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Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 


 

FORM 10-Q

 


 

(Mark One)

 

x  Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the quarterly period ended September 30, 2009

 

OR

 

o Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Commission File Number: 0-19756

 


 

 

Facet Biotech Corporation

(Exact name of registrant as specified in its charter)

 

Delaware

 

26-3070657

(State or other jurisdiction of

 

(I.R.S. Employer

incorporation or organization)

 

Identification Number)

 

1500 Seaport Boulevard

Redwood City, CA 94063

(Address of principal executive offices and Zip Code)

 

(650) 454-1000

(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  x No  o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the  preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes  o No  o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer o

 

Accelerated filer o

 

 

 

Non-accelerated filer x

 

Smaller reporting company o

(Do not check if a smaller reporting company)

 

 

 

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

 

As of October 27, 2009, there were 25,067,740 shares of the Registrant’s Common Stock outstanding.

 

 

 



Table of Contents

 

FACET BIOTECH CORPORATION

 

INDEX

 

 

 

Page

PART I.

FINANCIAL INFORMATION

3

 

 

 

ITEM 1.

FINANCIAL STATEMENTS (Unaudited)

3

 

 

 

 

Condensed Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2009 and 2008

3

 

 

 

 

Condensed Consolidated Balance Sheets at September 30, 2009 and December 31, 2008

4

 

 

 

 

Condensed Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2009 and 2008

5

 

 

 

 

Notes to the Condensed Consolidated Financial Statements

6

 

 

 

ITEM 2.

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

18

 

 

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

43

 

 

 

ITEM 4T.

CONTROLS AND PROCEDURES

44

 

 

 

PART II.

OTHER INFORMATION

44

 

 

 

ITEM 1.

LEGAL PROCEEDINGS

44

 

 

 

ITEM 1A.

RISK FACTORS

45

 

 

 

ITEM 5.

OTHER INFORMATION

45

 

 

 

ITEM 6.

EXHIBITS

45

 

 

 

 

Signatures

46

 

We own or have rights to numerous trademarks, trade names, copyrights and other intellectual property used in our business, including Facet Biotech and the Facet Biotech logo, each of which is considered a trademark. All other company names, tradenames and trademarks included in this Quarterly Report are trademarks, registered trademarks or trade names of their respective owners.

 

2



Table of Contents

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. FINANCIAL STATEMENTS

 

FACET BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

Revenues:

 

 

 

 

 

 

 

 

 

Collaboration

 

$

8,837

 

$

4,031

 

$

24,971

 

$

8,538

 

Other

 

2,011

 

925

 

6,027

 

3,075

 

Total revenues

 

10,848

 

4,956

 

30,998

 

11,613

 

 

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

45,084

 

41,173

 

96,288

 

123,455

 

General and administrative

 

9,525

 

11,328

 

27,863

 

35,078

 

Restructuring charges

 

(1,652

)

990

 

19,418

 

9,441

 

Asset impairment charges

 

185

 

 

1,028

 

3,784

 

Gain on sale of assets

 

 

 

 

(49,671

)

Total costs and expenses

 

53,142

 

53,491

 

144,597

 

122,087

 

Loss from operations

 

(42,294

)

(48,535

)

(113,599

)

(110,474

)

Interest and other income, net

 

678

 

8

 

2,803

 

13

 

Interest expense

 

(415

)

(427

)

(1,256

)

(1,293

)

Loss before income taxes

 

(42,031

)

(48,954

)

(112,052

)

(111,754

)

Income tax expense (benefit)

 

(1,116

)

17

 

(1,116

)

76

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(40,915

)

$

(48,971

)

$

(110,936

)

$

(111,830

)

 

 

 

 

 

 

 

 

 

 

Net loss per basic and diluted share

 

$

(1.70

)

$

(2.05

)

$

(4.63

)

$

(4.68

)

 

 

 

 

 

 

 

 

 

 

Shares used to compute net loss per basic and diluted share

 

23,999

 

23,901

 

23,940

 

23,901

 

 

See accompanying notes.

 

3



Table of Contents

 

FACET BIOTECH CORPORATION

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except per share data)

 

 

 

September 30,

 

December 31,

 

 

 

2009

 

2008

 

 

 

(unaudited)

 

(Note 1)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

58,950

 

$

397,611

 

Marketable securities

 

266,547

 

 

Prepaid and other current assets

 

10,810

 

19,382

 

Total current assets

 

336,307

 

416,993

 

Long-term restricted cash

 

6,387

 

5,807

 

Property and equipment, net

 

95,426

 

105,671

 

Intangible assets, net

 

6,174

 

7,409

 

Other assets

 

6,843

 

2,141

 

Total assets

 

$

451,137

 

$

538,021

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

2,215

 

$

337

 

Accrued compensation

 

6,602

 

3,498

 

Restructuring accrual, current portion

 

7,491

 

1,956

 

Other accrued liabilities

 

8,758

 

1,850

 

Deferred revenue, current portion

 

10,881

 

13,234

 

Lease financing liability, current portion

 

999

 

862

 

Total current liabilities

 

36,946

 

21,737

 

Deferred revenue, long-term portion

 

37,570

 

44,901

 

Restructuring accrual, long-term portion

 

10,667

 

 

Lease financing liability, long-term portion

 

24,538

 

25,316

 

Other long-term liabilities

 

5,403

 

10,434

 

Total liabilities

 

115,124

 

102,388

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, par value $0.01 per share, 10,000 shares authorized; no shares were outstanding at September 30, 2009 and December 31, 2008

 

 

 

Common stock, par value $0.01 per share, 140,000 shares authorized; 24,219 and 23,901 shares issued and outstanding at September 30, 2009 and December 31, 2008, respectively

 

242

 

239

 

Additional paid-in capital

 

464,215

 

455,380

 

Accumulated deficit

 

(130,433

)

(19,497

)

Accumulated other comprehensive income (loss), net of taxes

 

1,989

 

(489

)

Total stockholders’ equity

 

336,013

 

435,633

 

Total liabilities and stockholders’ equity

 

$

451,137

 

$

538,021

 

 

See accompanying notes.

 

4



Table of Contents

 

FACET BIOTECH CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

 

 

Nine Months Ended September 30,

 

 

 

2009

 

2008

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(110,936

)

$

(111,830

)

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

 

 

 

 

 

Asset impairment charges

 

1,028

 

3,784

 

Depreciation

 

9,528

 

14,805

 

Amortization of intangible assets

 

1,235

 

1,235

 

Stock-based compensation expense

 

7,203

 

6,617

 

Expense allocation from parent

 

 

1,512

 

Gain on sale of assets

 

 

(49,671

)

Loss (gain) on disposal of equipment

 

(8

)

208

 

Changes in assets and liabilities:

 

 

 

 

 

Other current assets

 

6,808

 

(10,360

)

Other assets

 

(4,702

)

502

 

Accounts payable

 

1,878

 

602

 

Restructuring accrual

 

16,202

 

783

 

Accrued liabilities

 

8,661

 

(7,122

)

Other long-term liabilities

 

(4,975

)

2,228

 

Deferred revenue

 

(9,684

)

25,915

 

Total adjustments

 

33,174

 

(8,962

)

Net cash used in operating activities

 

(77,762

)

(120,792

)

Cash flows from investing activities:

 

 

 

 

 

Purchases of marketable securities

 

(296,062

)

 

Maturities of marketable securities

 

34,825

 

 

Proceeds from the sale of property and equipment

 

211

 

236,560

 

Purchase of property and equipment

 

(551

)

(2,857

)

Transfer from (to) restricted cash

 

(580

)

25,005

 

Net cash provided by (used in) investing activities

 

(262,157

)

258,708

 

Cash flows from financing activities:

 

 

 

 

 

Issuance of common stock

 

1,899

 

 

Payments on lease financing liability

 

(641

)

(516

)

Transfers to parent

 

 

(137,400

)

Net cash provided by (used in) financing activities

 

1,258

 

(137,916

)

Net decrease in cash and cash equivalents

 

(338,661

)

 

Cash and cash equivalents at beginning of the period

 

397,611

 

 

Cash and cash equivalents at end the period

 

$

58,950

 

$

 

 

See accompanying notes.

 

5



Table of Contents

 

FACET BIOTECH CORPORATION

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

September 30, 2009

(unaudited)

 

1. Basis of Presentation and Summary of Significant Accounting Policies

 

Basis of Presentation

 

Facet Biotech Corporation (we, us, our, Facet Biotech, the Company) was organized as a Delaware corporation in July 2008 by PDL BioPharma, Inc. (PDL) as a wholly owned subsidiary of PDL. PDL organized the Company in preparation for the spin-off of the Company, which was effected on December 18, 2008 (the Spin-off). In connection with the Spin-off, PDL contributed to us PDL’s Biotechnology Business and PDL distributed to its stockholders all of the outstanding shares of our common stock. Following the Spin-off, we became an independent, publicly traded company owning and operating what previously had been PDL’s Biotechnology Business.

 

Prior to the Spin-off, PDL’s Biotechnology Business, now operated by the Company, was not operated by a legal entity separate from PDL and a direct ownership relationship did not exist among all the components comprising the Biotechnology Business. We describe the Biotechnology Business transferred to us by PDL in connection with the Spin-off as though the Biotechnology Business were our business for all historical periods described. However, Facet Biotech had not operated the Biotechnology Business prior to the Spin-off. References in these Condensed Consolidated Financial Statements to the historical assets, liabilities, products, business or activities of our business are intended to refer to the historical assets, liabilities, products, business or activities of the Biotechnology Business as those were conducted as part of PDL prior to the Spin-off.

 

For the purposes of preparing the financial statements of the Biotechnology Business for the three and nine months ended September 30, 2008, which were derived from PDL’s historical consolidated financial statements, allocations of revenues, research and development (R&D) expenses, asset impairment charges, restructuring charges, gains on sales of assets and non-operating income and expenses to Facet Biotech were made on a specific identification basis. Facet Biotech’s operating expenses also included allocations related to information technology and facilities costs. Management believes that the Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2008 include a reasonable allocation of costs incurred by PDL, which benefited Facet Biotech. However, such expenses may not be indicative of the actual level of expense that we would have incurred if we had operated as an independent, publicly traded company.

 

The accompanying condensed consolidated financial statements are unaudited, but include all adjustments (consisting only of normal, recurring adjustments) that we consider necessary for a fair presentation of our financial position at such dates and the operating results and cash flows for those periods. Certain information normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States (U.S. GAAP) has been condensed or omitted pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for quarterly reporting.

 

The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC. The Condensed Consolidated Balance Sheet as of December 31, 2008 is derived from our audited consolidated financial statements as of that date.

 

Our revenues, expenses, assets and liabilities vary during each quarter of the year. Therefore, the results and trends in these interim condensed consolidated financial statements may not be indicative of results for any other interim period or for the entire year. For example, revenue recognized in connection with the reimbursement of our R&D expenses under the terms of our collaboration agreements may vary period-to-period, and milestone payments received from our out-licensing agreements are often times recognized immediately when earned and could significantly affect the revenue reported in each period. In addition, our operating expenses may fluctuate significantly during periods in which we enter into in-licensing agreements or recognize restructuring or asset impairment charges.

 

Principles of Consolidation

 

The condensed consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries after elimination of inter-company accounts and transactions.

 

6



Table of Contents

 

Management Estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires the use of management’s estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates.

 

Revenue Recognition

 

Collaboration Agreements

 

Under our collaboration agreements with Biogen Idec Inc. (Biogen Idec), Bristol-Myers Squibb Company (BMS) and Trubion Pharmaceuticals, Inc. (Trubion), we share development costs related to the products covered by the applicable collaboration. The purpose of the collaboration agreements is to create synergies while bringing a product candidate to market by sharing technologies, know-how and costs. Once a product is brought to market, we would share in commercialization costs as well as in profits related to the product, or generate a royalty based on net sales. Our collaboration agreements with Biogen and BMS included the receipt of upfront fees.  For these arrangements, we are not able to establish fair value of the undelivered elements, which consist primarily of research and development services. As such, we recognize these upfront fees over the period of time that the research and development services are expected to be performed. For all of our collaborations, each quarter, we and our collaborator reconcile what each party has incurred in terms of development costs, and we record either a net receivable or a net payable on our consolidated balance sheet. For each quarterly period, if we have a net receivable from a collaborator, we recognize revenues by such amount, and if we have a net payable to our collaborator, we recognize additional R&D expenses by such amount. Therefore, our revenues and R&D expenses may fluctuate depending on which party in the collaboration is conducting the majority of the development activities in the reporting period.

 

Out-License Agreements

 

We have entered into license agreements under which companies have obtained from us licenses to certain of our intellectual property rights, including patent rights, related to certain development product candidates, which we outlicensed. In these arrangements, the licensee is customarily responsible for all of the development work on the licensed development product and we have no significant future performance obligations under these agreements. Upfront consideration that we receive for license agreements is recognized as revenue upon execution and delivery of the license agreement and when payment is reasonably assured. If the agreements require continuing involvement in the form of development, manufacturing or other commercialization efforts by us, we recognize revenues in the same manner as the final deliverable in the arrangement. Under our out-license agreements, we may also receive annual license maintenance fees, payable at the election of the licensee to maintain the license in effect. We have no performance obligations with respect to such fees, and they are recognized as they become due and when payment is reasonably assured.

 

Humanization Agreements

 

Under our humanization agreements, the licensee typically pays us an upfront fee to humanize an antibody. We recognize revenue related to these fees as the humanization work is performed or upon acceptance of the humanized antibody by the licensee if such acceptance clause exists in the agreement. Under our humanization agreements, we may also receive annual maintenance fees, payable at the election of the licensee to maintain the humanization and know-how licenses in effect. We have no performance obligations with respect to such fees, and therefore, we recognize these fees as revenues when they become due and when payment is reasonably assured.

 

Milestones

 

Our licensing and humanization arrangements may contain milestones related to reaching particular stages in product development. We recognize “at risk” milestone payments upon achievement of the underlying milestone event and when they are due and payable under the arrangement. Milestones are deemed to be “at risk” when, at the onset of an arrangement, management believes that they will require a reasonable amount of effort to be achieved and are not simply reached by the lapse of time or through a perfunctory effort. Milestones which are not deemed to be “at risk” are recognized as revenue in the same manner as up-front payments. We also receive milestone payments under patent license agreements, under which we have no further obligations, when our licensees reach certain stages of development with respect to the licensed product. We recognize these milestones as revenue once they have been reached and payment is reasonably assured.

 

7



Table of Contents

 

Significant Customers and Revenues by Geographic Area

 

The following table summarizes revenues as a percentage of total revenues from our licensees and collaborators, which individually accounted for 10% or more of our revenues for the three and nine months ended September 30, 2009 and 2008:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

 

 

2009

 

2008

 

2009

 

2008

 

Licensees

 

 

 

 

 

 

 

 

 

Biogen Idec

 

18

%

37

%

20

%

55

%

BMS

 

63

%

45

%

61

%

19

%

EKR Therapeutics, Inc.

 

15

%

*

 

15

%

*

 

Progenics Pharmaceuticals, Inc.

