UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 


 

FORM 10-Q

 

ý

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

 

 

SECURITIES EXCHANGE ACT OF 1934

 

 

 

 

 

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2005.

 

 

 

 

 

OR

 

 

 

o

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE

 

 

SECURITIES EXCHANGE ACT OF 1934

 

 

 

 

 

FOR THE TRANSITION PERIOD FROM                TO               .

 

 

 

 

 

Commission File Number 0-29889

 


 

Rigel Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

94-3248524

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. Employer Identification No.)

 

 

 

1180 Veterans Blvd.

 

 

South San Francisco, CA

 

94080

(Address of principal executive offices)

 

(Zip Code)

 

 

 

(650) 624-1100

 

 

(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

 

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

 

As of October 27, 2005, there were 24,162,531 shares of the registrant’s common stock outstanding.

 

 


 

RIGEL PHARMACEUTICALS, INC.

QUARTERLY REPORT ON FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2005

 

INDEX

 

PART I

FINANCIAL INFORMATION

 

Item 1.

Condensed Financial Statements (unaudited)

 

 

Condensed Balance Sheets-September 30, 2005 and December 31, 2004

 

 

Condensed Statement of Operations-three and nine months ended September 30, 2005 and 2004

 

 

Condensed Statements of Cash Flows-nine months ended September 30, 2005 and 2004

 

 

Notes to Condensed Financial Statements

 

 

Report of Independent Registered Public Accounting Firm

 

Item 2.

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

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

Item 4.

Controls and Procedures

 

PART II

OTHER INFORMATION

 

Item 6.

Exhibits

 

 

 

 

Signatures

 

 

Certifications

 

 

 

 

 

2



 

PART I  FINANCIAL INFORMATION

 

Item 1.    Condensed Financial Statements

 

RIGEL PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(in thousands, except shares and per share amounts)

 

 

 

September 30,
2005

 

December 31,
2004

 

 

 

(unaudited)

 

(Note 1)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

91,756

 

$

10,495

 

Available-for-sale securities

 

36,167

 

60,932

 

Accounts receivable

 

1,050

 

 

Other receivables

 

570

 

699

 

Prepaid expenses and other current assets

 

2,156

 

2,113

 

Total current assets

 

131,699

 

74,239

 

 

 

 

 

 

 

Property and equipment, net

 

2,663

 

2,813

 

Other assets

 

1,657

 

1,770

 

 

 

$

136,019

 

$

78,822

 

 

 

 

 

 

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

2,738

 

$

1,945

 

Accrued compensation

 

1,595

 

1,639

 

Other accrued liabilities

 

1,746

 

1,555

 

Deferred revenue

 

8,040

 

3,728

 

Deferred rent

 

 

1,230

 

Capital lease obligations

 

1,022

 

1,321

 

Total current liabilities

 

15,141

 

11,418

 

 

 

 

 

 

 

Long-term portion of capital lease obligations

 

980

 

781

 

Long-term portion of deferred revenue

 

4,768

 

4,180

 

Long-term portion of deferred rent

 

10,830

 

9,685

 

Other long-term liabilities

 

420

 

457

 

 

 

 

 

 

 

Commitments

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 24,154,428 and 19,661,295 shares issued and outstanding on September 30, 2005 and December 31, 2004, respectively

 

24

 

20

 

Additional paid-in capital

 

352,590

 

264,823

 

Deferred stock compensation

 

(30

)

(56

)

Accumulated other comprehensive loss

 

(75

)

(220

)

Accumulated deficit

 

(248,629

)

(212,266

)

Total stockholders’ equity

 

103,880

 

52,301

 

 

 

$

136,019

 

$

78,822

 

 


Note (1)               The balance sheet at December 31, 2004 has been derived from the audited financial statements at that date included in Rigel’s Annual Report on Form 10-K, for the year ended December 31, 2004.

 

See accompanying notes.

 

 

3



 

RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)

 

 

 

Three Months Ended
September  30,

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

(unaudited)

 

(unaudited)

 

Revenues:

 

 

 

 

 

 

 

 

 

Contract revenues from collaborations

 

$

3,282

 

$

659

 

$

10,506

 

$

3,633

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

13,676

 

13,266

 

38,656

 

36,228

 

General and administrative

 

3,383

 

3,711

 

9,686

 

9,370

 

 

 

17,059

 

16,977

 

48,342

 

45,598

 

Loss from operations

 

(13,777

)

(16,318

)

(37,836

)

(41,965

)

Interest income

 

935

 

255

 

1,667

 

684

 

Interest expense

 

(64

)

(73

)

(194

)

(248

)

Net loss

 

$

(12,906

)

$

(16,136

)

$

(36,363

)

$

(41,529

)

Net loss per share, basic and diluted

 

$

(0.56

)

$

(0.88

)

$

(1.74

)

$

(2.37

)

Weighted average shares used in computing net loss per common share, basic and diluted

 

23,235

 

18,386

 

20,958

 

17,552

 

 

See accompanying notes.

 

 

4



 

RIGEL PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(in thousands)

 

 

 

Nine Months Ended
September 30,

 

 

2005

 

2004

 

 

 

(unaudited)

 

Operating activities:

 

 

 

 

 

Net loss

 

$

(36,363

)

$

(41,529

)

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

 

 

 

 

 

Depreciation and amortization

 

683

 

1,553

 

Amortization of deferred stock compensation, net

 

17

 

101

 

Non-cash stock compensation

 

121

 

2,399

 

Changes in assets and liabilities:

 

 

 

 

 

Accounts receivable

 

(1,050

)

500

 

Other receivables

 

129

 

(86

)

Prepaid expenses and other current assets

 

(43

)

(124

)

Other assets

 

113

 

61

 

Accounts payable

 

793

 

1,105

 

Accrued compensation

 

(44

)

811

 

Other accrued liabilities

 

191

 

(110

)

Deferred revenue

 

4,900

 

(1,866

)

Deferred rent and other long-term liabilities

 

(122

)

4,309

 

Net cash used in operating activities

 

(30,675

)

(32,876

)

 

 

 

 

 

 

Investing activities:

 

 

 

 

 

Purchase of available-for-sale securities

 

(45,984

)

(70,904

)

Maturities of available-for-sale securities

 

70,894

 

41,585

 

Capital expenditures

 

(533

)

(853

)

Net cash provided by/(used in) investing activities

 

24,377

 

(30,172

)

 

 

 

 

 

 

Financing activities:

 

 

 

 

 

Proceeds from capital lease financing

 

1,191

 

454

 

Payments on capital lease obligations

 

(1,291

)

(1,743

)

Net proceeds from issuances of common stock

 

87,659

 

60,331

 

Net cash provided by financing activities

 

87,559

 

59,042

 

 

 

 

 

 

 

Net increase (decrease) in cash and cash equivalents

 

81,261

 

(4,006

)

Cash and cash equivalents at beginning of period

 

10,495

 

9,621

 

Cash and cash equivalents at end of period

 

$

91,756

 

$

5,615

 

 

See accompanying notes.

 

 

5



 

Rigel Pharmaceuticals, Inc.

Notes to Condensed Financial Statements

(unaudited)

 

In this Quarterly Report, “Rigel,” “we,” “us” and “our” refer to Rigel Pharmaceuticals, Inc.

 

1. Nature of Operations

 

We were incorporated in the state of Delaware on June 14, 1996. We are engaged in the discovery and development of a broad range of new small molecule product candidates.

 

2. Basis of Presentation

 

Our accompanying unaudited condensed financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and pursuant to the instructions to Form 10-Q and Article 10 of
Regulation S-X.  In our opinion, these unaudited condensed financial statements include all adjustments, consisting only of normal recurring adjustments, which we consider necessary to fairly state our financial position and the results of our operations and cash flows. Interim-period results are not necessarily indicative of results of operations or cash flows for a full-year period. The balance sheet at December 31, 2004 has been derived from audited financial statements at that date, but does not include all disclosures required by generally accepted accounting principles for complete financial statements.

 

These unaudited condensed financial statements and the notes accompanying them should be read in conjunction with our Annual Report on Form 10-K for the year ended December 31, 2004.

 

Comprehensive loss did not differ materially from the net loss as reported.

 

3. Net Loss Per Share

 

Basic net loss per share is computed based on the number of weighted average shares outstanding.  The calculation of diluted net loss per share excludes shares of potential common stock, consisting of stock options and warrants, because their effect is anti-dilutive.

 

4.  Stock Award Plans

 

We have elected to continue to follow Accounting Principles Board Opinion No. 25, or APB 25, “Accounting for Stock Issued to Employees,” to account for employee stock options because the alternative fair value method of accounting prescribed by Statement of Financial Accounting Standards, or FAS, No. 123, as amended by FAS No. 148 “Accounting for Stock-Based Compensation,” requires the use of option valuation models that were not developed for use in valuing employee stock options. Under APB 25, the intrinsic value method of accounting, no compensation expense is recognized because the exercise price of our employee stock options equals the market price of the underlying stock on the date of grant.

 

Pro forma information regarding net loss and net loss per share has been determined as if we had accounted for our employee stock options and employee stock purchase plan under the fair value method prescribed by FAS No. 123, as amended by FAS No. 148. The fair value for these options was estimated at the date of grant using the Black-Scholes model.

 

 

6



 

For purposes of pro forma disclosures, the estimated fair value of the options is amortized to expense over the vesting period of the options. Our pro forma information follows (in thousands, except per share amounts):

 

 

 

Three Months Ended
September  30,

 

Nine Months Ended
September 30,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

 

 

 

 

 

 

Net loss-as reported:

 

$

(12,906

)

$

(16,136

)

$

(36,363

)

$

(41,529

)

Less: Total stock-based employee compensation expense determined under APB 25

 

645

 

1,979

 

114

 

1,973

 

Add: Total stock-based employee compensation expense determined under the fair value based method for all awards

 

2,451

 

1,613

 

7,344

 

5,466

 

Pro forma net loss

 

$

(14,712

)

$

(15,770

)

$

(43,593

)

$

(45,022

)

Basic and diluted net loss per common share:

 

 

 

 

 

 

 

 

 

As reported

 

$

(0.56

)

$

(0.88

)

$

(1.74

)

$

(2.37

)

Pro forma

 

$

(0.63

)

$

(0.86

)

$

(2.08

)

$

(2.57

)

 

5. Revenue Recognition

 

Non-refundable, up-front payments received in connection with research and development collaboration agreements, including technology access fees, are deferred and recognized on a straight-line basis over the relevant periods of continuing involvement, generally the research term.

