Delaware
|
84-1460811
|
(State or Other Jurisdiction of Incorporation or Organization)
|
(I.R.S. Employer Identification No.)
|
|
|
3200 Walnut Street, Boulder, CO
|
80301
|
(Address of Principal Executive Offices)
|
(Zip Code)
|
|
|
(303) 381-6600
|
|
(Registrant’s Telephone Number, Including Area Code)
|
Large Accelerated Filer
x
|
Accelerated Filer
¨
|
Non-Accelerated Filer
¨
|
Smaller Reporting Company
¨
|
|
Emerging Growth Company
¨
|
|
|
|
|
|
Page No.
|
|
||
Condensed Consolidated
Financial Statements
|
|
|
|
Condensed Consolidated
Balance Sheets as of
September 30, 2018 and
June 30, 2018 (unaudited)
|
|
|
Condensed Consolidated Statements of Operations and Comprehensive Loss for the
three months ended September 30, 2018 and 2017 (unaudited)
|
|
|
Condensed Consolidated Statement of Stockholders' Equity for the three months ended September 30, 2018 (unaudited)
|
|
|
Condensed Consolidated
Statements of Cash Flows for the
three months ended
September 30, 2018 and 2017 (unaudited)
|
|
|
Notes to the Unaudited Condensed
Consolidated
Financial Statements
|
|
|
|
|
|
||
|
|
|
|
||
Item 5.
|
||
|
|
|
|
|
|
|
|
|
|
||
|
|
|
September 30,
|
|
June 30,
|
||||
|
2018
|
|
2018
|
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
130,507
|
|
|
$
|
114,748
|
|
Marketable securities
|
283,886
|
|
|
297,739
|
|
||
Accounts receivable
|
44,378
|
|
|
32,084
|
|
||
Prepaid expenses and other current assets
|
17,439
|
|
|
6,972
|
|
||
Total current assets
|
476,210
|
|
|
451,543
|
|
||
|
|
|
|
||||
Non-current assets
|
|
|
|
||||
Marketable securities
|
998
|
|
|
919
|
|
||
Property and equipment, net
|
6,860
|
|
|
7,128
|
|
||
Other non-current assets
|
151
|
|
|
774
|
|
||
Total non-current assets
|
8,009
|
|
|
8,821
|
|
||
Total assets
|
$
|
484,219
|
|
|
$
|
460,364
|
|
|
|
|
|
||||
Liabilities and Stockholders' Equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
14,609
|
|
|
$
|
14,059
|
|
Accrued outsourcing costs
|
34,264
|
|
|
31,853
|
|
||
Accrued compensation and benefits
|
17,194
|
|
|
16,695
|
|
||
Other accrued expenses
|
6,550
|
|
|
1,868
|
|
||
Deferred rent
|
724
|
|
|
707
|
|
||
Notes payable at fair value
|
—
|
|
|
15,899
|
|
||
Deferred revenue
|
11,425
|
|
|
12,350
|
|
||
Current portion of long-term debt
|
—
|
|
|
2,500
|
|
||
Total current liabilities
|
84,766
|
|
|
95,931
|
|
||
|
|
|
|
||||
Non-current liabilities
|
|
|
|
||||
Deferred rent
|
5,414
|
|
|
5,598
|
|
||
Deferred revenue
|
42,635
|
|
|
44,470
|
|
||
Long-term debt, net
|
131,093
|
|
|
93,376
|
|
||
Other non-current liabilities
|
1,243
|
|
|
1,246
|
|
||
Total non-current liabilities
|
180,385
|
|
|
144,690
|
|
||
Total liabilities
|
265,151
|
|
|
240,621
|
|
||
|
|
|
|
||||
Commitments and contingencies
|
|
|
|
||||
|
|
|
|
||||
Stockholders' equity
|
|
|
|
||||
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.001 par value; 280,000,000 shares authorized as of September 30, 2018 and June 30, 2018, 213,026,650 and 211,289,922 shares issued and outstanding as of September 30, 2018 and June 30, 2018, respectively
|
213
|
|
|
211
|
|
||
Additional paid-in capital
|
1,309,985
|
|
|
1,286,000
|
|
||
Accumulated other comprehensive loss
|
(312
|
)
|
|
(461
|
)
|
||
Accumulated deficit
|
(1,090,818
|
)
|
|
(1,066,007
|
)
|
||
Total stockholders' equity
|
219,068
|
|
|
219,743
|
|
||
Total liabilities and stockholders' equity
|
$
|
484,219
|
|
|
$
|
460,364
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
|
|
|
Three Months Ended
|
||||||
|
|
September 30,
|
||||||