 

*

 

*

 

*

 

10

%

Genentech, Inc. (a member of the Roche Group)

 

*

 

12

%

*

 

*

 

 


*Less than 10%

 

Cash Equivalents, Marketable Securities and Concentration of Credit Risk

 

We consider all highly liquid investments with original maturities of three months or less at the date of purchase to be cash equivalents. We place our cash equivalents and marketable securities with high-credit-quality financial institutions and, by policy, limit the amount of credit exposure in any one financial instrument.

 

Net Loss per Share

 

We calculate basic net loss per share by dividing net loss by the weighted-average number of common shares outstanding during the reported period. Diluted net loss per share is calculated using the sum of the weighted-average number of common shares outstanding and dilutive common equivalent shares outstanding. Common equivalent shares result from the assumed exercise of stock options, the assumed release of restrictions of issued restricted stock and the assumed issuance of common shares under our Employee Stock Purchase Plan (ESPP) using the treasury stock method. Since we were in a net loss position for the three and nine months ended September 30, 2009, we excluded the effect of 0.7 million and 0.3 million, respectively, of weighted-average common equivalent shares in the diluted net loss per share calculations as their effect would have been anti-dilutive.

 

For the three and nine months ended September 30, 2008, the computation of net loss per basic and diluted share and the weighted-average shares outstanding are presented based on the 23.9 million shares that were issued in connection with the Spin-off on December 18, 2008.

 

Income Taxes

 

Prior to July 2008, the operations of Facet Biotech were included in PDL’s consolidated U.S. federal and state income tax returns and in tax returns of certain PDL foreign subsidiaries. Prior to the Spin-off on December 18, 2008, our provision for income taxes was determined as if Facet Biotech had filed tax returns separate and apart from PDL.  The income tax expense for the three and nine months ended September 30, 2008 related solely to foreign taxes on income earned by our foreign operations.

 

The unrealized gain on the Trubion equity investment is reflected in other accumulated comprehensive income (loss) within stockholders’ equity net of the related $1.1 million deferred tax liability.  Such deferred tax liability was calculated using the 40% statutory tax rate.  In establishing the valuation allowance for our deferred tax assets, we need to consider sources of future taxable income.  The existence of the unrealized gain on the Trubion equity investment is considered to be a future source of taxable income and accordingly, we have reduced our valuation allowance on our deferred tax assets.  For the three months ended September 30, 2009, we recognized a tax benefit of approximately $1.1 million for the reduction in our valuation allowance on our deferred tax assets.  See Notes 4 and 9 for further details on our Trubion collaboration agreement and equity investment.

 

Subsequent Events

 

We have evaluated our subsequent events through November 3, 2009, when our financial statements were issued.

 

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Table of Contents

 

2. Stock-Based Compensation

 

Prior to January 2009, our employees had received stock-based compensation awards only under PDL’s equity compensation plans and, therefore, stock-based compensation expense pertaining to the three and nine months ended September 30, 2008 relate to stock-based compensation expense arising from PDL equity awards that was allocated to Facet Biotech’s operations.  All non-vested PDL equity instruments held by Facet Biotech employees were cancelled on December 18, 2008 when those employees ceased being employed by a wholly owned subsidiary of PDL as a result of the Spin-off.  In January 2009, we began granting equity awards under our 2008 Equity Incentive Plan and, in March 2009, we commenced employee participation in our 2008 Employee Stock Purchase Plan.

 

Stock-based compensation expense for employees and directors was as follows:

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

(in thousands)

 

2009

 

2008

 

2009

 

2008

 

Research and development

 

$

551

 

$

1,233

 

$

4,672

 

$

4,258

 

General and administrative

 

616

 

134

 

2,531

 

2,359

 

Total stock-based compensation expense

 

$

1,167

 

$

1,367

 

$

7,203

 

$

6,617

 

 

Valuation Assumptions

 

The stock-based compensation expense was determined using the Black-Scholes option valuation model.  Option valuation models require the input of subjective assumptions and these assumptions can vary over time.  The weighted-average assumptions underlying stock-based compensation related to awards granted under our equity plans were as follows:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30, 2009

 

September 30, 2009

 

Stock Option Plans

 

 

 

 

 

Expected life, in years

 

5.3

 

4.7

 

Risk free interest rate

 

2.5

%

1.8

%

Volatility

 

76

%

84

%

Dividend yield

 

 

 

 

 

 

 

 

 

Employee Stock Purchase Plans

 

 

 

 

 

Expected life, in years

 

0.5

 

0.5

 

Risk free interest rate

 

0.2

%

0.3

%

Volatility

 

90

%

102

%

Dividend yield

 

 

 

 

9



Table of Contents

 

Stock Option Activity

 

A summary of our stock option activity for the period is presented below:

 

(in thousands, except for per share amounts)

 

Number of
Shares

 

Weighted-
Average
Exercise Price

 

 

 

 

 

 

 

Outstanding as of December 31, 2008

 

 

$

 

Granted

 

1,166

 

$

6.19

 

Exercised

 

(1

)

$

6.17

 

Forfeited

 

(11

)

$

6.17

 

Outstanding as of March 31, 2009

 

1,154

 

$

6.19

 

Granted

 

732

 

$

9.55

 

Exercised

 

(12

)

$

9.38

 

Forfeited

 

(11

)

$

6.19

 

Outstanding as of June 30, 2009

 

1,863

 

$

7.48

 

Granted

 

616

 

$

10.36

 

Exercised

 

(143

)

$

9.15

 

Forfeited

 

(86

)

$

9.15

 

Outstanding as of September 30, 2009

 

2,250

 

$

8.10

 

 

 

 

 

 

 

Exercisable as of September 30, 2009

 

641

 

$

8.81

 

 

In April 2009, we granted approximately 699,000 fully-vested, at-the-money stock options to our employees (Value Transfer Grants). Consistent with the intent of these grants as disclosed in prior filings with the SEC, the Value Transfer Grants were provided to our employees to compensate them for the estimated value of vested PDL stock options that were forfeited in connection with the Spin-off. The total fair value of the Value Transfer Grants on the date of grant was $4.0 million, as calculated using the Black-Scholes valuation model. As these stock options were fully vested as of the grant date, we recognized 100% of the fair value of the Value Transfer Grants as stock-based compensation expense in the second quarter of 2009.

 

Total unrecognized compensation expense related to unvested stock options outstanding as of September 30, 2009, excluding potential forfeitures, was $7.9 million, which we expect to recognize over a weighted-average period of 3.4 years.

 

Restricted Stock Award Activity

 

A summary of our restricted stock award activity for the period is presented below:

 

 

 

Restricted Stock

 

(in thousands, except for per share amounts)

 

Number of
shares

 

Weighted-
average
grant-date
fair value

 

Unvested at December 31, 2008

 

 

$

 

Awards granted

 

687

 

$

6.18

 

Awards vested

 

(11

)

$

6.17

 

Awards forfeited

 

(20

)

$

6.17

 

Unvested at March 31, 2009

 

656

 

$

6.18

 

Awards granted

 

10

 

$

9.56

 

Awards vested

 

(9

)

$

6.17

 

Awards forfeited

 

(20

)

$

6.17

 

Unvested at June 30, 2009

 

637

 

$

6.23

 

Awards granted

 

285

 

$

9.51

 

Awards vested

 

(74

)

$

6.17

 

Awards forfeited

 

(13

)

$

6.80

 

Unvested at September 30, 2009

 

835

 

$

7.35

 

 

Total unrecognized compensation expense related to unvested restricted stock awards outstanding as of September 30, 2009, excluding potential forfeitures, was $5.3 million, which we expect to recognize over a weighted-average period of 2.5 years.

 

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Employee Stock Purchase Plan

 

The stock-based compensation expense recognized in connection with our ESPP for the three and nine months ended September 30, 2009 was $0.1 million and $0.3 million, respectively.  Prior to the Spin-off, employees of PDL’s Biotechnology Business were eligible to participate in PDL’s 1993 Employee Stock Purchase Plan (PDL ESPP). The stock-based compensation expense allocated to the Biotechnology Business and recognized in connection with the PDL ESPP for the three and nine months ended September 30, 2008 was $0.2 million and $0.5 million, respectively.

 

3. Comprehensive Loss

 

Comprehensive loss is comprised of net loss and other comprehensive income.  Specifically, we include in other comprehensive income the changes in unrealized gains and losses on our holdings of available-for-sale securities, which are excluded from our net loss. In addition, other comprehensive income includes the liability that has not yet been recognized as net periodic benefit cost for our postretirement benefit plan. The following table presents the calculation of our comprehensive loss:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

September 30,

 

September 30,

 

(in thousands)

 

2009

 

2008

 

2009

 

2008

 

Net loss

 

$

(40,915

)

$

(48,971

)

$

(110,936

)

$

(111,830

)

Other comprehensive income:

 

 

 

 

 

 

 

 

 

Change in unrealized gains and losses on available-for-sale securities, net of taxes

 

1,503

 

 

2,423

 

 

Change in postretirement benefit liability not yet recognized in net periodic benefit expense

 

19

 

19

 

55

 

55

 

Total comprehensive loss

 

$

(39,393

)

$

(48,952

)

$

(108,458

)

$

(111,775

)

 

4. Collaborative and Licensing Agreements

 

In August 2009, we and Trubion entered into a collaboration agreement for the global development and commercialization of TRU-016, a product candidate in phase 1 clinical trials for chronic lymphocytic leukemia.  Under the terms of the collaboration agreement, we paid Trubion an upfront license fee of $20.0 million and we may be obligated to pay Trubion up to $176.5 million in additional contingent payments if certain development, regulatory and sales milestones are achieved for each product under the collaboration agreement, the significant majority of which are for achievement of later-stage development, regulatory and sales-based milestones. We and Trubion will share equally the costs of all development, commercialization and promotional activities and all global operating profits.

 

In addition, we purchased 2,243,649 shares of newly issued shares of Trubion common stock for $10.0 million. Our $10.0 million equity investment in Trubion reflected an approximate 16% premium over the closing price of Trubion’s common stock on the date the stock purchase agreement was executed, resulting in a total premium of $1.4 million. Since the stock purchase agreement and the collaboration agreement were entered into concurrently, we recognized the $1.4 million premium as additional R&D expense in the third quarter of 2009. We recorded the $8.6 million fair value of the equity investment as marketable securities.  As Trubion’s early-stage technology to which we have licensed rights has not reached technological feasibility and has no alternative future uses, we recognized the $21.4 million upfront license fee as R&D expense in the third quarter of 2009. (See Note 9 for further details on the accounting treatment for our equity investment in Trubion.)

 

Both we and Trubion have the right to opt out of all rights and obligations to co-develop and co-commercialize any collaboration product at certain specified milestone points or upon the occurrence of certain events.  In addition, we have the right to terminate the collaboration agreement for any reason upon written notice to Trubion, provided that if we give notice on or before February 27, 2011, we are required to pay a termination fee of $10.0 million.

 

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For the three months ended September 30, 2009, we recorded a $0.5 million payable to Trubion which represents the net amount due to Trubion for R&D expense reimbursement under the cost sharing provisions of our agreement.  This $0.5 million was reflected as R&D expense in the period.

 

5. Sale of Manufacturing Assets and Clinical Supply Agreement

 

In March 2008, we sold our Minnesota manufacturing facility and related operations to an affiliate of Genmab A/S (Genmab) for total cash proceeds of $240.0 million. Under the terms of the purchase agreement, Genmab acquired our manufacturing and related administrative facilities in Brooklyn Park, Minnesota, and related assets therein, and assumed certain lease obligations related to our former facilities in Plymouth, Minnesota (together, the Manufacturing Assets). We recognized a pre-tax gain of $49.7 million upon the close of the sale in March 2008. Such gain represents the $240.0 million in gross proceeds, less the net book value of the underlying assets transferred of $185.4 million and $4.9 million in transaction costs and other charges.

 

In addition, to fulfill our then-anticipated clinical manufacturing needs through 2010, we entered into a clinical supply agreement with Genmab that became effective upon the close of the transaction in March 2008.  Under the terms of the clinical supply agreement, we committed to order and Genmab agreed to manufacture clinical drug substance for certain of our pipeline products through 2010.

 

In September 2009, we entered into an amendment to this clinical supply agreement which provides us the right to extend the manufacturing of any remaining committed batches beyond 2010 and up through 2012 in exchange for payment of additional fees.  In addition, we agreed to provide an additional deposit of $1.1 million with respect to the remaining committed manufacturing batches not yet scheduled for manufacturing. The total deposit in place under the Genmab supply agreement was $4.9 million as of September 30, 2009, which was classified as an other asset.

 

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6. Restructuring Charges

 

The following table summarizes the restructuring activity and restructuring accrual balances for the nine months ended September 30, 2009:

 

 

 

Personnel

 

Lease

 

 

 

(In thousands)

 

Costs

 

Related

 

Total

 

Balance at December 31, 2008

 

$

1,956

 

$

 

$

1,956

 

2008 Restructuring Plan

 

172

 

 

172

 

France Restructuring Plan

 

373

 

135

 

508

 

2009 Restructuring Plan

 

3,525

 

 

3,525

 

Total restructuring charges

 

4,070

 

135

 

4,205

 

Total payments

 

(3,399

)

(135

)

(3,534

)

Balance at March 31, 2009

 

2,627

 

 

2,627

 

 

 

 

 

 

 

 

 

2008 Restructuring Plan *

 

(147

)

 

(147

)

2009 Restructuring Plan

 

29

 

16,983

 

17,012

 

Total restructuring charges

 

(118

)

16,983

 

16,865

 

Total payments

 

(2,130

)

(1,025

)

(3,155

)

Deferred rent credit

 

 

5,983

 

5,983

 

Balance at June 30, 2009

 

379

 

21,941

 

22,320

 

 

 

 

 

 

 

 

 

2008 Restructuring Plan

 

24

 

 

24

 

2009 Restructuring Plan*

 

(82

)

(1,594

)

(1,676

)

Total restructuring charges

 

(58

)

(1,594

)

(1,652

)

Total payments

 

(308

)

(1,532

)

(1,840

)

Total adjustments

 

 

(670

)

(670

)

Balance at September 30, 2009

 

$

13

 

$

18,145

 

$

18,158

 

 


* Represents a change in estimate to previously recognized restructuring expenses

 

2008 Restructuring Plan

 

In an effort to reduce our operating costs, in March 2008 we commenced a restructuring plan pursuant to which we immediately eliminated approximately 120 employment positions and would eliminate approximately 130 additional employment positions over the subsequent 12 months (the 2008 Restructuring Plan). All impacted employees were notified in March 2008. Employees terminated in connection with the restructuring efforts were eligible for a specified severance package. We recognized severance charges for employees whose positions were terminated over the subsequent 12 months over their respective estimated service periods. Under the 2008 Restructuring Plan, we recognized restructuring charges of $1.0 million and $0.0 million during the three months ended September 30, 2008 and 2009, respectively. Such charges for the nine months ended September 30, 2008 and 2009 were $9.4 million and $0.0 million, respectively.  These charges primarily consisted of post-termination severance costs as well as salary accruals relating to the portion of the 60-day notice period over which the terminated employees would not be providing services to the Company. We have substantially paid all of our obligations under the 2008 Restructuring Plan.

