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| WYE > SEC Filings for WYE > Form 10-Q on 4-Aug-2008 | All Recent SEC Filings |
4-Aug-2008
Quarterly Report
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The following commentary should be read in conjunction with the consolidated condensed financial statements and notes to consolidated condensed financial statements on pages 7 to 22 of this report. When reviewing the commentary below, you should keep in mind the substantial risks and uncertainties that characterize our business. In particular, we encourage you to review the risks and uncertainties described in "Item 1A. RISK FACTORS" in our 2007 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 29, 2008. These risks and uncertainties could cause actual results to differ materially from those projected in forward-looking statements contained in this report or implied by past results and trends. Forward-looking statements are statements that attempt to forecast or anticipate future developments in our business; we encourage you to review the examples of our forward-looking statements under the heading "Cautionary Note Regarding Forward-Looking Statements" on pages 47 to 49 of this report. These statements, like all statements in this report, speak only as of their date (unless another date is indicated), and we undertake no obligation to update or revise these statements in light of future developments.
Overview
Our Business
Wyeth is one of the world's largest research-based pharmaceutical and health care products companies and is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, biotechnology products, vaccines, non-prescription medicines and animal health products.
We have three principal operating segments: Wyeth Pharmaceuticals (Pharmaceuticals), Wyeth Consumer Healthcare (Consumer Healthcare) and Fort Dodge Animal Health (Animal Health), which we manage separately because they develop, manufacture, distribute and sell distinct products and provide services that require differing technologies and marketing strategies. These segments reflect how senior management reviews the business, makes investing and resource allocation decisions, and assesses operating performance. The percentage of worldwide net revenue and revenue generated outside the United States by operating segment for the 2008 first half was as follows:
Consumer
Pharmaceuticals Healthcare Animal Health
% of 2008 first half worldwide 83% 12% 5%
net revenue
% of 2008 first half segment net 54% 52% 62%
revenue generated outside the
United States
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We also have a reportable Corporate segment primarily responsible for the audit, controller, treasury, tax and legal operations of our businesses. The Corporate segment maintains and/or incurs certain assets, liabilities, income, expense, gains and losses related to our overall management that are not allocated to the other reportable segments.
Our principal strategy for success is the development of innovative products. We strive to produce first-in-class and best-in-class therapies for significant unmet medical needs by leveraging our breadth of knowledge and our resources across three principal scientific development platforms: small molecules, biopharmaceuticals and vaccines.
We also strive to innovate commercially and change the way we approach our business in response to the challenging global health care environment. In 2008, we continued our productivity initiatives by launching Project Impact, a company-wide program designed to initially address short-term fiscal challenges, particularly the significant loss of sales and profits resulting from the launch of generic versions of PROTONIX. Longer-term, Project Impact will include strategic actions designed to fundamentally change how we conduct business across the entire Company and to adapt to the continuously changing environment.
In the 2008 first half, we received regulatory approvals for three new products. In February, the U.S. Food and Drug Administration (FDA) approved XYNTHA (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free), a recombinant factor VIII product for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis. Also, in February, the FDA approved PRISTIQ (desvenlafaxine), a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor, to treat adult patients with major depressive disorder. In April, we and our collaboration partner, Progenics Pharmaceuticals, Inc. (Progenics), received FDA approval for RELISTOR (methylnaltrexone bromide) for subcutaneous injection for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care. We and Progenics also have received approval from the European Commission and Health Canada for RELISTOR subcutaneous injection for the same indication. In May, the FDA granted fast track designation to our investigational 13-valent pneumococcal conjugate vaccine for use in infants and toddlers. In December 2007, we and our collaboration partner, Elan Corporation, plc, initiated a Phase 3 clinical program for our immunotherapeutic product candidate, bapineuzumab (AAB-001), for the treatment of patients with mild to moderate Alzheimer's disease. Results from the principal Phase 2 study of bapineuzumab were presented at the International Conference on Alzheimer's Disease on July 29, 2008. We continue to believe these results are encouraging and support the decision to initiate the Phase 3 clinical program.