|
|
2018
|
|
2017
|
||||
Revenue
|
|
|
|
|
||||
Product sales, net
|
|
$
|
13,993
|
|
|
$
|
—
|
|
Collaboration and license revenue
|
|
31,028
|
|
|
11,554
|
|
||
Reimbursement revenue
|
|
11,889
|
|
|
18,192
|
|
||
Total revenue
|
|
56,910
|
|
|
29,746
|
|
||
|
|
|
|
|
||||
Operating expenses
|
|
|
|
|
||||
Cost of goods sold
|
|
195
|
|
|
—
|
|
||
Research and development
|
|
55,550
|
|
|
53,204
|
|
||
Selling, general and administrative
|
|
24,890
|
|
|
12,048
|
|
||
Total operating expenses
|
|
80,635
|
|
|
65,252
|
|
||
|
|
|
|
|
||||
Loss from operations
|
|
(23,725
|
)
|
|
(35,506
|
)
|
||
|
|
|
|
|
||||
Other income (expense)
|
|
|
|
|
||||
Realized gain on investments
|
|
35
|
|
|
—
|
|
||
Change in fair value of notes payable
|
|
(65
|
)
|
|
200
|
|
||
Interest income
|
|
1,524
|
|
|
525
|
|
||
Interest expense
|
|
(2,580
|
)
|
|
(3,213
|
)
|
||
Total other income (expense), net
|
|
(1,086
|
)
|
|
(2,488
|
)
|
||
|
|
|
|
|
||||
Net loss
|
|
$
|
(24,811
|
)
|
|
$
|
(37,994
|
)
|
|
|
|
|
|
||||
Change in unrealized gain on marketable securities
|
|
149
|
|
|
34
|
|
||
|
|
|
|
|
||||
Comprehensive loss
|
|
$
|
(24,662
|
)
|
|
$
|
(37,960
|
)
|
|
|
|
|
|
||||
Weighted average shares outstanding – basic
|
|
212,193
|
|
|
174,772
|
|
||
Weighted average shares outstanding – diluted
|
|
212,193
|
|
|
174,772
|
|
||
|
|
|
|
|
||||
Net loss per share – basic
|
|
$
|
(0.12
|
)
|
|
$
|
(0.22
|
)
|
Net loss per share – diluted
|
|
$
|
(0.12
|
)
|
|
$
|
(0.22
|
)
|
|
|
|
|
|
||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
|
|
|
|
|
|
|
Additional Paid-in Capital
|
|
Accumulated Other Comprehensive Loss
|
|
Accumulated Deficit
|
|
Total
|
|||||||||||
|
|
Common Stock
|
|
|
|
|
|||||||||||||||||
|
|
Shares
|
|
Amounts
|
|
|
|
|
|||||||||||||||
Balance as of June 30, 2018
|
|
211,290
|
|
|
$
|
211
|
|
|
$
|
1,286,000
|
|
|
$
|
(461
|
)
|
|
$
|
(1,066,007
|
)
|
|
$
|
219,743
|
|
Shares issued for cash under employee share plans
|
|
503
|
|
|
1
|
|
|
2,255
|
|
|
—
|
|
|
—
|
|
|
2,256
|
|
|||||
Share-based compensation expense
|
|
—
|
|
|
—
|
|
|
4,812
|
|
|
—
|
|
|
—
|
|
|
4,812
|
|
|||||
Issuance of common stock, net of offering costs / At-the-market offering
|
|
1,234
|
|
|
1
|
|
|
16,918
|
|
|
—
|
|
|
—
|
|
|
16,919
|
|
|||||
Change in unrealized loss on marketable securities
|
|
—
|
|
|
—
|
|
|
—
|
|
|
149
|
|
|
—
|
|
|
149
|
|
|||||
Net loss
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(24,811
|
)
|
|
(24,811
|
)
|
|||||
Balance as of September 30, 2018
|
|
213,027
|
|
|
$
|
213
|
|
|
$
|
1,309,985
|
|
|
$
|
(312
|
)
|
|
$
|
(1,090,818
|
)
|
|
$
|
219,068
|
|
|
|||||||||||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
|
|
Three Months Ended
|
||||||
|
September 30,
|
||||||
|
2018
|
|
2017
|
||||
Cash flows from operating activities
|
|
|
|
||||
Net loss
|
$
|
(24,811
|
)
|
|
$
|
(37,994
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
Depreciation and amortization expense
|
533
|
|
|
577
|
|
||
Non-cash interest expense
|
1,441
|
|
|
1,961
|
|
||
Share-based compensation expense
|
4,812
|
|
|
5,583
|
|
||
Realized gain from investments, net
|
(35
|
)
|
|
—
|
|
||
Change in fair value of notes payable
|
65
|
|
|
(200
|
)
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Accounts receivable
|
(12,294
|
)
|
|
4,678
|
|
||
Prepaid expenses and other assets
|
(9,844
|
)
|
|
886
|
|
||
Accounts payable and other accrued expenses
|
4,268
|
|
|
1,287
|
|
||
Accrued outsourcing costs
|
2,411
|
|
|
6,145
|
|
||
