e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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 December 31, 2010
or
[ ] TRANSITION REPORT UNDER SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For the transition period from to
Commission File Number: 001-16633
Array BioPharma Inc.
(Exact Name of Registrant as Specified in Its Charter)
|
|
|
Delaware
|
|
84-1460811 |
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
(I.R.S. Employer Identification No.) |
|
|
|
3200 Walnut Street, Boulder, CO
|
|
80301 |
(Address of Principal Executive Offices)
|
|
(Zip Code) |
(303) 381-6600
(Registrants Telephone Number, Including Area Code)
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes x No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files).
Yes o No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large Accelerated Filer o Accelerated Filer x
Non-Accelerated Filer o Smaller Reporting Company o
(do not check if smaller reporting company)
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No x
As of
January 28, 2011, the registrant had 56,110,007 shares of common stock outstanding.
ARRAY BIOPHARMA INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED DECEMBER 31, 2010
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS
ARRAY BIOPHARMA INC.
Condensed Balance Sheets
(Amounts in Thousands, Except Share and Per Share Amounts)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
June 30, |
|
|
2010 |
|
2010 |
|
|
|
|
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
42,191 |
|
|
$ |
32,846 |
|
Marketable securities |
|
|
46,378 |
|
|
|
78,664 |
|
Prepaid expenses and other current assets |
|
|
6,222 |
|
|
|
5,788 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
94,791 |
|
|
|
117,298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term assets |
|
|
|
|
|
|
|
|
Marketable securities |
|
|
10,312 |
|
|
|
17,359 |
|
Property and equipment, net |
|
|
19,592 |
|
|
|
21,413 |
|
Other long-term assets |
|
|
2,822 |
|
|
|
3,109 |
|
|
|
|
|
|
|
|
Total long-term assets |
|
|
32,726 |
|
|
|
41,881 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
127,517 |
|
|
$ |
159,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
3,517 |
|
|
$ |
5,634 |
|
Accrued outsourcing costs |
|
|
4,328 |
|
|
|
4,907 |
|
Accrued compensation and benefits |
|
|
5,631 |
|
|
|
10,013 |
|
Other accrued expenses |
|
|
2,244 |
|
|
|
1,723 |
|
Deferred rent |
|
|
3,256 |
|
|
|
3,180 |
|
Deferred revenue |
|
|
49,645 |
|
|
|
52,474 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
68,621 |
|
|
|
77,931 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities |
|
|
|
|
|
|
|
|
Deferred rent |
|
|
16,639 |
|
|
|
18,301 |
|
Deferred revenue |
|
|
53,882 |
|
|
|
65,177 |
|
Long-term debt, net |
|
|
116,132 |
|
|
|
112,825 |
|
Other long-term liabilities |
|
|
2,885 |
|
|
|
1,623 |
|
|
|
|
|
|
|
|
Total long-term liabilities |
|
|
189,538 |
|
|
|
197,926 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
258,159 |
|
|
|
275,857 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders deficit |
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par value; 10,000,000 shares authorized,
no shares issued or outstanding |
|
|
- |
|
|
|
- |
|
Common stock, $0.001 par value; 120,000,000 shares
authorized; 56,031,369 and 53,224,248 shares
issued and outstanding, as of December 31, 2010 and
June 30, 2010, respectively |
|
|
56 |
|
|
|
53 |
|
Additional paid-in capital |
|
|
342,604 |
|
|
|
332,277 |
|
Warrants |
|
|
36,296 |
|
|
|
36,296 |
|
Accumulated other comprehesive income |
|
|
4,306 |
|
|
|
5,528 |
|
Accumulated deficit |
|
|
(513,904 |
) |
|
|
(490,832 |
) |
|
|
|
|
|
|
|
Total stockholders deficit |
|
|
(130,642 |
) |
|
|
(116,678 |
) |
|
|
|
|
|
|
|
Total liabilities and stockholders deficit |
|
$ |
127,517 |
|
|
$ |
159,179 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed financial statements.
1
ARRAY BIOPHARMA INC.
Condensed Statements of Operations and Comprehensive Loss
(Amounts in Thousands, Except Per Share Data)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
5,370 |
|
|
$ |
4,434 |
|
|
$ |
11,090 |
|
|
$ |
9,478 |
|
License and milestone revenue |
|
|
11,131 |
|
|
|
5,210 |
|
|
|
23,924 |
|
|
|
8,056 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
16,501 |
|
|
|
9,644 |
|
|
|
35,014 |
|
|
|
17,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
7,382 |
|
|
|
5,235 |
|
|
|
14,663 |
|
|
|
11,157 |
|
Research and development for proprietary programs |
|
|
14,482 |
|
|
|
19,104 |
|
|
|
28,337 |
|
|
|
38,305 |
|
General and administrative |
|
|
3,905 |
|
|
|
4,460 |
|
|
|
8,173 |
|
|
|
8,673 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
25,769 |
|
|
|
28,799 |
|
|
|
51,173 |
|
|
|
58,135 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(9,268 |
) |
|
|
(19,155 |
) |
|
|
(16,159 |
) |
|
|
(40,601 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized gains on auction rate securities, net |
|
|
865 |
|
|
|
1,165 |
|
|
|
798 |
|
|
|
948 |
|
Interest income |
|
|
136 |
|
|
|
257 |
|
|
|
356 |
|
|
|
561 |
|
Interest expense |
|
|
(4,175 |
) |
|
|
(4,092 |
) |
|
|
(8,067 |
) |
|
|
(7,534 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expenses, net |
|
|
(3,174 |
) |
|
|
(2,670 |
) |
|
|
(6,913 |
) |
|
|
(6,025 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(12,442 |
) |
|
|
(21,825 |
) |
|
|
(23,072 |
) |
|
|
(46,626 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in unrealized gains and losses on marketable securities |
|
|
(655 |
) |
|
|
93 |
|
|
|
(1,222 |
) |
|
|
1,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(13,097 |
) |
|
$ |
(21,732 |
) |
|
$ |
(24,294 |
) |
|
$ |
(44,638 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding - basic and diluted |
|
|
55,285 |
|
|
|
49,405 |
|
|
|
54,350 |
|
|
|
48,771 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.44 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.96 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed financial statements.
2
ARRAY BIOPHARMA INC.
Condensed Statement of Stockholders Deficit
(Amounts in Thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
|
|
|
|
Other |
|
|
|
|
|
|
|
|
|
Preferred Stock |
|
Common Stock |
|
Paid-in |
|
|
|
|
|
|
Comprehensive |
|
|
Accumulated |
|
|
|
|
|
|
Shares |
|
Amounts |
|
Shares |
|
Amounts |
|
Capital |
|
Warrants |
|
Income |
|
Deficit |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of June 30, 2010 |
|
|
- |
|
|
$ |
- |
|
|
|
53,224 |
|
|
$ |
53 |
|
|
$ |
332,277 |
|
|
$ |
36,296 |
|
|
$ |
5,528 |
|
|
$ |
(490,832 |
) |
|
$ |
(116,678 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock under stock option
and employee stock purchase plans |
|
|
- |
|
|
|
- |
|
|
|
606 |
|
|
|
1 |
|
|
|
1,490 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,491 |
|
Share-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,001 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,001 |
|
Issuance of common stock for cash,
net of offering costs |
|
|
- |
|
|
|
- |
|
|
|
921 |
|
|
|
1 |
|
|
|
2,855 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,856 |
|
Payment of employee bonus with stock |
|
|
- |
|
|
|
- |
|
|
|
1,280 |
|
|
|
1 |
|
|
|
3,981 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,982 |
|
Reclassification of unrealized gain out of accumulated
other comprehensive income to earnings |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,613 |
) |
|
|
- |
|
|
|
(1,613 |
) |
Change in unrealized gain on
marketable securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
391 |
|
|
|
- |
|
|
|
391 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(23,072 |
) |
|
|
(23,072 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2010 |
|
|
- |
|
|
$ |
- |
|
|
|
56,031 |
|
|
$ |
56 |
|
|
$ |
342,604 |
|
|
$ |
36,296 |
|
|
$ |
4,306 |
|
|
$ |
(513,904 |
) |
|
$ |
(130,642 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed financial statements.
3
ARRAY BIOPHARMA INC.
Condensed Statements of Cash Flows
(Amounts in Thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended December 31, |
|
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(23,072 |
) |
|
$ |
(46,626 |
) |
Adjustments to reconcile net loss to net cash (used in)
provided by operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
|
2,944 |
|
|
|
3,285 |
|
Non-cash interest expense for the Deerfield Credit Facility |
|
|
3,315 |
|
|
|
3,363 |
|
Share-based compensation expense |
|
|
2,001 |
|
|
|
2,996 |
|
Realized gains on auction rate securities, net |
|
|
(798 |
) |
|
|
(948 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
(487 |
) |
|
|
805 |
|
Accounts payable and other accrued expenses |
|
|
(1,596 |
) |
|
|
(865 |
) |
Accrued outsourcing costs |
|
|
(579 |
) |
|
|
259 |
|
Accrued compensation and benefits |
|
|
537 |
|
|
|
1,213 |
|
Deferred rent |
|
|
(1,586 |
) |
|
|
(1,514 |
) |
Deferred revenue |
|
|
(14,124 |
) |
|
|
52,823 |
|
Other liabilities |
|
|
1,574 |
|
|
|
- |
|
|
|
|
|
|
|
|
Net cash (used in) provided by operating activities |
|
|
(31,871 |
) |
|
|
14,791 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
Purchases of
property and equipment |
|
|
(1,123 |
) |
|
|
(748 |
) |
Purchases of marketable securities |
|
|
(29,244 |
) |
|
|
- |
|
Proceeds from sales and maturities of marketable securities |
|
|
68,497 |
|
|
|
9,853 |
|
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
38,130 |
|
|
|
9,105 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
Proceeds (exchanges) from exercise of stock options and shares issued
under the employee stock purchase plan |
|
|
230 |
|
|
|
(159 |
) |
Proceeds from the issuance of common stock for cash |
|
|
3,006 |
|
|
|
2,121 |
|
Payment of offering costs |
|
|
(150 |
) |
|
|
(306 |
) |
Proceeds from the issuance of long-term debt and warrants |
|
|
- |
|
|
|
40,000 |
|
Payment of transaction fee |
|
|
- |
|
|
|
(1,000 |
) |
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
3,086 |
|
|
|
40,656 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
9,345 |
|
|
|
64,552 |
|
Cash and cash equivalents as of beginning of period |
|
|
32,846 |
|
|
|
33,202 |
|
|
|
|
|
|
|
|
Cash and cash equivalents as of end of period |
|
$ |
42,191 |
|
|
$ |
97,754 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
4,722 |
|
|
$ |
3,631 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed financial statements.
4
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
NOTE 1 - OVERVIEW AND BASIS OF PRESENTATION
Organization
Array BioPharma Inc. (the Company) is a biopharmaceutical company focused on the discovery,
development and commercialization of targeted small molecule drugs to treat patients afflicted with
cancer and inflammatory diseases. The Companys proprietary drug development pipeline includes
clinical candidates that are designed to regulate therapeutically important target pathways. In
addition, leading pharmaceutical and biotechnology companies partner with the Company to discover
and develop drug candidates across a broad range of therapeutic areas.
Basis of Presentation
The Company follows the accounting guidance outlined in the Financial Accounting Standards Board
Codification. The accompanying unaudited Condensed Financial Statements have been prepared without
audit and do not include all of the disclosures required by the Financial Accounting Standards
Board Codification guidelines, which have been omitted pursuant to the rules and regulations of the
Securities and Exchange Commission (SEC) relating to requirements for interim reporting. The
year-end condensed balance sheet data was derived from audited financial statements but does not
include all disclosures required by accounting principles generally accepted in the United States
(U.S.). The unaudited Condensed Financial Statements reflect all adjustments (consisting only of
normal recurring adjustments) that, in the opinion of management, are necessary to present fairly
the financial position of the Company as of December 31, 2010, its results of operations for the
three and six months ended December 31, 2010 and 2009, and its cash flows for the three and six
months ended December 31, 2010 and 2009. Operating results for the six months ended December 31,
2010 are not necessarily indicative of the results that may be expected for the year ending June
30, 2011.
These unaudited Condensed Financial Statements should be read in conjunction with the Companys
audited Financial Statements and the notes thereto included in the Companys Annual Report on Form
10-K for the year ended June 30, 2010 filed with the SEC on August 12, 2010.
Certain fiscal 2010 amounts have been reclassified to conform to the current year presentation.
Specifically, Derivative Liabilities is now included in Other Long-term Liabilities, in the
accompanying Condensed Balance Sheets. Additionally, all gains and losses related to auction rate
securities in the Condensed Statements of Operations and Comprehensive Income are included in
Realized Gains on Auction Rate Securities, Net, whereas they were previously recorded in Impairment
of Marketable Securities and Interest Income, respectively.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally accepted
in the U.S. requires management to make estimates and assumptions that affect the reported amounts
of assets and liabilities, disclosure of contingent assets and liabilities at the date of the
financial statements, and the reported amounts of revenue and expenses during the reporting period.
Although management bases these estimates on historical data and other assumptions believed to be
reasonable under the circumstances, actual results could differ significantly from these estimates.
The Company believes the accounting estimates having the most significant impact on its financial
statements relate to (i) estimating the periods over which up-front and milestone payments from
collaboration agreements are recognized; (ii) estimating the fair value of the Companys auction
rate securities (ARS); (iii) estimating accrued outsourcing costs for clinical trials and
preclinical testing; and (iv) estimating the fair value of the Companys long-term debt that has
associated warrants and embedded derivatives, and the separate valuation of those warrants and
embedded derivatives.
5
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
Liquidity
The Company has incurred operating losses and has an accumulated deficit as a result of ongoing
research and development spending. As of December 31, 2010, the Company had an accumulated deficit
of $513.9 million. The Company had net losses of $12.4 million and $23.1 million for the three and
six months ended December 31, 2010, respectively, and $77.6 million, $127.8 million and $96.3
million for the fiscal years ended June 30, 2010, 2009 and 2008, respectively.
The Company has historically funded its operations from up-front fees and license and
milestone revenue received under its collaborations and out-licensing transactions, from the
issuance and sale of its equity securities and through debt provided by its credit facilities. For
example, the Company has received $115 million in the last twelve months as follows:
|
|
|
In December 2009, the Company received a $60 million up-front payment from Amgen Inc.
under a Collaboration and License Agreement |
|
|
|
In April 2010, the Company received $45 million in an upfront and milestone payment
under a License Agreement with Novartis Pharmaceutical International Ltd. |
|
|
|
In December 2010, the company received $10 million in a milestone payment under a
License Agreement with Celgene Corporation. |
The recognition of revenue under these agreements is discussed further in Note 4 Deferred
Revenue. However, until the Company can generate sufficient levels of cash from its operations,
which the Company does not expect to achieve in the foreseeable future, the Company will continue
to utilize its existing cash, cash equivalents and marketable securities. The Company believes that
its cash, cash equivalents and marketable securities, excluding the value of the auction rate
securities, or ARS, it holds, will enable it to continue to fund its operations for at least the
next 12 months. There can be no assurance, however, that sufficient funds will continue to be
available to the Company when needed from existing or future collaborations or from the proceeds of
debt or equity financings.
If the Company is unable to obtain additional funding from these or other sources to the extent or
when needed, it may be necessary to significantly reduce its current rate of spending through
reductions in staff and delaying, scaling back, or stopping certain research and development
programs. Insufficient funds may also require the Company to relinquish greater rights to product
candidates at an earlier stage of development or on less favorable terms to it or its stockholders
than the Company would otherwise choose in order to obtain up-front license fees needed to fund its
operations.
Fair Value Measurements
The Companys financial instruments are recognized and measured at fair value in the Companys
financial statements and primarily consist of cash and cash equivalents, marketable securities,
long-term investments, trade receivables and payables, long-term debt, embedded derivatives
associated with the long-term debt and warrants. The Company uses different valuation techniques to
measure the fair value of assets and liabilities, as discussed in more detail below. Fair value is
defined as the price that would be received or paid to sell the financial instruments in an orderly
transaction between market participants at the measurement date. The Company uses a framework for
measuring fair value based on a hierarchy that distinguishes sources of available information used
in fair value measurements and categorizes them into three levels:
|
|
|
Level I: Quoted prices in active markets for identical assets and liabilities. |
|
|
|
Level II: Observable inputs other than quoted prices in active markets for identical
assets and liabilities. |
|
|
|
Level III: Unobservable inputs. |
6
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
The Company discloses assets and liabilities measured at fair value based on their level in the
hierarchy. Considerable judgment is required in interpreting market data to develop estimates of
fair value for assets or liabilities for which there are no quoted prices in active markets, which
include the Companys ARS, warrants issued by the Company in connection with its long-term debt and
the embedded derivatives associated with the long-term debt. The use of different assumptions
and/or estimation methodologies may have a material effect on their estimated fair value.