 

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France Restructuring Plan

 

During the fourth quarter of 2008, we decided to close our offices in France, which at the time employed seven individuals. During the three and nine months ended September 30, 2009 we recognized $0.0 million and $0.5 million, respectively in restructuring charges under this restructuring plan. We have paid all obligations related to the closure of our French office as of September 30, 2009.

 

2009 Restructuring Plan

 

As a result of a strategic review process to enhance our focus and significantly reduce our operating expenses, we undertook a reduction in force in early 2009, pursuant to which we eliminated approximately 80 positions (the 2009 Restructuring Plan). As a result of the 2009 restructuring activities, we recognized charges related to severance benefits totaling $3.5 million for the nine months ended September 30, 2009. During the three months ended September 30, 2009, we recognized a credit of $0.1 million, representing a change in estimate from prior periods.  We have substantially paid all obligations related to the severance benefits under the 2009 Restructuring Plan.

 

In connection with the 2009 Restructuring Plan, we vacated approximately 85%, or approximately 240,000 square feet, of one of our two leased buildings in Redwood City (the Administration Building) and consolidated our operations into the other building (the Lab Building) during the second quarter of 2009. We consolidated our operations into the Lab Building to both reduce our future operating expenses and expedite potential future subleases for the vacated space. In connection with vacating this space in the Administration Building, we recognized lease-related restructuring charges of $17.0 million in the second quarter of 2009. The lease-related restructuring charges were comprised of a $23.0 million lease-related restructuring liability, which was calculated as the present value of the estimated future facility costs for which we will obtain no future economic benefit over the term of our lease, net of estimated future sublease income and a $6.0 million credit for an existing deferred rent liability associated with the vacated area of the Administration Building.

 

During the third quarter of 2009, based on updated assumptions resulting from our ongoing discussions with potential subtenants, we recognized a credit to our lease-related restructuring charges of $1.6 million, comprised of a favorable change in estimate of $2.4 million partially offset by $0.8 million of accretion expenses, which, in addition to payments and adjustments, reduced the lease-related restructuring liability to $18.1 million as of September 30, 2009.  The adjustments to the lease-related restructuring liability related to prepaid rent and property taxes as of September 2009.  This change in estimate reduced net loss per share for each of the three- and nine-months periods ended September 30, 2009 by $0.10.

 

The estimates underlying the fair value of the lease-related restructuring liability of $18.1 million involve significant assumptions regarding the time required to contract with subtenants, the amount of space we may be able to sublease, the range of potential future sublease rates and the level of leasehold improvements expenditures that we may incur to sublease the property. We have continued to evaluate a number of potential sublease scenarios with differing assumptions and have probability weighted these scenarios and calculated the present value of cash flows based on management’s best judgment.  We will continue to monitor and update the liability balance when future events impact our cash flow estimates related to the vacated area of the Administration Building.

 

In addition, in connection with our sublease efforts for the Administration Building, we are also pursuing sublease arrangements under which we could potentially contract with subtenants for both the Administration Building and the Lab Building, which we currently occupy. If we sublease these facilities for rates that are not significantly in excess of our costs, we would not likely recover the carrying value of certain assets associated with these facilities, which was approximately $60.0 million as of September 30, 2009. As such, we could potentially incur a substantial asset impairment charge, as much as the carrying value of such assets, if we were to sublease both of these buildings.

 

7. Asset Impairment Charges

 

Total asset impairment charges recognized during the three and nine months ended September 30, 2009 were $0.2 million and $1.0 million, respectively.  These impairment charges related to certain information technology projects that we terminated as well as to equipment that we no longer intend to utilize in our ongoing operations, primarily resulting from the consolidation of our operations almost entirely into one of our two leased buildings in Redwood City, as discussed in Note 6.

 

We recognized asset impairment charges of $0.0 million and $3.8 million during the three and nine months ended September 30, 2008, respectively, which primarily represented the costs of certain research equipment that we expect to have no future useful life and certain information technology projects that we terminated, in each case, as a result of our restructuring activities.

 

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8. Other Accrued Liabilities

 

Other accrued liabilities consisted of the following:

 

(in thousands)

 

September 30, 2009

 

December 31, 2008

 

Consulting and services

 

$

3,715

 

$

644

 

Accrued clinical and pre-clinical trial costs

 

985

 

1,031

 

Collaboration expense reimbursements

 

3,508

 

 

Other

 

550

 

175

 

Total

 

$

8,758

 

$

1,850

 

 

9. Cash Equivalents, Marketable Securities and Restricted Cash

 

At September 30, 2009, we had invested in money market funds, as well as marketable debt and equity securities. Our securities are classified as available-for-sale. Available-for-sale securities are carried at estimated fair value, which is based upon quoted market prices for these or similar instruments, with unrealized gains and losses reported in accumulated other comprehensive income (loss) in stockholders’ equity. The amortized cost of debt securities is adjusted for amortization of premiums and discounts from the purchase date to maturity. Such amortization is included in interest income. The cost of securities sold is based on the specific identification method. To date, we have not experienced credit losses on investments in these instruments. In addition, we do not require collateral for our investment activities. We did not have any cash equivalents or marketable securities as of December 31, 2008.

 

We have classified all of our available-for-sale securities as current assets since they are available for use in our daily operations.  The following table summarizes, by type of security, the amortized cost and estimated fair value of our available-for-sale securities as of September 30, 2009:

 

 

 

 

 

Gross

 

Gross

 

Estimated

 

 

 

Amortized

 

Unrealized

 

Unrealized

 

Fair

 

(In thousands)

 

Cost

 

Gains

 

Losses

 

Value

 

Institutional money market funds

 

 

 

 

 

 

 

 

 

maturity within 1 year

 

$

25,419

 

$

 

$

 

$

25,419

 

Securities of U.S. Government sponsored entities

 

 

 

 

 

 

 

 

 

maturity within 1 year

 

201,223

 

616

 

 

201,839

 

maturity between 1- 3 years

 

52,132

 

100

 

(7

)

52,225

 

U.S. corporate debt securities

 

 

 

 

 

 

 

 

 

maturity within 1 year

 

3,499

 

 

 

3,499

 

maturity between 1- 3 years

 

26,049

 

78

 

 

26,127

 

Marketable equity securities

 

8,593

 

2,760

 

 

11,353

 

Total marketable securities

 

$

316,915

 

$

3,554

 

$

(7

)

$

320,462

 

 

The following table presents the classification of available-for-sale securities on our Consolidated Balance Sheet.

 

 

 

September 30,

 

 

 

 

 

 

 

 

(In thousands)

 

2009

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

53,915

 

 

 

 

 

 

 

 

Marketable securities

 

266,547

 

 

 

 

 

 

 

 

Total

 

$

320,462

 

 

 

 

 

 

 

 

 

As of September 30, 2009 and December 31, 2008 we had a total of $6.4 million and $5.8 million of restricted cash, respectively, held in certificate of deposits to support letters of credit serving as security deposits for our Redwood City, California building and other operating leases.

 

We have excluded from the tables above $5.0 million of cash, which is included in the cash and cash equivalents caption in the Consolidated Balance Sheet as of September 30, 2009. As of December 31, 2008, all of our excess capital was held in cash accounts and was reflected as cash and cash equivalents in the Consolidated Balance Sheet.

 

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Table of Contents

 

10. Fair Value Measurements

 

We are required under U.S. GAAP to establish fair value using a three-tier hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:

 

·                  Level 1—quoted prices in active markets for identical assets and liabilities

 

·                  Level 2—observable inputs other than quoted prices in active markets for identical assets and liabilities

 

·                  Level 3—unobservable inputs

 

Marketable Securities

 

At September 30, 2009, we determined the fair values of our available-for-sale securities using Level 1 and Level 2 inputs, as reflected in the table below:

 

(in thousands)

 

Level 1

 

Level 2

 

Level 3

 

Total

 

Institutional money market funds

 

$

 25,419

 

$

 —

 

$

 —

 

$

 25,419

 

Securities of U.S. Government sponsored entities within one year

 

 

254,064

 

 

254,064

 

Corporate securities (1)

 

 

29,626

 

 

29,626

 

Marketable equity securities

 

11,353

 

 

 

11,353

 

 

 

 

 

 

 

 

 

 

 

Total financial assets measured on a recurring basis

 

$

 36,772

 

$

 283,690

 

$

 —

 

$

 320,462

 

 


(1)  All corporate securities held at September 30, 2009 were secured by the U.S. Government under the terms of the Treasury Loan Guarantee Program.

 

 

 

September 30,

 

 

 

 

 

 

 

 

(In thousands)

 

2009

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

 53,915

 

 

 

 

 

 

 

 

Marketable securities

 

266,547

 

 

 

 

 

 

 

 

Total

 

$

 320,462

 

 

 

 

 

 

 

 

 

Lease Financing Liability

 

In July 2006, we entered into agreements to lease two buildings in Redwood City, California, to serve as our corporate headquarters. The underlying lease term for these buildings was 15 years. Significant leasehold improvements were performed for one of the buildings (the Lab Building), which previously had never been occupied or improved for occupancy. Due to our involvement in and assumed risk during the construction period, as well as the nature of the leasehold improvements for the Lab Building, we were required to reflect the lease of the Lab Building in our financial statements as if we had purchased the building by recording the fair value of the building and a corresponding lease financing liability.  The carrying amount of this lease financing liability as of September 30, 2009 was $25.5 million, which approximated its fair value at that date.

 

11. Contingencies

 

As permitted under Delaware law, pursuant to the terms of our bylaws, we have agreed to indemnify our officers and directors and, pursuant to the terms of indemnification agreements, we have agreed to indemnify our executive officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving as an officer or director of the Company. While the maximum amount of potential future indemnification is unlimited, we have a director and officer insurance policy in place that limits our exposure and may enable us to recover a portion of any future amounts paid. We believe the fair value of these indemnification agreements and bylaw provisions is immaterial and, accordingly, we have not recorded the fair value liability associated with these agreements as of September 30, 2009 or as of December 31, 2008.

 

Under the terms of the Separation and Distribution Agreement, we and PDL each agreed to indemnify the other from and after the Spin-off with respect to the indebtedness, liabilities and obligations retained by our respective companies. These indemnification obligations could be significant. The ability to satisfy these indemnities if called upon to do so will depend upon the future financial strength of each of our companies. We cannot determine whether we will have to indemnify PDL for any substantial obligations in the future, nor can we be sure that, if PDL has to indemnify us for any substantial obligations, PDL will have the ability to satisfy those obligations.

 

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In April 2009, we became aware of assertions from one of PDL’s former commercial product distributors that it believes it should be reimbursed for certain amounts relating to sales rebates on the sale of the Busulfex® commercial product in Italy during the 2006 and 2007 fiscal periods. We believe these assertions are invalid and without merit. Under the terms of the indemnification provisions contained in the Separation and Distribution Agreement, we could be responsible for any amounts ultimately deemed due and payable to this distributor by PDL should these assertions be deemed valid. As any potential liability related to these assertions is not probable at this time, we have not recorded any liability relating to this matter on our balance sheet as of September 30, 2009.

 

In September 2009, purported stockholder John Dugdale filed a complaint in San Diego Superior Court on behalf of himself and all others similarly situated and derivatively on behalf of the Company, in the Superior Court of the State of California, County of San Diego (the Complaint). The Complaint purports to be both a stockholder class action and derivative action and alleges claims for breach of fiduciary duties, abuse of control, gross mismanagement and corporate waste against the Company’s directors Faheem Hasnain, Brad Goodwin, Gary Lyons, David R. Parkinson, Kurt Von Emster, Hoyoung Huh and Does 1-25 (the Defendants), in connection with certain offers made by Biogen Idec to acquire the Company, including the tender offer. The Complaint seeks declaratory and injunctive relief, including an order compelling Defendants to comply with their fiduciary duties, prohibiting Defendants “from entering into any contractual provisions which harm Facet or its shareholders” or that “prohibit [D]efendants from maximizing shareholder value,” and either invalidating or directing the rescission or redemption of the rights to purchase shares of Series A Preferred Stock issued pursuant to the Rights Agreement between the Company and Mellon Investor Services LLC, dated as of September 7, 2009 and any other “defensive measure that has or is intended to have the effect of making the consummation of an offer to purchase the Company more difficult or costly for a potential acquirer.” The Complaint further seeks fees and costs, including attorneys’ and experts’ fees. As we currently believe that the Complaint is without merit, we have not accrued any amounts related to this matter in the financial statements as of September 30, 2009

 

12. Release of Escrow Funds

 

In the second quarter of 2009, we received $1.0 million from an escrow account that was initially set up by PDL and EKR Therapeutics, Inc. (EKR) under the terms of EKR’s purchase of PDL’s former cardiovascular assets in March 2008.  In connection with EKR’s purchase of the cardiovascular assets, $6.0 million of the purchase price was placed in an escrow account for a period of one year to cover certain product-return and sales-rebate related costs. Through the term of the escrow agreement, EKR had submitted claims totaling approximately $5 million against the escrow account, which funds were released to EKR by the escrow agent. The rights and obligations under this escrow agreement were transferred to us upon the Spin-off and, in April 2009, the remaining escrow funds of $1.0 million were transferred to us. We recognized such amount in interest and other income, net in the second quarter of 2009.

 

13. Biogen Idec Inc.’s Tender Offer for Facet Biotech’s Common Stock

 

On September 21, 2009, Biogen Idec, through a wholly owned subsidiary, commenced an unsolicited tender offer to acquire the outstanding shares of common stock of the Company, subject to a number of terms and conditions contained in the tender offer documents that Biogen Idec filed with the SEC, for $14.50 per share in cash. On October 1, 2009, we filed a Schedule 14D-9 with the SEC in which our Board of Directors unanimously recommended that our stockholders reject the Biogen Idec offer and not tender their shares pursuant to Biogen Idec’s tender offer. On October 2, 2009, we filed a first amendment to our Schedule 14D-9 to disclose that our Board of Directors had approved certain programs intended to promote employee retention in light of the uncertainty created by the tender offer. Our Board of Directors approved certain amendments to the agreements governing the equity awards that the Company has granted to employees who are not participants in the Retention and Severance Plan (Non-RSP Employees) and the adoption of a severance plan for Non-RSP Employees that would provide benefits upon certain terminations of employment following a change in control of the Company.  On October 16, 2009 Biogen Idec extended its $14.50 per share tender offer to December 16, 2009. On October 19, 2009, we filed a second amendment to our Schedule 14D-9 to reiterate the recommendation of our Board of Directors that Facet Biotech stockholders reject Biogen Idec’s unsolicited tender offer. For information as to the reasons of our Board of Directors for their recommendation and further information related to the tender offer and these benefit programs, see our Schedule 14D-9 and amendments to the Schedule 14D-9 filed with the SEC.

 

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ITEM 2.

