10-Q 1 a13-19767_110q.htm 10-Q

Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 


 

FORM 10-Q

 

x

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended September 30, 2013

 

OR

 

o

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                  to                 .

 

Commission File Number: 000-50855

 


 

Auxilium Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

 

23-3016883

(State or other jurisdiction of

 

(I.R.S. Employer Identification No.)

incorporation or organization)

 

 

 

640 Lee Road, Chesterbrook, PA  19087

(Address of principal executive offices) (Zip Code)

 

(484) 321-5900

(Registrant’s telephone number, including area code)

 


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes x  No o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate web site, if any, every Interactive Data file required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes x  No ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company.  See definitions of “accelerated filer” “large accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.  (Check one):

 

Large accelerated filer x

 

Accelerated filer o

 

Non-accelerated filer o

 

Smaller reporting company o

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o  No x

 

As of October 31, 2013, the number of shares outstanding of the issuer’s common stock, $0.01 par value, was 49,578,201.

 

 

 




Table of Contents

 

PART I.  FINANCIAL INFORMATION

 

Item 1.  Financial Statements.

 

3



Table of Contents

 

AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

September 30,
2013

 

December 31,
2012

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

91,007

 

$

35,857

 

Short-term investments

 

30,375

 

121,573

 

Accounts receivable, trade, net

 

73,832

 

55,859

 

Accounts receivable, other

 

5,049

 

1,685

 

Inventories, current

 

44,749

 

22,134

 

Prepaid expenses and other current assets

 

10,109

 

3,762

 

Total current assets

 

255,121

 

240,870

 

Inventories, non-current

 

53,709

 

49,697

 

Property and equipment, net

 

36,247

 

29,220

 

Intangible assets, net

 

641,020

 

0

 

Goodwill

 

123,234

 

0

 

Other assets

 

18,896

 

7,605

 

Total assets

 

$

1,128,227

 

$

327,392

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

9,835

 

$

3,565

 

Accrued expenses

 

119,733

 

80,740

 

Deferred revenue, current portion

 

2,067

 

11,835

 

Deferred rent, current portion

 

1,007

 

936

 

Current portion of term loan

 

14,513

 

0

 

Contingent consideration, current

 

27,965

 

0

 

Total current liabilities

 

175,120

 

97,076

 

Term loan, long-term portion

 

243,267

 

0

 

Senior Convertible Notes

 

290,962

 

0

 

Deferred revenue, long-term portion

 

25,192

 

26,288

 

Deferred rent, long-term portion

 

7,576

 

4,140

 

Contingent consideration, long-term portion

 

92,279

 

0

 

Deferred tax liability

 

10,693

 

0

 

Total liabilities

 

845,089

 

127,504

 

Commitments and contingencies

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.01 par value per share, 5,000,000 shares authorized, no shares issued or outstanding

 

0

 

0

 

Common stock, $0.01 par value per share; authorized 120,000,000 shares; issued 49,571,310 and 49,419,104 shares at September 30, 2013 and December 31, 2012, respectively

 

496

 

494

 

Additional paid-in capital

 

588,559

 

525,354

 

Accumulated deficit

 

(302,077

)

(322,115

)

Treasury stock at cost: 144,245 and 136,405 shares at September 30, 2013 and December 31, 2012, respectively

 

(3,476

)

(3,337

)

Accumulated other comprehensive loss

 

(364

)

(508

)

Total stockholders’ equity

 

283,138

 

199,888

 

Total liabilities and stockholders’ equity

 

$

1,128,227

 

$

327,392

 

 

See accompanying notes to consolidated financial statements.

 

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Table of Contents

 

AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Statements of Operations

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Net revenues

 

$

108,140

 

$

71,043

 

$

274,831

 

$

222,819

 

Operating expenses*:

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

33,553

 

15,849

 

75,858

 

50,256

 

Research and development

 

11,816

 

10,591

 

37,300

 

32,771

 

Selling, general and administrative

 

62,809

 

55,344

 

182,013

 

144,874

 

Amortization of purchased intangibles

 

15,085

 

0

 

25,980

 

0

 

Contingent consideration

 

4,671

 

0

 

6,929

 

0

 

Total operating expenses

 

127,934

 

81,784

 

328,080

 

227,901

 

Income (loss) from operations

 

(19,794

)

(10,741

)

(53,249

)

(5,082

)

Interest expense

 

(8,912

)

 

(19,050

)

 

Other income, net

 

104

 

253

 

268

 

570

 

Income (loss) before inome taxes

 

(28,602

)

(10,488

)

(72,031

)

(4,512

)

Income tax benefit (expense)

 

(289

)

0

 

92,069

 

0

 

Net income (loss)

 

$

(28,891

)

$

(10,488

)

$

20,038

 

$

(4,512

)

Net income (loss) per common share:

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.59

)

$

(0.21

)

$

0.41

 

$

(0.09

)

Diluted

 

$

(0.59

)

$

(0.21

)

$

0.40

 

$

(0.09

)

 

 

 

 

 

 

 

 

 

 

Shares used to compute net income per common share:

 

 

 

 

 

 

 

 

 

Basic

 

49,384,637

 

49,078,321

 

49,304,543

 

48,636,444

 

Diluted

 

49,384,637

 

49,078,321

 

49,611,260

 

48,636,444

 

 


*includes the following amounts of stock-based compensation expense:

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

$

39

 

$

20

 

$

107

 

$

57

 

Research and development

 

675

 

801

 

2,077

 

2,045

 

Selling, general and administrative

 

2,656

 

2,719

 

9,162

 

9,010

 

 

See accompanying notes to consolidated financial statements.

 

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Table of Contents

 

AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Statements of Comprehensive Income (Loss)

(In thousands)

(Unaudited)

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Net income (loss)

 

$

(28,891

)

$

(10,488

)

$

20,038

 

$

(4,512

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

Unrealized gains (losses) on investments

 

41

 

(38

)

171

 

(12

)

Foreign currency translation adjustment

 

14

 

4

 

(27

)

(7

)

Total

 

55

 

(34

)

144

 

(19

)

Comprehensive income (loss)

 

$

(28,836

)

$

(10,522

)

$

20,182

 

$

(4,531

)

 

See accompanying notes to consolidated financial statements.

 

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Table of Contents

 

Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2013

 

2012

 

Cash flows from operating activities:

 

 

 

 

 

Net income (loss)

 

$

20,038

 

$

(4,512

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

Stock-based compensation

 

11,346

 

11,112

 

Depreciation and amortization

 

7,943

 

7,100

 

Amortization of purchased intangibles

 

25,980

 

0

 

Amoritization of debt discount and issuance costs

 

9,657

 

0

 

Contingent consideration

 

6,929

 

0

 

Release of valuation allowance for deferred tax assets

 

(92,607

)

0

 

Changes in operating assets and liabilities, net of acquisition:

 

 

 

 

 

Decrease (increase) in accounts receivable, trade and other

 

4,198

 

(4,624

)

Increase in inventories

 

(3,611

)

(13,110

)

Decrease (increase) in prepaid expenses and other assets

 

5,121

 

(1,790

)

Increase in accounts payable and accrued expenses

 

15,306

 

13,702

 

Increase (decrease) in deferred revenue

 

(10,864

)

4,295

 

Increase (decrease) in deferred rent

 

303

 

(849

)

Net cash provided by (used in) operating activities

 

(261

)

11,324

 

 

 

 

 

 

 

Cash flows from investing activities:

 

 

 

 

 

Business acquisition, net of cash acquired

 

(588,349

)

0

 

Purchases of short-term investments

 

(73,218

)

(154,001

)

Redemptions of short-term investments

 

164,428

 

138,490

 

Purchases of property and equipment

 

(7,786

)

(4,073

)

Sales and redemptions of long-term investments

 

1,600

 

100

 

Net cash used in investing activities

 

(503,325

)

(19,484

)

 

 

 

 

 

 

Cash flows from financing activities:

 

 

 

 

 

Proceeds from issuance of term loan, net of issuance costs

 

262,852

 

0

 

Repayment of term loan

 

(6,215

)

0

 

Proceeds from issuance of convertible debt, net of issuance costs

 

338,921

 

0

 

Payments of contingent consideration

 

(9,339

)

0

 

Purchase of convertible note hedge

 

(70,000

)

0

 

Proceeds from sale of warrants

 

41,475

 

0

 

Proceeds from exercise of common stock options

 

409

 

10,227

 

Employee Stock Purchase Plan purchases

 

962

 

1,720

 

Treasury stock acquisition

 

(139

)

(81

)

Payments from Board of Director stock purchases

 

47

 

87

 

Net cash provided by financing activities

 

558,973

 

11,953

 

 

 

 

 

 

 

Effect of exchange rate changes on cash

 

(237

)

14

 

Increase in cash and cash equivalents

 

55,150

 

3,807

 

Cash and cash equivalents, beginning of period

 

35,857

 

37,535

 

Cash and cash equivalents, end of period

 

$

91,007

 

$

41,342

 

 

 

 

 

 

 

Supplemental data:

 

 

 

 

 

Business acquisition:

 

 

 

 

 

Fair value of assets acquired, net of cash acquired

 

$

841,547

 

$

0

 

Purchase consideration representing compensation

 

8,309

 

0

 

Fair value of liabilities assumed and contingent consideration

 

(249,507

)

0

 

Fair value of warrants issued

 

(12,000

)

0

 

Net cash paid for acquisition

 

$

588,349

 

$

0

 

Interest paid

 

$

8,289

 

$

0

 

 

See accompanying notes to consolidated financial statements.

