SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 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: 000-29089
Agenus Inc.
(exact name of registrant as specified in its charter)
Delaware |
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06-1562417 |
(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
3 Forbes Road, Lexington, Massachusetts 02421
(Address of principal executive offices, including zip code)
Registrant’s telephone number, including area code:
(781) 674-4400
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 ☒ 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 ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 |
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☐ |
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Accelerated filer |
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☒ |
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Non-accelerated filer |
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☐ |
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Smaller reporting company |
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☐ |
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Emerging growth company |
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☐ |
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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 ☒
Number of shares outstanding of the issuer’s Common Stock as of November 2, 2018: 119,982,965 shares
Nine Months Ended September 30, 2018
Table of Contents
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Page |
PART I |
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ITEM 1. |
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2 |
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Condensed Consolidated Balance Sheets as of September 30, 2018 (Unaudited) and December 31, 2017 |
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2 |
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3 |
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4 |
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Notes to Unaudited Condensed Consolidated Financial Statements |
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5 |
ITEM 2. |
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Management's Discussion and Analysis of Financial Condition and Results of Operations |
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23 |
ITEM 3. |
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28 |
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ITEM 4. |
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29 |
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PART II |
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ITEM 1A. |
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30 |
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ITEM 6. |
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53 |
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54 |
PART I - FINANCIAL INFORMATION
AGENUS INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
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September 30, 2018 |
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December 31, 2017 |
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ASSETS |
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Cash and cash equivalents |
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$ |
46,169,404 |
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$ |
60,186,617 |
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Inventories |
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55,491 |
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79,491 |
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Accounts receivable |
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6,068,854 |
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1,134,493 |
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Prepaid expenses |
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14,530,053 |
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11,070,960 |
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Other current assets |
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811,925 |
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1,081,993 |
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Total current assets |
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67,635,727 |
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73,553,554 |
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Property, plant and equipment, net of accumulated amortization and depreciation of $37,108,300 and $34,029,085 at September 30, 2018 and December 31, 2017, respectively |
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25,838,782 |
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26,178,622 |
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Goodwill |
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22,959,112 |
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23,048,804 |
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Acquired intangible assets, net of accumulated amortization of $6,998,903 and $5,461,834 at September 30, 2018 and December 31, 2017, respectively |
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12,827,224 |
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14,406,650 |
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Other long-term assets |
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1,214,394 |
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1,214,394 |
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Total assets |
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$ |
130,475,239 |
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$ |
138,402,024 |
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LIABILITIES AND STOCKHOLDERS’ DEFICIT |
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Current portion, long-term debt |
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$ |
146,061 |
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$ |
20,639,735 |
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Current portion, liability related to sale of future royalties and milestones |
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23,920,667 |
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— |
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Current portion, deferred revenue |
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843,150 |
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4,484,882 |
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Accounts payable |
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11,146,451 |
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8,086,992 |
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Accrued liabilities |
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21,665,078 |
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21,569,449 |
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Other current liabilities |
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468,978 |
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1,657,063 |
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Total current liabilities |
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58,190,385 |
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56,438,121 |
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Long-term debt, net of current portion |
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13,053,895 |
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142,385,024 |
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Liability related to sale of future royalties and milestones, net of current portion |
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183,322,966 |
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— |
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Deferred revenue, net of current portion |
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1,469,131 |
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7,748,284 |
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Contingent purchase price considerations |
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2,917,000 |
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4,373,000 |
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Other long-term liabilities |
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2,914,480 |
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3,273,387 |
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Commitments and contingencies |
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STOCKHOLDERS’ DEFICIT |
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Preferred stock, par value $0.01 per share; 5,000,000 shares authorized: |
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Series A-1 convertible preferred stock; 31,620 shares designated, issued, and outstanding at September 30, 2018 and December 31, 2017; liquidation value of $32,780,230 at September 30, 2018 |
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316 |
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316 |
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Common stock, par value $0.01 per share; 240,000,000 shares authorized; 118,352,706 and 101,706,117 shares issued at September 30, 2018 and December 31, 2017, respectively |
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1,183,527 |
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1,017,061 |
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Additional paid-in capital |
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999,580,589 |
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951,811,958 |
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Accumulated other comprehensive loss |
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(1,615,893 |
) |
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(2,169,354 |
) |
Accumulated deficit |
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(1,129,556,515 |
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(1,026,475,773 |
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Total stockholders’ deficit attributable to Agenus Inc. |
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(130,407,976 |
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(75,815,792 |
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Non-controlling interest |
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(984,642 |
) |
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— |
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Total stockholders’ deficit |
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(131,392,618 |
) |
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(75,815,792 |
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Total liabilities and stockholders’ deficit |
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$ |
130,475,239 |
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$ |
138,402,024 |
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See accompanying notes to unaudited condensed consolidated financial statements.
