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Delaware
|
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2836
|
| |
38-3982704
|
|
|
(State or other jurisdiction of
incorporation or organization) |
| |
(Primary Standard Industrial
Classification Code Number) |
| |
(I.R.S. Employer
Identification Number) |
|
|
Yvan-Claude Pierre
Daniel I. Goldberg Divakar Gupta Cooley LLP 1114 Avenue of the Americas New York, New York 10036 (212) 479-6000 |
| |
Stuart M. Cable
Edwin M. O’Connor Seo Salimi Goodwin Procter LLP Exchange Place 53 State Street Boston, Massachusetts 02109 (617) 570-1000 |
|
|
Large accelerated filer ☐
|
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Accelerated filer ☐
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Non-accelerated filer ☒
(Do not check if a smaller reporting company) |
| |
Smaller reporting company ☐
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| | |
PER SHARE
|
| |
TOTAL
|
| ||||||
Public Offering Price
|
| | | $ | | | | | $ | | | ||
Underwriting Discounts and Commissions(1)
|
| | | $ | | | | | | $ | | | |
Proceeds to Oncobiologics, Inc. (Before Expenses)
|
| | | $ | | | | | | $ | | | |
TABLE OF CONTENTS
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Page
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| | | | 139 | | | |
| | | | 146 | | | |
| | | | 146 | | | |
| | | | 146 | | | |
| | | | F-1 | | |
| | |
Year Ended September 30,
|
| |
Three Months Ended December 31,
|
||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2014
|
| |
2015
|
||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
|||||||||
Consolidated Statements of Operations Data: | | | | | | |||||||||||||||||||
| | | | | | |||||||||||||||||||
Collaboration revenues
|
| | | $ | 9,050,542 | | | | | $ | 5,219,237 | | | | | $ | 2,934,555 | | | | | $ | 994,894 | |
Operating expenses: | | | | | | |||||||||||||||||||
| | | | | | |||||||||||||||||||
Research and development
|
| | | | 14,124,631 | | | | | | 38,876,040 | | | | | | 5,840,030 | | | | | | 12,733,976 | |
General and administrative
|
| | | | 7,318,314 | | | | | | 12,905,823 | | | | | | 1,237,839 | | | | | | 4,674,155 | |
| | | | | 21,442,945 | | | | | | 51,781,863 | | | | | | 7,077,869 | | | | | | 17,408,131 | |
Loss from operations
|
| | | | (12,392,403) | | | | | | (46,562,626) | | | | | | (4,143,314) | | | | | | (16,413,237) | |
Interest expense
|
| | | | 901,052 | | | | | | 2,297,339 | | | | | | 357,580 | | | | | | 398,975 | |
Loss before income taxes
|
| | | | (13,293,455) | | | | | | (48,859,965) | | | | | | (4,500,894) | | | | | | (16,812,212) | |
Income tax expense (benefit)
|
| | | | 439,018 | | | | | | (190,111) | | | | | | 406,363 | | | | | | 52,000 | |
Net loss
|
| | | | (13,732,473) | | | | | | (48,669,854) | | | | | | (4,907,257) | | | | | | (16,864,212) | |
Less: Net loss attributable to noncontrolling
interests |
| | | | — | | | | | | (1,276,571) | | | | | | — | | | | | | — | |
Net loss attributable to Oncobiologics, Inc.
|
| | | | (13,732,473) | | | | | | (47,393,283) | | | | | | (4,907,257) | | | | | | (16,864,212) | |
Accretion of redeemable preferred stock and noncontrolling interests
|
| | | | (3,588,996) | | | | | | (4,306,488) | | | | | | (1,071,164) | | | | | | (939,539) | |
Deemed dividends upon the repurchase of Series A redeemable preferred stock and redeemable noncontrolling interests
|
| | | | (3,336,855) | | | | | | (1,298,631) | | | | | | (1,230,998) | | | | | | — | |
Net loss attributable to common stockholders of Oncobiologics, Inc.
