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Year Ended December 31, | ||||||
2017 | 2016 | 2015 | ||||
Roche | 38% | 63% | 42% | |||
BMS | 32% | — | — | |||
Alexion | 13% | — | — | |||
Baxalta | 7% | 12% | 7% | |||
Lilly | — | 6% | 19% | |||
AbbVie | — | 4% | 17% |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
United States | $ | 196,274 | $ | 52,292 | $ | 77,149 | ||||||
Switzerland | 119,136 | 93,067 | 57,136 | |||||||||
All other foreign | 1,203 | 1,332 | 772 | |||||||||
Total revenues | $ | 316,613 | $ | 146,691 | $ | 135,057 |
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, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Numerator: | ||||||||||||
Net income (loss) | $ | 62,971 | $ | (103,023 | ) | $ | (32,231 | ) | ||||
Denominator: | ||||||||||||
Weighted average common shares outstanding for basic net income (loss) per share | 136,419 | 127,964 | 126,704 | |||||||||
Net effect of dilutive common stock equivalents | 2,649 | — | — | |||||||||
Weighted average common shares outstanding for diluted net income (loss) per share | 139,068 | 127,964 | 126,704 | |||||||||
Net income (loss) per share: | ||||||||||||
Basic | $ | 0.46 | $ | (0.81 | ) | $ | (0.25 | ) | ||||
Diluted | $ | 0.45 | $ | (0.81 | ) | $ | (0.25 | ) |
Standard | Description | Effective Date | Effect on the Financial Statements or Other Significant Matters | |||
In July 2015, the FASB issued ASU 2015-11, Inventory: Simplifying the Measurement of Inventory. | The new guidance requires that for entities that measure inventory using the first-in, first-out method, inventory should be measured at the lower of cost or net realizable value. Topic 330, Inventory, currently requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximate normal profit margin. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. | January 1, 2017. | The adoption did not have a material impact on our consolidated financial position or results of operations. | |||
In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740), Balance Sheet Classification of Deferred Tax Assets | The amendments in this update simplify the presentation of deferred income taxes by requiring that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. | January 1, 2017 | The adoption of this guidance did not have a significant impact on the Company’s financial statements. | |||
In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash. | Current U.S. GAAP either is unclear or does not include specific guidance on the eight cash flow classification issues included in ASU 2016-15. The new guidance is an improvement to U.S. GAAP and is intended to reduce the current and potential future diversity in practice. ASU 2016-18 provides additional classification guidance for restricted cash, which requires that restricted cash be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. | January 1, 2018. We have elected to early adopt as of January 1, 2017. | Cash and cash equivalents at the beginning-of-period and end-of-period total amounts in the Consolidated Statements of Cash Flows have been adjusted to include $0.5 million of restricted cash for each of the periods presented. | |||
Standard | Description | Effective Date | Effect on the Financial Statements or Other Significant Matters | |||
In January 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall; Recognition and Measurement of Financial Assets and Financial Liabilities. | The new guidance supersedes the guidance to classify equity securities with readily determinable fair values into different categories (that is, trading or available-for-sale) and requires equity securities to be measured at fair value with changes in the fair value recognized through net income. The new guidance requires public business entities that are required to disclose fair value of financial instruments measured at amortized cost on the balance sheet to measure that fair value using the exit price notion consistent with Topic 820, Fair Value Measurement. | January 1, 2018. | We currently do not hold equity securities, and we are evaluating the effect the updated standard will have on our consolidated financial statements and related disclosures. | |||
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). In March, April, May and December 2016, the FASB issued additional guidance related to Topic 606. | The new standard will supersede nearly all existing revenue recognition guidance. Under Topic 606, an entity is required to recognize revenue upon transfer of promised goods or services to customers in an amount that reflects the expected consideration to be received in exchange for those goods or services. Topic 606 defines a five-step process in order to achieve this core principle, which may require the use of judgment and estimates, and also requires expanded qualitative and quantitative disclosures relating to the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers, including