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 March 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
(State or Other Jurisdiction of
Incorporation or Organization)
|
|
84-1460811
(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 April 29, 2010, the
registrant had 53,105,714 shares of common stock outstanding.
ARRAY BIOPHARMA INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED MARCH 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)
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
June 30, |
|
|
2010 |
|
2009 |
ASSETS |
|
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
82,560 |
|
|
$ |
33,202 |
|
Marketable securities |
|
|
19 |
|
|
|
7,296 |
|
Prepaid expenses and other current assets |
|
|
5,205 |
|
|
|
4,419 |
|
|
|
|
|
|
Total current assets |
|
|
87,784 |
|
|
|
44,917 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term assets |
|
|
|
|
|
|
|
|
Marketable securities |
|
|
17,757 |
|
|
|
16,990 |
|
Property and equipment, net |
|
|
22,687 |
|
|
|
26,498 |
|
Other long-term assets |
|
|
3,251 |
|
|
|
6,650 |
|
|
|
|
|
|
Total long-term assets |
|
|
43,695 |
|
|
|
50,138 |
|
|
|
|
|
|
Total assets |
|
$ |
131,479 |
|
|
$ |
95,055 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS DEFICIT |
|
|
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
|
|
Accounts payable and other accrued expenses |
|
$ |
8,939 |
|
|
$ |
8,421 |
|
Accrued outsourcing costs |
|
|
5,314 |
|
|
|
4,759 |
|
Accrued compensation and benefits |
|
|
7,478 |
|
|
|
7,848 |
|
Deferred rent |
|
|
3,142 |
|
|
|
3,034 |
|
Deferred revenue |
|
|
41,432 |
|
|
|
11,233 |
|
Current portion of long-term debt |
|
|
- |
|
|
|
15,000 |
|
|
|
|
|
|
Total current liabilities |
|
|
66,305 |
|
|
|
50,295 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities |
|
|
|
|
|
|
|
|
Deferred rent |
|
|
19,098 |
|
|
|
21,481 |
|
Deferred revenue |
|
|
42,669 |
|
|
|
28,340 |
|
Long-term debt, net |
|
|
111,238 |
|
|
|
68,170 |
|
Derivative liabilities |
|
|
863 |
|
|
|
- |
|
Other long-term liability |
|
|
797 |
|
|
|
470 |
|
|
|
|
|
|
Total long-term liabilities |
|
|
174,665 |
|
|
|
118,461 |
|
|
|
|
|
|
Total liabilities |
|
|
240,970 |
|
|
|
168,756 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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; 51,134,346 and 48,125,776 shares
issued and outstanding, as of March 31, 2010 and
June 30, 2009, respectively |
|
|
51 |
|
|
|
48 |
|
Additional paid-in capital |
|
|
323,213 |
|
|
|
312,349 |
|
Warrants |
|
|
36,296 |
|
|
|
23,869 |
|
Accumulated
other comprehensive income |
|
|
5,933 |
|
|
|
3,234 |
|
Accumulated deficit |
|
|
(474,984 |
) |
|
|
(413,201 |
) |
|
|
|
|
|
Total stockholders deficit |
|
|
(109,491 |
) |
|
|
(73,701 |
) |
|
|
|
|
|
Total liabilities and stockholders deficit |
|
$ |
131,479 |
|
|
$ |
95,055 |
|
|
|
|
|
|
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 |
|
Nine Months Ended |
|
|
March 31, |
|
March 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
5,396 |
|
|
$ |
4,399 |
|
|
$ |
14,874 |
|
|
$ |
13,427 |
|
License and milestone revenue |
|
|
12,980 |
|
|
|
1,639 |
|
|
|
21,036 |
|
|
|
6,047 |
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
18,376 |
|
|
|
6,038 |
|
|
|
35,910 |
|
|
|
19,474 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
|
7,946 |
|
|
|
5,515 |
|
|
|
19,103 |
|
|
|
15,698 |
|
Research and development for proprietary drug discovery |
|
|
17,692 |
|
|
|
20,029 |
|
|
|
55,997 |
|
|
|
68,248 |
|
General and administrative |
|
|
4,264 |
|
|
|
4,461 |
|
|
|
12,938 |
|
|
|
13,435 |
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
29,902 |
|
|
|
30,005 |
|
|
|
88,038 |
|
|
|
97,381 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(11,526 |
) |
|
|
(23,967 |
) |
|
|
(52,128 |
) |
|
|
(77,907 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impairment of marketable securities |
|
|
- |
|
|
|
(3,381 |
) |
|
|
(217 |
) |
|
|
(17,742 |
) |
Gain (loss) on sale of marketable securities |
|
|
357 |
|
|
|
- |
|
|
|
1,521 |
|
|
|
- |
|
Interest income |
|
|
164 |
|
|
|
412 |
|
|
|
726 |
|
|
|
1,823 |
|
Interest expense |
|
|
(4,152 |
) |
|
|
(2,674 |
) |
|
|
(11,685 |
) |
|
|
(7,289 |
) |
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
|
(3,631 |
) |
|
|
(5,643 |
) |
|
|
(9,655 |
) |
|
|
(23,208 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(15,157 |
) |
|
|
(29,610 |
) |
|
|
(61,783 |
) |
|
|
(101,115 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in
unrealized gains (losses) on marketable securities |
|
|
711 |
|
|
|
(222 |
) |
|
|
2,699 |
|
|
|
2,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(14,446 |
) |
|
$ |
(29,832 |
) |
|
$ |
(59,084 |
) |
|
$ |
(98,944 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding - basic and diluted |
|
|
50,697 |
|
|
|
48,068 |
|
|
|
49,403 |
|
|
|
47,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share - basic and diluted |
|
$ |
(0.30 |
) |
|
$ |
(0.62 |
) |
|
$ |
(1.25 |
) |
|
$ |
(2.12 |
) |
|
|
|
|
|
|
|
|
|
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, 2009 |
|
|
- |
|
|
$ |
- |
|
|
|
48,125 |
|
|
$ |
48 |
|
|
$ |
312,349 |
|
|
$ |
23,869 |
|
|
$ |
3,234 |
|
|
$ |
(413,201 |
) |
|
$ |
(73,701 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock under stock option
and employee stock purchase plans |
|
|
- |
|
|
|
- |
|
|
|
708 |
|
|
|
1 |
|
|
|
1,111 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,112 |
|
Share-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,177 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
4,177 |
|
Issuance of common stock for cash,
net of offering costs |
|
|
- |
|
|
|
- |
|
|
|
1,301 |
|
|
|
1 |
|
|
|
3,165 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,166 |
|
Issuance of common stock warrants |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
12,427 |
|
|
|
- |
|
|
|
- |
|
|
|
12,427 |
|
Payment of employee bonus with stock |
|
|
- |
|
|
|
- |
|
|
|
1,000 |
|
|
|
1 |
|
|
|
2,411 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
2,412 |
|
Recognition of unrealized gain out of accumulated
other comprehensive income to earnings |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(915 |
) |
|
|
- |
|
|
|
(915 |
) |
Change in unrealized gain on
marketable securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
3,614 |
|
|
|
- |
|
|
|
3,614 |
|
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(61,783 |
) |
|
|
(61,783 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of March 31, 2010 |
|
|
- |
|
|
$ |
- |
|
|
|
51,134 |
|
|
$ |
51 |
|
|
$ |
323,213 |
|
|
$ |
36,296 |
|
|
$ |
5,933 |
|
|
$ |
(474,984 |
) |
|
$ |
(109,491 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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)
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended March 31, |
|
|
2010 |
|
2009 |
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(61,783 |
) |
|
$ |
(101,115 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
|
4,837 |
|
|
|
4,934 |
|
Non-cash interest expense for the Deerfield Credit Facility |
|
|
5,047 |
|
|
|
5,624 |
|
Share-based compensation expense |
|
|
4,177 |
|
|
|
4,283 |
|
Realized gain on marketable securities |
|
|
(1,521 |
) |
|
|
- |
|
Impairment of marketable securities |
|
|
217 |
|
|
|
17,742 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other current assets |
|
|
(76 |
) |
|
|
1,048 |
|
Accounts payable and other accrued expenses |
|
|
518 |
|
|
|
1,928 |
|
Accrued outsourcing costs |
|
|
555 |
|
|
|
(6,567 |
) |
Accrued compensation and benefits |
|
|
2,042 |
|
|
|
(697 |
) |
Deferred rent |
|
|
(2,275 |
) |
|
|
(2,015 |
) |
Deferred revenue |
|
|
44,528 |
|
|
|
702 |
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(3,734 |
) |
|
|
(74,133 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(1,026 |
) |
|
|
(2,953 |
) |
Purchases of marketable securities |
|
|
- |
|
|
|
(19,209 |
) |
Proceeds from sales and maturities of marketable securities |
|
|
10,840 |
|
|
|
50,733 |
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
9,814 |
|
|
|
28,571 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options and shares issued
under the employee stock purchase plan |
|
|
1,112 |
|
|
|
1,675 |
|
Proceeds from the issuance of common stock for cash |
|
|
3,536 |
|
|
|
- |
|
Payment of offering costs |
|
|
(370 |
) |
|
|
- |
|
Proceeds from the issuance of long-term debt and warrants |
|
|
40,000 |
|
|
|
40,000 |
|
Payment of transaction fee |
|
|
(1,000 |
) |
|
|
(1,000 |
) |
|
|
|
|
|
Net cash provided by financing activities |
|
|
43,278 |
|
|
|
40,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
49,358 |
|
|
|
(4,887 |
) |
Cash and cash equivalents as of beginning of period |
|
|
33,202 |
|
|
|
56,448 |
|
|
|
|
|
|
Cash and cash equivalents as of end of period |
|
$ |
82,560 |
|
|
$ |
51,561 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
6,106 |
|
|
$ |
1,480 |
|
|
|
|
|
|
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 March 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 proteins. 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 March 31, 2010, its results of operations for the three
and nine months ended March 31, 2010 and 2009, and its cash flows for the nine months ended March
31, 2010 and 2009. Operating results for the three and nine months ended March 31, 2010 are not
necessarily indicative of the results that may be expected for the year ending June 30, 2010.
