Item 1. Financial Statements.
iBio, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(In Thousands, except share and per share
amounts)
|
|
December 31,
2017
|
|
|
June 30, 2017
|
|
|
|
(Unaudited)
|
|
|
(See Note 2)
|
|
Assets
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
7,310
|
|
|
$
|
8,088
|
|
Accounts receivable – trade
|
|
|
136
|
|
|
|
175
|
|
Work in process
|
|
|
-
|
|
|
|
26
|
|
Prepaid expenses and other current assets
|
|
|
377
|
|
|
|
283
|
|
Total Current Assets
|
|
|
7,823
|
|
|
|
8,572
|
|
|
|
|
|
|
|
|
|
|
Fixed assets, net of accumulated depreciation
|
|
|
25,289
|
|
|
|
25,589
|
|
Intangible assets, net of accumulated amortization
|
|
|
1,702
|
|
|
|
1,823
|
|
Security deposit
|
|
|
26
|
|
|
|
26
|
|
Total Assets
|
|
$
|
34,840
|
|
|
$
|
36,010
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Equity
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable (related party of $83 and $87 as of December 31, 2017 and June 30, 2017, respectively)
|
|
$
|
701
|
|
|
$
|
749
|
|
Accrued expenses (related party of $911 and $650 as of December 31, 2017 and June 30, 2017, respectively)
|
|
|
1,130
|
|
|
|
924
|
|
Capital lease obligation - current portion
|
|
|
190
|
|
|
|
183
|
|
Deferred revenue
|
|
|
23
|
|
|
|
157
|
|
Total Current Liabilities
|
|
|
2,044
|
|
|
|
2,013
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligation - net of current portion
|
|
|
24,985
|
|
|
|
25,082
|
|
|
|
|
|
|
|
|
|
|
Total Liabilities
|
|
|
27,029
|
|
|
|
27,095
|
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity
|
|
|
|
|
|
|
|
|
iBio, Inc. Stockholders' Equity:
|
|
|
|
|
|
|
|
|
Preferred stock - $0.001 par value; 1,000,000 shares authorized; 1 share issued and outstanding as of both December 31, 2017 and June 30, 2017
|
|
|
-
|
|
|
|
-
|
|
Common stock - $0.001 par value; 275,000,000 and 175,000,000 shares
authorized as of December 31, 2017 and June 30, 2017, respectively,
115,318,510 and 89,118,510 shares issued and
outstanding as of
December 31, 2017 and June 30, 2017, respectively
|
|
|
115
|
|
|
|
89
|
|
Additional paid-in capital
|
|
|
87,574
|
|
|
|
80,977
|
|
Accumulated other comprehensive loss
|
|
|
(29
|
)
|
|
|
(29
|
)
|
Accumulated deficit
|
|
|
(79,848
|
)
|
|
|
(72,123
|
)
|
Total iBio, Inc. Stockholders' Equity
|
|
|
7,812
|
|
|
|
8,914
|
|
Noncontrolling interest
|
|
|
(1
|
)
|
|
|
1
|
|
Total Equity
|
|
|
7,811
|
|
|
|
8,915
|
|
Total Liabilities and Equity
|
|
$
|
34,840
|
|
|
$
|
36,010
|
|
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
iBio, Inc. and Subsidiaries
Condensed Consolidated Statements of
Operations and Comprehensive Loss
(Unaudited; In Thousands, except per share
amounts)
|
|
Three Months Ended
|
|
|
Six Months Ended
|
|
|
|
December 31,
|
|
|
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$
|
153
|
|
|
$
|
75
|
|
|
$
|
275
|
|
|
$
|
210
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (related party of $197, $206, $373 and $445), net of grant income of $0, $4, $44 and $40
|
|
|
993
|
|
|
|
1049
|
|
|
|
1,978
|
|
|
|
1,869
|
|
General and administrative (related party of $181, $187, $387 and $362)
|
|
|
2,587
|
|
|
|
2,351
|
|
|
|
5,085
|
|
|
|
4,820
|
|
Total operating expenses
|
|
|
3,580
|
|
|
|
3,400
|
|
|
|
7,063
|
|
|
|
6,689
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss
|
|
|
(3,427
|
)
|
|
|
(3,325
|
)
|
|
|
(6,788
|
)
|
|
|
(6,479
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense (related party of $479, $483, $959 and $966)
|
|
|
(479
|
)
|
|
|
(483
|
)
|
|
|
(959
|
)
|
|
|
(966
|
)
|
Interest income
|
|
|
4
|
|
|
|
12
|
|
|
|
9
|
|
|
|
25
|
|
Royalty income
|
|
|
2
|
|
|
|
4
|
|
|
|
11
|
|
|
|
16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other income (expense)
|
|
|
(473
|
)
|
|
|
(467
|
)
|
|
|
(939
|
)
|
|
|
(925
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
|
|
|
(3,900
|
)
|
|
|
(3,792
|
)
|
|
|
(7,727
|
)
|
|
|
(7,404
|
)
|
Net loss attributable to noncontrolling interest
|
|
|
1
|
|
|
|
563
|
|
|
|
2
|
|
|
|
1,114
|
|
Net loss attributable to iBio, Inc.
|
|
|
(3,899
|
)
|
|
|
(3,229
|
)
|
|
|
(7,725
|
)
|
|
|
(6.290
|
)
|
Preferred stock dividends
|
|
|
(65
|
)
|
|
|
-
|
|
|
|
(131
|
)
|
|
|
-
|
|
Net loss available to iBio, Inc.
|
|
$
|
(3,964
|
)
|
|
$
|
(3,229
|
)
|
|
$
|
(7,856
|
)
|
|
$
|
(6,290
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated net loss
|
|
$
|
(3,900
|
)
|
|
$
|
(3,792
|
)
|
|
$
|
(7,727
|
)
|
|
$
|
(7,404
|
)
|
Other comprehensive income (loss) - foreign currency translation adjustments
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss
|
|
$
|
(3,900
|
)
|
|
$
|
(3,792
|
)
|
|
$
|
(7,727
|
)
|
|
$
|
(7,404
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss per common share attributable to iBio, Inc. stockholders - basic and diluted
|
|
$
|
(0.04
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.07
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding - basic and diluted
|
|
|
96,609
|
|
|
|
89,109
|
|
|
|
96,127
|
|
|
|
89,109
|
|
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
iBio, Inc. and Subsidiaries
Condensed Consolidated Statement of Equity
Six Months Ended December 31, 2017
(Unaudited; In Thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional
|
|
|
Other
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock
|
|
|
Common Stock
|
|
|
Paid-In
|
|
|
Comprehensive
|
|
|
Accumulated
|
|
|
Noncontrolling
|
|
|
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Shares
|
|
|
Amount
|
|
|
Capital
|
|
|
Loss
|
|
|
Deficit
|
|
|
Interest
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of July 1, 2017
|
|
|
-
|
|
|
$
|
-
|
|
|
|
89,119
|
|
|
$
|
89
|
|
|
$
|
80,977
|
|
|
$
|
(29
|
)
|
|
$
|
(72,123
|
)
|
|
$
|
1
|
|
|
$
|
8,915
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sale of common stock
|
|
|
-
|
|
|
|
-
|
|
|
|
25,000
|
|
|
|
25
|
|
|
|
5,475
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
5,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs to raise capital
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(321
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(321
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitment fees for issuance of common stock
|
|
|
-
|
|
|
|
-
|
|
|
|
1,200
|
|
|
|
1
|
|
|
|
(1
|
)
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital – preferred stock
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,050
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
394
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
394
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
(7,725
|
)
|
|
|
(2
|
)
|
|
|
(7,727
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2017
|
|
|
-
|
|
|
$
|
-
|
|
|
|
115,319
|
|
|
$
|
115
|
|
|
$
|
87,574
|
|
|
$
|
(29
|
)
|
|
$
|
(79,848
|
)
|
|
$
|
(1
|
)
|
|
$
|
7,811
|
|
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
iBio, Inc. and Subsidiaries
Condensed Consolidated Statements of
Cash Flows
(Unaudited; In Thousands)
|
|
Six Months Ended
|
|
|
|
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
|
|
|
|
|
|
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
Consolidated net loss
|
|
$
|
(7,727
|
)
|
|
$
|
(7,404
|
)
|
Adjustments to reconcile consolidated net loss to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Share-based compensation
|
|
|
394
|
|
|
|
506
|
|
Amortization of intangible assets
|
|
|
169
|
|
|
|
176
|
|
Depreciation
|
|
|
679
|
|
|
|
650
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable – trade
|
|
|
39
|
|
|
|
459
|
|
Accounts receivable – unbilled
|
|
|
-
|
|
|
|
47
|
|
Work in process
|
|
|
26
|
|
|
|
(5
|
)
|
Prepaid expenses and other current assets
|
|
|
(94
|
)
|
|
|
(28
|
)
|
Security deposit
|
|
|
-
|
|
|
|
1
|
|
Accounts payable
|
|
|
(163
|
)
|
|
|
(255
|
)
|
Accrued expenses
|
|
|
206
|
|
|
|
(15
|
)
|
Deferred revenue
|
|
|
(134
|
)
|
|
|
31
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operating activities
|
|
|
(6,605
|
)
|
|
|
(5,837
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
Additions to intangible assets
|
|
|
(35
|
)
|
|
|
(226
|
)
|
Purchases of fixed assets
|
|
|
(277
|
)
|
|
|
(539
|
)
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(312
|
)
|
|
|
(765
|
)
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
Proceeds from sale of common stock
|
|
|
5,500
|
|
|
|
-
|
|
Costs to raise capital
|
|
|
(321
|
)
|
|
|
-
|
|
Proceeds from additional paid-in capital – preferred stock
|
|
|
1,050
|
|
|
|
-
|
|
Payment of capital lease obligation
|
|
|
(90
|
)
|
|
|
(83
|
)
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
6,139
|
|
|
|
(83
|
)
|
|
|
|
|
|
|
|
|
|
Net decrease in cash
|
|
|
(778
|
)
|
|
|
(6,685
|
)
|
Cash - beginning of period
|
|
|
8,088
|
|
|
|
23,014
|
|
Cash - end of period
|
|
$
|
7,310
|
|
|
$
|
16,329
|
|
|
|
|
|
|
|
|
|
|
Schedule of non-cash activities:
|
|
|
|
|
|
|
|
|
Unpaid intangible assets included in accounts payable
|
|
$
|
22
|
|
|
$
|
197
|
|
Intangible assets included in accounts payable in prior period, paid in current period
|
|
|
11
|
|
|
|
-
|
|
Fixed assets included in accounts payable in prior period, paid in current period
|
|
$
|
87
|
|
|
$
|
71
|
|
Unpaid fixed assets included in accounts payable
|
|
$
|
188
|
|
|
$
|
61
|
|
|
|
|
|
|
|
|
|
|
Supplemental cash flow information:
|
|
|
|
|
|
|
|
|
Cash paid during the period for interest
|
|
$
|
960
|
|
|
$
|
966
|
|
The accompanying notes are an integral part
of these unaudited condensed consolidated financial statements.
iBio, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial
Statements
(Unaudited)
iBio, Inc. and Subsidiaries (“iBio”
or the “Company”) is a biotechnology company focused on using our proprietary technologies and production facilities
to provide product development and manufacturing services to clients, collaborators and third-party customers as well as developing
and commercializing our own product candidates.
iBio was established as a public company
in August 2008 as the result of a spin-off from Integrated BioPharma, Inc. The Company operates in one business segment under the
direction of its Executive Chairman. The Company's wholly-owned and majority-owned subsidiaries are as follows:
iBIO DO BRASIL BIOFARMACÊUTICA
LTDA
("iBio Brazil") – iBio Brazil is a subsidiary organized in Brazil in which the Company has a 99% interest.
iBio Brazil was formed to manage and expand the Company's business activities in Brazil. The activities of iBio Brazil are intended
to include coordination and expansion of the Company's existing relationship with Fundacao Oswaldo Cruz/Fiocruz ("Fiocruz")
beyond the current Yellow Fever Vaccine program (see Note 7) and development of additional products with private sector participants
for the Brazilian market. iBio Brazil commenced operations during the first quarter of the fiscal year ended June 30, 2015.
iBio Manufacturing LLC
("iBio Manufacturing") – iBio Manufacturing, a wholly-owned subsidiary, is a Delaware limited liability company
formed in November 2015. iBio Manufacturing has not commenced any activities to date.
iBio CDMO LLC
("iBio
CDMO") – iBio CDMO is a Delaware limited liability company formed on December 16, 2015 as iBio CMO, LLC to develop and
manufacture plant-made pharmaceuticals. Effective July 1, 2017, iBio CMO changed its name to iBio CDMO. As of December 31, 2015,
the Company owned 100% of iBio CDMO. On January 13, 2016, the Company entered into a contract manufacturing joint venture with
an affiliate of Eastern Capital Limited (“Eastern”), a stockholder of the Company (the “Eastern Affiliate”).
The Eastern Affiliate contributed $15 million in cash for a 30% interest in iBio CDMO. The Company retained a 70% interest in iBio
CDMO and contributed a royalty-bearing license which grants iBio CDMO a non-exclusive license to use the Company’s proprietary
technologies for research purposes and an exclusive U.S. license for manufacturing purposes. The Company retained the exclusive
right to grant product licenses to those who wish to sell or distribute products made using the Company’s technologies.