significant judgments and estimates used. The new standard also defines accounting for certain costs related to origination and fulfillment of contracts with customers, including whether such costs should be capitalized. The new standard permits adoption either by using (i) a full retrospective approach for all periods presented in the period of adoption or (ii) a modified retrospective approach where the new standard is applied in the financial statements starting with the year of adoption. Under both approaches, cumulative impact of the adoption is reflected as an adjustment to retained earnings (accumulated equity (deficit)) as of the earliest date presented in accordance with the new standard. | January 1, 2018. Early adoption is permitted. | We plan to implement the new guidance on January 1, 2018 using the modified retrospective approach. We have substantially completed our evaluation of the effect that the updated standard will have on our consolidated financial statements and related disclosures. Adoption of the new guidance will impact the timing of recognition of payments related to certain of our license and collaboration agreements (1) and the timing of recognition of our sales-based royalties.(2) This standard will have a material impact on our consolidated financial statements. | |||
Standard | Description | Effective Date | Effect on the Financial Statements or Other Significant Matters | |||
In February 2016, the FASB issued ASU 2016-02, Leases. | The new guidance requires lessees to recognize assets and liabilities for most leases and provides enhanced disclosures. | January 1, 2019. Early adoption is permitted. | We are currently evaluating the effect the updated standard will have on our consolidated financial statements and related disclosures and do not intend to early adopt. We anticipate recognition of additional assets and corresponding liabilities related to our leases on our consolidated balance sheet. | |||
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments | The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. | January 1, 2020 | The Company does not believe the adoption will have a material impact on our consolidated financial position or results of operations. |
(1) | Under the new standard, we are required to assess whether licenses granted under our collaboration and license agreements are distinct in the context of the agreement from other performance obligations and functional when granted. We expect that license-related amounts, including upfront payments, exclusive designation fees, annual license maintenance fees, additional target fees, development, regulatory and sales-based milestones will be recognized, generally, at a point in time when earned. Currently, these amounts related to certain of our license and collaboration agreements are being amortized over the term of the collaboration agreement. For example, during the year ended December 31, 2017, we recognized revenue from amortization of license payments of $4.1 million. Total deferred revenue related to license payments under collaboration agreements as of December 31, 2017 was $51.8 million, which will be eliminated and recorded as a reduction to our accumulated deficit upon adoption of Topic 606. Under the new standard, license revenues would have totaled $198.4 million for the year ended December 31, 2017. |
(2) | Under the new standard, we expect sales-based royalties will be recognized in the quarter they are earned based on estimates, with a true-up to actual results following in the subsequent quarter. Sales-based royalty revenue earned under our collaboration and license agreements is presently recognized when the royalty reports are made available. Upon adoption of Topic 606, we will reduce our accumulated deficit and increase our accounts receivable, net, by the amount earned but not yet reported in our consolidated balance sheet of approximately $19.4 million. In 2017, we recognized royalty revenues of $63.5 million. Under the new standard, royalty revenues would have totaled $68.9 million for the year ended December 31, 2017. We have established a process to estimate sales-based royalty revenues in the quarter in which the sales occur going forward. |
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December 31, 2017 | ||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 117,427 | $ | — | $ | (235 | ) | $ | 117,192 | |||||||
U.S. Treasury securities | 66,601 | — | (201 | ) | 66,400 | |||||||||||
Commercial paper | 116,882 | — | — | 116,882 | ||||||||||||
$ | 300,910 | $ | — | $ | (436 | ) | $ | 300,474 |
December 31, 2016 | ||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 40,221 | $ | 1 | $ | (15 | ) | $ | 40,207 | |||||||
U.S. Treasury securities | 94,002 | 24 | (16 | ) | 94,010 | |||||||||||
Commercial paper | 4,000 | — | — | 4,000 | ||||||||||||
$ | 138,223 | $ | 25 | $ | (31 | ) | $ | 138,217 |
December 31, 2017 | December 31, 2016 | |||||||
