Document
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
_______________________________________________
FORM 10-Q
[ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended December 31, 2018
or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
_______________________________________________
Commission File Number: 001-16633
_______________________________________________
Array BioPharma Inc.
(Exact Name of Registrant as Specified in Its Charter)
|
| |
Delaware | 84-1460811 |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) |
| |
3200 Walnut Street, Boulder, CO | 80301 |
(Address of Principal Executive Offices) | (Zip Code) |
|
(303) 381-6600 |
(Registrant’s Telephone Number, Including Area Code) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.
|
| |
Large Accelerated Filer x | Accelerated Filer ¨ |
Non-Accelerated Filer ¨ | Smaller Reporting Company ¨ |
| Emerging Growth Company ¨ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
As of January 30, 2019, the registrant had 218,213,556 shares of common stock outstanding.
ARRAY BIOPHARMA INC.
QUARTERLY REPORT ON FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED DECEMBER 31, 2018
TABLE OF CONTENTS
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| June 30, 2018 (unaudited) | |
| Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and six months ended December 31, 2018 and 2017 (unaudited) | |
| Condensed Consolidated Statement of Stockholders' Equity for the three and six months ended December 31, 2018 and 2017 (unaudited) | |
| December 31, 2018 and 2017 (unaudited) | |
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PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
ARRAY BIOPHARMA INC.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited) |
| | | | | | | |
| December 31, | | June 30, |
| 2018 | | 2018 |
Assets | | | |
Current assets | | | |
Cash and cash equivalents | $ | 147,094 |
| | $ | 114,748 |
|
Marketable securities | 329,964 |
| | 297,739 |
|
Accounts receivable | 22,245 |
| | 32,084 |
|
Prepaid expenses and other current assets | 31,537 |
| | 6,972 |
|
Total current assets | 530,840 |
| | 451,543 |
|
| | | |
Non-current assets | | | |
Marketable securities | 1,095 |
| | 919 |
|
Property and equipment, net | 6,902 |
| | 7,128 |
|
Other non-current assets | 10,125 |
| | 774 |
|
Total non-current assets | 18,122 |
| | 8,821 |
|
Total assets | $ | 548,962 |
| | $ | 460,364 |
|
| | | |
Liabilities and Stockholders' Equity | | | |
Current liabilities | | | |
Accounts payable | $ | 10,420 |
| | $ | 14,059 |
|
Accrued outsourcing costs | 41,535 |
| | 31,853 |
|
Accrued compensation and benefits | 14,105 |
| | 16,695 |
|
Other accrued expenses | 4,639 |
| | 1,868 |
|
Deferred rent | 725 |
| | 707 |
|
Notes payable at fair value | — |
| | 15,899 |
|
Deferred revenue | 12,761 |
| | 12,350 |
|
Current portion of long-term debt | — |
| | 2,500 |
|
Total current liabilities | 84,185 |
| | 95,931 |
|
| | | |
Non-current liabilities | | | |
Deferred rent | 5,252 |
| | 5,598 |
|
Deferred revenue | 40,231 |
| | 44,470 |
|
Long-term debt, net | 132,654 |
| | 93,376 |
|
Other non-current liabilities | 1,289 |
| | 1,246 |
|
Total non-current liabilities | 179,426 |
| | 144,690 |
|
Total liabilities | 263,611 |
| | 240,621 |
|
| | | |
Commitments and contingencies |
| |
|
| | | |
Stockholders' equity | | | |
Preferred stock, $0.001 par value; 10,000,000 shares authorized, no shares issued and outstanding | — |
| | — |
|
Common stock, $0.001 par value; 340,000,000 and 280,000,000 shares authorized as of December 31, 2018 and June 30, 2018, respectively, 217,860,411 and 211,289,922 shares issued and outstanding as of December 31, 2018 and June 30, 2018, respectively | 218 |
| | 211 |
|
Additional paid-in capital | 1,387,422 |
| | 1,286,000 |
|
Accumulated other comprehensive loss | (109 | ) | | (461 | ) |
Accumulated deficit | (1,102,180 | ) | | (1,066,007 | ) |
Total stockholders' equity | 285,351 |
| | 219,743 |
|
Total liabilities and stockholders' equity | $ | 548,962 |
| | $ | 460,364 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. |
ARRAY BIOPHARMA INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except per share data)
(Unaudited)
|
| | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| December 31, | | December 31, |
| 2018 | | 2017 | | 2018 | | 2017 |
Revenue | | | | | | | |
Product sales, net | $ | 22,713 |
| | $ | — |
| | $ | 36,706 |
| | $ | — |
|
Collaboration and license revenue | 50,924 |
| | 19,823 |
| | 81,952 |
| | 31,377 |
|
Reimbursement revenue | 8,912 |
| | 22,395 |
| | 20,801 |
| | 40,587 |
|
Total revenue | 82,549 |
| | 42,218 |
| | 139,459 |
| | 71,964 |
|
| | | | | | | |
Operating expenses | | | | | | | |
Cost of goods sold | 786 |
| | — |
| | 981 |
| | — |
|
Research and development | 62,120 |
| | 56,329 |
| | 117,670 |
| | 109,533 |
|
Selling, general and administrative | 30,473 |
| | 11,607 |
| | 55,363 |
| | 23,655 |
|
Total operating expenses | 93,379 |
| | 67,936 |
| | 174,014 |
| | 133,188 |
|
| | | | | | | |
Loss from operations | (10,830 | ) | | (25,718 | ) | | (34,555 | ) | | (61,224 | ) |
| | | | | | | |
Other income (expense) | | | | | | | |
Loss on extinguishment and conversion of Notes | — |
| | (6,457 | ) | | — |
| | (6,457 | ) |
Realized gain on investments | — |
| | — |
| | 35 |
| | — |
|
Change in fair value of notes payable | — |
| | (300 | ) | | (65 | ) | | (100 | ) |
Interest income | 2,286 |
| | 1,255 |
| | 3,810 |
| | 1,780 |
|
Interest expense | (2,818 | ) | | (2,833 | ) | | (5,398 | ) | | (6,046 | ) |
Total other income (expense), net | (532 | ) | | (8,335 | ) | | (1,618 | ) | | (10,823 | ) |
| | | | | | | |
Net loss | $ | (11,362 | ) | | $ | (34,053 | ) | | $ | (36,173 | ) | | $ | (72,047 | ) |
| | | | | | | |
Change in unrealized gain (loss) on marketable securities | 203 |
| | (634 | ) | | 352 |
| | (600 | ) |
| | | | | | | |
Comprehensive loss | $ | (11,159 | ) | | $ | (34,687 | ) | | $ | (35,821 | ) | | $ | (72,647 | ) |
| | | | | | | |
Weighted average shares outstanding – basic | 215,872 |
| | 199,852 |
| | 214,032 |
| | 187,312 |
|
Weighted average shares outstanding – diluted | 215,872 |
| | 199,852 |
| | 214,032 |
| | 187,312 |
|
| | | | | | | |
Net loss per share – basic | $ | (0.05 | ) | | $ | (0.17 | ) | | $ | (0.17 | ) | | $ | (0.38 | ) |
Net loss per share – diluted | $ | (0.05 | ) | | $ | (0.17 | ) | | $ | (0.17 | ) | | $ | (0.38 | ) |
| | | | | | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. |
ARRAY BIOPHARMA INC.
Condensed Consolidated Statement of Stockholders' Equity
(In thousands)
(Unaudited)
|
| | | | | | | | | | | | | | | | | | | | | | | |
Three months ended December 31, 2018 |
| | | | | | Additional Paid-in Capital | | Accumulated Other Comprehensive Loss | | Accumulated Deficit | | Total |
| | Common Stock | | | | |
| | Shares | | Amounts | | | | |
Balance as of September 30, 2018 | | 213,027 |
| | $ | 213 |
| | $ | 1,309,985 |
| | $ | (312 | ) | | $ | (1,090,818 | ) | | $ | 219,068 |
|
Shares issued for cash under employee share plans | | 414 |
| | 1 |
| | 63 |
| | — |
| | — |
| | 64 |
|
Share-based compensation expense | | — |
| | — |
| | 5,530 |
| | — |
| | — |
| | 5,530 |
|
Issuance of common stock, net of offering costs / At-the-market offering | | 4,419 |
| | 4 |
| | 71,844 |
| | — |
| | — |
| | 71,848 |
|
Change in unrealized loss on marketable securities | | — |
| | — |
| | — |
| | 203 |
| | — |
| | 203 |
|
Net loss | | — |
| | — |
| | — |
| | — |
| | (11,362 | ) | | (11,362 | ) |
Balance as of December 31, 2018 | | 217,860 |
| | $ | 218 |
| | $ | 1,387,422 |
| | $ | (109 | ) | | $ | (1,102,180 | ) | | $ | 285,351 |
|
|
Six months ended December 31, 2018 |
| | | | | | Additional Paid-in Capital | | Accumulated Other Comprehensive Loss | | Accumulated Deficit | | Total |
| | Common Stock | | | | |
| | Shares | | Amounts | | | | |
Balance as of June 30, 2018 | | 211,290 |
| | $ | 211 |
| | $ | 1,286,000 |
| | $ | (461 | ) | | $ | (1,066,007 | ) | | $ | 219,743 |
|
Shares issued for cash under employee share plans | | 917 |
| | 2 |
| | 2,318 |
| | — |
| | — |
| | 2,320 |
|
Share-based compensation expense | | — |
| | — |
| | 10,342 |
| | — |
| | — |
| | 10,342 |
|
Issuance of common stock, net of offering costs / At-the-market offering | | 5,653 |
| | 5 |
| | 88,762 |
| | — |
| | — |
| | 88,767 |
|
Change in unrealized loss on marketable securities | | — |
| | — |
| | — |
| | 352 |
| | — |
| | 352 |
|
Net loss | | — |
| | — |
| | — |
| | — |
| | (36,173 | ) | | (36,173 | ) |
Balance as of December 31, 2018 | | 217,860 |
| | $ | 218 |
| | $ | 1,387,422 |
| | $ | (109 | ) | | $ | (1,102,180 | ) | | $ | 285,351 |
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. |
ARRAY BIOPHARMA INC.