On February 23, 2017, the Company
entered into an exchange agreement with the Eastern Affiliate, pursuant to which the Company acquired substantially all of the
interest in iBio CDMO held by the Eastern Affiliate in exchange for one share of the Company’s iBio CMO Preferred Tracking
Stock, par value $0.001 per share. After giving effect to the transaction, the Company owns 99.99% of iBio CDMO. See Note 9 for
a further discussion.
iBio CDMO’s operations
take place in Bryan, Texas in a facility controlled by another affiliate of Eastern (the “Second Eastern Affiliate”)
as sublandlord. The facility is a 139,000-square foot Class A life sciences building on the campus of Texas A&M University,
designed and equipped for plant-made manufacture of biopharmaceuticals. The Second Eastern Affiliate granted iBio CDMO a 34-year
capital lease for the facility as well as certain equipment (see Note 8). Commercial operations commenced in January 2016. iBio
CDMO expects to operate on the basis of three parallel lines of business: (1) development and manufacturing of third-party products;
(2) development and production of iBio’s proprietary product(s) for treatment of fibrotic diseases and/or other proprietary
iBio products; and (3) commercial technology transfer services including facility design, as needed.
Interim Financial Statements
The accompanying unaudited condensed consolidated
financial statements have been prepared from the books and records of the Company and include all normal and recurring adjustments
which, in the opinion of management, are necessary for a fair presentation in accordance with accounting principles generally accepted
in the United States ("U.S. GAAP") for interim financial information and Rule 8-03 of Regulation S-X promulgated by the
U.S. Securities and Exchange Commission. Accordingly, these interim financial statements do not include all of the information
and footnotes required for complete annual financial statements. Interim results are not necessarily indicative of the results
that may be expected for the full year. Interim unaudited condensed consolidated financial statements should be read in conjunction
with the audited financial statements and the notes thereto included in the Company's Annual Report on Form 10-K for the year ended
June 30, 2017, from which the accompanying condensed consolidated balance sheet dated June 30, 2017 was derived.
Principles of Consolidation
The condensed consolidated financial statements
include the accounts of the Company and its wholly-owned and majority-owned subsidiaries. All intercompany balances and transactions
have been eliminated as part of the consolidation.
Foreign Currency
The Company accounts
for foreign currency translation pursuant to Financial Accounting Standards Board ("FASB") Accounting Standards Codification
("ASC") 830, "
Foreign Currency Matters
." The functional currency of iBio Brazil is the Brazilian Real.
Under FASB ASC 830, all assets and liabilities are translated into United States dollars using the current exchange rate at the
end of each fiscal period. Revenues and expenses are translated using the average exchange rates prevailing throughout the respective
periods. All transaction gains and losses from the measurement of monetary balance sheet items denominated in Reals are reflected
in the statement of operations as appropriate. Translation adjustments are included in accumulated other comprehensive loss. For
the three and six months ended December 31, 2017 and 2016, any translation adjustments were considered immaterial and did not
have a significant impact on the Company's consolidated financial statements.
Going Concern
Since its spin-off from Integrated BioPharma,
Inc. in August 2008, the Company has incurred significant losses and negative cash flows from operations. As of December 31, 2017,
the Company's accumulated deficit was $79.8 million. For the six months ended December 31, 2017, the Company's net loss was approximately
$7.7 million and it had cash used in operating activities of $6.6 million. As of December 31, 2017, cash on hand is approximately
$7.3 million which is expected to support the Company's activities at least through May 31, 2018.
The Company has
historically financed its activities through the sale of common stock and warrants. Through December 31, 2017, the Company has
dedicated most of its financial resources to research and development, including the development and validation of its own technologies
and the development of a proprietary therapeutic product against fibrosis based upon those technologies, advancing its intellectual
property, the build-out and recommissioning of its CDMO facility, and general and administrative activities.
As of December
31, 2017, the Company has not completed development of or commercialized any vaccine or therapeutic product candidates. As such,
the Company expects to continue to incur significant expenses and operating losses for at least the next year. The Company anticipates
that its expenses and losses will increase substantially if the Company:
|
·
|
initiates clinical trials of its product candidates;
|
|
·
|
continues the research and development of its product candidates;
|
|
·
|
seeks to discover additional product candidates; and
|
|
·
|
adds operational, financial and management information systems and personnel, including personnel to support its product development and manufacturing efforts.
|
Becoming and remaining
profitable is dependent upon the Company’s ability to attract and retain customers for the development, manufacturing and
technology transfer services offered by the Company's subsidiary iBio CDMO. In addition, profitability will also depend on whether
the Company is successful at commercialization of its technologies and whether the Company, alone or with its licensees, develops
and eventually commercializes products that generate significant revenue.
On July 24, 2017, the Company entered into
a common stock purchase agreement with Lincoln Park Capital Fund, LLC ("Lincoln Park"), an Illinois limited liability
company, pursuant to which Lincoln Park has agreed to purchase from the Company up to an aggregate of $16,000,000 of the Company's
common stock (subject to certain limitations) from time to time over the 36-month term of the agreement (the "Lincoln Park
Purchase Agreement"). As a result, on July 24, 2017, 1,200,000 shares of the Company's common stock were issued to Lincoln
Park as consideration for Lincoln Park's commitment to purchase shares of its common stock under the agreement, and the Company
sold 2,500,000 shares of common stock to Lincoln Park in an initial purchase for an aggregate gross purchase price of $1,000,000.
See Note 9 for a further discussion of the transaction.
The extent to which the Company utilizes
the purchase agreement with Lincoln Park as a source of funding will depend on a number of factors, including the prevailing market
price of the Company's common stock, the volume of trading in the Company's common stock and the extent to which the Company is
able to secure funds from other sources. The number of shares that the Company may sell to Lincoln Park under the purchase agreement
on any given day and during the term of the agreement is limited. Additionally, the Company and Lincoln Park may not effect any
sales of shares of our common stock under the purchase agreement during the continuance of an event of default under the purchase
agreement.
On November 30, 2017, the Company sold 22,500,000 shares of
the Company’s common stock offered and sold pursuant to the Company’s effective shelf registration statement on Form
S-3 and an accompanying prospectus filed with the Securities and Exchange Commission (the “SEC”) on November 20, 2014,
and declared effective by the SEC on December 2, 2014, a preliminary prospectus supplement filed with the SEC on November 28, 2017,
and a final prospectus supplement filed with the SEC on November 30, 2017, in connection with the Company’s shelf takedown
relating to the offering. The net proceeds to the Company from the sale of the shares of common stock were approximately $4.2 million.
The history of significant losses, the
negative cash flow from operations, the limited cash resources currently on hand and the dependence by the Company on its ability
– about which there can be no certainty – to obtain additional financing to fund its operations after the current cash
resources are exhausted raises substantial doubt about the Company's ability to continue as a going concern. These financial statements
were prepared under the assumption that the Company will continue as a going concern and do not include any adjustments that might
result from the outcome of this uncertainty.
The Company plans to fund its future business
operations using cash on hand, through proceeds from the sale of additional equity or other securities, including sales of common
stock to Lincoln Park pursuant to the common stock purchase agreement entered into on July 24, 2017, and through proceeds realized
in connection with license and collaboration arrangements and the operation of our subsidiary, iBio CDMO.
The Company cannot be certain that such
funding will be available on favorable terms or available at all. To the extent that the Company raises additional funds by issuing
equity securities, its stockholders may experience significant dilution. If the Company is unable to raise funds when required
or on favorable terms, this assumption may no longer be operative, and the Company may have to: a) significantly delay, scale back,
or discontinue the product application and/or commercialization of its proprietary technologies; b) seek collaborators for its
technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or otherwise
dispose of rights to technologies, product candidates, or products that it would otherwise seek to develop or commercialize; or
d) possibly cease operations.
|
3.
|
Summary
of Significant Accounting Policies
|
The Company's significant accounting policies
are described in Note 3 of the Notes to Financial Statements in the Annual Report on Form 10-K for the year ended June 30, 2017.
Use of Estimates
The preparation of financial statements
in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities,
disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues
and expenses during the reporting period. These estimates include the valuation of intellectual property, legal and contractual
contingencies and share-based compensation. Although management bases its estimates on historical experience and various other
assumptions that are believed to be reasonable under the circumstances, actual results could differ from these estimates.
Revenue Recognition
The Company recognizes revenue when persuasive
evidence of an arrangement exists, delivery has occurred, the fee is fixed or determinable, and collectability is reasonably assured.
Deferred revenue represents billings to a customer to whom the services have not yet been provided.
The Company's contract revenue consists
primarily of amounts earned under contracts with third-party customers and reimbursed expenses under such contracts. The Company
analyzes its agreements to determine whether the elements can be separated and accounted for individually or as a single unit of
accounting in accordance with the Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC")
605-25, "
Revenue Arrangements with Multiple Deliverables
," and Staff Accounting Bulletin 104, "
Revenue
Recognition
." Allocation of revenue to individual elements that qualify for separate accounting is based on the separate
selling prices determined for each component, and total contract consideration is then allocated pro rata across the components
of the arrangement. If separate selling prices are not available, the Company will use its best estimate of such selling prices,
consistent with the overall pricing strategy and after consideration of relevant market factors. In Fiscal 2018 and Fiscal 2017,
the Company did not have any revenue arrangements with multiple deliverables.
The Company generates (or may generate
in the future) contract revenue under the following types of contracts:
Fixed-Fee
Under a fixed-fee contract, the
Company charges a fixed agreed upon amount for a deliverable. Fixed-fee contracts have fixed deliverables upon completion of the
project. Typically, the Company recognizes revenue for fixed-fee contracts after projects are completed, delivery is made and title
transfers to the customer, and collection is reasonably assured.
Time and Materials
Under a time and materials contract,
the Company charges customers an hourly rate plus reimbursement for other project specific costs. The Company recognizes revenue
for time and material contracts based on the number of hours devoted to the project multiplied by the customer's billing rate plus
other project specific costs incurred.
Grant Income
Grants are recognized as income
when all conditions of such grants are fulfilled or there is a reasonable assurance that they will be fulfilled. Grant income is
classified as a reduction of research and development expenses. Grant income amounted to approximately $0 and $44,000 for the three
and six months ended December 31, 2017, and approximately $4,000 and $40,000 for the three and six months ended December 31, 2016,
respectively.
Work in Process
Work in process consists primarily of the
cost of labor and other overhead incurred on contracts that have not been completed. Work in process totaled approximately $0 and
$26,000 at December 31, 2017 and June 30, 2017, respectively.
Research and Development
The Company accounts for research and development
costs in accordance with the FASB ASC 730-10, “
Research and Development
” (“ASC 730-10”). Under ASC
730-10, all research and development costs must be charged to expense as incurred. Accordingly, internal research and development
costs are expensed as incurred. Third-party research and development costs are expensed when the contracted work has been performed
or as milestone results have been achieved.
Fixed Assets
Fixed assets are stated at cost net of
accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets
ranging from three to fifteen years.
Assets held under the terms of capital
leases are included in fixed assets and are depreciated on a straight-line basis over the terms of the leases or the economic lives
of the assets. Obligations for future lease payments under capital leases are shown within liabilities and are analyzed between
amounts falling due within and after one year (see Note 5).
Intangible Assets
The Company accounts for intangible assets
at their historical cost and records amortization utilizing the straight-line method based upon their estimated useful lives. Patents
are amortized over a period of ten years and other intellectual property is amortized over a period from 16 to 23 years. The Company
reviews the carrying value of its intangible assets for impairment whenever events or changes in business circumstances indicate
the carrying amount of such assets may not be fully recoverable. Evaluating for impairment requires judgment, and recoverability
is assessed by comparing the projected undiscounted net cash flows of the assets over the remaining useful life to the carrying
amount. Impairments, if any, are based on the excess of the carrying amount over the fair value of the assets. There were no impairment
charges for the three and six months ended December 31, 2017 and 2016.
Foreign Currency
The Company accounts for foreign currency translation pursuant to FASB ASC 830, “
Foreign Currency Matters
” (“ASC
830”). The functional currency of iBio Brazil is the Brazilian Real. Under FASB ASC 830, all assets and liabilities are translated
into United States dollars using the current exchange rate at the end of each fiscal period. Revenues and expenses are translated
using the average exchange rates prevailing throughout the respective periods. All transaction gains and losses from the measurement
of monetary balance sheet items denominated in Reals are reflected in the statement of operations as appropriate. Translation adjustments
are included in accumulated other comprehensive loss.
Recently Issued Accounting Pronouncements
In May 2014, ASU No. 2014-09, "
Revenue
from Contracts with Customers
" ("ASU 2014-09") was issued, which is a new standard related to revenue recognition.
Under the new standard, recognition of revenue occurs when a customer obtains control of promised services or goods in an amount
that reflects the consideration to which the entity expects to receive in exchange for those goods or services. In addition, the
standard requires disclosure of the nature, amount, timing, and uncertainty of revenue and cash flows arising from customer contracts.
The standard must be adopted using either a full retrospective approach for all periods presented in the period of adoption or
a modified retrospective approach. In July 2015, the FASB issued ASU 2015-14, “
Revenue from Contracts with Customers -
Deferral of the Effective Date
,” which defers the implementation of this new standard to be effective for fiscal years
beginning after December 15, 2017. Early adoption is permitted effective January 1, 2017. In March 2016, the FASB issued ASU 2016-08,
“
Principal versus Agent Considerations
,” which clarifies the implementation guidance on principal versus agent
considerations in the new revenue recognition standard pursuant to ASU 2014-09. In April 2016, the FASB issued ASU 2016-10, “
Identifying
Performance Obligations and Licensing
,” and in May 2016, the FASB issued ASU 2016-12, “
Narrow-Scope Improvements
and Practical Expedients
,” which amend certain aspects of the new revenue recognition standard pursuant to ASU 2014-09.