 

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AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Statement of Stockholders’ Equity

Nine Months Ended September 30, 2013

(In thousands, except share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

Additional

 

 

 

 

 

 

 

other

 

 

 

 

 

Common stock

 

paid-in

 

Accumulated

 

Treasury Stock

 

comprehensive

 

 

 

 

 

Shares

 

Amount

 

capital

 

deficit

 

Shares

 

Cost

 

loss

 

Total

 

Balance, January 1, 2013

 

49,419,104

 

$

494

 

$

525,354

 

$

(322,115

)

136,405

 

$

(3,337

)

$

(508

)

$

199,888

 

Equity component of Senior Convertible Notes

 

0

 

0

 

64,361

 

0

 

0

 

0

 

0

 

64,361

 

Deferred tax benefit related to issuance of Senior Convertible Notes

 

0

 

0

 

1,295

 

0

 

0

 

0

 

0

 

1,295

 

Convertible Note Hedge

 

0

 

0

 

(70,000

)

0

 

0

 

0

 

0

 

(70,000

)

Sale of warrants

 

0

 

0

 

41,475

 

0

 

0

 

0

 

0

 

41,475

 

Issuance of warrants in business acquisition

 

0

 

0

 

12,000

 

0

 

0

 

0

 

0

 

12,000

 

Exercise of common stock options

 

40,112

 

0

 

409

 

0

 

0

 

0

 

0

 

409

 

Employee Stock Plan Purchases

 

66,458

 

1

 

961

 

0

 

0

 

0

 

0

 

962

 

Issuance of restricted stock

 

10,000

 

0

 

0

 

0

 

0

 

0

 

0

 

 

Cancellation of restricted stock

 

(250

)

0

 

0

 

0

 

0

 

0

 

0

 

 

Stock-based compensation

 

33,190

 

0

 

12,657

 

0

 

0

 

0

 

0

 

12,657

 

Proceeds from Board of Directors stock purchases

 

2,696

 

0

 

47

 

0

 

0

 

0

 

0

 

47

 

Treasury stock acquisition

 

0

 

0

 

0

 

0

 

7,840

 

(139

)

0

 

(139

)

Comprehensive income

 

0

 

0

 

0

 

0

 

0

 

0

 

144

 

144

 

Net income

 

0

 

0

 

0

 

20,038

 

0

 

0

 

0

 

20,038

 

Balance, September 30, 2013

 

49,571,310

 

$

496

 

$

588,559

 

$

(302,077

)

144,245

 

$

(3,476

)

$

(364

)

$

283,138

 

 

See accompanying notes to consolidated financial statements.

 

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AUXILIUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

 

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

 

(In thousands, except share and per share data)

 

September 30, 2013
(Unaudited)

 

1.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

(a)   Basis of Presentation

 

The accompanying unaudited consolidated financial statements include the accounts of Auxilium Pharmaceuticals, Inc. and its wholly owned subsidiaries (the “Company”), and have been prepared in accordance with U.S. generally accepted accounting principles for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) pertaining to Form 10-Q.  Certain disclosures required for complete annual financial statements are not included herein.  All significant intercompany accounts and transactions have been eliminated in consolidation.  The information at September 30, 2013 and for the respective three and nine month periods ended September 30, 2013 and 2012 is unaudited but includes all adjustments (consisting only of normal recurring adjustments) which, in the opinion of the Company’s management, are necessary to state fairly the financial information set forth herein.  The December 31, 2012 balance sheet amounts and disclosures included herein have been derived from the Company’s December 31, 2012 audited consolidated financial statements. The interim results are not necessarily indicative of results to be expected for the full fiscal year. These unaudited consolidated financial statements should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2012 included in the Company’s Annual Report on Form 10-K filed with the SEC.

 

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(b)         Revenue Recognition

 

Net revenues for the three and nine months ended September 30, 2013 and 2012 comprise the following:

 

 

 

Three months ended
September 30,

 

Nine months ended
September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Testim revenues-

 

 

 

 

 

 

 

 

 

Net U.S. revenues

 

$

50,701

 

$

54,642

 

$

149,165

 

$

175,004

 

International revenues

 

1,604

 

710

 

2,987

 

2,760

 

 

 

52,305

 

55,352

 

152,152

 

177,764

 

XIAFLEX revenues-

 

 

 

 

 

 

 

 

 

Net U.S. revenues

 

15,882

 

13,216

 

42,800

 

37,706

 

International revenues

 

1,676

 

2,475

 

14,344

 

7,349

 

 

 

17,558

 

15,691

 

57,144

 

45,055

 

Other net U.S. revenues-

 

 

 

 

 

 

 

 

 

TESTOPEL

 

20,636

 

0

 

35,017

 

0

 

Edex

 

7,958

 

0

 

12,991

 

0

 

Other

 

9,683

 

0

 

17,527

 

0

 

 

 

38,277

 

0

 

65,535

 

0

 

Total net revenues

 

$

108,140

 

$

71,043

 

$

274,831

 

$

222,819

 

 

Net U.S. revenues shown in the above table represent the product sales of the Company within the U.S., net of allowances provided on such sales. International revenues represent the amortization of deferred up-front and milestone payments the Company has received on its out-licensing agreements, together with royalties earned on product sales by the licensees.

 

As discussed in Note (2), on April 26, 2013, the Company acquired Actient Holdings LLC (“Actient”), a privately-held urology specialty pharmaceutical company with a diversified product offering of four marketed products in the urology space and two marketed products in the respiratory space.  TESTOPEL is a product used for the treatment of testosterone deficiency in aging men as well as androgen deficiency caused by other conditions. Edex is an injectable used for the treatment of erectile dysfunction. Other U.S. net revenues, as shown in the above table, for the three and nine months ended September 30, 2013 are sales of additional products the Company acquired in this acquisition. TESTOPEL and Edex and certain other of the Actient products do not currently have any patent protection. Therefore, the Company must rely on trade secrets and other unpatented proprietary information in order to obtain a competitive advantage with respect to such products.

 

TESTOPEL is sold under a buy-and-bill model. Under this model, the Company’s customers are health care providers who maintain a stock of TESTOPEL for future patient procedures. Revenue is recognized for this product upon the delivery, whereupon title passes, all obligations have been fulfilled, and collection of the related receivable is fixed, determinable, probable, and reasonably assured. The Company offers volume discounts and discounts for credit card payments when customer orders are received, and these discounts are recognized when the related product sales are recorded.

 

The Company recognizes revenue for Edex and other Actient branded pharmaceutical products upon the delivery of goods, whereupon title passes, all obligations have been fulfilled, and collection of the related receivable is fixed, determinable, probable, and reasonably assured. The Company provides for chargebacks (primarily related to its sales to government entities, such as the U.S. Veterans

 

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Administration), rebates, returns, and other adjustments in the same period the related product sales are recorded. Reserves for these government chargebacks, rebates, returns, and other adjustments are based upon analysis of historical data. Each period, the Company reviews its reserves for government chargebacks, rebates, returns, and other adjustments based on data available at that time. Any adjustment to these reserves results in charges to revenue.

 

For Actient non-drug medical devices, revenue is recognized upon the shipment of goods or upon the delivery of goods, whereupon title passes, all obligations have been fulfilled, and collection of the related receivable is fixed, determinable, probable, and reasonably assured. The Company records estimated sales returns and discounts as a reduction of net sales in the period revenue is recognized. The Company maintains an allowance for these returns and reduces reported revenue for expected returns from shipments each reporting period. This allowance is not significant and is based on historical and current trends in product returns.

 

Shipping and handling fees for Actient products are billed to customers, and are recognized in net revenues. Other shipping and handling costs are included in the cost of sales.

 

In the first quarter of 2012, the Company recorded a correction of an error in its financial statements for the year ended December 31, 2011 that resulted from an understatement of the accrual for government health plan charge-backs. This correction reduced Net revenues and Net income reported for the nine months ended September 30, 2012 in the amount of $820.  Management believes this adjustment is not material to the Company’s results of operations for 2012.

 

(c)          Net Income (Loss) Per Common Share

 

Basic income (loss) per common share is computed based on the weighted average number of common shares outstanding during the period. Diluted income (loss) per common share is computed based on the weighted average number of common shares outstanding and, if there is net income during the period, the dilutive impact of common stock equivalents outstanding during the period. Common stock equivalents are measured under the treasury stock method.

 

The following is a reconciliation of net income and weighted average common shares outstanding for purposes of calculating basic and diluted income per common share.

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

Basic income (loss) per share:

 

2013

 

2012

 

2013

 

2012

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(28,891

)

$

(10,488

)

$

20,038

 

$

(4,512

)

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding

 

49,408,597

 

49,129,521

 

49,339,449

 

48,663,474

 

Weighted-average unvested restricted common shares subject to forfeiture

 

(23,960

)

(51,200

)

(34,906

)

(27,030

)

 

 

 

 

 

 

 

 

 

 

Shares used in calculating basic net income (loss) per common share

 

49,384,637

 

49,078,321

 

49,304,543

 

48,636,444

 

Basic net income (loss) per common share

 

$

(0.59

)

$

(0.21

)

$

0.41

 

$

(0.09

)

 

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Three Months Ended September 30,

 

Nine Months Ended September 30,

 

Diluted income (loss) per share:

 

2013

 

2012

 

2013

 

2012

 

Numerator:

 

 

 

 

 

 

 

 

 

Net income (loss)

 

$

(28,891

)

$

(10,488

)

$

20,038

 

$

(4,512

)

 

 

 

 

 

 

 

 

 

 

Denominator:

 

 

 

 

 

 

 

 

 

Weighted-average common shares outstanding

 

49,408,597

 

49,129,521

 

49,339,449

 

48,663,474

 

Weighted-average unvested restricted common shares subject to forfeiture

 

(23,960

)

(51,200

)

(34,906

)

(27,030

)

Incremental shares from assumed conversions of stock compensation plans

 

0

 

0

 

306,717

 

0

 

 

 

 

 

 

 

 

 

 

 

Shares used in calculating diluted net income (loss) per common share

 

49,384,637

 

49,078,321

 

49,611,260

 

48,636,444

 

 

 

 

 

 

 

 

 

 

 

Diluted net income (loss) per common share

 

$

(0.59

)

$

(0.21

)

$

0.40

 

$

(0.09

)

 

Diluted net income per common share is computed giving effect to all potentially dilutive securities. The potentially dilutive shares include outstanding stock options and awards, outstanding warrants, and incremental shares issuable upon conversion of 1.5% Convertible Senior Notes due 2018 (“2018 Convertible Notes”) (See Note 9, Senior Convertible Notes). The following weighted-average number of stock options and restricted stock units were antidilutive and, therefore, excluded from the computation of diluted net income per common share for the three and nine month periods ended September 30, 2013: 6,920,292 and 6,444,978, respectively.

 

The Company has 1,250,000 warrants outstanding issued in connection with the acquisition of Actient as discussed in Note (2) and 14,481,950 warrants sold in connection with the issuance of convertible debt as discussed in Note (9). The warrants will not be considered in calculating the total dilutive weighted average shares outstanding until the price of the Company’s common stock exceeds the strike price of the warrants. When the market price of the Company’s common stock exceeds the strike price of the warrants, the effect of the additional shares that may be issued upon exercise of the warrants will be included in total dilutive weighted average shares outstanding using the treasury stock method.