Accordingly, the fair value estimates disclosed by the Company may not be indicative of the amount
that the Company or holders of the instruments could realize in a current market exchange.
The Company periodically reviews the realizability of each investment when impairment indicators
exist with respect to the investment. If an other-than-temporary impairment of the value of an
investment is deemed to exist, the cost basis of the investment is written down to its then
estimated fair value.
Cash and Cash Equivalents
Cash equivalents consist of short-term, highly liquid financial instruments that are readily
convertible to cash and have maturities of 90 days or less from the date of purchase and may
consist of money market funds, taxable commercial paper, U.S. government agency obligations and
corporate notes and bonds with high credit quality.
Marketable Securities
The Company has designated its marketable securities as of each balance sheet date as
available-for-sale securities and accounts for them at their respective fair values. Marketable
securities are classified as short-term or long-term based on the nature of these securities and
the availability of these securities to meet current operating requirements. Marketable securities
that are readily available for use in current operations are classified as short-term
available-for-sale securities and are reported as a component of current assets in the accompanying
Condensed Balance Sheets. Marketable securities that are not considered available for use in
current operations are classified as long-term available-for-sale securities and are reported as a
component of long-term assets in the accompanying Condensed Balance Sheets.
Securities that are classified as available-for-sale are carried at fair value, including accrued
interest, with temporary unrealized gains and losses reported as a component of Stockholders
Deficit until their disposition. The Company reviews all available-for-sale securities each period
to determine if they remain available-for-sale based on the Companys then current intent and
ability to sell the security if it is required to do so. The amortized cost of debt securities in
this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such
amortization is included in Interest Income in the accompanying Condensed Statements of Operations
and Comprehensive Loss. Realized gains and losses on ARS along with declines in value judged to be
other-than-temporary are reported in Realized Gains on Auction Rate Securities, Net in the
accompanying Condensed Statements of Operations and Comprehensive Loss when recognized. The cost of
securities sold is based on the specific identification method.
Under the fair value hierarchy, the Companys ARS are measured using Level III, or unobservable
inputs, as there is no active market for the securities. The most significant unobservable inputs
used in this method are estimates of the amount of time until a liquidity event will occur and the
discount rate, which incorporates estimates of credit risk and a liquidity premium (discount). Due
to the inherent complexity in valuing these securities, the Company engaged a third-party valuation
firm to perform an independent valuation of the ARS as part of the Companys overall fair value
analysis beginning with the first quarter of fiscal 2009 and continuing through the current
quarter. While the Company believes that the estimates used in the fair value analysis are
reasonable, a change in any of the assumptions underlying these estimates would result in different
fair value estimates for the ARS and could result in additional adjustments to the ARS, either
increasing or further decreasing their value, possibly by material amounts.
See Note 3 Marketable Securities for additional information about the Companys investments in
ARS.
7
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
Property and Equipment
Property and equipment are stated at historical cost less accumulated depreciation and
amortization. Additions and improvements are capitalized. Certain costs to internally develop
software are also capitalized. Maintenance and repairs are expensed as incurred.
Depreciation and amortization are computed on the straight-line method based on the following
estimated useful lives:
|
|
|
Furniture and fixtures
|
|
7 years |
Equipment
|
|
5 years |
Computer hardware and software
|
|
3 years |
The Company depreciates leasehold improvements associated with operating leases on a straight-line
basis over the shorter of the expected useful life of the improvements or the remaining lease term.
The carrying value for property and equipment is reviewed for impairment when events or changes in
circumstances indicate that the book value of the assets may not be recoverable. An impairment loss
would be recognized when estimated undiscounted future cash flows from the use of the asset and its
eventual disposition is less than its carrying amount.
Equity Investment
The Company has entered into one, and may in the future enter into additional, collaboration and
licensing agreements in which it receives an equity interest in consideration for all or a portion
of up-front, license or other fees under the terms of the agreement. The Company reports the value
of equity securities received from non-publicly traded companies in which it does not exercise a
significant controlling interest at cost as Other Long-term Assets in the accompanying Condensed
Balance Sheets. The Company monitors its investment for impairment at least annually and makes
appropriate reductions in the carrying value if it is determined that an impairment has occurred,
based primarily on the financial condition and near term prospects of the issuer.
Accrued Outsourcing Costs
Substantial portions of the Companys preclinical studies and clinical trials are performed by
third-party laboratories, medical centers, contract research organizations and other vendors
(collectively CROs). These CROs generally bill monthly or quarterly for services performed or
bill based upon milestone achievement. For preclinical studies, the Company accrues expenses based
upon estimated percentage of work completed and the contract milestones remaining. For clinical
studies, expenses are accrued based upon the number of patients enrolled and the duration of the
study. The Company monitors patient enrollment, the progress of clinical studies and related
activities to the extent possible through internal reviews of data reported to it by the CROs,
correspondence with the CROs and clinical site visits. The Companys estimates depend on the
timeliness and accuracy of the data provided by its CROs regarding the status of each program and
total program spending. The Company periodically evaluates the estimates to determine if
adjustments are necessary or appropriate based on information it receives.
Deferred Revenue
The Company records amounts received but not earned under its collaboration agreements as Deferred
Revenue, which are then classified as either current or long-term in the accompanying Condensed
Balance Sheets based on the period during which they are expected to be recognized as revenue.
8
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
Long-term Debt and Embedded Derivatives
The terms of the Companys long-term debt are discussed in detail in Note 5 Long-term Debt. The
accounting for these arrangements is complex and is based upon significant estimates by management.
The Company reviews all debt agreements to determine the appropriate accounting treatment when the
agreement is entered into and reviews all amendments to determine if the changes require accounting
for the amendment as a modification, or as an extinguishment and new debt. The Company also reviews
each long-term debt arrangement to determine if any feature of the debt requires bifurcation and/or
separate valuation. These features include hybrid instruments, which are comprised of at least two
components ((1) a debt host instrument and (2) one or more conversion features), warrants and other
embedded derivatives, such as puts and other rights of the debt holder.
The Company currently has two embedded derivatives related to its long-term debt with Deerfield
Private Design Fund, L.P. and Deerfield Private Design International Fund, L.P. (who are referred
to collectively as Deerfield), that were valued at $493 thousand and $825 thousand at December 31,
2010 and June 30, 2009, respectively and included in Other
Long-term Liabilities in the accompanying
Condensed Balance Sheets. The first is a variable interest rate structure that constitutes a
liquidity-linked variable spread feature. The second derivative is a significant transaction
contingent put option relating to Deerfields ability to accelerate the repayment of the debt in
the event of certain changes in control of the Company. Such event would occur if the acquirer did
not meet certain financial conditions, based on size and credit worthiness. Collectively, they are
referred to as the Embedded Derivatives. Under the fair value hierarchy, the Companys Embedded
Derivatives are measured using Level III, or unobservable inputs, as there is no active market for
them. The fair value of the variable interest rate structure is based on the Companys estimate of
the probable effective interest rate over the term of the Deerfield credit facilities. The fair
value of the put option is based on the Companys estimate of the probability that a change in
control that triggers Deerfields right to accelerate the debt will occur. With those inputs, the
fair value of each Embedded Derivative is calculated as the difference between the fair value of
the Deerfield credit facilities if the Embedded Derivatives are included and the fair value of the
Deerfield credit facilities if the Embedded Derivatives are excluded. Due to the inherent
complexity in valuing the Deerfield credit facilities and the Embedded Derivatives, the Company
engaged a third-party valuation firm to perform the valuation as part of its overall fair value
analysis as of July 31, 2009, the date the funds were disbursed under the credit facility entered
into in May 2009 and for each subsequent quarter end through the current quarter end. The estimated
fair value of the Embedded Derivatives was determined based on managements judgment and
assumptions and the use of different assumptions could result in significantly different estimated
fair values.
The initial fair value of the Embedded Derivatives was recorded as Derivative Liabilities and as
Debt Discount in the Companys Condensed Balance Sheets. Any change in the value of the Embedded
Derivatives is adjusted quarterly as appropriate and recorded to Derivative Liabilities in the
Condensed Balance Sheets and Interest Expense in the accompanying Condensed Statements of
Operations and Comprehensive Loss. The Debt Discount is being amortized from the draw date of July
31, 2009 to the end of the term of the Deerfield credit facilities using the effective interest
method and recorded as Interest Expense in the accompanying Condensed Statements of Operations and
Comprehensive Loss.
Warrants that the Company issues in connection with its long-term debt arrangements are reviewed to
determine if they should be classified as liabilities or as equity. All outstanding warrants issued
by the Company have been classified as equity. The Company values the warrants at issuance based on
a Black-Scholes option pricing model and then allocates a portion of the proceeds under the debt to
the warrants based upon their relative fair values.
Any transaction fees paid in connection with our long-term debt arrangements that qualify for
capitalization are recorded as Other Long-Term Assets in the Condensed Balance Sheets and amortized
to Interest Expense in the accompanying Condensed Statements of Operations and Comprehensive Loss
using the effective interest method over the term of the underlying debt agreement.
9
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
Income Taxes
The Company accounts for income taxes using the asset and liability method. The Company recognizes
the amount of income taxes payable or refundable for the year as well as deferred tax assets and
liabilities. Deferred tax assets and liabilities are determined based on the difference between the
financial statement carrying value and the tax basis of assets and liabilities and, using enacted
tax rates in effect for the year, reflect the expected effect these differences would have on
taxable income. Valuation allowances are recorded to reduce the amount of deferred tax assets when,
based upon available objective evidence, the expected reversal of temporary differences and
projections of future taxable income, management cannot conclude it is more likely than not that
some or all of the deferred tax assets will be realized.
Operating Leases
The Company has negotiated certain landlord/tenant incentives and rent holidays and escalations in
the base price of rent payments under its operating leases. For purposes of determining the period
over which these amounts are recognized or amortized, the initial term of an operating lease
includes the build-out period of leases, where no rent payments are typically due under the terms
of the lease and includes additional terms pursuant to any options to extend the initial term if it
is more likely than not that the Company will exercise such options. The Company recognizes rent
holidays and rent escalations on a straight-line basis over the initial lease term. The
landlord/tenant incentives are recorded as an increase to Deferred Rent in the accompanying
Condensed Balance Sheets and amortized on a straight-line basis over the initial lease term. The
Company has also entered into two sale-lease back transactions for its facilities in Boulder and
Longmont, Colorado, where the consideration received from the landlord is recorded as increases to
Deferred Rent in the accompanying Condensed Balance Sheets and amortized on a straight-line basis
over the lease term. Deferred Rent balances are classified as short-term or long-term in the
accompanying Condensed Balance Sheets based upon the period when reversal of the liability is
expected to occur.
Share-Based Compensation
The Company uses the fair value method of accounting for share-based compensation arrangements,
which requires that compensation expense be recognized based on the grant date fair value of the
arrangement. Share-based compensation arrangements include stock options granted under the
Companys Amended and Restated Stock Option and Incentive Plan (the Option Plan) and purchases of
common stock by its employees at a discount to the market price under the Companys Employee Stock
Purchase Plan (the ESPP).
The estimated grant date fair value of stock options is based on a Black-Scholes option pricing
model and is expensed on a straight-line basis over the vesting term. Compensation expense for
stock options is reduced for estimated forfeitures, which are estimated at the time of grant and
revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Compensation expense for purchases under the ESPP is recognized based on a Black-Scholes option
pricing model that incorporates the estimated fair value of the common stock during each offering
period and the percentage of the purchase discount.
Revenue Recognition
Most of the Companys revenue is from the Companys collaborators for research funding, up-front or
license fees and milestone payments derived from discovering and developing drug candidates. The
Companys agreements with collaboration partners include fees based on contracted annual rates for
full-time-equivalent employees working on a program and may also include non-refundable license and
up-front fees, non-refundable milestone payments that are triggered upon achievement of specific
research or development goals and future royalties on sales of products that result from the
collaboration. A small portion of the Companys revenue comes from the sale of compounds on a
per-compound basis. The Company reports revenue for discovery and the co-development of proprietary
drug candidates that the Company out-licenses as Collaboration Revenue. License and Milestone Revenue is combined and
10
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
consists of up-front fees and ongoing milestone payments from collaborators that are recognized
during the applicable period.
The Company recognizes revenue in accordance with Staff Accounting Bulletin No. 104, Revenue
Recognition (SAB 104), which establishes four criteria, each of which must be met, in order to
recognize revenue for the performance of services or the shipment of products. Revenue is
recognized when (a) persuasive evidence of an arrangement exists, (b) products are delivered or
services are rendered, (c) the sales price is fixed or determinable and (d) collectability is
reasonably assured.
Collaboration agreements that include a combination of discovery research funding, up-front or
license fees, milestone payments and/or royalties are evaluated to determine whether each
deliverable under the agreement has value to the customer on a stand-alone basis and whether
reliable evidence of fair value for the deliverable exists. Deliverables in an arrangement that do
not meet the separation criteria are treated as a single unit of accounting, generally applying
applicable revenue recognition guidance for the final deliverable to the combined unit of
accounting in accordance with SAB 104.
The Company recognizes revenue from non-refundable up-front payments and license fees on a
straight-line basis over the term of performance under the agreement, which is generally the
estimated research or development term. These advance payments are deferred and recorded as
Deferred Revenue upon receipt, pending recognition, and are classified as a short-term or long-term
liability in the accompanying Condensed Balance Sheets.
When the performance period is not specifically identifiable from the agreement, the Company
estimates the performance period based upon provisions contained within the agreement, such as the
duration of the research or development term, the existence, or likelihood of achievement of
development commitments and any other significant commitments of the Company.
The Company also has agreements that provide for milestone payments. In certain cases, a portion of
each milestone payment is recognized as revenue when the specific milestone is achieved based on
the applicable percentage of the estimated research or development term that has elapsed to the
total estimated research and/or development term. In other cases, when the milestone payment
finances the future development obligations of the Company, the revenue is recognized on a
straight-line basis over the estimated remaining development period. Certain milestone payments are
for activities for which there are no future obligations and as a result, are recognized when
earned in their entirety.
The Company periodically reviews the expected performance periods under each of its agreements that
provide for non-refundable up-front payments and license fees and milestone payments and adjusts
the amortization periods when appropriate to reflect changes in assumptions relating to the
duration of expected performance periods. Revenue recognition for non-refundable license fees and
up-front payments and milestone payments could be accelerated in the event of early termination of
programs or alternatively, decelerated, if programs are extended. As such, while changes to
such estimates have no impact on its reported cash flows, the Companys reported revenue is
significantly influenced by its estimates of the period over which its obligations are expected to
be performed.
Cost of Revenue and Research and Development for Proprietary Programs
The Company incurs costs in connection with performing research and development activities which
consist mainly of compensation, associated fringe benefits, share-based compensation, preclinical
and clinical outsourcing costs and other collaboration-related costs, including supplies, small
tools, facilities, depreciation, recruiting and relocation costs and other direct and indirect
chemical handling and laboratory support costs. The Company allocates these costs between Cost of
Revenue and Research and Development for Proprietary Programs based upon the respective time spent
by its scientists on development conducted for its collaborators and for its internal proprietary
programs. Cost of Revenue represents the costs associated with research and development, including
preclinical and clinical trials, conducted by the Company for its collaborators. Research and Development for Proprietary Programs
11
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
consists of direct and indirect costs for the Companys specific proprietary programs. The Company
does not bear any risk of failure for performing these activities and the payments are not
contingent on the success or failure of the research program. Accordingly, the Company expenses
these costs when incurred.
Where the Companys collaboration agreements provide for it to conduct research and development and
for which the Companys partner has an option to obtain the right to conduct further development
and to commercialize a product, the Company attributes a portion of its research and development
costs to Cost of Revenue based on the percentage of total programs under the agreement that the
Company concludes is likely to be selected by the partner. These costs may not be incurred equally
across all programs. In addition, the Company continually evaluates the progress of development
activities under these agreements and if events or circumstances change in future periods that the
Company reasonably believes would make it unlikely that a collaborator would exercise an option
with respect to the same percentage of programs, the Company will adjust the allocation
accordingly. See Note 4 Deferred Revenue, for further information about the Companys
collaborations.
Net Loss per Share
Basic net loss per share is computed by dividing net loss for the period by the weighted average
number of common shares outstanding during the period. Diluted net loss per share reflects the
additional dilution from potential issuances of common stock, such as stock issuable pursuant to
the exercise of stock options and warrants issued related to the Companys long-term debt. The
treasury stock method is used to calculate the potential dilutive effect of these common stock
equivalents. Potentially dilutive shares are excluded from the computation of diluted net loss per
share when their effect is anti-dilutive. As a result of the Companys net losses through the date
of these Financial Statements, all potentially dilutive securities were anti-dilutive and therefore
have been excluded from the computation of diluted net loss per share.