In December 2016, the FASB issued ASU 2016-20, “
Technical Corrections and Improvements to Topic 606, Revenue from Contracts
with Customers
” to clarify the codification or to correct unintended application of guidance. In September 2017 and November
2017, the FASB issued ASU 2017-13, “
Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606),
Leases (Topic 840), and Leases (Topic 842)
” and ASU 2017-14, “
Income Statement—Reporting Comprehensive
Income (Topic 220), Revenue Recognition (Topic 605), and Revenue from Contracts with Customers (Topic 606)
” which amends
certain aspects of the new revenue recognition standard.
The new standards are effective for fiscal
years beginning after December 15, 2017 including interim periods within that reporting period (quarter ending September 30, 2018
for the Company). The Company is currently evaluating the effects of adopting the new standards on its consolidated financial
statements but the adoption is not expected to have a significant impact on the Company's consolidated financial statements as
of the filing of this report.
Effective June 30, 2017, the Company adopted
ASU 2014-15, "
Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties
about an Entity's Ability to Continue as a Going Concern
" ("ASU 2014-15"). Before the issuance of ASU
2014-15, there was no guidance in U.S. GAAP about management's responsibility to evaluate whether there is substantial doubt about
an entity's ability to continue as a going concern or to provide related footnote disclosures. This guidance is expected to reduce
the diversity in the timing and content of footnote disclosures. ASU 2014-15 requires management to assess an entity's ability
to continue as a going concern by incorporating and expanding upon certain principles that are currently in auditing standards
generally accepted in the United States of America as specified in the guidance. The adoption of ASU 2014-15 did not have a significant
impact on the Company's consolidated financial statements.
On January 1, 2017, the Company adopted
ASU 2015-17, "
Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes
" ("ASU 2015-17").
ASU 2015-17 requires deferred tax assets and liabilities to be classified as noncurrent in the consolidated balance sheet. A reporting
entity should apply the amendment prospectively or retrospectively. The adoption of ASU 2015-17 did not have a significant impact
on its consolidated financial statements as the Company continues to provide a full valuation allowance against its net deferred
tax assets.
In January 2016, the FASB issued ASU 2016-01,
"
Financial Instruments – Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial
Liabilities
" ("ASU 2016-01"). The amendments require all equity investments to be measured at fair value with
changes in the fair value recognized through net income (other than those accounted for under the equity method of accounting or
those that result in consolidation of the investee). The amendments also require an entity to present separately in other comprehensive
income the portion of the total change in the fair value of a liability resulting from a change in the instrument-specific credit
risk when the entity has elected to measure the liability at fair value in accordance with the fair value option for financial
instruments. In addition, the amendments eliminate the requirement to disclose the fair value of financial instruments measured
at amortized cost for entities that are not public business entities and the requirement to disclose the method(s) and significant
assumptions used to estimate the fair value that is required to be disclosed for financial instruments measured at amortized cost
on the balance sheet for public business entities. This guidance is effective for fiscal years beginning after December 15, 2017,
including interim periods within those fiscal years (quarter ending September 30, 2018 for the Company). The Company will evaluate
the effects of adopting ASU 2016-01 if and when it is deemed to be applicable.
In February 2016, the FASB issued ASU 2016-02,
"
Leases (Topic 842)
" ("ASU 2016-02") which supersedes existing guidance on accounting for leases in
"
Leases (Topic 840)
." The standard requires lessees to recognize the assets and liabilities that arise from
leases on the balance sheet. A lessee should recognize in the balance sheet a liability to make lease payments (the lease
liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. The new guidance
is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those fiscal years (quarter
ending September 30, 2019 for the Company). The amendments should be applied at the beginning of the earliest period presented
using a modified retrospective approach with earlier application permitted as of the beginning of an interim or annual reporting
period. The Company is currently evaluating the effects of adopting ASU 2016-02 on its consolidated financial statements.
Effective July 1, 2017, the Company adopted
ASU 2016-09, "
Improvements to Employee Share-Based Payment Accounting
" ("ASU 2016-09"). ASU 2016-09
affects entities that issue share-based payment awards to their employees. ASU 2016-09 is designed to simplify several aspects
of accounting for share-based payment award transactions which include the income tax consequences, classification of awards as
either equity or liabilities, classification on the statement of cash flows and forfeiture rate calculations. The Company will
continue to estimate forfeitures at each reporting period, rather than electing an accounting policy change to record the impact
of such forfeitures as they occur. The adoption of ASU 2016-09 did not have a significant impact on the Company's consolidated
financial statements.
In August 2016, the FASB issued ASU
2016-15, "
Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments
" ("ASU
2016-15"). ASU 2016-15 will make eight targeted changes to how cash receipts and cash payments are presented and classified
in the statement of cash flows. ASU 2016-15 is effective for fiscal years beginning after December 15, 2017, and interim periods
within those fiscal years (quarter ending September 30, 2018 for the Company). The new standard will require adoption on a retrospective
basis unless it is impracticable to apply, in which case it would be required to apply the amendments prospectively as of the earliest
date practicable. The Company is currently in the process of evaluating the impact of ASU 2016-15 on its consolidated financial
statements but the adoption is not expected to have a significant impact on the Company's consolidated financial statements as
of the filing of this report.
In October 2016, the FASB issued ASU 2016-16,
"
Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory"
("ASU 2016-16") with
the objective to improve the accounting for the income tax consequences of intra-entity transfers of assets other than inventory.
The new standard will require entities to recognize the income tax consequences of an intra-entity transfer of non-inventory asset
when the transfer occurs. The guidance is effective for fiscal years beginning after December 15, 2017, and interim periods within
those fiscal years (quarter ending September 30, 2018 for the Company). Early adoption is permitted. The Company is currently evaluating
the effects of adopting ASU 2016-16 on its consolidated financial statements but the adoption is not expected to have a significant
impact as of the filing of this report.
Effective July 1, 2017, the Company adopted
ASU 2016-17, "
Consolidation (Topic 810): Interests Held Through Related Parties That Are Under Common Control
"
("ASU 2016-17"). ASU 2016-17 amends the guidance issued with ASU 2015-02 in order to make it less likely that a single
decision maker would individually meet the characteristics to be the primary beneficiary of a Variable Interest Entity ("VIE").
When a decision maker or service provider considers indirect interests held through related parties under common control, they
perform two steps. The second step was amended with this guidance to say that the decision maker should consider interests held
by these related parties on a proportionate basis when determining the primary beneficiary of the VIE rather than in their entirety
as was called for in the previous guidance. The adoption of ASU 2016-17 did not have a significant impact on the Company's consolidated
financial statements.
In January 2017, the FASB issued ASU 2017-01,
"
Business Combinations (Topic 805): Clarifying the Definition of a Business
" ("ASU 2017-01"). ASU 2017-01
clarifies the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions
should be accounted for as acquisitions (or disposals) of assets or businesses. The definition of a business affects many areas
of accounting including acquisitions, disposals, goodwill, and consolidation. The guidance is effective for annual periods beginning
after December 15, 2017, including interim periods within those periods (quarter ending September 30, 2018 for the Company). The
Company is currently evaluating the impact of adopting ASU 2017-01 on its consolidated financial statements but the adoption is
not expected to have a significant impact as of the filing of this report.
In May 2017, the FASB issued ASU 2017-09,
"
Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting
,
"
which provides guidance
about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting
in Topic 718. This pronouncement is effective for annual reporting periods beginning after December 15, 2017, including interim
periods within those periods (quarter ending September 30, 2018 for the Company). Early adoption is permitted. The Company is currently
evaluating the effects of adopting ASU 2017-09 on its consolidated financial statements but the adoption is not expected to have
a significant impact as of the filing of this report.
Management does not believe that any other
recently issued, but not yet effective, accounting standard if currently adopted would have a material effect on the accompanying
condensed consolidated financial statements.
|
4.
|
Financial
Instruments and Fair Value Measurement
|
The carrying values of cash, accounts receivable,
prepaid expenses and other current assets, accounts payable and accrued expenses in the Company's condensed consolidated balance
sheets approximated their fair values as of December 31, 2017 and June 30, 2017 due to their short-term nature. The carrying value
of the capital lease obligation approximated its fair value as of December 31, 2017 and June 30, 2017 as the interest rate used
to discount the lease payments approximated market.
iBio CDMO is leasing its facility in Bryan,
Texas as well as certain equipment from the Second Eastern Affiliate under a 34-year sublease. See Note 8 for more details of the
terms of the sublease.
The economic substance of the sublease
is that the Company is financing the acquisition of the facility and equipment and, accordingly, the facility and equipment are
recorded as assets and the lease is recorded as a liability. As the sublease involves real estate and equipment, the Company separated
the equipment component and accounted for the facility and equipment as if each was leased separately.
The following table summarizes by category
the gross carrying value and accumulated depreciation of fixed assets (in thousands):
|
|
December 31,
2017
|
|
|
June 30,
2017
|
|
Facility under capital lease
|
|
$
|
20,000
|
|
|
$
|
20,000
|
|
Equipment under capital lease
|
|
|
6,000
|
|
|
|
6,000
|
|
Facility improvements
|
|
|
337
|
|
|
|
332
|
|
Construction in process
|
|
|
240
|
|
|
|
-
|
|
Medical equipment
|
|
|
944
|
|
|
|
905
|
|
Office equipment and software
|
|
|
351
|
|
|
|
256
|
|
|
|
|
27,872
|
|
|
|
27,493
|
|
Accumulated depreciation – assets under capital lease
|
|
|
(2,416
|
)
|
|
|
(1,805
|
)
|
Accumulated depreciation – other
|
|
|
(167
|
)
|
|
|
(99
|
)
|
|
|
|
(2,583
|
)
|
|
|
(1,904
|
)
|
Net fixed assets
|
|
$
|
25,289
|
|
|
$
|
25,589
|
|
Depreciation expense was approximately
$340,000 and $326,000 for the three months ended December 31, 2017 and 2016, respectively, and for the six months ended December
31, 2017 and 2016, depreciation expense was approximately $679,000 and $650,000, respectively. Depreciation of the assets under
the capital lease amounted to approximately $306,000 and $312,000 for the three months ended December 31, 2017 and 2016, respectively.
Depreciation of the assets under the capital lease amounted to approximately $611,000 and $623,000 for the six months ended December
31, 2017 and 2016, respectively.
The Company has two categories of intangible
assets – intellectual property and patents. Intellectual property consists of all technology, know-how, data, and protocols
for producing targeted proteins in plants and related to any products and product formulations for pharmaceutical uses and for
other applications. Intellectual property includes, but is not limited to, certain technology for the development and manufacture
of novel vaccines and therapeutics for humans and certain veterinary applications acquired in December 2003 from Fraunhofer USA
Inc., acting through its Center for Molecular Biotechnology ("Fraunhofer"), pursuant to a Technology Transfer Agreement,
as amended (the "TTA"). The Company designates such technology further developed and acquired from Fraunhofer as iBioLaunch™
technology or as iBioModulator™ technology. The value on the Company's books attributed to patents owned or controlled by
the Company is based on payments for services and fees related to the protection of the Company's patent portfolio. The intellectual
property also includes certain trademarks.
In January 2014, the Company entered into
a license agreement with a U.S. university whereby iBio acquired exclusive worldwide rights to certain issued and pending patents
covering specific candidate products for the treatment of fibrosis (the "Licensed Technology"). The license agreement
provides for payment by the Company of a license issue fee, annual license maintenance fees, reimbursement of prior patent costs
incurred by the university, payment of a milestone payment upon regulatory approval for sale of a first product, and annual royalties
on product sales. In addition, the Company has agreed to meet certain diligence milestones related to product development benchmarks.
As part of its commitment to the diligence milestones, the Company successfully commenced production of a plant-made peptide comprising
the Licensed Technology before March 31, 2014. The next milestone – filing a New Drug Application with the FDA or foreign
equivalent covering the Licensed Technology ("IND") – initially became due on December 1, 2015, and on August 11,
2016, the agreement was amended and subsequent six-month extensions have been automatically granted extending the due date until
December 31, 2017. The Company and the university have agreed to set a new milestone schedule and are currently undergoing an analysis
based on new data and revised forecasted timelines.
The Company accounts for intangible assets
at their historical cost and records amortization utilizing the straight-line method based upon their estimated useful lives. Patents
are amortized over a period of 10 years and other intellectual property is amortized over a period from 16 to 23 years. The Company
reviews the carrying value of its intangible assets for impairment whenever events or changes in business circumstances indicate
the carrying amount of such assets may not be fully recoverable. Evaluating for impairment requires judgment, and recoverability
is assessed by comparing the projected undiscounted net cash flows of the assets over the remaining useful life to the carrying
amount. Impairments, if any, are based on the excess of the carrying amount over the fair value of the assets. There were no impairment
charges during Fiscal 2018 and Fiscal 2017.
The following table summarizes by category
the gross carrying value and accumulated amortization of intangible assets (in thousands):
|
|
December 31,
2017
|
|
|
June 30,
2017
|
|
Intellectual property – gross carrying value
|
|
$
|
3,100
|
|
|
$
|
3,100
|
|
Patents – gross carrying value
|
|
|
2,394
|
|
|
|
2,346
|
|
|
|
|
5,494
|
|
|
|
5,446
|
|
Intellectual property – accumulated amortization
|
|
|
(2,166
|
)
|
|
|
(2,088
|
)
|
Patents – accumulated amortization
|
|
|
(1,626
|
)
|
|
|
(1,535
|
)
|
|
|
|
(3,792
|
)
|
|
|
(3,623
|
)
|
Net intangible assets
|
|
$
|
1,702
|
|
|
$
|
1,823
|
|
Amortization expense was approximately
$84,000 and $88,000 for the three months ended December 31, 2017 and 2016, respectively, and for the six months ended December
31, 2017 and 2016, amortization expense was $169,000 and $176,000, respectively.
