|
Delaware
|
| |
2836
|
| |
38-3982704
|
|
|
(State or other jurisdiction of
incorporation or organization) |
| |
(Primary Standard Industrial
Classification Code Number) |
| |
(I.R.S. Employer
Identification Number) |
|
|
Large accelerated filer
☐
|
| |
Accelerated filer
☐
|
| |
Non-accelerated filer ☒
(Do not check if a smaller reporting company) |
| |
Smaller reporting company
☐
|
|
CALCULATION OF REGISTRATION FEE
|
| ||||||||||||||||||||||||
Title of each class of
securities to be registered |
| |
Amount to be
registered (1) |
| |
Aggregate
offering price per security |
| |
Maximum aggregate
offering price |
| |
Amount of
registration fee |
| ||||||||||||
Common stock, $0.01 par value per share
(2)
|
| | | | 833,332 | | | | | $ | 3.48 | | | | | $ | 2,899,995 | | | | | $ | 292.03 | | |
Series A warrants
(2)
|
| | | | 416,666 | | | | | $ | 0.32 | | | | | $ | 133,333 | | | | | $ | 13.43 | | |
Common stock, $0.01 par value per share, underlying the Series A warrants
(
3
)
|
| | | | 416,666 | | | | | $ | 6.60 | | | | | $ | 2,749,996 | | | | | $ | 276.92 | | |
Series B warrants
(2)
|
| | | | 416,666 | | | | | $ | 0.45 | | | | | $ | 187,500 | | | | | $ | 18.88 | | |
Common stock, $0.01 par value per share, underlying the Series B warrants
(
4
)
|
| | | | 416,666 | | | | | $ | 8.50 | | | | | $ | 3,541,661 | | | | | $ | 356.65 | | |
Total
|
| | | | | | | | | | | | | | | $ | 9,512,485 | | | | | $ | 957.91 | | |
|
TABLE OF CONTENTS
|
| |
Page
|
| |||
| | | | 1 | | | |
| | | | 9 | | | |
| | | | 50 | | | |
| | | | 51 | | | |
| | | | 52 | | | |
| | | | 52 | | | |
| | | | 53 | | | |
| | | | 54 | | | |
| | | | 55 | | | |
| | | | 57 | | | |
| | | | 59 | | | |
| | | | 76 | | | |
| | | | 100 | | | |
| | | | 108 | | | |
| | | | 121 | | | |
| | | | 126 | | | |
| | | | 128 | | | |
| | | | 134 | | | |
| | | | 134 | | | |
| | | | 134 | | | |
| | | | F-1 | | |
| | |
Units
|
| |
Common Stock
|
| |
Series A Warrants
|
| |
Series B Warrants
|
| ||||||||||||||||||||||||||||||||||||
2016
|
| |
High
|
| |
Low
|
| |
High
|
| |
Low
|
| |
High
|
| |
Low
|
| |
High
|
| |
Low
|
| ||||||||||||||||||||||||
May | | | | $ | 5.50 | | | | | $ | 5.00 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
June (1) | | | | $ | 5.30 | | | | | $ | 4.56 | | | | | $ | 4.47 | | | | | $ | 3.25 | | | | | $ | 0.50 | | | | | $ | 0.30 | | | | | $ | 0.65 | | | | | $ | 0.45 | | |
| | |
Before Offering
|
| |
After Offering
|
| ||||||||||||||||||
| | |
Securities
Held |
| |
Percentage
|
| |
Securities
Held |
| |
Percentage
|
| ||||||||||||
Common Stock
|
| | | | 2,027,978 (1 ) | | | | | | 8.8 % | | | | | | 1,392,974 (2 ) | | | | | | 6.0 % | | |
Series A Warrants
|
| | | | 667,968 | | | | | | 20.0 % | | | | | | 251,302 | | | | | | 7.5 % | | |
Series B Warrants
|
| | | | 667,968 | | | | | | 20.0 % | | | | | | 251,302 | | | | | | 7.5 % | | |
| | |
Year Ended September 30,
|
| |
Six Months Ended March 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2015
|
| |
2016
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
Consolidated Statements of Operations Data: | | | | | | ||||||||||||||||||||
| | | | | | | | | | | | | | | | ||||||||||
Collaboration revenues
|
| | | $ | 9,050,542 | | | | | $ | 5,219,237 | | | | | $ | 3,429,449 | | | | | $ | 1,989,788 | | |
Operating expenses: | | | | | | ||||||||||||||||||||
| | | | | | ||||||||||||||||||||
Research and development
|
| | | | 14,124,631 | | | | | | 38,876,040 | | | | | | 15,994,499 | | | | | | 16,872,253 | | |
General and administrative
|
| | | | 7,318,314 | | | | | | 12,905,823 | | | | | | 5,579,929 | | | | | | 4,484,717 | | |
| | | | | 21,442,945 | | | | | | 51,781,863 | | | | | | 21,574,428 | | | | | | 21,356,970 | | |
Loss from operations
|
| | | | (12,392,403 ) | | | | | | (46,562,626 ) | | | | | | (18,144,979 ) | | | | | | (19,367,182 ) | | |
Interest expense
|
| | | | 901,052 | | | | | | 2,297,339 | | | | | | 1,063,509 | | | | | | 936,910 | | |
Loss before income taxes
|
| | | | (13,293,455 ) | | | | | | (48,859,965 ) | | | | | | (19,208,488 ) | | | | | | (20,304,092 ) | | |
Income tax expense (benefit)
|
| | | | 439,018 | | | | | | (190,111 ) | | | | | | (319,855 ) | | | | | | 102,500 | | |
Net loss
|
| | | | (13,732,473 ) | | | | | | (48,669,854 ) | | | | | | (18,888,633 ) | | | | | | (20,406,592 ) | | |
Less: Net loss attributable to noncontrolling interests
|
| | | | — | | | | | | (1,276,571 ) | | | | | | — | | | | | | — | | |
Net loss attributable to Oncobiologics, Inc.
|
| | | | (13,732,473 ) | | | | | | (47,393,283 ) | | | | | | (18,888,633 ) | | | | | | (20,406,592 ) | | |
Accretion of redeemable preferred stock and noncontrolling interests
|
| | | | (3,588,996 ) | | | | | | (4,306,488 ) | | | | | | (2,105,693 ) | | | | | | (1,969,953 ) | | |
Deemed dividends upon the repurchase of Series A redeemable preferred stock and redeemable noncontrolling interests
|
| | | | (3,336,855 ) | | | | | | (1,298,631 ) | | | | | | (1,298,631 ) | | | | | | — | | |
Net loss attributable to common stockholders of Oncobiologics, Inc.
|
| | | $ | (20,658,324 ) | | | | | $ | (52,998,402 ) | | | | | $ | (22,292,957 ) | | | | | $ | (22,376,545 ) | | |
Per share information: (1) | | | | | | ||||||||||||||||||||
| | | | | | ||||||||||||||||||||
Net loss per share of common stock, basic and diluted
|
| | | $ | (2,43 ) | | | | | $ | (5.43 ) | | | | | $ | (2.38 ) | | | | | $ | (1.64 ) | | |
Weighted-average shares outstanding, basic and diluted
|
| | | | 8,509,654 | | | | | | 9,753,616 | | | | | | 9,377,450 | | | | | | 13,605,331 | | |
|
| | |
As of September 30,
|
| |
As of March 31,
2016 |
| ||||||||||||
| | |
2014
|
| |
2015
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||
Consolidated Balance Sheet Data: | | | | | |||||||||||||||
Cash
|
| | | $ | 2,349,313 | | | | | $ | 9,070,975 | | | | | $ | 2,842,194 | | |
Working capital (deficit)
|
| | | | (17,063,539 ) | | | | | | (21,877,366 ) | | | | | | (31,872,147 ) | | |
Total assets
|
| | | | 11,603,707 | | | | | | 35,008,621 | | | | | | 24,831,451 | | |
Debt obligations, current and long-term
|
| | | | 15,168,532 | | | | | | 21,961,828 | | | | | | 14,677,949 | | |
Redeemable preferred stock, common stock and noncontrolling interests
|
| | | | 24,704,011 | | | | | | 27,321,311 | | | | | | 17,396,626 | | |
Total stockholders’ equity (deficit)
|
| | | | (45,151,218 ) | | | | | | (54,873,803 ) | | | | | | (37,864,873 ) | | |
| | |
Year ended September 30,
|
| |
Six months ended March 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2015
|
| |
2016
|
| ||||||||||||
IPCA collaboration
|
| | | $ | 1,439,472 | | | | | $ | 1,702,377 | | | | | $ | 691,511 | | | | | $ | 210,866 | | |
Liomont collaboration
|
| | | | 34,091 | | | | | | 341,280 | | | | | | 150,148 | | | | | | 1,191,132 | | |
Huahai collaboration
|
| | | | 7,576,979 | | | | | | 3,175,580 | | | | | | 2,587,790 | | | | | | 587,790 | | |
| | | | $ | 9,050,542 | | | | | $ | 5,219,237 | | | | | $ | 3,429,449 | | | | | $ | 1,989,788 | | |
|
| | |
Year ended September 30,
|
| |
Six months ended March 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2015
|
| |
2016
|
| ||||||||||||
Milestone payments
|
| | | $ | 7,000,000 | | | | | $ | 2,500,000 | | | | | $ | 2,500,000 | | | | | $ | 1,000,000 | | |
Recognition of deferred revenues
|
| | | | 1,300,542 | | | | | | 1,919,237 | | | | | | 929,449 | | | | | | 989,788 | | |
Research and development payments
|
| | | | 750,000 | | | | | | 800,000 | | | | | | — | | | | | | — | | |