Condensed Consolidated Statement of Stockholders' Equity
(In thousands)
(Unaudited)
|
| | | | | | | | | | | | | | | | | | | | | | | |
Three Months Ended December 31, 2017 |
| | | | | | Additional Paid-in Capital | | Accumulated Other Comprehensive Loss | | Accumulated Deficit | | Total |
| | Common Stock | | | | |
| | Shares | | Amounts | | | | |
Balance as of September 30, 2017 | | 196,126 |
| | $ | 196 |
| | $ | 1,183,122 |
| | $ | (42 | ) | | $ | (956,655 | ) | | $ | 226,621 |
|
Shares issued for cash under employee share plans | | 2,463 |
| | 2 |
| | 13,178 |
| | — |
| | — |
| | 13,180 |
|
Share-based compensation expense | | — |
| | — |
| | 3,236 |
| | — |
| | — |
| | 3,236 |
|
Extinguishment of 2020 Notes | | 7,956 |
| | 8 |
| | (15,705 | ) | | — |
| | — |
| | (15,697 | ) |
Conversion of 2020 Notes | | 913 |
| | 1 |
| | 5,418 |
| | — |
| | — |
| | 5,419 |
|
Issuance of 2024 Notes | | — |
| | — |
| | 44,110 |
| | — |
| | — |
| | 44,110 |
|
Change in unrealized loss on marketable securities | | — |
| | — |
| | — |
| | (634 | ) | | — |
| | (634 | ) |
Net loss | | — |
| | — |
| | — |
| | — |
| | (34,053 | ) | | (34,053 | ) |
Balance as of December 31, 2017 | | 207,458 |
| | $ | 207 |
| | $ | 1,233,359 |
| | $ | (676 | ) | | $ | (990,708 | ) | | $ | 242,182 |
|
|
Six Months Ended December 31, 2017 |
| | | | | | Additional Paid-in Capital | | Accumulated Other Comprehensive Loss | | Accumulated Deficit | | Total |
| | Common Stock | | | | |
| | Shares | | Amounts | | | | |
Balance as of June 30, 2017 | | 171,308 |
| | $ | 171 |
| | $ | 930,293 |
| | $ | (76 | ) | | $ | (918,661 | ) | | $ | 11,727 |
|
Shares issued for cash under employee share plans | | 2,887 |
| | 2 |
| | 14,601 |
| | — |
| | — |
| | 14,603 |
|
Share-based compensation expense | | — |
| | — |
| | 8,819 |
| | — |
| | — |
| | 8,819 |
|
Issuance of common stock, net of offering costs / At-the-market offering | | 324 |
| | 1 |
| | 2,829 |
| | — |
| | — |
| | 2,830 |
|
Issuance of common stock, net of offering costs / Public offering | | 24,070 |
| | 24 |
| | 242,994 |
| | — |
| | — |
| | 243,018 |
|
Extinguishment of 2020 Notes | | 7,956 |
| | 8 |
| | (15,705 | ) | | — |
| | — |
| | (15,697 | ) |
Conversion of 2020 Notes | | 913 |
| | 1 |
| | 5,418 |
| | — |
| | — |
| | 5,419 |
|
Issuance of 2024 Notes | | — |
| | — |
| | 44,110 |
| | — |
| | — |
| | 44,110 |
|
Change in unrealized loss on marketable securities | | — |
| | — |
| | — |
| | (600 | ) | | — |
| | (600 | ) |
Net loss | | — |
| | — |
| | — |
| | — |
| | (72,047 | ) | | (72,047 | ) |
Balance as of December 31, 2017 | | 207,458 |
| | $ | 207 |
| | $ | 1,233,359 |
| | $ | (676 | ) | | $ | (990,708 | ) | | $ | 242,182 |
|
| | | | | | | | | | | | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. |
ARRAY BIOPHARMA INC.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited) |
| | | | | | | |
| Six Months Ended |
| December 31, |
| 2018 | | 2017 |
Cash flows from operating activities | | | |
Net loss | $ | (36,173 | ) | | $ | (72,047 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | | | |
Depreciation and amortization expense | 1,069 |
| | 1,138 |
|
Non-cash interest expense | 3,002 |
| | 3,640 |
|
Share-based compensation expense | 10,342 |
| | 8,819 |
|
Loss on extinguishment and conversion of Notes | — |
| | 6,457 |
|
Realized gain from investments, net | (35 | ) | | — |
|
Change in fair value of notes payable | 65 |
| | 100 |
|
Changes in operating assets and liabilities: | | | |
Accounts receivable | 9,839 |
| | 1,309 |
|
Prepaid expenses and other assets | (33,916 | ) | | (673 | ) |
Accounts payable and other accrued expenses | (1,832 | ) | | 2,539 |
|
Accrued outsourcing costs | 9,682 |
| | (4,087 | ) |
Accrued compensation and benefits | (1,457 | ) | | (3,400 | ) |
Deferred rent | (328 | ) | | 99 |
|
Deferred revenue | (3,828 | ) | | (14,241 | ) |
Other non-current liabilities | 132 |
| | 171 |
|
Net cash used in operating activities | (43,438 | ) | | (70,176 | ) |
| | | |
Cash flows from investing activities | | | |
Purchases of property and equipment | (843 | ) | | (212 | ) |
Proceeds from investment | 35 |
| | — |
|
Purchases of marketable securities | (234,099 | ) | | (338,060 | ) |
Proceeds from sales and maturities of marketable securities | 201,961 |
| | 91,421 |
|
Net cash used in investing activities | (32,946 | ) | | (246,851 | ) |
| | | |
Cash flows from financing activities | | | |
Proceeds from issuance of common stock / Public offering | — |
| | 258,750 |
|
Offering costs for issuance of common stock / Public offering | — |
| | (15,732 | ) |
Proceeds from issuance of common stock / At-the-market offering | 90,629 |
| | 2,917 |
|
Offering costs for the issuance of common stock / At-the-market offering | (1,862 | ) | | (87 | ) |
Net proceeds from employee stock purchases and options exercised | 1,187 |
| | 14,603 |
|
Payment of note payable | (15,000 | ) | | — |
|
Proceeds from the modification of long-term debt, net | 33,776 |
| | — |
|
Payment for debt issuance costs | — |
| | (4,306 | ) |
Net cash provided by financing activities | 108,730 |
| | 256,145 |
|
| | | |
Net increase in cash and cash equivalents | 32,346 |
| | (60,882 | ) |
Cash and cash equivalents at beginning of period | 114,748 |
| | 125,933 |
|
Cash and cash equivalents at end of period | $ | 147,094 |
| | $ | 65,051 |
|
| | | |
Supplemental disclosure of cash flow information | | | |
Cash paid for interest | $ | 3,213 |
| | $ | 2,161 |
|
Change in unrealized loss on marketable securities | $ | 352 |
| | $ | (600 | ) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
ARRAY BIOPHARMA INC.
Notes to the Unaudited Condensed Consolidated Financial Statements
NOTE 1 – OVERVIEW, BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Organization
Array BioPharma Inc. ("Array", "we", "us", "our" or "the Company") is a fully-integrated, biopharmaceutical company focused on the discovery, development and commercialization of transformative and well-tolerated targeted small molecule drugs to treat patients afflicted with cancer and other high-burden diseases. We were incorporated in the State of Delaware in 1998. Since our founding, we have progressed two drugs through clinical development and received regulatory approval. BRAFTOVI® and MEKTOVI® were approved by the Food and Drug Administration ("FDA") for commercial sales in the United States ("U.S.") in June 2018 and by the European Commission for commercial sales in the European Union through our partner, Pierre Fabre Medicamente SAS ("Pierre Fabre"), in September 2018.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC") for interim reporting and, as permitted under those rules, do not include all of the disclosures required by U.S. generally accepted accounting principles ("U.S. GAAP") for complete financial statements. The unaudited condensed consolidated financial statements reflect all normal and recurring adjustments that, in the opinion of management, are necessary to present fairly our financial position, results of operations and cash flows for the interim periods presented. Operating results for an interim period are not necessarily indicative of the results that may be expected for a full year. Our management performed an evaluation of our activities through the date of filing of this Quarterly Report on Form 10-Q.
These unaudited condensed consolidated financial statements should be read in conjunction with our audited financial statements and the notes thereto for the fiscal year ended June 30, 2018 included in our Annual Report on Form 10-K from which we derived our balance sheet data as of June 30, 2018.
We operate in one reportable segment and, accordingly, no segment disclosures have been presented herein. All of our equipment, leasehold improvements and other fixed assets are physically located within the U.S., and the vast majority of our agreements with partners are denominated in U.S. dollars.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires our management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. We base our estimates on our historical experience and on various other assumptions that we believe are reasonable under the circumstances. Our actual results could differ significantly from these estimates under different assumptions or conditions.
On an ongoing basis, we evaluate our estimates, including our most significant estimates related to revenue recognition, gross-to-net product sales adjustments, and estimating accrued outsourcing costs for clinical trials and preclinical testing.
