Alder Biopharmaceuticals
ALDER BIOPHARMACEUTICALS INC (Form: 10-Q, Received: 10/27/2016 16:03:52)

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

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

For the quarterly period ended September 30, 2016

OR

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

For the transition period from              to             

Commission File Number: 001-36431

 

Alder BioPharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

90-0134860

(State or other jurisdiction

of incorporation or organization)

 

(I.R.S. Employer

Identification No.)

11804 North Creek Parkway South

Bothell, WA 98011

(Address of principal executive offices including zip code)

Registrant’s telephone number, including area code: (425) 205-2900

 

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       No  

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 (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes       No  

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 the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

 (do not check if a smaller reporting company)

  

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       No  

As of October 21, 2016 the registrant had 50,296,261 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

Alder BioPharmaceuticals, Inc.

Quarterly Report on Form 10-Q

For the Quarter Ended September 30, 2016

INDEX

 

 

Page

 

PART I. FINANCIAL INFORMATION (Unaudited)

 

 

Item 1.

 

 

Condensed Consolidated Financial Statements

3

 

 

 

Condensed Consolidated Balance Sheets

3

 

 

 

Condensed Consolidated Statements of Operations

4

 

 

 

Condensed Consolidated Statements of Comprehensive Loss

5

 

 

 

Condensed Consolidated Statements of Cash Flows

6

 

 

 

Notes to Condensed Consolidated Financial Statements

7

 

Item 2.

 

 

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

13

 

Item 3.

 

 

Quantitative and Qualitative Disclosures About Market Risk

21

 

Item 4.

 

 

Controls and Procedures

22

 

PART II. OTHER  INFORMATION

 

 

Item 1.

 

 

Legal Proceedings

23

 

Item 1A.

 

 

Risk Factors

23

 

Item 6.

 

 

Exhibits

48

 

SIGNATURES

49

In this Quarterly Report on Form 10-Q, “we,” “our,” “us,” “Alder,” and “the Company” refer to Alder BioPharmaceuticals, Inc. and, where appropriate, its consolidated subsidiaries. “Alder” and the Alder logo are the property of Alder BioPharmaceuticals, Inc. This report contains references to our trademarks and to trademarks belonging to other entities. Solely for convenience, trademarks and trade names referred to in this report may appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our use or display of other companies’ trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

 

 

.

2


 

P ART I. – FINANCIAL INFORMATION

 

I tem 1.

Condensed Consolidated Financial Statements

Alder BioPharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(unaudited)

 

 

 

 

 

 

 

 

 

 

September 30,

 

 

December 31,

 

 

2016

 

 

2015

 

 

(in thousands, except share and per share data)

 

Assets

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

Cash and cash equivalents

$

170,632

 

 

$

206,492

 

Short-term investments

 

232,757

 

 

 

98,680

 

Prepaid expenses and other assets

 

23,682

 

 

 

17,029

 

Inventory

 

936

 

 

 

 

Total current assets

 

428,007

 

 

 

322,201

 

Long-term investments

 

 

 

 

75,840

 

Property and equipment, net

 

6,610

 

 

 

1,974

 

Investment in unconsolidated entity

 

956

 

 

 

 

Other assets

 

8,030

 

 

 

12

 

Total assets

$

443,603

 

 

$

400,027

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

Accounts payable

$

5,703

 

 

$

4,727

 

Accrued liabilities

 

10,952

 

 

 

7,583

 

Deferred rent

 

96

 

 

 

62

 

Total current liabilities

 

16,751

 

 

 

12,372

 

Long-term deferred rent

 

116

 

 

 

138

 

Total liabilities

 

16,867

 

 

 

12,510

 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

 

Common stock; $0.0001 par value; 200,000,000 shares authorized; 50,266,666 and 43,706,789 shares issued and outstanding, respectively

 

5

 

 

 

4

 

Additional paid-in capital

 

756,410

 

 

 

610,390

 

Accumulated deficit

 

(329,739

)

 

 

(222,376

)

Accumulated other comprehensive gain (loss)

 

60

 

 

 

(501

)

Total stockholders’ equity

 

426,736

 

 

 

387,517

 

Total liabilities and stockholders’ equity

$

443,603

 

 

$

400,027

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

3


 

Alder BioPharmaceuticals, Inc.

Condensed Consolidated Statements of Operations

(unaudited)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

(in thousands, except share and per share data)

 

Revenues

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue under license agreement

$

 

 

$

 

 

$

113

 

 

$

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

 

 

 

 

 

113

 

 

 

 

Research and development

 

29,491

 

 

 

22,852

 

 

 

90,971

 

 

 

47,975

 

General and administrative

 

6,239

 

 

 

4,318

 

 

 

18,750

 

 

 

11,925

 

Total operating expenses

 

35,730

 

 

 

27,170

 

 

 

109,834

 

 

 

59,900

 

Gain on license of clazakizumab

 

 

 

 

 

 

 

1,050

 

 

 

 

Loss from operations

 

(35,730

)

 

 

(27,170

)

 

 

(108,671

)

 

 

(59,900

)

Other income (expense)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

549

 

 

 

248

 

 

 

1,493

 

 

 

381

 

Foreign currency gain (loss)

 

(31

)

 

 

(159

)

 

 

(263

)

 