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, 2009 filed with the SEC on August 18, 2009.
Certain fiscal 2009 amounts have been reclassified to conform to the current year presentation.
Specifically, Accounts Payable and Other Accrued Expenses were aggregated into one line item,
Accounts Payable and Other Accrued Expenses, in the accompanying Condensed Balance Sheets.
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 fair value of the Companys auction rate securities
(ARS); (ii) estimating accrued outsourcing costs for clinical trials and preclinical testing;
(iii) 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; and
(iv) estimating the lives over which up-front and milestone payments from collaboration agreements
are recognized.
5
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
Liquidity
The Company has incurred operating losses and has an accumulated deficit primarily as a result of
ongoing research and development spending. As of March 31, 2010, the Company had an accumulated
deficit of $475.0 million. The Company had net losses of $15.2 million and $29.6 million for the
three months ended March 31, 2010 and 2009, respectively, and $61.8 million and $101.1 million for
the nine months ended March 31, 2010 and 2009, respectively. The Company had net losses of
$127.8 million, $96.3 million and $55.4 million for the fiscal years ended June 30, 2009, 2008 and
2007, respectively.
The Company has historically funded its operations through payments under its collaborations and
out-licensing transactions, the issuance of equity securities and through debt provided by its
credit facilities. 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 that were generated
primarily from these sources.
The Company believes that its cash, cash equivalents and marketable securities, including the $45
million upfront and milestone payment from Novartis International Pharmaceutical Ltd. discussed
below and excluding the value of the ARS it holds, will enable it to continue to fund its
operations for more than the next 12 months. The Companys current operating plan contemplates the
receipt of significant additional upfront payments from new collaboration or licensing deals and
milestone payments from existing collaborations in the next 12 months. The Company is currently in
active licensing discussions with a number of potential partners on select programs and recently
entered into two new licensing transactions that include upfront and milestone payments as well as
royalties. In December 2009, the Company received a $60 million up front payment from Amgen Inc.
under a Collaboration and License Agreement with Amgen for the Companys small-molecule glucokinase
activator, AMG 151 / ARRY-403. In April 2010, the Company signed a License Agreement with Novartis
International Pharmaceutical Ltd. under which the Company will receive $45 million in an upfront
and milestone payment in the fourth quarter of fiscal 2010, as discussed further in Note 10
Subsequent Event. There can be no guarantee, however, that the Company will be successful in
entering into new collaboration or licensing transactions that include upfront and milestone
payments or that the milestones will be achieved under existing collaborations resulting in the
payment of milestone payments when anticipated.
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
further 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.
6
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
Fair Value Measurements
The Companys financial instruments are recognized and measured at fair value in the Companys
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. 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 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. |
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 and the embedded derivatives associated
with the Companys 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 carrying value of the investment is written down to its
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 March 31, 2010 and June 30, 2009 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 will remain available-for-sale based on the Companys then current intent and
ability to sell the security if it is
7
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
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 are reported in Realized Gains (Losses) on Sales of Marketable Securities
in the accompanying Condensed Statements of Operations and Comprehensive Loss as incurred. Declines
in value judged to be other-than-temporary are reported in Impairment of Marketable Securities in
the accompanying Condensed Statements of Operations and Comprehensive Loss as 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 beginning with the first quarter of fiscal 2009
and continuing through the current fiscal 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.
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 reasonably assured
term of the leases.
The carrying value for property and equipment is reviewed for impairment when events or changes in
circumstances indicate 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 and may continue to enter into 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.
8
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
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 under its collaboration agreements, but not earned, as
Deferred Revenue, which are then classified as current or long-term in the accompanying Condensed
Balance Sheets based on period over which they are expected to be recognized as revenue.
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.
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 the
ability of Deerfield to accelerate the repayment of the debt in the event of certain changes in
control of the Company. 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 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
of July 31, 2009 and continuing through the current quarter. The estimated fair value of the
Embedded Derivatives was determined based on managements judgment and assumptions. The use of
different assumptions could result in significantly different estimated fair values.
The fair value of the Embedded Derivatives was initially recorded as Derivative Liabilities and as
Debt Discount in the Companys accompanying 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
9
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
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 issued by the Company 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 relating to the Companys 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.
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 initial lease term. Deferred Rent balances are classified as short-term or long-term in
the accompanying Condensed Balance Sheets based upon 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).
10
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
The estimated fair value of stock options is based on the 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, the sale of chemical compounds and
the co-development of proprietary drug candidates that the Company out-licenses, as Collaboration
Revenue. License and Milestone Revenue is combined and consists of the current periods recognized
up-front fees and ongoing milestone payments from collaborators.
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 related to 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 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 term, the specific number of
full-time-equivalent scientists working a defined number of hours per year at a stated price under
the agreement, the existence, or likelihood of achievement, of development commitments, and 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 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 related to activities for which there are no future obligations, and as a result, are
recognized when earned in their entirety.
11
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
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 related to non-refundable license
fees and up-front payments and to milestone payments could be accelerated in the event of early
termination of programs or alternatively, decelerated, if programs are extended.
Cost of Revenue and Research and Development Expenses for Proprietary Drug Discovery
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 Expenses for Proprietary Drug Discovery based upon the
respective time spent by its scientists on development conducted for its collaborators and for its
internal proprietary programs, respectively. 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 Expenses for Proprietary Drug Discovery consist of
direct and indirect costs related to 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 or 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.
For example, the Company granted Celgene Corporation an option to select up to two of four programs
developed under its collaboration agreement with Celgene and concluded that Celgene was likely to
exercise its option with respect to two of the four programs. Accordingly, the Company reported
costs associated with the Celgene collaboration as follows: 50% to Cost of Revenue, with the
remaining 50% to Research and Development Expenses for Proprietary Drug Discovery. 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 Expenses for Proprietary Drug Discovery. See Note 4 Deferred
Revenue, for further information about the Companys collaboration with Celgene.
Net Loss per Share
Basic net loss per share is computed by dividing net loss for the period by the weighted averaged
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 Condensed Financial Statements, all potentially
12
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
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 loss and unrealized gains
and losses on investments in available-for-sale marketable securities. The Company had no other
sources of comprehensive income (loss) for the fiscal periods presented.
Recent Accounting Pronouncements
Collaborative Arrangements - In the first quarter of fiscal 2010, new guidance relating to the
accounting practices and disclosures for collaborative arrangements became effective. A
collaborative arrangement is a contractual arrangement that involves a joint operating activity.
These arrangements involve two (or more) parties who are both (a) active participants in the
activity and (b) exposed to significant risks and rewards dependent on the commercial success of
the activity. If the Companys collaboration agreements are determined to be collaborative
arrangements, additional disclosures may be required by this guidance beginning with this Quarterly
Report on Form 10-Q. The Company determined that while certain agreements are collaborative
arrangements, none of the current activities being performed under those arrangements would require
a change to the accounting practices or disclosures made by the Company in its Quarterly Reports on
Form 10-Q and Annual Reports on Form 10-K.
Convertible Debt - In the first quarter of fiscal 2010, guidance relating to the accounting for
convertible debt became effective. The Company determined that none of its credit facilities are
considered convertible debt as defined under this accounting guidance and therefore this
pronouncement had no impact on its financial statements and disclosures.
Fair Value Measurements - In August 2009 and January 2010, new literature was issued giving
companies additional guidance relating to the fair value measurements and disclosures of
liabilities. The guidance issued in August 2009 was effective for the Company for the first
quarter of fiscal 2010 and was adopted at that time. The guidance issued in January 2010 was
effective for the Company for the third quarter of fiscal 2010 and was adopted at that time. The
effect of these new literatures is reflected in the accompanying Condensed Financial Statements.
Revenue Recognition for Multiple Deliverable Arrangements - In October 2009, new guidance was
issued related to multiple-deliverable revenue arrangements that are effective for the Company
prospectively for revenue arrangements entered into or materially modified subsequent to July 1,
2010. The objective of this change is to address the accounting for multiple-deliverable
arrangements to enable companies to account more easily for products or services (deliverables)
separately rather than as a combined unit. The Company is currently evaluating the impact of this
guidance on its financial statements.
Subsequent
Events - In February 2010, new guidance was issued related to the recognition and
disclosure of subsequent events. The guidance was effective when issued, and all material events occurring subsequent to March 31, 2010 are disclosed in the
accompanying Condensed Financial Statements.
Milestone Revenue Recognition - In March 2010, new guidance was issued related to accounting for
milestone revenue recognition. The guidance is effective for the Company for the first quarter of
fiscal 2011 though early adoption is permitted. The Company adopted the guidance in the current
quarter which didnt have a material impact on the Companys accompanying Condensed Financial Statements.
13
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
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.
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 March 31, |
|
Nine Months Ended March 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America |
|
$ |
18,310 |
|
|
$ |
6,005 |
|
|
$ |
35,706 |
|
|
$ |
19,111 |
|
Europe |
|
|
52 |
|
|
|
25 |
|
|
|
161 |
|
|
|
333 |
|
Asia Pacific |
|
|
14 |
|
|
|
8 |
|
|
|
43 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
18,376 |
|
|
$ |
6,038 |
|
|
$ |
35,910 |
|
|
$ |
19,474 |
|
|
|
|
|
|
|
|
|
|
Significant Collaborators
The following collaborators contributed greater than 10% of total revenue during the periods set
forth below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Nine Months Ended March 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amgen Inc. |
|
|
34.7 |
% |
|
|
0.0 |
% |
|
|
20.3 |
% |
|
|
0.0 |
% |
Celgene Corporation |
|
|
22.5 |
% |
|
|
23.7 |
% |
|
|
27.5 |
% |
|
|
22.0 |
% |
Genentech, Inc. |
|
|
42.1 |
% |
|
|
70.6 |
% |
|
|
48.0 |
% |
|
|
66.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
99.3 |
% |
|
|
94.3 |
% |
|
|
95.8 |
% |
|
|
88.4 |
% |
|
|
|
|
|
|
|
|
|
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 March 31, 2010.
