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Enzon Pharmaceuticals Is a Bio- Designed to Release Compounds At A NEW VISION for the FUTURE 2005 ANNUAL REPORT 685 Route 202/206 Bridgewater, NJ 08807 CORPORATE OVERVIEW PROPRIETARY TECHNOLOGIES, INCLUD- ING A SECOND-GENERATION PEGYLATION PLATFORM THAT UTILIZES LINKERS ENZON PHARMACEUTICALS IS A BIO- DESIGNED TO RELEASE COMPOUNDS AT PHARMACEUTICAL COMPANY DEDICATED A CONTROLLED RATE. ENZON COMPLE- TO THE DEVELOPMENT AND COMMER- MENTS ITS INTERNAL RESEARCH AND CIALIZATION OF THERAPEUTICS TO TREAT DEVELOPMENT EFFORTS WITH STRATEGIC PATIENTS WITH CANCER AND OTHER INITIATIVES, SUCH AS PARTNERSHIPS LIFE-THREATENING DISEASES. ENZON’S DESIGNED TO BROADEN ITS REVENUE SPECIALIZED SALES FORCE MARKETS BASE OR PROVIDE ACCESS TO PROMISING ABELCET®, ADAGEN®, DEPOCYT®, AND NEW TECHNOLOGIES OR PRODUCT ONCASPAR® IN NORTH AMERICA. IN DEVELOPMENT OPPORTUNITIES. ADDITION, ENZON ALSO RECEIVES ROYALTIES ON SALES OF PEG-INTRON®, MARKETED BY SCHERING-PLOUGH COR- PORATION, AND MACUGEN®, MARKETED BY OSI PHARMACEUTICALS AND PFIZER INC. ENZON’S PRODUCT-DRIVEN STRATEGY INCLUDES AN EXTENSIVE DRUG DEVELOP- MENT PROGRAM THAT LEVERAGES ITS SHAREHOLDER S ’ L E T T E R TO OUR SHAREHOLDERS Welcome to the new Enzon. When I came on board in late 2004, I joined a company that had a well established asset base. With nearly 25 years of biophar- maceutical experience, Enzon had a strong organizational heritage and infrastructure, proven research and development capabili- ties, state-of-the-art manufacturing expertise, and an experienced sales force. The important step is in line with our aim to Company’s proprietary technology platform focus on our key assets and provide greater provided substantial revenue and cash transparency to our investors. streams unique for a company its size. Growing the Top Line Yet despite these numerous advantages, Enzon Enzon’s revenue stream is driven by our four faced many challenges, including increas- marketed products—ONCASPAR, DEPOCYT, 1 ingly competitive market conditions for its ABELCET, and ADAGEN—and thus differen- lead product and a number of research and tiates us from many companies in our development programs that were falling short industry of similar size. Strong, sustainable of expectations. Upon a careful evaluation revenues are a vital ingredient in ensuring a of the business, it became clear that we prosperous future. One of our key strategies could improve our growth potential by better is making important investments in our managing our assets. brands, expanding their potential in their existing indications, and exploring potential A New Approach new indications and uses. 2005 was a year of transformation at Enzon. For the first time in the Company’s history, While our oncology products continued to we developed a long-term strategic plan to grow well in 2005, ABELCET’s sales were achieve our goal of becoming a sustainable, impacted by an increasingly competitive growth-oriented, fully-integrated biophar- environment. We took the necessary step of maceutical company. At our core, we are realigning our asset base with ABELCET’s technology-based, product-driven, and performance to ensure it was properly val- oncology-focused. Our new set of priorities ued and in line with expectations. will build a stronger Enzon. A critical area of focus for Enzon this year In 2005, we also changed a number of our was ONCASPAR, a product we developed and internal operations, including our operat- market in the United States for children with ing structure and performance measures. acute lymphoblastic leukemia. To capitalize This resulted in a change in our reportable on the strong attributes of ONCASPAR, we segments. These segments are Products, Royalties, and Contract Manufacturing. This 2005 established several key milestones for 2005. “ OUR SCIENTIFIC TEAM IS ACTIVELY Due to our confidence in the growth poten- IDENTIFYING NEW WAYS TO EVOLVE tial of the product, we renegotiated our roy- alty structure for ONCASPAR with OUR PROPRIETARY PEG PLATFORM.” Sanofi-Aventis. This transaction significantly improves our operating margins on PEG product development opportunities— ONCASPAR. In addition, the U.S. Food and particularly for new classes of drugs where Drug Administration (FDA) approved an our ability to apply this new technology may expanded label for ONCASPAR to include play an important role. intravenous administration, a convenient and important new option for pediatric cancer As part of our new approach to managing the patients. We also submitted a supplemental business, we have set higher standards in the biologics license application to the FDA laboratory and clinic for advancing com- requesting that ONCASPAR be approved as a pounds. As a result, we experienced con- first-line treatment for pediatric ALL patients. siderable attrition in our product pipeline over In 2006, we’ll be exploring ONCASPAR’s the last year. Most notably, we decided to potential activity in other cancer types. discontinue the development of Marqibo and pegamotecan based on new data that did not As we look to grow the top line, new clinical support further investment in these programs. data will be required