Bioxel Pharma Announces Results for the Third Quarter of 2005.SAINTE-FOY, Quebec -- Bioxel Pharma Inc. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension VENTURE:BIP BIP - An incorrect singular of BIPS. One billion instructions per second is 1 BIPS, not 1 BIP. ), a leading manufacturer of taxane active pharmaceutical ingredients (APIs) and developer of targeted oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. drugs, today announced results for the third quarter and nine-month period ending on September 30, 2005. "Bioxel Pharma Inc. set a clear mission for itself in 2005: to improve revenue growth in order to achieve operating profits Operating profit (or loss) Revenue from a firm's regular activities less costs and expenses and before income deductions. operating profit See operating income. in 2006, and thereby confirm its earnings objective. This mission is built on three strategic initiatives: broaden our client base with accelerated international expansion, enhance our product mix and lower our production costs," indicated Pascal Delmas, the Corporation's President and Chief Executive Officer. "In the third quarter, Bioxel's team proved it could translate this dynamic into concrete operational achievements that set the stage for future development and growth. We have secured new strategic customers in the rapidly expanding European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. generic market, we have significantly reduced our production costs and we have broadened our taxanes taxanes Oncology A family of antimitotic/antimicrotubule agents that inhibit cancer cell growth by stopping cell division product line to paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia); and docetaxel docetaxel /do·ce·tax·el/ (do?se-tak´s'l) an antineoplastic agent used particularly in treating carcinoma of the breast and non. manufactured by semi-synthesis. These are all indicators of strong performance that leave us confident about meeting our goals. In upcoming months, we will continue to implement our action plan with a focus on steadily improving Bioxel's results." HIGHLIGHTS FOR THE FIRST NINE MONTHS Bioxel signs first two-year supply agreement in Europe and wins its largest paclitaxel order The Corporation has executed a supply agreement for several kilograms of paclitaxel with a specialty pharmaceutical company currently in advanced stages of clinical development. Delivery will be completed in the fourth quarter and will lead to revenues of approximately $1 million. Bioxel expects to generate at least equivalent sales in 2006 with this new client. The Corporation has also entered into a renewable two-year paclitaxel manufacturing and supply agreement with a leading European generic manufacturer. The supply of paclitaxel to this new client should yield sales of $1.5 million to $2.0 million in 2006. This agreement reflects Bioxel's focus on expanding its market presence in Europe and broadening its client base, particularly with generic manufacturers.The Corporation is now positioned in both North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. and Europe with established partners offering promising sales growth potential. Qualification of Bioxel's manufacturing chain During the third quarter, three new pharmaceutical customers qualified Bioxel's manufacturing and supply chain. On the basis of product quality, regulatory compliance and manufacturing capacity, these customers have each made commitments to incorporate Bioxel's paclitaxel into their products. The Corporation is confident it will establish long-term supply agreements with these new partners in 2006. Ever-broader taxane mix The broadening of Bioxel's product mix is aimed at increasing its profit margins and at accelerating its sales growth in the near to medium term. In November 2005, Bioxel filed a second patent covering the manufacture of paclitaxel and docetaxel APIs by semi-synthesis. This new intellectual property satisfies the demand of its pharmaceutical partners who seek semi-synthetic taxanes manufactured using highly efficient processes and with guaranteed freedom to operate. The Corporation is currently developing pilot processes for the semi-synthesis of paclitaxel and docetaxel; these two APIs will complement the naturally sourced paclitaxel currently marketed by Bioxel.The Corporation has positioned itself to take advantage of the opening market opportunity for generic docetaxel, the active ingredient An active ingredient, also active pharmaceutical ingredient (or API), is the substance in a drug that is pharmaceutically active. Some medications may contain more than one active ingredient. in a blockbuster drug A blockbuster drug is a drug generating more than $1 billion of revenue for its owner each year. The search for blockbusters has been the foundation of the R&D strategy adopted by big pharmaceutical companies, but this looks set to change. sold by Sanofi-Aventis under the Taxotere(R) trademark that generates aggregate annual sales of approximately US$2 billion. Steadily growing results Sales of paclitaxel totaled $1.1 million for the first nine months of 2005, despite the continued deferral deferral - Waiting for quiet on the Ethernet. of Cell Therapeutics' order backlog Backlog The total