2
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2018 |
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2017 |
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2018 |
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2017 |
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Revenue: |
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Research and development |
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$ |
6,276,136 |
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$ |
3,359,399 |
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$ |
18,385,111 |
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$ |
34,522,815 |
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Non-cash royalty revenue related to the sale of future royalties |
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6,526,291 |
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— |
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11,947,982 |
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— |
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Total revenues |
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12,802,427 |
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3,359,399 |
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30,333,093 |
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34,522,815 |
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Operating expenses: |
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Research and development |
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(29,854,310 |
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(25,788,707 |
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(88,569,123 |
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(84,253,129 |
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General and administrative |
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(9,203,406 |
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(8,050,783 |
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(27,616,079 |
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(23,956,543 |
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Contingent purchase price consideration fair value adjustment |
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180,000 |
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(1,184,000 |
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1,456,000 |
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(123,000 |
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Operating loss |
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(26,075,289 |
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(31,664,091 |
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(84,396,109 |
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(73,809,857 |
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Other expense: |
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Loss on early extinguishment of debt |
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— |
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— |
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(10,766,625 |
) |
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— |
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Non-operating (expense) income |
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(117,172 |
) |
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(472,745 |
) |
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(1,489,835 |
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1,917,200 |
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Interest expense, net |
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(7,538,096 |
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(4,704,871 |
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(16,542,911 |
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(13,765,271 |
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Net loss |
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(33,730,557 |
) |
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(36,841,707 |
) |
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(113,195,480 |
) |
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(85,657,928 |
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Dividends on Series A-1 convertible preferred stock |
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(51,752 |
) |
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(51,426 |
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(155,011 |
) |
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(154,034 |
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Less: net loss attributable to non-controlling interest |
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(604,887 |
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— |
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(1,258,242 |
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— |
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Net loss attributable to Agenus Inc. common stockholders |
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$ |
(33,177,422 |
) |
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$ |
(36,893,133 |
) |
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$ |
(112,092,249 |
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$ |
(85,811,962 |
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Per common share data: |
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Basic and diluted net loss attributable to Agenus Inc. common stockholders |
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$ |
(0.29 |
) |
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$ |
(0.37 |
) |
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$ |
(1.04 |
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$ |
(0.88 |
) |
Weighted average number of Agenus Inc. common shares outstanding: |
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Basic and diluted |
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114,977,416 |
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99,891,980 |
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107,601,000 |
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97,557,409 |
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Other comprehensive loss: |
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Foreign currency translation (loss) gain |
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$ |
(38,276 |
) |
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$ |
231,177 |
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$ |
553,461 |
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$ |
(529,118 |
) |
Other comprehensive (loss) income |
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(38,276 |
) |
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231,177 |
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553,461 |
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(529,118 |
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Comprehensive loss |
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$ |
(33,215,698 |
) |
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$ |
(36,661,956 |
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$ |
(111,538,788 |
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$ |
(86,341,080 |
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See accompanying notes to unaudited condensed consolidated financial statements.
3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
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Nine Months Ended September 30, |
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2018 |
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2017 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(113,195,480 |
) |
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$ |
(85,657,928 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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4,744,672 |
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4,561,815 |
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Share-based compensation |
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5,694,829 |
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7,083,948 |
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Non-cash royalty revenue |
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(11,947,982 |
) |
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— |
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Non-cash interest expense |
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16,063,404 |
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13,360,630 |
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Loss (gain) on disposal of assets |
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117,817 |
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(19,822 |
) |
Gain on issuance of stock for settlement of milestone obligation |
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— |
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(14,063 |
) |
Change in fair value of contingent obligations |
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(1,456,000 |
) |
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123,000 |
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Loss on extinguishment of debt |
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10,766,625 |
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— |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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(4,934,361 |
) |
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9,160,979 |
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Inventories |
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24,000 |
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|
7,959 |
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Prepaid expenses |
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(3,469,828 |
) |
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(8,178,360 |
) |
Accounts payable |
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2,882,184 |
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1,006,808 |
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Deferred revenue |
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(1,064,391 |
) |
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(2,006,858 |
) |
Accrued liabilities and other current liabilities |
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222,462 |
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(5,962,198 |
) |
Other operating assets and liabilities |
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269,216 |
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(1,823,880 |
) |
Net cash used in operating activities |
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(95,282,833 |
) |
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(68,357,970 |
) |
Cash flows from investing activities: |
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Proceeds from sale of plant and equipment |
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6,187 |
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120,000 |
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Purchases of plant and equipment |
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(2,995,572 |
) |
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(2,366,429 |
) |
Purchases of held-to-maturity securities |
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— |
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(14,936,047 |
) |
Proceeds from securities held-to-maturity |
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— |
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15,000,000 |
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Net cash used in investing activities |
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(2,989,385 |
) |
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(2,182,476 |
) |
Cash flows from financing activities: |
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Net proceeds from sale of equity |
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41,279,969 |
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63,677,302 |
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Proceeds from employee stock purchases and option exercises |
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1,233,900 |
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|
833,982 |
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Purchase of treasury shares to satisfy tax withholdings |
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— |
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(527,223 |
) |
Proceeds from sale of future royalties |
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204,878,400 |
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— |
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Transaction costs from sale of future royalties and milestones |
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(494,394 |
) |
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— |
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Repayments of debt |
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(161,847,220 |
) |
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— |
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Payment of capital lease obligation |
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(193,164 |
) |
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(216,982 |
) |
Net cash provided by financing activities |
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84,857,491 |
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63,767,079 |
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Effect of exchange rate changes on cash |
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(602,486 |
) |
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|
400,708 |
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Net (decrease) increase in cash and cash equivalents |
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(14,017,213 |
) |
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(6,372,659 |
) |
Cash and cash equivalents, beginning of period |
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60,186,617 |
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|
71,448,016 |
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Cash and cash equivalents, end of period |
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$ |
46,169,404 |
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$ |
65,075,357 |
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Supplemental cash flow information: |
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Cash paid for interest |
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$ |
837,699 |
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$ |
837,699 |
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Supplemental disclosures - non-cash activities: |
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Purchases of plant and equipment in accounts payable and accrued liabilities |
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122,038 |
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|
222,203 |
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Issuance of common stock, $0.01 par value, issued in connection with the settlement of milestone obligation |
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— |
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|
1,485,937 |
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See accompanying notes to unaudited condensed consolidated financial statements.
