AnorMED reports fiscal 2006 third quarter results and announces MOZOBIL(TM) Phase III recruitment reaches 50%
February 7, 2006
VANCOUVER, Feb. 7 /CNW/ - AnorMED Inc. (AMEX:AOM, TSX:AOM) today reported financial results for its third fiscal quarter ended December 31, 2005. AnorMED recorded a net loss of $11,403,000 ($0.34 per common share) in this quarter. This is in comparison to the net loss incurred in the previous fiscal quarter ended September 30, 2005 of $9,255,000 ($0.29 per common share).
Our contract research and development expenditures, $9,181,000 in this third fiscal quarter, were 36% higher than the previous quarter and were 110% higher than the third quarter of the last fiscal year. The Phase III clinical trials for MOZOBIL are a significant portion of the increase due primarily to increased recruitment in our ongoing Phase III trials. AMD070 costs were also higher with the initiation of the XACT Phase II trial. Costs for manufacturing of drug substance and ongoing analytical work on drug product for MOZOBIL and AMD070 also contributed to increased costs during the quarter. We are continuing to manufacture drug product for AMD070, and are conducting analytical work on drug product for both AMD070 and MOZOBIL, and ongoing preclinical long-term toxicology studies for AMD070; therefore, we expect our research and development expenditures to continue to increase into the fourth quarter of this fiscal year.
General and administrative expenses increased by 23% over the previous quarter and by 50% over the comparable third quarter of last year. In November 2005 we received SEC approval to list and trade our common shares on the AMEX. This registration process resulted in non-recurring accounting and legal fees. In addition, we expect to incur a higher level of expenditure in these same areas, as well as in increased investor relations costs and insurance premiums, to maintain our U.S. registration, and to comply with the additional regulatory requirements of both Canada and the U.S. Business development activities increased this quarter as a result of travel and other expenses associated with discussions of potential strategic partnerships for the implementation of our development and commercial plans for MOZOBIL. Marketing expenditures will also increase as pre-commercialization activities for MOZOBIL in North America and Europe progress.
Interest income of $437,000 for this quarter rose by 12% in comparison to the second quarter due to the receipt of net proceeds of $32 million from our December financing and rising interest rates in both Canada and the U.S. Income from investments increased over 20% from the third quarter of Fiscal 2005 as a result of higher interest rates and higher average cash balances.
Capital expenditures of $483,000 were incurred during the quarter that were substantially higher than those made during the second quarter of $268,000 and during the third quarter of Fiscal 2005 of $93,000. In preparation for our future NDA filing, we entered into an agreement in the previous quarter with a supplier to install and validate an Electronic Database Management System (EDMS) so that we can electronically file our regulatory submissions with the FDA. In addition to the EDMS, expenditures were made on office renovations, computers and office equipment during the period.
Cash, cash equivalents, and short-term investments were $72,105,000, as at December 31, 2005, as compared to $49,245,000 at September 30, 2005. The Company's cash reserves are primarily held in investments with maturities less than 90 days, due to the relatively higher yields that continued to be available during the quarter for short-term maturities. The current cash on hand, as well as expected interest income, supplemented by contractual payments on existing licensing agreements, is estimated to be sufficient to fund the Company's operations into calendar 2007.
Stem Cell Transplant
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At the American Society of Hematology (ASH) meeting in Atlanta, Georgia December 10-13, 2005, we presented 6 oral and 6 poster presentations including new clinical data from the MOZOBIL clinical program. All the data presented continues to support the potential of MOZOBIL as a new standard of care for stem cell mobilization in cancer patients undergoing stem cell transplant. Data reported at ASH included new clinical results from the Compassionate Use Program (CUP), a Phase II study in Hodgkin's disease and an investigator sponsored study in allogeneic transplant. In addition, compelling retrospective data reported by the Mayo Clinic at ASH showed that the type of cells collected using MOZOBIL may positively impact patient outcome and survival.
Recruitment into the Phase III trials for MOZOBIL continues to make steady progress. To date, 148 out of 300 non-Hodgkin's lymphoma (NHL) patients and 162 out of 300 multiple myeloma (MM) patients have entered into the Phase III trials. Currently, 34 sites are recruiting NHL patients and 34 sites, including a site in Germany, are recruiting MM patients. We are maintaining our goal to complete Phase III enrollment and three month follow up by the end of calendar year 2006.
