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The Hectorol® Solution

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The Hectorol® Solution ANNUAL REPORT 2003 MISSION STATEMENT: Bone Care International is an innovative pharmaceutical Dedicated to Improving Patient Outcomes company dedicated to improving patient outcomes by delivering BOUT ONE ARE NTERNATIONAL NC unsurpassed vitamin A B C I , I . D-hormone therapies. Bone Care is commit- Bone Care International is a pharmaceutical company ted to discovering, engaged in discovering, developing and commercializing developing and improved vitamin D-hormone therapies to treat secondary commercializing hyperparathyroidism in patients with kidney (renal) products by fostering disease, osteoporosis and psoriasis. The company has a high performing two FDA approved products, Hectorol® (doxercalciferol) corporate culture which Capsules and Hectorol® (doxercalciferol) Injection, to treat values employees secondary hyperparathyroidism in end-stage renal disease and promotes an (ESRD) patients. entrepreneurial spirit. VITAMIN D-HORMONE AND SECONDARY HYPERPARATHYROIDISM Vitamin D-hormones have essential roles in human health. They regulate: 1. Parathyroid hormone (PTH) secretion by the parathyroid glands 2. The absorption of calcium by the small intestine 3. Muscle function 4. The proliferation and maturation of several types of normal and abnormal cells Vitamin D-hormone deficiency occurs when the kidneys begin to fail and are unable to provide adequate D-hormone. The majority of patients with ESRD have vitamin D deficiency. Inadequate levels of vitamin D-hormone may cause PTH secretion to rise which can lead to secondary hyperpara- thyroidism (SHPT). If SHPT is left untreated it may eventually result in cardiovascular compromise, reduced immunity, muscle weakness, and bone disease. Traditionally, the challenge in administering vitamin D-hormone therapy is to deliver a sufficient dose while maintaining normal levels of calcium and phosphorus. THE HECTOROL® SOLUTION ® Hectorol is the D2 analog that provides excellent D- hormone replacement therapy for ESRD patients by maintaining normal levels of vitamin D with a low risk of hypercalcemia through its unique pharmacokinetic profile. • Clinically significant iPTH suppression • Low incidence of hypercalcemia • Low incidence of hyperphosphatemia • The only D2 hormone available in both injectable and oral formulations TO OUR SHAREHOLDERS: June 2003 marked my one-year anniversary with Bone Care International. The past twelve months have been very rewarding as we have overcome challenges and achieved significant goals in our effort to improve the quality of life for the patients we serve and continue to build the value of our company. Paul L. Berns During fiscal 2003, we were successful in gaining FDA acceptance of a new manufacturer for our Hectorol® President and Injection brand, which has allowed the company to supply Chief Executive Officer sufficient inventory to support our existing and new patient demand. Despite the challenges associated with the interruption of the Hectorol® Injection supply during our mid fiscal year, we increased our total revenues by 30% reaching approximately $19.5 million in fiscal 2003 versus $15 million in the prior year. Additionally, we strategically invested $6 million in research and development initiatives to advance and grow the pipeline. As with any company, it is important to have a talented management team in place with the necessary skill set to analyze potential business opportunities and meet the challenges of a competitive market. We have continued to strengthen our management team by appointing Brian Hayden as Chief Financial Officer and Dr. Jeffrey Freitag as Vice President of Research and Development. We believe that their collective expertise in their relative fields will create additional value for our customers, employees and shareholders. Value is also created through appropriate corporate governance. All good companies are looking hard at their governance to make certain that their processes, environ- ment and oversight are proper and sound. At Bone Care International we have an experienced, fully engaged, majority independent board that continues to review and establish governance initiatives designed to hold manage- ment accountable and ensure that shareholders’ interests are well represented. As we prepare for future success, we will Hectorol® Capsules for the treatment of continue to focus on four key growth secondary hyperparathyroidism (SHPT) in initiatives for our business: chronic kidney disease patients prior to 1. Excellence in execution of our dialysis. In addition, we are