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December 31, 2014 | December 31, 2013 | |||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | |||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||
Money market funds | $ | 42,685 | $ | — | $ | 42,685 | $ | 5,711 | $ | — | $ | 5,711 | ||||||||||||
Available-for-sale marketable securities: | ||||||||||||||||||||||||
Corporate debt securities | — | 74,234 | 74,234 | — | 35,147 | 35,147 | ||||||||||||||||||
Commercial paper | — | — | — | — | 5,999 | 5,999 | ||||||||||||||||||
Certificate of deposit | — | — | — | — | 3,000 | 3,000 | ||||||||||||||||||
$ | 42,685 | $ | 74,234 | $ | 116,919 | $ | 5,711 | $ | 44,146 | $ | 49,857 |
Year Ended December 31, | |||||
2014 | 2013 | 2012 | |||
Roche | 57% | 64% | 45% | ||
Janssen | 20% | — | — | ||
Baxter | 3% | 10% | 17% | ||
Pfizer | 1% | 4% | 22% |
Year Ended December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
United States | $ | 31,397 | $ | 19,019 | $ | 22,724 | |||||
Switzerland | 42,791 | 35,157 | 18,913 | ||||||||
All other foreign | 1,146 | 623 | 688 | ||||||||
Total revenues | $ | 75,334 | $ | 54,799 | $ | 42,325 |
• | Product Returns. We allow the wholesalers to return product that is damaged or received in error. In addition, we accept unused product to be returned beginning six months prior to and ending twelve months following product expiration. Our estimates for expected returns of expired products are based primarily on an ongoing analysis of historical return patterns. |
• | 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. |
• | Prompt Payment Discounts. We offer cash discounts to certain wholesalers as an incentive to meet certain payment terms. We estimate prompt payment discounts based on contractual terms, historical utilization rates, as available, and our expectations regarding future utilization rates. |
• | 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. We also incur GPO administrative service fees for these transactions. In addition, we provide predetermined discounts under certain government programs. Our estimate for these chargebacks and fees take into consideration contractual terms, historical utilization rates, as available, and our expectations regarding future utilization rates. |
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. |
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December 31, 2014 | |||||||||||||||||
Description | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 74,275 | $ | 2 | $ | (43 | ) | $ | 74,234 |
December 31, 2013 | |||||||||||||||||
Description | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 35,130 | $ | 20 | $ | (3 | ) | $ | 35,147 | ||||||||
Commercial paper | 5,999 | — | — | 5,999 | |||||||||||||
Certificate of deposit | 3,000 | — | — | 3,000 | |||||||||||||
$ | 44,129 | $ | 20 | $ | (3 | ) | $ | 44,146 |
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December 31, 2014 | December 31, 2013 | |||||||
Accounts receivable from product sales to collaborators | $ | 6,361 | $ | 4,495 | ||||
Accounts receivable from other product sales | 2,133 | 1,505 | ||||||
Accounts receivable from revenues under collaborative agreements | 1,266 | 3,707 | ||||||
Subtotal | 9,760 | 9,707 | ||||||
Allowance for distribution fees and discounts | (611 | ) | (610 | ) | ||||
Total accounts receivable, net | $ | 9,149 | $ | 9,097 |
December 31, 2014 | December 31, 2013 | |||||||
Raw materials | $ | 553 | $ | 1,137 | ||||
Work-in-process | 5,207 | 4,280 | ||||||
Finished goods | 646 | 753 | ||||||
Total inventories | $ | 6,406 | $ | 6,170 |
December 31, 2014 | December 31, 2013 | |||||||
Prepaid manufacturing expenses | $ | 6,339 | $ | 5,884 | ||||
Prepaid research and development expenses | 2,380 | 3,522 | ||||||
Other prepaid expenses | 1,094 | 1,339 | ||||||