 

130

 

Other income

 

172

 

 

 

84

 

 

 

172

 

 

 

84

 

Total other income, net

 

690

 

 

 

173

 

 

 

1,402

 

 

 

595

 

Net loss before equity in net loss of unconsolidated entity

 

(35,040

)

 

 

(26,997

)

 

 

(107,269

)

 

 

(59,305

)

Equity in net loss of unconsolidated entity

 

(94

)

 

 

 

 

 

(94

)

 

 

 

Net loss

$

(35,134

)

 

$

(26,997

)

 

$

(107,363

)

 

$

(59,305

)

Net loss per share - basic and diluted

$

(0.70

)

 

$

(0.62

)

 

$

(2.25

)

 

$

(1.50

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used in net loss per share - basic and diluted

 

50,226,588

 

 

 

43,525,888

 

 

 

47,763,913

 

 

 

39,554,790

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

4


 

Alder BioPharmaceuticals, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(unaudited)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

(in thousands)

 

Net loss

$

(35,134

)

 

$

(26,997

)

 

$

(107,363

)

 

$

(59,305

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on securities available-for-sale, net of tax

 

(20

)

 

 

72

 

 

 

540

 

 

 

82

 

Foreign currency translation income (loss), net of tax

 

 

 

 

8

 

 

 

21

 

 

 

(20

)

Total other comprehensive income (loss)

 

(20

)

 

 

80

 

 

 

561

 

 

 

62

 

Comprehensive loss

$

(35,154

)

 

$

(26,917

)

 

$

(106,802

)

 

$

(59,243

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

5


 

Alder BioPharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

 

Nine Months Ended

 

 

September 30,

 

 

2016

 

 

2015

 

 

(in thousands)

 

Operating activities

 

 

 

 

 

 

 

Net loss

$

(107,363

)

 

$

(59,305

)

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

 

 

 

 

 

 

 

Non-cash gain on license of clazakizumab in exchange for investment in unconsolidated entity

 

(1,050

)

 

 

 

Equity in net loss of unconsolidated entity

 

94

 

 

 

 

Depreciation and amortization

 

1,014

 

 

 

571

 

Loss on retirement of property and equipment

 

 

 

 

2

 

Stock-based compensation

 

9,859

 

 

 

4,124

 

Other non-cash charges, net

 

222

 

 

 

7

 

Changes in operating assets and liabilities

 

 

 

 

 

 

 

Accounts receivable

 

 

 

 

113

 

Prepaid expenses and other assets

 

(14,264

)

 

 

(9,466

)

Inventory

 

(936

)

 

 

 

Accounts payable

 

968

 

 

 

5,822

 

Accrued liabilities

 

3,289

 

 

 

3,666

 

Deferred rent

 

12

 

 

 

(100

)

Net cash used in operating activities

 

(108,155

)

 

 

(54,566

)

Investing activities

 

 

 

 

 

 

 

Purchases of investments

 

(134,026

)

 

 

(180,500

)

Proceeds from maturities of investments

 

75,695

 

 

 

15,105

 

Proceeds from sales of investments

 

 

 

 

250

 

Purchases of property and equipment

 

(5,562

)

 

 

(722

)

Proceeds from sale of property and equipment

 

5

 

 

 

 

Net cash used in investing activities

 

(63,888

)

 

 

(165,867

)

Financing activities

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net of offering costs

 

134,871

 

 

 

406,634

 

Deferred offering costs

 

 

 

 

36

 

Proceeds from exercise of stock options and employee stock purchase plan

 

1,291

 

 

 

995

 

Net cash provided by financing activities

 

136,162

 

 

 

407,665

 

Effect of exchange rate changes on cash

 

21

 

 

 

(20

)

Net increase (decrease) in cash and cash equivalents

 

(35,860

)

 

 

187,212

 

Cash and cash equivalents

 

 

 

 

 

 

 

Beginning of period

 

206,492

 

 

 

46,795

 

End of period

$

170,632

 

 

$

234,007

 

 

 

 

 

 

 

 

 

Supplemental disclosures:

 

 

 

 

 

 

 

Purchases of property and equipment included in accounts payable and accrued liabilities

$

434

 

 

$

 

 

 

 

 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

6


 

Alder BioPharmaceuticals, Inc.

Notes to Condensed Consolidated Financial Statements

 

1.

Nature of Business

 

Alder BioPharmaceuticals, Inc. (the “Company”) is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. The Company has developed a proprietary antibody platform designed to select and manufacture antibodies that have the potential to maximize efficacy as well as speed of onset and durability of therapeutic response. The Company was incorporated in Delaware on May 20, 2002 and is located in Bothell, Washington.

Public Offerings

In January 2015, the Company completed an underwritten public offering of 6,900,000 shares of common stock, which included 900,000 shares the Company issued pursuant to the underwriters’ exercise of their option to purchase additional shares, at $29.50 per share.  The Company received $190.7 million in net proceeds, after deducting underwriting discounts and commissions of $12.2 million and offering expenses of $0.6 million.

In June 2015, the Company completed an underwritten public offering of 5,168,539 shares of common stock, which included 674,157 shares the Company issued pursuant to the underwriters’ exercise of their option to purchase additional shares, at $44.50 per share.  The Company received $215.9 million in net proceeds, after deducting underwriting discounts and commissions of $13.8 million and offering expenses of $0.3 million.