|
| | | $ | (20,658,324) | | | | | $ | (52,998,402) | | | | | $ | (7,209,419) | | | | | $ | (17,803,751) | |
Per share information:(1) | | | | | | |||||||||||||||||||
| | | | | | |||||||||||||||||||
Net loss per share of common stock, basic and
diluted |
| | | $ | (2.43) | | | | | $ | (5.43) | | | | | $ | (0.77) | | | | | $ | (1.36) | |
Weighted-average shares outstanding, basic and diluted
|
| | | | 8,509,654 | | | | | | 9,753,616 | | | | | | 9,377,450 | | | | | | 13,061,557 | |
Pro forma net loss per share of common stock – basic and diluted (unaudited)
|
| | | | | | | | | $ | (3.60) | | | | | | | | | | | $ | (1.20) | |
Pro forma weighted-average shares outstanding
(unaudited) |
| | | | | | | | | | 13,158,777 | | | | | | | | | | | | 14,046,456 | |
|
| | |
As of December 31, 2015
|
| |||||||||||||||
| | |
(Unaudited)
|
| |||||||||||||||
| | |
Actual
|
| |
Pro forma(1)
|
| |
Pro forma
as adjusted(2)(3) |
| |||||||||
Consolidated Balance Sheet Data: | | | | | |||||||||||||||
Cash | | | | $ | 5,582,255 | | | | | $ | 10,806,901 | | | | | $ | 63,806,901 | | |
Working capital (deficit)
|
| | | | (25,087,988) | | | | | | (22,562,819) | | | | | | 30,437,181 | | |
Total assets
|
| | | | 31,322,869 | | | | | | 33,797,518 | | | | | | 84,822,674 | | |
Debt obligations, current and long-term
|
| | | | 15,488,800 | | | | | | 15,488,800 | | | | | | 15,488,800 | | |
Redeemable common stock
|
| | | | 16,366,212 | | | | | | — | | | | | | — | | |
Total stockholders’ equity (deficit)
|
| | | | (30,914,816) | | | | | | (12,023,435) | | | | | | 40,976,565 | | |
| | |
As of December 31, 2015
|
| |||||||||||||||
| | |
(Unaudited)
|
| |||||||||||||||
| | |
Actual
|
| |
Pro forma
|
| |
Pro forma
as adjusted(1) |
| |||||||||
Cash
|
| | | $ | 5,582,255 | | | | | $ | 10,806,901 | | | | | $ | 63,806,091 | | |
Debt obligations, current and long term
|
| | | | 15,488,800 | | | | | | 15,488,800 | | | | | | 15,488,800 | | |
Redeemable common stock
|
| | | | 16,366,212 | | | | | | — | | | | | | — | | |
Stockholders’ equity (deficit): | | | | | | | | | | | | | | | |||||
Series A preferred stock, par value $0.01 per share: 10,000,000 shares authorized, 11,819 shares issued and outstanding actual; no shares issued and outstanding pro forma and pro forma as adjusted
|
| | | | 118 | | | | | | — | | | | | | — | | |
Common stock, par value $0.01 per share; 100,000,000
shares authorized, 12,339,877 shares issued and outstanding actual; 15,151,193 issued and outstanding pro forma; and 20,151,193 shares issued and outstanding pro forma as adjusted |
| | | | 123,399 | | | | | | 151,512 | | | | | | 201,512 | | |
Additional paid-in capital
|
| | | | 79,890,165 | | | | | | 98,753,551 | | | | | | 151,703,551 | | |
Accumulated deficit
|
| | | | (110,928,498) | | | | | | (110,928,498) | | | | | | (110,928,498) | | |
Total stockholders’ equity (deficit)
|
| | | | (30,914,816) | | | | | | (12,023,435) | | | | | | 40,976,565 | | |
Total capitalization
|
| | | $ | 940,196 | | | | | $ | 3,465,365 | | | | | $ | 56,465,365 | | |
|
|
Assumed initial public offering price per share
|
| | | | | | | | | $ | 12.00 | | |
|
Historical net tangible book value (deficit) per share at December 31, 2015
|
| | | $ | (2.51) | | | | | | | | |
|
