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December 31, 2013 | December 31, 2012 | |||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | |||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||
Money market funds | $ | 5,710,755 | $ | — | $ | 5,710,755 | $ | 98,024,269 | $ | — | $ | 98,024,269 | ||||||||||||
Available-for-sale marketable securities: | ||||||||||||||||||||||||
Corporate debt securities | — | 35,147,326 | 35,147,326 | — | — | — | ||||||||||||||||||
Commercial paper | — | 5,998,371 | 5,998,371 | — | — | — | ||||||||||||||||||
Certificate of deposit | — | 3,000,000 | 3,000,000 | — | — | — | ||||||||||||||||||
$ | 5,710,755 | $ | 44,145,697 | $ | 49,856,452 | $ | 98,024,269 | $ | — | $ | 98,024,269 |
• | Product Returns. The product returns reserve is based on management’s best estimate of the products sold that are anticipated to be returned. The product returns reserve is recorded as a reduction of product sales revenue in the same period the related product sales revenue is recognized and is included in accrued expenses. |
• | Distribution Fees. The distribution fees, based on contractually determined rates, arise from contractual agreements we have with certain wholesalers for distribution services they provide with respect to Hylenex recombinant. These fees are generally a fixed percentage of the price of the product purchased by the wholesalers. At the time the sale is made to the respective wholesalers, we record distribution fees as reduction of product sales revenue and accounts receivable. |
• | Prompt Payment Discounts. We offer cash discounts to certain wholesalers as an incentive to meet certain payment terms. We expect our customers will take advantage of this discount; therefore, at the time the sale is made to the respective wholesalers, we record the entire prompt payment discount, based on the gross amount of each invoice, as reduction of product sales revenue and accounts receivable. |
• | Other Discounts and Fees. We provide discounts to end-user members of certain GPOs under collective purchasing contracts between us and the GPOs. We also provide discounts to certain hospitals, who are members of the GPOs, with which we do not have contracts. The end-user members purchase products from the wholesalers at a contracted discounted price, and the wholesalers then charge back to us the difference between the current retail price and the price the end-users paid for the product. In the period product sales revenue is recognized, we estimate the related sales from our wholesalers to these GPOs and accrue for the chargebacks we anticipate from our wholesalers based on current contract prices and historical chargebacks activity. We record accrued chargebacks as a reduction to our accounts receivable. GPO administrative service fees for these transactions are also recorded in the same period the related product sales revenue is recognized and are included in accrued expenses. We also provide predetermined discounts under certain government programs, which are recorded at the time of sale. |
1. | The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, |
2. | The consideration relates solely to past performance, and |
3. | The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. |
Year Ended December 31, | ||||||||||||
2013 | 2012 | 2011 | ||||||||||
Research and development | $ | 4,475,530 | $ | 4,190,938 | $ | 2,815,362 | ||||||
Selling, general and administrative | 5,062,526 | 4,157,649 | 2,754,537 | |||||||||
