-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, LjG0pm1riGBgj7/GsB2bGGT5vQDWvL+pKfho1ywAjps8DuDSwx1PXUx7NZoD/41G iTTksiAsezLsxaqso4H9Xw== 0000891618-97-002376.txt : 19970520 0000891618-97-002376.hdr.sgml : 19970520 ACCESSION NUMBER: 0000891618-97-002376 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19970514 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 19970516 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: CELTRIX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000871395 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 943121462 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-18976 FILM NUMBER: 97610394 BUSINESS ADDRESS: STREET 1: 3055 PATRICK HENRY DR CITY: SANTA CLARA STATE: CA ZIP: 95054 BUSINESS PHONE: 4089882500 MAIL ADDRESS: STREET 2: 3055 PATRICK HENRY DRIVE CITY: SANTA CLARA STATE: CA ZIP: 95054 FORMER COMPANY: FORMER CONFORMED NAME: CELTRIX LABORATORIES INC DATE OF NAME CHANGE: 19600201 8-K 1 FORM 8-K DATED MAY 14, 1997 1 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K Current Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report: May 14, 1997 Commission File Number: 0-18976 CELTRIX PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 94-3121462 (State or other jurisdiction (I.R.S. Employer Identification No.) of incorporation or organization) 3055 Patrick Henry Drive, Santa Clara, CA 95054-1815 (Address of principal executive offices and zip code) Registrant's Telephone Number: (408) 988-2500 2 ITEM 5. OTHER EVENTS On May 14, 1997, Celtrix Pharmaceuticals, Inc., a Delaware corporation (the "Company") announced fiscal year-end financial results. Further details regarding this announcement are contained in the Company's news release dated May 14, 1997, attached as exhibit hereto and incorporated by reference herein. ITEM 7. FINANCIAL STATEMENTS, PRO FORMA FINANCIAL INFORMATION AND EXHIBITS (a) EXHIBITS Exhibit 21 Celtrix Pharmaceuticals, Inc. News Release dated May 14, 1997. 3 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. CELTRIX PHARMACEUTICALS, INC. (Registrant) Date: May 15, 1997 By: /s/ MARY ANNE RIBI ---------------------- Mary Anne Ribi Vice President, Finance & Administration and Chief Financial Officer (Duly authorized principal financial and accounting officer) 4 CELTRIX PHARMACEUTICALS, INC. INDEX TO EXHIBITS
Exhibit Number -------------- Exhibit 21 Celtrix Pharmaceuticals, Inc. Press Release dated May 14, 1997.
EX-21 2 CELTRIX PHARMACEUTICALS, INC. PRESS RELEASE 1 [CELTRIX LOGO AND LETTERHEAD] NEWS RELEASE CONTACT: Mary Anne Ribi Vice President and Chief Financial Officer (408) 988-2500 CELTRIX REPORTS FISCAL YEAR-END FINANCIAL RESULTS Significant Achievements in Clinical Development and Manufacturing SANTA CLARA, CA -- May 14, 1997 -- For the fiscal year ended March 31, 1997, Celtrix Pharmaceuticals, Inc. (Nasdaq: CTRX) reported revenues of $658,000 and a net loss of $12,696,000, or $0.83 per share. Operating expenses increased 6 percent to $13,818,000, due primarily to costs associated with human clinical studies and the manufacture of SomatoKine(R), the company's novel IGF-BP3 therapeutic composition. In comparison, revenues for the fiscal year ended March 31, 1996, were $1,750,000, due primarily to the sale of the company's Vitrogen(R) 100 Collagen business, receipts from an Orphan Drug Grant, and reimbursement from Genzyme Corporation for development work on TGF-beta-2. Operating expenses were $13,084,000 for the fiscal year ended March 31, 1996, and the net loss was $7,246,000, or $0.51 per share, which included a $3,463,000 gain on investment from the sale of Metra Biosystems securities held by Celtrix since 1990. At March 31, 1997, Celtrix had $5,788,000 in cash and investment balances. In April 1997, Celtrix raised an additional $13,950,000 in gross proceeds from a private equity placement. Along with year-end cash and investments, proceeds from this financing should be sufficient to fund Celtrix's operations through mid-1998. Clinical and Manufacturing Progress "Fiscal 1997 was a year of achievements for Celtrix in clinical development and product manufacturing," said Andreas Sommer, Ph.D., Celtrix's president and chief executive officer. "We conducted three Phase I human clinical studies of SomatoKine demonstrating significant safety and initial efficacy. Based on these results, we initiated Phase II feasibility studies for the treatment of hip fracture surgery, and by mid-1997, we expect to begin Phase