Accrued compensation and benefits
|
1,632
|
|
|
2,013
|
|
||
Deferred rent
|
(167
|
)
|
|
(88
|
)
|
||
Deferred revenue
|
(2,760
|
)
|
|
(2,926
|
)
|
||
Other long-term liabilities
|
(51
|
)
|
|
34
|
|
||
Net cash used in operating activities
|
(34,800
|
)
|
|
(18,044
|
)
|
||
|
|
|
|
||||
Cash flows from investing activities
|
|
|
|
||||
Purchases of property and equipment
|
(265
|
)
|
|
(24
|
)
|
||
Proceeds from investment
|
35
|
|
|
—
|
|
||
Purchases of marketable securities
|
(87,308
|
)
|
|
(104,468
|
)
|
||
Proceeds from sales and maturities of marketable securities
|
101,279
|
|
|
44,746
|
|
||
Net cash provided by (used in) investing activities
|
13,741
|
|
|
(59,746
|
)
|
||
|
|
|
|
||||
Cash flows from financing activities
|
|
|
|
||||
Proceeds from issuance of common stock / Public offering
|
—
|
|
|
258,750
|
|
||
Offering costs for issuance of common stock / Public offering
|
—
|
|
|
(15,732
|
)
|
||
Proceeds from issuance of common stock / At-the-market offering
|
17,288
|
|
|
2,917
|
|
||
Offering costs for the issuance of common stock / At-the-market offering
|
(369
|
)
|
|
(87
|
)
|
||
Net proceeds from employee stock purchases and options exercised
|
1,123
|
|
|
1,423
|
|
||
Payment of note payable
|
(15,000
|
)
|
|
—
|
|
||
Proceeds from the modification of long-term debt, net
|
33,776
|
|
|
—
|
|
||
Net cash provided by financing activities
|
36,818
|
|
|
247,271
|
|
||
|
|
|
|
||||
Net increase in cash and cash equivalents
|
15,759
|
|
|
169,481
|
|
||
Cash and cash equivalents at beginning of period
|
114,748
|
|
|
125,933
|
|
||
Cash and cash equivalents at end of period
|
$
|
130,507
|
|
|
$
|
295,414
|
|
|
|
|
|
||||
Supplemental disclosure of cash flow information
|
|
|
|
||||
Cash paid for interest
|
$
|
1,151
|
|
|
$
|
89
|
|
Change in unrealized loss on marketable securities
|
$
|
149
|
|
|
$
|
34
|
|
|
Three Months Ended
|
||||
|
September 30,
|
||||
|
2018
|
|
2017
|
||
Novartis Pharmaceutical
|
20.9
|
%
|
|
61.2
|
%
|
Pierre Fabre
|
38.2
|
%
|
|
13.8
|
%
|
Loxo Oncology
|
11.3
|
%
|
|
11.3
|
%
|
Total
|
70.4
|
%
|
|
86.3
|
%
|
|
Three Months Ended
|
||||||
|
September 30,
|
||||||
|
2018
|
|
2017
|
||||
Europe
|
$
|
33,688
|
|
|
$
|
22,296
|
|
North America
|
22,280
|
|
|
5,501
|
|
||
Asia Pacific
|
942
|
|
|
1,949
|
|
||
Total
|
$
|
56,910
|
|
|
$
|
29,746
|
|
|
September 30, 2018
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
$
|
283,952
|
|
|
$
|
—
|
|
|
$
|
(312
|
)
|
|
$
|
283,640
|
|
Mutual fund securities
|
246
|
|
|
—
|
|
|
—
|
|
|
246
|
|
||||
|
284,198
|
|
|
—
|
|
|
(312
|
)
|
|
283,886
|
|
||||
Long-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
998
|
|
|
—
|
|
|
—
|
|
|
998
|
|
||||
|
998
|
|
|
—
|
|
|
—
|
|
|
998
|
|
||||
Total
|
$
|
285,196
|
|
|
$
|
—
|
|
|
$
|
(312
|
)
|
|
$
|
284,884
|
|
|
June 30, 2018
|
||||||||||||||
|
|
|
Gross
|
|
Gross
|
|
|
||||||||
|
Amortized
|
|
Unrealized
|
|
Unrealized
|
|
Fair
|
||||||||
|
Cost
|
|
Gains
|
|
Losses
|
|
Value
|
||||||||
Short-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
$
|
297,965
|
|
|
$
|
—
|
|
|
$
|
(461
|
)
|
|
$
|
297,504
|
|
Mutual fund securities
|
235
|
|
|
—
|
|
|
—
|
|
|
235
|
|
||||
|
298,200
|
|
|
—
|
|
|
(461
|
)
|
|
297,739
|
|
||||
Long-term available-for-sale securities:
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
919
|
|
|
—
|
|
|
—
|
|
|
919
|
|
||||
|
919
|
|
|
—
|
|
|
—
|
|
|
919
|
|
||||
Total
|
$
|
299,119
|
|
|
$
|
—
|
|
|
$
|
(461
|
)
|
|
$
|
298,658
|
|
|
Amortized
|
|
Fair
|
||||
|
Cost
|
|
Value
|
||||
