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 September 30, 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)
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Delaware
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84-1460811 |
(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer Identification No.) |
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3200 Walnut Street, Boulder, CO
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80301 |
(Address of Principal Executive Offices)
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(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 November 4, 2010, the registrant had 55,265,544 shares of common stock outstanding.
ARRAY BIOPHARMA INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 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)
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September 30, |
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June 30, |
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2010 |
|
2010 |
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ASSETS |
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Current assets |
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|
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|
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Cash and cash equivalents |
|
$ |
33,292 |
|
|
$ |
32,846 |
|
Marketable securities |
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|
59,640 |
|
|
|
78,664 |
|
Prepaid expenses and other current assets |
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|
7,337 |
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|
5,788 |
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Total current assets |
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100,269 |
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|
117,298 |
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|
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Long-term assets |
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|
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|
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Marketable securities |
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15,729 |
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|
17,359 |
|
Property and equipment, net |
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20,291 |
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|
21,413 |
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Other long-term assets |
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2,965 |
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|
3,109 |
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Total long-term assets |
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|
38,985 |
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|
|
41,881 |
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Total assets |
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$ |
139,254 |
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$ |
159,179 |
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LIABILITIES AND STOCKHOLDERS DEFICIT |
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Current liabilities |
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|
|
|
|
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Accounts payable |
|
$ |
4,013 |
|
|
$ |
5,634 |
|
Accrued outsourcing costs |
|
|
3,980 |
|
|
|
4,907 |
|
Accrued compensation and benefits |
|
|
11,607 |
|
|
|
10,013 |
|
Other accrued expenses |
|
|
2,134 |
|
|
|
1,723 |
|
Deferred rent |
|
|
3,218 |
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|
|
3,180 |
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Deferred revenue |
|
|
52,290 |
|
|
|
52,474 |
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|
|
|
|
|
Total current liabilities |
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77,242 |
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|
77,931 |
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|
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|
|
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|
|
|
|
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Long-term liabilities |
|
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|
|
|
|
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Deferred rent |
|
|
17,472 |
|
|
|
18,301 |
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Deferred revenue |
|
|
53,341 |
|
|
|
65,177 |
|
Long-term debt, net |
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|
114,461 |
|
|
|
112,825 |
|
Derivative liabilities |
|
|
535 |
|
|
|
825 |
|
Other long-term liabilities |
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|
1,436 |
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|
798 |
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|
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|
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Total long-term liabilities |
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|
187,245 |
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197,926 |
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Total liabilities |
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264,487 |
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275,857 |
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Commitments and contingencies |
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Stockholders deficit |
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|
Preferred stock, $0.001 par value; 10,000,000 shares authorized,
no shares issued or outstanding |
|
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- |
|
|
|
- |
|
Common stock, $0.001 par value; 120,000,000 shares
authorized; 53,729,984 and 53,224,248 shares
issued and outstanding, as of September 30, 2010 and
June 30, 2010, respectively |
|
|
54 |
|
|
|
53 |
|
Additional paid-in capital |
|
|
334,918 |
|
|
|
332,277 |
|
Warrants |
|
|
36,296 |
|
|
|
36,296 |
|
Accumulated other comprehesive income |
|
|
4,961 |
|
|
|
5,528 |
|
Accumulated deficit |
|
|
(501,462 |
) |
|
|
(490,832 |
) |
|
|
|
|
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Total stockholders deficit |
|
|
(125,233 |
) |
|
|
(116,678 |
) |
|
|
|
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|
Total liabilities and stockholders deficit |
|
$ |
139,254 |
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|
$ |
159,179 |
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|
|
|
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|
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)
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Three Months Ended |
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September 30, |
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2010 |
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2009 |
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Revenue |
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Collaboration revenue |
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$ |
5,720 |
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$ |
5,044 |
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License and milestone revenue |
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12,793 |
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2,846 |
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|
|
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Total revenue |
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18,513 |
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|
7,890 |
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|
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|
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Operating expenses |
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|
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Cost of revenue |
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|
7,281 |
|
|
|
5,923 |
|
Research and development for proprietary programs |
|
|
13,855 |
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|
19,201 |
|
General and administrative |
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|
4,268 |
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|
4,213 |
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Total operating expenses |
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|
25,404 |
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|
29,337 |
|
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Loss from operations |
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|
(6,891 |
) |
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|
(21,447 |
) |
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|
|
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Other income (expense) |
|
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Losses on auction rate securities |
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|
(67 |
) |
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|
(217 |
) |
Interest income |
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|
220 |
|
|
|
304 |
|
Interest expense |
|
|
(3,892 |
) |
|
|
(3,442 |
) |
|
|
|
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|
Total other income (expense), net |
|
|
(3,739 |
) |
|
|
(3,355 |
) |
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|
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Net loss |
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|
(10,630 |
) |
|
|
(24,802 |
) |
|
|
|
|
|
|
|
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|
Change in unrealized gains and losses on marketable securities |
|
|
(567 |
) |
|
|
1,898 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(11,197 |
) |
|
$ |
(22,904 |
) |
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|
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|
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|
Weighted
average shares outstanding - basic and diluted |
|
|
53,415 |
|
|
|
48,137 |
|
|
|
|
|
|
|
|
|
|
|
|
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|
Net loss
per share - basic and diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.52 |
) |
|
|
|
|
|
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)
|
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|
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|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
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|
|
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Additional |
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Other |
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|
Preferred Stock |
|
Common Stock |
|
Paid-in |
|
|
|
|
|
Comprehensive |
|
Accumulated |
|
|
|
|
Shares |
|
Amounts |
|
Shares |
|
Amounts |
|
Capital |
|
Warrants |
|
Income |
|
Deficit |
|
Total |
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
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|
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|
|
|
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|
|
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|
Balance as of June 30, 2010 |
|
|
- |
|
|
$ |
- |
|
|
|
53,224 |
|
|
$ |
53 |
|
|
$ |
332,277 |
|
|
$ |
36,296 |
|
|
$ |
5,528 |
|
|
$ |
(490,832 |
) |
|
$ |
(116,678 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock under stock option
and employee stock purchase plans |
|
|
- |
|
|
|
- |
|
|
|
32 |
|
|
|
- |
|
|
|
93 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
93 |
|
Share-based compensation expense |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,098 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,098 |
|
Issuance of common stock for cash,
net of offering costs |
|
|
- |
|
|
|
- |
|
|
|
474 |
|
|
|
1 |
|
|
|
1,450 |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,451 |
|
Reclassification of unrealized gain out of accumulated
other comprehensive income to earnings |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(220 |
) |
|
|
- |
|
|
|
(220 |
) |
Change in unrealized gain on
marketable securities |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(347 |
) |
|
|
- |
|
|
|
(347 |
) |
Net loss |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(10,630 |
) |
|
|
(10,630 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of September 30, 2010 |
|
|
- |
|
|
$ |
- |
|
|
|
53,730 |
|
|
$ |
54 |
|
|
$ |
334,918 |
|
|
$ |
36,296 |
|
|
$ |
4,961 |
|
|
$ |
(501,462 |
) |
|
$ |
(125,233 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
Cash flows from operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(10,630 |
) |
|
$ |
(24,802 |
) |
Adjustments to reconcile net loss to net cash
used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
|
1,490 |
|
|
|
1,683 |
|
Non-cash interest expense for long-term debt |
|
|
1,517 |
|
|
|
1,762 |
|
Share-based compensation expense |
|
|
1,098 |
|
|
|
1,522 |
|
Losses on auction rate securities |
|
|
67 |
|
|
|
217 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(1,576 |
) |
|
|
907 |
|
Accounts payable and other accrued expenses |
|
|
(1,210 |
) |
|
|
(1,428 |
) |
Accrued outsourcing costs |
|
|
(927 |
) |
|
|
664 |
|
Accrued compensation and benefits |
|
|
1,345 |
|
|
|
899 |
|
Deferred rent |
|
|
(791 |
) |
|
|
(756 |
) |
Deferred revenue |
|
|
(12,020 |
) |
|
|
(1,556 |
) |
Other liabilities |
|
|
723 |
|
|
|
- |
|
|
|
|
|
|
Net cash used in operating activities |
|
|
(20,914 |
) |
|
|
(20,888 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities |
|
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(368 |
) |
|
|
(265 |
) |
Purchases of marketable securities |
|
|
(11,527 |
) |
|
|
- |
|
Proceeds from sales and maturities of marketable securities |
|
|
31,711 |
|
|
|
3,521 |
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
19,816 |
|
|
|
3,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options and shares issued
under the employee stock purchase plan |
|
|
93 |
|
|
|
3 |
|
Proceeds from the issuance of common stock for cash |
|
|
1,519 |
|
|
|
163 |
|
Payment of offering costs |
|
|
(68 |
) |
|
|
(35 |
) |
Proceeds from the issuance of long-term debt and warrants |
|
|
- |
|
|
|
40,000 |
|
Payment of transaction fee |
|
|
- |
|
|
|
(1,000 |
) |
|
|
|
|
|
Net cash provided by financing activities |
|
|
1,544 |
|
|
|
39,131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
|
446 |
|
|
|
21,499 |
|
Cash and cash equivalents as of beginning of period |
|
|
32,846 |
|
|
|
33,202 |
|
|
|
|
|
|
Cash and cash equivalents as of end of period |
|
$ |
33,292 |
|
|
$ |
54,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
|
|
Cash paid for interest |
|
$ |
2,349 |
|
|
$ |
1,208 |
|
|
|
|
|
|
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 September 30, 2010
(Unaudited)
NOTE 1 - OVERVIEW AND BASIS OF PRESENTATION
Organization
Array BioPharma Inc. (the Company) is a biopharmaceutical company focused on the discovery,
development and commercialization of targeted small molecule drugs to treat patients afflicted with
cancer and inflammatory diseases. The Companys proprietary drug development pipeline includes
clinical candidates that are designed to regulate therapeutically important target pathways. In
addition, leading pharmaceutical and biotechnology companies partner with the Company to discover
and develop drug candidates across a broad range of therapeutic areas.
Basis of Presentation
The Company follows the accounting guidance outlined in the Financial Accounting Standards Board
Codification. The accompanying unaudited Condensed Financial Statements have been prepared without
audit and do not include all of the disclosures required by the Financial Accounting Standards
Board Codification guidelines, which have been omitted pursuant to the rules and regulations of the
Securities and Exchange Commission (SEC) relating to requirements for interim reporting. The
year-end condensed balance sheet data was derived from audited financial statements but does not
include all disclosures required by accounting principles generally accepted in the United States
(U.S.). The unaudited Condensed Financial Statements reflect all adjustments (consisting only of
normal recurring adjustments) that, in the opinion of management, are necessary to present fairly
the financial position of the Company as of September 30, 2010, its results of operations for the
three months ended September 30, 2010 and 2009, and its cash flows for the three months ended
September 30, 2010 and 2009. Operating results for the three months ended September 30, 2010 are
not necessarily indicative of the results that may be expected for the year ending June 30, 2011.
These unaudited Condensed Financial Statements should be read in conjunction with the Companys
audited Financial Statements and the notes thereto included in the Companys Annual Report on Form
10-K for the year ended June 30, 2010 filed with the SEC on August 12, 2010.
Certain fiscal 2010 amounts have been reclassified to conform to the current year presentation.
Specifically, Accounts Payable and Other Accrued Expenses were separated into two line items,
Accounts Payable and Other Accrued Expenses, respectively, 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 periods over which up-front and milestone payments from
collaboration agreements are recognized; (ii) estimating the fair value of the Companys auction
rate securities (ARS); (iii) estimating accrued outsourcing costs for clinical trials and
preclinical testing; and (iv) estimating the fair value of the Companys long-term debt that has
associated warrants and embedded derivatives, and the separate valuation of those warrants and
embedded derivatives.
5
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
Liquidity
The Company has incurred operating losses and has an accumulated deficit as a result of ongoing
research and development spending. As of September 30, 2010, the Company had an accumulated deficit
of $501.5 million. The Company had net losses of $10.6 million for the three months ended September
30, 2010 and $77.6 million, $127.8 million and $96.3 million for the fiscal years ended June 30,
2010, 2009 and 2008, respectively.
The Company has historically funded its operations from up-front fees and license and
milestone revenue received under its collaborations and out-licensing transactions, from the
issuance and sale of its equity securities and through debt provided by its credit facilities. In
December 2009, for example, the Company received a $60 million up-front payment from Amgen Inc.
under a Collaboration and License Agreement and during the fourth quarter of fiscal 2010, the
Company received $45 million in an upfront and milestone payment under a License Agreement with
Novartis Pharmaceutical International Ltd. The recognition of revenue under these agreements is
discussed further in Note 4 Deferred Revenue. However, until the Company can generate sufficient
levels of cash from its operations, which the Company does not expect to achieve in the foreseeable
future, the Company will continue to utilize its existing cash, cash equivalents and marketable
securities that were generated primarily from revenue from its collaboration agreements, equity
offerings and debt. The Company believes that its cash, cash equivalents and marketable securities,
excluding the value of the ARS it holds, will enable it to continue to fund its operations for at
least the next 12 months. There can be no assurance, however, that sufficient funds will be
available to the Company when needed from existing or future collaborations or from the proceeds of
debt or equity financings.
If the Company is unable to obtain additional funding from these or other sources to the extent or
when needed, it may be necessary to significantly reduce its current rate of spending through
reductions in staff and delaying, scaling back, or stopping certain research and development
programs. Insufficient funds may also require the Company to relinquish greater rights to product
candidates at an earlier stage of development or on less favorable terms to it or its stockholders
than the Company would otherwise choose in order to obtain up-front license fees needed to fund its
operations.