In April 2016, the Company completed an underwritten public offering of 6,182,795 shares of common stock, which included 806,451 shares the Company issued pursuant to the underwriters’ exercise of their option to purchase additional shares, at $23.25 per share.  The Company received $134.9 million in net proceeds, after deducting underwriting discounts and commissions of $8.6 million and offering expenses of $0.3 million.

 

 

2.

Summary of Significant Accounting Policies

Principles of Consolidation

The accompanying unaudited condensed consolidated financial statements reflect the accounts of Alder BioPharmaceuticals, Inc. and its wholly-owned subsidiaries. All inter-company balances and transactions have been eliminated in consolidation. The condensed consolidated balance sheet data as of December 31, 2015 were derived from audited financial statements. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (“SEC”) and generally accepted accounting principles in the United States of America (“GAAP”) for unaudited condensed consolidated financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The accompanying unaudited condensed consolidated financial statements reflect all adjustments consisting of normal recurring adjustments which, in the opinion of management, are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. The Company manages its business as one operating segment; however, the Company operates in three   geographic regions: United States (Bothell, WA), Australia, and Ireland. Substantially all of the Company’s assets are located in, and revenues are generated in, the United States.

The Company has a relationship with a variable interest entity (“VIE”).  The Company evaluates VIEs to determine whether the Company is the primary beneficiary by performing a qualitative and quantitative analysis of each VIE that includes a review of, among other factors, the VIE’s capital structure, contractual terms, related party relationships, the Company’s fee arrangements and the design of the VIE.  This analysis includes determining whether the Company (1) has the power to direct matters that most significantly impact the activities of the VIE, and (2) has the obligation to absorb losses or the right to receive benefits of the VIE that could potentially be significant to the VIE.

In circumstances where the Company is not the primary beneficiary, but the Company has the ability to exercise significant influence over the operating and financial policies of a company in which it has an investment, the Company utilizes the equity method of accounting for recording investment activity. In assessing whether the Company exercises significant influence, it considers the nature and magnitude of the investment, the voting and protective rights held, any participation in the governance of the other company, and other relevant factors such as the presence of a collaboration or other business relationship. Under the equity method of accounting, the Company records in its results of operations its share of income or loss of the other company. If the Company’s share of losses exceeds the carrying value of its investment, it will suspend recognizing additional losses and will continue to do so unless the Company commits to providing additional funding. The Company monitors its investment to evaluate whether any decline in

7


 

value has occurred that would be other-th an-temporary, based on the implied value of recent company financings, public market prices of comparable companies, and general market conditions.  The carrying value of the investment is included in the Company’s condensed consolidated balance sheet as i nvestment in unconsolidated entity.

These unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015.

Use of Estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. The results of the Company’s operations for the three and nine months ended September 30, 2016 are not necessarily indicative of the results to be expected for the full year or for any other period.

Concentrations of Credit Risk

The Company is exposed to credit risk from its deposits of cash and cash equivalents and investments in excess of amounts insured by the Federal Deposit Insurance Corporation.

Other Non-Current Assets

Other non-current assets include an $8.0 million reservation fee paid to a third party to secure additional production capacity, which may become non-refundable if the Company does not fulfill an obligation to negotiate a contract manufacturing agreement in good faith. Upon execution of a contract manufacturing agreement with such third party, the Company may be obligated to pay additional manufacturing reservation fees and make purchase commitments.

Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes the revenue recognition requirements in Accounting Standards Codification 605, Revenue Recognition. This ASU stipulates that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments and assets recognized from costs incurred to obtain or fulfill a contract. In August 2015, the FASB issued ASU 2015-14 delaying the effective date for adoption by one year. The guidance is now effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period. Early adoption is not permitted, however, entities are allowed to apply the new revenue standard for annual reporting periods beginning after the original effective date of December 15, 2016, using the full retrospective or modified retrospective method. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

In March 2016, the FASB issued ASU 2016-08, Principal versus Agent Considerations (Reporting Revenue Gross versus Net). This ASU clarifies the implementation guidance on principal versus agent considerations. This ASU will become effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

In April 2016, the FASB issued ASU 2016-10, Identifying Performance Obligations and Licensing. This ASU clarifies two aspects of ASU 2014-09, Revenue from Contracts with Customers (Topic 606): identifying performance obligations and the licensing implementation guidance. This ASU will become effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

In May 2016, the FASB issued ASU 2016-12, Narrow-Scope Improvements and Practical Expedients. This ASU addresses certain issues in ASU 2014-09, Revenue from Contracts with Customers (Topic 606) regarding assessing collectability, presentation of sales taxes, noncash consideration, and completed contracts and contract modifications at transition. This ASU will become effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

8


 

In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements – Going Concern.  This ASU requires entities to evaluate for each annual and interim reporting period, whe ther there are conditions or events, considered in the aggregate, that raise substantial doubt about the entity’s ability to continue as a going concern within one year after the date that the financial statements are issued (or within one year after the d ate that the financial statements are available to be issued when applicable).  The ASU will become effective for interim and annual reporting periods ending after December 15, 2016. The Company is currently evaluating the impact of the adoption of this AS U on its consolidated financial statements.

