Helix Biopharma Announces Fiscal 2013 Q1 Results

AURORA, ON--(Marketwire - December 12, 2012) - Helix BioPharma Corp. (TSX: HBP) (FRANKFURT: HBP), a biopharmaceutical company developing drug candidates for the prevention and treatment of cancer, today announced its financial results and research and development update for the quarter ended October 31, 2012.

HIGHLIGHTS DURING THE QUARTER

During Q1 of fiscal 2013, the Company:

• Announced first patient enrollment and dosing in the European Phase I/II clinical study of L-DOS47 in Poland;

• Continued its cost reduction initiatives, including a further downsizing of staff in Saskatoon along with the decision to close the Saskatoon facility, effective November 30, 3012;

• Extended the expiry date of warrants issued in on September 8, 2009 for an additional six months, from September 7, 2012 to March 7, 2013; and

• The Company’s cash and cash equivalents, as at October 31, 2012 total $3,313,000 and the Company continues to pursue various options to raise cash.

SUBSEQUENT EVENT

On December 10, 2012, the Company announced that it has entered into a definitive agreement for the sale of its Rivex Pharma division to Pharmscience Inc. for gross cash proceeds of up to $8.5 million (the “Rivex Transaction”). The Rivex Transaction has been unanimously approved by the Company’s board of directors and is subject to the approval of Helix’s shareholders and certain other customary closing conditions. The board of directors has called an annual general and special meeting of shareholders to be held on January 24, 2013, at which the Company will seek shareholder approval of the Rivex Transaction. If approved by shareholders, the Company expects that the Rivex Transaction will close in late January, 2013.

RESULTS FROM OPERATIONS

Three month period ended October 31, 2012 compared to the same period in the previous year

Loss for the period
The Company recorded a loss of $2,077,000 and $3,244,000, respectively for the fiscal quarters ended October 31, 2012 and 2011 for a loss per common share of $0.03 and $0.05, respectively.

The lower loss in the fiscal quarter ended October 31, 2012 compared to the three month period ended October 31, 2011 is due to lower research & development and operating, general and administration expenses along with lower product revenue.

Revenues
Revenues totalled $882,000 and $1,122,000 for the fiscal quarters ended October 31, 2012 and 2011, respectively and represents a decrease of $240,000 (21.4%) when compared to the three month period ended October 31, 2011. The entire decrease is represented by a decrease in product revenue.

The decrease in product revenues is the result of discontinuing Normacol® in late fiscal 2012 in addition to lower sales volumes for Orthovisc® and Klean-Prep™. Sales of Orthovisc® were hindered in the quarter as a result of supplier backorders.

Cost of sales and margins
Cost of sales totalled $355,000 and $456,000 respectively for the fiscal quarters ended October 31, 2012 and 2011. As a percentage of product revenues, cost of sales were 40.2% and 40.6% for the fiscal quarters ended October 31, 2012 and 2011, respectively.

Research & development
Research and development costs for the fiscal quarters ended October 31, 2012 and 2011 totalled $1,608,000 and $2,111,000 respectively.

L-DOS47 research and development costs for the fiscal quarters ended October 31, 2012 and 2011 totalled $874,000 and $999,000, respectively. For the fiscal quarter ended October 31, 2011, the L-DOS47 research and development expenditures reflect expenditures associated with the preparation for commencement of a Polish Phase I/II clinical study and a U.S. Phase I clinical study with L-DOS47. On May 14, 2012 the Company announced the commencement of clinical site initiations and patient recruitment activities of its Polish Phase I/II clinical study in Poland. On October 23, 2012, the Company announced that the first patient has been enrolled and first dose administered in its Polish Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland.