 

Revenues related to collaborative research with our corporate collaborators are recognized as research services are performed over the related development funding periods for each contract. Under these agreements, we are required to perform research and development activities as specified in each respective agreement. The payments received are not refundable and are generally based on a contractual cost per full-time equivalent employee working on the project. Research and development expenses under the collaborative research agreements, except for the Merck collaboration signed in November 2004 related to ubiquitin ligases, approximate or exceed the revenue recognized under such agreements over the term of the respective agreements.  For the Merck collaboration, we are recognizing a pro-rata portion of the invoiced amounts for funding of our research scientists based on the headcount dedicated to the project.  It is our policy to recognize revenue based on our level of effort expended, however, revenue recognized will not exceed amounts billable under the arrangement which corresponds to cash receipts.

 

Milestones are recognized pursuant to collaborative agreements upon the achievement of these at risk milestones.

 

Royalties will be recognized as earned in accordance with the contract terms when the third party results are reliably measurable and collectibility is reasonably assured.

 

 

7



 

6. Cash, Cash Equivalents, and Available-For-Sale Securities

 

Available-for-sale securities consist of the following (in thousands):

 

 

 

Estimated
Fair Value at

 

 

 

September 30,
2005

 

December 31,
2004

 

 

 

 

 

 

 

Checking account

 

$

1,542

 

$

240

 

Money market funds

 

13,899

 

9,261

 

Federal agency securities

 

10,434

 

15,684

 

Corporate bonds and notes

 

102,048

 

46,242

 

 

 

$

127,923

 

$

71,427

 

 

 

 

 

 

 

Reported as:

 

 

 

 

 

Cash and cash equivalents

 

$

91,756

 

$

10,495

 

Available-for-sale securities

 

36,167

 

60,932

 

 

 

$

127,923

 

$

71,427

 

 

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Estimated
Fair Value

 

September 30, 2005

 

 

 

 

 

 

 

 

 

Federal agency securities

 

$

8,227

 

$

 

(9

)

$

8,218

 

Corporate bonds and notes

 

$

28,015

 

2

 

(68

)

27,949

 

Total

 

$

36,242

 

$

2

 

$

(77

)

$

36,167

 

 

 

 

Amortized
Cost

 

Gross
Unrealized
Gains

 

Gross
Unrealized
Losses

 

Fair Value

 

December 31, 2004

 

 

 

 

 

 

 

 

 

Federal agency securities

 

$

15,709

 

$

2

 

$

(27

)

$

15,684

 

Corporate bonds and notes

 

46,437

 

6

 

(201

)

46,242

 

Total

 

$

62,146

 

$

8

 

$

(228

)

$

61,926

 

 

At September 30, 2005, the above debt securities had a weighted average maturity of approximately 55 days with one security with a fair market value of $2.0 million having a maturity greater than 360 days.

 

The following table shows the gross unrealized losses and fair values of our investments in individual securities that are in an unrealized loss aggregated by investment category, (in thousands):

 

 

 

Fair Value

 

Unrealized
(Losses)/gains

 

September 30, 2005

 

 

 

 

 

Federal agency securities

 

$

5,475

 

$

(9

)

Corporate bonds and notes

 

23,967

 

(68

)

Total

 

$

29,442

 

$

(77

)

December 31, 2004

 

 

 

 

 

Federal agency securities

 

$

11,706

 

$

(27

)

Corporate bonds and notes

 

37,294

 

(201

)

Total

 

$

49,000

 

$

(228

)

 

At September 30, 2005, we had investments in individual securities with a fair market value of approximately $10.5 million that have been in a continuous unrealized loss position for more than twelve months. As of September 30, 2005, this unrealized loss position was approximately $33,000.  We have not recorded an impairment charge as of  September 30, 2005, since we have the ability and intent to hold these investments to maturity at which time no gain or loss would be recognized.  All of these investments will mature by December 31, 2005.  During the periods presented, there were no recorded realized gains or losses on investments.

 

 

8



 

As of September 30, 2005 a total of  18 individual securities were in an unrealized loss position.   As of December 31, 2004, 32 individual securities were in an unrealized loss position.

 

7. Merck Collaboration

 

In November 2004, we entered into a broad collaboration agreement with Merck & Co., Inc. to investigate ubiquitin ligases, a new class of drug target, to find treatments for cancer and potentially other diseases. At the time we entered into the agreement, we received an initial cash payment of $7.6 million and funding for our research scientists for two and a half years. We are recognizing the upfront payment ratably over the two and a half year term of the research agreement.   We are recognizing a pro-rata portion of the invoiced amounts for funding of our research scientists based on the headcount dedicated to the project.  The amount that is deferred is currently anticipated to be recognized as revenue at the end of the research phase of the agreement (May 2007) when all of our obligations have been fulfilled under the terms of the contract.  As of September 30, 2005, $859,000 remains deferred which represents amounts invoiced to Merck from the initiation of the research term in excess of the required headcount to be allocated to the project through the balance sheet date.   We are also eligible to receive milestone payments for preclinical and clinical events in the future. Merck is responsible for worldwide development and commercialization of any resulting compounds and will pay Rigel royalties on future product sales, if any. The collaboration is based on a number of new targets delivered by Merck and does not include our current ligase targets. In addition, we may nominate our own targets for potential inclusion in the collaboration.

 

8. Pfizer Collaboration

 

In January 2005, we signed a collaborative research and license agreement with Pfizer for the development of intrapulmonary products for the treatment of allergic asthma and chronic obstructive pulmonary disease (COPD). The collaboration is focused on our preclinical small molecule compounds, which inhibit IgE receptor signaling in respiratory tract mast cells by blocking the signaling enzyme Syk kinase.  The goal of the collaboration is for Pfizer to nominate two of the licensed compounds in order to commence advanced preclinical development with our assistance.    We will earn milestone payments  upon the selection of each of the two compounds, as well as in connection with other clinical events and royalties from sales of the resulting products upon marketing approval.  Pfizer is responsible for the manufacture of all preclinical and clinical materials for each compound/product and all costs associated with development and commercialization.

 

In connection with this collaboration, Pfizer paid us $10.0 million upfront and purchased $5.0 million of our common stock at a premium.  We are amortizing the upfront amount into revenue over 24 months which we consider to be the overall amount of time it will take Pfizer to nominate two of our compounds for advanced pre-clinical development.

 

9. Equipment Lease Line

 

In June 2005, our equipment credit line under an original master agreement was extended to create a total borrowing limit of $1.5 million.  We have the ability to draw down on this line through June 2006.  The payment period will be for three years with the interest rate on the line fixed at drawdown.  Each line has a bargain purchase buyout provision of $101.  As of September 30, 2005, no amounts have been drawn on this credit line.

 

10. Equity Financing

 

In July 2005, we completed a public offering in which we sold 4,197,500 shares of our common stock, including 547,500 shares issued upon exercise of an option granted to the underwriters to cover over-allotments, at a price to the public of $20.75 per share.  We received net proceeds of approximately $81.6 million after deducting underwriting discounts and commissions and related expenses.

 

 

11. Subsequent Event

 

On October 24, 2005 , we signed  a licensing agreement with Serono that grants to Serono an exclusive license to develop and commercialize product candidates from our Aurora kinase inhibitor program which includes R763. Under the terms of the agreement, we received initial payments totaling $25.0 million, comprised of a license fee of $10.0 million and the purchase of $15.0 million of our common stock, at a premium.

 

 

 

9



 

Report of Independent Registered Public Accounting Firm

 

The Board of Directors

Rigel Pharmaceuticals, Inc.

 

We have reviewed the condensed balance sheet of Rigel Pharmaceuticals, Inc. as of  September 30, 2005, and the related condensed statements of operations for the three-month and nine-month periods ended September 30, 2005 and 2004, and the condensed statements of cash flows for the nine-month periods ended September 30, 2005 and 2004.  These interim financial statements are the responsibility of the Company’s management.

 

We conducted our review in accordance with the standards of the Public Company Accounting Oversight Board (United States). A review of interim financial information consists principally of applying analytical procedures and making inquiries of persons responsible for financial and accounting matters. It is substantially less in scope than an audit conducted in accordance with the standards of the Public Company Accounting Oversight Board, the objective of which is the expression of an opinion regarding the financial statements taken as a whole. Accordingly, we do not express such an opinion.

 

Based on our review, we are not aware of any material modifications that should be made to the condensed interim financial statements referred to above for them to be in conformity with U.S. generally accepted accounting principles.

 

We have previously audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the condensed balance sheet of Rigel Pharmaceuticals, Inc. as of December 31, 2004, and the related statements of operations, shareholders’ equity, and cash flows for the year then ended not presented herein, and in our report dated March 10, 2005, we expressed an unqualified opinion on those financial statements. In our opinion, the information set forth in the accompanying balance sheet as of December 31, 2004, is fairly stated, in all material respects, in relation to the balance sheet from which it has been derived.

 

 

/s/ Ernst & Young LLP

Palo Alto, California

 

November 7, 2005

 

 

 

10



 

Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

This discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this report and the 2004 audited financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2004. Operating results for the three and nine months ended September 30, 2005 are not necessarily indicative of results that may occur in future periods.

 

Except for the historical information contained herein, the following discussion contains forward-looking statements that are based upon current expectations. Forward-looking statements involve risks and uncertainties and include statements related to:

 

                    our strategy;

 

                    the progress of our research programs, including clinical testing;

 

                    sufficiency of our cash resources;

 

                    revenues from existing and new collaborations;

 

                    product development; and

 

                    our research and development and other expenses.

 

Words such as “believe,” “anticipate,” “expect,” “estimate,” “plan” and similar expressions are intended to identify such forward-looking statements. There can be no assurance that these statements will prove to be correct. Our actual results and the timing of events could differ significantly from those discussed here. Factors that could cause or contribute to such differences include, but are not limited to, those discussed in “Risk Factors,” as well as those discussed elsewhere in this quarterly report.  You should consider our forward-looking statements in light of the risks discussed in “Risk Factors,” as well as our financial statements, related notes, and the other financial information appearing elsewhere in this report. Rigel undertakes no obligation to update any of the forward- looking statements contained herein to reflect any future events or developments.