Share-based compensation expense | $ | 9,538,056 | $ | 8,348,587 | $ | 5,569,899 | ||||||
Net share-based compensation expense, per basic and diluted share | $ | 0.08 | $ | 0.08 | $ | 0.05 | ||||||
Share-based compensation expense from: | ||||||||||||
Stock options | $ | 5,499,445 | $ | 4,722,629 | $ | 3,230,822 | ||||||
Restricted stock awards and restricted stock units | 4,038,611 | 3,625,958 | 2,339,077 | |||||||||
$ | 9,538,056 | $ | 8,348,587 | $ | 5,569,899 |
|
December 31, 2013 | |||||||||||||||||
Description | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 35,130,272 | $ | 20,185 | $ | (3,131 | ) | $ | 35,147,326 | ||||||||
Commercial paper | 5,998,371 | — | — | 5,998,371 | |||||||||||||
Certificate of deposit | 3,000,000 | — | — | 3,000,000 | |||||||||||||
$ | 44,128,643 | $ | 20,185 | $ | (3,131 | ) | $ | 44,145,697 |
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|
December 31, 2013 | December 31, 2012 | |||||||
Accounts receivable from product sales to collaborators | $ | 4,495,314 | $ | — | ||||
Accounts receivable from revenues under collaborative agreements | 3,707,248 | 15,058,163 | ||||||
Accounts receivable from other product sales | 1,505,004 | 823,064 | ||||||
9,707,566 | 15,881,227 | |||||||
Allowance for distribution fees and discounts | (610,482 | ) | (178,140 | ) | ||||
$ | 9,097,084 | $ | 15,703,087 |
December 31, 2013 | December 31, 2012 | |||||||
Raw materials | $ | 1,136,815 | $ | 1,127,061 | ||||
Work-in-process | 4,280,076 | 792,257 | ||||||
Finished goods | 753,091 | 751,378 | ||||||
$ | 6,169,982 | $ | 2,670,696 |
December 31, 2013 | December 31, 2012 | |||||||
Prepaid manufacturing expenses | $ | 5,884,040 | $ | 8,152,602 | ||||
Prepaid research and development expenses | 3,522,250 | 2,274,551 | ||||||
Other prepaid expenses | 1,338,758 | 2,250,791 | ||||||
Other assets | 356,328 | 74,944 | ||||||
11,101,376 | 12,752,888 | |||||||
Less long-term portion | 2,675,692 | — | ||||||
$ | 8,425,684 | $ | 12,752,888 |
December 31, 2013 | December 31, 2012 | |||||||
Research equipment | $ | 7,713,850 | $ | 6,360,004 | ||||
Computer and office equipment | 1,948,859 | 1,432,975 | ||||||
Leasehold improvements | 1,408,025 | 1,138,110 | ||||||
Building(1) | — | 1,450,000 | ||||||
11,070,734 | 10,381,089 | |||||||
Accumulated depreciation and amortization | (7,649,228 | ) | (6,680,627 | ) | ||||
$ | 3,421,506 | $ | 3,700,462 |
(1) | Represented capitalized building under a build-to-suit lease arrangement where we were considered the owner (for accounting purposes only) during the construction period. Upon the completion of the building construction in the fourth quarter of 2013, we met the sale-leaseback criteria for de-recognition of the building asset and liability; therefore, the building asset was removed from the consolidated balance sheet as of December 31, 2013. |
December 31, 2013 | December 31, 2012 | |||||||
Accrued compensation and payroll taxes | $ | 7,075,347 | $ | 4,053,590 | ||||
Accrued outsourced research and development expenses | 3,377,256 | 1,239,050 | ||||||
Accrued outsourced manufacturing expenses | 3,233,012 | 984,192 | ||||||
Other accrued expenses | 1,234,831 | 1,506,615 | ||||||
$ | 14,920,446 | $ | 7,783,447 |
December 31, 2013 | December 31, 2012 | |||||||
Collaborative agreements | $ | 51,184,897 | $ | 43,222,473 | ||||
Product sales | 1,958,381 | 623,510 | ||||||
Total deferred revenue | 53,143,278 | 43,845,983 | ||||||
Less current portion | 7,397,829 | 8,891,017 | ||||||
Deferred revenue, net of current portion | $ | 45,745,449 | $ | 34,954,966 |