Other assets | 1,535 | 356 | ||||||
Total prepaid expenses and other assets | 11,348 | 11,101 | ||||||
Less long-term portion | 1,205 | 2,676 | ||||||
Total prepaid expenses and other assets, current | $ | 10,143 | $ | 8,425 |
December 31, 2014 | December 31, 2013 | |||||||
Research equipment | $ | 8,474 | $ | 7,714 | ||||
Computer and office equipment | 2,178 | 1,949 | ||||||
Leasehold improvements | 1,518 | 1,408 | ||||||
Subtotal | 12,170 | 11,071 | ||||||
Accumulated depreciation and amortization | (9,219 | ) | (7,649 | ) | ||||
Property and equipment, net | $ | 2,951 | $ | 3,422 |
December 31, 2014 | December 31, 2013 | |||||||
Accrued compensation and payroll taxes | $ | 5,923 | $ | 7,075 | ||||
Accrued outsourced research and development expenses | 4,383 | 3,377 | ||||||
Accrued outsourced manufacturing expenses | 2,112 | 3,233 | ||||||
Other accrued expenses | 2,023 | 1,235 | ||||||
Total accrued expenses | 14,441 | 14,920 | ||||||
Less long-term accrued outsourced research and development expenses | 480 | 551 | ||||||
Total accrued expenses, current | $ | 13,961 | $ | 14,369 |
December 31, 2014 | December 31, 2013 | |||||||
Collaborative agreements | $ | 53,479 | $ | 51,185 | ||||
Product sales | 1,155 | 1,958 | ||||||
Total deferred revenue | 54,634 | 53,143 | ||||||
Less current portion | 7,367 | 7,398 | ||||||
Deferred revenue, net of current portion | $ | 47,267 | $ | 45,745 |
|
2015 | $ | 3,775 | ||
2016 | 25,077 | |||
2017 | 27,013 | |||
2018 | 6,501 | |||
2019 | — | |||
Total minimum payments | 62,366 | |||
Less amount representing interest | (12,366 | ) | ||
Gross balance of long-term debt | 50,000 | |||
Less unamortized debt discount | (140 | ) | ||
Present value of long-term debt | 49,860 | |||
Less current portion of long-term debt | — | |||
Long-term debt, less current portion and unamortized debt discount | $ | 49,860 |
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Year Ended December 31, | ||||||||||||
2014 | 2013 | 2012 | ||||||||||
Research and development | $ | 7,939 | $ | 4,476 | $ | 4,191 | ||||||
Selling, general and administrative | 7,335 | 5,062 | 4,158 | |||||||||
Share-based compensation expense | $ | 15,274 | $ | 9,538 | $ | 8,349 |
December 31, 2014 | ||||||
Unrecognized Expense | Remaining Weighted-Average Recognition Period (years) | |||||
Stock options | $ | 15,675 | 2.7 | |||
RSAs | $ | 7,153 | 1.6 | |||
RSUs | $ | 3,991 | 2.6 |
Shares Underlying Stock Options | Weighted Average Exercise Price per Share | Weighted Average Remaining Contractual Term (years) | Aggregate Intrinsic Value | ||||||||
Outstanding at January 1, 2012 | 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 | |||||||||
Granted | 2,271,143 | $13.02 | |||||||||
Exercised | (1,432,206 | ) | $5.43 | ||||||||
Canceled/forfeited | (1,185,960 | ) | $9.39 | ||||||||
Outstanding at December 31, 2014 | 6,353,892 | $9.18 | 6.5 | $11.2 | million | ||||||
Vested and expected to vest at December 31, 2014 | 6,025,883 | $9.05 | 6.4 | $10.9 | million | ||||||
Exercisable at December 31, 2014 | 3,944,408 | $7.36 | 4.6 | $8.9 | million |
Year Ended December 31, | |||||||||
2014 | 2013 | 2012 | |||||||
Expected volatility | 66.6-71.8% | 70.1-72.5% | 64.0-69.2% | ||||||
Average expected term (in years) | 5.7 | 5.7 | 5.6 | ||||||
Risk-free interest rate | 1.73-2.04% | 0.86-2.00% | 0.80-1.15% | ||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % |
Number of Shares | Weighted Average Grant Date Fair Value | ||||
Unvested at January 1, 2012 | 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 | |||
Granted | 1,055,122 | $11.15 | |||
Vested | (263,765 | ) | $8.33 | ||
Forfeited | (265,777 | ) | $10.86 | ||
Unvested at December 31, 2014 | 1,158,451 | $10.26 |
Number of Shares | Weighted Average Grant Date Fair Value | Weighted Average Remaining Contractual Term (yrs) | Aggregate Intrinsic Value | ||||||||