2008 First Half Financial Highlights
• Worldwide net revenue increased 6% over the 2007 first half to $11,656.0 million;
• Worldwide Pharmaceuticals net revenue increased 5% over the 2007 first half due primarily to higher sales of ENBREL, EFFEXOR, PREVNAR, Nutrition products, ZOSYN and BENEFIX and the favorable impact of foreign exchange. Also contributing to net revenue growth were our new products TYGACIL, TORISEL, and
PRISTIQ. The increase in Pharmaceuticals net revenue was offset, in part, by lower sales of PROTONIX due to generic competition in the United States;
• Consumer Healthcare net revenue increased 9% over the 2007 first half resulting from higher sales of CENTRUM, ADVIL and CALTRATE and the favorable impact of foreign exchange, which were partially offset by lower sales of ALAVERT and DIMETAPP; and
• Animal Health net revenue increased 6% over the 2007 first half due to higher sales of poultry products and livestock products driven by ZULVAC bluetongue vaccine and the favorable impact of foreign exchange, which were offset by lower sales of equine products.
Our Principal Products
Set forth below is a summary of net revenue performance of our principal
products in the 2008 first half:
2008 First % Increase
Half (Decrease) over
(Dollars in millions) Net Revenue 2007 First Half
EFFEXOR $2,043.6 9%
PREVNAR 1,396.5 12%
ENBREL
Outside U.S. and Canada 1,298.0 36%
Alliance revenue - U.S. and Canada 610.0 23%
Nutrition 841.3 19%
ZOSYN/TAZOCIN 661.2 18%
PREMARIN family 547.0 8%
PROTONIX family 387.2 (62)%
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• EFFEXOR (EFFEXOR and EFFEXOR XR) is our novel antidepressant for treating adult patients with major depressive disorder, generalized anxiety disorder, social anxiety disorder and panic disorder. EFFEXOR remains our largest franchise and the number one selling antidepressant globally. In the United States, demand for EFFEXOR XR prescriptions declined slightly in the 2008 first half as we shifted promotional support to the launch of PRISTIQ, our new product for the treatment of adult patients with major depressive disorder. See "Our Challenging Business Environment" beginning on page 31 for a discussion of generic competition for EFFEXOR and EFFEXOR XR.
• PREVNAR is our vaccine for preventing invasive pneumococcal disease in infants and children. PREVNAR is one of the world's best selling vaccines and now is available in 88 countries worldwide and is included in 24 national immunization programs (NIPs), with several additional countries announcing their intention to initiate NIPs.
• ENBREL is our treatment for rheumatoid arthritis, psoriasis and other conditions. We have exclusive rights to ENBREL outside the United States and Canada. We co-promote ENBREL with Amgen Inc. (Amgen) in the United States and Canada. ENBREL continues as the leading biotechnology brand in the world and ranks fifth in worldwide sales among the top pharmaceutical products.
• Nutrition includes our infant formula and toddler products NURSOY, PROGRESS, PROMIL and S-26. We continue to expand into new markets, grow our business in the countries where we compete, particularly in key emerging markets such as China, and shift the focus of our business to the more profitable premium sector of the market.
• ZOSYN (TAZOCIN internationally), our broad-spectrum I.V. antibiotic, continues to be the number one selling injectable antibiotic worldwide. Our new advanced formulation of ZOSYN launched during 2006 in the United States and in the majority of international markets in 2007. See "Our Challenging Business Environment" beginning on page 31 for a discussion of potential generic competition for ZOSYN.
• Our PREMARIN family of products remains the leading therapy to help women address moderate to severe menopausal symptoms. See "Our Challenging Business Environment" beginning on page 31 for a discussion of recent publications of analyses of the benefits and risks of hormone therapy.