In January 2016, the FASB issued ASU 2016-01, Financial Instruments-Overall. This ASU addresses certain aspects of recognition, measurement, presentation, and disclosure of financial instruments. This ASU will become effective for annual periods beginning after December 15, 2017. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

In February 2016, the FASB issued ASU 2016-02, Leases. This ASU requires the recognition of lease assets and lease liabilities on the balance sheet and disclosure of key information about leasing arrangements. This ASU will become effective for annual periods beginning after December 15, 2018. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

In March 2016, the FASB issued ASU 2016-09, Improvements to Employee Share-Based Payment Accounting. This ASU addresses areas for simplification in several aspects of the accounting for share-based payment including income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. This ASU will become effective for annual periods beginning after December 15, 2016. The Company is currently evaluating the impact of the adoption of this ASU on its consolidated financial statements.

The Company has reviewed other recent accounting pronouncements and concluded that they are either not applicable to the Company, or that no material effect is expected on the consolidated financial statements as a result of future adoption.

 

3.

Net Loss Per Share

Basic net loss per share is calculated by dividing net loss by the weighted average common shares outstanding during the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by adjusting the weighted average common shares outstanding for the dilutive effect of common stock equivalents outstanding for the period, determined using the treasury-stock method.

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss (in thousands)

$

(35,134

)

 

$

(26,997

)

 

$

(107,363

)

 

$

(59,305

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding - basic and diluted

 

50,226,588

 

 

 

43,525,888

 

 

 

47,763,913

 

 

 

39,554,790

 

Net loss per share - basic and diluted

$

(0.70

)

 

$

(0.62

)

 

$

(2.25

)

 

$

(1.50

)

 

 

The following weighted average numbers of outstanding stock options and employee stock purchase plan awards were excluded from the calculation of diluted net loss per share for the three and nine months ended September 30, 2016 and 2015 because including them would have had an anti-dilutive effect.  Therefore, basic and diluted net loss per share were the same for all periods presented.

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2016

 

 

2015

 

 

2016

 

 

2015

 

Stock options

 

4,495,289

 

 

 

2,843,263

 

 

 

4,172,383

 

 

 

2,895,160

 

Employee stock purchase plan

 

27,050

 

 

 

29,850

 

 

 

70,560

 

 

 

103,057

 

 

 

4,522,339

 

 

 

2,873,113

 

 

 

4,242,943

 

 

 

2,998,217

 

 

9


 

4.

Investments

 

Investments consisted of available-for-sale securities as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortized

Cost

 

 

Gross unrealized

gains

 

 

Gross unrealized

losses

 

 

Fair

Value

 

 

 

(in thousands)

 

Type of security as of September 30, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Negotiable certificates of deposit maturing in

   one year or less

 

$

14,250

 

 

$

9

 

 

$

(1

)

 

$

14,258

 

U.S. government agency obligations maturing in

   one year or less

 

 

218,446

 

 

 

71

 

 

 

(18

)

 

 

218,499

 

Total available-for-sale securities

 

$

232,696

 

 

$

80

 

 

$

(19

)

 

$

232,757

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Type of security as of December 31, 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Negotiable certificates of deposit maturing in

   one year or less

 

$

17,250

 

 

$

 

 

$

(14

)

 

$

17,236

 

Negotiable certificates of deposit maturing after

   one year through two years

 

 

1,000

 

 

 

 

 

 

(1

)

 

 

999

 

U.S. government agency obligations maturing in

   one year or less

 

 

81,582

 

 

 

 

 

 

(138

)

 

 

81,444

 

U.S. government agency obligations maturing after

   one year through two years

 

 

75,166

 

 

 

 

 

 

(325

)

 

 

74,841

 

Total available-for-sale securities

 

$

174,998

 

 

$

 

 

$

(478

)

 

$

174,520

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Realized gains and losses are determined based on the specific identification method and are reported in other income in the condensed consolidated statement of operations.  There were no realized gains or losses on sales of available-for-sale securities in the three and nine months ended September 30, 2016 and 2015.

 

 

5 .

Fair Value Disclosures

The Company holds financial instruments that are measured at fair value which is determined according to a fair value hierarchy that prioritizes the inputs and assumptions used, and the valuation techniques used to measure fair value. The three levels of the fair value hierarchy are described as follows:

 

Level   1

Inputs are unadjusted quoted prices in active markets for identical assets or liabilities.

 

Level   2

Inputs are quoted prices for similar assets and liabilities in active markets or quoted prices for identical or similar instruments in markets that are not active and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets.

 

Level   3

Inputs are unobservable inputs based on the Company’s own assumptions and valuation techniques used to measure assets and liabilities at fair value. The inputs require significant management judgment or estimation.

The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of fair value assets and liabilities and their placement within the fair value hierarchy levels.

The Company established the fair value of its assets and liabilities using the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date and established a fair value hierarchy based on the inputs used to measure fair value.