Unvested at January 1, 2012 | 148,000 | ||||||||||
Granted | 682,146 | $10.61 | |||||||||
Vested | (128,000 | ) | |||||||||
Forfeited | (20,000 | ) | |||||||||
Outstanding at December 31, 2012 | 682,146 | ||||||||||
Granted | 323,700 | $6.69 | |||||||||
Vested | (154,124 | ) | |||||||||
Forfeited | (115,367 | ) | |||||||||
Outstanding at December 31, 2013 | 736,355 | $9.06 | |||||||||
Granted | 305,535 | $13.71 | |||||||||
Vested | (194,368 | ) | $9.12 | ||||||||
Forfeited | (385,200 | ) | $8.84 | ||||||||
Outstanding at December 31, 2014 | 462,322 | $11.12 | 2.6 | $4.5 | million |
|
Year: | Operating Leases | |||
2015 | $ | 2,133 | ||
2016 | 2,142 | |||
2017 | 2,162 | |||
2018 | 82 | |||
Total minimum lease payments | $ | 6,519 |
|
December 31, | ||||||||
2014 | 2013 | |||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 120,707 | $ | 116,572 | ||||
Deferred revenue | 18,034 | 13,324 | ||||||
Research and development credits | 34,146 | 28,867 | ||||||
Share-based compensation | 5,381 | 2,495 | ||||||
Other, net | 891 | 853 | ||||||
179,159 | 162,111 | |||||||
Valuation allowance for deferred tax assets | (178,965 | ) | (161,968 | ) | ||||
Deferred tax assets, net of valuation | 194 | 143 | ||||||
Deferred tax liabilities: | ||||||||
Depreciation | (194 | ) | (143 | ) | ||||
Net deferred tax liabilities | (194 | ) | (143 | ) | ||||
Net deferred tax assets | $ | — | $ | — |
December 31, | ||||||||||||
2014 | 2013 | 2012 | ||||||||||
Federal income tax at 34% | $ | (23,247 | ) | $ | (28,383 | ) | $ | (18,208 | ) | |||
State income tax, net of federal benefit | (1,761 | ) | (1,745 | ) | (3,023 | ) | ||||||
Increase in valuation allowance | 16,998 | 33,525 | 20,954 | |||||||||
Foreign income subject to tax at other than federal statutory rate | 12,747 | — | — | |||||||||
Tax effect on non-deductible expenses and other | 540 | 5,219 | 1,293 | |||||||||
Research and development credits | (5,277 | ) | (8,616 | ) | (1,016 | ) | ||||||
$ | — | $ | — | $ | — |
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Quarter Ended | ||||||||||||||||
2014 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues(1) | $ | 11,966 | $ | 18,385 | $ | 14,606 | $ | 30,377 | ||||||||
Gross profit on product sales | $ | 3,048 | $ | 3,570 | $ | 4,476 | $ | 3,997 | ||||||||
Total operating expenses | $ | 37,185 | $ | 33,325 | $ | 33,632 | $ | 34,228 | ||||||||
Net loss | $ | (26,548 | ) | $ | (16,273 | ) | $ | (20,280 | ) | $ | (5,274 | ) | ||||
Net loss per share, basic and diluted | $ | (0.22 | ) | $ | (0.13 | ) | $ | (0.16 | ) | $ | (0.04 | ) | ||||
Shares used in computing basic and diluted net loss per share | 118,943 | 123,710 | 124,041 | 124,272 | ||||||||||||
Quarter Ended | ||||||||||||||||
2013 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues | $ | 11,833 | $ | 14,454 | $ | 16,013 | $ | 12,499 | ||||||||
Gross profit on product sales(2) | $ | 769 | $ | 1,816 | $ | 9,342 | $ | 6,266 | ||||||||
Total operating expenses | $ | 30,330 | $ | 36,574 | $ | 34,507 | $ | 33,822 | ||||||||
Net loss | $ | (19,289 | ) | $ | (22,912 | ) | $ | (19,292 | ) | $ | (21,986 | ) | ||||
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 | 112,417 | 112,486 | 112,765 | 113,550 |
(1) | Revenues for the quarter ended December 31, 2014 included $15.0 million in revenue under collaborative agreements from the Janssen Collaboration. |
(2) | 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 $0.9 million, $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. |
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Balance at Beginning of Period | Additions | Deductions | Balance at End of Period | |||||||||||||
For the year ended December 31, 2014 | ||||||||||||||||
Accounts receivable allowances (1) | $ | 610 | $ | 4,518 | $ | (4,519 | ) | $ | 609 | |||||||