| | | | $ | 9,050,542 | | | | | $ | 5,219,237 | | | | | $ | 3,429,449 | | | | | $ | 1,989,788 | | |
|
| | |
Six months ended March 31,
|
| | | | | | | |||||||||
| | |
2015
|
| |
2016
|
| |
Change
|
| |||||||||
| | |
(Unaudited)
|
| | | | | | | |||||||||
Collaboration revenues
|
| | | $ | 3,429,449 | | | | | $ | 1,989,788 | | | | | $ | (1,439,661 ) | | |
Operating expenses: | | | | | |||||||||||||||
Research and development
|
| | | | 15,994,499 | | | | | | 16,872,253 | | | | | | 877,754 | | |
General and administrative
|
| | | | 5,579,929 | | | | | | 4,484,717 | | | | | | (1,095,212 ) | | |
| | | | | 21,574,428 | | | | | | 21,356,970 | | | | | | (217,458 ) | | |
Loss from operations
|
| | | | (18,144,979 ) | | | | | | (19,367,182 ) | | | | | | (1,222,203 ) | | |
Interest expense
|
| | | | 1,063,509 | | | | | | 936,910 | | | | | | (126,599 ) | | |
Loss before income taxes
|
| | | | (19,208,488 ) | | | | | | (20,304,092 ) | | | | | | (1,095,604 ) | | |
Income tax expense (benefit)
|
| | | | (319,855 ) | | | | | | 102,500 | | | | | | 422,355 | | |
Net loss
|
| | | $ | (18,888,633 ) | | | | | $ | (20,406,592 ) | | | | | $ | (1,517,959 ) | | |
|
| | |
Six months ended
March 31, |
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(Unaudited)
|
| |||||||||
Preclinical and clinical development
|
| | | $ | 7,474,624 | | | | | $ | 10,555,088 | | |
Compensation and related benefits
|
| | | | 4,499,087 | | | | | | 7,654,906 | | |
Stock-based compensation
|
| | | | 3,734,993 | | | | | | (1,924,806 ) | | |
Regulatory filings and other
|
| | | | 285,795 | | | | | | 587,065 | | |
Total research and development expenses
|
| | | $ | 15,994,499 | | | | | $ | 16,872,253 | | |
|
| | |
Six months ended
March 31, |
| |||||||||
| | |
2015
|
| |
2016
|
| ||||||
| | |
(Unaudited)
|
| |||||||||
ONS-3010
|
| | | $ | 3,350,397 | | | | | $ | 6,679,178 | | |
ONS-1045
|
| | | | 3,314,520 | | | | | | 3,820,518 | | |
Other research and development
|
| | | | 1,095,502 | | | | | | 642,457 | | |
Personnel related and stock-based compensation
|
| | | | 8,234,080 | | | | | | 5,730,100 | | |
Total research and development expenses
|
| | | $ | 15,994,499 | | | | | $ | 16,872,253 | | |
|
| | |
Six months ended
March 31, |
| |||||||||
|
| |
2015
|
| |
2016
|
| ||||||
Professional fees
|
| | | $ | 760,709 | | | | | $ | 2,270,714 | | |
Compensation and related benefits
|
| | | | 1,213,956 | | | | | | 1,726,896 | | |
Stock-based compensation
|
| | | | 3,440,787 | | | | | | (31,529 ) | | |
Fees and other
|
| | | | 164,477 | | | | | | 518,636 | | |
Total general and administration expenses
|
| | | $ | 5,579,929 | | | | | $ | 4,484,717 | | |
|
| | |
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,
|
| |
Six months ended March 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2015
|
| |
2016
|
| ||||||||||||
| | | | | | | | | | | | | | |
(Unaudited)
|
| |||||||||
Net cash used in operating activities
|
| | | $ | (7,020,469 ) | | | | | $ | (27,476,200 ) | | | | | $ | (6,426,563 ) | | | | | $ | (19,070,494 ) | | |
Net cash used in investing activities
|
| | | | (2,366,772 ) | | | | | | (8,804,244 ) | | | | | | (2,020,557 ) | | | | | | (317,293 ) | | |
Net cash provided by financing activities
|
| | | | 11,474,146 | | | | | | 43,002,106 | | | | | | 6,523,628 | | | | | | 13,159,006 | | |
Net increase (decrease) in cash
|
| | | $ | 2,086,905 | | | | | $ | 6,721,662 | | | | | $ | (1,923,492 ) | | | | | $ | (6,228,781 ) | | |
|
| | |
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,
|
| |
Six months ended March 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2015
|
| |
2016
|
| ||||||||||||
Research and development
|
| | | $ | 671,745 | | | | | $ | 5,817,830 | | | | | $ | 3,734,993 | | | | | $ | (1,924,806 ) | | |
General and administrative
|
| | | | 3,286,735 | | | | | | 5,360,028 | | | | | | 3,440,787 | | | | | | (31,649 ) | | |
| | | | $ | 3,958,480 | | | | | $ | 11,177,858 | | | | | $ | 7,175,780 | | | | | $ | (1,956,455 ) | | |
|
| | |
Year ended September 30,
|
| |
Six months ended March 31,
|
| ||||||||||||||||||
| | |
2014
|
| |
2015
|
| |
2015
|
| |
2016
|
| ||||||||||||
Equity-classified compensation
|
| | | $ | 2,764,878 | | | | | $ | 8,925 | | | | | $ | 4,462 | | | | | $ | (4,348,317 ) | | |
Liability-classified compensation
|
| | | | 1,193,602 | | | | | | 11,168,933 | | | | | | 7,171,318 | | | | | | 2,391,862 | | |
| | | | $ | 3,958,480 | | | | | $ | 11,177,858 | | | | | $ | 7,175,780 | | | | | $ | (1,956,455 ) | | |
|
|
|
| |
|
|
Adverse Event
|
| |
ONS-3010
N (%) |
| |
EU-Humira
N (%) |
| |
U.S.-Humira
N (%) |
| |||||||||
Burning sensation
|
| | | | 12 (18.2 ) | | | | | | 29 (43.9 ) | | | | | | 31 (47.0 ) | | |
Headache
|
| | | | 29 (43.9 ) | | | | | | 20 (30.3 ) | | | | | | 27 (39.4 ) | | |
Nasopharyngitis
|
| | | | 12 (18.2 ) | | | | | | 19 (28.8 ) | | | | | | 12 (18.2 ) | | |
Name
|
| |
Age
|
| |
Position(s)
|
| |||
Executive Officers | | | | | | | | | | |
Pankaj Mohan, Ph.D.
|
| | | | 52 | | | | Chairman, President and Chief Executive Officer | |
Kenneth M. Bahrt, M.D.
|
| | | | 63 | | | | Chief Medical Officer | |
Kogan Bao, Ph.D.
|
| | | | 47 | | | | Vice President, Analytical Sciences | |
Scott A. Gangloff
|
| | | | 42 | | | | Senior Vice President, Development & Manufacturing | |
Lawrence A. Kenyon
|
| | | | 51 | | | | Chief Financial Officer and Secretary | |
Stephen J. McAndrew, Ph.D.
|
| | | | 62 | | | |
Senior Vice President, Business Strategy & Development
|
|
Elizabeth A. Yamashita
|
| | | | 55 | | | | Vice President, Regulatory Affairs | |
Non-Employee Directors | | | | | | | | | | |
Todd C. Brady, M.D., Ph.D.
(1)(3)
|
| | | | 44 | | | | Director | |
Scott Canute
(2)
|
| | | | 55 | | | | Director | |
Albert D. Dyrness
(2)(3)
|
| | | | 53 | | | | Director | |
Donald J. Griffith
|
| | | | 67 | | | | Director | |
Kurt J. Hilzinger
(1)(2)
|
| | | | 56 | | | | Director | |
Robin Smith Hoke
(1)(3)
|
| | | | 53 | | | | Director | |
Name
|
| |
Fees Earned
or Paid in Cash (1) ($) |
| |
Total
($) |
| ||||||
Todd C. Brady, M.D., Ph.D.
|
| | | | 100,000 | | | | | | 100,000 | | |
Scott Canute
|
| | | | 100,000 | | | | | | 100,000 | | |
Board Committee
|
| |
Chairperson Fee
|
| |
Member Fee
|
| ||||||
Audit Committee
|
| | | $ | 15,000 | | | | | $ | 7,500 | | |
Compensation Committee
|
| | | | 10,000 | | | | | | 5,000 | | |
Nominating and Corporate Governance Committee
|
| | | | 8,000 | | | | | | 4,000 | | |
Name and Principal Position
|
| |
Year
|
| |
Salary
($) |
| |
Bonus
($) (1) |
| |
Equity Plan
Awards ($) (2) |
| |
All Other
Compensation ($) (3) |
| |
Total
($) |
| |||||||||||||||
Pankaj Mohan, Ph.D.
Chairman, President and Chief Executive Officer |
| | | | 2015 | | | | | | 290,004 | | | | | | | | | — | | | | | | 29,839 | | | | | | 319,843 | | |
Kenneth M. Bahrt, M.D.
(4)
Chief Medical Officer |
| | | | 2015 | | | | | | 65,542 | | | | | | | | | 644,000 | | | | | | 6,881 | | | | | | 716,423 | | |
Elizabeth A. Yamashita
Vice President, Regulatory Affairs |
| | | | 2015 | | | | | | 235,746 | | | | | | | | | — | | | | | | 15,809 | | | | | | 251,555 | | |
| | | | | | | | |
Equity Awards
(1)
|
| |||||||||||||||||||||
| | |
Grant Date
|
| |
Number of
Securities Underlying Unexercised PSUs Exercisable (#) |
| |
Equity
Incentive Plan Awards: Number of Securities Underlying Unexercised Unearned PSUs (#) |
| |
Exercise
Price ($) |
| |
Expiration
Date |
| |||||||||||||||
Pankaj Mohan, Ph.D.
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Kenneth M. Bahrt, M.D.
