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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

x

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

For the quarterly period ended September 30, 2014

or

¨

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

For the transition period from                      to                      

Commission File Number: 001-36070

 

Five Prime Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

26-0038620

(State or other jurisdiction of

incorporation or organization)

 

(IRS Employer

Identification No.)

Two Corporate Drive

South San Francisco, California 94080

(415) 365-5600

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 

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  ¨

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  x    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. (Check one):

 

Large accelerated filer

 

¨

  

Accelerated filer

 

¨

 

 

 

 

Non-accelerated filer

 

x  (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 Exchange Act Rule 12b-2)     Yes  ¨    No  x

As of October 31, 2014, the number of outstanding shares of the registrant’s common stock was 21,550,672.

 

 

 

 

 

 


TABLE OF CONTENTS

 

PART I.

  

FINANCIAL INFORMATION

  

4

 

  

 

Item 1.

  

Financial Statements

  

4

 

  

 

  

 

Condensed Balance Sheets as of September 30, 2014 and December 31, 2013

  

4

 

  

 

  

 

Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2014 and 2013

  

5

 

  

 

  

 

Condensed Statements of Comprehensive Loss for the Three and Nine Months Ended September 30, 2014 and 2013

  

6

 

  

 

  

 

Condensed Statement of Cash Flows for the Nine Months Ended September 30, 2014 and 2013

  

7

 

  

 

  

 

Notes to Condensed Financial Statements

  

8

 

  

Item 2.

  

 

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

  

13

 

  

Item 3.

  

 

Quantitative and Qualitative Disclosures About Market Risk

  

22

 

  

Item 4.

  

 

Controls and Procedures

  

22

PART II.

  

 

OTHER INFORMATION

  

23

 

  

Item 1.

  

 

Legal Proceedings

  

23

 

  

Item 1A.

  

 

Risk Factors

  

23

 

  

Item 2.

  

 

Unregistered Sales of Equity Securities and Use of Proceeds

  

46

 

  

Item 6.

  

 

Exhibits

  

46

 

  

 

  

 

Signatures

  

47

 

  

 

  

 

Exhibit Index

  

48

In this report, unless otherwise stated or the context otherwise indicates, references to “Five Prime,” “the company,” “we,” “us,” “our” and similar references refer to Five Prime Therapeutics, Inc. The Five Prime logo and RIPPS ® are our registered trademarks. This report also contains registered marks, trademarks and trade names of other companies. All other trademarks, registered marks and trade names appearing in this report are the property of their respective holders.

 

 

 

2


SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA

This Quarterly Report on Form 10-Q contains forward-looking statements. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “plan,” “expect,” or similar expressions, or the negative or plural of these words or expressions. These forward-looking statements include statements concerning the following:

·

our estimates regarding our expenses, revenues, anticipated capital requirements and our needs for additional financing;

·

our or our partners’ ability to advance drug candidates into, and successfully complete, clinical trials alone or in combination with other drugs;

·

the timing of the initiation, progress and results of preclinical studies and research and development programs;

·

our expectations regarding the potential safety, efficacy or clinical utility of our product candidates;

·

the implementation, timing and likelihood of success of our plans to develop companion diagnostics for our product candidates;

·

our ability to maintain and establish collaborations;

·

the implementation of our business model, strategic plans for our business, drug candidates and technology;

·

the scope of protection we establish and maintain for intellectual property rights covering our drug candidates and technology;

·

the size of patient populations targeted by products we or our partners develop and market adoption of our potential products by physicians and patients;

·

the timing or likelihood of regulatory filings and approvals;

·

developments relating to our competitors’ and our industry; and

·

our expectations regarding licensing, acquisitions and strategic operations.

These statements are only current predictions and are subject to known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from those anticipated by the forward-looking statements. We discuss many of these risks in this report in greater detail under the heading “Risk Factors” and elsewhere in this report. You should not rely upon forward-looking statements as predictions of future events.

Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we are under no duty to update or revise any of the forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this report.

We obtained the industry, market and competitive position data in this quarterly report from our own internal estimates and research as well as from industry and general publications and research surveys and studies conducted by third parties. While we believe that each of these studies and publications is reliable, we have not independently verified market and industry data from third-party sources. While we believe our internal company research is reliable and the market definitions we use are appropriate, neither such research nor these definitions have been verified by any independent source.

 

 

 

3


PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

FIVE PRIME THERAPEUTICS, INC.

Condensed Balance Sheets

(In thousands)

 

 

SEPTEMBER 30,

 

 

DECEMBER 31,

 

 

2014

 

 

2013

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

13,128

 

 

$

8,161

 

Marketable securities

 

116,854

 

 

 

67,561

 

Receivable from collaborative partners

 

91

 

 

 

296

 

Prepaid and other current assets

 

1,775

 

 

 

1,640

 

Total current assets

 

131,848

 

 

 

77,658

 

Property and equipment, net

 

3,979

 

 

 

3,744

 

Other long-term assets

 

431

 

 

 

389

 

Total assets

$

136,258

 

 

$

81,791

 

Liabilities and stockholders' equity

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

672

 

 

$

348

 

Accrued personnel-related expenses

 

3,106

 

 

 

2,957

 

Other accrued liabilities

 

2,235

 

 

 

2,056

 

Deferred revenue, current portion

 

11,676

 

 

 

7,913

 

Deferred rent, current portion

 

611

 

 

 

549

 

Total current liabilities

 