Comprehensive Income (Loss)
The Companys comprehensive income (loss) consists of the Companys net losses and adjustments to
unrealized gains and losses on investments in available-for-sale marketable securities. The Company
had no other sources of comprehensive income (loss) for the periods presented.
NOTE 2 SEGMENTS, GEOGRAPHIC INFORMATION AND SIGNIFICANT COLLABORATORS
Segments
All operations of the Company are considered to be in one operating segment and, accordingly, no
segment disclosures have been presented. The physical location of all of the Companys equipment,
leasehold improvements and other fixed assets is within the U.S.
12
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
Geographic Information
All of the Companys collaboration agreements are denominated in U.S. dollars. The following table
details revenue from collaborators by geographic area based on the country in which collaborators
are located or the ship-to destination for the compounds (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America |
|
$ |
13,149 |
|
|
$ |
9,543 |
|
|
$ |
28,829 |
|
|
$ |
17,396 |
|
Europe |
|
|
3,345 |
|
|
|
86 |
|
|
|
6,174 |
|
|
|
109 |
|
Asia Pacific |
|
|
7 |
|
|
|
15 |
|
|
|
11 |
|
|
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
16,501 |
|
|
$ |
9,644 |
|
|
$ |
35,014 |
|
|
$ |
17,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Significant Collaborators
The following collaborators contributed greater than 10% of total revenue during the periods set
forth below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amgen, Inc. |
|
|
39% |
|
|
|
9% |
|
|
|
39% |
|
|
|
5% |
|
Genentech, Inc. |
|
|
21% |
|
|
|
46% |
|
|
|
22% |
|
|
|
54% |
|
Celgene Corporation |
|
|
19% |
|
|
|
43% |
|
|
|
21% |
|
|
|
33% |
|
Novartis
International
Pharmaceutical Ltd. |
|
|
20% |
|
|
|
- |
|
|
|
18% |
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99% |
|
|
|
98% |
|
|
|
100% |
|
|
|
92% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The loss of one or more significant collaborators could have a material adverse effect on the
Companys business, operating results or financial condition. The Company does not require
collateral to secure the payment obligations of its collaborators. Although the Company is impacted
by economic conditions in the biotechnology and pharmaceutical sectors, most collaborators pay in
advance and management does not believe significant credit risk exists in its recorded accounts
receivable as of December 31, 2010.
13
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
NOTE 3 MARKETABLE SECURITIES
Marketable securities consisted of the following as of December 31, 2010 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government agency securities |
|
|
46,040 |
|
|
|
- |
|
|
|
(2 |
) |
|
|
46,038 |
|
Mutual fund securities |
|
|
340 |
|
|
|
- |
|
|
|
- |
|
|
|
340 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
46,380 |
|
|
|
- |
|
|
|
(2 |
) |
|
|
46,378 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
|
5,185 |
|
|
|
4,308 |
|
|
|
- |
|
|
|
9,493 |
|
Mutual fund securities |
|
|
819 |
|
|
|
- |
|
|
|
- |
|
|
|
819 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
6,004 |
|
|
|
4,308 |
|
|
|
- |
|
|
|
10,312 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
52,384 |
|
|
$ |
4,308 |
|
|
$ |
(2 |
) |
|
$ |
56,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities consisted of the following as of June 30, 2010 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government agency securities |
|
$ |
78,653 |
|
|
$ |
- |
|
|
$ |
(5 |
) |
|
$ |
78,648 |
|
Mutual fund securities |
|
|
16 |
|
|
|
- |
|
|
|
- |
|
|
|
16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
78,669 |
|
|
|
- |
|
|
|
(5 |
) |
|
|
78,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
|
11,027 |
|
|
|
5,533 |
|
|
|
- |
|
|
|
16,560 |
|
Mutual fund securities |
|
|
799 |
|
|
|
- |
|
|
|
- |
|
|
|
799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
11,826 |
|
|
|
5,533 |
|
|
|
- |
|
|
|
17,359 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
90,495 |
|
|
$ |
5,533 |
|
|
$ |
(5 |
) |
|
$ |
96,023 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
estimated fair values of these marketable securities were classified into the following fair
value measurement categories (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
June 30, |
|
|
|
2010 |
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
Quoted prices in active markets for
identical assets (Level 1) |
|
$ |
47,197 |
|
|
$ |
79,463 |
|
Significant unobservable inputs (Level 3) |
|
|
9,493 |
|
|
|
16,560 |
|
|
|
|
|
|
|
|
|
$ |
56,690 |
|
|
$ |
96,023 |
|
|
|
|
|
|
|
|
14
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
The amortized cost and estimated fair value of available-for-sale securities by contractual
maturity as of December 31, 2010 was as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
46,380 |
|
|
$ |
46,378 |
|
Due in one year to three years |
|
|
819 |
|
|
|
819 |
|
Due after 10 years or more |
|
|
5,185 |
|
|
|
9,493 |
|
|
|
|
|
|
|
|
|
|
$ |
52,384 |
|
|
$ |
56,690 |
|
|
|
|
|
|
|
|
Auction Rate Securities
The Company is currently unable to readily liquidate its ARS. Since fiscal 2008, the auctions for
all of the ARS were unsuccessful. The lack of successful auctions resulted in the interest rate on
these investments increasing to LIBOR plus additional basis points as stipulated in the auction
rate agreements, ranging from 200 to 350 additional basis points, which has continued from the time
the auctions failed through the current quarter end. While the Company now earns a higher
contractual interest rate on these investments, the investments may not be liquid at a time when
the Company needs to access these funds. In the event the Company needs to access these funds and
liquidate the ARS prior to the time auctions of these investments are successful or the date on
which the original issuers retire these securities, the Company may be required to sell them in a
distressed sale in a secondary market, most likely for a lower value than their current estimated
fair value.
As of December 31, 2010, the Company held two securities with a par value of $12.3 million, a cost
basis of $5.2 million and an estimated fair value of $9.5 million. As of June 30, 2010, the
Company held five securities with a par value of $26.3 million, a cost basis of $11.0 million and
an estimated fair value of $16.6 million.
Under the fair value hierarchy, the Companys ARS are measured using Level III, or unobservable
inputs, as there is no active market for the securities. The most significant unobservable inputs
used in this method are the estimates of the amount of time until a liquidity event will occur and
the discount rate, which incorporates estimates of credit risk and a liquidity premium (discount).
Due to the inherent complexity in valuing these securities, the Company engaged a third-party
valuation firm to perform an independent valuation of the ARS as part of its overall fair value
analysis beginning with the first quarter of fiscal 2009 and continuing through the current
quarter.
While the Company believes that the estimates used in the fair value analysis are reasonable, a
change in any of the assumptions underlying these estimates would result in different fair value
estimates for the ARS and could result in additional changes to the ARS values, either increasing
or decreasing their value by a potentially material amount.
15
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
Based on its fair value analysis and fair value estimates as of each quarter end, the Company
recorded adjustments to the fair value of its ARS that are summarized below (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, |
|
December 31, |
|
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
$ |
746 |
|
|
$ |
506 |
|
|
$ |
746 |
|
|
$ |
2,402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized losses |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(358 |
) |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impairment losses |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(217 |
) |
Net unrealized gains reclassified from equity to earnings upon sale |
|
|
1,393 |
|
|
|
391 |
|
|
|
1,613 |
|
|
|
391 |
|
Additional gains (losses) incurred upon sale, net |
|
|
(528 |
) |
|
|
774 |
|
|
|
(815 |
) |
|
|
774 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized gains on auction rate securities, net |
|
$ |
865 |
|
|
$ |
1,165 |
|
|
$ |
798 |
|
|
$ |
948 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A rollforward of adjustments to the fair value of the ARS follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
December 31, |
|
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
Balance as of prior year end |
|
$ |
16,560 |
|
|
$ |
16,518 |
|
Unrealized gains |
|
|
746 |
|
|
|
2,402 |
|
Unrealized losses |
|
|
(358 |
) |
|
|
- |
|
Sale of ARS at sale price |
|
|
(6,640 |
) |
|
|
(2,848 |
) |
Impairment losses |
|
|
- |
|
|
|
(217 |
) |
Additional gains
(losses) incurred upon
sale, net |
|
|
(815 |
) |
|
|
774 |
|
|
|
|
|
|
|
|
Balance as of current quarter end |
|
$ |
9,493 |
|
|
$ |
16,629 |
|
|
|
|
|
|
|
|
NOTE 4 DEFERRED REVENUE
Deferred revenue consisted of the following (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
June 30, |
|
|
2010 |
|
2010 |
|
|
|
|
|
|
|
|
|
Amgen, Inc. |
|
$ |
40,611 |
|
|
$ |
50,595 |
|
Novartis International Pharmaceutical Ltd. |
|
|
37,156 |
|
|
|
42,781 |
|
Celgene Corporation |
|
|
23,207 |
|
|
|
20,492 |
|
Genentech, Inc. |
|
|
2,553 |
|
|
|
3,783 |
|
|
|
|
|
|
|
|
Total deferred revenue |
|
|
103,527 |
|
|
|
117,651 |
|
Less: Current portion |
|
|
(49,645 |
) |
|
|
(52,474 |
) |
|
|
|
|
|
|
|
Deferred revenue, long term |
|
$ |
53,882 |
|
|
$ |
65,177 |
|
|
|
|
|
|
|
|
16
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
Amgen Inc.
In December 2009, the Company granted Amgen the exclusive worldwide right to develop and
commercialize the Companys small molecule glucokinase activator, AMG 151/ARRY-403. Under the
Collaboration and License Agreement, the Company is responsible for completing Phase 1 clinical
trials on AMG 151. The Company will also conduct further research funded by Amgen to create second
generation glucokinase activators. Amgen is responsible for further development and
commercialization of AMG 151 and any resulting second generation compounds. The agreement also
provides the Company with an option to co-promote any approved drugs with Amgen in the U.S. with
certain limitations.
In partial consideration for the rights granted to Amgen under the agreement, Amgen paid the
Company an up-front fee of $60 million in December 2009. Amgen will also pay the Company for
research on second generation compounds based on the number of full-time-equivalent scientists
working on the discovery program.
The Company is also entitled to receive up to approximately $666 million in aggregate milestone
payments if all clinical and commercialization milestones specified in the agreement for AMG 151
and at least one backup compound are achieved. The Company will also receive royalties on sales of
any approved drugs developed under the agreement.
The Company estimates that its obligations under the agreement will continue until December 31,
2012 and, therefore, is recognizing the up-front fee on a straight-line basis from the date the
agreement was signed on December 13, 2009 through that time. The Company recognized $4.9 million
and $9.8 million of revenue under the agreement for the three and six months ended December 31,
2010, which is recorded in License and Milestone Revenue in the accompanying Condensed Statements
of Operations and Comprehensive Loss. The Company recognized $903
thousand in License and Milestone Revenue for both the three and six
months ended December 31, 2009.
The
Company recognized $1.3 million and $2.4 million of revenue for the three and six months ended
December 31, 2010, respectively, for research performed by its full-time-equivalent scientists
working on the discovery program, which is recorded in Collaboration Revenue in the accompanying
Condensed Statements of Operations and Comprehensive Loss.
During the three and six months ended December 31, 2010, the Company recognized $178 thousand and
$1.4 million, respectively, in collaboration Revenue and Cost of
Sales for the reimbursement of certain development
activities, in the
accompanying Condensed Statements of Operations and Comprehensive Loss.
Either party may terminate the agreement in the event of a material breach of a material obligation
under the agreement by the other party upon 90 days prior notice and Amgen may terminate the
agreement at any time upon notice of 60 or 90 days depending on the development activities going on
at the time of such notice. The parties have also agreed to indemnify each other for certain
liabilities arising under the agreement.
Novartis International Pharmaceutical Ltd.
The Company and Novartis International Pharmaceutical Ltd. entered into a License Agreement in
April 2010 granting Novartis the exclusive worldwide right to co-develop and commercialize
MEK162/ARRY-162, as well as other specified MEK inhibitors. Under the agreement, the Company is
responsible for completing the on-going Phase 1b expansion trial of MEK162 in patients with KRAS or
BRAF mutant colorectal cancer and for the further development of MEK162 for up to two indications.
Novartis is responsible for all other development activities and for the commercialization of
products under the agreement, subject to the Companys option to co-detail approved drugs in the
U.S.
In consideration for the rights granted to Novartis under the agreement, the Company received $45
million, comprising an upfront and milestone payment, in the fourth quarter of fiscal 2010, and is
also
17
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
entitled to receive up to approximately $422 million in aggregate milestone payments if all
clinical, regulatory and commercial milestones specified in the agreement are achieved. Novartis
will also pay the Company royalties on worldwide sales of any approved drugs, with royalties on
U.S. sales at a significantly higher level, assuming the Company continues to co-develop as
described below.
The Company estimates that its obligations under the agreement will continue until April 2014 and,
therefore, is recognizing the up-front fee and first milestone payment on a straight-line basis
from the date the agreement was signed in April 2010 through that time. The Company recognized $2.8
million and $5.6 million of revenue for the three and six months ended December 31, 2010,
respectively,which is recorded in License and Milestone Revenue in the accompanying Condensed
Statements of Operations and Comprehensive Loss.
The agreement contains co-development rights whereby the Company can elect to pay a percentage
share of the combined total development costs. During the first two years of the co-development
period, Novartis will reimburse the Company for 100% of the Companys development costs. Beginning
in year three, the Company will begin paying its percentage share of the combined development
costs, up to a maximum amount with annual caps, unless it opts out of paying its percentage share
of these costs. If the Company opts out of paying its share of combined developments costs with
respect to one or more products, the U.S. royalty rate would then be reduced for any such product
based on a specified formula, subject to a minimum that equals the royalty rate on sales outside
the U.S., and the Company would no longer have the right to develop or detail such product.
The Company is recording a receivable in the accompanying Condensed Balance Sheets for the amounts
due from Novartis for the reimbursement of the Companys development costs. The Company is
accruing its percentage share of the combined development costs in the accompanying Condensed
Balance Sheets as an Other Long-term Liability, on the basis of the Companys intention to begin
paying such amounts to Novartis beginning in year three of the co-development period.
The
Company incurred development costs of $1.7 million and $3.8 million during the three and six
months ended December 31, 2010, respectively and has recorded a corresponding receivable in Prepaid
and Other Current Assets in the accompanying Condensed Balance Sheets for the amounts due for the
current quarter ended December 31, 2010 of $1.7 million. The Companys share of the combined
development costs was $850 thousand and $1.6 million during the three and six months ended December
31, 2010, respectively,which is recorded in Cost of Sales in the accompanying Condensed Statements
of Operations and Comprehensive Loss and Other Long-Term Liabilities in the accompanying Condensed
Balance Sheets.
The agreement will be in effect on a product-by-product and county-by-country basis until no
further payments are due with respect to the applicable product in the applicable country, unless
terminated earlier. Either party may terminate the agreement in the event of an uncured material
breach of a material obligation under the agreement by the other party upon 90 days prior notice.
Novartis may terminate portions of the agreement following a change in control of the Company and
may terminate the agreement in its entirety or on a product-by-product basis with 180 days prior
notice. The Company and Novartis have each further agreed to indemnify the other party for
manufacturing or commercialization activities conducted by it under the agreement, negligence or
willful misconduct or breach of covenants, warranties or representations made by it under the
agreement.
Celgene Corporation
In September 2007, the Company entered into a worldwide strategic collaboration with Celgene
focused on the discovery, development and commercialization of novel therapeutics in cancer and
inflammation. Under the agreement, Celgene made an up-front payment of $40 million to the Company
to provide research funding for activities conducted by the Company. The Company is responsible for
all discovery development through Phase 1 or Phase 2a. Celgene has an option to select a limited
number of drugs developed under the collaboration that are directed to up to two of four mutually
selected discovery
18
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
targets and will receive exclusive worldwide rights to the drugs, except for limited co-promotional
rights in the U.S. The Company retains all rights to the programs for which Celgene does not
exercise its option.
In June 2009, the parties amended the agreement to substitute a new discovery target in place of an
existing target and Celgene paid the Company $4.5 million in consideration for the amendment. No
other terms of the agreement with Celgene were modified by the amendment. The option term of this
target will expire on or before June 2016, and the option term for the other targets will expire on
the earlier of completion of Phase 1 or Phase 2a trials for the applicable drug or September 2014.
In September 2009, Celgene notified the Company it was waiving its rights to one of the four
discovery targets under the collaboration, leaving it the option to select two of the remaining
three targets.
The Company is entitled to receive, for each drug for which Celgene exercises an option, potential
milestone payments of $200 million, if certain discovery, development and regulatory milestones are
achieved and an additional $300 million if certain commercial milestones are achieved. In November
2010, the Company earned and subsequently received a $10 million
milestone payment upon securing an
IND for one of the programs. The Company is also entitled to receive royalties on net sales of any
drugs.