For the year ended December 31, 2013 | ||||||||||||||||
Accounts receivable allowances (1) | $ | 178 | $ | 2,979 | $ | (2,547 | ) | $ | 610 | |||||||
For the year ended December 31, 2012 | ||||||||||||||||
Accounts receivable allowances (1) | $ | 15 | $ | 771 | $ | (608 | ) | $ | 178 |
(1) | Allowances are for chargebacks, prompt payment discounts and distribution fees related to Hylenex recombinant product sales. |
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• | Product Returns. We allow the wholesalers to return product that is damaged or received in error. In addition, we accept unused product to be returned beginning six months prior to and ending twelve months following product expiration. Our estimates for expected returns of expired products are based primarily on an ongoing analysis of historical return patterns. |
• | 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. |
• | Prompt Payment Discounts. We offer cash discounts to certain wholesalers as an incentive to meet certain payment terms. We estimate prompt payment discounts based on contractual terms, historical utilization rates, as available, and our expectations regarding future utilization rates. |
• | 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. We also incur GPO administrative service fees for these transactions. In addition, we provide predetermined discounts under certain government programs. Our estimate for these chargebacks and fees take into consideration contractual terms, historical utilization rates, as available, and our expectations regarding future utilization rates. |
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, 2014 | December 31, 2013 | |||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | |||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||
Money market funds | $ | 42,685 | $ | — | $ | 42,685 | $ | 5,711 | $ | — | $ | 5,711 | ||||||||||||
Available-for-sale marketable securities: | ||||||||||||||||||||||||
Corporate debt securities | — | 74,234 | 74,234 | — | 35,147 | 35,147 | ||||||||||||||||||
Commercial paper | — | — | — | — | 5,999 | 5,999 | ||||||||||||||||||
Certificate of deposit | — | — | — | — | 3,000 | 3,000 | ||||||||||||||||||
$ | 42,685 | $ | 74,234 | $ | 116,919 | $ | 5,711 | $ | 44,146 | $ | 49,857 |
|
Year Ended December 31, | |||||
2014 | 2013 | 2012 | |||
Roche | 57% | 64% | 45% | ||
Janssen | 20% | — | — | ||
Baxter | 3% | 10% | 17% | ||
Pfizer | 1% | 4% | 22% |
Year Ended December 31, | |||||||||||
2014 | 2013 | 2012 | |||||||||
United States | $ | 31,397 | $ | 19,019 | $ | 22,724 | |||||
Switzerland | 42,791 | 35,157 | 18,913 | ||||||||
All other foreign | 1,146 | 623 | 688 | ||||||||
Total revenues | $ | 75,334 | $ | 54,799 | $ | 42,325 |
|
December 31, 2014 | |||||||||||||||||
Description | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 74,275 | $ | 2 | $ | (43 | ) | $ | 74,234 |
December 31, 2013 | |||||||||||||||||
Description | Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 35,130 | $ | 20 | $ | (3 | ) | $ | 35,147 | ||||||||
Commercial paper | 5,999 | — | — | 5,999 | |||||||||||||
Certificate of deposit | 3,000 | — | — | 3,000 | |||||||||||||
$ | 44,129 | $ | 20 | $ | (3 | ) | $ | 44,146 |
|
December 31, 2014 | December 31, 2013 | |||||||
Accounts receivable from product sales to collaborators | $ | 6,361 | $ | 4,495 | ||||
Accounts receivable from other product sales | 2,133 | 1,505 | ||||||
Accounts receivable from revenues under collaborative agreements | 1,266 | 3,707 | ||||||
Subtotal | 9,760 | 9,707 | ||||||
Allowance for distribution fees and discounts | (611 | ) | (610 | ) | ||||
Total accounts receivable, net | $ | 9,149 | $ | 9,097 |
December 31, 2014 | December 31, 2013 | |||||||
Raw materials | $ | 553 | $ | 1,137 | ||||
Work-in-process | 5,207 | 4,280 | ||||||