|
| | | | 6/22/2015 | | | | | | 28,985 (2) | | | | | | — | | | | | | 3.45 | | | | | | 6/22/2025 | | |
Elizabeth A. Yamashita
|
| | | | 6/30/2015 | | | | | | 48,695 (3) | | | | | | — | | | | | | 3.45 | | | | | | 6/30/2024 | | |
Related Party
|
| |
# of Shares of
Series A Redeemable Preferred Stock Converted |
| |
# of Shares of
Common Stock Received Upon Conversion |
| |
# of Shares of
DE Series A Preferred Stock Received Upon Conversion |
|
Mr. Canute
|
| |
250 shares
|
| |
72,463 shares
|
| |
351 shares
|
|
Dr. Brady
|
| |
100 shares
|
| |
28,985 shares
|
| |
141 shares
|
|
Dr. Mohan’s immediate family
|
| |
150 shares
|
| |
43,478 shares
|
| |
212 shares
|
|
Mr. Gangloff’s immediate family
|
| |
55 shares
|
| |
15,942 shares
|
| |
79 shares
|
|
Mr. Griffith’s immediate family
|
| |
35 shares
|
| |
10,144 shares
|
| |
50 shares
|
|
Related Party
|
| |
# of Series A
Redeemable Preferred Stock Repurchased |
| |
Cash Received
|
| |
Principal
Amount of 4% Promissory Notes Received |
| |||||||||
Dr. Mohan
|
| | | | 175 | | | | | $ | — | | | | | $ | 423,003 | | |
Mr. Canute
|
| | | | 900 | | | | | $ | 500,000 | | | | | $ | 1,511,384 | | |
Mr. Griffith and his immediate family
|
| | | | 165 | | | | | $ | 130,000 | | | | | $ | 247,068 | | |
Mr. Gangloff’s immediate family
|
| | | | 45 | | | | | $ | 90,000 | | | | | $ | 12,580 | | |
Mr. Dyrness’ affiliate
|
| | | | 100 | | | | | $ | 200,000 | | | | | $ | 35,107 | | |
Related Party
|
| |
Restricted Stock
|
| |
PSUs
|
| ||||||
Mr. Gangloff
|
| | | | 115,942 | | | | | | 129,855 | | |
Mr. Griffith
|
| | | | 144,927 | | | | | | 162,318 | | |
Dr. McAndrew
|
| | | | 57,971 | | | | | | 64,927 | | |
Ms. Yamashita
|
| | | | 43,478 | | | | | | 48,695 | | |
Name of Beneficial Owner
|
| |
Number
|
| |
Percentage of Shares
Beneficially Owned |
| ||||||
Five Percent Stockholders (other than directors and officers): | | | | ||||||||||
Strides Pharma (UK) Limited
(1)
|
| | | | 1,739,130 | | | | | | 7.6 % | | |
Sabby Management, LLC
(2)
|
| | | | 2,227,998 | | | | | | 9.9 % | | |
Named Executive Officers and Directors: | | | | ||||||||||
Pankaj Mohan, Ph.D.,
Chairman, President and Chief Executive Officer
(3)
|
| | | | 7,488,678 | | | | | | 32.8 % | | |
Kenneth M. Bahrt, M.D.,
Chief Medical Officer
(4)
|
| | | | 4,000 | | | | | | * | | |
Elizabeth A. Yamashita,
Vice President, Regulatory Affairs
(5)
|
| | | | — | | | | | | — | | |
Todd C. Brady, M.D., Ph.D.,
Director
(6)
|
| | | | 124,303 | | | | | | * | | |
Scott Canute,
Director
(7)
|
| | | | 130,963 | | | | | | * | | |
Albert D. Dyrness,
Director
(8)
|
| | | | — | | | | | | — | | |
Donald J. Griffith,
Director
(9)
|
| | | | — | | | | | | — | | |
Kurt J. Hilzinger,
Director
(10)
|
| | | | — | | | | | | — | | |
Robin Smith Hoke,
Director
(11)
|
| | | | — | | | | | | — | | |
All executive officers and directors as a group (13 persons)
|
| | | | 7,747,944 | | | | | | 34.0 % | | |
| | |
Page
|
| |||
Audited Financial Statements | | | | | | | |
| | | | F-2 | | | |
| | | | F-3 | | | |
| | | | F-4 | | | |
| | | | F-5 | | | |
| | | | F-7 | | | |
| | | | F-8 | | | |
Unaudited Interim Financial Statements | | | | | | | |
| | | | F-28 | | | |
| | | | F-29 | | | |
| | | | F-30 | | | |
| | | | F-31 | | | |
| | | | F-32 | | |
| | |
September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Assets | | | | ||||||||||
Current assets: | | | | ||||||||||
Cash
|
| | | $ | 2,349,313 | | | | | $ | 9,070,975 | | |
Accounts receivable
|
| | | | — | | | | | | 20,000 | | |
Stock subscription receivable
|
| | | | — | | | | | | 4,280,149 | | |
Prepaid and other current assets
|
| | | | 797,279 | | | | | | 1,793,109 | | |
Total current assets
|
| | | | 3,146,592 | | | | | | 15,164,233 | | |
Property and equipment, net
|
| | | | 8,009,564 | | | | | | 17,759,938 | | |
Restricted cash
|
| | | | 211,452 | | | | | | 213,663 | | |
Deferred offering costs
|
| | | | — | | | | | | 960,563 | | |
Other assets
|
| | | | 236,099 | | | | | | 910,224 | | |
Total assets
|
| | | $ | 11,603,707 | | | | | $ | 35,008,621 | | |
Liabilities, redeemable preferred stock, common stock, noncontrolling interests and stockholders’ equity (deficit)
|
| | | ||||||||||
Current liabilities: | | | | ||||||||||
Current portion of debt
|
| | | $ | 725,706 | | | | | $ | 742,646 | | |
Current portion of capital lease obligations
|
| | | | 132,090 | | | | | | 862,849 | | |
Current portion of stockholder notes
|
| | | | 10,624,784 | | | | | | 14,214,196 | | |
Accounts payable
|
| | | | 3,101,445 | | | | | | 11,563,055 | | |
Accrued expenses
|
| | | | 2,560,279 | | | | | | 5,924,648 | | |
Income taxes payable
|
| | | | 1,564,411 | | | | | | 1,754,629 | | |
Deferred revenue
|
| | | | 1,501,416 | | | | | | 1,979,576 | | |
Total current liabilities
|
| | | | 20,210,131 | | | | | | 37,041,599 | | |
Long-term debt
|
| | | | 3,653,038 | | | | | | 2,922,764 | | |
Capital lease obligations
|
| | | | 32,914 | | | | | | 1,219,373 | | |
Stockholder notes
|
| | | | — | | | | | | 2,000,000 | | |
Deferred revenue
|
| | | | 6,313,342 | | | | | | 6,365,945 | | |
Stock-based compensation liability
|
| | | | 1,557,789 | | | | | | 12,726,722 | | |
Other liabilities
|
| | | | 283,700 | | | | | | 284,710 | | |
Total liabilities
|
| | | | 32,050,914 | | | | | | 62,561,113 | | |
Commitments (Note 9) | | | | ||||||||||
Redeemable preferred stock, common stock and noncontrolling interests: | | | | ||||||||||
Redeemable preferred stock, no par value:
|
| | | ||||||||||
Series A – 8,000 shares authorized; 3,681 and 3,568 shares issued and outstanding at September 30, 2014 and 2015, respectively; (liquidation preference of $5,072,653 at September 30, 2015)
|
| | | | 4,787,996 | | | | | | 5,072,653 | | |
Series B – 4,000 shares authorized; 4,000 shares issued and outstanding; (liquidation preference of $5,118,208 at September 30, 2015)
|
| | | | 4,589,872 | | | | | | 5,118,208 | | |
Redeemable common stock – 1,739,130 shares issued and outstanding
|
| | | | 12,225,096 | | | | | | 15,426,673 | | |
Redeemable noncontrolling interests
|
| | | | 3,101,047 | | | | | | 1,703,777 | | |
Total redeemable preferred stock, common stock and noncontrolling interests
|
| | | | 24,704,011 | | | | | | 27,321,311 | | |
Stockholders’ equity (deficit): | | | | ||||||||||
Common stock, no par value; 100,000,000 shares authorized; 7,670,783 and 9,436,294 shares issued
and outstanding at September 30, 2014 and 2015, respectively; actual |
| | | | — | | | | | | 39,844,900 | | |
Additional paid-in capital
|
| | | | — | | | | | | — | | |
Accumulated deficit
|
| | | | (45,151,218 ) | | | | | | (94,064,286 ) | | |
Total Oncobiologics, Inc. stockholders’ equity (deficit)
|
| | | | (45,151,218 ) | | | | | | (54,219,386 ) | | |
Noncontrolling interests
|
| | | | — | | | | | | (654,417 ) | | |
Total stockholders’ equity (deficit)
|
| | | | (45,151,218 ) | | | | | | (54,873,803 ) | | |
Total liabilities, redeemable preferred stock, common stock, noncontrolling interests and stockholders’
equity (deficit) |
| | | $ | 11,603,707 | | | | | $ | 35,008,621 | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Collaboration revenues
|
| | | $ | 9,050,542 | | | | | $ | 5,219,237 | | |
Operating expenses: | | | | ||||||||||
Research and development
|
| | | | 14,124,631 | | | | | | 38,876,040 | | |
General and administrative
|
| | | | 7,318,314 | | | | | | 12,905,823 | | |
| | | | | 21,442,945 | | | | | | 51,781,863 | | |
Loss from operations
|
| | | | (12,392,403 ) | | | | | | (46,562,626 ) | | |
Interest expense
|
| | | | 901,052 | | | | | | 2,297,339 | | |
Loss before income taxes
|
| | | | (13,293,455 ) | | | | | | (48,859,965 ) | | |
Income tax expense (benefit)
|
| | | | 439,018 | | | | | | (190,111 ) | | |
Net loss
|
| | | | (13,732,473 ) | | | | | | (48,669,854 ) | | |
Less: Net loss attributable to noncontrolling interests
|
| | | | — | | | | | | (1,276,571 ) | | |
Net loss attributable to Oncobiologics, Inc.
|
| | | | (13,732,473 ) | | | | | | (47,393,283 ) | | |
Accretion of redeemable preferred stock and noncontrolling interests
|
| | | | (3,588,996 ) | | | | | | (4,306,488 ) | | |
Deemed dividends upon the repurchase of Series A redeemable preferred stock and redeemable noncontrolling interests
|
| | | | (3,336,855 ) | | | | | | (1,298,631 ) | | |
Net loss attributable to common stockholders of Oncobiologics, Inc.