Liquidity
As of December 31, 2018 and June 30, 2018, we held cash, cash equivalents and marketable securities totaling $478.2 million and $413.4 million, respectively. With the exception of fiscal year 2015, we have incurred operating losses and an accumulated deficit as a result of ongoing research and development spending since inception. As of December 31, 2018, we had an accumulated deficit of $1.1 billion. Our results of operations were net losses of $11.4 million and $36.2 million for the three and six months ended December 31, 2018, respectively, and $147.3 million, $116.8 million and $92.8 million for the fiscal years ended June 30, 2018, 2017 and 2016, respectively.
We have historically funded our operations from upfront fees, proceeds from research and development reimbursement arrangements, license and milestone payments received under our drug collaborations and license agreements, and proceeds from the sale of equity securities and debt provided by convertible debt and other credit facilities. We believe that our cash, cash equivalents and marketable securities as of December 31, 2018 will enable us to continue to fund operations in the normal course of business for more than a twelve-month period from the date of filing this Quarterly Report on Form 10-Q. Until we can generate sufficient levels of cash from operations, which we do not expect to achieve in at least the next two years, and because sufficient funds may not be available to us when needed from existing collaborations, we expect that we will be required to continue to fund our operations in part through the sale of debt or equity securities, or through licensing select programs or partial economic rights that include upfront, royalty and/or milestone payments.
Our assessment of our future need for funding and our ability to continue to fund our operations are forward-looking statements that are based on assumptions that may prove to be wrong and that involve substantial risks and uncertainties. Our actual future capital requirements could vary as a result of a number of factors.
Concentration of Business Risks
The following counterparties contributed greater than 10% of our total revenue during at least one of the periods set forth below. The revenue from these counterparties as a percentage of total revenue was as follows:
|
| | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| December 31, | | December 31, |
| 2018 | | 2017 | | 2018 | | 2017 |
Loxo Oncology | 48.5 | % | | 5.7 | % | | 33.3 | % | | 8.0 | % |
Pierre Fabre | 7.9 | % | | 10.5 | % | | 20.3 | % | | 11.8 | % |
Novartis Pharmaceutical | 10.8 | % | | 53.1 | % | | 14.9 | % | | 56.4 | % |
Asahi Kasei | — | % | | 23.0 | % | | — | % | | 14.9 | % |
Total | 67.2 | % | | 92.3 | % | | 68.5 | % | | 91.1 | % |
The loss of one or more of our significant partners or collaborators could have a material adverse effect on our business, operating results or financial condition. Although we are impacted by economic conditions in the biotechnology and pharmaceutical sectors, management does not believe significant credit risk exists as of December 31, 2018.
Geographic Information
The following table details revenue by geographic area based on the country in which our partners, Customers or license holders are located (in thousands):
|
| | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| December 31, | | December 31, |
| 2018 | | 2017 | | 2018 | | 2017 |
North America | $ | 65,945 |
| | $ | 4,662 |
| | $ | 88,225 |
| | $ | 10,163 |
|
Europe | 15,446 |
| | 26,852 |
| | 49,135 |
| | 49,148 |
|
Asia Pacific | 1,158 |
| | 10,704 |
| | 2,099 |
| | 12,653 |
|
Total | $ | 82,549 |
| | $ | 42,218 |
| | $ | 139,459 |
| | $ | 71,964 |
|
Accounts Receivable
Novartis Pharmaceutical Ltd. and Novartis Pharma AG (collectively, "Novartis") accounted for 41% and 52% of our total accounts receivable balance as of December 31, 2018 and June 30, 2018, respectively. Loxo Oncology ("Loxo") accounted for 0% and 14% of our total accounts receivable balance as of December 31, 2018 and June 30, 2018, respectively. Pierre Fabre accounted for 13% and 13% of our total accounts receivable balance as of December 31, 2018 and June 30, 2018, respectively.
Summary of Significant Accounting Policies
Our significant accounting policies are described in Note 1 to our audited financial statements for the fiscal year ended June 30, 2018, included in our Annual Report on Form 10-K. Our significant accounting policies for the three and six months ended December 31, 2018 also included the policies discussed below related to revenue and cost of goods sold for commercial product sales. With the exception of those noted below, there have been no material changes in our significant accounting policies as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended June 30, 2018.
Product Sales, Net
We received approval from the FDA on June 27, 2018 to market BRAFTOVI + MEKTOVI in the U.S. for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation. We began selling BRAFTOVI + MEKTOVI in the U.S. in July 2018. We distribute our products principally through a limited number of specialty distributor and specialty pharmacy providers (collectively, our "Customers"). Our Customers subsequently sell our products to patients and health care providers. Separately, we enter into arrangements with third parties that provide for government-mandated and privately-negotiated rebates, chargebacks and discounts. Revenue is recognized when the Customer obtains control of our product, typically upon delivery to the Customer.
Revenue from product sales are recognized when our performance obligations are satisfied, which is when Customers obtain control of our product and occurs at a point in time, typically upon delivery.
Reserves for Variable Consideration
Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration, including rebates, chargebacks, discounts, patient assistance programs, estimated product returns and other allowances that are offered within contracts between us and our Customers. These estimates are based on the amounts earned or to be claimed for related sales and are classified as reductions of accounts receivable if the amount is payable to our Customers or a current liability if the amount is payable to a party other than a Customer. Where appropriate, these estimates take into consideration a range of possible outcomes which are probability-weighted for relevant factors such as industry data and forecasted customer buying and payment patterns, our historical experience, current contractual and statutory requirements, specific known market events and trends. Overall, these reductions to gross sales reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we adjust these estimates, which would affect product revenue and earnings in the period such variances become known.
Rebates: Rebates include mandated discounts under the Medicaid Drug Rebate Program ("Medicaid") and the Medicare Coverage Gap Program ("Medicare"). Rebates are amounts owed after the final dispensing of products to a benefit plan participant and are based upon contractual agreements or legal requirements with the public-sector benefit providers. These estimates for rebates are recorded in the same period the related gross revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses on the consolidated balance sheet. We estimate our Medicaid and Medicare rebates based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. The accrual for rebates is based on statutory discount rates and known sales to specialty pharmacy patients or expected utilization for specialty distributor sales to healthcare providers. As we gain more historical experience, estimates will be based on the expected utilization from historical data we have accumulated since the BRAFTOVI + MEKTOVI product launch. Rebates are generally invoiced and paid quarterly in arrears.
Chargebacks: Chargebacks are discounts that occur when contracted purchasers purchase directly from our specialty distributors at a discounted price. The specialty distributor, in turn, charges back the difference between the price initially paid to us by the specialty distributor and the discounted price paid to the specialty distributor by the contracted purchaser. Amounts for estimated chargebacks are established in the same period that the related gross revenue is recognized, resulting in a reduction of product revenue and accounts receivable. The accrual for specialty distributor chargebacks is estimated based on known chargeback rates, known sales to specialty distributors, and estimated utilization by types of contracted purchasers.
Discounts and Fees: Our payment terms are generally 45 days. Specialty distributors and specialty pharmacies are offered various forms of consideration, including service fees and prompt pay discounts for payment within a specified period. We expect these Customers will earn prompt pay discounts and therefore, we deduct the full amount of these discounts and service fees from product sales when revenue is recognized, resulting in a reduction of product revenue and accounts receivable.
Other Reserves: Patients who have commercial insurance and meet certain eligibility requirements may receive co-pay assistance. We estimate the amount of co-pay assistance provided to eligible patients based on the terms of the program when product is dispensed by specialty pharmacies to patients. These estimates are based on redemption information provided by third-party claims processing organizations and are recorded in accounts payable, accrued expenses and other liabilities on the unaudited condensed consolidated balance sheet.
We are offering a quick start program in the form of vouchers to eligible patients. We record amounts for estimated voucher redemptions in the same period that the related gross revenue is recognized, resulting in a reduction of product revenue and these amounts are recorded in accounts payable, accrued expenses and other liabilities on the unaudited condensed consolidated balance sheet. Our accrual for voucher redemptions is estimated based on observed voucher redemption rates.
Cost of Goods Sold
Cost of goods sold consists of the cost of goods sold to Customers, international partners under product supply agreements, and royalty expense based on net sales of BRAFTOVI. We capitalize inventory costs associated with the production of our products after regulatory approval or when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Otherwise, such costs are expensed as research and development. A portion of the costs of BRAFTOVI + MEKTOVI units recognized as revenue during the three and six months ended December 31, 2018 were expensed prior to FDA approval on June 27, 2018. We believe our cost of goods sold for the three and six months ended December 31, 2018 would have been $0.3 million and $0.7 million higher, respectively, if we had not previously expensed certain material and production costs with respect to the units sold. As of December 31, 2018, we had approximately $15.4 million of inventory on hand that was previously expensed as research and development expense and will not be reported as cost of goods sold in future periods when sales of BRAFTOVI + MEKTOVI are recognized as revenue.
Recently Adopted Accounting Standards
In May 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2014-09, "Revenue from Contracts with Customers (Topic 606)" ("ASU 2014-09") and has subsequently issued a number of amendments to ASU 2014-09 (collectively, "ASC 606"). The new standard, as amended, requires entities to recognize revenue from the transfer of promised goods or services to customers based on the amount of the consideration to which the entity expects to be entitled to receive in exchange for those goods or services.
The new standard was effective for us on July 1, 2018, prior to our first commercial product sale, and we elected to adopt it using a modified retrospective transition method applied only to contracts that were not completed as of July 1, 2018. Our adoption of ASU 2014-09 did not require any cumulative effect adjustment to opening retained earnings as of July 1, 2018 and did not have a material impact on our unaudited condensed consolidated financial statements.