Due in one year or less
|
$
|
283,952
|
|
|
$
|
283,640
|
|
BRAFTOVI
|
|
$
|
7,015
|
|
MEKTOVI
|
|
6,978
|
|
|
Total Net Product Sales
|
|
$
|
13,993
|
|
|
|
Returns
|
Other
|
Total
|
|
||||||
Balance as of June 30, 2018
|
|
$
|
—
|
|
$
|
(78
|
)
|
$
|
(78
|
)
|
|
Allowances for sales during prior periods
|
|
—
|
|
—
|
|
—
|
|
|
|||
Allowances for sales during the current period
|
|
50
|
|
3,410
|
|
3,460
|
|
|
|||
Credits/deductions issued for prior year sales
|
|
—
|
|
—
|
|
—
|
|
|
|||
Credits/deductions issued for sales during the current period
|
|
(11
|
)
|
(798
|
)
|
(809
|
)
|
|
|||
Balance as of September 30, 2018
|
|
$
|
39
|
|
$
|
2,534
|
|
$
|
2,573
|
|
|
|
|
Three Months Ended
|
||||||
|
|
September 30,
|
||||||
|
|
2018
|
|
2017
|
||||
Collaboration and other revenue
|
|
|
|
|||||
Pierre Fabre
|
|
$
|
6,029
|
|
|
$
|
3,349
|
|
Loxo
|
|
2,403
|
|
|
2,258
|
|
||
Mirati
|
|
994
|
|
|
1,389
|
|
||
Other partners
|
|
684
|
|
|
1,012
|
|
||
Total collaboration and other revenue
|
|
10,110
|
|
|
8,008
|
|
||
|
|
|
|
|
||||
License and milestone revenue
|
|
|
|
|
||||
Pierre Fabre
|
|
15,750
|
|
|
750
|
|
||
Loxo
|
|
4,000
|
|
|
1,107
|
|
||
Ono
|
|
918
|
|
|
918
|
|
||
Other partners
|
|
250
|
|
|
771
|
|
||
Total license and milestone revenue
|
|
20,918
|
|
|
3,546
|
|
||
Total collaboration and license revenue
|
|
$
|
31,028
|
|
|
$
|
11,554
|
|
|
|
|
|
|
||||
Reimbursement revenue
|
|
|
|
|
||||
Novartis
|
|
$
|
11,889
|
|
|
$
|
18,192
|
|
|
September 30,
|
|
June 30,
|
||||
|
2018
|
|
2018
|
||||
Ono
|
$
|
26,636
|
|
|
$
|
27,555
|
|
Pierre Fabre (1)
|
24,229
|
|
|
22,394
|
|
||
Mirati
|
1,695
|
|
|
2,468
|
|
||
Loxo
|
—
|
|
|
2,403
|
|
||
Other
|
1,500
|
|
|
2,000
|
|
||
Total deferred revenue
|
54,060
|
|
|
56,820
|
|
||
Less: Current portion
|
(11,425
|
)
|
|
(12,350
|
)
|
||
Deferred revenue, long-term portion
|
$
|
42,635
|
|
|
$
|
44,470
|
|
|
September 30,
|
|
June 30,
|
||||
|
2018
|
|
2018
|
||||
Notes payable at fair value
|
$
|
—
|
|
|
$
|
15,899
|
|
|
|
|
|
||||
2024 convertible senior notes
|
$
|
126,060
|
|
|
$
|
126,060
|
|
Silicon Valley Bank term loan (1)
|
53,500
|
|
|
16,200
|
|
||
Long-term debt, gross
|
179,560
|
|
|
142,260
|
|
||
Less: Unamortized debt discount and fees
|
(48,467
|
)
|
|
(46,384
|
)
|
||
Long-term debt, net
|
131,093
|
|
|
95,876
|
|
||
Less: Current portion
|
—
|
|
|
(2,500
|
)
|
||
Long-term debt, non-current portion
|
$
|
131,093
|
|
|
$
|
93,376
|
|
|
|
Three Months Ended
|
||||||
|
|
September 30,
|
||||||
|
|
2018
|
|
2017
|
||||
Silicon Valley Bank Term Loan
|
|
|
|
|
||||
Simple interest
|
|
$
|
282
|
|
|
$
|
90
|
|
Amortization of prepaid fees for line of credit
|
|
171
|
|
|
44
|
|
||
Amortization of debt discount
|
|
14
|
|
|
80
|
|
||
Total interest expense on the Silicon Valley Bank term loan
|
|
467
|
|
|
214
|
|
||
Convertible Senior Notes (1)
|
|
|
|
|
||||
Contractual interest
|
|
835
|
|
|
992
|
|
||
Amortization of debt discount
|
|
1,198
|
|
|
1,780
|
|
||
Amortization of debt issuance costs
|
|
73
|
|
|
101
|
|
||
Total interest expense on convertible senior notes
|
|
2,106
|
|
|
2,873
|
|
||
Other Debt
|
|
|
|
|
||||
Simple interest
|
|
7
|
|
|
126
|
|
||
Total interest expense on other debt
|
|
7
|
|
|
126
|
|
||
Total interest expense
|
|
$
|
2,580
|
|
|
$
|
3,213
|
|
•
|
Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments.
|
•
|
Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace.
|
•
|
Level 3: Significant unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation.