 


10


 

 

The following table presents the Company’s financial instruments by level within the fair value hierarchy:

 

 

 

Fair Value Measurement Using

 

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

 

(in thousands)

 

As of September 30, 2016

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

164,073

 

 

$

 

 

$

 

 

$

164,073

 

Short term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Negotiable certificates of deposit

 

 

 

 

 

14,258

 

 

 

 

 

 

14,258

 

U.S. government agency obligations

 

 

 

 

 

218,499

 

 

 

 

 

 

218,499

 

 

 

$

164,073

 

 

$

232,757

 

 

$

 

 

$

396,830

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

As of December 31, 2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash equivalents

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

203,330

 

 

$

 

 

$

 

 

$

203,330

 

Short term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Negotiable certificates of deposit

 

 

 

 

 

17,236

 

 

 

 

 

 

17,236

 

U.S. government agency obligations

 

 

 

 

 

81,444

 

 

 

 

 

 

81,444

 

Long term investments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Negotiable certificates of deposit

 

 

 

 

 

999

 

 

 

 

 

 

999

 

U.S. government agency obligations

 

 

 

 

 

74,841

 

 

 

 

 

 

74,841

 

 

 

$

203,330

 

 

$

174,520

 

 

$

 

 

$

377,850

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The Company’s negotiable certificates of deposit and U.S. government agency obligations are valued using fair value measurements that are considered to be Level 2.  The investment custodian provides the Company with valuations of its securities portfolio.  The primary source for the security valuation is Interactive Data Corporation (“IDC”), which evaluates securities based on market data.  IDC utilizes evaluated pricing models that vary by asset class and include available trade, bid, and other market information.  Generally, the methodology includes broker quotes, proprietary models, vast descriptive terms and conditions databases, as well as extensive quality control programs. The custodian utilizes proprietary valuation matrices for valuing all negotiable certificates of deposit.

 

Accounts receivable, accounts payable and accrued liabilities are carried at cost, which approximates fair value due to the short-term nature of these financial instruments.

     

6.

Gain on License of Clazakizumab and Investment in Unconsolidated Entity

 

In May 2016, the Company licensed the exclusive worldwide rights to its product candidate clazakizumab to Vitaeris, Inc. (“Vitaeris”), a newly formed company based in Vancouver, British Columbia, that is pursuing innovative therapeutic indications in chronic inflammatory diseases. In exchange for the rights to clazakizumab, the Company received an equity stake in Vitaeris and is eligible to receive royalties and certain other payments. In addition, Randall C. Schatzman, Ph.D., the Company’s president and chief executive officer, joined Vitaeris’ board of directors. Since clazakizumab was developed internally by the Company, all previous expenditures to develop the compound were recognized as expense in the period incurred and there was no carrying value on the Company’s condensed consolidated balance sheet. Therefore, in the nine months ended September 30, 2016, the Company recognized a gain on the license agreement of $1.1 million, which was determined as the fair value of the Company’s equity stake in Vitaeris. The Company recognized $0.1 million in revenue and cost of sales in the nine months ended September 30, 2016 related to the sale of drug supply inventory to Vitaeris at cost. The Company did not recognize any revenue or cost of sales in the three months ended September 30, 2016.

As of September 30, 2016, the Company held $0.9 million in inventory of finished goods related to clazakizumab on its condensed consolidated balance sheet. Clazakizumab has not received regulatory approval for commercial sale and the related inventory is currently held only for resale associated with the Vitaeris agreement. The Company values inventory at the lower of cost or market value which is determined using the specific identification basis. Inventory is reduced to net realizable value for excess, obsolete or unsalable inventory.

11


 

Vitaeris is a VIE for which the Company is not the primary beneficiary as the Company does not have the power to direct the activities that most significantly influence the economic performance of the entity.  In addition to the Company’s exchange of license rights for clazakizumab, Vitaeris was capitalized through cash inve stments by other parties. The investment in Vitaeris is accounted for under the equity method of accounting because the Company holds common stock of Vitaeris and has significant influence over the operating and financial policies of Vitaeris through its o wnership, license arrangement and representation on the board of directors. Therefore, the Company records its share of any loss or income generated by Vitaeris, which is recorded on a three-month lag, within the condensed consolidated statement of operati ons. The investment is reflected as an investment in unconsolidated entity on the Company’s condensed consolidated balance sheet which represents the investment in Vitaeris, net of the Company’s portion of any generated loss or income. The Company recorded $0.1 million in net loss with respect to Vitaeris for the three and nine months ended September 30, 2016 . This net loss reduced the Company’s carrying value of the Company’s investment in Vitaeris to $1.0 million which is classified as a non-current asset as of September 30, 2016. The Company has no implied or unfunded commitments related to Vitaeris and its maximum exposure to loss is limited to the current carrying value of the investment.

      

7.

Accrued Liabilities

Accrued liabilities consisted of the following for the dates indicated:

 

 

 

September 30,

 

 

December 31,

 

 

 

 

2016

 

 

2015

 

 

 

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

Compensation and benefits

 

$

3,908

 

 

$

3,156

 

 

Contracted research and development

 

 

6,545

 

 

 

3,675

 

 

Professional services and other

 

 

499

 

 

 

752

 

 

 

 

$

10,952

 

 

$

7,583

 

 

 

 

 

 

 

12


 

 

 

Item 2.

  

MANAGEMENT’S DISCUSSION AND ANALYSIS OF

 

  

FINANCIAL CONDITION AND RESULTS OF OPERATIONS

This section should be read in conjunction with our unaudited condensed consolidated financial statements and related notes included in Part I, Item 1 of this report and our audited consolidated financial statements and related notes thereto and management’s discussion and analysis of financial condition and results of operations for the year ended December 31, 2015 included in our Annual Report on Form 10-K.