Finished goods | 646 | 753 | ||||||
Total inventories | $ | 6,406 | $ | 6,170 |
December 31, 2014 | December 31, 2013 | |||||||
Prepaid manufacturing expenses | $ | 6,339 | $ | 5,884 | ||||
Prepaid research and development expenses | 2,380 | 3,522 | ||||||
Other prepaid expenses | 1,094 | 1,339 | ||||||
Other assets | 1,535 | 356 | ||||||
Total prepaid expenses and other assets | 11,348 | 11,101 | ||||||
Less long-term portion | 1,205 | 2,676 | ||||||
Total prepaid expenses and other assets, current | $ | 10,143 | $ | 8,425 |
December 31, 2014 | December 31, 2013 | |||||||
Research equipment | $ | 8,474 | $ | 7,714 | ||||
Computer and office equipment | 2,178 | 1,949 | ||||||
Leasehold improvements | 1,518 | 1,408 | ||||||
Subtotal | 12,170 | 11,071 | ||||||
Accumulated depreciation and amortization | (9,219 | ) | (7,649 | ) | ||||
Property and equipment, net | $ | 2,951 | $ | 3,422 |
December 31, 2014 | December 31, 2013 | |||||||
Accrued compensation and payroll taxes | $ | 5,923 | $ | 7,075 | ||||
Accrued outsourced research and development expenses | 4,383 | 3,377 | ||||||
Accrued outsourced manufacturing expenses | 2,112 | 3,233 | ||||||
Other accrued expenses | 2,023 | 1,235 | ||||||
Total accrued expenses | 14,441 | 14,920 | ||||||
Less long-term accrued outsourced research and development expenses | 480 | 551 | ||||||
Total accrued expenses, current | $ | 13,961 | $ | 14,369 |
December 31, 2014 | December 31, 2013 | |||||||
Collaborative agreements | $ | 53,479 | $ | 51,185 | ||||
Product sales | 1,155 | 1,958 | ||||||
Total deferred revenue | 54,634 | 53,143 | ||||||
Less current portion | 7,367 | 7,398 | ||||||
Deferred revenue, net of current portion | $ | 47,267 | $ | 45,745 |
|
2015 | $ | 3,775 | ||
2016 | 25,077 | |||
2017 | 27,013 | |||
2018 | 6,501 | |||
2019 | — | |||
Total minimum payments | 62,366 | |||
Less amount representing interest | (12,366 | ) | ||
Gross balance of long-term debt | 50,000 | |||
Less unamortized debt discount | (140 | ) | ||
Present value of long-term debt | 49,860 | |||
Less current portion of long-term debt | — | |||
Long-term debt, less current portion and unamortized debt discount | $ | 49,860 |
|
Year Ended December 31, | ||||||||||||
2014 | 2013 | 2012 | ||||||||||
Research and development | $ | 7,939 | $ | 4,476 | $ | 4,191 | ||||||
Selling, general and administrative | 7,335 | 5,062 | 4,158 | |||||||||
Share-based compensation expense | $ | 15,274 | $ | 9,538 | $ | 8,349 |
December 31, 2014 | ||||||
Unrecognized Expense | Remaining Weighted-Average Recognition Period (years) | |||||
Stock options | $ | 15,675 | 2.7 | |||
RSAs | $ | 7,153 | 1.6 | |||
RSUs | $ | 3,991 | 2.6 |
Shares Underlying Stock Options | Weighted Average Exercise Price per Share | Weighted Average Remaining Contractual Term (years) | Aggregate Intrinsic Value | ||||||||
Outstanding at January 1, 2012 | 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 | |||||||||
Granted | 2,271,143 | $13.02 | |||||||||
Exercised | (1,432,206 | ) | $5.43 | ||||||||
Canceled/forfeited | (1,185,960 | ) | $9.39 | ||||||||
Outstanding at December 31, 2014 | 6,353,892 | $9.18 | 6.5 | $11.2 | million | ||||||
Vested and expected to vest at December 31, 2014 | 6,025,883 | $9.05 | 6.4 | $10.9 | million | ||||||
Exercisable at December 31, 2014 | 3,944,408 | $7.36 | 4.6 | $8.9 | million |
Year Ended December 31, | |||||||||
2014 | 2013 | 2012 | |||||||
Expected volatility | 66.6-71.8% | 70.1-72.5% | 64.0-69.2% | ||||||
Average expected term (in years) | 5.7 | 5.7 | 5.6 | ||||||
Risk-free interest rate | 1.73-2.04% | 0.86-2.00% | 0.80-1.15% | ||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % |
Number of Shares | Weighted Average Grant Date Fair Value | ||||
Unvested at January 1, 2012 | 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 | |||