Fair Value Measurements
The Companys financial instruments are recognized and measured at fair value in the Companys
financial statements and 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 or paid to sell the financial instruments in an orderly
transaction between market participants at the measurement date. The Company uses a framework for
measuring fair value based on a hierarchy that distinguishes sources of available information used
in fair value measurements and categorizes them into three levels:
|
|
|
Level I: Quoted prices in active markets for identical assets and liabilities. |
|
|
|
|
Level II: Observable inputs other than quoted prices in active markets for identical
assets and liabilities. |
|
|
|
|
Level III: Unobservable inputs. |
The Company discloses assets and liabilities measured at fair value based on their level in the
hierarchy. Considerable judgment is required in interpreting market data to develop estimates of
fair value for assets or liabilities for which there are no quoted prices in active markets, which
include the Companys ARS, warrants issued by the Company in connection with its long-term debt and
the embedded derivatives associated with the long-term debt. The use of different assumptions
and/or estimation methodologies may have a material effect on their estimated fair value.
Accordingly, the fair value estimates disclosed by
6
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
the Company may not be indicative of the amount that the Company or holders of the instruments
could realize in a current market exchange.
The Company periodically reviews the realizability of each investment when impairment indicators
exist with respect to the investment. If an other-than-temporary impairment of the value of an
investment is deemed to exist, the cost basis of the investment is written down to its then
estimated fair value.
Cash and Cash Equivalents
Cash equivalents consist of short-term, highly liquid financial instruments that are readily
convertible to cash and have maturities of 90 days or less from the date of purchase and may
consist of money market funds, taxable commercial paper, U.S. government agency obligations and
corporate notes and bonds with high credit quality.
Marketable Securities
The Company has designated its marketable securities as of each balance sheet date as
available-for-sale securities and accounts for them at their respective fair values. Marketable
securities are classified as short-term or long-term based on the nature of these securities and
the availability of these securities to meet current operating requirements. Marketable securities
that are readily available for use in current operations are classified as short-term
available-for-sale securities and are reported as a component of current assets in the accompanying
Condensed Balance Sheets. Marketable securities that are not considered available for use in
current operations are classified as long-term available-for-sale securities and are reported as a
component of long-term assets in the accompanying Condensed Balance Sheets.
Securities that are classified as available-for-sale are carried at fair value, including accrued
interest, with temporary unrealized gains and losses reported as a component of Stockholders
Deficit until their disposition. The Company reviews all available-for-sale securities each period
to determine if they remain available-for-sale based on the Companys then current intent and
ability to sell the security if it is required to do so. The amortized cost of debt securities in
this category is adjusted for amortization of premiums and accretion of discounts to maturity. Such
amortization is included in Interest Income in the accompanying Condensed Statements of Operations
and Comprehensive Loss. Realized gains and losses on ARS along with declines in value judged to be
other-than-temporary are reported in Gains (Losses) on Sales of Auction Rate Securities in the
accompanying Condensed Statements of Operations and Comprehensive Loss when recognized. The cost of
securities sold is based on the specific identification method.
See Note 3 - Marketable
Securities Auction Rate Securities, below for more information about the valuation of the
Companys ARS.
Property and Equipment
Property and equipment are stated at historical cost less accumulated depreciation and
amortization. Additions and improvements are capitalized. Certain costs to internally develop
software are also capitalized. Maintenance and repairs are expensed as incurred.
Depreciation and amortization are computed on the straight-line method based on the following
estimated useful lives:
|
|
|
Furniture and fixtures
|
|
7 years |
Equipment
|
|
5 years |
Computer hardware and software
|
|
3 years |
The Company depreciates leasehold improvements associated with operating leases on a
straight-line basis over the shorter of the expected useful life of the improvements or the
remaining lease term.
7
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
The carrying value for property and equipment is reviewed for impairment when events or changes in
circumstances indicate that the book value of the assets may not be recoverable. An impairment loss
would be recognized when estimated undiscounted future cash flows from the use of the asset and its
eventual disposition is less than its carrying amount.
Equity Investment
The Company has entered into one, and may in the future enter into additional, collaboration and
licensing agreements in which it receives an equity interest in consideration for all or a portion
of up-front, license or other fees under the terms of the agreement. The Company reports the value
of equity securities received from non-publicly traded companies in which it does not exercise a
significant controlling interest at cost as Other Long-term Assets in the accompanying Condensed
Balance Sheets. The Company monitors its investment for impairment at least annually and makes
appropriate reductions in the carrying value if it is determined that an impairment has occurred,
based primarily on the financial condition and near term prospects of the issuer.
Accrued Outsourcing Costs
Substantial portions of the Companys preclinical studies and clinical trials are performed by
third-party laboratories, medical centers, contract research organizations and other vendors
(collectively CROs). These CROs generally bill monthly or quarterly for services performed or
bill based upon milestone achievement. For preclinical studies, the Company accrues expenses based
upon estimated percentage of work completed and the contract milestones remaining. For clinical
studies, expenses are accrued based upon the number of patients enrolled and the duration of the
study. The Company monitors patient enrollment, the progress of clinical studies and related
activities to the extent possible through internal reviews of data reported to it by the CROs,
correspondence with the CROs and clinical site visits. The Companys estimates depend on the
timeliness and accuracy of the data provided by its CROs regarding the status of each program and
total program spending. The Company periodically evaluates the estimates to determine if
adjustments are necessary or appropriate based on information it receives.
Deferred Revenue
The Company records amounts received but not earned under its collaboration agreements as Deferred
Revenue, which are then classified as either current or long-term in the accompanying Condensed
Balance Sheets based on the period during which they are expected to be recognized as revenue.
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 incurrence of new debt. The
Company also reviews each long-term debt arrangement to determine if any feature of the debt
requires bifurcation and/or separate valuation. These features include hybrid instruments, which
are comprised of at least two components ((1) a debt host instrument and (2) one or more conversion
features), warrants and other embedded derivatives, such as puts and other rights of the debt
holder.
The Company currently has two embedded derivatives related to its long-term debt with Deerfield
Private Design Fund, L.P. and Deerfield Private Design International Fund, L.P. (who are referred
to collectively as Deerfield). The first is a variable interest rate structure that constitutes a
liquidity-linked variable spread feature. The second derivative is a significant transaction
contingent put option relating to Deerfields ability to accelerate the repayment of the debt in
the event of certain changes in control of the Company. 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
8
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
active market for them. The fair value of the variable interest rate structure is based on the
Companys estimate of the probable effective interest rate over the term of the Deerfield credit
facilities. The fair value of the put option is based on the Companys estimate of the probability
that a change in control that triggers Deerfields right to accelerate the debt will occur. With
those inputs, the fair value of each Embedded Derivative is calculated as the difference between
the fair value of the Deerfield credit facilities if the Embedded Derivatives are included and the
fair value of the Deerfield credit facilities if the Embedded Derivatives are excluded. Due to the
inherent complexity in valuing the Deerfield credit facilities and the Embedded Derivatives, the
Company engaged a third-party valuation firm to perform the valuation as part of its overall fair
value analysis as of July 31, 2009, the date the funds were disbursed under the credit facility
entered into in May 2009, and for each subsequent quarter end through the current quarter end. The
estimated fair value of the Embedded Derivatives was determined based on managements judgment and
assumptions. The use of different assumptions could result in significantly different estimated
fair values.
The initial fair value of the Embedded Derivatives was recorded as Derivative Liabilities and as
Debt Discount in the Companys 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 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
9
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
to Deferred Rent in the accompanying Condensed Balance Sheets and amortized on a straight-line
basis over the initial lease term. The Company has also entered into two sale-lease back
transactions for its facilities in Boulder and Longmont, Colorado, where the consideration received
from the landlord is recorded as increases to Deferred Rent in the accompanying Condensed Balance
Sheets and amortized on a straight-line basis over the lease term. Deferred Rent balances are
classified as short-term or long-term in the accompanying Condensed Balance Sheets based upon the
period when reversal of the liability is expected to occur.
Share-Based Compensation
The Company uses the fair value method of accounting for share-based compensation arrangements
which requires that compensation expense be recognized based on the grant date fair value of the
arrangement. Share-based compensation arrangements include stock options granted under the
Companys Amended and Restated Stock Option and Incentive Plan (the Option Plan) and purchases of
common stock by its employees at a discount to the market price under the Companys Employee Stock
Purchase Plan (the ESPP).
The estimated fair value of stock options is based on a Black-Scholes option pricing model and is
expensed on a straight-line basis over the vesting term. Compensation expense for stock options is
reduced for estimated forfeitures, which are estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those estimates. Compensation
expense for purchases under the ESPP is recognized based on a Black-Scholes option pricing model
that incorporates the estimated fair value of the common stock during each offering period and the
percentage of the purchase discount.
Revenue Recognition
Most of the Companys revenue is from the Companys collaborators for research funding, up-front or
license fees and milestone payments derived from discovering and developing drug candidates. The
Companys agreements with collaboration partners include fees based on contracted annual rates for
full-time-equivalent employees working on a program and may also include non-refundable license and
up-front fees, non-refundable milestone payments that are triggered upon achievement of specific
research or development goals and future royalties on sales of products that result from the
collaboration. A small portion of the Companys revenue comes from the sale of compounds on a
per-compound basis. The Company reports revenue for discovery, the sale of chemical compounds and
the co-development of proprietary drug candidates that the Company out-licenses, as Collaboration
Revenue in the Companys Condensed Statements of Operations and Comprehensive Loss. License and
Milestone Revenue is combined in the Companys Condensed Statements of Operations and Comprehensive
Loss and consists of up-front fees and ongoing milestone payments from collaborators that are
recognized during the applicable period.
The Company recognizes revenue in accordance with Staff Accounting Bulletin No. 104, Revenue
Recognition (SAB 104), which establishes four criteria, each of which must be met, in order to
recognize revenue for the performance of services or the shipment of products. Revenue is
recognized when (a) persuasive evidence of an arrangement exists, (b) products are delivered or
services are rendered, (c) the sales price is fixed or determinable and (d) collectability is
reasonably assured.
Collaboration agreements that include a combination of discovery research funding, up-front or
license fees, milestone payments and/or royalties are evaluated to determine whether each
deliverable under the agreement has value to the customer on a stand-alone basis and whether
reliable evidence of fair value for the deliverable exists. Deliverables in an arrangement that do
not meet the separation criteria are treated as a single unit of accounting, generally applying
applicable revenue recognition guidance for the final deliverable to the combined unit of
accounting in accordance with SAB 104.
10
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
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
for activities for which there are no future obligations and as a result, are recognized when
earned in their entirety.
The Company periodically reviews the expected performance periods under each of its agreements that
provide for non-refundable up-front payments and license fees and milestone payments and adjusts
the amortization periods when appropriate to reflect changes in assumptions relating to the
duration of expected performance periods. Revenue recognition for non-refundable license fees and
up-front payments and milestone payments could be accelerated in the event of early termination of
programs or alternatively, decelerated, if programs are extended. As such, while such estimates
have no impact on its reported cash flows, the Companys reported revenue is significantly
influenced by its estimates of the period over which its obligations will be performed.
Cost of Revenue and Research and Development for Proprietary Programs
The Company incurs costs in connection with performing research and development activities which
consist mainly of compensation, associated fringe benefits, share-based compensation, preclinical
and clinical outsourcing costs and other collaboration-related costs, including supplies, small
tools, facilities, depreciation, recruiting and relocation costs and other direct and indirect
chemical handling and laboratory support costs. The Company allocates these costs between Cost of
Revenue and Research and Development for Proprietary Programs based upon the respective time spent
by its scientists on research and 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. 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. Research and Development for Proprietary Programs
consist of direct and indirect costs for the Companys specific proprietary programs.
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.
11
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
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 for Proprietary Programs. Celgene waived its rights
with respect to one of the programs during the second quarter of fiscal 2010, at which time
management determined that Celgene is likely to exercise its option to license one of the remaining
three programs. Accordingly, beginning October 1, 2009, the Company began reporting costs
associated with the Celgene collaboration as follows: 33.3% to Cost of Revenue, with the remaining
66.7% to Research and Development for Proprietary Programs. 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 average
number of common shares outstanding during the period. Diluted net loss per share reflects the
additional dilution from potential issuances of common stock, such as stock issuable pursuant to
the exercise of stock options and warrants issued related to the Companys long-term debt. The
treasury stock method is used to calculate the potential dilutive effect of these common stock
equivalents. Potentially dilutive shares are excluded from the computation of diluted net loss per
share when their effect is anti-dilutive. As a result of the Companys net losses through the date
of these Financial Statements, all potentially dilutive securities were anti-dilutive and therefore
have been excluded from the computation of diluted net loss per share.
Comprehensive Income (Loss)
The Companys comprehensive income (loss) consists of the Companys net losses and adjustments to
unrealized gains and losses on investments in available-for-sale marketable securities. The Company
had no other sources of comprehensive income (loss) for the periods presented.
NOTE 2 SEGMENTS, GEOGRAPHIC INFORMATION AND SIGNIFICANT COLLABORATORS
Segments
All operations of the Company are considered to be in one operating segment and, accordingly, no
segment disclosures have been presented. The physical location of all of the Companys equipment,
leasehold improvements and other fixed assets is within the U.S.