Topical Interferon Alpha-2b research and development expenses for the fiscal quarters ended October 31, 2012 and 2011 totalled $450,000 and $652,000, respectively. The Company’s research and development expenditures associated with Topical Interferon Alpha-2 for the current fiscal quarter have been limited and mainly reflect overhead costs associated with supporting the program. In the fiscal fourth quarter of 2012, the Company initiated a downsizing of the staff in the Saskatoon laboratory and in addition postponed the completion of work necessary to resolve the Medicines and Healthcare Regulatory Authority (“MHRA”) approval conditions associated with Helix’s December 2011 Phase III clinical trial application filing. Under the terms of this conditional approval, the Company must submit additional details, for approval by MHRA before proceeding with the Phase III trial, in the event the Company wishes to potentially extend the shelf life of its product beyond that which was stipulated in its clinical trial application. The Company proceeded with additional staff downsizing at its Saskatoon laboratory in October 2012, including a decision to close the Saskatoon laboratory by the end of November 2012. Costs associated with the downsizing were charged in the current quarter.

The Company also incurred corporate research and development expenses. Corporate research and development expenses totalling $284,000 and $460,000 respectively for the fiscal quarters ended October 31, 2012 and 2011. The lower expenses can be attributed to a reduction in payroll expense associated with headcount reductions of corporate research and development employees during fiscal 2012 in addition to a reduction in travel and consulting expenses.

Operating, general & administration
Operating, general and administration expenses for the fiscal quarters ended October 31, 2012 and 2011 totalled $764,000 and $1,275,000 respectively and represents a decrease of $511,000 (40.1%) when compared to the fiscal 2012 quarter. Lower operating, general and administration expenses are the result of ongoing cost cutting measures by the Company, with the most significant reductions related to lower legal and audit fees as a result of the Company having voluntarily surrendered its listing on the NYSE-MKT exchange in the United States, stock-based compensation expense, reduced headcount and investor relations activities.

Sales and marketing
Sales and marketing expenses for the fiscal quarters ended October 31, 2012 and 2011 totalled $204,000 and $298,000 and represents a decrease of $94,000 (31.5%) when compared to the fiscal 2012 quarter. The lower expenses can be attributed to lower promotion and advertising expenses, regulatory and compliance costs for the most recent quarter compared to the same period in the prior year, lower sales commissions as a result of lower sales and decreased stock-based compensation expense.

2012 AGM, Special Committee and Settlement
Expenses relating to the special committee of independent directors (the “Special Committee”) formed in connection with the Company’s contested annual general meeting of shareholders held on January 30, 2012 (the “2012 AGM”) and the subsequent settlement agreement entered into with certain of the concerned shareholders (the “Settlement”) for the fiscal quarters ended October 31, 2012 and 2011 totalled $nil and $245,000, respectively. The expense amount included in Q1 of fiscal 2012 primarily reflects legal expenses incurred by the Company.

Finance income and expense
Finance income and expense combined for the fiscal quarters ended October 31, 2012 and 2011 totalled $6,000 and $44,000 respectively. The decrease in interest income in Q1 of fiscal 2013 reflects lower cash balances.

Foreign exchange loss
Foreign exchange for the fiscal quarters ended October 31, 2012 and 2011 reflects losses of $34,000 and $25,000 respectively. Foreign exchange gains and losses result mainly from the sales and purchases that are denominated in currencies other than functional currencies. In addition, they can arise from purchase transactions, as well as recognized monetary financial assets and liabilities denominated in foreign currencies.

CASH FLOW

Operating activities
Cash used in operating activities for the three month periods ended October 31, 2012 and 2011 totalled $1,502,000 and $1,391,000 respectively and includes a net loss of $2,077,000 (2011 - $3,244,000) with significant adjustments in operating activities related to stock-based compensation of $96,000 (2011 - $386,000); depreciation of property, plant and equipment of $103,000 (2011 - $174,000); and $348,000 (2011 - $1,236,000) net increase to non-cash working capital.

Financing activities
Cash provided from financing activities for the three month periods ended October 31, 2012 and 2011 totalled $nil and $43,000 respectively and is attributable to proceeds from the exercise of stock options.