 

Overview

 

Rigel is a clinical stage drug development company that discovers and develops novel, small-molecule drugs for the treatment of inflammatory diseases, cancer and viral diseases. Our goal is to move one new product candidate for a significant indication into the clinic each year. We have achieved this goal since 2002. Our research focuses on intracellular signaling pathways and related targets that are critical to disease mechanisms. Our productivity has resulted in strategic collaborations with large pharmaceutical partners to develop and market our product candidates. We have three product development programs in allergy/asthma, rheumatoid arthritis and cancer.

 

Over the last couple of years, we have matured into a  clinical stage drug development company with multiple product candidates in various stages of development.

 

                    R112—Product Candidate for Allergic Rhinitis.  In April 2004, we initiated a Phase II “park study” clinical trial in which we measured allergic symptom improvement.   This randomized, placebo-controlled Phase II “park study” enrolled 319 patients with the primary objective of measuring the safety and efficacy of R112 as an intranasal treatment for allergic rhinitis. On August 2, 2004, we announced the results of this trial, which demonstrated that, in the study population, R112 reduced certain symptoms of allergic rhinitis in a statistically significant manner compared to placebo, had a favorable safety profile and had a rapid onset of action in symptom improvement. There were no significant drug-related adverse events reported in the trial, and adverse event frequencies were indistinguishable from placebo.  As early as the 30 to 45 minute time interval after dosing, R112 showed a significant improvement in symptom scores over placebo and demonstrated a rapid onset of action in symptom improvement.  Furthermore, these beneficial effects lasted throughout the entire

 

 

11



 

measurement period until the end of the park day.  In particular, symptoms most closely associated with chronic nasal congestion (e.g., stuffy nose) were dramatically improved with R112 over placebo.  Based on the results of the single and multi-dose trials, as well as the Phase II “park study,” we initiated an additional Phase II trial in August 2005 with top line data planned for by the end this year.  This trial, which enrolled 397 patients, is a randomized, double-blind study comparing R112 to placebo and Beconase AQ® (beclomethasone) nasal spray over a seven day period. We are also actively seeking to partner with a pharmaceutical company with respect to R112. Under the terms of an agreement with Pfizer, Inc., Pfizer has a limited right of negotiation for R112 under certain circumstances, but the agreement does not preclude us from partnering with other pharmaceutical companies with respect to R112.

 

                    R406/788—Product Candidate for Rheumatoid Arthritis. In January 2004, we selected R406 as our lead product candidate to treat rheumatoid arthritis.  R406 is a novel, oral Syk kinase inhibitor that, in preclinical studies, blocked the activation of mast cells and B cells that promote the swelling and inflammatory response.  Data from pre-clinical studies indication that R406 was effective in a rodent arthritis model and was without significant toxicity at doses well above the effective dose.  We initiated an escalating single-does and multiple-dose, placebo-controlled Phase I clinical trial of R406 in December 2004 and we announced the preliminary results of the trial in March 2005.   The results of this study indicated that R406 was well tolerated at plasma levels of R406 that we plan to use moving forward. The study also generated pharmacokinetic/pharmacodynamic data establishing a correlation between R406 plasma levels and the inhibition of its target.  We are also studying an oral solid dosage formulation of R406 called R788 (and sometimes referred to as R406/788). We completed a Phase I clinical study of R788 in a single center, double-blind, randomized, placebo-controlled trial to investigate the safety and pharmacokinetics of escalating single and multiple doses of R788. The results from this study are expected later this year.   We anticipate that the results from these studies will allow us to conduct broader, longer-term safety, efficacy and pharmacokinetic studies in 2006.

 

                    R763—Product Candidate for Oncology.  In July 2004, we identified R763 as a lead compound in our aurora kinase inhibition program, targeting cancer cell proliferation.  R763 is a potent, highly-selective, small-molecule inhibitor of aurora kinase.  We expect to file an IND by the end of 2005.  In October 2005 , we signed a licensing agreement with Serono that grants to Serono an exclusive license to develop and commercialize product candidates from our Aurora kinase inhibitor program which includes R763.  Under the agreement, we are responsible for filing the IND for R763 while Serono  will be responsible for the further development and commercialization of R763, as well as any other product candidates arising from our Aurora kinase inhibitor program.

 

In July 2005, we announced that we will undertake the development of other chemical scaffolds in our Hepatitis C virus program because preliminary findings from pre-clinical studies of a pro-drug of R803 showed insufficient bioavailability. We expect to bring these alternate scaffolds into pre-clinical studies in 2006.

 

In addition to the above mentioned product candidates, we have ongoing research programs involving back-up candidates for the product candidates above as well as drug discovery efforts in our immunology/inflammation, virology, and oncology programs.

 

Corporate Collaborations

 

We carry on research and development programs in connection with our corporate collaborations.  As of  October  30, 2005, we have collaborations with six major pharmaceutical/biotech companies, including one with Janssen Pharmaceutica N.V., a division of Johnson & Johnson, relating to oncology therapeutics and diagnostics, two with Pfizer Inc., one initiated in 1999 and the other in the first quarter of  2005, relating to asthma and allergy therapeutics, one with Novartis Pharma AG with respect to four different programs relating to immunology, oncology and chronic bronchitis, one with Daiichi Pharmaceuticals Co., Ltd. in the area of oncology, one with Merck, in the area of oncology, and one with Serono in the area of oncology . All of these collaborations, excluding the recent Pfizer and the Serono collaborations, have a research phase during which we receive or received funding based on the level of headcount allocated to a program. In all of these collaborations if certain conditions are met, we are entitled to receive future milestone payments and royalties. We cannot guarantee that these conditions will be met or that research and development efforts will be successful.  As a result, we may be precluded from receiving any milestone payments or royalties under these agreements. Only the Merck program currently provides for regular research reimbursement payments as the research phase of the Daiichi collaboration ended in August 2005.

 

 

We are exploring new opportunities with existing and potential collaborators. Our earliest partnerships focused on the early stages of drug discovery, specifically on target discovery and validation. Our collaborations with Daiichi and recently with Merck are both later stage focusing on drug discovery and development. Our 2005 collaboration with Pfizer

 

 

12



 

covers compounds at the preclinical and lead designation stages while our 2005 collaboration with Serono covers a compound for which an IND will be filed before the end of 2005.  We currently anticipate that in order to support our current research programs we will need to self-fund our own research programs, which involve an increased rate of spending, to later stages of development prior to partnering with collaborative partners. Therefore, it is expected that future collaborations may have an expanded focus and could include HTS, combinatorial and medicinal chemistry, preclinical evaluations and/or clinical development of compounds we have discovered. In addition, we believe these future collaborations could be structured to consist of upfront payments, the purchase of our common stock, milestone payments upon meeting certain conditions, research reimbursement payments and/or royalties upon commercialization of products resulting from the collaboration.

 

Critical Accounting Policies and the Use of Estimates

 

Our discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with U.S generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including those related to terms of the research collaborations, investments, stock compensation, impairment issues, the estimated useful life of assets and contingencies. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe the following critical accounting policies affect our more significant judgments and estimates used in the preparation of our financial statements.

 

We believe that there have been no significant changes in our critical accounting policies during the period ended September 30, 2005 as compared to those previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2004.

 

Revenue Recognition

 

We recognize revenue from our contract arrangements. Our revenue arrangements with multiple elements are divided into separate units of accounting if certain criteria are met, including whether the delivered element has stand-alone value to the customer and whether there is objective and reliable evidence of the fair value of the undelivered items. The consideration we receive is allocated among the separate units based on their respective fair values, and the applicable revenue recognition criteria are applied to each of the separate units. Advance payments received in excess of amounts earned are classified as deferred revenue until earned.

 

Non-refundable, up-front payments received in connection with research and development collaboration agreements, including technology access fees, are deferred and recognized on a straight-line basis over the relevant periods of continuing involvement, generally the research term.

 

Revenues related to collaborative research with our corporate collaborators are recognized as research services are performed over the related development funding periods for each contract. Under these agreements, we are required to perform research and development activities as specified in each respective agreement. The payments received are not refundable and are generally based on a contractual cost per full-time equivalent employee working on the project. Research and development expenses under the collaborative research agreements, except for the Merck collaboration signed in November 2004 related to ubiquitin ligases approximate or exceed the revenue recognized under such agreements over the term of the respective agreements.  For the Merck collaboration, we are recognizing a pro-rata portion of the invoiced amounts for funding of our research scientists based on the headcount dedicated to the project.  It is our policy to recognize revenue based on our level of effort expended, however, revenue recognized will not exceed amounts billable under the arrangement which corresponds to cash receipts.

 

Milestones are recognized pursuant to collaborative agreements upon the achievement of these at risk milestones.

 

Royalties will be recognized as earned in accordance with the contract terms when the third party results are reliably measurable and collectibility is reasonably assured.

 

 

13



 

Stock-based Compensation

 

 

 

 

 

 

 

Aggregate

 

 

 

 

 

Aggregate

 

 

 

Three months ended

 

Change

 

Nine months ended

 

Change

 

 

 

September 30,

 

2005 from

 

September 30,

 

2005 from

 

 

 

2005

 

2004

 

2004

 

2005

 

2004

 

2004

 

 

 

(in thousands)

 

Stock—based compensation from:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Re-priced employee options

 

$

633

 

$

1,953

 

$

(1,320

)

$

82

 

$

1,787

 

$

(1,705

)

Consultant options

 

139

 

310

 

(171

)

24

 

424

 

(400

)

Other employee options

 

12

 

26

 

(14

)

32

 

187

 

(155

)

Total

 

$

784

 

$

2,289

 

$

(1,505

)

$

138

 

$

2,398

 

$

(2,260

)

 

We record charges associated with the stock options that were eligible for re-pricing under a tender offer initiated in June 2003. All replacement options, as well as the eligible options that were not surrendered under the original offer to exchange, are being treated for financial reporting purposes as variable awards. Therefore, we are recording a non-cash charge, generally for the intrinsic value of the options as they vest, utilizing the graded vesting method, reflecting increases and decreases (down to, but not below, the exercise price) in the price of our common stock as compensation expense (recovery) in connection with the replacement options and the eligible options that were not exchanged. We expect to continue to reflect increases and decreases in the price of our common stock in our statement of operations with respect to these options until they are exercised, forfeited or terminated. The higher the market value of our common stock, the greater the compensation expense. For the three months ended September 30, 2005, we recorded non-cash compensation of $0.6 million related to all employee options eligible for replacement options.  This expense resulted from the increase in the market price of our common stock during this period.  For the three months ended September 30, 2004, we recorded non-cash compensation of $2.0 million related to all options eligible for the replacement.  This expense resulted from the increase in the market price of our common stock during this period.  We are currently evaluating option valuation methodologies and assumptions in light of SFAS 123R related to our employee stock option and employee stock purchase plans.