Increase per share attributable to pro forma adjustments
|
| | | | 1.72 | | | | | | | | |
|
Pro forma net tangible book value (deficit) per share at December 31, 2015
|
| | | | (0.79) | | | | | | | | |
|
Increase in pro forma net tangible book value (deficit) per share attributable to this offering
|
| | | | 2.82 | | | | | | | | |
|
Pro forma as adjusted net tangible book value per share after this offering
|
| | | | | | | | | | 2.03 | | |
|
Dilution in net tangible book value per share to new investors in this offering
|
| | | | | | | | | $ | 9.97 | | |
|
| | |
Shares Purchased
|
| |
Total Consideration
|
| |
Average Price
Per Share |
| |||||||||||||||||||||
| | |
Number
|
| |
Percent
|
| |
Amount
|
| |
Percent
|
| ||||||||||||||||||
Existing Stockholders
|
| | | | 15,151,193 | | | | | | 75% | | | | | $ | 81,394,129 | | | | | | 58% | | | | | $ | 5.37 | | |
New Investors
|
| | | | 5,000,000 | | | | | | 25 | | | | | | 60,000,000 | | | | | | 42 | | | | | | 12.00 | | |
Total
|
| | | | 20,151,193 | | | | | | 100% | | | | | $ | 141,394,129 | | | | | | 100% | | | | | | 7.02 | | |
|
| | |
Year Ended September 30,
|
| |
Three Months Ended December 31,
|
||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2014
|
| |
2015
|
||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
|||||||||
Consolidated Statements of Operations Data: | | | | | | |||||||||||||||||||
| | | | | | | | | | | | | | | | |||||||||
Collaboration revenues
|
| | | $ | 9,050,542 | | | | | $ | 5,219,237 | | | | | $ | 2,934,555 | | | | | $ | 994,894 | |
Operating expenses: | | | | | | |||||||||||||||||||
| | | | | | |||||||||||||||||||
Research and development
|
| | | | 14,124,631 | | | | | | 38,876,040 | | | | | | 5,840,030 | | | | | | 12,733,976 | |
General and administrative
|
| | | | 7,318,314 | | | | | | 12,905,823 | | | | | | 1,237,839 | | | | | | 4,674,155 | |
| | | | | 21,442,945 | | | | | | 51,781,863 | | | | | | 7,077,869 | | | | | | 17,408,131 | |
Loss from operations
|
| | | | (12,392,403) | | | | | | (46,562,626) | | | | | | (4,143,314) | | | | | | (16,413,237) | |
Interest expense
|
| | | | 901,052 | | | | | | 2,297,339 | | | | | | 357,580 | | | | | | 398,975 | |
Loss before income taxes
|
| | | | (13,293,455) | | | | | | (48,859,965) | | | | | | (4,500,894) | | | | | | (16,812,212) | |
Income tax expense (benefit)
|
| | | | 439,018 | | | | | | (190,111) | | | | | | 406,363 | | | | | | 52,000 | |
Net loss
|
| | | | (13,732,473) | | | | | | (48,669,854) | | | | | | (4,907,257) | | | | | | (16,864,212) | |
Less: Net loss attributable to noncontrolling interests
|
| | | | — | | | | | | (1,276,571) | | | | | | — | | | | | | — | |
Net loss attributable to Oncobiologics, Inc.
|
| | | | (13,732,473) | | | | | | (47,393,283) | | | | | | (4,907,257) | | | | | | (16,864,212) | |
Accretion of redeemable preferred stock and noncontrolling interests
|
| | | | (3,588,996) | | | | | | (4,306,488) | | | | | | (1,071,164) | | | | | | (939,539) | |
Deemed dividends upon the repurchase of Series A redeemable preferred stock and redeemable noncontrolling interests
|
| | | | (3,336,855) | | | | | | (1,298,631) | | | | | | (1,230,998) | | | | | | — | |
Net loss attributable to common stockholders of Oncobiologics, Inc.
