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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 

(Mark One)

 

ý

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

 

For the Quarter Ended June 30, 2004

 

or

 

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

Commission file number 333-12570

 


 

STRESSGEN BIOTECHNOLOGIES CORPORATION

(Exact name of registrant as specified in its charter)

 

Yukon Territory, Canada

 

N/A

(State of incorporation)

 

(IRS Employer Identification No.)

 

 

 

350-4243 Glanford Avenue
Victoria, British Columbia V8Z 4B9

Parent of Stressgen Biotechnologies, Inc.
6055 Lusk Boulevard
San Diego, CA

 

92121

(Address of principal executive offices)

 

(zip code)

 

 

 

(250) 744-2811
(858) 202-4900

(Registrant’s telephone number, including area code)

 


 

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 ý  No o

 

Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).  Yes ý  No o

 

As of July 30, 2004 the registrant had approximately 72,506,000 shares of Common Stock, no par value, outstanding.

 

 



 

Stressgen Biotechnologies Corporation and Subsidiaries

INDEX

Part I — Financial Information

 

 

 

 

Item 1.

Financial Statements (Unaudited)

 

 

 

Consolidated Balance Sheet
June 30, 2004 and December 31, 2003

 

 

 

Consolidated Statement of Operations and Accumulated Deficit
Three and Six Months Ended June 30, 2004 and 2003

 

 

 

Consolidated Statement of Cash Flows
Three and Six Months Ended June 30, 2004 and 2003

 

 

 

Notes to Consolidated Financial Statements

 

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

 

 

Factors That Could Affect Future Performance

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

 

Item 4.

Controls and Procedures

 

 

 

Part II — Other Information

 

 

 

Items 1 through 6

 

 

 

SIGNATURES AND CERTIFICATIONS

 

 



 

CONSOLIDATED BALANCE SHEET

(Unaudited)

 

Stressgen Biotechnologies Corporation and Subsidiaries

(Canadian dollars in thousands, except share information)

 

 

 

June 30,
2004

 

December 31,
2003

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

7,888

 

$

19,996

 

Short-term investments

 

32,003

 

32,094

 

Accounts receivable, net

 

575

 

733

 

Inventories

 

659

 

639

 

Other current assets

 

492

 

512

 

Total current assets

 

41,617

 

53,974

 

 

 

 

 

 

 

Plant and equipment

 

1,983

 

2,196

 

Deferred expenses, net of current portion

 

225

 

260

 

 

 

$

43,825

 

$

56,430

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

3,586

 

$

3,975

 

Current portion of deferred revenue

 

714

 

688

 

Current portion of notes payable and leases

 

522

 

518

 

Total current liabilities

 

4,822

 

5,181

 

 

 

 

 

 

 

Long-term liabilities:

 

 

 

 

 

Deferred revenue, net of current portion

 

1,785

 

2,065

 

Notes payable and leases, net of current portion

 

372

 

607

 

Total long-term liabilities

 

2,157

 

2,672

 

 

 

 

 

 

 

Total liabilities

 

6,979

 

7,853

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common shares and other equity – no par value;
unlimited shares authorized, 72,506,403 and 72,491,403 shares issued and outstanding at June 30, 2004 and December 31, 2003, respectively

 

216,412

 

196,849

 

Contributed surplus

 

16,328

 

2,207

 

Deferred stock compensation (Note 2)

 

 

(185

)

Accumulated deficit (Note 2)

 

(195,894

)

(150,294

)

Total stockholders’ equity

 

36,846

 

48,577

 

 

 

$

43,825

 

$

56,430

 

 

See accompanying notes to consolidated financial statements.

 

1



 

CONSOLIDATED STATEMENT OF OPERATIONS AND ACCUMULATED DEFICIT

(Unaudited)

 

Stressgen Biotechnologies Corporation and Subsidiaries

(Canadian dollars in thousands, except per share amounts)

 

 

 

Three months ended
June 30,

 

Six months ended
June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

Revenue:

 

 

 

 

 

 

 

 

 

Bioreagent sales

 

$

1,446

 

$

1,373

 

$

2,898

 

$

2,792

 

Collaborative R&D revenue

 

190

 

1,508

 

363

 

6,729

 

Total revenue

 

1,636

 

2,881

 

3,261

 

9,521

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

5,973

 

4,791

 

11,542

 

11,284

 

Selling, general and administrative

 

1,892

 

1,866

 

4,245

 

4,156

 

Cost of bioreagent sales

 

306

 

388

 

662

 

753

 

 

 

8,171

 

7,045

 

16,449

 

16,193

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

(6,535

)

(4,164

)

(13,188

)

(6,672

)

 

 

 

 

 

 

 

 

 

 

Other income (expenses):

 

 

 

 

 

 

 

 

 

Interest and other income, net

 

(48

)

255

 

302

 

458

 

Net foreign exchange gain (loss)

 

244

 

(485

)

291

 

(626

)

Interest expense

 

(27

)

(9

)

(55

)

(20

)

 

 

169

 

(239

)

538

 

(188

)

 

 

 

 

 

 

 

 

 

 

Net loss

 

(6,366

)

(4,403

)

(12,650

)

(6,860

)

 

 

 

 

 

 

 

 

 

 

Accumulated deficit, beginning of period

 

(189,528

)

(136,506

)

(150,294

)

(134,049

)

Cumulative effect of change in accounting policy (Note 2)

 

 

 

(32,950

)

 

Accumulated deficit, end of period

 

$

(195,894

)

$

(140,909

)

$

(195,894

)

$

(140,909

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per common share

 

$

(0.09

)

$

(0.07

)

$

(0.17

)

$

(0.11

)

 

 

 

 

 

 

 

 

 

 

Weighted average shares used to compute basic and diluted loss per common share  (in thousands)

 

72,506

 

61,198

 

72,502

 

60,721

 

 

See accompanying notes to consolidated financial statements.

 

2



 

CONSOLIDATED STATEMENT OF CASH FLOWS

(Unaudited)

 

Stressgen Biotechnologies Corporation and Subsidiaries

(Canadian dollars in thousands)

 

 

 

Three months ended
June 30,

 

Six months ended
June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

Cash flows from operating activities:

 

 

 

 

 

 

 

 

 

Net loss

 

$

(6,366

)

$

(4,403

)

$

(12,650

)

$

(6,860

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

 

Depreciation and amortization of plant and equipment

 

204

 

171

 

342

 

344

 

Loss on disposal of plant and equipment

 

44

 

 

59

 

 

Amortization of stock compensation expense

 

301

 

52

 

964

 

107

 

Unrealized foreign exchange (gain) loss

 

(232

)

178

 

(222

)

508

 

Loss on market value of investments

 

304

 

15

 

310

 

52

 

Changes in operating assets and liabilities

 

(15

)

2,140

 

(450

)

(2,217

)

Net cash used in operating activities

 

(5,760

)

(1,847

)

(11,647

)

(8,066

)

 

 

 

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

 

 

 

 

Purchase of short-term investments

 

(2,000

)

(8,767

)

(22,919

)

(31,191

)

Sales and maturities of short-term investments

 

12,008

 

4,264

 

22,943

 

4,862

 

Purchase of plant and equipment

 

(58

)

(42

)

(188

)

(54

)

Net cash provided by (used in) investing activities

 

9,950

 

(4,545

)

(164

)

(26,383

)

 

 

 

 

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

 

 

 

 

Proceeds on issuance of common shares

 

 

4,639

 

36

 

4,698

 

Share issue costs

 

 

 

(81

)

 

Repayment of borrowings

 

(114

)

(82

)

(231

)

(162

)

Net cash (used in) provided by financing activities

 

(114

)

4,557

 

(276

)

4,536

 

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

(6

)

(12

)

(21

)

(170

)

 

 

 

 

 

 

 

 

 

 

Increase (decrease) in cash and cash equivalents

 

4,070

 

(1,847

)

(12,108

)

(30,083

)

Cash and cash equivalents, beginning of period

 

3,818

 

2,966

 

19,996

 

31,202

 

Cash and cash equivalents, end of period

 

$

7,888

 

$

1,119

 

$

7,888

 

$

1,119

 

 

See accompanying notes to consolidated financial statements.

 

3



 

Stressgen Biotechnologies Corporation

Notes to Consolidated Financial Statements

(Canadian dollars)

(Unaudited)

 

1.             THE COMPANY AND ITS SIGNIFICANT ACCOUNTING POLICIES

 

The Company

 

Stressgen Biotechnologies Corporation (with its subsidiaries, “Stressgen” or the “Company”) is a biopharmaceutical company focused on the development and commercialization of innovative stress protein-based immunotherapeutics. The Company is developing a broad range of products for the treatment of viral infections and related cancers. Its lead product HspE7 targets a broad spectrum of human papillomavirus (HPV) related diseases.  The Company has also initiated research studies to evaluate stress protein (also known as heat shock protein) fusions, made through its proprietary CoValTM technology, for the treatment of hepatitis B and herpes simplex and is targeting hepatitis C.  Further, Stressgen has an internationally recognized bioreagents business with sales to scientists worldwide for the study of cellular stress, apoptosis, oxidative stress and neurobiology.

 

Basis of presentation

 

The consolidated financial statements include the assets, liabilities and operating results of the Company and its wholly-owned subsidiaries.  Intercompany accounts and transactions have been eliminated in consolidation.

 

Financial statements and estimates

 

The information at June 30, 2004 and for the three and six month periods ended June 30, 2004 and 2003 has been prepared by the Company and has not been audited.  The financial statements, in the opinion of management, include all adjustments necessary for their fair presentation in conformity with Canadian generally accepted accounting principles (“Canadian GAAP”), and conform in material respects with accounting principles generally accepted in the United States of America (“U.S. GAAP”), except as discussed in Note 7.  All such adjustments are of a normal and recurring nature.  These financial statements should be read in conjunction with the financial statements and notes thereto in the Company’s December 31, 2003 Annual Report on Form 10-K and March 31, 2004 Quarterly Report on Form 10-Q.  Certain information and footnote disclosures normally included in financial statements prepared in accordance with Canadian and U.S. GAAP have been condensed or omitted pursuant to the applicable Canadian regulatory and U.S. Securities and Exchange Commission rules and regulations.  Interim results are not necessarily indicative of results for the full year.

 

The preparation of financial statements in conformity with Canadian GAAP and U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses and related disclosures as of the date of the financial statements.  Significant estimates are used for, but not limited to, revenue recognition, accrual of clinical trial costs, measurement of stock-based compensation, and the allocation of indirect costs between research and development (R&D), selling, general and administrative (SG&A) and cost of bioreagent sales.  Actual results could differ from such estimates. 