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 September 30, |
|
|
2010 |
|
2009 |
|
North America |
|
$ |
15,680 |
|
|
$ |
7,853 |
|
Europe |
|
|
2,829 |
|
|
|
23 |
|
Asia Pacific |
|
|
4 |
|
|
|
14 |
|
|
|
|
|
|
|
|
$ |
18,513 |
|
|
$ |
7,890 |
|
|
|
|
|
|
12
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
Significant Collaborators
The following collaborators contributed greater than 10% of total revenue during the periods set
forth below:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
2010 |
|
2009 |
|
Amgen Inc. |
|
|
39.1 |
% |
|
|
0.0 |
% |
Genentech, Inc. |
|
|
23.1 |
% |
|
|
64.1 |
% |
Celgene Corporation |
|
|
22.3 |
% |
|
|
20.8 |
% |
Novartis International Pharmaceutical Ltd. |
|
|
15.2 |
% |
|
|
0.0 |
% |
InterMune, Inc. |
|
|
0.0 |
% |
|
|
12.7 |
% |
|
|
|
|
|
|
|
|
99.7 |
% |
|
|
97.6 |
% |
|
|
|
|
|
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 September 30, 2010.
NOTE 3 - MARKETABLE SECURITIES
Marketable securities consisted of the following as of September 30, 2010 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
Amortized |
|
Unrealized |
|
Unrealized |
|
Fair |
|
|
Cost |
|
Gains |
|
Losses |
|
Value |
|
|
|
|
Short-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government agency securities |
|
$ |
59,369 |
|
|
$ |
5 |
|
|
$ |
- |
|
|
$ |
59,374 |
|
Mutual fund securities |
|
|
266 |
|
|
|
- |
|
|
|
- |
|
|
|
266 |
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
59,635 |
|
|
|
5 |
|
|
|
- |
|
|
|
59,640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
|
10,060 |
|
|
|
4,956 |
|
|
|
- |
|
|
|
15,016 |
|
Mutual fund securities |
|
|
713 |
|
|
|
- |
|
|
|
- |
|
|
|
713 |
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
10,773 |
|
|
|
4,956 |
|
|
|
- |
|
|
|
15,729 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
70,408 |
|
|
$ |
4,961 |
|
|
$ |
- |
|
|
$ |
75,369 |
|
|
|
|
|
|
|
|
|
|
13
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
Marketable securities consisted of the following as of June 30, 2010 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
Gross |
|
|
|
|
Amortized |
|
Unrealized |
|
Unrealized |
|
Fair |
|
|
Cost |
|
Gains |
|
Losses |
|
Value |
|
|
|
|
Short-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. Government agency securities |
|
$ |
78,653 |
|
|
$ |
- |
|
|
$ |
(5 |
) |
|
$ |
78,648 |
|
Mutual fund securities |
|
|
16 |
|
|
|
- |
|
|
|
- |
|
|
|
16 |
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
78,669 |
|
|
|
- |
|
|
|
(5 |
) |
|
|
78,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term available-for-sale securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate securities |
|
|
11,027 |
|
|
|
5,533 |
|
|
|
- |
|
|
|
16,560 |
|
Mutual fund securities |
|
|
799 |
|
|
|
- |
|
|
|
- |
|
|
|
799 |
|
|
|
|
|
|
|
|
|
|
Sub-total |
|
|
11,826 |
|
|
|
5,533 |
|
|
|
- |
|
|
|
17,359 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
90,495 |
|
|
$ |
5,533 |
|
|
$ |
(5 |
) |
|
$ |
96,023 |
|
|
|
|
|
|
|
|
|
|
The estimated fair value of these marketable securities as of September 30, 2010 and June 30,
2010 were classified into the following fair value measurement categories as follows (dollars in
thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
June 30, |
|
|
2010 |
|
2010 |
|
Quoted prices in active markets for
identical assets (Level 1) |
|
$ |
60,353 |
|
|
$ |
79,463 |
|
Significant unobservable inputs (Level 3) |
|
|
15,016 |
|
|
|
16,560 |
|
|
|
|
|
|
|
|
$ |
75,369 |
|
|
$ |
96,023 |
|
|
|
|
|
|
The amortized cost and estimated fair value of available-for-sale securities by contractual
maturity as of September 30, 2010 is as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
Fair |
|
|
Cost |
|
Value |
|
Due in one year or less |
|
$ |
59,635 |
|
|
$ |
59,640 |
|
Due in one year to three years |
|
|
713 |
|
|
|
713 |
|
Due after 10 years or more |
|
|
10,060 |
|
|
|
15,016 |
|
|
|
|
|
|
|
|
$ |
70,408 |
|
|
$ |
75,369 |
|
|
|
|
|
|
Auction Rate Securities
The Company is currently unable to readily liquidate its ARS. Since fiscal 2008, the auctions for
all of the ARS were unsuccessful. The lack of successful auctions resulted in the interest rate on
these investments increasing to LIBOR plus additional basis points as stipulated in the auction
rate agreements, ranging from 200 to 350 additional basis points, which has continued from the time
the auctions failed
14
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
through the current quarter end. While the Company now earns a higher contractual interest rate on
these investments, the investments may not be liquid at a time when the Company needs to access
these funds. In the event the Company needs to access these funds and liquidate the ARS prior to
the time auctions of these investments are successful or the date on which the original issuers
retire these securities, the Company may be required to sell them in a distressed sale in a
secondary market, most likely for a lower value than their current estimated fair value.
As of September 30, 2010, the Company held four securities with a par value of $20.3 million and an
estimated fair value of $15.0 million. As of June 30, 2010, the Company held five securities with
a par value of $26.3 million and an estimated fair value of $16.6 million. The Company sold one of
the ARS in the first quarter of fiscal 2011 with a par value of $6 million and an estimated fair
value of $967 thousand for $900 thousand and realized a loss of $67 thousand, with $220 thousand
recognized from Accumulated Other Comprehensive Income.
On October 5, 2010, the Company sold one of the ARS with a par value of $3 million for $1.9 million
and realized a gain of $567 thousand, which was recognized in full 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 the estimates of the amount of time until a liquidity event will occur and
the discount rate, which incorporates estimates of credit risk and a liquidity premium (discount).
Due to the inherent complexity in valuing these securities, the Company engaged a third-party
valuation firm to perform an independent valuation of the ARS as part of its overall fair value
analysis beginning with the first quarter of fiscal 2009 and continuing through the current
quarter.
While the Company believes that the estimates used in the fair value analysis are reasonable, a
change in any of the assumptions underlying these estimates would result in different fair value
estimates for the ARS and could result in additional changes to the ARS values, either increasing
or decreasing their value by a potentially material amount.
As of September 30, 2010, the Company has recorded cumulative net fair value declines of $5.3
million from the original par value of the four ARS it held at that date.
Based on its fair value analysis and fair value estimates as of each period end, the Company
recorded adjustments to the fair value of its ARS as follows (dollars in thousands):
15
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
September 30, |
|
|
2010 |
|
2009 |
|
Balance as of prior year end |
|
$ |
16,560 |
|
|
$ |
16,518 |
|
Gains during period included in equity |
|
|
- |
|
|
|
1,898 |
|
Sale of ARS |
|
|
(900 |
) |
|
|
- |
|
Reclassification of unrealized gain from Accumulated Other Comprehensive Income
to earnings |
|
|
(220 |
) |
|
|
- |
|
Losses during period included in equity |
|
|
(357 |
) |
|
|
- |
|
Losses during period included in earnings
due to the sale of marketable securities |
|
|
(67 |
) |
|
|
- |
|
Losses during period included in earnings
due to impairment of marketable securities |
|
|
- |
|
|
|
(217 |
) |
|
|
|
|
|
Balance as of current quarter end |
|
$ |
15,016 |
|
|
$ |
18,199 |
|
|
|
|
|
|
NOTE 4 DEFERRED REVENUE
Deferred revenue consisted of the following (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
June 30, |
|
|
2010 |
|
2010 |
|
Amgen, Inc. |
|
$ |
45,693 |
|
|
$ |
50,595 |
|
Novartis International Pharmaceutical Ltd. |
|
|
39,969 |
|
|
|
42,781 |
|
Celgene Corporation |
|
|
16,393 |
|
|
|
20,492 |
|
Genentech, Inc. |
|
|
3,576 |
|
|
|
3,783 |
|
|
|
|
|
|
Total deferred revenue |
|
|
105,631 |
|
|
|
117,651 |
|
Less: Current portion |
|
|
(52,290 |
) |
|
|
(52,474 |
) |
|
|
|
|
|
Deferred revenue, long term |
|
$ |
53,341 |
|
|
$ |
65,177 |
|
|
|
|
|
|
Amgen Inc.
In December 2009, the Company granted Amgen the exclusive worldwide right to develop and
commercialize the Companys small molecule glucokinase activator, AMG 151/ARRY-403. Under the
Collaboration and License Agreement, the Company is responsible for completing Phase 1 clinical
trials on AMG 151. The Company will also conduct further research funded by Amgen to create second
generation glucokinase activators. Amgen is responsible for further development and
commercialization of AMG 151 and any resulting second generation compounds. The agreement also
provides the Company with an option to co-promote any approved drugs with Amgen in the U.S. with
certain limitations.
In partial consideration for the rights granted to Amgen under the agreement, Amgen paid the
Company an up-front fee of $60 million. 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.
16
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
The Company is also entitled to receive up to approximately $666 million in aggregate milestone
payments if all clinical and commercialization milestones specified in the agreement for AMG 151
and at least one backup compound are achieved. The Company will also receive royalties on sales of
any approved drugs developed under the agreement.
The Company estimates that its obligations under the agreement will continue until December 31,
2012 and, therefore, is recognizing the up-front fee on a straight-line basis from the date the
agreement was signed on December 13, 2009 through that time. The Company recognized $4.9 million of
revenue under the agreement for the three months ended September 30, 2010, which is recorded in
License and Milestone Revenue in the accompanying Condensed Statements of Operations and
Comprehensive Loss.
The Company recognized $1.1 million in revenue for the three months ended September 30, 2010 for
research performed by its full-time-equivalent scientists working on the discovery program, which
is recorded in Collaboration Revenue in the accompanying Condensed Statements of Operations and
Comprehensive Loss.
During the three months ended September 30, 2010, the Company recognized $1.2 million in revenue
and cost of sales for the reimbursement of certain development activities which is recorded in
Collaboration Revenue and Cost of Sales, respectively, in the accompanying Condensed Statements of
Operations and Comprehensive Loss.
Either party may terminate the agreement in the event of a material breach of a material obligation
under the agreement by the other party upon 90 days prior notice and Amgen may terminate the
agreement at any time upon notice of 60 or 90 days depending on the development activities going on
at the time of such notice. The parties have also agreed to indemnify each other for certain
liabilities arising under the agreement.
Novartis International Pharmaceutical Ltd.
The Company and Novartis International Pharmaceutical Ltd. entered into a License Agreement in
April 2010 granting Novartis the exclusive worldwide right to co-develop and commercialize
MEK162/ARRY-162, currently in a Phase 1b expansion trial in patients with KRAS or BRAF mutant
colorectal cancer, as well as ARRY-300 and other specified MEK inhibitors. Under the agreement, the
Company is responsible for completing the on-going expansion 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 U.S.
In consideration for the rights granted to Novartis under the agreement, the Company received
$45 million, comprising an upfront and milestone payment, in the fourth quarter of fiscal 2010, and
is also entitled to receive up to approximately $422 million in aggregate milestone payments if all
clinical, regulatory and commercial milestones specified in the agreement are achieved. Novartis
will also pay the Company royalties on worldwide sales of any approved drugs, with royalties on
U.S. sales at a significantly higher level, assuming the Company continues to co-develop as
described below.
The Company estimates that its obligations under the agreement will continue until April 2014 and,
therefore, is recognizing the up-front fee and first milestone on a straight-line basis from the
date the agreement was signed in April 2010 through that time. The Company recognized $2.8 million
of revenue for the three months ended September 30, 2010, which is recorded in License and
Milestone Revenue in the accompanying Condensed Statements of Operations and Comprehensive Loss.
The agreement contains co-development rights whereby the Company can elect to pay a percentage
share of the combined total development costs. During the first two years of the co-development
period, Novartis will reimburse the Company for 100% of the Companys development costs. Beginning
in year three, the Company will begin paying its percentage share of the combined development
costs, up to a
17
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
maximum amount with annual caps, unless it opts out of paying its percentage share of these costs.
If the Company opts out of paying its share of combined developments costs with respect to one or
more products, the U.S. royalty rate would then be reduced for any such product based on a
specified formula, subject to a minimum that equals the royalty rate on sales outside the U.S., and
the Company would no longer have the right to develop or detail such product.
The Company is recording a receivable in the accompanying Condensed Balance Sheets for the amounts
due from Novartis for the reimbursement of the Companys development costs. The Company is
accruing its percentage share of the combined development costs in the accompanying Condensed
Balance Sheets as an Other Long-term Liability, on the basis of the Companys intention to begin
paying such amounts to Novartis beginning in year three of the co-development period.
The Company incurred development costs of $2.1 million during the three months ended September 30,
2010 and recorded a corresponding receivable in Prepaid and Other Current Assets in the
accompanying Condensed Balance Sheets. The Companys share of the combined development costs was
$723 thousand during the three months ended September 30, 2010, which is recorded in Cost of Sales
in the accompanying Condensed Statements of Operations and Comprehensive Loss and Other Long-Term
Liabilities in the accompanying Condensed Balance Sheets.