Investing activities
Investing activities for the three month periods ended October 31, 2012 and 2011 totalled $13,000 and $17,000 respectively and mainly represents replacement of IT assets in both fiscal periods.

LIQUIDITY AND CAPITAL RESOURCES

Since inception, the Company has financed its operations from public and private sales of equity, proceeds received upon the exercise of warrants and stock options, and, to a lesser extent, from interest income from funds available for investment, government grants, investment tax credits, and revenues from distribution, licensing and contract services. Since the Company does not have net earnings from its operations, the Company’s long-term liquidity depends on its ability to access the capital markets, which depends substantially on the success of the Company’s ongoing research and development programs, as well as economic conditions relating to the state of the capital markets generally.

At October 31, 2012, the Company had cash and cash equivalents totaling $3,313,000 (July 31, 2012 - $4,862,000). The total number of common shares issued as at October 31, 2012 was 67,226,337 (July 31, 2012 - 67,226,337).

The Company’s cash resources have been severely strained by the costs incurred in connection with activities in fiscal 2012 including the 2012 AGM, Special Committee and Settlement Agreement. As a result, the Company’s cash position of $3,313,000 as at October 31, 2012 is insufficient to meet anticipated cash needs for working capital and capital expenditures through the next twelve months. Various cost-cutting and cost-deferral measures have been initiated in order to extend the Company’s cash resources, permitting it more time to seek additional financing. By prioritizing the monotherapy arm of the Company’s Polish Phase I/II clinical study for L-DOS47 and pushing out the non-monotherapy arms, coupled with certain cost-cutting and cost-deferral measures which have already taken place and are ongoing, the Company believes its current cash resources may not be sufficient to continue operations beyond March 2013.

Securing additional financing is of utmost priority to the Company. However, there is no assurance that additional financing can be obtained in a timely manner or at all.

Equity financing has historically been the Company’s primary source of funding, however, the market for equity financings for companies such as Helix is challenging, especially in the current economic environment. While the Company has been able to raise equity financing in recent years, there can be no assurance that additional funding by way of equity financing will continue to be available. Any additional equity financing, if secured, would result in dilution to the existing shareholders which may be significant. The Company may also seek additional funding from or through other sources, including technology licensing, co-development collaborations, mergers and acquisitions, joint ventures, and other strategic alliances, which, if obtained, may reduce the Company’s interest in its projects or products or result in significant dilution to existing shareholders. There can be no assurance, however, that any alternative sources of funding will be available. The failure of the Company to obtain additional financing on a timely basis may result in the Company reducing, delaying or cancelling one or more of its planned research, development and/or marketing programs, including clinical trials, further reducing overhead, or monetizing non-core assets, any of which could impair the current and future value of the business or cause the Company to consider ceasing operations and undergoing liquidation.

Given the Company’s conclusion about the insufficiency of its cash reserves, significant doubt may be cast about the Company’s ability to continue operating as a going concern. The continuation of the Company as a going concern for the foreseeable future depends mainly on raising sufficient capital, and in the interim, reducing, where possible, operating expenses (including making changes to the Company’s research and development plans), including the delay of one or more of the Company’s research and development programs, further reducing overhead and the possible disposition of assets (see Subsequent Event, above).

The Company’s condensed unaudited interim consolidated statement of net loss and comprehensive loss for the three month periods ending October 31, 2012 and 2011 and the condensed unaudited interim consolidated statement of cash flows for the three month periods ending October 31, 2012 and 2011 are summarized below:

The Company’s condensed unaudited interim consolidated statement of financial position as at October 31, 2012 and July 31, 2012 are summarized below:

 Consolidated Statement of Net Loss and Comprehensive Loss For the three month periods ended October 31, 2012 and 2011 (thousand $, except for per share data) Three months ended October 31 2012 2011 ---------- ---------- Revenue: Product revenue 882 1,122 Expenses: Cost of sales 355 456 Research and development 1,608 2,111 Operating, general and administration 764 1,275 Sales and marketing 204 298 Special committee and settlement - 245 ---------- ---------- 2,931 4,385 Loss before finance items (2,049) (3,263) Finance items: Finance income 10 49 Finance expense (4) (5) Foreign exchange (loss) (34) (25) ---------- ---------- (28) 19 ---------- ---------- Net loss & total comprehensive loss (2,077) (3,244) ========== ========== Loss per share: Basic & diluted (0.03) (0.05) ========== ========== Consolidated Statements of Cash Flows For the three month periods ended October 31, 2012 and 2011 (thousand $) Three months ended October 31 2012 2011 ---------- ---------- Cash provided by (used in): Loss for the period (2,077) (3,244) Items not involving cash: Depreciation of property, plant and equipment 103 174 Deferred lease credit (6) (7) Stock-based compensation 96 386 Stock-based consideration - 39 Foreign exchange loss (gain) 34 25 ---------- ---------- 227 617 Change in non-cash working capital 348 1,236 ---------- ---------- Operating activities (1,502) (1,391) Financing activities - 43 Investing activities (13) (17) Effect of exchange rate changes on cash and cash equivalents (34) (25) Cash and cash equivalents: Increase/(decrease) (1,549) (1,390) Beginning of the period 4,862 19,044 ---------- ---------- End of the period 3,313 17,654 ========== ========== Consolidated Statement of Financial Position (thousand $) October 31, July 31, 2012 2012 ----------- ----------- Non current assets 1,403 1,493 Current assets: Prepaids 141 107 Inventory 305 421 Accounts receivable 666 733 Cash and cash equivalents 3,313 4,862 ----------- ----------- 4,425 6,123 ----------- ----------- Total assets 5,828 7,616 =========== =========== Shareholders’ equity 4,243 6,224 Non current liabilities 17 23 Current liabilities: Deferred lease credit 25 25 Accrued liabilities 799 694 Accounts payable 744 650 ----------- ----------- 1,568 1,369 Total liabilities 1,585 1,392 ----------- ----------- Total liabilities and shareholders’ equity 5,828 7,616 =========== =========== 

The Company’s condensed unaudited interim consolidated financial statements and management’s discussion and analysis are being filed with the Canadian Securities Administrators and will be available under the Company’s profile on SEDAR at www.sedar.com as well as on the Company’s website at www.helixbiopharma.com. Shareholders have the ability to receive a hard copy of the Company’s unaudited condensed interim consolidated financial statements free of charge upon request at the address below.

About Helix BioPharma Corp.

Helix BioPharma Corp. is a biopharmaceutical company specializing in the field of cancer therapy. The company is actively developing innovative products for the prevention and treatment of cancer based on its proprietary technologies. Helix’s product development initiatives include its novel L-DOS47 new drug candidate and its Topical Interferon Alpha-2b. Helix is currently listed on the TSX and FSE under the symbol “HBP”.

Forward-Looking Statements and Risks and Uncertainties

This news release contains forward-looking statements and information (collectively, “forward-looking statements”) within the meaning of applicable Canadian securities laws. Forward-looking statements are statements and information that are not historical facts but instead include financial projections and estimates; statements regarding plans, goals, objectives, intentions and expectations with respect to the Company’s future business, operations, research and development, including the focus of the Company on its two drug candidates, L-DOS47 and Topical Interferon Alpha-2b (cervical lesions indication); and other information in future periods.