18,300

 

 

 

13,823

 

Deferred revenue, long-term portion

 

20,920

 

 

 

7,123

 

Deferred rent, long-term portion

 

1,672

 

 

 

2,146

 

Other long-term liabilities

 

504

 

 

 

673

 

Commitments

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

Common stock

 

22

 

 

 

17

 

Preferred stock

 

 

 

 

 

Additional paid-in capital

 

271,952

 

 

 

209,580

 

Accumulated other comprehensive income

 

60

 

 

 

3

 

Accumulated deficit

 

(177,172

)

 

 

(151,574

)

Total stockholders' equity

 

94,862

 

 

 

58,026

 

Total liabilities and stockholders' equity

$

136,258

 

 

$

81,791

 

 

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

 

 

 

4


FIVE PRIME THERAPEUTICS, INC.

Condensed Statements of Operations

(In thousands, except per share amounts)

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2014

 

 

2013

 

 

2014

 

 

2013

 

Collaboration revenue

$

6,059

 

 

$

3,482

 

 

$

14,586

 

 

$

10,006

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

9,803

 

 

 

8,193

 

 

 

30,602

 

 

 

24,708

 

General and administrative

 

3,360

 

 

 

2,607

 

 

 

9,664

 

 

 

7,385

 

Total operating expenses

 

13,163

 

 

 

10,800

 

 

 

40,266

 

 

 

32,093

 

Loss from operations

 

(7,104

)

 

 

(7,318

)

 

 

(25,680

)

 

 

(22,087

)

Interest income

 

57

 

 

 

7

 

 

 

148

 

 

 

35

 

Other income (expense), net

 

(41

)

 

 

77

 

 

 

(66

)

 

 

497

 

Net loss

$

(7,088

)

 

$

(7,234

)

 

$

(25,598

)

 

$

(21,555

)

Basic and diluted net loss per common share

$

(0.33

)

 

$

(2.74

)

 

$

(1.24

)

 

$

(12.60

)

Shares used to compute basic and diluted net loss per

   common share

 

21,521

 

 

 

2,637

 

 

 

20,619

 

 

 

1,711

 

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

 

 

 

5


FIVE PRIME THERAPEUTICS, INC.

Condensed Statements of Comprehensive Loss

(In thousands)

 

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

 

 

September 30,

 

 

September 30,

 

 

 

 

2014

 

 

2013

 

 

2014

 

 

2013

 

 

Net loss

 

$

(7,088

)

 

$

(7,234

)

 

$

(25,598

)

 

$

(21,555

)

 

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net unrealized gain (loss) on marketable securities

 

 

19

 

 

 

 

 

 

60

 

 

 

(6

)

 

Comprehensive loss

 

$

(7,069

)

 

$

(7,234

)

 

$

(25,538

)

 

$

(21,561

)

 

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

 

 

 

6


FIVE PRIME THERAPEUTICS, INC.

Condensed Statement of Cash Flows

(In thousands)

 

 

Nine Months Ended

 

 

September 30,

 

 

2014

 

 

2013

 

 

(Unaudited)

 

Operating activities

 

 

 

 

 

 

 

Net loss

$

(25,598

)

 

$

(21,555

)

Adjustments to reconcile net loss to net cash used in

   operating activities:

 

 

 

 

 

 

 

Depreciation and amortization

 

1,154

 

 

 

1,288

 

Loss on disposal of property and equipment

 

41

 

 

 

-

 

Stock-based compensation expense

 

2,230

 

 

 

1,554

 

Amortization of premium on marketable securities

 

1,075

 

 

 

272

 

Revaluation of preferred stock warrant liability

 

-

 

 

 

(500

)

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

Receivable from collaborative partners

 

205

 

 

 

14

 

Prepaid, other current assets, and other long-term assets

 

(539

)

 

 

(2

)

Accounts payable

 

324

 

 

 

467

 

Accrued personnel-related expenses

 

149

 

 

 

(154

)

Deferred revenue

 

17,560

 

 

 

2,677

 

Deferred rent

 

(412

)

 

 

189

 

Other accrued liabilities and other long-term liabilities

 

373

 

 

 

18

 

Net cash used in operating activities

 

(3,438

)

 

 

(15,732

)

Investing activities

 

 

 

 

 

 

 

Purchases of marketable securities

 

(121,016

)

 

 

(12,078

)

Maturities of marketable securities

 

70,705

 

 

 

29,435

 

Purchases of property and equipment

 

(1,430

)

 

 

(633

)

Net cash (used in) provided by investing activities

 

(51,741

)

 

 

16,724

 

Financing activities

 

 

 

 

 

 

 

Proceeds from public offering of common stock, net

 

40,099

 

 

 

64,887

 

Proceeds from the sale of common stock to collaborative partner

 

18,629

 

 

 

 

Proceeds from issuance of common stock under equity

   incentive plans

 

1,418

 

 

387

 

Payments under capital lease obligation

 

 

 

 

(9

)

Net cash provided by financing activities

 

60,146

 

 

 

65,265

 

Net increase in cash and cash equivalents

 

4,967

 

 

 

66,257

 

Cash and cash equivalents at beginning of period

 

8,161

 

 

 

11,391

 

Cash and cash equivalents at end of period

$

13,128

 

 

$

77,648

 

Supplemental schedule of noncash financing activities

 

 

 

 

 

 

 

Accrued and deferred offering costs

$

 

 

$

1,026

 

 

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

 

 

 

7


FIVE PRIME THERAPEUTICS, INC.