|
|
|
Fair Value Measurement as of September 30, 2018
|
||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Assets
|
|
|
|
|
|
|
|
|
||||||||
Current Assets
|
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
|
$
|
283,640
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
283,640
|
|
Mutual fund securities
|
|
246
|
|
|
—
|
|
|
—
|
|
|
246
|
|
||||
Long-term Assets
|
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
|
998
|
|
|
—
|
|
|
—
|
|
|
998
|
|
||||
Total assets
|
|
$
|
284,884
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
284,884
|
|
|
|
Fair Value Measurement as of June 30, 2018
|
||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Assets
|
|
|
|
|
|
|
|
|
||||||||
Current Assets
|
|
|
|
|
|
|
|
|
||||||||
U.S. treasury securities
|
|
$
|
297,504
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
297,504
|
|
Mutual fund securities
|
|
235
|
|
|
—
|
|
|
—
|
|
|
235
|
|
||||
Long-term Assets
|
|
|
|
|
|
|
|
|
||||||||
Mutual fund securities
|
|
919
|
|
|
—
|
|
|
—
|
|
|
919
|
|
||||
Total assets
|
|
$
|
298,658
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
298,658
|
|
|
|
|
|
|
|
|
|
|
||||||||
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Notes payable, at fair value
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
15,899
|
|
|
$
|
15,899
|
|
|
|
Notes Payable at Fair Value
|
||
Balance at June 30, 2018
|
|
$
|
15,899
|
|
Change in fair value
|
|
65
|
|
|
Settlement upon maturity
|
|
(15,964
|
)
|
|
Balance at September 30, 2018
|
|
$
|
—
|
|
•
|
Risk-free interest rate - We determine the risk-free interest rate by using a weighted average assumption equivalent to the expected term based on the U.S. Treasury constant maturity rate.
|
•
|
Expected term - We estimate the expected term of our options based upon historical exercises and post-vesting termination behavior.
|
•
|
Expected volatility - We estimate expected volatility using daily historical trading data of our common stock.
|
•
|
Dividend yield - We have never paid dividends and currently have no plans to do so; therefore, no dividend yield is applied.
|
|
Three Months Ended September 30, 2018
|
||
|
2018
|
|
2017
|
Risk-free interest rate
|
2.7% - 2.8%
|
|
1.6% - 1.8%
|
Expected option term in years
|
3.8
|
|
4.1
|
Expected volatility
|
66.6% - 67.0%
|
|
66.1% - 66.5%
|
Dividend yield
|
0%
|
|
0%
|
Weighted average grant date fair value
|
$7.90
|
|
$4.67
|
|
Number of
Options |
|
Weighted
Average Exercise Price |
|
Weighted Average Remaining Contractual Term (in years)
|
|
Aggregate Intrinsic Value (in thousands)
|
|||||
Outstanding balance at June 30, 2018
|
15,326,350
|
|
|
$
|
7.68
|
|
|
|
|
|
||
Granted
|
194,800
|
|
|
$
|
15.39
|
|
|
|
|
|
||
Exercised
|
(437,321
|
)
|
|
$
|
5.41
|
|
|
|
|
|
||
Forfeited
|
(237,011
|
)
|
|
$
|
9.37
|
|
|
|
|
|
||
Expired
|
(6,000
|
)
|
|
$
|
6.22
|
|
|
|
|
|
||
Outstanding balance at September 30, 2018
|
14,840,818
|
|
|
$
|
7.82
|
|
|
7.5
|
|
$
|
110,609
|
|
Vested and expected to vest at September 30, 2018
|
14,818,596
|
|
|
$
|
7.82
|
|
|
7.5
|
|
$
|
110,416
|
|
Exercisable at September 30, 2018
|
5,932,793
|
|
|
$
|
5.01
|
|
|
5.9
|
|
$
|
60,466
|
|
|
Number of RSUs
|
|
Weighted
Average Grant Date Fair Value |
|||
Unvested at June 30, 2018
|
959,730
|
|
|
$
|
9.28
|
|
Granted
|
20,000
|
|
|
15.34
|
|
|
Vested
|
(4,252
|
)
|
|
5.88
|
|
|
Forfeited
|
(15,839
|
)
|
|
9.72
|
|
|
Unvested at September 30, 2018
|
959,639
|
|
|
$
|
9.41
|
|
|
Three Months Ended
|
||||||
|
September 30,
|
||||||
|
2018
|
|
2017
|
||||
Net loss - basic and diluted
|
$
|
(24,811
|
)
|
|
$
|
(37,994
|
)
|
|
|
|
|
||||
Weighted average shares outstanding - basic and diluted
|
212,193
|
|
|
174,772
|
|
||
|
|
|
|
||||
Per share data:
|
|
|
|
||||
Basic and diluted
|
$
|
(0.12
|
)
|
|
$
|
(0.22
|
)
|
|
September 30,
|
||||
|
2018
|
|
2017
|
||
2.625% convertible senior notes
|
8,156
|
|
|
—
|
|
3.00% convertible senior notes
|
—
|
|
|
18,762
|
|
Stock options
|
14,841
|
|
|
14,224
|
|
Unvested RSUs
|
960
|
|
|
885
|
|
Total anti-dilutive common stock equivalents excluded from diluted loss per share calculation
|
23,957
|
|
|
33,871
|
|
|
Drug Candidate
|
|
Target/Disease State
|
|
Partner
|
|
Clinical Status
|
|
BRAFTOVI + MEKTOVI
|
|
BRAF and MEK inhibitors for advanced
BRAF
-mutant melanoma
|
|
Pierre Fabre Medicament SAS and Ono Pharmaceutical Co., Ltd.