NOTE 3 MARKETABLE SECURITIES
The Companys investments in marketable securities include domestic public corporate debt
securities, commercial paper issued by domestic public companies, obligations of U.S. federal
government agencies and ARS. All of these investments are held in the name of the Company at a
limited number of financial institutions. The Companys investments in marketable securities were
all classified as available-for-sale as of March 31, 2010 and June 30, 2009.
14
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
Marketable securities consisted of the following as of March 31, 2010 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mutual fund securities |
|
$ |
19 |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
19 |
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
19 |
|
|
|
- |
|
|
|
- |
|
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
|
11,028 |
|
|
|
5,933 |
|
|
|
- |
|
|
|
16,961 |
|
Mutual fund securities |
|
|
796 |
|
|
|
- |
|
|
|
- |
|
|
|
796 |
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
11,824 |
|
|
|
5,933 |
|
|
|
- |
|
|
|
17,757 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
11,843 |
|
|
$ |
5,933 |
|
|
$ |
- |
|
|
$ |
17,776 |
|
|
|
|
|
|
|
|
|
|
Marketable securities consisted of the following as of June 30, 2009 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Short-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government agency securities |
|
|
7,059 |
|
|
|
- |
|
|
|
- |
|
|
|
7,059 |
|
Mutual fund securities |
|
|
237 |
|
|
|
- |
|
|
|
- |
|
|
|
237 |
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
7,296 |
|
|
|
- |
|
|
|
- |
|
|
|
7,296 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
|
13,284 |
|
|
|
3,234 |
|
|
|
- |
|
|
|
16,518 |
|
Mutual fund securities |
|
|
472 |
|
|
|
- |
|
|
|
- |
|
|
|
472 |
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
13,756 |
|
|
|
3,234 |
|
|
|
- |
|
|
|
16,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
21,052 |
|
|
$ |
3,234 |
|
|
$ |
- |
|
|
$ |
24,286 |
|
|
|
|
|
|
|
|
|
|
The fair value measurement categories of these marketable securities as of March 31, 2010 and June
30, 2009 were as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
Quoted prices in active markets for
identical assets (Level 1) |
|
$ |
815 |
|
|
$ |
7,768 |
|
Significant unobservable inputs (Level 3) |
|
|
16,961 |
|
|
|
16,518 |
|
|
|
|
|
|
|
|
$ |
17,776 |
|
|
$ |
24,286 |
|
|
|
|
|
|
15
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
The amortized cost and estimated fair value of available-for-sale securities by contractual
maturity as of March 31, 2010 is as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Fair |
|
|
|
Cost |
|
Value |
|
Due in one year or less |
|
$ |
19 |
|
|
$ |
19 |
|
Due in one year to three years |
|
|
796 |
|
|
|
796 |
|
Due after 10 years or more |
|
|
11,028 |
|
|
|
16,961 |
|
|
|
|
|
|
|
|
$ |
11,843 |
|
|
$ |
17,776 |
|
|
|
|
|
|
Auction Rate Securities
The Companys ARS are currently not liquid. Auctions in the related markets for the ARS were
unsuccessful during fiscal 2009 and were suspended during the first and second quarters of fiscal
2009. 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 through the current fiscal
quarter. 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 March 31, 2010, the Company held five securities with a par value of $26.3 million and an
estimated fair value of $17.0 million. As of June 30, 2009, the Company held seven securities with
a par value of $32.9 million and an estimated fair value of $16.5 million. The Company sold one of
the ARS in the second quarter of fiscal 2010 with a par value of $4.0 million for $2.8 million and
realized a gain of $1.2 million, with $394 thousand recognized from Accumulated Other Comprehensive
Income. The Company sold one of the ARS in the third quarter of fiscal 2010 with a par value of
$2.6 million for $715 thousand and realized a gain of $357 thousand, with $524 thousand recognized
from Accumulated Other Comprehensive Income.
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 beginning with the first quarter of fiscal 2009
and continuing through the current fiscal 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.
16
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 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 March 31, |
|
Nine Months Ended March 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains |
|
$ |
1,210 |
|
|
$ |
- |
|
|
$ |
3,614 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Realized gains |
|
$ |
357 |
|
|
$ |
- |
|
|
$ |
1,521 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses attributable to the change in
unrealized losses |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
(1,939 |
) |
Other current period losses |
|
|
- |
|
|
|
(3,381 |
) |
|
|
(217 |
) |
|
|
(15,803 |
) |
|
|
|
|
|
|
|
|
|
Total impairment of marketable securities |
|
$ |
- |
|
|
$ |
(3,381 |
) |
|
$ |
(217 |
) |
|
$ |
(17,742 |
) |
|
|
|
|
|
|
|
|
|
The Company has recorded cumulative net fair value declines to its five ARS of $11.9 million as
of March 31, 2010.
A rollforward of adjustments to the fair value of the ARS for the nine months ended March 31, 2010
and 2009 follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended March 31, |
|
|
|
2010 |
|
2009 |
|
|
|
|
|
Balance as of prior year end |
|
$ |
16,518 |
|
|
$ |
29,089 |
|
Add: Current period gains included in equity |
|
|
3,614 |
|
|
|
239 |
|
Add: Current period gains included in earnings |
|
|
1,521 |
|
|
|
- |
|
Less: Sale of ARS |
|
|
(3,560 |
) |
|
|
- |
|
Less:
Recognition of unrealized gain from
Accumulated Other Comprehensive Income
|
|
|
(915 |
) |
|
|
- |
|
Less: Current period losses included in earnings |
|
|
(217 |
) |
|
|
(15,803 |
) |
|
|
|
|
|
Balance as of current quarter end |
|
$ |
16,961 |
|
|
$ |
13,525 |
|
|
|
|
|
|
17
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
NOTE 4
DEFERRED REVENUE
Deferred revenue consisted of the following (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
|
2010 |
|
2009 |
|
Amgen, Inc. |
|
$ |
55,521 |
|
|
$ |
- |
|
Celgene Corporation |
|
|
24,591 |
|
|
|
34,429 |
|
Genentech, Inc. |
|
|
3,989 |
|
|
|
5,060 |
|
Other |
|
|
- |
|
|
|
84 |
|
|
|
|
|
|
Total deferred revenue |
|
|
84,101 |
|
|
|
39,573 |
|
Less: Current portion |
|
|
(41,432 |
) |
|
|
(11,233 |
) |
|
|
|
|
|
Deferred revenue, long term |
|
$ |
42,669 |
|
|
$ |
28,340 |
|
|
|
|
|
|
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 / ARRY-403. 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 / ARRY-403 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. 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 / ARRY-403 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 $5.8 million of revenue for the three and nine months ended March 31, 2010, respectively, which
is recorded in License and Milestone Revenue 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.
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.
18
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
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 under the agreement. The Company is
responsible for all discovery and clinical 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 targets and will receive exclusive worldwide rights
to the drugs, except for limited co-promotional rights in the U.S. Celgenes option may be
exercised with respect to drugs directed at any of the four targets at any time until the earlier
of completion of Phase 1 or Phase 2a trials for the drug or September 2014. Additionally, 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. The Company
will also receive royalties on net sales of any drugs. The Company retains all rights to the other
programs. In June 2009, the parties amended the Celgene 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 provisions of the agreement with Celgene were modified by the
amendment. In September 2009, Celgene notified the Company it was waiving its rights to one of the
programs, leaving it the option to select two of the remaining three targets.
The Company had previously 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 and the
Company would complete its obligations at that time. Therefore, the unamortized balance as of
September 30, 2009 is being amortized on a straight line basis over the shorter period. The
Company recognized $4.1 million and $1.4 million for the three months ended March 31, 2010 and
2009, respectively. The Company recognized $9.8 million and $4.3 million for the nine months ended
March 31, 2010 and 2009, respectively. These amounts are recorded in License and Milestone Revenue
in the accompanying Condensed Statements of Operations and Comprehensive Loss.
Celgene can also choose to 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 Celgene had
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 its option, upon
six months written notice to the 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.
19
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
NOTE 5 LONG-TERM DEBT
Long-term debt consists of the following (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
Credit facility |
|
$ |
126,762 |
|
|
$ |
86,286 |
|
Refinance term loan |
|
|
15,000 |
|
|
|
- |
|
Term loan |
|
|
- |
|
|
|
10,000 |
|
Equipment line of credit |
|
|
- |
|
|
|
5,000 |
|
|
|
|
|
|
Long-term debt, gross |
|
|
141,762 |
|
|
|
101,286 |
|
Less: Unamortized discount on credit facility |
|
|
(30,524 |
) |
|
|
(18,116 |
) |
|
|
|
|
|
Long-term debt, net |
|
|
111,238 |
|
|
|
83,170 |
|
Less: Current portion |
|
|
- |
|
|
|
(15,000 |
) |
|
|
|
|
|
Long-term debt |
|
$ |
111,238 |
|
|
$ |
68,170 |
|
|
|
|
|
|
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 is
9,622,220 shares, without obtaining stockholder approval.
Prior to the disbursement of the 2009 Loan, simple interest accrued on the full $80 million principal
amount under the 2008 Loan at a 2.0% annual rate and
compound interest accrued at an additional 6.5% annual rate. From the date of the Facility Agreement for the 2008
Loan through the July 31, 2009
disbursement date of the 2009 Loan, accrued 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 amended upon disbursement of
the 2009 Loan on July 31, 2009. As of this date, simple interest began accruing on the $80 million
principal balance at the rate of 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.
Simple interest began to accrue on the 2009 Loan when it was drawn on July 31, 2009 at the rate of
7.5% per annum. This 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
20
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
between 8.5% per annum and 14.5% per annum for every $10 million by which it is less than $60
million as follows:
|
|
|
|
|
|
|
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
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 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.
To estimate fair value of the variable interest rate feature, the Company made 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 was also
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. Based on this analysis, the Company estimated the
effective interest rate over the term of the note will be 7.55% as of July 31, 2009.