Novici Biotech, LLC
In January 2012, the Company entered into
an agreement with Novici Biotech, LLC ("Novici") in which iBio's President is a minority stockholder. Novici performs
laboratory feasibility analyses of gene expression, protein purification and preparation of research samples. In addition, the
Company and Novici collaborate on the development of new technologies and product candidates for exclusive worldwide commercial
use by the Company. The accounts payable balance includes amounts due to Novici of approximately $83,000 and $87,000 at December
31, 2017 and June 30, 2017, respectively. Research and development expenses related to Novici were approximately $197,000 and $206,000
for the three months ended December 31, 2017 and 2016, respectively, and approximately $373,000 and $445,000 for the six months
ended December 31, 2017 and 2016, respectively.
Fraunhofer
Previously, Fraunhofer was the Company's
most significant vendor solely on the basis of the three-party Yellow Fever vaccine development program among Fiocruz/Bio-Manguinhos,
the Company, and Fraunhofer (described in greater detail below). The accounts payable balance under this three-party agreement
includes amounts due Fraunhofer of approximately $75,000 as of December 31, 2017 and June 30, 2017. See Note 14 – Commitments
and Contingencies.
On January 4, 2011, the Company entered
into the Collaboration and License Agreement (the "CLA") which is a three-party agreement involving the Company, Fraunhofer
and Fiocruz, a public entity, member of the Indirect Federal Public Administration and linked to the Health Ministry of Brazil,
acting through its unit Bio-Manguinhos. The CLA provides for the development of a yellow fever vaccine to be manufactured and distributed
within Latin America and Africa by Fiocruz. The CLA was supplemented by a bilateral agreement between iBio and Fraunhofer dated
December 27, 2010 in which the Company engaged Fraunhofer as a contractor to provide the research and development services (both,
together, the "Agreement"). The services are billed to Fiocruz at Fraunhofer's cost, so the Company's revenue is equivalent
to expense and there is no profit.
On June 12, 2014, Fiocruz, Fraunhofer and
iBio executed an amendment to the CLA (the "Amended Agreement") which provides for revised research and development,
work plans, reporting, objectives, estimated budget, and project billing process. For both the three and six months ended December
31, 2017, no revenue was recognized under the Amended Agreement. For the three and six months ended December 31, 2016, the Company
recognized revenue of $75,000 and $137,000, respectively, for work performed for Fiocruz pursuant to the Amended Agreement by the
Company's subcontractor, Fraunhofer, and recognized research and development expenses of the same amount due Fraunhofer for that
work. iBio and Fiocruz are currently evaluating plans for further collaboration without prospective reliance on older Fraunhofer-derived
technology and data.
In September
2013, the Company and Fraunhofer completed the Terms of Settlement for the TTA Seventh Amendment (the "Settlement Agreement").
Under the terms of the Settlement Agreement, various contractual obligations existing at June 30, 2013 were released, terminated
or modified. See Note 14 - Commitments and Contingencies for significant modifications.
On March 17, 2015, the Company filed a
Verified Complaint in the Court of Chancery of the State of Delaware against Fraunhofer and Vidadi Yusibov, Fraunhofer's Executive
Director. On November 3, 2017, the Company filed a Verified Complaint in the Court of Chancery of the State of Delaware against
Fraunhofer-Gesellschaft, the European unit of Fraunhofer. This complaint follows iBio’s pending litigation filed in March
2015 against Fraunhofer USA, Inc., the U.S. unit of Fraunhofer. See Note 14 - Lawsuits for additional information.
|
8.
|
Capital
Lease Obligation
|
As discussed above, iBio CDMO is leasing
its facility in Bryan, Texas as well as certain equipment from the Second Eastern Affiliate under a 34-year sublease (the "sublease").
iBio CDMO began operations at the facility on December 22, 2015 pursuant to agreements between iBio CDMO and the Second Eastern
Affiliate granting iBio CDMO temporary rights to access the facility. These temporary agreements were superseded by the Sublease
Agreement, dated January 13, 2016, between iBio CDMO and the Second Eastern Affiliate. The 34-year term of the sublease may be
extended by iBio CDMO for a ten-year period, so long as iBio CDMO is not in default under the sublease. Under the sublease, iBio
CDMO is required to pay base rent at an annual rate of $2,100,000, paid in equal quarterly installments on the first day of each
February, May, August and November. The base rent is subject to increase annually in accordance with increases in the Consumer
Price Index ("CPI"). The base rent under the Second Eastern Affiliate's ground lease for the property is subject to adjustment,
based on an appraisal of the property, in 2030 and upon any extension of the ground lease. The base rent under the sublease will
be increased by any increase in the base rent under the ground lease as a result of such adjustments. iBio CDMO is also responsible
for all costs and expenses in connection with the ownership, management, operation, replacement, maintenance and repair of the
property under the sublease.
In addition to the base rent, iBio CDMO
is required to pay, for each calendar year during the term, a portion of the total gross sales for products manufactured or processed
at the facility, equal to 7% of the first $5,000,000 of gross sales, 6% of gross sales between $5,000,001 and $25,000,000, 5%
of gross sales between $25,000,001 and $50,000,000, 4% of gross sales between $50,000,001 and $100,000,000, and 3% of gross sales
between $100,000,001 and $500,000,000. However, if for any calendar year period from January 1, 2018 through December 31, 2019,
iBio CDMO's applicable gross sales are less than $5,000,000, or for any calendar year period from and after January 1, 2020, its
applicable gross sales are less than $10,000,000, then iBio CDMO is required to pay the amount that would have been payable if
it had achieved such minimum gross sales and shall pay no less than the applicable percentage for the minimum gross sales for
each subsequent calendar year. Percentage rent amounted to approximately $7,000 and $29,000 for the three months ended December
31, 2017 and 2016, respectively, and $24,000 and $45,000 for the six months ended December 31, 2017 and 2016, respectively.
Interest expense incurred under the capital
lease obligation amounted to approximately $479,000 and $483,000 for the three months ended December 31, 2017 and 2016, respectively,
and $959,000 and $966,000 for the six months ended December 31, 2017 and 2016, respectively.
Future minimum payments under the capitalized
lease obligations are due as follows:
Fiscal period ending on December 31:
|
|
Principal
|
|
|
Interest
|
|
|
Total
|
|
2018
|
|
$
|
190,142
|
|
|
$
|
1,909,858
|
|
|
$
|
2,100,000
|
|
2019
|
|
|
205,025
|
|
|
|
1,894,975
|
|
|
|
2,100,000
|
|
2020
|
|
|
221,073
|
|
|
|
1,878,927
|
|
|
|
2,100,000
|
|
2021
|
|
|
238,377
|
|
|
|
1,861,623
|
|
|
|
2,100,000
|
|
2022
|
|
|
257,036
|
|
|
|
1,842,964
|
|
|
|
2,100,000
|
|
Thereafter
|
|
|
24,063,207
|
|
|
|
33,161,793
|
|
|
|
57,225,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total minimum lease payments
|
|
|
25,174,860
|
|
|
$
|
42,550,140
|
|
|
$
|
67,725,000
|
|
Less: current portion
|
|
|
(190,142
|
)
|
|
|
|
|
|
|
|
|
Long-term portion of minimum lease obligations
|
|
$
|
24,984,718
|
|
|
|
|
|
|
|
|
|
Preferred Stock
The Company's Board of Directors is authorized
to issue, at any time, without further stockholder approval, up to 1 million shares of preferred stock. The Board of Directors
has the authority to fix and determine the voting rights, rights of redemption and other rights and preferences of preferred stock.
iBio CMO Preferred Tracking Stock
On February 23, 2017, the Company entered
into an exchange agreement with the Eastern Affiliate pursuant to which the Company acquired substantially all of the interest
in iBio CDMO held by the Eastern Affiliate and issued one share of a newly created iBio CMO Preferred Tracking Stock, par value
$0.001 per share (the "Preferred Tracking Stock"), in exchange for 29,990,000 units of limited liability company interests
of iBio CDMO held by the Eastern Affiliate at an original issue price of $13 million. After giving effect to the transactions contemplated
in the Exchange Agreement, the Company owns 99.99% and the Eastern Affiliate owns 0.01% of iBio CDMO.
As described below under "
Eastern
– Share Purchase Agreements
," on January 13, 2016, the Company entered into a share purchase agreement with Eastern
which contained a three-year standstill agreement restricting additional acquisitions of the Company's equity by Eastern and its
controlled affiliates to limit its beneficial ownership of the Company's outstanding shares of common stock to a maximum of 38%,
absent the approval by a majority of the Company's Board of Directors. With respect to the standstill agreement, the Company's
Board of Directors, acting unanimously, invited the Eastern Affiliate to enter into the Exchange Agreement and approved the issuance
of one share of the Company's Preferred Tracking Stock to the Eastern Affiliate.
On February 23, 2017, the Board of Directors
of the Company created the Preferred Tracking Stock out of the Company's 1 million authorized shares of preferred stock. Terms
of the Preferred Tracking Stock include the following:
|
1.
|
The
Preferred Tracking Stock accrues dividends at the rate of 2% per annum on the original issue price. Accrued dividends are cumulative
and are payable if and when declared by the Board of Directors, upon an exchange of the shares of Preferred Tracking Stock and
upon a liquidation, winding up or deemed liquidation (such as a merger) of the Company. As of December 31, 2017, no dividends
have been declared. Accrued dividends total approximately $222,000 at December 31, 2017.
|
|
2.
|
The holders of Preferred Tracking Stock, voting separately
as a class, are entitled to approve by the affirmative vote of a majority of the shares of Preferred Tracking Stock outstanding
any amendment, alteration or repeal of any of the provisions of, or any other change to, the Certificate of Incorporation of the
Company or the Certificate of Designation that adversely affects the rights, powers or privileges of the Preferred Tracking Stock,
any increase in the number of authorized shares of Preferred Tracking Stock, the issuance or sale of any additional shares of
Preferred Tracking Stock or any securities convertible into or exercisable or exchangeable for Preferred Tracking Stock, the creation
or issuance of any shares of any additional class or series of capital stock unless the same ranks junior to the Preferred Tracking
Stock, or the reclassification or alteration of any existing security of the Company that is junior to or pari passu with the
Preferred Tracking Stock, if such reclassification or alteration would render such other security senior to the Preferred Tracking
Stock.
|
|
3.
|
Except as required by applicable law, the holders of Preferred Tracking Stock have no other voting rights.
|
|
4.
|
No dividend may be declared or paid or set aside for payment or other distribution declared or made upon the Company's common stock and no common stock may be redeemed, purchased or otherwise acquired for any consideration by the Company unless all accrued dividends on all outstanding shares of Preferred Tracking Stock are paid in full.
|
At the election of the Company or holders
of a majority outstanding shares of Preferred Tracking Stock, each outstanding share of Preferred Tracking Stock may be exchanged
for 29,990,000 units of limited liability company interests of iBio CDMO. Such exchange may be effected only after March 31, 2018,
or in connection with a winding up, liquidation or deemed liquidation (such as a merger) of the Company or iBio CDMO. In addition,
such exchange will take effect upon a change in control of iBio CDMO.
Common Stock
On December 19, 2017, the Company’s
stockholders approved an amendment of the Company’s certificate of incorporation increasing the number of authorized shares
of its common stock to 275 million. As of June 30, 2017, the Company had been authorized to issue up to 175 million shares of common
stock. In addition, as of December 31, 2017, the Company had reserved up to 15 million shares of common stock for incentive compensation
(stock options and restricted stock). No shares are reserved for the exercise of warrants.
Recent issuances of common stock include
the following:
Public offering
On November 30, 2017, the Company completed
a public offering of 22,500,000 shares of its common stock at a public offering price of $0.20 per share raising gross proceeds
of $4,500,000. The shares of common stock were issued pursuant to an underwriting agreement entered into between the Company and
Aegis Capital Corp. (“Aegis”).
The common stock was offered and sold pursuant
to the Company’s effective shelf registration statement on Form S-3 and an accompanying prospectus (Registration Statement
No. 333-200410) filed with the SEC on November 20, 2014, and declared effective by the SEC on December 2, 2014, a preliminary prospectus
supplement filed with the SEC on November 28, 2017, and a final prospectus supplement filed with the SEC on November 30, 2017,
in connection with the Company’s shelf takedown relating to the offering.
The Company paid Aegis a discount of 7%
to the public offering price with respect to shares purchased in the offering by investors who did not have a pre-existing relationship
with the Company prior to the offering (the “New Investors”), and a discount of 3.5% to the public offering price with
respect to shares purchased in the offering by investors who did have a pre-existing relationship with the Company. In addition
to the underwriting discounts, the Company issued to the Underwriter 110,000 shares of its common stock, equal to 2% of the aggregate
shares of common stock sold in the offering to the New Investors.
The Company incurred underwriting discounts,
commissions and other offering expenses of $311,000 related to closing and completion of this public offering.
Lincoln Park Purchase Agreement
On July 24, 2017, we entered into the Lincoln
Park Purchase Agreement pursuant to which Lincoln Park has agreed to purchase from us up to an aggregate of $16.0 million of the
Company's common stock (subject to certain limitations) from time to time over the 36-month term of the agreement. We also entered
into a registration rights agreement with Lincoln Park pursuant to which the Company filed with the Securities and Exchange Commission
(the "SEC") the registration statement to register for resale under the Securities Act of 1933, as amended, or the Securities
Act, the shares of common stock that have been or may be issued to Lincoln Park under the Purchase Agreement. The registration
statement was effective as of August 11, 2017.