The agreement will be in effect on a product-by-product and county-by-country basis until no
further payments are due with respect to the applicable product in the applicable country, unless
terminated earlier. Either party may terminate the agreement in the event of an uncured material
breach of a material obligation under the agreement by the other party upon 90 days prior notice.
Novartis may terminate portions of the agreement following a change in control of the Company and
may terminate the agreement in its entirety or on a product-by-product basis with 180 days prior
notice. The Company and Novartis have each further agreed to indemnify the other party for
manufacturing or commercialization activities conducted by it under the agreement, negligence or
willful misconduct or breach of covenants, warranties or representations made by it under the
agreement.
Celgene Corporation
In September 2007, the Company entered into a worldwide strategic collaboration with Celgene
focused on the discovery, development and commercialization of novel therapeutics in cancer and
inflammation. Under the agreement, Celgene made an up-front payment of $40 million to the Company
to provide research funding for activities conducted by the Company. The Company is responsible for
all discovery development through Phase 1 or Phase 2a. Celgene has an option to select a limited
number of drugs developed under the collaboration that are directed to up to two of four mutually
selected discovery 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 original 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 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. The
option term of this target will expire on or before June 2016/ No other terms 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.
Therefore, the unamortized
18
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
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 $1.6 million for the three months ended
September 30, 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 had Celgene
continued development of the program. Celgene may terminate the agreement in whole, or in part with
respect to individual drug development programs for which Celgene has exercised 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.
NOTE 5 LONG-TERM DEBT
Long-term debt consists of the following (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
June 30, |
|
|
2010 |
|
2010 |
|
Credit facility |
|
$ |
126,762 |
|
|
$ |
126,762 |
|
Refinance term loan |
|
|
15,000 |
|
|
|
15,000 |
|
|
|
|
|
|
Long-term debt, gross |
|
|
141,762 |
|
|
|
141,762 |
|
Less: Unamortized discount on credit facility |
|
|
(27,301 |
) |
|
|
(28,937 |
) |
|
|
|
|
|
Long-term debt, net |
|
|
114,461 |
|
|
|
112,825 |
|
|
|
|
|
|
Deerfield Credit Facilities
The Company has entered into two credit facilities (the Credit Facilities) with Deerfield Private
Design Fund, L.P. and Deerfield Private Design International Fund, L.P. (collectively Deerfield),
health care investment funds. Under a Facility Agreement entered into with Deerfield in April 2008,
the Company borrowed a total of $80 million (the 2008 Loan), which was funded in two $40 million
payments in June 2008 and December 2008. Certain terms of the 2008 Credit Facility, including the
interest rate and payment terms applicable to the 2008 Loan and covenants relating to minimum cash
and cash equivalent balances the Company must maintain, were amended in May 2009 when the Company
entered into a new Facility Agreement with Deerfield. Under this Facility Agreement, the Company
borrowed $40 million (the 2009 Loan), which it drew down on July 31, 2009.
Accrued interest on the Credit Facilities is payable monthly and the outstanding principal and
any unpaid accrued interest is due on or before April 2014. Interest and principal may be repaid,
at the Companys option, at any time with shares of the Companys common stock that have been
registered under the Securities Act of 1933, as amended, with certain restrictions, or in cash. The
maximum number of shares that the Company can issue to Deerfield under the Credit Facilities
without obtaining stockholder approval is 9,622,220 shares.
Prior to the disbursement of the 2009 Loan, simple interest was at a 2% annual rate and
compound interest accrued at an additional 6.5% annual rate on the $80 million principal balance
from the date of the Facility Agreement for the 2008 Loan through the July 31, 2009 disbursement
date of the 2009 Loan. During this period, simple interest on the 2008 Loan was payable quarterly.
The Company made these quarterly interest payments during fiscal 2009 and the first quarter of
fiscal 2010. The interest rate on the
19
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
2008 Loan was reduced upon disbursement of the 2009 Loan on July 31, 2009 to 7.5% per annum,
subject to adjustment as described below, and became payable monthly. Compound interest stopped
accruing on the 2008 Loan as of July 31, 2009.
The reduced 7.5% interest rate will continue to apply as long as the Companys total Cash and
Cash Equivalents and Marketable Securities on the first business day of each month during which
such principal amounts remain outstanding is at least $60 million. If the Companys total Cash and
Cash Equivalents and Marketable Securities in any month are less than $60 million, the interest
rate is adjusted to a rate between 8.5% per annum and 14.5% per annum for every $10 million by
which it is less than $60 million as follows:
|
|
|
|
|
Applied Interest |
Total Cash, Cash Equivalents and Marketable Securities |
|
Rate |
|
$60 million or greater |
|
7.5% |
Between $50 million and $60 million |
|
8.5% |
Between $40 million and $50 million |
|
9.5% |
Between $30 million and $40 million |
|
12.0% |
Less than $30 million |
|
14.5% |
The Credit Facilities contain two embedded derivatives: (1) the variable interest rate
structure described above and (2) Deerfields right to accelerate the loan upon certain changes of
control of the Company or an event of default, which is considered a significant transaction
contingent put option. As discussed in Note 1 Overview and Basis of Presentation under the
caption Long-term Debt and Embedded Derivatives, these derivatives must be valued and reported
separately in the Companys financial statements and are collectively referred to as the Embedded
Derivatives. Under the fair value hierarchy, the Company measured the fair value of the Embedded
Derivatives using Level III, or unobservable inputs.
In order to estimate fair value of the variable interest rate feature, the Company makes
assumptions as to interest rates that may be in effect during the term and the impact of repaying
the debt at maturity in cash and/or stock. Because the variable interest rate feature is tied to
the Companys cash and cash equivalent balances during the term of the Credit Facilities, the
Company is required to project its cash balances over this period, including forecasted up-front
revenue from new collaboration arrangements, milestone payments, other revenue, funds to be
provided from issuances of debt and/or equity, costs and expenses and other items. Such forecasts
are inherently subjective and, although management believes the assumptions upon which they are
based are reasonable, may not reflect actual results.
In order to estimate the fair value of the put right, the Company estimates the probability of
a change in control that would trigger Deerfields acceleration rights as specified in the loan
provisions. The Companys evaluation of this probability is based on its expectations as to the
size and financial strength of probable acquirers, including history of collaboration partners, the
probability of an acquisition occurring during the term of the Credit Facilities and other factors,
all of which are inherently uncertain and difficult to predict.
20
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
The assumptions for each period are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Estimated |
|
|
|
|
|
|
Probability of |
|
|
Estimated |
|
Triggering a |
|
|
Effective |
|
Change of |
|
|
Interest Rate |
|
Control |
|
July 31, 2009 |
|
|
7.55 |
% |
|
|
5.00 |
% |
September 30, 2009 |
|
|
7.55 |
% |
|
|
5.00 |
% |
December 31, 2009 |
|
|
7.54 |
% |
|
|
5.00 |
% |
March 31, 2010 |
|
|
7.54 |
% |
|
|
5.00 |
% |
June 30, 2010 |
|
|
7.54 |
% |
|
|
5.00 |
% |
September 30, 2010 |
|
|
7.54 |
% |
|
|
4.00 |
% |
Based on these assumptions, the Embedded Derivatives were initially valued as of July 31, 2009
at $1.1 million and recorded as Derivative Liabilities and as Debt Discount in the accompanying
Condensed Balance Sheets. The estimated fair value of the Embedded Derivatives based on these
assumptions was determined to be $535 thousand and $825 thousand as of September 30, 2010 and
June 30, 2010, respectively.
The change in value of the Embedded Derivatives of $290 thousand and $125 thousand was
recorded as a reduction to Interest Expense in the accompanying Condensed Statements of Operations
and Comprehensive Loss for the three months ended September 30, 2010 and 2009, respectively.
Management will continue to re-assess these assumptions at each reporting date and future changes
to these assumptions could materially change the estimated fair value of the Embedded Derivatives,
with a corresponding impact on the Companys reported results of operations.
The Company estimated that the fair value of the Deerfield debt was $99 million and
$95.4 million at September 30, 2010 and June 30, 2010, respectively.
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
21
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
total Cash, Cash Equivalents and Marketable Securities at the end of a fiscal quarter fall below
$20 million (which was reduced from $40 million when the Company entered into the 2009 Credit
Facility), all amounts outstanding under the Credit Facilities become immediately due and payable.
The Company is also required, subject to certain exceptions and conditions, to make payments of
principal equal to 15% of certain amounts it receives under collaboration, licensing, partnering,
joint venture and other similar arrangements entered into after January 1, 2011.
Warrants Issued to Deerfield
In consideration for providing the 2008 Credit Facility, the Company issued warrants to
Deerfield to purchase 6,000,000 shares of Common Stock at an exercise price of $7.54 per share (the
Prior Warrants). Pursuant to the terms of the Facility Agreement for the 2009 Loan, the Prior
Warrants were terminated and the Company issued new warrants to Deerfield to purchase
6,000,000 shares of Common Stock at an exercise price of $3.65 (the Exchange Warrants). The
Company also issued Deerfield warrants to purchase an aggregate of 6,000,000 shares of the
Companys Common Stock at an exercise price of $4.19 (the New Warrants and collectively with the
Exchange Warrants, the Warrants) when the funds were disbursed on July 31, 2009.
The Exchange Warrants contain substantially the same terms as the Prior Warrants, except that
the Exchange Warrants have a lower per share exercise price. The Warrants are exercisable
commencing January 31, 2010 and expire on April 29, 2014. Other than the exercise price, all other
provisions of the Exchange Warrants and the New Warrants are identical.
The Company allocated the $80 million proceeds under the 2008 Loan between the debt and the
Prior Warrants based upon their estimated relative fair values. The Company valued the Prior
Warrants using the Black-Scholes option pricing model using the following assumptions:
|
|
|
Risk-free interest rate of 3.3%; |
|
|
|
|
Volatility of 63.9%; |
|
|
|
|
Expected life of six years; and |
|
|
|
|
Dividend yield of zero. |
The Company allocated $20.6 million in value to equity and recorded it as Debt Discount in the
accompanying Condensed Balance Sheets. Because the 2008 Loan was drawn down in two separate
tranches, the Company is amortizing half of the Prior Warrant value from the first draw date and
the remaining half from the second draw date, in both cases to the end of the credit facility term,
to Interest Expense in the accompanying Condensed Statements of Operations and Comprehensive Loss.
The Company allocated the $40 million proceeds under the 2009 Loan between the debt and the
New Warrants based upon their estimated relative fair values. The Company valued the New Warrants
using the Black-Scholes option pricing model using the following assumptions:
|
|
|
Risk-free interest rate of 2.46%; |
|
|
|
|
Volatility of 63.59%; |
|
|
|
|
Expected life of five years; and |
|
|
|
|
Dividend yield of zero. |
The Company allocated $12.4 million in value to equity and recorded it as Debt Discount. The
Company is amortizing the discount from the July 31, 2009 draw date to the end of the Credit
Facility term to Interest Expense in the accompanying Condensed Statements of Operations and
Comprehensive Loss.
The Company calculated the incremental value of the Exchange Warrants as the difference
between the value of the Exchange Warrants at the new exercise price ($3.65) and the value of the
Prior Warrants at
22
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
the prior exercise price ($7.54). The Black-Scholes option pricing models used to calculate these
values used the following assumptions:
|
|
|
Risk-free interest rate of 1.86%; |
|
|
|
|
Volatility of 61.94%; |
|
|
|
|
Expected life of five years; and |
|
|
|
|
Dividend yield of zero. |
Prior to disbursement of the 2009 Loan, the Company recorded the incremental value of the
Exchange Warrants of $3.3 million as of June 30, 2009 in Other Long-Term Assets and Warrants in the
accompanying Condensed Balance Sheets. Following disbursement of the 2009 Loan on July 31, 2009,
the Company reclassified the balance of $3.3 million in Other Long-Term Assets to Debt Discount and
began amortizing the discount to Interest Expense in the accompanying Condensed Statements of
Operations and Comprehensive Loss from July 31, 2009 to the end of the term of the Credit
Facilities.
The interest expense recognized by the Company for the Deerfield Credit Facilities for the
three months ended September 30, 2010 and 2009, respectively, follows (dollars in thousands).
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
September 30, |
|
|
2010 |
|
2009 |
|
2.0% simple interest |
|
$ |
- |
|
|
$ |
124 |
|
6.5% compounding interest |
|
|
- |
|
|
|
476 |
|
7.5% simple interest |
|
|
2,250 |
|
|
|
1,500 |
|
Amortization of the transaction fees |
|
|
143 |
|
|
|
125 |
|
Amortization of the debt discounts |
|
|
1,637 |
|
|
|
1,285 |
|
Change in value of the Embedded Derivatives |
|
|
(290 |
) |
|
|
(125 |
) |
|
|
|
|
|
Total interest expense on the Deerfield Credit Facility |
|
$ |
3,740 |
|
|
$ |
3,385 |
|
|
|
|
|
|
Term Loan and Equipment Line of Credit
The Company entered into a Loan and Security Agreement (Loan and Security Agreement) with
Comerica Bank dated June 28, 2005, which has been subsequently amended. The Loan and Security
Agreement provides for a term loan, equipment advances and a revolving line of credit, all of which
are secured by a first priority security interest in the Companys assets, other than its
intellectual property.
The full $10 million term loan was advanced to the Company on June 30, 2005. The Company received
the total $5 million of equipment advances by June 30, 2007.
On September 30, 2009, the term and the interest rate structure of the Loan and Security Agreement
were amended. The maturity date was extended 120 days from June 28, 2010 to October 26, 2010.