To estimate the fair value of the put right, the Company estimated the probability of a change in
control that would trigger Deerfields acceleration rights as specified in the loan provisions.
The Companys evaluation of this probability was 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. The Company estimated the
probability of Deerfield exercising the change in control put to be 5% at July 31, 2009.
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.
As of each quarter end, the Company re-values the effective interest rate and the probability of
the exercise of the change in control put. The assumptions used at July 31, 2009, described above,
did not change at September 30, 2009, and the estimated fair value of the Embedded Derivatives was
determined to be $938 thousand. The assumptions used at December 31, 2009 changed nominally for
the effective interest rate to 7.54% and remained at 5% for the probability of the exercise of the
change of control put. The estimated fair value of the Embedded Derivatives was determined to be
$857 thousand as of December 31, 2009. The assumptions used at March 31, 2010 remained at 7.54%
for the effective interest rate and at 5% for the probability of the exercise of the change of
control put. The estimated fair
21
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
value of the Embedded Derivatives based on these assumptions was determined to be $863 thousand as
of March 31, 2010.
The change in value of the Embedded Derivatives of $7 thousand and $(199) thousand was recorded as
an increase (reduction) to Interest Expense in the accompanying Statements of Operations and
Comprehensive Loss for the three and nine months ended March 31, 2010, respectively. Management
will 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.
The Company estimated that the fair value of the Deerfield debt was $92.2 million and $48.7 million
at March 31, 2010 and June 30, 2009, respectively. The primary reason for the difference in fair
value is that the Company had drawn only $80 million of the total $120 million under the Credit
Facilities as of June 30, 2009.
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 15.0% 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.
22
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
The Exchange Warrants contain substantially the same terms as the Prior Warrants, except that the
Exchange Warrants did not become exercisable until January 31, 2010 and have a lower per share
exercise price. The Warrants are exercisable commencing January 31, 2009 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%; |
|
|
|
|
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 of $3.65 and the value of the Prior
Warrants at the prior exercise price of $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 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 March 31, 2010
(Unaudited)
A reconciliation of the total interest expense recognized by the Company for the Deerfield Credit
Facilities for the three and nine months ended March 31, 2010 and 2009 follows (dollars in
thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Nine Months Ended March 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.0% simple interest |
|
$ |
- |
|
|
$ |
395 |
|
|
$ |
124 |
|
|
$ |
1,201 |
|
6.5% compounding interest |
|
|
- |
|
|
|
1,339 |
|
|
|
476 |
|
|
|
4,012 |
|
7.5% simple interest |
|
|
2,250 |
|
|
|
- |
|
|
|
6,000 |
|
|
|
- |
|
Amortization of the transaction fees |
|
|
140 |
|
|
|
795 |
|
|
|
408 |
|
|
|
1,612 |
|
Amortization of the debt discounts |
|
|
1,538 |
|
|
|
88 |
|
|
|
4,362 |
|
|
|
180 |
|
Change in value of the Embedded Derivatives |
|
|
7 |
|
|
|
- |
|
|
|
(199 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total interest expense on the Deerfield Credit Facility |
|
$ |
3,935 |
|
|
$ |
2,617 |
|
|
$ |
11,171 |
|
|
$ |
7,005 |
|
|
|
|
|
|
|
|
|
|
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 was 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 Refinance 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 will 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 4.0%, based on the total dollar amount the Company has invested at Comerica and
in what investment option those funds are invested.
In addition, total available revolving lines of credit of $6.8 million have been established to
support outstanding 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 March 31, 2010, the Refinance Term Loan had an interest rate of 3.25% per annum. The Company
recognized $217 thousand and $57 thousand of interest for the three months ended March 31, 2010 and
2009, respectively. The Company recognized $514 thousand and $284 thousand of interest for the nine
months ended March 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 the
Company must hold in accounts at Comerica Bank per the Loan and Security Agreement based on the
Companys
24
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
total Cash, Cash Equivalent and Marketable Securities, which was modified as part of the March 31,
2010 amendment.
|
|
|
|
|
|
|
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 $15.0 million and $14.3 million as
of March 31, 2010 and June 30, 2009, respectively.
Commitment Schedule
A summary of the Companys contractual commitments as of March 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 March 31, |
|
|
|
2011 |
|
$ |
- |
|
2012 |
|
|
- |
|
2013 |
|
|
- |
|
2014 |
|
|
15,000 |
|
2015 |
|
|
126,762 |
|
|
|
|
|
|
$ |
141,762 |
|
|
|
|
NOTE 6 NET LOSS PER SHARE
As a result of the Companys net losses for the three-month periods ended March 31, 2010 and 2009
all potentially dilutive securities were anti-dilutive and therefore have been excluded from the
computation of diluted net loss per share. As of March 31, 2010 and 2009, the number of potentially
dilutive common stock equivalents excluded from the diluted net loss per share calculations was
1,303,485 shares and 440,659 shares, respectively.
NOTE 7 SHARE BASED COMPENSATION EXPENSE
The Company adopted the modified prospective method for expensing share-based compensation as of
July 1, 2005, which requires that all share-based payments to employees be recognized in the
25
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
Condensed Statements of Operations and Comprehensive Loss at the fair value of the award on the
grant date. Under this method, the Company recognizes compensation expense equal to the grant date
fair value for all share-based payments (i) granted prior to, but not yet vested, as of July 1,
2005 and (ii) granted on or after July 1, 2005. Shared-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 13
Employee Compensation Plans to the Companys audited financial statements included in its Annual
Report on Form 10-K for the year ended June 30, 2009 for more information about the assumptions
used by the Company under this valuation methodology. During the three and nine months ended
March 31, 2010, the Company made no material changes to these assumptions.
During the three months ended March 31, 2010 and 2009, the Company issued new stock options to
purchase a total of 939 thousand shares and 18 thousand shares of common stock, respectively. The
Company recognized compensation expense related to stock options of $1.0 million and $1.3 million
for the three months ended March 31, 2010 and 2009, respectively.
During the nine months ended March 31, 2010 and 2009, the Company issued new stock options to
purchase a total of 1.2 million shares and 1.3 million shares of common stock, respectively. The
Company recognized compensation expense related to stock options of $3.6 million and $4.0 million
for the nine months ended March 31, 2010 and 2009, respectively.
As of March 31, 2010, there was $5.9 million of total unrecognized compensation expense, including
the impact of expected forfeitures, related to unvested share-based compensation awards granted
under the Companys equity plans, which the Company expects to recognize over a weighted-average
period of 2.4 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 March 31, 2010 and 2009, the Company recognized compensation expense related to
its ESPP of $178 thousand and $193 thousand, respectively. During the nine months ended March 31,
2010 and 2009, the Company recognized compensation expense related to its ESPP of $608 thousand and
$579 thousand, respectively.
NOTE 8 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, if any, will be 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.
During the three months ended March 31, 2010, the Company sold 544,126 shares of common stock at an
average price of $2.60 per share, and received gross proceeds of $1.4 million. The Company paid
commissions to the Agent relating to these sales equal to $42 thousand and other expenses relating
to the closing of the Equity Distribution Agreement totaling $21 thousand.
During the nine months ended March 31, 2010, the Company sold 1,300,816 shares of common stock at
an average price of $2.72 per share, and received gross proceeds of $3.5 million. The Company paid
commissions to the Agent relating to these sales equal to $106 thousand and other expenses relating
to the closing of the Equity Distribution Agreement totaling $264 thousand.
26
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended March 31, 2010
(Unaudited)
NOTE 9 EMPLOYEE BONUS
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 payment of
cash to satisfy related withholding taxes. The liability for the bonus as of June 30, 2009 is
recorded in Accrued Compensation and Benefits in the accompanying Condensed Balance Sheets.
NOTE 10 SUBSEQUENT EVENT
The Company and Novartis International Pharmaceutical Ltd. entered into a License Agreement in
April 2010 (the Agreement) granting Novartis the exclusive worldwide right to co-develop and
commercialize MEK162 (ARRY-162), currently in a Phase 1 cancer trial, and MEK300 (ARRY-300), as well as other
specified MEK inhibitors. Under the Agreement, the Company is responsible for completing the
on-going Phase 1 clinical trial of MEK162 and 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 United States.
In consideration for the rights granted to Novartis under the Agreement, the Company will initially
receive $45 million, comprising an upfront and milestone payment, in the fourth quarter of fiscal
2010 and is also 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. The Company is entitled to receive additional commercial milestone payments for
MEK300, and for other MEK inhibitors. 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. The
Company will pay a percentage of development costs up to a maximum amount with annual caps. The
Company may opt out of paying its share of development costs with respect to one or more products;
in this event, 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 United
States, and the Company would no longer have the right to develop or detail such product.
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.
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 us 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 Part II, Item 1A of this Quarterly Report on Form 10-Q and Item 1A of our Annual Report on Form
10-K for the fiscal year ended June 30, 2009. 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 proteins. In addition, leading pharmaceutical and
biotechnology companies partner with us to discover and develop drug candidates across a broad
range of therapeutic areas.