 

We also record charges associated with options granted to consultants reflecting the periodic revaluation of outstanding consultant options based upon the current market value of our common stock and other assumptions, including the expected future volatility of our stock price. For the three months ended September 30 2005, we recorded non-cash compensation of $139,000 for revaluation of consultant options.   For the three months ended September 30, 2004, we recorded non-cash compensation of $310,000 for revaluation of consultant options.   We expect to see continued fluctuations in the future as a portion of these options are revalued based on the changes in the current market price of our common stock through the application of the graded vesting method.

 

Three and Nine Months Ended September 30, 2005 and 2004

 

Revenues

 

 

 

 

 

 

 

Aggregate

 

 

 

 

 

Aggregate

 

 

 

Three months ended

 

Change

 

Nine months ended

 

Change

 

 

 

September 30,

 

2005 from

 

September 30,

 

2005 from

 

 

 

2005

 

2004

 

2004

 

2005

 

2004

 

2004

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Contract revenue from collaborations

 

$

3,282

 

$

659

 

$

2,623

 

$

10,506

 

$

3,633

 

$

6,873

 

 

 

14



 

Revenues by collaborator were:

 

 

 

 

 

 

 

Aggregate

 

 

 

 

 

Aggregate

 

 

 

Three months ended

 

Change

 

Nine months ended

 

Change

 

 

 

September 30,

 

2005 from

 

September 30,

 

2005 from

 

 

 

2005

 

2004

 

2004

 

2005

 

2004

 

2004

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Merck

 

$

1,812

 

$

 

$

1,812

 

$

5,072

 

$

 

$

5,072

 

Pfizer

 

1,250

 

 

1,250

 

2,991

 

 

2,991

 

Daiichi

 

220

 

659

 

(439

)

2,443

 

1,967

 

476

 

Novartis

 

 

 

 

 

1,666

 

(1,666

)

Total

 

$

3,282

 

$

659

 

$

2,623

 

$

10,506

 

$

3,633

 

$

6,873

 

 

Contract revenues from collaborations for the three and nine months ended September 30, 2005 and 2004 consisted primarily of research support and amortization of upfront fees from our collaborations with Merck, Daiichi, Pfizer and, for the nine months ended September 30, 2004 only, Novartis.  In the nine months ended September 30, 2005, revenues included a  $900,000 milestone payment from Daiichi which primarily related to the acceptance by Daiichi of two compounds to move toward pre-clinical testing.  The increase in revenues for the three and nine months ended September 30, 2005 was due to the initiation of the Merck and Pfizer collaborations and the Daiichi milestone payment offset by the termination of the research phase of the Novartis oncology program in 2004.   We have deferred approximately $859,000 of research reimbursement revenue from Merck in order to only account for the headcount effort expended by us.  We expect this amount will be recognized as revenue no later than at the end of the research phase of the collaboration which will be May 2007.  We expect contract revenues from collaborations to be the significant component of our total revenues for the foreseeable future.

 

Research and Development Expenses

 

 

 

 

 

 

 

Aggregate

 

 

 

 

 

Aggregate

 

 

 

Three months ended

 

Change

 

Nine months ended

 

Change

 

 

 

September 30,

 

2005 from

 

September 30,

 

2005 from

 

 

 

2005

 

2004

 

2004

 

2005

 

2004

 

2004

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$

13,676

 

$

13,266

 

$

410

 

$

38,656

 

$

36,228

 

$

2,428

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock based compensation expense included in research and development expenses

 

$

570

 

$

1,634

 

$

(1,064

)

$

109

 

$

1,863

 

$

(1,754

)

 

The increase in research and development expenses of $0.4 million for the three months ended September 30, 2005 was primarily attributable to an increase in our preclinical and clinical costs and personnel costs offset by a reduction in  stock-based compensation expense related to the re-priced stock options subject to variable accounting, as discussed previously under “Stock-Based Compensation” in the “Critical Accounting Policies and the Use of Estimates” section.  The increase in our preclinical and clinical costs for the three months ended September 30, 2005 was attributable to costs associated with our R763, R112 and R788 programs.  The costs attributable to R763 were related to ongoing IND enabling studies, as well as the production of material for our upcoming clinical trials.  The costs attributable to R112 were related to clinical costs associated with the Phase II study initiated in August 2005.  The costs attributable to R788 were related to our ongoing clinical trials as well as continuing IND enabling studies. The increase in research and development expenses of $2.4 million for the nine months ended September 30, 2005 was primarily attributable to an increase in our preclinical and clinical costs and personnel costs offset by  a reduction in stock-based compensation expense related to the re-priced stock options subject to variable accounting.  The increase in our pre-clinical and clinical costs for the nine months ended September 30, 2005 was attributable to costs associated with our R788  and R763 programs, offset by a decrease in costs related to the R803 program, which was discontinued in July 2005.   We expect that research and development expenses will increase through the remainder of 2005 due to the completion of the Phase II study for R112.

 

The scope and magnitude of future research and development expenses are difficult to predict at this time given the number of studies that will need to be conducted for any of our potential products, as well as our limited capital resources. In general, biopharmaceutical-development involves a series of steps—beginning with identification of a potential target and including, among others, proof of concept in animals and Phase I, II and III clinical studies in humans—each of which is typically more expensive than the previous step. Success in development, therefore, results in increasing expenditures. Our

 

 

15



 

research and development expenditures currently include costs for scientific personnel, supplies, equipment, consultants, sponsored research, allocated facility costs, costs related to preclinical and clinical trials, and stock-based compensation.

 

General and Administrative Expenses

 

 

 

 

 

 

 

Aggregate

 

 

 

 

 

Aggregate

 

 

 

Three months ended

 

Change

 

Nine months ended

 

Change

 

 

 

September 30,

 

2005 from

 

September 30,

 

2005 from

 

 

 

2005

 

2004

 

2004

 

2005

 

2004

 

2004

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

General and administrative expenses

 

$

3,383

 

$

3,711

 

$

(328

)

$

9,686

 

$

9,370

 

$

316

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock based compensation expense included in general and administrative expenses

 

$

214

 

$

655

 

$

(441

)

$

29

 

$

535

 

$

(506

)

 

The decrease in general and administrative expenses of $0.3 million  for the three months ended September 30, 2005 was primarily attributable to a reduction in stock-based compensation expense related to the re-priced stock options subject to variable accounting, as discussed previously under “Stock-Based Compensation” in the “Critical Accounting Policies and the Use of Estimates” section.  The increase in general and administrative expenses of $0.3 million for the nine months ended September 30, 2005 was primarily attributable to increased legal costs associated with the expansion of our patent estate and personnel costs offset by a reduction in stock-based compensation expense related to the re-priced stock options subject to variable accounting.

 

Net Interest Income

 

 

 

 

 

 

 

Aggregate

 

 

 

 

 

Aggregate

 

 

 

Three months ended

 

Change

 

Nine months ended

 

Change

 

 

 

September 30,

 

2005 from

 

September 30,

 

2005 from

 

 

 

2005

 

2004

 

2004

 

2005

 

2004

 

2004

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net interest income

 

$

871

 

$

182

 

$

689

 

$

1,473

 

$

436

 

$

1,037

 

 

Interest income results from our interest-bearing cash and investment balances, whereas interest expense is the result of our capital lease obligations associated with fixed asset purchases.  The increase in both the three and nine months ended September 30, 2005 is  attributable to an increase in our overall investment balances as well as an increase in the interest rates earned on our investment balances.

 

Liquidity and Capital Resources

 

Cash Requirements

 

We have financed our operations from inception primarily through sales of equity securities, contract payments payable to us under our collaboration agreements and equipment financing arrangements.  In July 2005, we completed a public offering in which we sold 4,197,500 shares of our common stock, including 547,500 shares issued upon exercise of an option granted to the underwriters to cover over-allotments, at a price to the public of $20.75 per share which resulted in net proceeds to us of approximately $81.6 million after deducting underwriting discounts and commissions and related expenses.  We believe that our existing capital resources and anticipated proceeds from current collaborations will be sufficient to support our current operating plan through at least the next 18 months. Our operations will require significant additional funding in large part due to our research and development expenses, future preclinical and clinical-testing costs, our facility lease commitments and the absence of any meaningful revenues for the foreseeable future. The amount of future funds needed will depend largely on the timing and structure of potential future collaborations. We do not know whether additional financing will be available when needed, or that, if available, we will obtain financing on terms favorable to our stockholders or us. We have consumed substantial amounts of capital to date, and operating expenditures are expected to increase over the next several years as we expand our research and development activities.

 

On October 24, 2005 , we signed  a licensing agreement with Serono that grants to Serono an exclusive license to develop and commercialize product candidates from our Aurora kinase inhibitor program which includes R763. Under the terms of the agreement, we received initial payments totaling $25.0 million, comprised of a license fee of $10.0 million and the purchase of $15.0 million of our common stock, at a premium.

 

 

16



 

To the extent we raise additional capital by issuing equity securities, our stockholders could at that time experience substantial dilution. To the extent that we raise additional funds through collaboration and licensing arrangements, we may be required to relinquish some rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us. Our future funding requirements will depend upon many factors, including, but not limited to:

 

                    the progress and success of preclinical studies and clinical trials of our product candidates conducted by us or our collaborative partners or licensees;

 

                    our ability to establish new collaborations and to maintain our existing collaboration partnerships;

 

                    the progress of research programs carried out at Rigel;

 

                    any changes in the breadth of our research and development programs;

 

                    our ability to meet the milestones identified in our collaborative agreements that trigger payments;

 

                    the progress of the research and development efforts of our collaborators;

 

                    our ability to acquire or license other technologies or compounds that we seek to pursue;

 

                    our ability to manage our growth;

 

                    competing technological and market developments;

 

                    the costs and timing of obtaining, enforcing and defending our patent and intellectual rights;

 

                    the costs and timing of regulatory approvals; and

 

                    expenses associated with unforeseen litigation.