moving ahead customer plans to drive performance. with Phase IV post marketing clinical trials to provide additional clinical information 2. Drive scientific innovation. on the utility of Hectorol® in restoring vitamin 3. Establish corporate development D-hormone and in treating SHPT in end partnerships to provide new business stage renal disease (ESRD) patients. opportunities. During our first fiscal quarter of 2004 we 4. Lead the company with ethics to plan to file an Investigational New Drug ensure quality business decisions application (IND) for our lead pipeline create value for our patients, product LR-103, which will allow us to gain customers, employees and important insights about the product shareholders. profile and potential for additional clinical More specifically, we expect the following development opportunities. LR-103 is one areas to significantly enhance the growth of several novel vitamin D-hormone and evolution of the company. molecules discovered by our research Manufacturing and development organization. Working with our manufacturing partners, We further anticipate new strategic business we have increased production of Hectorol® development arrangements to advance our Injection allowing us to build inventory portfolio and position in the marketplace. and grow our revenues. We also anticipate In conclusion, I thank our employees for the seeking an additional injectable fine work they are doing daily to drive our manufacturer. vision for growth. And, I thank our new senior Commercial Growth management team for their commitment to excellence as we move forward and realize We will continue to expand and establish the full potential of our organization to create new relationships with our customers to value for patients, staff and shareholders. partner with them in the delivery of quality health outcomes for patients. Our goal is Sincerely, to build future revenues by gaining market share and fully participating in the expected overall growth of the market. Paul L. Berns Pipeline and Portfolio President & Chief Executive Officer In an effort to expand indications for the Hectorol® Capsules brand, we are working Bone Care International, Inc. with the FDA toward final approval of FINANCIAL HIGHLIGHTS In thousands, except per share data Year Ended June 30, 2003 2002 2001 2000 1999 Statements of Operations Revenues: Product sales $ 19,518 $ 14,991 $ 5,997 $ 259 $ — Other revenues — — — 126 — 19,518 14,991 5,997 385 — Cost and expenses: Cost of product sales 6,983 3,557 1,905 503 — Research and development 6,019 5,739 4,556 4,048 3,455 Marketing and administrative 18,768 13,856 9,859 6,282 2,855 31,770 23,152 16,320 10,833 6,310 Loss from operations (12,252) (8,161) (10,323) (10,448) (6,310) Interest income, net 574 1,257 1,309 656 533 Loss before income tax expense (11,678) (6,904) (9,014) (9,792) (5,777) Income tax expense — — — (13) — Net loss $(11,678) $ (6,904) $ (9,014) $ (9,805) $ (5,777) Net loss per common share – basic and diluted $ (0.82) $ (0.49) $ (0.70) $ (0.89) $ (0.57) Shares used in computing basic and diluted net loss per common share 14,175 14,084 12,884 11,071 10,055 Consolidated Balance Sheet Data Cash and cash equivalents $ 3,065 $ 2,024 $ 1,843 $ 4,736 $ 7,314 Marketable securities 13,625 18,437 15,080 4,972 — Long-term securities 913 3,720 14,424 — — Working capital 16,608 24,962 20,786 9,229 7,956 Total assets 26,848 34,684 40,477 12,460 10,303 Total long-term liabilities 650———— Accumulated deficit (53,198) (41,520) (34,616) (25,602) (15,797) Total shareholders' equity 20,443 32,024 38,098 11,083 9,717 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2003 Commission file number 0-27854 Bone Care International, Inc. (Exact Name of Registrant as Specified in its Charter) Wisconsin 39-1527471 (State or Other Jurisdiction of (IRS Employer Incorporation or Organization) Identification No.) 1600 Aspen Commons 53562 Middleton, Wisconsin (Zip Code) (Address of Principal Executive Offices) Registrant’s Telephone Number, Including Area Code: (608) 662-7800 Securities registered pursuant to Section 12(b) of the Act: None Securities registered pursuant to Section 12(g) of the Act: Common Stock, without par value Preferred Stock Purchase Rights (Title of Class) Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes No The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant was $141,577,720 as of December 31, 2002, assuming solely for purposes of this calculation that all directors and executive officers of the registrant are “affiliates.” This determination of affiliate status is not necessarily a conclusive determination for other purposes.
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