Granted | 1,055,122 | $11.15 | |||
Vested | (263,765 | ) | $8.33 | ||
Forfeited | (265,777 | ) | $10.86 | ||
Unvested at December 31, 2014 | 1,158,451 | $10.26 |
Number of Shares | Weighted Average Grant Date Fair Value | Weighted Average Remaining Contractual Term (yrs) | Aggregate Intrinsic Value | ||||||||
Unvested at January 1, 2012 | 148,000 | ||||||||||
Granted | 682,146 | $10.61 | |||||||||
Vested | (128,000 | ) | |||||||||
Forfeited | (20,000 | ) | |||||||||
Outstanding at December 31, 2012 | 682,146 | ||||||||||
Granted | 323,700 | $6.69 | |||||||||
Vested | (154,124 | ) | |||||||||
Forfeited | (115,367 | ) | |||||||||
Outstanding at December 31, 2013 | 736,355 | $9.06 | |||||||||
Granted | 305,535 | $13.71 | |||||||||
Vested | (194,368 | ) | $9.12 | ||||||||
Forfeited | (385,200 | ) | $8.84 | ||||||||
Outstanding at December 31, 2014 | 462,322 | $11.12 | 2.6 | $4.5 | million |
|
Year: | Operating Leases | |||
2015 | $ | 2,133 | ||
2016 | 2,142 | |||
2017 | 2,162 | |||
2018 | 82 | |||
Total minimum lease payments | $ | 6,519 |
|
December 31, | ||||||||
2014 | 2013 | |||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 120,707 | $ | 116,572 | ||||
Deferred revenue | 18,034 | 13,324 | ||||||
Research and development credits | 34,146 | 28,867 | ||||||
Share-based compensation | 5,381 | 2,495 | ||||||
Other, net | 891 | 853 | ||||||
179,159 | 162,111 | |||||||
Valuation allowance for deferred tax assets | (178,965 | ) | (161,968 | ) | ||||
Deferred tax assets, net of valuation | 194 | 143 | ||||||
Deferred tax liabilities: | ||||||||
Depreciation | (194 | ) | (143 | ) | ||||
Net deferred tax liabilities | (194 | ) | (143 | ) | ||||
Net deferred tax assets | $ | — | $ | — |
December 31, | ||||||||||||
2014 | 2013 | 2012 | ||||||||||
Federal income tax at 34% | $ | (23,247 | ) | $ | (28,383 | ) | $ | (18,208 | ) | |||
State income tax, net of federal benefit | (1,761 | ) | (1,745 | ) | (3,023 | ) | ||||||
Increase in valuation allowance | 16,998 | 33,525 | 20,954 | |||||||||
Foreign income subject to tax at other than federal statutory rate | 12,747 | — | — | |||||||||
Tax effect on non-deductible expenses and other | 540 | 5,219 | 1,293 | |||||||||
Research and development credits | (5,277 | ) | (8,616 | ) | (1,016 | ) | ||||||
$ | — | $ | — | $ | — |
|
Quarter Ended | ||||||||||||||||
2014 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues(1) | $ | 11,966 | $ | 18,385 | $ | 14,606 | $ | 30,377 | ||||||||
Gross profit on product sales | $ | 3,048 | $ | 3,570 | $ | 4,476 | $ | 3,997 | ||||||||
Total operating expenses | $ | 37,185 | $ | 33,325 | $ | 33,632 | $ | 34,228 | ||||||||
Net loss | $ | (26,548 | ) | $ | (16,273 | ) | $ | (20,280 | ) | $ | (5,274 | ) | ||||
Net loss per share, basic and diluted | $ | (0.22 | ) | $ | (0.13 | ) | $ | (0.16 | ) | $ | (0.04 | ) | ||||
Shares used in computing basic and diluted net loss per share | 118,943 | 123,710 | 124,041 | 124,272 | ||||||||||||
Quarter Ended | ||||||||||||||||
2013 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues | $ | 11,833 | $ | 14,454 | $ | 16,013 | $ | 12,499 | ||||||||
Gross profit on product sales(2) | $ | 769 | $ | 1,816 | $ | 9,342 | $ | 6,266 | ||||||||
Total operating expenses | $ | 30,330 | $ | 36,574 | $ | 34,507 | $ | 33,822 | ||||||||
Net loss | $ | (19,289 | ) | $ | (22,912 | ) | $ | (19,292 | ) | $ | (21,986 | ) | ||||
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 | 112,417 | 112,486 | 112,765 | 113,550 |
(1) | Revenues for the quarter ended December 31, 2014 included $15.0 million in revenue under collaborative agreements from the Janssen Collaboration. |
(2) | 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 $0.9 million, $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. |
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