 

It is the current intent and policy of the Company to settle conversions of the 2018 Convertible Notes through combination settlement, which involves repayment of the principal amount in cash and any excess of the conversion value over the principle amount (the “conversion spread”) in shares of common stock. Therefore, only the impact of the conversion spread will be included in total dilutive weighted average shares outstanding using the treasury stock method.  As such, the 2018 Convertible Notes will have no impact on diluted per share results until the price of the Company’s common stock exceeds the conversion price.

 

The call options to purchase the Company’s common stock, which were purchased to hedge against potential dilution upon conversion of the 2018 Convertible Notes, as discussed in Note 9, are not considered in calculating the total dilutive weighted average shares outstanding, as their effect would be anti-dilutive. Upon exercise, the call options will mitigate the dilutive effect of the 2018 Convertible Notes.

 

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(d)         New Accounting Pronouncements

 

In February 2013, the Financial Accounting Standards Board issued an Accounting Standards Update on reporting of amounts reclassified out of accumulated other comprehensive income. This guidance, which is effective for fiscal years beginning after December 15, 2012, requires companies to provide information about amounts reclassified out of accumulated other comprehensive income by component (the respective line items of the income statement).  The Company adopted this guidance as of January 1, 2013 and its adoption did not have a material effect on the Company’s consolidated financial statements.

 

(e)          Revision to previously issued financial statements

 

In connection with the preparation of the consolidated financial statements for the third quarter of 2013, an incorrect classification was identified with respect to the manner in which the Company classified the tenant improvement allowance of $3,204 provided by the lessor in the lease for its new corporate headquarters which commenced on January 1, 2013. At recognition of the tenant improvement allowance provided, the Company properly recorded on its Consolidated Balance Sheets the cost of the improvements as a fixed asset and the tenant improvement allowance as a deferred rent credit. In the Company’s Consolidated Statement of Cash Flows provided in its Quarterly Report on Form 10-Q for the quarterly periods ended March 31, 2013 and June 30, 2013, the tenant improvements were incorrectly classified as cash used in investing activities and the offsetting increase in deferred rent was incorrectly classified as an adjustment of cash flows provided by operating activities. The Company has now determined that the tenant improvement allowance should have been netted against the Purchases of property and equipment to reflect the non-cash nature of these transactions in the periods presented. The effect of the misclassification in the Consolidated Statement of Cash Flows for the three months ended March 31, 2013 and the six months ended June 30, 2013 was a $3,204 overstatement of both net cash provided by operating activities and net cash used in investing activities. The Company assessed this misclassification and concluded that it was not material to the Company’s previously issued financial statements. The Company has properly presented the tenant improvement transaction in the Consolidated Statement of Cash Flows for the nine months ended September 30, 2013. The revision of the three month period ended March 31, 2013 and six month period ended June 30, 2013 will be reflected in the Company’s first and second quarter filings of fiscal 2014, respectively. The Company’s Consolidated Statements of Operations for first and second quarters of 2013 and the Consolidated Balance Sheets as of March 31, 2013 and June 30, 2013 were not affected by this misclassification and remain unchanged.

 

2.     ACQUISITION OF ACTIENT

 

The Company executed the acquisition of Actient on April 26, 2013 to expand its specialty therapeutic offerings and expects to benefit from greater leverage in its commercial infrastructure and significant cross-selling opportunities. The total consideration for Actient included base cash consideration of $585,000 plus adjustments for working capital and cash acquired, contingent consideration based on future sales of certain acquired products, and the issuance of 1,250,000 warrants to purchase the Company common stock. The Company funded the cash payments with cash on hand and a $225,000 senior secured term loan (the “Term Loan”) (see Note 8).

 

The following table summarizes the fair value of the total consideration at April 26, 2013:

 

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Total

 

 

 

Acquisition-

 

 

 

Date

 

 

 

Fair value

 

Base cash consideration

 

$

585,000

 

Cash and working capital adjustment

 

14,863

 

Contingent consideration

 

40,969

 

Warrants

 

12,000

 

Total consideration

 

652,832

 

Consideration representing compensation

 

(8,309

)

Consideration allocated to net assets acquired

 

$

644,523

 

 

The above consideration representing compensation is the amount payable to former management of Actient upon completion of their retention period with the Company. This amount was amortized to expense by the Company as compensation cost over such retention period which ended during the third quarter of 2013.

 

The above contingent consideration represents a risk adjusted net present value relating to the following cash payments on achievement of the following sales milestones for Actient urology products as defined in the purchase agreement:

 

·                  $15 million if cumulative net sales of Actient’s urology products from and after the Closing equal $150 million;

·                  $10 million if cumulative net sales of Actient’s urology products during the twelve-month period commencing May 1, 2013 exceed $150 million; and

·                  $25 million if cumulative net sales of Actient’s urology products during the twenty four month-period commencing May 1, 2013 exceed $300 million.

 

The warrants issued in the acquisition have a strike price of $17.80 and a ten year life. The fair value assigned to the warrants was determined using the Black-Scholes valuation model, applying an expected term of ten years equal to the life of the warrants, the Company’s historical volatility of 50% as the expected volatility, a ten year risk-free interest of 1.70% and an expected zero percent dividend yield.  In accordance with governing accounting guidance, the Company concluded that the warrants were indexed to our stock and therefore they have been classified as an equity instrument.

 

The transaction was accounted for as a business combination under the acquisition method of accounting. Accordingly, the assets acquired and liabilities assumed were recorded at fair value, with the remaining purchase price recorded as goodwill.

 

The Company has preliminarily valued the acquired assets and liabilities based on their estimated fair value. These estimates are subject to change as additional information becomes available, including finalization of certain tax matters. The preliminary fair values included in the balance sheet as of September 30, 2013 are based on the best estimates of management. The completion of the valuation may result in adjustments to the carrying value of Actient’s assets and liabilities, revision of useful lives of intangibles assets, the determination of any residual amount that will be allocated to goodwill and the related tax effects. The related amortization of acquired assets is also subject to revision based on the final valuation. Any adjustments to the preliminary fair values will be made as soon as practicable but no later than one year from the April 26, 2013 acquisition date.

 

The following table summarizes the estimated fair values of the net assets acquired.

 

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Table of Contents

 

 

 

April 26,

 

 

 

2013

 

Cash

 

$

11,514

 

Accounts recievable, trade

 

25,344

 

Inventory

 

21,704

 

Prepaid expenses and other current assets

 

3,735

 

Property and equipment

 

3,028

 

Purchased intangibles

 

667,000

 

Goodwill

 

123,234

 

Other long-term assets

 

5,202

 

Total assets acquired

 

860,761

 

Contingent consideration assumed

 

(81,685

)

Other liabilities assumed

 

(30,016

)

Deferred tax liabilities

 

(104,537

)

Total net assets acquired

 

$

644,523

 

 

The purchased intangibles represent acquired product rights. The costs of these purchased product rights are being amortized to income on a straight-line basis over the below disclosed estimated lives and are tested for impairment whenever events or circumstances indicate that the carrying amount may not be recovered. The following is a summary of the fair value assigned to the product rights acquired and the amortization period assigned to these rights.

 

 

 

Fair value

 

Estimated
life in
years

 

TESTOPEL

 

$

491,000

 

12

 

Edex

 

70,000

 

11

 

Timm Medical

 

23,000

 

10

 

Striant

 

8,000

 

10

 

Theo-24

 

39,000

 

9

 

Semprex-D

 

32,000

 

10

 

Other products

 

4,000

 

2

 

Total

 

$

667,000

 

 

 

 

The contingent consideration assumed is earn-out consideration relating to acquisitions that were previously undertaken by Actient and principally represent royalties on future sales of certain Actient products. Of the amount shown in the above summary of net assets, $60,848 and $15,752 represent royalties payable on future sales of TESTOPEL and Edex, respectively. The TESTOPEL obligation is a 12% royalty payable on net sales of TESTOPEL through December 31, 2017, at which time such royalty obligation ceases. The Edex obligation is a 15% royalty payable on annual net sales in excess of $20,000. The Edex obligation will cease upon a generic market launch of a competitive product. The remaining amount of contingent consideration represent 6% to 15% royalty obligations on various Actient products, of which approximately $4,000 of such royalty obligation ceased in July 2013, and certain milestone obligations associated with the Company launch of implantable TRT products defined in Actient’s purchase agreements.

 

The difference between the total consideration and the fair value of the net assets acquired was recorded to Goodwill in the Consolidated balance sheet. This goodwill represents the excess of the purchase price over the fair value of the tangible and identifiable intangible assets acquired and liabilities assumed, principally representing the tax attributes of the acquisition and certain

 

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operational synergies. Approximately $400,000 of the intangibles and Goodwill are expected to be deductible for tax purposes.

 

In accordance with the relevant accounting guidance, goodwill is not amortized. However, it must be assessed for impairment using fair value measurement techniques on an annual basis or more frequently if facts and circumstances warrant such a review. The balance of Goodwill has been assigned to the Company’s single reporting unit, which is the single operating segment by which the chief decision maker manages the Company. For purposes of assessing the impairment of goodwill, the Company uses its market capitalization as an input to its determination of fair value. If the carrying amount of the net assets of the Company exceeds the fair value, then a goodwill impairment test is performed to measure the amount of the impairment loss, if any.

 

The operating results of Actient are reported in the Company’s financial statements beginning on April 26, 2013. The following table provides pro forma results of operations for the three and nine month periods ended September 30, 2013 and 2012, as if Actient had been acquired as of January 1, 2012, and both the initial Term Loan borrowing of $225,000, and the 2018 Convertible Notes, used to fund the Transaction had also occurred on January 1, 2012. The pro forma results include certain purchase accounting adjustments such as the estimated changes in depreciation and amortization expense on the acquired tangible and intangible assets. However, pro forma results do not include any anticipated cost savings or other effects of the integration of Actient.  Accordingly, such amounts are not necessarily indicative of the results if the acquisition had occurred on the dates indicated or which may occur in the future.