4
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2018
Note A - Business, Liquidity and Basis of Presentation
Agenus Inc. (including its subsidiaries, collectively referred to as “Agenus,” the “Company,” “we,” “us,” and “our”) is a clinical-stage immuno-oncology (“I-O”) company dedicated to becoming a leader in the discovery and development of innovative combination therapies and committed to bringing effective medicines to patients with cancer. Our business is designed to drive success in I-O through speed, innovation, and effective combination therapies. We have assembled fully integrated capabilities from novel target discovery, antibody generation, cell line development, and good manufacturing practice (“GMP”) manufacturing together with a comprehensive portfolio consisting of antibody-based therapeutics, adjuvants, cancer vaccine platforms, and cell therapy (through our subsidiary, AgenTus Therapeutics, Inc. (“AgenTus Therapeutics”)). We leverage our immune biology platforms to identify effective combination therapies for development and have developed productive partnerships to advance our innovation.
We are developing a comprehensive I-O portfolio driven by the following platforms and programs, which we intend to utilize individually and in combination:
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• |
our antibody discovery platforms, including our Retrocyte Display™, SECANT® yeast display, and phage display technologies designed to drive the discovery of future CPM antibody candidates; |
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• |
our antibody candidate programs, including our CPM programs; |
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• |
our vaccine programs, including Prophage™, AutoSynVax™ and PhosPhoSynVax ™; |
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• |
our saponin-based vaccine adjuvants, principally our QS-21 Stimulon® adjuvant, or QS-21 Stimulon; and |
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• |
our cell therapy subsidiary, AgenTus Therapeutics, which is designed to drive the discovery of future adoptive cell therapy, or “living drugs” (CAR-T and TCR) programs. |
Our business activities include product research and development, intellectual property prosecution, manufacturing, regulatory and clinical affairs, corporate finance and development activities, and support of our collaborations. Our product candidates require clinical trials and approvals from regulatory agencies, as well as acceptance in the marketplace. Part of our strategy is to develop and commercialize some of our product candidates by continuing our existing arrangements with academic and corporate collaborators and licensees and by entering into new collaborations.
Our cash and cash equivalents at September 30, 2018 were $46.2 million, a decrease of $14.0 million from December 31, 2017.
The following table outlines our quarter end cash and cash equivalents balances and the changes therein (in millions).
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Quarter Ended |
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|
|
March 31, 2018 |
|
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June 30, 2018 |
|
|
September 30, 2018 |
|
|||
Cash and cash equivalents |
|
$ |
52.3 |
|
|
$ |
43.2 |
|
|
$ |
46.2 |
|
(Decrease) increase in cash and cash equivalents |
|
$ |
(7.8 |
) |
|
$ |
(9.2 |
) |
|
$ |
3.0 |
|
Cash used in operating activities |
|
$ |
(40.2 |
) |
|
$ |
(30.5 |
) |
|
$ |
(24.6 |
) |
Reported net loss |
|
$ |
(54.3 |
) |
|
$ |
(25.2 |
) |
|
$ |
(33.7 |
) |
We have incurred significant losses since our inception. As of September 30, 2018, we had an accumulated deficit of $1.1 billion. Since our inception, we have successfully financed our operations through the sale of equity, notes, corporate partnerships, and interest income. Based on our current plans, including the additional funding we received during October 2018 (see Note O), and funding we anticipate from other sources, including out-licensing and/or partnering opportunities, we believe that our cash resources of $46.2 million as of September 30, 2018 will be sufficient to satisfy our liquidity requirements into the second quarter of 2019. We also continue to monitor the likelihood of success of our key initiatives and can discontinue funding of such activities if they do not prove to be successful, restrict capital expenditures and/or reduce the scale of our operations if necessary. In spite of these anticipated sources of funding and our ability to control our cash burn, in accordance with the requirements of ASU 2014-15, we are required to disclose the existence of a substantial doubt regarding our ability to continue as a going concern for twelve months from when these financial statements were issued.