Forward-Looking Statements

This discussion contains certain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are identified by words such as “believe,” “will,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “could,” “potentially” or the negative of these terms or similar expressions. You should read these statements carefully because they discuss future expectations, contain projections of future results of operations or financial condition, or state other “forward-looking” information. These statements relate to our future plans, objectives, expectations, intentions and financial performance and the assumptions that underlie these statements. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those anticipated in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in this report in Part II, Item 1A — “Risk Factors,” and elsewhere in this report. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. These statements, like all statements in this report, speak only as of their date, and we undertake no obligation to update or revise these statements in light of future developments.

 

Overview

We are a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. We have developed a proprietary antibody platform designed to select antibodies that have the potential to maximize efficacy as well as speed of onset and durability of therapeutic response. In addition, we believe our ability to efficiently manufacture antibodies using our yeast-based manufacturing technology, MabXpress, allows us to target diseases that traditionally have not been addressed by antibodies.

We believe the clinical data obtained to date in our development program for ALD403, our wholly-owned lead product candidate, exhibits the potential to transform the way physicians treat migraine prevention. ALD403 is a genetically engineered monoclonal antibody for the prevention of migraine that blocks the calcitonin gene-related peptide (CGRP). ALD403 was discovered by Alder scientists. In April 2014, we announced top-line data from our Phase 2 clinical trial of ALD403 in patients experiencing migraine on 5-14 days per month (frequent episodic migraine). The data demonstrated that ALD403 acted rapidly after a single intravenous infusion (infusion), and demonstrated persistent migraine prevention over the entire 12-week study period. In March 2016, we announced positive top-line data from our Phase 2b clinical trial of ALD403 in patients experiencing 15 or more headache days per month of which at least 8 days per month are migraine (chronic migraine). The data demonstrated that ALD403 acted rapidly after a single infusion and demonstrated persistent migraine prevention over the entire 12-week study period, meeting both primary and secondary efficacy endpoints. We also announced in March 2016 positive Phase 1 clinical trial data demonstrating that the pharmacokinetics and pharmacodynamics by infusion, subcutaneous (SC) or intramuscular (IM) injection of ALD403 support a quarterly single injection dosing strategy.

We initiated our late stage clinical trial program in October 2015 with PR evention O f M igraine via I ntravenous ALD403 S afety and E fficacy 1 (PROMISE 1), a pivotal clinical trial evaluating the safety and efficacy of ALD403 administered via infusion once every 12 weeks in approximately 800 patients with frequent episodic migraine.  PROMISE 1 is a double-blind, placebo-controlled Phase 3 clinical trial in which patients are randomized equally to either one of three doses of ALD403 or placebo administered twice (once every 12 weeks) across sites in the United States and Europe.  Patient recruitment for PROMISE 1 was completed in October 2016. Also in October 2016, we met with the U.S. Food and Drug Administration (FDA) regarding our ALD403 pivotal clinical trial program.  Based on input from the FDA, we finalized the design of the ALD403 pivotal clinical trial program, as follows:  

 

As previously reported, we will initiate a second pivotal study, PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 2 (PROMISE 2), in 2016 that will evaluate the safety and efficacy of ALD403 in patients with chronic migraine. The study will be a double-blind, placebo-controlled Phase 3 clinical trial enrolling approximately 1,050 patients randomized to either one of two dose levels of ALD403 or placebo administered via infusion once every 12 weeks across sites in the United States and Europe.

 

13


 

 

o

The PROMISE 2 study primary endpoint will be the mean reduction in migraine days from baseline over weeks 1 to 12.

 

 

o

The PROMISE 2 study key secondary endpoints will be the 75% responder rate over weeks 1 to 12 as determined by the change in migraine days between ALD403 and placebo, and the 75% responder rate over weeks 1 to 4 as determined by the change in migraine days between ALD403 and placebo.

 

We are aligning the primary and key secondary endpoints of PROMISE 1 with the PROMISE 2 study endpoints for consistency between the two Phase 3 studies. The modification of the endpoints will not affect the conduct of the trial, including the expected top-line PROMISE 1 data readout in the first half of 2017.

 

Both the PROMISE 1 and PROMISE 2 study protocols were developed to be consistent with current standards for evaluating new investigational drug therapies for migraine prevention while also highlighting ALD403’s clinical attributes observed to date, including significant benefit achieved in the first month, sustained 12-week efficacy after a single treatment and robust efficacy as determined by the 75% responder rate.

 

We will initiate an open-label study of ALD403 to confirm the long term safety and tolerability of ALD403 as required by the FDA. This study will be a Phase 3 clinical trial and will consist of 120 patients receiving ALD403 administered by infusion once every 12 weeks for one year. We expect this study to begin in the first quarter of 2017.

 

No additional studies were requested by the FDA beyond PROMISE 1, PROMISE 2 and the open-label study.

 

The planned timing for the availability of top-line data from PROMISE 2 is the first half of 2018.

 

The planned timing for the submission of our Biologics License Application (BLA) to the FDA remains the second half of 2018.

We continue to plan to progress our alternate ALD403 formulation suitable for self-administration, as a single SC or IM injection, to more advanced studies in 2017.