value of sales orders waiting to be fulfilled. Notes: This figure is used mainly in the manufacturing industry. Increases or decreases in a company's backlog indicate the future direction of sales and earnings. . Recently signed agreements will yield benefits in the fourth quarter and will translate into strong revenue growth in 2006. Growth margins have held steady at 22% for the first nine months of the year, in line with the Corporation's objectives, as compared to a gross loss of $372,000 in 2004. The operating loss operating loss The excess of operating expenses over revenue. As with operating income, operating losses exclude revenues and expenses from operations that are not considered a regular part of the business. Also called deficit. Compare operating income. as of September 30, 2005 was down by almost 40% at $1.4 million.This was attributed to the combined positive impact of lower commercial paclitaxel manufacturing costs and fixed cost reduction measures put in place in the first quarter. FINANCIAL HIGHLIGHTS The information below should be read in conjunction with the selected financial data included herein. Third Quarter Bioxel kept up its momentum from the beginning of fiscal 2005 and recorded revenues of $282,000 resulting primarily from sale of paclitaxel to generic manufacturers. The Corporation achieved a positive profit margin of 20% for the third quarter. Furthermore, administrative expenses have been kept under $400,000 since early in 2005.The third quarter expense of $308,000 was a one-year quarterly low. The Corporation also issued 3,337,227 common shares as payment of $815,000 in accrued interest Accrued Interest The interest that has accumulated on a bond since the last interest payment up to but not including the settlement date. There are two methods for calculating accrued interest: 1) 360-day year method, used for corporate and municipal bonds. on principal of $1.5 million in outstanding convertible debentures Convertible Debenture Any type of debenture that can be converted into some other security. Notes: For example, a convertible bond can be converted into stock. , in accordance Accordance is Bible Study Software for Macintosh developed by OakTree Software, Inc.[] As well as a standalone program, it is the base software packaged by Zondervan in their Bible Study suites for Macintosh. with the conditions of the debentures. Interest on these debentures is now payable on a semi-annual basis in cash. Finally, it was confirmed that Bioxel's common shares qualify for hedging purposes under the SME (1) (Small and Medium-sized Enterprise) See SMB. (2) (Subject Matter Expert) An individual who is well-versed in the policies and procedures of a particular department or division. Growth Stock Plan. First Nine Months of 2005 Financial Results The Corporation recorded sales of $1.1 million during the nine-month period ended September 30, 2005, compared with $1.7 million for the equivalent period of 2004. The lower sales were due to the deferral of Cell Therapeutics' order backlog. Gross profit totaled $239,000, as opposed to a gross loss of $372,000 in the previous year. This clear improvement of $611,000 was attributable to the lower ongoing costs of manufacturing as compared with the June 2004 start-up costs of the commercial paclitaxel manufacturing unit. The Corporation's higher gross margin and reduced fixed operating cost enabled it to greatly reduce its operating loss and net loss as compared with the first nine months of 2004. Research and development expenses amounted to $355,000 for the nine-month period ended September 30, 2005, versus a comparable value of $353,000 for the equivalent period of 2004. Administrative expenses went from $1.2 million to $1.0 million, this major reduction of $200,000 was related to the lower total payroll, professional fees and public corporation costs. Selling expenses also declined, from $312,000 on September 30, 2004 to $281,000 as of September 30, 2005.This was a result of changes made in compensation structure. Financial expenses amounted to $443,000 as of September 30, 2005, down from $568,000 during the same period in 2004. This decrease of $125,000 was due mainly to lower interest expenses on the debenture debenture (dəbĕn`chər), document acknowledging indebtedness. In Great Britain a debenture is practically the same as a bond, and debenture stock is similar to preferred stock. following amendment to the agreement arranged in 2004, combined with interest expenses associated with the new loans obtained in 2004. These includethe BioLevier loan from Investissement Quebec and an equipment loan. Amortization expenses increased by $338,000 to $810,000, up from $472,000 as a result of the amortization of the commercial-scale purification purification, in religion, the ceremonial removal of what the religion deems unclean. The usual agents of purification are water (as in baptism), bodily alteration (as in circumcision), and fire. equipment brought on stream as of June 2004. Overall, the Corporation incurred a net loss of $2.8 million or $0.05 per share for the nine-month period ended September 30, 2005, compared with $3.5 million or $0.08 per share in 2004. At the end of the third quarter of 2005, the Corporation posted a year-to-date