We have examined our revenue recognition policies and contracts related to our collaboration, co-development and product revenue streams to determine the impact of the new standard using the five-step process prescribed by ASC 606 and recognize revenue for our categories of revenue as follows:
Product sales: Revenue from product sales is recognized when our performance obligations are satisfied, which is when customers obtain control of our product and occurs at a point in time, typically upon delivery.
Licenses of intellectual property: If the license granted to our intellectual property is determined to be a discrete performance obligation from the other performance obligations identified in the arrangement, we recognize revenue from non-refundable, upfront fees allocated to the license when the license is transferred to the licensee and the recipient of the license is able to use and benefit from the license. For licenses that are determined to not be distinct from other performance obligations, such as development activities, we recognize revenue over time, using an input method as the related performance obligations are satisfied.
Upfront payments are recorded as deferred revenue upon receipt and are recognized as revenue during subsequent periods as our performance obligations are met.
Milestone payments: Developmental and regulatory milestone payments generally relate to performance obligations that have been completed in the past and are recognized as revenue in the period in which the milestone is achieved and material risk of reversal of revenue has passed. Due to the uncertainty of drug development and the high historical failure rates generally associated with drug development, we may not receive any additional milestone payments under our agreements. We reevaluate the likelihood of achieving future milestones at the end of each reporting period. If the risk of significant reversal is resolved, future milestone revenue from an arrangement will be recognized as revenue in the period the risk is relieved. Adoption of ASC 606 has the effect of accelerating recognition of revenue for certain commercial milestone payments as compared to the legacy accounting guidance.
Product royalty and commercial milestone revenues: We have entered into arrangements that include sales-based royalties or commercial milestone payments for which the license is deemed to be the predominant item to which the royalties or milestones relate. We recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty was allocated has been satisfied (or partially satisfied).
In August 2016, the FASB issued ASU No. 2016-15, "Statement of Cash Flows (Topic 230)" ("ASU 2016-15"). This amendment provides guidance on the presentation and classification of specific cash flow items to improve consistency within the statement of cash flows. ASU 2016-15 is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2017, with early adoption permitted. We adopted the new standard on July 1, 2018 and did not have a material impact on our consolidated financial statements.
In May 2017, the FASB issued ASU 2017-09, "Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting" ("ASU 2017-09"), which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. ASU 2017-19 is effective prospectively for the annual period ending June 30, 2019 and interim periods within that annual period. Early adoption is permitted. We adopted the new standard on July 1, 2018 and did not have a material impact on our consolidated financial statements.
Recently Issued Accounting Standards
In February 2016, the FASB issued ASU No. 2016-02, "Leases (Topic 842)" ("ASU 2016-02") which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. In July 2018, the FASB issued ASU 2018-11, “Leases (Topic 842): Targeted Improvements” and ASU 2018-10, “Codification Improvements to Topic 842, Leases.” ASU 2016-02 and the subsequent modifications are identified as “ASC 842.” The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018, with early adoption permitted upon issuance. We are currently evaluating the impact that ASU 2016-02 will have on our unaudited condensed consolidated financial statements and related disclosures and plan to adopt the new standard on July 1, 2019.
In November 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2018-18, “Collaborative Arrangements (Topic 808): Clarifying the Interaction between Topic 808 and Topic 606” (“ASU 2018-18”). The standard provides guidance on the interaction between Revenue Recognition (Topic 606) and Collaborative Arrangements (Topic 808) by aligning the unit of account guidance between the two topics and clarifying whether certain transactions between collaborative participants should be accounted for as revenue under Topic 606. ASU 2018-18 is effective for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. We are currently evaluating the impact ASU 2018-18 will have on our unaudited condensed consolidated financial statements and related disclosures, but do not expect it to have a material impact on our consolidated financial statements.
NOTE 2 – MARKETABLE SECURITIES
Marketable securities consisted of the following as of December 31, 2018 and June 30, 2018 (in thousands):
|
| | | | | | | | | | | | | | | |
| December 31, 2018 |
| | | Gross | | Gross | | |
| Amortized | | Unrealized | | Unrealized | | Fair |
| Cost | | Gains | | Losses | | Value |
Short-term available-for-sale securities: | | | | | | | |
U.S. treasury securities | $ | 198,762 |
| | $ | — |
| | $ | (98 | ) | | $ | 198,664 |
|
Commercial paper | 101,533 |
| | — |
| | — |
| | 101,533 |
|
Corporate bonds | 19,913 |
| | — |
| | (16 | ) | | 19,897 |
|
Asset-backed securities | 9,648 |
| | 5 |
| | — |
| | 9,653 |
|
Mutual fund securities | 217 |
| | — |
| | — |
| | 217 |
|
| 330,073 |
| | 5 |
| | (114 | ) | | 329,964 |
|
Long-term available-for-sale securities: | | | | | | | |
Mutual fund securities | 1,095 |
| | — |
| | — |
| | 1,095 |
|
| 1,095 |
| | — |
| | — |
| | 1,095 |
|
Total | $ | 331,168 |
| | $ | 5 |
| | $ | (114 | ) | | $ | 331,059 |
|
|
| | | | | | | | | | | | | | | |
| June 30, 2018 |
| | | Gross | | Gross | | |
| Amortized | | Unrealized | | Unrealized | | Fair |
| Cost | | Gains | | Losses | | Value |
Short-term available-for-sale securities: | | | | | | | |
U.S. treasury securities | $ | 297,965 |
| | $ | — |
| | $ | (461 | ) | | $ | 297,504 |
|
Mutual fund securities | 235 |
| | — |
| | — |
| | 235 |
|
| 298,200 |
| | — |
| | (461 | ) | | 297,739 |
|
Long-term available-for-sale securities: | | | | | | | |
Mutual fund securities | 919 |
| | — |
| | — |
| | 919 |
|
| 919 |
| | — |
| | — |
| | 919 |
|
Total | $ | 299,119 |
| | $ | — |
| | $ | (461 | ) | | $ | 298,658 |
|
The mutual fund securities shown in the above tables are securities held under the Array BioPharma Inc. Deferred Compensation Plan.
As of December 31, 2018, the amortized cost and estimated fair value of available-for-sale debt securities by contractual maturity were as follows (in thousands):
|
| | | | | | | |
| Amortized | | Fair |
| Cost | | Value |
Due in one year or less | $ | 329,856 |
| | $ | 329,747 |
|
NOTE 3 – PRODUCT REVENUE
Our commercial stage products include BRAFTOVI and MEKTOVI, which received FDA approval on June 27, 2018 as a combination therapy for the treatment of patients with unresectable or metastatic melanoma with BRAFV600E or BRAFV600K mutation, as detected by an FDA-approved test.
We record gross-to-net sales accruals for rebates, chargebacks, discounts, estimated product returns and other allowances that are offered within contracts between us and our Customers and other indirect customers relating to the sales of our products.
Our provisions for discounts, early payments, rebates, sales returns, distributor service fees and chargebacks, and other incentives are under terms that are customary in the industry and are provided for in the same period in which the related sales are recorded.
Net product revenues by product for the three and six months ended December 31, 2018 was as follows (in thousands):
|
| | | | | | | | |
| | Three Months Ended December 31, 2018 | | Six Months Ended December 31, 2018 |
BRAFTOVI | | $ | 11,371 |
| | $ | 18,386 |
|
MEKTOVI | | 11,342 |
| | 18,320 |
|
Total net product sales | | $ | 22,713 |
| | $ | 36,706 |
|
Gross-to-net sales accruals and the balance in the related allowance accounts for the six months ended December 31, 2018 were as follows (in thousands):
|
| | | | | | | | | | |
| | Returns | Other | Total |
Balance as of June 30, 2018 | | $ | — |
| $ | — |
| $ | — |
|
Allowances for sales during prior periods | | — |
| — |
| — |
|
Allowances for sales during the current period | | 67 |
| 7,950 |
| 8,017 |
|
Credits/deductions issued for prior year sales | | — |
| — |
| — |
|
Credits/deductions issued for sales during the current period | | (26 | ) | (5,155 | ) | (5,181 | ) |
Balance as of December 31, 2018 | | $ | 41 |
| $ | 2,795 |
| $ | 2,836 |
|
There were no product sales or gross-to-net accruals during the three and six months ended December 31, 2017.
NOTE 4 – COLLABORATION AND OTHER AGREEMENTS
The following table summarizes total revenue recognized for the periods indicated (in thousands):
|
| | | | | | | | | | | | | | | | |
| | Three Months Ended | | Six Months Ended |
| | December 31, | | December 31, |
| | 2018 | | 2017 | | 2018 | | 2017 |
Collaboration and other revenue | | | | | | | |
Pierre Fabre | | $ | 5,427 |
| | $ | 3,674 |
| | $ | 11,456 |
| | $ | 7,023 |
|
Loxo | | — |
| | 2,395 |
| | 2,403 |
| | 4,653 |
|
Mirati | | 1,216 |
| | 1,422 |
| | 2,210 |
| | 2,811 |
|
Other partners | | 1,806 |
| | 1,017 |
| | 2,490 |
| | 2,029 |
|
Total collaboration and other revenue | | 8,449 |
| | 8,508 |
| | 18,559 |
| | 16,516 |
|
| | | | | | | | |
License and milestone revenue | | | | | | | | |
Loxo | | 40,000 |
| | — |
| | 44,000 |
| | 1,107 |
|
Pierre Fabre | | 1,074 |
| | 750 |
| | 16,824 |
| | 1,500 |
|
Ono | | 918 |
| | 919 |
| | 1,836 |
| | 1,837 |
|
Asahi Kasei | | — |
| | 9,437 |
| | — |
| | 10,000 |
|
Other partners | | 482 |
| | 209 |
| | 732 |
| | 417 |
|
Total license and milestone revenue | | 42,474 |
| | 11,315 |
| | 63,392 |
| | 14,861 |
|
Total collaboration and license revenue | | $ | 50,924 |
| | $ | 19,823 |
| | $ | 81,952 |
| | $ | 31,377 |
|
| | | | | | | | |
Reimbursement revenue | | | | | | | | |
Novartis | | $ | 8,912 |
| | $ | 22,395 |
| | $ | 20,801 |
| | $ | 40,587 |
|
Collaboration and License Revenue
The terms of our collaboration and license agreements include substantial ongoing collaboration and cost-sharing activities between the companies and may require us to perform future development and commercialization activities. In accordance with the revenue recognition criteria under ASC 606, Revenue from Contracts with Customers, we identified the following performance obligations in each of the following collaboration agreements, excluding Loxo: (1) the license rights and (2) clinical development and other services. For each agreement, we determined that the license rights are not distinct from the clinical development and other activities, and as such, are combined with certain other activities to form a performance obligation. Accordingly, any non-refundable upfront payments received under the agreements have been recorded as deferred revenue and are being recognized over the period during which management expects that substantial development activities will be performed.