 

 

 

Unaudited pro forma consolidated results

 

 

 

Three months ended
September 30,

 

Nine months ended
Septemebr 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Net revenues

 

$

108,140

 

$

103,031

 

$

323,970

 

$

315,158

 

Net income (loss) attributable to the Company

 

$

(18,187

)

$

(46,944

)

$

(52,603

)

$

(5,885

)

Net income (loss) per common share-

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.37

)

$

(0.96

)

$

(1.07

)

$

(0.12

)

Diluted

 

$

(0.37

)

$

(0.96

)

$

(1.07

)

$

(0.12

)

 

3.     MERGER TRANSITION AND RESTRUCTURING ACTIVITIES

 

As discussed in Note (2), $8,309 of the Actient purchase consideration represents compensation payable to former Actient management upon completion of their retention period with the Company. This amount was recorded as a prepaid asset as of the date of the acquisition and was being amortized to expense as compensation cost over such retention period which ended during the third quarter of 2013. As of September 30, 2013, all of this merger consideration has been expensed.

 

In connection with the acquisition of Actient, the Company undertook actions to realign its sales, sales support, and management activities and staffing which included severance benefits to former Actient employees. For former Actient employees that have agreed to continue employment with the Company for a merger transition period, the severance payable upon completion of their retention period is being expensed over their respective retention period. All severance obligations are expected to amount to $6,060, of which during the three and nine months ended September 30, 2013 $1,850 and $4,973, respectively, has been expensed and $1,189 had been paid.

 

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4.     FAIR VALUE MEASUREMENTS

 

The authoritative literature for fair value measurements established a three-tier fair value hierarchy, which prioritizes the inputs in measuring fair value. These tiers are as follows: Level 1, defined as observable inputs such as quoted market prices in active markets; Level 2, defined as inputs other than the quoted prices in active markets that are either directly or indirectly observable; and Level 3, defined as significant unobservable inputs (entity developed assumptions) in which little or no market data exists.

 

The following tables present the Company’s fair value hierarchy for the Company’s financial assets and liabilities measured at fair value on a recurring basis as of September 30, 2013 and December 31, 2012:

 

 

 

September 30 ,2013

 

 

 

Fair Value

 

Level 1

 

Level 2

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

91,007

 

$

91,007

 

$

0

 

$

0

 

Short-term investments

 

30,375

 

7,148

 

23,227

 

0

 

Total financial assets

 

$

121,382

 

$

98,155

 

$

23,227

 

$

0

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

Contingent consideration

 

$

120,244

 

$

0

 

$

0

 

$

120,244

 

 

 

 

 

December 31, 2012

 

 

 

Fair Value

 

Level 1

 

Level 2

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

35,857

 

$

35,857

 

$

0

 

$

0

 

Short-term investments

 

121,573

 

31,459

 

90,114

 

0

 

Long-term investments:

 

 

 

 

 

 

 

 

 

Auction rate securities

 

1,442

 

0

 

0

 

1,442

 

Total financial assets

 

$

158,872

 

$

67,316

 

$

90,114

 

$

1,442

 

 

 

 

 

 

 

 

 

 

 

Liabilities

 

 

 

 

 

 

 

 

 

Contingent consideration

 

$

0

 

$

0

 

$

0

 

$

0

 

 

Financial assets

 

The Company considers its short-term investments to be “available for sale” and accordingly classifies them as current, as management can sell these investments at any time at their option. The cost basis of short-term investments held at September 30, 2013 approximated the fair value of these securities. Related unrealized gains and losses are recorded as a component of accumulated other comprehensive income (loss) in the equity section of the accompanying balance sheet. The amount of unrealized loss on short-term investments amounted to $184 as of September 30, 2013.

 

Fair value for Level 1 is based on quoted market prices. Fair value for Level 2 is based on quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active and model-based valuation techniques for which all significant assumptions are observable in the market or can be corroborated by observable market data for substantially the full term of the assets. Inputs are obtained from various sources including market participants, dealers and brokers. The securities classified as Level 3 are auction rate securities that are not actively traded.  The Company determined the fair value of these securities based on a discounted cash flow model which incorporated a discount period, coupon rate, liquidity discount and coupon history.  In determining the fair value, the Company also considered the rating of the securities by investment rating agencies and whether the securities were backed by the United States government.

 

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Table of Contents

 

There was no Level 3 financial asset activity during the three months ended September 30, 2013. The following table summarizes the changes in the financial assets measured at fair value using Level 3 inputs for the nine months ended September 30, 2013:

 

Long -term Investments

 

Nine months
ended
September 30,
2013

 

 

 

 

 

Beginning balance

 

$

1,442

 

Transfers into Level 3

 

0

 

Sales and redemptions of securities

 

(1,528

)

Unrealized gain- included in other comprehensive income

 

86

 

Ending balance

 

$

0

 

 

 

 

 

Total realized loss on sale of securities included in Investment income (loss), net for the period

 

$

(72

)

 

There were no transfers between Level 1 and 2 during the nine months ended September 30, 2013.

 

Contingent consideration

 

The Level 3 liability is contingent consideration related to the acquisition of Actient described in Note 2. The range of the undiscounted amounts of contingent consideration ultimately payable is principally dependent on future sales of the products acquired. Fair value is determined based on assumptions and projections relevant to revenues and discounted cash flow model using a risk-adjusted discount rate of 14%. Assumptions include the expected value of royalties and milestone payments due on estimated settlement dates, volatility of product supply, demand and prices, and the Company’s cost of money. The Company assesses these assumptions on an ongoing basis as additional information impacting the assumptions is obtained. A 1% change in this discount rate would have a $1.7 million change in the contingent consideration liability. Changes in the fair value of contingent consideration related to the updated assumptions and estimates are recognized in the consolidated statements of operations.

 

The table below provides a roll forward of the fair value of contingent consideration since the Actient acquisition date.

 

Contingent consideration

 

 

 

 

 

 

 

Fair value at date of Actient acquisition, April 26, 2013

 

$

122,654

 

Change in contingent consideration charged to operations

 

6,929

 

Payments of contingent consideration

 

(9,339

)

Ending balance, September 30, 2013

 

$

120,244

 

 

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Debt outstanding

 

Management estimates that the fair value of the Term Loan outstanding at September 30, 2013 approximates its principal value of $268,785 based upon market interest rates (a Level 2 fair value measurement). The fair value of the 2018 Convertible Notes at September 30, 2013 approximates its par value of $350,000 based on active trading activity in this security (a Level 1 fair value measurement).

 

5.     INVENTORIES

 

Inventories consist of the following: 

 

 

 

September 30,

 

December 31,

 

 

 

2013

 

2012

 

Raw materials

 

$

8,023

 

$

8,183

 

Work-in-process

 

70,119

 

53,037

 

Finished goods

 

20,316

 

10,611

 

 

 

98,458

 

71,831

 

Inventories, current

 

44,749

 

22,134

 

Inventories, non-current

 

$

53,709

 

$

49,697

 

 

The Company recorded the acquired Actient inventories at their fair value, which required a step-up in value of $11,704 to record the acquired inventories at their net realizable value. As the acquired inventories are sold, this step-up in value is recorded as cost of goods sold in the Consolidated Statement of Operations. During the three and nine months ended September 30, 2013, $5,403 and $9,898, respectively, of the inventory step-up was recognized as Cost of goods sold.

 

6.     ACCRUED EXPENSES

 

Accrued expenses consist of the following:

 

 

 

September 30,

 

December 31,

 

 

 

2013

 

2012

 

Payroll and related expenses

 

$

18,775

 

$

15,048

 

Royalty expenses

 

10,064

 

10,949

 

Research and development expenses

 

3,607

 

2,972

 

Sales and marketing expenses

 

14,873

 

8,017

 

Rebates, discounts and returns accrual

 

46,918

 

38,066

 

Accrued interest

 

1,094

 

0

 

Purchase option payable

 

7,000

 

0

 

Other

 

17,402

 

5,688

 

 

 

$

119,733

 

$

80,740

 

 

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Table of Contents

 

7.              COLLABORATION AND LICENSE AGREEMENTS

 

(a) Sobi

 

On July 15, 2013, the Company and Swedish Orphan Biovitrum AB (publ) (“Sobi”) announced that they had entered into a collaboration agreement (the “Sobi Agreement”). Under the Sobi Agreement, Sobi was granted the right to develop and commercialize XIAPEX (the European Union tradename for XIAFLEX) for the treatment in humans of Peyronie’s disease (“Peyronie’s”), if approved, and Dupuytren’s contracture (“Dupuytren’s”) in 28 European Union member countries, Switzerland, Norway, Iceland, 18 Central Eastern Europe/Commonwealth of Independent countries, including Russia and Turkey, and 22 Middle Eastern & North African countries (the “Sobi Territory”).  Under the Sobi Agreement, Sobi will be responsible for the all development costs specific to the Sobi Territory and the Company will be responsible for development costs not specific to the Sobi Territory. In addition, Sobi will be solely responsible for costs associated with obtaining and maintaining regulatory approval for XIAPEX in the Sobi Territory as well as post-regulatory approval filing date development activities. The Company will be responsible for all clinical and commercial manufacturing and supply of XIAPEX for the Sobi Territory.

 

Under the terms of the Sobi Agreement, the Company expects to receive significant tiered royalties, within the range of 55-65%, 50-60% and 45-55% based on sales of XIAPEX in the Sobi Territory, which include payment for product supply.  The tiered royalty percentages will decrease by approximately 10% upon the occurrence of certain manufacturing milestones or July 1, 2016, whichever is earlier.  Additionally, Sobi could make up to $40 million in potential sales milestone payments to the Company.

 

Subject to each party’s termination rights, the term of the Sobi Agreement extends on a product-by-product basis from the date of the Sobi Agreement until the 10th anniversary of the date of the Sobi Agreement. The term of the Sobi Agreement will be automatically extended for sequential two year periods unless a notice of non-renewal is provided in writing to the other party at least six months prior to expiration of the then current term.

 

For accounting purposes, the Company has determined that the Sobi Agreement includes multiple deliverables, including development and commercialization rights and manufacturing and product supply. In accordance with the accounting guidance on revenue recognition for multiple-element agreements, the product supply element of the Sobi Agreement meets the criteria for separation. Therefore, it is being treated as a single unit of accounting and, accordingly, the associated royalties on net sales of the product will be recognized as revenue when earned. All other deliverables under the contract are being accounted for as one unit of accounting since each of these elements does not have stand-alone value to Sobi. All potential future milestone payments are considered to relate to this one combined unit of accounting and will be amortized to revenue on a straight-line basis over the life of the Sobi Agreement. When future milestones are earned, the Company will record as revenue a cumulative catch-up adjustment on the date each milestone is earned for the period of time since contract commencement through the date of the milestone.