deficit of $23.4 million and contributed surplus of $2.1 million related to the change in the Canadian accounting standard regarding the stock option incentive plan and the cancellation of warrants. Shareholders' equity Shareholders' Equity A firms' total assets minus its total liabilities. Equivalently, it is share capital plus retained earnings minus treasury shares. Shareholders' equity is the amount by which a company is financed through common and preferred shares. and convertible debentures totaled $3.6 million, compared with $6.1 million as of December 31, 2004. Cash Position and Sources of Financing Besides the cash and cash equivalents from its ongoing business operations Business operations are those activities involved in the running of a business for the purpose of producing value for the stakeholders. Compare business processes. The outcome of business operations is the harvesting of value from assets , Bioxel's financial resources have so far been derived from the issue of share capital, convertible debentures, loans to finance the purchase of property, plant and equipment, tax credits receivable, subsidies from various sources and an Investissement Quebec loan under the BioLevier program. As the Corporation is in the commercial development stage, it intends to continue funding its operations using these same sources. Bioxel's cash and temporary investment amounted to $720,000 as of September 30, 2005, compared with $3.2 million as of December 31, 2004. Working capital totaled $2.7 million as of September 30, 2005, down from $4.3 million as of December 31, 2004. This decline in cash and cash equivalents was due mainly to the cash flows used by operating activities. The Corporation also had an authorized au·thor·ize tr.v. au·thor·ized, au·thor·iz·ing, au·thor·iz·es 1. To grant authority or power to. 2. To give permission for; sanction: operating line of credit of $500,000, secured by a first ranking movable hypothec Hy`poth´ec n. 1. (Scot. Law) A landlord's right, independently of stipulation, over the stocking (cattle, implements, etc.), and crops of his tenant, as security for payment of rent. on accounts receivable accounts receivable n. the amounts of money due or owed to a business or professional by customers or clients. Generally, accounts receivable refers to the total amount due and is considered in calculating the value of a business or the business' problems in paying and inventories, which was unused as of September 30, 2005. During the first nine months of 2005, Bioxel's operating activities used cash flows of $2.3 million, reflecting an operating loss of $1.6 million including non-cash items and a $741,000 increase in working capital requirements Capital requirements Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. . Cash flows used for operations were primarily focused on commercial development efforts, research and development and the underlying administrative costs administrative costs, n.pl the overhead expenses incurred in the operation of a dental benefits program, excluding costs of dental services provided. . Investing activities used cash flows of $347,000, consisting of $308,000 to purchase property, plant and equipment for the semi-synthesis process and commercial-scale paclitaxel production, and $39,000 in patent filing legal fees. Finally, financing activities provided cash flows of $193,000 pursuant to the fixed schedule for long-term debt Long-Term Debt Loans and financial obligations lasting over one year. Notes: For example debts obligations such as bonds and notes which have maturities greater than one year would be considered long-term debt. repayments, coupled with a $643,000 consideration reflecting the third instalment of the loan granted by Investissement Quebec under the BioLevier program. STOCK OPTIONS Bioxel also announced today that its Board of Directors had awarded 337,500 common share purchase options (262,500 at an exercise price of $0.33 to its directors and 75,000 at an exercise price of $0.23 to an officer under his employment contract) under the Corporation's stock option plan. Since September 30, 2005, 330,500 options have matured. OUTLOOK The operational priority for upcoming quarters remains sales growth. Recent events already reflect Bioxel's ability to achieve its marketing objectives in Europe and North America. Efforts now under way will remain on track and will lead to further use of the Corporation's paclitaxel manufacturing facilities in 2006. Bioxel's second goal for the coming months is to implement delocalized outsourcing (1) Contracting with outside consultants, software houses or service bureaus to perform systems analysis, programming and datacenter operations. Contrast with insourcing. See netsourcing, ASP, SSP and facilities management. solutions in order to increase its production chain efficiency and flexibility.This will also improve profit margins and sharpen sharp·en tr. & intr.v. sharp·ened, sharp·en·ing, sharp·ens To make or become sharp or sharper. sharp Bioxel's competitive edge. Finally, the development of taxanes produced by semi-synthesis will continue and intensify in·ten·si·fy v. in·ten·si·fied, in·ten·si·fy·ing, in·ten·si·fies v.tr. 1. To make intense or more intense: , with a view to