 

Foreign currency translation

 

The Company uses the Canadian dollar as its consolidated functional currency.  Monetary assets and liabilities that are denominated in U.S. dollars or British pounds are translated into Canadian dollars at the rates of exchange prevailing at the balance sheet date.  Non-monetary assets and liabilities are translated at historical exchange rates.  Revenue and expenses are translated at the average rate of exchange for the period of such transactions. 

 

4



 

Revenue recognition

 

Revenue from product sales of the Company’s bioreagent business is recognized upon delivery to customers when persuasive evidence of an arrangement exists, the price is fixed or determinable and collection is reasonably assured.  Revenue also includes amounts charged for shipping and handling costs. 

 

Revenue from collaborative research and development arrangements may include multiple elements within a single contract.  The Company’s accounting policy complies with the revenue determination requirements set forth in EITF 00-21, Accounting for Revenue Arrangements with Multiple Deliverables, and EIC 142, Revenue Arrangements with Multiple Deliverables, relating to the separation of multiple deliverables into individual accounting units with determinable fair values.  Payments received under collaborative arrangements may include the following:  non-refundable fees at inception of contract for technology rights; funding for services performed; milestone payments for specific achievements; and payments based upon resulting sales of products. 

 

The Company recognizes collaborative research and development revenues as services are rendered consistent with the performance requirements of the contract.  Revenue from non-refundable contract fees where the Company has continuing involvement through research and development collaborations or other contractual obligations, less the fair market value of any related warrants, is recognized ratably over the development period or the period for which Stressgen continues to have a performance obligation.  The period of development is evaluated on a regular basis.  In December 2003, the Company increased the development period by one year to reflect management’s research and development plan.  Revenue from performance milestones is recognized upon the achievement of the milestones as specified in the agreement, provided payment is proportionate to the effort expended.  Payments are recorded as deferred revenue if they are received in advance of performance or delivery.

 

Clinical trial accruals

 

The Company recognizes expenses related to its ongoing clinical trials using a methodology designed to accrue estimated costs in the appropriate accounting periods when the expenses are incurred.    The Company recognizes clinical trial costs in three distinct phases that correspond with the period during which the services are performed:  the start-up phase, the patient accrual phase, and the close-out phase. The start up portion of the trial contract is accrued during the trial planning and protocol writing period.  The per patient accrual cost is recognized as each patient enters the trial.  The close-out portion of the trial is recognized as the final analyses of patient data are prepared.  Based on the design of the trial including number of patients, number of clinical sites, method of treatment, and follow-up, the proportion of the cost of each phase could vary from trial to trial.   As each trial continues, the Company evaluates the total contract costs and makes adjustments accordingly. Changes to the cost estimates are charged to expense in the appropriate period based on the facts and timing of the adjustment.

 

Stock-based compensation plan

 

In September 2003, the CICA Accounting Standards Board released revised transitional provisions for Stock-Based Compensation and Other Stock-Based Payments, Section 3870 (CICA 3870), to provide the same alternative methods of transition as is provided in the U.S. for voluntary adoption of the fair value based method of accounting.   In January 2004, the Company adopted the recommendations of the CICA 3870.  This standard requires that all stock-based awards made to non-employees be measured and recognized using a fair value based method.  The standard encourages the use of a fair value based method for all awards granted to employees, but only requires the use of a fair value based method for direct awards of stock, stock appreciation rights, and awards that call for settlement in cash or other assets. 

 

5



 

Awards that a company has the ability to settle in stock are recorded as equity, whereas awards that the entity is required to or has a practice of settling in cash are recorded as liabilities. 

 

The Company has two stock-based compensation plans, which are described in Note 5.  The Company typically grants options with an exercise price equal to the fair market value of the underlying common stock.  Under the principles of CICA 3870, compensation expense is recognized over the vesting period of the grant based on the estimated fair value at the time of grant using the Black-Scholes method.  Any consideration paid by directors, employees and others on exercise of stock options is credited to common shares.  See further discussion of the change in accounting policy in Note 2. 

 

Accounting pronouncements

 

The Emerging Issues Task Force (EITF) recently deliberated regarding Issue 03-01, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments.”  The Issue is intended to address the meaning of other-than-temporary impairment and its application to certain investments held at cost.  The EITF reached a consensus regarding disclosure requirements concerning unrealised losses on available-for-sale debt and equity securities accounted for under SFAS No. 115 “Accounting for Certain Investments in Debt and Equity Securities” and SFAS No. 124, “Accounting for Certain Investments Held for Not-for-Profit Organizations.”  The guidance for evaluating whether an investment is other-than-temporarily impaired is to be applied in reporting periods beginning after June 15, 2004.  The disclosure requirements apply to annual financial statements for fiscal years ending after December 15, 2003 for investments accounted for under SFAS Nos. 115 and 124.  For all other investments within the scope of this Issue, the disclosure requirements apply to fiscal years ending after June 15, 2004.  Additional disclosure requirements for cost method investments apply to fiscal years ending after June 15, 2004.  The Issue does not affect the current period.  The Company is currently evaluating the effect of this pronouncement on its financial statements. 

 

2.             CHANGE IN ACCOUNTING POLICY

 

In January 2004 the Company changed its accounting policy relating to stock based compensation awards, retroactive to January 1, 1995, in accordance with the recommendation of CICA 3870.  As permitted by the September 30, 2003 transitional provisions issued by the CICA Accounting Standards Board related to CICA 3870, the Company has applied this change using the retroactive method without restatement.  Expense related to stock-based compensation awards is calculated using the Black-Scholes option pricing model and recognized over the vesting period of the grant.  Previously, the Company used the intrinsic value method for valuing stock-based compensation awards granted to employees and directors where compensation expense was recognized for the excess, if any, of the quoted market price of Company’s common shares over the compensation award exercise price on the day that options were granted. 

 

6



 

The following pro forma information presents the net loss and the basic loss per common share had CICA 3870 been retroactively applied:

 

(in thousands, except per share amounts)

 

Three months ended
June 30, 2003

 

Six months ended
June 30, 2003

 

 

 

 

 

 

 

Net loss under Canadian GAAP

 

$

(4,403

)

$

(6,860

)

 

 

 

 

 

 

Stock-based compensation expense under intrinsic value method

 

52

 

107

 

Stock-based employee compensation expense under the fair value method

 

(841

)

(1,559

)

Pro forma net loss under Canadian GAAP

 

$

(5,192

)

$

(8,312

)

Pro forma basic loss per common share under Canadian GAAP

 

$

(0.08

)

$

(0.14

)

 

To implement the fair value method for stock-based compensation beginning January 1, 2004, the Company recorded an adjustment to beginning accumulated deficit of $32,950,000, comprised of $17,105,000 related to the fair value expense calculated on options granted on or after January 1, 1995, $16,434,000 related to compensation expense on the release of contingently issuable shares completed in 1999, offset by a $589,000 reversal of previously recorded expense under the principles of APB Opinion No. 25, Accounting for Stock Issued to Employees.  Under the principles of CICA 3870, the Company reclassified $3,174,000 from contributed surplus to common stock related to the historical exercise of employee stock options.  The Company recorded expense of $301,000 and $964,000 for the three and six month periods ended June 30, 2004, representing the amortization of the fair value of compensation based on the vesting period of stock options granted to employees and directors.  The weighted-average per-share fair values of the individual options granted during the three month periods ended June 30, 2004 and 2003 were $0.50 and $1.60, respectively.   The weighted-average per-share fair values of the individual options granted during the six month periods ended June 30, 2004 and 2003 were $0.68 and $1.05.   The fair value of the options was determined using a Black-Scholes option-pricing model with the following assumptions:

 

 

 

For the three months
ended June 30,

 

For the six months
ended June 30,

 

 

 

2004

 

2003

 

2004

 

2003

 

Dividend yield

 

0

%

0

%

0

%

0

%

Volatility

 

61

%

88

%

65

%

74

%

Risk-free interest rate

 

3.8

%

2.2

%

3.5

%

2.5

%

Expected life

 

4 years

 

4 years

 

4 years

 

4 years

 

 

The FASB issued SFAS No. 148, Accounting for Stock-Based Compensation, Transition and Disclosure (SFAS 148) in December 2002.  SFAS 148 provides alternative transition methods for entities that voluntarily elect to adopt the fair value recognition provisions of FASB Statement No. 123, Accounting for Stock-Based Compensation (SFAS 123), to stock-based employee compensation.  Under the provisions of SFAS 123, fair value accounting is required for all grants made on or after January 1, 1995.  The Company has not elected to adopt the provisions of SFAS 123.  See Note 7 for the reconciliation between Canadian and U.S. GAAP. 

 

7



 

3.            COLLABORATIVE AGREEMENT

 

On December 2, 2003, the Company announced it had restructured its June 24, 2002 collaboration agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (together, “Roche”), providing for the development and commercialization of the pharmaceutical fusion product candidate, HspE7.  Under the restructured terms Roche was granted an option to develop the first generation HspE7, a license to develop a second generation HspE7 product, and an option to negotiate rights to the Company’s CoValTM fusion product candidates for the treatment of cancer and hepatitis C.

 

In connection with the first generation of HspE7, the restructured agreement gives the Company the right to develop and commercialize the product for indications other than genital warts, including control of regulatory matters such as U.S. Investigational New Drug applications.  The Company can conduct dose-ranging studies in patients with genital warts.  In the original agreement the Company was responsible for clinical development expenses related to the recurrent respiratory papillomatosis (RRP) indication.  In the new agreement the Company is responsible for the manufacturing and other costs of all indications it develops.

 

The Company recorded collaborative R&D revenue of $190,000 and $1,508,000 during the three month periods ended June 30, 2004 and 2003, respectively. Collaborative R&D revenue for the six month periods ended June 30, 2004 and 2003 was $363,000 and $6,729,000, respectively.  Collaborative R&D revenue during the three and six month periods in 2004 relates principally to the amortization of upfront license fees in accordance with Staff Accounting Bulletin (SAB) No. 101 “Revenue Recognition in Financial Statements.”  Collaborative R&D revenue for the six month period ended June 30, 2003 includes $4,003,000 for development activities, a time-based development payment of $2,214,000 and $512,000 from the amortization of upfront license fees. 