|
| | | $ | (20,658,324 ) | | | | | $ | (52,998,402 ) | | |
Per share information: | | | | ||||||||||
Net loss per share of common stock, basic and diluted
|
| | | $ | (2.43 ) | | | | | $ | (5.43 ) | | |
Weighted-average shares outstanding, basic and diluted
|
| | | | 8,509,654 | | | | | | 9,753,616 | | |
Pro forma net loss per share of common stock – basic and diluted (unaudited)
|
| | | | | | | | | $ | (3.35 ) | | |
Pro forma weighted average shares outstanding (unaudited)
|
| | | | | | | | | | 14,143,696 | | |
|
| | |
Redeemable Preferred Stock, Common Stock and Noncontrolling Interests
|
| | |
Stockholders’ Equity (Deficit)
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Preferred Stock
|
| |
Common Stock
|
| |
Noncontrolling
Interests |
| | |
Common Stock
|
| |
Accumulated
Deficit |
| |
Noncontrolling
Interests |
| |
Total
Stockholders’ Equity (Deficit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Series A
|
| |
Series B
|
| | | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |||||||||||||||||||||||||||||||||||||||||||||||||
Balance at October 1, 2013
|
| | | | 6,995 | | | | | $ | 8,226,922 | | | | | | 3,600 | | | | | $ | 3,067,039 | | | | | | — | | | | | $ | — | | | | | $ | 2,829,733 | | | | | | | 9,665,786 | | | | | $ | — | | | | | $ | (22,608,182 ) | | | | | $ | — | | | | | $ | (22,608,182 ) | | |
Sale of redeemable common stock, net of issuance
costs |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,739,130 | | | | | | 10,895,000 | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Sale of Series B redeemable preferred stock and common stock, net of issuance costs
|
| | | | — | | | | | | — | | | | | | 400 | | | | | | 252,000 | | | | | | — | | | | | | — | | | | | | — | | | | | | | 115,942 | | | | | | 148,000 | | | | | | — | | | | | | — | | | | | | 148,000 | | |
Issuance of restricted stock
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | 90,869 | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Repurchase of restricted stock in exchange for notes
payable |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | (636,376 ) | | | | | | (148,000 ) | | | | | | (949,750 ) | | | | | | — | | | | | | (1,097,750 ) | | |
Exchange of restricted stock for performance-based stock units
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | (602,463 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Reclassification of equity classified stock-based compensation
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (364,187 ) | | | | | | — | | | | | | (364,187 ) | | |
Employee tax witholdings related to
the vesting of restricted stock |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | (2,831 ) | | | | | | — | | | | | | (23,153 ) | | | | | | — | | | | | | (23,153 ) | | |
Repurchase of common stock
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | (960,144 ) | | | | | | — | | | | | | (3,312,500 ) | | | | | | — | | | | | | (3,312,500 ) | | |
Repurchase of Series A redeemable
preferred stock and deemed dividends |
| | | | (3,314 ) | | | | | | (4,155,679 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (3,336,855 ) | | | | | | — | | | | | | (3,336,855 ) | | |
Stock-based compensation
expense |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | 2,764,878 | | | | | | — | | | | | | — | | | | | | 2,764,878 | | |
Accretion of redeemable preferred stock, common stock and noncontrolling interests
|
| | | | — | | | | | | 716,753 | | | | | | — | | | | | | 1,270,833 | | | | | | — | | | | | | 1,330,096 | | | | | | 271,314 | | | | | | | — | | | | | | (2,764,878 ) | | | | | | (824,118 ) | | | | | | — | | | | | | (3,588,996 ) | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (13,732,473 ) | | | | | | — | | | | | | (13,732,473 ) | | |
Balance at September 30, 2014
|
| | | | 3,681 | | | | | | 4,787,996 | | | | | | 4,000 | | | | | | 4,589,872 | | | | | | 1,739,130 | | | | | | 12,225,096 | | | | | | 3,101,047 | | | | | | | 7,670,783 | | | | | | — | | | | | | (45,151,218 ) | | | | | | — | | | | | | (45,151,218 ) | | |
| | |
Redeemable Preferred Stock, Common Stock and Noncontrolling Interests
|
| | |
Stockholders’ Equity (Deficit)
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Preferred Stock
|
| |
Common Stock
|
| |
Noncontrolling
Interests |
| | |
Common Stock
|
| |
Accumulated
Deficit |
| |
Noncontrolling
Interests |
| |
Total
Stockholders’ Equity (Deficit) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Series A
|
| |
Series B
|
| | | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |||||||||||||||||||||||||||||||||||||||||||||||||
Distribution of common stock in Sonnet Biotherapeutics, Inc. to stockholders
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (221,154 ) | | | | | | 221,154 | | | | | | — | | |
Contributions to noncontrolling interests
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | 401,000 | | | | | | 401,000 | | |
Repurchase of Series A redeemable
preferred stock and deemed dividends |
| | | | (113 ) | | | | | | (142,370 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (83,631 ) | | | | | | — | | | | | | (83,631 ) | | |
Repurchase of redeemable noncontrolling interests and deemed dividends
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,546,818 ) | | | | | | | — | | | | | | — | | | | | | (1,215,000 ) | | | | | | — | | | | | | (1,215,000 ) | | |
Forfeitures of restricted stock
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
Sale of common stock, net of issuance costs
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | 1,765,511 | | | | | | 44,142,463 | | | | | | — | | | | | | — | | | | | | 44,142,463 | | |
Accretion of redeemable preferred stock, common stock and noncontrolling interests
|
| | | | — | | | | | | 427,027 | | | | | | — | | | | | | 528,336 | | | | | | — | | | | | | 3,201,577 | | | | | | 149,548 | | | | | | | — | | | | | | (4,306,488 ) | | | | | | — | | | | | | — | | | | | | (4,306,488 ) | | |
Stock-based compensation
expense |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | 8,925 | | | | | | — | | | | | | — | | | | | | 8,925 | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (47,393,283 ) | | | | | | (1,276,571 ) | | | | | | (48,669,854 ) | | |
Balance at September 30, 2015
|
| | | | 3,568 | | | | | $ | 5,072,653 | | | | | | 4,000 | | | | | $ | 5,118,208 | | | | | | 1,739,130 | | | | | $ | 15,426,673 | | | | | $ | 1,703,777 | | | | | | | 9,436,294 | | | | | $ | 39,844,900 | | | | | $ | (94,064,286 ) | | | | | $ | (654,417 ) | | | | | $ | (54,873,803 ) | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Operating activities: | | | | ||||||||||
Net loss
|
| | | $ | (13,732,473 ) | | | | | $ | (48,669,854 ) | | |
Adjustments to reconcile net loss to net cash used in operating activities:
|
| | | ||||||||||
Depreciation and amortization
|
| | | | 878,477 | | | | | | 1,824,600 | | |
Non-cash interest expense
|
| | | | 12,264 | | | | | | 12,264 | | |
Stock-based compensation
|
| | | | 3,958,480 | | | | | | 11,177,858 | | |
Changes in operating assets and liabilities:
|
| | | ||||||||||
Accounts receivable
|
| | | | — | | | | | | (20,000 ) | | |
Prepaid expenses and other current assets
|
| | | | (719,302 ) | | | | | | (1,021,852 ) | | |
Other assets
|
| | | | (84,330 ) | | | | | | (322,729 ) | | |
Accounts payable
|
| | | | (96,403 ) | | | | | | 6,580,722 | | |
Accrued expenses
|
| | | | 598,266 | | | | | | 2,240,800 | | |
Income taxes payable
|
| | | | 1,084,921 | | | | | | 190,218 | | |
Deferred revenue
|
| | | | 949,458 | | | | | | 530,763 | | |
Other liabilities
|
| | | | 130,173 | | | | | | 1,010 | | |
Net cash used in operating activities
|
| | | | (7,020,469 ) | | | | | | (27,476,200 ) | | |
Investing activities: | | | | ||||||||||
Purchase of property and equipment
|
| | | | (2,366,772 ) | | | | | | (8,804,244 ) | | |
Net cash used in investing activities
|
| | | | (2,366,772 ) | | | | | | (8,804,244 ) | | |
Financing activities: | | | | ||||||||||
Proceeds from the sale of Series B redeemable preferred stock
|
| | | | 252,000 | | | | | | — | | |
Repurchase of Series A redeemable preferred stock
|
| | | | (4,128,000 ) | | | | | | (226,001 ) | | |
Proceeds from the sale of redeemable common stock
|
| | | | 10,895,000 | | | | | | — | | |
Proceeds from the sale of common stock
|
| | | | 148,000 | | | | | | 41,249,998 | | |
Proceeds from the sale of equity in noncontrolling interest
|
| | | | — | | | | | | 401,000 | | |
Payments of capital leases obligations
|
| | | | (193,973 ) | | | | | | (686,676 ) | | |
Proceeds from debt
|
| | | | 2,460,434 | | | | | | — | | |
Repayment of debt
|
| | | | (753,531 ) | | | | | | (725,598 ) | | |
Proceeds from stockholder notes
|
| | | | 6,000,000 | | | | | | 10,880,252 | | |
Repayment of stockholder notes
|
| | | | (3,125,000 ) | | | | | | (7,888,658 ) | | |
Change in restricted cash
|
| | | | (3,383 ) | | | | | | (2,211 ) | | |
Payment of employee tax witholdings related to the vesting of restricted stock
|
| | | | (23,153 ) | | | | | | — | | |
Payment of financing costs
|
| | | | (54,248 ) | | | | | | — | | |
Net cash provided by financing activities
|
| | | | 11,474,146 | | | | | | 43,002,106 | | |
Net increase in cash
|
| | | | 2,086,905 | | | | | | 6,721,662 | | |
Cash at beginning of year
|
| | | | 262,408 | | | | | | 2,349,313 | | |
Cash at end of year
|
| | | $ | 2,349,313 | | | | | $ | 9,070,975 | | |
Supplemental disclosure of cash flow information | | | | | | | | | | | | | |
Cash paid for interest
|
| | | $ | 817,965 | | | | | $ | 1,402,209 | | |
Cash paid for taxes
|
| | | $ | 1,750 | | | | | $ | 2,250 | | |
Supplemental schedule of noncash investing activities: | | | | ||||||||||
Purchases of property and equipment in accounts payable and accrued expenses
|
| | | $ | (215,907 ) | | | | | $ | (2,770,730 ) | | |
Supplemental schedule of noncash financing activities: | | | | ||||||||||
Accretion of redeemable preferred stock
|
| | | $ | 3,588,996 | | | | | $ | 4,306,488 | | |
Deemed dividend upon repurchase of Series A redeemable preferred stock in excess of carrying value
|
| | | $ | (3,336,855 ) | | | | | $ | (1,298,631 ) | | |
Reclassification of equity classified stock-based compensation
|
| | | $ | (364,187 ) | | | | | $ | — | | |
Issuance of notes upon repurchase of restricted stock and common stock
|
| | | $ | 4,410,250 | | | | | $ | — | | |
Issuance of subscription receivable upon sale of common stock
|
| | | $ | — | | | | | $ | (4,280,149 ) | | |
Distribution of common stock in Sonnet Biotherapeutics Inc. to stockholders
|
| | | $ | — | | | | | $ | (221,154 ) | | |
Issuance of capital lease obligations in connection with purchase of property and
equipment |
| | | $ | 215,908 | | | | | $ | 2,603,894 | | |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses
|
| | | $ | — | | | | | $ | 2,310,961 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Series A redeemable preferred stock
|
| | | | 1,066,956 | | | | | | 1,034,181 | | |
Series B redeemable preferred stock
|
| | | | 1,159,418 | | | | | | 1,159,418 | | |
Unvested shares of restricted common stock
|
| | | | 32,463 | | | | | | — | | |
Convertible stockholder note
|
| | | | — | | | | | | 96,618 | | |
| Numerator: | | | |||||
|
Net loss applicable to common stockholders of Oncobiologics, Inc.