The five most advanced wholly-owned programs in our development pipeline as of March 31, 2010
are as follows:
|
1. |
|
MEK162, a MEK inhibitor for cancer |
|
|
2. |
|
ARRY-380, a HER2 inhibitor for breast cancer |
|
|
3. |
|
ARRY-520, a KSP inhibitor for acute myeloid leukemia, or AML, and multiple myeloma, or
MM |
|
|
4. |
|
ARRY-614, a p38/Tie 2 dual inhibitor for myelodysplastic syndrome, or MDS |
|
|
5. |
|
ARRY-543, a HER2/EGFR inhibitor for solid tumors |
In addition to these proprietary development programs, the seven most advanced partnered drugs in
clinical development as of March 31, 2010 are as follows:
|
1. |
|
AMG 151 / ARRY-403, a glucokinase activator for Type 2 diabetes, partnered with Amgen
Inc. |
|
|
2. |
|
AZD6244, a MEK inhibitor for cancer, partnered with AstraZeneca, PLC |
|
|
3. |
|
AZD8330, a MEK inhibitor for cancer, partnered with AstraZeneca, PLC |
28
|
4. |
|
RG7227/ITMN-191, a hepatitis C virus (HCV) protease inhibitor danoprevir, partnered
with InterMune, Inc./Roche Holding AG |
|
|
5. |
|
LY2603618/IC83, a Chk inhibitor for cancer, partnered with Eli Lilly and Company |
|
|
6. |
|
VTX-2337, a Toll-like receptor for cancer, partnered with VentiRx Pharmaceuticals, Inc. |
|
|
7. |
|
VTX-1463, a Toll-like receptor for allergy, partnered with VentiRx Pharmaceuticals,
Inc. |
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. Our
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 proprietary pipeline of research and development programs on spending of
$403.2 million from our inception through March 31, 2010. Although we continue to commit
significant resources to create our own proprietary drug candidates and to build a commercial-stage
biopharmaceutical company, due to ongoing uncertainty in the capital markets as well as general
economic conditions that have negatively affected the biopharmaceutical market, we reduced our
spending on our proprietary discovery and development programs to focus on advancing our most
promising clinical programs through proof-of-concept, which we believe will maximize their value,
and, on our most promising discovery candidates. In the third quarter of fiscal 2010, our spending
on research and development for proprietary drug discovery was $17.7 million, down from $20.0
million for the same quarter in fiscal 2009. In the first nine months of fiscal 2010 and 2009, our
spending on research and development for proprietary drug discovery was $56.0 million and $68.2
million, respectively. In fiscal 2009, we spent $89.6 million in research and development for
proprietary drug discovery expenses, as compared to $90.3 million and $57.5 million for fiscal
years 2008 and 2007, respectively.
As part of our efforts to conserve our capital resources, we reduced our workforce in January 2009
by approximately 40 employees, or 10%, who were primarily in discovery research and support
positions, resulting in a restructuring charge of approximately $1.5 million in the third quarter
of fiscal 2009. We are also accelerating our efforts to partner select discovery and development
programs that will provide funding, development and commercial resources, with the goal of
optimizing the value of our drug portfolio.
We have received a total of $426.6 million in research funding and in up-front and milestone
payments from our collaboration partners through March 31, 2010. Under our existing collaboration
agreements as of March 31, 2010, we have the potential to earn up to over $2.0 billion in additional
milestone payments if we or our collaborators achieve all the drug discovery objectives detailed in
those agreements, as well as the potential to earn royalties on any resulting product sales from 16
drug development programs.
Our significant collaborators as of March 31, 2010 include:
|
|
|
Amgen Inc., which entered into a worldwide strategic collaboration with us to
develop and commercialize our glucokinase activator, AMG 151 / ARRY-403. |
|
|
|
|
Genentech, Inc., which entered into a worldwide strategic collaboration agreement
with us focused on the discovery, development and commercialization of novel
therapeutics. |
|
|
|
|
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. |
|
|
|
|
AstraZeneca, which licensed three of our MEK inhibitors for cancer, including
AZD6244 (ARRY-886), which is currently in multiple Phase 2 clinical trials. |
|
|
|
|
InterMune, Inc., which collaborated with us on the discovery of RG7227/ITMN-191, a
novel small molecule inhibitor of the Hepatitis C Virus NS3/4 protease. InterMune and
its development partner, Roche, have reported that they are currently advancing the
drug in a Phase 2b trial evaluating ITMN-191 in combination with standard of care
therapies. |
29
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 2010
refers to the fiscal year ended June 30, 2010 and the third quarter of fiscal 2010 refers to the
three months ended March 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.
In addition, we may license our compounds and enter into collaborations in Japan through an agent.
The following collaborators contributed greater than 10% of total revenue for the three and nine
months ended March 31, 2010 and 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Nine Months Ended March 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amgen Inc. |
|
|
34.7 |
% |
|
|
0.0 |
% |
|
|
20.3 |
% |
|
|
0.0 |
% |
Celgene Corporation |
|
|
22.5 |
% |
|
|
23.7 |
% |
|
|
27.5 |
% |
|
|
22.0 |
% |
Genentech, Inc. |
|
|
42.1 |
% |
|
|
70.6 |
% |
|
|
48.0 |
% |
|
|
66.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
99.3 |
% |
|
|
94.3 |
% |
|
|
95.8 |
% |
|
|
88.4 |
% |
|
|
|
|
|
|
|
|
|
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 March 31, |
|
Nine Months Ended March 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America |
|
$ |
18,310 |
|
|
$ |
6,005 |
|
|
$ |
35,706 |
|
|
$ |
19,111 |
|
Europe |
|
|
52 |
|
|
|
25 |
|
|
|
161 |
|
|
|
333 |
|
Asia Pacific |
|
|
14 |
|
|
|
8 |
|
|
|
43 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
18,376 |
|
|
$ |
6,038 |
|
|
$ |
35,910 |
|
|
$ |
19,474 |
|
|
|
|
|
|
|
|
|
|
All of our collaboration agreements are denominated in U.S. dollars.
30
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.
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, accrued outsourcing costs, accrued expenses, 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.
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
auction rate securities, or ARS, warrants issued by us or 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 carrying value of the investment is written down to its 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. 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 extinguishment and new debt. We also review each long-term debt arrangement to
determine if any feature of the debt requires bifurcation and/or separate valuation. These features
include
31
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 Private
Design Fund, L.P. and Deerfield Private Design International Fund, L.P. (who we refer to
collectively as Deerfield). 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 the ability of Deerfield to accelerate repayment of the debt in
the event of certain changes in control of our company. 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 of July 31, 2009, the date funds were disbursed under the credit facility entered into
in May 2009, and as of September 30, 2009 and March 31, 2010. 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 fair value of the Embedded Derivatives was initially 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 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 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.
Marketable Securities
We have designated our marketable securities as of March 31, 2010 and June 30, 2009 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.
32
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 will remain available-for-sale based on our 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 discounts to maturity. Such amortization is
included in Interest Income in the accompanying Condensed Statements of Operations and
Comprehensive Loss. Realized gains and losses are reported in Interest Income and Interest Expense,
respectively, in the accompanying Condensed Statements of Operations and Comprehensive Loss as
incurred. Declines in value judged to be other-than-temporary are reported in Impairment of
Marketable Securities in the accompanying Condensed Statements of Operations and Comprehensive Loss
as 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 beginning with the first quarter of fiscal 2009 and continuing
through the current fiscal 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 as well
as Other Income (Expense) in the Results of Operations discussion in Managements Discussion and
Analysis of Financial Condition and Results of Operations included elsewhere in this Quarterly
Report on Form 10-Q.
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.
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 research funding, the sale of chemical compounds and the co-development of proprietary drug
candidates we out-license, as
33
Collaboration Revenue. License and Milestone Revenue is combined and consists of the current
periods recognized up-front fees and ongoing milestone payments from collaborators.
We recognize revenue in accordance with Staff Accounting Bulletin No. 104, Revenue Recognition
(SAB 104). SAB 104 establishes four criteria, each of which must be met, in order to recognize
revenue related to 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
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 term, the specific number of full-time-equivalent scientists
working a defined number of hours per year at a stated price under the agreement, the existence, or
likelihood of achievement, of development commitments, and 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 related to
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 adjusts the
amortization periods when appropriate to reflect changes in assumptions relating to the duration of
expected performance periods. Revenue recognition related to non-refundable license fees and
up-front payments and to milestone payments could be accelerated in the event of early termination
of programs or alternatively, decelerated, if programs are extended.
Cost of Revenue and Research and Development Expenses for Proprietary Drug Discovery
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 most of these costs between Cost of Revenue and Research
and Development Expenses for Proprietary Drug Discovery based upon the respective time spent by our
scientists on our collaborations and for our internal proprietary
programs, respectively. Preclinical and clinical outsourcing costs
are charged directly to the collaboration program. 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 Expenses for
Proprietary Drug Discovery consist of direct and indirect costs related to specific proprietary
programs. We do not bear any risk of failure for performing
34
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 or 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.
For example, we granted Celgene Corporation an option to select up to two of four programs
developed under our collaboration agreement with Celgene and concluded that Celgene was likely to
exercise its option with respect to two of the four programs. Accordingly, we reported costs
associated with the Celgene collaboration as follows: 50% to Cost of Revenue, with the remaining
50% to Research and Development Expenses for Proprietary Drug Discovery through September 30, 2009,
when 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, we 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 Expenses for Proprietary Drug Discovery
beginning October 1, 2009. See Note 4, Deferred Revenue, for further information about the
Companys collaboration with Celgene.
Results of Operations
Collaboration Revenue
Collaboration Revenue consists of revenue for our performance of drug discovery and development
activities in collaboration with partners and to a small degree the sale of chemical compounds.
A summary of our collaboration revenue follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Change 2010 vs. |
|
|
Nine Months Ended |
|
|
Change 2010 vs. |
|
|
|
March 31 |
|
2009 |
|
March 31, |
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
5,396 |
|
|
$ |
4,399 |
|
|
$ |
997 |
|
|
|
22.7 |
% |
|
$ |
14,874 |
|
|
$ |
13,427 |
|
|
$ |
1,447 |
|
|
|
10.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The increase in Collaboration Revenue of $997 thousand, or 22.7%, in the three months ended March
31, 2010 was from $1.5 million of revenue from our new collaboration with Amgen. Partially
offsetting this was a slight decrease to the number of FTEs engaged on our collaboration with
Genentech as well as the expiration of our research activities under
our collaboration agreement with VentiRx. The increase during the
nine months ended March 31, 2010 was also driven by $800 thousand of additional revenue under our
collaboration with Genentech, of which $650 thousand recorded in the first quarter of fiscal 2010
was for the finalization of contract rates for services rendered in the prior fiscal year. This increase was offset by fewer scientists
engaged on the Genentech program in the third quarter of fiscal 2010
and a $675 thousand decrease in
revenue from our collaboration with VentiRx which ended in September 2009.