 

4.             SIGNIFICANT CONTRACTUAL ACTIVITY

 

On January 28, 2004, the Company entered into a biological services agreement with Avecia Limited for manufacturing and process development of HspE7.  Under the terms of the contract, payments are due in British pounds.  The contract is a multi-year agreement for process development and manufacturing of clinical supplies, and may also include the manufacturing of commercial drug substance.  The Company purchased British pounds in anticipation of making payments in that currency.  The services agreement contains cancellation fees based on a sliding percentage of certain future program milestones.  The cancellation fee as of June 30, 2004 would have been $4,290,000.

 

5.             BALANCE SHEET DETAILS

 

At June 30, 2004 the Company had outstanding principal balances of $894,000 and $1,125,000, respectively, in the form of fixed rate capital leases and term loans including the September 2003 term loan with Oxford Finance Corporation (Oxford).  At June 30, 2004 the outstanding principal balance was $761,000 on the Oxford loan.  Under the terms of the Oxford loan, the Company must issue a letter of credit for the outstanding loan balance if our combined cash, cash equivalents, and short-term investments fall below $6,000,000.

 

8



 

The following tables provide details of selected balance sheet items:

 

(In thousands)

 

June 30,
2004

 

December 31,
2003

 

Accounts receivable:

 

 

 

 

 

Trade accounts receivable

 

$

610

 

$

492

 

Collaborative receivable

 

 

277

 

Less:  allowance for doubtful accounts

 

(35

)

(36

)

 

 

$

575

 

$

733

 

 

 

 

 

 

 

Inventories:

 

 

 

 

 

Raw materials, net of $26 provision for obsolescence

 

$

204

 

$

202

 

Work in progress, net of $156 provision for obsolescence

 

178

 

146

 

Finished goods, net of $142 provision for obsolescence

 

277

 

291

 

 

 

$

659

 

$

639

 

 

 

 

 

 

 

Accounts payable and accrued liabilities:

 

 

 

 

 

Trade accounts payable

 

$

1,856

 

$

1,461

 

Accrued compensation and benefits

 

1,161

 

1,009

 

Clinical trial accruals

 

528

 

1,409

 

Other accrued liabilities

 

41

 

96

 

 

 

$

3,586

 

$

3,975

 

 

 

 

June 30, 2004 (unaudited)

 

December 31,
2003

 

(In thousands)

 

Cost

 

Accumulated
Depreciation

 

Net Book
Value

 

Net Book
Value

 

Plant and equipment:

 

 

 

 

 

 

 

 

 

Laboratory equipment

 

$

4,154

 

$

2,683

 

$

1,471

 

$

1,626

 

Computer equipment

 

1,054

 

818

 

236

 

292

 

Furniture and fixtures

 

437

 

294

 

143

 

172

 

Leasehold improvements

 

795

 

662

 

133

 

106

 

 

 

$

6,440

 

$

4,457

 

$

1,983

 

$

2,196

 

 

Stockholders’ equity

 

In June 2002 the Company issued 2,036,436 common shares for $7,657,000 pursuant to the collaboration agreement with Roche (see Note 3).  The equity was issued at a per share price determined by the weighted average price of common shares of the Company during the ten business days prior to the Roche transaction.  

 

At the time of the original collaboration agreement, Roche received two warrants to purchase the common stock of Stressgen.  The Company allocated $1,264,000 as the fair value of the warrants, determined by independent valuation.  In April 2003, Roche exercised the first warrant to acquire 1,413,600 common shares at $3.25, resulting in net proceeds of $4,594,000 to the Company.  Under the original collaboration agreement, the Company had the right to call the second warrant resulting in an issuance of a range of shares and exercise price depending upon the price of the Company’s common stock. In connection with the restructured collaboration agreement, Roche has a continued right to exercise the second warrant for

 

9



 

814,574 shares at a purchase price of $3.76 per share at any time until June 28, 2007.  The Company no longer has the right to call the second warrant. 

 

Employee share option plan

 

The following table summarizes information related to all stock options outstanding and exercisable under the Company’s 1996 and 2001 stock-based compensation plans as of June 30, 2004.

 

 

 

Options Outstanding

 

Options Exercisable

 

Range of
Exercise Prices

 

Number
Outstanding

 

Weighted
Average
Remaining
Contractual Life
(in years)

 

Weighted
Average
Exercise
Price

 

Number
Exercisable

 

Weighted
Average
Exercise
Price

 

 

 

 

 

 

 

 

 

 

 

 

 

$0.98 - $1.99

 

1,377,395

 

7.6

 

$

1.70

 

885,197

 

$

1.74

 

$2.00 - $3.99

 

618,500

 

8.1

 

$

3.24

 

378,963

 

$

3.39

 

$4.00 - $5.99

 

1,215,095

 

7.0

 

$

4.91

 

1,056,395

 

$

4.90

 

$6.00 - $8.00

 

1,527,100

 

5.7

 

$

6.19

 

1,526,411

 

$

6.19

 

 

 

4,738,090

 

 

 

 

 

3,846,966

 

 

 

 

At June 30, 2004, there were 581,514 options available for future grant under the 2001 Plan.  At July 30, 2004 there were approximately 4,729,000 options outstanding.

 

10



 

6.             SEGMENT INFORMATION

 

The Company manages its operations in two reportable segments, Biotechnology and Bioreagents.  Revenues are allocated to countries based on customer locations. 

 

 

 

Three months ended
June 30,

 

Six months ended
June 30,

 

(In thousands)

 

2004

 

2003

 

2004

 

2003

 

Bioreagents

 

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

U.S.

 

$

998

 

$

947

 

$

1,956

 

$

1,855

 

Canada

 

58

 

69

 

131

 

126

 

Other

 

390

 

357

 

811

 

811

 

 

 

1,446

 

1,373

 

2,898

 

2,792

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

492

 

435

 

933

 

754

 

Selling, general and administrative

 

222

 

425

 

577

 

913

 

Cost of bioreagent sales

 

306

 

388

 

662

 

753

 

 

 

1,020

 

1,248

 

2,172

 

2,420

 

Operating income

 

$

426

 

$

125

 

$

726

 

$

372

 

 

 

 

 

 

 

 

 

 

 

Biotechnology

 

 

 

 

 

 

 

 

 

Collaborative R&D revenue

 

$

190

 

$

1,508

 

$

363

 

$

6,729

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

5,481

 

4,356

 

10,609

 

10,530

 

Selling, general and administrative

 

1,670

 

1,441

 

3,668

 

3,243

 

 

 

7,151

 

5,797

 

14,277

 

13,773

 

Operating loss

 

$

(6,961

)

$

(4,289

)

$

(13,914

)

$

(7,044

)

 

 

 

 

 

 

 

 

 

 

Totals

 

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

Bioreagent sales

 

$

1,446

 

$

1,373

 

$

2,898

 

$

2,792

 

Collaborative R&D revenue

 

190

 

1,508

 

363

 

6,729

 

Total revenue

 

1,636

 

2,881

 

3,261

 

9,521

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

5,973

 

4,791

 

11,542

 

11,284

 

Selling, general and administrative

 

1,892

 

1,866

 

4,245

 

4,156

 

Cost of bioreagent sales

 

306

 

388

 

662

 

753

 

 

 

8,171

 

7,045

 

16,449

 

16,193

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

$

(6,535

)

$

(4,164

)

$

(13,188

)

$

(6,672

)

 

The Company does not allocate interest and other income, or interest on capital lease obligations to each segment.

 

At June 30, 2004 and December 31, 2003, respectively, $1,814,000 and $2,006,000 of plant and equipment supported the Biotechnology operating segment while the remaining $169,000 and $190,000 supported the Bioreagent operating segment.

 

11



 

7.             THE EFFECT OF APPLYING ACCOUNTING PRINCIPLES GENERALLY ACCEPTED IN THE U.S.

 

These financial statements have been prepared in accordance with Canadian GAAP which, except as set out below, conform in all material respects to U.S. GAAP.  Effect on the consolidated financial statements:

 

Balance Sheet

 

(In thousands)

 

June 30,
2004

 

December 31,
2003

 

Current assets under Canadian GAAP

 

$

41,617

 

$

53,974

 

Adjustments to Canadian GAAP

 

 

 

Current assets under U.S. GAAP

 

$

41,617

 

$

53,974

 

 

 

 

 

 

 

Stockholders’ equity under Canadian GAAP

 

$

36,846

 

$

48,577

 

 

 

 

 

 

 

Adjustment to common stock (a)

 

(17,295

)

 

Adjustment to deferred stock compensation (a)

 

(133

)

 

Adjustment to accumulated deficit (a)

 

17,428

 

 

 

 

 

 

Stockholders’ equity under U.S. GAAP

 

$

36,846

 

$

48,577

 

 

Statement of Operations

 

 

 

Three months ended
June 30,

 

Six months ended
June 30,

 

(In thousands except per share amounts)

 

2004

 

2003

 

2004

 

2003

 

Net loss under Canadian GAAP

 

$

(6,366

)

$

(4,403

)

$

(12,650

)

$

(6,860

)

Reversal of unrealized foreign exchange (gain) loss on investments (b)

 

(238

)

166

 

(243

)

338

 

Loss on market value of investments (b)

 

304

 

15

 

310

 

52

 

Reversal of stock compensation expense (a)

 

301

 

 

964

 

 

Stock compensation expense under APB No. 25 (a)

 

(15

)

 

(52

)

 

 

 

352

 

181

 

979

 

390

 

 

 

 

 

 

 

 

 

 

 

Net loss under U.S. GAAP

 

$

(6,014

)

$

(4,222

)

$

(11,671

)

$

(6,470

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per common share under Canadian GAAP

 

$

(0.09

)

$

(0.07

)

$

(0.17

)

$

(0.11

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted loss per common share under U.S. GAAP

 

$

(0.08

)

$

(0.07

)

$

(0.16

)

$

(0.11

)

 

 

 

 

 

 

 

 

 

 

Common shares used to compute basic and diluted loss per share under Canadian and U.S. GAAP

 

72,506

 

61,198

 

72,502

 

60,721

 

 

12



 

Statement of Cash Flows

 

For all periods presented there are no significant differences under Canadian and U.S. GAAP in net cash (used in) provided by operating, investing and financing activities.

 

Differences

 

As disclosed in Note 11 to the financial statements in the Company’s December 31, 2003 Annual Report on Form 10-K, differences exist for the Company between Canadian and U.S. GAAP. 

 

The following notes outline the differences that affect the Company for the three and six month periods ended June 30, 2004 and 2003.