Upon execution of the agreement, the Company estimated that its discovery obligations under the
agreement would continue through September 2014 and accordingly was recognizing as revenue the
up-front fees received from the date of receipt through September 2014. Effective October 1, 2009,
the Company estimated that its discovery efforts under the agreement will conclude by September
2011. Therefore, the unamortized balance as of December 31, 2009 was amortized on a straight line
basis over the shorter period. Effective October 1, 2010, the Company estimated that its discovery
efforts under the agreement will conclude by March 2012. Therefore, the unamortized balance as of
September 30, 2010 is being amortized on a straight line basis over the longer period.
The Company estimated its development obligations related to the $10 million milestone would
continue through May 2013.
The Company recognized License and Milestone Revenue under the Celgene agreement of $3.2 million
and $4.1 million for the three months ended December 31, 2010 and 2009, respectively, and $7.3
million and $5.7 million for the six months ended December 31, 2010 and 2009, respectively.
As discussed above, the Company granted Celgene Corporation an option to select up to two of four
programs developed under its collaboration agreement and concluded that Celgene was likely to
exercise its option with respect to two of the four programs. Accordingly, upon execution of the
agreement, the Company began reporting costs associated with the Celgene collaboration as follows:
50% to Cost of Revenue, with the remaining 50% to Research and Development for Proprietary
Programs. Celgene waived its rights with respect to one of the programs during the second quarter
of fiscal 2010, at which time management determined that Celgene is likely to exercise its option
to license one of the remaining three programs. Accordingly, beginning October 1, 2009, the Company
began reporting costs associated with the Celgene collaboration as follows: 33.3% to Cost of
Revenue, with the remaining 66.7% to Research and Development for Proprietary Programs. In the
second quarter of fiscal 2011, the Company concluded that Celgene is likely to exercise its option
to license two of the remaining three programs. Accordingly, beginning October 1, 2010, the Company
began reporting costs associated with the Celgene collaboration as follows: 66.7% to Cost of
Revenue, with the remaining 33.3% to Research and Development for Proprietary Programs.
Celgene can terminate any drug development program for which it has not exercised an option at any
time, provided that it must give the Company prior notice. In this event, all rights to the program
remain with the Company and it would no longer be entitled to receive milestone payments for
further development or regulatory milestones that it could have achieved had Celgene continued
development of the program. Celgene may terminate the agreement in whole, or in part with respect
to individual drug development programs for which Celgene has exercised an option, upon six months
written notice to the
19
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
Company. In addition, either party may terminate the agreement, following certain cure periods, in
the event of a breach by the other party of its obligations under the agreement.
NOTE 5 LONG-TERM DEBT
Long-term debt consists of the following (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
June 30, |
|
|
2010 |
|
2010 |
|
|
|
|
|
|
|
|
|
Credit Facilities |
|
$ |
126,762 |
|
|
$ |
126,762 |
|
Refinance Term Loan |
|
|
15,000 |
|
|
|
15,000 |
|
|
|
|
|
|
|
|
Long-term debt, gross |
|
|
141,762 |
|
|
|
141,762 |
|
Less: Unamortized discount on credit facility |
|
|
(25,630 |
) |
|
|
(28,937 |
) |
|
|
|
|
|
|
|
Long-term debt, net |
|
$ |
116,132 |
|
|
$ |
112,825 |
|
|
|
|
|
|
|
|
Deerfield Credit Facilities
The Company has entered into two credit facilities (the Credit Facilities) with Deerfield Private
Design Fund, L.P. and Deerfield Private Design International Fund, L.P. (collectively Deerfield),
health care investment funds. Under a Facility Agreement entered into with Deerfield in April 2008,
the Company borrowed a total of $80 million (the 2008 Loan), which was funded in two $40 million
payments in June 2008 and December 2008. Certain terms of the 2008 Credit Facility, including the
interest rate and payment terms applicable to the 2008 Loan and covenants relating to minimum cash
and cash equivalent balances the Company must maintain, were amended in May 2009 when the Company
entered into a new Facility Agreement with Deerfield. Under this Facility Agreement, the Company
borrowed $40 million (the 2009 Loan), which it drew down on July 31, 2009.
Accrued interest on the Credit Facilities is payable monthly and the outstanding principal and
any unpaid accrued interest is due on or before April 2014. Interest and principal may be repaid,
at the Companys option, at any time with shares of the Companys common stock that have been
registered under the Securities Act of 1933, as amended, with certain restrictions, or in cash. The
maximum number of shares that the Company can issue to Deerfield under the Credit Facilities
without obtaining stockholder approval is 9,622,220 shares.
Prior to the disbursement of the 2009 Loan, simple interest was at a 2% annual rate and
compound interest accrued at an additional 6.5% annual rate on the $80 million principal balance
from the date of the Facility Agreement for the 2008 Loan through the July 31, 2009 disbursement
date of the 2009 Loan. During this period, simple interest on the 2008 Loan was payable quarterly.
The Company made these
quarterly interest payments during fiscal 2009 and the first quarter of fiscal 2010. The interest
rate on the 2008 Loan was reduced upon disbursement of the 2009 Loan on July 31, 2009 to 7.5% per
annum, subject to adjustment as described below, and became payable monthly. Compound interest
stopped accruing on the 2008 Loan as of July 31, 2009.
The reduced 7.5% interest rate will continue to apply as long as the Companys total Cash and
Cash Equivalents and Marketable Securities on the first business day of each month during which
such principal amounts remain outstanding is at least $60 million. If the Companys total Cash and
Cash Equivalents and Marketable Securities in any month are less than $60 million, the interest
rate is adjusted to a rate between 8.5% per annum and 14.5% per annum for every $10 million by
which it is less than $60 million as follows:
20
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
|
|
|
|
|
|
|
Applied Interest |
|
Total Cash, Cash Equivalents and Marketable Securities |
|
Rate |
|
|
|
|
|
$60 million or greater |
|
|
7.5% |
|
Between $50 million and $60 million |
|
|
8.5% |
|
Between $40 million and $50 million |
|
|
9.5% |
|
Between $30 million and $40 million |
|
|
12.0% |
|
Less than $30 million |
|
|
14.5% |
|
The Credit Facilities contain two embedded derivatives: (1) the variable interest rate structure
described above and (2) Deerfields right to accelerate the loan upon certain changes of control of
the Company or an event of default, which is considered a significant transaction contingent put
option. As discussed in Note 1 Overview and Basis of Presentation under the caption Long-term
Debt and Embedded Derivatives, these derivatives must be valued and reported separately in the
Companys financial statements and are collectively referred to as the Embedded Derivatives.
Under the fair value hierarchy, the Company measured the fair value of the Embedded Derivatives
using Level III, or unobservable inputs.
In order to estimate fair value of the variable interest rate feature, the Company makes
assumptions as to interest rates that may be in effect during the term and the impact of repaying
the debt at maturity in cash and/or stock. Because the variable interest rate feature is tied to
the Companys cash and cash equivalent balances during the term of the Credit Facilities, the
Company is required to project its cash balances over this period, including forecasted up-front
revenue from new collaboration arrangements, milestone payments, other revenue, funds to be
provided from issuances of debt and/or equity, costs and expenses and other items. Such forecasts
are inherently subjective and, although management believes the assumptions upon which they are
based are reasonable, may not reflect actual results.
In order to estimate the fair value of the put right, the Company estimates the probability of
a change in control that would trigger Deerfields acceleration rights as specified in the loan
provisions. Such event would occur if the acquirer did not meet certain financial conditions, based
on size and credit worthiness. The Companys evaluation of this probability is based on its
expectations as to the size and financial strength of probable acquirers, including history of
collaboration partners, the probability of an acquisition occurring during the term of the Credit
Facilities and other factors, all of which are inherently uncertain and difficult to predict.
Based on these assumptions, the Embedded Derivatives were initially valued as of July 31, 2009 at
$1.1 million and recorded as Derivative Liabilities and as Debt Discount in the accompanying
Condensed Balance Sheets. The estimated fair value of the Embedded Derivatives based on these
assumptions was determined to be $493 thousand and $825 thousand as of December 31, 2010 and June
30, 2010, respectively.
The Company recorded a change in value of the Embedded Derivatives of $42 thousand and $81
thousand for the three months ended December 31, 2010 and 2009, respectively. The Company recorded
a change in value of the Embedded Derivatives of $332 thousand and $206 thousand for the six
months ended December 31, 2010 and 2009, respectively. These changes were recorded as a reduction
to Interest Expense in the accompanying Condensed Statements of Operations and Comprehensive Loss.
Management will continue to re-assess these assumptions at each reporting date and future changes
to these assumptions could materially change the estimated fair value of the Embedded Derivatives,
with a corresponding impact on the Companys reported results of operations.
21
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
The
Company estimated that the fair value of the Deerfield debt was $101.3 million and $95.4
million at December 31, 2010 and June 30, 2010,
respectively, using an interest rate lattice model
that incorporates the estimates discussed above related to the Embedded Derivatives.
The Company paid Deerfield transaction fees totaling $2 million when the Company drew the
funds under the 2008 Loan and $500 thousand on July 10, 2009 and $500 thousand when the funds were
drawn under the 2009 Loan. The transaction fees are included in Other Long-term Assets in the
accompanying Condensed Balance Sheets. The Company is amortizing these transaction fees to Interest
Expense in the accompanying Condensed Statements of Operations and Comprehensive Loss over the
respective terms of each of the Credit Facilities. Other direct issuance costs in connection with
the transactions were expensed as incurred and were not significant.
The Credit Facilities are secured by a second priority security interest in the Companys
assets, including accounts receivable, equipment, inventory, investment property and general
intangible assets, excluding copyrights, patents, trademarks, service marks and certain related
intangible assets. This security interest and the Companys obligations under the Credit Facilities
are subordinate to the Companys obligations to Comerica Bank and to Comericas security interest,
under the Loan and Security Agreement between the Company and Comerica Bank dated June 28, 2005, as
amended, discussed below.
The Facility Agreements for both Credit Facilities contain representations, warranties and
affirmative and negative covenants that are customary for credit facilities of this type. The
Facility Agreements restrict the Companys ability to, among other things, sell certain assets,
engage in a merger or change in control transaction, incur debt, pay cash dividends and make
investments. The Facility Agreements also contain events of default that are customary for credit
facilities of this type, including payment defaults, covenant defaults, insolvency type defaults
and events of default relating to liens, judgments, material misrepresentations and the occurrence
of certain material adverse events. In addition, if the Companys total Cash, Cash Equivalents and
Marketable Securities at the end of a fiscal quarter fall below $20 million (which was reduced from
$40 million when the Company entered into the 2009 Credit Facility), all amounts outstanding under
the Credit Facilities become immediately due and payable. The Company is also required, subject to
certain exceptions and conditions, to make payments of principal equal to 15% of certain amounts it
receives under collaboration, licensing, partnering, joint venture and other similar arrangements
entered into after January 1, 2011.
Warrants Issued to Deerfield
In consideration for providing the 2008 Credit Facility, the Company issued warrants to
Deerfield to purchase 6,000,000 shares of Common Stock at an exercise price of $7.54 per share (the
Prior Warrants). Pursuant to the terms of the Facility Agreement for the 2009 Loan, the Prior
Warrants were terminated and the Company issued new warrants to Deerfield to purchase 6,000,000
shares of Common Stock at an exercise price of $3.65 (the Exchange Warrants). The Company also
issued Deerfield warrants to purchase an aggregate of 6,000,000 shares of the Companys Common
Stock at an exercise price of $4.19 (the New Warrants and collectively with the Exchange
Warrants, the Warrants) when the funds were disbursed on July 31, 2009.
The Exchange Warrants contain substantially the same terms as the Prior Warrants, except that
the Exchange Warrants have a lower per share exercise price. The Warrants are exercisable
commencing January 31, 2010 and expire on April 29, 2014. Other than the exercise price, all other
provisions of the Exchange Warrants and the New Warrants are identical.
The Company allocated the $80 million proceeds under the 2008 Loan between the debt and the
Prior Warrants based upon their estimated relative fair values. The Company valued the Prior
Warrants using the Black-Scholes option pricing model using the following assumptions:
|
|
|
Risk-free interest rate of 3.3%; |
|
|
|
|
Volatility of 63.9%; |
22
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
|
|
|
Expected life of six years; and |
|
|
|
|
Dividend yield of zero. |
The Company allocated $20.6 million in value to equity and recorded it as Debt Discount in the
accompanying Condensed Balance Sheets. Because the 2008 Loan was drawn down in two separate
tranches, the Company is amortizing half of the Prior Warrant value from the first draw date and
the remaining half from the second draw date, in both cases to the end of the credit facility term,
to Interest Expense in the accompanying Condensed Statements of Operations and Comprehensive Loss.
The Company allocated the $40 million proceeds under the 2009 Loan between the debt and the
New Warrants based upon their estimated relative fair values. The Company valued the New Warrants
using the Black-Scholes option pricing model using the following assumptions:
|
|
|
Risk-free interest rate of 2.46%; |
|
|
|
|
Volatility of 63.59%; |
|
|
|
|
Expected life of five years; and |
|
|
|
|
Dividend yield of zero. |
The Company allocated $12.4 million in value to equity and recorded it as Debt Discount. The
Company is amortizing the discount from the July 31, 2009 draw date to the end of the Credit
Facility term to Interest Expense in the accompanying Condensed Statements of Operations and
Comprehensive Loss.
The Company calculated the incremental value of the Exchange Warrants as the difference
between the value of the Exchange Warrants at the new exercise price ($3.65) and the value of the
Prior Warrants at the prior exercise price ($7.54). The Black-Scholes option pricing models used to
calculate these values used the following assumptions:
|
|
|
Risk-free interest rate of 1.86%; |
|
|
|
|
Volatility of 61.94%; |
|
|
|
|
Expected life of five years; and |
|
|
|
|
Dividend yield of zero. |
Prior to disbursement of the 2009 Loan, the Company recorded the incremental value of the
Exchange Warrants of $3.3 million as of June 30, 2009 in Other Long-Term Assets and Warrants in the
accompanying Condensed Balance Sheets. Following disbursement of the 2009 Loan on July 31, 2009,
the Company reclassified the balance of $3.3 million in Other Long-Term Assets to Debt Discount and
began amortizing the discount to Interest Expense in the accompanying Condensed Statements of
Operations and Comprehensive Loss from July 31, 2009 to the end of the term of the Credit
Facilities.
23
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
The interest expense recognized by the Company for the Deerfield Credit Facilities follows (dollars
in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest |
|
|
2,250 |
|
|
|
2,250 |
|
|
|
4,500 |
|
|
|
4,350 |
|
Amortization of the transaction fees |
|
|
143 |
|
|
|
143 |
|
|
|
286 |
|
|
|
268 |
|
Amortization of the debt discounts |
|
|
1,670 |
|
|
|
1,540 |
|
|
|
3,307 |
|
|
|
2,824 |
|
Change in value of the Embedded Derivatives |
|
|
(42 |
) |
|
|
(81 |
) |
|
|
(332 |
) |
|
|
(206 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest expense on the Deerfield Credit Facility |
|
$ |
4,021 |
|
|
$ |
3,852 |
|
|
$ |
7,761 |
|
|
$ |
7,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Term Loan and Equipment Line of Credit
The Company entered into a Loan and Security Agreement (Loan and Security Agreement) with
Comerica Bank dated June 28, 2005, which has been subsequently amended. The Loan and Security
Agreement provides for a term loan, equipment advances and a revolving line of credit, all of which
are secured by a first priority security interest in the Companys assets, other than its
intellectual property.
The full $10 million term loan was advanced to the Company on June 30, 2005. The Company received
the total $5 million of equipment advances by June 30, 2007.
On September 30, 2009, the term and the interest rate structure of the Loan and Security Agreement
were amended. The maturity date was extended 120 days from June 28, 2010 to October 26, 2010.
Effective October 1, 2009, the outstanding balances under the term loan and the equipment advances
accrued interest on a monthly basis at a rate equal to 2.75% above the Prime Rate, as quoted by
Comerica Bank, but not less than the sum of Comerica Banks daily adjusting LIBOR rate plus 2.5%
per annum.
On March 31, 2010, the term and interest rate structure of the Loan and Security Agreement were
amended. The term loan and equipment advances were also combined into one instrument referred to as
the term loan. The maturity date was extended three years from October 26, 2010 to October 26,
2013. Effective April 1, 2010, the outstanding balances under the term loan and the equipment
advances bear interest on a monthly basis at the Prime Rate, as quoted by Comerica Bank, but will
not be less than the sum of Comerica Banks daily adjusting LIBOR rate plus an incremental
contractually predetermined rate. This rate is variable, ranging from the Prime Rate to the Prime
Rate plus 4%, based on the total dollar amount the Company has invested at Comerica and in what
investment option those funds are invested.