 

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

 

This report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward looking statements” for purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or licensing or collaborative arrangements, any statements regarding future economic conditions or performance, and any statement of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as “believes,” “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential,” or “continue” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements contained in this report are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including the risk factors set forth below, and for the reasons described elsewhere in this report. All forward-looking statements and reasons why results may differ included in this report are made as of the date hereof, and we assume no obligation to update these forward-looking statements or reasons why actual results might differ.

 

OVERVIEW

 

The information included in this management’s discussion and analysis of financial conditions should be read in conjunction with the consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2008 filed with the Securities and Exchange Commission (SEC) and our unaudited Consolidated Financial Statements for the three and nine months ended September 30, 2009, as well as other disclosures, including the disclosures under “Risk Factors,” that have been included in this Quarterly Report on Form 10-Q.

 

Facet Biotech Corporation (we, us, our, the Company) is a biotechnology company dedicated to advancing our pipeline of five clinical-stage products, leveraging our research and development capabilities to identify and develop new oncology drugs and applying our proprietary next-generation protein engineering technologies to potentially improve the clinical performance of protein therapeutics.

 

Basis of Presentation

 

Facet Biotech was organized as a Delaware corporation in July 2008 by PDL BioPharma, Inc. (PDL) as a wholly owned subsidiary of PDL. PDL organized the Company in preparation for the spin-off of the Company, which was effected on December 18, 2008 (the Spin-off). Prior to the Spin-off, PDL’s Biotechnology Business was not operated by a legal entity separate from PDL and a direct ownership relationship did not exist among all the components comprising the Biotechnology Business. We describe the Biotechnology Business transferred to us by PDL in connection with the Spin-off as though the Biotechnology Business were our business for all historical periods described. However, Facet Biotech had not conducted any operations prior to the Spin-off. References in this quarterly report to the historical assets, liabilities, products, business or activities of our business are intended to refer to the historical assets, liabilities, products, business or activities of the Biotechnology Business as those were conducted as part of PDL prior to the Spin-off.

 

We have prepared the condensed consolidated financial statements for the three and nine months ended September 30, 2008 using PDL’s historical cost basis of the various activities that comprised the Biotechnology Business as a component of PDL, and such financial statements reflect the results of operations and cash flows of the Biotechnology Business as a component of PDL. The statements of operations for the three and nine months ended September 30, 2008 include expense allocations for general corporate overhead functions historically shared with PDL, including finance, legal, human resources, investor relations and other administrative functions, which include the costs of salaries, benefits, stock-based compensation and other related costs, as well as consulting and other professional services. Where appropriate, these allocations were made on a specific identification basis. Otherwise, the expenses related to services provided to the Biotechnology Business by PDL were allocated to Facet Biotech based on the relative percentages, as compared to PDL’s other businesses, of headcount or another appropriate methodology depending on the nature of each item of cost to be allocated.

 

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Recent Developments

 

The following represents the significant events or developments that have occurred in the nine months ended September 30, 2009 and up to the date of the filing of this quarterly report:

 

·                  In January 2009, we undertook a restructuring effort pursuant to which we eliminated approximately 80 positions, and our workforce is now comprised of approximately 200 employment positions. We recognized costs related to severance and post-termination benefits totaling $3.5 million in the nine months ended September 30, 2009.

 

·                  In the first quarter for 2009, we and Biogen Idec Inc. (Biogen Idec) announced that the United States Food and Drug Administration (FDA) and European regulatory agencies agreed to consider an expanded SELECT study, which is an ongoing study of daclizumab in patients with relapsing-remitting multiple sclerosis (MS), as a registration-enabling study, thus requiring us to conduct only one additional registration-enabling study. As a result, we have amended the SELECT study protocol to increase the sample size from 300 to 600 patients and change the primary endpoint to annualized relapse rate, and have submitted the amended protocol to the appropriate regulatory authorities.

 

·                  During the second quarter of 2009, we consolidated nearly all of our operations into one of our two leased buildings in Redwood City, resulting in our ceasing use of the significant majority of one of our leased buildings.  As a result, we recognized total lease-related restructuring charges of $15.4 million in the second and third quarters of 2009 in connection with these consolidation efforts (including a $1.6 million reduction to the charges recognized in the third quarter of 2009).

 

·                  In August 2009, we announced our decision, along with Biogen Idec, to continue planning for the phase 3 trial of daclizumab in MS. On July 31, 2009, a futility analysis was performed with respect to the SELECT trial to ensure safety of the subjects and to evaluate whether the trial should continue. As described in an unblinding plan submitted to the FDA, an independent statistician analyzed clinical data from approximately 150 trial subjects that had completed at least six months of treatment. An independent safety monitoring committee reviewed the interim data and recommended to Biogen Idec and the Company the continuation of the SELECT study with both daclizumab dose arms (150mg and 300mg). In addition, to determine whether the collaboration should trigger the DECIDE phase 3 trial and to inform the design of this phase 3 trial, certain prearranged employees of each of the Company and Biogen Idec (which employees are no longer directly involved in the management of the SELECT study) reviewed summary data tables prepared by the independent statistician from the interim analysis. Based on this review and data from prior studies, these prearranged personnel recommended on behalf of the Company and Biogen Idec that the collaboration should initiate the DECIDE phase 3 study, which is the second and final required registration-enabling study. SELECT remains an ongoing blinded study. In August 2009, we submitted a Special Protocol Assessment to the FDA and we, together with Biogen Idec, are working with the FDA to finalize the protocol for the DECIDE study. We expect to initiate the phase 3 trial during the first half of 2010.

 

·                 In August 2009, we and Trubion Pharmaceuticals, Inc (Trubion) entered in to a collaboration agreement for the global development and commercialization of TRU-016, a CD37-directed small modular immunopharmaceutical in phase 1 clinical trials for chronic lymphocytic leukemia. The collaboration agreement covers TRU-016 in all indications and all other CD37-directed protein therapeutics. Under the terms of the collaboration agreement, we paid Trubion an upfront license fee of $20.0 million and we may be obligated to pay Trubion up to $176.5 million in additional contingent payments if certain development, regulatory and sales milestones are achieved for each product under the collaboration agreement, the significant majority of which are for achievement of later-stage development, regulatory and sales-based milestones. In addition, we purchased 2,243,649 shares of newly issued Trubion common stock for an aggregate purchase price of $10.0 million. (See Note 4 to the Condensed Consolidated Financial Statement for more details on the collaboration agreement.)

 

·                  In September 2009, FBC Acquisition Corp, a wholly owned subsidiary of Biogen Idec, announced that it had commenced a tender offer (Biogen Idec’s tender offer) to acquire all of our outstanding shares for $14.50 per share in cash.  After careful consideration, our Board of Directors determined that the Biogen Idec offer was not in the best interests of our stockholders and unanimously recommended that our stockholders reject the offer and not tender their shares to Biogen Idec for purchase. We publicly announced our Board’s recommendation on October 1, 2009, which was reiterated on October 19, 2009 after Biogen Idec extended its $14.50 per share tender offer to December 16, 2009.

 

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Summary Financial Results for the Third Quarter of 2009

 

In the third quarter of 2009, we recognized total revenues of $10.8 million, generally consistent with the amounts recognized in each of the first two quarters of 2009.  Our revenues continue to be comprised primarily of revenues related to our collaborations with BMS and Biogen Idec.  Our total costs and expenses in the third quarter of 2009 were $53.1 million, consisting primarily of $45.1 million in research and development (R&D) expenses and $9.5 million in general and administrative (G&A) expenses. Although our restructuring activities conducted in the first half of 2009 reduced the run-rate of employee-related expenses in our R&D and G&A functions, both R&D and G&A expenses for the third quarter of 2009 increased as compared to prior 2009 periods.  R&D expenses, which were $45.1 million the third quarter of 2009, increased significantly compared to each of the first two quarters of 2009 due primarily to a $20.0 million upfront payment recognized in the current period upon the execution of our collaboration with Trubion.  G&A expenses of $9.5 million incurred in the third quarter of 2009 increased from the second quarter of 2009 due largely to $2.5 million in expenses incurred during the period related to responding to Biogen Idec’s tender offer. Our net loss for the third quarter of 2009 was $40.9 million. (See “Results of Operations” for further details on our financial results for the period.)

 

At September 30, 2009, we had cash, cash equivalents, marketable securities and restricted cash of $331.9 million, compared to $403.4 million at December 31, 2008, representing a change of $71.5 million for the first nine months of 2009.  The $20.0 million upfront payment made to Trubion upon execution of the collaboration agreement in the third quarter of 2009 was a significant contributor to the change in these balances.

 

Research and Development Programs

 

We currently have several investigational compounds in various stages of development for the treatment of cancer and immunologic diseases, four of which we are developing with our collaboration partners; two with Biogen Idec, one with Bristol-Myers Squibb Company (BMS) and one with Trubion. The table below lists the compounds for which we are pursuing development activities either on our own or in collaboration with other companies. None of our product candidates have been approved by the FDA or commercialized in the indication in which our trials are focused. Not all clinical trials for each product candidate are listed below. The development and commercialization of our product candidates are subject to numerous risks and uncertainties, as noted in our “Risk Factors” of this Quarterly Report. For additional details on each product in the table below, please refer to Item 1 in our Annual Report on Form 10-K for the year ended December 31, 2008 as well as the Recent Developments section of this report above.

 

Product Candidate

 

Indication/Description

 

Program Status

 

Collaborator

 

Daclizumab

 

Multiple sclerosis

 

Phase 2b

 

Biogen Idec

 

Volociximab (M200)

 

Non-small cell lung cancer

 

Phase 1

 

Biogen Idec

 

Elotuzumab (HuLuc63)

 

Multiple myeloma

 

Phase 1

 

BMS

 

TRU-016

 

Chronic lymphocytic leukemia

 

Phase 1

 

Trubion

 (a)

PDL192

 

Solid tumors

 

Phase 1

 

 

PDL241

 

Immunologic diseases

 

Preclinical

 

 (b)

Other preclinical research candidates

 

Oncology

 

Candidates under evaluation

 

 

 


(a)             In August 2009, we entered into a collaboration agreement with Trubion for the development of TRU-016, a CD37-directed small modular immunopharmaceutical in phase 1 clinical trials for chronic lymphocytic leukemia. The collaboration agreement covers TRU-016 in all indications and all other CD37-directed protein therapeutics. See Note 4 to the Condensed Consolidated Financial Statements for more details on the collaboration agreement with Trubion.

(b)            BMS has an option to expand our collaboration to include the PDL241 antibody after completion of certain pre-agreed preclinical studies, which we completed and submitted to BMS in the fourth quarter of 2009.

 

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CRITICAL ACCOUNTING POLICIES AND THE USE OF ESTIMATES

 

There have been no material changes in our critical accounting policies, estimates and judgments during the quarter ended September 30, 2009 compared to the disclosures in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2008, except for the following addition:

 

Restructuring

 

In connection with our 2009 restructuring activities, we vacated and ceased use of approximately 85% of one of our two leased buildings in Redwood City (the Administration Building) and consolidated our operations into the other building (the Lab Building) during the second quarter of 2009. In connection with vacating this space within the Administration Building, we recognized lease-related restructuring charges of $17.0 million in the second quarter of 2009. These charges are comprised of our initial estimate of $23.0 million for the Lease Restructuring Liability, which represented the present value of the estimated facility costs for which we will obtain no future economic benefit offset by estimated future sublease income, partially offset by a $6.0 million credit for a then- existing deferred rent liability associated with the vacated area of the Administration Building.

 

During the third quarter of 2009, based on updated assumptions resulting from continued discussions with potential subtenants, we recognized a credit to our lease-related restructuring charges of $1.6 million, driven by a change in estimate of $2.4 million, which, in addition to payments and adjustments, reduced the lease-related restructuring liability to $18.1 million as of September 30, 2009. The total estimated obligations under the lease for the Administration Building, as of September 30, 2009, are summarized below (these amounts exclude obligations related to the Lab Building):

 

 

 

Payments Due by Period

 

 

 

Less Than

 

 

 

 

 

More than

 

 

 

(in thousands)

 

1 Year

 

1-3 Years

 

4-5 Years

 

5 Years

 

Total

 

Lease payments(1)

 

$

 3,226

 

$

 6,453

 

$

 11,823

 

$

 58,071

 

$

 79,573

 

Other lease related obligations(2)

 

3,693

 

7,571

 

7,830

 

30,798

 

49,892

 

 


(1)          Lease payments represent actual and estimated contractual rental payments under our lease for the Administration Building. These lease obligations reflect our estimates of future lease payments, which are subject to potential escalations based on market conditions after the year 2014 and, therefore, could be lower or higher than amounts included in the table.

 

(2)          Other lease-related obligations reflect estimated amounts that we are contractually required to pay over the term of the Administration Building lease, including insurance, property taxes and common area maintenance fees. Such amounts are estimated based on historical costs that we have incurred since the inception of the lease.

 

We derived our estimates for the $18.1 million Lease Restructuring Liability, which involved significant assumptions regarding the time required to contract with subtenants, the amount of idle space we would be able to sublease and potential future sublease rates, based on discussions with our brokers and discussions currently in process with potential subtenants. The present value factor, which also affects the level of accretion expense that we will recognize as additional restructuring charges over the term of the lease, is based on our estimate of Facet Biotech’s current credit-risk adjusted borrowing rate.

 

We have established a number of potential scenarios with differing assumptions and have calculated the present value of and applied probability weighting to each scenario based on management’s best judgment.  Changes in the assumptions underlying these scenarios, as well as the relative likelihood applied to each scenario, could have a material impact on our restructuring charge and Lease Restructuring Liability.  For example, using a set of assumptions of contracting the entire property with a single subtenant within one year for 100% of our lease costs would result in a favorable adjustment of approximately $6.5 million to our Lease Restructuring Liability.  However, a scenario in which we would contract with several subtenants over a period of five years at lease rates approximating 75% of our costs, and assuming an average vacancy rate of 40% over the remaining term of our lease, would result in an unfavorable adjustment of $11.3 million to our Lease Restructuring Liability.

 

We are required to continue to update our estimate of the Lease Restructuring Liability in future periods as conditions warrant, and we expect to further revise our estimate in future periods as we continue our discussions with potential subtenants.

 

In addition, in connection with our sublease efforts for the Administration Building, we are also pursuing sublease arrangements under which we could potentially contract with subtenants for both the Administration Building and the Lab Building (which we currently occupy). If we sublease these facilities for rates that are not significantly in excess of our costs, we would not likely recover the carrying value of certain assets associated with these facilities, which was approximately $60.0 million as of September 30, 2009. As such, we could potentially recognize a substantial asset impairment charge, as much as the carrying value of such assets, if we were to sublease both of these buildings.

 

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RESULTS OF OPERATIONS

 

Revenues

 

Revenues consist of (1) license and milestone revenues from collaborations, (2) reimbursement of R&D expenses under collaborations and (3) other revenues. Other revenues include license, maintenance and milestone revenues from the out-licensing of our technologies, humanization revenues and royalties.