 


(a)           As discussed in Note 2, on January 1, 2004, the Company adopted fair value accounting for all stock options as required by CICA 3870.  The Company is required to record the expense of the fair value of all stock options over their respective vesting term.  The Company used the “Retrospective method without Restatement.”  This method requires the Company to record the cumulative expense as an adjustment to accumulated deficit for the period beginning January 1, 1995 through December 31, 2003 and begin recording the expense to retained earnings in 2004.  The Company has not adopted SFAS 123 for U.S. reporting purposes, which would require fair value based accounting for grants made on or after January 1, 1995. 

 

Under the principles of SFAS 123, the Company would have recorded $19,277,000 of deferred compensation related to the total fair value for stock options granted between January 1, 1995 and June 30, 2004.  The following table illustrates the effect on net loss and loss per share under U.S. GAAP if the Company had applied the fair value accounting provisions of SFAS 123 to employee stock based compensation:

 

 

 

Three months ended
June 30,

 

Six months ended
June 30,

 

(In thousands except per share amounts)

 

2004

 

2003

 

2004

 

2003

 

Net loss under U.S. GAAP

 

$

(6,014

)

$

(4,222

)

$

(11,671

)

$

(6,470

)

 

 

 

 

 

 

 

 

 

 

Stock-based compensation under APB No. 25

 

15

 

52

 

52

 

107

 

Stock-based compensation expense recorded under SFAS 123

 

(301

)

(841

)

(964

)

(1,559

)

Pro forma net loss under U.S. GAAP

 

$

(6,300

)

$

(5,011

)

$

(12,583

)

$

(7,922

)

 

 

 

 

 

 

 

 

 

 

Pro forma loss per common share

 

$

(0.09

)

$

(0.08

)

$

(0.17

)

$

(0.13

)

 

(b)           Under U.S. GAAP Statement of Financial Accounting Standards (SFAS) No. 115, Accounting for Certain Investments in Debt and Equity Securities, the Company would have classified certain of its short-term securities as available-for-sale and, accordingly, would have included the changes in net unrealized holding gains or losses on these securities as a component of stockholders’ equity rather than in operations. 

 

13



 

SFAS No. 130, Reporting Comprehensive Income, establishes standards for the reporting and display of comprehensive loss and its components in a full set of general-purpose financial statements.  Comprehensive loss is as follows:

 

 

 

Three months ended
June 30,

 

Six months ended
June 30,

 

(In thousands)

 

2004

 

2003

 

2004

 

2003

 

 

 

 

 

 

 

 

 

 

 

Net loss under U.S. GAAP

 

$

(6,014

)

$

(4,222

)

$

(11,671

)

$

(6,470

)

Other comprehensive income

 

 

 

 

 

 

 

 

 

Adjustment to unrealized foreign exchange gain (loss) on investments

 

238

 

(166

)

243

 

(338

)

Adjustment of market losses on investments

 

(304

)

(15

)

(310

)

(52

)

Comprehensive net loss under U.S. GAAP

 

$

(6,080

)

$

(4,403

)

$

(11,738

)

$

(6,860

)

 

8.             SUPPLEMENTAL CASH FLOW INFORMATION

 

The changes in operating assets and liabilities are as follows:

 

 

 

Three months ended
June 30,

 

Six months ended
June 30,

 

(In thousands)

 

2004

 

2003

 

2004

 

2003

 

Collaborative receivable

 

$

 

$

3,867

 

$

277

 

$

2,710

 

Trade receivables

 

26

 

(38

)

(119

)

(158

)

Inventories

 

(59

)

145

 

(20

)

141

 

Other current assets

 

165

 

241

 

20

 

184

 

Deferred expenses, net of current portion

 

17

 

58

 

35

 

120

 

Accounts payable and accrued liabilities

 

(45

)

(1,592

)

(389

)

(4,101

)

Deferred revenue

 

(119

)

(541

)

(254

)

(1,113

)

 

 

$

(15

)

$

2,140

 

$

(450

)

$

(2,217

)

Supplemental disclosures of cash flows:

 

 

 

 

 

 

 

 

 

Interest paid

 

$

28

 

$

9

 

$

56

 

$

20

 

 

 

 

 

 

 

 

 

 

 

Supplemental disclosures of non-cash transactions

 

 

 

 

 

 

 

 

 

Reversal of deferred compensation

 

$

 

$

 

$

185

 

$

 

 

14



 

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

This “Management’s Discussion and Analysis of Financial Condition and Results of Operations” is dated as of July 30, 2004.  It should be read in conjunction with our June 30, 2004 consolidated financial statements and related notes therein, which are prepared in accordance with Canadian GAAP and with our December 31, 2003 Annual Report on Form 10-K.  The differences from U.S. GAAP, as they affect our consolidated financial statements, are described in Note 7 to our consolidated quarterly financial statements and in Note 11 to our Form 10-K.  All amounts following are expressed in Canadian dollars unless otherwise indicated. 

 

The discussion contains forward-looking statements that involve risk and uncertainties.  The predictions described in these statements may not materialize if management’s current expectations regarding our future performance prove incorrect. Our results could also be affected by factors including, but not limited to, our reliance on collaborative partners and other risks described below under “Factors That May Affect Future Performance.”  The forward-looking statements are based on currently available information; we disclaim any obligation to update them. 

 

Overview

 

From our inception in 1990 to 1993, our core business involved the sale of bioreagent products.  Although we have retained and expanded our bioreagent business worldwide, our primary focus since 1993 has been the research and development of innovative stress protein-based fusion products that will stimulate the body’s immune system to combat viral infections and related cancers.  Our core, exclusively licensed technology involves the fusion of heat shock proteins with viral or cancer-associated antigens.  The lead product candidate developed with this technology, HspE7, targets a variety of human papillomavirus-related diseases, including genital warts, recurrent respiratory papillomatosis, anal intraepithelial neoplasia, cervical intraepithelial neoplasia and cervical cancer, among others.   We are also performing research studies on potential treatments for hepatitis B and herpes simplex and are evaluating fusion proteins to treat infections caused by hepatitis C. 

 

We have incurred significant losses since our inception and expect to incur substantial losses for the foreseeable future as we invest in our research and product development programs, including manufacturing, pre-clinical studies and clinical trials, and regulatory activities.  At June 30, 2004 our accumulated deficit was $195,894,000.  Historically, we have depended principally on equity financings, cash flows from our bioreagent business and funding from research collaborations to fund our business activities.  We intend to pursue additional equity financings, markets permitting, and to seek additional research collaborations to fund our business activities.

 

Our success will depend upon the safety and efficacy of our immunotherapeutic products in pre-clinical studies and clinical trials, and upon obtaining the necessary regulatory approvals to market our products.  The marketability of our products will be influenced by competition from alternative therapies and the degree of protection our intellectual property provides. We believe there will be significant markets for our therapeutic products should these products prove to be effective in human clinical trials.

 

Restructured Roche Agreement

 

On December 2, 2003, we announced a restructuring of our June 24, 2002 collaboration agreement with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (together, “Roche”), providing for the development and commercialization of our pharmaceutical fusion product candidate, HspE7.  Under the restructured terms we granted Roche an option to develop the first generation HspE7, a license to develop a second generation HspE7 product, and an option to negotiate rights to our CoValTM fusion product candidates for the treatment of cancer and hepatitis C.

 

In connection with the first generation of HspE7, the restructured agreement gives us the right to develop and commercialize the product for indications other than genital warts, including control of regulatory

 

15



 

matters such as U.S. Investigational New Drug applications.  We can conduct dose-ranging studies in patients with genital warts.  In the original agreement we were responsible for clinical development expenses related to the recurrent respiratory papillomatosis (RRP) indication.  In the new agreement we are responsible for the manufacturing and other costs of all indications we develop.  If Roche exercises its rights to the first generation product it will fund all prospective development costs.  Roche can exercise its rights to the first generation of HspE7 by paying a fee, in which case it would also become responsible for event-driven milestones that could result in aggregate payments to Stressgen of up to $207,000,000 (US $138,000,000). Under that scenario Stressgen would record first generation HspE7 product sales in the U.S. and Canada for three years following approval of a Biologics License Application (BLA) with the U.S. Food and Drug Administration, would receive sales-based payments of approximately 35% in the U.S. and Canada thereafter, and would receive sales-based payments (similar to royalties) of 20% of sales in countries outside the US and Canada. 

 

By paying additional fees, Roche can exclusively develop the second generation HspE7 product.  In such case Roche would be required to pay the costs of development, manufacturing and commercialization of the product and to pay us defined milestones. We would also receive tiered, progressive sales-based payments that we believe are competitive with other agreements of this stage and type.  Commercial success payments of up to $127,500,000 (US $85,000,000) become payable depending upon the aggregate net sales of either or both generations of the HspE7 product.

 

The restructured collaboration agreement gives Stressgen the right to discuss, negotiate and execute an alternative agreement with a third-party for the development and commercialization of HspE7 through a license, partnership, joint venture or similar transaction.  Roche can terminate this right by paying us a fee, which in 2005 would be $15,000,000 or $22,500,000 (US$10,000,000 or US$15,000,000).

 

Roche has separate non-exclusive rights to negotiate licenses to our CoValTM fusion product candidates for the treatment of cancer and hepatitis C.  Roche can pay additional fees to make these rights exclusive until January 1, 2007.

 

As part of our financial responsibility for manufacturing we pay Avecia Limited (Avecia) for process development, scale-up and manufacturing of clinical supplies under a contract discussed below.  

 

Liquidity and Capital Resources

 

Since inception we have relied principally on equity financings, research collaborations and cash flows generated from our bioreagents business to fund our research and development programs, operations and capital expenditures.  Through June 30, 2004 we have raised net proceeds of $198,238,000 through equity transactions. 

 

We will need to obtain significant additional funds through financings or strategic transactions to continue product development, manufacturing and commercialization.  If adequate funds are not available from those sources, we will be required to delay, reduce the scope of, or eliminate the development of HspE7 or other research or development programs.  Based on our current spending to support our research and development programs, as well as the existing regulatory environment and general economic conditions, our current capital resources are sufficient to fund operations for over twelve months.  

 

We employ a financial performance measurement system designed to ensure our revenues and expenses are consistent with management’s operational objectives and budgetary constraints.  Our cash utilization in 2004 is dependent upon several factors, including the timing and progress of clinical development of HspE7 and the cost of manufacturing clinical supplies. 