|
2014 | $ | 3,460,417 | ||
2015 | 17,435,636 | |||
2016 | 18,677,512 | |||
2017 | 18,677,512 | |||
2018 | 5,806,459 | |||
Total minimum payments | 64,057,536 | |||
Less amount representing interest | (14,057,536 | ) | ||
Gross balance of long-term debt | 50,000,000 | |||
Less unamortized debt discount | (228,263 | ) | ||
Present value of long-term debt | 49,771,737 | |||
Less current portion of long-term debt | — | |||
Long-term debt, less current portion and unamortized debt discount | $ | 49,771,737 |
|
|
Shares Underlying Stock Options | Weighted Average Exercise Price per Share | Weighted Average Remaining Contractual Term (yrs) | Aggregate Intrinsic Value | ||||||||
Outstanding at January 1, 2011 | 7,975,365 | $3.87 | |||||||||
Granted | 1,624,768 | $7.79 | |||||||||
Exercised | (3,137,056 | ) | $1.71 | ||||||||
Canceled/forfeited | (593,293 | ) | $6.72 | ||||||||
Outstanding at December 31, 2011 | 5,869,784 | $5.82 | |||||||||
Granted | 1,215,442 | $9.90 | |||||||||
Exercised | (444,637 | ) | $4.56 | ||||||||
Canceled/forfeited | (260,722 | ) | $8.34 | ||||||||
Outstanding at December 31, 2012 | 6,379,867 | $6.59 | |||||||||
Granted | 1,806,392 | $7.14 | |||||||||
Exercised | (1,270,362 | ) | $4.34 | ||||||||
Canceled/forfeited | (214,982 | ) | $8.18 | ||||||||
Outstanding at December 31, 2013 | 6,700,915 | $7.11 | 6.4 | $52.8 | million | ||||||
Vested and expected to vest at December 31, 2013 | 6,352,654 | $7.07 | 6.3 | $50.3 | million | ||||||
Exercisable at December 31, 2013 | 3,747,566 | $6.55 | 4.8 | $31.6 | million |
Year Ended December 31, | |||||||||
2013 | 2012 | 2011 | |||||||
Expected volatility | 70.1-72.5% | 64.0-69.2% | 64.0-65.1% | ||||||
Average expected term (in years) | 5.7 | 5.6 | 5.8 | ||||||
Risk-free interest rate | 0.86-2.00% | 0.80-1.15% | 1.14-2.55% | ||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % |
Number of Shares | Weighted Average Grant Date Fair Value | ||||||
Unvested at January 1, 2011 | 120,000 | $ | 7.67 | ||||
Granted | 353,508 | $ | 6.51 | ||||
Vested | (120,000 | ) | $ | 7.67 | |||
Forfeited | (5,625 | ) | $ | 6.67 | |||
Unvested at December 31, 2011 | 347,883 | $ | 6.51 | ||||
Granted | 380,158 | $ | 10.29 | ||||
Vested | (339,758 | ) | $ | 6.51 | |||
Forfeited | (5,963 | ) | $ | 10.81 | |||
Unvested at December 31, 2012 | 382,320 | $ | 10.21 | ||||
Granted | 476,096 | $ | 6.88 | ||||
Vested | (211,178 | ) | $ | 8.78 | |||
Forfeited | (14,367 | ) | $ | 8.17 | |||
Unvested at December 31, 2013 | 632,871 | $ | 8.23 |
Number of Shares | Weighted Average Purchase Price | Weighted Average Remaining Contractual Term (yrs) | Aggregate Intrinsic Value | ||||||||||
Unvested at January 1, 2011 | — | $ | — | ||||||||||
Granted | 163,000 | $ | — | ||||||||||
Vested | (15,000 | ) | $ | — | |||||||||
Forfeited | — | $ | — | ||||||||||
Unvested at December 31, 2011 | 148,000 | $ | — | ||||||||||
Granted | 682,146 | $ | — | ||||||||||
Vested | (128,000 | ) | $ | — | |||||||||
Forfeited | (20,000 | ) | $ | — | |||||||||
Unvested at December 31, 2012 | 682,146 | $ | — | ||||||||||
Granted | 323,700 | $ | — | ||||||||||
Vested | (154,124 | ) | $ | — | |||||||||
Forfeited | (115,367 | ) | $ | — | |||||||||
Unvested at December 31, 2013 | 736,355 | $ | — | 1.6 | $11.0 | million | |||||||
Expected to vest at December 31, 2013 | 627,647 | $ | — | 1.5 | $9.4 | million |
|
Year: | Operating Leases | |||
2014 | $ | 1,995,000 | ||
2015 | 2,062,000 | |||
2016 | 2,081,000 | |||
2017 | 2,122,000 | |||