Notes to Condensed Financial Statements

September 30, 2014

 

1.

Description of Business

Five Prime Therapeutics, Inc. (we, us, our or the Company) is a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics. Protein therapeutics are antibodies or drugs developed from extracellular proteins or protein fragments that block disease processes, including cancer and inflammatory diseases. We were incorporated in December 2001 in Delaware. Our operations are based in South San Francisco, California and we operate in one segment.

Unaudited Interim Financial Information

The accompanying financial information as of September 30, 2014 is unaudited. The Condensed Financial Statements included in this report reflect all adjustments (consisting only of normal recurring adjustments) that our management considers necessary for the fair statement of the results of operations for the interim periods covered and of the financial condition of the Company at the date of the interim balance sheet. The December 31, 2013 Condensed Balance Sheet was derived from audited financial statements, but does not include all disclosures required by generally accepted accounting principles in the United States of America, or GAAP. The results for interim periods are not necessarily indicative of the results for the entire year or any other interim period. The accompanying Condensed Financial Statements and related financial information should be read in conjunction with the audited financial statements and the related notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the U.S. Securities and Exchange Commission.

Follow-on Public Offering

In February 2014, we completed a public offering of 3,450,000 shares of our common stock, or our Follow-on Public Offering, which included shares we issued pursuant to our underwriters’ exercise of their over-allotment option. We received net proceeds of $40.1 million, after underwriting discounts, commissions and offering expenses, from the Follow-on Public Offering.

 

2.

Summary of Significant Accounting Policies

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions about future events that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements as well as reported amounts of revenue and expenses during the reporting period. Actual results could differ materially from those estimates.

Reclassifications

We have reclassified certain prior period amounts to conform to the current period presentation. We reclassified certain liabilities, primarily those related to unbilled receipts, from accounts payable to other accrued liabilities on our balance sheets and made related conforming reclassifications on our statements of cash flows.

Fair Value of Financial Instruments

We determine the fair value of financial and nonfinancial assets and liabilities using the fair value hierarchy, which describes three levels of inputs that may be used to measure fair value, as follows:

Level 1—Quoted prices in active markets for identical assets or liabilities;

Level 2—Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and

Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

We determine the fair value of Level 1 assets using quoted prices in active markets for identical assets. We review trading activity and pricing for Level 2 investments as of each measurement date. Level 2 inputs, obtained from various third-party data providers, represent quoted prices for similar assets in active markets and were derived from observable market data, or, if not directly observable, were derived from or corroborated by other observable market data.

8


In certain cases where there is limited activity or less transparency around inputs to valuation, we classify securities as Level 3 within the valuation hierarchy.

The following table summarizes, for assets recorded at fair value, the respective fair values and the classifications by level of input within the fair value hierarchy defined above (in thousands):

 

 

SEPTEMBER 30, 2014

 

 

 

 

 

 

BASIS OF FAIR VALUE

 

 

 

 

 

 

MEASUREMENTS

 

 

TOTAL

 

 

LEVEL 1

 

 

LEVEL 2

 

 

LEVEL 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

$

8,925

 

 

$

8,925

 

 

$

 

 

$

 

U.S. Treasury securities

 

106,330

 

 

 

106,330

 

 

 

 

 

 

 

U.S. government agency securities

 

10,524

 

 

 

 

 

 

10,524

 

 

 

 

Total cash equivalents and marketable securities

$

125,779

 

 

$

115,255

 

 

$

10,524

 

 

$

 

 

 

 

DECEMBER 31, 2013

 

 

 

 

 

 

BASIS OF FAIR VALUE

 

 

 

 

 

 

MEASUREMENTS

 

 

TOTAL

 

 

LEVEL 1

 

 

LEVEL 2

 

 

LEVEL 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

$

6,456

 

 

$

6,456

 

 

$

 

 

$

 

U.S. Treasury securities

 

18,852

 

 

 

18,852

 

 

 

 

 

 

 

U.S. government agency securities

 

48,709

 

 

 

 

 

 

48,709

 

 

 

 

Total cash equivalents and marketable securities

$

74,017

 

 

$

25,308

 

 

$

48,709

 

 

$

 

 

 

    

Net Loss Per Share of Common Stock

We compute basic net loss per common share by dividing net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period. We did not include potentially dilutive securities consisting of stock options, preferred stock warrants, common stock warrants and convertible preferred stock in the diluted net loss per common share calculations for all periods presented because the inclusion of such shares would have had an antidilutive effect. The convertible preferred stock contained certain participation rights.

We excluded the following securities (in thousands) from the calculation of diluted net loss per share as the effect would have been antidilutive:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2014

 

 

2013

 

 

2014

 

 

2013

 

Convertible preferred stock

 

 

 

 

9,174

 

 

 

 

 

 

9,675

 

Options to purchase common stock

 

2,404

 

 

 

2,235

 

 

 

2,253

 

 

 

2,235

 

Warrants to purchase preferred stock

 

 

 

 

75

 

 

 

 

 

 

79

 

Warrants to purchase common stock

 

 

 

 

2

 

 

 

 

 

 

2

 

 

 

2,404

 

 

 

11,486

 

 

 

2,253

 

 

 

11,991

 

 

Recently Issued Accounting Standards

In May 2014, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-09, “Revenue from Contracts with Customers.” ASU 2014-09 supersedes the revenue recognition requirements in “Topic 605, Revenue Recognition” and requires entities to recognize revenue in a way that depicts 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. ASU 2014-09 is effective retrospectively for annual or interim reporting periods beginning after December 15, 2016, with early application not permitted. We are currently evaluating the effect the adoption of ASU 2014-09 will have on our financial statements.