35
x
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 |
|
|
Nine Months Ended |
|
|
|
March 31, |
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
License revenue |
|
$ |
9,230 |
|
|
$ |
1,635 |
|
|
$ |
16,286 |
|
|
$ |
4,768 |
|
Milestone revenue |
|
|
3,750 |
|
|
|
4 |
|
|
|
4,750 |
|
|
|
1,279 |
|
|
|
|
|
|
Total license and milestone revenue |
|
$ |
12,980 |
|
|
$ |
1,639 |
|
|
$ |
21,036 |
|
|
$ |
6,047 |
|
|
|
|
|
|
For the three and nine months ended March 31, 2010 and 2009, License Revenue increased $7.6 million
and $11.5 million, respectively, over the same periods in the prior year. The increase during the
three months ended March 31, 2010 includes $4.9 million in revenue for our new collaboration with
Amgen and $2.7 million in additional revenue recognized under the Celgene collaboration due to
shortening the estimated performance period from five to two years as of September 30, 2009. (See
Note 4, Deferred Revenue Celgene Corporation to the accompanying Condensed Financial
Statements.)
For the three and nine months ended March 31, 2010 and 2009, Milestone Revenue increased $3.7
million and $3.5 million, respectively, over the same periods in the prior year. The increase
during the three and nine months ended March 31, 2010 includes
$3.6 million in milestones received
for the advancement of certain research programs under our collaboration with Genentech.
Additionally, during the first six months of fiscal 2009 we earned a $1.0 million milestone from
VentiRx; we similarly earned a $1.0 million milestone from InterMune during the same period in
fiscal 2010.
Cost of Revenue
Cost of Revenue represents costs attributable to discovery and development including preclinical
and clinical trials we may conduct for our collaborators and the cost of chemical compounds sold
from our inventory. 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.
36
A summary of our Cost of Revenue follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
Change 2010 vs. |
|
|
|
March 31, |
|
Change 2010 vs. 2009 |
|
March 31, |
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue |
|
$ |
7,946 |
|
|
$ |
5,515 |
|
|
$ |
2,431 |
|
|
|
44.1 |
% |
|
$ |
19,103 |
|
|
$ |
15,698 |
|
|
$ |
3,405 |
|
|
|
21.7 |
% |
Cost of revenue as a percentage
of total revenue |
|
|
43.2 |
% |
|
|
91.3 |
% |
|
|
|
|
|
|
|
|
|
|
53.2 |
% |
|
|
80.6 |
% |
|
|
|
|
|
|
|
|
Cost of Revenue increased in absolute dollars and decreased as a percentage of total revenue for
the three and nine months ended March 31, 2010 as compared to the same periods in the prior year.
The increase in absolute dollars is for preclinical and clinical outsourcing costs for the
advancement of certain collaboration programs, including Celgene and our new program with Amgen.
These increases were offset by the change in estimate for the Celgene cost allocation from 50%
to Cost of Revenue and 50% to Research and Development Expenses for Proprietary Drug Discovery to
33.3% and 67.7%, respectively, as discussed further in Note 4 Deferred Revenue to the
accompanying Condensed Financial Statements. In addition, there were fewer scientists engaged on
our collaboration with Genentech and our collaboration with VentiRx expired in September 2009.
The decrease as a percentage of total revenue was because of the increase in license and milestone
revenue recognized related to shortening the Celgene recognition period and advancing research
programs under our Genentech collaboration, as well as the additional
revenue for services in the prior year
from Genentech following finalization of contracted rate
changes
that had no associated incremental costs, as discussed above.
Research and Development Expenses for Proprietary Drug Discovery
Our research and development expenses for proprietary drug discovery include costs associated with
our proprietary drug programs for scientific and clinical personnel, supplies, inventory,
equipment, small tools, travel and meals, depreciation, consultants, sponsored research, allocated
facility costs, costs related to 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 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.
The following table shows our research and development expenses by categories of costs for the
periods presented (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
Change 2010 vs. |
|
|
|
March 31, |
|
Change 2010 vs. 2009 |
|
March 31, |
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
Salaries, benefits and share-based
compensation |
|
$ |
8,209 |
|
|
$ |
9,989 |
|
|
$ |
(1,780 |
) |
|
|
(17.8 |
%) |
|
$ |
24,088 |
|
|
$ |
29,902 |
|
|
$ |
(5,814 |
) |
|
|
(19.4 |
%) |
Outsourced services and consulting |
|
|
4,094 |
|
|
|
4,420 |
|
|
|
(326 |
) |
|
|
(7.4 |
%) |
|
|
14,818 |
|
|
|
18,713 |
|
|
|
(3,895 |
) |
|
|
(20.8 |
%) |
Laboratory supplies |
|
|
2,642 |
|
|
|
1,702 |
|
|
|
940 |
|
|
|
55.2 |
% |
|
|
8,419 |
|
|
|
9,338 |
|
|
|
(919 |
) |
|
|
(9.8 |
%) |
Facilities and depreciation |
|
|
2,357 |
|
|
|
2,816 |
|
|
|
(459 |
) |
|
|
(16.3 |
%) |
|
|
7,524 |
|
|
|
8,087 |
|
|
|
(563 |
) |
|
|
(7.0 |
%) |
Other |
|
|
390 |
|
|
|
1,102 |
|
|
|
(712 |
) |
|
|
(64.6 |
%) |
|
|
1,148 |
|
|
|
2,208 |
|
|
|
(1,060 |
) |
|
|
(48.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development
for proprietary drug discovery |
|
$ |
17,692 |
|
|
$ |
20,029 |
|
|
$ |
(2,337 |
) |
|
|
(11.7 |
%) |
|
$ |
55,997 |
|
|
$ |
68,248 |
|
|
$ |
(12,251 |
) |
|
|
(18.0 |
%) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development Expenses for Proprietary Drug Discovery for the three and nine months
ended March 31, 2010 decreased from the prior year due to shifting our development efforts towards
our
37
most advanced programs and reduced resources devoted to early discovery research, which
occurred after the second quarter of fiscal 2009. We believe our spending on research and
development for our proprietary programs will continue to trend down during fiscal 2010 because our
development costs for AMG 151 / ARRY-403 will be shifted to Amgen under our collaboration agreement
with Amgen; because our development costs for MEK162 and MEK300 will be shared and deferred with
Novartis under our license agreement with them. The increase in costs
for laboratory supplies for the three
months ended March 31, 2010 as compared to 2009 is due to decreased purchase volumes in the third
quarter of fiscal 2009 as a result of cost containment measures and the head count reduction
discussed further in Note 10 Restructuring Charges in our Report on Form 10-K for the year ended
June 30, 2009.
General and Administrative Expenses
General and Administrative Expenses consist mainly of compensation and associated fringe benefits
not included in Cost of Revenue or Research and Development Expenses for Proprietary Drug Discovery
and include other 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 |
|
|
|
|
|
|
|
|
|
|
Nine Months Ended |
|
|
Change 2010 vs. |
|
|
|
March 31, |
|
Change 2010 vs. 2009 |
|
March 31, |
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
$ |
4,264 |
|
|
$ |
4,461 |
|
|
$ |
(197 |
) |
|
|
(4.4 |
%) |
|
$ |
12,938 |
|
|
$ |
13,435 |
|
|
$ |
(497 |
) |
|
|
(3.7 |
%) |
General and Administrative Expenses remained relatively consistent between the three and nine
months ended March 31, 2010 and 2009. In the third quarter of fiscal 2009, we recorded a
non-recurring reduction in estimate of compensation expense for employee bonuses related to our
staff reduction. Additionally, we incurred $178 thousand and $800 thousand less in patent related
expenses in the three and nine month periods, respectively. Decreased patent expenses in the nine
month period ended March 31, 2010 was partially offset by higher compensation related expenses.
38
Other Income (Expense)
A summary of our Other Income (Expense) follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
March 31, |
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
Impairment of marketable securities |
|
$ |
- |
|
|
$ |
(3,381 |
) |
|
$ |
(217 |
) |
|
$ |
(17,742 |
) |
Gain (loss) on sale of marketable securities |
|
|
357 |
|
|
|
- |
|
|
|
1,521 |
|
|
|
- |
|
Interest income |
|
|
164 |
|
|
|
412 |
|
|
|
726 |
|
|
|
1,823 |
|
Interest expense |
|
|
(4,152 |
) |
|
|
(2,674 |
) |
|
|
(11,685 |
) |
|
|
(7,289 |
) |
|
|
|
|
|
Total other income (expense) |
|
$ |
(3,631 |
) |
|
$ |
(5,643 |
) |
|
$ |
(9,655 |
) |
|
$ |
(23,208 |
) |
|
|
|
|
|
The impairment of marketable securities is from the decline in the estimated fair value of our ARS.
The investment gains detailed in the table above are the result of the realized gains recorded on
the sale of two of our ARS, which were sold in December 2009 and February 2010. See Note 3
Marketable Securities in the accompanying Condensed Financial Statements for further information
on our ARS.
Interest Income decreased during the three and nine months ended March 31, 2010 as compared to the
same periods in fiscal 2009 primarily due to the sale of our two ARS as well as lower effective
interest rates and lower average cash and cash equivalent balances in the first nine months of
fiscal 2010.
Interest Expense increased in the third quarter and first nine months of fiscal 2010 compared to
the same periods in fiscal 2009 due to increased borrowings under the Deerfield credit facilities.