We re-evaluate the likelihood of achieving future milestones at the end of each reporting period. Any remaining future milestone payments discussed in this Quarterly Report on Form 10-Q are related to performance obligations that have been not yet been satisfied. If the risk of significant reversal for a milestone becomes resolved in the future, then the revenue associated with the respective milestone will be recognized in the the period the risk is removed.
Pierre Fabre
On November 10, 2015, we entered into an agreement with Pierre Fabre (the "PF Agreement") pursuant to which we granted Pierre Fabre rights to commercialize encorafenib and binimetinib in all countries except for the U.S., Canada, Japan, Korea and Israel, where we retain our ownership rights (subject to rights granted to Ono Pharmaceutical Co., Ltd. ("Ono") under the agreement with Ono).
The PF Agreement closed in December 2015 (the "Effective Date"). All clinical trials involving encorafenib and binimetinib that were ongoing or planned at the Effective Date, including the COLUMBUS trial and other then-ongoing Novartis sponsored and investigator sponsored clinical studies, continued to be conducted pursuant to the terms of the Novartis Agreements. Further worldwide development activities are governed by a Global Development Plan ("GDP") with Pierre Fabre. Pierre Fabre will jointly fund worldwide development costs under the GDP, with Array covering 60% and Pierre Fabre covering 40% of such costs.
In connection with the PF Agreement, we received a $30.0 million upfront payment during the year ended June 30, 2016 which has been recorded as deferred revenue and is being recognized through 2025, which is the period through which management expects that substantial development activities will be performed. In September 2018, we earned a $15.0 million milestone under the PF Agreement upon regulatory approval in the European Union, which was fully recognized as collaboration and license revenue during the period.
The PF Agreement contains additional substantive potential milestone payments of up to $390.0 million for achievement of seven commercialization milestones if certain net sales amounts are achieved for any licensed indications. We are further eligible for multiple tiered double-digit royalties on annual net sales of encorafenib and binimetinib in the PF territory, starting at 20% for annual net sales under €50.0 million and increasing to 35% for annual net sales in excess of €100.0 million subject to certain adjustments.
Ono Pharmaceutical Co., Ltd.
Effective May 31, 2017, we entered into a License, Development and Commercialization Agreement (the “Ono Agreement”) with Ono, pursuant to which we granted Ono exclusive rights to commercialize encorafenib and binimetinib in Japan and the Republic of Korea (the “Ono Territory”), along with the right to develop these products in the Ono Territory. We retain all rights outside the Ono Territory, as well as the right to conduct development and manufacturing activities in the Ono Territory.
All ongoing clinical trials involving encorafenib and binimetinib, including the BEACON CRC and COLUMBUS trials, continued as planned as of the effective date of the Ono Agreement, and Ono is entitled to the data derived from such studies. As part of the Ono Agreement, Ono obtained the right to participate in any future global development of encorafenib and binimetinib by contributing 12% of those future costs. Ono is responsible for seeking, and for any development of encorafenib and binimetinib specifically necessary to obtain, regulatory and marketing approvals for products in the Ono Territory. We will furnish clinical supplies of drug substance to Ono for use in Ono’s development efforts, and Ono may elect to have us provide commercial supplies of drug product to Ono pursuant to a commercial supply agreement to be entered into between Ono and us, in each case the costs of which will be borne by Ono.
We have also agreed to discuss and agree on a strategy with Ono to ensure the supply to Ono of companion diagnostics for use with encorafenib and binimetinib in certain indications in the Ono Territory.
Under the terms of the Ono Agreement, we received a non-refundable upfront cash payment of ¥3.5 billion, or $31.2 million, and we retain all rights to conduct, either on our own or through third parties, all clinical studies and file related regulatory filings with respect to encorafenib and binimetinib and to develop, manufacture and commercialize encorafenib and binimetinib outside the Ono Territory (subject to rights we have granted to Pierre Fabre in certain countries). The upfront payment has been recorded as deferred revenue and is being recognized through 2025 which is the period through which management expects that substantial development activities will be performed. We are entitled to receive potential milestone payments of up to ¥900.0 million for the achievement of two remaining development milestones, ¥5.0 billion for the achievement of eight regulatory milestones relating to certain Marketing Authorization Application filings and approval in Japan for two specified indications, and ¥10.5 billion for the achievement of five commercialization milestones if certain annual net sales targets are achieved. A portion of these milestones is related to the advancement of the Phase 3 BEACON CRC trial in the Ono Territory. We are further eligible for tiered double-digit royalties on annual net sales of encorafenib and binimetinib in the Ono Territory, starting at 22% for annual net sales under ¥10.0 billion and increasing to 25% for annual net sales in excess of ¥10.0 billion subject to certain adjustments. As of December 31, 2018, ¥1.0 billion was the equivalent of approximately $9.1 million.
Loxo
We are party to a Drug Discovery Collaboration Agreement, as amended, with Loxo (the “Loxo Agreement”). Under the terms of the Loxo Agreement, Loxo funded discovery and preclinical programs conducted by us, including LOXO-195, a next generation selective TRK inhibitor, LOXO-292, a RET inhibitor, and FGFR programs (the "Loxo Programs"). The research phase concluded in September 2018. Loxo is responsible for all additional preclinical and clinical development and commercialization.
We identified the following performance obligations: (1) the conduct of the research activities under the discovery program, including related technology transfer (the "research services deliverable"), (2) an exclusive worldwide license granted to Loxo to certain of our technology and our interest in collaboration technology, as well as exclusive worldwide marketing rights (the "license deliverable") and (3) participation on the Joint Research Committee ("JRC"). The Loxo Agreement provides for no general right of return for any non-contingent performance obligation. All the identified non-contingent performance obligations were considered distinct; therefore they are treated as separate performance obligations. Delivery of the research services and JRC participation obligations were completed throughout the research discovery program term. The license deliverable was complete as of September 30, 2013.
During the three months ended September 30, 2018, we earned a $4.0 million milestone under the Loxo Agreement for the initiation of a registration enabling study for LOXO-292, which was fully recognized as collaboration and license revenue during the period. During the three months ended December 31, 2018, we recognized milestone revenue of $40.0 million related to the first commercial sale of Vitrakvi by Loxo. We received a $20.0 million cash payment during the three months ended December 31, 2018 and will receive two additional payments of $10.0 million on each of the one year and two year anniversaries of the first commercial sale. In accordance with ASC 606, we recognized the entire $40.0 million as revenue during the three months ended December 31, 2018 as our performance obligations have been satisfied, payment is contingent upon only the passage of time, and we determined that it is not probable that a significant reversal of revenue would occur. The $20.0 million of additional payments are reflected as $10.0 million in other current assets and $10.0 million in other non-current assets in our unaudited condensed consolidated balance sheet as of December 31, 2018.
The Drug Discovery Collaboration Agreement with Loxo contains substantive potential milestone payments of up to $7.0 million for two remaining development milestones and up to $595.0 million for the achievement of twenty commercialization milestones if certain net sales amounts are achieved for any licensed drug candidates in the U.S., the European Union and Japan plus royalties on sales of any resulting drugs.
Mirati
We are party to agreements with Mirati Therapeutics, Inc. (the "Mirati Agreements"). During April 2018, Mirati elected to exercise an option to take an exclusive, worldwide license to an active compound under one such agreement for which we received $2.0 million and we continue to receive additional fees as reimbursement for research and development services. The option exercise fee, received in the three months ended June 30, 2018, was recorded
as deferred revenue and is being recognized as revenue over two years, the period during which we expect that substantial development activities will be performed.
The Mirati Agreements contain substantive potential milestone payments of up to $18.3 million for seven remaining developmental milestones and up to $674.0 million for the achievement of fourteen commercialization milestones if certain net sales amounts are achieved in the U.S., the European Union and Japan.
Dr. Charles Baum, a current member of our Board of Directors, is the President and Chief Executive Officer of Mirati.
Other Collaboration Arrangements
In addition to the collaboration arrangements described above, we have entered into a number of other collaborative arrangements that include the potential for us to receive future milestone payments of up to $48.5 million for development milestones, up to $73.0 million for regulatory milestones, up to $159.5 million for sales milestones over a period of several years in addition to royalties on potential future product sales. Our ability to receive payments under these collaborations is contingent upon our collaboration partners' continued involvement in the programs and the lack of any adverse events which could cause the discontinuance of the programs.
