1 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934, FOR THE QUARTERLY PERIOD ENDED MARCH 31, 1997. Commission File Number 0-28308 COLLAGENEX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 52-1758016 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 301 South State Street, Newtown, PA 18940 (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code: (215) 579-7388 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 --- --- Indicate the number of shares outstanding of each of the issuer's classes of common stock as of March 31, 1997: Common Stock $0.01 par value 7,543,579 1 2 COLLAGENEX PHARMACEUTICALS, INC. AND SUBSIDIARY (A DEVELOPMENT STAGE ENTERPRISE) CONDENSED CONSOLIDATED BALANCE SHEETS DECEMBER 31,1996 AND MARCH 31,1997 12/31/96 3/31/97 -------- ------- (unaudited) (in thousands except share amounts) ASSETS Current Assets: Cash and cash equivalents $ 9,848 $ 8,690 Short-term investments 8,367 8,273 Interest receivable 66 129 Prepaid expenses 88 224 -------- -------- Total current assets 18,369 17,316 Equipment, net 57 69 Other assets 11 11 -------- -------- Total assets $ 18,437 $ 17,396 ======== ======== LIABILITIES and STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable $ 46 $ 314 Accrued expenses 799 887 -------- -------- Total current liabilities 845 1,201 -------- -------- Stockholders' equity: Preferred stock, $0.01 par value; 5,000,000 shares authorized; none issued and outstanding -- -- Common stock, $0.01 par value; 25,000,000 shares authorized; 7,535,533 and 7,543,579 shares issued and outstanding in 1996 and 1997, respectively 75 75 Additional paid-in capital 35,552 35,556 Deferred compensation (296) (272) Deficit accumulated during the development stage (17,739) (19,164) -------- -------- Stockholders' equity 17,592 16,195 -------- -------- Commitments Total liabilities and stockholders' equity $ 18,437 $ 17,396 ======== ======== See accompanying notes to unaudited condensed consolidated financial statements. 2 3 COLLAGENEX PHARMACEUTICALS, INC. AND SUBSIDIARY (A DEVELOPMENT STAGE ENTERPRISE) CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED MARCH 31,1996 AND 1997 AND FOR THE PERIOD FROM JANUARY 10, 1992 (INCEPTION) TO MARCH 31,1997 (UNAUDITED) THREE MONTHS ENDED FOR THE PERIOD FROM MARCH 31, 1/10/92 (INCEPTION) 1996 1997 to 3/31/97 ---- ---- -------------------- (in thousands, except share amounts) Revenues Licensing Fees $ -- $ -- $ 400 Operating expenses incurred in the development stage: Research and development 976 693 13,737 General and administrative 418 968 6,782 ----------- ----------- ----------- Total operating expenses 1,394 1,661 20,519 Other income (expense) Interest income 61 236 1,099 Other expense -- -- (144) ----------- ----------- ----------- Net loss $ (1,333) $ (1,425) $ (19,164) =========== =========== =========== Accretion of undeclared dividends attributable to mandatorily redeem- able convertible preferred stock $ 383 $ -- $ 2,597 =========== =========== =========== Net loss allocable to common stockholders $ (1,716) $ (1,425) $ (21,761) =========== =========== =========== Proforma net loss per share $ (0.24) $ (0.19) =========== =========== Shares used in computing proforma net loss per share 5,545,896 7,538,572 =========== =========== See accompanying notes to unaudited condensed consolidated financial statements. 3 4 COLLAGENEX PHARMACEUTICALS, INC. AND SUBSIDIARY (A DEVELOPMENT STAGE ENTERPRISE) CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED MARCH 31,1996 AND 1997 AND FOR THE PERIOD FROM JANUARY 10, 1992 (INCEPTION) TO MARCH 31,1997 (UNAUDITED) THREE MONTHS ENDED FOR THE PERIOD MARCH 31, FROM 1/10/92 1996 1997 (INCEPTION) TO 3/31/97 ---- ---- --------------------- (IN THOUSANDS) Cash flows from operating activities: Net loss $ (1,333) $ (1,425) $(19,164) Adjustments to reconcile net loss to net cash used in operating activities: Non-cash research and development expense -- -- 514 Non-cash compensation expense 80 24 197 Non-cash consulting expense -- -- 15 Depreciation and amortization expense 1 6 30 Change in assets and liabilities: Increase in accounts and interest receivable -- (63) (129) Increase in prepaid expenses (49) (136) (224) Increase in other assets (6) -- (11) Increase in accounts payable 365 268 314 Increase in accrued expenses 125 88 887 -------- -------- -------- Net cash used in operating activities (817) (1,238) (17,571) Cash flows from investing activities: Organizational costs -- -- (5) Capital expenditures (22) (18) (94) Purchase of short-term investments (available for sale) -- (4,450) (16,740) Proceeds from the sale of short-term investments (available for sale) -- 4,544 8,467 -------- -------- -------- Net cash provided by (used in) investing activities (22) 76 (8,372) -------- -------- -------- Cash flows from financing activities: Proceeds from issuance of preferred stock 1 -- 13,508 Proceeds from issuance of common stock -- 4 18,100 Proceeds from issuance of promissory notes -- -- 3,150 Repayment of promissory note -- -- (125) -------- -------- -------- Net cash provided by financing activities 1 4 34,633 -------- -------- -------- Net increase (decrease) in cash and cash equivalents (838) (1,158) 8,690 Cash and cash equivalents at beginning of period 5,806 9,848 -- -------- -------- -------- Cash and cash equivalents at end of period $ 4,968 $ 8,690 $ 8,690 ======== ======== ======== 4 5 (Continued from preceding page) THREE MONTHS ENDED FOR THE PERIOD MARCH 31, FROM 1/10/92 1996 1997 (INCEPTION) TO 3/31/97 ---- ---- --------------------- (in thousands) Supplemental disclosure of cash flows information: Cash paid for interest $ -- $ -- $ 23 ====== ========= ======= Supplemental schedule of non-cash financing activities: Conversion of mandatorily redeemable convertible preferred stock to common stock $ -- $ -- $19,628 ====== ========= ======= Accretion of undeclared dividends attributable to mandatorily redeemable convertible preferred stock $ 383 $ -- $ 2,597 ====== ========= ======= Conversion of promissory notes plus accrued interest to preferred stock $ -- $ -- $ 2,903 ====== ========= ======= Deferred compensation $ 360 $ -- $ 469 ====== ========= ======= Preferred stock issued in connection with technology license agreements $ -- $ -- $ 498 ====== ========= ======= See accompanying notes to unaudited condensed consolidated financial statements. 5 6 COLLAGENEX PHARMACEUTICALS, INC. AND SUBSIDIARY NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS MARCH 31, 1996 AND 1997 (UNAUDITED) (1) BASIS OF PRESENTATION The unaudited condensed consolidated financial statements included herein have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission and in accordance with generally accepted accounting principles. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted pursuant to such rules and regulations. These unaudited financial statements should be read in conjunction with the Company's 1996 audited financial statements and footnotes. The accompanying unaudited consolidated financial statements include the results of the Company and its wholly-owned subsidiary (CollaGenex International, Ltd.). All intercompany accounts and transactions have been eliminated. In the opinion of the Company's management, the accompanying unaudited condensed financial statements have been prepared on a basis substantially consistent with the audited financial statements and contain adjustments, all of which are of a normal recurring nature, necessary to present fairly its financial position as of March 31, 1997, its results of operations for the three months ended March 31, 1996 and 1997 and for the period January 10, 1992 (inception) to March 31, 1997, and its cash flows for the three months ended March 31, 1996 and 1997 and for the period January 10, 1992 (inception) to March 31, 1997. Interim reports are not necessarily indicative of results anticipated for the full fiscal year. (2) SUBSEQUENT EVENT - COMPLETION OF FOLLOW-ON OFFERING OF COMMON STOCK On April 8, 1997, the Company completed a follow-on offering of 1,000,000 shares of its common stock at a price of $12.50 per share. The net proceeds from the offering after underwriting fees and other expenses were $11.6 million. 