• Sales of PROTONIX (pantoprazole sodium), our branded proton pump inhibitor indicated for gastroesophageal reflux disease, have been adversely affected during 2008 by the "at risk" launch of generic pantoprazole tablets in the United States by Teva Pharmaceuticals USA, Inc. (Teva) and Sun Pharmaceutical Industries Ltd. (Sun). We launched our own generic version of PROTONIX tablets in the 2008 first quarter. While our own generic has had some success in the marketplace, the sales of our own generic have not, and cannot, offset the substantial harm caused by the launch of infringing generics. We will continue to vigorously pursue our litigation against Teva, Sun and other infringing generics. See "Our Challenging Business Environment" beginning on page 31 for a discussion of generic competition for PROTONIX.
For more detail regarding our principal products, the preceding summary should be read in conjunction with our principal product summary in the overview section of "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our 2007 Financial Report as incorporated in our 2007 Annual Report on Form 10-K and in our Quarterly Report on Form 10-Q for the 2008 first quarter.
Our Product Pipeline
Our continued success depends, in large part, on the discovery and development of new and innovative pharmaceutical products and additional indications for existing products.
With respect to TYGACIL (tigecycline), our innovative broad-spectrum I.V. antibiotic for serious, hospital-based infections, in May 2008, we received an approvable letter from the FDA with respect to our supplemental New Drug Application supporting TYGACIL as a treatment for community-acquired pneumonia and as a treatment for additional resistant pathogens in the approved complicated skin and skin structure infection and complicated intra-abdominal infection indications. In its letter, the FDA requested that, before the application could be approved, we provide additional analyses to support the safety and efficacy of TYGACIL for the treatment of patients with community-acquired pneumonia with illness severe enough to require hospitalization, including those who are at higher risk of mortality. In addition, the FDA requested information regarding the benefit/risk of
TYGACIL for any potential of liver toxicity. We had provided the requested liver information to the FDA during the latter part of the review period, and the FDA acknowledged in its letter that it had not yet reviewed this information. We expect that the timeline for submitting our complete response to the approvable letter will become more clear following discussions with the FDA. In April 2008, we withdrew our regulatory filing in the European Union (EU) for TYGACIL for the treatment of community-acquired pneumonia based on the opinion of the Committee for Medicinal Products for Human Use (CHMP) that our clinical data were not sufficient to allow the CHMP to conclude a positive benefit/risk balance in community-acquired pneumonia at this time. We also intend to commence new Phase 2 clinical trials of TYGACIL for the treatment of hospital-acquired pneumonia in the 2008 third quarter.
Our New Drug Application (NDA) filing for PRISTIQ a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor, for the treatment of adult patients with major depressive disorder (MDD) was approved by the FDA in February 2008. FDA approval was subject to several post-marketing commitments, including conducting and submitting data from a new long-term maintenance (relapse prevention) study, a sexual dysfunction study, pediatric studies and a study exploring lower doses. The FDA also requested an additional non-clinical toxicity study. We began shipping PRISTIQ in April 2008 and conducted our full U.S. launch of the product in May 2008. In September 2007, we submitted our Marketing Authorization Application (MAA) in Europe for desvenlafaxine for MDD. The CHMP has raised concerns about efficacy, and we do not anticipate receiving a CHMP opinion until early 2009.
With respect to our NDA filing with the FDA for PRISTIQ as a non-hormonal treatment for vasomotor symptoms associated with menopause, we received an approvable letter from the FDA on July 23, 2007. In its letter, the FDA indicated that before the application could be approved, it would be necessary for us to provide additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of PRISTIQ in this indication. The FDA requested that these data come from a randomized, placebo-controlled clinical trial of a duration of one year or more conducted in postmenopausal women. The FDA also requested that we address certain chemistry, manufacturing and controls deficiencies prior to approval. The FDA also made clinical and chemistry requests, which the FDA indicated were not approvability issues. The requested clinical trial currently is under way and will take at least 18 months to complete. With respect to regulatory review of desvenlafaxine for the treatment of vasomotor symptoms in the EU, we believe additional data will be necessary to address questions raised by the CHMP regarding the risk/benefit profile of desvenlafaxine in this indication, which could include data from the new study requested by the FDA. As a result, in March 2008, we withdrew our MAA in the EU for this indication.
