UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 1996 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 0-27854 BONE CARE INTERNATIONAL, INC. (Exact name of registrant as specified in its charter) Wisconsin 2830 39-1527471 (State of (Primary Standard Industry (IRS Employer Incorporation) Classification Code Number Identification No.) 313 West Beltline Highway Madison, Wisconsin 53713 608-274-7533 (Address, including zip code, and telephone number, including area code, of Registrant's principal executive offices) 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 X No --- --- As of October 31, 1996, 4,353,691 shares of the registrant's Common Stock, no par value, were outstanding. BONE CARE INTERNATIONAL, INC., AND SUBSIDIARY FORM 10-Q For the quarterly period ended September 30, 1996 TABLE OF CONTENTS PART I - FINANCIAL INFORMATION Page Item 1. Financial statements Consolidated Balance Sheets September 30, 1996, and June 30, 1996. . . . . . . . . . 3 Consolidated Statements of Operations Three Months Ended September 30, 1996 and 1995 . . . . . . . . . . . . . . . . . . . . . . . . 5 Consolidated Statements of Cash Flows Three Months Ended September 30, 1996 and 1995 . . . . . . . . . . . . . . . . . . . . . . . . 6 Notes to Consolidated Financial Statements . . . . . . . 7 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. . . . . . . . . . . 8 PART II - OTHER INFORMATION. . . . . . . . . . . . . . . . . . . . 9 SIGNATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . .10 EXHIBIT INDEX. . . . . . . . . . . . . . . . . . . . . . . . . . .11 PART 1. FINANCIAL INFORMATION ITEM 1. Financial Statements BONE CARE INTERNATIONAL, INC., AND SUBSIDIARY Consolidated Balance Sheets Assets - --------------------------------------------------------------------------- September 30, June 30, 1996 1996 (Unaudited) (Audited) - --------------------------------------------------------------------------- Current assets: Cash and cash equivalents $10,755,612 $11,060,843 Receivables 1,997 1,619 Prepaid expenses 18,000 20,695 - --------------------------------------------------------------------------- Total current assets 10,775,609 11,083,157 Property, plant and equipment--at cost: Lab improvements 21,092 21,092 Furniture and fixtures 21,180 20,390 Machinery and other equipment 225,453 215,979 - --------------------------------------------------------------------------- 267,725 257,461 Less accumulated depreciation 199,637 192,677 - --------------------------------------------------------------------------- 68,088 64,784 Excess of cost over fair value of net assets acquired, net of accumulated amortization of $575,874 at September 30, 1996 and $553,512 at June 30, 1996 784,043 806,405 Patent fees, net of accumulated amortization of $278,462 at September 30, 1996 and $251,462 at June 30, 1996 336,110 306,979 - --------------------------------------------------------------------------- $11,963,850 $12,261,325 =========================================================================== See accompanying notes to consolidated financial statements. BONE CARE INTERNATIONAL, INC., AND SUBSIDIARY Consolidated Balance Sheets Liabilities and Shareholders' Equity - --------------------------------------------------------------------------- September 30, June 30, 1996 1996 (Unaudited) (Audited) - --------------------------------------------------------------------------- Current liabilities: Accounts payable $ 63,963 $ 73,236 Accrued liabilities: Compensation payable 12,635 4,133 Property, payroll, and other taxes 1,048 1,750 - --------------------------------------------------------------------------- Total current liabilities 77,646 79,119 Shareholders' equity: Preferred stock--authorized 1,000,000 shares of $.001 par value; none issued - - Common stock--authorized 14,000,000 shares of no par value; issued and outstanding 4,353,691 shares at September 30, 1996 and 4,353,691 at June 30, 1996 11,393,883 11,393,883 Additional paid-in capital 3,524,275 3,524,275 - --------------------------------------------------------------------------- 14,918,158 14,918,158 Accumulated deficit (3,031,954) (2,735,952) - --------------------------------------------------------------------------- 11,886,204 12,182,206 - --------------------------------------------------------------------------- $11,963,850 $12,261,325 =========================================================================== See accompanying notes to consolidated financial statements. BONE CARE INTERNATIONAL, INC., AND SUBSIDIARY Consolidated Statements of Operations (Unaudited) - ------------------------------------------------------------------------------ Three months ended September 30, September 30 1996 1995 - ------------------------------------------------------------------------------ REVENUES $ 525 $ - OPERATING EXPENSES Cost of sales 3,785 - Research and development 369,364 125,727 General and administrative 67,893 40,273 - ------------------------------------------------------------------------------ 441,042 166,000 - ------------------------------------------------------------------------------ Loss from operations (440,517) (166,000) - ------------------------------------------------------------------------------ OTHER INCOME (EXPENSE): Interest income 144,515 333 Interest expense - Lunar Corporation - (10,339) - ------------------------------------------------------------------------------ 144,515 (10,006) - ------------------------------------------------------------------------------ NET LOSS $ (296,002) $(176,006) ============================================================================== Net loss per common share $(0.07) $(0.21) ============================================================================== Weighted average number of common shares 4,353,691 848,942 ============================================================================== BONE CARE INTERNATIONAL, INC., AND SUBSIDIARY Consolidated Statements of Cash Flows (Unaudited) - --------------------------------------------------------------------------- Three months ended September 30, September 30, 1996 1995 - --------------------------------------------------------------------------- Cash flows from operating activities: Net loss $ (296,002) $ (176,006) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 56,322 28,451 Changes in assets and liabilities: Receivables (378) 1,748 Prepaid expenses 2,695 - Accounts payable (9,273) (4,875) Accrued liabilities 7,800 7,419 - --------------------------------------------------------------------------- Net cash used in operating activities (238,836) (143,263) - --------------------------------------------------------------------------- Cash flows from investing activities: Additions to property, plant and equipment (10,264) - Patent fees (56,131) (534) - --------------------------------------------------------------------------- Net cash used in investing activities $ (66,395) $ (534) - --------------------------------------------------------------------------- Cash flows from financing activities: Proceeds from Lunar Corporation advances - 130,339 Net cash provided by financing activities - 130,339 - --------------------------------------------------------------------------- Net decrease in cash and cash equivalents (305,231) (13,458) Cash and cash equivalents at beginning of period 11,060,843 22,595 - --------------------------------------------------------------------------- Cash and cash equivalents at end of period $10,755,612 $ 9,137 =========================================================================== See accompanying notes to consolidated financial statements. BONE CARE INTERNATIONAL, INC., AND SUBSIDIARY NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Unaudited) (1) BASIS OF PRESENTATION The consolidated financial statements of Bone Care International, Inc. (the "Company") presented herein, without audit except for balance sheet information at June 30, 1996, have been prepared pursuant to the rules of the Securities and Exchange Commission for quarterly reports on Form 10-Q and do not include all of the information and note disclosures required by generally accepted accounting principles. These statements should be read in conjunction with the consolidated financial statements and notes thereto for the year ended June 30, 1996, included in the Company's Form 10-K as filed with the Securities and Exchange Commission on September 27, 1996. The consolidated balance sheet as of September 30, 1996, the consolidated statements of income for the three months ended September 30, 1996 and 1995, and the consolidated statements of cash flows for the three months ended September 30, 1996 and 1995 are unaudited but, in the opinion of management, include all adjustments (consisting of normal, recurring adjustments) necessary for a fair presentation of results for these interim periods. The Company has reclassified the presentation of certain prior year information to conform with the current presentation format. The results of operations for the three months ended September 30, 1996, are not necessarily indicative of the results to be expected for the entire fiscal year ending June 30, 1997. Item 2. Management Discussion and Analysis of Financial Condition and Results of Operations Results of Operations Revenue of $525 in the three months ended September 30, 1996 relate to contract services performed by Continental Assays Corporation, a subsidiary of the Company. Research and development expenses increased to $369,364 in the three months ended September 30, 1996 from $125,727 in the three months ended September 30, 1995. These increases are primarily due to higher expenditures for clinical trials of one-alpha D2 for treating secondary hyperparathyroidism associated with end-stage renal disease. Interest income increased to $144,515 in the three months ended September 30, 1996 from $333 in the three months ended September 30, 1995. These increases are due to higher cash balances which resulted from capital contributions made in fiscal year 1996 by Lunar Corporation ("Lunar") and Draxis Health, Inc., the Company's shareholders at the time of the contributions. On May 8, 1996, Lunar distributed its ownership of the Company to its shareholders. There was no interest expense in the three months ended September 30, 1996 compared to $10,339 in the three months ended September 30, 1995. Interest expense in the three months ended September 30, 1995 relates exclusively to loans made by Lunar to the Company. Lunar canceled outstanding loans in the amount of $634,683 in October 1995 in exchange for additional shares of the Company's common stock. Liquidity and Capital Resources Cash and cash equivalents decreased $305,231 to $10,755,612 in the three months ended September 30, 1996. The decrease is primarily due to increased research and development activities, including clinical trials of one-alpha D2 as a therapy for secondary hyperparathyroidism in end-stage renal disease, and for general corporate purposes. The Company currently estimates that approximately $5 million will be needed to complete clinical trials of one-alpha D2 and at least $2 million will be needed to fund corporate and administrative expenses over the next two years. It is currently anticipated that the remaining $3.8 million will be used for the development of other products. Management believes current levels of cash and cash equivalents are adequate to finance the Company's operations through the end of fiscal 1998. The Company may require additional funds for research and development activities after that time. Additional funds also could be required before that time if the Company were to expand the scope of its activities. There is no assurance additional financing will be available on acceptable terms. PART II - OTHER INFORMATION BONE CARE INTERNATIONAL, INC., AND SUBSIDIARY Item 1. Legal Proceedings None Item 2. Changes in Securities None Item 3. Defaults Upon Senior Securities None Item 4. Submission of Matters to a Vote of Security Holders None Item 5. Other Information Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995: Certain statements in this filing, and elsewhere (such as in other filings by the Company with the Securities and Exchange Commission, press releases, presentations by the Company or its management and oral statements) constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the Company to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, among other things, no assurance of successful product development, technological risks, uncertainty of regulatory approvals, regulatory policies in the United States and other countries, availability of additional financing, reimbursement policies of public and private health care payors, developments in patents and other proprietary rights, competition from existing therapies and from new therapies, and market and general economic factors. Item 6. Exhibits and Reports on Form 8-K (a) Exhibits furnished: (11) Statement Re: Computation of Earnings Per Share (27) Financial Data Schedule (b) Reports on Form 8-K No reports on Form 8-K were filed by the Company during the quarter ended September 30, 1996. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. BONE CARE INTERNATIONAL, INC. (Registrant) Date: November 13, 1996 Charles W. Bishop - ----------------------------- ------------------------------------------ Charles W. Bishop President (Principal Executive Officer) Date: November 13, 1996 Robert A. Beckman - ----------------------------- ------------------------------------------ Robert A. Beckman Vice President of Finance and Treasurer (Principal Financial and Accounting Officer) BONE CARE INTERNATIONAL, INC., AND SUBSIDIARY Exhibit Index For the Quarterly Period Ended September 30, 1996 No. Description Page 11 Statement Regarding Computation of Earnings Per Share . . . . . .12 27 Financial Data Schedule . . . . . . . . . . . . . . . . . . . . .13