9


 

3.

Cash Equivalents and Marketable Securities

The following is a summary of our cash equivalents and marketable securities (in thousands):

 

 

SEPTEMBER 30, 2014

 

 

AMORTIZED

 

 

UNREALIZED

 

 

UNREALIZED

 

 

ESTIMATED

 

 

COST BASIS

 

 

GAINS

 

 

LOSSES

 

 

FAIR VALUE

 

 

(unaudited)

 

Money market funds

$

8,925

 

 

$

 

 

$

 

 

$

8,925

 

U.S. Treasury securities

 

106,274

 

 

 

57

 

 

 

(1

)

 

 

106,330

 

U.S. government agency securities

 

10,520

 

 

 

4

 

 

 

 

 

 

10,524

 

 

 

125,719

 

 

 

61

 

 

 

(1

)

 

 

125,779

 

Less: cash equivalents

 

(8,925

)

 

 

 

 

 

 

 

 

(8,925

)

Total marketable securities

$

116,794

 

 

$

61

 

 

$

(1

)

 

$

116,854

 

 

 

 

DECEMBER 31, 2013

 

 

AMORTIZED

 

 

UNREALIZED

 

 

UNREALIZED

 

 

ESTIMATED

 

 

COST BASIS

 

 

GAINS

 

 

LOSSES

 

 

FAIR VALUE

 

Money market funds

$

6,456

 

 

$

 

 

$

 

 

$

6,456

 

U.S. Treasury securities

 

18,848

 

 

 

4

 

 

 

 

 

 

18,852

 

U.S. government agency securities

 

48,709

 

 

 

3

 

 

 

(3

)

 

 

48,709

 

 

 

74,013

 

 

 

7

 

 

 

(3

)

 

 

74,017

 

Less: cash equivalents

 

(6,456

)

 

 

 

 

 

 

 

 

(6,456

)

Total marketable securities

$

67,557

 

 

$

7

 

 

$

(3

)

 

$

67,561

 

 

As of September 30, 2014, the amortized cost and estimated fair value of our available-for-sale securities by contractual maturity are shown below (in thousands):

 

 

Amortized

 

 

Estimated

 

 

Cost

 

 

Fair Value

 

 

(unaudited)

 

Debt securities maturing:

 

 

 

 

 

 

 

In one year or less

$

96,527

 

 

$

96,574

 

In one to two years

 

29,192

 

 

 

29,205

 

Total marketable securities

$

125,719

 

 

$

125,779

 

 

We determined that the gross unrealized losses of $1,000 on our marketable securities as of September 30, 2014 were temporary in nature. We currently do not intend to sell these securities prior to maturity and do not consider these investments to be other-than-temporarily impaired at September 30, 2014. There were no sales of available-for-sale securities in any of the periods presented.

 

4.

Equity Incentive Plans

The following table summarizes option activity under our stock plans and related information:

 

 

OPTIONS OUTSTANDING

 

 

 

 

 

 

WEIGHTED

 

 

WEIGHTED

 

 

 

 

 

 

AVERAGE

 

 

AVERAGE

 

 

NUMBER OF

 

 

EXERCISE PRICE

 

 

REMAINING

 

 

SHARES

 

 

PER SHARE

 

 

CONTRACTUAL TERM

 

Balance at December 31, 2013

 

2,236,997

 

 

$

6.09

 

 

 

 

 

Options granted

 

780,195

 

 

$

11.62

 

 

 

 

 

Options exercised

 

(188,439

)

 

$

5.29

 

 

 

 

 

Options forfeited

 

(59,623

)

 

$

7.63

 

 

 

 

 

Balance at September 30, 2014

 

2,769,130

 

 

$

7.67

 

 

 

 

 

Options exercisable

 

1,440,891

 

 

$

6.03

 

 

 

6.00

 

 

10


 

As of September 30, 2014, there were 3,393,083 shares of common stock available for future issuance under our 2013 Omnibus Incentive Plan.

Stock-Based Compensation

We calculate employee stock-based compensation expense based on awards ultimately expected to vest reduced by estimated forfeitures. We estimate forfeitures at the time of grant and revise forfeitures, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Total stock-based compensation expense recognized was as follows (in thousands):

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2014

 

 

2013

 

 

2014

 

 

2013

 

Research and development

$

383

 

 

$

261

 

 

$

1,112

 

 

$

661

 

General and administrative

 

471

 

 

 

258

 

 

 

1,118

 

 

 

893

 

Total

$

854

 

 

$

519

 

 

$

2,230

 

 

$

1,554

 

 

We estimated the fair value of each stock option using the Black-Scholes option-pricing model based on the date of grant of such stock option with the following assumptions:

 

 

Three Months Ended

 

 

Nine Months Ended

 

 

September 30,

 

 

September 30,

 

 

2014

 

 

2013

 

 

2014

 

 

2013

 

Expected term (years)

5.4-6.7

 

 

5.3-6.1

 

 

5.3-6.7

 

 

5.0-6.1

 

Expected volatility

 

85

%

 

 

85

%

 

 

85

%

 

 

85

%

Risk-free interest rate

1.7-2.0

 

 

1.4-1.6%

 

 

1.6-2.0

 

 

0.8-1.6%

 

Expected dividend yield

 

0

%

 

 

0

%

 

 

0

%

 

 

0

%

 

As of September 30, 2014, we had $8.4 million of total unrecognized compensation expense related to nonvested employee and director stock options that we expect to recognize over a weighted-average period of 3.1 years.