 

(b) Pfizer Agreement Transition

 

In December 2008, the Company entered into a development, commercialization and supply agreement with Pfizer, Inc. (“Pfizer”) (the “Pfizer Agreement”). Under the Pfizer Agreement, the Company granted to Pfizer the right to develop and commercialize, with the right to sublicense, XIAPEX for the treatment of Dupuytren’s contracture (“Dupuytren’s”) and, if approved, Peyronie’s in the European Union (the “EU”) and certain Eurasian countries listed therein (collectively, the “Territory”).  On November 6, 2012, the Company and Pfizer entered into an amendment (the “Pfizer Amendment”) to the Pfizer Agreement in which they agreed to mutually terminate the Pfizer Agreement, effective April 24, 2013 (the “Termination Date”). Prior to the Termination Date, the Pfizer and the Company continued to perform all of their obligations as described in the Pfizer Agreement.  After April 24, 2013, all rights held by Pfizer to commercialize XIAPEX and the responsibility for regulatory activities for XIAPEX in the Territory reverted, at no cost, to the Company. In addition, Pfizer maintained, as provided in the Pfizer Agreement, the right to sell its remaining XIAPEX inventory for the six month period following the

 

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Table of Contents

 

Termination Date so long as Pfizer continued to make the commercialization and royalty payments on such sales that were established pursuant to the Pfizer Agreement.

 

On March 28, 2013, the Company and Pfizer entered into a transition services agreement (the “Transition Services Agreement”) relating to the transition from Pfizer to the Company of the development and commercialization activities related to XIAPEX for the treatment of Dupuytren’s and, if approved, for the treatment of Peyronie’s. Notwithstanding the Pfizer Amendment, the Transition Services Agreement provides, and sets out schedules, for, among other matters, an orderly transition of regulatory approvals and licenses, packaging and labeling responsibilities, distribution activities, pharmacovigilance obligations, recall obligations, product testing activities, ongoing clinical trial activities and redesign of packaging.

 

A summary of certain terms of the Transition Services Agreement is set forth below:

 

·                  Pfizer assigned to the Company the ongoing management and continued performance of certain clinical trials for XIAPEX, including the transfer of data, effective May 31, 2013.

 

·                  Until July 31, 2013, Pfizer continued to sell in the Territory any of its XIAPEX inventory that remained on hand and paid to the Company any commercialization payments due under the original Pfizer Agreement.

 

·                  Pfizer and the Company cooperated in working toward the transfer of the EU and the Swiss marketing authorizations to the Company The EU marketing authorization has now been transferred to the Company and the Swiss marketing authorization has now been transferred to Medius AG on our behalf.  In addition to Pfizer’s selling of its own inventory, Pfizer distributed XIAPEX on behalf of the Company until July 31, 2013.

 

·                  Upon the transfer of the applicable marketing authorizations, the Company will submit registrations related to pharmacovigilance with respect to XIAPEX.  Pfizer will continue to be responsible for the pharmacovigilance system until such registrations have been approved.

 

·                  Pfizer agreed to package and label XIAPEX bulk product, manufactured by the Company, for the Company’s distribution in the Territory to the extent ordered by the Company by April 5, 2013. (Such order was placed with Pfizer.) The Company has packaging and labeling responsibility for all subsequent production of XIAPEX.

 

·                  After February 28, 2014, Pfizer will not provide any further support to the Company with respect to the supply of XIAPEX.

 

·                  The term of the Transition Services Agreement commenced on March 28, 2013 and ends on April 24, 2014; provided that the rights and obligations of Pfizer and the Company that expressly terminate on a date prior to April 24, 2014, will terminate on such date.

 

(c) Co-promotion Agreement with GSK

 

On July 31, 2013, the Company and GlaxoSmithKline LLC (“GSK”) agreed to mutually terminate their co-promotion agreement for the sale of Testim. As a result, the Company reversed to income for the nine months ended September 30, 2013 the $1,015 accrual recorded in 2012 for post-expiration obligations to GSK.

 

8.              TERM LOAN

 

In order to partially fund a portion of the costs and related expenses of the acquisition of Actient described in Note (2), the Company entered into a Term Loan agreement with a syndicate of banks to borrow $225,000 in principal value. In September 2013, the Company borrowed an additional $50,000

 

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under the Term Loan agreement. The original issue discount together with issuance costs of the Term Loan, amounting to $12,148, is being accreted to Interest expense over the stated term of the Term Loan agreement and the unamortized balance has been deducted from the Term Loan balance shown in the Balance Sheet.

 

The Term Loan is collateralized by a first priority security interest on certain real and all personal property of the Company and certain of its subsidiaries including (i) a pledge of all of the equity interests held by the Company and such subsidiaries and (ii) a lien encumbering all intellectual property owned by the Company and such subsidiaries.  The obligations of the Company and such subsidiaries under the Term Loan agreement are unconditionally cross guaranteed by the Company and such subsidiaries.

 

The Term Loan principal must be repaid in equal quarterly installments of 1.25% per quarter commencing on June 30, 2013, with the remainder of the borrowings to be paid on the maturity date of April 26, 2017, unless otherwise prepaid prior to such date in accordance with the terms of the Term Loan. The principal amount outstanding is subject to mandatory prepayment from excess positive cash flow and upon the happening of certain events including: (i) receipt of net cash proceeds from dispositions; (ii) receipt of net cash proceeds from the sale or issuance of debt or equity; and (iii) receipt of proceeds from casualty and condemnation events, in each case subject to certain limitations and conditions set forth in the Term Loan. The Company can elect loans to bear interest at a rate equal to either Base Rate (as defined in the agreement) or LIBOR, plus a margin.  The Base Rate interest rate margin is 4.00% and the LIBOR interest rate margin is 5.00%. The Term Loan agreement also establishes a floor rate for both the Base Rate and LIBOR options. As of the date hereof, the Company has elected to base the interest rate of the borrowings on LIBOR. As of September 30, 2013, the total interest rate on the Term Loan principal was 6.25%.

 

The Term Loan contains no financial covenants but contains usual and customary operating and restrictive covenants for a facility of this type. Events of default under the Term Loan are also usual and customary for transactions of this type. As of September 30, 2013, the Company was in compliance with Term Loan covenants.

 

9.              SENIOR CONVERTIBLE NOTES

 

In January 2013, the Company issued $350 million aggregate principal amount of the 2018 Convertible Notes, in a registered public offering. Interest is payable semi-annually in arrears on January 15 and July 15, commencing on July 15, 2013.

 

The 2018 Convertible Notes are senior unsecured obligations that will rank senior in right of payment to any future indebtedness of the Company that is expressly subordinated in right of payment, will rank equal in right of payment to any unsecured indebtedness that is not so subordinated, will rank effectively junior in right of payment to any future secured indebtedness to the extent of the value of the assets securing such indebtedness, and will rank structurally junior to any indebtedness and other liabilities (including trade payables) of the Company’s subsidiaries. Prior to July 15, 2018, the 2018 Convertible Notes are convertible only upon certain specified events. The initial conversion rate for the 2018 Convertible Notes is 41.3770 shares of common stock per $1,000 principal amount of the 2018 Convertible Notes, representing an initial effective conversion price of approximately $24.17 per share of common stock. The conversion rate is subject to adjustment for certain events as outlined in the indenture governing the 2018 Convertible Notes, but will not be adjusted for accrued and unpaid interest.

 

The Company received net proceeds of $310,396 from issuance of the 2018 Convertible Notes, net of $11,079 debt issuance costs and net payments of $28,525 related to our hedge transactions. The debt issuance costs have been allocated on a pro-rata basis to the debt ($8,975) and equity ($2,104) components of the transaction. The debt component of the issuance costs is included in Other assets and is

 

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being accreted to interest expense over the stated term of the 2018 Convertible Notes. The equity component was netted against the proceeds and included in additional paid-in capital.

 

The Company may not redeem the 2018 Convertible Notes prior to maturity. However, in the event of a fundamental change, as defined in the indenture, the holders of the 2018 Convertible Notes may require us to purchase all or a portion of their 2018 Convertible Notes at a purchase price equal to 100% of the principal amount of the 2018 Convertible Notes, plus accrued and unpaid interest, if any, to the repurchase date. Holders who convert their 2018 Convertible Notes in connection with a make-whole fundamental change, as defined in the indenture, may be entitled to a make-whole premium in the form of an increase in the conversion rate.

 

Prior to July 15, 2018, the 2018 Convertible Notes are convertible only under the following circumstances: (1) during any fiscal quarter commencing after March 31, 2013 (and only during such fiscal quarter), if the last reported sale price of the Company common stock for at least 20 trading days (whether or not consecutive) during the period of 30 consecutive trading days ending on the last trading day of the immediately preceding fiscal quarter is greater than or equal to 130% of the applicable conversion price on each applicable trading day; (2) during the five business day period after any ten consecutive trading day period (the “ 2018 Convertible Notes Measurement Period”) in which, for each trading day of such 2018 Convertible Notes Measurement Period, the trading price per $1,000 principal amount of 2018 Convertible Notes on such trading day was less than 98% of the product of the last reported sale price of our common stock on such trading day and the applicable conversion rate on such trading day; or (3) upon the occurrence of specified distributions and corporate events. As of September 30, 2013, none of the conditions allowing holders of the 2018 Convertible Notes to convert had been met.

 

In accordance with the governing accounting guidance, the Company determined that the embedded conversion option in the 2018 Convertible Notes is not required to be separately accounted for as a derivative. However, since the 2018 Convertible Notes are within the scope of the accounting guidance for debt with conversion and other options, the Company is required to separate the 2018 Convertible Notes into a liability component and equity component. The carrying amount of the liability component is calculated by measuring the fair value of a similar liability (including any embedded features other than the conversion option) that does not have an associated equity component. The carrying amount of the equity component representing the embedded conversion option is determined by deducting the fair value of the liability component from the initial proceeds ascribed to the 2018 Convertible Notes as a whole. The excess of the principal amount of the liability component over its carrying amount is amortized to interest cost over the expected life of a similar liability that does not have an associated equity component using the effective interest method. The equity component is not remeasured as long as it continues to meet the conditions for equity classification in the accounting guidance for contracts in an entity’s own equity.