The following table presents the components of Interest Expense for the three and nine months ended
March 31, 2010 and 2009 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Nine Months Ended March 31, |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
Deerfield Credit Facility: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.0% simple interest |
|
$ |
- |
|
|
$ |
395 |
|
|
$ |
124 |
|
|
$ |
1,201 |
|
6.5% compounding interest |
|
|
- |
|
|
|
1,339 |
|
|
|
476 |
|
|
|
4,012 |
|
7.5% simple interest |
|
|
2,250 |
|
|
|
- |
|
|
|
6,000 |
|
|
|
- |
|
Amortization of transaction fees |
|
|
140 |
|
|
|
795 |
|
|
|
408 |
|
|
|
1,612 |
|
Amortization of debt discounts |
|
|
1,538 |
|
|
|
88 |
|
|
|
4,362 |
|
|
|
180 |
|
Change in value of the Embedded Derivatives |
|
|
7 |
|
|
|
- |
|
|
|
(199 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
Total interest expense on Deerfield Credit Facility |
|
|
3,935 |
|
|
|
2,617 |
|
|
|
11,171 |
|
|
|
7,005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comerica Loan: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Variable interest |
|
|
217 |
|
|
|
57 |
|
|
|
514 |
|
|
|
284 |
|
|
|
|
|
|
|
|
|
|
Total interest expense on Comerica Loan |
|
|
217 |
|
|
|
57 |
|
|
|
514 |
|
|
|
284 |
|
|
|
|
|
|
|
|
|
|
Total interest expense |
|
$ |
4,152 |
|
|
$ |
2,674 |
|
|
$ |
11,685 |
|
|
$ |
7,289 |
|
|
|
|
|
|
|
|
|
|
The determination of the estimated fair values of the financial instruments related to the
Deerfield credit facilities and the ARS requires significant management judgment with regard to
expectations of future cash balances, general and specific economic conditions, forecasts of
interest rate behaviors, evaluation of potential acquirers and similar other factors. While we
believe that the estimates used in the fair value analysis of the ARS, warrants and the Embedded
Derivatives are reasonable, a change in any of the assumptions underlying these estimates would
result in different fair value estimates and could result in
39
material changes in their fair value.
Future changes to the estimated fair values of the Embedded Derivatives will be reflected in our
earnings. See Note 3 Marketable Securities and Note 5 Long-term Debt to the accompanying
Condensed Financial Statements for additional information about the ARS and these Embedded
Derivatives.
Liquidity and Capital Resources
We have incurred operating losses and have an accumulated deficit primarily as a result of ongoing
spending for Research and Development Expenses for Proprietary Drug Discovery. As of March 31,
2010, we had an accumulated deficit of $475.0 million. We had net losses of $15.2 million and
$29.6 million for the three months ended March 31, 2010 and 2009, respectively. We had net losses
of $61.8 million and $101.1 million for the nine months ended March 31, 2010 and 2009,
respectively. We had net losses of $127.8 million, $96.3 million and $55.4 million for the fiscal
years ended June 30, 2009, 2008 and 2007, respectively.
We have historically funded our operations through revenue from our collaborations and
out-licensing transactions, the issuance of equity securities and through debt provided by our
credit facilities. 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 that were generated primarily from these sources.
We believe that our cash, cash equivalents and marketable securities, including the $45 million
upfront and milestone payment from Novartis International Pharmaceutical Ltd. discussed below and
excluding the value of the ARS we hold, will enable us to continue to fund our operations for more
than the next 12 months. We have recently signed and are currently in active licensing discussions
with a number of potential partners on select programs. In December 2009, we received a $60 million
up front payment from Amgen Inc. under a Collaboration and License Agreement with Amgen for our
small-molecule glucokinase activator, AMG 151 / ARRY-403. In April 2010, we signed a License
Agreement with Novartis International Pharmaceutical Ltd. under which we will receive $45 million
in an upfront and milestone payment in the fourth quarter of fiscal 2010, as discussed further in
Note 10 Subsequent Event to the accompanying Condensed Financial Statements. Our current
operating plan contemplates the receipt of significant additional upfront payments from new
collaboration or licensing deals and milestone payments from existing collaborations in the next 12
months. There can be no guarantee, however, that we will be successful in entering into new
collaboration or licensing transactions that include such payments or that the milestones will be
achieved under existing collaborations resulting in the receipt of milestone payments when
anticipated.
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.
We cannot assure that we will be successful in obtaining new or in retaining existing out-license
or collaboration agreements, in securing agreements for the co-development of our proprietary drug
candidates, or in receiving milestone and/or royalty payments under those agreements when
anticipated or at all, that our existing cash, cash equivalents and marketable securities resources
will be adequate or that additional financing will be available when needed or that, if available,
this financing will be obtained on terms favorable to us or our stockholders. If we raise
additional funds by issuing equity or convertible debt securities, substantial dilution to existing
stockholders may result.
40
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 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; |
|
|
|
|
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.
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 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 fair value. In the second and
third quarters of fiscal 2010, we sold ARS with a par value of $4.0 million and $2.6 million,
respectively, for $2.8 million and for $715 thousand, respectively.
Following is a summary of our cash, cash equivalents and marketable securities (dollars in
thousands):
41
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
June 30, |
|
|
|
|
|
|
|
|
|
2010 |
|
|
2009 |
|
|
$ Change |
|
|
% Change |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
82,560 |
|
|
$ |
33,202 |
|
|
$ |
49,358 |
|
|
|
148.7 |
% |
Marketable securities - short-term |
|
|
19 |
|
|
|
7,296 |
|
|
|
(7,277 |
) |
|
|
(99.7 |
%) |
Marketable securities - long-term |
|
|
17,757 |
|
|
|
16,990 |
|
|
|
767 |
|
|
|
4.5 |
% |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
100,336 |
|
|
$ |
57,488 |
|
|
$ |
42,848 |
|
|
|
74.5 |
% |
|
|
|
|
|
|
|
|
|
Cash Flow Activities
Following is a summary of our cash flows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months Ended March 31, |
|
Change 2009 vs. 2008 |
|
|
2010 |
|
|
2009 |
|
|
$ |
|
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
(3,734 |
) |
|
$ |
(74,133 |
) |
|
$ |
70,399 |
|
|
|
(95.0 |
%) |
Investing activities |
|
|
9,814 |
|
|
|
28,571 |
|
|
|
(18,757 |
) |
|
|
(65.7 |
%) |
Financing activities |
|
|
43,278 |
|
|
|
40,675 |
|
|
|
2,603 |
|
|
|
6.4 |
% |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
49,358 |
|
|
$ |
(4,887 |
) |
|
$ |
54,245 |
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
* |
|
Percentage calculated was
not meaningful |
First Nine Months of Fiscal 2010 - Net cash used in operating activities for the first half of
fiscal 2010 was $3.7 million, compared to $74.1 million for fiscal 2009. The difference is
primarily attributable to the receipt of $60 million from Amgen Inc. in December 2009 under our
License and Collaboration Agreement with them, and to a lesser extent, reduced spending on
advancing our own proprietary programs, which decreased net loss, as
well as the issuance of stock as
payment of 2009 employee bonuses during fiscal 2010 compared to cash bonus distribution during the
prior year.
Net cash provided by investing activities was $9.8 million and $28.6 million in the first nine
months of fiscal 2010 and 2009, respectively. During the first nine months of fiscal 2010, we
invested $2.0 million less in property and equipment than we did in the same period of the prior
year related to our plan to reduce overall spending. There were no purchases of marketable
securities as well as fewer proceeds from sales compared to the same period in the prior year as a
result of our initiative to invest our monies in more liquid, U.S. treasury backed securities.
Net cash provided by financing activities was $43.3 million and $40.7 million for the first nine
months of fiscal 2010 and 2009, respectively. This increase was
primarily due to the net proceeds of $3.2 million from sales
of shares of our common stock under our Equity Distribution Agreement with Piper Jaffray & Co.
during the first nine months of fiscal 2010.
42
Obligations and Commitments
The following table shows our contractual obligations and commitments as of March 31, 2010 (dollars
in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than |
|
|
1 to 3 |
|
|
4 to 5 |
|
|
|
|
|
|
|
|
|
1 Year |
|
|
Years |
|
|
Years |
|
|
Over 5 Years |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt obligations (1) |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
141,762 |
|
|
$ |
- |
|
|
$ |
141,762 |
|
Interest on debt obligations (3) (4) |
|
|
9,488 |
|
|
|
18,976 |
|
|
|
10,030 |
|
|
|
- |
|
|
|
38,494 |
|
Operating lease commitments (2) |
|
|
7,868 |
|
|
|
15,989 |
|
|
|
16,445 |
|
|
|
10,687 |
|
|
|
50,989 |
|
Purchase obligations (2) |
|
|
15,805 |
|
|
|
1,497 |
|
|
|
6 |
|
|
|
1 |
|
|
|
17,309 |
|
|
|
|
Total |
|
$ |
33,161 |
|
|
$ |
36,462 |
|
|
$ |
168,243 |
|
|
$ |
10,688 |
|
|
$ |
248,554 |
|
|
|
|
(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 March 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 March 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 March 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 $9.9 million are for outsourced services for clinical trials and
other research and development costs. Additional purchase obligations of $4.2 million were primarily for software to support the advancement of clinical trials, lab supplies and ongoing equipment and facilities maintenance. The remaining $3.2 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, such as 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
March 31, 2010, we have had little 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 March 31, 2010, $17.0 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 income (loss) positively or negatively by $1.0 million based on the current balance
of $100.3 million of investments classified as cash and cash equivalents, and short-term and
long-term marketable securities available for sale.
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 March
31, 2010,
43
we held five securities with a par value of $26.3 million and a fair value of $17.0
million. As of June 30,
2009, we held seven securities with a par value of $32.9 million and a fair value of $16.5 million.
We sold one of the ARS in the second quarter of fiscal 2010 with a par value of $4.0 million for
$2.8 million and realized a gain of $1.2 million, with $394 thousand reclassified from Accumulated
Other Comprehensive Income. We sold another ARS in the third quarter of fiscal 2010 with a par
value of $2.6 million for $715 thousand and realized a gain of $357 thousand, with $524 thousand
reclassified to earnings from Accumulated Other Comprehensive Income.