 

5.

Collaborative Research and Development Agreements

Bristol-Myers Squibb Company

On March 14, 2014, we entered into a research collaboration and license agreement, referred to as the immuno-oncology collaboration, with Bristol-Myers Squibb Company, or BMS, to carry out a research program to (i) discover novel interacting proteins in two undisclosed immune checkpoint pathways, which we refer to as the checkpoint pathways, using our target discovery platform; (ii) further the understanding of target biology with respect to targets in these checkpoint pathways; and (iii) discover and pre-clinically develop compounds suitable for development for human therapeutic uses against targets in these checkpoint pathways. Under the immuno-oncology collaboration, we granted BMS an exclusive, worldwide license to research, develop and commercialize products directed towards certain targets in the checkpoint pathways. BMS will have an option to take exclusive licenses to additional targets we may identify in these checkpoint pathways during the course of the immuno-oncology collaboration. We received an upfront payment of $20.0 million from BMS in April 2014 in connection with our entry into the immuno-oncology collaboration and expect to receive $9.5 million in research funding over the course of the three-year research term based on the research activities currently planned under the research plan. BMS may extend the research term for two additional one-year periods on a year-by-year basis, during which extensions we would be obligated to perform additional services as agreed to with BMS and BMS would be obligated to pay us research funding with respect to such services.

We applied the FASB Accounting Standards Update, or ASU, No. 2009-13, Multiple-Deliverable Revenue Arrangements, in evaluating the appropriate accounting for the immuno-oncology collaboration. In accordance with this guidance, we concluded that we should account for the immuno-oncology collaboration as a single unit of accounting and recognize the immuno-oncology collaboration consideration in the same manner as the final deliverable, which is research service. The $20.0 million upfront payment was recorded as deferred revenue and is being recognized over the five-year research period under the collaboration. In addition, BMS agreed to pay us $9.5 million of research funding over the initial three-year research program term. We received $2.3 million of research funding during the nine months ended September 30, 2014 related to research we performed under the immuno-oncology collaboration.

We are eligible to receive certain contingent payments with respect to each target subject to the immuno-oncology collaboration and royalties on sales of products related to such targets, if any.

11


In accordance with ASU No. 2010-17, Milestone Method of Revenue Recognition, we determined that the remaining contingent payments under the immuno-oncology collaboration do not constitute milestone payments and will not be accounted for under the milestone method of revenue recognition. The events leading to these payments under the collaboration do not meet the definition of a milestone under ASU 2010-17 because the achievement of these events solely depends on BMS’s performance. Any revenue from these contingent payments would be subject to an allocation of arrangement consideration and would be recognized over any remaining period of performance obligations, if any, relating to the collaboration. If we have no remaining performance obligations under the immuno-oncology collaboration at the time the contingent payment is triggered, we would recognize the contingent payment as revenue in full upon the triggering event.

In connection with the immuno-oncology collaboration, BMS purchased 994,352 shares of our common stock at a price per share of $21.16, for an aggregate purchase price of $21.0 million. We determined that the purchase price of $21.16 per share exceeded the fair value of our common stock by $2.4 million and, therefore, recorded the $2.4 million as deferred revenue, which we will recognize in the same manner as the $20.0 million up-front payment.

During the three and nine months ended September 30, 2014, we recognized $2.0 million and $4.1 million, respectively, of revenue under the immuno-oncology collaboration. As of September 30, 2014, we had deferred revenue relating to the immuno-oncology collaboration of $20.6 million.

The immuno-oncology collaboration will terminate upon the expiration of all payment obligations under the collaboration. In addition, BMS may terminate the immuno-oncology collaboration in its entirety or on a collaboration target-by-collaboration target basis at any time with advance written notice and either party may terminate the collaboration in its entirety or on a collaboration target-by-collaboration target basis with written notice for the other party’s material breach if such party fails to cure the breach or immediately upon certain insolvency events.

GlaxoSmithKline

Respiratory Diseases Discovery Collaboration

In April 2014, we amended our research collaboration and license agreement, referred to as the respiratory diseases collaboration, with Glaxo Group Limited, or GSK, that we originally entered into in April 2012 to identify new therapeutic approaches to treat refractory asthma and chronic obstructive pulmonary disease function. Pursuant to the respiratory diseases collaboration, GSK has an option to elect to include additional screening assays under the research plan. The amendment allows GSK to terminate any additional screening assay it elects under the research plan within nine months of so electing, which termination right lapsed unexercised in October 2014. Concurrent with the amendment, GSK exercised its option and expanded the research plan to include two additional screening assays. In connection with GSK’s exercise of its option, we are entitled to receive up to $1.0 million in additional research funding in 16 equal quarterly payments for each additional screening assay, for a total of up to $2.0 million in additional research funding for both additional screening assays, of which we have received $0.5 million as of September 30, 2014.

 

 

 

12


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

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related notes thereto for the year ended December 31, 2013 included in our Annual Report on Form 10-K, as filed with the U.S. Securities and Exchange Commission (SEC) on March 26, 2014.