|
| | | $ | (52,998,402 ) | | |
|
Effect of pro forma adjustments:
|
| | |||||
|
Accretion of redeemable preferred stock and noncontrolling interests
|
| | | | 4,306,488 | | |
|
Deemed dividends
|
| | | | 1,298,631 | | |
|
Pro forma net loss attributable to common stockholders of Oncobiologics,
Inc. |
| | | $ | (47,393,283 ) | | |
| Denominator: | | | |||||
|
Weighted-average common shares outstanding
|
| | | | 9,753,616 | | |
|
Effect of pro forma adjustments:
|
| | |||||
|
Exchange of Series A and Series B redeemable preferred stock
|
| | | | 2,193,599 | | |
|
Exchange of Parilis Preferred Units
|
| | | | 226,663 | | |
|
Conversion of Series A Preferred Stock liquidation value
|
| | | | 1,969,818 | | |
|
Shares used in computing unaudited pro forma weighted-average basic and diluted common shares outstanding
|
| | | | 14,143,696 | | |
|
Unaudited pro forma basic and diluted net loss per common share
|
| | | $ | (3.35 ) | | |
|
| | |
September 30, 2014
|
|||||||||||||||
| | |
(Level 1)
|
| |
(Level 2)
|
| |
(Level 3)
|
|||||||||
Liabilities | | | | | ||||||||||||||
Stock-based compensation liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 1,557,789 | |
|
| | |
September 30, 2015
|
|||||||||||||||
| | |
(Level 1)
|
| |
(Level 2)
|
| |
(Level 3)
|
|||||||||
Liabilities | | | | | ||||||||||||||
Stock-based compensation liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 12,726,722 | |
|
|
Balance at October 1, 2013
|
| | | $ | — | | |
|
Issued
|
| | | | 364,187 | | |
|
Change in fair value
|
| | | | 1,193,602 | | |
|
Balance at September 30, 2014
|
| | | | 1,557,789 | | |
|
Change in fair value
|
| | | | 11,168,933 | | |
|
Balance at September 30, 2015
|
| | | $ | 12,726,722 | | |
|
| | |
September 30,
|
| |||
| | |
2014
|
| |
2015
|
|
Risk-free interest rate
|
| |
1.8%
|
| |
1.4%
|
|
Derived service period
|
| |
5 years
|
| |
5 years
|
|
Expected volatility
|
| |
60%
|
| |
60%
|
|
Annual dividend yield
|
| |
0%
|
| |
0%
|
|
Fair value of common stock
|
| |
$7.62 per share
|
| |
$25.79 per share
|
|
| | |
September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Laboratory equipment
|
| | | $ | 6,847,970 | | | | | $ | 10,936,364 | | |
Leasehold improvements
|
| | | | 2,756,291 | | | | | | 9,889,521 | | |
Computer software and hardware
|
| | | | 224,150 | | | | | | 402,075 | | |
Construction in process
|
| | | | — | | | | | | 175,425 | | |
| | | | | 9,828,411 | | | | | | 21,403,385 | | |
Less: accumulated depreciation and amortization
|
| | | | (1,818,847 ) | | | | | | (3,643,447 ) | | |
| | | | $ | 8,009,564 | | | | | $ | 17,759,938 | | |
|
|
2016
|
| | | $ | 1,087,192 | | |
|
2017
|
| | | | 1,053,748 | | |
|
2018
|
| | | | 295,010 | | |
| | | | | | 2,435,950 | | |
|
Less: amounts representing interest
|
| | | | (353,728 ) | | |
|
Less: current portion
|
| | | | (862,849 ) | | |
|
Capital lease obligations, excluding current portion
|
| | | $ | 1,219,373 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Compensation
|
| | | $ | 1,907,684 | | | | | $ | 2,321,508 | | |
Research and development
|
| | | | 170,513 | | | | | | 951,759 | | |
Interest payable
|
| | | | 106,940 | | | | | | 806,475 | | |
Deferred offering costs
|
| | | | — | | | | | | 657,892 | | |
Professional fees
|
| | | | 131,668 | | | | | | 594,572 | | |
Director fees
|
| | | | 239,420 | | | | | | 414,421 | | |
Other accrued expenses
|
| | | | 4,054 | | | | | | 178,021 | | |
| | | | $ | 2,560,279 | | | | | $ | 5,924,648 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Series A repurchase notes
|
| | | $ | 3,014,534 | | | | | $ | 800,534 | | |
Parilis Series A repurchase notes
|
| | | | — | | | | | | 2,275,818 | | |
Restricted stock repurchase notes
|
| | | | 1,097,750 | | | | | | 1,097,750 | | |
Common stock repurchase note
|
| | | | 2,812,500 | | | | | | 2,812,500 | | |
Convertible note
|
| | | | — | | | | | | 2,000,000 | | |
Working capital notes
|
| | | | 3,700,000 | | | | | | 7,227,594 | | |
| | | | | 10,624,784 | | | | | | 16,214,196 | | |
Less current portion
|
| | | | (10,624,784 ) | | | | | | (14,214,196 ) | | |
Stockholder notes, excluding current portion
|
| | | $ | — | | | | | $ | 2,000,000 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Term loans-Bank
|
| | | $ | 3,935,574 | | | | | $ | 3,404,759 | | |
Equipment loans
|
| | | | 528,876 | | | | | | 334,093 | | |
Unamortized debt discount
|
| | | | (85,706 ) | | | | | | (73,442 ) | | |
| | | | | 4,378,744 | | | | | | 3,665,410 | | |
Less current portion
|
| | | | 725,706 | | | | | | 742,646 | | |
Long-term debt, excluding current portion
|
| | | $ | 3,653,038 | | | | | $ | 2,922,764 | | |
|
|
2016
|
| | | $ | 742,646 | | |
|
2017
|
| | | | 717,794 | | |
|
2018
|
| | | | 637,479 | | |
|
2019
|
| | | | 509,864 | | |
|
2020
|
| | | | 523,062 | | |
|
Thereafter
|
| | | | 608,007 | | |
| | | | | $ | 3,738,852 | | |
|
|
2016
|
| | | $ | 888,710 | | |
|
2017
|
| | | | 865,763 | | |
|
2018
|
| | | | 865,763 | | |
|
2019
|
| | | | 876,323 | | |
|
2020
|
| | | | 887,045 | | |
|
Thereafter
|
| | | | 643,749 | | |
| | | | | $ | 5,027,353 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Research and development
|
| | | $ | 671,745 | | | | | $ | 5,817,830 | | |
General and administrative
|
| | | | 3,286,735 | | | | | | 5,360,028 | | |
| | | | $ | 3,958,480 | | | | | $ | 11,177,858 | | |
|
| | |
September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Equity-classified compensation
|
| | | $ | 2,764,878 | | | | | $ | 8,925 | | |
Liability-classified compensation
|
| | | | 1,193,602 | | | | | | 11,168,933 | | |
| | | | $ | 3,958,480 | | | | | $ | 11,177,858 | | |
|
|
Balance at October 1, 2013
|
| | | | — | | |
|
Issued in exchange for restricted shares and stock options
|
| | | | 711,430 | | |
|
Additional issuances
|
| | | | 16,864 | | |
|
Forfeitures
|
| | | | (69,796 ) | | |
|
Balance at September 30, 2014
|
| | | | 658,498 | | |
|
Grants
|
| | | | 39,988 | | |
|
Forfeitures
|
| | | | (11,473 ) | | |
|
Balance at September 30, 2015
|
| | | | 687,013 | | |
|
| | |
Employees
|
| |
Non
Employees |
| |
Weighted
Average Grant Date Fair Value |
| |||||||||
Balance at October 1, 2013
|
| | | | 657,681 | | | | | | 555,217 | | | | | $ | 1.04 | | |
Granted
|
| | | | 90,869 | | | | | | — | | | | | | 5.55 | | |
Vested
|
| | | | (29,565 ) | | | | | | (2,898 ) | | | | | | 0.69 | | |
Exchange for PSUs
|
| | | | (573,478 ) | | | | | | (28,986 ) | | | | | | 1.38 | | |
Repurchased for stockholder notes
|
| | | | (115,942 ) | | | | | | (520,435 ) | | | | | | 1.35 | | |
Balance at September 30, 2014
|
| | | | 29,565 | | | | | | 2,898 | | | | | | 0.69 | | |
Vested
|
| | | | (29,565 ) | | | | | | (2,898 ) | | | | | | 0.69 | | |
Balance at September 30, 2015
|
| | | | — | | | | | | — | | | | | $ | — | | |
|
| | |
Number of
Options |
| |
Weighted
Average Exercise Price Per Share |
| ||||||
Balance at October 1, 2013
|
| | | | 31,304 | | | | | $ | 3.45 | | |
Exchange for PSUs
|
| | | | (31,304 ) | | | | | | 3.45 | | |
Balance at September 30, 2014
|
| | | | — | | | | | $ | — | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
State tax, including sale of New Jersey losses and credits
|
| | | $ | (833,403 ) | | | | | | (725,969 ) | | |
Foreign tax provision
|
| | | | 1,272,421 | | | | | | 535,858 | | |
| | | | $ | 439,018 | | | | | $ | (190,111 ) | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
U.S. federal statutory rate
|
| | | | (34.0 )% | | | | | | (34.0 )% | | |
State taxes, net of federal benefit
|
| | | | (5.1 ) | | | | | | (5.5 ) | | |
Foreign withholding tax
|
| | | | 9.6 | | | | | | 1.1 | | |
Permanent differences
|
| | | | 2.7 | | | | | | 1.8 | | |
Foreign tax credits
|
| | | | (9.6 ) | | | | | | (1.1 ) | | |
Research and development credit
|
| | | | (11.7 ) | | | | | | (6.9 ) | | |
Change in valuation allowance
|
| | | | 51.1 | | | | | | 44.6 | | |
Other
|
| | | | 0.3 | | | | | | (0.4 ) | | |
Effective income tax rate
|
| | | | 3.3 % | | | | | | (0.4 )% | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Current and long term deferred tax assets: | | | | ||||||||||
Net operating loss carryforwards
|
| | | $ | 7,340,745 | | | | | $ | 20,164,392 | | |
Stock compensation
|
| | | | 1,853,056 | | | | | | 6,317,492 | | |
Deferred revenue
|
| | | | 3,121,214 | | | | | | 3,333,201 | | |
Research and development credit carryforward
|
| | | | 2,680,441 | | | | | | 5,979,964 | | |
Foreign tax credits
|
| | | | 2,067,091 | | | | | | 2,602,949 | | |
Accruals and others
|
| | | | 1,040,117 | | | | | | 1,072,422 | | |
Gross deferred tax assets
|
| | | | (18,102,664 ) | | | | | | (39,470,420 ) | | |
Less valuation allowance
|
| | | | (17,400,409 ) | | | | | | (38,694,795 ) | | |
| | | | | 702,255 | | | | | | 775,625 | | |
Deferred tax liability: | | | | ||||||||||
Fixed assets
|
| | | | (702,255 ) | | | | | | (775,625 ) | | |
Net deferred tax assets
|
| | | $ | — | | | | | $ | — | | |
|
| | |
Year Ended September 30,
|
| |||||||||
| | |
2014
|
| |
2015
|
| ||||||
Balance at beginning of year
|
| | | $ | 479,490 | | | | | $ | 1,564,411 | | |
Additions based on tax positions related to the current year
|
| | | | 1,084,921 | | | | | | 190,218 | | |
Balance at end of year
|
| | | $ | 1,564,411 | | | | | $ | 1,754,629 | | |
|
| | |
March 31,
2016 |
| |
September 30,
2015 |
||||||
Assets
|
||||||||||||
Current assets: | | | | |||||||||
Cash
|
| | | $ | 2,842,194 | | | | | $ | 9,070,975 | |
Accounts receivable
|
| | | | 504,857 | | | | | | 20,000 | |
Stock subscription receivable
|
| | | | — | | | | | | 4,280,149 | |
Related party receivable
|
| | | | 43,187 | | | | | | — | |
Prepaid and other current assets
|
| | | | 712,767 | | | | | | 1,793,109 | |
Total current assets
|
| | | | 4,103,005 | | | | | | 15,164,233 | |
Property and equipment, net
|
| | | | 17,358,388 | | | | | | 17,759,938 | |
Restricted cash
|
| | | | 214,773 | | | | | | 213,663 | |
Deferred offering costs
|
| | | | 2,272,408 | | | | | | 960,563 | |
Other assets
|
| | | | 882,877 | | | | | | 910,224 | |
Total assets
|
| | | $ | 24,831,451 | | | | | $ | 35,008,621 | |
Liabilities, redeemable preferred stock, common stock, noncontrolling interests and stockholders’ equity (deficit)
|
||||||||||||
Current liabilities: | | | | |||||||||
Current portion of debt
|
| | | $ | 760,013 | | | | | $ | 742,646 | |
Current portion of capital lease obligations
|
| | | | 907,274 | | | | | | 862,849 | |
Current portion of stockholder notes
|
| | | | 9,653,401 | | | | | | 14,214,196 | |
Accounts payable
|
| | | | 14,416,288 | | | | | | 11,563,055 | |
Accrued expenses
|
| | | | 6,403,971 | | | | | | 5,924,648 | |
Income taxes payable
|
| | | | 1,854,629 | | | | | | 1,754,629 | |