II feasibility studies for the treatment of severe burns. Clinical findings from the hip fracture study will guide expansion into a full Phase II clinical study planned for later this fiscal year. These findings also will guide the possible initiation of clinical studies to treat severe osteoporosis." "In other company activities, we scaled up our manufacturing process during the fiscal year, building sufficient SomatoKine inventory to accommodate Phase II clinical feasibility studies," Dr. Sommer said. "In addition, Celtrix received three additional U.S. patents, further protecting our technology and product applications." -more- 2 "Celtrix Reports Fiscal Year-End Financial Results" Page 2 Celtrix is a biopharmaceutical company developing novel therapeutics for the treatment of seriously debilitating, degenerative conditions primarily associated with severe trauma, chronic diseases or aging. The company's focus is on SomatoKine, a novel IGF-BP3 complex, for use in regenerating lost muscle, bone and other tissues essential for the patient's health and quality of life. Initial product development programs target acute traumatic injury, such as hip fracture surgery in the elderly, and severe burns. Other potential indications include severe osteoporosis and protein wasting diseases associated with cancer, AIDS and other life-threatening conditions. Through strategic alliances with Celtrix, The Green Cross Corporation is developing SomatoKine for the treatment of osteoporosis in Japan, and Genzyme Corporation is developing TGF-beta-2 as part of a comprehensive approach to tissue repair and the treatment of systemic disease. This news release contains certain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Actual results may differ materially from the statements made, as a result of various factors, including risks associated with future company research, clinical study results, the regulatory approval process, competitive products and other factors which are listed from time to time in Celtrix's Securities and Exchange Commission (SEC) filings. These forward-looking statements represent Celtrix's judgment as of the date of this news release. - FINANCIAL CHARTS FOLLOW - 3 CELTRIX PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (In thousands)
March 31, March 31, 1997 1996 ---------- ---------- ASSETS Current assets: Cash, cash equivalents and short-term investments $5,268 (1) $17,593 Restricted cash 520 50 Receivables and other current assets 197 195 ------- ------- Total current assets 5,985 17,838 Property and equipment, net 8,423 10,013 Intangible and other assets, net 2,548 2,294 ------- ------- $16,956 $30,145 ======= ======= LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 1,380 $ 1,301 Current portion of long-term obligations 328 633 ------- ------- Total current liabilities 1,708 1,934 Deferred rent 1,038 1,187 Long-term obligations - 238 Stockholders' equity 14,210 26,786 ------- ------- $16,956 $30,145 ======= =======
(1) The Company completed a private placement of 5.7 million shares of common stock at $2.438 per share in April 1997. The net proceeds to the Company were $13.3 million. The following unaudited pro forma financial data gives effect as of March 31, 1997 to this financing: Cash, cash equivalents, restricted cash, and short-term investment $19,088 Stockholders' equity $27,510
4 CELTRIX PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands, except per share amounts)
Three Months Ended Year Ended March 31, March 31, ------------------------ ----------------------- 1997 1996 1997 1996 -------- -------- -------- -------- Revenues: Product sales $ 11 $ 11 $ 31 $ 99 Other revenues 539 722 627 1,651 -------- -------- -------- -------- 550 733 658 1,750 Costs and expenses: Cost of sales 1 2 5 31 Research and development 3,011 2,935 11,999 10,990 General and administrative 506 455 1,814 2,063 -------- -------- -------- -------- 3,518 3,392 13,818 13,084 -------- -------- -------- -------- Operating loss (2,968) (2,659) (13,160) (11,334) Interest income, net 65 178 464 625 Gain on investment - 1,144 - 3,463 -------- -------- -------- -------- Net loss $ (2,903) $ (1,337) $(12,696) $ (7,246) ======== ======== ======== ======== Net loss per share $ (0.19) $ (0.09) $ (0.83) $ (0.51) ======== ======== ======== ======== Shares used in computing net loss per share 15,263 15,214 15,238 14,161 ======== ======== ======== ========
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