|
| | | $ | (20,658,324) | | | | | $ | (52,998,402) | | | | | $ | (7,209,419) | | | | | $ | (17,803,751) | |
Per share information:(1) | | | | | | |||||||||||||||||||
| | | | | | |||||||||||||||||||
Net loss per share of common stock, basic and diluted
|
| | | $ | (2,43) | | | | | $ | (5.43) | | | | | $ | (0.77) | | | | | $ | (1.36) | |
Weighted-average shares outstanding, basic and diluted
|
| | | | 8,509,654 | | | | | | 9,753,616 | | | | | | 9,377,450 | | | | | | 13,061,557 | |
Pro forma net loss per share of common stock – basic
and diluted (unaudited) |
| | | | | | | | | $ | (3.60) | | | | | | | | | | | $ | (1.20) | |
Pro forma weighted-average shares outstanding (unaudited)
|
| | | | | | | | | | 13,158,777 | | | | | | | | | | | | 14,046,456 | |
|
| | |
As of September 30,
|
| |
As of December 31,
2015 |
| ||||||||||||
| | |
2014
|
| |
2015
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||
Consolidated Balance Sheet Data: | | | | | |||||||||||||||
Cash
|
| | | $ | 2,349,313 | | | | | $ | 9,070,975 | | | | | $ | 5,582,255 | | |
Working capital (deficit)
|
| | | | (17,063,539) | | | | | | (21,877,366) | | | | | | (25,087,988) | | |
Total assets
|
| | | | 11,603,707 | | | | | | 35,008,621 | | | | | | 31,322,869 | | |
Debt obligations, current and long-term
|
| | | | 15,168,532 | | | | | | 21,961,828 | | | | | | 15,488,800 | | |
Redeemable preferred stock, common stock and noncontrolling interests
|
| | | | 24,704,011 | | | | | | 27,321,311 | | | | | | 16,366,212 | | |
Total stockholders’ equity (deficit)
|
| | | | (45,151,218) | | | | | | (54,873,803) | | | | | | (30,914,816) | | |
| | |
Year ended September 30,
|
| |
Three months ended December 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2014
|
| |
2015
|
| ||||||||||||
IPCA Collaboration
|
| | | $ | 1,439,472 | | | | | $ | 1,702,377 | | | | | $ | 586,078 | | | | | $ | 105,433 | | |
Liomont Collaboration
|
| | | | 34,091 | | | | | | 341,280 | | | | | | 54,582 | | | | | | 595,566 | | |
Huahai Collaboration
|
| | | | 7,576,979 | | | | | | 3,175,580 | | | | | | 2,293,895 | | | | | | 293,895 | | |
| | | | $ | 9,050,542 | | | | | $ | 5,219,237 | | | | | $ | 2,934,555 | | | | | $ | 994,894 | | |
|
| | |
Year ended September 30,
|
| |
Three months ended December 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2014
|
| |
2015
|
| ||||||||||||
Milestone payments
|
| | | $ | 7,000,000 | | | | | $ | 2,500,000 | | | | | $ | 2,500,000 | | | | | $ | 500,000 | | |
Recognition of deferred revenues
|
| | | | 1,300,542 | | | | | | 1,919,237 | | | | | | 434,555 | | | | | | 494,894 | | |
Research and development payments
|
| | | | 750,000 | | | | | | 800,000 | | | | | | — | | | | | | — | | |
| | | | $ | 9,050,542 | | | | | $ | 5,219,237 | | | | | $ | 2,934,555 | | | | | $ | 994,894 | | |
|
| | |
Three Months Ended December 31,
|
| | | | | | | |||||||||
| | |
2014
|
| |
2015
|
| |
Change
|
| |||||||||
| | |
(Unaudited)
|
| | | | | | | |||||||||
Collaboration revenues
|
| | | $ | 2,934,555 | | | | | $ | 994,894 | | | | | $ | (1,939,661) | | |
Operating expenses: | | | | | |||||||||||||||
Research and development
|
| | | | 5,840,030 | | | | | | 12,733,976 | | | | | | 6,893,946 | | |
General and administrative
|
| | | | 1,237,839 | | | | | | 4,674,155 | | | | | | 3,436,316 | | |