Estimated Fair Value | ||||||||
Due within one year | $ | 213,426 | $ | 132,221 | ||||
After one but within five years | 87,048 | 5,996 | ||||||
$ | 300,474 | $ | 138,217 |
December 31, 2017 | December 31, 2016 | |||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | |||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||
Money market funds | $ | 142,091 | $ | — | $ | 142,091 | $ | 60,916 | $ | — | $ | 60,916 | ||||||||||||
Commercial paper | — | 15,700 | 15,700 | — | — | — | ||||||||||||||||||
Available-for-sale marketable securities: | ||||||||||||||||||||||||
Corporate debt securities | — | 117,192 | 117,192 | — | 40,207 | 40,207 | ||||||||||||||||||
U.S. Treasury securities | 66,400 | — | 66,400 | 94,010 | — | 94,010 | ||||||||||||||||||
Commercial paper | — | 116,882 | 116,882 | — | 4,000 | 4,000 | ||||||||||||||||||
$ | 208,491 | $ | 249,774 | $ | 458,265 | $ | 154,926 | $ | 44,207 | $ | 199,133 |
|
As of December 31, 2017 | |||
Upfront license fee payment for the application of rHuPH20 to the initial exclusive targets | $ | 20,000 | |
Election of additional exclusive targets and annual license maintenance fees for the right to designate the remaining targets as exclusive targets | 23,000 | ||
Clinical development milestone payments | 13,000 | ||
Regulatory milestone payments | 8,000 | ||
Sales-based milestone payments | 22,000 | ||
Total payments received | $ | 86,000 |
As of December 31, 2017 | |||
Upfront license fee payment for the application of rHuPH20 to the initial exclusive target | $ | 10,000 | |
Regulatory milestone payments | 3,000 | ||
Sales-based milestone payments | 9,000 | ||
Total payments received | $ | 22,000 |
As of December 31, 2017 | |||
Alexion Collaboration | $ | 40,000 | |
BMS Collaboration | 105,000 | ||
Lilly Collaboration | 33,000 | ||
AbbVie Collaboration | 29,000 | ||
Janssen Collaboration | 30,250 | ||
Pfizer Collaboration | 16,500 | ||
Total payments received | $ | 253,750 |
Consideration allocated to license fees: | |||
Alexion Collaboration | $ | 40,000 | |
BMS Collaboration | 101,400 | ||
Lilly Collaboration | 33,000 | ||
AbbVie Collaboration | 23,000 | ||
Janssen Collaboration | 15,250 | ||
Pfizer Collaboration | 12,500 | ||
Total consideration allocated to license fees | $ | 225,150 |
|
December 31, 2017 | December 31, 2016 | |||||||
Accounts receivable from product sales to collaborators | $ | 18,475 | $ | 7,854 | ||||
Accounts receivable from revenues under collaborative agreements | 2,142 | 6,151 | ||||||
Accounts receivable from other product sales | 2,075 | 2,234 | ||||||
Subtotal | 22,692 | 16,239 | ||||||
Allowance for distribution fees and discounts | (559 | ) | (559 | ) | ||||
Total accounts receivable, net | $ | 22,133 | $ | 15,680 |
December 31, 2017 | December 31, 2016 | |||||||
Raw materials | $ | 377 | $ | 761 | ||||
Work-in-process | 2,131 | 12,850 | ||||||
Finished goods | 2,638 | 1,012 | ||||||
Total inventories | $ | 5,146 | $ | 14,623 |
December 31, 2017 | December 31, 2016 | |||||||
Prepaid manufacturing expenses | $ | 2,337 | $ | 9,663 | ||||
Prepaid research and development expenses | 7,793 | 8,613 | ||||||
Other prepaid expenses | 2,585 | 1,661 | ||||||
Other assets | 6,717 | 1,530 | ||||||
Total prepaid expenses and other assets | 19,432 | 21,467 | ||||||
Less long-term portion | 5,553 | 219 | ||||||
Total prepaid expenses and other assets, current | $ | 13,879 | $ | 21,248 |
December 31, 2017 | December 31, 2016 | |||||||
Research equipment | $ | 10,970 | $ | 10,479 | ||||
Computer and office equipment | 3,725 | 3,373 | ||||||
Leasehold improvements | 2,715 | 2,331 | ||||||
Subtotal | 17,410 | 16,183 | ||||||
Accumulated depreciation and amortization | (13,890 | ) | (11,919 | ) | ||||
Property and equipment, net | $ | 3,520 | $ | 4,264 |
December 31, 2017 | December 31, 2016 | |||||||
Accrued outsourced research and development expenses | $ | 18,757 | $ | 9,522 | ||||
Accrued compensation and payroll taxes | 13,384 | 11,539 | ||||||
Accrued outsourced manufacturing expenses | 2,504 | 3,225 | ||||||
Other accrued expenses | 5,396 | 4,552 | ||||||
Total accrued expenses | 40,041 | 28,838 | ||||||
Less long-term portion | 440 | 17 | ||||||
Total accrued expenses, current | $ | 39,601 | $ | 28,821 |
December 31, 2017 | December 31, 2016 | |||||||
Collaborative agreements | ||||||||
License fees and event-based payments: | ||||||||
Roche | $ | 39,379 | $ | 35,709 | ||||
Other | 15,999 | 8,209 | ||||||
55,378 | 43,918 | |||||||
Reimbursement for research and development services | — | 700 | ||||||
Product sales | 5,487 | — | ||||||
Total deferred revenue | 60,865 | 44,618 | ||||||
Less current portion | 6,568 | 4,793 | ||||||
Deferred revenue, net of current portion | $ | 54,297 | $ | 39,825 |
|
2018 | $ | 94,125 | ||
2019 | 105,758 | |||
2020 | 27,311 | |||
2021 | 4,755 | |||
2022 | — | |||
Total minimum payments | 231,949 | |||
Less amount representing interest | (26,792 | ) | ||