6 7 COLLAGENEX PHARMACEUTICALS, INC AND SUBSIDIARY MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS OVERVIEW The Company began operations in January 1992 and is engaged in the development and commercialization of innovative, proprietary medical therapies for the treatment of periodontal disease and other dental pathologies. Since inception, the Company has had no revenues from product sales and has funded its operations primarily from the proceeds of public and private offerings of equity securities. Substantially all of the Company's expenditures to date have been for pharmaceutical development activities and general and administrative expenses. Since inception, the Company has operated with a minimal number of employees. Substantially all pharmaceutical development activities, including clinical trials, have been contracted to independent contract research and other organizations. The Company anticipates that it will significantly increase the number of its employees over the next several years, primarily in selling, general and administrative areas, in anticipation of regulatory approval and market commercialization of Periostat. The Company has incurred losses each year since inception and had an accumulated deficit of $19.2 million at March 31, 1997. The Company expects to continue to incur losses in the foreseeable future from expenditures on marketing, drug development, manufacturing and administrative activities. The Company does not expect to generate any revenues from product sales in 1997. No assurance can be given that product sales will be achieved in the future. Successful future operations will depend on the Company's ability to develop, obtain regulatory approval for and commercialize its products. Statements contained or incorporated by reference in this Quarterly Report on Form 10-Q that are not based on historical fact are "forward-looking statements" within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements may be identified by the use of forward-looking terminology such as "may", "will", "expect", "estimate", "anticipate", "continue", or similar terms, variations of such terms or the negative of those terms. This Form 10-Q contains forward-looking statements that involve risks and uncertainties. The Company's business of developing pharmaceutical products is subject to a number of significant risks, including risks inherent in research and development activities and in conducting business in a highly regulated environment. The success of the Company depends to a large degree upon obtaining FDA and foreign regulatory approval to market products currently 7 8 under development. There can be no assurance that any of the Company's product candidates will be approved by any regulatory authority for marketing in any jurisdiction or, if approved, that any such products will be successfully commercialized by the Company. The Company's actual results may differ materially from the results discussed in the forward-looking statements contained herein. RESULTS OF OPERATIONS From inception through March 31, 1997, the Company had no revenues from product sales. Operating expenses consist of research and development expenses and general and administrative expenses. Research and development expenses consist primarily of funds paid to contract research organizations for the provision of services and materials for drug development & clinical trials. General and administrative expenses consist primarily of personnel salaries and benefits, professional and consulting fees, facilities and general office expenses. The Company anticipates that selling, general and administrative expenses will increase during the next several years due to the expansion of its commercial infrastructure, primarily in sales, marketing and finance. The Company earned $400,000 in licensing fee revenue in 1996 when it signed a licensing agreement with Boehringer Mannheim Italia. Research and development expenses decreased $283,000, or 29%, during the three months ended March 31, 1997 over the comparable year earlier period due to lower contract costs associated with the New Drug Application ("NDA") for Periostat(R), which was submitted to the FDA in August 1996. General and administrative expenses increased $550,000, or 132%, during this period due to the hiring of additional staff in finance and commercial development, the initiation of certain prelaunch sales and marketing activities, and higher insurance and professional fees associated with becoming a public company. LIQUIDITY AND CAPITAL RESOURCES On June 20, 1996, the Company completed an initial public offering of 2,000,000 shares of Common Stock at a price of $10.00 per share, which generated net proceeds to the Company of approximately $18.0 million after underwriting fees and related expenses. An additional $11.6 million, net of underwriting fees and expenses, was raised as a result of the Company's follow-on offering of 1,000,000 shares of Common Stock completed on April 8, 1997 at a price of $12.50 per share (See Note 2). At March 31, 1997, the Company had cash, cash