to generate awareness 2 and use of our key brands. To address this As we rebuild our product portfolio, we will constant need for new data, we have created pursue strategic transactions that complement life-cycle management plans to expand the our internal work. We will also continue to potential of ONCASPAR and DEPOCYT. We evaluate new ways to broaden our revenue have also carefully considered how best to base with new products and partnerships, support ABELCET and will be initiating new such as contract manufacturing and licensing programs to drive data and grow sales. agreements. This past year’s acquisition of the exclusive rights to recombinant human MBL Focusing on Innovation (Mannose-Binding Lectin), a protein therapy Our heritage is steeped in innovation, and in being developed for immuno-compromised 2005 we took the first steps towards becom- cancer patients, marked an important first ing a leader in second-generation PEGylation step in advancing that goal, and is an excellent technology. Our scientific team is actively example of the type of projects we intend to identifying new ways to evolve our proprietary add to our product pipeline. We believe in PEG platform, including maximizing the poten- being held accountable for the quality of our tial of our second-generation Customized accomplishments—not the quantity. Linker Technology™ and identifying new Maximizing the Return on Our Assets We are looking at our business fundamentals in a new way to achieve organizational effi- ciency and maximize the return on our asset base. We have taken a very active stance on finance, discovery, development, and com- mercialization of pharmaceuticals. the management of the growth potential of A new corporate culture at Enzon has emerged our product line. The royalty payments we during the past year that is energetic, collab- receive from our PEG technology allow us to orative, accountable, committed to open invest back into our business. We will con- and honest communications, and driven tinue to invest in key new products to sustain by our five operating principles—People our growth potential. who are passionate for success, strive for Our manufacturing infrastructure and expertise their performance to exceed expectations, represent an important opportunity. In con- take pride in a job well done, and believe junction with our long-term planning process, that promises made must be delivered. we have designed a detailed business plan Looking Ahead for our manufacturing organization. This plan We have a lot to look forward to. We are is focused on new contract manufacturing working hard, making disciplined and arrangements, as well as improving our pro- focused decisions, and starting to see results. cesses and expanding utilization of our com- The Company’s fundamental operating per- plex manufacturing capabilities to improve formance remains strong. Enzon is on a new the margins on our marketed brands. track to becoming a stronger, more focused 3 Creating a Culture of Excellence organization that is well-equipped to deliver The ultimate key to the success of a company solid growth and increased shareholder value begins with its people. Since joining Enzon, over the long-term. one of my top priorities has been infusing We hope that you are pleased with the new strength throughout the organization with direction we’ve taken to achieve our goals high-caliber people who are excited about and we look forward to a productive 2006. building the future of Enzon. We have placed a high priority on attracting, retaining, and developing highly qualified and accom- plished people. Jeffrey H. Buchalter In particular, we deepened the pharmaceuti- cal expertise of our executive management Chairman, President, and team by hiring executives with extensive Chief Executive Officer pharmaceutical and oncology experience. In addition, new members of our Board of Directors bring extremely successful perfor- mance records from large pharmaceutical companies and have expertise in accounting, 2005 A RICH HERITAGE IN PEGYLATION LAYS THE GROUNDWORK FOR THE DEVELOPMENT 4 OF OUR SECOND-GENERATION CUSTOMIZED LINKER TECHNOLOGY™. RESEARCH AND DEVELOPMENT complements our goal of achieving sustain- able growth. We are committed to making targeted and disciplined investments in thera- peutic areas, particularly oncology, where we can make a unique contribution. Beyond PEG, another exciting area of focus To date, Enzon has successfully developed at Enzon is recombinant human Mannose- two of our four marketed products and has Binding Lectin (rhMBL), a naturally occurring a long heritage of innovation. Since our human plasma protein that plays a key role in inception in 1981, a key area of focus has the immune system’s defense against infec- been PEGylation, our proprietary technology tions. This program represents a promising that utilizes the chemical attachment of poly- clinical development opportunity for MBL- ethylene glycol (PEG) to help extend the life deficient patients who are susceptible to seri- of treatments in the body before they are ous infections, such as people with cancer broken down and eliminated.
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