Effective October 1, 2009, the outstanding balances under the term loan and the equipment advances
accrued interest on a monthly basis at a rate equal to 2.75% above the Prime Rate, as quoted by
Comerica Bank, but not less than the sum of Comerica Banks daily adjusting LIBOR rate plus 2.5%
per annum.
On March 31, 2010, the term and interest rate structure of the Loan and Security Agreement were
amended. The term loan and equipment advances were also combined into one instrument referred to as
the term loan. The maturity date was extended three years from October 26, 2010 to October 26,
2013.
23
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
Effective April 1, 2010, the outstanding balances under the term loan and the equipment advances
bear interest on a monthly basis at the Prime Rate, as quoted by Comerica Bank, but will not be
less than the sum of Comerica Banks daily adjusting LIBOR rate plus an incremental contractually
predetermined rate. This rate is variable, ranging from the Prime Rate to the Prime Rate plus 4%,
based on the total dollar amount the Company has invested at Comerica and in what investment option
those funds are invested.
In addition, revolving lines of credit of $6.8 million have been established to support standby
letters of credit in relation to the Companys facilities leases. These standby letters of credit
expire on January 31, 2014 and August 31, 2016.
As of September 30, 2010, the term loan had an interest rate of 3.25% per annum. The Company
recognized $125 thousand and $58 thousand of interest for the three months ended September 30, 2010
and 2009, respectively. These charges are recorded in Interest Expense in the accompanying
Condensed Statements of Operations and Comprehensive Loss.
The following table outlines the level of Cash, Cash Equivalents and Marketable Securities, which
the Company must hold in accounts at Comerica Bank per the Loan and Security Agreement based on the
Companys total Cash, Cash Equivalent and Marketable Securities, which was modified as part of the
March 31, 2010 amendment.
|
|
|
|
|
|
|
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 million as of September 30,
2010 and June 30, 2010.
24
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
Commitment Schedule
A summary of the Companys contractual commitments as of September 30, 2010 under the Credit
Facilities and the Loan and Security Agreement discussed above are as follows (dollars in
thousands):
|
|
|
|
|
For the twelve months ended September 30, |
|
|
|
|
2011 |
|
$ |
- |
|
2012 |
|
|
- |
|
2013 |
|
|
- |
|
2014 |
|
|
141,762 |
|
2015 |
|
|
- |
|
|
|
|
|
|
$ |
141,762 |
|
|
|
|
NOTE 6 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
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 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 12 - Employee Compensation Plans to the Companys audited financial statements
included in its Annual Report on Form 10-K for the year ended June 30, 2010 for more information
about the assumptions used by the Company under this valuation methodology. During the three
months ended September 30, 2010, the Company made no material changes to these assumptions.
During the three months ended September 30, 2010 and 2009, the Company issued new stock options to
purchase a total of 29,700 shares and 3,000 shares of common stock, respectively. The Company
recognized compensation expense for stock options of $908 thousand and $1.3 million for the three
months ended September 30, 2010 and 2009, respectively.
As of September 30, 2010, there was $4.3 million of total unrecognized compensation expense,
including the impact of expected forfeitures, for unvested share-based compensation awards granted
under the Companys equity plans, which the Company expects to recognize over a weighted-average
period of 2.2 years.
The fair value of common stock purchased under the ESPP is based on the estimated fair value of the
common stock during the offering period and the percentage of the purchase discount. During the
three months ended September 30, 2010 and 2009, the Company recognized compensation expense for its
ESPP of $190 thousand and $184 thousand, respectively.
25
ARRAY BIOPHARMA INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
For the quarter ended September 30, 2010
(Unaudited)
NOTE 7 EQUITY DISTRIBUTION AGREEMENT
On September 18, 2009, the Company entered into an Equity Distribution Agreement with Piper
Jaffray & Co. (the Agent) pursuant to which the Company agreed to sell from time to time, up to
an aggregate of $25 million in shares of its $.001 par value common stock, through the Agent that
have been registered on a registration statement on Form S-3 (File No. 333-15801). Sales of the
shares made pursuant to the Equity Distribution Agreement, 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 September 30, 2010, the Company sold 473,882 shares of common stock
at an average price of $3.21 per share, and received gross proceeds of $1.5 million. The Company
paid commissions to the Agent relating to these sales equal to $46 thousand and other expenses
relating to the closing of the Equity Distribution Agreement totaling $22 thousand.
NOTE 8 EMPLOYEE BONUS
The Company has an annual performance bonus program for its employees in which employees may
receive a bonus payable in cash or in shares of common stock if the Company meets certain
financial, discovery, development and partnering goals during a fiscal year. The bonus is
typically paid in the second quarter of the next fiscal year, and the Company accrues an estimate
of the expected aggregate bonus in Accrued Compensation and Benefits in the accompanying Condensed
Balance Sheets.
As of September 30, 2010, the Company had $7.8 million accrued in Accrued Compensation and Benefits
in the accompanying Condensed Balance Sheets, of which $1.3 million is for the fiscal 2011 Bonus
Program and $6.5 million is for the fiscal 2010 Performance Bonus Program. As of June 30, 2010 and
2009, the Company had $6.5 million and $4.2 million, respectively, accrued for the fiscal 2010 and
fiscal 2009 Performance Bonus Programs, which is recorded in Accrued Compensation and Benefits in
the accompanying Condensed Balance Sheets.
On October 5, 2009, the Company paid bonuses to approximately 350 eligible employees having an
aggregate value of $3.9 million under the fiscal 2009 Performance Bonus Program through the
issuance of a total of 1,000,691 shares of its common stock valued at $2.4 million and a payment of
cash to satisfy related withholding taxes.
On October 4, 2010, the Company paid bonuses to approximately 350 eligible employees having an
aggregate value of $6.5 million under the fiscal 2010 Performance Bonus Program through the
issuance of a total of 1,280,143 shares of its common stock and payment of cash to
satisfy related withholding taxes.
26
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
Managements Discussion and Analysis of Financial Condition and Results of Operations contains
forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995, including statements about our expectations related to the progress and success of drug
discovery activities conducted by Array and by our collaborators, our ability to obtain additional
capital to fund our operations and/or reduce our research and development spending, realizing new
revenue streams and obtaining future out-licensing collaboration agreements that include up-front
milestone and/or royalty payments, our ability to realize up-front milestone and royalty payments
under our existing or any future agreements, future research and development spending and
projections relating to the level of cash we expect to use in operations, our working capital
requirements and our future headcount requirements. In some cases, forward-looking statements can
be identified by the use of terms such as may, will, expects, intends, plans,
anticipates, estimates, potential, or continue, or the negative thereof or other comparable
terms. These statements are based on current expectations, projections and assumptions made by
management and are not guarantees of future performance. Although we believe that the expectations
reflected in the forward-looking statements contained herein are reasonable, these expectations or
any of the forward-looking statements could prove to be incorrect and actual results could differ
materially from those projected or assumed in the forward-looking statements. Our future financial
condition, as well as any forward-looking statements are subject to significant risks and
uncertainties, including but not limited to the factors set forth under the heading Risk Factors
in Item 1A under Part II of this Quarterly Report under Item 1A of the Annual Report on Form 10-K
for the fiscal year ended June 30, 2010 we filed with the Securities and Exchange Commission on
August 12, 2010. All forward looking statements are made as of the date hereof and, unless required
by law, we undertake no obligation to update any forward-looking statements.
The following discussion of our financial condition and results of operations should be read in
conjunction with the financial statements and notes to those statements included elsewhere in this
quarterly report. The terms we, us, our and similar terms refer to Array BioPharma Inc.
Overview
We are a biopharmaceutical company focused on the discovery, development and commercialization of
targeted small molecule drugs to treat patients afflicted with cancer and inflammatory diseases.
Our proprietary drug development pipeline includes clinical candidates that are designed to
regulate therapeutically important target pathways. In addition, leading pharmaceutical and
biotechnology companies partner with us to discover and develop drug candidates across a broad
range of therapeutic areas.
27
The six most advanced programs currently in clinical trials that we are developing alone or with a
partner are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical |
Program |
|
Indication |
|
Ownership |
|
Status |
|
|
|
|
|
|
|
1. AMG 151/ARRY-403
|
|
Glucokinase activator for Type 2 diabetes
|
|
Array/Amgen, Inc.
|
|
Phase 1 |
|
|
|
|
|
|
|
2. MEK162/ARRY-162
|
|
MEK inhibitor for cancer
|
|
Array/Novartis
|
|
Phase 1b |
|
|
|
|
International |
|
|
|
|
|
|
Pharmaceutical Ltd. |
|
|
|
|
|
|
|
|
|
3. ARRY-380
|
|
HER2 inhibitor for breast cancer
|
|
Array
|
|
Phase 1 |
|
|
|
|
|
|
|
4. ARRY-520
|
|
Kinesin spindle protein, or KSP, inhibitor for
|
|
Array
|
|
Phase 2 |
|
|
multiple myeloma, or MM |
|
|
|
|
|
|
|
|
|
|
|
5. ARRY-543
|
|
HER2/EGFR inhibitor for solid tumors
|
|
Array
|
|
Phase 1b |
|
|
|
|
|
|
|
6. ARRY-614
|
|
p38/Tie2 dual inhibitor for myelodysplastic
|
|
Array
|
|
Phase 1 |
|
|
syndrome, or MDS |
|
|
|
|
In addition to these development programs, the six most advanced partnered drugs in clinical
development are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Clinical |
Program |
|
Indication |
|
Ownership |
|
Status |
|
|
|
|
|
|
|
1. Selumetinib/AZD6244
|
|
MEK inhibitor for cancer
|
|
Array/AstraZeneca,
|
|
Phase 2 |
|
|
|
|
PLC |
|
|
|
|
|
|
|
|
|
2. Danoprevir/RG7227
|
|
Hepatitis C virus (HCV) protease inhibitor
|
|
Array/Roche Holding
|
|
Phase 2 |
|
|
|
|
AG |
|
|
|
|
|
|
|
|
|
3. GDC-0068
|
|
AKT kinase inhibitor for cancer
|
|
Array/Genentech Inc.
|
|
Phase 1 |
|
|
|
|
|
|
|
4. LY2603618/IC83
|
|
Checkpoint kinase, or Chk-1, inhibitor for
|
|
Array/Eli Lilly and
|
|
Phase 2 |
|
|
cancer
|
|
Company |
|
|
|
|
|
|
|
|
|
5. VTX-2337
|
|
Toll-like receptor for cancer
|
|
Array/VentiRx
|
|
Phase 1 |
|
|
|
|
Pharmaceuticals, Inc. |
|
|
|
|
|
|
|
|
|
6. VTX-1463
|
|
Toll-like receptor for allergy
|
|
Array/VentiRx
|
|
Phase 1 |
|
|
|
|
Pharmaceuticals, Inc. |
|
|
Any information we report about the development plans or the progress or results of clinical
trials or other development activities of our partners is based on information that has been
reported to us or is otherwise publicly disclosed by our partners.
We also have a portfolio of proprietary and partnered drug discovery programs that we believe will
generate an average of one to two Investigational New Drug, or IND, applications per year. We have
active, partnered programs with Amgen, Celgene, Genentech and Novartis in which we may earn
milestone payments and royalties. Our internal discovery efforts have also generated additional
early-
28
stage drug candidates and we may choose to out-license select promising candidates through research
partnerships prior to filing an IND application. Our internal drug discovery programs include an
inhibitor that targets the kinase Chk-1 for the treatment of cancer and a program directed to
discovering inhibitors of a family of tyrosine kinase, or Trk, receptors for the treatment of pain.
Our Chk-1 inhibitor is a selective, oral drug candidate that has shown prolonged inhibition of the
Chk-1 target in preclinical studies.
We have built our clinical and discovery programs through spending $414.4 million from our
inception through September 30, 2010. During the first three months of fiscal 2011 we spent $13.9
million in research and development for proprietary programs. In fiscal 2010, we spent
$72.5 million in research and development for proprietary programs, compared to $89.6 million and
$90.3 million for fiscal years 2009 and 2008, respectively. During fiscal 2010, we signed strategic
collaborations with Novartis and Amgen. Together these collaborations provided Array with
$105 million in initial payments, over $1 billion in potential milestone payments if all clinical
and commercialization milestones under the agreements are achieved; potential double digit
royalties and potential commercial co-detailing rights.
We have received a total of $485 million in research funding and in up-front and milestone payments
from our collaboration partners since inception through September 30, 2010. Under our existing
collaboration agreements, we have the potential to earn over $2.7 billion in additional milestone
payments if we or our collaborators achieve all the drug discovery, development and
commercialization objectives detailed in those agreements, as well as the potential to earn
royalties on any resulting product sales from 17 drug development programs.
Our significant collaborators include:
|
|
|
Amgen, which entered into a worldwide strategic collaboration with us to develop and
commercialize our glucokinase activator, AMG 151. |
|
|
|
|
AstraZeneca, which licensed three of our MEK inhibitors for cancer, including
selumetinib, which is currently in multiple Phase 2 clinical trials. |
|
|
|
|
Celgene Corporation, which entered into a worldwide strategic collaboration agreement
with us focused on the discovery, development and commercialization of novel therapeutics
in cancer and inflammation. |
|
|
|
|
Genentech, which entered into a worldwide strategic collaboration agreement with us
focused on the discovery, development and commercialization of novel therapeutics. One
drug, GDC-0068, an AKT inhibitor for cancer, entered a Phase 1 trial during the first half
of 2010. The other programs are in preclinical development. |
|
|
|
|
Roche Holding AG, which acquired danoprevir, a novel small molecule inhibitor of the
Hepatitis C Virus NS3/4 protease from InterMune, which we had invented in collaboration
with Intermune. Danoprevir is currently in Phase 2b clinical trials. |
|
|
|
|
Novartis, which entered into a worldwide strategic collaboration with us to develop and
commercialize our MEK inhibitor, MEK162, and other MEK inhibitors identified in the
agreement. |
Our fiscal year ends on June 30. When we refer to a fiscal year or quarter, we are referring to the
year in which the fiscal year ends and the quarters during that fiscal year. Therefore, fiscal 2011
refers to the fiscal year ended June 30, 2011.