Our future liquidity needs will be determined primarily by the success of our operations with respect to the progression of our product candidates and key development and regulatory events in the future. Potential sources of additional funding include: (1) pursuing collaboration, out-licensing and/or partnering opportunities for our portfolio programs and product candidates with one or more third parties, (2) renegotiating third party agreements, (3) selling assets, (4) securing additional debt financing and/or (5) selling
5
equity securities. We believe the execution of one or more of these transactions will enable us to fund our planned operations for at least one year from when these financial statements were issued. Our ability to address our liquidity needs will largely be determined by the success of our product candidates and key development and regulatory events and our decisions in the future as well as the execution of one or more of the aforementioned contemplated transactions.
The accompanying unaudited interim condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions to Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete annual consolidated financial statements. In the opinion of our management, the condensed consolidated financial statements include all normal and recurring adjustments considered necessary for a fair presentation of our financial position and operating results. All significant intercompany transactions and accounts have been eliminated in consolidation. Operating results for the nine months ended September 30, 2018, are not necessarily indicative of the results that may be expected for the year ending December 31, 2018. For further information, refer to our consolidated financial statements and footnotes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2017 filed with the Securities and Exchange Commission (the “SEC”) on March 16, 2018.
The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Management bases its estimates on historical experience and on various assumptions that are believed to be reasonable under the circumstances. Actual results could differ materially from those estimates.
For our foreign subsidiaries the local currency is the functional currency. Assets and liabilities of our foreign subsidiaries are translated into U.S. dollars using rates in effect at the balance sheet date while revenues and expenses are translated into U.S. dollars using average exchange rates during the period. The cumulative translation adjustment resulting from changes in exchange rates are included in the consolidated balance sheets as a component of accumulated other comprehensive loss in total stockholders’ deficit.
Note B - Summary of Significant Accounting Policies
Except as detailed below, there have been no material changes to our significant accounting policies during the nine months ended September 30, 2018, as compared to the significant accounting policies disclosed in Note 2 of the Consolidated Financial Statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.
Revenue
In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes existing revenue recognition guidance. We adopted ASU 2014-09 and its related amendments (collectively known as “ASC 606”) on January 1, 2018 using the modified retrospective method- i.e., by recognizing the cumulative effect of initially applying ASC 606 as an adjustment to the opening balance of equity at January 1, 2018. The reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition (“ASC 605”). The adoption of ASC 606 represents a change in accounting principle that will more closely align revenue recognition with the delivery of our goods and services and will provide financial statement readers with enhanced disclosures. The details of the significant changes and quantitative impact of the changes are disclosed in Note J.
In accordance with ASC 606, revenue is recognized when a customer obtains control of promised goods or services. The amount of revenue recognized reflects the consideration to which we expect to be entitled to receive in exchange for these goods and services. To achieve this core principle, we apply the following five steps:
1) Identify the contract with the customer
A contract with a customer exists when (i) the Company enters into an enforceable contract with a customer that defines each party’s rights regarding the goods or services to be transferred and identifies the related payment terms, (ii) the contract has commercial substance, and (iii) the Company determines that collection of substantially all consideration for goods and services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration. The Company applies judgment in determining the customer’s intent and ability to pay, which is based on a variety of factors including the customer’s historical payment experience, or in the case of a new customer, published credit and financial information pertaining to the customer.
2) Identify the performance obligations in the contract
6
Performance obligations promised in a contract are identified based on the goods and services that will be transferred to the customer that are both capable of being distinct, whereby the customer can benefit from the good or service either on its own or together with other available resources, and are distinct in the context of the contract, whereby the transfer of the good or service is separately identifiable from other promises in the contract. To the extent a contract includes multiple promised goods and services, the Company must apply judgment to determine whether promised goods and services are capable of being distinct and are distinct in the context of the contract. If these criteria are not met, the promised goods and services are accounted for as a combined performance obligation.
3) Determine the transaction price
The transaction price is determined based on the consideration to which the Company will be entitled in exchange for transferring goods and services to the customer. To the extent the transaction price includes variable consideration, the Company estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Company’s judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. Any estimates, including the effect of the constraint on variable consideration, are evaluated at each reporting period for any changes. Determining the transaction price requires significant judgment, which is discussed in further detail for each of the Company’s contracts with customers in Note J.
4) Allocate the transaction price to performance obligations in the contract
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation on a relative stand-alone selling price basis unless the transaction price is variable and meets the criteria to be allocated entirely to a performance obligation or to a distinct service that forms part of a single performance obligation. The consideration to be received is allocated among the separate performance obligations based on relative stand-alone selling prices. Determining the amount of the transaction price to allocate to each separate performance obligation requires significant judgement, which is discussed in further detail for each of the Company’s contracts with customers in Note J.