Gross balance of long-term debt | 205,157 | |||
Less unamortized debt discount | (2,806 | ) | ||
Present value of long-term debt | 202,351 | |||
Less current portion of long-term debt | (77,211 | ) | ||
Long-term debt, less current portion and unamortized debt discount | $ | 125,140 |
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Year: | Operating Leases | |||
2018 | $ | 2,415 | ||
2019 | 2,785 | |||
2020 | 2,824 | |||
2021 | 2,470 | |||
2022 | 2,506 | |||
Total minimum lease payments | $ | 13,000 |
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Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
United States | $ | 160,938 | $ | 6,384 | $ | 11,724 | ||||||
Foreign | (99,328 | ) | (108,245 | ) | (43,955 | ) | ||||||
Net income (loss) before income taxes | $ | 61,610 | $ | (101,861 | ) | $ | (32,231 | ) |
December 31, | ||||||||
2017 | 2016 | |||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 32,630 | $ | 103,296 | ||||
Deferred revenue | 8,815 | 15,354 | ||||||
Research and development and orphan drug credits | 75,224 | 73,701 | ||||||
Share-based compensation | 7,423 | 8,844 | ||||||
Alternative minimum tax credit | 5,532 | 1,494 | ||||||
Other, net | 2,270 | 1,021 | ||||||
131,894 | 203,710 | |||||||
Valuation allowance for deferred tax assets | (126,189 | ) | (203,370 | ) | ||||
Deferred tax assets, net of valuation | 5,705 | 340 | ||||||
Deferred tax liabilities: | ||||||||
Depreciation | (173 | ) | (340 | ) | ||||
Total deferred tax liabilities | (173 | ) | (340 | ) | ||||
Net deferred tax asset (liability) | $ | 5,532 | $ | — |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Current - federal | $ | 4,051 | $ | 1,145 | $ | — | ||||||
Current - state | 120 | 17 | — | |||||||||
Deferred - federal | (5,532 | ) | — | — | ||||||||
Deferred - state | — | — | — | |||||||||
$ | (1,361 | ) | $ | 1,162 | $ | — |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Federal income tax expense (benefit) at 34% | $ | 20,947 | $ | (34,633 | ) | $ | (10,959 | ) | ||||
State income tax benefit, net of federal income tax impact | 930 | (653 | ) | 5,524 | ||||||||
(Decrease) increase in valuation allowance | (77,181 | ) | 11,252 | 4,045 | ||||||||
Enactment of the Tax Cuts and Jobs Act | 17,132 | — | — | |||||||||
Foreign income subject to tax at other than federal statutory rate | 33,674 | 36,803 | 14,945 | |||||||||
Shared-based compensation | 525 | 3,735 | (4,990 | ) | ||||||||
Non-deductible expenses and other | 5,779 | 698 | 6,457 | |||||||||
Research and development credits, net | 4,162 | (1,084 | ) | (3,861 | ) | |||||||
Orphan drug credits, net of federal add back | (7,329 | ) | (14,956 | ) | (11,161 | ) | ||||||
$ | (1,361 | ) | $ | 1,162 | $ | — |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Gross unrecognized tax benefits at beginning of period | $ | 12,799 | $ | 4,898 | $ | — | ||||||
Increases in tax positions for prior years | — | 5,615 | — | |||||||||
Decreases in tax positions for prior years | (2,518 | ) | (4,898 | ) | — | |||||||
Increases in tax positions for current year | 4,147 | 7,184 | 4,898 | |||||||||
Gross unrecognized tax benefits at end of period | $ | 14,428 | $ | 12,799 | $ | 4,898 |
Expires in: | |||||||||||||||
Net Operating Loss | 2018 | 2021 and beyond | 2028 and beyond | ||||||||||||
Federal | $ | 88,516 | — | $ | 88,516 | — | |||||||||
California | $ | 243,080 | — | — | $ | 243,080 |
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Quarter Ended | ||||||||||||||||
2017 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues (1) (2) | $ | 29,568 | $ | 33,750 | $ | 63,731 | $ | 189,564 | ||||||||
Gross profit on product sales | $ | 3,890 | $ | 4,992 | $ | 5,257 | $ | 5,105 | ||||||||
Total operating expenses | $ | 57,094 | $ | 59,228 | $ | 55,654 | $ | 63,635 | ||||||||
Net income (loss) | $ | (32,897 | ) | $ | (30,763 | ) | $ | 2,749 | $ | 123,882 | ||||||
Net income (loss) per share: | ||||||||||||||||
Basic | $ | (0.26 | ) | $ | (0.23 | ) | $ | 0.02 | $ | 0.87 | ||||||
Diluted | $ | (0.26 | ) | $ | (0.23 | ) | $ | 0.02 | $ | 0.85 | ||||||
Shares used in computing net income (loss) per share: | ||||||||||||||||
Basic | 128,615 | 134,013 | 141,190 | 141,718 | ||||||||||||
Diluted | 128,615 | 134,013 | 143,236 | 145,633 | ||||||||||||
Quarter Ended | ||||||||||||||||
2016 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues | $ | 42,499 | $ | 33,336 | $ | 31,853 | $ | 39,003 | ||||||||
Gross profit on product sales | $ | 5,178 | $ | 5,391 | $ | 4,197 | $ | 5,420 | ||||||||
Total operating expenses | $ | 58,668 | $ | 55,059 | $ | 54,596 | $ | 61,578 | ||||||||
Net loss | $ | (19,816 | ) | $ | (26,875 | ) | $ | (28,946 | ) | $ | (27,386 | ) | ||||
Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.21 | ) | $ | (0.23 | ) | $ | (0.21 | ) | ||||
Shares used in computing basic and diluted net loss per share | 127,615 | 127,958 | 128,154 | 128,185 |