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

(in thousands)

 

2009

 

2008

 

% Change

 

2009

 

2008

 

% Change

 

License and milestone revenues from collaborations

 

$

 2,961

 

$

 2,122

 

40

%

$

 9,059

 

$

 5,772

 

57

%

Reimbursement of R&D expenses from collaborations

 

5,876

 

1,909

 

208

%

15,912

 

2,766

 

475

%

Other

 

2,011

 

925

 

117

%

6,027

 

3,075

 

96

%

Total revenues

 

$

 10,848

 

$

 4,956

 

119

%

$

 30,998

 

$

 11,613

 

167

%

 

Total revenues increased by $5.9 million during the quarter ended September 30, 2009 from the comparable 2008 period due primarily to an additional $4.0 million of reimbursement of R&D expenses and $0.6 million of license revenues recognized under our collaboration with BMS, which became effective in September 2008.  The increase in revenues under our collaboration with BMS was driven by the timing of the effectiveness of the agreement in 2008, resulting in a full quarter of revenue in the 2009 period as compared to approximately one month of revenue in the comparable 2008 period. In addition, we recognized $1.6 million of royalties received under our agreement with EKR Therapeutics, Inc. (EKR) in other revenue during the third quarter of 2009. These increases in revenues were partially offset by a $0.5 million milestone payment that we recognized in the third quarter of 2008, with no similar revenues recognized in the third quarter of 2009.

 

The increase of $19.4 million in total revenues during the nine months ended September 30, 2009 from the comparable period in 2008 was driven primarily by an additional $14.0 million of R&D reimbursement revenues and $2.6 million of license revenues recognized in connection with our collaboration with BMS, as well as $4.6 million of royalties received under our agreement with EKR.  These increases in revenues were partially offset by $2.5 million in milestone payments that we received during the nine months ended September 30, 2008 from certain of our licensees as compared to $0.5 million in milestone payments for the comparable 2009 period, which were reflected as other revenue.

 

With respect to the reimbursement of development costs, each quarter, we and our collaborators reconcile the development costs each party has incurred, and we record either a net receivable or a net payable in our consolidated financial statements. For each quarterly period, if we have a net receivable from a collaborator, we recognize revenues by such amount, and if we have a net payable to our collaborator, we recognize additional R&D expenses by such amount. Therefore, our revenues and R&D expenses may fluctuate depending on which party in our collaborations is incurring the majority of the development costs in any particular quarterly period.

 

Future revenues will vary from period to period and will depend substantially on (1) whether we are successful in our existing collaborations and receive milestone payments thereunder, (2) the potential milestone payments we receive related to our out-licensing agreements, (3) whether and to what extent expected development timelines change, which would impact the rate at which we recognize revenue related to certain previously received collaboration payments, (4) the level of royalties we receive under the asset purchase agreement with EKR, which was assigned to us by PDL in connection with the Spin-off, and (5) whether we enter into new collaboration agreements or out-license agreements. Our future collaboration revenues also will vary depending on which party in any collaboration is incurring the majority of development costs in any period (see our policy for revenues recognized under our collaboration agreements in Note 1 to the Condensed Consolidated Financial Statements).

 

In October 2009, we and EKR executed an amendment to the purchase agreement under which EKR purchased rights to PDL’s former Cardiovascular Assets in March 2008, which agreement was assigned to us by PDL in connection with the Spin-Off. Under the terms of the amendment, we, among other things: received from EKR an upfront payment of $2.0 million; increased the royalty rate on certain formulations of Cardene® (the Cardene Pre-Mixed Bag) sales, which is based on a tiered-fee schedule dependant on levels of product sales for each 12-month period from July 1 to June 30 ranging in the low- to mid-teens from the prior flat rate of 10%; and extended the royalty term for royalties on Cardene Pre-Mixed Bag sales from December 31, 2014 to December 31, 2017. The amended royalty structure is effective for EKR’s Cardene Pre-Mixed Bag product sales beginning on July 1, 2009, which will impact our revenues beginning in the fourth quarter of

 

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2009.  In connection with these and other changes, we eliminated EKR’s potential obligation to pay Facet two remaining $30 million milestone payments, which would have been payable if and when EKR achieved certain sales thresholds of the Cardene Pre-Mixed Bag. As disclosed in our previous SEC filings, we expected, and we continue to expect, significant generic competition in the market upon the expiration of the patents covering the Cardene® IV product in November 2009 and, therefore, we did not expect that EKR would meet the Cardene Pre-Mixed Bag sales thresholds that would trigger either of the $30 million milestone payments or otherwise receive material amounts of royalties on sales of the Cardene Pre-Mixed Bag product. We continue to expect that future revenues under the EKR agreement will not be material.

 

Costs and Expenses

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

(in thousands)

 

2009

 

2008

 

% Change

 

2009

 

2008

 

% Change

 

Research and development

 

$

45,084

 

$

41,173

 

9

%

$

96,288

 

$

123,455

 

(22

)%

General and administrative

 

9,525

 

11,328

 

(16

)%

27,863

 

35,078

 

(21

)%

Restructuring charges

 

(1,652

)

990

 

*

 

19,418

 

9,441

 

106

%

Asset impairment charges

 

185

 

 

*

 

1,028

 

3,784

 

(73

)%

Gain on sale of assets

 

 

 

*

 

 

(49,671

)

*

 

Total costs and expenses

 

$

53,142

 

$

53,491

 

(1

)%

$

144,597

 

$

122,087

 

18

%

 


*  Not presented as calculation is not meaningful.

 

Research and Development Expenses

 

Our R&D activities include (1) research, (2) process sciences, manufacturing and quality, and (3) preclinical sciences and clinical development. Our research activities include progressing candidates with validated targets and biological pathways from the preclinical stage to the clinic, utilizing translational research to better inform the clinical investigation of our therapeutics and refining our protein engineering technology platform. Our process sciences, manufacturing and quality activities include process, pharmaceutical and analytical development as well as supply chain and quality functions. Preclinical sciences and clinical development are comprised of preclinical development, toxicology, pharmacokinetics, bioanalytics and clinical development, which includes regulatory, safety, medical writing, biometry, clinical operations and program management.  Our total R&D expenses for the three and nine months ended September 30, 2009, grouped by functional area within our R&D organization, were as follows:

 

 

 

Three Months Ended

 

Nine Months Ended

 

(in thousands)

 

September 30, 2009

 

September 30, 2009

 

Research

 

$

5,914

 

$

17,481

 

Process sciences, manufacturing and quality

 

8,217

 

25,466

 

Preclinical sciences and clinical development

 

30,953

 

53,341

 

 

 

 

 

 

 

Total R&D expenses

 

$

45,084

 

$

96,288

 

 

We track our costs and expenses on a functional area basis and, as a result, we do not have detailed or complete cost breakdowns for our development programs.  However, commencing in 2009, our financial systems allow us to develop estimates of the direct costs associated with each of our active clinical and preclinical programs (Direct Program Costs), which include out-of-pocket expenses as well as estimated employee-related costs.  Out-of-pocket costs include costs of conducting our clinical trials, such as fees to clinical research organizations (CROs) and clinical investigators, and monitoring, data management, drug supply and manufacturing expenses, costs of conducting preclinical studies and technology licensing fees.  The employee-related costs were estimated by applying an average per-employee cost for our R&D organization to the number of direct employees dedicated to the programs during the three and nine months ended September 30, 2009.  Our Direct Program Costs do not include: (1) allocations of R&D management or overhead costs, (2) allocations of facilities and information technology (IT) expenses, (3) depreciation expenses, (4) amortization of intangible assets, or (5) stock-based compensation.

 

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The following table reflects our estimated Direct Program Costs for each of our active clinical and preclinical development programs, as well as Other Direct R&D Costs and Costs Allocated to R&D, as described in the footnotes below, for the three and nine months ended September 30, 2009:

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

(in thousands)

 

September 30, 2009

 

% of R&D Expenses

 

September 30, 2009

 

% of R&D Expenses

 

Estimated Direct Program Costs:

 

 

 

 

 

 

 

 

 

Daclizumab (1)

 

$

3,974

 

 

 

$

10,218

 

 

 

Elotuzumab (2)

 

7,103

 

 

 

18,814

 

 

 

PDL 192

 

1,147

 

 

 

3,594

 

 

 

PDL 241

 

1,078

 

 

 

3,621

 

 

 

TRU-016 (3)

 

21,937

 

 

 

21,937

 

 

 

Volociximab (4)

 

709

 

 

 

3,019

 

 

 

Other R&D Programs (5)

 

1,521

 

 

 

4,789

 

 

 

 

 

 

 

 

 

 

 

 

 

Total estimated direct program costs

 

$

37,469

 

83

%

$

65,992

 

69

%

 

 

 

 

 

 

 

 

 

 

Other Direct R&D Costs (6)

 

1,233

 

3

%

7,071

 

7

%

 

 

 

 

 

 

 

 

 

 

Costs Allocated to R&D:

 

 

 

 

 

 

 

 

 

Depreciation and amortization

 

1,025

 

2

%

3,100

 

3

%

Corporate overhead (7)

 

4,806

 

11

%

15,453

 

16

%

Stock compensation

 

551

 

1

%

4,672

 

5

%

 

 

 

 

 

 

 

 

 

 

Total R&D expenses

 

$

45,084

 

 

 

$

96,288

 

 

 

 


(1)

 

Daclizumab costs include $2.8 million and $6.8 million in expense reimbursements payable to Biogen Idec under our collaboration agreement for the three and nine months ended September 30, 2009, respectively.

(2)

 

Elotuzumab costs include $5.9 million and $15.9 million of development expenses that are reimbursable to us by BMS under our collaboration agreement for the three and nine months ended September 30, 2009, respectively. The amounts that are reimbursable by BMS are reflected within collaboration revenues in the condensed consolidated financial statements for the three and nine months ended September 30, 2009.

(3)

 

TRU-016 costs include $21.4 million related to the upfront payments made to Trubion in connection with the execution of our collaboration agreement and $0.5 million in expense reimbursements payable to Trubion under our collaboration agreement for both the three and nine months ended September 30, 2009.

(4)

 

Volociximab costs include $0.3 million and $0.7 million in expense reimbursements payable to Biogen Idec under our collaboration agreement for the three and nine months ended September 30, 2009, respectively.

(5)

 

Other R&D Programs consist primarily of research, protein engineering and preclinical trial activities related to programs that have not reached the late preclinical stage.

(6)

 

Other Direct R&D Costs include non-program R&D costs, such as non-program specific research, process sciences and manufacturing activities, quality and compliance activities related to laboratory, manufacturing and clinical practices, and senior management time across all of our R&D activities as senior management does not allocate its time to specific programs.

(7)

 

Corporate overhead represents allocations of facilities and IT costs to R&D expenses.

 

R&D expenses increased by $3.9 million during the quarter ended September 30, 2009 from the comparable 2008 period primarily due to expenses in connection with our collaboration agreement with Trubion, which was executed during the third quarter of 2009 (see Note 4 to the Condensed Consolidated Financial Statements).  This increase was offset by lower employee-related and overhead expenses in 2009 resulting from the impact of both the sale of the Manufacturing Assets during the first quarter of 2008 and our restructuring activities.

 

R&D expenses decreased by $27.2 million during the nine months ended September 30, 2009 from the comparable 2008 period.  This decrease was primarily due to lower employee-related and overhead expenses in 2009 resulting from the impact of both the sale of the Manufacturing Assets during the first quarter of 2008 and our restructuring activities. Such decreases in R&D expenses were partially offset by the recognition of expenses in connection with our collaboration agreement with Trubion, which was executed during the third quarter of 2009.

 

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We expect increases or decreases in our R&D expenses in the future to correlate generally with the number of products we have under development, the number of trials related to each product and the phases of such development programs. Future R&D expenses also will depend on whether we acquire the rights to additional products through in-licensing agreements or other means or enter into new collaboration agreements and will vary from period to period depending on which party in our existing collaboration, and any potential new collaboration, is incurring the majority of development costs in any period.

 

General and Administrative Expenses

 

General and administrative (G&A) expenses generally consist of costs of personnel, professional services, consulting and other expenses related to our administrative functions, including finance, information technology, facilities, legal, human resources, business development and marketing, and an allocation of facility and overhead costs. The $1.8 million and $7.2 million decreases for the three and nine months ended September 30, 2009, respectively, from the comparable 2008 periods were driven by lower legal and other expenses associated with PDL’s broader strategic initiatives that were underway during 2008 as well as lower employee-related expenses in 2009 resulting from our restructuring plans and other cost reduction activities.  These decreases in G&A expenses were partially offset by higher legal and financial expenses incurred in the third quarter of 2009 to address Biogen Idec’s unsolicited tender offer.

 

Since we have substantially completed the personnel-related restructuring activities contemplated under our previously announced plans, going forward, with the exception of expenses related to our efforts to address Biogen Idec’s public offer to acquire our company, we expect our G&A expenses to be generally flat going forward. Our future G&A expenses may continue to increase as a result of Biogen Idec’s unsolicited public offer to acquire our outstanding common stock and the related effort on our part to review and respond appropriately to potential future developments.

 

Restructuring Charges

 

For the three months ended September 30, 2009, we recognized a credit of $1.6 million for restructuring charges, which primarily related to a $2.4 million change in estimate, largely the result of ongoing discussions with potential subtenants, for our lease-related restructuring liability established in the second quarter of 2009.  For the nine months ended September 30, 2009, restructuring charges of $19.4 million included $3.9 million of personnel charges and $15.5 million in lease-related restructuring charges.  Restructuring charges of $1.0 million and $9.4 million for the three and nine months ended September 30, 2008, respectively, were comprised primarily of personnel-related charges. See Note 6 to the Condensed Consolidated Financial Statements for additional information on our restructuring activities.

 

With respect to the Administration Building, we are required to continue to update our estimate of the lease-related restructuring liability in future periods as conditions warrant, and we expect to further revise our estimate in future periods as we continue our discussions with potential subtenants.

 

Asset Impairment Charges

 

Total asset impairment charges recognized during the three and nine months ended September 30, 2009 were $0.1 million and $1.0 million, respectively, and such charges were $0.0 million and $3.8 million for the three and nine months ended September 30, 2008, respectively.  The asset impairment charges in all periods presented primarily represented the costs of certain equipment that we expect to have no future useful life and certain information technology projects that we terminated that have no future benefit to us, in each case, as a result of our restructuring activities, as discussed in Note 6 to the Condensed Consolidated Financial Statements.

 

In connection with our sublease efforts for the Administration Building, we are also pursuing sublease arrangements under which we could potentially contract with subtenants for both the Administration Building and the Lab Building (which we currently occupy). If we sublease these facilities for rates that are not significantly in excess of our costs, we would not likely recover the carrying value of certain assets associated with these facilities, which was approximately $60.0 million as of September 30, 2009. As such, we could incur a substantial asset impairment charge, as much as the carrying value of such assets, if we were to sublease both of these buildings.

 

 

Gain on Sale of Assets

 

In March 2008, we sold our Manufacturing Assets to an affiliate of Genmab for total cash proceeds of $240.0 million. We recognized a pre-tax gain of $49.7 million upon the close of the sale in March 2008.