 

The Company has determined that a 5.0% effective interest rate is appropriate to calculate the accretion of the bond discount, which is being recorded as interest expense over the stated term of the 2018 Convertible Notes. (The amount by which interest expense, calculated using the effective interest rate of 5.0%, exceeds the interest expense related to the coupon rate of 1.5% is non-cash interest expense.) The effective rate is based on the interest rate for a similar instrument that does not have a conversion feature. The Company may be required to pay additional interest upon occurrence of certain events as outlined in the indenture governing the 2018 Convertible Notes. As of September 30, 2013, the remaining term of the 2018 Convertible Notes is 4.8 years.

 

Upon conversion of a note, holders of the 2018 Convertible Notes will receive up to the principal amount of the converted note in cash and any excess conversion value (conversion spread) in shares of our common stock. The amount of cash and the number of shares of our common stock, if any, will be based on a 60 trading day observation period as described in the indenture. As described in Note 1

 

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Summary of Significant Accounting Policies, the conversion spread will be included in the denominator for the computation of diluted net income per common share, using the treasury stock method, if the effect is dilutive.

 

As discussed above, to hedge against potential dilution upon conversion of the 2018 Convertible Notes, the Company purchased call options on its common stock. The call options give the Company the right to purchase up to 14,481,950 shares of our common stock at $24.17 per share subject to certain adjustments that correspond to the potential adjustments to the conversion rate for the 2018 Convertible Notes. The Company paid an aggregate of $70,000 to purchase these call options. The call options will expire on July 15, 2018, unless earlier terminated or exercised. To reduce the cost of the hedge, in a separate transaction, the Company sold warrants. These warrants give the holder the right to purchase up to 14,481,950 shares of common stock of the Company at $27.36 per share, subject to certain adjustments. These warrants will be exercisable and will expire in equal installments for a period of 140 trading days beginning on October 15, 2018. The Company received an aggregate of $41,475 from the sale of these warrants. In accordance with governing accounting guidance, the Company concluded that the call options and warrants were indexed to our stock. Therefore, the call options and warrants were classified as equity instruments and will not be marked to market prospectively unless certain conditions occur. The net amount of $28,525 was recorded as a reduction to additional paid-in capital. The settlement terms of the call options provide for net share settlement and the settlement terms of the warrants provide for net share or cash settlement at the option of the Company.

 

10.       STOCK OPTIONS AND STOCK AWARDS

 

Under the Company’s 2004 Equity Compensation Plan, as amended (the “2004 Plan”), as approved by the stockholders of the Company, qualified and nonqualified stock options and stock awards may be granted to employees, non-employee directors, consultants and advisors who provide services. As of September 30, 2013, the Company had granted non-qualified stock options and stock awards under the 2004 Plan. At September 30, 2013, there were 2,971,412 shares available for future grants under the 2004 Plan.

 

(a)         Stock Option Information

 

During the nine months ended September 30, 2013, the Company granted non-qualified stock options to purchase shares of the Company’s common stock pursuant to the 2004 Plan. These options expire ten years from date of grant. Their exercise prices represent the closing price of the common stock of the Company on the respective dates that the options were granted and they vest rateably over four years at one year intervals from the grant date, assuming continued employment of the grantee.

 

The following tables summarize stock option activity for the nine month period ended September 30, 2013:

 

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Nine Months Ended September 30, 2013

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

Weighted

 

average

 

 

 

 

 

 

 

average

 

remaining

 

Aggregate

 

 

 

 

 

exercise

 

contractual

 

intrinsic

 

Stock options

 

Shares

 

price

 

life (in years)

 

value

 

Options outstanding:

 

 

 

 

 

 

 

 

 

Outstanding at December 31, 2012

 

6,626,176

 

$

22.50

 

 

 

 

 

Granted

 

1,172,209

 

17.58

 

 

 

 

 

Exercised

 

(40,112

)

10.20

 

 

 

 

 

Forfeited

 

(316,562

)

25.11

 

 

 

 

 

Outstanding at September 30, 2013

 

7,441,711

 

21.68

 

6.94

 

$

7,479

 

Exercisable at September 30, 2013

 

4,050,142

 

23.46

 

5.62

 

6,117

 

 

The aggregate intrinsic values in the preceding table represent the total pre-tax intrinsic value, based on the Company’s stock closing price of $18.20 as of September 30, 2013, that would have been received by the option holders had all option holders exercised their options as of that date. During the three months ended September 30, 2013, total intrinsic value of options exercised was $336. As of September 30, 2013, exercisable options to purchase 948,561 shares of the Company’s common stock were in-the-money.

 

(b)         Stock Awards

 

During the nine months ended September 30, 2013, the Company granted a total of 140,550 performance-based restricted stock unit awards to certain officers. The right to receive shares of common stock will be earned (subject to vesting) upon attainment of two performance goals, weighted as follows: 50% weighting on attaining a specified level of net income for the year ending December 31, 2013 and 50% weighting based upon the timing of approval, and labelling required, by the U.S. Food and Drug Administration (the “FDA”) for the supplemental Biologic License Application (“sBLA”) for XIAFLEX for Peyronie’s. The number of shares of restricted stock units earned will vest 33% on the date of determination that the performance goal is achieved with an additional 33% vesting on the first anniversary, and the remaining balance vesting on the second anniversary, of the date of determination for the performance goal achievement. As of September 30, 2013, management estimates that the issuance of approximately 24,000 shares of restricted stock is probable under these awards.

 

In addition to an annual grant of stock options, during the nine months ended September 30, 2013, the Company granted 318,474 restricted share units to employees. These restricted share units generally vest ratably over three years at one year intervals from the grant date. Upon vesting, each restricted share unit is converted into one share of the common stock of the Company.

 

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(c)          Restricted Stock

 

During the nine months ended September 30, 2013, the Company granted to members of the Board of Directors 10,000 restricted shares and 20,000 deferred stock units.  These awards will vest on the date of the 2014 annual shareholders meeting, assuming continued service of the grantee.

 

The following table summarizes the restricted stock activity for the nine-month period ended September 30, 2013:

 

 

 

 

 

Weighted

 

 

 

 

 

average

 

 

 

 

 

grant-date

 

 

 

Shares

 

fair value

 

Nonvested at December 31, 2012

 

48,700

 

$

23.76

 

Issued

 

10,000

 

14.37

 

Vested

 

(34,490

)

24.16

 

Cancelled

 

(250

)

24.62

 

Nonvested at September 30, 2013

 

23,960

 

19.27

 

 

(d)  Valuation Assumptions and Expense Information

 

Total stock-based compensation costs charged against income for the nine months ended September 30, 2013 and 2012 amounted to $11,346 and $11,112, respectively. Stock-based compensation costs capitalized as part of inventory amounted to $6,178 at September 30, 2013 and $4,866 at December 31, 2012, respectively.

 

The fair value of each stock option award was estimated on the date of grant using the Black-Scholes model and applying the assumptions in the following table.

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended 
September 30,

 

 

 

2013

 

2012

 

2013

 

2012

 

Weighted average assumptions:

 

 

 

 

 

 

 

 

 

Expected life of options (in years)

 

6.25

 

6.25

 

6.27

 

6.26

 

Risk-free interest rate

 

1.90

%

1.17

%

1.20

%

1.05

%

Expected volatility

 

47.84

%

50.17

%

48.78

%

50.69

%

Expected dividend yield

 

0.00

%

0.00

%

0.00

%

0.00

%

 

During the nine months ended September 30, 2013, the weighted-average grant-date fair value of options granted was $8.42. As of September 30, 2013, there was approximately $25,500 of total unrecognized stock-based compensation cost related to all share-based payments that will be recognized over the weighted-average period of 2.41 years.

 

11.       INCOME TAXES

 

The Company’s effective income tax rate benefits (expense) were (1.0 %) and 128.0% for the three months and nine months ended September 30, 2013, respectively.  The income tax expense for the three months ended September 30, 2013 results from income taxes payable in certain state jurisdictions. The effective income tax rate benefits results from the reversal of a portion of the valuation allowance against the Company’s deferred tax assets, net of recognition of income taxes on current income in certain state jurisdictions and certain discrete items of tax.

 

The effective income tax rates were 0.0% and 0.0% for the three months and nine months ended September 30, 2012, respectively, as a result of the full valuation allowance.

 

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Since inception through March 31, 2013, the Company has maintained a full valuation allowance equal to its cumulative net deferred tax assets given its history of operating losses. During the second quarter of 2013, in conjunction with the accounting associated with the Actient acquisition described in Note (2), the Company recorded deferred tax liabilities related to differences between the book basis and the tax basis of the Actient amortizable assets. These deferred tax liabilities will serve as reversible temporary differences that give rise to future taxable income and, therefore, they serve as a source of income that permits the recognition of certain existing deferred tax assets of the Company. Solely on this basis, management determined that it is more likely than not that a portion of its valuation allowance was no longer required.  As a result of the release of the valuation allowance, the Company recorded a tax benefit of $92,607 in the consolidated statement of operations for the nine month period ended September 30, 2013 and an additional tax benefit of $1,295 in Additional paid-in capital related to the 2018 Convertible Notes. Offsetting the benefit of the release of the valuation allowance, the Company recorded for the three months and nine months ended September 30, 2013 a provision of $289 and $538, respectively, for income taxes on current income in certain state jurisdictions.

 

Additionally, as a result of the purchase accounting adjustments discussed above, the Company is establishing deferred tax liabilities of $10,635 for certain state jurisdictions. These deferred tax liabilities result from the differences between the book and tax basis of certain Actient amortizable assets in jurisdictions in which there are no offsetting deferred tax assets.

 

Because the Actient acquisition deferred tax liabilities are provisional amounts that are subject to the finalization of the purchase accounting, this tax benefit may be revised during the acquisition measurement period as explained in Note (2). Since the Company has only looked to reversible taxable differences and feasible tax-planning strategies in assessing the need for the valuation allowance, a portion of its deferred tax assets are not more likely than not to be utilized and remain offset by a valuation allowance. On a quarterly basis, management assesses whether it remains more likely than not that the deferred tax assets will not be realized.  In the event the Company determines at a future time that it would realize additional deferred tax assets, the Company will decrease its deferred tax asset valuation allowance and record an income tax benefit in the period when the Company makes such determination.