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.
29
The following collaborators contributed greater than 10% of our total revenue for the periods
presented:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
2010 |
|
2009 |
|
|
|
|
|
|
|
|
|
Amgen Inc. |
|
|
39.1 |
% |
|
|
0.0 |
% |
Genentech, Inc. |
|
|
23.1 |
% |
|
|
64.1 |
% |
Celgene Corporation |
|
|
22.3 |
% |
|
|
20.8 |
% |
Novartis International Pharmaceutical Ltd. |
|
|
15.2 |
% |
|
|
0.0 |
% |
InterMune, Inc. |
|
|
0.0 |
% |
|
|
12.7 |
% |
|
|
|
|
|
|
|
|
99.7 |
% |
|
|
97.6 |
% |
|
|
|
|
|
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 September 30, |
|
|
2010 |
|
2009 |
|
North America |
|
$ |
15,680 |
|
|
$ |
7,853 |
|
Europe |
|
|
2,829 |
|
|
|
23 |
|
Asia Pacific |
|
|
4 |
|
|
|
14 |
|
|
|
|
|
|
|
|
$ |
18,513 |
|
|
$ |
7,890 |
|
|
|
|
|
|
All of our collaboration agreements are denominated in U.S. dollars.
Critical Accounting Policies and Estimates
Managements discussion and analysis of financial condition and results of operations are based
upon our accompanying Condensed Financial Statements, which have been prepared in accordance with
accounting principles generally accepted in the U.S. The preparation of these financial statements
requires us to make estimates and assumptions that affect the reported amounts of assets,
liabilities, revenue and expenses as well as the disclosure of contingent assets and liabilities.
We regularly review our estimates and assumptions.
These estimates and assumptions, which are based upon historical experience and on various other
factors believed to be reasonable under the circumstances, form the basis for making judgments
about the carrying values of assets and liabilities that are not readily apparent from other
sources. Reported amounts and disclosures may have been different had management used different
estimates and assumptions or if different conditions had occurred in the periods presented.
Below is a discussion of the policies and estimates that we believe involve a high degree of
judgment and complexity.
30
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, the sale of chemical compounds and the co-development of proprietary drug
candidates we out-license, as Collaboration Revenue. License and Milestone Revenue is combined and
consists of up-front fees and ongoing milestone payments from collaborators that are recognized
during the applicable period.
We recognize revenue in accordance with Staff Accounting Bulletin No. 104, Revenue Recognition
(SAB 104). SAB 104 establishes four criteria, each of which must be met, in order to recognize
revenue for the performance of services or the shipment of products. Revenue is recognized when
(a) persuasive evidence of an arrangement exists, (b) products are delivered or services are
rendered, (c) the sales price is fixed or determinable and (d) collectability is reasonably
assured.
Collaboration agreements that include a combination of discovery research funding, up-front or
license fees, milestone payments and/or royalties are evaluated to determine whether each
deliverable under the agreement has value to the customer on a stand-alone basis and whether
reliable evidence of fair value for the deliverable exists. Deliverables in an arrangement that do
not meet the separation criteria are treated as a single unit of accounting, generally applying
applicable revenue recognition guidance for the final deliverable to the combined unit of
accounting in accordance with SAB 104.
We recognize revenue from non-refundable up-front payments and license fees on a straight-line
basis over the term of performance under the agreement, which is generally the estimated research
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 for activities for
which there are no future obligations and as a result, are recognized when earned in their
entirety.
We periodically review the expected performance periods under each of our agreements that provide
for non-refundable up-front payments and license fees and milestone payments and adjust the
amortization periods when appropriate to reflect changes in assumptions relating to the duration of
expected performance periods. Revenue recognition for non-refundable license fees and up-front
payments and milestone payments could be accelerated in the event of early termination of programs
or alternatively, decelerated, if programs are extended. As such, while such estimates have no
impact on our reported cash flows, our reported revenue is significantly influenced by our
estimates of the period over which our obligations are expected to be performed.
31
Cost of Revenue and Research and Development for Proprietary Programs
We incur costs in connection with performing research and development activities which consist
mainly of compensation, associated fringe benefits, share-based compensation, preclinical and
clinical outsourcing costs and other collaboration-related costs, including supplies, small tools,
facilities, depreciation, recruiting and relocation costs and other direct and indirect chemical
handling and laboratory support costs. We allocate these costs between Cost of Revenue and Research
and Development for Proprietary Programs based upon the respective time spent by our scientists on
development conducted for our collaborations and for our internal proprietary programs,
respectively. Cost of Revenue represents the costs associated with research and development,
including preclinical and clinical trials, conducted by us for our collaborators. Research and
Development for Proprietary Programs consist of direct and indirect costs for our specific
proprietary programs. We do not bear any risk of failure for performing these activities and the
payments are not contingent on the success or failure of the research program. Accordingly, we
expense these costs when incurred.
Where our collaboration agreements provide for us to conduct research 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 for Proprietary Programs 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. As a result, 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 for Proprietary Programs. See Note 4 Deferred Revenue for
further information about our collaboration with Celgene.
Accrued Outsourcing Costs
Substantial portions of our preclinical studies and clinical trials are performed by third-party
laboratories, medical centers, contract research organizations and other vendors (collectively
CROs). These CROs generally bill monthly or quarterly for services performed or bill based upon
milestone achievement. For preclinical studies, we accrue expenses based upon estimated percentage
of work completed and the contract milestones remaining. For clinical studies, expenses are accrued
based upon the number of patients enrolled and the duration of the study. We monitor patient
enrollment, the progress of clinical studies and related activities to the extent possible through
internal reviews of data reported to us by the CROs, correspondence with the CROs and clinical site
visits. Our estimates depend on the timeliness and accuracy of the data provided by the CROs
regarding the status of each program and total program spending. We periodically evaluate our
estimates to determine if adjustments are necessary or appropriate based on information we receive.
Marketable Securities
We have designated our marketable securities as of each balance sheet date as available-for-sale
securities and account for them at their respective fair values. Marketable securities are
classified as short-term or long-term based on the nature of these securities and the availability
of these securities to
32
meet current operating requirements. Marketable securities that are readily available for use in
current operations are classified as short-term available-for-sale securities and are reported as a
component of current assets in the accompanying Condensed Balance Sheets. Marketable securities
that are not considered available for use in current operations are classified as long-term
available-for-sale securities and are reported as a component of long-term assets in the
accompanying Condensed Balance Sheets.
Securities that are classified as available-for-sale are carried at fair value, including accrued
interest, with temporary unrealized gains and losses reported as a component of Stockholders
Deficit until their disposition. We review all available-for-sale securities each period to
determine if they remain available-for-sale based on our 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 on ARS along with declines in value judged to be
other-than-temporary are reported in Gains (Losses) on Auction Rate Securities in the accompanying
Condensed Statements of Operations and Comprehensive Loss when recognized. The cost of securities
sold is based on the specific identification method.
Under the fair value hierarchy, our ARS are measured using Level III, or unobservable inputs, as
there is no active market for the securities. The most significant unobservable inputs used in this
method are estimates of the amount of time until a liquidity event will occur and the discount
rate, which incorporates estimates of credit risk and a liquidity premium (discount). Due to the
inherent complexity in valuing these securities, we engaged a third-party valuation firm to perform
an independent valuation of the ARS as part of our overall fair value analysis beginning with the
first quarter of fiscal 2009 and continuing through the current quarter. While we believe that the
estimates used in the fair value analysis are reasonable, a change in any of the assumptions
underlying these estimates would result in different fair value estimates for the ARS and could
result in additional adjustments to the ARS, either increasing or further decreasing their value,
possibly by material amounts.
See Note 3 Marketable Securities for additional information about our investments in ARS 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.
Fair Value Measurements
Our financial instruments are recognized and measured at fair value in our financial statements and
mainly consist of cash and cash equivalents, marketable securities, long-term investments, trade
receivables and payables, long-term debt, embedded derivatives associated with the long-term debt
and warrants. We use different valuation techniques to measure the fair value of assets and
liabilities, as discussed in more detail below. Fair value is defined as the price that would be
received to sell the financial instruments in an orderly transaction between market participants at
the measurement date. We use a framework for measuring fair value based on a hierarchy that
distinguishes sources of available information used in fair value measurements and categorizes them
into three levels:
|
|
|
Level I: |
Quoted prices in active markets for identical assets and liabilities. |
|
|
|
|
Level II: |
Observable inputs other than quoted prices in active markets for identical
assets and liabilities. |
|
|
|
|
Level III: |
Unobservable inputs. |
We disclose assets and liabilities measured at fair value based on their level in the hierarchy.
Considerable judgment is required in interpreting market data to develop estimates of fair value
for assets or liabilities for which there are no quoted prices in active markets, which include our
ARS, warrants issued by us or 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.
33
Accordingly, the fair value estimates disclosed by us may not be indicative of the amount that we
or holders of the instruments could realize in a current market exchange.
We periodically review the realizability of each investment when impairment indicators exist with
respect to the investment. If an other-than-temporary impairment of the value of an investment is
deemed to exist, the cost basis of the investment is written down to its then estimated fair value.
Long-term Debt and Embedded Derivatives
The terms of our long-term debt are discussed in detail in Note 5 Long-term Debt included
elsewhere in this Quarterly Report on Form 10-Q. The accounting for these arrangements is complex
and is based upon significant estimates by management. We review all debt agreements to determine
the appropriate accounting treatment when the agreement is entered into and review all amendments
to determine if the changes require accounting for the amendment as a modification, or as an
extinguishment and new debt. We also review each long-term debt arrangement to determine if any
feature of the debt requires bifurcation and/or separate valuation. These features include hybrid
instruments, which are comprised of at least two components ((1) a debt host instrument and (2) one
or more conversion features), warrants and other embedded derivatives, such as puts and other
rights of the debt holder.
We currently have two embedded derivatives related to our long-term debt with Deerfield. 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 part of our overall fair value
analysis as of July 31, 2009, the date funds were disbursed under the credit facility entered into
in May 2009 and for each subsequent quarter end through the current quarter end. The estimated fair
value of the Embedded Derivatives was determined based on managements judgment and assumptions and
the use of different assumptions could result in significantly different estimated fair values.
The initial fair value of the Embedded Derivatives was recorded as Derivative Liabilities and as
Debt Discount in our Condensed Balance Sheets. Any change in the value of the Embedded Derivatives
is adjusted quarterly as appropriate and recorded to Derivative Liabilities in the Condensed
Balance Sheets and Interest Expense in the accompanying Condensed Statements of Operations and
Comprehensive Loss. The Debt Discount is being amortized from the draw date of July 31, 2009 to the
end of the term of the Deerfield credit facilities using the effective interest method and recorded
as Interest Expense in the accompanying Condensed Statements of Operations and Comprehensive Loss.
Warrants that we issue in connection with our long-term debt arrangements are reviewed to determine
if they should be classified as liabilities or as equity. All outstanding warrants issued by us
have been classified as equity. We value the warrants at issuance based on a Black-Scholes option
pricing model and then allocate a portion of the proceeds under the debt to the warrants based upon
their relative fair values.
Any transaction fees paid in connection with our long-term debt arrangements that quality for
capitalization are recorded as Other Long-Term Assets in the Condensed Balance Sheets and amortized
34
to Interest Expense in the accompanying Condensed Statements of Operations and Comprehensive
Loss using the effective interest method over the term of the underlying debt agreement.
Results of Operations
Collaboration Revenue
Collaboration Revenue consists of revenue for our performance of drug discovery and development
activities in collaboration with partners, which include: co-development of proprietary drug
candidates we out-license as well as screening, lead generation and lead optimization research,
custom synthesis and process research and to a small degree the development and sale of chemical
compounds.
A summary of our collaboration revenue follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
|
|
September 30, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
5,720 |
|
|
$ |
5,044 |
|
|
$ |
676 |
|
|
|
13.4 |
% |
|
|
|
|
|
|
|
|
|
Collaboration revenue increased $676 thousand, or 13.4%, for the three months ended September 30,
2010 compared to the same period last year. During the current quarter, we recognized $1.1 million
and $1.2 million of additional revenue from Amgen under our research collaboration and for the
reimbursement of development costs, respectively. These increases were partially offset by
decreased revenue under our collaborations with Genentech and VentiRx. In the first quarter of
fiscal 2010 we recorded $633 thousand of revenue for the finalization of Genentech contract rates
for services rendered in the prior fiscal year that did not recur in the current quarter.
Additionally, we had fewer scientists engaged on the Genentech and VentiRx programs in the current
period compared to the same period last year.
License and Milestone Revenue
License and Milestone Revenue are combined and consist of up-front license fees and ongoing
milestone payments from collaborators.