2018 | 80,000 | |||
Thereafter | — | |||
Total minimum lease payments | $ | 8,340,000 |
|
December 31, | ||||||||
2013 | 2012 | |||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 116,572,000 | $ | 86,732,000 | ||||
Deferred revenue | 13,324,000 | 17,345,000 | ||||||
Research and development credits | 28,867,000 | 20,286,000 | ||||||
Share-based compensation | 2,495,000 | 2,975,000 | ||||||
Depreciation | — | 179,000 | ||||||
Other, net | 853,000 | 926,000 | ||||||
162,111,000 | 128,443,000 | |||||||
Valuation allowance for deferred tax assets | (161,968,000 | ) | (128,443,000 | ) | ||||
Deferred tax assets, net of valuation | 143,000 | — | ||||||
Deferred tax liabilities: | ||||||||
Depreciation | (143,000 | ) | — | |||||
Net deferred tax liabilities | (143,000 | ) | — | |||||
Net deferred tax assets | $ | — | $ | — |
December 31, | ||||||||||||
2013 | 2012 | 2011 | ||||||||||
Federal income tax at 34% | $ | (28,383,000 | ) | $ | (18,208,000 | ) | $ | (6,722,000 | ) | |||
State income tax, net of federal benefit | (1,745,000 | ) | (3,023,000 | ) | (1,153,000 | ) | ||||||
Increase in valuation allowance | 33,525,000 | 20,954,000 | 9,935,000 | |||||||||
Tax effect on non-deductible expenses and other | 5,219,000 | 1,293,000 | 1,671,000 | |||||||||
Research and development credits | (8,616,000 | ) | (1,016,000 | ) | (3,731,000 | ) | ||||||
$ | — | $ | — | $ | — |
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Quarter Ended | ||||||||||||||||
2013 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues | $ | 11,833,540 | $ | 14,453,810 | $ | 16,013,164 | $ | 12,498,933 | ||||||||
Gross profit on product sales(1) | $ | 769,623 | $ | 1,815,903 | $ | 9,342,187 | $ | 6,266,250 | ||||||||
Total operating expenses | $ | 30,329,313 | $ | 36,574,458 | $ | 34,507,020 | $ | 33,822,293 | ||||||||
Net loss | $ | (19,288,369 | ) | $ | (22,911,511 | ) | $ | (19,292,368 | ) | $ | (21,986,303 | ) | ||||
Net loss per share, basic and diluted | $ | (0.17 | ) | $ | (0.20 | ) | $ | (0.17 | ) | $ | (0.19 | ) | ||||
Shares used in computing basic and diluted net loss per share | 112,416,792 | 112,486,211 | 112,765,155 | 113,550,229 | ||||||||||||
Quarter Ended | ||||||||||||||||
2012 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues(2) | $ | 7,440,179 | $ | 7,757,175 | $ | 5,334,323 | $ | 21,793,549 | ||||||||
Gross profit on product sales | $ | 116,650 | $ | 381,822 | $ | 488,719 | $ | 805,851 | ||||||||
Total operating expenses | $ | 22,580,577 | $ | 21,805,273 | $ | 25,364,160 | $ | 26,200,662 | ||||||||
Net loss | $ | (15,119,181 | ) | $ | (14,021,119 | ) | $ | (20,005,846 | ) | $ | (4,405,856 | ) | ||||
Net loss per share, basic and diluted | $ | (0.14 | ) | $ | (0.13 | ) | $ | (0.18 | ) | $ | (0.04 | ) | ||||
Shares used in computing basic and diluted net loss per share | 107,589,514 | 112,063,665 | 112,305,002 | 112,323,056 |
(1) | Gross profit on product sales for the quarters ended June 30, 2013, September 30, 2013 and December 31, 2013 excluded manufacturing costs related to the product sales of bulk rHuPH20 for Herceptin SC and HyQvia in the amounts of $873,000, $6.5 million and $2.6 million, respectively. Such costs were incurred prior to European marketing approvals for Herceptin SC and HyQvia, and therefore, they were charged to research and development expenses in the periods the costs were incurred. |
(2) | Revenues for the quarter ended December 31, 2012 included $9.5 million in revenues under collaborative agreements from the Pfizer Collaboration. |