We also continue to develop our Phase II program to address other segments of the transplant market including evaluating the potential of MOZOBIL in combination with different therapies and patient populations, such as with Rituxan. We have recently initiated a small standard Phase I safety study in renal patients required for the New Drug Application. In addition, investigator sponsored studies are ongoing to evaluate MOZOBIL as a single agent in allogeneic transplantation and the Compassionate Use Program continues to provide MOZOBIL to cancer patients who fail to collect enough stem cells for transplant using standard regimens.
HIV Entry Inhibitor
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On November 29, 2005, we initiated patient enrollment in a new AnorMED funded and driven Phase Ib/IIa study in HIV patients termed XACT. This new trial involves two sites; one in the U.S. and the other in the U.K. It is an open label dose-escalation/de-escalation study designed to look at preliminary activity and safety of AMD070 in HIV patients. We plan to report preliminary data from this study in the first quarter of 2006 and proof of principle in the fall. Also, our in house research program continues to make progress in the identification of HIV entry inhibitors targeting the CCR5 receptor. Selection of a lead for clinical development is planned for the first quarter of calendar 2006.
Financing
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In December 2005 we completed a bought deal financing for gross proceeds of $34.5M. The net proceeds will be used to fund Phase II and Phase III trials for MOZOBIL, for the ongoing development of AMD070 and CCR5 HIV entry inhibitors as well as for general corporate purposes.
Other updates
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We recently announced that certain shareholders that are controlled by Felix J. Baker and Julian C. Baker have filed a requisition for a special meeting of AnorMED shareholders, for the purpose of replacing the Board of Directors with a new slate proposed by them. Felix Baker is a Director of AnorMED. On February 3, 2006 AnorMED announced its intention to hold a Special Meeting of the Shareholder to be held on April 11, 2006 in Vancouver, BC. In addition, AnorMED's Board of Directors has adopted a Shareholder Rights Plan.
Upcoming Key Events
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- Report preliminary activity and safety of AMD070 in HIV patients
- Report preclinical data on AMD070 at the Keystone Cell Biology of Virus Entry, Replication and Pathogenesis meeting February 24 - March 1, 2006 in Santa Fe, New Mexico
- Report clinical data from ongoing Phase II trials with MOZOBIL at the Bone Marrow Transplant Tandem Meeting, February 16-20, 2006 in Honolulu, Hawaii and at the European Bone Marrow Transplant Meeting March 19-22, 2006 in Hamburg, Germany
- Complete Phase III recruitment for MOZOBIL in stem cell transplant
- Initiate patient enrollment into Phase I safety study of MOZOBIL in cardiac patients
- Receive milestone payments from Shire contingent upon additional European approvals for FOSRENOL
- Select lead CCR5 HIV inhibitor candidate
- Complete XACT study and submit AMD070 safety and activity data to the World AIDS Conference August 13-18, 2006 and/or the Interscience Conference on Antimicrobial Agents and Chemotherapy September 27-30, 2006
<< AnorMED Inc. - Financial Highlights Third Quarter Report - 2006 CONSOLIDATED BALANCE SHEETS (In thousands of Canadian dollars) As at As at December 31 March 31 ------------------------------------------------------------------------- 2005 2005 ------------------------------------------------------------------------- (unaudited) (audited) ASSETS Current assets Cash and cash equivalents $ 66,635 $ 57,834 Short-term investments 5,470 7,440 Accounts receivable 401 513 Prepaid expenses 1,500 1,001 -------------- ------------ 74,006 66,788 Security deposit 100 100 Long-term investment 281 292 Property and equipment, net 3,333 3,040 -------------- ------------ $77,720 $70,220 -------------- ------------ -------------- ------------ LIABILITIES AND SHAREHOLDERS' EQUITY Current liabilities Accounts payable and accrued liabilities $ 7,735 $ 4,709 Shareholders' equity Share capital Issued and outstanding: Common shares - 40,525,492 185,999 153,786 (March 31, 2005 - 31,829,493) Additional paid-in capital 2,642 1,698 Accumulated deficit (118,656) (89,973) -------------- ------------ 