 

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Interest and Other Income and Interest Expense

 

 

 

Three Months Ended

 

 

 

Nine Months Ended

 

 

 

 

 

September 30,

 

 

 

September 30,

 

 

 

(in thousands)

 

2009

 

2008

 

% Change

 

2009

 

2008

 

% Change

 

Interest and other income, net

 

$

 678

 

$

 8

 

*

 

$

 2,803

 

$

 13

 

*

 

Interest expense

 

$

 (415

)

$

 (427

)

(3

)%

$

 (1,256

)

$

 (1,293

)

(3

)%

 


* Not presented as calculation is not meaningful.

 

Interest and other income, net includes interest earned on our cash and available-for-sale securities accounts during the periods as well as any other non-operating income that we earn. The increase in interest and other income, net during the nine months ended September 30, 2009 from the comparable period in 2008 was primarily due to $1.0 million that we received upon closure of an escrow account established as part of the purchase agreement under which EKR acquired PDL’s former cardiovascular assets in March 2008. In connection with EKR’s purchase of the cardiovascular assets, $6.0 million of the purchase price was placed in an escrow account for a period of one year to cover certain product-return and sales-rebate related costs. Through March 2009, EKR had submitted claims totaling approximately $5 million against the escrow account, which funds were released to EKR by the escrow agent. The rights and obligations under this escrow agreement were transferred to us upon the Spin-off and, in April 2009, the remaining escrow funds of $1.0 million were transferred to us. In addition, interest income increased from 2008 due to our investment during the three and nine months ended September 30, 2009 of the $405 million cash distribution to us from PDL in December 2008 in connection with the Spin-off.

 

Interest expense consists of a portion of our lease payments on one of our two leased buildings in Redwood City, California. For accounting purposes, we are considered to be the owner of the leased property and we have recorded the fair value of the building and a corresponding long-term financing liability on our Consolidated Balance Sheets.

 

Income Taxes

 

Prior to July 2008, the operations of Facet Biotech were included in PDL’s consolidated U.S. federal and state income tax returns and in tax returns of certain PDL foreign subsidiaries. Prior to the Spin-off on December 18, 2008, our provision for income taxes was determined as if Facet Biotech had filed tax returns separate and apart from PDL. The income tax expense recognized in the 2008 periods related solely to foreign taxes on income earned by our foreign operations.

 

In establishing the valuation allowance for our deferred tax assets, we need to consider sources of future taxable income.  The existence of the unrealized gain on the Trubion equity investment is considered to be a future source of taxable income and accordingly, we have reduced our valuation allowance on our deferred tax assets.  For the three months ended September 30, 2009, we recognized a tax benefit of approximately $1.1 million for the reduction in our valuation allowance on our deferred tax assets.  Other than tax benefits or provisions related to any gains on our marketable equity securities, we do not expect to recognize any federal or state income tax expense during 2009 based upon our projected U.S. tax loss for 2009.  We have dissolved our foreign operations and, therefore, we expect our foreign tax expense will be minimal for 2009.

 

 

LIQUIDITY AND CAPITAL RESOURCES

 

In connection with the Spin-off, PDL provided to us cash and cash equivalents of $405 million. We expect this initial $405 million cash contribution, as well as future payments from Biogen Idec and BMS related to our collaboration agreements with these entities, and royalty and milestone revenues from certain other agreements, will fund our operations and working capital requirements to approximately the end of 2012 based on current operating plans. Prior to the Spin-off on December 18, 2008, the Biotechnology Business of PDL was funded entirely by PDL.

 

Net cash used in operating activities for the nine months ended September 30, 2009 was $77.8 million, compared to $120.8 million in the corresponding period in 2008. The decrease in net cash used in operating activities during this period was primarily attributable to higher R&D reimbursement and royalty revenues, lower employee-related and overhead expenses resulting from the sale of our Manufacturing Assets during the first quarter of 2008 and our restructuring efforts, and changes in our working capital balances. The factors that contributed to the decrease in net cash used in operating activities were partially offset by the $20.0 million upfront payment to Trubion upon the execution of our collaboration agreement, as well as additional legal and financial expenses incurred in connection with the unsolicited tender offer from Biogen Idec.

 

Net cash used in investing activities was $262.2 million for the nine months ended September 30, 2009, compared to net cash provided by investing activities of $258.7 million in the comparable 2008 period. The net cash used in investing activities in the nine months ended September 30, 2009 was primarily related to the net purchases of marketable securities.  The net cash provided by investing activities in the comparable period of 2008 was attributable primarily to net proceeds of $236.6 million received in connection with the sale of the Manufacturing Assets and the release of $25.0 million of restricted cash relating to our Redwood City, California, facility.

 

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Net cash provided by financing activities for the nine months ended September 30, 2009 was $1.3 million, compared to $137.9 million used in financing activities in the comparable period in 2008. In 2009, cash provided by financing activities related to proceeds from the issuance of common stock in connection with employee stock option exercises, partially offset by payments applied against our lease financing liability. Net cash used in financing activities in 2008 was primarily due to net funding to our parent company and payments applied against our lease financing liability.

 

Our future capital requirements will depend on numerous factors, including, among others, progress of product candidates in clinical trials; the continued or additional support by our collaborators or other third parties of R&D efforts and clinical trials; investment in existing and new R&D programs; time required to gain regulatory approvals; our ability to obtain and retain funding from third parties under collaborative arrangements; the demand for our potential products, if and when approved; potential acquisitions of technology, product candidates or businesses by us; our ability to sublease our excess capacity; the ability of our licensees to obtain regulatory approval and successfully manufacture and market products licensed under our patents; and the costs of defending or prosecuting any patent opposition or litigation necessary to protect our proprietary technology. In order to develop and obtain regulatory approval for our potential products, we will need to raise substantial additional funds through equity or debt financings, collaborative or out-licensing arrangements or other means. We cannot provide assurance that such additional financing will be available on acceptable terms, if at all, and such financing may only be available on terms dilutive to our stockholders.

 

As of September 30, 2009, our contractual commitments had not changed materially from those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2008, with the exception of the scheduled payments made under our Redwood City facilities leases. Our material contractual obligations under lease, debt and contract manufacturing agreements as of December 31, 2008 were as follows:

 

 

 

Payments Due by Period

 

 

 

Less Than

 

 

 

 

 

More than

 

 

 

(In thousands)

 

1 Year

 

1-3 Years

 

3-5 Years

 

5 Years

 

Total

 

CONTRACTUAL OBLIGATIONS

 

 

 

 

 

 

 

 

 

 

 

Lease payments (1)

 

$

 6,779

 

$

 13,914

 

$

 16,777

 

$

 100,334

 

$

 137,804

 

Other lease related obligations (2)

 

5,827

 

11,922

 

12,296

 

53,412

 

83,457

 

Other (3)

 

398

 

340

 

178

 

1,345

 

2,261

 

Contract manufacturing(4)

 

3,789

 

6,400

 

 

 

10,189

 

Total contractual obligations

 

$

 16,793

 

$

 32,576

 

$

 29,251

 

$

 155,091

 

$

 233,711

 

 


(1)

 

Lease payments represent actual and estimated contractual rental payments under our property leases in Redwood City, California and Paris, France. Included in these contractual obligations are amounts related to the Lab Building in Redwood City, for which we have a liability on our consolidated financial statement of $25.5 million as of September 30, 2009. These lease obligations reflect our estimates of future lease payments, which are subject to potential escalations based on market conditions after the year 2014 and, therefore, could be lower or higher than amounts included in the table.  As of September 30, 2009, we had a lease-related restructuring liability of $18.1 million related to our Administration Building, which we vacated during the second quarter of 2009. See Note 6 to the Condensed Consolidated Financial Statements for additional information on our restructuring activities.

 

 

 

(2)

 

Other lease-related obligations reflect estimated amounts that we are contractually required to pay over the term of the Redwood City leases, including insurance, property taxes and common area maintenance fees. Such amounts are estimated based on historical costs that we have incurred since the inception of the leases.

 

 

 

(3)

 

Other contractual obligations include post-retirement benefits and other operating leases for office equipment.

 

 

 

(4)

 

Contract manufacturing obligations represent minimum purchase commitments under our clinical supply agreement with Genmab. See Note 5 to the Condensed Consolidated Financial Statements for further details.

 

We have committed to make potential future “milestone” payments to third parties as part of collaboration, in-licensing and product development programs. Payments under these agreements generally become due and payable only upon achievement of certain clinical development, regulatory and/or commercial milestones. Because the achievement of these milestones has not yet occurred,

 

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such contingencies have not been recorded in our Consolidated Balance Sheet as of September 30, 2009. We estimate that such milestones that could be due and payable over the next year approximate $6.0 million and milestones that could be due and payable over the next three years approximate $33.5 million.

 

In addition to the contractual obligation discussed above, under the terms of the Separation and Distribution Agreement, we agreed to indemnify PDL with respect to indebtedness, liabilities and obligations, other than PDL’s convertible notes, that PDL will retain that do not relate to PDL’s Royalty Business. In April 2009, we became aware of assertions from one of PDL’s former commercial product distributors that it believes it should be reimbursed for certain amounts relating to sales rebates on the sale of the Busulfex® commercial product in Italy during the 2006 and 2007 fiscal periods. We believe these assertions are invalid and without merit. Under the terms of the indemnification provisions contained in the Separation and Distribution Agreement, we could be responsible for any amounts ultimately deemed due and payable to this distributor by PDL should these assertions be deemed valid. As any potential liability related to these assertions is not probable at this time, we have not recorded any liability relating to this matter on our balance sheet as of September 30, 2009.

 

RISK FACTORS

 

This Quarterly Report includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. All statements other than statements of historical facts are “forward looking statements” for purposes of these provisions, including any projections of earnings, revenues or other financial items, any statements of the plans and objectives of management for future operations, any statements concerning proposed new products or licensing or collaborative arrangements, any statements regarding future economic conditions or performance, and any statement of assumptions underlying any of the foregoing. In some cases, forward-looking statements can be identified by the use of terminology such as “believes,” “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential,” or “continue” or the negative thereof or other comparable terminology. Although we believe that the expectations reflected in the forward- looking statements contained in this Quarterly Report are reasonable, there can be no assurance that such expectations or any of the forward-looking statements will prove to be correct, and actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial condition and results of operations, as well as any forward-looking statements, are subject to inherent risks and uncertainties, including the risk factors set forth below, and for the reasons described elsewhere in this Quarterly Report. All forward-looking statements and reasons why results may differ included in this Quarterly Report are made as of the date hereof, and we assume no obligation to update these forward-looking statements or reasons why actual results might differ.

 

We are subject to a takeover bid that is disruptive to our business and may distract our management and employees and create uncertainty that may adversely affect our business and results.

 

On September 21, 2009, Biogen Idec, through a wholly owned subsidiary, launched an unsolicited tender offer to acquire the outstanding shares of common stock of the Company, subject to a number of terms and conditions contained in the tender offer documents Biogen Idec filed with the SEC. On October 1, 2009, the Company issued a press release announcing it had filed documents with the SEC in which our Board of Directors unanimously recommended that the Company’s stockholders reject the Biogen Idec offer and not tender their shares pursuant to Biogen Idec’s tender offer.  On October 16, 2009, Biogen Idec extended its tender offer to December 16, 2009.  On October 19, 2009, we issued another press release reiterating the recommendation of our Board of Directors that Facet Biotech stockholders reject Biogen Idec’s unsolicited tender offer.

 

The review and consideration of Biogen Idec’s unsolicited offer (and any alternate proposals that may be made by other parties) have become and may continue to be a significant distraction for our management and employees and have required, and may continue to require, the expenditure of significant time and resources by us. Moreover, the unsolicited nature of Biogen Idec’s offer has also created uncertainty for our employees and this uncertainty may adversely affect our ability to retain key employees and to attract new employees. Biogen Idec’s unsolicited offer has created and may continue to create uncertainty for current and potential collaboration partners, licensees and other business partners, which may cause them to terminate, or not to renew or enter into, arrangements with us. These consequences, alone or in combination, may harm our business and may have a material adverse effect on our results of operations.  We believe that the future trading price of our common stock is likely to be volatile and could be subject to wide price fluctuations based on many factors, including uncertainty associated with the unsolicited offer by Biogen Idec.

 

Litigation directly or indirectly resulting from Biogen Idec’s unsolicited tender offer may negatively impact our business, results of operations and financial condition.

 

On September 24, 2009, purported stockholder John Dugdale filed a complaint in San Diego Superior Court on behalf of himself and all others similarly situated and derivatively on behalf of the Company, in the Superior Court of the State of California, County of San Diego (the Complaint). The Complaint purports to be both a stockholder class action and derivative action and alleges claims for breach of fiduciary duties, abuse of control, gross mismanagement and corporate waste against the Company’s directors Faheem

 

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Hasnain, Brad Goodwin, Gary Lyons, David R. Parkinson, Kurt Von Emster, Hoyoung Huh and Does 1-25 (the Defendants), in connection with certain offers made by Biogen Idec to acquire the Company, including the tender offer. The Complaint seeks declaratory and injunctive relief, including an order compelling Defendants to comply with their fiduciary duties, prohibiting Defendants “from entering into any contractual provisions which harm Facet or its shareholders” or that “prohibit [D]efendants from maximizing shareholder value,” and either invalidating or directing the rescission or redemption of the rights to purchase shares of Series A Preferred Stock issued pursuant to the Rights Agreement between the Company and Mellon Investor Services LLC, dated as of September 7, 2009 and any other “defensive measure that has or is intended to have the effect of making the consummation of an offer to purchase the Company more difficult or costly for a potential acquirer.” The Complaint further seeks fees and costs, including attorneys’ and experts’ fees. Other lawsuits may be filed against us and our directors with similar or additional allegations relating to Biogen Idec’s unsolicited offer, our adoption of a stockholder rights plan or other events related to the unsolicited offer. Such claims and any resultant litigation could subject us to liability, could be time consuming and expensive to defend, and could result in the diversion of our time and attention, any of which could materially and adversely affect our business, results of operations and financial condition. Moreover, there can be no assurance as to the reaction of our employees, stockholders, collaboration partners, licensees and other business partners to the institution or ultimate resolution of any such proceedings.

 

Unless our clinical studies demonstrate the safety and efficacy of our product candidates, we will not be able to commercialize our product candidates.

 

To obtain regulatory approval to market and sell any of our existing or future product candidates, we must satisfy the FDA and other regulatory authorities abroad, through extensive preclinical and clinical studies, that our product candidates have an acceptable safety profile and are efficacious. We may not conduct the types of testing eventually required by regulatory authorities to demonstrate an adequate safety profile for the particular indication, or the tests may indicate that the safety profile of our product candidates is unacceptably inferior to therapeutics with comparable efficacy or otherwise unsuitable for use in humans in light of the expected therapeutic benefit of the product candidate. Clinical trials and preclinical testing are expensive, can take many years and have an uncertain outcome. In addition, initial testing in preclinical studies or in phase 1 or phase 2 clinical trials may indicate that the safety profile of a product candidate is adequate for approval, but does not ensure that safety issues may not arise in later trials, or that the overall safety profile for a product candidate will be sufficient for regulatory approval in any particular product indication. We may experience numerous unforeseen events during, or as a result of, the preclinical testing or clinical studies or clinical development, which could delay or prevent our ability to develop or commercialize our product candidates, including:

 

·                  our testing or trials may produce inconclusive or negative safety results, which may require us to conduct additional testing or trials or to abandon product candidates that we believed to be promising;

 

·                  our product candidates may have unacceptable pharmacology, toxicology or carcinogenicity; and

 

·                  our product candidates may cause significant adverse effects in patients.