In addition, revolving lines of credit of $6.8 million have been established to support standby
letters of credit in relation to the Companys facilities leases. These standby letters of credit
expire on January 31, 2014 and August 31, 2016.
As of December 31, 2010, the term loan had an interest rate of 3.25% per annum. The Company
recognized $127 thousand and $239 thousand of interest expense for the three months ended December
31, 2010 and 2009, respectively. The Company recognized $252 thousand and $297 thousand of interest
expense for the six months ended December 31, 2010 and 2009, respectively. These charges are
recorded in Interest Expense in the accompanying Condensed Statements of Operations and
Comprehensive Loss.
The following table outlines the level of Cash, Cash Equivalents and Marketable Securities, which
the Company must hold in accounts at Comerica Bank per the Loan and Security Agreement based on the
Companys total Cash, Cash Equivalent and Marketable Securities, which was modified as part of the
March 31, 2010 amendment.
24
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
|
|
|
|
|
|
|
Cash on Hand |
|
Total Cash, Cash Equivalents and Marketable Securities |
|
at Comerica |
|
|
|
|
|
Greater than $40 million |
|
$ |
- |
|
Between $25 million and $40 million |
|
$ |
10,000,000 |
|
Less than $25 million |
|
$ |
22,000,000 |
|
The Loan and Security Agreement contains representations and warranties and affirmative and
negative covenants that are customary for credit facilities of this type. The Loan and Security
Agreement restricts the Companys ability to, among other things, sell certain assets, engage in a
merger or change in control transaction, incur debt, pay cash dividends and make investments. The
Loan and Security Agreement also contains events of default that are customary for credit
facilities of this type, including payment defaults, covenant defaults, insolvency type defaults
and events of default relating to liens, judgments, material misrepresentations and the occurrence
of certain material adverse events.
The estimated fair value of the Loan and Security Agreement was determined using a discounted cash
flow model and was calculated at $15 million as of December 31, 2010 and June 30, 2010.
Commitment Schedule
A summary of the Companys contractual commitments as of December 31, 2010 under the Credit
Facilities and the Loan and Security Agreement discussed above are as follows (dollars in
thousands):
|
|
|
|
|
For the twelve months ended December 31, |
|
|
|
|
2011 |
|
$ |
- |
|
2012 |
|
|
- |
|
2013 |
|
|
15,000 |
|
2014 |
|
|
126,762 |
|
2015 |
|
|
- |
|
|
|
|
|
|
|
$ |
141,762 |
|
|
|
|
|
NOTE 6 SHARE BASED COMPENSATION EXPENSE
All share-based payments to employees are recognized in the Condensed Statements of Operations and
Comprehensive Loss based on the fair value of the award on the grant date. Share-based
compensation arrangements include stock option grants under the Option Plan and purchases of common
stock at a discount under the ESPP. The fair value of all stock options granted by the Company is
estimated on the date of grant using the Black-Scholes option pricing model. The Company recognizes
share-based compensation expense on a straight-line basis over the vesting term of stock option
grants. See Note 12 - Employee Compensation Plans to the Companys audited financial statements
included in its Annual Report on Form 10-K for the year ended June 30, 2010 for more information
about the assumptions used by the Company under this valuation methodology. During the three and
six months ended December 31, 2010 and 2009, the Company made no material changes to these
assumptions.
During the three months ended December 31, 2010 and 2009, the Company issued new stock options to
purchase a total of 158,600 shares and 214,000 shares of common stock, respectively. The Company
recognized compensation expense for stock options of $750 thousand and $1.2 million for the three
months ended December 31, 2010 and 2009, respectively.
25
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
During the six months ended December 31, 2010 and 2009, the Company issued new stock options to
purchase a total of 213,300 shares and 255,000 shares of common stock, respectively. The Company
recognized compensation expense for stock options of $1.7 million and $2.5 million for the six
months ended December 31, 2010 and 2009, respectively.
As of December 31, 2010, there was $4.0 million of total unrecognized compensation expense,
including the impact of expected forfeitures, for unvested share-based compensation awards granted
under the Companys equity plans, which the Company expects to recognize over a weighted-average
period of 2.2 years.
The fair value of common stock purchased under the ESPP is based on the estimated fair value of the
common stock during the offering period and the percentage of the purchase discount. During the
three months ended December 31, 2010 and 2009, the Company recognized compensation expense for its
ESPP of $153 thousand and $246 thousand, respectively. During the six months ended December 31,
2010 and 2009, the Company recognized compensation expense for its ESPP of $343 thousand and $430
thousand, respectively.
NOTE 7 EQUITY DISTRIBUTION AGREEMENT
On September 18, 2009, the Company entered into an Equity Distribution Agreement with Piper Jaffray
& Co. (the Agent) pursuant to which the Company agreed to sell from time to time, up to an
aggregate of $25 million in shares of its $.001 par value common stock, through the Agent that have
been registered on a registration statement on Form S-3 (File No. 333-15801). Sales of the shares
made pursuant to the Equity Distribution Agreement are made on the NASDAQ Stock Market by means of
ordinary brokers transactions at market prices. Additionally, under the terms of the Equity
Distribution Agreement, the Company may sell shares of its common stock through the Agent, on the
NASDAQ Global Market or otherwise, at negotiated prices or at prices related to the prevailing
market price.
A summary of the transaction data follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of shares sold |
|
|
446,611 |
|
|
|
696,700 |
|
|
|
920,493 |
|
|
|
756,690 |
|
Average price per share |
|
$ |
3.33 |
|
|
$ |
2.81 |
|
|
$ |
3.27 |
|
|
$ |
2.80 |
|
Gross proceeds (in thousands) |
|
$ |
1,487 |
|
|
$ |
1,958 |
|
|
$ |
3,006 |
|
|
$ |
2,120 |
|
Commissions (in thousands) |
|
$ |
(45 |
) |
|
$ |
(59 |
) |
|
$ |
(90 |
) |
|
$ |
(64 |
) |
Other costs (in thousands) |
|
$ |
(36 |
) |
|
$ |
(2 |
) |
|
$ |
(60 |
) |
|
$ |
(242 |
) |
NOTE 8 EMPLOYEE BONUS
The Company has an annual performance bonus program for its employees in which employees may
receive a bonus payable in cash or in shares of common stock if the Company meets certain
financial, discovery, development and partnering goals during a fiscal year. The bonus is
typically paid in the second quarter of the next fiscal year, and the Company accrues an estimate
of the expected aggregate bonus in Accrued Compensation and Benefits in the accompanying Condensed
Balance Sheets.
As of December 31, 2010, the Company had $2.8 million accrued in Accrued Compensation and Benefits
for the fiscal 2011 Bonus Program. As of June 30, 2010 and 2009, the Company had $6.5 million and
$4.2 million, respectively, accrued for the fiscal 2010 and fiscal 2009 Performance Bonus Programs.
26
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended December 31, 2010
(Unaudited)
On October 4, 2010, the Company paid bonuses to approximately 330 eligible employees having an
aggregate value of $6.5 million under the fiscal 2010 Performance Bonus Program through the
issuance of a total of 1,280,143 shares of its common stock and payment of cash to satisfy related
withholding taxes.
On October 5, 2009, the Company paid bonuses to approximately 350 eligible employees having an
aggregate value of $3.9 million under the fiscal 2009 Performance Bonus Program through the
issuance of a total of 1,000,691 shares of its common stock valued at $2.4 million and a payment of
cash to satisfy related withholding taxes.
27
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Managements Discussion and Analysis of Financial Condition and Results of Operations contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995, including statements about our expectations related to the progress and success of drug
discovery activities conducted by Array and by our collaborators, our ability to obtain additional
capital to fund our operations and/or reduce our research and development spending, realizing new
revenue streams and obtaining future out-licensing collaboration agreements that include up-front
milestone and/or royalty payments, our ability to realize up-front milestone and royalty payments
under our existing or any future agreements, future research and development spending and
projections relating to the level of cash we expect to use in operations, our working capital
requirements and our future headcount requirements. In some cases, forward-looking statements can
be identified by the use of terms such as may, will, expects, intends, plans,
anticipates, estimates, potential, or continue, or the negative thereof or other comparable
terms. These statements are based on current expectations, projections and assumptions made by
management and are not guarantees of future performance. Although we believe that the expectations
reflected in the forward-looking statements contained herein are reasonable, these expectations or
any of the forward-looking statements could prove to be incorrect and actual results could differ
materially from those projected or assumed in the forward-looking statements. Our future financial
condition, as well as any forward-looking statements are subject to significant risks and
uncertainties, including but not limited to the factors set forth under the heading Risk Factors
in Item 1A under Part II of this Quarterly Report and under Item 1A of the Annual Report on Form
10-K for the fiscal year ended June 30, 2010 we filed with the Securities and Exchange Commission
on August 12, 2010. All forward looking statements are made as of the date hereof and, unless
required by law, we undertake no obligation to update any forward-looking statements.
The following discussion of our financial condition and results of operations should be read in
conjunction with the financial statements and notes to those statements included elsewhere in this
quarterly report. The terms we, us, our and similar terms refer to Array BioPharma Inc.
Overview
We are a biopharmaceutical company focused on the discovery, development and commercialization of
targeted small molecule drugs to treat patients afflicted with cancer and inflammatory diseases.
Our proprietary drug development pipeline includes clinical candidates that are designed to
regulate therapeutically important target pathways. In addition, leading pharmaceutical and
biotechnology companies partner with us to discover and develop drug candidates across a broad
range of therapeutic areas.
28
The most advanced programs currently in clinical trials that we are developing internally or
with a partner are as follows:
|
|
|
|
|
|
|
Program |
|
Target and Indication |
|
Ownership |
|
Clinical Status |
|
1. MEK162 (ARRY-162)
|
|
MEK inhibitor for cancer
|
|
Array/Novartis
|
|
Phase 1 |
|
|
|
|
|
|
|
2. ARRY-380
|
|
HER2 inhibitor for breast cancer
|
|
Array
|
|
Phase 1 |
|
|
|
|
|
|
|
3. ARRY-520
|
|
KSP inhibitor for multiple myeloma or MM
|
|
Array
|
|
Phase 2 |
|
|
|
|
|
|
|
4. ARRY-543
|
|
HER2/EGFR inhibitor for cancer
|
|
Array
|
|
Phase 1b |
|
|
|
|
|
|
|
5. ARRY-614
|
|
p38/Tie2 dual inhibitor for myelodysplastic syndrome or MDS
|
|
Array
|
|
Phase 1 |
|
|
|
|
|
|
|
6. ARRY-382
|
|
cFMS inhibitor for cancer
|
|
Array/Celgene option
|
|
Phase 1 |
|
|
|
|
|
|
|
In addition to these development programs, the most advanced partnered drugs in clinical
development are as follows: |
|
|
|
|
|
|
|
Program |
|
Target and Indication |
|
Ownership |
|
Clinical Status |
|
1. Selumetinib (AZD6244)
|
|
MEK inhibitor for cancer
|
|
Array/AstraZeneca
|
|
Phase 2 |
|
|
|
|
|
|
|
2. AMG 151 (ARRY-403)
|
|
Glucokinase activator for Type 2 diabetes
|
|
Array/Amgen
|
|
Phase 1 |
|
|
|
|
|
|
|
3. Danoprevir (RG7227)
|
|
Protease inhibitor for Hepatitis C virus
|
|
Array/Roche
|
|
Phase 2 |
|
|
|
|
|
|
|
4. GDC-0068
|
|
AKT inhibitor for cancer
|
|
Array/Genentech
|
|
Phase 1 |
|
|
|
|
|
|
|
5. VTX-2337
|
|
Toll-like receptor for cancer
|
|
Array/VentiRx
|
|
Phase 1 |
|
|
|
|
|
|
|
6. VTX-1463
|
|
Toll-like receptor for allergy
|
|
Array/VentiRx
|
|
Phase 1 |
|
|
|
|
|
|
|
7. LY2603618
|
|
Chk-1 inhibitor for cancer
|
|
Array/Eli Lilly
|
|
Phase 2 |
Any information we report about the development plans or the progress or results of clinical trials
or other development activities of our partners is based on information that has been reported to
us or is otherwise publicly disclosed by our partners.
We also have a portfolio of proprietary and partnered drug discovery programs that we believe will
generate an average of one to two Investigational New Drug, or IND, applications per year. We have
active, partnered programs with Amgen, Celgene, Genentech and Novartis in which we may earn
milestone payments and royalties.
Our internal discovery efforts have also generated additional early-stage drug candidates, and we
may choose to out-license select promising candidates through research partnerships prior to filing
an IND application.
We have built our clinical and discovery programs through spending $428.9 million from our
inception through December 31, 2010. During the first three and six months of fiscal 2011 we spent
$14.5 million and $28.3 million in research and development for proprietary programs, respectively.
In fiscal 2010, we
29
spent $72.5 million in research and development for proprietary programs,
compared to $89.6 million and $90.3 million for fiscal years 2009 and 2008, respectively. During
fiscal 2010, we signed strategic collaborations with Novartis and Amgen. Together these
collaborations provided Array with $105 million in initial payments, over $1 billion in potential
milestone payments if all clinical and commercialization milestones under the agreements are
achieved, potential double digit royalties and potential commercial co-detailing rights.
We have received a total of $503.3 million in research funding and in up-front and milestone
payments from our collaboration partners since inception through December 31, 2010. Under our
existing collaboration agreements, we have the potential to earn over $3.1 billion in additional
milestone payments if we or our collaborators achieve all the drug discovery, development and
commercialization objectives detailed in those agreements, as well as the potential to earn
royalties on any resulting product sales from 17 drug development programs.
Our significant collaborators include:
|
|
|
Amgen, which entered into a worldwide strategic collaboration with us to develop and
commercialize our glucokinase activator, AMG 151. |
|
|
|
|
AstraZeneca, which licensed three of our MEK inhibitors for cancer, including
Selumetinib, which is currently in multiple Phase 2 clinical trials. |
|
|
|
|
Celgene Corporation, which entered into a worldwide strategic collaboration agreement
with us focused on the discovery, development and commercialization of novel therapeutics
in cancer and inflammation. |
|
|
|
|
Genentech, which entered into a worldwide strategic collaboration agreement with us
focused on the discovery, development and commercialization of novel therapeutics. One
drug, GDC-0068, an AKT inhibitor for cancer, entered a Phase 1 trial during the first half
of 2010. The other programs are in preclinical development. |
|
|
|
|
Roche Holding AG, which acquired Danoprevir, a novel small molecule inhibitor of the
Hepatitis C Virus NS3/4 protease from InterMune, which we had invented in collaboration
with InterMune. Danoprevir is currently in Phase 2b clinical trials. |
|
|
|
|
Novartis, which entered into a worldwide strategic collaboration with us to develop and
commercialize our MEK inhibitor, MEK162. |
Fiscal Periods
Our fiscal year ends on June 30. When we refer to a fiscal year or quarter, we are referring to the
year in which the fiscal year ends and the quarters during that fiscal year. Therefore, fiscal 2011
refers to the fiscal year ending June 30, 2011 and the second quarter refers to the quarter ended
December 31, 2010.
Business Development and Collaborator Concentrations
We currently license or partner certain of our compounds and/or programs and enter into
collaborations directly with pharmaceutical and biotechnology companies through opportunities
identified by our business development group, senior management, scientists and customer referrals.
30
The following collaborators contributed greater than 10% of our total revenue for the periods
presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
Amgen, Inc. |
|
|
39% |
|
|
|
9% |
|
|
|
39% |
|
|
|
5% |
|
Genentech, Inc. |
|
|
21% |
|
|
|
46% |
|
|
|
22% |
|
|
|
54% |
|
Celgene Corporation |
|
|
19% |
|
|
|
43% |
|
|
|
21% |
|
|
|
33% |
|
Novartis
International
Pharmaceutical Ltd. |
|
|
20% |
|
|
|
- |
|
|
|
18% |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
99% |
|
|
|
98% |
|
|
|
100% |
|
|
|
92% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
In general, certain of our collaborators may terminate their collaboration agreements with 90 to
180 days prior notice. Our agreement with Genentech can be terminated with 120 days notice.
Celgene may terminate its agreement with us with six months notice. Amgen may terminate its
agreement with us at any time upon notice of 60 or 90 days depending on the development activities
going on at the time of such notice.
The following table details revenue from our collaborators by region based on the country in which
collaborators are located or the ship-to destination for compounds (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
North America |
|
$ |
13,149 |
|
|
$ |
9,543 |
|
|
$ |
28,829 |
|
|
$ |
17,396 |
|
Europe |
|
|
3,345 |
|
|
|
86 |
|
|
|
6,174 |
|
|
|
109 |
|
Asia Pacific |
|
|
7 |
|
|
|
15 |
|
|
|
11 |
|
|
|
29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
16,501 |
|
|
$ |
9,644 |
|
|
$ |
35,014 |
|
|
$ |
17,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
All of our collaboration agreements are denominated in U.S. dollars.