(1) | Revenues for the quarter ended December 31, 2017 included $101.4 million, $40.0 million and $15.0 million in revenue under collaborative arrangements from BMS, Alexion and Janssen, respectively. |
(2) | Revenues for the quarter ended September 30, 2017 included $30.0 million in revenue under collaborative arrangements from the 2017 Roche Collaboration. |
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Balance at Beginning of Period | Additions | Deductions | Balance at End of Period | |||||||||||||
For the year ended December 31, 2017 | ||||||||||||||||
Accounts receivable allowances (1) | $ | 559 | $ | 4,645 | $ | (4,645 | ) | $ | 559 | |||||||
For the year ended December 31, 2016 | ||||||||||||||||
Accounts receivable allowances (1) | $ | 967 | $ | 4,795 | $ | (5,203 | ) | $ | 559 | |||||||
For the year ended December 31, 2015 | ||||||||||||||||
Accounts receivable allowances (1) | $ | 611 | $ | 4,150 | $ | (3,794 | ) | $ | 967 |
(1) | Allowances are for chargebacks, prompt payment discounts and distribution fees related to Hylenex recombinant product sales. |
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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. |
Standard | Description | Effective Date | Effect on the Financial Statements or Other Significant Matters | |||
In July 2015, the FASB issued ASU 2015-11, Inventory: Simplifying the Measurement of Inventory. | The new guidance requires that for entities that measure inventory using the first-in, first-out method, inventory should be measured at the lower of cost or net realizable value. Topic 330, Inventory, currently requires an entity to measure inventory at the lower of cost or market. Market could be replacement cost, net realizable value, or net realizable value less an approximate normal profit margin. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. | January 1, 2017. | The adoption did not have a material impact on our consolidated financial position or results of operations. | |||
In November 2015, the FASB issued ASU 2015-17, Income Taxes (Topic 740), Balance Sheet Classification of Deferred Tax Assets | The amendments in this update simplify the presentation of deferred income taxes by requiring that deferred tax liabilities and assets be classified as noncurrent in a classified statement of financial position. | January 1, 2017 | The adoption of this guidance did not have a significant impact on the Company’s financial statements. | |||
In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows: Classification of Certain Cash Receipts and Cash Payments. In November 2016, the FASB issued ASU 2016-18, Statement of Cash Flows: Restricted Cash. | Current U.S. GAAP either is unclear or does not include specific guidance on the eight cash flow classification issues included in ASU 2016-15. The new guidance is an improvement to U.S. GAAP and is intended to reduce the current and potential future diversity in practice. ASU 2016-18 provides additional classification guidance for restricted cash, which requires that restricted cash be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. | January 1, 2018. We have elected to early adopt as of January 1, 2017. | Cash and cash equivalents at the beginning-of-period and end-of-period total amounts in the Consolidated Statements of Cash Flows have been adjusted to include $0.5 million of restricted cash for each of the periods presented. | |||
Standard | Description | Effective Date | Effect on the Financial Statements or Other Significant Matters | |||
In January 2016, the FASB issued ASU 2016-01, Financial Instruments - Overall; Recognition and Measurement of Financial Assets and Financial Liabilities. | The new guidance supersedes the guidance to classify equity securities with readily determinable fair values into different categories (that is, trading or available-for-sale) and requires equity securities to be measured at fair value with changes in the fair value recognized through net income. The new guidance requires public business entities that are required to disclose fair value of financial instruments measured at amortized cost on the balance sheet to measure that fair value using the exit price notion consistent with Topic 820, Fair Value Measurement. | January 1, 2018. | We currently do not hold equity securities, and we are evaluating the effect the updated standard will have on our consolidated financial statements and related disclosures. | |||
