ITEM 1. FINANCIAL STATEMENTS
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONDENSED CONSOLIDATED BALANCE SHEETS
|
|
December 31,
2017
|
|
|
March 31, 2017
|
|
|
|
(Unaudited)
|
|
|
(Audited)
|
|
ASSETS
|
|
|
|
|
|
|
|
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash
|
|
$
|
7,244,388
|
|
|
$
|
10,594,693
|
|
Accounts receivable, net of allowance for doubtful accounts of $-0-, respectively
|
|
|
1,161,240
|
|
|
|
934,059
|
|
Inventory
|
|
|
5,298,943
|
|
|
|
6,415,966
|
|
Prepaid expenses and other current assets
|
|
|
1,059,396
|
|
|
|
468,002
|
|
Total current assets
|
|
|
14,763,967
|
|
|
|
18,412,720
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net of accumulated depreciation of $8,122,878 and $7,426,752, respectively
|
|
|
9,132,998
|
|
|
|
9,039,404
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net of accumulated amortization of $-0-, respectively
|
|
|
7,704,609
|
|
|
|
6,419,091
|
|
|
|
|
|
|
|
|
|
|
Other assets:
|
|
|
|
|
|
|
|
|
Restricted cash - debt service for NJEDA bonds
|
|
|
390,654
|
|
|
|
389,081
|
|
Security deposits
|
|
|
81,932
|
|
|
|
50,846
|
|
Total other assets
|
|
|
472,586
|
|
|
|
439,927
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
32,074,160
|
|
|
$
|
34,311,142
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES, MEZZANINE EQUITY AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
1,444,178
|
|
|
$
|
1,049,815
|
|
Accrued expenses
|
|
|
1,785,603
|
|
|
|
794,628
|
|
Deferred revenue, current portion
|
|
|
1,013,333
|
|
|
|
1,013,333
|
|
Bonds payable, current portion, net of bond issuance costs
|
|
|
75,822
|
|
|
|
70,822
|
|
Loans payable, current portion
|
|
|
424,160
|
|
|
|
416,148
|
|
Total current liabilities
|
|
|
4,743,096
|
|
|
|
3,344,746
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
Deferred revenue, net of current portion
|
|
|
1,505,557
|
|
|
|
2,265,557
|
|
Bonds payable, net of current portion and bond issuance costs
|
|
|
1,504,589
|
|
|
|
1,583,956
|
|
Senior secured promissory note - related party
|
|
|
1,200,000
|
|
|
|
-
|
|
Loans payable, net current portion
|
|
|
636,701
|
|
|
|
577,612
|
|
Derivative financial instruments - warrants
|
|
|
2,550,254
|
|
|
|
843,464
|
|
Other long-term liabilities
|
|
|
39,587
|
|
|
|
31,770
|
|
Total long-term liabilities
|
|
|
7,436,688
|
|
|
|
5,302,359
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
|
12,179,784
|
|
|
|
8,647,105
|
|
|
|
|
|
|
|
|
|
|
Mezzanine equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series J convertible preferred stock; par value $0.01; 50 shares authorized, 24.0344 issued and outstanding as of December 31, 2017; 0 shares authorized, 0 issued and outstanding as of March 31, 2017
|
|
|
13,903,957
|
|
|
|
-
|
|
|
|
|
|
|
|
|
|
|
Shareholders’ equity:
|
|
|
|
|
|
|
|
|
Common stock; par value $0.001; 995,000,000 shares authorized; 788,801,827 shares issued and 788,701,827 outstanding as of December 31, 2017; 928,031,448 shares issued and 927,931,448 outstanding as of March 31, 2017
|
|
|
788,804
|
|
|
|
928,034
|
|
Additional paid-in capital
|
|
|
145,205,780
|
|
|
|
163,896,410
|
|
Treasury stock; 100,000 shares as of December 31, 2017 and March 31, 2017; at cost
|
|
|
(306,841
|
)
|
|
|
(306,841
|
)
|
Accumulated deficit
|
|
|
(139,697,324
|
)
|
|
|
(138,853,566
|
)
|
Total shareholders’ equity
|
|
|
5,990,419
|
|
|
|
25,664,037
|
|
Total liabilities, mezzanine equity and shareholders’ equity
|
|
$
|
32,074,160
|
|
|
$
|
34,311,142
|
|
The accompanying notes are an integral
part of these unaudited condensed consolidated financial statements.
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
|
|
For the Three Months Ended December 31,
|
|
|
For the Nine Months Ended December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Manufacturing fees
|
|
$
|
2,083,826
|
|
|
$
|
1,885,765
|
|
|
$
|
4,160,949
|
|
|
$
|
6,470,697
|
|
Licensing fees
|
|
|
451,628
|
|
|
|
444,884
|
|
|
|
1,700,856
|
|
|
|
1,816,796
|
|
Total revenue
|
|
|
2,535,454
|
|
|
|
2,330,649
|
|
|
|
5,861,805
|
|
|
|
8,287,493
|
|
Cost of revenue
|
|
|
1,419,829
|
|
|
|
1,726,751
|
|
|
|
3,049,830
|
|
|
|
5,755,997
|
|
Gross profit
|
|
|
1,115,625
|
|
|
|
603,898
|
|
|
|
2,811,975
|
|
|
|
2,531,496
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
2,514,435
|
|
|
|
1,526,183
|
|
|
|
6,944,182
|
|
|
|
4,312,337
|
|
General and administrative
|
|
|
614,994
|
|
|
|
694,321
|
|
|
|
2,068,028
|
|
|
|
2,060,380
|
|
Non-cash compensation through issuance of stock options
|
|
|
37,961
|
|
|
|
84,785
|
|
|
|
208,719
|
|
|
|
258,954
|
|
Depreciation and amortization
|
|
|
7,196
|
|
|
|
21,032
|
|
|
|
21,149
|
|
|
|
64,408
|
|
Total operating expenses
|
|
|
3,174,586
|
|
|
|
2,326,321
|
|
|
|
9,242,078
|
|
|
|
6,696,079
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(2,058,961
|
)
|
|
|
(1,722,423
|
)
|
|
|
(6,430,103
|
)
|
|
|
(4,164,583
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense and amortization of debt issuance costs
|
|
|
(92,458
|
)
|
|
|
(55,563
|
)
|
|
|
(245,730
|
)
|
|
|
(181,883
|
)
|
Change in fair value of derivative instruments
|
|
|
605,448
|
|
|
|
1,571,471
|
|
|
|
4,767,884
|
|
|
|
9,468,320
|
|
Interest income
|
|
|
4,461
|
|
|
|
3,151
|
|
|
|
12,862
|
|
|
|
9,407
|
|
Other income (expense), net
|
|
|
517,451
|
|
|
|
1,519,059
|
|
|
|
4,535,016
|
|
|
|
9,295,844
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations before income tax provision
|
|
|
(1,541,510
|
)
|
|
|
(203,364
|
)
|
|
|
(1,895,087
|
)
|
|
|
5,131,261
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benefit from sale of state net operating loss credits
|
|
|
1,051,329
|
|
|
|
1,870,114
|
|
|
|
1,051,329
|
|
|
|
1,870,114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
|
(490,181
|
)
|
|
|
1,666,750
|
|
|
|
(843,758
|
)
|
|
|
7,001,375
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in carrying value of convertible preferred share mezzanine equity
|
|
|
-
|
|
|
|
-
|
|
|
|
-
|
|
|
|
20,714,286
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common shareholders’
|
|
$
|
(490,181
|
)
|
|
$
|
1,666,750
|
|
|
$
|
(843,758
|
)
|
|
$
|
27,715,661
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic income (loss) per share attributable to common shareholders’
|
|
$
|
(0.00
|
)
|
|
$
|
0.00
|
|
|
$
|
(0.00
|
)
|
|
$
|
0.03
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income (loss) per
share attributable to common shareholders’
|
|
$
|
(0.00
|
)
|
|
$
|
0.00
|
|
|
$
|
(0.01
|
)
|
|
$
|
(0.00
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic weighted average common shares outstanding
|
|
|
788,442,363
|
|
|
|
904,763,177
|
|
|
|
796,647,284
|
|
|
|
811,794,206
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted weighted average common shares outstanding
|
|
|
795,122,364
|
|
|
|
910,505,291
|
|
|
|
803,327,285
|
|
|
|
817,536,320
|
|
The accompanying notes are an integral
part of these unaudited condensed consolidated financial statements.
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF SHAREHOLDERS’
EQUITY
(UNAUDITED)
|
|
Common Stock
|
|
|
Additional
|
|
|
Treasury Stock
|
|
|
Accumulated
|
|
|
Total Shareholders’
|
|
|
|
Shares
|
|
|
Amount
|
|
|
Paid-In Capital
|
|
|
Shares
|
|
|
Amount
|
|
|
Deficit
|
|
|
Equity
|
|
Balance at March 31, 2017
|
|
|
928,031,448
|
|
|
$
|
928,034
|
|
|
$
|
163,896,410
|
|
|
|
100,000
|
|
|
$
|
(306,841
|
)
|
|
$
|
(138,853,566
|
)
|
|
$
|
25,664,037
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(843,758
|
)
|
|
|
(843,758
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common shares pursuant to the exercise of cash warrants
|
|
|
2,910,532
|
|
|
|
2,910
|
|
|
|
178,998
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
181,908
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares issued as initial commitment shares pursuant to the Lincoln Park purchase agreement
|
|
|
5,540,551
|
|
|
|
5,541
|
|
|
|
914,191
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
919,732
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares issued as additional commitment shares pursuant to the Lincoln Park purchase agreement
|
|
|
167,336
|
|
|
|
167
|
|
|
|
22,755
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
22,922
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares sold pursuant to the Lincoln Park purchase agreement
|
|
|
10,169,281
|
|
|
|
10,169
|
|
|
|
1,197,931
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,208,100
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs associated with raising capital
|
|
|
|
|
|
|
|
|
|
|
(992,610
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(992,610
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-cash compensation through the issuance of employee stock options
|
|
|
|
|
|
|
|
|
|
|
208,719
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
208,719
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retirement of common shares pursuant to the issuance of Series J convertible preferred shares
|
|
|
(158,017,321
|
)
|
|
|
(158,017
|
)
|
|
|
(20,220,614
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,378,631
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2017
|
|
|
788,801,827
|
|
|
$
|
788,804
|
|
|
$
|
145,205,780
|
|
|
|
100,000
|
|
|
$
|
(306,841
|
)
|
|
$
|
(139,697,324
|
)
|
|
$
|
5,990,419
|
|
The accompanying notes are an integral
part of these unaudited condensed consolidated financial statements.
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARY
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
|
|
For the Nine Months Ended December 31,
|
|
|
|
2017
|
|
|
2016
|
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(843,758
|
)
|
|
$
|
7,001,375
|
|
Adjustments to reconcile net (loss) income to net cash used in operating activities:
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
706,759
|
|
|
|
504,932
|
|
Change in fair value of derivative financial instruments - warrants
|
|
|
(4,767,884
|
)
|
|
|
(9,468,320
|
)
|
Non-cash compensation accrued
|
|
|
925,000
|
|
|
|
1,232,950
|
|
Non-cash compensation from the issuance of common stock and options
|
|
|
208,719
|
|
|
|
272,705
|
|
Non-cash rent expense and lease accretion
|
|
|
7,820
|
|
|
|
(18,250
|
)
|
Change in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
(227,181
|
)
|
|
|
985,619
|
|
Inventory
|
|
|
1,117,023
|
|
|
|
(2,735,085
|
)
|
Prepaid expenses and other current assets
|
|
|
(622,480
|
)
|
|
|
(388,915
|
)
|
Accounts payable, accrued expenses and other current liabilities
|
|
|
460,338
|
|
|
|
(434,885
|
)
|
Deferred revenue and customer deposits
|
|
|
(760,000
|
)
|
|
|
(759,997
|
)
|
Net cash used in operating activities
|
|
|
(3,795,644
|
)
|
|
|
(3,807,871
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(291,115
|
)
|
|
|
(804,762
|
)
|
Intellectual property costs
|
|
|
(85,518
|
)
|
|
|
(7,292
|
)
|
Restricted cash
|
|
|
(1,573
|
)
|
|
|
-
|
|
Net cash used in investing activities
|
|
|
(378,206
|
)
|
|
|
(812,054
|
)
|
|
|
|
|
|
|
|
|
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Proceeds from the issuance of stock
|
|
|
1,208,100
|
|
|
|
5,770,163
|
|
Proceeds from cash warrant and options exercises
|
|
|
181,908
|
|
|
|
1,856,480
|
|
Proceeds and repayments of line of credit, related party - net
|
|
|
-
|
|
|
|
(718,309
|
)
|
Payment of bond principal
|
|
|
(85,000
|
)
|
|
|
(209,366
|
)
|
Other loan payments
|
|
|
(431,507
|
)
|
|
|
(290,189
|
)
|
Costs associated with raising capital
|
|
|
(49,956
|
)
|
|
|
(17,671
|
)
|
Net cash provided by financing activities
|
|
|
823,545
|
|
|
|
6,391,108
|
|
|
|
|
|
|
|
|
|
|
Net change in cash
|
|
|
(3,350,305
|
)
|
|
|
1,771,183
|
|
|
|
|
|
|
|
|
|
|
Cash, beginning of period
|
|
|
10,594,693
|
|
|
|
11,512,179
|
|
|
|
|
|
|
|
|
|
|
Cash, end of period
|
|
$
|
7,244,388
|
|
|
$
|
13,283,362
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash and non-cash transactions:
|
|
|
|
|
|
|
|
|
Cash paid for interest
|
|
$
|
67,573
|
|
|
$
|
142,351
|
|
Financing of equipment purchases and insurance renewal
|
|
$
|
498,604
|
|
|
$
|
308,834
|
|
Issuance of Senior Secured Promissory Note pursuant ANDA asset acquisition
|
|
$
|
1,200,000
|
|
|
$
|
-
|
|
Commitment shares issued to Lincoln Park Capital
|
|
$
|
942,654
|
|
|
$
|
69,425
|
|
Change in carrying value of convertible preferred mezzanine equity
|
|
$
|
-
|
|
|
$
|
20,714,286
|
|
Conversion of Series I convertible preferred shares into common shares
|
|
$
|
-
|
|
|
$
|
23,571,429
|
|
Retirement of common shares pursuant to the issuance of Series J convertible preferred shares
|
|
$
|
20,378,631
|
|
|
$
|
-
|
|
The accompanying notes are an integral
part of these unaudited condensed consolidated financial statements.
NOTE 1. SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Overview
Elite Pharmaceuticals,
Inc. (the “Company” or “Elite”) was incorporated on October 1, 1997 under the laws of the State of Delaware,
and its wholly-owned subsidiary Elite Laboratories, Inc. (“Elite Labs”) which was incorporated on August 23, 1990 under
the laws of the State of Delaware. On January 5, 2012, Elite Pharmaceuticals was reincorporated under the laws of the State of
Nevada. Elite Labs engages primarily in researching, developing and licensing proprietary orally administered, controlled-release
drug delivery systems and products with abuse deterrent capabilities and the manufacture of generic, oral dose pharmaceuticals.
The Company is equipped to manufacture controlled-release products on a contract basis for third parties and itself, if and when
the products are approved. These products include drugs that cover therapeutic areas for pain, allergy, bariatric and infection.
Research and development activities are done so with an objective of developing products that will secure marketing approvals from
the United States Food and Drug Administration (“FDA”), and thereafter, commercially exploiting such products.
Principles of Consolidation
The accompanying unaudited
condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the
United States (“GAAP”) and in conformity with the instructions on Form 10-Q and Rule 8-03 of Regulation S-X and the
related rules and regulations of the Securities and Exchange Commission (“SEC”). The unaudited condensed consolidated
financial statements include the accounts of the Company and its wholly-owned subsidiary, Elite Laboratories, Inc. All significant
intercompany accounts and transactions have been eliminated in consolidation. The unaudited condensed consolidated financial statements
reflect all adjustments, consisting of normal recurring accruals, which are, in the opinion of management, necessary for a fair
presentation of such statements. The results of operations for the three and nine months ended December 31, 2017 are not necessarily
indicative of the results that may be expected for the entire year.
Going Concern
In connection with
the preparation of the financial statements as of and for the nine month period ended December 31, 2017, the Company conducted
an evaluation as to whether there were conditions and events, considered in the aggregate, which raised substantial doubt as to
the entity’s ability to continue as a going concern within one year after the date of the issuance, or the date the financial
statements were available for issuance, noting that there did not appear to be evidence of substantial doubt of the entity’s
ability to continue as a going concern.
Segment Information
Financial Accounting
Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 280,
Segment Reporting
,
establishes standards for reporting information about operating segments. Operating segments are defined as components of an enterprise
about which separate financial information is available that is evaluated regularly by the chief operating decision maker, or decision-making
group, in deciding how to allocate resources and in assessing performance. The Company’s chief operating decision maker is
the Chief Executive Officer, who reviews the financial performance and the results of operations of the segments prepared in accordance
with GAAP when making decisions about allocating resources and assessing performance of the Company.
The Company has determined
that its reportable segments are products whose marketing approvals were secured via an Abbreviated New Drug Applications (“ANDA”)
and products whose marketing approvals were secured via a New Drug Application (“NDA”). ANDA products are referred
to as generic pharmaceuticals and NDA products are referred to as branded pharmaceuticals.
There are currently
no intersegment revenues. Asset information by operating segment is not presented below since the chief operating decision maker
does not review this information by segment. The reporting segments follow the same accounting policies used in the preparation
of the Company’s condensed unaudited consolidated financial statements.
Revenue Recognition
The Company enters
into licensing, manufacturing and development agreements, which may include multiple revenue generating activities, including,
without limitation, milestones, licensing fees, product sales and services. These multiple elements are assessed in accordance
with ASC 605-25,
Revenue Recognition – Multiple-Element Arrangements
in order to determine whether particular components
of the arrangement represent separate units of accounting.
An arrangement component
is considered to be a separate unit of accounting if the deliverable relating to the component has value to the customer on a standalone
basis, and if the arrangement includes a general right of return relative to the delivered item, delivery or performance of the
undelivered item is considered probable and substantially in control of the Company.
The Company recognizes
payments received pursuant to a multiple revenue agreement as revenue, only if the related delivered item(s) have stand-alone value,
with the arrangement being accordingly accounted for as a separate unit of accounting. If such delivered item(s) are considered
to either not have stand-alone value, the arrangement is accounted for as a single unit of accounting, and the payments received
are recognized as revenue over the estimated period of when performance obligations relating to the item(s) will be performed.
Whenever the Company
determines that an arrangement should be accounted for as a single unit of accounting, it determines the period over which the
performance obligations will be performed, and revenue will be recognized. If it cannot reasonably estimate the timing and the
level of effort to complete its performance obligations under a multiple-element arrangement, revenues are then recognized on a
straight-line basis over the period encompassing the expected completion of such obligations, with such period being reassessed
at each subsequent reporting period.
Arrangement consideration
is allocated at the inception of the arrangement to all deliverables on the basis of their relative selling price (the relative
selling price method). When applying the relative selling price method, the selling price of each deliverable is determined using
vendor-specific objective evidence of selling price, if such exists; otherwise, third-party evidence of selling price. If neither
vendor-specific objective evidence nor third-party evidence of selling price exists for a deliverable, the Company uses its best
estimate of the selling price for that deliverable when applying the relative selling price method. In deciding whether we can
determine vendor-specific objective evidence or third-party evidence of selling price, the Company does not ignore information
that is reasonably available without undue cost and effort.
When determining the
selling price for significant deliverables under a multiple-element revenue arrangement, the Company considers any or all of the
following, without limitation, depending on information available or information that could be reasonably available without undue
cost and effort: vendor-specific objective evidence, third party evidence or best estimate of selling price. More specifically,
factors considered can include, without limitation and as appropriate: size of market for a specific product; number of suppliers
and other competitive market factors; forecast market shares and gross profits; barriers/time frames to market entry/launch; intellectual
property rights and protections; exclusive or non-exclusive arrangements; costs of similar/identical deliverables from third parties;
contractual terms, including, without limitation, length of contract, renewal rights, commercial terms, and profit allocations;
and other commercial, financial, tangible and intangible factors that may be relevant in the valuation of a specific deliverable.
Milestone payments
are accounted for in accordance with ASC 605-28,
Revenue Recognition – Milestone Method
for any deliverables or units
of accounting under which the Company must achieve a defined performance obligation which is contingent upon future events or circumstances
that are uncertain as of the inception of the arrangement providing for such future milestone payment. Determination of the substantiveness
of a milestone is a matter of subjective assessment performed at the inception of the arrangement, and with consideration earned
from the achievement of a milestone meeting all of the following:
|
·
|
It must be either commensurate with the
Company’s performance in achieving the milestone or the enhancement of the value of the delivered item(s) as a result of
a specific outcome resulting from the Company’s performance to achieve the milestone; and,
|
|
·
|
It relates solely to past performance;
and,
|
|
·
|
It is reasonable relative to all of the
deliverables and payment terms (including other potential milestone consideration) within the arrangement.
|
Collaborative Arrangements
Contracts are considered
to be collaborative arrangements when they satisfy the following criteria defined in ASC 808,
Collaborative Arrangements
:
|
·
|
The parties to the contract must actively
participate in the joint operating activity; and,
|
|
·
|
The joint operating activity must expose
the parties to the possibility of significant risk and rewards, based on whether or not the activity is successful.
|
The Company entered
into a sales and distribution licensing agreement with Epic Pharma LLC, dated June 4, 2015 (the “2015 Epic License Agreement”),
which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly,
in accordance with GAAP.
The Company entered
into a Master Development and License Agreement with SunGen Pharma LLC dated August 24, 2016 (the “SunGen Agreement”),
which has been determined to satisfy the criteria for consideration as a collaborative agreement, and is accounted for accordingly,
in accordance with GAAP.
Cash
The Company considers
all highly liquid investments with an original maturity of three months or less to be cash equivalents. Cash and cash equivalents
consist of cash on deposit with banks and money market instruments. The Company places its cash and cash equivalents with high-quality,
U.S. financial institutions and, to date has not experienced losses on any of its balances.
Restricted Cash
As of December 31,
2017, and March 31, 2017, the Company had $390,654 and $389,081, respectively, of restricted cash, related to debt service reserve
in regard to the New Jersey Economic Development Authority (“NJEDA”) bonds (see Note 6).
Accounts Receivable
Accounts receivable
are comprised of balances due from customers, net of estimated allowances for uncollectible accounts. In determining collectability,
historical trends are evaluated, and specific customer issues are reviewed on a periodic basis to arrive at appropriate allowances.
Inventory
Inventory is recorded
at the lower of cost or market on a first-in first-out basis.
Long-Lived Assets
The Company periodically
evaluates the fair value of long-lived assets, which include property and equipment and intangibles, whenever events or changes
in circumstances indicate that its carrying amounts may not be recoverable.
Property and equipment
are stated at cost. Depreciation is provided on the straight-line method based on the estimated useful lives of the respective
assets which range from three to forty years. Major repairs or improvements are capitalized. Minor replacements and maintenance
and repairs which do not improve or extend asset lives are expensed currently.
Upon retirement or
other disposition of assets, the cost and related accumulated depreciation are removed from the accounts and the resulting gain
or loss, if any, is recognized in income.
Intangible Assets
The Company capitalizes
certain costs to acquire intangible assets; if such assets are determined to have a finite useful life they are amortized on a
straight-line basis over the estimated useful life. Costs to acquire indefinite lived intangible assets, such as costs related
to ANDAs are capitalized accordingly.
The Company tests its
intangible assets for impairment at least annually (as of March 31st) and whenever events or circumstances change that indicate
impairment may have occurred. A significant amount of judgment is involved in determining if an indicator of impairment has occurred.
Such indicators may include, among others and without limitation: a significant decline in the Company’s expected future
cash flows; a sustained, significant decline in the Company’s stock price and market capitalization; a significant adverse
change in legal factors or in the business climate of the Company’s segments; unanticipated competition; and slower growth
rates.
As of December 31,
2017, the Company did not identify any indicators of impairment.
Research and Development
Research and development expenditures
are charged to expense as incurred.
Contingencies
Occasionally, the Company
may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision
for a liability when it believes that it is both probable that a liability has been incurred, and the amount can be reasonably
estimated. If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s
condensed consolidated financial statements. Contingencies are inherently unpredictable and the assessments of the value can involve
a series of complex judgments about future events and can rely heavily on estimates and assumptions.
Income Taxes
Income taxes are accounted
for under the asset and liability method. Deferred income tax assets and liabilities are determined based on differences between
financial reporting and tax bases of assets and liabilities, and net operating loss and other tax credit carry-forwards. These
items are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The
Company records a valuation allowance to reduce the deferred income tax assets to the amount that is more likely than not to be
realized.
Warrants and Preferred Shares
The accounting treatment
of warrants and preferred share series issued is determined pursuant to the guidance provided by ASC 470,
Debt
, ASC 480,
Distinguishing Liabilities from Equity
, and ASC 815,
Derivatives and Hedging
, as applicable. Each feature of a freestanding
financial instruments including, without limitation, any rights relating to subsequent dilutive issuances, dividend issuances,
equity sales, rights offerings, forced conversions, optional redemptions, automatic monthly conversions, dividends and exercise
are assessed with determinations made regarding the proper classification in the Company’s financial statements.
Stock-Based Compensation
The Company accounts
for stock-based compensation in accordance with ASC Topic 718,
Compensation-Stock Compensation
. Under the fair value recognition
provisions of this topic, stock-based compensation cost is measured at the grant date based on the fair value of the award and
is recognized as an expense on a straight-line basis over the requisite service period, based on the terms of the awards. The cost
of the stock-based payments to nonemployees that are fully vested and non-forfeitable as at the grant date is measured and recognized
at that date, unless there is a contractual term for services in which case such compensation would be amortized over the contractual
term.
In accordance with
the Company’s Director compensation policy and certain employment contracts, director’s fees and a portion of employee’s
salaries are to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the valuation of
such share being calculated on a quarterly basis and equal to the average closing price of the Company’s common stock.
Earnings (Loss) Per Share Applicable
to Common Shareholders’
The Company follows
ASC 260,
Earnings Per Share
, which requires presentation of basic and diluted earnings (loss) per share (“EPS”)
on the face of the income statement for all entities with complex capital structures and requires a reconciliation of the numerator
and denominator of the basic EPS computation to the numerator and denominator of the diluted EPS computation. In the accompanying
financial statements, basic earnings (loss) per share is computed by dividing net income (loss) by the weighted average number
of shares of common stock outstanding during the period. Diluted EPS excluded all dilutive potential shares if their effect was
anti-dilutive.
The following is
the computation of earnings (loss) per share applicable to common shareholders for the periods indicated:
|
|
For the Three Months Ended
December 31,
|
|
|
For the Nine Months Ended
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Numerator
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common shareholders - basic
|
|
$
|
(490,181
|
)
|
|
$
|
1,666,750
|
|
|
$
|
(843,758
|
)
|
|
$
|
27,715,661
|
|
Effect of dilutive instrument on net income (loss)
|
|
|
(605,448
|
)
|
|
|
(1,571,471
|
)
|
|
|
(4,767,884
|
)
|
|
|
(30,182,606
|
)
|
Net income (loss) attributable to common shareholders - diluted
|
|
$
|
(1,095,629
|
)
|
|
$
|
95,279
|
|
|
$
|
(5,611,642
|
)
|
|
$
|
(2,466,945
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares of common stock outstanding - basic
|
|
|
788,442,363
|
|
|
|
904,763,177
|
|
|
|
796,647,284
|
|
|
|
811,794,206
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dilutive effect of stock options, warrants and convertible securities
|
|
|
6,680,001
|
|
|
|
5,742,114
|
|
|
|
6,680,001
|
|
|
|
5,742,114
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares of common stock outstanding - diluted
|
|
|
795,122,364
|
|
|
|
910,505,291
|
|
|
|
803,327,285
|
|
|
|
817,536,320
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.00
|
)
|
|
$
|
0.00
|
|
|
$
|
(0.00
|
)
|
|
$
|
0.03
|
|
Diluted
|
|
$
|
(0.00
|
)
|
|
$
|
0.00
|
|
|
$
|
(0.01
|
)
|
|
$
|
(0.00
|
)
|
Fair Value of Financial Instruments
ASC Topic 820,
Fair
Value Measurements and Disclosures
(“ASC Topic 820”) provides a framework for measuring fair value in accordance
with generally accepted accounting principles.
ASC Topic 820 defines
fair value as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between
market participants at the measurement date. ASC Topic 820 establishes a fair value hierarchy that distinguishes between (1) market
participant assumptions developed based on market data obtained from independent sources (observable inputs) and (2) an entity’s
own assumptions about market participant assumptions developed based on the best information available in the circumstances (unobservable
inputs).
The fair value hierarchy
consists of three broad levels, which gives the highest priority to unadjusted quoted prices in active markets for identical assets
or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy
under ASC Topic 820 are described as follows:
|
·
|
Level 1 –
|
Unadjusted quoted prices in active markets for identical assets or liabilities that are accessible at the measurement date.
|
|
·
|
Level 2 –
|
Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 2 inputs include quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; inputs other than quoted prices that are observable for the asset or liability; and inputs that are derived principally from or corroborated by observable market data by correlation or other means.
|
|
·
|
Level 3 –
|
Inputs that are unobservable for the asset or liability.
|
Measured on a Recurring
Basis
The following table
presents information about our liabilities measured at fair value on a recurring basis, aggregated by the level in the fair value
hierarchy within which those measurements fell:
|
|
|
|
|
Fair Value Measurement Using
|
|
|
|
Amount at Fair
Value
|
|
|
Level 1
|
|
|
Level 2
|
|
|
Level 3
|
|
December 31, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative financial instruments - warrants
|
|
$
|
2,550,254
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
2,550,254
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2017
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derivative financial instruments - warrants
|
|
$
|
843,464
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
843,464
|
|
See Note 12 for specific
inputs used in determining fair value.
The carrying amounts
of the Company’s financial assets and liabilities, such as cash, accounts receivable, prepaid expenses and other current
assets, accounts payable and accrued expenses, approximate their fair values because of the short maturity of these instruments.
Non-Financial Assets
that are Measured at Fair Value on a Non-Recurring Basis
Non-financial assets
such as intangible assets, and property and equipment are measured at fair value only when an impairment loss is recognized. The
Company did not record an impairment charge related to these assets in the periods presented.
Treasury Stock
The Company records
treasury stock at the cost to acquire it and includes treasury stock as a component of shareholders’ equity.
Recently Adopted Accounting Pronouncements
In January 2017, the
Financial Accounting Standards Board (“FASB”) issued Accounting Standard Update (“ASU”) 2017-01,
Business
Combinations: Clarifying the Definition of a Business
, which amends the current definition of a business. Under ASU 2017-01,
to be considered a business, an acquisition would have to include an input and a substantive process that together significantly
contributes to the ability to create outputs. ASU 2017-01 further states that when substantially all of the fair value of gross
assets acquired is concentrated in a single asset (or a group of similar assets), the assets acquired would not represent a business.
The new guidance also narrows the definition of the term “outputs” to be consistent with how it is described in Topic
606,
Revenue from Contracts with Customers
. The changes to the definition of a business will likely result in more acquisitions
being accounted for as asset acquisitions. The guidance is effective for the annual period beginning after December 15, 2017, with
early adoption permitted. The Company has elected to early adopt ASU 2017-01 and to apply it to any transaction, which occurred
prior to the issuance date that has not been reported in financial statements that have been issued or made available for issuance.
Recently Issued Accounting Pronouncements
In May 2014, the FASB
issued ASU 2014-09,
Revenue from Contracts with Customers (Topic 606)
. The core principle of ASU 2014-09 is that an entity
should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration
to which the entity expects to be entitled in exchange for those goods and services. This standard is effective for fiscal years
and interim reporting periods beginning after December 15, 2016. In August 2015, the FASB issued ASU 2015-14, Revenue
from Contracts
with Customers (Topic 606): Deferral of the Effective Date.
The amendments in this update deferred the effective date
for implementation of ASU 2014-09 by one year and is now effective for annual reporting periods beginning after December 15, 2017.
Early application is permitted only as of annual reporting periods beginning after December 15, 2016 including interim reporting
periods within that period. Topic 606 is effective for the Company in the first quarter of Fiscal 2019. The Company is currently
evaluating the new revenue recognition guidance. The Company has completed its initial impact assessment and has commenced an in-depth
evaluation of the adoption impact, which involves review of selected revenue arrangements. Based on the Company’s preliminary
review, the Company believes that the timing and measurement of revenue for its customers will be similar to the Company’s
current revenue recognition. However, this view is preliminary and could change based on further analysis associated with the conversion
and implementation phases of our ASU 2014-09 project.
From March 2016 through
September 2017, the FASB issued ASU 2016-08,
Revenue from Contracts with Customers (Topic 606): Principal versus Agent Considerations
(Reporting Revenue Gross versus Net),
ASU 2016-10,
Revenue from Contracts with Customers (Topic 606): Identifying Performance
Obligations and Licensing,
ASU 2016-11,
Revenue Recognition (Topic 605) and Derivatives and Hedging (Topic 815): Rescission
of SEC Guidance Because of Accounting Standards Updates 2014-09 and 2014-16 Pursuant to Staff Announcements at the March 3, 2016
EITF Meeting,
ASU No. 2016-12,
Revenue from Contracts with Customers (Topic 606):Narrow-Scope Improvements and Practical
Expedients
, ASU No. 2016-20,
Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers
and ASU No. 2017-13,
Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840),
and Leases (Topic 842): Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission
of Prior SEC Staff Announcements and Observer Comments.
These amendments are intended to improve and clarify the implementation
guidance of Topic 606. The effective date and transition requirements for the amendments are the same as the effective date and
transition requirements of ASU No. 2014-09 and ASU No. 2015-14.
In February 2016,
the FASB issued ASU No. 2016-02,
Leases (Topic 842)
, which is effective for public entities for annual reporting periods
beginning after December 15, 2018. Under ASU 2016-02, lessees will be required to recognize the following for all leases (with
the exception of short-term leases) at the commencement date: 1) a lease liability, which is a lessee’s obligation to make
lease payments arising from a lease, measured on a discounted basis, and 2) a right-of-use asset, which is an asset that represents
the lessee’s right to use, or control the use of, a specified asset for the lease term. The Company is currently evaluating
the effects of ASU 2016-02 on its unaudited condensed 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 eliminates the diversity in practice related to the classification of certain cash receipts and payments for debt prepayment
or extinguishment costs, the maturing of a zero-coupon bond, the settlement of contingent liabilities arising from a business combination,
proceeds from insurance settlements, distributions from certain equity method investees and beneficial interests obtained in a
financial asset securitization. ASU 2016-15 designates the appropriate cash flow classification, including requirements to allocate
certain components of these cash receipts and payments among operating, investing and financing activities. The guidance is effective
for the Company beginning after December 15, 2017, although early adoption is permitted. The Company is currently evaluating the
effects of ASU 2016-15 on its unaudited condensed consolidated financial statements.
In November 2016, the
FASB issued ASU No. 2016-18,
Statement of Cash Flows (Topic 230) Restricted Cash a consensus of the FASB Emerging Issues Task
Force
. ASU 2016-18 requires restricted cash and cash equivalents to be included with cash and cash equivalents on the statement
cash flows. The new standard is expected to be effective for fiscal years, and interim periods within those years, beginning after
December 15, 2017, with early adoption permitted. The Company is currently evaluating the effects of ASU 2016-18 on its unaudited
condensed consolidated financial statements.
In
July 2017, the FASB issued ASU 2017-11,
Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480)
and Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features; II.
Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and
Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception
. Part I of this update addresses the
complexity of accounting for certain financial instruments with down round features. Down round features are features of
certain equity-linked instruments (or embedded features) that result in the strike price being reduced on the basis of the
pricing of future equity offerings. Current accounting guidance creates cost and complexity for entities that issue financial
instruments (such as warrants and convertible instruments) with down round features that require fair value measurement of
the entire instrument or conversion option. Part II of this update addresses the difficulty of navigating
Topic 480,
Distinguishing Liabilities from Equity
, because of the existence of extensive pending content in the FASB Accounting
Standards Codification. This pending content is the result of the indefinite deferral of accounting requirements about
mandatorily redeemable financial instruments of certain nonpublic entities and certain mandatorily redeemable noncontrolling
interests. The amendments in Part II of this update do not have an accounting effect. This ASU is effective for fiscal years,
and interim periods within those years, beginning after December 15, 2018. The Company is currently assessing the potential
impact of adopting ASU 2017-11 on its unaudited condensed consolidated financial statements and related disclosures.
NOTE 2. ASSET ACQUISITION
On May 15, 2017, Elite
Laboratories, Inc., a wholly-owned subsidiary of the Company entered into an asset purchase agreement with Mikah Pharma, LLC (“Mikah”
and/or the “Seller”), a related party, to acquire the Abbreviated New Drug Applications for Trimipramine Maleate Capsules
and testing data, studies, and formulations created in connection therewith including but not limited to (i) the ANDA(s) (Trimipramine
Maleate Capsules, 25, 50 and 100 mg ) (the “Product”), (ii) any correspondence with the United States Food and Drug
Administration in Seller’s files with respect to the ANDA(s), (iii) the right of reference to the Drug Master Files, as set
forth in the ANDA(s); (iv) the ANDA(s) Technology and Scientific Materials; (v) all rights to manufacture, sell or otherwise exploit
any products resulting therefrom including all rights to revenues generated therefrom; and (vi) a royalty free limited license
to use any ANDA(s) Technology and Scientific Materials which is common to the Product and any other product of Seller, but only
for Buyer’s use in connection with the manufacture of any product (the “Purchased Assets”). Mikah is owned by
Nasrat Hakim, the CEO, President and Chairman of the Board of the Company. For consideration of the purchased assets, the Company
issued a Secured Promissory Note for the principal sum of $1,200,000 (see Note 8).
The Company evaluated
the acquisition of the purchased assets under ASC 805,
Business Combinations
and ASU 2017-01 and concluded that as substantially
all of the fair value of the gross assets acquired is concentrated in an identifiable group of similar assets, the transaction
did not meet the requirements to be accounted for as a business combination and therefore was accounted for as an asset acquisition.
Accordingly, the purchase price of the purchased assets was allocated entirely to an identifiable intangible asset as follows:
ANDA acquisition costs
|
|
$
|
1,200,000
|
|
Total assets acquired
|
|
$
|
1,200,000
|
|
NOTE 3. INVENTORY
Inventory consisted
of the following:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
Finished goods
|
|
$
|
126,663
|
|
|
$
|
221,657
|
|
Work-in-progress
|
|
|
6,946
|
|
|
|
283,086
|
|
Raw materials
|
|
|
5,165,334
|
|
|
|
5,911,223
|
|
|
|
|
5,298,943
|
|
|
|
6,415,966
|
|
Less: Inventory reserve
|
|
|
-
|
|
|
|
-
|
|
|
|
$
|
5,298,943
|
|
|
$
|
6,415,966
|
|
NOTE 4. PROPERTY AND EQUIPMENT, NET
Property and equipment
consisted of the following:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
Land, building and improvements
|
|
$
|
7,655,317
|
|
|
$
|
7,308,890
|
|
Laboratory, manufacturing and warehouse equipment
|
|
|
9,175,466
|
|
|
|
8,764,406
|
|
Office equipment and software
|
|
|
308,434
|
|
|
|
276,201
|
|
Furniture and fixtures
|
|
|
49,804
|
|
|
|
49,804
|
|
Transportation equipment
|
|
|
66,855
|
|
|
|
66,855
|
|
|
|
|
17,255,876
|
|
|
|
16,466,156
|
|
Less: Accumulated depreciation
|
|
|
(8,122,878
|
)
|
|
|
(7,426,752
|
)
|
|
|
$
|
9,132,998
|
|
|
$
|
9,039,404
|
|
Depreciation expense
was $285,496 and $166,602 for the three months and $696,126 and $504,932 for the nine months ended December 31, 2017 and 2016,
respectively.
NOTE 5. INTANGIBLE ASSETS
The following table
summarizes the Company’s intangible assets as of December 31, 2017 and March 31, 2017:
|
|
December 31, 2017
|
|
|
|
Estimated
|
|
|
Gross
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful
|
|
|
Carrying
|
|
|
|
|
|
Accumulated
|
|
|
Net Book
|
|
|
|
Life
|
|
|
Amount
|
|
|
Additions
|
|
|
Amortization
|
|
|
Value
|
|
Patent application costs
|
|
|
*
|
|
|
$
|
371,774
|
|
|
$
|
85,518
|
|
|
$
|
-
|
|
|
$
|
457,292
|
|
ANDA acquisition costs
|
|
|
Indefinite
|
|
|
|
6,047,317
|
|
|
|
1,200,000
|
|
|
|
-
|
|
|
|
7,247,317
|
|
|
|
|
|
|
|
$
|
6,419,091
|
|
|
$
|
1,285,518
|
|
|
$
|
-
|
|
|
$
|
7,704,609
|
|
|
|
March 31, 2017
|
|
|
|
Estimated
|
|
|
Gross
|
|
|
|
|
|
|
|
|
|
|
|
|
Useful
|
|
|
Carrying
|
|
|
|
|
|
Accumulated
|
|
|
Net Book
|
|
|
|
Life
|
|
|
Amount
|
|
|
Additions
|
|
|
Amortization
|
|
|
Value
|
|
Patent application costs
|
|
|
*
|
|
|
$
|
364,482
|
|
|
$
|
7,292
|
|
|
$
|
-
|
|
|
$
|
371,774
|
|
ANDA acquisition costs
|
|
|
Indefinite
|
|
|
|
6,047,317
|
|
|
|
-
|
|
|
|
-
|
|
|
|
6,047,317
|
|
|
|
|
|
|
|
$
|
6,411,799
|
|
|
$
|
7,292
|
|
|
$
|
-
|
|
|
$
|
6,419,091
|
|
* Patent application
costs were incurred in relation to the Company’s abuse deterrent opioid technology. Amortization of the patent costs will
begin upon the issuance of marketing authorization by the FDA. Amortization will then be calculated on a straight-line basis through
the expiry of the related patent(s).
NOTE 6. NJEDA BONDS
During August 2005,
the Company refinanced a bond issue occurring in 1999 through the issuance of Series A and B Notes tax-exempt bonds (the “NJEDA
Bonds” and/or “Bonds”). During July 2014, the Company retired all outstanding Series B Notes, at par, along with
all accrued interest due and owed.
In relation to the
Series A Notes, the Company is required to maintain a debt service reserve. The debt serve reserve is classified as restricted
cash on the accompanying unaudited condensed consolidated balance sheets. The NJEDA Bonds require the Company to make an annual
principal payment on December 1
st
based on the amount specified in the loan documents and semi-annual interest payments
on March 1
st
and December 1
st
, equal to interest due on the outstanding principal. The annual interest rate
on the Series A Note is 6.5%. The NJEDA Bonds are collateralized by a first lien on the Company’s facility and equipment
acquired with the proceeds of the original and refinanced bonds.
The following tables
summarize the Company’s bonds payable liability:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
Gross bonds payable
|
|
|
|
|
|
|
|
|
NJEDA Bonds - Series A Notes
|
|
$
|
1,760,000
|
|
|
$
|
1,845,000
|
|
Less: Current portion of bonds payable (prior to deduction of bond offering costs)
|
|
|
(90,000
|
)
|
|
|
(85,000
|
)
|
Long-term portion of bonds payable (prior to deduction of bond offering costs)
|
|
$
|
1,670,000
|
|
|
$
|
1,760,000
|
|
|
|
|
|
|
|
|
|
|
Bond offering costs
|
|
$
|
354,453
|
|
|
$
|
354,453
|
|
Less: Accumulated amortization
|
|
|
(174,864
|
)
|
|
|
(164,231
|
)
|
Bond offering costs, net
|
|
$
|
179,589
|
|
|
$
|
190,222
|
|
|
|
|
|
|
|
|
|
|
Current portion of bonds payable - net of bond offering costs
|
|
|
|
|
|
|
|
|
Current portions of bonds payable
|
|
$
|
90,000
|
|
|
$
|
85,000
|
|
Less: Bonds offering costs to be amortized in the next 12 months
|
|
|
(14,178
|
)
|
|
|
(14,178
|
)
|
Current portion of bonds payable, net of bond offering costs
|
|
$
|
75,822
|
|
|
$
|
70,822
|
|
|
|
|
|
|
|
|
|
|
Long term portion of bonds payable - net of bond offering costs
|
|
|
|
|
|
|
|
|
Long term portion of bonds payable
|
|
$
|
1,670,000
|
|
|
$
|
1,760,000
|
|
Less: Bond offering costs to be amortized subsequent to the next 12 months
|
|
|
(165,411
|
)
|
|
|
(176,044
|
)
|
Long term portion of bonds payable, net of bond offering costs
|
|
$
|
1,504,589
|
|
|
$
|
1,583,956
|
|
Amortization expense
was $3,544 for the three months and $10,633 for the nine months ended December 31, 2017 and 2016, respectively.
NOTE 7. LOANS PAYABLE
Loans payable consisted
of the following:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
Equipment and insurance financing loans payable, between approximately 4% and 13%
interest and maturing between August 2018 and November 2022
|
|
$
|
1,060,861
|
|
|
$
|
993,760
|
|
Less: Current portion of loans payable
|
|
|
(424,160
|
)
|
|
|
(416,148
|
)
|
Long-term portion of loans payable
|
|
$
|
636,701
|
|
|
$
|
577,612
|
|
The interest expense
associated with the loans payable was $29,853 and $21,603 for the three months and $70,634 and $64,932 for the nine months ended
December 31, 2017 and 2016, respectively.
NOTE 8. RELATED PARTY SECURED PROMISSORY
NOTE WITH MIKAH PHARMA LLC
For consideration of
the assets acquired on May 15, 2017, as discussed in Note 2, the Company issued a Secured Promissory Note (the “Note”)
to Mikah for the principal sum of $1,200,000. The Note matures on December 31, 2020 in which the Company shall pay the outstanding
principal balance of the Note. Interest shall be computed on the unpaid principal amount at the per annum rate of ten percent (10%);
provided, upon the occurrence of an Event of Default as defined within the Note, the principal balance shall bear interest from
the date of such occurrence until the date of actual payment at the per annum rate of fifteen percent (15%). All interest payable
hereunder shall be computed on the basis of actual days elapsed and a year of 360 days. Installment payments of interest on the
outstanding principal shall be paid as follows: quarterly commencing August 1, 2017 and on November 1, February 1, May 1 and August
1 of each year thereafter. All unpaid principal and accrued but unpaid interest shall be due and payable in full on the Maturity
Date. The interest expense associated with the Note was $30,000 for the three months and $75,000 for the nine months ended December
31, 2017, respectively.
NOTE 9. DEFERRED REVENUE
Deferred revenues in
the aggregate amount of $2,518,890 as of December 31, 2017, were comprised of a current component of $1,013,333 and a long-term
component of $1,505,557. Deferred revenues in the aggregate amount of $3,278,890 as of March 31, 2017, were comprised of a current
component of $1,013,333 and a long-term component of $2,265,557. These line items represent the unamortized amounts of a $200,000
advance payment received for a TAGI licensing agreement with a fifteen-year term beginning in September 2010 and ending in August
2025 and the $5,000,000 advance payment Epic Collaborative Agreement with a five-year term beginning in June 2015 and ending in
May 2020. These advance payments were recorded as deferred revenue when received and are earned, on a straight-line basis over
the life of the licenses. The current component is equal to the amount of revenue to be earned during the 12-month period immediately
subsequent to the balance date and the long-term component is equal to the amount of revenue to be earned thereafter.
NOTE 10. COMMITMENTS AND CONTINGENCIES
Occasionally, the Company
may be involved in claims and legal proceedings arising from the ordinary course of its business. The Company records a provision
for a liability when it believes that is both probable that a liability has been incurred, and the amount can be reasonably estimated.
If these estimates and assumptions change or prove to be incorrect, it could have a material impact on the Company’s condensed
consolidated financial statements. Contingencies are inherently unpredictable and the assessments of the value can involve a series
of complex judgments about future events and can rely heavily on estimates and assumptions.
Operating Leases – 135
Ludlow Ave.
The
Company entered into an operating lease for a portion of a one-story warehouse, located at 135 Ludlow Avenue, Northvale, New Jersey
(the “135 Ludlow Ave. lease”). The 135 Ludlow Ave. lease is for approximately 15,000 square feet of floor space and
began on July 1, 2010. During July 2014, the Company modified the 135 Ludlow Ave. lease in which the Company was permitted to occupy
the entire 35,000 square feet of floor space in the building (“135 Ludlow Ave. modified lease”).
The
135 Ludlow Ave. modified lease, includes an initial term, which expired on December 31, 2016 with two tenant renewal options of
five years each, at the sole discretion of the Company. On June 22, 2016, the Company exercised the first of these renewal options,
with such option including a term that begins on January 1, 2017 and expires on December 31, 2021.
The
135 Ludlow Ave. property required significant leasehold improvements and qualifications, as a prerequisite, for its intended future
use. Manufacturing, packaging, warehousing and regulatory activities are currently conducted at this location. Additional renovations
and construction to further expand the Company’s manufacturing resources are in progress.
Rent
expense is recorded on the straight-line basis. Rents paid in excess is recognized as deferred rent. Rent expense under the 135
Ludlow Ave. modified lease for the three-month ended December 31, 2017 and 2016 was $54,909 and $45,213, respectively and $164,727
and $135,639 for the nine months ended December 31, 2017 and 2016, respectively. Rent expense is recorded in general and administrative
expense in the unaudited condensed consolidated statements of operations. Deferred rent as of December 31, 2017 and March 31, 2017
was $8,604 and $2,152, respectively and recorded as a component of other long-term liabilities.
The
Company has an obligation for the restoration of its leased facility and the removal or dismantlement of certain property and equipment
as a result of its business operation in accordance with ASC 410,
Asset Retirement and Environmental Obligations – Asset
Retirement Obligations
. The Company records the fair value of the asset retirement obligation in the period in which it is
incurred. The Company increases, annually, the liability related to this obligation. The liability is accreted to its present value
each period and the capitalized cost is depreciated over the useful life of the related asset. Upon settlement of the liability,
the Company records either a gain or loss. As of December 31, 2017, and March 31, 2017, the Company had a liability of $30,976
and $29,616, respectively and recorded as a component of other long-term liabilities.
NOTE 11. MEZZANINE EQUITY
Series I convertible preferred stock
On
February 6, 2014, the Company created the Series I Convertible Preferred Stock (“Series I Preferred”). A total of 495.758
shares of Series I Preferred were authorized, 100 shares are issued and outstanding, with a stated value of $100,000 per share
and a par value of $0.01. On August 16, 2016, the 100 shares issued and outstanding were converted into 142,857,143 shares of common
stock at the stated conversion price of $0.07. In conjunction with the Certificate of Designations (“COD”), the shares
converted were retired, cancelled, and returned to the status of authorized by unissued preferred stock. There are 395.758 shares
authorized, 0 issued and outstanding as of December 31, 2017 and March 31, 2017, respectively.
The COD for the Series
I Preferred contained the following features:
|
·
|
Conversion feature - the Series I Preferred
Shares may be converted, at the option of the Holder, into the Company’s Common Stock at a stated conversion price of $0.07
|
|
·
|
Subsequent dilutive issuances - if the
Company issues options at a price below the Conversion Price, then the Conversion Price will be reduced.
|
|
·
|
Subsequent dividend issuances - if the
Company issues Common Stock in lieu of cash in satisfaction of its dividend obligation on its Series C Certificate, the applicable
Conversion Price of the Series I Preferred is adjusted.
|
The Company
has determined that the Series I Preferred host instrument was more akin to equity than debt and that the above financial instruments
were clearly and closely related to the host instrument, with bifurcation and classification as a derivative liability being not
required.
Based on
the Company’s review of the COD, the host instrument, the Series I Preferred Shares, was classified as mezzanine equity.
The above identified embedded financial instruments: Conversion Feature, Subsequent Dilutive Issuances and Subsequent Dividend
Issuances will not be bifurcated from the host and are therefore classified as mezzanine equity with the Series I Preferred. The
Series I Preferred was carried at the maximum redemption value, with changes in this value charged to retained earnings or to additional
paid-in capital in the absence of retained earnings.
Changes
in carrying value are also subtracted from net income (loss), (in a manner like the treatment of dividends paid on preferred stock),
in arriving at net income (loss) available to common shareholders used in the calculation of earnings per share.
Authorized,
issued and outstanding shares, along with carrying value and change in value as of the periods presented are as follows:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
Shares authorized
|
|
|
395.758
|
|
|
|
395.758
|
|
Shares outstanding
|
|
|
-
|
|
|
|
-
|
|
Par value
|
|
$
|
0.01
|
|
|
$
|
0.01
|
|
Stated value
|
|
$
|
100,000
|
|
|
$
|
100,000
|
|
Conversion price
|
|
$
|
0.07
|
|
|
$
|
0.07
|
|
Common shares to be issued upon redemption
|
|
|
-
|
|
|
|
-
|
|
Closing price on valuation date
|
|
$
|
0.09
|
|
|
$
|
0.15
|
|
|
|
|
|
|
|
|
|
|
Carrying value of Series I convertible preferred stock
|
|
$
|
-
|
|
|
$
|
-
|
|
|
|
For the Three Months Ended
December 31,
|
|
|
For the Nine Months Ended
December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Change in carrying value of convertible preferred share mezzanine equity - Series I
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
-
|
|
|
$
|
20,714,286
|
|
Series J convertible preferred stock
On April 28, 2017,
the Company created the Series J Convertible Preferred Stock (“Series J Preferred”) in conjunction with the Certificate
of Designations (“Series J COD”). A total of 50 shares of Series J Preferred were authorized, 24.0344 shares are issued
and outstanding, with a stated value of $1,000,000 per share and a par value of $0.01 as of December 31, 2017.
The issued
shares were pursuant to an Exchange Agreement with Nasrat Hakim, (“Hakim”) a related party and the
Company’s President, Chief Executive Officer and Chairman of the Board of Directors. Per to the Exchange Agreement the
Company exchanged 158,017,321 shares of Common Stock for 24.0344 shares of Series J Preferred and warrants to purchase
79,008,661 shares of common stock at $1.1521 per share. The aggregate stated value of the Series J Preferred issued was equal
to the aggregate value of the shares of common stock exchanged, with such value of each share of Common Stock exchanged being
equal to the closing price of the Common Stock on April 27, 2017. In connection with the Exchange Agreement, the Company also
issued warrants to purchase 79,008,661 shares of common stock at $0.1521 per share, and such warrants are classified as
liabilities on the accompanying unaudited condensed consolidated balance sheet (See Note 12).
Each Series J Preferred
is convertible at the option of the holder into shares of common stock, that is the earlier of (i) the date that shareholder approval
is obtained and the requisite corporate action has been effected regarding a Fundamental Transaction (as defined in the Series
J COD); or (ii) not less than three years subsequent to the Original Issue Date (the date of the first issuance of any shares of
the Series J Preferred Stock) (the “Conversion Date”). The number of common shares is calculated by dividing the Stated
Value of such share of Series J Preferred by the Conversion Price. The conversion price for the Series J Preferred shall equal
$0.1521, subject to adjustment as discussed below.
Based on the current
conversion price, the Series J Preferred is convertible into 158,017,321 shares of common stock. The conversion price is subject
to the following adjustments: (i) stock dividends and splits, (ii) sale or grant of shares below the conversion price, (iii) pro
rata distributions; or (iv) fundamental changes (merger, consolidation, or sale of all or substantially all assets).
If upon any Conversion
Date there is not a sufficient number of authorized shares of Common Stock (that are not issued, outstanding or reserved for issuance)
available to effect the entire conversion of the then outstanding shares of Series J Preferred Stock and the then outstanding common
stock purchase warrants issued in conjunction therewith (an “Authorized Share Deficiency”), such conversion shall not
exceed the Issuable Maximum (as defined in the Series J COD); however, the Company shall use its best efforts to obtain shareholder
approval within two (2) years of the date of first issuance of Series J Preferred Stock to permit the balance of the conversion.
If shareholder approval is not obtained due to an insufficient number of shareholder votes for passage, the Company shall continue
to solicit for shareholder approval annually thereafter. As of December 31, 2017, the Company does not have a sufficient number
of unreserved authorized shares to effect the entire conversion, notwithstanding that the earliest possible Conversion Date is
April 28, 2020.
Solely during any period
of time during which an Authorized Share Deficiency exists commencing on or after the fourth anniversary of the Original Issue
Date (“Dividend Commencement Date” and collectively the “Dividend Entitlement Period”), holders of Series
J Preferred shall be entitled to receive, and the Company shall pay, dividends at the rate per share (as a percentage of the Stated
Value per share) of 20% per annum, payable quarterly, in arrears, on January 1, April 1, July 1 and October 1, in cash or duly
authorized, validly issued, fully paid and non-assessable shares of Series J Preferred, or a combination thereof (the amount to
be paid in shares of Series J Preferred, the “Dividend Share Amount”). The form of dividend payments to each holder shall
be made, at the option of the Holders, (i) in cash, to the extent that funds are legally available for the payment of dividends
in cash, (ii) in shares of Series J Preferred Stock, or (iii) a combination thereof. The Series J Preferred shall rank senior to
the common stock with respect to payment of dividends and pari passu to the common stock with respect to liquidation, dissolution
or winding up of the Company.
The holders of the
Series J Preferred shall have voting rights on any matter presented to the shareholders of the Company for their action or consideration
at any meeting of shareholders of the Company (or by written consent of shareholders in lieu of meeting). Each holder shall be
entitled to cast the number of votes equal to the number of whole shares of common stock into which the shares of Series J Preferred
held by the holder are convertible as of the record date for determining the shareholders entitled to vote on such matter regardless
of whether an Authorized Share Deficiency Exists.
The Company has determined
that the Series J Preferred host instrument was more akin to equity than debt and that the above identified conversion feature,
subject to adjustments, was clearly and closely related to the host instrument, and accordingly bifurcation and classification
of the conversion feature as a derivative liability was not required. The Company has accounted for the Series J Preferred as contingently
redeemable preferred stock for which redemption is not probable. Accordingly, the Series J Preferred is presented in mezzanine
equity based on their initial measurement amount (fair value), as required by ASC 480-10-S99,
Distinguishing Liabilities from
Equity – SEC Material
. No subsequent adjustment of the initial measurement amounts for these contingently redeemable
Series J Preferred is necessary unless the redemption of the Series J Preferred becomes probable. Accordingly, the amount presented
as temporary equity for the contingently redeemable Series J Preferred outstanding is its issuance-date fair value. The Series
J Preferred was initially measured at its fair value, $13,903,957.
The fair value of the
Series J Preferred issued by the Company pursuant to the exchange agreement was calculated using a Monte Carlo Simulation of stock
price and expected future behaviors related to shareholder approval provisions. The following are the key assumptions used in the
Monte Carlo Simulation:
|
|
April 28, 2017
|
|
Fair value of the Company’s common stock
|
|
$
|
0.1521
|
|
Conversion price
|
|
$
|
0.1521
|
|
Number of Series J Preferred issued
|
|
|
24.0344
|
|
Fully diluted shares outstanding as of measurement date
|
|
|
923,392,780
|
|
Risk-free rate
|
|
|
2.30
|
%
|
Volatility
|
|
|
90.00
|
%
|
Shareholder approval threshold
|
|
$
|
0.1521
|
|
Probability of approval if ending stock price is greater than threshold - midpoint
|
|
|
82.50
|
%
|
Probability of approval if ending stock price is greater than threshold - midpoint
|
|
|
17.50
|
%
|
Trials
|
|
|
200,000
|
|
Authorized, issued
and outstanding shares, along with carrying value and change in value as of the periods presented are as follows:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
Shares authorized
|
|
|
50.000
|
|
|
|
-
|
|
Shares outstanding
|
|
|
20
|
|
|
|
-
|
|
Par value
|
|
$
|
0.01
|
|
|
$
|
-
|
|
Stated value
|
|
$
|
1,000,000
|
|
|
$
|
-
|
|
Conversion price
|
|
$
|
0.15
|
|
|
$
|
-
|
|
Common shares to be issued upon conversion
|
|
|
158,017,321
|
|
|
|
-
|
|
Carrying value of Series J convertible preferred stock
|
|
$
|
13,903,957
|
|
|
$
|
-
|
|
NOTE 12. DERIVATIVE FINANCIAL INSTRUMENTS – WARRANTS
The Company evaluates
and accounts for its freestanding instruments in accordance with ASC 815,
Accounting for Derivative Instruments and Hedging
Activities
.
The
Company issued warrants, with terms of five to seven years, to various corporations and individuals, in connection with the sale
of securities, loan agreements and consulting agreements.
A summary of warrant activity is as follows:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
|
|
Warrant Shares
|
|
|
Weighted Average
Exercise Price
|
|
|
Warrant Shares
|
|
|
Weighted
Average
Exercise
Price
|
|
Balance at beginning of period
|
|
|
9,379,219
|
|
|
$
|
0.0625
|
|
|
|
41,586,066
|
|
|
$
|
0.0625
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants granted pursuant to the issuance of Series J convertible preferred shares
|
|
|
79,008,661
|
|
|
$
|
0.1521
|
|
|
|
-
|
|
|
$
|
-
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants exercised, forfeited and/or expired, net
|
|
|
(2,910,532
|
)
|
|
|
|
|
|
|
(32,206,847
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of period
|
|
|
85,477,348
|
|
|
$
|
0.1426
|
|
|
|
9,379,219
|
|
|
$
|
0.0625
|
|
The fair value of the warrants issued by
the Company prior to April 1, 2017, net of warrant exercised, forfeited and/or expired, net (6,468,687 warrant shares) was calculated
using the Black-Scholes model and the following assumptions:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
Fair value of the Company’s common stock
|
|
$
|
0.09
|
|
|
$
|
0.15
|
|
Volatility (based on the Company’s historical volatility)
|
|
|
58.2% - 58.4
|
%
|
|
|
72.5% - 73.1
|
%
|
Exercise price
|
|
$
|
0.0625
|
|
|
$
|
0.0625
|
|
Estimated life (in years)
|
|
|
0.2 - 0.3
|
|
|
|
1.0 - 1.1
|
|
Risk free interest rate (based on 1-year treasury rate)
|
|
|
1.39% - 1.45
|
%
|
|
|
1.02% - 1.03
|
%
|
Fair value of derivative financial instruments - warrants
|
|
$
|
198,883
|
|
|
$
|
843,464
|
|
On April 28, 2017,
the Company entered into an exchange agreement (the “Exchange Agreement”) with Nasrat Hakim, the Chairman of the Board,
President, and Chief Executive Officer of the Company, pursuant to which the Company issued to Mr. Hakim 23.0344 shares of its
newly designated Series J Convertible Preferred Stock (“Series J Preferred”) and Warrants to purchase an aggregate
of 79,008,661 shares of its Common Stock (the “Series J Warrants” and, along with the Series J Preferred issued to
Mr. Hakim, the “Securities”) in exchange for 158,017,321 shares of Common Stock owned by Mr. Hakim. The fair value
of the Series J Warrants was determined to be $6,474,673 upon issuance at April 28, 2017.
The Series J Warrants
are exercisable for a period of 10 years from the date of issuance, commencing on the earlier of (i) the date that Shareholder
Approval is obtained, and the requisite corporate action has been effected; or (ii) April 28, 2020. The initial exercise price
is $0.1521 per share and the Series J Warrants can be exercised for cash or on a cashless basis. The exercise price is subject
to adjustment for any issuances or deemed issuances of common stock or common stock equivalents at an effective price below the
then exercise price. Such exercise price adjustment feature prohibits the Company from being able to conclude the warrants are
indexed to its own stock and thus such warrants are classified as liabilities and measured initially and subsequently at fair value.
The Series J Warrants also provide for other standard adjustments upon the happening of certain customary events. The Series J
Warrants are not exercisable during any period when an Authorized Share Deficiency exists and will expire on the expiry date, without
regards to the existence of an Authorized Shares Deficiency (see Note 11). As of December 31, 2017, the Company does not have a
sufficient number of unreserved authorized shares to effect the entire conversion of the Series J Preferred, therefore the Series
J Warrants are not currently exercisable. Please also see Note 11.
The fair value of the
warrants issued by the Company pursuant to the issuance of Series J convertible preferred shares (79,008,661 warrant shares) was
calculated using a Monte Carlo Simulation because of the probability assumptions associated with the Shareholder Approval provisions.
The following are the key assumptions used in the Monte Carlo Simulation:
|
|
December 31, 2017
|
|
|
April 28, 2017
|
|
Fair value of the Company’s common stock
|
|
$
|
0.0920
|
|
|
$
|
0.1521
|
|
Initial exercise price
|
|
$
|
0.1521
|
|
|
$
|
0.1521
|
|
Number of common warrants
|
|
|
79,008,661
|
|
|
|
79,008,661
|
|
Fully diluted shares outstanding as of measurement date
|
|
|
788,801,827
|
|
|
|
923,392,780
|
|
Warrant term (in years)
|
|
|
9.33
|
|
|
|
10.00
|
|
Risk-free rate
|
|
|
1.93
|
%
|
|
|
2.30
|
%
|
Volatility
|
|
|
90.00
|
%
|
|
|
90.00
|
%
|
Shareholder approval threshold
|
|
$
|
0.1580
|
|
|
$
|
0.1521
|
|
Probability of approval is ending stock price is greater than threshold - midpoint
|
|
|
75.00
|
%
|
|
|
82.50
|
%
|
Probability of approval is ending stock price is greater than threshold - midpoint
|
|
|
10.00
|
%
|
|
|
17.50
|
%
|
Trials
|
|
|
100,000
|
|
|
|
200,000
|
|
Fair value of derivative financial instruments - warrants
|
|
$
|
2,351,371
|
|
|
$
|
6,474,673
|
|
The changes in warrants
(Level 3 financial instruments) measured at fair value on a recurring basis for the nine months ended December 31, 2017 were as
follows:
Balance as of March 31, 2017
|
|
$
|
843,464
|
|
Fair value of warrants granted pursuant to the issuance of Series J convertible preferred shares
|
|
|
6,474,674
|
|
Change in fair value of derivative financial instruments - warrants
|
|
|
(4,767,884
|
)
|
Balance as of December 31, 2017
|
|
$
|
2,550,254
|
|
NOTE 13. SHAREHOLDERS’ EQUITY
Lincoln Park Capital – April
10, 2014 Purchase Agreement
On April 10, 2014,
the Company entered into a Purchase Agreement (the “2014 LPC Purchase Agreement”) and a Registration Rights Agreement
with Lincoln Park Capital Fund, LLC (“Lincoln Park”). Pursuant to the terms of the 2014 LPC Purchase Agreement, Lincoln
Park had agreed to purchase from the Company up to $40 million of common stock (subject to certain limitations) from time to time
over a 36-month period.
Upon execution of the
Purchase Agreement, the Company issued 1,928,641 shares of our common stock to Lincoln Park pursuant to the Purchase Agreement
as consideration for its commitment to purchase additional shares of our common stock under that agreement and were obligated to
issue up to an additional 1,928,641 commitment shares to Lincoln Park pro rata as up to $40 million of the Company’s common
stock is purchased by Lincoln Park.
The 2014 LPC Purchase
Agreement expired on June 1, 2017. During the term of the 2014 LPC Purchase Agreement, the Company sold an aggregate of 110.6 million
shares to Lincoln Park, for aggregate gross proceeds of approximately $27.0 million. In addition, the Company issued an aggregate
of 3.2 million commitment shares.
Lincoln Park Capital – May
1, 2017 Purchase Agreement
On May 1, 2017, the
Company entered into a purchase agreement (the “2017 LPC Purchase Agreement”), together with a registration rights
agreement (the “2017 LPC Registration Rights Agreement”), with Lincoln Park.
Under the terms and
subject to the conditions of the 2017 LPC Purchase Agreement, the Company has the right to sell to and Lincoln Park is obligated
to purchase up to $40 million in shares of common stock, subject to certain limitations, from time to time, over the 36-month period
commencing on June 5, 2017. The Company may direct Lincoln Park, at its sole discretion and subject to certain conditions, to purchase
up to 500,000 shares of common stock on any business day, provided that at least one business day has passed since the most recent
purchase, increasing to up to 1,000,000 shares, depending upon the closing sale price of the common stock (such purchases, “Regular
Purchases”). However, in no event shall a Regular Purchase be more than $1,000,000. The purchase price of shares of common
stock related to the future funding will be based on the prevailing market prices of such shares at the time of sales. In addition,
the Company may direct Lincoln Park to purchase additional amounts as accelerated purchases under certain circumstances. Sales
of shares of common stock to Lincoln Park under the 2017 LPC Purchase Agreement are limited to no more than the number of shares
that would result in the beneficial ownership by Lincoln Park and its affiliates, at any single point in time, of more than 4.99%
of the then outstanding shares of common stock.
In connection with
the 2017 LPC Purchase Agreement, the Company issued to Lincoln Park 5,540,550 shares of common stock and are required to issue
up to 5,540,550 additional shares of Common Stock pro rata as the Company requires Lincoln Park to purchase shares under the 2017
LPC Purchase Agreement over the term of the agreement. Lincoln Park has represented to the Company, among other things, that it
is an “accredited investor” (as such term is defined in Rule 501(a) of Regulation D under the Securities Act of 1933,
as amended (the “Securities Act”)). The Company sold the securities in reliance upon an exemption from registration
contained in Section 4(a)(2) under the Securities Act. The securities sold may not be offered or sold in the United States absent
registration or an applicable exemption from registration requirements.
The 2017 LPC Purchase
Agreement and the 2017 LPC 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 2017 LPC Purchase Agreement at any time, at no cost or penalty. Actual sales of shares of common stock to Lincoln Park under
the 2017 LPC Purchase Agreement will depend on a variety of factors to be determined by us from time to time, including, among
others, market conditions, the trading price of the Common Stock and determinations by us as to the appropriate sources of funding
for us and our operations. There are no trading volume requirements or, other than the limitation on beneficial ownership discussed
above, restrictions under the 2017 LPC Purchase Agreement. Lincoln Park has no right to require any sales by the Company but is
obligated to make purchases from the Company as directed in accordance with the 2017 LPC Purchase Agreement. Lincoln Park has covenanted
not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of our shares.
The net proceeds received
by us under the 2017 LPC Purchase Agreement will depend on the frequency and prices at which the Company sell shares of common
stock to Lincoln Park. A registration statement on form S-3 was filed with the SEC on May 10, 2017 and was declared effective on
June 5, 2017.
Summary of Common Stock Activity
During the nine months
ended December 31, 2017, the Company issued the following shares of Common Stock:
Issuance of shares
of common stock pursuant to the exercise of warrants
The Company issued
2,910,532 shares of its common stock totaling $181,908 in connection with the exercise of cash warrants.
Issuance of shares
of common stock to Lincoln Park
The Company issued
5,540,551 shares of its common stock as initial commitment shares pursuant to the 2017 LPC Purchase Agreement, 167,336 shares of
its common stock as additional commitment shares, pursuant to the 2017 LPC Purchase Agreement with Lincoln Park, as consideration
for their commitment to purchase additional shares of the Company’s common stock. In addition, the Company issued 10,169,281
shares of its common stock for proceeds totaling $1,208,100 in connection with the 2017 LPC Purchase Agreement with Lincoln Park.
NOTE 14. STOCK-BASED COMPENSATION
Part of the compensation
paid by the Company to its Directors and employees consists of the issuance of common stock or via the granting of options to purchase
common stock.
Stock-based Director Compensation
The Company’s
Director compensation policy was instituted in October 2009 and further revised in January 2016, includes provisions that a portion
of director’s fees are to be paid via the issuance of shares of the Company’s common stock, in lieu of cash, with the
valuation of such shares being calculated on quarterly basis and equal to the average closing price of the Company’s common
stock.
During the nine months
ended December 31, 2017, the Company did not issue any shares of common stock to its Directors in payment of director’s fees.
During the nine months
ended December 31, 2017, the Company accrued director’s fees totaling $90,000, which will be paid via cash payments totaling
$30,000 and the issuance of 510,292 shares of Common Stock.
As of December 31,
2017, the Company owes its Directors a total of $40,000 in cash payments and 645,492 shares of Common Stock in payment of director
fees totaling $80,000 due and owing. The Company anticipates that these shares of Common Stock will be issued during prior to the
end of the current fiscal year.
Stock-based Employee Compensation
Employment contracts
with the Company’s President and Chief Executive Officer, Chief Financial Officer and certain other employees includes provisions
for a portion of each employee’s salaries to be paid via the issuance of shares of the Company’s common stock, in lieu
of cash, with the valuation of such shares being calculated on a quarterly basis and equal to the average closing price of the
Company’s common stock.
During the nine months
ended December 31, 2017, the Company did not issue any shares pursuant to employment contracts with the Company’s President
and Chief Executive Officer, Chief Financial Officer or certain other employees.
During the nine months
ended December 31, 2017, the Company accrued salaries and fees totaling $621,750 owed to the Company’s President and Chief
Executive Officer, Chief Financial Officer and certain other employees and consultants, which are to be paid via the issuance of
a total of 5,287,898 shares of Common Stock.
As of December 31,
2017, the Company owes its President and Chief Executive Officer, Chief Financial Officer and certain other employees and consultants,
a total of 6,688,914 shares of Common Stock in payment of salaries and fees totaling $829,000 due and owing. The Company anticipates
that these shares of common stock will be issued prior to the end of the current fiscal year.
Options
Under its 2014 Stock
Option Plan and prior options plans, the Company may grant stock options to officers, selected employees, as well as members of
the Board of Directors and advisory board members. All options have generally been granted at a price equal to or greater than
the fair market value of the Company’s Common Stock at the date of the grant. Generally, options are granted with a vesting
period of up to three years and expire ten years from the date of grant.
|
|
|
|
|
Weighted
|
|
|
Weighted Average
|
|
|
|
|
|
|
Shares
|
|
|
Average
|
|
|
Remaining Contractual
|
|
|
Aggregate Intrinsic
|
|
|
|
Underlying Options
|
|
|
Exercise Price
|
|
|
Term (in years)
|
|
|
Value
|
|
Outstanding at March 31, 2017
|
|
|
6,737,667
|
|
|
$
|
0.20
|
|
|
|
6.7
|
|
|
$
|
258,747
|
|
Granted
|
|
|
560,000
|
|
|
|
0.16
|
|
|
|
|
|
|
|
|
|
Forfeited and expired
|
|
|
(516,667
|
)
|
|
|
0.59
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2017
|
|
|
6,781,000
|
|
|
$
|
0.17
|
|
|
|
6.3
|
|
|
$
|
65,880
|
|
Exercisable at December 31, 2017
|
|
|
5,511,000
|
|
|
$
|
0.17
|
|
|
|
5.7
|
|
|
$
|
65,880
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The
aggregate intrinsic value for outstanding options is calculated as the difference between the exercise price of the underlying
awards and the quoted price of the Company common stock as of December 31, 2017 and March 31, 2017 of $0.09 and $0.15, respectively.
The fair value of the
options was calculated using the Black-Scholes model and the following assumptions:
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
Volatility (based on the Company’s historical volatility)
|
|
|
121% -
123
|
%
|
|
|
120% -
121
|
%
|
Exercise price
|
|
$
|
0.09
- 0.24
|
|
|
$
|
0.13
- 0.33
|
|
Estimated term (in years)
|
|
|
10
|
|
|
|
10
|
|
Risk free interest rate (based on 1-year treasury rate)
|
|
|
2.2% -
2.4
|
%
|
|
|
1.5% -
2.5
|
%
|
Forfeiture rate
|
|
|
4.7%
- 20.1
|
%
|
|
|
2.3% -
4.6
|
%
|
Fair value of options granted
|
|
$
|
79,215
|
|
|
$
|
373,055
|
|
Non-cash compensation through issuance of stock options
|
|
$
|
208,719
|
|
|
$
|
357,955
|
|
NOTE 15. SALE OF NEW JERSEY STATE NET
OPERATING LOSSES
During the three months
ended December 31, 2017, Elite Labs, a wholly owned subsidiary of Elite, received final approval from the New Jersey Economic Development
Authority for the sale of net tax benefits of $536,233 relating to New Jersey net operating losses and net tax benefits of $606,516
relating to R&D tax credits. The Company sold the net tax benefits approved for sale at a transfer price equal to ninety-two
cents for every benefit dollar for total net proceeds of $1,051,329.
NOTE 16. CONCENTRATIONS AND CREDIT RISK
Revenues
Three customers accounted
for substantially all the Company’s revenues for the three months ended December 31, 2017. These three customers accounted
for approximately 53%, 21% and 17% of revenues each, respectively. The same three customers accounted for approximately 55%, 12%
and 24% of revenues for the nine months ended December 31, 2017.
Three customers accounted
for substantially all the Company’s revenues for the three months ended December 31, 2016. These three customers accounted
for approximately 41%, 37% and 17% of revenues each, respectively. The same three customers accounted for approximately 46%, 32%
and 17% of revenues for the nine months ended December 31, 2016.
Accounts Receivable
Three customers accounted
for all the Company’s accounts receivable as of December 31, 2017. These three customers accounted for approximately 52%,
22%, and 12% of accounts receivable each, respectively.
Four customers accounted
for all the Company’s accounts receivable as of March 31, 2017. These four customers accounted for approximately 53%, 17%,
14%, and 12% of accounts receivable as of March 31, 2017.
Purchasing
Seven suppliers
accounted for more than 69% of the Company’s purchases of raw materials for the nine months ended December 31, 2017. Included
in these seven suppliers are two suppliers that accounted for approximately 31% and 9% of purchases each, respectively.
Three suppliers
accounted for more than 65% of the Company’s purchases of raw materials for the nine months ended December 31, 2016. These
three suppliers accounted for approximately 48%, 9% and 9% of purchases each, respectively.
NOTE 17. SEGMENT RESULTS
FASB ASC 280-10-50
requires use of the “management approach” model for segment reporting. The management approach is based on the way
a company’s management organized segments within the company for making operating decisions and assessing performance. Reportable
segments are based on products and services, geography, legal structure, management structure, or any other manner in which management
disaggregates a company.
The Company has determined
that its reportable segments are Abbreviated New Drug Applications (“ANDA”) for generic products and New Drug Applications
(“NDA”) for branded products. The Company identified its reporting segments based on the marketing authorization relating
to each and the financial information used by its chief operating decision maker to make decisions regarding the allocation of
resources to and the financial performance of the reporting segments.
Asset information by
operating segment is not presented below since the chief operating decision maker does not review this information by segment.
The reporting segments follow the same accounting policies used in the preparation of the Company’s unaudited condensed consolidated
financial statements.
The following represents selected information
for the Company’s reportable segments:
|
|
For the Three Months Ended December 31,
|
|
|
For the Nine Months Ended December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Revenue by Segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANDA
|
|
$
|
2,285,454
|
|
|
$
|
2,080,649
|
|
|
$
|
5,111,805
|
|
|
$
|
7,537,493
|
|
NDA
|
|
|
250,000
|
|
|
|
250,000
|
|
|
|
750,000
|
|
|
|
750,000
|
|
|
|
$
|
2,535,454
|
|
|
$
|
2,330,649
|
|
|
$
|
5,861,805
|
|
|
$
|
8,287,493
|
|
|
|
For the Three Months Ended December 31,
|
|
|
For the Nine Months Ended December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Operating Loss by Segment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ANDA
|
|
$
|
(322,063
|
)
|
|
$
|
(302,110
|
)
|
|
$
|
(1,417,044
|
)
|
|
$
|
(38,576
|
)
|
NDA
|
|
|
(893,029
|
)
|
|
|
(351,186
|
)
|
|
|
(2,257,718
|
)
|
|
|
(1,240,085
|
)
|
|
|
$
|
(1,215,092
|
)
|
|
$
|
(653,296
|
)
|
|
$
|
(3,674,762
|
)
|
|
$
|
(1,278,661
|
)
|
The table below reconciles
the Company’s operating loss by segment to income (loss) from operations before provision for income taxes as reported in
the Company’s unaudited condensed consolidated statements of operations.
|
|
For the Three Months Ended December 31,
|
|
|
For the Nine Months Ended December 31,
|
|
|
|
2017
|
|
|
2016
|
|
|
2017
|
|
|
2016
|
|
Operating loss by segment
|
|
$
|
(1,215,092
|
)
|
|
$
|
(653,296
|
)
|
|
$
|
(3,674,762
|
)
|
|
$
|
(1,278,661
|
)
|
Corporate unallocated costs
|
|
|
(105,351
|
)
|
|
|
(1,017,047
|
)
|
|
|
(1,832,723
|
)
|
|
|
(2,017,976
|
)
|
Interest income
|
|
|
4,461
|
|
|
|
3,151
|
|
|
|
12,862
|
|
|
|
9,407
|
|
Interest expense and amortization of debt issuance costs
|
|
|
(92,458
|
)
|
|
|
(55,563
|
)
|
|
|
(245,730
|
)
|
|
|
(181,883
|
)
|
Depreciation and amortization expense
|
|
|
(7,196
|
)
|
|
|
(21,032
|
)
|
|
|
(21,149
|
)
|
|
|
(64,408
|
)
|
Significant non-cash items
|
|
|
(731,322
|
)
|
|
|
(31,048
|
)
|
|
|
(901,469
|
)
|
|
|
(803,538
|
)
|
Change in fair value of derivative instruments
|
|
|
605,448
|
|
|
|
1,571,471
|
|
|
|
4,767,884
|
|
|
|
9,468,320
|
|
Income (loss) from operations
|
|
$
|
(1,541,510
|
)
|
|
$
|
(203,364
|
)
|
|
$
|
(1,895,087
|
)
|
|
$
|
5,131,261
|
|
NOTE 18. COLLABORATIVE AGREEMENT WITH
EPIC PHARMA LLC
On June 4, 2015, the
Company entered into the 2015 Epic License Agreement, which provides for the exclusive right to market, sell and distribute, by
Epic Pharma LLC (“Epic”) of SequestOx™, an abuse deterrent opioid which employs the Company’s proprietary
pharmacological abuse-deterrent technology. Epic will be responsible for payment of product development and pharmacovigilance costs,
sales, and marketing of SequestOx™, and Elite will be responsible for the manufacture of the product. Under the 2015 Epic
License Agreement, Epic will pay Elite non-refundable payments totaling $15 million, with such amount representing the cost of
an exclusive license to ELI-200, the cost of developing the product and certain filings and a royalty based on an amount equal
to 50% of profits derived from net product sales as defined in the 2015 Epic License Agreement. The initial term of the exclusive
right to product development sales and distribution is five years (“Epic Exclusivity Period”); the license is renewable
upon mutual agreement at the end of the initial term.
In June 2015, Elite
received non-refundable payments totaling $5 million from Epic for the exclusive right to product development sales and distribution
of SequestOx™ pursuant to the Epic Collaborative Agreement, under which it agreed to not permit marketing or selling of SequestOx™
within the United States of America to any other party. Such exclusive rights are considered a significant deliverable element
of the Epic Collaborative Agreement pursuant to ASC 605-25,
Revenue Recognition – Multiple Element Arrangements
. These
nonrefundable payments represent consideration for certain exclusive rights to ELI-200 and will be recognized ratably over the
Epic Exclusivity Period.
In addition, in January
2016, a New Drug Application for SequestOx™ was filed, thereby earning the Company a non-refundable $2.5 million milestone,
pursuant to the 2015 Epic License Agreement. The filing of this NDA represents a significant deliverable element as defined within
the Epic Collaborative pursuant to ASC 605-25,
Revenue Recognition – Multiple Element Arrangements
. Accordingly, the
Company has recognized the $2.5 million milestone, which was paid by Epic and related to this deliverable as income during the
year ended March 31, 2016.
To date, the Company
received payments totaling $7.5 million pursuant to the 2015 Epic License Agreement, with all amounts being non-refundable. An
additional $7.5 million is due upon approval by the FDA of the NDA filed for SequestOx™, and license fees based on commercial
sales of SequestOx™. Revenues relating to these additional amounts due under the 2015 Epic License Agreement will be recognized
as the defined elements are completed and collectability is reasonably assured.
Please note that on
July 15, 2016, the FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the
SequestOx™ NDA is complete and the application is not ready for approval in its present form. On December 21, 2016, the Company
met with the FDA for an end-of-review meeting to discuss steps that it could take to obtain approval of SequestOx™. Based
on this and the meeting minutes received from the FDA on January 23, 2017, the Company formulated a plan to address the issues
cited by the FDA in the CRL, with such plan including, without limitation, modifying the SequestOx™ formulation, conducting
bioequivalence and bioavailability fed and fasted studies, comparing the modified formulation to the original formulation. On July
7, 2017, the Company reported topline results from a pivotal bioequivalence fed study for SequestOx™. This study resulted
in a mean Tmax of 4.6 hr., with a range of 0.5 hr. to 12 hr. and a mean Tmax of the comparator, Roxicodone
®
of
3.4 hr. with a range of 0.5 hr. to 12 hr. A key objective of this study was to determine if the reformulated SequestOx™ had
a similar Tmax to the comparator when taken with a high fat meal. Based on these results, the Company paused clinical trials for
this formulation of SequestOx™. On January 30, 2018, the Company reported positive topline results from a pilot study conducted
for a modified SequestOx™ wherein, based on the results of this pilot study, the modified SequestOx™ formulation is
expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal trial under
fed conditions. The Company intends to review these study results with the FDA and discuss pharmacokinetic study requirements for
a re-submission of the NDA. There can be no assurances of the success of any future clinical trials, or if such trials are successful,
there can be no assurances that an intended future resubmission of the NDA product filing, if made, will be accepted by or receive
marketing approval from the FDA, and accordingly, there can be no assurances that the Company will earn and receive the additional
$7.5 million or future license fees. If the Company does not receive these payments or fees, it will materially and adversely affect
our financial condition. In addition, even if marketing authorization is received, there can be no assurances that there will be
future revenues or profits, or that any such future revenues or profits would be in amounts that provide adequate return on the
significant investments made to secure this marketing authorization.
NOTE 19. COLLABORATIVE AGREEMENT WITH
SUNGEN PHARMA LLC
On August 24, 2016,
as amended, the Company entered into the SunGen Agreement. The SunGen Agreement provides that Elite and SunGen Pharma LLC will
engage in the research, development, sales, and marketing of eight generic pharmaceutical products. Two of the products are classified
as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers (the “Beta Blocker
Products”) and the remaining four products consist of antidepressants, antibiotics and antispasmodics.
Under the terms of
the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will
share substantially in the profits from sales of the Products. Upon approval, the know-how and intellectual property rights to
the products will be owned jointly by Elite and SunGen. SunGen shall have the exclusive right to market and sell the Beta Blocker
Products using SunGen’s label and Elite shall have the exclusive right to market and sell the CNS Products using Elite’s
label. Elite will manufacture and package all four products on a cost-plus basis.
On December 1, 2016
and July 24, 2017, Elite Labs and SunGen executed an amendment to the parties’ 2016 Development and License Agreement (the
“Amended Agreement”), to undertake and engage in the research, development, sales and marketing of four additional
generic pharmaceutical products bringing the total number of products under the amended agreement to eight. The product classes
for the additional four products include antidepressants, antibiotics, and antispasmodics.
Under the terms of
the Amended Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will
share substantially in the profits from sales of the products. Upon approval, the know-how and intellectual property rights to
the products will be owned jointly by Elite and SunGen. Three products will be owned jointly by Elite and SunGen; three shall be
owned by SunGen while Elite shall have the marketing rights once the products are approved by the FDA; and two shall be owned by
Elite while SunGen shall have the marketing rights once the products are approved by the FDA. Elite will manufacture and package
all eight products on a cost-plus basis.
NOTE 20. RELATED PARTY TRANSACTION AGREEMENTS WITH EPIC PHARMA
LLC
The Company has entered
into two agreements with Epic which constitute agreements with a related party due to the management of Epic including a member
on our Board of Directors at the time such agreements were executed.
On June 4, 2015, the
Company entered into the 2015 Epic License Agreement (please see Note 18 above). The 2015 Epic License Agreement includes milestone
payments totaling $10 million upon the filing with and approval of a New Drug Application (“NDA”) with the FDA. The
Company has determined these milestones to be substantive, with such assessment being made at the inception of the 2015 Epic License
Agreement, and based on the following:
|
·
|
The Company’s performance is required to achieve each milestone; and
|
|
·
|
The milestones will relate to past performance, when achieved; and
|
|
·
|
The milestones are reasonable relative to all of the deliverables and payment terms within the
2015 Epic License Agreement
|
After marketing authorization
is received from the FDA, Elite will receive a license fee which is based on profits achieved from the commercial sales of ELI-200.
On January 14, 2016, the Company filed an NDA with the FDA for SequestOx™, thereby earning a $2.5 million milestone pursuant
to the 2015 Epic License Agreement. The Company has received payment of this amount from Epic. Please note that on July 15, 2016,
the FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx™
NDA is complete and the application is not ready for approval in its present form. On December 21, 2016, the Company met with the
FDA for an end-of-review meeting to discuss steps that it could take to obtain approval of SequestOx™. Based on this and
the meeting minutes received from the FDA on January 23, 2017, the Company formulated a plan to address the issues cited by the
FDA in the CRL, with such plan including, without limitation, modifying the SequestOx™ formulation, conducting bioequivalence
and bioavailability fed and fasted studies, comparing the modified formulation to the original formulation. On July 7, 2017, the
Company reported topline results from a pivotal bioequivalence fed study for SequestOx™. This study resulted in a mean Tmax
of 4.6 hr., with a range of 0.5 hr. to 12 hr. and a mean Tmax of the comparator, Roxicodone
®
of 3.4 hr. with a
range of 0.5 hr. to 12 hr. A key objective of this study was to determine if the reformulated SequestOx™ had a similar Tmax
to the comparator when taken with a high fat meal. On January 30, 2018, the Company reported positive topline results from a pilot
study conducted for a modified SequestOx™ wherein, based on the results of this pilot study, the modified SequestOx™
formulation is expected to achieve bioequivalence with a Tmax range equivalent to the reference product when conducted in a pivotal
trial under fed conditions. The Company intends to review these study results with the FDA and discuss pharmacokinetic study requirements
for a re-submission of the NDA. There can be no assurances of the success of any future clinical trials, or if such trials are
successful, there can be no assurances that an intended future resubmission of the NDA product filing, if made, will be accepted
by or receive marketing approval from the FDA, and accordingly, there can be no assurances that the Company will earn and receive
the additional $7.5 million or future license fees. If the Company does not receive these payments or fees, it will materially
and adversely affect our financial condition. In addition, even if marketing authorization is received, there can be no assurances
that there will be future revenues or profits, or that any such future revenues or profits would be in amounts that provide adequate
return on the significant investments made to secure this marketing authorization.
On October 2, 2013,
Elite executed the Epic Pharma Manufacturing and License Agreement (the “Epic Generic Agreement”), which granted rights
to Epic to manufacture twelve generic products whose ANDA’s are owned by Elite, and to market, in the United States and Puerto
Rico, six of these products on an exclusive basis, and the remaining six products on a non-exclusive basis. These products will
be manufactured at Epic, with Epic being responsible for the manufacturing site transfer supplements that are a prerequisite to
each product being approved for commercial sale. In addition, Epic is responsible for all regulatory and pharmacovigilance matters,
as well as all marketing and distribution activities. Elite has no further obligations or deliverables under the Epic Generic Agreement.
Pursuant to the Epic
Generic Agreement, Elite will receive $1.8 million, payable in increments that require the commercialization of all six exclusive
products if the full amount is to be received, plus license fees equal to a percentage that is not less than 50% and not greater
than 60% of profits achieved from commercial sales of the products, as defined in the Epic Generic Agreement. While Epic has launched
four of the six exclusive products and Elite has collected $1.0 million of the $1.8 million total fee, collection of the remaining
$800k is contingent upon Epic filing the required supplements with and receiving approval from the FDA for the remaining exclusive
generic products. There can be no assurances of Epic filing these supplements, or getting approval of any supplements filed. Accordingly,
there can be no assurances of Elite receiving the remaining $800k due under the Epic Generic Agreement, or future license fees
related thereto. Please also note that all commercialization, regulatory, manufacturing, marketing and distribution activities
are being conducted solely by Epic, without Elite’s participation.
Both the 2015 Epic
License Agreement and the Epic Generic Agreement contain license fees that will be earned and payable to the Company, after the
FDA has issued marketing authorization(s) for the related product(s). License fees are based on commercial sales of the products
achieved by Epic and calculated as a percentage of net sales dollars realized from such commercial sales. Net sales dollars consist
of gross invoiced sales less those costs and deductions directly attributable to each invoiced sale, including, without limitation,
cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments, returns, short date adjustments,
charge backs, promotions, and marketing costs. The rate applied to the net sales dollars to determine license fees due to the Company
is equal to an amount negotiated and agreed to by the parties to each agreement, with the following significant factors, inputs,
assumptions, and methods, without limitation, being considered by either or both parties:
|
·
|
Assessment of the opportunity for each product in the market, including consideration of the following,
without limitation: market size, number of competitors, the current and estimated future regulatory, legislative, and social environment
for abuse deterrent opioids and the other generic products to which the underlying contracts are relevant;
|
|
·
|
Assessment of various avenues for monetizing SequestOx™ and the twelve ANDA’s owned
by the Company, including the various combinations of sites of manufacture and marketing options;
|
|
·
|
Elite’s resources and capabilities with regards to the concurrent development of abuse deterrent
opioids and expansion of its generic business segment, including financial and operational resources required to achieve manufacturing
site transfers for twelve approved ANDA’s;
|
|
·
|
Capabilities of each party with regards to various factors, including, one or more of the following:
manufacturing, marketing, regulatory and financial resources, distribution capabilities, ownership structure, personnel, assessments
of operational efficiencies and entity stability, company culture and image;
|
|
·
|
Stage of development of SequestOx™ and manufacturing site transfer and regulatory requirements
relating to the commercialization of the generic products at the time of the discussions/negotiations, and an assessment of the
risks, probability, and time frames for achieving marketing authorizations from the FDA for each product.
|
|
·
|
Assessment of consideration offered; and
|
|
·
|
Comparison of the above factors among the various entities with whom the Company was engaged in
discussions relating to the commercialization of SequestOx™ and the manufacture/marketing of the twelve generics related
to the Epic Generic Agreement.
|
This transaction is
not to be considered as an arms-length transaction.
Please also note that,
effective April 7, 2016, all Directors on the Company’s Board of Directors that were also owners/managers of Epic had resigned
as Directors of the Company and all current members of the Company’s Board of Directors have no relationship to Epic. Accordingly,
Epic no longer qualifies as a party that is related to the Company.
NOTE 21. MANUFACTURING, LICENSE AND DEVELOPMENT AGREEMENTS
The Company has entered
into the following active agreements:
|
·
|
License agreement with Precision Dose, dated September 10, 2010 (the “Precision Dose License
Agreement”); and,
|
|
·
|
Manufacturing and Supply Agreement with Ascend Laboratories Inc., dated June 23, 2011 and as
amended on September 24, 2012, January 19, 2015 and July 20, 2015, and as extended on August 9, 2016 (the “Ascend
Manufacturing Agreement”); and,
|
|
·
|
Development and License Agreement with SunGen (the “July 2017 SunGen Agreement”).
|
The Precision Dose
Agreement provides for the marketing and distribution, by Precision Dose and its wholly owned subsidiary, TAGI Pharma, of Phentermine
37.5mg tablets (launched in April 2011), Phentermine 15mg capsules (launched in April 2013), Phentermine 30mg capsules (launched
in April 2013), Hydromorphone 8mg tablets (launched in March 2012), Naltrexone 50mg tablets (launched in September 2013) and certain
additional products that require approval from the FDA which has not been received. Precision Dose will have the exclusive right
to market these products in the United States and Puerto Rico and a non-exclusive right to market the products in Canada. Pursuant
to the Precision Dose License Agreement, Elite received $200k at signing, and is receiving milestone payments and a license fee
which is based on profits achieved from the commercial sale of the products included in the agreement.
Revenue
from the $200k payment made upon signing of the Precision Dose Agreement is being recognized over the life of the Precision Dose
Agreement.
The milestones, totaling
$500k (with $405k already received), consist of amounts due upon the first shipment of each identified product, as follows: Phentermine
37.5mg tablets ($145k), Phentermine 15 & 30mg capsules ($45k), Hydromorphone 8mg ($125k), Naltrexone 50mg ($95k) and the balance
of $95k due in relation to the first shipment of generic products which still require marketing authorizations from the FDA, and
to which there can be no assurances of such marketing authorizations being granted and accordingly there can be no assurances that
the Company will earn and receive these milestone amounts. These milestones have been determined to be substantive, with such determination
being made by the Company after assessments based on the following:
|
·
|
The Company’s performance is required to achieve each milestone; and
|
|
·
|
The milestones will relate to past performance, when achieved; and
|
|
·
|
The milestones are reasonable relative to all of the deliverables and payment terms within the
Precision Dose License Agreement.
|
The license fees provided
for in the Precision Dose Agreement are calculated as a percentage of net sales dollars realized from commercial sales of the related
products. Net sales dollars consist of gross invoiced sales less those costs and deductions directly attributable to each invoiced
sale, including, without limitation, cost of goods sold, cash discounts, Medicaid rebates, state program rebates, price adjustments,
returns, short date adjustments, charge backs, promotions, and marketing costs. The rate applied to the net sales dollars to determine
license fees due to the Company is equal to an amount negotiated and agreed to by the parties to the Precision Dose License Agreement,
with the following significant factors, inputs, assumptions, and methods, without limitation, being considered by either or both
parties:
|
·
|
Assessment of the opportunity for each generic product in the market, including consideration of
the following, without limitation: market size, number of competitors, the current and estimated future regulatory, legislative,
and social environment for each generic product, and the maturity of the market;
|
|
·
|
Assessment of various avenues for monetizing the generic products, including the various combinations
of sites of manufacture and marketing options;
|
|
·
|
Capabilities of each party with regards to various factors, including, one or more of the following:
manufacturing resources, marketing resources, financial resources, distribution capabilities, ownership structure, personnel, assessment
of operational efficiencies and stability, company culture and image;
|
|
·
|
Stage of development of each generic product, all of which did not have FDA approval at the time
of the discussions/negotiations and an assessment of the risks, probability, and time frame for achieving marketing authorizations
from the FDA for the products;
|
|
·
|
Assessment of consideration offered by Precision and other entities with whom discussions were
conducted; and,
|
|
·
|
Comparison of the above factors among the various entities with whom the Company was engaged in
discussions relating to the commercialization of the generic products.
|
The Ascend Manufacturing
Agreement provides for the manufacturing by Elite of Methadone 10mg for supply to Ascend Laboratories LLC (“Ascend”).
Ascend is the owner of the approved ANDA for Methadone 10mg, and the Northvale Facility is an approved manufacturing site for this
ANDA. There are no license fees or milestones relating to this agreement. All revenues earned are recognized as manufacturing revenues
on the date of shipment of the product, when title for the goods is transferred, and for which the price is agreed to and it has
been determined that collectability is reasonably assured. The initial shipment of Methadone 10mg pursuant to the Ascend Manufacturing
Agreement occurred in January 2012 and expires on December 31, 2017. The Company is evaluating extension of this agreement and
there have not been any formal negotiations of such with Ascend to date.
The new Development
and License Agreement with SunGen is to collaborate, develop and commercialize generic pharmaceutical products based upon a unique
drug delivery platform used for extended release products. The Company and SunGen intend to begin with the development of five
generic extended release products and to develop additional such products subsequently. More than a dozen products utilize this
type of technology. This new co-development agreement will build upon the success of the first development agreement between the
Company and SunGen and signed in 2016.
Under the terms of
the July 2017 SunGen Agreement, the Company and SunGen will share the responsibilities and costs of the development and marketing
of the products. Upon FDA approval, the products will be owned jointly by Elite and SunGen. Elite will manufacture and package
all products on a cost-plus basis.
NOTE 22. RELATED PARTY AGREEMENTS WITH MIKAH PHARMA LLC
Pursuant to the asset
acquisition as discussed in Note 2 , on May 17, 2017, Elite Labs, executed an assignment agreement with Mikah, pursuant to which
the Company acquired all rights, interests, and obligations under a supply and distribution agreement (the “Distribution
Agreement”) with Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s”) originally entered into by Mikah
on May 7, 2017 and relating to the supply, sale and distribution of generic Trimipramine Maleate Capsules 25mg, 50mg and 100mg
(“Trimipramine”).
On May 22, 2017, the
Company executed an assignment agreement with Mikah, pursuant to which the Company acquired all rights, interests and obligations
under a manufacturing and supply agreement with Epic Pharma LLC (“Epic”) originally entered into by Mikah on June 30,
2015 and relating to the manufacture and supply of Trimipramine (the “Manufacturing Agreement”).
Mikah is owned by Nasrat Hakim, the
Chief Executive Officer, President and Chairman of the Board of the Company.
Under the Manufacturing
Agreement, Epic will manufacture Trimipramine under license from the Company pursuant to the FDA approved and currently marketed
ANDA that was acquired in conjunction with the Company’s entry into these agreements (see Note 2).
Under the Distribution
Agreement, the Company will supply Trimipramine on an exclusive basis to Dr. Reddy’s and Dr. Reddy’s will be responsible
for all marketing and distribution of Trimipramine in the United States, its territories, possessions and commonwealth. The Trimipramine
will be manufactured by Epic and transferred to Dr. Reddy’s at cost, without markup.
Dr. Reddy’s will pay to the Company
a share of the profits, calculated without any deduction for cost of sales and marketing, derived from the sale of Trimipramine.
The Company’s share of these profits is in excess of 50%
NOTE 23. SUBSEQUENT EVENTS
The Company has evaluated
subsequent events from the balance sheet date through February 2, 2018, the date the accompanying financial statements were issued.
The following are material subsequent events.
Common Stock sold pursuant to the
Lincoln Park Purchase Agreement
Subsequent to December
31, 2017 and up to February 2, 2017 (the latest practicable date), a total of 2,677,495 shares of Common Stock were sold and 37,604
additional commitment shares were issued, pursuant to the Lincoln Park Purchase Agreement. Proceeds received from such transactions
totaled $271,475.
FDA Approval of Phendimetrazine
Tartrate Tablets USP
On January 2, 2018,
the Company announced that it received approval of its abbreviated new drug application (“ANDA”) from the U.S. Food
and Drug Administration (“FDA”) for Phendimetrazine Tartrate Tablets USP, 35mg. This product approval is from an ANDA
that the Company filed approximately six years ago. Subsequent to this filing, the Company obtained a second, approved ANDA for
this product and the Company has been selling this product for more than five years. The Company is considering strategic options,
including divestiture, for this newly approved ANDA.
ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
THREE AND NINE MONTHS ENDED DECEMBER
31, 2017 (UNAUDITED)
COMPARED TO THE
THREE AND NINE MONTHS ENDED DECEMBER
31, 2016 (UNAUDITED)
The following discussion
of our financial condition and results of operations for the three and nine months ended December 31, 2017 and 2016 should be read
in conjunction with our unaudited condensed consolidated financial statements and the notes to those statements that are included
elsewhere in this report. Our discussion includes forward-looking statements based upon current expectations that involve risks
and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ
materially from those anticipated in these forward-looking statements as a result of a number of factors, including those set forth
under Item 1A. Risk Factors appearing in our Annual Report on Form 10-K for the year ended March 31, 2017, as filed on June 14,
2017 with the SEC. We use words such as “anticipate,” “estimate,” “plan,” “project,”
“continuing,” “ongoing,” “expect,” “believe,” “intend,” “may,”
“will,” “should,” “could,” and similar expressions to identify forward-looking statements.
Unless expressly
indicated or the context requires otherwise, the terms “Elite”, the “Company”, “we”, “us”,
and “our” refer to Elite Pharmaceuticals, Inc. and subsidiary.
Background
We are a specialty
pharmaceutical company principally engaged in the development and manufacture of oral, controlled-release products, using proprietary
know-how and technology, particularly as it relates to abuse resistant products.
We occupy manufacturing,
warehouse, laboratory and office space at 165 Ludlow Avenue and 135 Ludlow Avenue in Northvale, NJ (the “Northvale Facility”). The
Northvale Facility operates under Current Good Manufacturing Practice (“cGMP”) and is a United States Drug Enforcement
Agency (“DEA”) registered facility for research, development and manufacturing.
Strategy
We focus our efforts
on the following areas: (i) development of our pain management products; (ii) manufacturing of a line of generic pharmaceutical
products with approved Abbreviated New Drug Application’s (“ANDAs”); (iii) development of additional generic
pharmaceutical products; (iv) development of the other products in our pipeline including the products with our partners; (v) commercial
exploitation of our products either by license and the collection of royalties, or through the manufacture of our formulations;
and (vi) development of new products and the expansion of our licensing agreements with other pharmaceutical companies, including
co-development projects, joint ventures and other collaborations.
Our focus is on the
development of various types of drug products, including branded drug products which require new drug applications (“NDAs”)
under Section 505(b)(1) or 505(b)(2) of the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Drug Price
Competition Act”) as well as generic drug products which require ANDAs.
We believe that our
business strategy enables us to reduce its risk by having a diverse product portfolio that includes both branded and generic products
in various therapeutic categories and to build collaborations and establish licensing agreements with companies with greater resources
thereby allowing us to share costs of development and improve cash-flow.
Commercial Products
We own, license or
contract manufacture the following products currently being sold commercially:
Product
|
|
Branded
Product
Equivalent
|
|
Therapeutic
Category
|
|
Launch
Date
|
Phentermine HCl 37.5mg tablets (“Phentermine 37.5mg”)
|
|
Adipex-P®
|
|
Bariatric
|
|
April 2011
|
Lodrane D ® Immediate Release capsules (“Lodrane D”)
|
|
n/a
|
|
OTC Allergy
|
|
September 2011
|
Methadone HCl 10mg tablets (“Methadone 10mg”)
|
|
Dolophine®
|
|
Pain
|
|
January 2012
|
Hydromorphone HCl 8mg tablets (“Hydromorphone 8mg”)
|
|
Dilaudid®
|
|
Pain
|
|
March 2012
|
Phendimetrazine Tartrate 35mg tablets (“Phendimetrazine 35mg”)
|
|
Bontril®
|
|
Bariatric
|
|
November 2012
|
Phentermine HCl 15mg and 30mg capsules (“Phentermine 15mg” and “Phentermine 30mg”)
|
|
Adipex-P®
|
|
Bariatric
|
|
April 2013
|
Naltrexone HCl 50mg tablets (“Naltrexone 50mg”)
|
|
Revia®
|
|
Pain
|
|
September 2013
|
Isradipine 2.5mg and 5mg capsules (“Isradipine 2.5mg” and “Isradipine 5mg”)
|
|
n/a
|
|
Cardiovascular
|
|
January 2015
|
Hydroxyzine HCl 10mg, 25mg and 50mg tablets (“Hydroxyzine 10mg” and “Hydroxyzine 25mg” and “Hydroxyzine 50mg”)
|
|
Atarax®, Vistaril®
|
|
Antihistamine
|
|
April 2015
|
Oxycodone HCl Immediate Release 5mg, 10mg, 15mg, 20mg and 30mg tablets (“OXY IR 5mg”, “Oxy IR 10mg”, “Oxy IR 15mg”, “OXY IR 20mg” and “Oxy IR 30mg”)
|
|
Roxicodone®
|
|
Pain
|
|
March 2016
|
Trimipramine Maleate Immediate Release 25mg, 50mg and 100mg capsules (“Trimipramine 25mg”, “Trimipramine 50mg”, “Trimipramine 100mg”)
|
|
Surmontil®
|
|
Antidepressant
|
|
May 2017
|
Note: Phentermine 15mg and Phentermine
30mg are collectively and individually referred to as “Phentermine Capsules”. Isradipine 2.5mg and Isradipine 5mg are
collectively and individually referred to as “Isradipine Capsules”. Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine
50mg are collectively and individually referred to as “Hydroxyzine”. Oxy IR 5mg, Oxy IR 10mg, Oxy IR 15mg Oxy IR 20mg
and Oxy IR 30mg are collectively and individually referred to as “Oxy IR”. Trimipramine 25mg, Trimipramine 50mg, and
Trimipramine 100mg are collectively and individually referred to as “Trimipramine”.
Phentermine 37.5mg
The approved ANDA for
Phentermine 37.5mg was acquired pursuant to an asset purchase agreement with Epic Pharma LLC (“Epic”) dated September
10, 2010 (the “Phentermine Purchase Agreement”).
Sales and marketing
rights for Phentermine 37.5mg are included in the licensing agreement between the Company and Precision Dose Inc. (“Precision
Dose”) dated September 10, 2010 (the “Precision Dose License Agreement”). Please see the section below titled
“Precision Dose License Agreement” for further details of this agreement.
The first shipment
of Phentermine 37.5mg was made to Precision Dose’s wholly owned subsidiary, TAGI Pharmaceuticals Inc. (“TAGI”),
pursuant to the Precision Dose License Agreement, with such initial shipment triggering a milestone payment under this agreement.
Phentermine 37.5mg is currently being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.
Lodrane D®
On September 27, 2011,
the Company, along with ECR Pharmaceuticals (“ECR”), launched Lodrane D®, an immediate release formulation of brompheniramine
maleate and pseudoephedrine HCl, an effective, low-sedating antihistamine combined with a decongestant.
Lodrane D® is marketed
under the Over-the-Counter Monograph (the “OTC Monograph”) and accordingly, under the Code of Federal Regulations can
be lawfully marketed in the US without prior approval of the United States Food and Drug Administration (“FDA”). Within
the past few years, the FDA has revised its enforcement policies, significantly limiting the circumstances under which these unapproved
products may be marketed. If the FDA determines that a company is distributing an unapproved product that requires approval, the
FDA may take enforcement action in a variety of ways, including, without limitation, product seizures and seeking a judicial injunction
against distribution.
ECR products have since
been divested so that Lodrane D® is promoted and distributed in the United States of America (“U.S.”) now by Valeant
Pharmaceuticals International Inc. Lodrane D® is available over-the-counter but also has physician promotion. Lodrane D®
is one of the only adult brompheniramine containing products available to the consumer at this time.
There have been several
mergers relating to ECR and successor entities and transfer of brand name ownership since this product was originally launched.
Lodrane D® is accordingly currently promoted and distributed in the U.S. by Valeant Pharmaceuticals International Inc. (“Valeant”).
Lodrane D® is available over-the-counter but also has physician promotion. Lodrane D® is the one of the only adult brompheniramine
containing products available to the consumer at this time.
Elite is manufacturing
the product for Valeant and will receive manufacturing revenues for this product.
Methadone 10mg
Methadone 10mg is contract
manufactured by Elite for Ascend Laboratories, LLC (“Ascend”), the owner of the approved ANDA.
On January 17, 2012,
Elite commenced shipping Methadone 10mg tablets to Ascend pursuant to a commercial manufacturing and supply agreement dated June
23, 2011, as amended on September 24, 2012 and January 19, 2015, July 20, 2015 and as extended on August 9, 2016 between Elite
and Ascend (the “Methadone Manufacturing and Supply Agreement”). Under the terms of the Methadone Manufacturing and
Supply Agreement, Elite performs manufacturing and packaging of Methadone 10mg for Ascend.
Hydromorphone
8mg
The approved ANDA for
Hydromorphone 8mg was acquired pursuant to an asset purchase agreement with Mikah Pharma LLC (“Mikah Pharma”) dated
May 18, 2010 (the “Hydromorphone Purchase Agreement”). Transfer of the manufacturing process of Hydromorphone 8mg to
the Northvale Facility, a prerequisite of the Company’s commercial launch of the product, was approved by the FDA on January
23, 2012.
Sales and marketing
rights for Hydromorphone 8mg are included in the Precision Dose License Agreement. Please see the section below titled “Precision
Dose License Agreement” for further details of this agreement.
The first shipment
of Hydromorphone 8mg was made to TAGI, pursuant to the Precision Dose License Agreement, in March 2012, with such initial shipment
triggering a milestone payment under this agreement. Hydromorphone 8mg is currently being manufactured by Elite and distributed
by TAGI under the Precision Dose License Agreement.
Phendimetrazine
Tartrate 35mg
The ANDA for Phendimetrazine
35mg was acquired by Elite as part of the asset purchase agreement between the Company and Mikah Pharma, dated August 1, 2013 (the
“Mikah ANDA Purchase”). Please see “Thirteen Abbreviated New Drug Applications” below for more information
on this agreement. The Northvale Facility was already an approved manufacturing site for this product as of the date of the Mikah
ANDA Purchase. Prior to the acquisition of this ANDA, Elite had been manufacturing this product on a contract basis pursuant to
a manufacturing and supply agreement with Mikah Pharma, dated June 1, 2011.
Phendimetrazine 35mg
is currently a commercial product being manufactured by Elite and distributed by Epic Pharma LLC (“Epic”) on a non-exclusive
basis, and by Elite.
On January 2, 2018,
the Company announced that an ANDA filed approximately six years ago for Phendimetrazine 35mg was approved by the FDA, resulting
in the Company owning two approved ANDA’s for this product. The Company is considering strategic options, including divestiture,
for this newly approved ANDA.
Phentermine 15mg
and Phentermine 30mg
Phentermine 15mg capsules
and Phentermine 30mg capsules were developed by the Company, with Elite receiving approval of the related ANDA in September 2012.
Sales and marketing
rights for Phentermine 15mg and Phentermine 30mg are included in the Precision Dose License Agreement. Please see the section below
titled “Precision Dose License Agreement” for further details of this agreement.
The first shipments
of Phentermine 15mg and Phentermine 30mg were made to TAGI, pursuant to the Precision Dose License Agreement, in April 2013, with
such initial shipments triggering a milestone payment under this agreement. Phentermine 15mg and Phentermine 30mg are currently
being manufactured by Elite and distributed by TAGI under the Precision Dose License Agreement.
Naltrexone 50mg
The approved ANDA for
Naltrexone 50mg was acquired by the Company pursuant to an asset purchase agreement between the Company and Mikah Pharma dated
August 27, 2010 (the “Naltrexone Acquisition Agreement”) for aggregate consideration of $200,000.
Sales and marketing
rights for Naltrexone 50mg are included in the Precision Dose License Agreement. Please see the section below titled “Precision
Dose License Agreement” for further details of this agreement.
The first shipment
of Naltrexone 50mg was made to TAGI, pursuant to the Precision Dose License Agreement, in September 2013, with such initial shipment
triggering a milestone payment under this agreement. Naltrexone 50mg is currently being manufactured by Elite and distributed by
TAGI under the Precision Dose License Agreement.
Isradipine 2.5mg
and Isradipine 5mg
The approved ANDAs
for Isradipine 2.5mg and Isradipine 5mg were acquired by Elite as part of the Mikah ANDA Purchase.
Sales and marketing
rights for Isradipine 2.5mg and Isradipine 5mg are included in the Epic Manufacturing and License Agreement. Please see the section
below titled “Manufacturing and License Agreement with Epic Pharma LLC” for further details of this agreement.
The first shipment
of Isradipine 2.5mg and Isradipine 5mg were made to Epic, pursuant to the Epic Manufacturing and License Agreement, in January
2015. Isradipine 2.5mg and Isradipine 5mg are currently being manufactured by Elite and distributed by Epic under the Epic Manufacturing
and License Agreement.
Hydroxyzine 10mg,
Hydroxyzine 25mg and Hydroxyzine 50mg
The approved ANDAs
for Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg were acquired by Elite as part of the Mikah ANDA Purchase.
Sales and marketing
rights for Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg are included in the Epic Manufacturing and License Agreement.
The first shipment
of Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg were made by Epic, pursuant to the Epic Manufacturing and License Agreement,
in April 2015. Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg are currently being manufactured and distributed by Epic
under the Epic Manufacturing and License Agreement.
Oxycodone 5mg,
Oxycodone 10mg, Oxycodone 15mg, Oxycodone 20mg and Oxycodone 30mg (“Oxy IR”)
We received notification
from Epic in October 2015 of the approval by the FDA of Epic’s ANDA for Oxy IR. This product was an Identified IR Product
in the Epic Strategic Alliance Agreement Dated March 18, 2009 (the “Epic Strategic Alliance”). Oxy IR was developed
at the Northvale Facility pursuant to the Epic Strategic Alliance, in which we are entitled to a Product Fee of 15% of Profits
as defined in the Epic Strategic Alliance. The first commercial sale of Oxy IR occurred in March 2016, and sales by Epic of this
product are ongoing.
Trimipramine
25mg, Trimipramine 50mg, and Trimipramine 100mg
Through Elite Labs,
Elite acquired an approved and currently marketed ANDA for Trimipramine Maleate Capsules (“Trimipramine”) 25, 50 and
100 mg, from Mikah Pharma. Through agreements assigned to Elite in the acquisition, Dr. Reddy’s Laboratories, Inc. will market
and sell the Trimipramine products and Epic Pharma will manufacture the products. The Epic Pharma agreement insures the uninterrupted
supply of generic Trimipramine. Trimipramine is a generic version of Surmontil®, a tricyclic antidepressant. Surmontil®
and generic Trimipramine have total US sales of approximately $2 million in 2016 according to IMS Health Data (“IMS”).
The ANDA purchased by Elite is currently the only marketed generic Trimipramine product.
Filed products under FDA review
SequestOx™
- Immediate Release Oxycodone with sequestered Naltrexone
SequestOx™ is
our lead abuse-deterrent candidate for the management of moderate to severe pain where the use of an opioid analgesic is appropriate.
SequestOx™ is an immediate-release Oxycodone Hydrochloride containing sequestered Naltrexone which incorporates 5mg, 10mg,
15mg, 20mg and 30mg doses of oxycodone into capsules.
In January 2016, the
Company submitted a 505(b)(2) New Drug Application for SequestOx™, after receiving a waiver of the $2.3 million filing fee
from the FDA. In March 2016, the Company received notification of the FDA’s acceptance of this filing and that such filing
has been granted priority review by the FDA with a target action under the Prescription Drug User Fee Act (“PDUFA”)
of July 14, 2016.
On July 15, 2016, the
FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx™
NDA is complete and the application is not ready for approval in its present form.
On December 21, 2016,
the Company met with the FDA for an end-of-review meeting to discuss steps that it could take to obtain approval of SequestOx™.
Based on this and the meeting minutes received from the FDA on January 23, 2017, the Company formulated a plan to address the issues
cited by the FDA in the CRL, with such plan including, without limitation, modifying the SequestOx™ formulation, conducting
bioequivalence and bioavailability fed and fasted studies, comparing the modified formulation to the original formulation.
On July 7, 2017, the
Company reported topline results from a pivotal bioequivalence fed study for or SequestOx™. The mean Tmax (the amount of
time that a drug is present at the maximum concentration in serum) of SequestOx
TM
was 4.6 hr. with a range of 0.5 hr.
to 12 hr. and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr. with a range of 0.5 hr. to 12 hr. A key objective for
the study was to determine if the reformulated SequestOx
TM
had a similar Tmax to the comparator when taken with a high
fat meal. Based on these results, the Company paused clinical trials for this formulation of SequestOx™. On January 30, 2018,
the Company reported positive topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the
results of this pilot study, the modified SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range
equivalent to the reference product when conducted in a pivotal trial under fed conditions. The Company intends to review these
study results with the FDA and discuss pharmacokinetic study requirements for a re-submission of the NDA. The Company will continue
to pursue extended release products with its proprietary abuse deterrent technology.
There can be no assurances
of the success of any future clinical trials, or if such trials are successful, there can be no assurances that an intended future
resubmission of the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA, and accordingly,
there can be no assurances that the Company will earn and receive the additional $7.5 million or future license fees. If the Company
does not receive these payments or fees, it will materially and adversely affect our financial condition. In addition, even if
marketing authorization is received, there can be no assurances that there will be future revenues or profits, or that any such
future revenues or profits would be in amounts that provide adequate return on the significant investments made to secure this
marketing authorization.
Oxycodone hydrochloride
and acetaminophen USP CII (generic version of Percocet®)
On August 9, 2016,
the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII)
5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen. Percocet® is a combination medication and is used to help relieve
moderate to severe pain. On September 7, 2017, the Company received a CRL from the FDA for the ANDA filed for this product. The
Company has responded to the CRL and submitted the required amendment which the Company believes addresses the deficiencies identified
in the CRL. As of the date of filing of this Quarterly Report on Form 10-Q, the Company has received no further communication from
the FDA in relation to this product.
Hydrocodone bitartrate
and acetaminophen tablets USP CII (generic version of Norco
®
)
On December 12, 2016,
the Company filed an ANDA with the FDA for a generic version of Norco
®
(hydrocodone bitartrate and acetaminophen
tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets. Norco
®
is a combination medication
and is used to help relieve moderate to moderately severe pain.
The combination products
of hydrocodone and acetaminophen have total annual US sales of approximately $700 million, according to IMS Health Data.
The Company received a CRL from the FDA in October 2017 regarding this ANDA filing with actions required to resolve the deficiencies
being in process. The Company intends to submit a response to the FDA addressing the deficiencies noted in the CRL and expects
such response to be submitted prior to year end.
Oxycodone Hydrochloride
Extended Release (generic version of OxyContin
®
)
On September 20, 2017,
the Company filed an ANDA with the FDA for a generic version of OxyContin
®
(extended release Oxycodone Hydrochloride)
tablets. OxyContin
®
is approved for the management of pain severe enough to require daily, around-the-clock, long-term
opioid treatment and for which alternative treatment options are inadequate. OxyContin
®
is formulated such that
the tablets provide physical abuse deterrent properties. IMS reported approximately $2.3 billion in revenue for OxyContin
®
and its equivalents in 2016. The FDA has requested additional information related to this filing and the Company expects to submit
a response to the FDA’s request later this year.
Undisclosed generic
for management of pain
In 2017, the Company
filed an ANDA with the FDA for a generic version of an undisclosed generic to a reference product approved for the management of
pain. IMS reported approximately $40 million in revenue for this undisclosed product and its equivalents in 2016. The Company has
not received a response from the FDA regarding this ANDA filing.
There can be no assurances
that any of these products will receive marketing authorization and achieve commercialization within this time period, or at all.
In addition, even if marketing authorization is received, there can be no assurances that there will be future revenues of profits,
or that any such future revenues or profits would be in amounts that provide adequate return on the significant investments made
to secure these marketing authorizations.
Approved Products Not Yet Commercialized
We currently own seven
different approved ANDAs, all of which were acquired as part of the Mikah ANDA Purchase. Each approved ANDA requires manufacturing
site transfers as a prerequisite to commencement of commercial manufacturing and distribution. The products relating to each approved
ANDA are included in the Epic Manufacturing and License Agreement, with Elite granting ANDA specific, exclusive or non-exclusive
market rights (depending on the ANDA) to Epic. Commercial manufacturing of these products is expected to be transferred to either
Epic or the Northvale Facility, with the required supplements to be filed with FDA in the manner and time frame that is economically
beneficial to us.
Asset Acquisition Agreements
Generic Phentermine
Capsules
On September 10, 2010,
together with our wholly owned subsidiary, Elite Laboratories, Inc., executed a purchase agreement (the “Phentermine Purchase
Agreement”) with Epic for the purpose of acquiring from Epic, an ANDA for a generic phentermine product (the “Phentermine
ANDA”), with such being filed with the FDA at the time the Phentermine Purchase Agreement was executed. On February 4, 2011,
the FDA approved the Phentermine ANDA. The acquisition of the Phentermine ANDA closed on March 31, 2011 and Elite paid the full
acquisition price of $450,000 from the purchase agreement with Epic Pharma.
This product is being
marketed and distributed by Precision Dose and its wholly owned subsidiary, TAGI, pursuant to the Precision Dose License Agreement,
a description of which is set forth below.
Generic Hydromorphone
HCl Product
On May 18, 2010, we
executed an asset purchase agreement with Mikah Pharma (the “Hydromorphone Purchase Agreement”). Pursuant to the Hydromorphone
Purchase Agreement, the Company acquired from Mikah Pharma an approved ANDA for Hydromorphone 8 mg for aggregate consideration
of $225,000, comprised of an initial payment of $150,000, which was made on May 18, 2010. A second payment of $75,000 was due to
be paid to Mikah Pharma on June 15, 2010, with the Company having the option to make this payment in cash or by issuing to Mikah
Pharma 937,500 shares of our common stock. We elected and did issue 937,500 shares of Common Stock during the quarter ended December
31, 2010, in full payment of the $75,000 due to Mikah Pharma pursuant to the Hydromorphone Purchase Agreement dated May 18, 2010.
This product is currently
being marketed and distributed by Precision Dose and its wholly owned subsidiary, TAGI, pursuant to the Precision Dose License
Agreement, a description of which is set forth below.
Generic Naltrexone
Product
On August 27, 2010,
we executed an asset purchase with Mikah Pharma (the “Naltrexone Acquisition Agreement”). Pursuant to the Naltrexone
Acquisition Agreement, Elite acquired from Mikah Pharma the ANDA number 75-274 (Naltrexone Hydrochloride Tablets USP, 50 mg), and
all amendments thereto, that have to date been filed with the FDA seeking authorization and approval to manufacture, package, ship
and sell the products described in this ANDA within the United States and its territories (including Puerto Rico) for aggregate
consideration of $200,000. In lieu of cash, Mikah Pharma agreed to accept product development services to be performed by us.
This product is being
marketed and distributed by Precision Dose and its wholly owned subsidiary, TAGI, pursuant to the Precision Dose License Agreement,
a description of which is set forth below.
Thirteen Abbreviated
New Drug Applications
On August 1, 2013,
Elite executed the Mikah ANDA Purchase with Mikah Pharma and acquired a total of thirteen ANDAs, consisting of twelve ANDAs approved
by the FDA and one ANDA under active review with the FDA, and all amendments thereto (the “Mikah Thirteen ANDA Acquisition”)
for aggregate consideration of $10,000,000, payable pursuant to a secured convertible note due in August 2016.
Each of the products
referenced in the twelve approved ANDAs require manufacturing site approval with the FDA. We believe that the site transfers qualify
for Changes Being Effected in 30 Days (“CBE 30”) review, with one exception, which would allow for the product manufacturing
transfer on an expedited basis. However, we can give no assurances that all will qualify for CBE 30 review, or on the timing of
these transfers of manufacturing site, or on the approval by the FDA of the transfers of manufacturing site.
As of the date of filing
of this Quarterly Report on Form 10-Q, the following products included in the Mikah Purchase Agreement have successfully achieved
manufacturing site transfers:
|
·
|
Isradipine 2.5mg and Isradipine 5mg
|
|
·
|
Hydroxyzine 10mg, Hydroxyzine 25mg and Hydroxyzine 50mg
|
We have executed the
Epic Pharma Manufacturing and License Agreement, relating to the manufacturing, marketing and sale of these twelve ANDAs. Please
see below for further details on the Epic Pharma Manufacturing and License Agreement.
Trimipramine
In May 2017, through
Elite Labs, we acquired from Mikah Pharma an FDA approved ANDA for Trimipramine for aggregate consideration of $1,200,000. In conjunction
with this acquisition, we also acquired from Mikah Pharma all rights, interests, and obligations under a supply and distribution
agreement with Dr. Reddy’s Laboratories, Inc. relating to the supply, sale and distribution of generic Trimipramine, and
under a manufacturing and supply agreement with Epic Pharma relating to the manufacture and supply of Trimipramine.
Please see Note 22:
Related Party Agreements with Mikah Pharma LLC to the Financial Statements above.
Licensing, Manufacturing and Development
Agreements
Sales and Distribution Licensing
Agreement with Epic Pharma LLC for SequestOx™
On June 4, 2015, we
executed an exclusive License Agreement (the “2015 SequestOx™ License Agreement”) with Epic, to market and sell
in the U.S., SequestOx™, an immediate release oxycodone with sequestered naltrexone capsule, owned by us. Epic will have
the exclusive right to market ELI-200 and its various dosage forms as listed in Schedule A of the Agreement. Epic is responsible
for all regulatory and pharmacovigilance matters related to the products. Pursuant to the 2015 SequestOx™ License Agreement,
Epic will pay us non-refundable payments totaling $15 million, with such amount representing the cost of an exclusive license to
SequestOx™, the cost of developing the product, the filing of a NDA with the FDA and the receipt of the approval letter for
the NDA from the FDA. As of the date of filing of this annual report on Form 10-K, the Company has received $7.5 million of
the $15 million in non-refundable payments due pursuant to the 2015 SequestOx™ License Agreement, with such amount consisting
of $5 million being due and owing on the execution date of the 2015 SequestOx™ License Agreement, and $2.5 million being
earned as of January 14, 2016, the date of Elite’s filing of an NDA with the FDA for the relevant product. Both of these
non-refundable fees (i.e., the $5 million fee and the $2.5 million fee), have been paid by Epic.
The remaining $7.5
million in non-refundable payments due pursuant to the 2015 SequestOx™ License Agreement is due on the FDA’s approval
of SequestOx™ for commercial sale in the United States of America (please see the paragraph below for further details). In
addition, we will receive a license fee computed as a percentage (50%) of net sales of the products as defined in the 2015 SequestOx™
License Agreement and is entitled to multi-million-dollar minimum annual license fees we will manufacture the product for sale
by Epic on a cost-plus basis and both parties agree to execute a separate Manufacturing and Supply Agreement. The license fee is
payable quarterly for the term of the 2015 SequestOx™ License Agreement. The term of the 2015 SequestOx™ License Agreement
is five years and may be extended for an additional five years upon mutual agreement of the parties. Elite can terminate the 2015
SequestOx™ License Agreement on 90 days’ written notice in the event that Epic does not pay us certain minimum annual
license fees over the initial five-year term of the 2015 SequestOx™ License Agreement. Either party may terminate this 2015
SequestOx™ License Agreement upon a material breach and failure to cure that breach by the other party within a specified
period. Please note that there was a change in management of Epic that occurred in May 2016, concurrent with a change in ownership
of Epic. The new management of Epic has advised us of their desire to renegotiate the 2015 SequestOx™ License Agreement.
Prior to conclusion of these renegotiations, in July 2016, the Company received a Complete Response Letter from the FDA stating
that the FDA’s review of the Company’s NDA was complete and the application was not ready for approval in its present
form. Subsequently, the Company has met with the FDA to discuss steps it could take to obtain approval of SequestOx™, conducted
a pivotal bioequivalence fed study on a modified formulation, with results reported in July 2017, that did not indicate the required
characteristics of a comparator, and a pilot study on a further modified formulation, with results reported in January 2018, that
indicated the expectation of bioequivalence with the comparator when conducted in a pivotal trial under fed conditions. The Company
intends to review the latest study results with the FDA and discuss pharmacokinetic study requirements for a re-submission of the
NDA for SequestOx™. Negotiations with Epic have not been concluded due to the status of the application with the FDA, and
the Company believes that the conclusion of such negotiations will be significantly influenced by the future status and potential
approval of a re-submission with the FDA of the NDA for SequestOx™. While the 2015 SequestOx™ License Agreement is
still in effect, achievement of the commercial terms and conditions strongly correlates to the status of the related product NDA.
As a prudent business practice, we continue to cooperate and communicate with Epic, as well as maintaining other options relating
to the license and/or distribution of SequestOx™. We believe that if agreement is reached with Epic on revised terms and
conditions and amendment is made to the 2015 SequestOx™ License Agreement, such amendment may materially differ from the
current 2015 SequestOx™ License Agreement.
On July 15, 2016, the
FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx™
NDA is complete and the application is not ready for approval in its present form.
On December 21, 2016,
the Company met with the FDA for an end-of-review meeting to discuss steps that it could take to obtain approval of SequestOx™.
Based on this and the meeting minutes received from the FDA on January 23, 2017, the Company formulated a plan to address the issues
cited by the FDA in the CRL, with such plan including, without limitation, modifying the SequestOx™ formulation, conducting
bioequivalence and bioavailability fed and fasted studies, comparing the modified formulation to the original formulation.
On July 7, 2017, the
Company reported topline results from a pivotal bioequivalence fed study for or SequestOx™. The mean Tmax (the amount of
time that a drug is present at the maximum concentration in serum) of SequestOx
TM
was 4.6 hr. with a range of 0.5 hr.
to 12 hr. and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr. with a range of 0.5 hr. to 12 hr. A key objective for
the study was to determine if the reformulated SequestOx
TM
had a similar Tmax to the comparator when taken with a high
fat meal. Based on these results, the Company paused clinical trials for this formulation of SequestOx™.
On January 30, 2018,
the Company reported positive topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the
results of this pilot study, the modified SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range
equivalent to the reference product when conducted in a pivotal trial under fed conditions. The Company intends to review these
study results with the FDA and discuss pharmacokinetic study requirements for a re-submission of the NDA.
The Company will continue
to pursue extended release products with its proprietary abuse deterrent technology.
There can be no assurances
of the success of any future clinical trials, or if such trials are successful, there can be no assurances that an intended future
resubmission of the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA, and accordingly,
there can be no assurances that the Company will earn and receive the additional $7.5 million or future license fees. If the Company
does not receive these payments or fees, it will materially and adversely affect our financial condition. In addition, even if
marketing authorization is received, there can be no assurances that there will be future revenues or profits, or that any such
future revenues or profits would be in amounts that provide adequate return on the significant investments made to secure this
marketing authorization.
Manufacturing
and License Agreement with Epic Pharma LLC
On October 2, 2013,
we executed the Epic Pharma Manufacturing and License Agreement (the “Epic Manufacturing and License Agreement”). This
agreement granted Epic certain rights to manufacture, market and sell in the United States and Puerto Rico the twelve approved
ANDAs acquired by us pursuant to the Mikah Thirteen ANDA Acquisition. Of the twelve approved ANDAs, Epic will have the exclusive
right to market six products as listed in Schedule A of the Epic Manufacturing and License Agreement, and a non-exclusive right
to market six products as listed in Schedule D of the Epic Manufacturing and License Agreement. Epic will manufacture the products
and is responsible for all regulatory and pharmacovigilance matters related to the products and for all costs related to the site
transfer for all products. We have no further obligations or deliverables under the Epic Manufacturing and License Agreement. Pursuant
to the Epic Manufacturing and License Agreement, we will receive a license fee and milestone payments. The license fee will be
computed as a percentage of the gross profit, as defined in the Epic Manufacturing and License Agreement, earned by Epic a result
of sales of the products. The manufacturing cost used for the calculation of the license fee is a predetermined amount per unit
plus the cost of the drug substance (API) and the sales cost for the calculation is predetermined based on net sales.
If we manufacture any
product for sale by Epic, then Epic shall pay us the same predetermined manufacturing cost per unit plus the cost of the API. The
license fee is payable monthly for the term of the Epic Manufacturing and License Agreement. Epic shall pay to us certain milestone
payments as defined by the Epic Manufacturing and License Agreement. The term of the Epic Manufacturing and License Agreement is
five years and may be extended for an additional five years upon mutual agreement of the parties. Twelve months following the launch
of a product covered by the Epic Manufacturing and License Agreement, we may terminate the marketing rights for any product if
the license fee paid, by Epic, falls below a designated amount for a nine-month period of that product. We may also terminate the
exclusive marketing rights if Epic is unable to meet the annual unit volume forecast for a designated product group for any year,
subject to the ability of Epic, during the succeeding nine-month period, to achieve at least one-half of the prior year’s
minimum annual unit forecast. The Epic Manufacturing and License Agreement may be terminated by mutual agreement, as a result of
a breach by either party that is not cured within 60 days’ notice of the breach, or by us as a result of Epic Pharma becoming
a party to a bankruptcy, reorganization or other insolvency proceeding that continues for a period of 30 days or more.
Trimipramine
Acquisition
On May 16, 2017, we
executed an asset purchase agreement with Mikah Pharma, and acquired from Mikah Pharma (the “Trimipramine Acquisition”)
an FDA approved ANDA for Trimipramine for aggregate consideration of $1,200,000, payable pursuant to a senior secured note due
on December 31, 2020 (the “Trimipramine Note”). Mikah Pharma is owned by Nasrat Hakim, the Chairman of the Board of
Directors, President and Chief Executive Officer (CEO) of the Company.
The Trimipramine Note
bears interest at the rate of 10% per annum, payable quarterly. All principal and unpaid interest is due and payable on December
31, 2020. Pursuant to a security agreement, repayment of the Trimipramine Note is secured by the ANDA acquired in the Acquisition.
Trimipramine
Distribution Agreement with Dr. Reddy’s Laboratories, Inc. and Manufacturing Agreement with Epic
On May 17, 2017, in
conjunction with the Trimipramine Acquisition, the Company executed an assignment agreement with Mikah Pharma, pursuant to which
the Company acquired all rights, interests, and obligations under a supply and distribution agreement (the “Reddy’s
Trimipramine Distribution Agreement”) with Dr. Reddy’s Laboratories, Inc. (“Dr. Reddy’s”) originally
entered into by Mikah Pharma on May 7, 2017 and relating to the supply, sale and distribution of generic Trimipramine Maleate Capsules
25mg, 50mg and 100mg.
On May 22, 2017, the
Company executed an assignment agreement with Mikah Pharma, pursuant to which the Company acquired all rights, interests and obligations
under a manufacturing and supply agreement with Epic originally entered into by Mikah in 2011 and amended on June 30, 2015 and
relating to the manufacture and supply of Trimipramine (the “Trimipramine Manufacturing Agreement”).
Under the Trimipramine
Manufacturing Agreement, Epic will manufacture Trimipramine under license from the Company pursuant to the FDA approved and currently
marketed Abbreviated New Drug Application that was acquired in conjunction with the Company’s entry into these agreements.
Under the Reddy’s
Trimipramine Distribution Agreement, the Company will supply Trimipramine on an exclusive basis to Dr. Reddy’s and Dr. Reddy’s
will be responsible for all marketing and distribution of Trimipramine in the United States, its territories, possessions, and
commonwealth. The Trimipramine will be manufactured by Epic and transferred to Dr. Reddy’s at cost, without markup.
Dr. Reddy’s will
pay to the Company a share of the profits, calculated without any deduction for cost of sales and marketing, derived from the sale
of Trimipramine. The Company’s share of these profits is in excess of 50%.
Methadone Manufacturing
and Supply Agreement
On June 23, 2011, as
amended and extended, we entered into an agreement to manufacture and supply Methadone 10mg to ThePharmaNetwork LLC (the “Methadone
Manufacturing and Supply Agreement”). ThePharmaNetwork LLC was subsequently acquired by Alkem Laboratories Ltd (“Alkem”)
and now goes by the name Ascend Laboratories LLC (“Ascend”) and is a wholly owned subsidiary of Alkem.
Ascend in the owner
of the approved ANDA for Methadone 10mg, and the Northvale Facility is an approved manufacturing site for this ANDA. The Methadone
Manufacturing and Supply Agreement provides for the manufacture and packaging by the Company of Ascend’s methadone hydrochloride
10mg tablets.
The initial shipment
of Methadone 10mg pursuant to the Methadone Manufacturing and Supply Agreement occurred in January 2012.
On August 26, 2016,
the Methadone Manufacturing and Supply Agreement was amended and extended through December 31, 2017. The Company is discussing
further extension of this agreement. We continue to manufacture this product pursuant to the terms of the agreement[?].
Precision Dose
License Agreement
On September 10, 2010,
we executed a License Agreement with Precision Dose (the “Precision Dose License Agreement”) to market and distribute
Phentermine 37.5mg, Phentermine 15mg, Phentermine 30mg, Hydromorphone 8mg, Naltrexone 50mg, and certain additional products that
require approval from the FDA, through its wholly-owned subsidiary, TAGI, in the United States, Puerto Rico and Canada. Phentermine
37.5mg was launched in April 2011. Hydromorphone 8mg was launched in March 2012. Phentermine 15mg and Phentermine 30mg were launched
in April 2013. Naltrexone 50mg was launched in September 2013. Precision Dose will have the exclusive right to market these products
in the United States and Puerto Rico and a non-exclusive right to market the products in Canada.
Pursuant to the Precision
Dose License Agreement, Elite will receive a license fee and milestone payments. The license fee will be computed as a percentage
of the gross profit, as defined in the Precision Dose License Agreement, earned by Precision Dose as a result of sales of the products.
The license fee is payable monthly for the term of the Precision Dose License Agreement. The milestone payments will be paid in
six installments. The first installment was paid upon execution of the Precision Dose License Agreement. The remaining installments
are to be paid upon FDA approval and initial shipment of the products to Precision Dose. The term of the Precision Dose License
Agreement is 15 years and may be extended for 3 successive terms, each of 5 years.
Master Development
and License Agreement with SunGen Pharma LLC
On August 24, 2016,
as amended we entered into an agreement with SunGen Pharma LLC (“SunGen”) (the “SunGen Agreement”) to undertake
and engage in the research, development, sales and marketing of eight generic pharmaceutical products. Two of the products are
classified as CNS stimulants (the “CNS Products”), two of the products are classified as beta blockers and the remaining
four products consist of antidepressants, antibiotics and antispasmodics.
Under the terms of
the SunGen Agreement, Elite and SunGen will share in the responsibilities and costs in the development of these products and will
share substantially in the profits from sales. Upon approval, the know-how and intellectual property rights to the products will
be owned jointly by Elite and SunGen. Three of the eight products will be jointly owned, three products will be owned by SunGen,
with Elite having exclusive marketing rights and the remaining two products will be owned by Elite, with SunGen having exclusive
marketing rights. Elite will manufacture and package all eight products on a cost-plus basis.
On January 10, 2018,
the Company reported positive topline results from pivotal bioequivalence studies for an undisclosed extended-release generic product
in co-development with SunGen Pharma. The topline results indicate that the generic product is bioequivalent to the branded product.
The studies were single dose crossover comparative bioavailability studies in healthy male and female volunteers in both the fed
and fasting states. A fasting study with product beads sprinkled on to applesauce also demonstrated bioequivalence to the branded
product. MS Health reported approximately $1.6 billion in revenue for the generic market for this product in 2017.
Products Under Development
Elite’s research
and development activities are primarily focused on developing its proprietary abuse deterrent technology and the development of
a range of abuse deterrent opioid products that utilize this technology or other approaches to abuse deterrence.
Elite’s proprietary
abuse-deterrent technology, utilizes the pharmacological approach to abuse deterrence and consists of a multi-particulate capsule
which contains an opioid agonist in addition to naltrexone, an opioid antagonist used primarily in the management of alcohol dependence
and opioid dependence. When this product is taken as intended, the naltrexone is designed to pass through the body unreleased while
the opioid agonist releases over time providing therapeutic pain relief for which it is prescribed. If the multi-particulate beads
are crushed or dissolved, the opioid antagonist, naltrexone, is designed to release. The absorption of the naltrexone is intended
to block the euphoria by preferentially binding to same receptors in the brain as the opioid agonist and thereby reducing the incentive
for abuse or misuse by recreational drug abusers.
We filed an NDA for
the first product to utilize our abuse deterrent technology, Immediate Release Oxycodone 5mg, 10mg, 15mg, 20mg and 30mg with sequestered
Naltrexone (collectively and individually referred to as “SequestOx™”), on January 14, 2016.
On July 15, 2016, the
FDA issued a Complete Response Letter, or CRL, regarding the NDA. The CRL stated that the review cycle for the SequestOx™
NDA is complete and the application is not ready for approval in its present form.
On December 21, 2016,
the Company met with the FDA for an end-of-review meeting to discuss steps that it could take to obtain approval of SequestOx™.
Based on this and the meeting minutes received from the FDA on January 23, 2017, the Company formulated a plan to address the issues
cited by the FDA in the CRL, with such plan including, without limitation, modifying the SequestOx™ formulation, conducting
bioequivalence and bioavailability fed and fasted studies, comparing the modified formulation to the original formulation.
On July 7, 2017, the
Company reported topline results from a pivotal bioequivalence fed study for or SequestOx™. The mean Tmax (the amount of
time that a drug is present at the maximum concentration in serum) of SequestOx
TM
was 4.6 hr. with a range of 0.5 hr.
to 12 hr. and the mean Tmax of the comparator, Roxicodone®, was 3.4 hr. with a range of 0.5 hr. to 12 hr. A key objective for
the study was to determine if the reformulated SequestOx
TM
had a similar Tmax to the comparator when taken with a high
fat meal. Based on these results, the Company paused clinical trials for this formulation of SequestOx™. On January 30, 2018,
the Company reported positive topline results from a pilot study conducted for a modified SequestOx™ wherein, based on the
results of this pilot study, the modified SequestOx™ formulation is expected to achieve bioequivalence with a Tmax range
equivalent to the reference product when conducted in a pivotal trial under fed conditions. The Company intends to review these
study results with the FDA and discuss pharmacokinetic study requirements for a re-submission of the NDA. The Company will continue
to pursue extended release products with its proprietary abuse deterrent technology.
There can be no assurances
of the success of any future clinical trials, or if such trials are successful, there can be no assurances that an intended future
resubmission of the NDA product filing, if made, will be accepted by or receive marketing approval from the FDA, and accordingly,
there can be no assurances that the Company will earn and receive the additional $7.5 million or future license fees. If the Company
does not receive these payments or fees, it will materially and adversely affect our financial condition. In addition, even if
marketing authorization is received, there can be no assurances that there will be future revenues or profits, or that any such
future revenues or profits would be in amounts that provide adequate return on the significant investments made to secure this
marketing authorization.
On August 9, 2016,
the Company filed an ANDA with the FDA for a generic version of Percocet® (oxycodone hydrochloride and acetaminophen, USP CII)
5mg, 7.5mg and 10mg tablets with 325mg of acetaminophen (“Generic Oxy/APAP”). Percocet® is a combination medication,
with abuse deterrence, and is used to help relieve moderate to severe pain. On September 7, 2017, the Company received a CRL from
the FDA for the ANDA filed for this product. The Company has responded to the CRL and submitted the required amendment which the
Company believes addresses the deficiencies identified in the CRL. As of the date of filing of this Quarterly Report on Form 10-Q,
the Company has received no further communication from the FDA in relation to this product. Please note that there can be no assurances
of this product receiving marketing authorization, or achieving commercialization. In addition, even if marketing authorization
is received and the product is commercialized, there can be no assurances of future revenues or profits in such amounts that would
provide adequate return on the significant investments made to secure marketing authorization for this product.
On December 12, 2016,
the Company filed an ANDA with the FDA for a generic version of Norco
®
(hydrocodone bitartrate and acetaminophen
tablets USP CII) 2.5mg/325mg, 5mg/325mg, 7.5mg/325mg and 10mg/325mg tablets (“Generic Hydrocodone/APAP”). Norco
®
is a combination medication and is used to help relieve moderate to moderately severe pain. The Company received a CRL from the
FDA in October 2017 regarding this ANDA filing with actions required to resolve the deficiencies being in process. The Company
intends to submit a response to the FDA addressing the deficiencies noted in the CRL and expects such response to be submitted
prior to year end. Please note that there can be no assurances of this product receiving marketing authorization, or achieving
commercialization. In addition, even if marketing authorization is received and the product is commercialized, there can be no
assurances of future revenues or profits in such amounts that would provide adequate return on the significant investments made
to secure marketing authorization for this product.
On September 20, 2017,
the Company filed an ANDA with the FDA for a generic version of OxyContin
®
(extended release Oxycodone Hydrochloride)
tablets (“Generic Extended Release Oxycodone”). OxyContin
®
is approved for the management of pain severe
enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
OxyContin
®
is formulated such that the tablets provide physical abuse deterrent properties. IMS reported approximately
$2.3 billion in revenue for OxyContin
®
and its equivalents in 2016. The FDA has requested additional information
related to this filing and the Company expects to submit a response to the FDA’s request later this year. Please note that
there can be no assurances of this product receiving marketing authorization, or achieving commercialization. In addition, even
if marketing authorization is received and the product is commercialized, there can be no assurances of future revenues or profits
in such amounts that would provide adequate return on the significant investments made to secure marketing authorization for this
product.
The Company believes
that the abuse deterrent technology can be applied to and incorporated into a wide range of opioids used today for pain management
and has, to date, identified 10 additional products for potential development. All of these products are at early stages of development,
with research and development activities mainly consisting of in-house process development and laboratory studies. Extensive efficacy
and safety studies, similar to those conducted for SequestOx™, Generic Oxy/APAP, Generic Hydrocodone/APAP, and Generic Extended
Release Oxycodone have not yet been conducted for these other products. As a result, costs incurred in relation to the development
of these 10 products have not been material.
Research and development
costs were $2.7 and $1.5 million for the three months ended December 31, 2017 and 2016, respectively and $7.1 million and $4.3
million for the nine months ended December 31, 2017 and 2016, respectively. Costs incurred during the prior fiscal year relate
almost entirely to the development of the abuse deterrent opioid product, SequestOx
™
, Generic Oxy/APAP, Generic
Hydrocodone/APAP and costs incurred during the current fiscal year relate almost entirely to the development of the abuse deterrent
opioid products, SequestOx™, Generic Oxy/APAP, Generic Hydrocodone/APAP, Generic Extended Release Oxycodone, and the generic,
undisclosed pain product.
On June 4, 2015, the
Company entered into a sales and distribution licensing agreement which included a non-refundable payment of $5 million to Elite
for prior research and development activities, with such representing the first material net cash inflows being generated by ELI-200.
On January 14, 2016, the Company filed an NDA with the FDA for SequestOx™, thereby earning a non-refundable $2.5 million
milestone. An additional $7.5 million non-refundable milestone is due upon the FDA’s approval of Elite’s NDA. Please
note, as further detailed above, there can be no assurances of the Company receiving marketing authorization for SequestOx™,
and accordingly, there can be no assurances that the Company will earn and receive the additional $7.5 million or future license
fees. The non-receipt by the Company of these payments and or fees will materially and adversely affect our financial condition.
Please note that, while
the FDA is required to review applications within certain timeframes, during the review process, the FDA frequently requests that
additional information be submitted. The effect of such request and subsequent submission can significantly extend the time for
the NDA review process. Until an NDA is actually approved, there can be no assurances that the information requested and submitted
will be considered adequate by the FDA to justify approval. The packaging and labeling of our developed products are also subject
to FDA regulation. Based on the foregoing, it is impossible to anticipate the amount of time that will be needed to obtain FDA
approval to market any product. In addition, there can be no assurances of the Company filing the required application(s) with
the FDA or of the FDA approving such application(s) if filed, and the Company’s ability to successfully develop and commercialize
products incorporating its abuse deterrent technology is subject to a high level of risk as detailed in “Item 1A-Risk Factors-Risks
Related to our Business” of the Annual Report on Form 10-K filed with the SEC on June 14, 2017, and further detailed in “Item
1A-Risk Factors” in this quarterly report on Form 10-Q.
Abuse-Deterrent and Sustained Release
Opioids
The abuse-deterrent
opioid products utilize our patented abuse-deterrent technology that is based on a pharmacological approach. These products are
combinations of a narcotic agonist formulation intended for use in patients with pain, and an antagonist, formulated to deter abuse
of the drug. Both, agonist and antagonist, have been on the market for a number of years and sold separately in various dose strengths.
We have filed Investigational New Drug applications (“INDs”) for two abuse resistant products under development and
have tested products in various pharmacokinetic and efficacy studies. We expect to continue to develop multiple abuse resistant
products. Products utilizing the pharmacological approach to deter abuse such as Suboxone®, a product marketed in the United
States by Reckitt Benckiser Pharmaceuticals, Inc., and Embeda®, a product marketed in the United States by Pfizer, Inc., have
been approved by the FDA and are being marketed in the United States.
We have developed,
licensed to Epic the marketing rights to SequestOx™, immediate release Oxycodone with Naltrexone, and have retained the rights
to the remainder of these abuse resistant and sustained release opioid products. We may license these products at a later date
to a third party who could provide funding for the remaining clinical studies and who could provide sales and distribution for
the product.
We also developed controlled
release technology for oxycodone under a joint venture with Elan which terminated in 2002. According to the Elan Termination Agreement,
we acquired all proprietary, development and commercial rights for the worldwide markets for the products developed by the joint
venture, including the sustained release opioid products. Upon licensing or commercialization of an oral controlled release formulation
of oxycodone for the treatment of pain, we will pay a royalty to Elan pursuant to the Elan Termination Agreement. If we were to
sell the product itself, we will pay a 1% royalty to Elan based on the product’s net sales, and if we enter into an agreement
with another party to sell the product, we will pay a 9% royalty to Elan based on our net revenues from this product. We are allowed
to recoup all development costs including research, process development, analytical development, clinical development and regulatory
costs before payment of any royalties to Elan.
Patents
Since our incorporation,
we have secured the following patents, of which two have been assigned for a fee to another pharmaceutical company. Our patents
are:
PATENT
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EXPIRATION DATE
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U.S. patent 5,837,284 (assigned to Celgene Corporation)
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November 2018
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U.S. patent 6,620,439
|
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October 2020
|
U.S. patent 6,635,284 (assigned to Celgene Corporation)
|
|
March 2018
|
U.S. patent 6,926,909
|
|
April 2023
|
U.S. patent 8,182,836
|
|
April 2024
|
U.S. patent 8,425,933
|
|
April 2024
|
U.S. patent 8,703,186
|
|
April 2024
|
Canadian patent 2,521,655
|
|
April 2024
|
Canadian patent 2,541,371
|
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September 2024
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U.S. patent 9,056,054
|
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June 2030
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E.P. patent 1615623
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April 2024
|
We also have pending
applications for two additional U.S. patents and two foreign patents. We intend to apply for patents for other products in the
future; however, there can be no assurance that any of the pending applications or other applications which we may file will be
granted. We have also filed corresponding foreign applications for key patents.
Prior to the enactment
in the United States of new laws adopting certain changes mandated by the General Agreement on Tariffs and Trade (“GATT”),
the exclusive rights afforded by a U.S. Patent were for a period of 17 years measured from the date of grant. Under GATT, the term
of any U.S. Patent granted on an application filed subsequent to June 8, 1995 terminates 20 years from the date on which the patent
application was filed in the United States or the first priority date, whichever occurs first. Future patents granted on an application
filed before June 8, 1995, will have a term that terminates 20 years from such date, or 17 years from the date of grant, whichever
date is later.
Under the Drug Price
Competition Act, a U.S. product patent or use patent may be extended for up to five years under certain circumstances to compensate
the patent holder for the time required for FDA regulatory review of the product. Such benefits under the Drug Price Competition
Act are available only to the first approved use of the active ingredient in the drug product and may be applied only to one patent
per drug product. There can be no assurance that we will be able to take advantage of this law.
Also, different countries
have different procedures for obtaining patents, and patents issued by different countries provide different degrees of protection
against the use of a patented invention by others. There can be no assurance, therefore, that the issuance to us in one country
of a patent covering an invention will be followed by the issuance in other countries of patents covering the same invention, or
that any judicial interpretation of the validity, enforceability, or scope of the claims in a patent issued in one country will
be similar to the judicial interpretation given to a corresponding patent issued in another country. Furthermore, even if our patents
are determined to be valid, enforceable, and broad in scope, there can be no assurance that competitors will not be able to design
around such patents and compete with us using the resulting alternative technology.
Trademarks
SequestOx™ is
a trademark owned by Elite, which received a Notice of Allowance by the United States Patent and Trademark Office on December 22,
2015.
We currently plan to
license at least some of our products to other entities in the marketing of pharmaceuticals, but may also sell products under our
own brand name in which case we may register trademarks for those products.
Sources and Availability of Raw Materials;
Manufacturing
A significant portion
of our raw materials may be available only from foreign sources. Foreign sources can be subject to the special risks of doing business
abroad, including:
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greater possibility for disruption due
to transportation or communication problems;
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·
|
the relative instability of some foreign
governments and economies;
|
|
·
|
interim price volatility based on labor
unrest, materials or equipment shortages, export duties, restrictions on the transfer of funds, or fluctuations in currency exchange
rates; and,
|
|
·
|
uncertainty regarding recourse to a dependable
legal system for the enforcement of contracts and other rights.
|
While we currently
obtain the raw materials that we need from over 20 suppliers, some materials used in our products are currently available from
only one supplier or a limited number of suppliers. The FDA requires identification of raw material suppliers in applications for
approval of drug products. If raw materials were unavailable from a specified supplier, FDA approval of a new supplier could delay
the manufacture of the drug involved.
We have acquired pharmaceutical
manufacturing equipment for manufacturing our products. We have registered our facilities with the FDA and the DEA.
Dependence on One or a Few Major Customers
Each year we have had
one or a few customers that have accounted for a large percentage of our limited revenues, therefore the termination or restructuring
of a contract with a customer may result in the loss of material amount or substantially all of our revenues. We are constantly
working to develop new relationships with existing or new customers, but despite these efforts we may not, at the time that any
of our current contracts expire, have other contracts in place generating similar or material revenue. We have agreements with
Epic, Precision Dose and Ascend for the licensing, sales and distribution of products that we manufacture. We are currently renegotiating
a licensing contract with Epic, which may result in the termination of an existing contract or an amended licensing contract that
is materially different from that already in place. We receive revenues to manufacture these products and also receive a profit
split or royalties based on in-market sales of the products.
Critical Accounting Policies and Estimates
The preparation of
the unaudited condensed consolidated financial statements and related disclosures in conformity with GAAP, and our discussion and
analysis of its financial condition and operating results require our management to make judgments, assumptions and estimates that
affect the amounts reported in its condensed consolidated financial statements and accompanying notes. Note 1
–
Summary
of Significant Accounting Policies, of the Notes to Condensed Consolidated Financial Statements of this Quarterly Report on Form
10-Q describes the significant accounting policies and methods used in the preparation of our unaudited condensed consolidated
financial statements. Management bases its estimates on historical experience and on various other assumptions it believes to be
reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets
and liabilities. Actual results may differ from these estimates and such differences may be material.
Results of Operations
The following set forth
our results of operations for the periods presented. The period-to-period comparison of financial results is not necessarily indicative
of future results.
Three months
ended December 31, 2017 compared to December 31, 2016
Revenue, Cost of
revenue and Gross profit:
|
|
For the Three Months Ended December 31,
|
|
|
Change
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percentage
|
|
Manufacturing fees
|
|
$
|
2,083,826
|
|
|
$
|
1,885,765
|
|
|
$
|
198,061
|
|
|
|
11
|
%
|
Licensing fees
|
|
|
451,628
|
|
|
|
444,884
|
|
|
|
6,744
|
|
|
|
2
|
%
|
Total revenue
|
|
|
2,535,454
|
|
|
|
2,330,649
|
|
|
|
204,805
|
|
|
|
9
|
%
|
Cost of revenue
|
|
|
1,419,829
|
|
|
|
1,726,751
|
|
|
|
(306,922
|
)
|
|
|
-18
|
%
|
Gross profit
|
|
$
|
1,115,625
|
|
|
$
|
603,898
|
|
|
$
|
511,727
|
|
|
|
85
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit - percentage
|
|
|
44
|
%
|
|
|
26
|
%
|
|
|
|
|
|
|
|
|
Total revenues for
the three-month period ended December 31, 2017 increased by $0.2 million or 9%, to $2.5 as compared to $2.3 million, for the corresponding
period in 2016 primarily due to the following:
Manufacturing fees
increased by $0.2 million, or 11%, due to a growth in the generic product lines manufactured during the quarter.
Licensing fees increased
by $0.006 million, or 2%. This increase is primarily due to the timing of in-market sales of the Company’s generic products,
as well as margins achieved by the Company’s licensed marketing partners. License fees earned are based on in-market sales
and accordingly, there is a natural lag between manufacturing revenues earned by the Company and related license fees being earned
from in market sales occurring subsequent to the Company’s shipment of licensed generic products to its marketing partners.
In market profits achieved by the Company’s marketing partners are also a factor, with a direct correlation to the license
fee revenues earned by the Company.
Costs of revenue consists
of manufacturing costs. Our costs of revenue decreased by $0.3 million or 18%, to $1.4 million as compared to $1.7 million for
the corresponding period in 2016. Costs of revenue consists of manufacturing and assembly costs, with each product having a unique
cost profile correlating to the underlying cost of the materials consumed, direct labor hours expended and overhead resources utilized.
The decrease in overall costs of revenues is due in large part to manufacturing operations in the current quarter consisting of
a lower cost profile product mix, as compared to manufacturing operations in the same quarter of the prior year, despite there
being an increase in overall manufacturing revenues for the current quarter as compared to the same quarter of the prior year.
Our gross profit margin
was 44% during the three months ended December 31, 2017 as compared to 26% during the three months ended December 31, 2016. The
increase in gross margin is due to the product mix of generics manufactured during the quarter.
Operating expenses:
|
|
For the Three Months Ended December 31,
|
|
|
Change
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percentage
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
2,514,435
|
|
|
$
|
1,526,183
|
|
|
$
|
988,252
|
|
|
|
65
|
%
|
General and administrative
|
|
|
614,994
|
|
|
|
694,321
|
|
|
|
(79,327
|
)
|
|
|
-11
|
%
|
Non-cash compensation
|
|
|
37,961
|
|
|
|
84,785
|
|
|
|
(46,824
|
)
|
|
|
-55
|
%
|
Depreciation and amortization
|
|
|
7,196
|
|
|
|
21,032
|
|
|
|
(13,836
|
)
|
|
|
-66
|
%
|
Total operating expenses
|
|
$
|
3,174,586
|
|
|
$
|
2,326,321
|
|
|
$
|
848,265
|
|
|
|
36
|
%
|
Operating expenses
consist of research and development costs, general and administrative, non-cash compensation through the issuance of stock options
and depreciation and amortization expenses. Operating expenses for the three-month period ended December 31, 2017 increased by
$0.9 million, or 36%, to $3.2 million, as compared to $2.3 million for the corresponding period in 2016.
Research and development
costs for the three months ended December 31, 2017 were $2.5 million, an increase of $1.0 million or 65% from $1.5 million of such
costs for the comparable period of the prior year. The increase was due to increased product development activities culminating
in positive topline results from pivotal and pilot studies for several products and progress made towards the filing of additional
ANDA applications.
General and administrative
expenses for the three months ended December 31, 2017 and 2016 were $0.6 million and $0.7 million, respectively. The decrease is
due to ongoing cost reduction efforts. Please note however, that regulatory fees and compliance costs, including, without limitation,
fees and costs related to compliance with FDA, DEA and Sarbanes Oxley regulations have significantly increased and represent areas
of costs that have a weak correlation to the Company’s cost reduction efforts.
Non-cash
compensation expense through the issuance of stock options for the three months ended December 31, 2017 and 2016 was $0.04
million and $0.08 million, respectively. The decrease in non-cash compensation expense derives from the timing in
amortization of the value of employee stock options issued over the course of the last three years and a decrease in the
number of options granted as compared to the corresponding period in 2016.
Depreciation and amortization
expense for the three months ended December 31, 2017 was $0.01 million, a decrease of $0.01 million, or 66% from $0.02 million
of such costs for the comparable period of the prior year. The decrease was due to the combination of increased facility utilization
and higher depreciation absorption rates currently as a result of facility expansion and improvements over the last year, and the
application of resources between commercial and product development activity.
As a result of the
foregoing, our loss from operations for the three months ended December 31, 2017 was $2.1 million, compared to a loss from operations
of $1.7 million for the three months ended December 31, 2016.
Other income (expense):
|
|
For the Three Months Ended December 31,
|
|
|
Change
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percentage
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense and amortization of debt issuance costs
|
|
$
|
(92,458
|
)
|
|
$
|
(55,563
|
)
|
|
$
|
(36,895
|
)
|
|
|
66
|
%
|
Change in fair value of derivative instruments
|
|
|
605,448
|
|
|
|
1,571,471
|
|
|
|
(966,023
|
)
|
|
|
-61
|
%
|
Interest income
|
|
|
4,461
|
|
|
|
3,151
|
|
|
|
1,310
|
|
|
|
42
|
%
|
Other income (expense), net
|
|
$
|
517,451
|
|
|
$
|
1,519,059
|
|
|
$
|
(1,001,608
|
)
|
|
|
-66
|
%
|
Other
income (expense), net for the three months ended December 31, 2017 was net other income of $0.5 million, a decrease in net
other income of $1.0 million from the net other income of $1.5 million for the comparable period of the prior year. The
decrease in other income was due to other income relating to changes in the fair value of our outstanding warrants during the
three months ended December 31, 2017 totaling a decrease in other income of $1.0 million, as compared to the prior period.
Please note that derivative income (expenses) is determined in large part by the number of warrants outstanding and the
change in the closing price of the Company’s Common Stock as of the end of the period, as compared to the closing price
at the beginning of the period, with a strong inverse relationship between derivative income (expenses) and increases in the
closing price of the Company’s Common Stock.
As
a result of the foregoing, our net loss for the three months ended December 31, 2017 was $0.5 million, compared to a net income
of $1.7 million for the comparable period of the prior year.
Change in value
of convertible preferred share mezzanine equity:
There were no changes
in the value of our convertible preferred stock, which is included in the calculation of net income (loss) attributable to common
shareholders for the three months ended December 31, 2017 and 2016, respectively. Accordingly, net income attributable to common
shareholders for the three months ended December 31, 2017 was a net loss of $0.5 million, compared to net income of $1.7 million
for the comparable period of the prior year.
Nine months ended
December 31, 2017 compared to December 31, 2016
Revenue, Cost of
revenue and Gross profit:
|
|
For the Nine Months Ended December 31,
|
|
|
Change
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percentage
|
|
Manufacturing fees
|
|
$
|
4,160,949
|
|
|
$
|
6,470,697
|
|
|
$
|
(2,309,748
|
)
|
|
|
-36
|
%
|
Licensing fees
|
|
|
1,700,856
|
|
|
|
1,816,796
|
|
|
|
(115,940
|
)
|
|
|
-6
|
%
|
Total revenue
|
|
|
5,861,805
|
|
|
|
8,287,493
|
|
|
|
(2,425,688
|
)
|
|
|
-29
|
%
|
Cost of revenue
|
|
|
3,049,830
|
|
|
|
5,755,997
|
|
|
|
(2,706,167
|
)
|
|
|
-47
|
%
|
Gross profit
|
|
$
|
2,811,975
|
|
|
$
|
2,531,496
|
|
|
$
|
280,479
|
|
|
|
11
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit - percentage
|
|
|
48
|
%
|
|
|
31
|
%
|
|
|
|
|
|
|
|
|
Total revenues
for the nine-month period ended December 31, 2017 decreased by $2.4 million or 29%, to $5.9 million, as compared to $8.3 million,
for the corresponding period in 2016 primarily due to the following:
Manufacturing fees
decreased by $2.3 million, or 36%, due to a decrease (in the first two quarters of the year) related to generic Methadone and Naltrexone
sales.
Licensing fees decreased
by $0.1 million, or 6%. This decrease is primarily due to the timing of in-market sales of the Company’s generic products,
as well as margins achieved by the Company’s licensed marketing partners. License fees earned are based on in-market sales
and accordingly, there is a natural lag between manufacturing revenues earned by the Company and related license fees being earned
from in market sales occurring subsequent to the Company’s shipment of licensed generic products to its marketing partners.
In market profits achieved by the Company’s marketing partners are also a factor, with a direct correlation to the license
fee revenues earned by the Company.
Costs of revenue consists
of manufacturing and assembly costs. Our costs of revenue decreased by $2.7 million or 47%, to $3.0 million as compared to $5.7
million for the corresponding period in 2016. In addition to the direct correlation between manufacturing revenues and costs of
revenues, please note that cost of revenue consists of manufacturing and assembly costs, with each product having a unique cost
profile correlating to the underlying cost of the materials consumed, direct labor hours expended and overhead resources utilized.
The decrease in costs of revenues is due in large part to the strong correlation between manufacturing revenues and these costs,
combined with effects of the difference in products manufactured as compared between the years.
Our gross profit margin
was 48% during the nine months ended December 31, 2017 as compared to 31% during the nine months ended December 31, 2016. The increase
in gross margin is due to the product mix of generics manufactured during the quarter and the application of resources between
commercial and product development activity.
Operating expenses:
|
|
For the Nine Months Ended December 31,
|
|
|
Change
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percentage
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
6,944,182
|
|
|
$
|
4,312,337
|
|
|
$
|
2,631,845
|
|
|
|
61
|
%
|
General and administrative
|
|
|
2,068,028
|
|
|
|
2,060,380
|
|
|
|
7,648
|
|
|
|
0
|
%
|
Non-cash compensation
|
|
|
208,719
|
|
|
|
258,954
|
|
|
|
(50,235
|
)
|
|
|
-19
|
%
|
Depreciation and amortization
|
|
|
21,149
|
|
|
|
64,408
|
|
|
|
(43,259
|
)
|
|
|
-67
|
%
|
Total operating expenses
|
|
$
|
9,242,078
|
|
|
$
|
6,696,079
|
|
|
$
|
2,545,999
|
|
|
|
38
|
%
|
Operating expenses
consist of research and development costs, general and administrative, non-cash compensation and depreciation and amortization
expenses. Operating expenses for the nine-month period ended December 31, 2017 increased by $2.5 million, or 38%, to $9.2 million,
as compared to $6.7 million for the corresponding period in 2016.
Research and development
costs for the nine months ended December 31, 2017 were $6.9 million, an increase of $2.6 million or 61% from $4.3 million of such
costs for the comparable period of the prior year. The increase was due to increased product development activities culminating
in positive topline results from pivotal and pilot studies of several products and the filing of two ANDA’s and progress
made toward additional ANDA filings.
General and administrative
expenses for the nine months ended December 31, 2017 and 2016 were $2.1 million and $2.1 million, respectively. Although these
costs are almost unchanged as compared to the prior year, please note that while the Company continues diligent cost reduction
efforts in this area, there have been significant increases in regulatory fees and costs relating to compliance with FDA, DEA and
Sarbanes Oxley regulations, which have a weak correlation to the Company’s cost reduction efforts, and which have offset,
in large part, cost reductions achieved elsewhere.
Non-cash compensation
expense for the nine months ended December 31, 2017 and 2016 was $0.2 million and $0.3 million, respectively. The decrease in non-cash
compensation expense derives from the timing in amortization of the value of employee stock options issued over the course of the
last three years and a decrease in the
number of options granted as compared to the corresponding period in 2016.
Depreciation and amortization
expense for the nine months ended December 31, 2017 was $0.02 million, a decrease of $0.04 million, or 67% from $0.06 million of
such costs for the comparable period of the prior year. The decrease was due to the combination of increased facility utilization
and higher depreciation absorption rates currently as a result of facility expansion and improvements over the last year, and the
application of resources between commercial and product development activity.
As a result of the
foregoing, our loss from operations for the nine months ended December 31, 2017 was $6.4 million, compared to a loss from operations
of $4.2 million for the nine months ended December 31, 2016.
Other income (expense):
|
|
For the Nine Months Ended December 31,
|
|
|
Change
|
|
|
|
2017
|
|
|
2016
|
|
|
Dollars
|
|
|
Percentage
|
|
Other income (expense):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense and amortization of debt issuance costs
|
|
$
|
(245,730
|
)
|
|
$
|
(181,883
|
)
|
|
$
|
(63,847
|
)
|
|
|
35
|
%
|
Change in fair value of derivative instruments
|
|
|
4,767,884
|
|
|
|
9,468,320
|
|
|
|
(4,700,436
|
)
|
|
|
-50
|
%
|
Interest income
|
|
|
12,862
|
|
|
|
9,407
|
|
|
|
3,455
|
|
|
|
37
|
%
|
Other income (expense), net
|
|
$
|
4,535,016
|
|
|
$
|
9,295,844
|
|
|
$
|
(4,760,828
|
)
|
|
|
-51
|
%
|
Other income (expense),
net for the nine months ended December 31, 2017 was net other income of $4.5 million, a decrease in net other income of $4.8 million
from net other income of $9.3 million for the comparable period of the prior year. The decrease in other income was due to derivative
income relating to changes in the fair value of our outstanding warrants during the quarter ended December 31, 2017 totaling a
decrease in other income of $4.7 million, as compared to the prior period. Please note that derivative income (expenses) is determined
in large part by the number of warrants outstanding and the change in the closing price of the Company’s Common Stock as
of the end of the period, as compared to the closing price at the beginning of the period, with a strong inverse relationship between
derivative revenues and increases in the closing price of the Company’s Common Stock.
As
a result of the foregoing, our net loss for the nine months ended December 31, 2017 was $0.8 million, compared to a net income
of $7.0 million for the comparable period of the prior year.
Change in value
of convertible preferred share mezzanine equity:
There was no change
in the value of our convertible preferred stock, which is included in the calculation of net income (loss) attributable to common
shareholders for the nine months ended December 31, 2017, and an increase of $20.7 million for the nine months ended December 31,
2016. Accordingly, net income attributable to common shareholders for the nine months ended December 31, 2017 was a net loss of
$0.8 million, compared to net income of $27.7 million for the comparable period of the prior year.
Liquidity and Capital Resources
Capital Resources
|
|
December 31, 2017
|
|
|
March 31, 2017
|
|
|
Change
|
|
Current assets
|
|
$
|
14,763,967
|
|
|
$
|
18,412,720
|
|
|
$
|
(3,648,753
|
)
|
Current liabilities
|
|
|
4,743,096
|
|
|
|
3,344,746
|
|
|
|
1,398,350
|
|
Working capital
|
|
|
10,020,871
|
|
|
|
15,067,974
|
|
|
|
(5,047,103
|
)
|
The Company considers
cash and working capital balances as several of the factors the Company uses in evaluating its performance, without limitation.
As of December 31, 2017, the Company had cash on hand of $7.2 million and a working capital surplus of $10.0 million. We believe
that such resources, combined with the Company’s access to part or all of the remaining $38.8 million available pursuant
to the $40.0 million equity line with Lincoln Park is sufficient to fund operations through the current operating cycle. For the
nine months ended December 31, 2017, we had losses from operations totaling $6.4 million, and net other income totaling $4.5 million,
resulting in a net loss of $0.8 million.
The Company does not
anticipate being profitable for the fiscal year ending March 31, 2018, due in large part to its plans to conduct clinical development
and commercialization activities on a range of abuse deterrent opioid products, on an accelerated and simultaneous basis. Such
activities require the investment of significant amounts in clinical trials, safety and efficacy studies, bioequivalence studies,
product manufacturing, regulatory expertise and filings, as well as investments in manufacturing and lab equipment and software.
In order to finance these significant expenditures, the Company entered into a new purchase agreement with Lincoln Park Capital
Fund, with such agreement providing the Company with an equity line totaling $40 million. We believe this amount of financing,
if received, is sufficient to fund the commercialization of the abuse deterrent opioid products identified. Please see below for
further details on the financing transactions with Lincoln Park.