We and our collaboration partner, Progenics, received approval for RELISTOR subcutaneous injection for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care, when response to laxative therapy has not been sufficient, from the FDA in April 2008 and from the European Commission in July 2008. RELISTOR subcutaneous injection also was approved in March 2008 in Canada, where it
was launched in May 2008. We began shipping subcutaneous RELISTOR in the United States in June 2008, and we intend to launch subcutaneous RELISTOR in Europe on a country-by-country basis over the next several months. In May 2008, we and Progenics announced that the primary and secondary endpoints were not achieved in the second of two Phase 3 clinical trials of RELISTOR for intravenous use in the management of post-operative ileus in patients recovering from segmental colectomy surgical procedures, consistent with the earlier findings of the first Phase 3 intravenous post-operative ileus study announced in March 2008. In addition to the two studies in segmental colectomy patients, we are conducting a Phase 3 study of intravenous RELISTOR for the management of post-operative ileus in patients who have undergone surgical repair of large abdominal hernias. We and Progenics are studying the results of both Phase 3 intravenous post-operative ileus studies to determine whether and how to continue development of this formulation of RELISTOR for this indication. We also are working with Progenics to develop an oral formulation of RELISTOR.
Our NDA for XYNTHA was approved by the FDA in February 2008. XYNTHA is a recombinant factor VIII product for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis. XYNTHA is manufactured and formulated using an albumin-free process and state-of-the-art nanofiltration technology. It also is the only recombinant factor VIII product to utilize an entirely non-human and non-animal based purification process. Our EU regulatory filing for REFACTO AF, the trade name for XYNTHA in the EU, remains under regulatory review.
With respect to VIVIANT (bazedoxifene), our selective estrogen receptor modulator for postmenopausal osteoporosis, the FDA has advised us that it expects to convene an advisory committee to review our pending NDAs for both the treatment and prevention indications. In December 2007, we received a second approvable letter from the FDA with respect to the prevention indication. In its letter, the FDA identified several remaining questions regarding issues that had been previously identified during the review process and that were not fully resolved by our complete response to the first approvable letter, which we received in April 2007. More specifically, the FDA has requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events and has identified certain issues concerning data collection and reporting and requested additional source documents. In the letter, the FDA also indicated that the data from the Asian clinical studies that we submitted in late 2007 were not reviewed for this action. The approvable letter did not request the initiation of any new studies. In our February 2008 end-of-review conference with the FDA for the prevention indication, we agreed to conduct and submit further analyses of data from our clinical trials prior to the expected advisory committee meeting. In May 2008, we received an approvable letter from the FDA with respect to our NDA for VIVIANT for the treatment indication. In its letter, the FDA requested information similar to that outlined in its December 2007 approvable letter for the NDA for VIVIANT for the prevention indication. We expect that the FDA-requested advisory committee meeting will be scheduled following submission of our complete response to the approvable letters with respect to the prevention and treatment indications, which we plan to file by the end of 2008. Depending on the outcome of further dialogue with the FDA, the filing may be delayed until the first half of 2009. In September 2007, we submitted our MAA in Europe for VIVIANT
for the treatment and prevention of osteoporosis. During the ongoing review, the assessors have raised several questions regarding the efficacy results and non-clinical safety data and have raised concerns similar to the FDA regarding data collection and reporting. We plan to submit a response in the third quarter of 2008. We anticipate further feedback from the CHMP following our submission, after which we will assess our available regulatory options.