69,985 65,511 -------------- ------------ $ 77,720 $ 70,220 -------------- ------------ -------------- ------------ CONSOLIDATED STATEMENTS OF OPERATIONS (In thousands of Canadian dollars, For the three months For the nine months except per share ended ended amounts) December 31 December 31 ------------------------------------------------- ----------------------- (unaudited) 2005 2004 2005 2004 ------------------------------------------------- ----------------------- Revenue Licensing $ - $ 21,600 $ 25 $ 23,921 Expenses Research and development 9,181 4,380 22,726 13,461 General and administrative 2,460 1,639 6,187 4,703 Amortization 225 218 645 668 ----------- ----------- ----------- ----------- 11,866 6,237 29,558 18,832 ----------- ----------- ----------- ----------- Other income (expense) Interest and other income 437 364 1,240 1,032 Foreign exchange gain (loss) 26 121 (390) 106 Other expenses - - - (777) ----------- ----------- ----------- ----------- 463 485 850 361 ----------- ----------- ----------- ----------- Net income (loss) $ (11,403) $ 15,848 $ (28,683) $ 5,450 ----------- ----------- ----------- ----------- ----------- ----------- ----------- ----------- Income (loss) per common share $ (0.34) $ 0.50 $ (0.88) $ 0.17 Diluted income (loss) per common share $ (0.34) $ 0.48 $ (0.88) $ 0.16 CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (In thousands of Total Canadian dollars, Accumu- Additional share- except share Common lated paid-in holders' amounts) (unaudited) shares Amount deficit capital equity ------------------------------------------------------------------------- Balance at March 31, 2005 31,829,493 $153,786 $(89,973) $1,698 $65,511 Issued for cash 14,800 51 - - 51 Issued on exercise of options 1,399 7 - (3) 4 Stock-based compensation - - - 333 333 Net loss - - (8,025) - (8,025) ------------------------------------------------------------------------- Balance at June 30, 2005 31,845,692 153,844 (97,998) 2,028 57,874 Issued for cash 1,000 3 - - 3 Issued on exercise of options 24,000 58 - - 58 Stock-based compensation - - - 305 305 Net loss - - (9,255) - (9,255) ------------------------------------------------------------------------- Balance at September 30, 2005 31,870,692 153,905 (107,253) 2,333 48,985 Issued for cash 16,500 55 - - 55 Issued on exercise of options 13,300 42 - (9) 33 Issued for cash pursuant to public financing 8,625,000 34,500 - - 34,500 Share issue costs - (2,503) - - (2,503) Stock-based compensation - - - 318 318 Net loss - - (11,403) - (11,403) ------------------------------------------------------------------------- Balance at December 31, 2005 40,525,492 $185,999 $(118,656) $2,642 $69,985 ----------------------------------------------------- ----------------------------------------------------- Total Accumu- Additional share- Common lated paid-in holders' shares Amount deficit capital equity ------------------------------------------------------------------------- Balance at March 31, 2004 31,740,148 $153,452 $(87,804) $401 $66,049 Issued for cash 450 3 - - 3 Issued on exercise of options 15,800 66 - (15) 51 Stock-based compensation - - - 230 230 Net loss - - (3,814) - (3,814) ------------------------------------------------------------------------- Balance at June 30, 2004 31,756,398 153,521 (91,618) 616 62,519 Issued for cash 10,860 48 - - 48 Issued on exercise of options 45,498 144 - (3) 141 Stock-based compensation - - - 374 374 Net loss - - (6,584) - (6,584) ------------------------------------------------------------------------- Balance at September 30, 2004 31,812,756 153,713 (98,202) 987 56,498 Issued for cash 1,600 10 - - 10 Issued on exercise of options 9,597 41 - (4) 37 Stock-based compensation - - - 349 349 Net income - - 15,848 - 15,848 ------------------------------------------------------------------------- Balance at December 31, 2004 31,823,953 $153,764 $(82,354) $1,332 $72,742 ----------------------------------------------------- ----------------------------------------------------- CONSOLIDATED STATEMENTS OF CASH FLOWS For the three months For the nine months (In thousands of ended ended Canadian dollars) December 31 December 31 ------------------------------------------------- ----------------------- (unaudited) 2005 2004 2005 2004 ------------------------------------------------- ----------------------- Cash provided by (used in): Operations: Net income (loss) $ (11,403) $ 15,848 $ (28,683) $ 5,450 