Critical Accounting Policies and Estimates
Managements discussion and analysis of financial condition and results of operations are based
upon our accompanying Condensed Financial Statements, which have been prepared in accordance with
accounting principles generally accepted in the U.S. The preparation of these financial statements
requires us to make estimates and assumptions that affect the reported amounts of assets,
liabilities, revenue and expenses as well as the disclosure of contingent assets and liabilities.
We regularly review our estimates and assumptions.
These estimates and assumptions, which are based upon historical experience and on various other
factors believed to be reasonable under the circumstances, form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other
sources. Reported amounts and disclosures may have been different had management used different
estimates and assumptions or if different conditions had occurred in the periods presented.
Below is a discussion of the policies and estimates that we believe involve a high degree of
judgment and complexity.
31
Revenue Recognition
Most of our revenue is from our collaborators for research funding, up-front or license fees and
milestone payments derived from discovering and developing drug candidates. Our agreements with
collaboration partners include fees based on contracted annual rates for full-time-equivalent
employees working on a program and may also include non-refundable license and up-front fees,
non-refundable milestone payments that are triggered upon achievement of specific research or
development goals and future royalties on sales of products that result from the collaboration. A
small portion of our revenue comes from the sale of compounds on a per-compound basis. We report
revenue for discovery and the co-development of proprietary drug candidates we out-license as
Collaboration Revenue. License and Milestone Revenue is combined and consists of up-front fees and
ongoing milestone payments from collaborators that are recognized during the applicable period.
We recognize revenue in accordance with Staff Accounting Bulletin No. 104, Revenue Recognition
(SAB 104), which establishes four criteria, each of which must be met, in order to recognize
revenue for the performance of services or the shipment of products. Revenue is recognized when (a)
persuasive evidence of an arrangement exists, (b) products are delivered or services are rendered,
(c) the sales price is fixed or determinable and (d) collectability is reasonably assured.
Collaboration agreements that include a combination of discovery research funding, up-front or
license fees, milestone payments and/or royalties are evaluated to determine whether each
deliverable under the agreement has value to the customer on a stand-alone basis and whether
reliable evidence of fair value for the deliverable exists. Deliverables in an arrangement that do
not meet the separation criteria are treated as a single unit of accounting, generally applying
applicable revenue recognition guidance for the final deliverable to the combined unit of
accounting in accordance with SAB 104.
We recognize revenue from non-refundable up-front payments and license fees on a straight-line
basis over the term of performance under the agreement, which is generally the estimated research
or development term. These advance payments are deferred and recorded as Deferred Revenue upon
receipt, pending recognition, and are classified as a short-term or long-term liability in the
accompanying Condensed Balance Sheets.
When the performance period is not specifically identifiable from the agreement, we estimate the
performance period based upon provisions contained within the agreement, such as the duration of
the research or development term, the existence, or likelihood of achievement of development
commitments and any other significant commitments of ours.
We also have agreements that provide for milestone payments. In certain cases, a portion of each
milestone payment is recognized as revenue when the specific milestone is achieved based on the
applicable percentage of the estimated research or development term that has elapsed to the total
estimated research and/or development term. In other cases, when the milestone payment finances the
future development obligations of the Company, the revenue is recognized on a straight-line basis
over the estimated remaining development period. Certain milestone payments are for activities for
which there are no future obligations and as a result, are recognized when earned in their
entirety.
We periodically review the expected performance periods under each of our agreements that provide
for non-refundable up-front payments and license fees and milestone payments and adjust the
amortization periods when appropriate to reflect changes in assumptions relating to the duration of
expected performance periods. Revenue recognition for non-refundable license fees and up-front
payments and milestone payments could be accelerated in the event of early termination of programs
or alternatively, decelerated, if programs are extended. As such, while changes to such estimates
have no impact on our reported cash flows, our reported revenue is significantly influenced by our
estimates of the period over which our obligations are expected to be performed.
32
Cost of Revenue and Research and Development for Proprietary Programs
We incur costs in connection with performing research and development activities which consist
mainly of compensation, associated fringe benefits, share-based compensation, preclinical and
clinical outsourcing costs and other collaboration-related costs, including supplies, small tools,
facilities, depreciation, recruiting and relocation costs and other direct and indirect chemical
handling and laboratory support costs. We allocate these costs between Cost of Revenue and Research
and Development for Proprietary Programs based upon the respective time spent by our scientists on
development conducted for our collaborators and for our internal proprietary programs. Cost of
Revenue represents the costs associated with research and development, including preclinical and
clinical trials, conducted by us for our collaborators. Research and Development for Proprietary
Programs consist of direct and indirect costs for our specific proprietary programs. We do not bear
any risk of failure for performing these activities and the payments are not contingent on the
success or failure of the research program. Accordingly, we expense these costs when incurred.
Where our collaboration agreements provide for us to conduct research and development and for which
our partner has an option to obtain the right to conduct further development and to commercialize a
product, we attribute a portion of its research and development costs to Cost of Revenue based on
the percentage of total programs under the agreement that we conclude is likely to be selected by
the partner. These costs may not be incurred equally across all programs. In addition, we
continually evaluate the progress of development activities under these agreements and if events or
circumstances change in future periods that we reasonably believe would make it unlikely that a
collaborator would exercise an option with respect to the same percentage of programs, we will
adjust the allocation accordingly. See Note 4 Deferred Revenue, for further information about
our collaborations.
Accrued Outsourcing Costs
Substantial portions of our preclinical studies and clinical trials are performed by third-party
laboratories, medical centers, contract research organizations and other vendors (collectively
CROs). These CROs generally bill monthly or quarterly for services performed or bill based upon
milestone achievement. For preclinical studies, we accrue expenses based upon estimated percentage
of work completed and the contract milestones remaining. For clinical studies, expenses are accrued
based upon the number of patients enrolled and the duration of the study. We monitor patient
enrollment, the progress of clinical studies and related activities to the extent possible through
internal reviews of data reported to us by the CROs, correspondence with the CROs and clinical site
visits. Our estimates depend on the timeliness and accuracy of the data provided by the CROs
regarding the status of each program and total program spending. We periodically evaluate our
estimates to determine if adjustments are necessary or appropriate based on information we receive.
Marketable Securities
We have designated our marketable securities as of each balance sheet date as available-for-sale
securities and account for them at their respective fair values. Marketable securities are
classified as short-term or long-term based on the nature of these securities and the availability
of these securities to meet current operating requirements. Marketable securities that are readily
available for use in current operations are classified as short-term available-for-sale securities
and are reported as a component of current assets in the accompanying Condensed Balance Sheets.
Marketable securities that are not considered available for use in current operations are
classified as long-term available-for-sale securities and are reported as a component of long-term
assets in the accompanying Condensed Balance Sheets.
Securities that are classified as available-for-sale are carried at fair value, including accrued
interest, with temporary unrealized gains and losses reported as a component of Stockholders
Deficit until their disposition. We review all available-for-sale securities each period to
determine if they remain available-for-sale based on our then current intent and ability to sell
the security if we are required to do so. The amortized cost of debt securities in this category is
adjusted for amortization of premiums and accretion of
33
discounts to maturity. Such amortization is
included in Interest Income in the accompanying Condensed Statements of Operations and
Comprehensive Loss. Realized gains and losses on ARS along with declines in value judged to be
other-than-temporary are reported in Realized Gains on Auction Rate Securities, Net in the
accompanying Condensed Statements of Operations and Comprehensive Loss when recognized. The cost of
securities sold is based on the specific identification method.
Under the fair value hierarchy, our ARS are measured using Level III, or unobservable inputs, as
there is no active market for the securities. The most significant unobservable inputs used in this
method are estimates of the amount of time until a liquidity event will occur and the discount
rate, which incorporates estimates of credit risk and a liquidity premium (discount). Due to the
inherent complexity in valuing these securities, we engaged a third-party valuation firm to perform
an independent valuation of the ARS as part of our overall fair value analysis beginning with the
first quarter of fiscal 2009 and continuing through the current quarter. While we believe that the
estimates used in the fair value analysis are reasonable, a change in any of the assumptions
underlying these estimates would result in different fair value estimates for the ARS and could
result in additional adjustments to the ARS, either increasing or further decreasing their value,
possibly by material amounts.
See Note 3 Marketable Securities for additional information about our investments in ARS.
Fair Value Measurements
Our financial instruments are recognized and measured at fair value in our financial statements and
mainly consist of cash and cash equivalents, marketable securities, long-term investments, trade
receivables and payables, long-term debt, embedded derivatives associated with the long-term debt
and warrants. We use different valuation techniques to measure the fair value of assets and
liabilities, as discussed in more detail below. Fair value is defined as the price that would be
received to sell the financial instruments in an orderly transaction between market participants at
the measurement date. We use a framework for measuring fair value based on a hierarchy that
distinguishes sources of available information used in fair value measurements and categorizes them
into three levels:
|
|
|
Level I: Quoted prices in active markets for identical assets and liabilities. |
|
|
|
|
Level II: Observable inputs other than quoted prices in active markets for identical
assets and liabilities. |
|
|
|
|
Level III: Unobservable inputs. |
We disclose assets and liabilities measured at fair value based on their level in the hierarchy
described above. Considerable judgment is required in interpreting market data to develop estimates
of fair value for assets or liabilities for which there are no quoted prices in active markets,
which include our ARS, warrants issued by us or the embedded derivatives associated with our
long-term debt. The use of
different assumptions and/or estimation methodologies may have a material effect on their estimated
fair value. Accordingly, the fair value estimates disclosed by us may not be indicative of the
amount that we or holders of the instruments could realize in a current market exchange.
We periodically review the realizability of each investment when impairment indicators exist with
respect to the investment. If an other-than-temporary impairment of the value of an investment is
deemed to exist, the cost basis of the investment is written down to its then estimated fair value.
Long-term Debt and Embedded Derivatives
The terms of our long-term debt are discussed in detail in Note 5 Long-term Debt included
elsewhere in this Quarterly Report on Form 10-Q. The accounting for these arrangements is complex
and is based upon significant estimates by management. We review all debt agreements to determine
the appropriate accounting treatment when the agreement is entered into and review all amendments
to determine if the changes require accounting for the amendment as a modification, or as an
extinguishment and new debt. We also review each long-term debt arrangement to determine if any
feature of the debt requires
34
bifurcation and/or separate valuation. These features include hybrid
instruments, which are comprised of at least two components ((1) a debt host instrument and (2) one
or more conversion features), warrants and other embedded derivatives, such as puts and other
rights of the debt holder.
We
currently have two embedded derivatives related to our long-term debt with Deerfield that were
valued at $493 thousand and $825 thousand at December 31, 2010 and June 30, 2009, respectively and
included in Other Long-term Liabilities in the accompanying Condensed Balance Sheets. The first is
a variable interest rate structure that constitutes a liquidity-linked variable spread feature. The
second derivative is a significant transaction contingent put option relating to Deerfields
ability to accelerate the repayment of the debt in the event of certain changes in control of our
company. Such event would occur if the acquirer did not meet certain financial conditions, based on
size and credit worthiness. Collectively, they are referred to as the Embedded Derivatives.
Under the fair value hierarchy, our Embedded Derivatives are measured using Level III, or
unobservable inputs, as there is no active market for them. The fair value of the variable interest
rate structure is based on our estimate of the probable effective interest rate over the term of
the Deerfield credit facilities. The fair value of the put option is based on our estimate of the
probability that a change in control that triggers Deerfields right to accelerate the debt will
occur. With those inputs, the fair value of each Embedded Derivative is calculated as the
difference between the fair value of the Deerfield credit facilities if the Embedded Derivatives
are included and the fair value of the Deerfield credit facilities if the Embedded Derivatives are
excluded. Due to the inherent complexity in valuing the Deerfield credit facilities and the
Embedded Derivatives, we engaged a third-party valuation firm to perform the valuation as part of
our overall fair value analysis as of July 31, 2009, the date the funds were disbursed under the
credit facility entered into in May 2009 and for each subsequent quarter end through the current
quarter end. The estimated fair value of the Embedded Derivatives was determined based on
managements judgment and assumptions and the use of different assumptions could result in
significantly different estimated fair values.
The initial fair value of the Embedded Derivatives was recorded as Derivative Liabilities and as
Debt Discount in our Condensed Balance Sheets. Any change in the value of the Embedded Derivatives
is adjusted quarterly as appropriate and recorded to Derivative Liabilities in the Condensed
Balance Sheets and Interest Expense in the accompanying Condensed Statements of Operations and
Comprehensive Loss. The Debt Discount is being amortized from the draw date of July 31, 2009 to the
end of the term of the Deerfield credit facilities using the effective interest method and recorded
as Interest Expense in the accompanying Condensed Statements of Operations and Comprehensive Loss.
Warrants that we issue in connection with our long-term debt arrangements are reviewed to determine
if they should be classified as liabilities or as equity. All outstanding warrants issued by us
have been classified as equity. We value the warrants at issuance based on a Black-Scholes option
pricing model and then allocate a portion of the proceeds under the debt to the warrants based upon
their relative fair values.
Any transaction fees paid in connection with our long-term debt arrangements that qualify for
capitalization are recorded as Other Long-Term Assets in the Condensed Balance Sheets and amortized
to Interest Expense in the accompanying Condensed Statements of Operations and Comprehensive Loss
using the effective interest method over the term of the underlying debt agreement.
Results of Operations
Collaboration Revenue
Collaboration Revenue consists of revenue for our performance of drug discovery and development
activities in collaboration with partners, which include: co-development of proprietary drug
candidates we out-license as well as research, or discovery, that includes screening, lead
generation, lead optimization and pharmacological testing.
35
A summary of our collaboration revenue follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
Six Months Ended |
|
Change 2010 vs. |
|
|
December 31, |
|
2009 |
|
December 31, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
2010 |
|
2009 |
|
$ |
|
% |
|
Collaboration revenue |
|
$ |
5,370 |
|
|
$ |
4,434 |
|
|
$ |
936 |
|
|
|
21% |
|
|
$ |
11,090 |
|
|
$ |
9,478 |
|
|
$ |
1,612 |
|
|
|
17% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue increased $936 thousand, or 21.1%, for the three months ended December 31,
2010 compared to the same period last year. During the current quarter, we recognized $1.5 million
of additional revenue from Amgen under our research collaboration and for development. We also
received $514 thousand in pass through costs from our collaboration with Novartis. These increases
were partially offset by decreased revenue under our collaborations with Genentech.
Collaboration revenue increased $1.6 million, or 17% for the six months ended December 31, 2010
compared to the same period in the prior year. During the first two quarters of fiscal 2011, we
recognized $3.8 million of additional revenue from Amgen under our research collaboration and for
development. We also received $514 thousand in pass through costs from our collaboration with
Novartis. These increases were partially offset by decreased revenue under our collaborations with
Genentech. In the first quarter of fiscal 2010 we recorded $633 thousand of revenue for the
finalization of Genentech contract rates for services rendered in the prior fiscal year that did
not recur in the current year. Additionally, we had fewer scientists engaged on the Genentech
programs as compared to last year.
License and Milestone Revenue
License and Milestone Revenue are combined and consist of up-front license fees and ongoing
milestone payments from collaborators.
A summary of our license and milestone revenue follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
Six Months Ended |
|
Change 2010 vs. |
|
|
December 31, |
|
2009 |
|
December 31, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
2010 |
|
2009 |
|
$ |
|
% |
|
License revenue |
|
$ |
10,363 |
|
|
$ |
5,210 |
|
|
|
5,153 |
|
|
|
99 |
% |
|
|
22,094 |
|
|
|
7,056 |
|
|
|
15,038 |
|
|
|
213 |
% |
Milestone revenue |
|
|
768 |
|
|
|
- |
|
|
|
768 |
|
|
|
- |
|
|
|
1,830 |
|
|
|
1,000 |
|
|
|
830 |
|
|
|
83 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
$ |
11,131 |
|
|
$ |
5,210 |
|
|
$ |
5,921 |
|
|
|
114 |
% |
|
$ |
23,924 |
|
|
$ |
8,056 |
|
|
$ |
15,868 |
|
|
|
197 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue increased $5.2 million for the three months ended December 31, 2010 compared to the
same period last year. During the current quarter, we recognized $4.0 million in incremental
revenue from our collaboration with Amgen and $2.5 million in revenue recognized for our
collaboration with Novartis. This was offset by $1.4 million
less revenue recognized under the
Celgene collaboration due to our conclusion that the remaining estimated performance period
increased from four to four and a half years effective September 30, 2010 as discussed in Note 4
Deferred Revenue to the accompanying Condensed Financial Statements.