With respect to APRELA (bazedoxifene/conjugated estrogens), our tissue selective estrogen complex under development for menopausal symptoms and osteoporosis, we met with the FDA in early 2008 to review the results from our Phase 3 clinical trials and discuss our planned NDA filing. Both of the principal doses studied in these trials (20 mg BZA/0.625 mg CE and 20 mg BZA/0.45 mg CE) provided efficacy for bone protection and relief of vasomotor symptoms associated with menopause. In one of these trials - SMART-1 - endometrial safety was demonstrated at both doses. In a second of these trials presented at the 13th World Congress of Gynecological Endocrinology in Florence, Italy - SMART-4 - endometrial safety was demonstrated at the lower dose, but the incidence of endometrial hyperplasia was slightly higher than satisfactory at the higher dose. We believe that this slightly higher incidence likely resulted from the relatively low bioavailability of bazedoxifene in one of the formulations used in the SMART-4 trial as compared with the formulation used in SMART-1. While our discussions with the FDA are not yet complete, this could result in an initial NDA filing for only the lower dose (20 mg BZA/0.45 mg CE). We must successfully complete additional work before filing our NDA, including finalizing our proposed commercial formulation and linking it to the formulations used in the clinical trials, and we now expect to file our initial NDA no earlier than the second half of 2009. Depending on the outcome of this work and future interactions with the FDA, it is possible that additional clinical data may be necessary to support approval.
Our EU regulatory filing for ANYA, the proposed trade name in the EU for LYBREL (levonorgestrel/ethinyl estradiol), a new low-dose, non-cyclic continuous combination oral contraceptive that was approved by the FDA in May 2007, remains under regulatory review. We have not achieved approval in the first two phases of the review, and we now are in the Pan-European arbitration phase pursuant to which the application was referred to an external scientific advisory group to which we expect to present data in the 2008 third quarter. Following this presentation, we expect that CHMP will deliver its opinion. The final regulatory outcome for ANYA likely will be known by year-end 2008.
Our Phase 3 clinical program for our new 13-valent pneumococcal conjugate vaccine remains ongoing, with the FDA granting fast track designation to the vaccine for use in infants and toddlers in May 2008. We plan to submit our biologics license application for the vaccine to the FDA on a rolling basis as sections of the application are completed in order to facilitate the FDA's review. Assuming positive results in our Phase 3 program, we expect to complete our U.S. filing for pediatric use of the vaccine in the first quarter of 2009 and in adults in early 2010. We are targeting filing for pediatric use outside the United States in the first quarter of 2009 but also are exploring opportunities to accelerate that timing.
In December 2007, we and our collaboration partner, Elan Corporation, plc, initiated a Phase 3 clinical program for our immunotherapeutic product candidate, bapineuzumab (AAB-001), for the treatment of patients with mild to moderate Alzheimer's disease. Results from the
principal Phase 2 study of bapineuzumab were presented at the International Conference on Alzheimer's Disease on July 29, 2008. We continue to believe these results are encouraging and support the decision to initiate the Phase 3 clinical program.
We also have two Phase 3 clinical programs in oncology under way: inotuzumab ozogamicin (CMC-544), a targeted calicheamicin conjugate under development for the treatment of follicular lymphoma, and bosutinib (SKI-606), a targeted kinase inhibitor under development for the treatment of chronic myelogenous leukemia.
In May 2008, we withdrew our new drug application for EFFEXOR XR for the treatment of major depressive disorder in Japan.
We continue to actively pursue in-licensing opportunities and strategic collaborations to supplement our internal research and development efforts. We face heavy competition from our peers in securing these relationships but believe that the excellence of our research and development and commercial organizations and the breadth of our expertise across traditional pharmaceuticals, biotechnology and vaccines position us well.
Certain Product Liability Litigation
Diet Drug Litigation
We continue to address the challenges of our diet drug litigation, which is described in greater detail in Note 14 to our consolidated financial statements, "Contingencies and Commitments," contained in our 2007 Financial Report as incorporated in our 2007 Annual Report on Form 10-K and in Note 8 to our consolidated condensed financial statements, "Contingencies and Commitments," contained in this Quarterly Report on Form 10-Q and our Quarterly Report on Form 10-Q for the 2008 First Quarter. The $1,369.6 million reserve balance at June 30, 2008 represents our best estimate, within a range of outcomes, of the . . .
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