A summary of our license and milestone revenue follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
|
|
September 30, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
License revenue |
|
$ |
11,731 |
|
|
$ |
1,846 |
|
|
$ |
9,885 |
|
|
|
535.5 |
% |
Milestone revenue |
|
|
1,062 |
|
|
|
1,000 |
|
|
|
62 |
|
|
|
6.2 |
% |
|
|
|
|
|
|
|
|
|
Total license and milestone revenue |
|
$ |
12,793 |
|
|
$ |
2,846 |
|
|
$ |
9,947 |
|
|
|
349.5 |
% |
|
|
|
|
|
|
|
|
|
License revenue increased $9.9 million in the first quarter of fiscal 2011 compared to the prior
year as a result of $4.9 million in revenue for our new collaboration with Amgen, $2.5 million in
revenue for our new collaboration with Novartis and $2.5 million in additional revenue recognized
under the Celgene collaboration due to our conclusion that the remaining estimated performance
period decreased from five
35
to two years effective September 30, 2009 as discussed in Note 4 Deferred Revenue to the accompanying Condensed Financial Statements.
Total Milestone Revenue remained consistent with the prior year. In the current quarter, we were
paid and recognized $750 thousand for the advancement of one of our programs with Genentech. In
addition, we recognized $313 thousand of the $5 million milestone payment we received from Novartis
in June 2010. In the first quarter of fiscal 2010, we recognized $1 million in milestone revenue
from InterMune for the advancement of danoprevir into Phase 2b clinical trials.
Cost of Revenue
Cost of Revenue represents costs attributable to discovery and development including preclinical
and clinical trials we conduct for our collaborators and to a smaller degree 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.
A summary of our Cost of Revenue follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
|
|
September 30, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
Cost of revenue |
|
$ |
7,281 |
|
|
$ |
5,923 |
|
|
$ |
1,358 |
|
|
|
22.9 |
% |
Cost of revenue as a percentage
of total revenue |
|
|
39.3% |
|
|
|
75.1% |
|
|
|
|
|
|
|
|
|
Cost of Revenue increased in absolute dollars and decreased as a percentage of total revenue for
the first quarter of fiscal 2011 compared to the prior year. The increase in absolute dollars was
for transitioning the underlying program costs for our AMG 151 and MEK162 programs from Research
and Development for Proprietary Programs to Cost of Revenue after we partnered these programs with
Amgen and Novartis, respectively, during the second half of fiscal 2010. These increases were
partially offset by changes to our collaboration with Celgene that were effective as of the second
quarter of fiscal 2010 and which resulted in the change in estimate for the Celgene cost allocation
from 50% to Cost of Revenue and 50% to Research and Development for Proprietary Programs 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. The decrease as a percentage of total revenue was because of greater
License and Milestone Revenue recognized during the period.
Research and Development for Proprietary Programs
Our research and development expenses for proprietary programs 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 for preclinical and clinical trials and share-based compensation. We manage our
proprietary programs based on scientific data and achievement of research plan goals. Our
scientists record their time to specific projects when possible; however, many activities
simultaneously benefit multiple projects and cannot be readily attributed to a 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.
36
The following table shows our research and development expenses by categories of costs for the
periods presented (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
|
|
September 30, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
Salaries, benefits and share-based
compensation |
|
$ |
6,576 |
|
|
$ |
7,674 |
|
|
$ |
(1,098 |
) |
|
|
(14.3 |
%) |
Outsourced services and consulting |
|
|
2,599 |
|
|
|
5,878 |
|
|
|
(3,279 |
) |
|
|
(55.8 |
%) |
Laboratory supplies |
|
|
2,333 |
|
|
|
2,785 |
|
|
|
(452 |
) |
|
|
(16.2 |
%) |
Facilities and depreciation |
|
|
2,021 |
|
|
|
2,521 |
|
|
|
(500 |
) |
|
|
(19.8 |
%) |
Other |
|
|
326 |
|
|
|
343 |
|
|
|
(17 |
) |
|
|
(5.0 |
%) |
|
|
|
|
|
|
|
|
|
Total research and development
for proprietary programs |
|
$ |
13,855 |
|
|
$ |
19,201 |
|
|
$ |
(5,346 |
) |
|
|
(27.8 |
%) |
|
|
|
|
|
|
|
|
|
Research and Development for Proprietary Programs for the first quarter of fiscal 2011 decreased
from the prior year because our development costs for AMG 151 and MEK162 shifted out of Research
and Development for Proprietary Programs to Cost of Revenue as a result of partnering the programs
with Amgen and Novartis, respectively. These decreases were partially offset by an increased
allocation of expenses for the Celgene programs as discussed under Cost of Revenue.
We expect our spending on Outsourced Services and Consulting for our proprietary programs will
increase from the relatively reduced level of the first quarter of fiscal 2011 during the remainder
of fiscal 2011 as ongoing clinical trials continue to advance and additional clinical and
preclinical studies are initiated.
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 for Proprietary Programs 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 |
|
Change 2010 vs. |
|
|
|
September 30, |
|
2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
General and administrative |
|
$ |
4,268 |
|
|
$ |
4,213 |
|
|
$ |
55 |
|
|
|
1.3 |
% |
37
Other Income (Expense)
A summary of our Other Income (Expense) follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Change 2010 vs. |
|
|
|
September 30, |
|
2009 |
|
|
2010 |
|
2009 |
|
2010 |
|
2009 |
|
Gains (losses) on auction rate securities |
|
$ |
(67 |
) |
|
$ |
(217 |
) |
|
$ |
150 |
|
|
|
(69.1 |
%) |
Interest income |
|
|
220 |
|
|
|
304 |
|
|
|
(84 |
) |
|
|
(27.6 |
%) |
Interest expense |
|
|
(3,892 |
) |
|
|
(3,442 |
) |
|
|
(450 |
) |
|
|
13.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense) |
|
$ |
(3,739 |
) |
|
$ |
(3,355 |
) |
|
$ |
(384 |
) |
|
|
11.4 |
% |
|
|
|
|
|
|
|
|
|
Interest Expense increased in the first quarter of fiscal 2011 compared to the same period in the
prior year due to increased borrowings under the Deerfield credit facilities, partially offset by a
lower interest rate on the debt.
The following table presents the components of Interest Expense for the three months ended
September 30, 2010 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
September 30, |
|
|
2010 |
|
2009 |
|
Deerfield Credit Facility: |
|
|
|
|
|
|
|
|
2.0% simple interest |
|
$ |
- |
|
|
$ |
124 |
|
6.5% compounding interest |
|
|
- |
|
|
|
476 |
|
7.5% simple interest |
|
|
2,250 |
|
|
|
1,500 |
|
Amortization of the transaction fees |
|
|
143 |
|
|
|
125 |
|
Amortization of the debt discounts |
|
|
1,637 |
|
|
|
1,285 |
|
Change in value of the Embedded Derivatives |
|
|
(290 |
) |
|
|
(125 |
) |
|
|
|
|
|
Total interest expense on Deerfield Credit Facility |
|
|
3,740 |
|
|
|
3,385 |
|
|
|
|
|
|
|
|
|
|
Comerica Loan: |
|
|
|
|
|
|
|
|
Variable interest and amortization of transaction fees |
|
|
152 |
|
|
|
57 |
|
|
|
|
|
|
Total interest expense on Comerica Loan |
|
|
152 |
|
|
|
57 |
|
|
|
|
|
|
Total interest expense |
|
$ |
3,892 |
|
|
$ |
3,442 |
|
|
|
|
|
|
Liquidity and Capital Resources
We have incurred operating losses and an accumulated deficit as a result of ongoing research and
development spending. As of September 30, 2010, we had an accumulated deficit of $501.5 million. We
had a net loss for the three months ended September 30, 2010 of $10.6 million. We had net losses
of $77.6 million, $127.8 million and $96.3 million for the fiscal years ended June 30, 2010, 2009
and 2008, respectively.
38
We have historically funded our operations through up-front fees and license and milestone payments
received under our collaboration and out-licensing transactions, from the proceeds from the
issuance and sale of equity securities and through debt provided by our credit facilities. In
December 2009, we received a $60 million up-front payment from Amgen under a Collaboration and
License Agreement and in the fourth quarter of fiscal 2010, we received $45 million in an upfront
and milestone payment under a License Agreement with Novartis International Pharmaceutical Ltd.
The recognition of revenue under these agreements is discussed further in Note 4 Deferred
Revenue to the accompanying Condensed Financial Statements. 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 revenue from its collaboration agreements, equity offerings and debt. We
believe that our cash, cash equivalents and marketable securities, and excluding the value of the
ARS we hold, will enable us to continue to fund our operations
for at least the next 12 months. There can be no assurance that we will be successful in entering
into future collaborations, however, or that other funds will be available to us when needed.
There can be no assurance, however, that the funds expected to be received under existing or future
collaborations or from debt or equity financings will be available to us when needed. If we are
unable to obtain additional funding from these or other sources to the extent or when needed, it
may be necessary to significantly reduce our current rate of spending through further reductions in
staff and delaying, scaling back or stopping certain research and development programs.
Insufficient funds may also require us to relinquish greater rights to product candidates at an
earlier stage of development or on less favorable terms to us or our stockholders than we would
otherwise choose in order to obtain up-front license fees needed to fund our operations.
Our ability to realize milestone or royalty payments under existing collaboration agreements and to
enter into new partnering arrangements that generate additional revenue through up-front fees and
milestone or royalty payments, is subject to a number of risks, many of which are beyond our
control and include the following: the drug development process is risky and highly uncertain and
we may not be successful in generating proof-of-concept data to create partnering opportunities
and, even if we are, we or our collaborators may not be successful in commercializing drug
candidates we create; our collaborators have substantial control and discretion over the timing and
continued development and marketing of drug candidates we create and, therefore, we may not receive
milestone, royalty or other payments when anticipated or at all; the drug candidates we develop may
not obtain regulatory approval; and, if regulatory approval is received, drugs we develop will
remain subject to regulation or may not gain market acceptance, which could delay or prevent us
from generating milestone, royalty revenue or product revenue from the commercialization of these
drugs.
Our assessment of our future need for funding is a forward-looking statement that is based on
assumptions that may prove to be wrong and that involve substantial risks and uncertainties. Our
actual future capital requirements could vary as a result of a number of factors, including:
|
|
|
Our ability to enter into agreements to out-license, co-develop or commercialize our
proprietary drug candidates and the timing of payments under those agreements throughout
each candidates development stage; |
|
|
|
|
The number and scope of our research and development programs; |
|
|
|
|
The progress and success of our preclinical and clinical development activities; |
|
|
|
|
The progress of the development efforts of our collaborators; |
|
|
|
|
Our ability to maintain current collaboration agreements; |
|
|
|
|
The costs involved in enforcing patent claims and other intellectual property rights; |
|
|
|
|
The costs and timing of regulatory approvals; and/or |
|
|
|
|
The expenses associated with unforeseen litigation, regulatory changes, competition and
technological developments, general economic and market conditions and the extent to which
we acquire or invest in other businesses, products and technologies. |
39
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 primarily of our investments in ARS.
See Note 3 Marketable
Securities in the accompanying Condensed Financial Statements for more information regarding our
ARS. Our ability to sell the ARS is substantially limited due to auctions that continue to be
suspended for these securities in the related markets. In the event we need to access these funds
and liquidate the ARS prior to the time auctions of these investments are successful or the date on
which the original issuers retire these securities, we may be required to sell them in a distressed
sale in a secondary market, most likely for a lower value than their current estimated fair value.
Following is a summary of our cash, cash equivalents and marketable securities (dollars in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
June 30, |
|
|
|
|
|
|
2010 |
|
2010 |
|
$ Change |
|
% Change |
|
Cash and cash equivalents |
|
$ |
33,292 |
|
|
$ |
32,846 |
|
|
$ |
446 |
|
|
|
1.4 |
% |
Marketable
securities - short-term |
|
|
59,640 |
|
|
|
78,664 |
|
|
|
(19,024 |
) |
|
|
(24.2 |
%) |
Marketable
securities - long-term |
|
|
15,729 |
|
|
|
17,359 |
|
|
|
(1,630 |
) |
|
|
(9.4 |
%) |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
108,661 |
|
|
$ |
128,869 |
|
|
$ |
(20,208 |
) |
|
|
(15.7 |
%) |
|
|
|
|
|
|
|
|
|
Cash Flow Activities
Following is a summary of our cash flows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
September 30, |
|
Change 2010 vs. 2009 |
|
|
2010 |
|
2009 |
|
$ |
|
% |
|
Cash flows provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
(20,914 |
) |
|
$ |
(20,888 |
) |
|
$ |
(26 |
) |
|
|
0.1 |
% |
Investing activities |
|
|
19,816 |
|
|
|
3,256 |
|
|
|
16,560 |
|
|
|
508.6 |
% |
Financing activities |
|
|
1,544 |
|
|
|
39,131 |
|
|
|
(37,587 |
) |
|
|
(96.1 |
%) |
|
|
|
|
|
|
|
|
|
Total |
|
$ |
446 |
|
|
$ |
21,499 |
|
|
$ |
(21,053 |
) |
|
|
(97.9 |
%) |
|
|
|
|
|
|
|
|
|
Net cash used in operating activities for the first quarter of fiscal 2011 was consistent with the
same period of the prior year.
Net cash provided by investing activities was $19.8 million and $3.3 million in the first quarter
of fiscal 2011 and 2010, respectively. Prior to the fourth quarter of fiscal 2010, we did not
purchase additional marketable securities upon the maturity of securities we held, and as such,
cash flows provided by investing activities in the first quarter of fiscal 2010 reflected only cash
received upon the maturities of marketable securities. In the first quarter of fiscal 2011, the
marketable securities matured and provided
40
cash at a higher level than the same period last year, which was offset in part by purchases of new
marketable securities and the acquisition of equipment.