 

Insufficient funds may require us to delay, scale back or eliminate some or all of our research or development programs, to lose rights under existing licenses or to relinquish greater or all rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose or may adversely affect our ability to operate as a going concern.

 

As of September 30, 2005, we had $127.9 million in cash, cash equivalents and available-for-sale securities, as compared to $71.4 million as of December 31, 2004, an increase of $56.5 million.  The increase is primarily attributable to net proceeds of $81.6 million received from our public offering in July 2005, offset by operating spending for the nine months ended September 30, 2005.  We also received $1.2 million under our equipment financing arrangements which was offset by $1.3 million in debt service payments during this period.   For the three and nine months ended September 30, 2005 and 2004, we maintained an investment portfolio primarily in depository accounts and corporate commercial paper. Cash in excess of immediate requirements is invested with regard to liquidity and capital preservation. Wherever possible, we seek to minimize the potential effects of concentration and degrees of risk.

 

 

 

 

 

 

 

 

 

 

17



 

Contractual Obligations

 

The following are our contractual commitments (by fiscal year) as of September 30, 2005 associated with debt obligations, contracted research obligations, and lease obligations:

 

 

 

Total

 

2005

 

2006 -2008

 

2009 -2010

 

2011-2018

 

 

 

(in thousands)

 

Debt obligations(1)

 

$2,109

 

$259

 

$1,850

 

$—

 

$—

 

License commitments

 

300

 

 

300

 

 

 

Facilities leases, net of sublease(2)(3)

 

170,564

 

1,943

 

39,591

 

26,878

 

102,152

 

Total

 

$172,973

 

$2,202

 

$41,741

 

$26,878

 

$102,152

 

 


(1)                                  As of September 30, 2005, we had $2.0 million in debt obligations associated with our equipment additions. All existing debt agreements as of September 30, 2005 are secured by the equipment financed and are due in monthly installments through 2008.

 

(2)                                  During May 2004, we initiated a sublease of approximately 15,000 square feet of our premises to a tenant for a period of two years.  This sublease was amended in September 2005 to extend the term for one additional year.  The facilities lease obligations above are reflective of the new sublease income stream.

 

(3)                                  The payments above reflect the fifteen years of the lease term of our facility through January 2018.

 

 

18



 

Risk Factors

 

In evaluating our business, you should carefully consider the following risks, as well as the other information contained in this quarterly report on Form 10-Q. If any of the following risks actually occurs, our business could be harmed. The risks and uncertainties described below are not the only ones facing us. Additional risks and uncertainties not presently known to us, or that we currently see as immaterial, may also harm our business.

 

We will need additional capital in the future to sufficiently fund our operations and research.

 

We have consumed substantial amounts of capital to date, and operating expenditures are expected to increase over the next several years.  In July 2005, we completed a public offering in which we sold 4,197,500 shares of our common stock, including 547,500 shares issued upon exercise of an option granted to the underwriters to cover over-allotments, at a price to the public of $20.75 per share, which resulted in net proceeds to us of approximately $81.6 million after deducting underwriting discounts and commissions and related expenses.  We believe that our existing capital resources and anticipated proceeds from current collaborations will be sufficient to support our current operating plan through at least the next 18 months. Our operations will require significant additional funding in large part due to our research and development expenses, future preclinical and clinical-testing costs, and the absence of any meaningful revenues for the foreseeable future. The amount of future funds needed will depend largely on the timing and structure of potential future collaborations. We do not know whether additional financing will be available when needed, or that, if available, we will obtain financing on terms favorable to our stockholders or us. We have consumed substantial amounts of capital to date, and operating expenditures are expected to increase over the next several years as we expand our infrastructure and research and development activities.

 

On October 24, 2005 , we signed  a licensing agreement with Serono that grants to Serono an exclusive license to develop and commercialize product candidates from our Aurora kinase inhibitor program which includes R763. Under the terms of the agreement, we received initial payments totaling $25.0 million, comprised of a license fee of $10.0 million and the purchase of $15.0 million of our common stock, at a premium.

 

To the extent we raise additional capital by issuing equity securities, our stockholders could at that time experience substantial dilution. To the extent that we raise additional funds through collaboration and licensing arrangements, we may be required to relinquish some rights to our technologies or product candidates, or grant licenses on terms that are not favorable to us.

 

Our future funding requirements will depend on many uncertain factors.

 

Our future funding requirements will depend upon many factors, including, but not limited to:

 

                    the progress and success of preclinical studies and clinical trials of our product candidates conducted by us or our collaborative partners or licensees;

 

                    our ability to establish new collaborations and to maintain our existing collaboration partnerships;

 

                    the progress of research programs carried out by us;

 

                    any changes in the breadth of our research and development programs;

 

                    our ability to meet the milestones identified in our collaborative agreements that trigger payments;

 

                    the progress of the research and development efforts of our collaborative partners;

 

                    our ability to acquire or license other technologies or compounds that we seek to pursue;

 

                    our ability to manage our growth;

 

                    competing technological and market developments;

 

                    the costs and timing of obtaining, enforcing and defending our patent and intellectual rights;

 

                    the costs and timing of regulatory approvals and filings by us and our collaborators; and

 

                    expenses associated with unforeseen litigation.

 

 

19



 

Insufficient funds may require us to delay, scale back or eliminate some or all of our research or development programs, to lose rights under existing licenses or to relinquish greater or all rights to product candidates at an earlier stage of development or on less favorable terms than we would otherwise choose or may adversely affect our ability to operate as a going concern.

 

Our success as a company is uncertain due to our history of operating losses and the uncertainty of future profitability.

 

Due in large part to the significant research and development expenditures required to identify and validate new product candidates and pursue our development efforts, we have not been profitable and have incurred operating losses since we were incorporated in June 1996. The extent of our future losses and the timing of potential profitability are highly uncertain, and we may never achieve profitable operations. We incurred net losses of $36.4 million for the first nine months of 2005, $56.3 million in 2004 and $41.2 million in 2003. Currently, our revenues are generated solely from research payments pursuant to our collaboration agreements and licenses and are insufficient to generate profitable operations. As of September 30, 2005, we had an accumulated deficit of approximately $248.6 million. We expect to incur losses for at least the next several years and expect that these losses could increase as we expand our research and development activities and incur significant clinical and testing costs.

 

There is a high risk that  drug discovery and development efforts might not successfully generate good product candidates.

 

At the present time, the majority of our operations are in various stages of drug identification and development. We currently have two product compounds in the clinical testing stage. In our industry, it is statistically unlikely that the limited number of compounds that we have identified as potential product candidates will actually lead to successful product development efforts, and we do not expect any drugs resulting from our research to be commercially available for several years, if at all. Our product compounds in the clinic and our future leads for potential drug compounds are subject to the risks and failures inherent in the development of pharmaceutical products. These risks include, but are not limited to, the inherent difficulty in selecting the right drug and drug target and avoiding unwanted side effects as well as unanticipated problems relating to product development, testing, regulatory compliance, manufacturing, marketing, competition and costs and expenses that may exceed current estimates. The results of preliminary studies do not necessarily predict clinical or commercial success, and larger later-stage clinical trials may fail to confirm the results observed in the preliminary studies. With respect to our own compounds in development, we have established anticipated timelines for clinical development based on existing knowledge of the compound. However, we cannot provide assurance that we will meet any of these timelines with respect to the initiation or completion of clinical studies.

 

We expect to initiate clinical trials of R763 in the beginning of 2006. Because of the uncertainty of whether the accumulated preclinical evidence (pharmacokinetic, pharmacodynamic, safety and/or other factors) or early clinical results will be observed in later clinical trials, we can make no assurance regarding the likely results from our future clinical trials or the impact of those results on our business.

 

We might not be able to commercialize our product candidates successfully if problems arise in the clinical testing and approval process.

 

Commercialization of our product candidates depends upon successful completion of preclinical studies and clinical trials. Preclinical testing and clinical development are long, expensive and uncertain processes. We do not know whether we, or any of our collaborative partners, will be permitted to undertake clinical trials of potential products beyond the trials already concluded and the trials currently in process. It will take us or our collaborative partners several years to complete any such testing, and failure can occur at any stage of testing. Interim results of trials do not necessarily predict final results, and acceptable results in early trials may not be repeated in later trials. A number of companies in the pharmaceutical industry, including biotechnology companies, have suffered significant setbacks in advanced clinical trials, even after achieving promising results in earlier trials. Moreover, we or our collaborative partners or regulators may decide to discontinue development of any or all of these projects at any time for commercial, scientific or other reasons. For example, if patients experience undesirable adverse events, we may be required to halt or suspend a clinical trial.

 

 

 

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Delays in clinical testing could result in increased costs to us.

 

Significant delays in clinical testing could materially impact our product development costs. We do not know whether planned clinical trials will begin on time, will need to be halted or revamped or will be completed on schedule, or at all. Clinical trials can be delayed for a variety of reasons, including delays in obtaining regulatory approval to commence a study, delays in reaching agreement on acceptable clinical study agreement terms with prospective clinical sites, delays in obtaining institutional review board approval to conduct a study at a prospective clinical site or delays in recruiting subjects to participate in a study. Environmental conditions may impact the execution of some clinical trials, particularly during the allergy season for our allergic rhinitis program.

 

In addition, we typically rely on third-party clinical investigators to conduct our clinical trials and other third-party organizations to oversee the operations of such trials and to perform data collection and analysis. As a result, we may face additional delaying factors outside our control if these parties do not perform their obligations in a timely fashion. While we have not yet experienced delays that have materially impacted our clinical trials or product development costs, delays of this sort could occur for the reasons identified above or other reasons. If we have delays in testing or approvals, our product development costs will increase. For example, we may need to make additional payments to third-party investigators and organizations to retain their services or we may need to pay recruitment incentives. If the delays are significant, our financial results and the commercial prospects for our product candidates will be harmed, and our ability to become profitable will be delayed.