Due to these unsuccessful auctions and continuing uncertainty and volatility in the credit markets,
the fair value of our ARS has fluctuated and we have therefore recorded fair value adjustments to
our ARS. We recorded an unrealized gain of $711 thousand for the three months ended March 31,
2010. We recorded an unrealized gain of $2.7 million and a realized loss of $217 thousand for the
nine months ended March 31, 2010, respectively. We recorded a realized loss of $3.4 million and of
$17.7 million for the three and nine months ended March 31, 2009, respectively. The unrealized
gains are included in Accumulated Other Comprehensive Income in the accompanying Condensed Balance
Sheets. The realized losses are included in Impairment of Marketable Securities in the accompanying
Statements of Income and Comprehensive Loss because they are considered other than temporary. We
have recorded cumulative loss adjustments of $11.9 million to the ARS as of March 31, 2010. 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 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 March 31, 2010, we had $141.8 million of debt outstanding, exclusive of the debt discount of
$30.5 million. The Refinance Term Loan under our senior secured credit facility with Comerica Bank
of $15.0 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 March 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. 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 March 31, 2010 would result in a change in our annual interest expense of $1.2 million.
Historically, and as of March 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 March 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 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.
44
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
March 31, 2010 that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
45
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 March 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, 2009 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 expect to continue to incur significant research and development expenses, which may make it
difficult for us to attain profitability.
We have expended substantial funds to discover and develop our drug candidates, and additional
substantial funds will be required for further development, including pre-clinical testing and
clinical trials of any product candidates, and to manufacture and market any products that are
approved for commercial sale. Because the successful development of our products is uncertain, we
are unable to precisely estimate the actual funds we will require to develop and potentially
commercialize them.
If we are unable to generate enough revenue, or to secure additional funding and/or reduce our
current rate of research and development spending, we may not be able to fund our current
operations. This may result in an inability to maintain a level of liquidity necessary to continue
operating our business and the loss of all or part of the investment of our stockholders in our
common stock. In addition, under our credit facility with Deerfield Private Design Fund, L.P. and
Deerfield Private Design International Fund, L.P. (who we refer to collectively as Deerfield) and
our loan agreement with Comerica Bank, if we are unable to maintain certain levels of cash and
marketable securities, the lenders may be able to accelerate our obligations under our agreements
with them. There is no guaranty that we will secure additional financing needed to fund our current
operations and maintain lender-required levels of cash.
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 March 31, 2010, we had an accumulated deficit of $475.0 million. We had net
losses of $15.2 million and $29.6 million for the three months ended March 31, 2010 and 2009,
respectively. We had net losses of $61.8 million and $101.1 million for the nine months ended
March 31, 2010 and 2009, respectively. We had net losses of $127.8 million, $96.3 million and
$55.4 million, for the fiscal years ended June 30, 2009, 2008 and 2007, 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, and expansion of our clinical and scientific capabilities. At the same time, we expect that revenue
from the sales of our research tools and services will continue to decline as a percentage of total
revenue as we devote more resources to drug discovery and our proprietary drug programs. As a
result, we may not be able to achieve or maintain profitability.
46
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.
Genentech, Celgene and Amgen accounted for 48.0%, 27.5% and 20.3%, respectively, of our total
revenue for the first nine months of fiscal 2010; and Genentech and Celgene accounted for 66.4% and
22.0%, respectively, of our total revenue in the same period of fiscal 2009. 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 one of
our major collaborators cancels, declines to renew or reduces the scope of its contract with us,
our revenue may significantly decrease.
Our investments in ARS are not currently liquid and our inability to access these funds may
adversely affect our liquidity, capital resources and results of operations. We may be required to
further adjust the carrying value of our investment through an impairment charge.
A portion of our investment portfolio is invested in ARS. During the fiscal year ended June 30,
2008, auctions for all of the ARS, amounting to seven securities, were unsuccessful. During the
first quarter of fiscal 2009, auctions were suspended when Lehman Brothers filed for bankruptcy. As
a result, these securities are no longer readily convertible to cash. In the event we need to
access these funds, we will not be able to sell these securities for cash until a secondary market
develops for these securities. We can make no assurances that this will occur prior to the time
that we may need to access these investments or, if they do, what value we will realize on our ARS.
In addition, as currently there is not an active market for these securities, we estimated the
fair value of these securities using a discounted cash flow model based on assumptions that
management believes to be reasonable but that may prove to be inaccurate. Due to the unsuccessful
auctions and continuing uncertainty and volatility in the credit markets, the fair value of our ARS
has fluctuated and we have therefore recorded fair value adjustments to our ARS. Based on this
analysis, we recorded an unrealized gain of $1.2 million for the three months ended March 31, 2010.
We recorded an unrealized gain of $3.6 million and a realized loss of $217 thousand for the nine
months ended March 31, 2010, respectively. We recorded a realized loss of $3.4 million and of
$17.7 million for the three and nine months ended March 31, 2009, respectively. If the market
makers in these securities are unable to successfully conduct future auctions or the issuers
credit ratings deteriorate, or if our estimates of fair value later prove to be inaccurate, we may
be required to further adjust the carrying value of some or all of these investments. In addition,
if we are required to liquidate these ARS prior to the time auctions for them are successful or the
issuer redeems them, we may be required to sell them at a significant discount to their par value.
47
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 proprietary pipeline of research
and development programs on spending of $403.2 million from our inception through March 31, 2010.
We continue to commit significant resources to create our own proprietary drug candidates and to
build a commercial-stage biopharmaceutical company. In the first nine months of fiscal 2010 and
2009, our spending on research and development for proprietary drug discovery was $56.0 million and
$68.2 million, respectively. In fiscal 2009, we spent $89.6 million in research and development
for proprietary drug discovery expenses, as compared to $90.3 million and $57.5 million for fiscal
years 2008 and 2007, 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 accelerate initiatives during fiscal
2010 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 $63.7 million from our
operating activities in the first nine months of fiscal 2010 exclusive of the $60 million up-front
license fee from Amgen Inc., and $92.9 million, $45.7 million and $44.5 million in our operating
activities in fiscal 2009, 2008 and 2007, respectively. In addition, a portion of our cash flow is
dedicated to the payment of interest under our existing senior secured credit facility with
Comerica Bank, and to the payment of principal and interest on our credit facilities with
Deerfield. In addition, the Senior Credit Facility and the Deerfield Credit
Facilities become due and payable in 2013 and 2014, respectively. Our debt
48
obligations could therefore render us more vulnerable to competitive pressures and economic
downturns and impose some restrictions on our operations.
Our current operating plan and assumptions could change as a result of many factors, and we could
require additional funding sooner than anticipated. In addition, we are currently unable to
liquidate ARS we hold with an aggregate cost of $26.3 million and a fair value of $17.0 million.
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.
Recent disruptions in the financial markets could affect our ability to obtain financing for
development of our proprietary drug programs and other purposes on reasonable terms and have other
adverse effects on us and the market price of our common stock.
The United States stock and credit markets have recently experienced significant price
volatility, dislocations and liquidity disruptions, which have caused market prices of many stocks
to fluctuate substantially and the spreads on prospective debt financings to widen considerably.
These circumstances have materially impacted liquidity in the financial markets, making terms for
certain financings less attractive, and in some cases have resulted in the unavailability of
financing. For example, during the first quarter of fiscal 2009, auctions for ARS that we hold were
suspended when Lehman Brothers filed for bankruptcy and we are currently unable to liquidate these
securities. Continued uncertainty in the stock and credit markets may negatively impact our ability
to access additional financing for our research and development activities and other purposes on
reasonable terms, which may cause us to curtail or delay our discovery and development efforts and
harm our business. In January 2009, we announced plans designed to conserve our existing capital
and to allow us to obtain additional capital outside the financial markets by accelerating
partnering opportunities and focusing resources on advancing the development of our most advanced
clinical programs. As part of these efforts we also reduced our workforce by 40 employees. A
prolonged downturn in the financial markets, however, may cause us to seek alternative sources of
potentially less attractive financing, and may require us to make further adjustments to our
business plan. These events also may make it more difficult or costly for us to raise capital
through the issuance of equity or debt. The disruptions in the financial markets may have a
material adverse effect on the market value of our common stock and other adverse effects on us and
our business.
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 $2.83 and $2.24, respectively,
during the third quarter of fiscal 2010; $2.81 and $1.72, respectively, during the second quarter
of fiscal 2010; $4.45 and $2.38, respectively during the first quarter of fiscal 2010; $8.79 and
$2.51, respectively, during fiscal 2009; $12.91 and $4.66, respectively, in fiscal 2008; and $14.40
and $7.55, respectively, in fiscal 2007. 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.
49
We may not be able to recruit and retain the experienced scientists and management we need to
compete in the drug research and development industry.
We had 338 employees as of March 31, 2010, and our future success depends upon our ability to
attract, retain and motivate highly skilled scientists and management. Our ability to achieve our
business strategies, including progressing drug candidates through later stage development or
commercialization, attracting new collaborators and retaining, renewing and expanding existing
collaborations, depends on our ability to hire and retain high caliber scientists and other
qualified experts, particularly in clinical development and commercialization. We compete with
pharmaceutical and biotechnology companies, contract research companies and academic and research
institutions to recruit personnel and face significant competition for qualified personnel,
particularly clinical development personnel. We may incur greater costs than anticipated, or may
not be successful, in attracting new scientists or management or in retaining or motivating our
existing personnel.
Our future success also depends on the personal efforts and abilities of the principal members of
our senior management and scientific staff to provide strategic direction, manage our operations
and maintain a cohesive and stable environment. In particular, we rely on the services of Robert E.
Conway, our Chief Executive Officer; Dr. Kevin Koch, our President and Chief Scientific Officer;
Dr. David L. Snitman, our Chief Operating Officer and Vice President, Business Development; R.
Michael Carruthers, our Chief Financial Officer; and John R. Moore, our Vice President and General
Counsel. We have employment agreements with all of the above personnel that are terminable upon 30
days prior notice.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM 5. OTHER INFORMATION
None
ITEM 6. EXHIBITS
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Exhibit Number |
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Description of Exhibit |
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31.1
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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
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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
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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. |
50
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 3rd day of May 2010.
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ARRAY BIOPHARMA INC.
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By: |
/s/ Robert E. Conway
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Robert E. Conway |
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Chief Executive Officer |
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By: |
/s/ R. Michael Carruthers
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R. Michael Carruthers |
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Chief Financial Officer
(Principal Financial and
Accounting Officer) |
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51