5) Recognize revenue when or as the Company satisfies a performance obligation
The Company satisfies performance obligations either over time or at a point in time. Revenue is recognized over time if either 1) the customer simultaneously receives and consumes the benefits provided by the entity’s performance, 2) the entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced, or 3) the entity’s performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for performance completed to date. If the entity does not satisfy a performance obligation over time, the related performance obligation is satisfied at a point in time by transferring the control of a promised good or service to a customer. Examples of control are using the asset to produce goods or services, enhance the value of other assets, settle liabilities, and holding or selling the asset. ASC 606 requires the Company to select a single revenue recognition method for the performance obligation that faithfully depicts the Company’s performance in transferring control of the goods and services. The guidance allows entities to choose between two methods to measure progress toward complete satisfaction of a performance obligation:
|
1. |
Output methods - recognize revenue on the basis of direct measurements of the value to the customer of the goods or services transferred to date relative to the remaining goods or services promised under the contract (e.g. surveys of performance completed to date, appraisals of results achieved, milestones reached, time elapsed, and units of produced or units delivered); and |
|
2. |
Input methods - recognize revenue on the basis of the entity’s efforts or inputs to the satisfaction of a performance obligation (e.g., resources consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction of that performance obligation. |
Licenses of intellectual property: If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.
7
Milestone payments: At the inception of each arrangement that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. ASC 606 suggests two alternatives to use when estimating the amount of variable consideration: the expected value method and the most likely amount method. Under the expected value method, an entity considers the sum of probability-weighted amounts in a range of possible consideration amounts. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for the Company to use the same approach for all contracts. The Company uses the most likely amount method for development and regulatory milestone payments. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis. The Company recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment.
Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes 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 has been allocated has been satisfied (or partially satisfied).
Up-front Fees: Depending on the nature of the agreement, up-front payments and fees may be recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.
Impact of Adopting ASC 606 on Financial Statements
We adopted ASC 606 using the modified retrospective method. The cumulative effect of applying the new guidance to all contracts with customers that were not completed as of January 1, 2018 was recorded as an adjustment to accumulated deficit as of the adoption date. We elected to apply a practical expedient to reflect the aggregate effect of all modifications that occurred before January 1, 2018 when identifying the satisfied and unsatisfied performance obligations, determining the transaction price, and allocating the transaction price to the satisfied and unsatisfied performance obligations. The estimated effect of applying this practical expedient results in a slower recognition of the transaction price, as more consideration is allocated to performance obligations originally identified as a material right at contract inception. As a result of applying the modified retrospective method to adopt the new revenue guidance, the following adjustments were made to the consolidated balance sheet as of January 1, 2018 (in thousands):
|
|
As Reported December 31, 2017 |
|
|
ASC 606 Adjustment |
|
|
Adjusted January 1, 2018 |
|
|||
Consolidated Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Current portion, deferred revenue |
|
$ |
4,485 |
|
|
$ |
(2,986 |
) |
|
$ |
1,499 |
|
Deferred revenue, net of current portion |
|
|
7,748 |
|
|
|
(5,870 |
) |
|
|
1,878 |
|
Accumulated deficit |
|
$ |
(1,026,476 |
) |
|
$ |
8,856 |
|
|
$ |
(1,017,620 |
) |
Impact of ASC 606 on Financial Statements
In accordance with Topic 606, the disclosure of the impact of adoption to our condensed consolidated statements of income and balance sheets was as follows (in thousands):
8
|
Nine months ended September 30, 2018 |
|
||||||||||||||
|
|
As Reported Under ASC 606 |
|
|
Adjustments |
|
|
Notes |
|
|
Balances without Adoption of ASC 606 |
|
||||
Consolidated Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
$ |
6,069 |
|
|
$ |
(5,000 |
) |
|
|
(1 |
) |
|
$ |
1,069 |
|
Current portion, deferred revenue |