 

We lack the capability to manufacture compounds for development and rely on third parties to manufacture our product candidates, and we may be unable to obtain required material in a timely manner, at an acceptable cost or at a quality level required to receive regulatory approval.

 

We currently do not have manufacturing capabilities or experience necessary to produce our product candidates, including R112, R788 and R763 for preclinical testing and clinical trials. We rely on a single third-party contractor to produce R112 bulk drug substance and another single third-party contractor to produce R763.  We also rely on different single manufacturers for finished R112 and R788 product for preclinical and clinical testing. We will rely on manufacturers to deliver materials on a timely basis and to comply with applicable regulatory requirements, including the U.S. Food and Drug Administration’s, or FDA’s current Good Manufacturing Practices, or GMP. These outsourcing efforts with respect to manufacturing preclinical and clinical supplies will result in a dependence on our suppliers to timely manufacture and deliver sufficient quantities of materials produced under GMP conditions to enable us to conduct planned preclinical studies, clinical trials and, if possible, to bring products to market in a timely manner.

 

Our current and anticipated future dependence upon these third-party manufacturers may adversely affect our ability to develop and commercialize product candidates on a timely and competitive basis. These manufacturers may not be able to produce material on a timely basis or manufacture material at the quality level or in the quantity required to meet our development timelines and applicable regulatory requirements. We may not be able to maintain or renew our existing third-party manufacturing arrangements, or enter into new arrangements, on acceptable terms, or at all. Our third-party manufacturers could terminate or decline to renew our manufacturing arrangements based on their own business priorities, at a time that is costly or inconvenient for us. If we are unable to contract for the production of materials in sufficient quantity and of sufficient quality on acceptable terms, our planned clinical trials may be significantly delayed. Manufacturing delays could postpone the filing of our IND applications and/or the initiation of clinical trials that we have currently planned.

 

Our third-party manufacturers may not be able to comply with the GMP regulations, other applicable FDA regulatory requirements or similar regulations applicable outside of the United States. Additionally, if we are required to enter into new supply arrangements, we may not be able to obtain approval from the FDA of any alternate supplier in a timely manner, or at all, which could delay or prevent the clinical development and commercialization of any related product candidates. Failure of our third-party manufacturers or us to obtain approval from the FDA or to comply with applicable regulations could result in sanctions being imposed on us, including fines, civil penalties, delays in or failure to grant marketing approval of our product candidates, injunctions, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of products and compounds, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect our business.

 

Because most of our expected future revenues are contingent upon collaborative and license agreements, we might not meet our strategic objectives.

 

Our ability to generate revenue in the near term depends on our ability to enter into additional collaborative agreements with third parties and to maintain the agreements we currently have in place. Our ability to enter into new collaborations and the revenue, if any, that may be recognized under these collaborations is highly uncertain. If we are unable to enter into new

 

 

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collaborations, our business prospects could be harmed, which could have an immediate adverse effect on the trading price of our stock.

 

To date, most of our revenues have been related to the research phase of each of our collaborative agreements. Such revenues are for specified periods, and the impact of such revenues on our results of operations is partially offset by corresponding research costs. Following the completion of the research phase of each collaborative agreement, additional revenues may come only from milestone payments and royalties, which may not be paid, if at all, until some time well into the future. The risk is heightened due to the fact that unsuccessful research efforts may preclude us from receiving any milestone payments under these agreements. Our receipt of revenues from collaborative arrangements is also significantly affected by the timing of efforts expended by us and our collaborators and the timing of lead compound identification. In late 2001, we recorded the first revenue from achievement of milestones in both the Pfizer and Johnson & Johnson collaborations. During 2002, we recorded our first milestone for both Novartis and Daiichi. Under many agreements, however, milestone payments may not be earned until the collaborator has advanced products into clinical testing, which may never occur or may not occur until some time well into the future. If we are not able to generate revenue under our collaborations when and in accordance with our expectations or the expectations of industry analysts, this failure could harm our business and have an immediate adverse effect on the trading price of our stock.

 

Our business requires us to generate meaningful revenue from royalties and licensing agreements. To date, we have not received any revenue from royalties for the commercial sale of drugs, and we do not know when we will receive any such revenue, if at all. Likewise, we have not licensed any lead compounds or drug development candidates to third parties, and we do not know whether any such license will be entered into on acceptable terms in the future, if at all.

 

If our current corporate collaborations or license agreements are unsuccessful, our research and development efforts could be delayed.

 

Our strategy depends upon the formation and sustainability of multiple collaborative arrangements and license agreements with third parties in the future. We rely on these arrangements for not only financial resources, but also for expertise that we expect to need in the future relating to clinical trials, manufacturing, sales and marketing, and for licenses to technology rights. To date, we have entered into several such arrangements with corporate collaborators; however, we do not know if such third parties will dedicate sufficient resources or if any development or commercialization efforts by third parties will be successful. Should a collaborative partner fail to develop or commercialize a compound or product to which it has rights from us, such failure might delay ongoing research and development efforts at Rigel because we might not receive any future milestone payments and we would not receive any royalties associated with such compound or product. In addition, the continuation of some of our partnered drug discovery and development programs may be dependent on the periodic renewal of our corporate collaborations.

 

The research phase of our collaboration with Johnson & Johnson ended in December 2003, and the research phases conducted at our facilities under our broad collaboration with Novartis ended in July 2004. The research phase of our corporate collaboration agreement with Daiichi ended in August 2005.  In November 2004, we signed a new corporate collaboration with Merck, in January 2005 we signed an additional collaboration with Pfizer, and in October 2005 we signed an additional collaboration with Serono. These agreements could be terminated by the other party, and we may not be able to renew these collaborations on acceptable terms, if at all, or negotiate additional corporate collaborations on acceptable terms, if at all. If these collaborations terminate or are not renewed, any resultant loss of revenues from these collaborations or loss of the expertise of our collaborative partners could adversely affect our business.

 

Conflicts also might arise with collaborative partners concerning proprietary rights to particular compounds. While our existing collaborative agreements typically provide that we retain milestone payments and royalty rights with respect to drugs developed from certain derivative compounds, any such payments or royalty rights may be at reduced rates, and disputes may arise over the application of derivative payment provisions to such drugs, and we may not be successful in such disputes.

 

We are also a party to various license agreements that give us rights to use specified technologies in our research and development processes. The agreements pursuant to which we have in-licensed technology permit our licensors to terminate the agreements under certain circumstances. If we are not able to continue to license these and future technologies on commercially reasonable terms, our product development and research may be delayed.

 

If conflicts arise between our collaborators or advisors and us, any of them may act in their self-interest, which may be adverse to our stockholders’ interests.

 

If conflicts arise between us and our corporate collaborators or scientific advisors, the other party may act in its self-interest and not in the interest of our stockholders. Some of our corporate collaborators are conducting multiple product

 

 

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development efforts within each disease area that is the subject of the collaboration with us. In some of our collaborations, we have agreed not to conduct, independently or with any third party, any research that is competitive with the research conducted under our collaborations. Our collaborators, however, may develop, either alone or with others, products in related fields that are competitive with the products or potential products that are the subject of these collaborations. Competing products, either developed by our collaborators or to which our collaborators have rights, may result in their withdrawal of support for our product candidates.

 

If any of our corporate collaborators were to breach or terminate its agreement with us or otherwise fail to conduct the collaborative activities successfully and in a timely manner, the preclinical or clinical development or commercialization of the affected product candidates or research programs could be delayed or terminated. We generally do not control the amount and timing of resources that our corporate collaborators devote to our programs or potential products. We do not know whether current or future collaborative partners, if any, might pursue alternative technologies or develop alternative products either on their own or in collaboration with others, including our competitors, as a means for developing treatments for the diseases targeted by collaborative arrangements with us.

 

Our success is dependent on intellectual property rights held by us and third parties, and our interest in such rights is complex and uncertain.

 

Our success will depend to a large part on our own, our licensees’ and our licensors’ ability to obtain and defend patents for each party’s respective technologies and the compounds and other products, if any, resulting from the application of such technologies. We have over 150 pending patent applications and over 50 issued patents in the United States that are owned or exclusively licensed in our field as well as pending corresponding foreign patent applications. In the future, our patent position might be highly uncertain and involve complex legal and factual questions. For example, we may be involved in interferences before the United States Patent and Trademark Office. Interferences are complex and expensive legal proceedings and there is no assurance we will be successful in such proceedings. An interference could result in our losing our patent rights and/or our freedom to operate and/or require us to pay significant royalties. Additional uncertainty may result because no consistent policy regarding the breadth of legal claims allowed in biotechnology patents has emerged to date. Accordingly, we cannot predict the breadth of claims allowed in our or other companies’ patents.

 

Because the degree of future protection for our proprietary rights is uncertain, we cannot ensure that:

 

                    we were the first to make the inventions covered by each of our pending patent applications;

 

                    we were the first to file patent applications for these inventions;

 

                    others will not independently develop similar or alternative technologies or duplicate any of our technologies;

 

                    any of our pending patent applications will result in issued patents;

 

                    any patents issued to us or our collaborators will provide a basis for commercially-viable products or will provide us with any competitive advantages or will not be challenged by third parties;

 

                    we will develop additional proprietary technologies that are patentable; or

 

                    the patents of others will not have a negative effect on our ability to do business.

 

We rely on trade secrets to protect technology where we believe patent protection is not appropriate or obtainable. However, trade secrets are difficult to protect. While we require employees, collaborators and consultants to enter into confidentiality agreements, we may not be able to adequately protect our trade secrets or other proprietary information in the event of any unauthorized use or disclosure or the lawful development by others of such information.

 

We are a party to certain in-license agreements that are important to our business, and we generally do not control the prosecution of in-licensed technology. Accordingly, we are unable to exercise the same degree of control over this intellectual property as we exercise over our internally-developed technology. Moreover, some of our academic institution licensors, research collaborators and scientific advisors have rights to publish data and information in which we have rights. If we cannot maintain the confidentiality of our technology and other confidential information in connection with our collaborations, then our ability to receive patent protection or protect our proprietary information will be impaired. In addition, some of the technology we have licensed relies on patented inventions developed using U.S. government resources. The U.S. government retains certain rights, as defined by law, in such patents, and may choose to exercise such rights. Certain of our in-licenses may be terminated if

 

 

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we fail to meet specified obligations. If we fail to meet such obligations and any of our licensors exercise their termination rights, we could lose our rights under those agreements. If we lose any of our rights, it may adversely affect the way we conduct our business. In addition, because certain of our licenses are sublicenses, the actions of our licensors may affect our rights under those licenses.