Overview

Five Prime Therapeutics, Inc. (we, us, our, FivePrime or the Company) is a clinical-stage biotechnology company focused on discovering and developing novel protein therapeutics. Protein therapeutics are antibodies or drugs developed from extracellular proteins or protein fragments that block disease processes, including for cancer and inflammatory diseases. We have developed a library of more than 5,700 human extracellular proteins, which we believe represent substantially all of the body’s medically important targets for protein therapeutics. We screen this comprehensive library with our proprietary high-throughput protein screening technologies to identify new targets for protein therapeutics. This platform has allowed us to develop a pipeline of novel product candidates for cancer and inflammatory diseases and to generate $274.7 million under our collaboration arrangements through September 30, 2014.

We currently have two product candidates in clinical development and we expect to announce the initiation of a Phase 1 clinical trial of a third product candidate by the end of 2014.  Each of our product candidates has an innovative mechanism of action and addresses patient populations for which better therapies are needed. In addition, we are pursuing companion diagnostics for each of our lead programs to allow us to select patients most likely to benefit from treatment and therefore accelerate clinical development and improve patient care.

Our most advanced product candidate, FP-1039/GSK3052230, or FP-1039, is a protein therapeutic that “traps” and neutralizes cancer-promoting fibroblast growth factors, or FGFs, involved in cancer cell proliferation and new blood vessel formation. We have completed a Phase 1 clinical trial, and our partner, GlaxoSmithKline, or GSK, is conducting a three-arm Phase 1b clinical trial in squamous non-small cell lung cancer, or NSCLC, patients with abnormally high levels of FGFR1 and malignant pleural mesothelioma, or MPM, patients. We expect clinical results from the dose escalation phase from one or two arms of this trial by the end of 2014.

Our second clinical-stage product, FPA008, is an antibody that inhibits colony stimulating factor-1 receptor, or CSF1R, which we are developing to treat patients with inflammatory diseases, including rheumatoid arthritis, or RA. CSF1R is a cell surface protein that controls the survival and function of certain immune response cells called monocytes and macrophages. Monocytes and macrophages are commonly involved in the aberrant immune response and inflammatory processes seen in some chronic inflammatory conditions, such as RA. We began a Phase 1 clinical trial for FPA008 in October 2013 and expect preliminary data, including inflammation and bone turnover biomarker data, from the healthy volunteer portion of this trial by the end of 2014. We plan to begin dosing RA patients in this Phase 1 clinical trial by the end of 2014. We expect to commence clinical development of FPA008 in solid tumors in 2015.

We are also developing FPA144, an antibody that inhibits FGF receptor 2b, or FGFR2b, to treat patients with gastric cancer and potentially other solid tumors. In preclinical studies, FPA144 was highly effective in blocking the growth of gastric tumors that had abnormally high levels of FGFR2b. We plan to begin enrolling patients in a Phase 1 clinical trial for FPA144 by the end of 2014.  We plan to initially test escalating doses of FPA144 in patients with solid tumors and, after dose escalation, begin treating gastric cancer patients with FGFR2 gene-amplified or FGFR2b over-expressing tumors.

We have no products approved for commercial sale and have not generated any revenue from product sales to date. We continue to incur significant research and development and other expenses related to our ongoing operations. We have incurred losses in each period since our inception in 2002, with the exception of the fiscal year ended 2011, due to collaboration revenues from product candidates under collaboration agreements with third parties. For the nine months ended September 30, 2014 and for the year ended December 31, 2013, we reported a net loss of $25.6 million and $28.9 million, respectively. As of September 30, 2014, we had an accumulated deficit of $177.2 million.

Our management’s discussion and analysis of our financial condition and results of operations are based upon our unaudited consolidated financial statements included in this Quarterly Report on Form 10-Q, which we prepared in accordance with GAAP for interim periods and with Regulation S-X promulgated under the Securities and Exchange Act of 1934, as amended, or the Exchange Act.

Third Quarter 2014 and Other Recent Highlights

GSK continues to actively enroll all three arms of the Phase 1b clinical trial of FP-1039. We expect to have preliminary findings from at least one of the arms by year end 2014.  

13


We initiated Part 3 of the Phase 1 clinical trial of FPA008 in RA patients. Part 3 of this trial begins with open-label dose escalation of FPA008 before advancing into randomized double-blind, placebo-controlled testing in patients with active RA who are on methotrexate background therapy.

We filed an IND in late September 2014 to initiate a Phase 1 clinical trial of FPA144 in gastric cancer patients and have been granted permission to move into clinical studies. We expect to announce first patient enrolled in this trial by the end of 2014.

During the third quarter, GSK exercised its option under our muscle disease collaboration to license an undisclosed muscle disease target that we identified using our proprietary target discovery platform.  We granted GSK an exclusive, worldwide license to products containing or directed to the target.  We received a payment of $1.5 million in connection with the option exercise and are entitled to receive up to $122.5 million in milestone payments as well as royalties on net sales of products related to the target.

In October 2014, we announced the expansion of our respiratory diseases research collaboration with GSK.  The scope of the collaboration was broadened to include two additional respiratory disease discovery programs for a six-month evaluation period and GSK subsequently committed to continue these for an additional 18 months.  We will receive an aggregate of $2.0 million in research funding for this expansion, $0.5 million of which we have already received.  We will also be eligible to receive up to $193.8 million in potential option exercise fees and milestone payments, as well as tiered royalties on global net sales for each product resulting from a selected drug target under the respiratory disease research collaboration.