|
|
Approved in US and EU
|
|
Encorafenib
|
|
BRAF inhibitor for
BRAF
-mutant CRC
|
|
Pierre Fabre Medicament SAS and Ono Pharmaceutical Co., Ltd.
|
|
Phase 3
|
|
Binimetinib
|
|
MEK inhibitor for
BRAF
-mutant CRC and other cancers
|
|
Pierre Fabre Medicament SAS and Ono Pharmaceutical Co., Ltd.
|
|
Phase 3
|
|
Selumetinib (1)
|
|
MEK inhibitor for cancer and NF1 (2)
|
|
AstraZeneca, PLC
|
|
Phase 2 / Registration Trial
|
|
Ganovo/Danoprevir (1)
|
|
Protease inhibitor for Hepatitis C virus
|
|
Roche Holding AG
|
|
Approved in China
|
|
Larotrectinib / LOXO-101 (1)
|
|
PanTrk inhibitor for cancer
|
|
Loxo Oncology, Inc.
|
|
Phase 2 / Registration Trial / NDA (3)
|
|
ARRY-797
|
|
p38 inhibitor for Lamin A/C-related dilated cardiomyopathy
|
|
Wholly-owned by Array
|
|
Phase 3
|
|
Ipatasertib / GDC-0068 (1)
|
|
AKT inhibitor for cancer
|
|
Genentech, Inc.
|
|
Phase 3
|
|
Tucatinib / ONT-380 (1)
|
|
HER2 inhibitor for breast cancer
|
|
Seattle Genetics, Inc.
|
|
Phase 2 / Registration Trial
|
|
Varlitinib / ASLAN001 (1)
|
|
Pan-HER2 inhibitor for gastric or breast cancer
|
|
ASLAN Pharmaceuticals Pte Ltd.
|
|
Phase 2 / 3
|
|
LOXO-292 (1)
|
|
Ret inhibitor for cancer
|
|
Loxo Oncology, Inc.
|
|
Phase 2 / Registration Trial
|
|
ARRY-382
|
|
CSF1R inhibitor for cancer
|
|
Wholly-owned by Array
|
|
Phase 2
|
|
Motolimod / VTX-2337 (1)
|
|
Toll-like receptor for cancer
|
|
Celgene Corp. / VentiRx Pharmaceuticals, Inc.
|
|
Phase 2
|
|
Prexasertib / LY2606368 (1)
|
|
CHK-1 inhibitor for cancer
|
|
Eli Lilly and Company
|
|
Phase 2
|
|
LOXO-195 (1)
|
|
Trk inhibitor for cancer
|
|
Loxo Oncology, Inc.
|
|
Phase 1 / 2
|
|
AK-1830 (1)
|
|
TrkA selective inhibitor for inflammation
|
|
Asahi Kasei Pharma Corporation
|
|
Phase 1
|
|
Three Months Ended
|
|
Change
|
|
|||||||||||
|
September 30,
|
|
2018 vs. 2017
|
|
|||||||||||
|
2018
|
|
2017
|
|
$
|
|
%
|
|
|||||||
Product sales, net
|
$
|
13,993
|
|
|
$
|
—
|
|
|
$
|
13,993
|
|
|
(a)
|
|
|
Collaboration and license revenue
|
31,028
|
|
|
11,554
|
|
|
19,474
|
|
|
169
|
%
|
|
|||
Reimbursement revenue
|
11,889
|
|
|
18,192
|
|
|
(6,303
|
)
|
|
(35
|
)%
|
|
|||
Total revenue
|
$
|
56,910
|
|
|
$
|
29,746
|
|
|
$
|
27,164
|
|
|
91
|
%
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
|
|
Change
|
|||||||||||
|
September 30,
|
|
2018 vs. 2017
|
|||||||||||
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
Cost of goods sold
|
$
|
195
|
|
|
$
|
—
|
|
|
$
|
195
|
|
|
(a)
|
|
Research and development
|
55,550
|
|
|
53,204
|
|
|
2,346
|
|
|
4
|
%
|
|||
Selling, general and administrative
|
24,890
|
|
|
12,048
|
|
|
12,842
|
|
|
107
|
%
|
|||
Total operating expenses
|
$
|
80,635
|
|
|
$
|
65,252
|
|
|
$
|
15,383
|
|
|
24
|
%
|
|
Three Months Ended
|
|
Change
|
|||||||||||
|
September 30,
|
|
2018 vs. 2017
|
|||||||||||
|
2018
|
|
2017
|
|
$
|
|
%
|
|||||||
Realized gain on investments
|
$
|
35
|
|
|
$
|
—
|
|
|
$
|
35
|
|
|
(a)
|
|
Change in fair value of notes payable
|
(65
|
)
|
|
200
|
|
|
(265
|
)
|
|
(133
|
)%
|
|||
Interest income
|
1,524
|
|
|
525
|
|
|
999
|
|
|
190
|
%
|
|||
Interest expense
|
(2,580
|
)
|
|
(3,213
|
)
|
|
633
|
|
|
(20
|
)%
|
|||
Total other income (expense), net
|
$
|
(1,086
|
)
|
|
$
|
(2,488
|
)
|
|
$
|
1,402
|
|
|
(56
|
)%
|
|
September 30, 2018
|
|
June 30, 2018
|
|
$ Change
|
||||||
Cash and cash equivalents
|
$
|
130,507
|
|
|
$
|
114,748
|
|
|
$
|
15,759
|
|
Marketable securities – current
|
283,886
|
|
|
297,739
|
|
|
(13,853
|
)
|
|||
Marketable securities – non-current
|
998
|
|
|
919
|
|
|
79
|
|
|||
Total
|
$
|
415,391
|
|
|
$
|
413,406
|
|
|
$
|
1,985
|
|
|
Three Months Ended
September 30, |
|
|
||||||||
|
2018
|
|
2017
|
|
$ Change
|
||||||
Cash flows provided by (used in):
|
|
|
|
|
|
||||||
Operating activities
|
$
|
(34,800
|
)
|
|
$
|
(18,044
|
)
|
|
$
|
(16,756
|
)
|
Investing activities
|
13,741