 

If a dispute arises regarding the infringement or misappropriation of the proprietary rights of others, such dispute could be costly and result in delays in our research and development activities and partnering.

 

Our success will also depend, in part, on our ability to operate without infringing or misappropriating the proprietary rights of others. There are many issued patents and patent applications filed by third parties relating to products or processes that are similar or identical to ours or our licensors, and others may be filed in the future. There can be no assurance that our activities, or those of our licensors, will not infringe patents owned by others. We believe that there may be significant litigation in the industry regarding patent and other intellectual property rights, and we do not know if we or our collaborators would be successful in any such litigation. Any legal action against our collaborators or us claiming damages or seeking to enjoin commercial activities relating to the affected products, our methods or processes could:

 

                    require our collaborators or us to obtain a license to continue to use, manufacture or market the affected products, methods or processes, which may not be available on commercially reasonable terms, if at all;

 

                    prevent us from using the subject matter claimed in the patents held by others;

 

                    subject us to potential liability for damages;

 

                    consume a substantial portion of our managerial and financial resources; and

 

                    result in litigation or administrative proceedings that may be costly, whether we win or lose.

 

If we are unable to obtain regulatory approval to market products in the United States and foreign jurisdictions, we might not be permitted to commercialize products from our research and development.

 

Due, in part, to the early stage of our product candidate research and development process, we cannot predict whether regulatory clearance will be obtained for any product that we, or our collaborative partners, hope to develop. Satisfaction of regulatory requirements typically takes many years, is dependent upon the type, complexity and novelty of the product and requires the expenditure of substantial resources. Of particular significance to us are the requirements relating to research and development and testing.

 

Before commencing clinical trials in humans in the United States, we, or our collaborative partners, will need to submit and receive approval from the FDA of an IND. Clinical trials are subject to oversight by institutional review boards and the FDA and:

 

                    must be conducted in conformance with the FDA’s good clinical practices and other applicable regulations;

 

                    must meet requirements for institutional review board oversight;

 

                    must meet requirements for informed consent;

 

                    are subject to continuing FDA oversight;

 

                    may require large numbers of test subjects; and

 

                    may be suspended by us, our collaborators or the FDA at any time if it is believed that the subjects participating in these trials are being exposed to unacceptable health risks or if the FDA finds deficiencies in the IND or the conduct of these trials.

 

While we have stated that we intend to file additional INDs, this is only a statement of intent, and we may not be able to do so because we may not be able to identify potential product candidates. In addition, the FDA may not approve any IND in a timely manner, or at all.

 

 

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Before receiving FDA approval to market a product, we must demonstrate that the product is safe and effective in the patient population and the indication that will be treated. Data obtained from preclinical and clinical activities are susceptible to varying interpretations that could delay, limit or prevent regulatory approvals. In addition, delays or rejections may be encountered based upon additional government regulation from future legislation or administrative action or changes in FDA policy during the period of product development, clinical trials and FDA regulatory review. Failure to comply with applicable FDA or other applicable regulatory requirements may result in criminal prosecution, civil penalties, recall or seizure of products, total or partial suspension of production or injunction, as well as other regulatory action against our potential products or us. Additionally, we have limited experience in conducting and managing the clinical trials necessary to obtain regulatory approval.

 

If regulatory approval of a product is granted, this approval will be limited to those indications or disease states and conditions for which the product is demonstrated through clinical trials to be safe and efficacious. We cannot ensure that any compound developed by us, alone or with others, will prove to be safe and efficacious in clinical trials and will meet all of the applicable regulatory requirements needed to receive marketing approval.

 

Outside the United States, our ability, or that of our collaborative partners, to market a product is contingent upon receiving a marketing authorization from the appropriate regulatory authorities. This foreign regulatory approval process typically includes all of the risks associated with FDA approval described above and may also include additional risks.

 

If our competitors develop technologies that are more effective than ours, our commercial opportunity will be reduced or eliminated.

 

The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. Many of the drugs that we are attempting to discover will be competing with existing therapies. In addition, a number of companies are pursuing the development of pharmaceuticals that target the same diseases and conditions that we are targeting. We face competition from pharmaceutical and biotechnology companies both in the United States and abroad.

 

Our competitors may utilize discovery technologies and techniques or partner with collaborators in order to develop products more rapidly or successfully than we, or our collaborators, are able to do. Many of our competitors, particularly large pharmaceutical companies, have substantially greater financial, technical and human resources than we do. In addition, academic institutions, government agencies and other public and private organizations conducting research may seek patent protection with respect to potentially competitive products or technologies and may establish exclusive collaborative or licensing relationships with our competitors.

 

We believe that our ability to compete is dependent, in part, upon our ability to create, maintain and license scientifically-advanced technology and upon our and our collaborators’ ability to develop and commercialize pharmaceutical products based on this technology, as well as our ability to attract and retain qualified personnel, obtain patent protection or otherwise develop proprietary technology or processes and secure sufficient capital resources for the expected substantial time period between technological conception and commercial sales of products based upon our technology. The failure by us or any of our collaborators in any of those areas may prevent the successful commercialization of our potential drug targets.

 

Our competitors might develop technologies and drugs that are more effective or less costly than any that are being developed by us or that would render our technology and potential drugs obsolete and noncompetitive. In addition, our competitors may succeed in obtaining the approval of the FDA or other regulatory agencies for product candidates more rapidly. Companies that complete clinical trials, obtain required regulatory agency approvals and commence commercial sale of their drugs before their competitors may achieve a significant competitive advantage, including certain patent and FDA marketing exclusivity rights that would delay or prevent our ability to market certain products. Any drugs resulting from our research and development efforts, or from our joint efforts with our existing or future collaborative partners, might not be able to compete successfully with competitors’ existing or future products or obtain regulatory approval in the United States or elsewhere.

 

Our ability to generate revenues will be diminished if our collaborative partners fail to obtain acceptable prices or an adequate level of reimbursement for products from third-party payors or government agencies.

 

The drugs we hope to develop may be rejected by the marketplace due to many factors, including cost. Our ability to commercially exploit a drug may be limited due to the continuing efforts of government and third-party payors to contain or reduce the costs of health care through various means. For example, in some foreign markets, pricing and profitability of prescription pharmaceuticals are subject to government control. In the United States, we expect that there will continue to be a number of federal and state proposals to implement similar government control. In addition, increasing emphasis on managed care in the United States will likely continue to put pressure on the pricing of pharmaceutical products. Cost control initiatives could decrease the price that any of our collaborators would receive for any products in the future. Further, cost control

 

 

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initiatives could adversely affect our collaborators’ ability to commercialize our products and our ability to realize royalties from this commercialization.

 

Our ability to commercialize pharmaceutical products with collaborators may depend, in part, on the extent to which reimbursement for the products will be available from:

 

                    government and health administration authorities;

 

                    private health insurers; and

 

                    other third-party payors.

 

Significant uncertainty exists as to the reimbursement status of newly-approved healthcare products. Third-party payors, including Medicare, are challenging the prices charged for medical products and services. Government and other third-party payors increasingly are attempting to contain healthcare costs by limiting both coverage and the level of reimbursement for new drugs and by refusing, in some cases, to provide coverage for uses of approved products for disease indications for which the FDA has not granted labeling approval. Third-party insurance coverage may not be available to patients for any products we discover and develop, alone or with collaborators. If government and other third-party payors do not provide adequate coverage and reimbursement levels for our products, the market acceptance of these products may be reduced.

 

If product liability lawsuits are successfully brought against us, we may incur substantial liabilities and may be required to limit commercialization of our products.

 

The testing and marketing of medical products entail an inherent risk of product liability. If we cannot successfully defend ourselves against product liability claims, we may incur substantial liabilities or be required to limit commercialization of our products although we are not currently aware of any specific causes for concern with respect to clinical liability claims. We currently do not have product liability insurance, and our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, alone or with corporate collaborators. We, or our corporate collaborators, might not be able to obtain insurance at a reasonable cost, if at all. While under various circumstances we are entitled to be indemnified against losses by our corporate collaborators, indemnification may not be available or adequate should any claim arise.

 

Our research and development efforts will be seriously jeopardized, if we are unable to attract and retain key employees and relationships.

 

As a small company with only 151 employees as of September 30, 2005, our success depends on the continued contributions of our principal management and scientific personnel and on our ability to develop and maintain important relationships with leading academic institutions, scientists and companies in the face of intense competition for such personnel. In particular, our research programs depend on our ability to attract and retain highly skilled chemists, other scientists, and development, regulatory and clinical personnel. If we lose the services of any of our personnel, our research and development efforts could be seriously and adversely affected. Our employees can terminate their employment with us at any time.

 

We depend on various scientific consultants and advisors for the success and continuation of our research and development efforts.

 

We work extensively with various scientific consultants and advisors. The potential success of our drug discovery and development programs depends, in part, on continued collaborations with certain of these consultants and advisors. We, and various members of our management and research staff, rely on certain of these consultants and advisors for expertise in our research, regulatory and clinical efforts. Our scientific advisors are not our employees and may have commitments to, or consulting or advisory contracts with, other entities that may limit their availability to us. We do not know if we will be able to maintain such consulting agreements or that such scientific advisors will not enter into consulting arrangements, exclusive or otherwise, with competing pharmaceutical or biotechnology companies, any of which would have a detrimental impact on our research objectives and could have a material adverse effect on our business, financial condition and results of operations.

 

 

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If we use biological and hazardous materials in a manner that causes injury or violates laws, we may be liable for damages.

 

Our research and development activities involve the controlled use of potentially harmful biological materials as well as hazardous materials, chemicals and various radioactive compounds. We cannot completely eliminate the risk of accidental contamination or injury from the use, storage, handling or disposal of these materials. In the event of contamination or injury, we could be held liable for damages that result, and such liability could exceed our resources. We are also subject to federal, state and local laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. The cost of compliance with, or any potential violation of, these laws and regulations could be significant.