 

Even if we are able to demonstrate efficacy of any product candidate, any adverse safety events would increase our costs and could delay or prevent our ability to continue the development of or commercialize our product candidates, which would adversely impact our business, financial condition and results of operations. We are aware that our drug candidates can cause various adverse side effects in humans, some of which are predictable and some of which are unpredictable. We proceed to evaluate the safety and efficacy of these drug candidates based on data we accumulate from preclinical assessments and ongoing clinical studies. We believe that our drug candidates have an acceptable safety profile for the potential indications in which we are currently conducting clinical trials. Data from ongoing or future clinical trials may indicate that a drug candidate causes unanticipated or more significant adverse side effects either used alone or when used in combination with other drugs, in particular patient populations or at increased dosages or frequency of administration. This may lead us to conclude that the drug candidate does not have an acceptable safety profile for a particular patient population or use.

 

The clinical development of drug products is inherently uncertain and expensive and subject to extensive government regulation.

 

Our future success depends almost entirely upon the success of our clinical development efforts. Clinical development, however, is a lengthy, time-consuming and expensive process and subject to significant risks of failure. In addition, we must expend significant amounts to comply with extensive government regulation of the clinical development process.

 

Before obtaining regulatory approvals for the commercial sale of any products, we must demonstrate through preclinical testing and clinical trials that our product candidates are safe and effective for their intended use in humans. We have incurred and will continue to incur substantial expense for, and we have devoted and expect to continue to devote a significant amount of time to, preclinical testing and clinical trials. Despite the time and expense incurred, our clinical trials may not adequately demonstrate the safety and effectiveness of our product candidates.

 

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Completion of clinical development generally takes several years or more. The length of time necessary to complete clinical trials and submit an application for marketing and manufacturing approvals varies significantly according to the type, complexity and intended use of the product candidate and is difficult to predict. Further, we, the FDA, the European Medicines Agency (EMEA), investigational review boards or data safety monitoring boards may decide to temporarily suspend or permanently terminate ongoing trials. Failure to comply with extensive regulations may result in unanticipated delay, suspension or cancellation of a trial or the FDA’s or EMEA’s refusal to accept test results. As a result of these factors, we cannot predict the actual expenses that we will incur with respect to preclinical or clinical trials for any of our potential products, and we expect that our expense levels will fluctuate unexpectedly in the future. Despite the time and expense incurred, we cannot guarantee that we will successfully develop commercially viable products that will achieve FDA or EMEA approval or market acceptance, and failure to do so would materially harm our business, financial condition and results of operations.

 

Early clinical trials such as phase 1 and 2 trials generally are designed to gather information to determine whether further trials are appropriate and, if so, how such trials should be designed. As a result, data gathered in these trials may indicate that the endpoints selected for these trials are not the most relevant for purposes of assessing the product or the design of future trials. Moreover, success or failure in meeting such early clinical trial endpoints may not be dispositive of whether further trials are appropriate and, if so, how such trials should be designed. We may decide, or the FDA or other regulatory agencies may require us, to make changes in our plans and protocols. Such changes may relate, for example, to changes in the standard of care for a particular disease indication, comparability of efficacy and toxicity of potential drug product where a change in the manufacturing process or manufacturing site is proposed, or competitive developments foreclosing the availability of expedited approval procedures. We may be required to support proposed changes with additional preclinical or clinical testing, which could delay the expected time line for concluding clinical trials.

 

Larger or later stage clinical trials may not produce the same results as earlier trials. Many companies in the pharmaceutical and biotechnology industries, including us, have suffered significant setbacks in clinical trials, including advanced clinical trials, even after promising results had been obtained in earlier trials. For example, in August 2007, PDL announced that it would terminate the phase 3 program of its visilizumab antibody in intravenous steroid-refractory ulcerative colitis because data from treated patients showed insufficient efficacy and an inferior safety profile in the visilizumab arm compared to IV steroids alone.

 

Even when a drug candidate shows evidence of efficacy in a clinical trial, it may be impossible to further develop or receive regulatory approval for the drug if it causes an unacceptable incidence or severity of side effects, or further development may be slowed by the need to find dosing regimens that do not cause such side effects.

 

In addition, we may not be able to successfully commence and complete all of our planned clinical trials without significant additional resources and expertise because we have a number of potential products in clinical development. The approval process takes many years, requires the expenditure of substantial resources, and may involve post-marketing surveillance and requirements for post-marketing studies. The approval of a product candidate may depend on the acceptability to the FDA or other regulatory agencies of data from our clinical trials. Regulatory requirements are subject to frequent change. Delays in obtaining regulatory approvals may:

 

·                  adversely affect the successful commercialization of any drugs that we develop;

 

·                  impose costly procedures on us;

 

·                  diminish any competitive advantages that we may attain; and

 

·                  adversely affect our receipt of any revenues or royalties.

 

In addition, we may encounter regulatory delays or failures of our clinical trials as a result of many factors, all of which may increase the costs and expense associated with the trial, including:

 

·                  changes in regulatory policy during the period of product development;

 

·                  delays in obtaining sufficient supply of materials to enroll and complete clinical studies according to planned timelines;

 

·                  delays in obtaining regulatory approvals to commence a study;

 

·                  delays in identifying and reaching agreement on acceptable terms with prospective clinical trial sites;

 

·                  delays in the enrollment of patients;

 

·                  lack of efficacy during clinical trials; or

 

·                  unforeseen safety issues.

 

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Regulatory review of our clinical trial protocols may cause us in some cases to delay or abandon our planned clinical trials. Our potential inability to commence or continue clinical trials, to complete the clinical trials on a timely basis or to demonstrate the safety and efficacy of our potential products, further adds to the uncertainty of regulatory approval for our potential products.

 

We may be unable to enroll a sufficient number of patients in a timely manner in order to complete our clinical trials.

 

The rate of completion of clinical trials is significantly dependent upon the rate of patient enrollment. Patient enrollment is a function of many factors, including:

 

·                  the size of the patient population;

 

·                  perceived risks and benefits of the drug under study;

 

·                  availability of competing therapies, including those in clinical development;

 

·                  availability of clinical drug supply;

 

·                  availability of clinical trial sites;

 

·                  design of the protocol;

 

·                  proximity of and access by patients to clinical sites;

 

·                  patient referral practices of physicians;

 

·                  eligibility criteria for the study in question; and

 

·                  efforts of the sponsor of and clinical sites involved in the trial to facilitate timely enrollment.

 

We may have difficulty obtaining sufficient patient enrollment or clinician support to conduct our clinical trials as planned, and we may need to expend substantial additional funds to obtain access to resources or delay or modify our plans significantly. These considerations may result in our being unable to successfully achieve our projected development timelines, or potentially even lead us to consider the termination of ongoing clinical trials or development of a product for a particular indication.

 

If our collaborations are not successful or are terminated by our collaborators, we may not effectively develop and market some of our product candidates.

 

We have agreements with biotechnology and other companies to develop, manufacture and market certain of our potential products. In some cases, we rely on our collaborators to manufacture such products and essential components for those products, design and conduct clinical trials, compile and analyze the data received from these trials, obtain regulatory approvals and, if approved, market these licensed products. As a result, we may have limited or no control over the manufacturing, development and marketing of these potential products and little or no opportunity to review the clinical data prior to or following public announcement. In addition, the design of the clinical studies may not be sufficient or appropriate for regulatory review and approval and we may have to conduct further studies in order to facilitate approval.

 

In September 2005 we entered into collaboration agreements with Biogen Idec for the joint development of daclizumab in certain indications, including MS, and volociximab (M200) in all indications; in August 2008 with BMS for the co-development of elotuzumab in multiple myeloma and other potential oncology indications; and in August 2009 with Trubion for the co-development of TRU-016, a product candidate in phase 1 clinical trials for chronic lymphocytic leukemia. These agreements are particularly important to us. The collaboration agreements provide significant combined resources for the development, manufacture and potential commercialization of covered products. We and our collaborators each assume certain responsibilities and share expenses. Because of the broad scope of the collaborations, we are particularly dependent upon the performance by Biogen Idec, BMS and Trubion of their respective obligations under the agreements. The failure of our collaborators to perform their obligations, our failure to perform our obligations, our failure to effectively manage the relationships, or a material contractual dispute between us and either of our collaborators could have a material adverse effect on our prospects or financial results. Moreover, our financial results depend in substantial part upon our efforts and related expenses for these programs. Our revenues and expenses recognized under each collaboration will vary depending on the work performed by us and our collaborators in any particular reporting period.

 

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We rely on other collaborators, such as contract manufacturers, clinical research organizations, medical institutions and clinical investigators, including physician sponsors, to conduct nearly all of our clinical trials, including recruiting and enrolling patients in the trials. If these parties do not successfully carry out their contractual duties or meet expected deadlines, we may be delayed or may not obtain regulatory approval for or commercialize our product candidates. If any of the third parties upon whom we rely to conduct our clinical trials do not comply with applicable laws, successfully carry out their obligations or meet expected deadlines, our clinical trials may be extended, delayed or terminated.

 

If the quality or accuracy of the clinical data obtained by third party contractors is compromised due to their failure to adhere to applicable laws, our clinical protocols or for other reasons, we may not obtain regulatory approval for or successfully commercialize any of our product candidates. If our relationships with any of these organizations or individuals terminates, we believe that we would be able to enter into arrangements with alternative third parties. However, replacing any of these third parties could delay our clinical trials and could jeopardize our ability to obtain regulatory approvals and commercialize our product candidates on a timely basis, if at all.

 

Our collaborators can terminate our collaborative agreements under certain conditions, and in some cases on short notice. A collaborator may terminate its agreement with us or separately pursue alternative products, therapeutic approaches or technologies as a means of developing treatments for the diseases targeted by us, or our collaborative effort. Even if a collaborator continues to contribute to the arrangement, it may nevertheless decide not to actively pursue the development or commercialization of any resulting products. In these circumstances, our ability to pursue potential products could be severely limited.

 

In 2004 and 2005, we entered into two collaboration arrangements with Roche for the joint development and commercialization of daclizumab for the treatment of asthma and other respiratory diseases and transplant indications. In 2006, Roche notified us of its election to discontinue its involvement in both of these collaboration arrangements. As a result of the termination of this relationship, we suspended the active clinical development of daclizumab in these indications and, consequently, the development expenses related to the development of daclizumab in these indications were reduced from historical and forecasted levels. Under the terms of the agreement governing this collaboration with Roche, the costs of clinical studies and other development costs were shared by Roche through the effective termination dates, so our financial condition was not materially affected as a result of the termination of these collaborations.

 

Continued funding and participation by collaborators will depend on the continued timely achievement of our research and development objectives, the retention of key personnel performing work under those agreements and on each collaborator’s own financial, competitive, marketing and strategic capabilities and priorities. These considerations include:

 

·                  the commitment of each collaborator’s management to the continued development of the licensed products or technology;

 

·                  the relationships among the individuals responsible for the implementation and maintenance of the development efforts; and

 

·                  the relative advantages of alternative products or technology being marketed or developed by each collaborator or by others, including their relative patent and proprietary technology positions, and their ability to manufacture potential products successfully.

 

Our ability to enter into new relationships and the willingness of our existing collaborators to continue development of our potential products depends upon, among other things, our patent position with respect to such products. If we are unable to successfully maintain our patents we may be unable to collect royalties on existing licensed products or enter into additional agreements.

 

In addition, our collaborators may independently develop products that are competitive with products that we have licensed to them. This could reduce our revenues or the likelihood of achieving revenues under our agreements with these collaborators.

 

If our research and development efforts are not successful, we may not be able to effectively develop new products.

 

We are engaged in research activities intended to, among other things, progress therapeutic candidates into clinical development. In the near-term, we will focus on obtaining new product candidates through various means, including in-licensing them from or entering in to strategic collaborations with institutions or other biotechnology or pharmaceutical companies. Acquiring rights to products in this manner poses risks, including that we may not be unable to successfully integrate the research, development and commercialization capabilities necessary to bring these products to market. In addition, we may not be able to identify or acquire suitable products to in-license.

 

Our antibody product candidates are in various stages of development and many are in an early development stage. If we are unsuccessful in our research efforts to identify and obtain rights to new validated targets and develop product candidates that lead to the required regulatory approvals and the successful commercialization of products, our ability to develop new products could be harmed.

 

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We must protect our patent and other intellectual property rights to succeed.

 

Our success is dependent in significant part on our ability to develop and protect patent and other intellectual property rights and operate without infringing the intellectual property rights of others.

 

Our pending patent applications may not result in the issuance of valid patents or the claims and claim scope of our issued patents may not provide competitive advantages. Also, our patent protection may not prevent others from developing competitive products using related or other technology that does not infringe our patent rights. A number of companies, universities and research institutions have filed patent applications or received patents in the areas of antibodies and other fields relating to our programs. Some of these applications or patents may be competitive with our applications or have claims that could prevent the issuance of patents to us or result in a significant reduction in the claim scope of our issued patents. In addition, patent applications are confidential for a period of time after filing. We therefore may not know that a competitor has filed a patent application covering subject matter similar to subject matter in one of our patent applications or that we were the first to invent the innovation we seek to patent. This may lead to disputes including interference proceeding or litigation to determine rights to patentable subject matter. These disputes are often expensive and may result in our being unable to patent an innovation.

 

The scope, enforceability and effective term of patents can be highly uncertain and often involve complex legal and factual questions and proceedings. No consistent policy has emerged regarding the breadth of claims in biotechnology patents, so that even issued patents may later be modified or revoked by the relevant patent authorities or courts. These proceedings could be expensive, last several years and either prevent issuance of additional patents to us or result in a significant reduction in the scope or invalidation of our patents. Any limitation in claim scope could reduce our ability to negotiate future collaborative research and development agreements based on these patents. Moreover, the issuance of a patent in one country does not assure the issuance of a patent with similar claim scope in another country, and claim interpretation and infringement laws vary among countries, so we are unable to predict the extent of patent protection in any country.

 

In addition to seeking the protection of patents and licenses, we also rely upon trade secrets, know-how and continuing technological innovation that we seek to protect, in part, by confidentiality agreements with employees, consultants, suppliers and licensees. If these agreements are not honored, we might not have adequate remedies for any breach. Additionally, our trade secrets might otherwise become known or patented by our competitors.

 

We may need to obtain patent licenses from others in order to manufacture or sell our potential products and we may not be able to obtain these licenses on terms acceptable to us or at all.