Deferred Revenue
Deferred revenue balances were as follows for the dates indicated (in thousands):
|
| | | | | | | |
| December 31, | | June 30, |
| 2018 | | 2018 |
Ono | $ | 25,718 |
| | $ | 27,555 |
|
Pierre Fabre (1) | 25,982 |
| | 22,394 |
|
Mirati | 1,292 |
| | 2,468 |
|
Loxo | — |
| | 2,403 |
|
Other | — |
| | 2,000 |
|
Total deferred revenue | 52,992 |
| | 56,820 |
|
Less: Current portion | (12,761 | ) | | (12,350 | ) |
Deferred revenue, long-term portion | $ | 40,231 |
| | $ | 44,470 |
|
(1) Balance as of December 31, 2018 includes a $5.1 million prepayment for commercial drug supply of BRAFTOVI and MEKTOVI
Reimbursement Revenue
On March 2, 2015 (the "Effective Date"), we regained development and commercialization rights to binimetinib under the Termination and Asset Transfer Agreement with Novartis and to encorafenib under the Asset Transfer Agreement with Novartis (which we collectively refer to as the “Novartis Agreements”). Along with global ownership of both assets, the Novartis Agreements transferred to us a 2% royalty obligation offset by certain expenses, which is payable based on net sales of encorafenib and is expensed as costs of goods sold as incurred.
Amounts provided by Novartis related to the development and commercialization of binimetinib and encorafenib are reported as reimbursement revenue on our unaudited condensed consolidated statements of operations. See Note 3 of Notes to Consolidated Financial Statements included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2018 for additional details related to our agreements with Novartis related to encorafenib and binimetinib.
NOTE 5 – DEBT
Outstanding debt consists of the following (in thousands):
|
| | | | | | | |
| December 31, | | June 30, |
| 2018 | | 2018 |
Notes payable at fair value | $ | — |
| | $ | 15,899 |
|
| | | |
2024 convertible senior notes | $ | 126,060 |
| | $ | 126,060 |
|
Silicon Valley Bank term loan (1) | 53,500 |
| | 16,200 |
|
Long-term debt, gross | 179,560 |
| | 142,260 |
|
Less: Unamortized debt discount and fees | (46,906 | ) | | (46,384 | ) |
Long-term debt, net | 132,654 |
| | 95,876 |
|
Less: Current portion | — |
| | (2,500 | ) |
Long-term debt, non-current portion | $ | 132,654 |
| | $ | 93,376 |
|
(1) Outstanding debt owed to Silicon Valley Bank includes a final payment fee of $3.5 million and $1.2 million as of December 31, 2018 and June 30, 2018, respectively.
Redmile Notes Payable
On August 6, 2018, the Redmile Notes Payable matured and became payable pursuant to the Note Purchase Agreement dated September 2, 2016, as amended. On that date, we repaid $16.0 million to the Note holders, which included the $10.0 million principal, a $5.0 million exit fee and approximately $1.0 million accrued interest. Following the repayment of the Redmile Notes Payable, we had no notes payable recorded at fair value.
Silicon Valley Bank Term Loan
On August 10, 2018 (the “Amended Effective Date”), we entered into an Amended and Restated Loan and Security Agreement (the “Amended Loan Agreement”) with Silicon Valley Bank ("SVB") providing for a term loan in the original principal amount of $50.0 million and maintaining our existing letters of credit with SVB. The Amended Loan Agreement amends and restates our prior Loan and Security Agreement (the "Loan Agreement") with SVB. We utilized the proceeds from the term loan for repayment in full all outstanding obligations under our prior Loan Agreement with SVB, repayment in full of our obligations under the Redmile Notes Payable, and as working capital to fund general business requirements. The entire term loan amount was borrowed on the Amended Effective Date.
The outstanding principal amount under the term loan bears interest at a floating per annum rate equal to the Prime Rate minus 2.0% (but not less than 0.0%) and was 3.5% as of December 31, 2018. We must make monthly payments of interest under the term loan commencing with the first month after the Amended Effective Date until maturity and, commencing on September 1, 2020 and monthly thereafter, we must make payments of principal under the term loan based on a thirty-six-month amortization schedule. A final payment of principal, accrued interest on the term loan and on any outstanding advances, as well as the final payment fee associated with the Amended Loan Agreement of $3.5 million are due on the maturity date of August 1, 2023. The resulting debt discount is being recognized using the effective interest method over the term of the loan. In accordance with ASC 470-50, we accounted for the exchange as a debt modification and the issuance costs paid to SVB associated with the Amended Loan Agreement were recorded as debt discount and were added to the remaining unamortized debt discount associated with prior Loan Agreement.
We granted SVB a first priority security interest in all of our assets other than our intellectual property, provided that accounts and proceeds of our intellectual property constitutes collateral and we have agreed not to encumber our intellectual property without SVB’s consent. The Amended Loan Agreement contains customary covenants, including restrictions on changes in control of Array, the incurrence of additional indebtedness, future encumbrances on our assets, the payment of dividends or distributions on our common stock and the sale, lease, transfer or disposition of encorafenib and binimetinib outside of certain markets if our cash and cash equivalents maintained with SVB fall below certain levels. In addition, we must maintain a liquidity ratio, defined as (i) our unrestricted cash and cash equivalents divided by (ii) all of our outstanding obligations owed to SVB, of at least 2.00 to 1.00, measured monthly.
2.625% Convertible Senior Notes Due 2024
On December 1, 2017, we issued and sold $126.1 million aggregate principal amount of 2.625% convertible senior notes due 2024 (the "2024 Notes") in exchange for our now retired 2020 Notes. The 2024 Notes are our direct unsecured obligations and rank equal in right of payment with all of our other existing and future unsecured and unsubordinated indebtedness. The 2024 Notes are effectively subordinated to any of our existing and future secured indebtedness, including our indebtedness under the Amended Loan Agreement with SVB, to the extent of the value of our assets that secure such indebtedness.
The 2024 Notes will mature on December 1, 2024 and bear interest at a rate of 2.625%, payable semiannually in arrears on June 1 and December 1 of each year, beginning on June 1, 2018.
In accordance with ASC 470-20, we used an effective interest rate of 9.75% to determine the liability component of the 2024 Notes. This resulted in the recognition of $80.4 million as the liability component of the 2024 Notes and the recognition of the residual $45.7 million as the debt discount with a corresponding increase to additional paid-in capital for the equity component of the 2024 Notes. The underwriting discount and estimated offering expenses of $4.3 million were allocated between the debt and equity issuance costs in proportion to the allocation of the liability and equity components of the 2024 Notes. Equity issuance costs of $1.6 million were recorded as an offset to additional paid-in capital. Total debt issuance costs of $2.7 million were recorded on the issuance date and are reflected in our unaudited condensed consolidated balance sheets for all periods presented on a consistent basis with the debt discount, or as a direct deduction from the carrying value of the associated debt liability. The debt discount and debt issuance costs will be amortized as non-cash interest expense through December 1, 2024. The balance of unamortized debt issuance costs was $2.4 million and $2.6 million as of December 31, 2018 and June 30, 2018, respectively.
The fair value of the 2024 Notes was approximately $152.9 million and $169.0 million at December 31, 2018 and June 30, 2018, respectively, and was determined using Level 2 inputs based on their quoted market values.
Summary of Interest Expense
The following table shows the details of our interest expense for all of our debt arrangements outstanding during the periods presented, including contractual interest, and amortization of debt discount, debt issuance costs and loan transaction fees that were charged to interest expense (in thousands):
|
| | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| December 31, | | December 31, |
| 2018 | | 2017 | | 2018 | | 2017 |
Silicon Valley Bank Term Loan | | | | | | | |
Simple interest | 402 |
| | 87 |
| | $ | 685 |
| | $ | 180 |
|
Amortization of prepaid fees for line of credit | 260 |
| | 44 |
| | 430 |
| | 85 |
|
Amortization of debt discount | 14 |
| | 81 |
| | 29 |
| | 162 |
|
Total interest expense on the Silicon Valley Bank term loan | 676 |
| | 212 |
| | 1,144 |
| | 427 |
|
Convertible Senior Notes (1) | | | | | | | |
Contractual interest | 835 |
| | 896 |
| | 1,670 |
| | 1,889 |
|
Amortization of debt discount | 1,227 |
| | 1,512 |
| | 2,425 |
| | 3,291 |
|
Amortization of debt issuance costs | 74 |
| | 87 |
| | 147 |
| | 187 |
|
Total interest expense on convertible senior notes | 2,136 |
| | 2,495 |
| | 4,242 |
| | 5,367 |
|
Other Debt | | | | | | | |
Simple interest | $ | 6 |
| | $ | 126 |
| | 12 |
| | 252 |
|
Total interest expense on other debt | 6 |
| | 126 |
| | 12 |
| | 252 |
|
Total interest expense | $ | 2,818 |
| | $ | 2,833 |
| | $ | 5,398 |
| | $ | 6,046 |
|
(1) Includes the 2024 Notes and 2020 Notes (retired)
NOTE 6 – FAIR VALUE MEASUREMENTS
We use the following three-level hierarchy that maximizes the use of observable inputs and minimizes the use of unobservable inputs to value our financial instruments:
| |
• | Level 1: Observable inputs such as unadjusted quoted prices in active markets for identical instruments. |
| |
• | Level 2: Quoted prices for similar instruments that are directly or indirectly observable in the marketplace. |
| |
• | Level 3: Significant unobservable inputs which are supported by little or no market activity and that are financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. |
Financial instruments measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. Our assessment of the significance of a particular input to the fair value measurement in its entirety requires us to make judgments and consider factors specific to the asset or liability. The use of different assumptions and/or estimation methodologies may have a material effect on estimated fair values. Accordingly, the fair value estimates disclosed or initial amounts recorded may not be indicative of the amount that we or holders of the instruments could realize in a current market exchange.