|
|
|
(59,746
|
)
|
|
73,487
|
|
|||
Financing activities
|
36,818
|
|
|
247,271
|
|
|
(210,453
|
)
|
|||
Total
|
$
|
15,759
|
|
|
$
|
169,481
|
|
|
$
|
(153,722
|
)
|
|
|
|
|
Incorporated by Reference
|
||||
Exhibit Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Date Filed
|
3.1
|
|
|
Filed herewith
|
|||||
3.2
|
|
|
10-Q
|
|
001-16633
|
|
2/6/2018
|
|
4.1
|
|
|
S-1/A
|
|
333-45922
|
|
10/27/2000
|
|
4.2
|
|
|
8-K
|
|
001-16633
|
|
12/4/2017
|
|
4.3
|
|
|
8-K
|
|
001-16633
|
|
12/4/2017
|
|
31.1
|
|
|
Filed herewith
|
|||||
31.2
|
|
|
Filed herewith
|
|||||
32.1
|
|
|
Furnished
|
|||||
101.INS
|
|
XBRL Instance Document
|
|
Filed herewith
|
||||
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
Filed herewith
|
||||
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
Filed herewith
|
||||
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
Filed herewith
|
||||
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
Filed herewith
|
||||
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
Filed herewith
|
By:
|
/s/ RON SQUARER
|
|
Ron Squarer
|
|
Chief Executive Officer
|
|
|
|
|
By:
|
/s/ JASON HADDOCK
|
|
Jason Haddock
|
|
Chief Financial Officer
|
|
(Principal Financial and Accounting Officer)
|
1.
|
The name of the corporation is Array BioPharma Inc.
|
FIRST:
|
The name of the corporation is Array BioPharma Inc. (the “
Corporation
”). The Corporation was originally incorporated on February 6, 1998 pursuant to the DGCL. An Amended and Restated Certificate of Incorporation of the Corporation was filed with the Secretary of State of the State of Delaware on or about November 21, 2000 (the “
Certificate of Incorporation
”). A Certificate of Correction to the Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on or about November 19, 2004.
|
SECOND:
|
That the board of directors of the Corporation duly adopted resolutions approving the following amendment to the Certificate of Incorporation (the “
Amendment
”) in accordance with the provisions of Section 242 of the DGCL, declaring such Amendment to be advisable and calling for the approval of the stockholders of the Corporation to such Amendment.
|
THIRD:
|
The Amendment was duly adopted and approved in accordance with the provisions of Section 211 of the DGCL by the required vote of the stockholders of the Corporation at the Annual Meeting of the stockholders of the Corporation.
|
FOURTH:
|
That the Corporation’s Certificate of Incorporation is hereby amended as provided herein. Section 4.1 shall be deleted in its entirety and replaced with the following:
|
FIFTH:
|
Except as expressly amended by this Amendment, the provisions of the Certificate of Incorporation shall remain in full force and effect.
|
1.
|
The name of the corporation (hereinafter called the “corporation”) is:
|
/s/ R. Michael Carruthers
Name: R. Michael Carruthers
Title: Chief Financial Officer
|
|
Number of shares of Series B Preferred Stock owned prior to Conversion: ________
|
Number of shares of Series B Preferred Stock to be Converted: _________________
|
Number of shares of Common Stock to be Issued: ___________________________
|
Address for delivery of physical certificates: ______________________
or
for DWAC Delivery:
DWAC Instructions:
Broker no: _________
Account no: ___________
|
[HOLDER]
By:___________________________________
Name:
Title:
Date:
|
FIRST:
|
The name of the corporation is Array BioPharma Inc. (the “
Corporation
”). The Corporation was originally incorporated on February 6, 1998 pursuant to the DGCL. An Amended and Restated Certificate of Incorporation of the Corporation was filed with the Secretary of State of the State of Delaware on or about November 21, 2000 (the “
Certificate of Incorporation
”). A Certificate of Correction to the Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on or about November 19, 2004.