|
|
843 |
|
|
|
1,045 |
|
|
|
(2 |
) |
|
|
1,888 |
|
Deferred revenue, net of current portion |
|
|
1,469 |
|
|
|
4,863 |
|
|
|
(2 |
) |
|
|
6,332 |
|
Accumulated deficit |
|
|
(1,129,557 |
) |
|
|
(10,908 |
) |
|
|
(3 |
) |
|
|
(1,140,465 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
18,385 |
|
|
$ |
(2,051 |
) |
|
|
(4 |
) |
|
$ |
16,334 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, 2018 |
|
|||||||||||||
Consolidated Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development revenue |
|
$ |
6,276 |
|
|
$ |
(790 |
) |
|
|
(4 |
) |
|
$ |
5,486 |
|
|
(1) |
Adjustment to accounts receivable to reflect a milestone recognized under ASC 606 and included in accounts receivable on September 30, 2018. |
|
(2) |
Adjustment to deferred revenue to reflect recognition of revenue under ASC 605 primarily attributable to the change in the timing of revenue recognition for amounts received under the Incyte Collaboration Agreement, see Note J. |
|
(3) |
Adjustment to accumulated deficit to reflect the reversal of the cumulative transition adjustment and the difference in revenue from ASC 606 to ASC 605, see Note J. |
|
(4) |
Adjustment to reflect the difference in revenue recognition from ASC 606 to ASC 605 primarily attributable to the timing of milestone recognition and the change in recognition of an upfront fee related to the GSK License and Amended Supply Agreements, see Note J. |
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of common shares outstanding (including common shares issuable under our Directors’ Deferred Compensation Plan, or “DDCP”). Diluted income per common share is calculated by dividing net income attributable to common stockholders by the weighted average number of common shares outstanding (including common shares issuable under our DDCP) plus the dilutive effect of outstanding instruments such as warrants, stock options, non-vested shares, convertible preferred stock, and convertible notes. Because we reported a net loss attributable to common stockholders for all periods presented, diluted loss per common share is the same as basic loss per common share, as the effect of utilizing the fully diluted share count would have reduced the net loss per common share. Therefore, the following potentially dilutive securities have been excluded from the computation of diluted weighted average shares outstanding as of September 30, 2018 and 2017, as they would be anti-dilutive:
|
|
Three and Nine Months Ended September 30, |
|
|||||
|
|
2018 |
|
|
2017 |
|
||
Warrants |
|
|
2,900,000 |
|
|
|
4,351,450 |
|
Stock options |
|
|
16,917,576 |
|
|
|
14,749,924 |
|
Non-vested shares |
|
|
2,221,795 |
|
|
|
1,915,991 |
|
Convertible preferred stock |
|
|
333,333 |
|
|
|
333,333 |
|
Cash equivalents consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands):
|
|
September 30, 2018 |
|
|
December 31, 2017 |
|
||||||||||
|
|
Cost |
|
|
Estimated Fair Value |
|
|
Cost |
|
|
Estimated Fair Value |
|
||||
Institutional money market funds |
|
$ |
25,372 |
|
|
$ |
25,372 |
|
|
$ |
57,036 |
|
|
$ |
57,036 |
|
As a result of the short-term nature of our investments, there were minimal unrealized holding gains or losses for the three and nine months ended September 30, 2018 and 2017.
9
Note E - Goodwill and Acquired Intangible Assets
The following table sets forth the changes in the carrying amount of goodwill for the nine months ended September 30, 2018 (in thousands):
Balance, December 31, 2017 |
|
$ |
23,049 |
|
Foreign currency translation adjustment |
|
|
(90 |
) |
Balance, September 30, 2018 |
|
$ |
22,959 |
|
Acquired intangible assets consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands):
|
|
As of September 30, 2018 |
|
|||||||||||
|
|
Amortization period (years) |
|
Gross carrying amount |
|
|
Accumulated amortization |
|
|
Net carrying amount |
|
|||
Intellectual property |
|
7-15 years |
|
$ |
16,520 |
|
|
$ |
(5,684 |
) |
|
$ |
10,836 |
|
Trademarks |
|
4.5 years |
|
|
821 |
|
|
|
(821 |
) |
|
|
- |
|
Other |
|
2-6 years |
|
|
569 |
|
|
|
(494 |
) |
|
|
75 |
|
In-process research and development |
|
Indefinite |
|
|
1,916 |
|
|
|
— |
|
|
|
1,916 |
|
Total |
|
|
|
$ |
19,826 |
|
|
$ |
(6,999 |
) |
|
$ |
12,827 |
|
|
|
As of December 31, 2017 |
|
|||||||||||
|
|
Amortization period (years) |
|
Gross carrying amount |
|
|
Accumulated amortization |
|
|
Net carrying amount |
|
|||
Intellectual property |
|
7-15 years |
|
$ |
16,545 |
|
|
$ |
(4,290 |
) |
|
$ |
12,255 |
|
Trademarks |
|
4.5 years |
|
|
826 |
|
|
|
(711 |
) |
|
|
115 |
|
Other |
|
2-6 years |
|
|
570 |
|
|
|
(461 |
) |
|
|
109 |
|
In-process research and development |
|
Indefinite |
|
|
1,928 |
|
|
|
— |
|
|
|
1,928 |
|
Total |
|
|
|
$ |
19,869 |
|
|
$ |
(5,462 |
) |
|
$ |
14,407 |
|
The weighted average amortization period of our finite-lived intangible assets is 9 years. Amortization expense related to acquired intangibles is estimated at $0.5 million for the remainder of 2018 and $1.9 million for each of the years ending December 31, 2019, 2020, 2021 and 2022.