License
revenue increased $15 million, or 213%, for the six months ended December 31, 2010 as
compared to the prior year. During the six months ended December 31, 2010, we recognized $9.0
million in incremental revenue for our collaboration with Amgen and $5 million in revenue for our new collaboration with Novartis. License revenue recognized under our collaboration with
Celgene also increased $1.1 million because of the net impact of
changes to the amortization period
of the upfront fee. We concluded on September 30, 2009 that the remaining estimated performance
period decreased from seven to four years, which accelerated the recognition of revenue for the
remainder of fiscal 2010. We concluded on September 30, 2010 that the remaining estimated
performance period increased by six months to four and a half years, which reduced the rate at
which we recognized the remaining revenue
36
beginning
in the second quarter of fiscal 2011. See
additional discussion on the Celgene collaboration in Note 4 Deferred Revenue to the
accompanying Condensed Financial Statements.
Total Milestone Revenue increased $768 thousand for the three months ended December 31, 2010
compared to the same period last year. In the current quarter, we recognized $312 thousand of the
$5 million milestone payment we received from Novartis in June 2010 and $456 thousand of the $10
million milestone payment we received from Celgene in November 2010.
Total Milestone Revenue increased $830 thousand, or 83%for the six months ended December 31, 2010
compared to the same period last year. This increase consisted of $750 thousand we received and
recognized for the advancement of one of our programs with Genentech, $625 thousand in revenue
recognized of the $5 million milestone payment we received from Novartis in June 2010 and $456
thousand in revenue recognized of the $10 million milestone payment we received from Celgene in
November 2010. These increases were offset by our recognition of $1 million in milestone revenue
from InterMune for the advancement of Danoprevir into Phase 2b clinical trials.
Cost of Revenue
Cost of Revenue represents costs for research or discovery and development including preclinical
and clinical trials we conduct for our collaborators. These costs consist mainly of compensation,
associated fringe benefits, share-based compensation, preclinical and clinical outsourcing costs
and other collaboration-related costs, including supplies, small tools, travel and meals,
facilities, depreciation, recruiting and relocation costs and other direct and indirect chemical
handling and laboratory support costs.
A summary of our Cost of Revenue follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
Six Months Ended |
|
Change 2010 vs. |
|
|
December 31, |
|
2009 |
|
December 31, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
2010 |
|
2009 |
|
$ |
|
% |
|
Cost of revenue |
|
$ |
7,382 |
|
|
$ |
5,235 |
|
|
$ |
2,147 |
|
|
|
41% |
|
|
$ |
14,663 |
|
|
$ |
11,157 |
|
|
$ |
3,506 |
|
|
|
31% |
|
Cost of revenue as a percentage
of total revenue |
|
|
45% |
|
|
|
54% |
|
|
|
|
|
|
|
|
|
|
|
42% |
|
|
|
64% |
|
|
|
|
|
|
|
|
|
Cost of Revenue increased in absolute dollars and decreased as a percentage of total revenue for
the three and six months ended December 31, 2010 compared to the same periods in the prior year.
The increase in absolute dollars was for transitioning the underlying program costs for our AMG 151
and MEK162 programs from Research and Development for Proprietary Programs to Cost of Revenue after
we partnered these programs with Amgen and Novartis, respectively. Additionally, effective October
1, 2010, we increased the percentage of costs allocated under the Celgene collaboration from 33.3% to
Cost of Revenue to 67.7%, as discussed further in Note 4 Deferred Revenue to the accompanying
Condensed Financial Statements. These increases were partially offset by fewer scientists engaged
on our collaboration with Genentech than in the prior fiscal year periods.
The
decrease of Cost of Revenue as a percentage of total revenue in the three and six month periods
was because of greater License and Milestone Revenue recognized during the periods.
Research and Development for Proprietary Programs
Research and development expenses include costs associated with our proprietary programs for
scientific and clinical personnel, supplies, inventory, equipment, small tools, travel and meals,
depreciation, consultants, sponsored research, allocated facility costs, costs for preclinical and
clinical trials and share-based compensation. We manage our proprietary programs based on
scientific data and achievement of research plan goals. Our scientists record their time to
specific projects when possible; however, many activities simultaneously benefit multiple projects
and cannot be readily attributed to a
37
specific project. Accordingly, the accurate assignment of
time and costs to a specific project is difficult and may not give a true indication of the actual
costs of a particular project. As a result, we do not report costs on a program basis.
Research and Development for Proprietary Programs by categories of costs follows (dollars in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
Six Months Ended |
|
Change 2010 vs. |
|
|
December 31, |
|
2009 |
|
December 31, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
2010 |
|
2009 |
|
$ |
|
% |
|
Salaries, benefits and share-based
compensation |
|
$ |
6,643 |
|
|
$ |
8,205 |
|
|
$ |
(1,562 |
) |
|
|
-19 |
% |
|
$ |
13,189 |
|
|
$ |
15,879 |
|
|
$ |
(2,690 |
) |
|
|
-17 |
% |
Outsourced services and consulting |
|
|
3,210 |
|
|
|
4,846 |
|
|
|
(1,636 |
) |
|
|
-34 |
% |
|
|
5,809 |
|
|
|
10,724 |
|
|
|
(4,915 |
) |
|
|
-46 |
% |
Laboratory supplies |
|
|
2,260 |
|
|
|
2,992 |
|
|
|
(732 |
) |
|
|
-24 |
% |
|
|
4,593 |
|
|
|
5,777 |
|
|
|
(1,184 |
) |
|
|
-20 |
% |
Facilities and depreciation |
|
|
1,980 |
|
|
|
2,646 |
|
|
|
(666 |
) |
|
|
-25 |
% |
|
|
4,001 |
|
|
|
5,167 |
|
|
|
(1,166 |
) |
|
|
-23 |
% |
Other |
|
|
389 |
|
|
|
415 |
|
|
|
(26 |
) |
|
|
-6 |
% |
|
|
745 |
|
|
|
758 |
|
|
|
(13 |
) |
|
|
-2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development
for proprietary programs |
|
$ |
14,482 |
|
|
$ |
19,104 |
|
|
$ |
(4,622 |
) |
|
|
-24 |
% |
|
$ |
28,337 |
|
|
$ |
38,305 |
|
|
$ |
(9,968 |
) |
|
|
-26 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development for Proprietary Programs for the first quarter of fiscal 2011 decreased
from the prior year because we moved development costs for AMG 151 and MEK162 out of Research and
Development for Proprietary Programs to Cost of Revenue as a result of partnering the programs with
Amgen and Novartis, respectively. These decreases were partially offset by changes to the
allocation of expenses for the Celgene programs as discussed under Cost of Revenue as well as
increased costs to advance wholly-owned programs through clinical studies.
General and Administrative Expenses
General and Administrative Expenses consist mainly of compensation and associated fringe benefits,
management, business development, accounting, information technology and administration costs,
including patent filing and prosecution, recruiting and relocation, consulting and professional
services, travel and meals, sales commissions, facilities, depreciation and other office expenses.
A summary of our General and Administrative Expenses follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
Six Months Ended |
|
Change 2010 vs. |
|
|
December 31, |
|
2009 |
|
December 31, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
2010 |
|
2009 |
|
$ |
|
% |
|
General and administrative |
|
$ |
3,905 |
|
|
$ |
4,460 |
|
|
$ |
(555 |
) |
|
|
-12 |
% |
|
$ |
8,173 |
|
|
$ |
8,673 |
|
|
$ |
(500 |
) |
|
|
-6 |
% |
General and administrative expenses decreased in the most recent periods because stock compensation
expense decreased as a result of multiple options becoming fully vested and decreased corporate
legal costs. These were offset by increased patent costs.
38
Other Income (Expense)
A summary of our Other Income (Expense) follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
Six Months Ended |
|
Change 2010 vs. |
|
|
December 31, |
|
2009 |
|
December 31, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
2010 |
|
2009 |
|
$ |
|
% |
|
Realized gains on auction rate securities, net |
|
$ |
865 |
|
|
$ |
1,165 |
|
|
$ |
(300 |
) |
|
|
-26 |
% |
|
$ |
798 |
|
|
$ |
948 |
|
|
$ |
(150 |
) |
|
|
-16 |
% |
Interest income |
|
|
136 |
|
|
|
257 |
|
|
|
(121 |
) |
|
|
-47 |
% |
|
|
356 |
|
|
|
561 |
|
|
|
(205 |
) |
|
|
-37 |
% |
Interest expense |
|
|
(4,175 |
) |
|
|
(4,092 |
) |
|
|
(83 |
) |
|
|
2 |
% |
|
|
(8,067 |
) |
|
|
(7,534 |
) |
|
|
(533 |
) |
|
|
7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other expense, net |
|
$ |
(3,174 |
) |
|
$ |
(2,670 |
) |
|
$ |
(504 |
) |
|
|
19 |
% |
|
$ |
(6,913 |
) |
|
$ |
(6,025 |
) |
|
$ |
(888 |
) |
|
|
15 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest Expense increased in the first six months of fiscal 2011 compared to the same period in
the prior year due to increased borrowings under the Deerfield credit facilities, partially offset
by a lower interest rate on the debt.
Components of Interest Expense are as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
Credit Facilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest |
|
|
2,250 |
|
|
|
2,250 |
|
|
|
4,500 |
|
|
|
4,350 |
|
Amortization of the transaction fees |
|
|
143 |
|
|
|
143 |
|
|
|
286 |
|
|
|
268 |
|
Amortization of the debt discounts |
|
|
1,670 |
|
|
|
1,540 |
|
|
|
3,307 |
|
|
|
2,824 |
|
Change in value of the Embedded Derivatives |
|
|
(42 |
) |
|
|
(81 |
) |
|
|
(332 |
) |
|
|
(206 |
) |
|
|
|
Total interest expense on Deerfield Credit Facility |
|
|
4,021 |
|
|
|
3,852 |
|
|
|
7,761 |
|
|
|
7,236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Term Loan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Variable interest and amortization of transaction fees |
|
|
154 |
|
|
|
240 |
|
|
|
306 |
|
|
|
298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest expense on Comerica Loan |
|
|
154 |
|
|
|
240 |
|
|
|
306 |
|
|
|
298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total interest expense |
|
$ |
4,175 |
|
|
$ |
4,092 |
|
|
$ |
8,067 |
|
|
$ |
7,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liquidity and Capital Resources
We have incurred operating losses and an accumulated deficit as a result of ongoing research and
development spending. As of December 31, 2010, we had an accumulated deficit of $513.9 million. We
had a net loss for the three and six months ended December 31, 2010 of $12.4 million and $23.1
million, respectively. We had net losses of $77.6 million, $127.8 million and $96.3 million for
the fiscal years ended June 30, 2010, 2009 and 2008, respectively.
We have historically funded our operations through up-front fees and license and milestone payments
received under our collaboration and out-licensing transactions, from the proceeds from the
issuance and sale of equity securities and through debt provided by our credit facilities. For
example, we have received $115 million in the last twelve months as follows:
|
|
|
In December 2009, we received a $60 million up-front payment from Amgen Inc. under a
Collaboration and License Agreement |
|
|
|
|
In April 2010, we received $45 million in an upfront and milestone payment under a
License Agreement with Novartis Pharmaceutical International Ltd. |
|
|
|
|
In December 2010, we received $10 million in a milestone payment under a License
Agreement with Celgene Corporation. |
39
The recognition of revenue under these agreements is discussed further in Note 4 Deferred
Revenue.Until we can generate sufficient levels of cash from our operations, which we do not expect
to achieve in the foreseeable future, we will continue to utilize our existing cash, cash
equivalents and marketable securities. We believe that our cash, cash equivalents and marketable
securities, and excluding the value of the ARS we hold, will enable us to continue to fund our
operations for at least the next 12 months. There can be no assurance that we will be successful
in entering into future collaborations, however, or that other funds will be available to us when
needed.
There can be no assurance, however, that the funds expected to be received under existing or future
collaborations or from debt or equity financings will be available to us when needed. If we are
unable to obtain additional funding from these or other sources to the extent or when needed, it
may be necessary to significantly reduce our current rate of spending through further reductions in
staff and delaying, scaling back or stopping certain research and development programs.
Insufficient funds may also require us to relinquish greater rights to product candidates at an
earlier stage of development or on less favorable terms to us or our stockholders than we would
otherwise choose in order to obtain up-front license fees needed to fund our operations.
Our ability to realize milestone or royalty payments under existing collaboration agreements and to
enter into new partnering arrangements that generate additional revenue through up-front fees and
milestone or royalty payments is subject to a number of risks, many of which are beyond our control
and include the following:
|
|
|
The drug development process is risky and highly uncertain and we may not be successful
in generating proof-of-concept data to create partnering opportunities and, even if we are,
we or our collaborators may not be successful in commercializing drug candidates we create; |
|
|
|
|
Our collaborators have substantial control and discretion over the timing and continued
development and marketing of drug candidates we create and, therefore, we may not receive
milestone, royalty or other payments when anticipated or at all; |
|
|
|
|
The drug candidates we develop may not obtain regulatory approval; and |
|
|
|
|
If regulatory approval is received, drugs we develop will remain subject to regulation
or may not gain market acceptance, which could delay or prevent us from generating
milestone, royalty revenue or product revenue from the commercialization of these drugs. |
Our assessment of our future need for funding is a forward-looking statement that is based on
assumptions that may prove to be wrong and that involve substantial risks and uncertainties. Our
actual future capital requirements could vary as a result of a number of factors, including:
|
|
|
Our ability to enter into agreements to out-license, co-develop or commercialize our
proprietary drug candidates and the timing of payments under those agreements throughout
each candidates development stage; |
|
|
|
|
The number and scope of our research and development programs; |
|
|
|
|
The progress and success of our preclinical and clinical development activities; |
|
|
|
|
The progress and success of the development efforts of our collaborators; |
|
|
|
|
Our ability to maintain current collaboration agreements; |
|
|
|
|
The costs involved in enforcing patent claims and other intellectual property rights; |
|
|
|
|
The costs and timing of regulatory approvals; and/or |
|
|
|
|
The expenses associated with unforeseen litigation, regulatory changes, competition and
technological developments, general economic and market conditions and the extent to which
we acquire or invest in other businesses, products and technologies. |
Cash, Cash Equivalents and Marketable Securities
Cash equivalents are short-term, highly liquid financial instruments that are readily convertible
to cash and have maturities of 90 days or less from the date of purchase.
40
Marketable securities classified as short-term consist primarily of various financial
instruments such as commercial paper, U.S. government agency obligations and corporate notes and
bonds with high credit quality with maturities of greater than 90 days when purchased. Marketable
securities classified as long-term consist primarily of our investments in ARS. See Note 3
Marketable Securities in the accompanying Condensed Financial Statements for more information
regarding our ARS. Our ability to sell the ARS is substantially limited due to auctions that
continue to be suspended for these securities in the related markets. In the event we need to
access these funds and liquidate the ARS prior to the time auctions of these investments are
successful or the date on which the original issuers retire these securities, we may be required to
sell them in a distressed sale in a secondary market, most likely for a lower value than their
current estimated fair value.
Following is a summary of our cash, cash equivalents and marketable securities (dollars in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
June 30, |
|
|
|
|
2010 |
|
2010 |
|
$ Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
42,191 |
|
|
$ |
32,846 |
|
|
$ |
9,345 |
|
Marketable securities - short-term |
|
|
46,378 |
|
|
|
78,664 |
|
|
|
(32,286 |
) |
Marketable securities - long-term |
|
|
10,312 |
|
|
|
17,359 |
|
|
|
(7,047 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
98,881 |
|
|
$ |
128,869 |
|
|
$ |
(29,988 |
) |
|
|
|
|
|
|
|
|
|
|
Cash Flow Activities
Following is a summary of our cash flows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
|
|
December 31, |
|
|
|
|
|
2010 |
|
2009 |
|
$ Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
(31,871 |
) |
|
$ |
14,791 |
|
|
$ |
(46,662 |
) |
Investing activities |
|
|
38,130 |
|
|
|
9,105 |
|
|
|
29,025 |
|
Financing activities |
|
|
3,086 |
|
|
|
40,656 |
|
|
|
(37,570 |
) |
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
9,345 |
|
|
$ |
64,552 |
|
|
$ |
(55,207 |
) |
|
|
|
|
|
|
|
|
|
|
Net
cash used in operating activities for the six months ended December 31, 2010 increased $46.7
million over the same period in the prior year. This was due to the $60 million up-front license
fee from Amgen in December of 2009 that did not recur. Partially
offsetting this was a reduction in net loss of $23.5 million in the six months ended December 31, 2010 as compared to the same
period in 2009.