|
Balance at Beginning of Period | Additions | Deductions | Balance at End of Period | |||||||||||||
For the year ended December 31, 2013 | ||||||||||||||||
Accounts receivable allowances (1) | $ | 178,140 | $ | 2,979,646 | $ | (2,547,304 | ) | $ | 610,482 | |||||||
For the year ended December 31, 2012 | ||||||||||||||||
Accounts receivable allowances (1) | $ | 15,429 | $ | 770,614 | $ | (607,903 | ) | $ | 178,140 | |||||||
For the year ended December 31, 2011 | ||||||||||||||||
Accounts receivable allowances (1) | $ | — | $ | 15,429 | $ | — | $ | 15,429 |
(1) | Allowances are for chargebacks, prompt payment discounts and distribution fees related to Hylenex recombinant product sales. |
|
• | Product Returns. The product returns reserve is based on management’s best estimate of the products sold that are anticipated to be returned. The product returns reserve is recorded as a reduction of product sales revenue in the same period the related product sales revenue is recognized and is included in accrued expenses. |
• | Distribution Fees. The distribution fees, based on contractually determined rates, arise from contractual agreements we have with certain wholesalers for distribution services they provide with respect to Hylenex recombinant. These fees are generally a fixed percentage of the price of the product purchased by the wholesalers. At the time the sale is made to the respective wholesalers, we record distribution fees as reduction of product sales revenue and accounts receivable. |
• | Prompt Payment Discounts. We offer cash discounts to certain wholesalers as an incentive to meet certain payment terms. We expect our customers will take advantage of this discount; therefore, at the time the sale is made to the respective wholesalers, we record the entire prompt payment discount, based on the gross amount of each invoice, as reduction of product sales revenue and accounts receivable. |
• | Other Discounts and Fees. We provide discounts to end-user members of certain GPOs under collective purchasing contracts between us and the GPOs. We also provide discounts to certain hospitals, who are members of the GPOs, with which we do not have contracts. The end-user members purchase products from the wholesalers at a contracted discounted price, and the wholesalers then charge back to us the difference between the current retail price and the price the end-users paid for the product. In the period product sales revenue is recognized, we estimate the related sales from our wholesalers to these GPOs and accrue for the chargebacks we anticipate from our wholesalers based on current contract prices and historical chargebacks activity. We record accrued chargebacks as a reduction to our accounts receivable. GPO administrative service fees for these transactions are also recorded in the same period the related product sales revenue is recognized and are included in accrued expenses. We also provide predetermined discounts under certain government programs, which are recorded at the time of sale. |
1. | The consideration is commensurate with either the entity’s performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, |
2. | The consideration relates solely to past performance, and |
3. | The consideration is reasonable relative to all of the deliverables and payment terms within the arrangement. |
|
December 31, 2013 | December 31, 2012 | |||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | |||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||