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). In March, April, May and December 2016, the FASB issued additional guidance related to Topic 606. | The new standard will supersede nearly all existing revenue recognition guidance. Under Topic 606, an entity is required to recognize revenue upon transfer of promised goods or services to customers in an amount that reflects the expected consideration to be received in exchange for those goods or services. Topic 606 defines a five-step process in order to achieve this core principle, which may require the use of judgment and estimates, and also requires expanded qualitative and quantitative disclosures relating to the nature, amount, timing and uncertainty of revenue and cash flows arising from contracts with customers, including significant judgments and estimates used. The new standard also defines accounting for certain costs related to origination and fulfillment of contracts with customers, including whether such costs should be capitalized. The new standard permits adoption either by using (i) a full retrospective approach for all periods presented in the period of adoption or (ii) a modified retrospective approach where the new standard is applied in the financial statements starting with the year of adoption. Under both approaches, cumulative impact of the adoption is reflected as an adjustment to retained earnings (accumulated equity (deficit)) as of the earliest date presented in accordance with the new standard. | January 1, 2018. Early adoption is permitted. | We plan to implement the new guidance on January 1, 2018 using the modified retrospective approach. We have substantially completed our evaluation of the effect that the updated standard will have on our consolidated financial statements and related disclosures. Adoption of the new guidance will impact the timing of recognition of payments related to certain of our license and collaboration agreements (1) and the timing of recognition of our sales-based royalties.(2) This standard will have a material impact on our consolidated financial statements. | |||
Standard | Description | Effective Date | Effect on the Financial Statements or Other Significant Matters | |||
In February 2016, the FASB issued ASU 2016-02, Leases. | The new guidance requires lessees to recognize assets and liabilities for most leases and provides enhanced disclosures. | January 1, 2019. Early adoption is permitted. | We are currently evaluating the effect the updated standard will have on our consolidated financial statements and related disclosures and do not intend to early adopt. We anticipate recognition of additional assets and corresponding liabilities related to our leases on our consolidated balance sheet. | |||
In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326), Measurement of Credit Losses on Financial Instruments | The standard amends the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses for most financial assets and certain other instruments that aren’t measured at fair value through net income. | January 1, 2020 | The Company does not believe the adoption will have a material impact on our consolidated financial position or results of operations. |
|
Year Ended December 31, | ||||||
2017 | 2016 | 2015 | ||||
Roche | 38% | 63% | 42% | |||
BMS | 32% | — | — | |||
Alexion | 13% | — | — | |||
Baxalta | 7% | 12% | 7% | |||
Lilly | — | 6% | 19% | |||
AbbVie | — | 4% | 17% |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
United States | $ | 196,274 | $ | 52,292 | $ | 77,149 | ||||||
Switzerland | 119,136 | 93,067 | 57,136 | |||||||||
All other foreign | 1,203 | 1,332 | 772 | |||||||||
Total revenues | $ | 316,613 | $ | 146,691 | $ | 135,057 |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Numerator: | ||||||||||||
Net income (loss) | $ | 62,971 | $ | (103,023 | ) | $ | (32,231 | ) | ||||
Denominator: | ||||||||||||
Weighted average common shares outstanding for basic net income (loss) per share | 136,419 | 127,964 | 126,704 | |||||||||
Net effect of dilutive common stock equivalents | 2,649 | — | — | |||||||||
Weighted average common shares outstanding for diluted net income (loss) per share | 139,068 | 127,964 | 126,704 | |||||||||
Net income (loss) per share: | ||||||||||||
Basic | $ | 0.46 | $ | (0.81 | ) | $ | (0.25 | ) | ||||
Diluted | $ | 0.45 | $ | (0.81 | ) | $ | (0.25 | ) |
|
December 31, 2017 | ||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 117,427 | $ | — | $ | (235 | ) | $ | 117,192 | |||||||
U.S. Treasury securities | 66,601 | — | (201 | ) | 66,400 | |||||||||||
Commercial paper | 116,882 | — | — | 116,882 | ||||||||||||
$ | 300,910 | $ | — | $ | (436 | ) | $ | 300,474 |
December 31, 2016 | ||||||||||||||||
Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Estimated Fair Value | |||||||||||||
Corporate debt securities | $ | 40,221 | $ | 1 | $ | (15 | ) | $ | 40,207 | |||||||
U.S. Treasury securities | 94,002 | 24 | (16 | ) | 94,010 | |||||||||||
Commercial paper | 4,000 | — | — | 4,000 | ||||||||||||
$ | 138,223 | $ | 25 | $ | (31 | ) | $ | 138,217 |
December 31, 2017 | December 31, 2016 | |||||||
Estimated Fair Value | ||||||||
Due within one year | $ | 213,426 | $ | 132,221 | ||||
After one but within five years | 87,048 | 5,996 | ||||||
$ | 300,474 | $ | 138,217 |
December 31, 2017 | December 31, 2016 | |||||||||||||||||||||||
Level 1 | Level 2 | Total estimated fair value | Level 1 | Level 2 | Total estimated fair value | |||||||||||||||||||