Net cash provided by financing activities was $1.5 million and $39.1 million in the first quarter
of fiscal 2011 and 2010, respectively. The difference between the periods is attributable to the
$39 million in net proceeds we received in the first quarter of fiscal 2010 under the Deerfield
credit facilities. During the first quarter of fiscal 2011 and 2010, we also received $1.5 million
and $128 thousand, respectively, of net proceeds from sales of shares of our common stock under our
Equity Distribution Agreement with Piper Jaffray & Co.
Obligations and Commitments
The following table shows our contractual obligations and commitments by maturity as of
September 30, 2010 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than |
|
1 to 3 |
|
4 to 5 |
|
Over 5 |
|
|
|
|
|
1 Year |
|
Years |
|
Years |
|
Years |
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt obligations (1) |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
141,762 |
|
|
$ |
- |
|
|
$ |
141,762 |
|
|
Interest on debt obligations (3) (4) |
|
|
9,488 |
|
|
|
18,976 |
|
|
|
5,291 |
|
|
|
- |
|
|
|
33,755 |
|
|
Operating lease commitments (2) |
|
|
7,919 |
|
|
|
16,175 |
|
|
|
16,462 |
|
|
|
6,585 |
|
|
|
47,141 |
|
|
Purchase obligations (2) |
|
|
14,015 |
|
|
|
1,806 |
|
|
|
3 |
|
|
|
- |
|
|
|
15,824 |
|
|
|
|
Total |
|
$ |
31,422 |
|
|
$ |
36,957 |
|
|
$ |
163,518 |
|
|
$ |
6,585 |
|
|
$ |
238,482 |
|
|
|
|
|
|
|
(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 September 30, 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 September 30, 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 September 30, 2010 were
five to 10 years and generally require us to pay the real estate taxes, insurance and other
operating costs. Equipment lease terms generally range from three to five years.
Purchase obligations totaling $8.6 million are for outsourced services for clinical trials and
other research and development costs. Purchase obligations totaling $3.7 million are for software
related expenses. The remaining $3.5 million is for all other purchase commitments.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Market risk represents the risk of loss that may impact our financial position, results of
operations or cash flows due to adverse changes in financial and commodity market prices, the
liquidity of ARS we hold and fluctuations in interest rates. All of our collaboration agreements
and nearly all purchase orders are denominated in U.S. dollars. As a result, historically and as of
September 30, 2010, we have had little or no exposure to market risk from changes in foreign
currency or exchange rates.
Our investment portfolio, without regard to our ARS, is comprised primarily of readily marketable,
high-quality securities diversified and structured to minimize market risks. We target our average
portfolio maturity at one year or less. Our exposure to market risk for changes in interest rates
relates primarily to our investments in marketable securities. Marketable securities held in our
investment portfolio are
41
subject to changes in market value in response to changes in interest rates and liquidity. As of
September 30, 2010, $15 million of our investment portfolio was invested in ARS that are not
marketable as discussed below. In addition, a significant change in market interest rates could
have a material impact on interest income earned from our investment portfolio. A theoretical
100 basis point change in interest rates and security prices would impact our annual net loss
positively or negatively by $1.1 million based on the current balance of $108.7 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
September 30, 2010, we held four securities with a par value of $20.3 million and an estimated fair
value of $15 million. As of June 30, 2010, we held five securities with a par value of
$26.3 million and an estimated fair value of $16.6 million.
We sold one of the ARS in the first quarter of fiscal 2011 with a par value of $6 million and an
estimated fair value of $967 thousand for $900 thousand and realized a loss of $67 thousand, with
$220 thousand recognized from Accumulated Other Comprehensive Income.
On October 5, 2010, we sold one of the ARS with a par value of $3 million for $1.9 million and
realized a gain of $567 thousand, which was recognized in full from Accumulated Other Comprehensive
Income.
Due to unsuccessful auctions and continuing uncertainty and volatility in the credit markets, the
estimated fair value of our ARS has fluctuated and we have therefore recorded fair value
adjustments to our ARS as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
September 30, |
|
|
2010 |
|
2009 |
|
Balance as of prior year end |
|
$ |
16,560 |
|
|
$ |
16,518 |
|
Gains during period included in equity |
|
|
- |
|
|
|
1,898 |
|
Sale of ARS |
|
|
(900 |
) |
|
|
- |
|
Reclassification of unrealized gain from
Accumulated Other Comprehensive Income
to earnings |
|
|
(220 |
) |
|
|
- |
|
Losses during period included in equity |
|
|
(357 |
) |
|
|
- |
|
Losses during period included in earnings
due to the sale of marketable securities |
|
|
(67 |
) |
|
|
- |
|
Losses during period included in earnings
due to impairment of marketable securities |
|
|
- |
|
|
|
(217 |
) |
|
|
|
|
|
Balance as of current quarter end |
|
$ |
15,016 |
|
|
$ |
18,199 |
|
|
|
|
|
|
We have recorded cumulative net loss adjustments of $5.3 million to the four ARS we held as of
September 30, 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 the funds invested in any of our ARS prior to the time auctions of these investments are
successful or the original issuers retire these securities, we will be required to sell them in a
distressed sale in a secondary market, most likely for a significantly lower amount than their
current fair value.
As of September 30, 2010, we had $141.8 million of debt outstanding, exclusive of the debt discount
of $27.3 million. The term loan under our senior secured credit facility with Comerica Bank of
$15 million is variable rate debt. Assuming constant debt levels, a theoretical change of 100 basis
points on our current
42
interest rate of 3.25% on the Comerica debt as of September 30, 2010 would result in a change in
our annual interest expense of $150 thousand. The interest rate on our long-term debt under the
credit facilities with Deerfield is variable based on our total cash, cash equivalents and
marketable securities balances. However, as long as our total cash, cash equivalents and marketable
securities balances remain above $60 million, our interest rate is fixed at 7.5%. Assuming constant
debt levels, a theoretical change of 100 basis points on our current rate of interest of 7.5% on
the Deerfield credit facilities as of September 30, 2010 would result in a change in our annual
interest expense of $1.2 million.
Historically and as of September 30, 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 September 30, 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. 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
September 30, 2010 that have materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting.
43
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 September 30, 2010 we
believe to be material to the risk factors set forth in our Annual Report on Form 10-K for the
fiscal year ended June 30, 2010 filed with the Securities and Exchange Commission. The risks and
uncertainties described below are not the only ones that we face and are more fully described in
our Annual Report on Form 10-K and in other reports we file with the Securities and Exchange
Commission. Additional risks and uncertainties not presently known to us or that we currently
believe are immaterial also may negatively impact our business.
Risks Related to Our Business
We have a history of operating losses and may not achieve or sustain profitability.
We have incurred significant operating and net losses and negative cash flows from operations since
our inception. As of September 30, 2010, we had an accumulated deficit of $501.5 million. We had
net losses of $10.6 million for the three months ended September 30, 2010. We had net losses of
$77.6 million, $127.8 million and $96.3 million, for the fiscal years ended June 30, 2010, 2009 and
2008, respectively. We expect to incur additional losses and negative cash flows in the future, and
these losses may continue or increase in part due to anticipated levels of expenses for research
and development, particularly clinical development, expansion of our clinical and scientific
capabilities, and acquisitions of complementary technologies or in-licensed drug candidates. 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.
Moreover, if we do achieve profitability, the level of any profitability cannot be predicted and
may vary significantly. Much of our current revenue is non-recurring in nature and unpredictable as
to timing and amount. While several of our out-licensing and collaboration agreements provide for
royalties on product sales, given that none of our drug candidates have been approved for
commercial sale, that our drug candidates are at early stages of development and that drug
development entails a high degree of risk of failure, we do not expect to receive any royalty
revenue for several years, if at all. For the same reasons, we may never realize much of the
milestone revenue provided for in our out-license and collaboration agreements. Similarly, drugs we
select to commercialize ourselves or partner for later-stage co-development and commercialization
may not generate revenue for several years, or at all.
Because we rely on a small number of collaborators for a significant portion of our revenue, if one
or more of our major collaborators terminates or reduces the scope of its agreement with us, our
revenue may significantly decrease.
A relatively small number of collaborators account for a significant portion of our revenue. Amgen,
Genentech, Celgene and Novartis accounted for 39.1%, 23.1%, 22.3% and 15.2%, respectively, of our
total revenue for the first three months of fiscal 2011; and Genentech and Celgene accounted for
64.1% and 20.8%, respectively, of our total revenue in the prior year. 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
44
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.
We may not be successful in entering into additional out-license agreements on favorable terms,
which may adversely affect our liquidity or require us to change our spending priorities on our
proprietary programs.
We are committing significant resources to create our own proprietary drug candidates and to build
a commercial-stage biopharmaceutical company. We have built our clinical and discovery programs
through spending $414.4 million from our inception through September 30, 2010. During the first
three months of fiscal 2011 we spent $13.9 million in research and development for proprietary
programs. In fiscal 2010, we spent $72.5 million in research and development for proprietary
programs, compared to $89.6 million and $90.3 million for fiscal years 2009 and 2008, respectively.
Our proprietary drug discovery programs are in their early stage of development and are
unproven. Our ability to continue to fund our planned spending on our proprietary drug programs
and in building our commercial capabilities depends to a large degree on up-front fees, milestone
payments and other revenue we receive as a result of our partnered programs. To date, we have
entered into six out-licensing agreements for the development and commercialization of our drug
candidates, and we plan to continue initiatives during fiscal 2011 to partner select clinical
candidates to obtain additional capital. We may not be successful, however in entering into
additional out-licensing agreements with favorable terms, including up-front, milestone, royalty
and/or license payments and the retention of certain valuable commercialization or co-promote
rights, as a result of factors, many of which are outside of our control. These factors include:
|
● |
|
Our ability to create valuable proprietary drugs targeting large market
opportunities; |
|
|
● |
|
Research and spending priorities of potential licensing partners; |
|
|
● |
|
Willingness of and the resources available to pharmaceutical and
biotechnology companies to in-license drug candidates to fill their clinical pipelines; |
|
|
● |
|
The success or failure, and timing, or pre-clinical and clinical trials on
our proprietary programs we intend to out-license; or |
|
|
● |
|
Our ability or inability to generate proof-of-concept data and to agree
with a potential partner on the value of proprietary drug candidates we are seeking to
out-license, or on the related terms. |
If we are unable to enter into out-licensing agreements and realize milestone, license and/or
upfront fees when anticipated, it may adversely affect our liquidity and we may be forced to
curtail or delay development of all or some of our proprietary programs, which in turn may harm our
business and the value of our stock. In addition, insufficient funds may require us to relinquish
greater rights to product candidates at an earlier stage of development or on less favorable terms
to us or our stockholders than we would otherwise choose in order to obtain funding for further
development and/or up-front license fees needed to fund our operations.
If we need but are unable to obtain additional funding to support our operations, we could be
unable to successfully execute our operating plan or be forced to reduce our operations.
We have historically funded our operations through revenue from our collaborations and out-license
transactions, the issuance of equity securities and debt financing. We used $20.9 million from our
operating activities in the first three months of both fiscal 2011 and 2010. 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 principal from the Senior credit facility and the Deerfield
credit facilities becomes due and payable in 2013 and 2014. Our debt obligations could therefore
render us more vulnerable to competitive pressures and economic downturns and impose some
restrictions on our operations.
45
Our current operating plan and assumptions could change as a result of many factors, and we could
require additional funding sooner than anticipated. If we are unable to meet our capital
requirements from cash generated by our future operating activities and are unable to obtain
additional funds when needed, we may be required to curtail operations significantly or to obtain
funds through other arrangements on unattractive terms, which could prevent us from successfully
executing our operating plan. If we raise additional capital through the sale of equity or
convertible debt securities, the issuance of those securities would result in dilution to our
stockholders.
Because our stock price may be volatile, our stock price could experience substantial declines.
The market price of our common stock has historically experienced and may continue to experience
volatility. The high and low closing bids for our common stock were $3.44 and $2.67, respectively,
during the first quarter of fiscal 2011; $4.45 and $1.72, respectively, during the fiscal 2010;
$8.79 and $2.51, respectively, during fiscal 2009; and $12.91 and $4.66, respectively, in fiscal
2008. Our quarterly operating results, the success or failure of our internal drug discovery
efforts, decisions to delay, modify or cease one or more of our development programs, uncertainties
about our ability to continue to operate as a going concern, changes in general conditions in the
economy or the financial markets and other developments affecting our collaborators, our
competitors or us could cause the market price of our common stock to fluctuate substantially. This
volatility coupled with market declines in our industry over the past several years have affected
the market prices of securities issued by many companies, often for reasons unrelated to their
operating performance, and may adversely affect the price of our common stock. In the past,
securities class action litigation has often been instituted following periods of volatility in the
market price of a companys securities. A securities class action suit against us could result in
potential liabilities, substantial costs and the diversion of managements attention and resources,
regardless of whether we win or lose.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. RESERVED
ITEM 5. OTHER INFORMATION
None
46
ITEM 6. EXHIBITS
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Exhibit Number |
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Description of Exhibit |
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10.1* |
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6th Amendment to the Drug Discovery
Collaboration Agreement between the Registrant and
Genentech, Inc. |
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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. |
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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. |
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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. |
* Confidential treatment of redacted portions has been applied for.
47
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized, in the City
of Boulder, State of Colorado, on this 8th day of November 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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48