Money market funds | $ | 5,710,755 | $ | — | $ | 5,710,755 | $ | 98,024,269 | $ | — | $ | 98,024,269 | ||||||||||||
Available-for-sale marketable securities: | ||||||||||||||||||||||||
Corporate debt securities | — | 35,147,326 | 35,147,326 | — | — | — | ||||||||||||||||||
Commercial paper | — | 5,998,371 | 5,998,371 | — | — | — | ||||||||||||||||||
Certificate of deposit | — | 3,000,000 | 3,000,000 | — | — | — | ||||||||||||||||||
$ | 5,710,755 | $ | 44,145,697 | $ | 49,856,452 | $ | 98,024,269 | $ | — | $ | 98,024,269 |
|
December 31, 2013 | |||||||||||||||||
Description | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 35,130,272 | $ | 20,185 | $ | (3,131 | ) | $ | 35,147,326 | ||||||||
Commercial paper | 5,998,371 | — | — | 5,998,371 | |||||||||||||
Certificate of deposit | 3,000,000 | — | — | 3,000,000 | |||||||||||||
$ | 44,128,643 | $ | 20,185 | $ | (3,131 | ) | $ | 44,145,697 |
|
December 31, 2013 | December 31, 2012 | |||||||
Accounts receivable from product sales to collaborators | $ | 4,495,314 | $ | — | ||||
Accounts receivable from revenues under collaborative agreements | 3,707,248 | 15,058,163 | ||||||
Accounts receivable from other product sales | 1,505,004 | 823,064 | ||||||
9,707,566 | 15,881,227 | |||||||
Allowance for distribution fees and discounts | (610,482 | ) | (178,140 | ) | ||||
$ | 9,097,084 | $ | 15,703,087 |
December 31, 2013 | December 31, 2012 | |||||||
Raw materials | $ | 1,136,815 | $ | 1,127,061 | ||||
Work-in-process | 4,280,076 | 792,257 | ||||||
Finished goods | 753,091 | 751,378 | ||||||
$ | 6,169,982 | $ | 2,670,696 |
December 31, 2013 | December 31, 2012 | |||||||
Prepaid manufacturing expenses | $ | 5,884,040 | $ | 8,152,602 | ||||
Prepaid research and development expenses | 3,522,250 | 2,274,551 | ||||||
Other prepaid expenses | 1,338,758 | 2,250,791 | ||||||
Other assets | 356,328 | 74,944 | ||||||
11,101,376 | 12,752,888 | |||||||
Less long-term portion | 2,675,692 | — | ||||||
$ | 8,425,684 | $ | 12,752,888 |
December 31, 2013 | December 31, 2012 | |||||||
Research equipment | $ | 7,713,850 | $ | 6,360,004 | ||||
Computer and office equipment | 1,948,859 | 1,432,975 | ||||||
Leasehold improvements | 1,408,025 | 1,138,110 | ||||||
Building(1) | — | 1,450,000 | ||||||
11,070,734 | 10,381,089 | |||||||
Accumulated depreciation and amortization | (7,649,228 | ) | (6,680,627 | ) | ||||
$ | 3,421,506 | $ | 3,700,462 |
(1) | Represented capitalized building under a build-to-suit lease arrangement where we were considered the owner (for accounting purposes only) during the construction period. Upon the completion of the building construction in the fourth quarter of 2013, we met the sale-leaseback criteria for de-recognition of the building asset and liability; therefore, the building asset was removed from the consolidated balance sheet as of December 31, 2013. |
December 31, 2013 | December 31, 2012 | |||||||
Accrued compensation and payroll taxes | $ | 7,075,347 | $ | 4,053,590 | ||||
Accrued outsourced research and development expenses | 3,377,256 | 1,239,050 | ||||||
Accrued outsourced manufacturing expenses | 3,233,012 | 984,192 | ||||||
Other accrued expenses | 1,234,831 | 1,506,615 | ||||||
$ | 14,920,446 | $ | 7,783,447 |
December 31, 2013 | December 31, 2012 | |||||||
Collaborative agreements | $ | 51,184,897 | $ | 43,222,473 | ||||
Product sales | 1,958,381 | 623,510 | ||||||
Total deferred revenue | 53,143,278 | 43,845,983 | ||||||
Less current portion | 7,397,829 | 8,891,017 | ||||||