The following tables show the fair value of our financial instruments classified into the fair value hierarchy and measured on a recurring basis on the unaudited condensed consolidated balance sheets as of December 31, 2018 and June 30, 2018 (in thousands):
|
| | | | | | | | | | | | | | | | |
| | Fair Value Measurement as of December 31, 2018 |
| | Level 1 | | Level 2 | | Level 3 | | Total |
Assets | | | | | | | | |
Current Assets | | | | | | | | |
U.S. treasury securities | | $ | — |
| | $ | 198,664 |
| | $ | — |
| | $ | 198,664 |
|
Commercial paper | | — |
| | 101,533 |
| | — |
| | 101,533 |
|
Corporate bonds | | — |
| | 19,897 |
| | — |
| | 19,897 |
|
Asset-backed securities | | — |
| | 9,653 |
| | — |
| | 9,653 |
|
Mutual fund securities | | 217 |
| | — |
| | — |
| | 217 |
|
Long-term Assets | | | | | | | | |
Mutual fund securities | | 1,095 |
| | — |
| | — |
| | 1,095 |
|
Total assets | | $ | 1,312 |
| | $ | 329,747 |
| | $ | — |
| | $ | 331,059 |
|
|
| | | | | | | | | | | | | | | | |
| | Fair Value Measurement as of June 30, 2018 |
| | Level 1 | | Level 2 | | Level 3 | | Total |
Assets | | | | | | | | |
Current Assets | | | | | | | | |
U.S. treasury securities | | $ | 297,504 |
| | $ | — |
| | $ | — |
| | $ | 297,504 |
|
Mutual fund securities | | 235 |
| |
|
| | — |
| | 235 |
|
Long-term Assets | | | | | | | | |
Mutual fund securities | | 919 |
| | — |
| | — |
| | 919 |
|
Total assets | | $ | 298,658 |
| | $ | — |
| | $ | — |
| | $ | 298,658 |
|
| | | | | | | | |
Liabilities | | |
| | |
| | |
| | |
|
Notes payable, at fair value | | $ | — |
| | $ | — |
| | $ | 15,899 |
| | $ | 15,899 |
|
Our debt-based marketable securities are classified as level 2 within the valuation hierarchy. We estimate the fair values of these marketable securities by taking into consideration valuations obtained from third-party pricing sources. These pricing sources utilize industry standard valuation models, including both income and market-based
approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. During the three months ended December 31, 2018, we diversified our investment portfolio and are classifying our investments in debt securities, including U.S. treasury securities, as Level 2 securities.
The table below provides a rollforward of the changes in fair value of Level 3 financial instruments for the three and six months ended December 31, 2018, comprised of the Redmile Notes (in thousands):
|
| | | | | | | | | | | | | | | | |
| | Three Months Ended December 31, | | Six Months Ended December 31, |
| | 2018 | | 2017 | | 2018 | | 2017 |
Beginning balance | | $ | — |
| | $ | 12,400 |
| | $ | 15,899 |
| | $ | 12,600 |
|
Change in fair value | | — |
| | 300 |
| | 65 |
| | 100 |
|
Settlement upon maturity | | — |
| | | | (15,964 | ) | | — |
|
Ending balance | | $ | — |
| | $ | 12,700 |
| | $ | — |
| | $ | 12,700 |
|
NOTE 7 – STOCKHOLDERS’ EQUITY
Common Stock Offering
On September 19, 2017, the Company closed an underwritten public offering of 24.1 million shares of its common stock, which included 3.1 million shares of common stock issued upon the exercise in full of the option to purchase additional shares granted to the underwriters in the offering. The shares were sold to the public at an offering price of $10.75 per share. The total net proceeds from the offering were $243.0 million, after underwriting discounts and commissions and offering expenses of approximately $15.7 million. The Company expects to continue to use the net proceeds from this offering to fund research and development efforts, including clinical trials for its proprietary candidates, build and scale its commercial capabilities, and for general working capital and corporate purposes.
At-the-Market Equity Offering
We entered into a sales agreement with Cantor Fitzgerald & Co. ("Cantor") dated March 27, 2013, which has been subsequently amended to permit Cantor, acting as our sales agent, to sell shares of our common stock from time to time in an at-the-market offering ("ATM Offering"). All sales of shares have been made pursuant to an effective shelf registration statement on Form S-3 filed with the SEC.
On May 9, 2018, we entered into our current sales agreement with Cantor (the "Sales Agreement"), pursuant to which we may, from time to time, sell up to $125.0 million in shares of our common stock through Cantor, acting as our sales agent and/or principal, in an ATM Offering. We are not required to sell shares under the Sales Agreement. We will pay Cantor a commission of up to 3% of the aggregate gross proceeds we receive from all sales of our common stock under the Sales Agreement. Unless otherwise terminated, the Sales Agreement continues until the earlier of selling all shares available under the Sales Agreement or May 9, 2021. We received net proceeds on sales under the Sales Agreement of approximately $88.8 million at a weighted average price of $16.03 (excluding commissions) during the six months ended December 31, 2018. We received net proceeds on sales under our prior sales agreement with Cantor of approximately $2.8 million at a weighted average price of $9.02 during the six months ended December 31, 2017.
NOTE 8 – SHARE-BASED COMPENSATION
Share-based compensation expense for all equity awards issued pursuant to the Array BioPharma Amended and Restated Stock Option and Incentive Plan (the "Option and Incentive Plan") and for estimated shares to be issued under the Employee Stock Purchase Plan ("ESPP") for the current purchase period was approximately $5.5 million and $3.2 million for the three months ended December 31, 2018 and 2017, respectively, and $10.3 million and $8.8 million for the six months ended December 31, 2018 and 2017, respectively.
We use the Black-Scholes option pricing model to estimate the fair value of our share-based awards. In applying this model, we use the following assumptions:
| |
• | Risk-free interest rate - We determine the risk-free interest rate by using a weighted average assumption equivalent to the expected term based on the U.S. Treasury constant maturity rate. |
| |
• | Expected term - We estimate the expected term of our options based upon historical exercises and post-vesting termination behavior. |
| |
• | Expected volatility - We estimate expected volatility using daily historical trading data of our common stock. |
| |
• | Dividend yield - We have never paid dividends and currently have no plans to do so; therefore, no dividend yield is applied. |
Option Awards
The fair values of our employee option awards were estimated using the assumptions below, which yielded the following weighted average grant date fair values for the periods presented:
|
| | | |
| Six Months Ended December 31, 2018 |
| 2018 | | 2017 |
Risk-free interest rate | 2.7% - 3.0% | | 1.6% - 2.0% |
Expected option term in years | 3.8 - 5.1 | | 3.9 - 4.1 |
Expected volatility | 63.5% - 67.0% | | 66.1% - 67.0% |
Dividend yield | 0% | | 0% |
Weighted average grant date fair value | $8.95 | | $5.37 |
The following table summarizes our stock option activity under the Option and Incentive Plan for the six months ended December 31, 2018:
|
| | | | | | | | | | | | |
| Number of Options | | Weighted Average Exercise Price | | Weighted Average Remaining Contractual Term (in years) | | Aggregate Intrinsic Value (in thousands) |
Outstanding balance at June 30, 2018 | 15,326,350 |
| | $ | 7.68 |
| | | | |
Granted | 4,358,163 |
| | $ | 15.91 |
| | | | |
Exercised | (702,102 | ) | | $ | 5.14 |
| | | | |
Forfeited | (309,347 | ) | | $ | 9.77 |
| | | | |
Expired | (6,000 | ) | | $ | 6.22 |
| | | | |
Outstanding balance at December 31, 2018 | 18,667,064 |
| | $ | 9.66 |
| | 7.9 | | $ | 94,649 |
|
Vested and expected to vest at December 31, 2018 | 18,644,842 |
| | $ | 9.66 |
| | 7.9 | | $ | 94,477 |
|
Exercisable at December 31, 2018 | 7,153,673 |
| | $ | 6.08 |
| | 6.2 | | $ | 58,480 |
|
The aggregate intrinsic value in the above table is calculated as the difference between the closing price of our common stock at December 31, 2018, of $14.25 per share and the exercise price of the stock options that had strike prices below the closing price. The total intrinsic value of all options exercised was $7.6 million during the six months ended December 31, 2018. The total intrinsic value of all options exercised during the six months ended December 31, 2017 was $14.8 million. The grant date fair value of options that vested during the six months ended December 31, 2018 and 2017 was $9.3 million and $6.1 million, respectively.
As of December 31, 2018, we had approximately $68.3 million of total unrecognized compensation expense related to the unvested stock options shown in the table above, which is expected to be recognized over a weighted average period of 3.3 years.
Restricted Stock Units
The Option and Incentive Plan provides for the issuance of restricted stock units ("RSUs") that each represent the right to receive one share of our common stock, cash or a combination of cash and stock, typically following achievement of time- or performance-based vesting conditions. Our RSU grants that vest subject to continued service over a defined period of time, will typically vest between one to four years, with a percentage vesting on each anniversary date of the grant, or they may be vested in full on the date of grant. Vested RSUs will be settled in shares of common stock upon the vesting date, upon a predetermined delivery date, upon a change in control of Array, or upon the employee leaving Array. All outstanding RSUs may only be settled through the issuance of common stock to recipients and we intend to continue to grant RSUs that may only be settled in stock. RSUs are assigned the value of our common stock at date of grant, and the grant date fair value is amortized over the applicable vesting period.