In October 2014, we appointed Robert Sikorski, M.D., Ph.D., as Vice President of Global Clinical Development. Dr. Sikorski is in charge of overseeing the global clinical development activities for our product candidates.  

In October 2014, we appointed William Ringo, a strategic advisor at Sofinnova Ventures, to our Board of Directors. The addition of Mr. Ringo increased the number of directors to nine.  

14


Product Pipeline

The following table summarizes key information about our three most advanced product candidates:

 

PRODUCT CANDIDATE

  

INDICATION

  

COMMERCIAL RIGHTS

  

STAGE OF

DEVELOPMENT

AND ANTICIPATED

MILESTONES

 

FP-1039

  

 

FGFR1 gene-amplified tumors, e.g., squamous NSCLC, and FGF-2 overexpressing tumors, e.g., MPM

  

 

GlaxoSmithKline: U.S., EU and Canada

Five Prime: Co-promote in U.S.; retained rest of world rights 

  

 

 

Phase 1b clinical trial underway, consisting of Arms A and B in squamous NSCLC and Arm C in MPM; two of the three arms are nearing completion of the dose escalation phase, which will allow us to choose a dose for expansion that is tolerable in combination with standard chemotherapy.

 

 

 

 

 

FPA008

  

Rheumatoid arthritis; other inflammatory and fibrotic diseases and cancer

  

Five Prime: Global

  

Phase 1 clinical trial underway; part 3 initiated with open-label dose escalation in RA patients.

 

 

Preliminary Phase 1 clinical trial data from healthy volunteers expected by end of 2014.

 

 

Advancement to dosing in RA patients expected by the end of 2014.

 

 

Expect to commence clinical development in solid tumors in 2015.

 

 

 

 

 

FPA144

  

FGFR2 gene-amplified or FGFR2b protein over-expressing tumors, e.g., gastric cancer

  

Five Prime: Global

  

Received IND clearance for Phase 1 clinical trial.

 

 

 

 

 

 

 

Expect to announce first patient enrolled by the end of 2014.

Financial Overview

Collaboration Revenue

We have not generated any revenue from product sales. Our revenue to date has been derived from upfront payments, research and development funding and milestone payments under collaboration and license agreements with our collaboration partners.  We currently have research collaborations in muscle diseases and respiratory diseases and an FP-1039 product collaboration and license agreement with GSK, a fibrosis and CNS research collaboration with UCB Pharma S.A., or UCB, and an immuno-oncology collaboration with BMS.

15


Summary Revenue by Collaboration Partner

The following is a comparison of collaboration revenue for the three and the nine months ended September 30, 2014 and 2013:

 

 

THREE MONTHS ENDED

 

 

NINE MONTHS ENDED

 

 

SEPTEMBER 30,

 

 

SEPTEMBER 30,

 

(in millions)

2014

 

 

2013

 

 

2014

 

 

2013

 

R&D Funding

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Respiratory Diseases Collaboration

$

0.9

 

 

$

0.7

 

 

$

2.6

 

 

$

2.1

 

Muscle Diseases Collaboration

 

 

 

 

0.7

 

 

 

0.8

 

 

 

2.3

 

FP-1039  Product Collaboration

 

0.1

 

 

 

 

 

 

0.1

 

 

 

0.1

 

Fibrosis and CNS Collaboration

 

 

 

 

0.1

 

 

 

0.1

 

 

 

0.1

 

Immuno-oncology Collaboration

 

0.9

 

 

 

 

 

 

1.7

 

 

 

 

Other

 

 

 

 

 

 

 

0.1

 

 

 

0.1

 

Ratable Revenue Recognition

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Respiratory Diseases Collaboration

 

0.7

 

 

 

0.7

 

 

 

2.0

 

 

 

2.0

 

Muscle Diseases Collaboration

 

 

 

 

0.6

 

 

 

0.9

 

 

 

1.8

 

Fibrosis and CNS Collaboration

 

0.8

 

 

 

0.6

 

 

 

2.2

 

 

 

1.4

 

Immuno-oncology Collaboration

 

1.1

 

 

 

 

 

 

2.4

 

 

 

 

Milestone and Contingent Payments

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Muscle Diseases Collaboration

 

1.6

 

 

 

0.1

 

 

 

1.7

 

 

 

0.1

 

Total

$

6.1

 

 

$

3.5

 

 

$

14.6

 

 

$

10.0

 

 

We expect that any revenue we generate will fluctuate from period to period as a result of the timing and amount of milestones and other payments from our existing collaborations or any new collaborations we may enter into.

Research and Development

Research and development expenses consist of costs we incur in performing internal and collaborative research and development activities. Expenses incurred related to collaborative research and development agreements approximate the revenue recognized under these agreements. Research and development costs consist of salaries and benefits, including associated stock-based compensation, lab supplies and facility costs, as well as fees paid to other entities that conduct certain research and development activities, including manufacturing, on our behalf.

We are conducting research and development activities on several oncology and inflammatory disease targets and products.