 

At June 30, 2004, we had $39,891,000 of cash, cash equivalents and short-term investments. The $12,199,000 decrease since December 31, 2003 is due principally to spending related to the development of HspE7.  At June 30, 2004 and December 31, 2003, approximately 30% and 24%, respectively, of cash, cash equivalents and short-term investments were held in U.S. dollars.  During the first half of 2004, we purchased British pounds to fund payments made to Avecia.  At June 30, 2004 approximately 6% of our

 

16



 

cash, cash equivalents and short-term investments were held in British pounds.  Periodically we may purchase additional British pounds based on future anticipated payments in that currency.

 

Our capital expenditures totaled $58,000 and $42,000 during the three month periods ended June 30, 2004 and 2003, respectively.  For the six month periods ended June 30, 2004 and 2003 capital expenditures were $188,000 and $54,000, respectively.  Spending in the first half of 2004 consisted of tenant improvements on our facilities, laboratory equipment, and computer related hardware.  Capital expenditures are expected to decrease during the remainder of 2004, although additional purchases are planned to support our research, development and regulatory requirements.

 

At June 30, 2004 and December 31, 2003 we had outstanding principal balances of $894,000 and $1,125,000, respectively, in the form of fixed rate capital leases and term loans including our September 2003 term loan with Oxford Finance Corporation (Oxford).  At June 30, 2004 and December 31, 2003 the outstanding principal balances were $761,000 and $906,000 on the Oxford loan.  Under the terms of the Oxford loan, we must issue a letter of credit for the outstanding loan balance if our combined cash, cash equivalents, and short-term investments fall below $6,000,000.

 

Contractual Obligations

 

Our contractual obligations consist of operating leases for facilities, capital leases to finance equipment and a term loan to increase working capital cash flows.  Details of these commitments are described in our 2003 Annual Report on Form 10-K under the section “Liquidity and Capital Resources.”  In January 2004 we entered into a biological services agreement with Avecia that is cancellable subject to specified termination conditions. The services agreement, which is further discussed below, specifies cancellation fees based on a sliding percentage of certain future program milestones.  The cancellation fee as of June 30, 2004 would have been $4,290,000.  During the three and six month periods ended June 30, 2004 there were no material changes to our contractual obligations. 

 

We have entered into various contracts for research, process development and limited product manufacturing to further the development of HspE7.  Due to our goal to retain a flexible development program, we typically negotiate termination provisions so that our financial obligations are limited to paying for work performed up to the termination date and if applicable, pre-established cancellation fees.  Except as disclosed above we currently do not have other significant research and development contracts subject to cancellation fees.  We have not entered into any minimum supply agreements with any service vendors or contract manufacturers. 

 

We expect to seek additional funds from various sources, including corporate partners that enter into research and development collaborations with us, and public and private equity financings.  If we raise additional funds by issuing equity securities, substantial dilution to our existing shareholders may result.  We may need to obtain funds through collaborative arrangements with others that are on unfavorable terms.  We may also have to relinquish rights to certain of our technologies, product candidates or products that we would otherwise seek to develop ourselves.

 

Results of Operations 

 

For the three month periods ended June 30, 2004 and 2003, our net loss was $6,366,000 and $4,403,000, respectively, or $0.09 and $0.07 per common share, respectively.  Our net losses for the six month periods ended June 30, 2004 and 2003 were $12,650,000 and $6,860,000, respectively, or $0.17 and $0.11 per common share, respectively.  Our increased net loss during the current quarter and the first half of 2004 compared to the same periods in 2003 is due principally to spending on research and development (R&D) activities related to manufacturing development that was previously funded by Roche.

 

Collaborative R&D revenue

 

We recorded collaborative R&D revenue of $190,000 and $1,508,000 during the three month periods ended

 

17



 

June 30, 2004 and 2003, respectively. Collaborative R&D revenue for the six month periods ended June 30, 2004 and 2003 was $363,000 and $6,729,000, respectively.  Collaborative R&D revenue during both periods in 2004 relates principally to the amortization of upfront license fees in accordance with Staff Accounting Bulletin (SAB) No. 101 “Revenue Recognition in Financial Statements.”  Collaborative R&D revenue for the six month period ended June 30, 2003 includes $4,003,000 for development activities, a time-based development payment of $2,214,000 and $512,000 from the amortization of upfront license fees.  Under the terms of the restructured HspE7 collaboration agreement, we expect future collaborative R&D revenue to include amortization of the initial up-front license fee, which reflects the anticipated development period of HspE7 and recognition of future milestone revenues.

 

Bioreagent sales 

 

The production and sale of bioreagents supports our business strategy by building our market presence in stress proteins and strengthening our strategic relationships with companies, academic institutions and stress response researchers. Our products are sold directly to end-users and through third party distributors.  For the three month periods ended June 30, 2004 and 2003, we reported a 5% increase in bioreagent sales to $1,446,000 from $1,373,000.  Bioreagent sales increased by 4% to $2,898,000 during the six month period ended June 30, 2004 from $2,792,000 during the same period in 2003. U.S. and Canadian dollar denominated sales in the first half of 2004 compared to the same period in 2003 increased by 11% and 10%, respectively, aided by the introduction of new products and several higher priced kit-based research products.  The foreign exchange rate applied to U.S. denominated sales was lower in the first half of 2004 compared to the first half of 2003, thereby diluting the reported improvement in U.S. dollar sales.

 

Research and development

 

Research and development includes costs associated with therapeutic product development, clinical studies, ongoing exploratory research and bioreagent product development.  In order to optimize our financial flexibility, we employ clinical research organizations to conduct our clinical trials and engage contract manufacturers to assist us with product development and manufacturing.

 

Our R&D spending during the first half of 2004 was devoted principally to activities in support of developing HspE7, including in-house research activities, spending to support the final stages of our clinical trials, and activities to support the process development and manufacturing of HspE7.  During the first half of 2004 approximately 80% of our R&D spending related to efforts developing HspE7, compared to approximately 60% for the same period in 2003.  The remaining spending relates to research supporting our bioreagent business and exploratory research involving our follow-on CoValTM fusion proteins.  

 

On June 30, 2004 we held an End of Phase II/Pre-Phase III meeting with the U.S. Food and Drug Administration (FDA) for HspE7 to discuss a path forward for the clinical development of HspE7 for recurrent respiratory papillomatosis (RRP).  Following the FDA’s recommendation, we will be submitting a final pivotal clinical trial protocol for a Special Protocol Assessment (SPA).  Under a SPA, the sponsor and the FDA formally agree to the details of the study protocol.  After our meeting with the FDA, we continue to believe that in mid-2007 we may be able to submit a Biologics License Application to the FDA for RRP as the first indication for HspE7. 

 

In January 2004, we entered into a biological services agreement with Avecia.  The contract is a multi-year agreement for process development, scale-up and manufacturing of clinical supplies.  Although the timelines may change for specific manufacturing events covered by the contract, such as GMP bulk release, cell paste production and fill/finish, we believe clinical-grade supplies will be available in the second quarter of 2005. We may also have Avecia manufacture commercial drug substance. 

 

R&D spending increased by approximately 25% to $5,973,000 during the three months ended June 30, 2004, compared with $4,791,000 for the same period in 2003.  For the six months ended June 30, 2004, R&D spending increased by approximately 2% to $11,542,000 from $11,284,000 for the same period in 2003.  This increase is due principally to increased spending at Avecia, which began early in 2004; in

 

18



 

contrast, in 2003 our third-party spending focused on Roche-requested manufacturing initiatives, which are complete.  Our spending at Avecia is expected to increase during the second half of 2004 as we transition from process development activities to initial production runs of bulk drug substance for our upcoming pivotal trial. 

 

During the second half of 2004, we expect to continue to devote the majority of planned R&D spending to support HspE7 development.  We anticipate that R&D spending will continue to increase during the second half of 2004 due to our planned HspE7 manufacturing and development activities and the start-up of additional clinical trials. 

 

Selling, general and administrative expenses 

 

Selling, general and administrative expense, or SG&A, includes executive management, business development, investor relations, legal support and general administrative activities.   

 

SG&A spending increased by approximately 1% to $1,892,000 for the three month periods ended June 30, 2004 from $1,866,000 for the same period in 2003.  For the six month periods ended June 30, 2004 and 2003, SG&A spending was $4,245,000 and $4,156,000, respectively.

 

Cost of bioreagent sales

 

The aggregate cost of bioreagent sales as a percentage of bioreagent sales was approximately 21% and 28% for the three month periods ended June 30, 2004 and 2003, respectively, resulting in gross margins of 79% and 72%, respectively.   For the six month periods ended June 30, 2004 and 2003 the aggregate cost of sales was approximately 23% and 27%, respectively, resulting in gross margins of 77% and 73%, respectively.  Our improved gross margin during the three and six month periods ended June 30, 2004 as compared to 2003 is due principally to fewer adjustments to inventory reserves in the first half of 2004 and initiatives to bring kit manufacturing in-house. 

 

Interest and other income

 

Interest and other income decreased during the three month periods ended June 30, 2004 by 119% to a loss of $48,000 compared with income of $255,000 during the same period in 2003.  During the six month periods ended June 30, 2004 and 2003 interest and other income decreased by 34% to $302,000 from $458,000, respectively.  The decrease is due principally to a $293,000 temporary write-down of our fixed income investment portfolio recorded in the second quarter 2004. 

 

Net foreign exchange gain/loss

 

For the three month period ended June 30, 2004 we recorded a net foreign exchange gain of $244,000 compared with a loss of $485,000 for the same period in 2003.  During the first half of 2004, we recorded foreign exchange a gain of $291,000 compared to a loss of $626,000 for the same period in 2003.  The volatility of the U.S. dollar compared to the Canadian dollar in 2003 caused the 2003 foreign exchange loss.

 

Basic and diluted loss per share

 

The 45% increase in net loss to $6,366,000 for the three month periods ended June 30, 2004 compared with $4,403,000 for the same period in 2003, was diluted by a 18% increase in the weighted average number of common shares outstanding, resulting in basic and diluted loss per share of $0.09 in 2004 and $0.07 in 2003The 84% increase in net loss to $12,650,000 for the six month periods ended June 30, 2004 compared with $6,860,000 for the same period in 2003, was diluted by a 19% increase in the weighted average number of common shares outstanding, resulting in basic and diluted loss per share of $0.17 in 2004 and $0.11 in 2003.