Cash equivalents: | ||||||||||||||||||||||||
Money market funds | $ | 142,091 | $ | — | $ | 142,091 | $ | 60,916 | $ | — | $ | 60,916 | ||||||||||||
Commercial paper | — | 15,700 | 15,700 | — | — | — | ||||||||||||||||||
Available-for-sale marketable securities: | ||||||||||||||||||||||||
Corporate debt securities | — | 117,192 | 117,192 | — | 40,207 | 40,207 | ||||||||||||||||||
U.S. Treasury securities | 66,400 | — | 66,400 | 94,010 | — | 94,010 | ||||||||||||||||||
Commercial paper | — | 116,882 | 116,882 | — | 4,000 | 4,000 | ||||||||||||||||||
$ | 208,491 | $ | 249,774 | $ | 458,265 | $ | 154,926 | $ | 44,207 | $ | 199,133 |
|
As of December 31, 2017 | |||
Upfront license fee payment for the application of rHuPH20 to the initial exclusive targets | $ | 20,000 | |
Election of additional exclusive targets and annual license maintenance fees for the right to designate the remaining targets as exclusive targets | 23,000 | ||
Clinical development milestone payments | 13,000 | ||
Regulatory milestone payments | 8,000 | ||
Sales-based milestone payments | 22,000 | ||
Total payments received | $ | 86,000 |
As of December 31, 2017 | |||
Upfront license fee payment for the application of rHuPH20 to the initial exclusive target | $ | 10,000 | |
Regulatory milestone payments | 3,000 | ||
Sales-based milestone payments | 9,000 | ||
Total payments received | $ | 22,000 |
As of December 31, 2017 | |||
Alexion Collaboration | $ | 40,000 | |
BMS Collaboration | 105,000 | ||
Lilly Collaboration | 33,000 | ||
AbbVie Collaboration | 29,000 | ||
Janssen Collaboration | 30,250 | ||
Pfizer Collaboration | 16,500 | ||
Total payments received | $ | 253,750 |
Consideration allocated to license fees: | |||
Alexion Collaboration | $ | 40,000 | |
BMS Collaboration | 101,400 | ||
Lilly Collaboration | 33,000 | ||
AbbVie Collaboration | 23,000 | ||
Janssen Collaboration | 15,250 | ||
Pfizer Collaboration | 12,500 | ||
Total consideration allocated to license fees | $ | 225,150 |
|
December 31, 2017 | December 31, 2016 | |||||||
Accounts receivable from product sales to collaborators | $ | 18,475 | $ | 7,854 | ||||
Accounts receivable from revenues under collaborative agreements | 2,142 | 6,151 | ||||||
Accounts receivable from other product sales | 2,075 | 2,234 | ||||||
Subtotal | 22,692 | 16,239 | ||||||
Allowance for distribution fees and discounts | (559 | ) | (559 | ) | ||||
Total accounts receivable, net | $ | 22,133 | $ | 15,680 |
December 31, 2017 | December 31, 2016 | |||||||
Raw materials | $ | 377 | $ | 761 | ||||
Work-in-process | 2,131 | 12,850 | ||||||
Finished goods | 2,638 | 1,012 | ||||||
Total inventories | $ | 5,146 | $ | 14,623 |
December 31, 2017 | December 31, 2016 | |||||||
Prepaid manufacturing expenses | $ | 2,337 | $ | 9,663 | ||||
Prepaid research and development expenses | 7,793 | 8,613 | ||||||
Other prepaid expenses | 2,585 | 1,661 | ||||||
Other assets | 6,717 | 1,530 | ||||||
Total prepaid expenses and other assets | 19,432 | 21,467 | ||||||
Less long-term portion | 5,553 | 219 | ||||||
Total prepaid expenses and other assets, current | $ | 13,879 | $ | 21,248 |
December 31, 2017 | December 31, 2016 | |||||||
Research equipment | $ | 10,970 | $ | 10,479 | ||||
Computer and office equipment | 3,725 | 3,373 | ||||||
Leasehold improvements | 2,715 | 2,331 | ||||||
Subtotal | 17,410 | 16,183 | ||||||
Accumulated depreciation and amortization | (13,890 | ) | (11,919 | ) | ||||
Property and equipment, net | $ | 3,520 | $ | 4,264 |
December 31, 2017 | December 31, 2016 | |||||||
Accrued outsourced research and development expenses | $ | 18,757 | $ | 9,522 | ||||
Accrued compensation and payroll taxes | 13,384 | 11,539 | ||||||
Accrued outsourced manufacturing expenses | 2,504 | 3,225 | ||||||
Other accrued expenses | 5,396 | 4,552 | ||||||
Total accrued expenses | 40,041 | 28,838 | ||||||
Less long-term portion | 440 | 17 | ||||||
Total accrued expenses, current | $ | 39,601 | $ | 28,821 |
December 31, 2017 | December 31, 2016 | |||||||
Collaborative agreements | ||||||||
License fees and event-based payments: | ||||||||
Roche | $ | 39,379 | $ | 35,709 | ||||
Other | 15,999 | 8,209 | ||||||
55,378 | 43,918 | |||||||
Reimbursement for research and development services | — | 700 | ||||||
Product sales | 5,487 | — | ||||||
Total deferred revenue | 60,865 | 44,618 | ||||||
Less current portion | 6,568 | 4,793 | ||||||
Deferred revenue, net of current portion | $ | 54,297 | $ | 39,825 |
|
2018 | $ | 94,125 | ||
2019 | 105,758 | |||
2020 | 27,311 | |||
2021 | 4,755 | |||
2022 | — | |||
Total minimum payments | 231,949 | |||
Less amount representing interest | (26,792 | ) | ||
Gross balance of long-term debt | 205,157 | |||
Less unamortized debt discount | (2,806 | ) | ||
Present value of long-term debt | 202,351 | |||
Less current portion of long-term debt | (77,211 | ) | ||
Long-term debt, less current portion and unamortized debt discount | $ | 125,140 |