10
Debt obligations consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands):
Debt instrument |
|
Principal at September 30, 2018 |
|
|
Non-cash Interest |
|
|
Unamortized Debt Issuance Costs |
|
|
Unamortized Debt Discount |
|
|
Balance at September 30, 2018 |
|
|||||
Current Portion: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debentures |
|
$ |
146 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
146 |
|
Long-term Portion: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2015 Subordinated Notes |
|
|
14,000 |
|
|
|
— |
|
|
|
— |
|
|
|
(946 |
) |
|
|
13,054 |
|
Total |
|
$ |
14,146 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
(946 |
) |
|
$ |
13,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debt instrument |
|
Principal at December 31, 2017 |
|
|
Non-cash Interest |
|
|
Unamortized Debt Issuance Costs |
|
|
Unamortized Debt Discount |
|
|
Balance at December 31, 2017 |
|
|||||
Current Portion: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Debentures |
|
$ |
146 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
146 |
|
Note Purchase Agreement |
|
|
15,000 |
|
|
|
5,494 |
|
|
|
— |
|
|
|
— |
|
|
|
20,494 |
|
Total current |
|
|
15,146 |
|
|
|
5,494 |
|
|
|
— |
|
|
|
— |
|
|
|
20,640 |
|
Long-term Portion: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2015 Subordinated Notes |
|
|
14,000 |
|
|
|
— |
|
|
|
— |
|
|
|
(1,375 |
) |
|
|
12,625 |
|
Note Purchase Agreement |
|
|
100,000 |
|
|
|
31,323 |
|
|
|
(1,362 |
) |
|
|
(201 |
) |
|
|
129,760 |
|
Total long-term |
|
|
114,000 |
|
|
|
31,323 |
|
|
|
(1,362 |
) |
|
|
(1,576 |
) |
|
|
142,385 |
|
Total |
|
$ |
129,146 |
|
|
$ |
36,817 |
|
|
$ |
(1,362 |
) |
|
$ |
(1,576 |
) |
|
$ |
163,025 |
|
We have capital lease agreements that expire in 2020 for equipment with a carrying value of approximately $950,000, which is included in property, plant and equipment, net on our condensed consolidated balance sheet. Under the terms of the capital lease agreements, we will remit payments to the lessors of $94,000 for the remainder of 2018, $375,000 for the year ending December 31, 2019 and $165,000 for the year ending December 31, 2020. As of September 30, 2018, our remaining obligation under the capital lease agreements is approximately $550,000, of which $360,000 and $180,000 are classified as other current and other long-term liabilities, respectively, on our condensed consolidated balance sheet.
In January 2018, we, through our wholly-owned subsidiary, Antigenics LLC (“Antigenics”), entered into a Royalty Purchase Agreement (the “HCR Royalty Purchase Agreement”) with Healthcare Royalty Partners III, L.P., and certain of its affiliates (collectively “HCR”), whereby we received gross proceeds of $190.0 million (refer to Note G). Concurrently with the closing of the HCR Royalty Purchase Agreement, we used $161.9 million of these proceeds to redeem Antigenics’ $115.0 million principal amount of notes issued pursuant to the Note Purchase Agreement dated September 4, 2015 with Oberland Capital SA Zermatt LLC and the purchasers named therein (the “Note Purchase Agreement”), as well as the associated accrued and unpaid interest, and the Note Purchase Agreement and the notes issued thereunder were redeemed in full and terminated. In connection with this redemption, we recorded a $10.8 million loss on early extinguishment of debt which primarily reflects the payment of premiums to fully redeem the notes and the write-off of unamortized debt issuance costs and discounts.
Note G – Liability Related to the Sale of Future Royalties and Milestones
The following table shows the activity within the liability account in the nine months ended September 30, 2018 (in thousands):
11
|
Nine months ended September 30, 2018 |
|
||
Liability related to sale of future royalties and milestones - beginning balance |
|
$ |
— |
|
Proceeds from sale of future royalties and milestones |
|
|
205,000 |
|
Non-cash royalty revenue |
|
|
(11,948 |
) |
Non-cash interest expense recognized |
|
|
14,741 |
|
Liability related to sale of future royalties and milestones - ending balance |
|
|
207,793 |
|
Less: unamortized transaction costs |
|
|
(549 |
) |
Liability related to sale of future royalties and milestones, net |
|
$ |
207,244 |
|
Healthcare Royalty Partners
On January 6, 2018, we, through Antigenics, entered into the HCR Royalty Purchase Agreement with HCR, which closed on January 19, 2018. Pursuant to the terms of the HCR Royalty Purchase Agreement, we sold to HCR 100% of Antigenics’ worldwide rights to receive royalties from GlaxoSmithKline (“GSK”) on sales of GSK’s vaccines containing our QS-21 Stimulon adjuvant. At closing, we received gross proceeds of $190.0 million from HCR. As part of the transaction, we reimbursed HCR for transaction costs of $100,000 and incurred approximately $500,000 in transaction costs of our own, which are presented net of the liability in the consolidated balance sheet and will be amortized to interest expense over the estimated life of the HCR Royalty Purchase Agreement. Although we sold all of our rights to receive royalties on sales of GSK’s vaccines containing QS-21, as a result of our obligation to HCR, we are required to account for these royalties as revenue when earned, and we recorded the $190.0 million in proceeds from this transaction as a liability on our condensed consolidated balance sheet that will be amortized using the interest method over the estimated life of the HCR Royalty Purchase Agreement. The liability is classified between the current and non-current portion of liability related to sale of future royalties and milestones in the consolidated balance sheets based on the estimated recognition of the royalty payments to be received by HCR in the next 12 months from the financial statement reporting date.
During the nine months ended September 30, 2018, we recognized $11.9 million of non-cash royalty revenue, and we recorded $14.7 million of related non-cash interest expense related to the HCR Royalty Purchase Agreement.