 

Our facilities are located near known earthquake fault zones, and the occurrence of an earthquake or other catastrophic disaster could cause damage to our facilities and equipment, which could require us to cease or curtail operations.

 

Our facilities are located in the San Francisco Bay Area near known earthquake fault zones and are vulnerable to significant damage from earthquakes. We are also vulnerable to damage from other types of disasters, including fires, floods, power loss, communications failures and similar events. If any disaster were to occur, our ability to operate our business at our facilities would be seriously, or potentially completely, impaired, and our research could be lost or destroyed. In addition, the unique nature of our research activities and of much of our equipment could make it difficult for us to recover from a disaster. The insurance we maintain may not be adequate to cover our losses resulting from disasters or other business interruptions.

 

Our stock price may be volatile, and our stockholders’ investment in our stock could decline in value.

 

The market prices for our securities and those of other biotechnology companies have been highly volatile and may continue to be highly volatile in the future. The following factors, in addition to other risk factors described in this section, may have a significant impact on the market price of our common stock:

 

                    the receipt or failure to receive the additional funding necessary to conduct our business;

 

                    the progress and success of preclinical studies and clinical trials of our product candidates conducted by us or our collaborative partners or licensees;

 

                    selling by large stockholders;

 

                    announcements of technological innovations or new commercial products by our competitors or us;

 

                    developments concerning proprietary rights, including patents;

 

                    developments concerning our collaborations;

 

                    publicity regarding actual or potential medical results relating to products under development by our competitors or us;

 

                    regulatory developments in the United States and foreign countries;

 

                    litigation;

 

                    economic and other external factors or other disaster or crisis; and

 

                    period-to-period fluctuations in financial results.

 

Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult.

 

Provisions of our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us, even if doing so would benefit our stockholders. These provisions:

 

                    establish that members of the board of directors may be removed only for cause upon the affirmative vote of stockholders owning a majority of our capital stock;

 

 

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                    authorize the issuance of “blank check” preferred stock that could be issued by our board of directors to increase the number of outstanding shares and thwart a takeover attempt;

 

                    limit who may call a special meeting of stockholders;

 

                    prohibit stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;

 

                    establish advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted upon at stockholder meetings;

 

                    provide for a board of directors with staggered terms; and

 

                    provide that the authorized number of directors may be changed only by a resolution of our board of directors.

 

In addition, Section 203 of the Delaware General Corporation Law, which imposes certain restrictions relating to transactions with major stockholders, may discourage, delay or prevent a third party from acquiring us.

 

 

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Item 3.           Quantitative and Qualitative Disclosures About Market Risk

 

The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive from our investments without significantly increasing risk. Some of the securities in which we invest may have market risk. This means that a change in prevailing interest rates may cause the fair value amount of the investment to fluctuate. For example, if we hold a security that was issued with a fixed interest rate at the then-prevailing rate and the prevailing interest rate later rises, the market value amount of our investment will decline. To minimize this risk in the future, we intend to maintain our portfolio of cash equivalents, short-term investments and other long-term investments in a variety of securities, including commercial paper, money market funds and government and non-government debt securities For the three months ended September 30, 2005 and 2004, we maintained an investment portfolio primarily in depository accounts and corporate commercial paper. Due to the short-term nature of the majority of these investments, we believe we do not have a material exposure to interest rate risk arising from our investments. Therefore, no quantitative tabular disclosure is provided.

 

We have operated primarily in the United States, and all funding activities with our collaborators to date have been made in U.S. dollars. Accordingly, we have not had any exposure to foreign currency rate fluctuations.

 

Item 4.    Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures.  Based on our management’s evaluation (with the participation of our chief executive officer and chief financial officer), our chief executive officer and chief financial officer have concluded that, subject to limitations described below, our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended), were effective as of September 30, 2005 to ensure that information required to be disclosed by us in reports that we file or submit under Exchange Act is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and is accumulated and communicated to our management including our chief executive officer and chief financial officer, to allow timely decisions regarding required disclosure.

 

Changes in Internal Controls.  There were no changes in our internal controls over financial reporting during the quarter ended September 30, 2005 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

Limitations on the Effectiveness of Controls. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the controls are met. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues, if any, within a company have been detected. Accordingly, our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance that the objectives of our disclosure control system are met and, as set forth above, our chief executive officer and chief financial officer have concluded, based on their evaluation as of the end of the period covered by this quarterly report on Form 10-Q, that our disclosure controls and procedures were sufficiently effective to provide reasonable assurance that the objectives of our disclosure control system were met.

 

 

 

29



 

PART II OTHER INFORMATION

 

 

Item 6.    Exhibits

 

a)             Exhibits:

 

The exhibits listed on the accompanying index to exhibits are filed or incorporated by reference (as stated therein) as part of this Quarterly Report on Form 10-Q.

 

 

 

 

Exhibit Number

 

Description of Document

3.1

 

Amended and Restated Certificate of Incorporation.(1)

3.2

 

Amended and Restated Bylaws.(2)

4.1

 

Specimen Common Stock Certificate.(1)

4.2

 

Amended and Restated Investor Rights Agreement, between Rigel and holders of Rigel’s Series B, Series C, Series D and Series E preferred stock, dated February 3, 2000.(2)

4.3

 

Form of warrant to purchase shares of common stock.(2)

4.7

 

Amended and Restated Warrant issued to Kwacker Limited for the purchase of shares of common stock.(3)

4.8

 

Warrant issued to TBCC Funding Trust II for the purchase of shares of common stock.(4)

4.10

 

Warrant issued to Kwacker Limited for the purchase of shares of common stock.(3)

4.23

 

Second Investor Rights Agreement between Rigel and certain investors, dated June 26, 2003.(5)

4.24

 

Common Stock Purchase Agreement by and between Rigel and Pfizer Inc., dated March 10, 2005(6)

10.14

 

License and Research Agreement (Amended and Restated) between Rigel and Cell Genesys, Inc., dated September 2, 1999, as amended and restated on March 26, 2001.(7)

15.1

 

Letter re: unaudited interim financial information.

31.1

 

Certification required by Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act.

31.2

 

Certification required by Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act.

32.1

 

Certification required by Rule 13a-14(b) or Rule 15d-14(b) of the Exchange Act and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).

 


(1)

 

Filed as an exhibit to Rigel’s Current Report on Form 8-K on June 24, 2003 and incorporated herein by reference.

(2)

 

Filed as an exhibit to Rigel’s Registration Statement on Form S-1, as amended, and incorporated herein by reference.

(3)

 

Filed as an exhibit to Rigel’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002 and incorporated herein by reference.

(4)

 

Filed as an exhibit to Rigel’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2002 and incorporated herein by reference.

(5)

 

Filed as an exhibit to Rigel’s Annual Report on Form 10-K for the fiscal year ended December 31, 2003 and incorporated herein by reference.

(6)

 

Filed as Exhibit B to the Collaborative Research and License Agreement by and between Rigel and Pfizer Inc., dated January 18, 2005, filed as an exhibit to Rigel’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 and incorporated herein by reference.

(7)

 

Confidential treatment requested as to specific portions, which portions are omitted and filed separately with the Securities and Exchange Commission.

 

 

 

 

 

 

 

 

 

 

 

 

30



 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

RIGEL PHARMACEUTICALS, INC.

 

 

 

 

 

 

 

By:

/s/ JAMES M. GOWER

 

 

James M. Gower

 

 

Chief Executive Officer

 

 

 

 

 

 

 

Date:

November 8, 2005

 

 

 

 

 

 

 

By:

/s/ JAMES H. WELCH

 

 

James H. Welch

 

 

Vice President, Chief Financial Officer and Corporate

 

 

Secretary

 

 

(Principal Financial and Accounting Officer)

 

 

 

 

 

 

 

Date:

November 8, 2005

 

 

31



 

INDEX TO EXHIBITS

 

Exhibit Number

 

Description of Document

3.1

 

Amended and Restated Certificate of Incorporation.(1)

3.2

 

Amended and Restated Bylaws.(2)

4.1

 

Specimen Common Stock Certificate.(1)

4.2

 

Amended and Restated Investor Rights Agreement, between Rigel and holders of Rigel’s Series B, Series C, Series D and Series E preferred stock, dated February 3, 2000.(2)

4.3

 

Form of warrant to purchase shares of common stock.(2)

4.7

 

Amended and Restated Warrant issued to Kwacker Limited for the purchase of shares of common stock.(3)

4.8

 

Warrant issued to TBCC Funding Trust II for the purchase of shares of common stock.(4)

4.10

 

Warrant issued to Kwacker Limited for the purchase of shares of common stock.(3)

4.23

 

Second Investor Rights Agreement between Rigel and certain investors, dated June 26, 2003.(5)

4.24

 

Common Stock Purchase Agreement by and between Rigel and Pfizer Inc., dated March 10, 2005(6)

10.14

 

License and Research Agreement (Amended and Restated) between Rigel and Cell Genesys, Inc., dated September 2, 1999, as amended and restated on March 26, 2001.(7)

15.1

 

Letter re: unaudited interim financial information.

31.1

 

Certification required by Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act.

31.2

 

Certification required by Rule 13a-14(a) or Rule 15d-14(a) of the Exchange Act.

32.1

 

Certification required by Rule 13a-14(b) or Rule 15d-14(b) of the Exchange Act and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).

 


(1)

 

Filed as an exhibit to Rigel’s Current Report on Form 8-K on June 24, 2003 and incorporated herein by reference.

(2)

 

Filed as an exhibit to Rigel’s Registration Statement on Form S-1, as amended, and incorporated herein by reference.

(3)

 

Filed as an exhibit to Rigel’s Annual Report on Form 10-K for the fiscal year ended December 31, 2002 and incorporated herein by reference.

(4)

 

Filed as an exhibit to Rigel’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2002 and incorporated herein by reference.

(5)

 

Filed as an exhibit to Rigel’s Annual Report on Form 10-K for the fiscal year ended December 31, 2003 and incorporated herein by reference.

(6)

 

Filed as Exhibit B to the Collaborative Research and License Agreement by and between Rigel and Pfizer Inc., dated January 18, 2005, filed as an exhibit to Rigel’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 and incorporated herein by reference.

(7)

 

Confidential treatment requested as to specific portions, which portions are omitted and filed separately with the Securities and Exchange Commission.