As a result, on July 24, 2017, 1,200,000
newly issued shares of the Company's common stock, equal to three percent of the $16 million availability, were issued to Lincoln
Park as consideration for Lincoln Park's commitment to purchase shares of the Company's common stock under the agreement, and 2,500,000
newly issued shares of common stock, valued at $0.40 per share, were sold to Lincoln Park in an initial purchase for an aggregate
gross purchase price of $1,000,000.
Under the terms and subject to the conditions
of the Lincoln Park Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln
Park is obligated to purchase up to, an additional $15.0 million worth of shares of the Company's common stock. Such future sales
of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company's
option, over the 36-month term of the agreement.
As contemplated by the Lincoln Park Purchase
Agreement, and so long as the closing price of the Company's common stock exceeds $0.25 per share, then the Company may direct
Lincoln Park, at its sole discretion to purchase up to 100,000 shares of its common stock on any business day, provided that one
business day has passed since the most recent purchase. The price per share for such purchases will be equal to the lower of: (i)
the lowest sale price on the applicable purchase date and (ii) the arithmetic average of the three (3) lowest closing sale prices
for the Company's common stock during the ten (10) consecutive business days ending on the business day immediately preceding such
purchase date (in each case, to be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split
or other similar transaction that occurs on or after the date of the purchase agreement). The maximum amount of shares subject
to any single regular purchase increases as the Company's share price increases, subject to a maximum of $1.0 million.
In addition to regular purchases, the Company
may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional purchases if the closing sale
price of the common stock exceeds certain threshold prices as set forth in the purchase agreement. In all instances, the Company
may not sell shares of its common stock to Lincoln Park under the purchase agreement if it would result in Lincoln Park beneficially
owning more than 9.99% of its common stock. There are no trading volume requirements or restrictions under the purchase agreement
nor any upper limits on the price per share that Lincoln Park must pay for shares of common stock.
The Lincoln Park Purchase Agreement and
the registration rights agreement contain customary representations, warranties, agreements and conditions to completing future
sale transactions, indemnification rights and obligations of the parties. The Company has the right to terminate the purchase agreement
at any time, at no cost or penalty. During any "event of default" under the purchase agreement, all of which are outside
of Lincoln Park's control, Lincoln Park does not have the right to terminate the purchase agreement; however, the Company may not
initiate any regular or other purchase of shares by Lincoln Park, until such event of default is cured. In addition, in the event
of bankruptcy proceedings by or against the Company, the purchase agreement will automatically terminate.
Actual sales of shares of common stock
to Lincoln Park under the purchase agreement will depend on a variety of factors to be determined by the Company from time to time,
including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate
sources of funding for the Company and its operations. Lincoln Park has no right to require any sales by the Company, but is obligated
to make purchases from the Company as it directs in accordance with the purchase agreement. Lincoln Park has covenanted not to
cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of the Company's shares.
Aspire Capital – 2015 Facility
On May 15, 2015, the Company entered into
a common stock purchase agreement (the "2015 Aspire Purchase Agreement") with Aspire Capital, pursuant to which the Company
has the option to require Aspire Capital to purchase up to an aggregate of $15.0 million of shares of the Company's common stock
(the "Purchase Shares") upon and subject to the terms of the 2015 Aspire Purchase Agreement. In consideration for entering
into the purchase agreement, Aspire Capital received a commitment fee of 450,000 shares
(the "Commitment
Shares")
.
No shares have been sold under the 2015 Facility as of the date of the filing
of this report and the
2015 Aspire Purchase Agreement was terminated on July 21, 2017.
Eastern – Share Purchase Agreements
On January 13, 2016, the Company entered
into a share purchase agreement with Eastern pursuant to which Eastern agreed to purchase 3,500,000 shares of the Company's common
stock at a price of $0.622 per share. The Company received proceeds of $2,177,000 and the shares were issued on January 25, 2016.
In addition, Eastern agreed to exercise warrants it had previously acquired to purchase 1,784,000 shares of the Company's common
stock at an exercise price of $0.53 per share. The Company received proceeds of approximately $945,000 from the exercise of the
warrants and the shares were issued on January 25, 2016.
On January 13, 2016, the Company entered
into a separate share purchase agreement with Eastern pursuant to which Eastern agreed to purchase 6,500,000 shares of the Company's
common stock at a price of $0.622 per share, subject to the approval of the Company's stockholders. The Company's stockholders
approved the issuance of the 6,500,000 shares to Eastern at the Company's annual meeting on April 7, 2016. On April 13, 2016, the
Company issued the 6,500,000 shares and received proceeds of $4,043,000. These shares are subject to a three-year standstill agreement
(the “Standstill Agreement”)which will restrict additional acquisitions of the Company's equity by Eastern and its
controlled affiliates to limit its beneficial ownership of the Company's outstanding shares of common stock to a maximum of 38%,
absent the approval by a majority of the Company's Board of Directors.
On February 23, 2017, the Company entered
into an exchange agreement with the Eastern Affiliate pursuant to which the Company acquired substantially all of the interest
in iBio CDMO held by the Eastern Affiliate and issued one share of a newly created iBio CMO Preferred Tracking Stock, par value
$0.001 per share (the "Preferred Tracking Stock"), in exchange for 29,990,000 units of limited liability company interests
of iBio CDMO held by the Eastern Affiliate at an original issue price of $13 million. After giving effect to the transactions contemplated
in the Exchange Agreement, the Company owns 99.99% and the Eastern Affiliate owns 0.01% of iBio CDMO.
On November 27, 2017, the Company's Board
of Directors authorized the Company’s Chief Executive Officer to invite Eastern to purchase shares in the November 2017 public
offering described above, provided that such purchase did not result in Eastern being the beneficial owner of more than 40% of
the aggregate number of shares the Company
’
s outstanding common stock rather than the limit of 38% set forth in the
Standstill Agreement. As of the date of the filing of this report, Eastern beneficially owned approximately 40% of our outstanding
shares of common stock.
iBio CDMO
In December 2017, the Eastern Affiliate
contributed $1.05 million to iBio for working capital purposes which has been recorded as additional paid-in capital. Subsequently,
the Company contributed $3.5 million into iBio CDMO. The $3.5 million contribution has been eliminated in the consolidated financial
statements.
|
10.
|
Earnings
(Loss) Per Common Share
|
Basic earnings (loss) per common share
is computed by dividing the net income (loss) allocated to common stockholders by the weighted-average number of shares of common
stock outstanding during the period. For purposes of calculating diluted earnings (loss) per common share, the denominator includes
both the weighted-average number of shares of common stock outstanding during the period and the number of common stock equivalents
if the inclusion of such common stock equivalents is dilutive. Dilutive common stock equivalents potentially include stock options
and warrants using the treasury stock method. The following table summarizes the components of the earnings (loss) per common share
calculation (in thousands, except per share amounts):
|
|
Three Months ended
December 31,
|
|
|
Six Months ended
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Basic and diluted numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss attributable to iBio, Inc.
|
|
$
|
(3,899
|
)
|
|
$
|
(3,229
|
)
|
|
$
|
(7,725
|
)
|
|
$
|
(6,290
|
)
|
Preferred stock dividends
|
|
|
65
|
|
|
|
-
|
|
|
|
131
|
|
|
|
-
|
|
Net loss available to iBio, Inc. stockholders
|
|
$
|
(3,964
|
)
|
|
$
|
(3,229
|
)
|
|
$
|
(7,856
|
)
|
|
$
|
(6,290
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding
|
|
|
96,609
|
|
|
|
89,109
|
|
|
|
96,127
|
|
|
|
89,109
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share amount
|
|
$
|
(0.04
|
)
|
|
$
|
(0.04
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.07
|
)
|
In Fiscal 2018 and Fiscal 2017, the Company
incurred net losses which cannot be diluted; therefore, basic and diluted loss per common share are the same. As of December 31,
2017 and 2016, shares issuable which could potentially dilute future earnings included approximately 13.6 million and 12.3 million
stock options, respectively.
|
11.
|
Share-Based
Compensation
|
The following table summarizes the components
of share-based compensation expense in the condensed consolidated statements of operations (in thousands):
|
|
Three Months Ended
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
Research and development
|
|
$
|
10
|
|
|
$
|
5
|
|
General and administrative
|
|
|
179
|
|
|
|
236
|
|
Totals
|
|
$
|
189
|
|
|
$
|
241
|
|
|
|
Six Months Ended
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
Research and development
|
|
$
|
24
|
|
|
$
|
11
|
|
General and administrative
|
|
|
370
|
|
|
|
495
|
|
Totals
|
|
$
|
394
|
|
|
$
|
506
|
|
Stock Options
On August 12, 2008, the Company adopted
the 2008 Omnibus Equity Incentive Plan (the “Plan”) for employees, officers, directors and external service providers.
The Plan provided that the Company may grant options to purchase stock and/or make awards of restricted stock up to an aggregate
amount of 10 million shares. On December 17, 2013, the Plan was amended to increase the number of shares reserved for awards under
the Plan from 10 million to 15 million. As of December 31, 2017, there were approximately 1.3 million shares of common stock reserved
for future issuance under the Plan. Stock options granted under the Plan may be either incentive stock options (as defined by Section
422 of the Internal Revenue Code of 1986, as amended) or non-qualified stock options at the discretion of the Board of Directors.
Vesting of service awards occurs ratably on the anniversary of the grant date over the service period, generally three or five
years, as determined at the time of grant. Vesting of performance awards occurs when the performance criteria have been satisfied.
The Company uses historical data to estimate forfeiture rates.
Issuance of stock options during Fiscal 2018 were as follows
:
On July 1, 2017, the Company granted stock
options to an employee to purchase 50,000 shares of common stock. These options vest ratably over a three-year service period,
expire ten years from the date of grant, and have a weighted-average exercise price of $0.40 per share.
The following table summarizes all stock
option activity during Fiscal 2018:
|
|
Stock
Options
|
|
|
Weighted-
average
Exercise
Price
|
|
|
Weighted-
average
Remaining
Contractual
Term (in years)
|
|
|
Aggregate
Intrinsic Value
(in thousands)
|
|
Outstanding as of July 1, 2017
|
|
|
13,548,334
|
|
|
$
|
1.21
|
|
|
|
5.8
|
|
|
$
|
138
|
|
Granted
|
|
|
50,000
|
|
|
|
0.39
|
|
|
|
|
|
|
|
|
|
Forfeited/expired
|
|
|
(42,500
|
)
|
|
|
0.40
|
|
|
|
|
|
|
|
|
|
Outstanding as of December 31, 2017
|
|
|
13,555,834
|
|
|
$
|
1.21
|
|
|
|
5.4
|
|
|
$
|
-
|
|
Vested and, as of December 31, 2017, expected to vest
|
|
|
13,513,517
|
|
|
$
|
1.21
|
|
|
|
5.4
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable as of December 31, 2017
|
|
|
11,256,688
|
|
|
$
|
1.27
|
|
|
|
4.7
|
|
|
$
|
-
|
|
The weighted-average grant date fair value
of stock options granted during the six months ended December 31, 2017 was $0.34 per share. As of December 31, 2017, there was
approximately $735,000 of total unrecognized compensation cost related to non-vested stock options that the Company expects to
recognize over a weighted-average period of 1.5 years.
The Company estimated the fair value of
options granted using the Black-Scholes option pricing model with the following assumptions:
Risk-free interest rate
|
|
|
2.23
|
%
|
Dividend yield
|
|
|
0
|
%
|
Volatility
|
|
|
103.10
|
%
|
Expected term (in years)
|
|
|
9
|
|
|
12.
|
Related
Party Transactions
|
Novici Biotech, LLC
In January 2012, the Company entered into
an agreement with Novici in which iBio's President is a minority stockholder. See Note 7.
Agreements with Eastern Capital Limited
and its Affiliates
As more fully discussed in Note 9, the
Company entered into two share purchase agreements with Eastern and sold 10 million shares of common stock at a price of $0.622
per share. The Company received proceeds of $6,220,000. In addition, Eastern agreed to exercise warrants it had previously acquired
to purchase 1,784,000 shares of the Company's common stock at an exercise price of $0.53 per share. The Company received proceeds
of approximately $945,000 from the exercise of the warrants.
Concurrently with the execution of the
Purchase Agreements, iBio entered into a contract manufacturing joint venture with an affiliate of Eastern to develop and manufacture
plant-made pharmaceuticals through iBio's recently formed subsidiary, iBio CDMO. The Eastern Affiliate contributed $15.0 million
in cash to iBio CDMO, for a 30% interest in iBio CDMO. iBio retained a 70% equity interest in iBio CDMO. As the majority equity
holder, iBio has the right to appoint a majority of the members of the Board of Managers that manages the iBio CDMO joint venture.
Specified material actions by the joint venture require the consent of iBio and the Eastern Affiliate. iBio contributed to the
capital of iBio CDMO a royalty bearing license, which grants iBio CDMO a non-exclusive license to use the iBio's proprietary technologies
for research purposes and an exclusive U.S. license for manufacturing purposes. iBio retains all other rights in its intellectual
property, including the right for itself to commercialize products based on its proprietary technologies or to grant licenses to
others to do so.
