the independent directors. Roche expects to complete the transaction as soon as possible following negotiation of a definitive merger agreement.
Posted on July 21, 2008 @ 09:32 am
Roche
1H08 Revenues: $21.5 billion (+4%)
1H08 Earnings: $5.6 billion (-2%)
Comments: Pharmaceutical sales were $16.8 billion (+3%). Oncology sales increased 15%, driven by Avastin (+36% to $2.3 billion), MabThera/Rituxan (+17% to $2.8 billion), Herceptin (+11% to $2.4 billion), Tarceva, (+28% to $574.2 million) and Xeloda (+14% to $560.5 million), which offset lower Tamiflu sales. Tamiflu sales declined $1.1 billion compared to 1H07 due to reduced pandemic stockpiling orders. R&D expenses were $4.0 billion (+12%).
Posted on July 21, 2008 @ 09:31 am
AMRI opened its first in vitro biology lab in Singapore and completed a 10,000-sq.- ft. lab expansion for medicinal chemistry discovery services, doubling the capacity of its Science Park III facility.
The in vitro biology group will test compounds synthesized by AMRI’s Singapore-based medicinal chemistry teams to deliver potency data using cell-based or biochemical assays. AMRI anticipates hiring an additional 70 or more chemists and biologists to staff the facility during the next three years.
“This expansion continues AMRI’s investment in building out a worldwide drug discovery and development platform. Along with parallel investments in the U.S., India and Hungary, AMRI’s global footprint is gaining a critical mass and customers’ acceptance due to our focus on quality, highest standards and a strong brand of excellence. This latest investment in Singapore continues our plan to provide customers a broad range of services, capabilities and geographic choices,” said chairman, chief executive officer and president Thomas E. D’Ambra, Ph.D.
Posted on July 21, 2008 @ 09:26 am
Quentin Roach has been named senior vice president and chief procurement officer,
Bristol-Myers Squibb. Mr. Roach will be responsible for global leadership for supplier relationship management, company-wide sourcing strategies, and procurement of all materials and services.
“As we transition Bristol-Myers Squibb to a next-generation BioPharma model, Quentin will play a key role in continuing to maximize the strategic value that procurement can deliver to the company,” said Carlo de Notaristefani, president of Technical Operations. “He brings extensive procurement and supply chain experience that will serve him well in his new position,” said Mr. de Notaristefani.
Prior to joining the company, Mr. Roach was vice president of Global Customer Strategy & Process Management at Bausch & Lomb Inc., where he also led the company’s Global Customer Strategy Steering Committee. While at Bausch & Lomb, he held a number of leadership roles in sourcing and procurement, supply chain, and packaging engineering. Earlier, he was chief purchasing officer and director of Auxiliary Operations at the University of Rochester/Strong Health System. He held a number of procurement and operations roles at other companies including Delphi Automotive Systems and General Motors Corp.
Posted on July 18, 2008 @ 08:40 am
Teva Pharmaceutical Industries and
Barr Pharmaceuticals have signed a definitive agreement under which Teva will acquire Barr for $7.5 billion plus the assumption of approximately $1.5 billion of debt. The acquisition will expand Israel-based Teva's presence in the U.S. and Eastern European generics markets as well as add to Teva’s specialty pharmaceutical platform through the addition of Barr’s substantial women’s health portfolio.
Shlomo Yanai, president and chief executive officer of Teva, said, “The acquisition of Barr will elevate Teva’s market leadership to a new level. The combination of our two companies provides an outstanding opportunity strategically and economically: It will enhance our market share and leadership position in the U.S. and key global markets, further strengthen our portfolio and pipeline, and provide upside to our strategic plan, by allowing us to exceed our 20/20 goals for 2012.”
Bruce Downey, chairman and chief executive officer of Barr, said, “This transaction will enable Teva to capitalize on Barr's portfolio of unique generic and proprietary products, benefit from our capabilities in biologics, and expand its presence in important Central and Eastern European markets. This agreement has the full support of Barr's board of directors and senior management, and will benefit the shareholders, customers and employees of Barr.”
The combined global company will operate directly in more than 60 countries and employ approximately 37,000 people worldwide. The transaction is expected to close in late 2008.
Posted on July 18, 2008 @ 08:38 am
Gilead Sciences
2Q Revenues: $1.3 billion, (+22%)
2Q Earnings: $442.8 million (+9%)*
YTD Revenues: $2.5 billion (+22%)
YTD Earnings: $939.0 million (+15%)
Comments: Product sales were a record $1.2 billion in the quarter driven by the antiviral franchise ($1.1 billion, up 34%), including the strong growth of Atripla and continued growth of Truvada. Atripla sales were $355.1 million (+67%) and Truvada sales were $516.1 million (+34%). R&D expenses in the quarter were $176.5 million (+30%)
*Earnings in the quarter include an after-tax stock-based compensation expense of $26.4 million and an in-process research and development expense of $7.8 million.