 

Other companies, universities and research institutions may obtain patents that could limit our ability to use, import, manufacture, market or sell our products or impair our competitive position. As a result, we may need to obtain licenses from others before we could continue using, importing, manufacturing, marketing, or selling our products. We may not be able to obtain required licenses on terms acceptable to us, if at all. If we do not obtain required licenses, we may encounter significant delays in product development while we redesign potentially infringing products or methods or we may not be able to market our products at all.

 

We do not have a license to an issued U.S. patent assigned to Stanford University and Columbia University, which may cover a process used to produce our potential products. We have been advised that an exclusive license has been previously granted to a third party, Centocor, under this patent. If our processes were found to be covered by either of these patents, we might need to obtain licenses or to significantly alter our processes or products. We might not be able to successfully alter our processes or products to avoid conflicts with these patents or to obtain licenses on acceptable terms or at all.

 

We do not have licenses to issued U.S. patents which may cover one of our development-stage products. If we successfully develop this product, we might need to obtain licenses to these patents to commercialize the product. In the event that we need to obtain licenses to these patents, we may not be able to do so on acceptable terms or at all.

 

The failure to gain market acceptance of our product candidates among the medical community would adversely affect any product revenue we may receive in the future.

 

Even if approved, our product candidates may not gain market acceptance among physicians, patients, third-party payers and the medical community. We may not achieve market acceptance even if clinical trials demonstrate safety and efficacy and we obtain the necessary regulatory and reimbursement approvals. The degree of market acceptance of any product candidates that we develop will depend on a number of factors, including:

 

·                  establishment and demonstration of clinical efficacy and safety;

 

·                  cost-effectiveness of our product candidates;

 

·                  their potential advantage over alternative treatment methods;

 

·                  reimbursement policies of government and third-party payers; and

 

·                  marketing and distribution support for our product candidates, including the efforts of our collaborators where they have marketing and distribution responsibilities.

 

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Physicians will not recommend our products until clinical data or other factors demonstrate the safety and efficacy of our product as compared to conventional drug and other treatments. Even if we establish the clinical safety and efficacy of our product candidates, physicians may elect not to use our product for any number of other reasons, including whether the mode of administration of our products is effective for certain indications. Antibody products, including our product candidates as they would be used for certain disease indications, are typically administered by infusion or injection, which requires substantial cost and inconvenience to patients. Our product candidates, if successfully developed, may compete with a number of drugs and therapies that may be administered more easily. The failure of our product candidates to achieve significant market acceptance would materially harm our business, financial condition and results of operations.

 

We face significant competition.

 

We face significant competition from entities who have substantially greater resources than we have, more experience in the commercialization and marketing of pharmaceuticals, superior product development capabilities and superior personnel resources. Potential competitors in the United States and other countries include major pharmaceutical, biotechnology and chemical companies, specialized pharmaceutical companies and universities and other research institutions. These entities have developed and are developing human or humanized antibodies or other compounds for treating cancers or immunologic diseases that may compete with our products in development and technologies that may compete with our development products or antibody technologies. These competitors may succeed in more rapidly developing and marketing technologies and products that are more effective than our product candidates or technologies or that would render any future commercialized products or technology obsolete or noncompetitive. Our product candidates and any future commercialized products may also face significant competition from both brand-name and generic manufacturers that could adversely affect any future sales of our products.

 

If daclizumab were to be approved for the treatment of relapsing multiple sclerosis, it would face competition from currently approved and marketed products, including interferon-beta agents, such as Biogen Idec’s Avonex®, Bayer HealthCare Pharmaceuticals’ Betaseron®, Novartis Pharmaceutical Corporation’s (Novartis) Extavia® and EMD Serono Inc.’s Rebif®, a non-interferon immune modifier, Teva Pharmaceutical Industries Ltd.’s Copaxone®, and a monoclonal antibody, Biogen Idec and Elan Pharmaceuticals, Inc.’s Tysabri®. Further competition could arise from drugs currently in development, including Merck Serono S.A.’s Movectro (oral cladribine), Novartis fingolimod and other monoclonal antibodies in development, such as Genzyme Corporation’s Campath®, Genmab A/S’s ofatumumab, and Genentech, Inc. (Genentech) and Roche’s ocrelizumab.

 

If elotuzumab were to be approved for the treatment of multiple myeloma, it could face competition from currently approved and marketed products, including Celgene Corporation’s Revlimid® and Thalomid® and Millennium Pharmaceuticals, Inc.’s Velcade®. Further competition could arise from drugs currently in development, including Centocor, Inc.’s CNTO-328, Novartis’ Panobinostat, Merck & Co., Inc.’s Vorinostat, Proteolix Inc.’s carfilzomib, Genentech and Seattle Genetics, Inc.’s dacetuzumab, Novartis and Xoma Ltd.’s lucatumumab, and Pfizer Inc.’s (Pfizer) CP-751871.

 

If volociximab (M200) were to be approved for the treatment of non-small cell lung cancer or ovarian cancer, it would face competition from a number of other anti-angiogenic agents in pre-clinical and clinical development, including antibody candidates such as Pfizer’s CP-751,871, ImClone Systems Incorporated’s (ImClone) Erbitux® and Novartis’s ASA404, each of which are in more advanced stages of development than is volociximab. In addition, many other VEGF or VEGFR targeted agents are in advanced stage of development and many other anti-angiogenesis agents are in earlier stage of development, which could compete with volociximab should it be approved for marketing.

 

If PDL192 were to be approved for the treatment of solid tumors, it would face competition from many agents that are used for solid tumors, such as ImClone’s Erbitux®, Genentech’s Avastin®, and other monoclonal antibodies and targeted agents in development which potentially modulate the TWEAK pathway, including Biogen Idec’s anti-Tweak monoclonal antibody, BIIB023.

 

If TRU-016 were to be approved for the treatment of chronic lymphocytic leukemia, it would face competition from certain products that are used for such indication, such as Genentech’s and Biogen Idec’s Rituxan®, Genzyme Corporation’s alemtuzumab and Genmab A/S and GlaxoSmithKline’s Arzerra®. In addition, TRU-016 may face competition in the future from Celgene’s Revlimid® or other drugs presently in development, if these agents are approved in the future for this indication.

 

Any product that we or our collaborators succeed in developing and for which regulatory approval is obtained must then compete for market acceptance and market share. The relative speed with which we and our collaborators can develop products, complete the clinical testing and approval processes, and supply commercial quantities of the products to the market compared to competitive companies will affect market success. In addition, the amount of marketing and sales resources and the effectiveness of the marketing used with respect to a product will affect its marketing success.

 

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The biotechnology and pharmaceutical industries are highly competitive. None of our current product candidates is approved for marketing and we do not expect any of our candidates to receive marketing approval in the next several years, if at all. The competitive environment for any of our product candidates which may be approved for marketing at the time of commercialization is highly speculative and uncertain, but we anticipate that such products would face substantial competition from marketed products and from product candidates in development, if approved.

 

Changes in the U.S. and international health care industry, including regarding reimbursement rates, could adversely affect the commercial value of our development product candidates.

 

The U.S. and international health care industry is subject to changing political, economic and regulatory influences that may significantly affect the purchasing practices and pricing of pharmaceuticals. The FDA and other health care policies may change, and additional government regulations may be enacted, which could prevent or delay regulatory approval of our product candidates. Cost containment measures, whether instituted by health care providers or imposed by government health administration regulators or new regulations, could result in greater selectivity in the purchase of drugs. As a result, third-party payers may challenge the price and cost effectiveness of our products. In addition, in many major markets outside the United States, pricing approval is required before sales may commence. As a result, significant uncertainty exists as to the reimbursement status of approved health care products.

 

We may not be able to obtain or maintain our desired price for the products we develop. Any product we introduce may not be considered cost effective relative to alternative therapies. As a result, adequate third-party reimbursement may not be available to enable us to obtain or maintain prices sufficient to realize an appropriate return on our investment in product development, should any of our development products be approved for marketing. Also, the trend towards managed health care in the United States and the concurrent growth of organizations such as health maintenance organizations, as well as legislative proposals to reform health care or reduce government insurance programs, may all result in lower prices, reduced reimbursement levels and diminished markets for our development products. These factors will also affect the products that are marketed by our collaborators and licensees. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are not able to maintain regulatory compliance, we might not be permitted to market our future products and our business could suffer.

 

We may be unable to obtain or maintain regulatory approval for our products.

 

Even if the FDA grants us marketing approval for a product, the FDA may impose post-marketing requirements, such as:

 

·                  labeling and advertising requirements, restrictions or limitations, such as the inclusion of warnings, precautions, contra-indications or use limitations that could have a material impact on the future profitability of our product candidates;

 

·                  adverse event reporting;

 

·                  testing and surveillance to monitor our product candidates and their continued compliance with regulatory requirements; and

 

·                  inspection of products and manufacturing operations and, if any inspection reveals that the product or operation is not in compliance, prohibiting the sale of all products, suspending manufacturing or withdrawing market clearance.

 

The discovery of previously unknown problems with our product candidates, including adverse events of unanticipated severity or frequency, may result in restrictions of the products, including withdrawal from manufacture. Additionally, certain material changes affecting an approved product such as manufacturing changes or additional labeling claims are subject to further FDA review and approval. The FDA may revisit and change its prior determination with regard to the safety or efficacy of our products and withdraw any required approvals after we obtain them. Even prior to any formal regulatory action requiring labeling changes or affecting manufacturing, we could voluntarily decide to cease the distribution and sale or recall any of our future products if concerns about their safety and efficacy develop.

 

As part of the regulatory approval process, we or our contractors must demonstrate the ability to manufacture the pharmaceutical product to be approved. Accordingly, the manufacturing process and quality control procedures are required to comply with the applicable FDA Current Good Manufacturing Practice (cGMP) regulations and other regulatory requirements. Good manufacturing practice regulations include requirements relating to quality control and quality assurance as well as the corresponding maintenance of records and documentation.

 

Manufacturing facilities must pass an inspection by the FDA before initiating commercial manufacturing of any product. Pharmaceutical product manufacturing establishments are also subject to inspections by state and local authorities as well as inspections by authorities of other countries. To supply pharmaceutical products for use in the United States, foreign manufacturing establishments must comply with these FDA approved guidelines. These foreign manufacturing establishments are subject to periodic inspection by the FDA or by corresponding regulatory agencies in these countries under reciprocal agreements with the FDA. The FDA enforces post-marketing regulatory requirements, such as cGMP requirements, through periodic unannounced inspections. Failure to pass an inspection could disrupt, delay or shut down our manufacturing operations. Although we do not have currently marketed products, the foregoing considerations would be important to our future selection of contract manufacturers.

 

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Our collaborators, licensees and we also are subject to foreign regulatory requirements regarding the manufacture, development, marketing and sale of pharmaceutical products and, if the particular product is manufactured in the United States, FDA and other U.S. export provisions. These requirements vary widely in different countries. Difficulties or unanticipated costs or price controls may be encountered by us or our licensees or marketing collaborators in our respective efforts to secure necessary governmental approvals. This could delay or prevent us, our licensees or our marketing collaborators from marketing potential pharmaceutical products.

 

Further, regulatory approvals may be withdrawn if we do not comply with regulatory standards or if problems with our products occur. In addition, under a Biologics License Application (BLA), the manufacturer continues to be subject to facility inspection and the applicant must assume responsibility for compliance with applicable pharmaceutical product and establishment standards. If we fail to comply with applicable FDA and other regulatory requirements at any stage during the regulatory process, we may be subject to sanctions, including:

 

·                  warning letters;

 

·                  clinical holds;

 

·                  product recalls or seizures;

 

·                  changes to advertising;

 

·                  injunctions;

 

·                  refusal of the FDA to review pending market approval applications or supplements to approval applications;

 

·                  total or partial suspension of product manufacturing, distribution, marketing and sales;

 

·                  civil penalties;

 

·                  withdrawals of previously approved marketing applications; and

 

·                  criminal prosecutions.

 

We rely on sole source, third parties to manufacture our products.

 

We do not have the capability to manufacture any of our development-stage products. We rely upon third parties, including Biogen Idec and Genmab, for our manufacturing requirements, and we will be reliant on BMS for the manufacture of elotuzumab if this program progresses into phase 2 development. If we experience supply problems with our manufacturing partners, there may not be sufficient supplies of our development-stage products for us to meet clinical trial demand, in which case our operations and results could suffer. In addition, routine failures in the manufacturing process may lead to increased expenses and result in unforeseen delays in the progress of our clinical studies.

 

Our products must be manufactured in facilities that comply with FDA and other regulations, and the process for qualifying and obtaining approval for a manufacturing facility is time-consuming. The manufacturing facilities on which we rely will be subject to ongoing, periodic unannounced inspection by the FDA and state agencies to ensure compliance with good manufacturing practices and other requirements.

 

If our relationship with Genmab or Biogen Idec were to terminate unexpectedly or on short notice or expire without being renewed, our ability to meet clinical trial demand for our development-stage products could be adversely affected while we qualify a new manufacturer for that product and our operations and future results could suffer. In addition, we would need to expend a significant amount of time and incur significant costs to qualify a new manufacturer and transfer technology to the new manufacturer, which would also adversely affect our results of operations.

 

Product supply interruptions, whether as a result of regulatory action or the termination of a relationship with a manufacturer, could significantly delay clinical development of our potential products, reduce third-party or clinical researcher interest and support of proposed clinical trials, and possibly delay commercialization and sales of these products.

 

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Our ability to file for, and to obtain, regulatory approvals for our products, as well as the timing of such filings, will depend on the abilities of the contract manufacturers we engage. We or our contract manufacturers may encounter problems with the following:

 

·                  development of advanced manufacturing procedures, process controls and scalability of our manufacturing processes;

 

·                  production costs and yields;

 

·                  quality control and assurance;

 

·                  availability of qualified personnel;

 

·                  availability of raw materials;

 

·                  adequate training of new and existing personnel;

 

·                  ongoing compliance with standard operating procedures;

 

·                  ongoing compliance with applicable regulations;

 

·                  production costs; and

 

·                  development of advanced manufacturing techniques and process controls.

 

Manufacturing changes may result in delays in obtaining regulatory approval or marketing for our products.

 

When we make changes in the manufacturing process driven by increases in demand for our products in clinical studies, we may be required to demonstrate to the FDA and corresponding foreign authorities that the changes have not caused the resulting drug material to differ significantly from the drug material previously produced. Further, any significant manufacturing changes for the production of our product candidates could result in delays in development or regulatory approval or in the reduction or interruption of commercial sales of our product candidates. Our or our contract manufacturers’ inability to maintain manufacturing operations in compliance with applicable regulations within our planned time and cost parameters could materially harm our business, financial condition and results of operations.

 

We have made manufacturing changes and are likely to make additional manufacturing changes for the production of our products currently in clinical development. These manufacturing changes or an inability to immediately show comparability between old new materials before and after making manufacturing changes could result in delays in development or regulatory approvals or in reduction or interruption of commercial sales and could impair our competitive position.

 

We must comply with extensive government regulations and laws.

 

We and our collaboration partners are subject to extensive regulation by federal government, state governments, and the foreign countries in which we con