In connection with the joint venture, the
Second Eastern Affiliate, which controls the subject property as sublandlord, granted iBio CDMO a 34-year sublease of a Class A
life sciences building in Bryan, Texas, on the campus of Texas A&M University, designed and equipped for plant-made manufacture
of biopharmaceuticals. Accrued expenses at December 31, 2017 and June 30, 2017 due to the Second Eastern Affiliate amounted to
$911,000 and $650,000, respectively. General and administrative expenses related to Second Eastern Affiliate were approximately
$158,000 and $180,000 for the three months ended December 31, 2017 and 2016, respectively, and approximately $342,000 and $347,000
for the six months ended December 31, 2017 and 2016, respectively. Interest expense related to the Second Eastern Affiliate amounted
to approximately $479,000 and $483,000 for the three months ended December 31, 2017 and 2016, respectively, and $959,000 and $966,000
for the six months ended December 31, 2017 and 2016, respectively. The terms of the sublease are described in Note 8.
A three-year standstill agreement (the
"Standstill Agreement") that took effect upon the issuance of the Eastern Shares pursuant to the 6,500,000 Purchase Agreement
restricts additional acquisitions of iBio equity by Eastern and its controlled affiliates to limit its beneficial ownership of
the Company's outstanding shares of common stock to a maximum of 38%, absent approval by a majority of the Company's Board of Directors.
On November 27, 2017, the Company's Board of Directors authorized the Company’s Chief Executive Officer to invite Eastern
to purchase shares in the November 2017 public offering described in Note 9, provided that such purchase did not result in Eastern
being the beneficial owner of more than 40% of the aggregate number of shares the Company's outstanding common stock rather than
the limit of 38% set forth in the Standstill Agreement.
On February 23, 2017, the Company entered
into an exchange agreement with the Eastern Affiliate pursuant to which the Company acquired substantially all of the interest
in iBio CDMO held by the Eastern Affiliate and issued one share of the iBio CMO Preferred Tracking Stock, par value $0.001 per
share (the "Preferred Tracking Stock"), in exchange for 29,990,000 units of limited liability company interests of iBio
CDMO held by the Eastern Affiliate at an original issue price of $13 million. After giving effect to the transactions contemplated
in the Exchange Agreement, the Company owns 99.99% and the Eastern Affiliate owns 0.01% of iBio CDMO.
Month-to-Month Lease with Minority Stockholder
The Company is renting office space on
a month-to-month basis from an entity owned by a minority stockholder of the Company. Rent was $2,500 per month effective December
2015 through February 2017 and increased to $7,500 per month effective March 2017. Rent expense totaled $22,500 and $7,500 for
the three months ended December 31, 2017 and 2016, respectively, and $45,000 and $15,000 for the six months ended December 31,
2017 and 2016, respectively.
The Company recorded no income tax expense
for the six months ended December 31, 2017 and 2016 because the estimated annual effective tax rate was zero. As of December 31,
2017, the Company continues to provide a valuation allowance against its net deferred tax assets since the Company believes it
is more likely than not that its deferred tax assets will not be realized.
In December 2017, the United States Government
passed new tax legislation that, among other provisions, will lower the corporate tax rate from 35% to 21%. In addition to applying
the new lower corporate tax rate in 2018 and thereafter to any taxable income we may have, the legislation affects the way we can
use and carryforward net operating losses previously accumulated and results in a revaluation of deferred tax assets and liabilities
recorded on our balance sheet. Given that current deferred tax assets are offset by a full valuation allowance, these changes will
have no net impact on the balance sheet. However, if we become profitable, we will receive a reduced benefit from such deferred
tax assets.
|
14.
|
Commitments
and Contingencies
|
Agreements
In September 2013,
the Company and Fraunhofer entered into an agreement, the Terms of Settlement for the TTA Seventh Amendment (the “2013 Settlement
Agreement”). Under the terms of the 2013 Settlement Agreement, various payment obligations, including accrued payment obligations
existing at June 30, 2013, were released, terminated or modified. The significant modifications are as follows:
The Company’s obligation under the
TTA, prior to the 2013 Settlement Agreement, to make three $1 million payments to Fraunhofer in April 2013, November 2013, and
April 2014 (the “Guaranteed Annual Payments”) was terminated and replaced with an undertaking to engage Fraunhofer
for at least $3 million in work requested and directed by iBio before December 31, 2015. As of December 31, 2015, the total engagement
of Fraunhofer for such work requested was at least $3.0 million. In addition to the foregoing, the Company sought to engage Fraunhofer
for substantial additional other work, but Fraunhofer did not respond to the Company’s requests for proposals for such work.
The Company’s obligation to remit
to Fraunhofer minimum annual royalty payments in the amount of $200,000 was terminated. Instead, the 2013 Settlement Agreement
provided that, for a period of up to 15 years, the Company would pay Fraunhofer one percent (1%) of all receipts derived by the
Company from sales of products produced utilizing the iBioLaunch™ or iBioModulator™ technology and ten percent (10%)
of all receipts derived by the Company from licensing those technologies to third parties. The 2013 Settlement Agreement provided
for royalty payments to Fraunhofer only on technology license revenues that iBio actually would receive, and on revenues from actual
sales by iBio of products derived from the technology developed by Fraunhofer under the TTA, until the later of November 2023 or
until such time as the aggregate royalty payments totaled at least $4 million. All new intellectual property invented by Fraunhofer
during the period of the TTA is owned by and was required to be transferred to iBio, and Fraunhofer was required to make technology
transfer, which Fraunhofer refused to perform. In the lawsuit against Fraunhofer, iBio is seeking rescission of these royalty provisions
of the 2013 Settlement Agreement. In any event, the 2013 Settlement Agreement does not apply to, and the Company has no financial
obligations to Fraunhofer with respect to, the Company’s use of, or revenues derived from, technologies developed independently
of Fraunhofer.
On June 12, 2014, Fiocruz, Fraunhofer and
iBio executed an amendment to the CLA (the “Amended Agreement”) to create a new research and development plan for the
development of a recombinant Yellow Fever vaccine providing revised reporting, objectives, estimated budget, and project billing
process. By its execution of the Amended Agreement, iBio again engaged Fraunhofer to act as the Company’s subcontractor for
performance of research and development services for the new research and development plan covered by the Amended Agreement and
to have Fraunhofer bill Fiocruz directly on behalf of the Company at the rates, amounts and times provided in the Amended Agreement
with the proceeds of such billings and only the proceeds paid to Fraunhofer for its services so the Company’s expense is
equal to its revenue and no profit would be recognized for these activities under the Amended Agreement. For the year ended June
30, 2015, $2.1 million in research and development services were performed by Fraunhofer for the Company pursuant to the amended
CLA. As of December 31, 2015, the total engagement of Fraunhofer for work requested by iBio was at least $3.0 million. See Note
7 - Significant Vendors for additional information. In addition to the foregoing, the Company sought to engage Fraunhofer for substantial
additional other work, but Fraunhofer did not respond to the Company’s requests for proposals for such work.
On January 14, 2014 (the “Effective
Date”), the Company entered into an exclusive worldwide License Agreement (“LA”) with the University of Pittsburgh
(“UP”) covering all of the U.S. and foreign patents and patent applications and related intellectual property owned
by UP pertinent to the use of endostatin peptides for the treatment of fibrosis. The Company paid an initial license fee of $20,000
and is required to pay all of UP’s patent prosecution costs that were incurred prior to, totaling $30,627, and subsequent
to the Effective Date. On each anniversary date the Company is to pay license fees ranging from $25,000 to $150,000 for the first
five years and $150,000 on each subsequent anniversary date until the first commercial sale of the licensed technology. Beginning
with commercial sales of the technology or approval by the FDA or foreign equivalent, the Company will be required to pay milestone
payments, royalties and a percentage of any non-royalty sublicense income to UP.
On December 30, 2013, the Company entered
into a Project Agreement with the Medical University of South Carolina ("MUSC") providing for the performance of research
and development services by MUSC related to peptides for the treatment of fibrosis. The agreement requires the Company to make
payments totaling $78,000 through December 1, 2014 and provides the Company with certain intellectual property rights. Effective
September 1, 2014, the Company and MUSC executed an Amendment to the agreement. The Amendment extended the term of the agreement
to December 31, 2015 and increased the total payments due MUSC from the Company by $161,754.
Lawsuits
On March 17, 2015, the Company filed a
Verified Complaint in the Court of Chancery of the State of Delaware against Fraunhofer and Vidadi Yusibov (“Yusibov”),
Fraunhofer’s Executive Director, seeking monetary damages and equitable relief based on Fraunhofer’s material and continuing
breaches of their contracts with the Company. On September 16, 2015, the Company voluntarily dismissed its action against Yusibov,
without prejudice, and thereafter on September 29, 2015, the Company filed a Verified Amended Complaint against Fraunhofer alleging
material breaches of its agreements with the Company and seeking monetary damages and equitable relief against Fraunhofer. The
Court bifurcated the action to first resolve the threshold question in the case–the scope of iBio’s ownership of the
technology developed or held by Fraunhofer–before proceeding with the rest of the case and the parties stipulated their agreement
to that approach. After considering the parties’ written submissions and oral argument, the Court resolved the threshold
issue in favor of iBio on July 29, 2016, holding that iBio owns all proprietary rights of any kind to all plant-based technology
of Fraunhofer developed or held as of December 31, 2014, including know-how, and was entitled to receive a technology transfer
from Fraunhofer. Fraunhofer’s motion to dismiss iBio’s contract claims was denied by the Court on February 24, 2017.
The Court at that time also granted, over Fraunhofer’s opposition, iBio’s motion to supplement and amend the Complaint
to add additional state law claims against Fraunhofer. Fraunhofer filed an answer and counterclaims in March 2017, but in May 2017,
Fraunhofer obtained new counsel, and with iBio’s agreement (as a matter of procedure), filed an amended answer and amended
counterclaims in July 2017. The Company replied to those counterclaims on August 9, 2017. In November 2017, the Company engaged
new counsel to further lead its litigation efforts, and on November 3, 2017, the Company filed a Verified Complaint in the Court
of Chancery of the State of Delaware against Fraunhofer-Gesellschaft, the European unit of Fraunhofer. This complaint follows iBio’s
pending litigation filed in March 2015, described above, against Fraunhofer USA, Inc., the U.S. unit of Fraunhofer. The parties
have continued to proceed with written discovery. The Company is unable to predict the further outcome of this action
at this time.
In accordance
with FASB ASC 280, "
Segment Reporting
," the Company discloses financial and descriptive information about its
reportable segments. The Company operates in two segments, iBio, Inc. and iBio CDMO. Management has determined that the activity
of iBio CDMO should be segregated as a separate segment and that the activity of iBio Brazil is currently immaterial and is to
be included in the activity of iBio, Inc. These segments are components of the Company about which separate financial information
is available and regularly evaluated by the chief operating decision maker in deciding how to allocate resources and in assessing
performance.
Three Months Ended December 31, 2017 (in thousands)
|
|
iBio, Inc.
|
|
|
iBio CDMO
|
|
|
Eliminations
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues - external customers
|
|
$
|
153
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
153
|
|
Revenues – intersegment
|
|
|
330
|
|
|
|
96
|
|
|
|
(426
|
)
|
|
|
-
|
|
Research and development
|
|
|
676
|
|
|
|
482
|
|
|
|
(165
|
)
|
|
|
993
|
|
General and administrative
|
|
|
1,221
|
|
|
|
1,694
|
|
|
|
(328
|
)
|
|
|
2,587
|
|
Operating loss
|
|
|
(1,414
|
)
|
|
|
(2,013
|
)
|
|
|
-
|
|
|
|
(3,427
|
)
|
Interest expense
|
|
|
-
|
|
|
|
(479
|
)
|
|
|
-
|
|
|
|
(479
|
)
|
Interest and other income
|
|
|
4
|
|
|
|
2
|
|
|
|
-
|
|
|
|
6
|
|
Consolidated net loss
|
|
|
(1,410
|
)
|
|
|
(2,490
|
)
|
|
|
-
|
|
|
|
(3,900
|
)
|
Total assets
|
|
|
21,563
|
|
|
|
26,002
|
|
|
|
(12,725
|
)
|
|
|
34,840
|
|
Fixed assets, net
|
|
|
7
|
|
|
|
25,282
|
|
|
|
-
|
|
|
|
25,289
|
|
Intangible assets, net
|
|
|
1,702
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,702
|
|
Depreciation expense
|
|
|
-
|
|
|
|
341
|
|
|
|
-
|
|
|
|
341
|
|
Amortization of intangible assets
|
|
|
84
|
|
|
|
-
|
|
|
|
-
|
|
|
|
84
|
|
Three Months Ended December 31, 2016 (in thousands)
|
|
iBio, Inc.
|
|
|
iBio CDMO
|
|
|
Eliminations
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues - external customers
|
|
$
|
75
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
75
|
|
Revenues – intersegment
|
|
|
260
|
|
|
|
407
|
|
|
|
(667
|
)
|
|
|
-
|
|
Research and development
|
|
|
1,016
|
|
|
|
447
|
|
|
|
(414
|
)
|
|
|
1,049
|
|
General and administrative
|
|
|
1,241
|
|
|
|
1,363
|
|
|
|
(253
|
)
|
|
|
2,351
|
|
Operating loss
|
|
|
(1,922
|
)
|
|
|
(1,403
|
)
|
|
|
-
|
|
|
|
(3,325
|
)
|
Interest expense
|
|
|
-
|
|
|
|
(483
|
)
|
|
|
-
|
|
|
|
(483
|
)
|
Interest and other income
|
|
|
9
|
|
|
|
7
|
|
|
|
-
|
|
|
|
16
|
|
Consolidated net loss
|
|
|
(1,913
|
)
|
|
|
(1,879
|
)
|
|
|
-
|
|
|
|
(3,792
|
)
|
Total assets
|
|
|
9,870
|
|
|
|
34,333
|
|
|
|
(15
|
)
|
|
|
44,188
|
|
Fixed assets, net
|
|
|
7
|
|
|
|
25,446
|
|
|
|
-
|
|
|
|
25,453
|
|
Intangible assets, net
|
|
|
1,960
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,960
|
|
Depreciation expense
|
|
|
1
|
|
|
|
325
|
|
|
|
-
|
|
|
|
326
|
|
Amortization of intangible assets
|
|
|
88
|
|
|
|
-
|
|
|
|
-
|
|
|
|
88
|
|
Six Months Ended December 31, 2017 (in thousands)
|
|
iBio, Inc.
|
|
|
iBio CDMO
|
|
|
Eliminations
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues - external customers
|
|
$
|
237
|
|
|
$
|
38
|
|
|
$
|
-
|
|
|
$
|
275
|
|
Revenues – intersegment
|
|
|
631
|
|
|
|
306
|
|
|
|
(937
|
)
|
|
|
-
|
|
Research and development
|
|
|
1,294
|
|
|
|
966
|
|
|
|
(282
|
)
|
|
|
1,978
|
|
General and administrative
|
|
|
2,320
|
|
|
|
3,392
|
|
|
|
(627
|
)
|
|
|
5,085
|
|
Operating loss
|
|
|
(2,746
|
)
|
|
|
(4,042
|
)
|
|
|
-
|
|
|
|
(6,788
|
)
|
Interest expense
|
|
|
-
|
|
|
|
(959
|
)
|
|
|
-
|
|
|
|
(959
|
)
|
Interest and other income
|
|
|
16
|
|
|
|
4
|
|
|
|
-
|
|
|
|
20
|
|
Consolidated net loss
|
|
|
(2,730
|
)
|
|
|
(4,997
|
)
|
|
|
-
|
|
|
|
(7,727
|
)
|
Total assets
|
|
|
21,563
|
|
|
|
26,002
|
|
|
|
(12,725
|
)
|
|
|
34,840
|
|
Fixed assets, net
|
|
|
7
|
|
|
|
25,282
|
|
|
|
-
|
|
|
|
25,289
|
|
Intangible assets, net
|
|
|
1,702
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,702
|
|
Depreciation expense
|
|
|
1
|
|
|
|
678
|
|
|
|
-
|
|
|
|
679
|
|
Amortization of intangible assets
|
|
|
169
|
|
|
|
-
|
|
|
|
-
|
|
|
|
169
|
|
Six Months Ended December 31, 2016 (in thousands)
|
|
iBio, Inc.
|
|
|
iBio CDMO
|
|
|
Eliminations
|
|
|
Total
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues - external customers
|
|
$
|
161
|
|
|
$
|
49
|
|
|
$
|
-
|
|
|
$
|
210
|
|
Revenues – intersegment
|
|
|
412
|
|
|
|
589
|
|
|
|
(1,001
|
)
|
|
|
-
|
|
Research and development
|
|
|
1,700
|
|
|
|
768
|
|
|
|
(599
|
)
|
|
|
1,869
|
|
General and administrative
|
|
|
2,588
|
|
|
|
2,634
|
|
|
|
(402
|
)
|
|
|
4,820
|
|
Operating loss
|
|
|
(3,715
|
)
|
|
|
(2,764
|
)
|
|
|
-
|
|
|
|
(6,479
|
)
|
Interest expense
|
|
|
-
|
|
|
|
(966
|
)
|
|
|
-
|
|
|
|
(966
|
)
|
Interest and other income
|
|
|
27
|
|
|
|
14
|
|
|
|
-
|
|
|
|
41
|
|
Consolidated net loss
|
|
|
(3,688
|
)
|
|
|
(3,716
|
)
|
|
|
-
|
|
|
|
(7,404
|
)
|
Total assets
|
|
|
9,870
|
|
|
|
34,333
|
|
|
|
(15
|
)
|
|
|
44,188
|
|
Fixed assets, net
|
|
|
7
|
|
|
|
25,446
|
|
|
|
-
|
|
|
|
25,453
|
|
Intangible assets, net
|
|
|
1,960
|
|
|
|
-
|
|
|
|
-
|
|
|
|
1,960
|
|
Depreciation expense
|
|
|
2
|
|
|
|
648
|
|
|
|
-
|
|
|
|
650
|
|
Amortization of intangible assets
|
|
|
176
|
|
|
|
-
|
|
|
|
-
|
|
|
|
176
|
|
On January 4, 2018, the Company
received notification from the NYSE AMERICAN LLC (“NYSE American”) pursuant to Section 1003(f)(v) of the NYSE American’s
Company Guide that, due to the Company’s current low selling share price, the Company’s continued listing on the NYSE
American is predicated on the Company effecting a reverse stock split or otherwise demonstrating sustained improvement in its share
price within a reasonable period of time, which the NYSE American has determined to be no later than July 5, 2018.
The Company’s common stock
will continue to be listed on the NYSE American while it attempts to regain compliance with the listing standards noted, subject
to the Company’s compliance with other continued listing requirements. The Company’s common stock will continue to
trade under the symbol “IBIO,” but will have an added designation of “.BC” to indicate that the Company
is not in compliance with the NYSE American’s listing standards.
The NYSE American notification
does not affect the Company’s business operations or its reporting obligations under the Securities and Exchange Commission
regulations and rules and does not conflict with or cause an event of default under any of the Company’s material agreements.
Item 2. Management's Discussion and
Analysis of Financial Condition and Results of Operations.
The following information should be read
together with the financial statements and the notes thereto and other information included elsewhere in this Quarterly Report
on Form 10-Q and in our Annual Report on Form 10-K for the year ended June 30, 2017. Unless the context requires otherwise, references
in this Quarterly Report on Form 10-Q to “iBio,” the “Company,” “we,” “us,” or
“our” and similar terms mean iBio, Inc.
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains
“forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended.
For this purpose, any statements contained herein regarding our strategy, future operations, financial position, future revenues,
projected costs and expenses, prospects, plans and objectives of management, other than statements of historical facts, are forward-looking
statements. The words “anticipate”, “believe”, “estimate”, “may”, “plan”,
“will”, “would” and similar expressions are intended to identify forward-looking statements, although not
all forward-looking statements contain these identifying words. Such statements reflect our current views with respect to future
events. Because these forward-looking statements involve known and unknown risks and uncertainties, actual results, performance
or achievements could differ materially from those expressed or implied by these forward-looking statements for a number of important
reasons, including those discussed in this “Management’s Discussion and Analysis of Financial Condition and Results
of Operations” and elsewhere in this Quarterly Report on Form 10-Q, as well as in the section titled “Risk Factors”
in the Company’s Annual Report on Form 10-K for the year ended June 30, 2017. We cannot guarantee any future results, levels
of activity, performance or achievements. Should one or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those described in this Quarterly Report on Form 10-Q as anticipated,
believed, estimated or expected. The forward-looking statements contained in this Quarterly Report on Form 10-Q represent our estimates
as of the date of this Quarterly Report on Form 10-Q (unless another date is indicated) and should not be relied upon as representing
our expectations as of any other date. While we may elect to update these forward-looking statements, we specifically disclaim
any obligation to do so.
Overview
We are a biotechnology company focused
on using our proprietary technologies and production facilities to provide product development and manufacturing services to clients,
collaborators and third-party customers as well as developing and commercializing our own product candidates. Our assets and capabilities
include proprietary and transformative methods for the development, improvement, and production of biologics using hydroponically
grown, transiently-transfected green plants for recombinant protein production.
Our technologies have been successfully
used with a diverse range of biopharmaceutical product candidates including products against fibrotic diseases, vaccines, enzyme
replacements, monoclonal antibodies, and recombinant versions of marketed products that are currently derived from human blood
plasma. iBio technologies have been used to advance development of certain products that have been commercially infeasible to develop
with conventional technologies such as Chinese hamster ovary cell systems and microbial fermentation methods. We have also used
our technologies to create and produce experimental, proprietary derivatives of pre-existing products with improved properties.
We believe that our technologies and our
development and manufacturing capabilities offer clients and collaborators multiple advantages over the use of legacy methods,
including increased efficiency in early-stage product screening, more predictable and shorter time frames during preclinical product
development and testing, and significant time and cost savings in making the transitions between clinical trial phases and eventual
product launch. In addition, our technologies are applicable to both improving process efficiency and also to improving product
quality and performance characteristics. We expect demand for our technologies and services to increase steadily and to provide
significant revenue opportunities with clients addressing the expanding global market for biopharmaceutical products because the
competitive success of new products often depends on improved efficacy and safety or on reduced development time and cost-effective
manufacturing processes. We believe our technologies and capabilities deliver these benefits to our collaborators and clients.
We expect to provide services and participate
in collaborative development programs with a diverse group of clients and collaborators to enable us to achieve positive cash flow
from operations sufficient for use in developing our own product candidates and enabling us to participate in the success of selected
products developed jointly with collaborators. Our current product pipeline is comprised of proprietary candidates for the treatment
of a range of fibrotic diseases including systemic scleroderma and idiopathic pulmonary fibrosis. IBIO-CFB03, based on exclusively
in-licensed university patents and newer patent applications filed by iBio, is our lead therapeutic candidate being advanced for
IND development. On an ongoing basis, we evaluate product candidate opportunities originating in both academic institutions and
corporate research programs, to which iBio technologies can add value, as potential opportunities for iBio.
We developed and implemented a new business
model as a result of the ongoing litigation against our original research and development contractor. Our new business model comprises
three key elements:
|
1.
|
CDMO
Facility Activities
- the creation of a contract development and manufacturing organization to produce revenue through the
provision of services based on our technologies and capabilities;
|
|
2.
|
Product Candidate Pipeline
- the advancement of select product candidates developed by iBio or through partnering with collaborators, and
|
|
3.
|
Facility Design and Build-out / Technology Transfer
- the design and development for others of facilities based on our new technologies and experience along with the provision of commercial technology transfer.
|
We accomplished the first part of our new
business plan through the acquisition of control of the large manufacturing facility that is now controlled and operated by our
subsidiary, iBio CDMO LLC (“iBio CDMO” or “CDMO”) (formerly known as iBio CMO, LLC) under a capital lease.
The facility includes human resources, laboratory and pilot-scale operations, and large-scale automated hydroponic systems capable
of growing over four million plants as “in process inventory” and delivering over 300 kilograms of therapeutic protein
active pharmaceutical ingredient per year. The facility capacity can also be doubled by adding additional plant growth equipment
in a space already available for that purpose.
We have integrated into our iBio CDMO operations
the rights iBio has obtained to certain patented and unpatented technologies developed for it by Novici Biotech LLC, in addition
to novel manufacturing methods and processes developed by iBio CDMO. These technologies, methods, and processes are applied by
iBio CDMO to a variety of tasks performed for clients, collaborators, and for iBio itself, including product and process development,
analytical, and manufacturing services. iBio CDMO is promoting commercial collaborations with third parties on the basis of these
technology advantages and plans to work with customers to achieve laboratory scale technical milestones that can form the basis
of longer-term manufacturing business arrangements.
In addition to the generation of revenue
from services through iBio CDMO, a second goal of our new business model is through partnering and out-licensing of our new technologies,
to create opportunities for iBio to share in the successful development and commercialization of selected product candidates by
our collaborators and licensees as well as advance our own product candidates. We expect to accomplish this objective through both
investments we make to acquire or develop our own proprietary product candidates and also by participating with select customers
and collaborators in the value created through the development, with our technologies, and manufacture of their product candidates.
iBio itself is a client of iBio CDMO for further IND advancement of its proprietary products beginning with IBIO-CFB03 for the
treatment of a range of fibrotic diseases. iBio will work with iBio CDMO on the production of IBIO-CFB03 for clinical trials and,
with clinical success, for commercial launch.
The third element of our new business model
is the use of iBio technologies to create and operate manufacturing facilities at substantially lower capital and operating costs.
Due to the lower capital and operating cost requirements for biopharmaceutical (both vaccines and therapeutics) production via
iBio technologies versus legacy methods, certain corporations and governments that have not already established manufacturing capacity
for biologic products are client prospects for both development and for commercial technology transfer services to enable autonomous
manufacturing in the market being served. In some cases, we have additional opportunities to increase the value of these uses of
our technologies by offering custom facility design services.
Results of Operations
Comparison of Three Months ended
December 31, 2017 ("Fiscal 2018") versus December 31, 2016 ("Fiscal 2017")
Revenue
Gross revenue for Fiscal 2018 and Fiscal
2017 was approximately $153,000 and $75,000, respectively, an increase of approximately $78,000, primarily attributable to an increase
in third-party proof of concept, feasibility study and small-scale production contracts offset by no revenue recognized for the
technology services previously performed pursuant to the agreement with Bio-Manguinhos/Fiocruz (“Fiocruz”).
Previously, revenue had been attributable
to technology services provided to Fiocruz in connection with the development by Fiocruz of a yellow fever vaccine using our
iBioLaunch™ technology. To fulfill our obligations, we engaged Fraunhofer USA Inc. (“Fraunhofer”) as a subcontractor
to perform the services required. During 2013, the Company, Fiocruz and Fraunhofer were awaiting approval by the Brazilian government
of a contract amendment reflecting the agreed modifications to the work plan. During this waiting period, no revenues were recognized
by us in connection with services provided to Fiocruz through the subcontract arrangement with Fraunhofer. In June 2014, we, Fiocruz
and Fraunhofer amended their Collaboration and License Agreement reflecting the agreed modifications to the work plan and work
was resumed by Fraunhofer for us to continue development of a yellow fever vaccine using our iBioLaunch™ technology.
Research and development expenses
Research and development expenses for Fiscal
2018 and Fiscal 2017 were $993,000 and $1,049,000, respectively, a decrease of approximately $56,000. The decrease was primarily
attributed to an increase in research and development personnel costs at iBio CDMO offset by the decrease in contracted research
expenses with Fiocruz.
General and administrative expenses
General and administrative expenses for
Fiscal 2018 and Fiscal 2017 were approximately $2,586,000 and $2,351,000, respectively, an increase of approximately $235,000.
General and administrative expenses principally include officer and employee salaries and benefits, depreciation and amortization,
professional fees, facility repairs and maintenance, rent, utilities, consulting services, and other costs associated with being
a publicly traded company. The increase resulted from an increase in general and administrative expenses related to the iBio CDMO
operations offset by a reduction of legal and consulting expenses incurred by iBio, Inc.
Other income
Other income (expense) for Fiscal 2018
and Fiscal 2017 was approximately ($473,000) and ($467,000), respectively.
As discussed above, iBio CMO's operations
take place in a facility in Bryan, Texas under a 34-year sublease. Such sublease is accounted for as a capital lease. In Fiscal
2018 and Fiscal 2017, other income (expense) included interest expense of $479,000 and $483,000, respectively, incurred under the
capital lease offset by interest and royalty income of $6,000 and $16,000, respectively.
Net loss attributable to noncontrolling
interest
This represents the share of the loss in
iBio CDMO for an affiliate of Eastern Capital Limited (“Eastern”), a stockholder of the Company (the “Eastern
Affiliate”). The noncontrolling interest held by the Eastern Affiliate represented 0.01% and 30% in Fiscal 2018 and Fiscal
2017, respectively.
On February 23, 2017, the Company entered
into an exchange agreement with the Eastern Affiliate pursuant to which the Company acquired substantially all of the interest
in iBio CDMO held by the Eastern Affiliate and issued one share of a newly created iBio CMO Preferred Tracking Stock, par value
$0.001 per share (the "Preferred Tracking Stock"), in exchange for 29,990,000 units of limited liability company interests
of iBio CDMO held by the Eastern Affiliate at an original issue price of $13 million. After giving effect to the transactions contemplated
in the Exchange Agreement, the Company owns 99.99% and the Eastern Affiliate owns 0.01% of iBio CDMO.
Comparison of Six Months ended December
31, 2017 ("Fiscal 2018") versus December 31, 2016 ("Fiscal 2017")
Revenue
In Fiscal 2018 and 2017, gross revenue
was approximately $275,000 and $210,000, respectively, an increase of approximately $65,000, primarily attributable to an increase
in third-party proof of concept, feasibility study and small-scale production contracts offset by no revenue recognized for the
technology services previously performed pursuant to the agreement with Fiocruz.
Previously, revenue had been attributable
to technology services provided to FioCruz in connection with the development by FioCruz of a yellow fever vaccine using our
iBioLaunch™ technology. To fulfill our obligations, we engaged Fraunhofer USA Inc. ("Fraunhofer") as a subcontractor
to perform the services required. During 2013, the Company, FioCruz and Fraunhofer were awaiting approval by the Brazilian government
of a contract amendment reflecting the agreed modifications to the work plan. During this waiting period, no revenues were recognized
by the Company in connection with services provided to FioCruz through the subcontract arrangement with Fraunhofer. In June 2014,
the Company, FioCruz and Fraunhofer amended their Collaboration and License Agreement reflecting the agreed modifications to the
work plan and work was resumed by Fraunhofer for the Company to continue development of a yellow fever vaccine using the Company's
iBioLaunch
™
technology.
Research and development expenses
In Fiscal 2018 and 2017, research and development
expenses were $1,978,000 and $1,869,000, respectively, an increase of approximately $109,000. The increase was primarily related
to an increase in research and development personnel costs at iBio CDMO offset by the decrease in contracted research expenses
with Fiocruz.
General and administrative expenses
In Fiscal 2018 and 2017, general and administrative
expenses were approximately $5,084,000 and $4,820,000, respectively, an increase of approximately $264,000. General and administrative
expenses principally include officer and employee salaries and benefits, depreciation and amortization, professional fees, facility
repairs and maintenance, rent, utilities, consulting services, and other costs associated with being a publicly traded company.
The increase resulted from an increase in general and administrative expenses related to the iBio CDMO operations offset by a reduction
of legal and consulting expenses incurred by iBio, Inc.
Other income
In Fiscal 2018 and 2017, other income (expense)
was approximately ($939,000) and ($925,000), respectively.
As discussed above, iBio CMO's operations
take place in a facility in Bryan, Texas under a 34-year sublease. Such sublease is accounted for as a capital lease. In Fiscal
2018 and 2017 other income (expense) included interest expense of $959,000 and $966,000, respectively, incurred under the capital
lease offset by interest and royalty income of $20,000 and $41,000, respectively.
Net loss attributable to noncontrolling
interest
This represents the share of the loss in
iBio CDMO for the Eastern Affiliate in Fiscal 2018. The noncontrolling interest held by the Eastern Affiliate represented 0.01%
and 30% in Fiscal 2018 and Fiscal 2017, respectively.
On February 23, 2017, the Company entered
into an exchange agreement with the Eastern Affiliate pursuant to which the Company acquired substantially all of the interest
in iBio CDMO held by the Eastern Affiliate and issued one share of a newly created iBio CMO Preferred Tracking Stock, par value
$0.001 per share (the "Preferred Tracking Stock"), in exchange for 29,990,000 units of limited liability company interests
of iBio CDMO held by the Eastern Affiliate at an original issue price of $13 million. After giving effect to the transactions contemplated
in the Exchange Agreement, the Company owns 99.99% and the Eastern Affiliate owns 0.01% of iBio CDMO.
Liquidity and Capital Resources
As of December 31, 2017, we had cash of
$7.3 million as compared to $8.1 million as of June 30, 2017.
Net Cash Used in Operating Activities
Net cash used in operating activities was
approximately $6.6 million. The decrease in cash was attributable to funding our net loss for the period.
Net Cash Used in Investing Activities
Net cash used in investing activities was
approximately $312,000. Cash used in investing activities was attributable to the additions of intangible assets of $35,000 and
the capitalization of fixed assets primarily for iBio CDMO of $277,000.
Net Cash Provided by Financing Activities
Net cash provided by financing activities
was $6.1 million. On July 24, 2017, we sold 2,500,000 shares of our common stock to Lincoln Park Capital Fund, LLC (“Lincoln
Park”) for an aggregate purchase price of $1,000,000 and on November 30, 2017, we sold 22,500,000 shares of our common stock
under a public offering for gross proceeds of $4.5 million. In addition, the Eastern Affiliate contributed $1.05 million for working
capital purposes. The proceeds were offset by costs to raise capital of $321,000 and principal payments on our capital lease obligation
of $90,000.
Funding Requirements
We have incurred significant losses and
negative cash flows from operations since our spin-off from Integrated BioPharma, Inc. in August 2008. As of December 31, 2017,
our accumulated deficit was approximately $79.8 million, and we used approximately $6.6 million of cash for operating activities
for Fiscal 2018. As of December 31, 2017, cash on hand is approximately $7.3 million which is expected to support the Company's
activities at least through May 31, 2018.
We plan to fund our future business operations
using cash on hand, through proceeds from the sale of additional equity or other securities, including sales of common stock to
Lincoln Park (see discussion below) pursuant to the common stock purchase agreement entered into on July 24, 2017, and through
proceeds realized in connection with license and collaboration arrangements and the operation of our subsidiary, iBio CDMO. We
cannot be certain that such funding will be available on favorable terms or available at all. To the extent that the Company raises
additional funds by issuing equity securities, its stockholders may experience significant dilution. If we are unable to raise
funds when required or on favorable terms, this assumption may no longer be operative, and we may have to: a) significantly delay,
scale back, or discontinue the product application and/or commercialization of its proprietary technologies; b) seek collaborators
for its technology and product candidates on terms that are less favorable than might otherwise be available; c) relinquish or
otherwise dispose of rights to technologies, product candidates, or products that it would otherwise seek to develop or commercialize;
or d) possibly cease operations
.
On November 30, 2017, the Company completed
a public offering of 22,500,000 shares of its common stock at a public offering price of $0.20 per share raising gross proceeds
of $4,500,000. The shares of common stock were issued pursuant to an underwriting agreement entered into between the Company and
Aegis. The Company incurred underwriting discounts, commissions and other offering expenses of $311,000 related to closing and
completion of this public offering.
On July 24, 2017, we entered into the Lincoln
Park Purchase Agreement pursuant to which Lincoln Park has agreed to purchase from us up to an aggregate of $16,000,000 of our
common stock (subject to certain limitations) from time to time over the 36-month term of the agreement. As a result, on July 24,
2017, 1,200,000 shares of our common stock were issued to Lincoln Park as consideration for Lincoln Park’s commitment to
purchase shares of our common stock under the agreement, and 2,500,000 shares of common stock were sold to Lincoln Park in an initial
purchase for an aggregate gross purchase price of $1,000,000. Despite any further proceeds we may receive pursuant to the
Lincoln
Park Purchase Agreement
, we may still need additional capital to fully implement our business, operating and development
plans for periods beyond February 9, 2019.
The extent to which we utilize the purchase
agreement with Lincoln Park as a source of funding will depend on a number of factors, including the prevailing market price of
our common stock, the volume of trading in our common stock and the extent to which we are able to secure funds from other sources.
The number of shares that we may sell to Lincoln Park under the purchase agreement on any given day and during the term of the
agreement is limited. Additionally, we and Lincoln Park may not effect any sales of shares of our common stock under the purchase
agreement during the continuance of an event of default under the purchase agreement. Even if we are able to access the full $16.0
million under the purchase agreement, we may still need additional capital to fully implement our business, operating and development
plans.
On January 13, 2016, we entered into a
contract manufacturing joint venture with the Eastern Affiliate whereby the Eastern Affiliate contributed $15 million in cash for
a 30% interest in our subsidiary iBio CDMO. We retained a 70% interest in iBio CDMO. On February 23, 2017, we entered into an exchange
agreement with the Eastern Affiliate pursuant to which we acquired substantially all of the interest in iBio CDMO held by the Eastern
Affiliate in exchange for one share of the Company’s iBio CMO Preferred Tracking Stock. After giving effect to the transaction,
we own 99.99% of iBio CDMO.
On January 13, 2016, we also entered into
share purchase agreements with Eastern pursuant to which Eastern agreed to purchase 10 million shares of our common stock at $0.622
per share. The closing for the sale of 3,500,000 of such shares occurred on January 25, 2016. The closing for the remaining 6,500,000
shares occurred in April 2016. In addition, Eastern agreed to exercise warrants it previously acquired to purchase 1,784,000 shares
of our common stock at $0.53 per share.
As of the date of the filing of this report,
Eastern beneficially owned approximately 40% of our outstanding shares of common stock. See Note 9 in the consolidated financial
statements for a further description of the transactions.
Notice of Delisting or Failure to Satisfy
a Continued Listing Rule or Standard
On January 4, 2018, we received notification
from the NYSE AMERICAN LLC (“NYSE American”) pursuant to Section 1003(f)(v) of the NYSE American’s Company Guide
that, due to the Company’s current low selling share price, the Company’s continued listing on the NYSE American is
predicated on our effecting a reverse stock split or otherwise demonstrating sustained improvement in our share price within a
reasonable period of time, which the NYSE American has determined to be no later than July 5, 2018.
The Company’s common stock will continue
to be listed on the NYSE American while we attempt to regain compliance with the listing standards noted, subject to the Company’s
compliance with other continued listing requirements. The Company’s common stock will continue to trade under the symbol
“IBIO,” but will have an added designation of “.BC” to indicate that the Company is not in compliance with
the NYSE American’s listing standards.
The NYSE American notification does not
affect our business operations or reporting obligations under the Securities and Exchange Commission regulations and rules and
does not conflict with or cause an event of default under any of the Company’s material agreements.
Off-Balance Sheet Arrangements
As part of our ongoing business, we do
not participate in transactions that generate relationships with unconsolidated entities or financial partnerships, such as entities
often referred to as structured finance or special purpose entities ("SPEs"), which would have been established for the
purpose of facilitating off-balance sheet arrangements or other contractually limited purposes. As of December 31, 2017, we were
not involved in any SPE transactions.
Critical Accounting Policies and Estimates
A critical accounting policy is one that
is both important to the portrayal of a company's financial condition and results of operations and requires management's most
difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are
inherently uncertain.
Our condensed consolidated financial statements
are presented in accordance with U.S. GAAP, and all applicable U.S. GAAP accounting standards effective as of December 31, 2017
have been taken into consideration in preparing the condensed consolidated financial statements. The preparation of condensed consolidated
financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses
and related disclosures. Some of those estimates are subjective and complex, and, consequently, actual results could differ from
those estimates. The following accounting policies and estimates have been highlighted as significant because changes to certain
judgments and assumptions inherent in these policies could affect our condensed consolidated financial statements:
|
·
|
Valuation of intellectual property;
|
|
·
|
Revenue recognition;
|
|
|
|
|
·
|
Legal and contractual contingencies;
|
|
·
|
Research and development expenses; and
|
|
·
|
Share-based compensation expenses.
|
We base our estimates, to the extent possible,
on historical experience. Historical information is modified as appropriate based on current business factors and various assumptions
that we believe are necessary to form a basis for making judgments about the carrying value of assets and liabilities. We evaluate
our estimates on an on-going basis and make changes when necessary. Actual results could differ from our estimates.