10-Q
MEDICINES CO /DE filed this form 10-Q on 9 Aug 2017
- velhartice.info

expire in August 2024. In December 2013, the FDA designated Vabomere a QIDP. We expect that if the NDA for Vabomere is approved, Vabomere would receive an additional five years of non-patent exclusivity. In April 2015, the FDA designated the new formulation of Minocin IV a QIDP for certain additional potential indications involving gram-negative bacteria, and we expect that if we submit a supplemental NDA for one or more of those indications and such supplemental NDA is approved, Minocin IV would receive an additional five years of non-patent exclusivity with respect to such indications.

Results of Operations

Three and Six Months Ended June 30, 2017 Compared to Three and Six Months Ended June 30, 2016

Total Net Revenues:

Total net revenues decreased 65.8% to $18.7 million for the three months ended June 30, 2017 as compared to $54.7 million for the three months ended June 30, 2016. Total net revenues decreased 59.1% to $43.0 million for the six months ended June 30, 2017 as compared to $105.0 million for the six months ended June 30, 2016.

 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2017
 
2016
 
Change $
 
Change %
 
2017
 
2016
 
Change $
 
Change %
 
(in thousands)
 
 
 
(in thousands)
 
 
Net product revenues
$
13,355

 
$
30,324

 
$
(16,969
)
 
(56.0
)%
 
$
27,200

 
$
61,699

 
$
(34,499
)
 
(55.9
)%
Royalty revenues
5,387

 
24,407

 
(19,020
)
 
(77.9
)%
 
15,758

 
43,338

 
(27,580
)
 
(63.6
)%
Total net revenues
$
18,742

 
$
54,731

 
$
(35,989
)
 
(65.8
)%
 
$
42,958

 
$
105,037

 
$
(62,079
)
 
(59.1
)%

Net Product Revenues:

The following table reflects the components of net product revenues for the three and six months ended June 30, 2017 and 2016:

 
Three Months Ended June 30,
 
Six Months Ended June 30,
 
2017
 
2016
 
Change $
 
Change %
 
2017
 
2016
 
Change $
 
Change %
 
(in thousands)
 
 
 
(in thousands)
 
 
Angiomax
$
5,316

 
$
15,806

 
$
(10,490
)
 
(66.4
)%
 
$
12,200

 
$
32,683

 
$
(20,483
)
 
(62.7
)%
Other products
8,039

 
14,518

 
(6,479
)
 
(44.6
)%
 
15,000

 
29,016

 
(14,016
)
 
(48.3
)%
Net product revenues
$
13,355

 
$
30,324

 
$
(16,969
)
 
(56.0
)%
 
$
27,200

 
$
61,699

 
$
(34,499
)
 
(55.9
)%

Net product revenues decreased by $17.0 million, or 56.0%, to $13.4 million in the three months ended June 30, 2017 compared to $30.3 million in the three months ended June 30, 2016, reflecting decreases in net product revenues in the United States of $14.8 million and in international markets of $2.2 million.

Net product revenues decreased by $34.5 million, or 55.9%, to $27.2 million in the six months ended June 30, 2017 compared to $61.7 million in the six months ended June 30, 2016, reflecting decreases of $30.4 million in the United States and of $4.1 million in international markets.

Angiomax. Net product revenues from sales of Angiomax decreased by $10.5 million, or 66.4%, to $5.3 million in the three months ended June 30, 2017 compared to $15.8 million in the three months ended June 30, 2016. Net product revenues from sales of Angiomax decreased by $20.5 million, or 62.7%, to $12.2 million in the six months ended June 30, 2017 compared to $32.7 million in the six months ended June 30, 2016. The decrease in the three and six months ended June 30, 2017 was attributed to reductions in price and volume due to an increase in the number of generic versions of bivalirudin in the United States. Of the $5.3 million and $12.2 million of net product revenues from sales of Angiomax in the three and six months ended June 30, 2017, respectively, $3.1 million and $6.8 million, respectively, related to shipments of generic Angiomax to Sandoz. For the three and six months ended June 30, 2016, $6.3 million and $10.7 million, respectively, related to shipments of generic Angiomax to Sandoz.



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