|
SECOND:
|
That the board of directors of the Corporation duly adopted resolutions approving the following amendment to the Certificate of Incorporation (the “
Amendment
”) in accordance with the provisions of Section 242 of the DGCL, declaring such Amendment to be advisable and calling for the approval of the stockholders of the Corporation to such Amendment.
|
THIRD:
|
The Amendment was duly adopted and approved in accordance with the provisions of Section 211 of the DGCL by the required vote of the stockholders of the Corporation at the Annual Meeting of the stockholders of the Corporation.
|
FOURTH:
|
That the Corporation’s Certificate of Incorporation is hereby amended as provided herein. Section 4.1 shall be deleted in its entirety and replaced with the following:
|
|
4.1 Authorized Shares.
The total number of shares of all classes of stock that the Corporation shall have the authority to issue is 230,000,000 of which 220,000,000 shall be common stock, all of one class, having a par value of $.001 per share (the “
Common Stock
”), and 10,000,000 of such shares shall be Preferred Stock, having a par value of $.001 per share (the “
Preferred Stock
”).
|
FIFTH:
|
Except as expressly amended by this Amendment, the provisions of the Certificate of Incorporation shall remain in full force and effect.
|
|
ARRAY BIOPHARMA INC.
|
|
|
/s/ R. Michael Carruthers
Name: R. Michael Carruthers
Title: Chief Financial Officer
|
FIRST:
|
The name of the corporation is Array BioPharma Inc. (the "Corporation"). The Corporation was originally incorporated on February 6, 1998 pursuant to the DGCL. An Amended and Restated Certificate of Incorporation of the Corporation was filed with the Secretary of State of the State of Delaware on November 21, 2000 (the "Certificate of Incorporation"). A Certificate of Correction to the Certificate of Incorporation was filed with the Secretary of State of the State of Delaware on November 22, 2004. Certificates of Amendment to the Certificate of Incorporation were filed with the Secretary of State of the State of Delaware on November 5, 2007 and October 24, 2012.
|
SECOND:
|
That the board of directors of the Corporation duly adopted resolutions approving the following amendment to the Certificate of Incorporation (the "Amendment") in accordance with the provisions of Section 242 of the DGCL, declaring such Amendment to be advisable and calling for the approval of the stockholders of the Corporation to such Amendment.
|
THIRD:
|
The Amendment was duly adopted and approved in accordance with the provisions of Section 211 of the DGCL by the required vote of the stockholders of the Corporation at the Annual Meeting of the stockholders of the Corporation.
|
FOURTH:
|
That the Corporation's Certificate of Incorporation is hereby amended as provided herein. Section 4.1 shall be deleted in its entirety and replaced with the following:
|
FIFTH:
|
Except as expressly amended by this Amendment, the provisions of the Certificate of Incorporation shall remain in full force and effect.
|
|
|
|
FIRST:
|
|
The name of the corporation is Array BioPharma Inc. (the “
Corporation
”).
|
|
|
|
SECOND:
|
|
That the board of directors of the Corporation duly adopted resolutions approving the following amendment to the Certificate of Incorporation (the “
Amendment
”) in accordance with the provisions of Section 242 of the DGCL, declaring such Amendment to be advisable and calling for the approval of the stockholders of the Corporation to such Amendment.
|
|
|
|
THIRD:
|
|
The Amendment was duly adopted and approved in accordance with the provisions of Section 242 of the DGCL by the required vote of stockholders of the Corporation at the 2018 Annual Meeting of Stockholders of the Corporation.
|
|
|
|
FOURTH:
|
|
That the Corporation’s Certificate of Incorporation is hereby amended as provided herein.
Section 4.1 shall be deleted in its entirety and replaced with the following:
|
|
|
|
|
|
4.1 Authorized Shares.
The total number of shares of all classes of stock that the Corporation shall have the authority to issue is 350,000,000 of which 340,000,000 shall be common stock, all of one class, having a par value of $.001 per share (the “
Common Stock
”), and 10,000,000 of such shares shall be Preferred Stock, having a par value of $.001 per share (the “
Preferred Stock
”).
|
|
|
|
FIFTH:
|
|
Except as expressly amended by this Amendment, the provisions of the Certificate of Incorporation shall remain in full force and effect.
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Array BioPharma Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within this entity, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
October 30, 2018
|
By:
|
/s/ RON SQUARER
|
|
|
|
Ron Squarer
|
|
|
|
Chief Executive Officer
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Array BioPharma Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within this entity, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
Date:
|
October 30, 2018
|
By:
|
/s/ JASON HADDOCK
|
|
|
|
Jason Haddock
|
|
|
|
Principal Accounting Officer
|
(a)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(b)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Registrant.
|
Date:
|
October 30, 2018
|
/s/ RON SQUARER
|
|
|
Ron Squarer
|
|
|
Chief Executive Officer
|
|
|
|
|
|
|
|
|
/s/ JASON HADDOCK
|
|
|
Jason Haddock
|
|
|
Principal Accounting Officer
|
|
|
|