 

19



 

Differences between Canadian and U.S. generally accepted accounting principles

 

Our consolidated financial statements include adjustments necessary for their fair presentation in accordance with Canadian GAAP.  Certain adjustments would be required if these statements were to be prepared in all material respects in accordance with U.S. GAAP.

 

To conform to U.S. GAAP, our net loss would decrease by $352,000 and $979,000 for the three and six month periods ended June 30, 2004.  The principal differences under U.S. GAAP as opposed to Canadian GAAP for the three and six month periods ended June 30, 2004 were the reversal of an unrealized foreign exchange gain on investments of $238,000 and $243,000, a reversal of a loss on market value of investments of $304,000 and $310,000 and the reversal of stock compensation expense totaling $301,000 and $964,000 related to fair value stock option accounting adopted beginning January 1, 2004, offset by stock compensation expense of $15,000 and $52,000 that would be recorded under APB Opinion No. 25.  U.S. GAAP does not currently require fair value accounting on stock based compensation.  Therefore, under the provisions of APB Opinion No. 25, no expense is recorded for options granted with an exercise price equal to the fair value of the stock on the day of grant.  Under APB Opinion No. 25 expense is incurred when stock options are granted at exercise prices less than the fair value of the underlying stock.  Further, under U.S. GAAP, adjustments to the market value of our investment portfolio would be recorded as a component of stockholders’ equity.  Under Canadian GAAP unfavorable market value adjustments are recorded as a component of retained earnings.  

 

To conform to U.S. GAAP our net loss would decrease by $181,000 and $390,000 for the three and six month periods ended June 30, 2003.  The principal differences under U.S. GAAP as opposed to Canadian GAAP for the current quarter and first half of 2003, respectively, were the reversal of unrealized foreign exchange loss on investments of $166,000 and $338,000, coupled with a $15,000 and $52,000 reversal of a loss on market value of investments.

 

Basic net loss per common share under U.S. GAAP would have been $0.08 and $0.16 in the three and six month periods ended June 30, 2004, respectively.  Basic net loss per common share under U.S. GAAP would have been $0.07 and $0.11 in the three and six month periods ended June 30, 2003, respectively.   Our current assets and stockholders’ equity at June 30, 2004 are the same under U.S. GAAP and Canadian GAAP.  

 

Summary of Quarterly Results

 

The following is a summary of the unaudited quarterly results of operations for the previous eight quarters beginning with the quarter ended June 30, 2004.

 

20



 

 

 

Quarter ended

 

(In thousands except per share amounts)

 

June 30, 2004

 

March 31, 2004

 

December 31, 2003

 

September 30, 2003

 

Net revenues

 

 

 

 

 

 

 

 

 

Canadian and U.S. GAAP

 

$

1,636

 

$

1,625

 

$

1,727

 

$

2,171

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

 

 

 

 

 

 

 

Canadian and U.S. GAAP

 

5,973

 

5,569

 

3,572

 

6,009

 

 

 

 

 

 

 

 

 

 

 

Net loss (1)

 

 

 

 

 

 

 

 

 

Canadian GAAP

 

(6,366

)

(6,284

)

(3,762

)

(5,623

)

U.S. GAAP

 

(6,014

)

(5,657

)

(3,365

)

(5,463

)

 

 

 

 

 

 

 

 

 

 

Basic loss per common share

 

 

 

 

 

 

 

 

 

Canadian GAAP

 

$

(0.09

)

$

(0.09

)

$

(0.06

)

$

(0.09

)

U.S. GAAP

 

$

(0.08

)

$

(0.08

)

$

(0.05

)

$

(0.09

)

 

 

 

Quarter ended

 

 

 

June 30, 2003

 

March 31, 2003

 

December 31, 2002

 

September 30, 2002

 

Net revenues

 

 

 

 

 

 

 

 

 

Canadian and U.S. GAAP

 

$

2,881

 

$

6,640

 

$

5,320

 

$

5,826

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

 

 

 

 

 

 

 

 

Canadian and U.S. GAAP

 

4,791

 

6,493

 

7,167

 

7,447

 

 

 

 

 

 

 

 

 

 

 

Net loss (1)

 

 

 

 

 

 

 

 

 

Canadian GAAP

 

(4,403

)

(2,457

)

(4,059

)

(2,280

)

U.S. GAAP

 

(4,222

)

(2,248

)

(3,981

)

(3,668

)

 

 

 

 

 

 

 

 

 

 

Basic loss per common share

 

 

 

 

 

 

 

 

 

Canadian GAAP

 

$

(0.07

)

$

(0.04

)

$

(0.07

)

$

(0.04

)

U.S. GAAP

 

$

(0.07

)

$

(0.04

)

$

(0.07

)

$

(0.06

)

 


(1)           To conform these results to U.S. GAAP, certain adjustments would be made.  The principal differences between U.S. GAAP and Canadian GAAP are described in detail in the notes to our 2003 and 2002 financial statements and our March 31, 2004 and June 30, 2004 interim financial statements.

 

Our quarterly financial results over the past eight quarters were principally affected by variations in revenues from our Roche collaboration and variations in R&D spending.  Our collaborative R&D revenues have decreased over time due principally to our December 2003 restructured Roche agreement under which we are not reimbursed for R&D spending related to HspE7.   Another variation in our revenues occurred in the first quarter of 2003 when we received a time based development milestone.  There have not been any milestone payments since that time.  The fluctuation of R&D expense over the most recent eight quarters relates to timing of spending associated with our clinical trials, process development and manufacturing of HspE7.   See the discussion under the captions “Results of Operations—Collaborative R&D Revenue” and “Results of Operations—Research and Development” for additional information. 

 

Critical Accounting Policies

 

Our significant accounting policies are disclosed in Note 1 to our consolidated financial statements herein.  Certain of our policies require the application of management judgment in making estimates and assumptions that affect the amounts reported in the consolidated financial statements and disclosures made in the accompanying notes.  Those estimates and assumptions are based on historical experience and various other factors deemed applicable and reasonable under the circumstances.  The use of judgment in

 

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determining such estimates and assumptions is, by nature, subject to a degree of uncertainty.  Accordingly, actual results could differ from the estimates made.  Our critical accounting policies include:

 

Revenue recognition

 

Revenue from collaborative R&D arrangements may include multiple elements within a single contract.  Our accounting policy complies with the revenue determination requirements set forth in EITF 00-21 “Accounting for Revenue Arrangements with Multiple Deliverables,” and EIC 142 “Revenue Arrangements with Multiple Deliverable,” relating to the separation of multiple deliverables into individual accounting units with determinable fair values.  We estimate the fair value of deliverables in collaboration agreements using standard industry techniques.  Changes in the determination of fair values or performance periods relating to certain deliverables, and associated milestones, could impact the timing of future revenue streams.  

 

Clinical trial accruals

 

Clinical trial costs constitute a significant portion of R&D expense.  We recognize expenses related to our ongoing clinical trials using a methodology designed to accrue estimated costs in the appropriate accounting periods in which the expenses are incurred.    We recognize clinical trial costs in three distinct phases that correspond with the period during which the services are performed:  the start-up phase, the patient accrual phase, and the close-out phase. Based on the design of the trial, including the number of patients, number of clinical sites, method of treatment, and follow-up, the allocation of trial costs to each phase could vary from trial to trial.   Using our current trial accrual methodology, our liability for clinical trials as of June 30, 2004 is $528,000, which includes the estimated effect of any work-in-process terminated at the end of the reporting period.  Alternatively, if we utilized a percentage of completion approach and used an operational estimate of the actual work completed as of June 30, 2004 compared to the total contract value, our clinical trial liability would decrease by approximately $72,000. 

 

Stock-based compensation

 

In September 2003 the CICA Accounting Standards Board released revised transitional provisions for Stock-Based Compensation and Other Stock-Based Payments, Section 3870, to provide the same alternative methods of transition as is provided in the U.S. for voluntary adoption of the fair value based method of accounting.  The AcSB has also amended Section 3870 to require that all transactions whereby goods and services are received in exchange for stock-based compensation and other payments result in expenses that should be recognized in financial statements, and that this requirement would be applicable for financial periods beginning on or after January 1, 2004.  Section 3870 requires that share-based transactions should be measured on a fair value basis. We retroactively adopted the provisions of CICA Section 3870 beginning January 1, 1995.  See the detail at Note 2 in the financial statements included herein. 

 

New Accounting Pronouncement

 

The Emerging Issues Task Force (EITF) recently deliberated regarding Issue 03-01, “The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments.”  The Issue is intended to address the meaning of other-than-temporary impairment and its application to certain investments held at cost.  The EITF reached a consensus regarding disclosure requirements concerning unrealised losses on available-for-sale debt and equity securities accounted for under SFAS No. 115 “Accounting for Certain Investments in Debt and Equity Securities” and SFAS No. 124, “Accounting for Certain Investments Held for Not-for-Profit Organizations.”  The guidance for evaluating whether an investment is other-than-temporarily impaired is to be applied in reporting periods beginning after June 15, 2004.  The disclosure requirements apply to annual financial statements for fiscal years ending after December 15, 2003 for investments accounted for under SFAS Nos. 115 and 124.  For all other investments within the scope of this Issue, the disclosure requirements apply to fiscal years ending after June 15, 2004.  Additional disclosure requirements for cost method investments apply to fiscal years ending after June 15, 2004.  The

 

22



 

Issue does not affect the current period.  We are currently evaluating the effect of this pronouncement on our financial statements. 

 

FACTORS THAT MAY AFFECT FUTURE PERFORMANCE

 

Before investing in our common stock you should carefully consider the following risk factors, the other information included herein and the information included in our other reports and filings.  Our business, financial condition, and the trading price of our common stock could be adversely affected by these and other risks.

 

We are an Early Stage Development Company

 

Our biotechnology business is still at an early stage of development.  Significant additional research and development and clinical trials must be completed before our technology can be commercialized.  We have not completed the development of any therapeutic products and, therefore, have not begun to market or generate revenues from the commercialization of any therapeutic products.  We have undertaken only limited human clinical trials for HspE7 and cannot assure you that subsequent trials will generate comparable results, that the results obtained from laboratory or research studies for our other products will be replicated in human studies, that our human studies will demonstrate efficacy or that our studies and trials will not identify undesirable side effects of our products.  There are no assurances that any of our therapeutic products will:

 

      meet applicable health regulatory standards

 

      obtain required regulatory approvals or clearances

 

      be produced in commercial quantities at reasonable costs

 

      be successfully marketed or

 

      be profitable enough that we will recoup the investment made in such product candidates.

