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Segment Reporting
3 Months Ended
Mar. 31, 2017
Segment Reporting  
Segment Reporting

6.  Segment Reporting

 

The Company’s business is the development, manufacture, and marketing of pharmaceutical products. The Company has established two reporting segments that each report to the Chief Operating Decision Maker, or CODM, as defined in ASC 280, Segment Reporting.  The Company’s performance is assessed and resources are allocated by the CODM based on the following two reportable segments:

 

·

Finished pharmaceutical products

·

Active pharmaceutical ingredients, or API

 

The finished pharmaceutical products segment manufactures, markets and distributes enoxaparin, naloxone, lidocaine, as well as various other critical and non-critical care drugs.  The API segment manufactures and distributes recombinant human insulin API and porcine insulin API for external customers and internal product development.

 

Selected financial information by reporting segment is presented below:

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

March 31, 

 

 

 

2017

 

2016

 

 

 

(in thousands)

 

Net revenues:

    

 

    

    

 

    

 

Finished pharmaceutical products

 

$

55,934

 

$

58,554

 

API

 

 

736

 

 

812

 

Total net revenues

 

 

56,670

 

 

59,366

 

 

 

 

 

 

 

 

 

Gross profit:

 

 

 

 

 

 

 

Finished pharmaceutical products

 

 

24,310

 

 

25,824

 

API

 

 

(1,482)

 

 

(922)

 

Total gross profit

 

 

22,828

 

 

24,902

 

 

 

 

 

 

 

 

 

Operating expenses

 

 

21,424

 

 

20,827

 

 

 

 

 

 

 

 

 

Income from operations

 

 

1,404

 

 

4,075

 

Non-operating income (expenses)

 

 

100

 

 

(259)

 

 

 

 

 

 

 

 

 

Income before income taxes

 

$

1,504

 

$

3,816

 

 

The Company manages its business segments to the gross profit level and manages its operating and other costs on a company-wide basis.  The Company does not identify total assets by segment for internal purposes, as the Company’s CODM does not assess performance, make strategic decisions, or allocate resources based on assets.

 

The amount of net revenues in the finished pharmaceutical product segment is presented below:

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended

 

 

 

March 31, 

 

 

 

2017

 

2016

 

 

 

(in thousands)

 

Finished pharmaceutical products net revenues:

    

 

    

    

 

    

 

Enoxaparin

 

$

10,410

 

$

18,358

 

Naloxone

 

 

10,939

 

 

10,254

 

Epinephrine

 

 

9,574

 

 

4,392

 

Lidocaine

 

 

8,289

 

 

9,908

 

Phytonadione

 

 

7,886

 

 

6,126

 

Other finished pharmaceutical products

 

 

8,836

 

 

9,516

 

Total finished pharmaceutical products net revenues

 

$

55,934

 

$

58,554

 

 

Discontinuation of epinephrine injection, USP vial product

 

In March 2017, the FDA requested the Company to discontinue the manufacturing and distribution of its epinephrine injection, USP vial product, which has been marketed under the “grandfather” exception to the FDA’s “Prescription Drug Wrap-Up” program. Unless the FDA grants the Company’s request for an extension of time to sell epinephrine vials, the Company will discontinue selling this product in the second quarter of 2017. For the year ended December 31, 2016, the Company recognized $18.6 million in net revenues for the sale of this product. A charge of $3.3 million was included in the cost of revenues in its consolidated statements of operations for the year ended December 31, 2016 to adjust the related inventory items and firm purchase commitments to their net realizable value due to the anticipated discontinuation of the product.

 

Net revenues and carrying values of long-lived assets of enterprises by geographic regions are as follows:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net Revenue

 

Long-Lived Assets

 

 

 

Three Months Ended

 

 

 

 

 

 

 

 

 

March 31, 

 

March 31, 

 

December 31, 

 

 

 

2017

 

2016

 

2017

 

2016

 

 

 

(in thousands)

 

United States

    

$

55,930

    

$

58,538

    

$

106,352

    

$

104,110

 

China

 

 

 —

 

 

 —

 

 

36,034

 

 

35,085

 

France

 

 

740

 

 

828

 

 

14,914

 

 

13,659

 

United Kingdom

 

 

 —

 

 

 —

 

 

89

 

 

90

 

Total

 

$

56,670

 

$

59,366

 

$

157,389

 

$

152,944