As royalties are remitted to HCR from GSK, the balance of the recorded liability will be effectively repaid over the life of the HCR Royalty Purchase Agreement. To determine the amortization of the recorded liability, we are required to estimate the total amount of future royalty payments to be received by HCR. The sum of these amounts less the $190.0 million proceeds we received will be recorded as interest expense over the life of the HCR Royalty Purchase Agreement. Periodically, we assess the estimated royalty payments to be paid to HCR from GSK, and to the extent the amount or timing of the payments is materially different from our original estimates, we will prospectively adjust the amortization of the liability. During the three months ended September 30, 2018, our estimate of the effective annual interest rate over the life of the agreement increased to 14.6%, which results in a prospective interest rate of 14.0%.
There are a number of factors that could materially affect the amount and timing of royalty payments from GSK, all of which are not within our control. Such factors include, but are not limited to, changing standards of care, the introduction of competing products, manufacturing or other delays, biosimilar competition, patent protection, adverse events that result in governmental health authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates, and other events or circumstances that could result in reduced royalty payments from GSK, all of which would result in a reduction of non-cash royalty revenues and the non-cash interest expense over the life of the HCR Royalty Purchase Agreement. Conversely, if sales of GSK’s vaccines containing QS-21 are more than expected, the non-cash royalty revenues and the non-cash interest expense recorded by us would be greater over the life of the HCR Royalty Purchase Agreement.
Pursuant to the HCR Royalty Purchase Agreement, we will also be entitled to receive up to $40.4 million in milestone payments based on sales of GSK’s vaccines as follows: (i) $15.1 million upon reaching $2.0 billion last-twelve-months net sales any time prior to 2024 and (ii) $25.3 million upon reaching $2.75 billion last-twelve-months net sales any time prior to 2026.
Additionally, pursuant to the HCR Royalty Purchase Agreement, we would owe approximately $25.9 million to HCR in 2021 (the “Rebate Payment”) if neither of the following sales milestones are achieved: (i) 2019 sales exceed $1.0 billion or (ii) 2020 sales exceed $1.75 billion. As part of the transaction, we provided a guaranty for the potential Rebate Payment and secured the obligation with substantially all of our assets pursuant to a security agreement, subject to certain customary exceptions and excluding all assets necessary for AgenTus Therapeutics.
XOMA
12
On September 20, 2018, we, through our wholly-owned subsidiary, Agenus Royalty Fund, LLC, entered into a Royalty Purchase Agreement (the “XOMA Royalty Purchase Agreement”) with XOMA (US) LLC (“XOMA”). Pursuant to the terms of the XOMA Royalty Purchase Agreement, XOMA paid us $15.0 million at closing in exchange for the right to receive 33% of the future royalties and 10% of the future milestones that we are entitled to receive from Incyte Corporation (“Incyte”) and Merck Sharpe & Dohme (“Merck”) under our agreements with each party (see Note J), net of certain of our obligations to a third party and excluding the $5.0 million milestone from Incyte that we recognized in the quarter ended September 30, 2018. We retained 90% of the future milestones and 67% of the future royalties under our agreements with Incyte and Merck. Although we sold our rights to receive 33% of future royalties and 10% of future milestones, as a result of our significant continued involvement in the generation of the potential royalties and milestones, we are required to account for the full amount of these royalties and milestones as revenue when earned, and we recorded the $15.0 million in proceeds from this transaction as a liability on our condensed consolidated balance sheet. Under the terms of the XOMA Royalty Purchase Agreement, should the percentage of milestones and royalties ultimately received by XOMA fail to repay the amount received by us at closing we would have no further obligation to XOMA.
Accrued liabilities consisted of the following as of September 30, 2018 and December 31, 2017 (in thousands):
|
|
September 30, 2018 |
|
|
December 31, 2017 |
|
||
Payroll |
|
$ |
5,364 |
|
|
$ |
7,790 |
|
Professional fees |
|
|
2,790 |
|
|
|
2,021 |
|
Contract manufacturing costs |
|
|
5,883 |
|
|
|
5,528 |
|
Research services |
|
|
6,260 |
|
|
|
4,663 |
|
Other |
|
|
1,368 |
|
|
|
1,567 |
|
Total |
|
$ |
21,665 |
|
|
$ |
21,569 |
|
Note I - Fair Value Measurements
We measure our contingent purchase price considerations at fair value.
The fair values of our contingent purchase price considerations, $2.9 million, are based on significant inputs not observable in the market, which require them to be reported as Level 3 liabilities within the fair value hierarchy. The valuation of these liabilities use assumptions we believe would be made by a market participant and are based on estimates from a Monte Carlo simulation of our market capitalization and share price, and other factors impacting the probability of triggering the milestone payments. Market capitalization and share price were evolved using a geometric Brownian motion, calculated daily for the life of the contingent purchase price considerations.
Liabilities measured at fair value are summarized below (in thousands):
Description |
|
September 30, 2018 |
|
|
Quoted Prices in Active Markets for Identical Assets (Level 1) |
|
|
Significant Other Observable Inputs (Level 2) |
|
|