Deferred revenue
|
| | | | 1,979,576 | | | | | | 1,979,576 | |
Total current liabilities
|
| | | | 35,975,152 | | | | | | 37,041,599 | |
Long-term debt
|
| | | | 2,547,139 | | | | | | 2,922,764 | |
Capital lease obligations
|
| | | | 810,122 | | | | | | 1,219,373 | |
Stockholder notes
|
| | | | — | | | | | | 2,000,000 | |
Deferred revenue
|
| | | | 5,376,157 | | | | | | 6,365,945 | |
Stock-based compensation liability
|
| | | | — | | | | | | 12,726,722 | |
Other liabilities
|
| | | | 591,128 | | | | | | 284,710 | |
Total liabilities
|
| | | | 45,299,698 | | | | | | 62,561,113 | |
Redeemable preferred stock, common stock and noncontrolling interests: | | | | |||||||||
Redeemable preferred stock, no par value:
|
| | | |||||||||
Series A — No shares authorized, issued and outstanding at March 31, 2016; 8,000 shares authorized; 3,568 issued and outstanding at September 30, 2015
|
| | | | — | | | | | | 5,072,653 | |
Series B — No shares authorized, issued and outstanding at March 31, 2016; 4,000 shares authorized, issued and outstanding at September 30, 2015;
|
| | | | — | | | | | | 5,118,208 | |
Redeemable common stock — 1,739,130 shares issued and outstanding
|
| | | | 17,396,626 | | | | | | 15,426,673 | |
Redeemable noncontrolling interests
|
| | | | — | | | | | | 1,703,777 | |
Total redeemable preferred stock, common stock and noncontrolling interests
|
| | | | 17,396,626 | | | | | | 27,321,311 | |
Stockholders’ equity (deficit): | | | | |||||||||
Series A preferred stock, par value $0.01 per share: 10,000,000 shares authorized, 11,819 shares issued and outstanding at March 31, 2016 (liquidation preference of $11,819,000 at March 31, 2016); No shares authorized, issued and outstanding at September 30, 2015
|
| | | | 118 | | | | | | — | |
Common stock, par value $0.01 per share; 100,000,000 shares authorized at March 31, 2016; 12,427,164 shares issued and outstanding at March 31, 2016; No shares authorized, issued and outstanding at September 30, 2015
|
| | | | 124,272 | | | | | | — | |
Common stock, no shares authorized issued and oustanding at March 31, 2016; no par value; 100,000,000 shares authorized; 9,436,294 shares issued and outstanding at September 30, 2015
|
| | | | — | | | | | | 39,844,900 | |
Additional paid-in capital
|
| | | | 76,481,615 | | | | | | — | |
Accumulated deficit
|
| | | | (114,470,878 ) | | | | | | (94,064,286 ) | |
Total Oncobiologics, Inc. stockholders’ equity (deficit)
|
| | | | (37,864,873 ) | | | | | | (54,219,386 ) | |
Non controlling interests
|
| | | | — | | | | | | (654,417 ) | |
Total stockholders’ equity (deficit)
|
| | | | (37,864,873 ) | | | | | | (54,873,803 ) | |
Total liabilities, redeemable preferred stock, common stock, noncontrolling interests and stockholders’ equity (deficit)
|
| | | $ | 24,831,451 | | | | | $ | 35,008,621 | |
|
| | |
Three Months Ended March 31,
|
| |
Six Months Ended March 31,
|
| ||||||||||||||||||
| | |
2016
|
| |
2015
|
| |
2016
|
| |
2015
|
| ||||||||||||
Collaboration revenues
|
| | | $ | 994,894 | | | | | $ | 494,894 | | | | | $ | 1,989,788 | | | | | $ | 3,429,449 | | |
Operating expenses: | | | | | | ||||||||||||||||||||
Research and development
|
| | | | 4,138,277 | | | | | | 10,154,469 | | | | | | 16,872,253 | | | | | | 15,994,499 | | |
General and administrative
|
| | | | (189,438 ) | | | | | | 4,342,090 | | | | | | 4,484,717 | | | | | | 5,579,929 | | |
| | | | | 3,948,839 | | | | | | 14,496,559 | | | | | | 21,356,970 | | | | | | 21,574,428 | | |
Loss from operations
|
| | | | (2,953,945 ) | | | | | | (14,001,665 ) | | | | | | (19,367,182 ) | | | | | | (18,144,979 ) | | |
Interest expense, net
|
| | | | 537,935 | | | | | | 705,929 | | | | | | 936,910 | | | | | | 1,063,509 | | |
Loss before income taxes
|
| | | | (3,491,880 ) | | | | | | (14,707,594 ) | | | | | | (20,304,092 ) | | | | | | (19,208,488 ) | | |
Income tax expense (benefit)
|
| | | | 50,500 | | | | | | (726,218 ) | | | | | | 102,500 | | | | | | (319,855 ) | | |
Net loss
|
| | | | (3,542,380 ) | | | | | | (13,981,376 ) | | | | | | (20,406,592 ) | | | | | | (18,888,633 ) | | |
Accretion of redeemable preferred stock and noncontrolling interests
|
| | | | (1,030,414 ) | | | | | | (1,034,529 ) | | | | | | (1,969,953 ) | | | | | | (2,105,693 ) | | |
Deemed dividends upon the repurchase of Series A redeemable preferred stock and redeemable noncontrolling interests
|
| | | | — | | | | | | (67,633 ) | | | | | | — | | | | | | (1,298,631 ) | | |
Net loss attributable to common stockholders of Oncobiologics, Inc.
|
| | | $ | (4,572,794 ) | | | | | $ | (15,083,538 ) | | | | | $ | (22,376,545 ) | | | | | $ | (22,292,957 ) | | |
Per share information: | | | | | | ||||||||||||||||||||
Net loss per share of common stock, basic and diluted
|
| | | $ | (0.32 ) | | | | | $ | (1.61 ) | | | | | $ | (1.64 ) | | | | | $ | (2.38 ) | | |
Weighted average shares outstanding, basic and diluted
|
| | | | 14,155,081 | | | | | | 9,377,450 | | | | | | 13,605,331 | | | | | | 9,377,450 | | |
|
| | |
Redeemable Preferred Stock, Common Stock and Noncontrolling Interests
|
| | |
Stockholders’ Equity (Deficit)
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Preferred Stock
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
Additional
Paid-in Capital |
| |
Accumulated
Deficit |
| |
Noncontrolling
Interests |
| |
Total
Stockholders’ Equity (Deficit) |
| |||||||||||||||||||||||||||||||||
| | |
Series A
|
| |
Series B
|
| |
Common Stock
|
| |
Noncontrolling
Interests |
| | |
Series A Preferred Stock
|
| |
Common Stock
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| | |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |
Shares
|
| |
Amount
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Balance at October 1,
2015 |
| | | | 3,568 | | | | | $ | 5,072,653 | | | | | | 4,000 | | | | | $ | 5,118,208 | | | | | | 1,739,130 | | | | | $ | 15,426,673 | | | | | $ | 1,703,777 | | | | | | | — | | | | | $ | — | | | | | | 9,436,294 | | | | | $ | 39,844,900 | | | | | $ | — | | | | | $ | (94,064,286 ) | | | | | $ | (654,417 ) | | | | | $ | (54,873,803 ) | | |
Deconsolidation of Sonnet Biotherapeutics, Inc.
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 654,417 | | | | | | 654,417 | | |
Employee tax witholdings related to the vesting of restricted stock
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | (2,782 ) | | | | | | (71,760 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | (71,760 ) | | |
Reincorporation to a Delaware Corporation
|
| | | | (3,568 ) | | | | | | (5,072,653 ) | | | | | | (4,000 ) | | | | | | (5,118,208 ) | | | | | | — | | | | | | — | | | | | | — | | | | | | | 10,193 | | | | | | 102 | | | | | | 2,193,601 | | | | | | (39,656,869 ) | | | | | | 49,847,628 | | | | | | — | | | | | | — | | | | | | 10,190,861 | | |
Issuance of common stock upon the dissolution of Parilis
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,703,777 ) | | | | | | | 1,626 | | | | | | 16 | | | | | | 226,663 | | | | | | 2,267 | | | | | | 1,701,494 | | | | | | — | | | | | | — | | | | | | 1,703,777 | | |
Sale of common stock, net of
issuance costs |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | 573,388 | | | | | | 5,734 | | | | | | 16,132,179 | | | | | | — | | | | | | — | | | | | | 16,137,913 | | |
Reclassification of
stock-based compensation liability |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 15,118,584 | | | | | | — | | | | | | — | | | | | | 15,118,584 | | |
Stock-based compensation expense
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (4,348,317 ) | | | | | | — | | | | | | — | | | | | | (4,348,317 ) | | |
Accretion of redeemable common stock
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 1,969,953 | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (1,969,953 ) | | | | | | — | | | | | | — | | | | | | (1,969,953 ) | | |
Net loss
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (20,406,592 ) | | | | | | — | | | | | | (20,406,592 ) | | |
Balance at March 31,
2016 |
| | | | — | | | | | $ | — | | | | | | — | | | | | $ | — | | | | | | 1,739,130 | | | | | $ | 17,396,626 | | | | | $ | — | | | | | | | 11,819 | | | | | $ | 118 | | | | | | 12,427,164 | | | | | $ | 124,272 | | | | | $ | 76,481,615 | | | | | $ | (114,470,878 ) | | | | | $ | — | | | | | $ | (37,864,873 ) | | |
|
| | |
Six Months Ended March 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
OPERATING ACTIVITIES | | | | ||||||||||
Net loss
|
| | | $ | (20,406,592 ) | | | | | $ | (18,888,633 ) | | |
Adjustments to reconcile net loss to net cash used in operating activities:
|
| | | ||||||||||
Depreciation and amortization
|
| | | | 1,192,074 | | | | | | 441,071 | | |
Non-cash interest expense
|
| | | | 6,090 | | | | | | 6,105 | | |
Stock-based compensation
|
| | | | (1,956,455 ) | | | | | | 7,175,780 | | |
Loss on disposal of fixed assets
|
| | | | 13,647 | | | | | | — | | |
Changes in operating assets and liabilities:
|
| | | ||||||||||
Accounts receivable
|
| | | | (484,857 ) | | | | | | (1,072,910 ) | | |
Prepaid expenses and other current assets
|
| | | | 1,080,342 | | | | | | 263,667 | | |
Other assets
|
| | | | 27,347 | | | | | | (100,000 ) | | |
Accounts payable
|
| | | | 1,878,794 | | | | | | 3,344,446 | | |
Accrued expenses
|
| | | | 156,677 | | | | | | 732,247 | | |
Income taxes payable
|
| | | | 100,000 | | | | | | 151,113 | | |
Deferred revenue
|
| | | | (989,788 ) | | | | | | 1,520,551 | | |
Other liabilities
|
| | | | 312,227 | | | | | | — | | |
Net cash used in operating activities
|
| | | | (19,070,494 ) | | | | | | (6,426,563 ) | | |
INVESTING ACTIVITIES | | | | ||||||||||
Purchase of property and equipment
|
| | | | (317,293 ) | | | | | | (2,020,557 ) | | |
Net cash used in investing activities
|
| | | | (317,293 ) | | | | | | (2,020,557 ) | | |
FINANCING ACTIVITIES
|
| | | ||||||||||
Repurchase of Series A redeemable preferred stock
|
| | | | — | | | | | | (226,001 ) | | |
Proceeds from the sale of common stock
|
| | | | 16,137,913 | | | | | | — | | |
Proceeds from subscriptions receivable
|
| | | | 4,280,149 | | | | | | — | | |
Proceeds from stockholders notes
|
| | | | — | | | | | | 8,380,252 | | |
Payments of capital leases obligations
|
| | | | (443,326 ) | | | | | | (254,869 ) | | |
Repayment of debt
|
| | | | (364,348 ) | | | | | | (375,754 ) | | |
Payment of deferred offering costs
|
| | | | (200,000 ) | | | | | | — | | |
Repayment of stockholder notes
|
| | | | (6,560,795 ) | | | | | | (1,000,000 ) | | |
Change in restricted cash
|
| | | | (1,110 ) | | | | | | — | | |
Proceeds from related party receivable
|
| | | | 783,374 | | | | | | — | | |
Deconsolidation of Sonnet Biotherapeutics, Inc.