 

None of our therapeutic product candidates are expected to be commercially available for several years.  It is possible that we will not successfully develop any therapeutic products.

 

We Have a History of Operating Losses and May Never Become Profitable

 

We have not recorded any revenues from the sale of therapeutic products and have accumulated substantial net losses.  We expect we will incur continued losses for at least the next several years while our primary activities are research, development, and clinical trials.  To become profitable we, either alone or with one or more partners, must develop, manufacture and successfully market therapeutic product candidates.

 

We Must Obtain Additional Financing to Execute Our Business Plan

 

The revenues from the production and sale of bioreagents and the projected revenues from collaborators are not adequate to support either the development of HspE7 under the restructured Roche Collaboration Agreement or our other therapeutic product development programs.  We will need substantial additional funds to pursue further research and development; conduct clinical trials; obtain regulatory approvals; file, prosecute, defend and enforce our intellectual property rights and market our products.  We will seek additional funds through public or private equity or debt financing, strategic transactions and/or from other sources.  We could enter into collaborative arrangements for the development of particular products that would lead to our relinquishing some or all rights to the related technology or products.

 

There are no assurances that future funding will be available on favorable terms or at all.  If additional funding is not obtained, we will need to reduce, defer or cancel development programs, planned initiatives

 

23



 

or overhead expenditures, to the extent necessary.  The failure to fund our capital requirements would have a material adverse effect on our business, financial condition and results of operations.

 

Our Success Depends On Collaborative Partners, Licensees and Other Third Parties Over Whom We Have Limited Control

 

Due to the complexity of the process of developing therapeutics, our core business depends on arrangements with pharmaceutical companies, corporate and academic collaborators, licensors, licensees and others for the research, development, clinical testing, technology rights, manufacturing, marketing and commercialization of our products. We have various research collaborations and outsource many other business functions, including clinical trials and manufacturing.  Our license agreements could obligate us to diligently bring potential products to market, make milestone payments and royalties that, in some instances, could be substantial, and incur the costs of filing and prosecuting patent applications.  There are no assurances that we will be able to establish or maintain collaborations that are important to our business on favorable terms, or at all. 

 

A number of risks arise from our dependence on collaborative agreements with third parties.  Product development and commercialization efforts could be adversely affected if any collaborative partner:

 

      terminates or suspends its agreement with us

 

      causes delays

 

      fails to timely develop or manufacture in adequate quantities a substance needed in order to conduct clinical trials

 

      fails to adequately perform clinical trials

 

      determines not to develop, manufacture or commercialize a product to which it has rights or

 

      otherwise fails to meet its contractual obligations. 

 

Our collaborative partners could pursue other technologies or develop alternative products that could compete with the products we are developing.

 

The Profitability of Our Products Will Depend in Part on Our Ability to Protect Proprietary Rights and Operate Without Infringing the Proprietary Rights of Others

 

The profitability of our products will depend in part on our ability to obtain and maintain patents and licenses and preserve trade secrets, and the period our intellectual property remains exclusive.  We must also operate without infringing the proprietary rights of third parties and without third parties circumventing our rights. The patent positions of pharmaceutical and biotechnology enterprises, including ours, are uncertain and involve complex legal and factual questions for which important legal principles are largely unresolved.  For example, no consistent policy has emerged regarding the breadth of biotechnology patent claims that are granted by the U.S. Patent and Trademark Office or enforced by the U.S. federal courts.  In addition, the scope of the originally claimed subject matter in a patent application can be significantly reduced before a patent is issued.  The biotechnology patent situation outside the U.S. is even more uncertain, is currently undergoing review and revision in many countries, and may not protect our intellectual property rights to the same extent as the laws of the U.S.  Because patent applications are maintained in secrecy in some cases, we cannot be certain that we or our licensors are the first creators of inventions described in our pending patent applications or patents or the first to file patent applications for such inventions. 

 

Other companies may independently develop similar products and design around any patented products we develop.  We cannot assure you that:

 

24



 

      any of our patent applications will result in the issuance of patents

 

      we will develop additional patentable products

 

      the patents we have been issued will provide us with any competitive advantages

 

      the patents of others will not impede our ability to do business or

 

      third parties will not be able to circumvent our patents. 

 

On October 22, 2002 Antigenics Inc. announced that it had filed an opposition in the European Patent Office to a European patent and requests for re-examination in the U.S. Patent and Trademark Office of two U.S. patents we licensed in connection with our platform technology.  In October 2003 Antigenics filed an opposition in the European Patent Office to an additional, product specific, European patent.  It could take several years to obtain results from these proceedings.  Until we receive final results from the opposition and re-examination processes, we will not be able to assure investors of the success of our planned vigorous defense of the patents.

 

A number of pharmaceutical, biotechnology, research and academic companies and institutions have developed technologies, filed patent applications or received patents on technologies that may relate to our business.  If these technologies, applications or patents conflict with ours, the scope of our current or future patents could be limited or our patent applications could be denied.  Our business may be adversely affected if competitors independently develop competing technologies, especially if we do not obtain, or obtain only narrow, patent protection.  If patents that cover our activities are issued to other companies, we may not be able to obtain licenses at a reasonable cost, or at all; develop our technology; or introduce, manufacture or sell the products we have planned. 

 

Patent litigation is becoming widespread in the biotechnology industry.  Such litigation may affect our efforts to form collaborations, to conduct research or development, to conduct clinical testing or to manufacture or market any products under development.  There are no assurances that our patents would be held valid or enforceable by a court or that a competitor’s technology or product would be found to infringe our patents in the event of patent litigation.  Our business could be materially affected by an adverse outcome to such litigation.  Similarly, we may need to participate in interference proceedings declared by the U.S. Patent and Trademark Office or equivalent international authorities to determine priority of invention.  We could incur substantial costs and devote significant management resources to defend our patent position or to seek a declaration that another company’s patents are invalid. 

 

Much of our know-how and technology may not be patentable, though it may constitute trade secrets. There are no assurances that we will be able to meaningfully protect our trade secrets.  We cannot assure you that any of our existing confidentiality agreements with employees, consultants, advisors or collaborators will provide meaningful protection for our trade secrets, know-how or other proprietary information in the event of any unauthorized use or disclosure.  Collaborators, advisors or consultants may dispute the ownership of proprietary rights to our technology, for example by asserting that they developed the technology independently.

 

We May Encounter Difficulties in Manufacturing our Products

 

Our manufacturing experience in bioreagents is not directly applicable to the manufacture of therapeutic products.  We have not yet introduced any therapeutic products and have no experience manufacturing immunotherapeutics ourselves.  Before our products can be profitable, they must be produced in commercial quantities in a cost-effective manufacturing process that complies with regulatory requirements, including GMP, production and quality control regulations.  Because we do not have facilities for the production of therapeutic products such as HspE7, we contract with third parties for process development, the scale-up of manufacturing our products from the laboratory bench to commercial quantities, manufacturing of bulk materials, product characterization, filling the product into vials,

 

25



 

packaging and related processes.  If there are delays or difficulties in developing a commercial manufacturing process, performing manufacturing or transferring HspE7 between contractors performing different aspects of the manufacturing process, we may not be able to conduct clinical trials, obtain regulatory approval or meet demand for our products.

 

Production of our products could require raw materials which are scarce or which can be obtained only from a limited number of sources.  If our manufacturers were unable to obtain adequate supplies of such raw materials, the development, regulatory approval and marketing of our products could be delayed.

 

We Could Need More Clinical Trials or Take More Time to Complete Our Clinical Trials Than We Have Planned

 

Clinical trials vary in design by factors including dosage, end points, length, controls, and numbers and types of patients enrolled.  We may need to conduct a series of trials to demonstrate the safety and efficacy of our products.  The results of these trials may not demonstrate safety or efficacy sufficiently for regulatory authorities to approve our products. 

 

Regulatory authorities may require us to determine whether our products delay or prevent disease recurrence.  Clinical trials to show that a disease does not recur take longer to complete than clinical trials that end when patients stop having specific symptoms.  The actual schedules for our clinical trials could vary dramatically from the forecasted schedules due to factors including changes in trial design, conflicts with the schedules of participating clinicians and clinical institutions, delayed patient accrual and changes affecting product supplies for clinical trials. 

 

We rely on collaborators, including academic institutions, governmental agencies and clinical research organizations, to conduct, supervise, monitor and design some or all aspects of clinical trials involving our products.  The National Cancer Institute is sponsoring some HspE7 clinical trials.  Since these trials depend on governmental participation and funding, we have less control over their timing and design than trials we sponsor.  Delays in or failure to commence or complete any planned clinical trials could delay the ultimate timelines for product release.  Such delays could reduce investors’ confidence in our ability to develop products, likely causing our share price to decrease.

 

We May Not Be Able to Obtain the Regulatory Approvals or Clearances That Are Necessary to Commercialize Our Products

 

The U.S., Canada and other countries impose significant statutory and regulatory obligations upon the manufacture and sale of human therapeutic products.  Each regulatory authority typically has a lengthy approval process in which it examines pre-clinical and clinical data and the facilities in which the product is manufactured.  Regulatory submissions must meet complex criteria to demonstrate the safety and efficacy of the ultimate products.  Addressing these criteria requires considerable data collection, verification and analysis.  We may spend time and money preparing regulatory submissions or applications without assurances as to whether they will be approved on a timely basis or at all. 

 

Our product candidates, some of which are currently in the early stages of development, will require significant additional development and pre-clinical and clinical testing prior to their commercialization. These steps and the process of obtaining required approvals and clearances can be costly and time-consuming.  If our potential products are not successfully developed, cannot be proven to be safe and effective through clinical trials, or do not receive applicable regulatory approvals and clearances, or if there are delays in the process:

 

      the commercialization of our products could be adversely affected;

 

      any competitive advantages of the products could be diminished; and

 

26



 

      revenues or collaborative milestones from the products could be reduced or delayed.

 

Governmental and regulatory authorities may approve a product candidate for fewer indications or narrower circumstances than requested or may condition approval on the performance of post-marketing studies for a product candidate.  Even if a product receives regulatory approval and clearance, it may later exhibit adverse side effects that limit or prevent its widespread use or that force us to withdraw the product from the market. 

 

Any marketed product and its manufacturer will continue to be subject to strict regulation after approval.  Results of post-marketing programs may limit or expand the further marketing of products.  Unforeseen problems with an approved product or any violation of regulations could result in restrictions on the product, including its withdrawal from the market and possible civil actions.