Items not involving cash Amortization 225 218 645 668 Loss on disposal of property and equipment 19 - 33 7 Licensing revenue received in shares - - - (1,281) Unrealized foreign exchange loss on long-term investment - 31 11 46 Loss on revaluation of long-term investment - - - 777 Compensatory stock options 318 349 956 953 Changes in non-cash operating working capital Accounts receivable (101) 6 112 21 Prepaid expenses (633) (532) (499) (555) Accounts payable and accrued liabilities 2,833 (678) 3,026 (1,334) ----------- ----------- ----------- ----------- (8,742) 15,242 (24,399) 4,752 ----------- ----------- ----------- ----------- Investments: Net sale (purchase) of short-term investments (2,982) 6,872 1,970 (1,833) Proceeds on disposal of property and equipment - - 16 - Purchase of property and equipment (483) (93) (987) (590) ----------- ----------- ----------- ----------- (3,465) 6,779 999 (2,423) ----------- ----------- ----------- ----------- Financing: Issuance of shares, net of share issue costs 32,085 47 32,201 290 ----------- ----------- ----------- ----------- Increase in cash and cash equivalents 19,878 22,068 8,801 2,619 Cash and cash equivalents, beginning of the period 46,757 21,159 57,834 40,608 ----------- ----------- ----------- ----------- Cash and cash equivalents, end of the period $66,635 $43,227 $66,635 $43,227 ----------- ----------- ----------- ----------- ----------- ----------- ----------- -----------
AnorMED is a chemistry-based biopharmaceutical company focused on the discovery, development and commercialization of new therapeutic products in the areas of hematology, HIV and oncology. The Company has a product in Phase III development, a product in Phase II development and a research program focused on a novel class of compounds that target specific chemokine receptors known to be involved in a variety of diseases including HIV. Additional information on AnorMED Inc. is available on the Company's website www.anormed.com.
Note: Certain of the statements contained in this press release may contain forward-looking statements within the meaning of applicable securities laws, including the Ontario Securities Act, Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934. Statements regarding strategy, future operations, future financial position, future revenues, projected costs, prospects and plans and objectives of management are forward-looking statements. The words "anticipates, "believes", "budgets", "could", estimates", expects," forecasts", "intends", "may", "plans", "projects", "schedule", "should", "will", "would", "maintaining" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Plans, intentions or expectations disclosed in any forward-looking statements should not be read as guarantees of future results or events, and will not necessarily be accurate indications of whether or the times at or by which such results or events will be achieved. Forward-looking statement involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Investors are referred to the discussion of such risks, uncertainties and other factors in AnorMED's Final Short Form Prospectus dated December 1, 2005 filed on SEDAR with Canadian securities regulatory authorities and in Exhibit 99.1 to AnorMED's Report on Form 6-K filed with the U.S. Securities and Exchange Commission on December 23, 2005. Except as required by law, AnorMED expressly disclaims any intention and undertakes no obligation to update any forward-looking statements as conditions change.
TELECONFERENCE CALL NOTIFICATION: Tuesday, February 7, 2006 4:30pm
EST/1:30pm PST
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On February 7, 2006, AnorMED Inc. will host a teleconference call at 4:30 pm EST (1:30 pm PST). To participate in the teleconference please dial 1-800-818-6210 in Canada and the U.S. or 1-416-641-6700 Internationally before 4:30 pm EST. This call will be taped, available one hour after the teleconference, and on replay until March 9, 2006. To hear a complete replay, please call 1-416-626-4100. The reservation number required for access is No. 21282050. This call will also be webcast from AnorMED's website at www.anormed.com.
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For further information: Elisabeth Whiting, M.Sc., VP, Corporate Development & Communications, Tel: (604) 530-1057, e-mail: ewhiting@anormed.com; W.J. (Bill) Adams, C.A., Chief Financial Officer, Tel: (604) 530-1057, e-mail: info@anormed.com