|
| | | | (401,091 ) | | | | | | — | | |
Payment of employee tax witholdings related to the vesting of restricted stock
|
| | | | (71,760 ) | | | | | | — | | |
Net cash provided by financing activities
|
| | | | 13,159,006 | | | | | | 6,523,628 | | |
Net decrease in cash
|
| | | | (6,228,781 ) | | | | | | (1,923,492 ) | | |
Cash at beginning of period
|
| | | | 9,070,975 | | | | | | 2,349,313 | | |
Cash at end of period
|
| | | $ | 2,842,194 | | | | | $ | 425,821 | | |
Supplemental disclosure of cash flow information
|
| | | ||||||||||
Cash paid for interest
|
| | | $ | 794,663 | | | | | $ | 855,446 | | |
Cash paid for taxes
|
| | | $ | 2,500 | | | | | $ | 2,250 | | |
Supplemental schedule of noncash investing activities: | | | | ||||||||||
Purchases of property and equipment in accounts payable and accrued expenses
|
| | | $ | 635,341 | | | | | $ | 2,769,817 | | |
Supplemental schedule of noncash financing activities: | | | | ||||||||||
Accretion of redeemable preferred stock, common stock and noncontrolling interests
|
| | | $ | 1,969,953 | | | | | $ | 2,105,693 | | |
Deemed dividend upon repurchase of Series A redeemable preferred stock in excess of carrying value
|
| | | $ | — | | | | | $ | 1,215,000 | | |
Issuance of common and series A preferred stock to redeemable preferred stockholders and
noncontrolling interests upon reincorporation |
| | | $ | (11,894,638 ) | | | | | $ | — | | |
Reclassification of equity classified stock-based compensation
|
| | | $ | (15,118,584 ) | | | | | $ | — | | |
Issuance of capital lease obligations in connection with purchase of property and
equipment |
| | | $ | 78,500 | | | | | $ | — | | |
Deferred offering costs and common stock issuance costs in accounts payable and accrued expenses
|
| | | $ | (1,111,845 ) | | | | | $ | — | | |
|
| | |
March 31,
|
| |||||||||
| | |
2016
|
| |
2015
|
| ||||||
Series A redeemable preferred stock
|
| | | | — | | | | | | 1,059,710 | | |
Series B redeemable preferred stock
|
| | | | — | | | | | | 1,159,418 | | |
Series A preferred stock
|
| | | | 984,899 | | | | | | — | | |
Performance-based stock units
|
| | | | 247,887 | | | | | | — | | |
Restricted stock units
|
| | | | 1,066,039 | | | | | | — | | |
Unvested shares of restricted common stock
|
| | | | — | | | | | | 32,463 | | |
Convertible stockholder note
|
| | | | 96,618 | | | | | | 96,618 | | |
| | |
September 30, 2015
|
| |||||||||||||||
| | |
(Level 1)
|
| |
(Level 2)
|
| |
(Level 3)
|
| |||||||||
Liabilities | | | | | |||||||||||||||
Stock-based compensation liability
|
| | | $ | — | | | | | $ | — | | | | | $ | 12,726,722 | | |
|
|
Balance at October 1, 2015
|
| | | $ | 12,726,722 | | |
|
Change in fair value
|
| | | | 2,391,862 | | |
|
Reclassification to stockholders’ equity
|
| | | | (15,118,584 ) | | |
|
Balance at March 31, 2016
|
| | | $ | — | | |
|
| | |
September 30,
2015 |
|
Risk-free interest rate
|
| |
1.4%
|
|
Derived service period
|
| |
5 years
|
|
Expected volatility
|
| |
60%
|
|
Annual dividend yield
|
| |
0%
|
|
Fair value of common stock
|
| |
$25.79 per share
|
|
| | |
March 31,
2016 |
| |
September 30,
2015 |
| ||||||
Laboratory equipment
|
| | | $ | 10,840,204 | | | | | $ | 10,936,364 | | |
Leasehold improvements
|
| | | | 9,927,614 | | | | | | 9,889,521 | | |
Computer software and hardware
|
| | | | 409,684 | | | | | | 402,075 | | |
Construction in process
|
| | | | 940,621 | | | | | | 175,425 | | |
| | | | | 22,118,123 | | | | | | 21,403,385 | | |
Less: accumulated depreciation and amortization
|
| | | | (4,759,735 ) | | | | | | (3,643,447 ) | | |
| | | | $ | 17,358,388 | | | | | $ | 17,759,938 | | |
|
| | |
March 31,
2016 |
| |
September 30,
2015 |
| ||||||
Compensation
|
| | | $ | 3,137,855 | | | | | $ | 2,321,508 | | |
Research and development
|
| | | | 1,679,473 | | | | | | 951,759 | | |
Interest payable
|
| | | | 682,538 | | | | | | 806,475 | | |
Deferred offering costs
|
| | | | 450,648 | | | | | | 657,892 | | |
Professional fees
|
| | | | 280,333 | | | | | | 594,572 | | |
Director fees
|
| | | | — | | | | | | 414,421 | | |
Other accrued expenses
|
| | | | 173,124 | | | | | | 178,021 | | |
| | | | $ | 6,403,971 | | | | | $ | 5,924,648 | | |
|
| | |
Three months ended March 31,
|
| |
Six months ended March 31,
|
| ||||||||||||||||||
| | |
2016
|
| |
2015
|
| |
2016
|
| |
2015
|
| ||||||||||||
Research and development
|
| | | $ | (3,281,214 ) | | | | | $ | 3,650,718 | | | | | $ | (1,924,806 ) | | | | | $ | 3,734,993 | | |
General and administrative
|
| | | | (1,165,275 ) | | | | | | 3,379,388 | | | | | | (31,649 ) | | | | | | 3,440,787 | | |
| | | | $ | (4,446,489 ) | | | | | $ | 7,030,106 | | | | | $ | (1,956,455 ) | | | | | $ | 7,175,780 | | |
|
| | |
Three months ended March 31,
|
| |
Six months ended March 31,
|
| ||||||||||||||||||
| | |
2016
|
| |
2015
|
| |
2016
|
| |
2015
|
| ||||||||||||
Equity-classified compensation
|
| | | $ | (4,446,489 ) | | | | | $ | 2,231 | | | | | $ | (4,348,317 ) | | | | | $ | 4,462 | | |
Liability-classified compensation
|
| | | | — | | | | | | 7,027,875 | | | | | | 2,391,862 | | | | | | 7,171,318 | | |
| | | | $ | (4,446,489 ) | | | | | $ | 7,030,106 | | | | | $ | (1,956,455 ) | | | | | $ | 7,175,780 | | |
|
| | |
Number
of PSUs |
| |
Base
Price Per PSU |
| ||||||
Balance at October 1, 2015
|
| | | | 687,013 | | | | | $ | 3.45 | | |
Forfeitures
|
| | | | (4,346 ) | | | | | | 3.45 | | |
Exchanged for restricted stock units
|
| | | | (434,780 ) | | | | | | 3.45 | | |
Balance at March 31, 2016
|
| | | | 247,887 | | | | | $ | 6.33 | | |
|
| | |
Number
of RSUs |
| |
Grant Date
Fair Value |
| ||||||
Balance at October 1, 2015
|
| | | | — | | | | | $ | — | | |
Granted | | | | | 674,890 | | | | | | 29.05 | | |
Forfeitures | | | | | (154 ) | | | | | | 29.05 | | |
Issued in connection with PSU exchange
|
| | | | 391,303 | | | | | | 29.05 | | |
Balance at March 31, 2016
|
| | | | 1,066,039 | | | | | $ | 29.05 | | |
|
Item
|
| |
Amount to
be paid |
| |||
SEC registration fee
|
| | | $ | 957.91 | | |
Legal fees and expenses
|
| | | | 35,000 | | |
Accounting fees and expenses
|
| | | | 15,000 | | |
Printing and miscellaneous expenses
|
| | | | 24,042.09 | | |
Total
|
| | | $ | 75,000 | | |
|
| | | | ONCOBIOLOGICS, INC. | | |||
| | | | By: | | | /s/ Pankaj Mohan | |
| | | | | | | Pankaj Mohan, Ph.D. | |
| | | | | | | Chairman, President and Chief Executive Officer | |
|
Signature
|
| |
Title
|
| |
Date
|
|
|
/s/ Pankaj Mohan
Pankaj Mohan, Ph.D.
|
| |
Chairman, President and Chief Executive Officer
(Principal Executive Officer) |
| |
June 30, 2016
|
|
|
/s/ Lawrence A. Kenyon
Lawrence A. Kenyon
|
| |
Chief Financial Officer
(Principal Accounting and Financial Officer) |
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June 30, 2016
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/s/ Todd C. Brady
Todd C. Brady, M.D., Ph.D.
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Director
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June 30, 2016
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/s/ Scott Canute
Scott Canute
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Director
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June 30, 2016
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/s/ Albert D. Dyrness
Albert D. Dyrness
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Director
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June 30, 2016
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/s/ Donald J. Griffith
Donald J. Griffith
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Director
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June 30, 2016
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/s/ Kurt J. Hilzinger
Kurt J. Hilzinger
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Director
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June 30, 2016
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/s/ Robin Smith Hoke
Robin Smith Hoke
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Director
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June 30, 2016
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Exhibit
Number |
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Description
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3.1 | | | Amended and Restated Certificate of Incorporation of Oncobiologics, Inc. (incorporated by reference to Exhibit 3.1 to the Registrant’s current report on Form 8-K filed on May 19, 2016). | |
3.2 | | | Amended and Restated Bylaws of Oncobiologics, Inc. (incorporated by reference to Exhibit 3.2 to the Registrant’s current report on Form 8-K filed on May 19, 2016). | |
4.1 | | | Warrant Agreement by and between Oncobiologics, Inc. and American Stock Transfer & Trust Company LLC, as Warrant Agent dated May 18, 2016 (incorporated by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q filed on June 27, 2016). | |
4.2 | | | Form of Series A warrant certificate (included in Exhibit 4.1). | |
4.3 | | | Form of Series B warrant certificate (included in Exhibit 4.1). | |
5.1 | | | Opinion of Cooley LLP. | |
10.1 | | | Investors’ Rights Agreement by and among Oncobiologics, Inc. and certain of its stockholders, dated March 10, 2014, as amended (incorporated by reference to Exhibit 10.1 to the Registrant’s registration statement on Form S-1 filed on May 11, 2016). | |
10.2 | | | 2011 Stock Incentive Plan (incorporated by reference to Exhibit 10.2 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.3 | | | 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.3 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.4 | | | Forms of agreements and award grant notices for 2015 Equity Incentive Plan (incorporated by reference to Exhibit 10.4 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.5 | | | 2016 Employee Stock Purchase Plan (incorporated by reference to Exhibit 10.5 to the Registrant’s registration statement on Form S-1 filed on February 12, 2016). | |
10.6 | | | Employment Agreement between Oncobiologics, Inc. and Pankaj Mohan, Ph.D., dated January 1, 2011 (incorporated by reference to Exhibit 10.6 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.7 | | | Offer Letter between Oncobiologics, Inc. and Lawrence A. Kenyon, dated September 3, 2015 (incorporated by reference to Exhibit 10.7 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.8 | | | Offer Letter between Oncobiologics, Inc. and Elizabeth A. Yamashita, dated March 27, 2014 (incorporated by reference to Exhibit 10.8 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.9 | | | Offer Letter between Oncobiologics, Inc. and Kenneth Bahrt, M.D., dated June 14, 2015 (incorporated by reference to Exhibit 10.9 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.10 | | | Letter between Oncobiologics, Inc. and Todd Brady, dated September 12, 2014 (incorporated by reference to Exhibit 10.10 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.11 | | | Letter between Oncobiologics, Inc. and Scott Canute, dated October 10, 2011 (incorporated by reference to Exhibit 10.11 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.12 | | | Form of Indemnity Agreement, by and between Oncobiologics, Inc. and each of its directors and executive officers (incorporated by reference to Exhibit 10.12 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.13† | | | Research License Agreement by and between Oncobiologics, Inc. and Selexis SA, effective as of October 3, 2011, as amended by Amendment No. 1 dated as of October 9, 2014 (incorporated by reference to Exhibit 10.13 to the Registrant’s registration statement on Form S-1 filed on February 26, 2016). | |
10.14† | | | ONS-3010 Commercial License Agreement by and between Oncobiologics, Inc. and Selexis SA effective as of April 11, 2013, as amended effective as of May 21, 2014 (incorporated by reference to Exhibit 10.14 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.15† | | | ONS-1045 Commercial License Agreement by and between Oncobiologics, Inc. and Selexis SA effective as of April 11, 2013, as amended effective as of May 21, 2014 (incorporated by reference to Exhibit 10.15 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.16† | | | ONS-1050 Commercial License Agreement by and between Oncobiologics, Inc. and Selexis SA effective as of April 11, 2013, as amended effective as of May 21, 2014 (incorporated by reference to Exhibit 10.16 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.17 | | | Joint Participation Agreement by and between Oncobiologics, Inc. and Zhejiang Huahai Pharmaceutical Co., Ltd., effective as of May 6, 2013, as amended by that Amendment No. 1 and Mutual Termination Agreement re: Joint Participation Agreement, dated December 23, 2014 (incorporated by reference to Exhibit 10.17 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
Exhibit
Number |
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Description
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10.18 | | | Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of March 18, 2011 (incorporated by reference to Exhibit 10.18 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.19 | | | First Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of December 2013 (incorporated by reference to Exhibit 10.19 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.20 | | | Second Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of July 18, 2014 (incorporated by reference to Exhibit 10.20 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.21 | | | Third Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of January 16, 2015 (incorporated by reference to Exhibit 10.21 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.22 | | | Fourth Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of February 9, 2015 (incorporated by reference to Exhibit 10.22 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.23 | | | Fifth Amendment to Lease Agreement by and between Oncobiologics, Inc. and Cedar Brook 7 Corporate Center, LP, dated as of September 26, 2015 (incorporated by reference to Exhibit 10.23 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.24 | | | Lease Agreement by and between Cedar Brook East Corporate Center, LP and Oncobiologics, Inc., dated as of August 31, 2015 (incorporated by reference to Exhibit 10.24 to the Registrant’s registration statement on Form S-1 filed on January 15, 2016). | |
10.25 | | | Employment Agreement between Oncobiologics, Inc. and Pankaj Mohan, Ph.D., dated February 22, 2016 (incorporated by reference to Exhibit 10.25 to the Registrant’s registration statement on Form S-1 filed on April 27, 2016). | |
10.26 | | | Employment Agreement between Oncobiologics, Inc. and Kenneth Bahrt, M.D., dated February 22, 2016 (incorporated by reference to Exhibit 10.26 to the Registrant’s registration statement on Form S-1 filed on April 27, 2016). | |
10.27 | | | Employment Agreement between Oncobiologics, Inc. and Elizabeth A. Yamashita, dated February 24, 2016 (incorporated by reference to Exhibit 10.27 to the Registrant’s registration statement on Form S-1 filed on April 27, 2016). | |
10.28 | | | Employment Agreement between Oncobiologics, Inc. and Lawrence A. Kenyon, dated February 18, 2016 (incorporated by reference to Exhibit 10.28 to the Registrant’s registration statement on Form S-1 filed on April 27, 2016). | |
10.29 | | | Form of Amended and Restated Performance Stock Unit Agreement for 2011 Stock Incentive Plan (incorporated by reference to Exhibit 10.29 to the Registrant’s registration statement on Form S-1 filed on April 27, 2016). | |
10.30 | | | Form of Warrant to Purchase Common Stock (incorporated by reference to Exhibit 10.30 to the Registrant’s registration statement on Form S-1 filed on May 11, 2016). | |
10.31 | | | Securities Purchase Agreement between Oncobiologics, Inc. and Sabby Healthcare Master Fund Ltd., dated May 11, 2016 (incorporated by reference to Exhibit 10.1 to the Registrant’s current report on Form 8-K filed on May 19, 2016). | |
23.1 | | | Consent of independent registered public accounting firm. | |
23.2 | | | Consent of Cooley LLP (included in Exhibit 5.1). | |
24.1 | | | Power of Attorney (included on signature page). | |
101.INS | | | XBRL Instance Document | |
101.SCH | | | XBRL Taxonomy Extension Schema Document | |
101.CAL | | | XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF | | | XBRL Definition Linkbase Document | |
101.LAB | | | XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE | | | XBRL Taxonomy Extension Presentation Linkbase Document | |
Exhibit 5.1
Daniel I. Goldberg
+1 212 479 6722
dgoldberg@cooley.com
June 30, 2016
Oncobiologics, Inc.
7 Clarke Drive
Cranbury, New Jersey 08512
Ladies and Gentlemen:
You have requested our opinion, as counsel to Oncobiologics, Inc., a Delaware corporation (the “ Company ”), in connection with the filing by the Company of a Registration Statement on Form S-1 (the “ Registration Statement ”) with the Securities and Exchange Commission, including a related prospectus filed with the Registration Statement (the “ Prospectus ”), covering the registration for the offer and resale of the following securities held by the selling stockholder identified in the Prospectus: (i) 833,332 shares of common stock, par value $0.01 per share (the “ Common Stock ”) of the Company (the “ Shares ”), (ii) 416,666 Series A Warrants, each to purchase one share of Common Stock (the “ Series A Warrants ”), (iii) 416,666 Series B Warrants, each to purchase one share of Common Stock (the “ Series B Warrants ” and together with the Series A Warrants, the “ Warrants ”) and (iv) up to 416,666 shares of Common Stock issuable upon exercise of 416,666 Series A Warrants (the “ Series A Warrant Shares ”), and 416,666 shares of Common Stock issuable upon exercise of 416,666 Series B Warrants (the “ Series B Warrant Shares ” and together with the Series A Warrant Shares, the “ Warrant Shares ”). The Warrants have been issued pursuant to a Warrant Agreement between the Company and American Stock Trust & Transfer Company, LLC, as warrant agent, dated as of May 18, 2016 (the “ Warrant Agreement ”).
In connection with this opinion, we have examined and relied upon (a) the Registration Statement and the Prospectus, (b) the Company’s Amended and Restated Certificate of Incorporation and Amended and Restated Bylaws, each as currently in effect, (c) the Warrant Agreement, including the forms of the Warrants attached thereto and (d) originals or copies certified to our satisfaction of such records, documents, certificates, memoranda and other instruments as in our judgment are necessary or appropriate to enable us to render the opinion expressed below. We have undertaken no independent verification with respect to such matters. We have assumed the genuineness and authenticity of all documents submitted to us as originals, the conformity to originals of all documents submitted to us as copies thereof, the accuracy, completeness and authenticity of certificates of public officials and the due execution and delivery of all documents by persons other than the Company where due execution and delivery are a prerequisite to the effectiveness thereof. As to certain factual matters, we have relied upon a certificate of an officer of the Company and have not sought independently to verify such matters. With regard to our opinion as to the Warrant Shares, (i) we have assumed that the exercise price of the Warrants at the time of exercise is equal to or greater than the par value of the Common Stock, and (ii) we express no opinion to the extent that, notwithstanding its current reservation of shares of Common Stock, future issuances of securities, including the Warrant Shares, of the Company and/or antidilution adjustments to outstanding securities, including the Warrants, of the Company cause the Warrants to be exercisable for more shares of Common Stock than the number that then remain authorized but unissued.
Our opinion is expressed only with respect to the law of the State of New York and the General Corporation Law of the State of Delaware . We express no opinion as to whether the laws of any particular jurisdiction are applicable to the subject matter hereof. We are not rendering any opinion as to compliance with any federal or state antifraud law, rule or regulation relating to securities, or to the sale or issuance thereof.
Cooley LLP 1114 Avenue of the Americas New
York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
June 30, 2016
Page Two
On the basis of the foregoing, and in reliance thereon, we are of the opinion that: (i) the Shares have been validly issued and are fully paid and nonassessable, (ii) the Warrants constitute valid and binding obligations of the Company, subject to applicable bankruptcy, insolvency and similar laws affecting creditors’ rights generally and to equitable principles of general applicability; and (iii) the Warrant Shares, when issued and sold by the Company in accordance with the Warrant Agreement, will be validly issued, fully paid and non-assessable.
We consent to the reference to our firm under the caption “Legal Matters” in the Prospectus included in the Registration Statement and to the filing of this opinion as an exhibit to the Registration Statement.
Sincerely,
Cooley LLP
By: | /s/ Daniel I. Goldberg |
Daniel I. Goldberg |
Cooley LLP 1114 Avenue of the Americas New
York, NY 10036
t: (212) 479-6000 f: (212) 479-6275 cooley.com
Exhibit 23.1
Consent of Independent Registered Public Accounting Firm
The Board of Directors
Oncobiologics, Inc.:
We consent to the use of our report included herein and to the reference to our firm under the heading “Experts” in the prospectus. Our report dated November 16, 2015, except as to the recapitalization described in Note 3, which is as of April 26, 2016, contains an explanatory paragraph that states that Oncobiologics, Inc. has incurred recurring losses and negative cash flows from operations since inception and has an accumulated deficit at September 30, 2015 of $94.1 million and $14.2 million of indebtedness that is due on demand, which raises substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ KPMG LLP
Philadelphia, Pennsylvania
June 30, 2016