Forward-looking statements include, without limitation, statements concerning (i) the Company’s ability to operate on a going concern being dependent mainly on obtaining additional financing; (ii) the Company’s growth and future prospects being dependent on the success of one or both of L-DOS47 and Topical Interferon Alpha-2b; (iii) the Company’s priority continuing to be L-DOS47; (iv) the Company’s development programs for Topical Interferon Alpha-2b, DOS47 and L-DOS47; (v) future expenditures, insufficiency of the Company’s current cash resources and the need for financing and cost-cutting and/or cost-deferral measures; (vi) future financing requirements, the seeking of additional funding and anticipated future revenue and operating losses; and (vii) the completion of the Rivex Transaction, including the satisfaction of the conditions to closing the Rivex Transaction, and the anticipated timelines for completing the Rivex Transaction. Forward-looking statements can further be identified by the use of forward-looking terminology such as “expects”, “plans”, “designed to”, “potential”, “is developing”, “believe”, “intended”, “continues”, “opportunities”, “anticipated”, “2012", “2013", “next”, ongoing”, “pursue”, “to seek”, “proceed”, “objective”, “estimate”, “future”, “wish”, or the negative thereof or any other variations thereon or comparable terminology referring to future events or results, or that events or conditions “will”, “may”, “could”, “would”, or “should” occur or be achieved, or comparable terminology referring to future events or results.

Forward-looking statements are statements about the future and are inherently uncertain, and are necessarily based upon a number of estimates and assumptions that are also uncertain. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, such statements involve risks and uncertainties, and undue reliance should not be placed on such statements. Forward-looking statements, including financial outlooks, are intended to provide information about management’s current plans and expectations regarding future operations, including without limitation, future financing requirements, and may not be appropriate for other purposes. Certain material factors, estimates or assumptions have been applied in making forward-looking statements in this news release, including, but not limited to, the safety and efficacy of L-DOS47 and Topical Interferon Alpha-2b (low-grade cervical lesions); that sufficient financing will be obtained in a timely manner to allow the Company to continue operations; that sufficient cost-deferral and/or cost-cutting measures will be taken; the timely provision of services and supplies, including Interferon alpha-2b raw materials, or other performance of contracts by third parties; future revenue and costs; the absence of any material changes in business strategy or plans, other than the implementation of cost-deferral and/or cost-cutting measures; the timely receipt of required regulatory approvals, and strategic partner support; that the Rivex Transaction will be completed on the anticipated timelines; that the conditions precedent set forth in the definitive purchase agreement, including the condition that Helix’s shareholders approve the Rivex Transaction, are satisfied or waived within the timelines required by the definitive purchase agreement; and that there will be no changes in market, economic, industry or regulatory conditions.

The Company’s actual results could differ materially from those anticipated in the forward-looking statements contained in this news release as a result of numerous known and unknown risks and uncertainties, including without limitation, the risk that the Company’s assumptions may prove to be incorrect; the risk that additional financing may not be obtainable in a timely manner, or at all, and that the Company may be unsuccessful in its cost-cutting and cost-deferral initiatives; clinical trials may not commence or complete within anticipated timelines or may fail; third party suppliers of necessary services or of drug product and other materials may fail to perform or be unwilling or unable to supply the Company, which could cause delay or cancellation of the Company’s research and development or distribution activities; necessary regulatory approvals may not be granted or may be withdrawn; the Company may not be able to secure necessary strategic partner support; general economic conditions, intellectual property and insurance risks; changes in business strategy or plans; that the Rivex Transaction is not completed on the anticipated timelines or at all; that the conditions precedent set forth in the definitive purchase agreement, including the condition that the Company’s shareholders approve the Rivex Transaction are not satisfied or waived within the timelines required by the definitive purchase agreement; and other risks and uncertainties referred to elsewhere in this news release, any of which could cause actual results to vary materially from current results or the Company’s anticipated future results. Certain of these risks and uncertainties, and others affecting the Company, are more fully described in the Helix’s Annual Report, in particular under the headings “Forward-looking Statements” and “Risk Factors”, and other reports filed with the Canadian Securities Administrators from time to time at www.sedar.com. Forward-looking statements and information are based on the beliefs, assumptions, opinions and expectations of Helix’s management on the date of this new release, and Helix does not assume any obligation to update any forward-looking statement or information should those beliefs, assumptions, opinions or expectations, or other circumstances change, except as required by law.