Efficacy data from our Phase 2 proof-of-concept trial in patients with frequent episodic migraine and from our Phase 2b clinical trial in patients with chronic migraine established that ALD403 significantly reduced the number of days on which a migraine patient experiences migraines. In our Phase 2 proof-of-concept trial, 27-41% of patients experienced complete migraine-free relief (p<0.05), that is 100% suppression of migraine occurrence, in any given month and migraines were completely prevented in 16% of patients for the entire three-month study period (p<0.001). The top-line 12-week data from our Phase 2b clinical trial confirmed the ability of ALD403 to deliver a high level of efficacy.  In that trial, 33% and 31% of chronic migraine patients dosed with 300 mg and 100 mg, respectively, of ALD403 experienced a 75% decrease in their migraines from an average of 16 or more migraine days per month (p<0.05) over the 12-week study period, meeting the primary efficacy endpoint for the trial. In addition, a single administration of ALD403 resulted in an immediate and durable mean reduction in migraine days from baseline throughout the 12 weeks at the 300 mg (p < 0.01), 100 mg (p < 0.01) and 30 mg (p < 0.05) dose levels, meeting the secondary efficacy endpoint. The top-line 24-week data from our Phase 2b clinical trial announced on July 25, 2016 confirmed and extended the 12-week data. The 75% responder rate for the entire 24 weeks at the 300 mg, 100 mg and 30 mg dose levels was 31%, 29% and 30%, respectively, compared to a placebo rate of 20%. ALD403 also demonstrated a persistent mean reduction in migraine days from baseline throughout the 24-week period.  The statistical analysis plan for the Phase 2b trial does not provide for analyses of statistical significance at time points post the primary endpoint at 12 weeks. Endpoints will also be evaluated at week 48, which will mark the end of study.

Ongoing and future clinical trials are aimed at supporting our objective of regulatory approval of ALD403 at the earliest opportunity for the prevention of migraine in the subpopulation of migraineurs (approximately 13 million patients) who we believe to be candidates for a preventative migraine therapy. Assuming regulatory approval, we plan to focus our initial commercialization efforts on high-prescribing neurologists and headache centers in the United States employing a specialty sales force. To maximize the potential commercial opportunity of ALD403 while we focus on the U.S. specialty market, we may explore strategic arrangements that provide additional capabilities and infrastructure, and improve the potential return on our investments while improving access for physicians and patients.

In mid-2016, we nominated ALD1910, a preclinical wholly-owned monoclonal antibody that targets pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), as a development candidate. ALD1910 is undergoing investigational new drug (IND)-enabling studies for the prevention of migraine. PACAP-38 is a protein that is active in mediating the initiation of migraine, and we believe that ALD1910 holds potential as a treatment for migraineurs who have an inadequate response to therapeutics directed at CGRP or its receptor. To date, we have not incurred significant external costs for ALD1910.  

In mid-2016, we terminated development of ALD1613, a wholly-owned therapeutic agent that targets adrenocorticotropic hormone (ACTH), based on preclinical studies identifying novel target specific toxicology findings that may limit human clinical utility.

14


 

In May 2016, we licensed the exclusive worldwide rights for our product candidate clazakizumab to Vitaeris, Inc., or Vitaeris, a newly formed company based in Vancouver, British Columbia, that will pursue innovative therapeutic indications in chronic inflammatory diseases. In exchange for the rights to clazakizumab, we received an equity stake in Vitaeris and are eligibl e to receive royalties and certain other payments. Clazakizumab is designed to block the pro-inflammatory cytokine IL-6 and, prior to the license to Vitaeris, successfully completed two Phase 2b clinical trials establishing proof-of-concept in patients wit h rheumatoid arthritis. We believe that clazakizumab has the potential for further development as a therapeutic agent for one or more additional diseases where high levels of IL-6 are believed to play a role.

We were incorporated in 2002 and have not generated any product revenue. Through September 30, 2016, our operations have been primarily funded by $621.8 million of net proceeds in public offerings, $111.4 million in private placements of our capital stock, and $135.0 million in upfront payments, milestones and research and development payments from our collaborators and government grants. In April 2016, we completed an underwritten public offering of 6,182,795 shares of common stock resulting in net proceeds of $134.9 million, after deducting underwriting discounts, commissions and offering expenses.

As of September 30, 2016, we had an accumulated deficit of $329.7 million. We expect to experience increasing operating losses for the foreseeable future. We expect our expenses will increase substantially in connection with our ongoing activities, particularly the clinical development of ALD403 for the prevention of migraine.

We will not generate revenues from product sales unless and until we or our future collaborators successfully complete development and obtain regulatory approval for one or more of our product candidates, which we expect will take a number of years and is subject to significant uncertainty. If we obtain regulatory approval for ALD403, ALD1910 or any future product candidate, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution to the extent that such costs are not paid by future collaborators. We will need to obtain substantial additional sources of funding to develop ALD403 as currently contemplated. If such additional funding is not available on favorable terms or at all, we may need to delay or reduce the scope of our development programs or grant rights in the United States, as well as outside the United States, to our product candidates to one or more partners.