 

The manufacturers of our products will be required to comply with applicable good manufacturing practices regulations, which include requirements relating to quality control and quality assurance, as well as the maintenance of records and documentation.  If the manufacturers cannot comply with regulatory requirements, including applicable good manufacturing practice requirements, we may not be allowed to develop or market the product candidates.  If we or our manufacturers fail to comply with applicable regulatory requirements at any stage during the regulatory process, we may be subject to sanctions, including fines, product recalls or seizures, injunctions, refusal of regulatory agencies to review pending market approval applications or supplements to approve applications, total or partial suspension of production, civil penalties, withdrawals of previously approved marketing applications and criminal prosecution.

 

Competitors May Develop and Market Drugs That Are Less Expensive, More Effective or Safer, Making Our Products Obsolete or Uncompetitive

 

Many competitors and potential competitors have substantially greater product development capabilities and financial, scientific, marketing and human resources than we do.  Technological competition from pharmaceutical companies and biotechnology companies is intense and is expected to increase.  Other companies have developed technologies that could be the basis for competitive products.  Some of these products have an entirely different approach or means of accomplishing the desired therapeutic effect than products we are developing.  Alternative products may be developed that are more effective, work faster and are less costly than our products.  Competitors may succeed in developing products earlier than us, obtaining approvals and clearances for such products more rapidly than us, or developing products that are more effective than ours.  In addition, other forms of medical treatment, such as surgery, may be competitive with our products. Over time, our technology or products may become obsolete or uncompetitive.  

 

Our Products May Not Gain Market Acceptance

 

Products such as HspE7 may not gain market acceptance among physicians, patients, healthcare payors and the medical community.  The degree of market acceptance of any product depends on a number of factors, including establishment and demonstration of clinical efficacy and safety, cost-effectiveness, clinical advantages over alternative products, and marketing and distribution support for the products.  Limited information regarding these factors is available in connection with our products or products that may compete with ours.

 

Our sales experience is limited to the sale of bioreagents.  To directly market and distribute any pharmaceutical products, we or our collaborators will need a marketing and sales force with appropriate technical expertise and supporting distribution capabilities.  We may not be able to establish sales, marketing and distribution capabilities or enter into arrangements with third parties on acceptable terms.  If we or our partners cannot successfully market and sell our products, our ability to generate revenue will be limited.  

 

27



 

Our Operations and the Use of Our Products Could Subject Us to Damages Relating to Injuries or Accidental Contamination

 

The human clinical trials we conduct, including trials in children, may have unforeseen long-term health implications.  We have only limited amounts of product liability insurance for our clinical trials.  We may not correctly anticipate or be able to maintain on acceptable terms the level of insurance coverage that would adequately cover potential liabilities from proposed clinical trials and eventual commercial sales.  Product liability insurance is expensive, difficult to obtain and may not be available in the future.  If we cannot obtain sufficient insurance coverage or other protection against potential product liability claims, the commercialization of our products may become financially infeasible.  If any liabilities from a claim exceed the limit of insurance coverage, we may not have the resources to pay them.

 

Our research and development processes involve the controlled use of hazardous and radioactive materials.  We are subject to federal, provincial and local laws and regulations governing the use, manufacture, storage, handling and disposal of such materials and waste products.  The risk of accidental contamination or injury from handling and disposing of such materials cannot be completely eliminated. In the event of an accident involving hazardous or radioactive materials, we could be held liable for resulting damages.  We are not insured with respect to this liability. Such liability could exceed our resources.  In the future we could incur significant costs to comply with environmental laws and regulations.

 

Our Success Depends On Attracting and Retaining Qualified Personnel

 

We depend on a core management and scientific team.  The loss of any of these individuals could prevent us from achieving our business objective of commercializing our product candidates.  Our future success will depend in large part on our continued ability to attract and retain other highly qualified scientific, technical and management personnel, as well as personnel with expertise in clinical testing and government regulation.  We face competition for personnel from other companies, universities, public and private research institutions, government entities and other organizations.  If our recruitment and retention efforts are unsuccessful, our business operations could suffer.

 

Our Revenues Will Depend Upon the Availability of Reimbursement from Third-Party Payors That Are Increasingly Challenging the Price and Examining the Cost Effectiveness of Medical Products and Services

 

Sales of therapeutic products depends in part upon the availability of reimbursement from third-party payors, including government health administration authorities, managed care providers, private health insurers and other organizations.  These third-party payors increasingly attempt to contain costs by challenging the price of products and services and limiting the coverage and level of reimbursement for pharmaceutical products.  Third party reimbursement for our products may be inadequate to enable us to maintain prices that provide a return on our product development investment.  Governments continue to propose and pass legislation designed to reduce healthcare costs.  This legislation could further limit reimbursement.  If government and third-party payors do not adequately reimburse patients for the costs of our products, the market for our products may be limited.

 

Our Share Price Has Been and Is Likely to Continue to Be Highly Volatile

 

As is typical for biotechnology companies without an approved product on the market, our share price has been highly volatile in the past and is likely to continue to be volatile. The price of our shares could be materially affected by factors including:

 

      the announcement of clinical trials results by us or our competitors

 

      regulatory actions

 

      safety issues

 

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      changes affecting patents or exclusive licenses

 

      future issuances of shares

 

      the announcement of technological innovations

 

      the release of publications

 

      the development of new commercial products

 

      changes in regulations

 

      the release of financial results

 

      public concerns over risks relating to biotechnology

 

      sales of shares by existing shareholders and

 

      changes in analyst recommendations.

 

The market for our shares, which are traded on the Toronto Stock Exchange, may be more limited than it would be if they were traded on NASDAQ or a U.S. exchange.

 

Item 3.   QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

We use the Canadian dollar as our measurement and functional currency.  As a result, we are exposed to foreign currency fluctuations through our operations because a substantial amount of our contract research and development spending has been transacted in other currencies, principally in U.S. dollars and British pounds.  We hold investment balances in the currencies in which we have expenditures planned during the foreseeable future.  During the first half of 2004, we purchased British pounds to mitigate our currency exposure based on spending plans with Avecia.  Our U.S. dollar denominated expenses and revenues are partially matched by our bioreagent product sales, 95% of which are in U.S. dollars.  We translate monetary assets and liabilities into Canadian dollars using the rates of exchange prevailing at our balance sheet date. We record the resulting exchange gains and losses in our statement of operations.  Although we do not currently engage in hedging or other activities to reduce foreign currency risk, beyond matching investments proportionately with anticipated spending, we may do so in the future if conditions change.

 

A hypothetical change in U.S dollar exchange rates by applying a 10% change to our June 30, 2004 foreign exchange rate, then applying that rate to our average level of U.S. investments during 2004, would result in a $890,000 impact.  If the value of the Canadian dollar relative to the U.S. dollar were to increase by 10%, our net loss would decrease by $890,000.  Further, if the value of the Canadian dollar relative to the U.S. dollar were to decrease by 10%, our net loss would increase by $890,000.

 

A hypothetical change in British pound exchange rates by applying a 10% change to our June 30, 2004 foreign exchange rate, then applying that rate to our average level of British pound investments during the year, would result in a $106,000 impact.  If the value of the Canadian dollar relative to the British pound were to increase by 10%, our net loss would decrease by $106,000.  Further, if the value of the Canadian dollar relative to the British pound were to decrease by 10%, our net loss would increase by $106,000.

 

We are also exposed to interest rate risk, because we maintain cash equivalent and short-term investment portfolio holdings of various issuers, types, and maturity dates with large banks and investment banking institutions.  The market value of these short-term investments on any day during the investment term may vary as a result of market interest rate fluctuations.  Changing market interest rates during the quarter affected our fixed income security valuations, resulting in a temporary write-down of our investment portfolio during the second quarter of $293,000.

 

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To differentiate between the affect of a change in the market valuation of securities caused by market interest rate changes versus a change in the annual rate of interest we could earn on a security, we calculated that a hypothetical change in interest rates comparable to a 10% change to our average rate of return would result in a $86,000 impact.  If interest rates were to increase by 10%, our net loss would decrease by $86,000.  Further, if interest rates were to decrease by 10%, our net loss would increase by $86,000.

 

We have not used derivative financial instruments in our investment portfolio.  We classify our investments as available-for-sale at the time of purchase and re-evaluate this designation as of each balance sheet date. We had $39,891,000 in cash, cash equivalents and short-term investments as of June 30, 2004.

 

Item 4.  CONTROLS AND PROCEDURES

 

Our chief financial officer and chief executive officer concluded as of June 30, 2004 that our disclosure controls and procedures (as defined in Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended) are effective and designed to alert them to material information relating to Stressgen and its consolidated subsidiaries, based on the evaluation of these controls and procedures as required by paragraph (b) of Rule 15d-15.

 

PART II—OTHER INFORMATION

 

Item 4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITIES HOLDERS
 

On May 12, 2004 we held our annual general meeting.  The shareholders elected the six directors listed below.  In each case, over 99% of the shareholders that voted cast their votes in favor of the candidate.  The specific number of votes for and withheld from each candidate are specified below:

 

Joann Data – 28,747,616 for (27,413 withheld)

Elizabeth Greetham – 28,746,616 for (28,413 withheld)

Daniel Korpolinski – 28,661,466 for (113,563 withheld)

Ian Lennox – 28,749,676 for (25,353 withheld)

Margot Northey – 28,747,326 for (27,703 withheld)

Jay Short – 28,731,216 for (43,813 withheld)

 

In addition, Deloitte & Touche LLP was reappointed as our independent auditor by a vote of 28,745,954 shares (29,075 withheld).

 

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Item 6.  EXHIBITS AND REPORTS ON FORM 8-K
 

On May 7, 2004 we filed a report on Form 8-K containing our financial results for the first quarter of 2004.

 

 

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.

 

 

Stressgen Biotechnologies Corporation

 

 

Date: August 5, 2004

/s/ Gregory M. McKee

 

 

Gregory M. McKee

 

Vice President, Corporate Development
and Chief Financial Officer
(Principal Financial and Accounting
Officer duly authorized to sign
this report on behalf of the registrant)

 

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INDEX OF EXHBITS

 

Exhibit No.

 

Description

3.9*

 

Articles of Continuance of the Company

3.10*

 

By-Laws of the Company

4.4*

 

Form of Stock Certificate

31.1

 

Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer

31.2

 

Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer

32

 

Section 1350 Certification

 


* Incorporated by reference to the Company’s Form 10-Q for the quarter ended June 30, 2001, as filed with the Commission on August 2, 2001