 

12.       LITIGATION

 

Hatch-Waxman Litigation

 

Testim, XIAFLEX, TESTOPEL, Edex®, and the Company’s other marketed products are approved under the provisions of the U.S. Food, Drug and Cosmetic Act that renders each susceptible to potential competition from generic manufacturers via the Abbreviated New Drug Application (“ANDA”) procedure or the 505(b)(2) New Drug Application (“505(b)(2) NDA”) procedure. Generic manufacturers can sell their products at prices much lower than those charged by the innovative pharmaceutical companies who have incurred substantial expenses associated with the research and development of the drug product.

 

The ANDA procedure and the 505(b)(2) NDA procedure include provisions allowing generic manufacturers to challenge the effectiveness of the innovator’s patent protection long before the generic manufacturer actually commercializes their products through the paragraph IV certification procedure. In recent years, generic manufacturers have used paragraph IV certifications extensively to challenge patents on a wide array of innovative pharmaceuticals, and we expect this trend to continue and to implicate drug products with even relatively small total revenues.

 

TESTOPEL and Edex and certain other of the Company’s products do not currently have any patent protection and, as a result, potential competitors face fewer barriers in introducing competing products.  Therefore, the Company must rely on trade secrets and other unpatented proprietary information in order to obtain a competitive advantage, which it may be unable to do. While the Company

 

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attempts to protect its proprietary information as trade secrets effectively, the Company cannot guarantee that the measures it has taken will provide effective protection for its proprietary information. It is possible that the Company’s competitors will independently develop products that compete with TESTOPEL and Edex and certain other of its products.

 

Upsher-Smith Litigations

 

The Company is currently engaged in separate litigations with Upsher-Smith Pharmaceuticals, Inc. (“Upsher-Smith”) in Federal court in Delaware regarding Upsher-Smith’s attempts to bring a generic testosterone gel product to market via an ANDA or 505(b)(2) NDA using Testim as its reference listed drug.  Upsher-Smith will not be able to lawfully launch a generic or branded generic version of Testim in the U.S. without the necessary approval from the FDA.  On August 16, 2013, the FDA granted tentative approval of the Upsher-Smith NDA (as defined below) with the brand name VogelxoTM for the Upsher-Smith testosterone gel product.  The previously pending ANDA litigation in Federal court in New Jersey was dismissed in March 2013, and, although Upsher-Smith initially appealed, the Company and Upsher-Smith have since jointly agreed to dismiss the appeal.  We refer to the ANDA litigation in Delaware as the “Delaware Upsher-Smith ANDA Litigation”, the 505(b)(2) NDA litigation in Delaware as the “Delaware Upsher-Smith 505(b)(2) NDA Litigation”, the litigation in New Jersey as the “New Jersey Upsher-Smith ANDA Litigation”, and all three of them collectively as the “Upsher-Smith Litigations”.

 

Delaware ANDA

 

In October 2008, the Company and its licensor, CPEX Pharmaceuticals, Inc. (FCB I LLC’s (“FCB”) predecessor in interest to Testim), received notice that Upsher-Smith filed an ANDA containing a paragraph IV certification seeking approval from the FDA to market a generic version of Testim prior to the January 2025 expiration of the ‘968 Patent. Shortly after, the Company commenced the Delaware Upsher-Smith ANDA Litigation.  Although it would seem unlikely based on (i) the FDA’s public statements in its responses to the Citizen’s Petitions submitted by each of the Company and AbbVie Inc. (“AbbVie”) and (ii) Upsher-Smith’s public stance that its generic product has different penetration enhancers than Testim, the FDA could approve the generic product proposed in Upsher-Smith’s ANDA. With FDA approval, even if the Delaware Upsher-Smith ANDA Litigation remains pending, Upsher-Smith may nevertheless choose to launch this generic product at risk of infringing the ‘968 patent.  Although administratively closed in December 2011, the Delaware Upsher-Smith ANDA Litigation has not been dismissed or finally resolved and could also result in a finding that Upsher-Smith’s proposed testosterone product does not infringe the ‘968 Patent or that the ‘968 Patent is invalid and/or unenforceable.  All discovery obligations of the parties continue to be in effect.   In April 2012, the Company and FCB received a notice from Upsher-Smith in connection with its ANDA advising the Company and FCB of Upsher-Smith’s Paragraph IV certification relating to the eight additional patents listed in the Orange Book in addition to the ‘968 patent-in-suit, and asserting that Upsher-Smith does not believe that the product for which it is seeking approval infringes any of the Orange Book listed Testim patents and that those patents are invalid.  A tenth U.S. patent issued to FCB on May 15, 2012 and was listed in the Orange Book.

 

New Jersey ANDA

 

On March 27, 2013, the Company and FCB learned that Judge Linares of the United States District Court for the District of New Jersey ruled in favor of Auxilium and FCB on their motion to dismiss the lawsuit previously filed by Upsher-Smith on September 10, 2012.  On April 25, 2013, Upsher-Smith filed a Notice of Appeal, appealing the dismissal to the United States Court of Appeals for the Federal Circuit.  On June 14, 2013, the Court dismissed the appeal pursuant to a joint motion filed by us and Upsher-Smith, thereby terminating the lawsuit.  The lawsuit had sought a declaration of non-infringement and/or invalidity of FCB’s U.S. Patent Nos.: 7,608,605; 7,608,606; 7,608,607; 7,608,608; 7,608,609; 7,608,610; 7,935,690; and 8,063,029.  All of the eight referenced patents cover our Testim®

 

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1% testosterone gel, and the eight referenced patents are among the ten FCB patents covering Testim that are currently listed in the Orange Book.  The referenced patents will expire between 2023 and 2025.

 

Delaware 505(b)(2) NDA

 

On or about December 28, 2012, the Company and FCB became aware of a notice from Upsher-Smith that advised the Company and FCB of Upsher-Smith’s filing of a 505(b)(2) NDA containing a Paragraph IV certification under 21 U.S.C. Section 314.52(c) for testosterone gel (the “Upsher-Smith NDA”). This Paragraph IV certification notice refers to the ten U.S. patents, covering Testim, that are listed in the Orange Book.  These ten patents are owned by FCB and are exclusively licensed to Auxilium and will expire between 2023 and 2025.  Upsher-Smith may seek to have any drug approved under the Upsher-Smith NDA as a generic or branded generic version of Testim.  On January 28, 2013, the Company and FCB filed a lawsuit in the United States District Court for the District of Delaware against Upsher-Smith for infringement of FCB’s ten patents listed in the Orange Book as covering Testim® 1% testosterone gel.  A hearing on Upsher-Smith’s previously filed motion for summary judgment was held on June 28, 2013, and by request of the Court, the parties submitted additional briefing in the weeks following the hearing.  On August 16, 2013, the FDA granted tentative approval of the Upsher-Smith NDA with the brand name Vogelxo for the Upsher-Smith testosterone gel product.  The Company is currently awaiting a ruling on the summary judgment motion from the Court which the Company believes could come at any time.  If summary judgment is granted, Upsher-Smith could launch a 1% testosterone gel product using Testim as the reference drug immediately after such ruling, if it receives final approval by the FDA.  If summary judgment is not granted, the trial is currently scheduled to commence in June 2014.

 

On March 26, 2013, the Company submitted a Citizen’s Petition to the FDA with respect to Upsher-Smith’s 505(b)(2) NDA referencing Testim.  The Company requested that, in the event of FDA final approval of the Upsher-Smith 505(b)(2) NDA, the FDA: (i) refrain from designating Upsher-Smith’s testosterone gel as therapeutically equivalent to Testim and (ii) require that the label for the Upsher-Smith testosterone gel state that the product is not interchangeable with other testosterone transdermal gels.  Since any such approval by the FDA would be pursuant to a 505(b)(2) NDA and not pursuant to an ANDA, it is unclear at this time whether such an Upsher-Smith product would receive a therapeutically equivalent rating to Testim or a different rating.  Although the FDA has not yet substantively replied to this Citizen Petition, the FDA did recently communicate to the Company that it has not yet resolved the issues raised in the Citizen Petition. The therapeutic equivalence rating may determine whether the Upsher-Smith testosterone product, if launched, would be launched as a generic, a branded generic, or simply another branded competitor in the TRT gel market.  It is unclear at this time when the FDA will substantively respond to the Company’s Citizen Petition.

 

Watson Litigation

 

ANDA Litigation with Watson

 

On May 24, 2012, the Company and FCB filed a lawsuit against Watson Pharmaceuticals, Inc. (now known as Actavis, Inc.) (“Watson”) for infringement of FCB’s ten patents listed in the Orange Book as covering Testim® 1% testosterone gel (the “Watson Litigation”).  The lawsuit was filed in the United States District Court for the District of New Jersey on May 23, 2012 in response to a notice letter, dated April 12, 2012, sent by Watson Laboratories, Inc. (NV) regarding its filing with the FDA of an ANDA for a generic 1% testosterone gel product.  This letter also stated that the ANDA contained Paragraph IV certifications with respect to the nine patents listed in the Orange Book on that date as covering Testim.  The Company’s lawsuit filed against Watson involves those nine patents, as well as a tenth patent covering Testim that was issued on May 15, 2012 and is listed in the Orange Book.

 

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Other Matters

 

The Company is also party to various other actions and claims arising in the normal course of business that it does not believe are material.  The Company believes that amounts accrued for awards or assessments in connection with all such matters are adequate and that the ultimate resolution of these matters will not have a material adverse effect on the its financial position or the manner in which the Company conduct its business. However, there exists a reasonable possibility of loss in excess of the amounts accrued, the amount of which cannot currently be estimated. While the Company does not believe that the amount of such excess loss could be material to its financial position, any such loss could have a material adverse effect on its results of operations or the manner in which the Company conducts its business in the period(s) during which the underlying matters are resolved.

 

13.  SUBSEQUENT EVENT

 

On October 10, 2013, the Company and VIVUS, Inc. (“VIVUS,” and together with the Company, the “Parties”, and each individually, a “Party”) entered into a License and Commercialization Agreement (the “License Agreement”).  Under the License Agreement, the Company was granted the exclusive right to commercialize VIVUS’s pharmaceutical product STENDRATM (avanafil) (the “Product”) for the treatment of any urological disease or condition in humans, including male erectile dysfunction (the “Field”), in the United States and Canada and their respective territories (the “Territory”).  A summary of certain terms of the License Agreement is set forth below.

 

Upfront, Milestone and Royalty Payments:

 

·                  The Company paid to VIVUS a one-time license fee of $30,000.