The following table summarizes the status of our unvested RSUs under the Option and Incentive Plan as of December 31, 2018 and changes during the six months ended December 31, 2018:
|
| | | | | | |
| Number of RSUs | | Weighted Average Grant Date Fair Value |
Unvested at June 30, 2018 | 959,730 |
| | $ | 9.28 |
|
Granted | 617,518 |
| | 15.87 |
|
Vested | (224,294 | ) | | 9.98 |
|
Forfeited | (21,084 | ) | | 9.51 |
|
Unvested at December 31, 2018 | 1,331,870 |
| | $ | 12.21 |
|
As of December 31, 2018, we had $15.1 million of total unrecognized compensation cost related to unvested RSUs granted under the Option and Incentive Plan. The cost is expected to be recognized over a weighted-average period of approximately 3.3 years. The fair market value for RSUs that vested during the six months ended December 31, 2018 and 2017 was $2.2 million and $1.8 million, respectively. RSUs granted during the six months ended December 31, 2018 and 2017 had a fair value of $9.8 million and $5.3 million, respectively.
Employee Stock Purchase Plan
The ESPP allows qualified employees (as defined in the ESPP) to purchase shares of our common stock at a price equal to 85% of the lower of (i) the closing price at the beginning of the offering period or (ii) the closing price at the end of the offering period. Effective each January 1, a new 12-month offering period begins that will end on December 31 of that year. However, if the closing stock price on July 1 is lower than the closing stock price on the preceding January 1, then the original 12-month offering period terminates, and the purchase rights under the original offering period roll forward into a new six-month offering period that begins July 1 and ends on December 31. As of December 31, 2018, we had 0.9 million shares available for issuance under the ESPP, of which 0.2 million shares were subsequently issued in January 2019 in accordance with the 2018 ESPP purchase.
NOTE 9 - RELATED PARTY TRANSACTIONS
We are party to Drug Discovery Collaboration Option Agreements, as amended, with Mirati pursuant to which we provide certain drug discovery and research activities to Mirati from which we have received upfront payments, license fees, milestone payments and reimbursement for research and development services and under which we are entitled to receive additional milestone payments based on achievement of certain milestones, as described in Note 4 - Collaboration and Other Agreements. Dr. Charles Baum, a current member of our Board of Directors, is the President and Chief Executive Officer of Mirati.
We are also a party to a Master Collaboration Agreement with ArcherDX for project-specific collaborations in the field of development and commercialization of in vitro diagnostics and companion diagnostics for Array Compounds. Pursuant to this agreement, we will make future payments to ArcherDX for contract milestones, ongoing costs and pass-through expenses for project work plans. Kyle Lefkoff, a current member of our Board of Directors, is also a Director of ArcherDX. We have not yet made any payments to ArcherDX.
NOTE 10 - NET LOSS PER SHARE
Basic and diluted loss per common share are computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted loss per share includes the determinants of basic net income per share and, in addition, gives effect to the potential dilution that would occur if securities or other contracts to issue common stock were exercised, vested or converted into common stock, unless they are anti-dilutive.
The following table summarizes the net loss per share calculation (in thousands, except per share amount):
|
| | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| December 31, | | December 31, |
| 2018 | | 2017 | | 2018 | | 2017 |
Net loss - basic and diluted | $ | (11,362 | ) | | $ | (34,053 | ) | | $ | (36,173 | ) | | $ | (72,047 | ) |
| | | | | | | |
Weighted average shares outstanding - basic and diluted | 215,872 |
| | 199,852 |
| | 214,032 |
| | 187,312 |
|
| | | | | | | |
Per share data: | | | | | | | |
Basic and diluted | $ | (0.05 | ) | | $ | (0.17 | ) | | $ | (0.17 | ) | | $ | (0.38 | ) |
For the periods presented, all common stock equivalents are excluded from the computation of diluted loss per share, as the result would be anti-dilutive. Common stock equivalents are not included in the calculations of diluted loss per share because to do so would have been anti-dilutive, include the following (amounts in thousands):
|
| | | | | |
| December 31, |
| 2018 | | 2017 |
2.625% convertible senior notes | 8,156 |
| | 8,156 |
|
Stock options | 18,667 |
| | 14,910 |
|
Unvested RSUs | 1,332 |
| | 1,245 |
|
Total anti-dilutive common stock equivalents excluded from diluted loss per share calculation | 28,155 |
| | 24,311 |
|
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management’s Discussion and Analysis of Financial Condition and Results of Operations contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by the use of terms such as "may", "will", "expects", "intends", "plans", "anticipates", "estimates", "potential", or "continue", or the negative thereof or other comparable terms. These statements are based on current expectations, projections and assumptions made by management and are not guarantees of future performance. Although we believe that the expectations reflected in the forward-looking statements contained herein are reasonable, these expectations or any of the forward-looking statements could prove to be incorrect and actual results could differ materially from those projected or assumed in the forward-looking statements. Our future financial condition, as well as any forward-looking statements are subject to significant risks and uncertainties including, but not limited to the factors set forth under the heading “Item 1A." Risk Factors” under Part II of this Quarterly Report on Form 10-Q and under "Forward Looking Statements" and "Item 1A. Risk Factors" under Part I of our Annual Report on Form 10-K for the fiscal year ended June 30, 2018, and in other reports we file with the SEC. All forward-looking statements are made as of the date of this report and, unless required by law, we undertake no obligation to update any forward-looking statements.
The following discussion of our financial condition and results of operations should be read in conjunction with our unaudited condensed consolidated financial statements and related notes to those statements included elsewhere in this Quarterly Report on Form 10-Q, our audited consolidated financial statements and related notes to those statements included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2018, and with the information under the heading "Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the fiscal year ended June 30, 2018. The terms “we”, “us”, “our”, "the Company", or "Array" refer to Array BioPharma Inc.
Our fiscal year ends on June 30. When we refer to a fiscal year or quarter, we are referring to the year in which the fiscal year ends and the quarters during that fiscal year. Therefore, fiscal 2019 refers to the fiscal year ending June 30, 2019, and the second or current quarter refers to the three months ended December 31, 2018.
Overview
We are a fully-integrated, biopharmaceutical company focused on the discovery, development and commercialization of transformative and well-tolerated targeted small molecule drugs to treat patients afflicted with cancer and other high-burden diseases. We market BRAFTOVI® (encorafenib) capsules in combination with MEKTOVI® (binimetinib) tablets for the treatment of patients with unresectable or metastatic melanoma with a BRAFV600E or BRAFV600K mutation in the United States ("US") and with partners in other major worldwide markets. Our lead clinical programs, encorafenib and binimetinib, are being investigated in over 30 clinical trials across a number of solid tumor indications, including a Phase 3 trial in BRAF-mutant metastatic colorectal cancer ("CRC"). Our pipeline includes several additional programs being advanced by us or current license-holders, including the following programs currently in registration trials: selumetinib (partnered with AstraZeneca), LOXO-292 (partnered with Loxo Oncology), ipatasertib (partnered with Genentech), tucatinib (partnered with Seattle Genetics) and ARRY-797. Vitrakvi® (larotrectinib, partnered with Loxo Oncology) is approved in the United States and Ganovo® (danoprevir, partnered with Roche and licensed by Roche to Ascletis Pharmaceuticals Co., Ltd. in China) is approved in China .
Our most significant approved and clinical stage drugs include:
|
| | | | | | | |
| Drug Candidate | | Target/Disease State | | Partner | | Clinical Status |
| BRAFTOVI + MEKTOVI | | BRAF and MEK inhibitors for advanced BRAF-mutant melanoma
| | Pierre Fabre Medicament SAS and Ono Pharmaceutical Co., Ltd. | | Approved |
| Encorafenib
| | BRAF inhibitor for BRAF-mutant CRC | | Pierre Fabre Medicament SAS and Ono Pharmaceutical Co., Ltd. | | Phase 3 |
| Binimetinib
| | MEK inhibitor for BRAF-mutant CRC and other cancers | | Pierre Fabre Medicament SAS and Ono Pharmaceutical Co., Ltd. | | Phase 3 |
| Vitrakvi / Larotrectinib (1)(2) | | PanTrk inhibitor for cancer | | Loxo Oncology, Inc. | | Approved |
| Ganovo / Danoprevir (1) | | Protease inhibitor for Hepatitis C virus | | Roche Holding AG | | Approved (3) |
| Selumetinib (1) | | MEK inhibitor for NF1 (4) | | AstraZeneca, PLC | | Phase 2 / Registration Trial |
| Tucatinib / ONT-380 (1) | | HER2 inhibitor for breast cancer | | Seattle Genetics, Inc. | | Phase 2 / Registration Trial |
| | | | | | | |
| Ipatasertib / GDC-0068 (1) | | AKT inhibitor for cancer | | Genentech, Inc. | | Phase 3 |
| Varlitinib / ASLAN001 (1) | | Pan-HER2 inhibitor for cancer | | ASLAN Pharmaceuticals Pte Ltd. | | Phase 2 / 3 |
| ARRY-797 | | p38 inhibitor for Lamin A/C-related dilated cardiomyopathy | | Wholly-owned by Array | | Phase 3 |
| | | | | | | |
| LOXO-292 (1) | | Ret inhibitor for cancer | | Loxo Oncology, Inc. | | Phase 2 / Registration Trial |
| ARRY-382 | | CSF1R inhibitor for cancer | | Wholly-owned by Array | | Phase 2 |
| Motolimod / VTX-2337 (1) | | Toll-like receptor for cancer | | Celgene Corp. / VentiRx Pharmaceuticals, Inc. | | Phase 2 |
| Prexasertib / LY2606368 (1) | | CHK-1 inhibitor for cancer | | Eli Lilly and Company | | Phase 2 |
| LOXO-195 (1) | | Trk inhibitor for cancer | | |