Net cash provided by investing activities was $38.1 million and $9.1 million in the first two
quarters of fiscal 2011 and 2010, respectively. Prior to the fourth quarter of fiscal 2010, we did
not purchase additional marketable securities upon the maturity of securities we held, and as such,
cash flows provided by investing activities in the first two quarters of fiscal 2010 reflected only
cash received upon the maturities of marketable securities. In the first six months of fiscal
2011, the marketable securities matured and provided cash at a higher level than the same period
last year.
Net cash provided by financing activities was $3.1 million and $40.6 million in the first two
quarters of fiscal 2011 and 2010, respectively. The difference between the periods is attributable
to the $39 million in net proceeds we received in the first quarter of fiscal 2010 under the
Deerfield credit facilities. During the first two quarters of fiscal 2011 and 2010, we also
received $2.9 million and $1.8 million, respectively, of
41
net proceeds from sales of shares of our common stock under our Equity Distribution Agreement with
Piper Jaffray & Co.
Obligations and Commitments
The following table shows our contractual obligations and commitments by maturity as of December
31, 2010 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than |
|
|
1 to 3 |
|
|
4 to 5 |
|
|
Over 5 |
|
|
|
|
|
|
1 Year |
|
|
Years |
|
|
Years |
|
|
Years |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt obligations (1) |
|
$ |
- |
|
|
$ |
15,000 |
|
|
$ |
126,762 |
|
|
$ |
- |
|
|
$ |
141,762 |
|
Interest on debt obligations (3) (4) |
|
|
9,488 |
|
|
|
18,894 |
|
|
|
3,000 |
|
|
|
- |
|
|
|
31,382 |
|
Operating lease commitments (2) |
|
|
7,991 |
|
|
|
16,336 |
|
|
|
16,471 |
|
|
|
4,513 |
|
|
|
45,311 |
|
Purchase obligations (2) |
|
|
13,518 |
|
|
|
1,745 |
|
|
|
53 |
|
|
|
- |
|
|
|
15,316 |
|
|
|
|
Total |
|
$ |
30,997 |
|
|
$ |
51,975 |
|
|
$ |
146,286 |
|
|
$ |
4,513 |
|
|
$ |
233,771 |
|
|
|
|
(1) |
|
Reflected in the accompanying Condensed Balance Sheets. |
|
(2) |
|
These obligations are not reflected in the accompanying Condensed Balance Sheets. |
|
(3) |
|
Interest on the variable debt obligations under the Loan and Security Agreement with Comerica
Bank is calculated at 3.25%, the interest rate in effect as of December 31, 2010. |
|
(4) |
|
Interest on the variable debt obligation under the credit facilities with Deerfield is
calculated at 7.5%, the interest rate in effect as of December 31, 2010. |
We are obligated under non-cancelable operating leases for all of our facilities and under certain
equipment leases. Original lease terms for our facilities in effect as of December 31, 2010 were
five to 10 years and generally require us to pay the real estate taxes, insurance and other
operating costs. Equipment lease terms generally range from three to five years.
Purchase obligations totaling $8.7 million are for outsourced services for clinical trials and
other research and development costs. Purchase obligations totaling $3.6 million are for software
related expenses. The remaining $3.0 million is for all other purchase commitments.
ITEM
3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Market risk represents the risk of loss that may impact our financial position, results of
operations or cash flows due to adverse changes in financial and commodity market prices, the
liquidity of ARS we hold and fluctuations in interest rates. All of our collaboration agreements
and nearly all purchase orders are denominated in U.S. dollars. As a result, historically and as of
December 31, 2010, we have had little or no exposure to market risk from changes in foreign
currency or exchange rates.
Our investment portfolio, without regard to our ARS, is comprised primarily of readily marketable,
high-quality securities diversified and structured to minimize market risks. We target our average
portfolio maturity at one year or less. Our exposure to market risk for changes in interest rates
relates primarily to our investments in marketable securities. Marketable securities held in our
investment portfolio are subject to changes in market value in response to changes in interest
rates and liquidity. As of December 31, 2010, $9.5 million of our investment portfolio was invested
in ARS that are not marketable as discussed below. In addition, a significant change in market
interest rates could have a material impact on interest income earned from our investment
portfolio. A theoretical 100 basis point change in interest rates and security prices would impact
our annual net loss positively or negatively by $990 thousand based on the current balance of $98.9
million of investments classified as cash and cash equivalents and short-term and long-term
marketable securities available for sale.
42
Our long-term marketable securities investment portfolio includes ARS. During the fiscal year ended
June 30, 2008 and subsequent thereto, auctions for all of our ARS were unsuccessful.
As of December 31, 2010, the Company held two securities with a par value of $12.3 million, a cost
basis of $5.2 million and an estimated fair value of $9.5 million. As of June 30, 2010, the
Company held five securities with a par value of $26.3 million, a cost basis of $11.0 million and
an estimated fair value of $16.6 million.
Due to unsuccessful auctions and continuing uncertainty and volatility in the credit markets, the
estimated fair value of our ARS has fluctuated and we have therefore recorded fair value
adjustments to our ARS as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
December 31, |
|
December 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
$ |
746 |
|
|
$ |
506 |
|
|
$ |
746 |
|
|
$ |
2,402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized losses |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(358 |
) |
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impairment losses |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(217 |
) |
Net unrealized gains reclassified from equity to earnings upon sale |
|
|
1,393 |
|
|
|
391 |
|
|
|
1,613 |
|
|
|
391 |
|
Additional gains (losses) incurred upon sale, net |
|
|
(528 |
) |
|
|
774 |
|
|
|
(815 |
) |
|
|
774 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized gains on auction rate securities, net |
|
$ |
865 |
|
|
$ |
1,165 |
|
|
$ |
798 |
|
|
$ |
948 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Due to the volatility of the underlying credit markets, the fair value of the ARS may continue to
fluctuate and we may experience additional impairments. In the event we need to access the funds
invested in any of our ARS prior to the time auctions of these investments are successful or the
original issuers retire these securities, we will be required to sell them in a distressed sale in
a secondary market, most likely for a significantly lower amount than their current fair value.
As of December 31, 2010, we had $141.8 million of debt outstanding, exclusive of the debt discount
of $25.6 million. The term loan under our senior secured credit facility with Comerica Bank of $15
million is variable rate debt. Assuming constant debt levels, a theoretical change of 100 basis
points on our current interest rate of 3.25% on the Comerica debt as of December 31, 2010 would
result in a change in our annual interest expense of $150 thousand. The interest rate on our
long-term debt under the credit facilities with Deerfield is variable based on our total cash, cash
equivalents and marketable securities balances. However, as long as our total cash, cash
equivalents and marketable securities balances remain above $60 million, our interest rate is fixed
at 7.5%. Assuming constant debt levels, a theoretical change of 100 basis points on our current
rate of interest of 7.5% on the Deerfield credit facilities as of December 31, 2010 would result in
a change in our annual interest expense of $1.2 million.
Historically and as of December 31, 2010, we have not used foreign currency derivative instruments
or engaged in hedging activities.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Under the supervision and with the participation of our Chief Executive Officer, Chief Financial
Officer and other senior management personnel, we evaluated the effectiveness of the design and
operation of our disclosure controls and procedures as of the end of the period covered by this
Quarterly Report on Form 10-Q (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities
Exchange Act of 1934). Based on this evaluation, our Chief Executive Officer and Chief Financial
Officer have concluded that our disclosure controls and procedures as of December 31, 2010 were
effective to provide a reasonable level of assurance that the information we are required to
disclose in reports that we submit or file under the
43
Securities Act of 1934 (i) is recorded,
processed, summarized and reported within the time periods specified in the SEC rules and forms;
and (ii) is accumulated and communicated to our management, including our Chief Executive Officer
and Chief Financial Officer, as appropriate to allow timely decisions regarding required
disclosure. Our disclosure controls and procedures are designed to provide reasonable assurance
that such information is accumulated and communicated to management. Our disclosure controls and
procedures include components of our internal control over financial reporting. Managements
assessment of the effectiveness of our disclosure controls and procedures is expressed at a
reasonable level of assurance because an internal control system, no matter how well designed and
operated, can provide only reasonable, but not absolute, assurance that the internal control
systems objectives will be met.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting during the quarter ended
December 31, 2010 that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
44
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
None
ITEM 1A. RISK FACTORS
Investing in our common stock is subject to a number of risks and uncertainties. We have updated
the following risk factors to reflect changes during the quarter ended December 31, 2010 we believe
to be material to the risk factors set forth in our Annual Report on Form 10-K for the fiscal year
ended June 30, 2010 filed with the Securities and Exchange Commission. The risks and uncertainties
described below are not the only ones that we face and are more fully described in our Annual
Report on Form 10-K and in other reports we file with the Securities and Exchange Commission.
Additional risks and uncertainties not presently known to us or that we currently believe are
immaterial also may negatively impact our business.
Risks Related to Our Business
We have a history of operating losses and may not achieve or sustain profitability.
We have incurred significant operating and net losses and negative cash flows from operations since
our inception. As of December 31, 2010, we had an accumulated deficit of $513.9 million. We had net
losses of $12.4 million and $23.1 million, respectively for the three and six months ended December
31, 2010. We had net losses of $77.6 million, $127.8 million and $96.3 million, for the fiscal
years ended June 30, 2010, 2009 and 2008, respectively. We expect to incur additional losses and
negative cash flows in the future, and these losses may continue or increase in part due to
anticipated levels of expenses for research and development, particularly clinical development,
expansion of our clinical and scientific capabilities, and acquisitions of complementary
technologies or in-licensed drug candidates. As a result, we may not be able to achieve or maintain
profitability.
Moreover, if we do achieve profitability, the level of any profitability cannot be predicted and
may vary significantly. Much of our current revenue is non-recurring in nature and unpredictable as
to timing and amount. While several of our out-licensing and collaboration agreements provide for
royalties on product sales, given that none of our drug candidates have been approved for
commercial sale, that our drug candidates are at early stages of development and that drug
development entails a high degree of risk of failure, we do not expect to receive any royalty
revenue for several years, if at all. For the same reasons, we may never realize much of the
milestone revenue provided for in our out-license and collaboration agreements. Similarly, drugs we
select to commercialize ourselves or partner for later-stage co-development and commercialization
may not generate revenue for several years, or at all.
Because we rely on a small number of collaborators for a significant portion of our revenue, if one
or more of our major collaborators terminates or reduces the scope of its agreement with us, our
revenue may significantly decrease.
A relatively small number of collaborators account for a significant portion of our revenue. Amgen,
Genentech, Celgene and Novartis accounted for 39%, 22%, 21% and 18%, respectively, of our total
revenue for the first six months of fiscal 2011; and 5%, 54%, 33% and 0% for the first six months
of the prior year, respectively. We expect that revenue from a limited number of collaborators,
including Celgene, Genentech, Amgen and Novartis, will account for a large portion of our revenue
in future quarters. In general, our collaborators may terminate their contracts with us upon 60 to
180 days notice for a number of reasons. In addition, some of our major collaborators can
determine the amount of products delivered and research or development performed under these
agreements. As a result, if any
45
one of our major collaborators cancels, declines to renew or reduces the scope of its contract with
us, our revenue may significantly decrease.
We may not be successful in entering into additional out-license agreements on favorable terms,
which may adversely affect our liquidity or require us to change our spending priorities on our
proprietary programs.
We are committing significant resources to create our own proprietary drug candidates and to build
a commercial-stage biopharmaceutical company. We have built our clinical and discovery programs
through spending $428.9 million from our inception through December 31, 2010. During the first six
months of fiscal 2011 we spent $28.3 million in research and development for proprietary programs.
In fiscal 2010, we spent $72.5 million in research and development for proprietary programs,
compared to $89.6 million and $90.3 million for fiscal years 2009 and 2008, respectively. Our
proprietary drug discovery programs are in their early stage of development and are unproven. Our
ability to continue to fund our planned spending on our proprietary drug programs and in building
our commercial capabilities depends to a large degree on up-front fees, milestone payments and
other revenue we receive as a result of our partnered programs. To date, we have entered into six
out-licensing agreements for the development and commercialization of our drug candidates, and we
plan to continue initiatives during fiscal 2011 to partner select clinical candidates to obtain
additional capital. We may not be successful, however in entering into additional out-licensing
agreements with favorable terms, including up-front, milestone, royalty and/or license payments and
the retention of certain valuable commercialization or co-promote rights, as a result of factors,
many of which are outside of our control. These factors include:
|
● |
|
Our ability to create valuable proprietary drugs targeting large market
opportunities; |
|
|
● |
|
Research and spending priorities of potential licensing partners; |
|
|
● |
|
Willingness of and the resources available to pharmaceutical and
biotechnology companies to in-license drug candidates to fill their clinical pipelines; |
|
|
● |
|
The success or failure, and timing, or pre-clinical and clinical trials on
our proprietary programs we intend to out-license; or |
|
|
● |
|
Our ability or inability to generate proof-of-concept data and to agree
with a potential partner on the value of proprietary drug candidates we are seeking to
out-license, or on the related terms. |
If we are unable to enter into out-licensing agreements and realize milestone, license and/or
upfront fees when anticipated, it may adversely affect our liquidity and we may be forced to
curtail or delay development of all or some of our proprietary programs, which in turn may harm our
business and the value of our stock. In addition, insufficient funds may require us to relinquish
greater rights to product candidates at an earlier stage of development or on less favorable terms
to us or our stockholders than we would otherwise choose in order to obtain funding for further
development and/or up-front license fees needed to fund our operations.
If we need but are unable to obtain additional funding to support our operations, we could be
unable to successfully execute our operating plan or be forced to reduce our operations.
We have historically funded our operations through revenue from our collaborations and out-license
transactions, the issuance of equity securities and debt financing. We used $31.9 million for our
operating activities in the first six months of fiscal 2011. A portion of our cash flow is
dedicated to the payment of interest under our existing senior secured Term Loan with Comerica
Bank, and to the payment of principal and interest on our credit facilities with Deerfield. In
addition, the principal amounts outstanding under the senior credit facility and the Deerfield
credit facilities becomes due and payable in 2013 and 2014, respectively. Our debt obligations
could therefore render us more vulnerable to competitive pressures and economic downturns and
impose some restrictions on our operations.
46
Our current operating plan and assumptions could change as a result of many factors, and we could
require additional funding sooner than anticipated. If we are unable to meet our capital
requirements from cash generated by our future operating activities and are unable to obtain
additional funds when needed, we may be required to curtail operations significantly or to obtain
funds through other arrangements on unattractive terms, which could prevent us from successfully
executing our operating plan. If we raise additional capital through the sale of equity or
convertible debt securities, the issuance of those securities would result in dilution to our
stockholders.
Because our stock price may be volatile, our stock price could experience substantial declines.
The market price of our common stock has historically experienced and may continue to experience
volatility. The high and low closing bids for our common stock were $3.58 and $2.98, respectively
for the second quarter of fiscal 2011; $3.44 and $2.67, respectively, during the first quarter of
fiscal 2011; $4.45 and $1.72, respectively, during the fiscal 2010; $8.79 and $2.51, respectively,
during fiscal 2009; and $12.91 and $4.66, respectively, in fiscal 2008. Our quarterly operating
results, the success or failure of our internal drug discovery efforts, decisions to delay, modify
or cease one or more of our development programs, uncertainties about our ability to continue to
operate as a going concern, changes in general conditions in the economy or the financial markets
and other developments affecting our collaborators, our competitors or us could cause the market
price of our common stock to fluctuate substantially. This volatility coupled with market declines
in our industry over the past several years have affected the market prices of securities issued by
many companies, often for reasons unrelated to their operating performance, and may adversely
affect the price of our common stock. In the past, securities class action litigation has often
been instituted following periods of volatility in the market price of a companys securities. A
securities class action suit against us could result in potential liabilities, substantial costs
and the diversion of managements attention and resources, regardless of whether we win or lose.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. RESERVED
ITEM 5. OTHER INFORMATION
None
ITEM
6. EXHIBITS
|
|
|
Exhibit Number |
|
Description of Exhibit |
|
|
|
31.1
|
|
Certification of Chief Executive Officer pursuant to
Rule 13a-14(a) and 15d-14(a) of the Securities Exchange
Act of 1934, as amended. |
31.2
|
|
Certification of Chief Financial Officer pursuant to
Rule 13a-14(a) and 15d-14(a) of the Securities Exchange
Act of 1934, as amended. |
32.1
|
|
Certifications of Chief Executive Officer and Chief
Financial Officer pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002. |
47
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City
of Boulder, State of Colorado, on this 31st day of January 2011.
|
|
|
|
|
|
|
ARRAY BIOPHARMA INC.
|
|
|
By: |
/s/ Robert E. Conway
|
|
|
|
Robert E. Conway |
|
|
|
Chief Executive Officer |
|
|
|
|
|
By: |
/s/ R. Michael Carruthers
|
|
|
|
R. Michael Carruthers |
|
|
|
Chief Financial Officer
(Principal Financial and
Accounting Officer) |
|
48