| | | | | 7,077,869 | | | | | | 17,408,131 | | | | | | 10,330,262 | | |
Loss from operations
|
| | | | (4,143,314) | | | | | | (16,413,237) | | | | | | (12,269,923) | | |
Interest expense
|
| | | | 357,580 | | | | | | 398,975 | | | | | | 41,395 | | |
Loss before income taxes
|
| | | | (4,500,894) | | | | | | (16,812,212) | | | | | | (12,311,318) | | |
Income tax expense
|
| | | | 406,363 | | | | | | 52,000 | | | | | | (354,363) | | |
Net loss
|
| | | $ | (4,907,257) | | | | | $ | (16,864,212) | | | | | $ | (11,956,955) | | |
|
| | |
Three months ended
December 31, |
| |
Period from
January 5, 2010 (inception) through December 31, 2015 |
| ||||||||||||
| | |
2014
|
| |
2015
|
| ||||||||||||
| | |
(Unaudited)
|
| | | | | | | |||||||||
Preclinical and clinical development
|
| | | $ | 3,524,528 | | | | | $ | 7,007,033 | | | | | $ | 40,174,156 | | |
Compensation and related benefits
|
| | | | 2,193,204 | | | | | | 3,815,357 | | | | | | 27,366,937 | | |
Stock-based compensation
|
| | | | 84,275 | | | | | | 1,356,408 | | | | | | 7,907,386 | | |
Regulatory filings and other
|
| | | | 38,023 | | | | | | 555,178 | | | | | | 2,765,050 | | |
Total research and development expenses
|
| | | $ | 5,840,030 | | | | | $ | 12,733,976 | | | | | $ | 78,213,529 | | |
|
| | |
Three months ended
December 31, |
| |
Period from
January 5, 2010 (inception) through December 31, 2015 |
| ||||||||||||
| | |
2014
|
| |
2015
|
| ||||||||||||
| | |
(Unaudited)
|
| | | | | | | |||||||||
ONS-3010
|
| | | $ | 1,547,912 | | | | | $ | 4,208,306 | | | | | $ | 19,405,507 | | |
ONS-1045
|
| | | | 1,718,730 | | | | | | 2,740,735 | | | | | | 17,652,009 | | |
Other research and development
|
| | | | 295,909 | | | | | | 613,169 | | | | | | 5,881,689 | | |
Personnel related and stock-based compensation
|
| | | | 2,277,479 | | | | | | 5,171,766 | | | | | | 35,274,324 | | |
Total research and development expenses
|
| | | $ | 5,840,030 | | | | | $ | 12,733,976 | | | | | $ | 78,213,529 | | |
|
| | |
Year Ended September 30,
|
| | ||||||||||||||
| | |
2014
|
| |
2015
|
| |
Change
|
| |||||||||
Collaboration revenues
|
| | | $ | 9,050,542 | | | | | $ | 5,219,237 | | | | | $ | (3,831,305) | | |
Operating expenses: | | | | | |||||||||||||||
Research and development
|
| | | | 14,124,631 | | | | | | 38,876,040 | | | | | | 24,751,409 | | |
General and administrative
|
| | | | 7,318,314 | | | | | | 12,905,823 | | | | | | 5,587,509 | | |
| | | | | 21,442,945 | | | | | | 51,781,863 | | | | | | 30,338,918 | | |
Loss from operations
|
| | | | (12,392,403) | | | | | | (46,562,626) | | | | | | (34,170,223) | | |
Interest expense
|
| | | | 901,052 | | | | | | 2,297,339 | | | | | | 1,396,287 | | |
Loss before income taxes
|
| | | | (13,293,455) | | | | | | (48,859,965) | | | | | | (35,566,510) | | |
Income tax expense (benefit)
|
| | | | 439,018 | | | | | | (190,111) | | | | | | (629,129) | | |
Net loss
|
| | | $ | (13,732,473) | | | | | $ | (48,669,854) | | | | | $ | (34,937,381) | | |
|
| | |
Year ended September 30,
|
| |
Period from
January 5, 2010 (inception) through September 30, 2015 |
| ||||||||||||
| | |
2014
|
| |
2015
|
| ||||||||||||
Preclinical and clinical development
|
| | | $ | 6,715,346 | | | | | $ | 21,714,405 | | | | | $ | 33,167,123 | | |
Compensation and related benefits
|