Deferred revenue, net of current portion | $ | 45,745,449 | $ | 34,954,966 |
|
2014 | $ | 3,460,417 | ||
2015 | 17,435,636 | |||
2016 | 18,677,512 | |||
2017 | 18,677,512 | |||
2018 | 5,806,459 | |||
Total minimum payments | 64,057,536 | |||
Less amount representing interest | (14,057,536 | ) | ||
Gross balance of long-term debt | 50,000,000 | |||
Less unamortized debt discount | (228,263 | ) | ||
Present value of long-term debt | 49,771,737 | |||
Less current portion of long-term debt | — | |||
Long-term debt, less current portion and unamortized debt discount | $ | 49,771,737 |
|
Shares Underlying Stock Options | Weighted Average Exercise Price per Share | Weighted Average Remaining Contractual Term (yrs) | Aggregate Intrinsic Value | ||||||||
Outstanding at January 1, 2011 | 7,975,365 | $3.87 | |||||||||
Granted | 1,624,768 | $7.79 | |||||||||
Exercised | (3,137,056 | ) | $1.71 | ||||||||
Canceled/forfeited | (593,293 | ) | $6.72 | ||||||||
Outstanding at December 31, 2011 | 5,869,784 | $5.82 | |||||||||
Granted | 1,215,442 | $9.90 | |||||||||
Exercised | (444,637 | ) | $4.56 | ||||||||
Canceled/forfeited | (260,722 | ) | $8.34 | ||||||||
Outstanding at December 31, 2012 | 6,379,867 | $6.59 | |||||||||
Granted | 1,806,392 | $7.14 | |||||||||
Exercised | (1,270,362 | ) | $4.34 | ||||||||
Canceled/forfeited | (214,982 | ) | $8.18 | ||||||||
Outstanding at December 31, 2013 | 6,700,915 | $7.11 | 6.4 | $52.8 | million | ||||||
Vested and expected to vest at December 31, 2013 | 6,352,654 | $7.07 | 6.3 | $50.3 | million | ||||||
Exercisable at December 31, 2013 | 3,747,566 | $6.55 | 4.8 | $31.6 | million |
Year Ended December 31, | |||||||||
2013 | 2012 | 2011 | |||||||
Expected volatility | 70.1-72.5% | 64.0-69.2% | 64.0-65.1% | ||||||
Average expected term (in years) | 5.7 | 5.6 | 5.8 | ||||||
Risk-free interest rate | 0.86-2.00% | 0.80-1.15% | 1.14-2.55% | ||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % |
Number of Shares | Weighted Average Grant Date Fair Value | ||||||
Unvested at January 1, 2011 | 120,000 | $ | 7.67 | ||||
Granted | 353,508 | $ | 6.51 | ||||
Vested | (120,000 | ) | $ | 7.67 | |||
Forfeited | (5,625 | ) | $ | 6.67 | |||
Unvested at December 31, 2011 | 347,883 | $ | 6.51 | ||||
Granted | 380,158 | $ | 10.29 | ||||
Vested | (339,758 | ) | $ | 6.51 | |||
Forfeited | (5,963 | ) | $ | 10.81 | |||
Unvested at December 31, 2012 | 382,320 | $ | 10.21 | ||||
Granted | 476,096 | $ | 6.88 | ||||
Vested | (211,178 | ) | $ | 8.78 | |||
Forfeited | (14,367 | ) | $ | 8.17 | |||
Unvested at December 31, 2013 | 632,871 | $ | 8.23 |
Number of Shares | Weighted Average Purchase Price | Weighted Average Remaining Contractual Term (yrs) | Aggregate Intrinsic Value | ||||||||||
Unvested at January 1, 2011 | — | $ | — | ||||||||||
Granted | 163,000 | $ | — | ||||||||||
Vested | (15,000 | ) | $ | — | |||||||||
Forfeited | — | $ | — | ||||||||||
Unvested at December 31, 2011 | 148,000 | $ | — | ||||||||||
Granted | 682,146 | $ | — | ||||||||||
Vested | (128,000 | ) | $ | — | |||||||||
Forfeited | (20,000 | ) | $ | — | |||||||||
Unvested at December 31, 2012 | 682,146 | $ | — | ||||||||||
Granted | 323,700 | $ | — | ||||||||||
Vested | (154,124 | ) | $ | — | |||||||||
Forfeited | (115,367 | ) | $ | — | |||||||||
Unvested at December 31, 2013 | 736,355 | $ | — | 1.6 | $11.0 | million | |||||||
Expected to vest at December 31, 2013 | 627,647 | $ | — | 1.5 | $9.4 | million |
|
Year: | Operating Leases | |||
2014 | $ | 1,995,000 | ||
2015 | 2,062,000 | |||
2016 | 2,081,000 | |||
2017 | 2,122,000 | |||