We have a research and development team that designs, manages and evaluates the results of all of our research and development activities. We conduct nearly all of the core target discovery and early research and preclinical activities internally and rely on third parties, such as clinical research organizations, or CROs, and clinical manufacturing organizations, or CMOs, for the execution of certain of our research and development activities, such as toxicology studies, drug substance and drug product manufacturing and the conduct of clinical trials. We account for research and development costs on a program-by-program basis. In the early phases of research and discovery, our costs are often related to improving our discovery platform or preliminary screening activities and are not necessarily allocable to a specific target. We assign costs for such activities to a distinct non-program related project code. We allocate research management, overhead, common usage laboratory supplies and facility costs on a full-time equivalent basis.

The following is a comparison of research and development expenses for the three and the nine months ended September 30, 2014 and 2013:

 

 

THREE MONTHS ENDED

 

 

NINE MONTHS ENDED

 

 

SEPTEMBER 30,

 

 

SEPTEMBER 30,

 

(in millions)

2014

 

 

2013

 

 

2014

 

 

2013

 

Product programs:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

FP-1039

$

 

 

$

0.2

 

 

$

0.3

 

 

$

0.7

 

FPA008

 

2.3

 

 

 

2.6

 

 

 

6.1

 

 

 

7.5

 

FPA144

 

1.9

 

 

 

1.2

 

 

 

8.6

 

 

 

3.8

 

Early preclinical programs, collectively

 

 

 

 

0.4

 

 

 

0.3

 

 

 

2.5

 

Subtotal pipeline

 

4.2

 

 

 

4.4

 

 

 

15.3

 

 

 

14.5

 

Product and discovery collaborations

 

3.7

 

 

 

2.7

 

 

 

9.7

 

 

 

7.5

 

Early research and discovery

 

1.9

 

 

 

1.1

 

 

 

5.6

 

 

 

2.7

 

Total research and development expenses

$

9.8

 

 

$

8.2

 

 

$

30.6

 

 

$

24.7

 

16


 

We expect our research and development expenses to increase as we expand our internal cancer immunotherapy discovery and research efforts, advance our development programs further and advance additional drug candidates into clinical development, in particular as we increase the number and size of our clinical trials. We began a Phase 1 clinical trial for FPA008 in October 2013 and expect to begin a Phase 1 clinical trial for FPA144 in selected patients by the end of 2014. The process of conducting preclinical studies and clinical trials necessary to obtain regulatory approval is costly and time-consuming. We or our partners may never succeed in achieving marketing approval for any of our drug candidates. Numerous factors may affect the probability of success for each drug candidate, including preclinical data, clinical data, competition, manufacturing capability and commercial viability.

FP-1039, our most-advanced product candidate entered Phase 1b clinical development in July 2013, FPA008 entered Phase 1 clinical development in October 2013, we expect FPA144 to begin enrolling patients in a Phase I clinical trial by the end of 2014 and our other product candidates are in preclinical development; therefore, the successful development of our drug candidates is highly uncertain and may not result in approved products. Completion dates and completion costs can vary significantly for each drug candidate and are difficult to predict for each product. Given the uncertainty associated with clinical trial enrollments and the risks inherent in the development process, we are unable to determine the duration and completion costs of the current or future clinical trials of our drug candidates or if, or to what extent, we will generate revenues from the commercialization and sale of any of our drug candidates. We anticipate we will make determinations as to which programs to pursue and how much funding to direct to each program on an ongoing basis in response to the outcome of research, nonclinical and clinical activities of each drug candidate, as well as ongoing assessments as to each drug candidate’s commercial potential. We will need to raise additional capital or may seek additional product collaborations in the future in order to complete the development and commercialization of our drug candidates.

General and Administrative

General and administrative expenses consist primarily of salaries and related benefits, including associated stock-based compensation, related to our executive, finance, legal, business development, human resource 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 expect our general and administrative expenses to increase as we expand our operations to support our increased research and development activities and due to increasing the amount of space we lease in our corporate headquarters building. Also, we expect our intellectual property-related legal expenses, including those related to preparing, filing, prosecuting and maintaining patent applications, to increase as our intellectual property portfolio expands.

Interest Income

Interest income consists of interest income earned on our cash and cash equivalents and marketable securities.

Other Income (Expense), Net

Other income (expense), net consists primarily of the revaluation of the preferred stock warrant liability and the gain or loss on the disposal of property and equipment, if any. Upon the completion of our IPO in September 2013, the preferred stock warrant liability was reclassified to additional paid-in capital and we no longer record any related periodic fair value adjustment.

Critical Accounting Policies and Estimates

We based our management’s discussion and analysis of financial condition and results of operations upon our unaudited condensed financial statements, which we prepared in accordance with GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an on-going basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions. Our significant accounting policies are more fully described in Note 2 of the accompanying unaudited condensed financial statements and in Note 1 to our audited financial statements contained in our Annual Report on Form 10-K, or our Annual Report, as filed with the Securities and Exchange Commission, or SEC, on March 26, 2014. There have been no significant or material changes in our critical accounting policies during the nine months ended September 30, 2014, as compared to those disclosed in “Management’s Discussion and Analysis of Financial Condition and Results of Operations – Critical Accounting Policies and Use of Estimates” in our Annual Report.

17


Results of Operations

Comparison for the Three Months Ended September 30, 2014 and 2013

 

 

THREE MONTHS ENDED

 

 

SEPTEMBER 30,

 

(in millions)

2014

 

 

2013

 

Collaboration revenue

$

6.1

 

 

$

3.5

 

Operating expenses:

 

 

 

 

 

 

 

Research and development

 

9.8

 

 

 

8.2

 

General and administrative

 

3.4