equivalents and short-term investments of approximately $17.0 million excluding the proceeds of the follow-on offering completed during April 1997. This was a decrease of $1.2 million from the $18.2 million balance at December 31, 1996. In accordance with investment guidelines approved by the Company's board of directors, cash balances in excess of those required to fund operations 8 9 have been invested in short-term U.S. Treasury securities and commercial paper with a credit rating no lower than A1/P1. The Company's working capital of $16.1 million at March 31, 1997 reflected a decrease of $1.4 million from December 31, 1996 due primarily to expenses incurred in operating activities during the quarter. The Company had no debt outstanding (other than accounts payable and accrued expenses) at March 31, 1997. The Company has no lines of credit, and no capital leases were outstanding at March 31, 1997. The Company anticipates that its existing working capital, including the funds received as a result of the follow-on offering of 1,000,000 shares of Common Stock completed April 8, 1997, will be sufficient to fund the Company's operations through at least 1998. The Company's future capital requirements and the adequacy of its available funds will depend on many factors, including the timing of FDA approval, if any, of the Company's NDA for Periostat(R), such NDA having been submitted to the FDA in August 1996, the size and scope of the Company's sales and marketing effort, the terms of agreements entered into with corporate partners, if any, and the results of research and development and pre-clinical and clinical studies for other applications of the Company's core technology. Over the long term, the Company's liquidity is dependent on market acceptance of its products and technology. PART II. OTHER INFORMATION ITEM 2. CHANGES IN SECURITIES The following information relates to all securities of the Company sold by the Company within the past quarter which were not registered under the securities laws: 1. The Company has, during the quarter, granted stock options pursuant to its 1996 Stock Plan and its 1996 Non-Employee Director Stock Option Plan which have not yet been registered under the securities laws. The following table sets forth certain information regarding such grants during the quarter: NUMBER OF SHARES EXERCISE PRICE --------- -------------- 145,500 $9.00 2. The Company has issued shares of its Common Stock to employees pursuant to the exercise of stock options that were granted under its 1992 Stock Option Plan which have 9 10 not yet been registered under the securities laws. The following table sets forth certain information regarding such exercises during the quarter: NUMBER RANGE OF OF SHARES EXERCISE PRICES --------- -------------- 8,046 $0.20-$1.20 No underwriter was employed by the Company in connection with the issuance and sale of the securities described above. The Company believes that the issuance and sale of all of the foregoing securities were exempt from registration under either (i) Section 4(2) of the Securities Act of 1933, as amended (the "Act") as transactions not involving any public offering, or (ii) Rule 701 under the Act as transactions made pursuant to a written compensatory benefit plan or pursuant to a written contract relating to compensation. Appropriate legends were affixed to the stock certificates issued in such transactions. All recipients had adequate access to information about the Company. ITEM 5. OTHER INFORMATION On April 8, 1997, the Company completed a follow-on offering of 1,000,000 shares of its Common Stock at a price of $12.50 per share. The net proceeds from the offering after underwriting fees and other expenses were $11.6 million. ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K (a) Exhibits 27 - Financial Data Schedule (b) Reports on Form 8-K No reports on Form 8-K were filed during the quarter in which this report on Form 10-Q is filed. 10 11 SIGNATURES Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized. CollaGenex Pharmaceuticals, Inc. Date: May 14, 1997 By: /s/ Brian M. Gallagher, Ph.D. --------------------------------------------- Brian M. Gallagher, Ph.D. President and Chief Executive Officer (Principal Executive Officer) Date: May 14, 1997 By: /s/ Nancy C. Broadbent --------------------------------------------- Nancy C. Broadbent Chief Financial Officer (Principal Financial and Accounting Officer) 11