|
Year: | Operating Leases | |||
2018 | $ | 2,415 | ||
2019 | 2,785 | |||
2020 | 2,824 | |||
2021 | 2,470 | |||
2022 | 2,506 | |||
Total minimum lease payments | $ | 13,000 |
|
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
United States | $ | 160,938 | $ | 6,384 | $ | 11,724 | ||||||
Foreign | (99,328 | ) | (108,245 | ) | (43,955 | ) | ||||||
Net income (loss) before income taxes | $ | 61,610 | $ | (101,861 | ) | $ | (32,231 | ) |
December 31, | ||||||||
2017 | 2016 | |||||||
Deferred tax assets: | ||||||||
Net operating loss carryforwards | $ | 32,630 | $ | 103,296 | ||||
Deferred revenue | 8,815 | 15,354 | ||||||
Research and development and orphan drug credits | 75,224 | 73,701 | ||||||
Share-based compensation | 7,423 | 8,844 | ||||||
Alternative minimum tax credit | 5,532 | 1,494 | ||||||
Other, net | 2,270 | 1,021 | ||||||
131,894 | 203,710 | |||||||
Valuation allowance for deferred tax assets | (126,189 | ) | (203,370 | ) | ||||
Deferred tax assets, net of valuation | 5,705 | 340 | ||||||
Deferred tax liabilities: | ||||||||
Depreciation | (173 | ) | (340 | ) | ||||
Total deferred tax liabilities | (173 | ) | (340 | ) | ||||
Net deferred tax asset (liability) | $ | 5,532 | $ | — |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Current - federal | $ | 4,051 | $ | 1,145 | $ | — | ||||||
Current - state | 120 | 17 | — | |||||||||
Deferred - federal | (5,532 | ) | — | — | ||||||||
Deferred - state | — | — | — | |||||||||
$ | (1,361 | ) | $ | 1,162 | $ | — |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Federal income tax expense (benefit) at 34% | $ | 20,947 | $ | (34,633 | ) | $ | (10,959 | ) | ||||
State income tax benefit, net of federal income tax impact | 930 | (653 | ) | 5,524 | ||||||||
(Decrease) increase in valuation allowance | (77,181 | ) | 11,252 | 4,045 | ||||||||
Enactment of the Tax Cuts and Jobs Act | 17,132 | — | — | |||||||||
Foreign income subject to tax at other than federal statutory rate | 33,674 | 36,803 | 14,945 | |||||||||
Shared-based compensation | 525 | 3,735 | (4,990 | ) | ||||||||
Non-deductible expenses and other | 5,779 | 698 | 6,457 | |||||||||
Research and development credits, net | 4,162 | (1,084 | ) | (3,861 | ) | |||||||
Orphan drug credits, net of federal add back | (7,329 | ) | (14,956 | ) | (11,161 | ) | ||||||
$ | (1,361 | ) | $ | 1,162 | $ | — |
Year Ended December 31, | ||||||||||||
2017 | 2016 | 2015 | ||||||||||
Gross unrecognized tax benefits at beginning of period | $ | 12,799 | $ | 4,898 | $ | — | ||||||
Increases in tax positions for prior years | — | 5,615 | — | |||||||||
Decreases in tax positions for prior years | (2,518 | ) | (4,898 | ) | — | |||||||
Increases in tax positions for current year | 4,147 | 7,184 | 4,898 | |||||||||
Gross unrecognized tax benefits at end of period | $ | 14,428 | $ | 12,799 | $ | 4,898 |
Expires in: | |||||||||||||||
Net Operating Loss | 2018 | 2021 and beyond | 2028 and beyond | ||||||||||||
Federal | $ | 88,516 | — | $ | 88,516 | — | |||||||||
California | $ | 243,080 | — | — | $ | 243,080 |
|
Quarter Ended | ||||||||||||||||
2017 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues (1) (2) | $ | 29,568 | $ | 33,750 | $ | 63,731 | $ | 189,564 | ||||||||
Gross profit on product sales | $ | 3,890 | $ | 4,992 | $ | 5,257 | $ | 5,105 | ||||||||
Total operating expenses | $ | 57,094 | $ | 59,228 | $ | 55,654 | $ | 63,635 | ||||||||
Net income (loss) | $ | (32,897 | ) | $ | (30,763 | ) | $ | 2,749 | $ | 123,882 | ||||||
Net income (loss) per share: | ||||||||||||||||
Basic | $ | (0.26 | ) | $ | (0.23 | ) | $ | 0.02 | $ | 0.87 | ||||||
Diluted | $ | (0.26 | ) | $ | (0.23 | ) | $ | 0.02 | $ | 0.85 | ||||||
Shares used in computing net income (loss) per share: | ||||||||||||||||
Basic | 128,615 | 134,013 | 141,190 | 141,718 | ||||||||||||
Diluted | 128,615 | 134,013 | 143,236 | 145,633 | ||||||||||||
Quarter Ended | ||||||||||||||||
2016 (Unaudited): | March 31, | June 30, | September 30, | December 31, | ||||||||||||
Total revenues | $ | 42,499 | $ | 33,336 | $ | 31,853 | $ | 39,003 | ||||||||
Gross profit on product sales | $ | 5,178 | $ | 5,391 | $ | 4,197 | $ | 5,420 | ||||||||
Total operating expenses | $ | 58,668 | $ | 55,059 | $ | 54,596 | $ | 61,578 | ||||||||
Net loss | $ | (19,816 | ) | $ | (26,875 | ) | $ | (28,946 | ) | $ | (27,386 | ) | ||||
Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.21 | ) | $ | (0.23 | ) | $ | (0.21 | ) | ||||
Shares used in computing basic and diluted net loss per share | 127,615 | 127,958 | 128,154 | 128,185 |
(1) | Revenues for the quarter ended December 31, 2017 included $101.4 million, $40.0 million and $15.0 million in revenue under collaborative arrangements from BMS, Alexion and Janssen, respectively. |
(2) | Revenues for the quarter ended September 30, 2017 included $30.0 million in revenue under collaborative arrangements from the 2017 Roche Collaboration. |
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