2018 | 80,000 | |||
Thereafter | — | |||
Total minimum lease payments | $ | 8,340,000 |
|
December 31, | ||||||||
2013 | 2012 | |||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 116,572,000 | $ | 86,732,000 | ||||
Deferred revenue | 13,324,000 | 17,345,000 | ||||||
Research and development credits | 28,867,000 | 20,286,000 | ||||||
Share-based compensation | 2,495,000 | 2,975,000 | ||||||
Depreciation | — | 179,000 | ||||||
Other, net | 853,000 | 926,000 | ||||||
162,111,000 | 128,443,000 | |||||||
Valuation allowance for deferred tax assets | (161,968,000 | ) | (128,443,000 | ) | ||||
Deferred tax assets, net of valuation | 143,000 | — | ||||||
Deferred tax liabilities: | ||||||||
Depreciation | (143,000 | ) | — | |||||
Net deferred tax liabilities | (143,000 | ) | — | |||||
Net deferred tax assets | $ | — | $ | — |
December 31, | ||||||||||||
2013 | 2012 | 2011 | ||||||||||
Federal income tax at 34% | $ | (28,383,000 | ) | $ | (18,208,000 | ) | $ | (6,722,000 | ) | |||
State income tax, net of federal benefit | (1,745,000 | ) | (3,023,000 | ) | (1,153,000 | ) | ||||||
Increase in valuation allowance | 33,525,000 | 20,954,000 | 9,935,000 | |||||||||
Tax effect on non-deductible expenses and other | 5,219,000 | 1,293,000 | 1,671,000 | |||||||||
Research and development credits | (8,616,000 | ) | (1,016,000 | ) | (3,731,000 | ) | ||||||
$ | — | $ | — | $ | — |
|
Quarter Ended | ||||||||||||||||
2013 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues | $ | 11,833,540 | $ | 14,453,810 | $ | 16,013,164 | $ | 12,498,933 | ||||||||
Gross profit on product sales(1) | $ | 769,623 | $ | 1,815,903 | $ | 9,342,187 | $ | 6,266,250 | ||||||||
Total operating expenses | $ | 30,329,313 | $ | 36,574,458 | $ | 34,507,020 | $ | 33,822,293 | ||||||||
Net loss | $ | (19,288,369 | ) | $ | (22,911,511 | ) | $ | (19,292,368 | ) | $ | (21,986,303 | ) | ||||
Net loss per share, basic and diluted | $ | (0.17 | ) | $ | (0.20 | ) | $ | (0.17 | ) | $ | (0.19 | ) | ||||
Shares used in computing basic and diluted net loss per share | 112,416,792 | 112,486,211 | 112,765,155 | 113,550,229 | ||||||||||||
Quarter Ended | ||||||||||||||||
2012 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues(2) | $ | 7,440,179 | $ | 7,757,175 | $ | 5,334,323 | $ | 21,793,549 | ||||||||
Gross profit on product sales | $ | 116,650 | $ | 381,822 | $ | 488,719 | $ | 805,851 | ||||||||
Total operating expenses | $ | 22,580,577 | $ | 21,805,273 | $ | 25,364,160 | $ | 26,200,662 | ||||||||
Net loss | $ | (15,119,181 | ) | $ | (14,021,119 | ) | $ | (20,005,846 | ) | $ | (4,405,856 | ) | ||||
Net loss per share, basic and diluted | $ | (0.14 | ) | $ | (0.13 | ) | $ | (0.18 | ) | $ | (0.04 | ) | ||||
Shares used in computing basic and diluted net loss per share | 107,589,514 | 112,063,665 | 112,305,002 | 112,323,056 |
(1) | Gross profit on product sales for the quarters ended June 30, 2013, September 30, 2013 and December 31, 2013 excluded manufacturing costs related to the product sales of bulk rHuPH20 for Herceptin SC and HyQvia in the amounts of $873,000, $6.5 million and $2.6 million, respectively. Such costs were incurred prior to European marketing approvals for Herceptin SC and HyQvia, and therefore, they were charged to research and development expenses in the periods the costs were incurred. |
(2) | Revenues for the quarter ended December 31, 2012 included $9.5 million in revenues under collaborative agreements from the Pfizer Collaboration. |
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