| | | | 6,424,884 | | | | | | 10,202,065 | | | | | | 23,477,173 | | |
Stock-based compensation
|
| | | | 671,745 | | | | | | 5,817,830 | | | | | | 6,625,385 | | |
Regulatory filings and other
|
| | | | 312,656 | | | | | | 1,141,740 | | | | | | 2,209,872 | | |
Total research and development expenses
|
| | | $ | 14,124,631 | | | | | $ | 38,876,040 | | | | | $ | 65,479,553 | | |
|
| | |
Year ended September 30,
|
| |
Period from
January 5, 2010 (inception) through September 30, 2015 |
| ||||||||||||
| | |
2014
|
| |
2015
|
| ||||||||||||
ONS-3010 | | | | $ | 4,641,138 | | | | | $ | 6,942,002 | | | | | $ | 15,197,201 | | |
ONS-1045 | | | | | 1,819,446 | | | | | | 12,763,886 | | | | | | 14,911,274 | | |
Other research and development
|
| | | | 567,418 | | | | | | 3,150,257 | | | | | | 5,268,520 | | |
Personnel related and stock-based compensation
|
| | | | 7,096,629 | | | | | | 16,019,895 | | | | | | 30,102,558 | | |
Total research and development expenses
|
| | | $ | 14,124,631 | | | | | $ | 38,876,040 | | | | | $ | 65,479,553 | | |
|
| | |
Year Ended September 30,
|
| |
Three months ended December 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2014
|
| |
2015
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
Net cash used in operating activities
|
| | | $ | (7,020,469) | | | | | $ | (27,476,200) | | | | | $ | (3,666,423) | | | | | $ | (12,012,281) | | |
Net cash used in investing activities
|
| | | | (2,366,772) | | | | | | (8,804,244) | | | | | | (527,877) | | | | | | (364,242) | | |
Net cash provided by financing activities
|
| | | | 11,474,146 | | | | | | 43,002,106 | | | | | | 3,670,527 | | | | | | 8,887,803 | | |
Net increase (decrease) in cash
|
| | | $ | 2,086,905 | | | | | $ | 6,721,662 | | | | | $ | (523,773) | | | | | $ | (3,488,720) | | |
|
| | |
Payments Due by Period
|
| |||||||||||||||||||||||||||
| | |
Total
|
| |
Less Than
1 Year |
| |
1 − 3
Years |
| |
3 – 5
Years |
| |
More Than
5 Years |
| |||||||||||||||
Operating lease commitments(1)(5)
|
| | | $ | 5,027,353 | | | | | $ | 888,710 | | | | | $ | 1,731,526 | | | | | $ | 1,763,368 | | | | | $ | 643,749 | | |
Debt obligations(2)
|
| | | | 19,953,048 | | | | | | 14,956,842 | | | | | | 3,355,273 | | | | | | 1,032,926 | | | | | | 608,007 | | |
Capital leases(3)
|
| | | | 2,082,222 | | | | | | 862,849 | | | | | | 1,219,373 | | | | | | — | | | | | | — | | |
Total(4)
|
| | | $ | 27,062,623 | | | | | $ | 16,708,401 | | | | | $ | 6,306,172 | | | | | $ | 2,796,294 | | | | | $ | 1,251,756 | | |
|
| | |
Year ended September 30,
|
| |
Three months ended December 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2014
|
| |
2015
|
| ||||||||||||
Research and development
|
| | | $ | 671,745 | | | | | $ | 5,817,830 | | | | | $ | 84,275 | | | | | $ | 1,356,408 | | |
General and administrative
|
| | | | 3,286,735 | | | | | | 5,360,028 | | | | | | 61,399 | | | | | | 1,133,626 | | |
| | | | $ | 3,958,480 | | | | | $ | 11,177,858 | | | | | $ | 145,674 | | | | | $ | 2,490,034 | | |
|
| | |
Year ended September 30,
|
| |
Three months ended December 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2014
|
| |
2015
|
| ||||||||||||
Equity-classified compensation
|
| | | $ | 2,764,878 | | | | | $ | 8,925 | | | | | $ | 2,231 | | | | | $ | 98,172 | | |
Liability-classified compensation
|
| | | |