 

Financial Operations Overview

Revenue Under License Agreement and Cost of Sales

We recognized $0.1 million in revenue under license agreement and $0.l million in cost of sales in the nine months ended September 30, 2016 relating to the sale of inventory to Vitaeris at cost. We did not recognize any revenue or cost of sales in the three months ended September 30, 2016 or in the three and nine months ended September 30, 2015. We have not generated any revenues from the sale of products. In the future, we may generate revenues from product sales and from collaboration agreements in the form of license fees, milestone payments, reimbursements for clinical supply and development costs and royalties on product sales. We expect that any revenues we generate will fluctuate from quarter to quarter as a result of the uncertain timing and amount of such payments and sales.

Research and Development Expenses

Research and development expenses represent costs incurred by us for the discovery and development of our product candidates. The following items are included in research and development expenses:

 

external costs under agreements with clinical research organizations, or CROs, contract manufacturing organizations, or CMOs, and other significant third-party vendors or consultants used to perform preclinical, clinical and manufacturing activities;

 

internal costs including employee-related costs such as salaries, benefits, stock-based compensation expense, travel, laboratory consumables and services for our research and development personnel; and

 

allocated facilities, depreciation, and other expenses, which include rent and maintenance of facilities, information technology services and other infrastructure expenses.

We use our employee and infrastructure resources across multiple research and development programs directed toward evaluating our monoclonal antibodies for selecting product candidates. We manage certain activities such as preclinical toxicology studies, clinical trial operations and manufacture of product candidates through third-party CROs, CMOs or other third-party vendors. We track our significant external costs by each product candidate. We do not, however, assign or allocate to individual product candidates or development programs our internal costs and we group these internal research and development activities into three categories:

15


 

 

Category

  

Description

 

Preclinical discovery and development

  

 

Research and development expenses incurred in activities substantially in support of discovery of new targets through the selection of a single product candidate. These activities encompass the discovery and translational medicine functions, including pharmacokinetic and drug metabolism preclinical studies, toxicology and early strain and assay development activities.

 

Pharmaceutical operations

  

 

Research and development expenses incurred related to manufacturing preclinical study and clinical trial materials, including scale-up process development and quality control activities.

 

Clinical development

  

 

Research and development expenses incurred related to Phase 1, Phase 2 and Phase 3 clinical trials, including regulatory affairs activities.

 

We plan to increase our research and development expenses for the foreseeable future as we continue the development of ALD403 and advance ALD1910 and our future product candidates into clinical development. The timing and amount of research and development expenses incurred will depend largely upon the outcomes of current and future clinical trials for our product candidates as well as the related regulatory requirements, manufacturing costs and any costs associated with the advancement of our preclinical programs. We cannot determine with certainty the duration and completion costs of the current or future clinical trials of our product candidates. The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, including:  

 

the scope, rate of progress, and expense of our ongoing, as well as any additional, clinical trials and other research and development activities;

 

future clinical trial results;

 

potential changes in government regulation; and

 

the timing and receipt of any regulatory approvals.

A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate.

 

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation, related to our executive, business development, intellectual property, investor relations, finance, human resources and support functions. Other general and administrative expenses include allocated facility-related costs not otherwise included in research and development expenses, travel expenses and professional fees for auditing, tax and legal services, including intellectual property related legal services. We also incur expenses as a result of being a public company, including expenses related to compliance with the rules and regulations of the SEC, and those of the NASDAQ Stock Market LLC, or NASDAQ, additional insurance expenses, investor relations activities and other administrative and professional services.  

 

Results of Operations

Comparison of the Three and Nine Months Ended September 30, 2016 and 2015

Revenue Under License Agreement and Cost of Sales

We recognized $0.1 million in revenue under license agreement and cost of sales in the nine months ended September 30, 2016 relating to the sale of drug supply inventory to Vitaeris at cost. We did not recognize any revenue or cost of sales in the three months ended September 30, 2016 or in the three and nine months ended September 30, 2015.

16


 

Research and Development Expenses

Research and development expenses incurred in the three and nine months ended September 30, 2016 and 2015 were as follows:

 

 

Three Months Ended

 

 

 

 

 

 

Nine Months Ended

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

September 30,

 

 

 

 

 

 

2016

 

 

2015

 

 

% change

 

 

2016

 

 

2015

 

 

% change

 

 

(dollars in thousands)

 

 

 

 

 

 

(dollars in thousands)

 

 

 

 

 

External costs:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ALD403

$

18,034

 

 

$

13,870

 

 

 

30

%

 

$

53,808

 

 

$

25,065

 

 

 

115

%

ALD1613

 

358

 

 

 

1,862

 

 

 

(81

%)

 

 

6,171

 

 

 

3,918

 

 

 

58

%

Clazakizumab

 

163

 

 

 

66

 

 

 

147

%

 

 

244

 

 

 

144

 

 

 

69

%

Unallocated internal costs:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preclinical discovery and development

 

4,389

 

 

 

3,584

 

 

 

22

%

 

 

13,132

 

 

 

9,914

 

 

 

32

%

Pharmaceutical operations

 

4,482

 

 

 

2,656

 

 

 

69

%

 

 

12,817

 

 

 

6,918

 

 

 

85

%

Clinical development

 

2,065

 

 

 

814

 

 

 

154

%

 

 

4,799

 

 

 

2,016

 

 

 

138

%

Total research and development expenses

$

29,491

 

 

$

22,852