building new strategic partnerships with pharmaceutical companies during the first half of 2006. For the entire 2005 fiscal year, Bioxel confirms the three-tiered focus stated at the close of the second quarter, i.e.: - topping $2 million in sales, despite the deferral of Cell Therapeutics' order backlog; - achieving a profit margin of over 20% as a percentage of sales; and - lowering by more than 30% the operating loss compared with 2004. ABOUT BIOXEL PHARMA Bioxel Pharma Inc. is an emerging leader in biopharmaceuticals, focused on developing, manufacturing and marketing taxane pharmaceutical ingredients. Taxanes are used in drug products for the treatment of cancer and other diseases, including psoriasis psoriasis (sôrī`əsĭs), occasionally acute but usually chronic and recurrent inflammation of the skin. The exact cause is unknown, but the disease appears to be an inherited, possibly autoimmune disorder that causes the , rheumatoid arthritis rheumatoid arthritis Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. , Alzheimer's disease Alzheimer's disease (ăls`hī'mərz, ôls–), degenerative disease of nerve cells in the cerebral cortex that leads to atrophy of the brain and senile dementia. and cardiovascular disease Cardiovascular disease Disease that affects the heart and blood vessels. Mentioned in: Lipoproteins Test cardiovascular disease . The Corporation sells cGMP paclitaxel and develops a portfolio of other generic taxane APIs and taxane-based proprietary products for improved cancer therapy. This announcement includes forward-looking statements forward-looking statement A projected financial statement based on management expectations. A forward-looking statement involves risks with regard to the accuracy of assumptions underlying the projections. that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect future results. These include risks and uncertainties that could affect Bioxel's products under development such as regulatory factors, technological developments and competitive factors. Achievement of the objectives set forth in this release is subject to these risks and uncertainties. The Corporation's results, or the measures it adopts, could differ materially from those indicated or underlying these statements, or could have an impact on the realization of financial projections.
Bioxel Pharma Inc.
Selected Financial Data (Unaudited)
Three months ended, Nine months ended
September 30, September 30,
Earnings 2005 2004 2005 2004
---------------------------------------------------------------------
$ $ $ $
Revenues 282,008 645,256 1,113,366 1,685,507
Manufacturing cost 226,388 486,898 873,938 2,057,534
Gross margin (gross
loss) 55,620 158,358 239,428 (372,027)
Research and
development expenses 140,391 161,422 354,823 353,339
Selling expenses 81,655 88,679 280,986 311,561
Stock-based
compensation 173,573 272,419
Administrative
expenses 308,302 375,904 1,016,005 1,200,414
Financial expenses 120,783 263,968 442,848 567,943
Amortization 265,754 222,879 810,375 471,654
---------------------------------------------------------------------
Net loss 803,392 952,980 2,803,290 3,549,886
---------------------------------------------------------------------
Net loss and diluted
net loss per share 0,01 0,02 0,05 0,08
---------------------------------------------------------------------
---------------------------------------------------------------------
Weighted average
number of
shares outstanding 56,882,611 47,325,186 55,079,514 45,130,225
---------------------------------------------------------------------
---------------------------------------------------------------------
As of As of
September 30, December 31,
Balance Sheet 2005 2004
(unaudited) (audited)
---------------------------------------------------------------------
$ $
Cash 170,370 181,714
Temporary investment 550,000 3,000,000
Other current assets 3,843,955 3,677,752
---------------------------------------------------------------------
Total current assets 4,564,325 6,859,466
---------------------------------------------------------------------
---------------------------------------------------------------------
Property, plant and equipment 4,699,289 5,000,824
Other long-term assets 995,521 1,143,714
---------------------------------------------------------------------
Total assets 10,259,135 13,004,004
---------------------------------------------------------------------
---------------------------------------------------------------------
Current liabilities 1,887,584 2,599,152
Long-term debt 2,235,496 2,556,812
BioLevier note payable 2,495,480 1,737,270
Liability component of convertible
debentures 1,183,366 1,834,310
Shareholders' equity 2,457,209 4,276,460
---------------------------------------------------------------------
Total liabilities and shareholders' equity 10,259,135 13,004,004
---------------------------------------------------------------------
---------------------------------------------------------------------
The TSX Venture Exchange TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. has not reviewed the contents of this pre ss release and accepts no responsibility for the adequacy or the accur acy thereof. BIOXEL PHARMA INC. (TSX VENTURE:BIP) |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion