>If Allergan elects to opt-in, Apricus may receive up to a total of $25 million in upfront and potential regulatory milestones, plus a double-digit royalty<
We all know that the upfront could be as little as $1 million (or less) with the remaining $24 million in regulatory milestones payable who knows when.
James, page 62 of the 10K has that amount in the column of Commercial Launch Milestones.
The following table summarizes the potential future milestones the Company is eligible for by commercialization partner (in thousands) as of December 31, 2015:
| | | | | | | | | | | | | | | | | |
Commercialization Partner
|
|
Regulatory Milestones (1)
|
|
Commercial Launch Milestones (1)
|
|
Sales Milestones (1)
|
|
Total
|
Sandoz
|
|
$
|
319
|
|
|
$
|
1,500
|
|
|
$
|
45,613
|
|
|
$
|
47,432
|
|
Recordati
|
|
—
|
|
|
1,093
|
|
|
37,692
|
|
|
38,785
|
|
Takeda
|
|
437
|
|
|
—
|
|
|
36,600
|
|
|
37,037
|
|
Allergan
|
|
—
|
|
|
25,000
|
|
|
—
|
|
|
25,000
|
|
Majorelle
|
|
2,000
|
|
|
—
|
|
|
16,934
|
|
|
18,934
|
|
Ferring
|
|
2,000
|
|
|
—
|
|
|
14,000
|
|
|
16,000
|
|
Abbott Laboratories Limited, now a subsidiary of Mylan N.V. (“Mylan”)
|
|
225
|
|
|
—
|
|
|
13,000
|
|
|
13,225
|
|
Bracco
|
|
—
|
|
|
—
|
|
|
4,916
|
|
|
4,916
|
|
Neopharm Scientific Limited (“Neopharm”)
|
|
250
|
|
|
—
|
|
|
4,000
|
|
|
4,250
|
|
Elis Pharmaceuticals Limited (“Elis”)
|
|
100
|
|
|
—
|
|
|
1,900
|
|
|
2,000
|
|
|
|
$
|
5,331
|
|
|
$
|
27,593
|
|
|
$
|
174,655
|
|
|
$
|
207,579
|
|
Also, look at the paragraph below.
. ALLERGAN IN-LICENSING AGREEMENT
In 2009, Warner Chilcott Company, Inc., now a subsidiary of Allergan, acquired the commercial rights to Vitaros® in the United States. In September 2015, the Company entered into a license agreement and amendment to the original agreement with Warner Chilcott Company, Inc., granting the Company exclusive rights to develop and commercialize Vitaros® in the United States in exchange for a $1.0 million upfront payment and an additional $1.5 million in potential regulatory milestone payments to Allergan.
Upon the Food and Drug Administration’s approval of a new drug application for Vitaros® in the United States, Allergan has the right to exercise a one-time opt-in right to assume all future commercialization activities in the United States. If Allergan exercises its opt-in right, the Company is eligible to receive up to a total of $25.0 million in upfront and potential launch milestone payments, plus a high double-digit royalty on Allergan’s net sales of the product. If Allergan does not exercise its opt-in right, the Company may commercialize the product and in return will pay Allergan a high double-digit royalty on its net sales of the product.
Since the intangibles acquired in the license agreement do not have alternative future use, all costs incurred were treated as research and development expense. The Company recorded research and development expense of approximately $1.05 million during the third quarter of 2015, which represented the upfront payment made as well as transaction costs incurred.
I believe that if/when the FDA approves the NDA for Vitaros, Allergan will have their one time shot at taking over Vitaros again, if they decide to do so, then Apricus would get an amount between $1M - $24M for giving back rights to Allergan, then once Vitaros is launched, the remaining amont, $1.1 - $25M would be due to Apricus. Approval of Vitaros and Commercial Launch would be the two keys to the $25M chest. First key gets you a presumed lower amount - who knows exactly how much - the second key gets you the rest.
What is "AG"? Is that shorthand for a separate "agreement"? Authorized Generic. They have a profit share structure in place with Apricus if/when this ever reaches the Market as a generic. |