·                  The Company will make a $15,000 regulatory milestone payment to VIVUS if the FDA approves the STENDRA label expansion described below.

·                  The Company may make up to an aggregate of $255,000 in potential milestone payments to VIVUS based on the achievement of certain net sales targets by the Company.

·                  The Company will make royalty payments to VIVUS based on tiered percentages of the aggregate annual net sales of the Product in the Territory on a quarterly basis.  The percentage of the Company’s aggregate annual net sales to be paid to VIVUS increases in accordance with the achievement of specified thresholds of aggregate annual net sales of the Product in the Territory.  At the lowest tier, the royalty payable is in the range of 5% to 10% and, at the highest tier, the royalty payable is in the range of 15% to 20%.

·                  If the Company’s net sales of the Product in a country are reduced by certain amounts following the entry of a generic product to the market, royalty payments will be reduced by an amount that will be a function of the degree to which the Parties agree the market for the Product has been reduced.

·                  The Company may also make royalty payments and, if a certain annual sales threshold is met, a milestone payment to VIVUS in satisfaction of VIVUS’s payment obligations to Mitsubishi Tanabe Pharma Corporation (“MTPC”) set forth in an agreement between MTPC and VIVUS, as amended, pursuant to which MTPC granted VIVUS certain intellectual property rights relating to the Product in exchange for certain royalty and milestone payments to MTPC.  Should any royalties be payable to MTPC, they will be in a range of 4% to 7%.  The maximum amount payable for the future milestone (assuming there are no sales anywhere outside of the United States) is $6,000 and is payable only if annual sales exceed a certain threshold.

 

Term of the License Agreement:

 

·                  Subject to each Party’s termination rights, the License Agreement will remain in effect until the later of, on a country by country basis, (i) ten years from the date the Product launches in such country, and (ii) the expiration of the last to expire patent covering the Product in such country.

 

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Upon the expiration of the term of the License Agreement, the license grant by VIVUS to the Company will become fully paid-up, royalty-free, perpetual and irrevocable.

 

Exclusivity:

 

·                  Neither of the Parties is permitted to directly or indirectly develop, commercialize, or in-license any product that competes with the Product in the Territory during a period of five years from the effective date of the License Agreement.

 

Licenses/Intellectual Property:

 

·                  VIVUS granted the Company an exclusive license (even as to VIVUS), with a right to sublicense, subject to certain limitations, under certain of VIVUS’s trademarks, including STENDRA, to market, sell and distribute the Product in the Territory.

·                  VIVUS granted the Company an exclusive license (even as to VIVUS), with a right to sublicense, subject to certain limitations, under certain of VIVUS’s patents and know-how (i) to use, distribute, import, promote, market, sell, offer for sale or otherwise commercialize Products in the Field in the Territory, (ii) to make and have made Products anywhere in the world, with certain exceptions, and (iii) to conduct certain development activities on the Product in the Field in support of obtaining regulatory approval in the Territory.

 

Manufacturing rights/supply obligations/pricing:

 

·                  The Company will obtain the Product exclusively from VIVUS pursuant to a Commercial Supply Agreement entered into between the Company and VIVUS, as further described below.  At a time selected by the Company, but no later than the third anniversary of the effective date of the License Agreement, the Company may elect to transfer control of the supply chain for the Product to itself or its designee (the “Supply Chain Transfer”).

 

Development and commercialization responsibilities and costs:

 

·                  VIVUS shall be responsible for conducting any post-Regulatory Approval studies that are required by the FDA. The costs of conducting such studies shall be shared equally, up to a maximum aggregate payment by the Company of $4,000, and once such maximum is reached, VIVUS shall be solely responsible for such costs. VIVUS has billed the Company $2,100 of such costs. Any additional post-Regulatory Approval studies that the Company determines to conduct with respect to the Product shall be conducted by the Company at its sole expense.

·                  At VIVUS’s sole cost and expense, VIVUS shall be responsible for preparing and filing with the FDA the appropriate documents to obtain a label expansion for the Product referencing a specific time of onset.  VIVUS shall use its commercially reasonable efforts to obtain approval of such label expansion filing.

·                  The Company will be solely responsible for commercializing the Product in the Field in the Territory during the term of the License Agreement, subject to its annual marketing plans, and will be solely responsible for all costs and expenses associated with such commercialization activities.

 

Right to terminate agreement/license:

 

·                  Either Party may terminate the License Agreement as a result of the other Party’s material breach or bankruptcy.

·                  VIVUS may terminate the License Agreement immediately upon written notice to the Company if it is excluded from participation in the United States federal healthcare programs.

 

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·                  After the first anniversary of the Product launch in the United States, the Company may terminate the License Agreement for any reason upon 180 days written notice.

·                  The Company may terminate the License Agreement upon a generic entry into the market upon 30 days written notice.

 

Commercial Supply Agreement between the Company and VIVUS

 

On October 10, 2013, the Company and VIVUS entered into a Commercial Supply Agreement (the “Supply Agreement”).  Under the Supply Agreement, VIVUS will be the exclusive supplier to the Company of the Product for commercialization by the Company in the Field in the Territory under the terms of the License Agreement.  A summary of certain terms of the Supply Agreement is set forth below.

 

Supply of Product:

 

·                  VIVUS will manufacture the Product, directly or through one or more third party subcontractors.

·                  VIVUS currently obtains the Product solely from MTPC and will continue to obtain the Product solely from MTPC (who will have an obligation to supply VIVUS until June 30, 2015) unless and until VIVUS qualifies with the FDA a third party manufacturer who is able to manufacture the Product in accordance with required specifications and applicable laws.

 

Minimum Purchase Requirements:

 

·                  The Company will purchase all of its requirements for the Product from VIVUS, subject to the Supply Chain Transfer described above.

·                  For 2015 and each subsequent year during the term, should the Company fail to purchase an agreed minimum amount of the Product from VIVUS, it will reimburse VIVUS for the shortfall as it relates to VIVUS’s out-of-pocket costs to acquire certain raw materials needed to manufacture the Product.

 

Price of Product:

 

·                  The Company will pay to VIVUS its manufacturing cost plus a certain percentage mark up for each unit of Product.

 

Term:

 

·                  Subject to each Party’s termination rights, the term of the Supply Agreement will remain until December 31, 2018.

·                  Either Party may terminate the Supply Agreement as a result of the other Party’s material breach or bankruptcy.

·                  Either Party may terminate the Supply Agreement if the License Agreement is terminated. The Supply Agreement will automatically terminate upon the completion of the Supply Chain Transfer.

 

Item 2.                     Management’s Discussion and Analysis of Financial Condition and Results of Operations.

 

The following discussion is qualified in its entirety by, and should be read in conjunction with, the more detailed information set forth in the consolidated financial statements and the notes thereto appearing elsewhere in this report.

 

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Special Note Regarding Forward-Looking Statements

 

Certain statements in this “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere in this Quarterly Report are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements made with respect to our strategy, progress and timing of development programs and related trials, the timing of actions to be taken by regulatory authorities, the efficacy, market acceptance and commercial viability of our products and product candidates, third-party coverage and reimbursement for XIAFLEX®, the commercial benefits available to us as a result of our agreements with third parties, future operations, future financial position, future revenues, projected costs, the size of addressable markets, prospects, plans and objectives of management and other statements regarding matters that are not historical facts.

 

In some cases you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “seem,” “seek,” “future,” “continue,” or “appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words.  Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements.  Such risks and uncertainties include, among other things:

 

·                  our ability to integrate the operations of Actient Holdings LLC (“Actient”) and its subsidiaries into our operations successfully and efficiently;

 

·                  our ability to materialize the synergies and benefits, including revenue and profits growth, from the acquisition of Actient;

 

·                  the risks or costs associated with the Actient acquisition being greater than we anticipate;

 

·                  the risks associated with entering the medical device business as a result of the Actient acquisition;

 

·                  the commercial success of our products in the U.S. and, through our collaborators, internationally;

 

·                  our ability to successfully launch new products, including STENDRA, and to successfully launch new indications, or obtain label expansions, for existing products, including XIAFLEX for the treatment of Peyronie’s and XIAFLEX for the treatment of multiple cords in Dupuytren’s, in each case if approved by the U.S. Food and Drug Administration (“FDA”);

 

·                  achieving greater market acceptance of our products by physicians and patients;

 

·                  obtaining and maintaining third-party payor coverage and reimbursement for our products and, if approved, our product candidates;

 

·                  obtaining approval from the FDA and other similar regulatory agencies in other countries for XIAFLEX for the treatment of Peyronie’s;

 

·                  the size of addressable markets for our products and product candidates;

 

·                  maximizing revenues of our products in the currently approved indications;

 

·                  competing effectively with other products in our products’ therapeutic areas, including potential generic and branded generic competition;

 

·                  our ability to successfully defend our intellectual property, including the various litigations regarding Testim in which we are currently involved;

 

·                  growth in sales of our products;

 

·                  growth of the overall testosterone replacement therapy (“TRT”) and erectile dysfunction (“ED”) markets;

 

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·                  the ability to manufacture or have manufactured our products and other product candidates in commercial quantities at reasonable costs and compete successfully against other products and companies;

 

·                 the ability to leverage our investment in our sales force, as well as our expertise in clinical development and regulatory strategy, with the addition of new products;

 

·                  the availability of, and ability to obtain, additional funds through public or private offerings of debt or equity securities;

 

·                  the ability to service all of our outstanding indebtedness;

 

·                  obtaining and maintaining all necessary patents or licenses;

 

·                  the costs associated with acquiring, and the ability to acquire, additional product candidates or approved products;

 

·                  the ability to enroll patients in clinical trials for our product candidates in the expected timeframes;

 

·                  the ability to obtain authorization from the FDA or other regulatory authorities to initiate clinical trials of our product candidates within the expected timeframes;

 

·                  the ability to deliver on our current pipeline;

 

·                  the ability to build out our business and development pipeline in specialty therapeutic areas through corporate development and licensing activities or acquisition activities;

 

·                  demonstrating the safety and efficacy of product candidates at each stage of development;

 

·                  results of clinical trials;

 

·                  meeting applicable regulatory standards, filing for and receiving required regulatory approvals;

 

·                  complying with the terms of our licenses and other agreements;

 

·                  changes in industry practice;

 

·                  changes in the markets for, acceptance by the medical community of, and exclusivity protection for, our products and product candidates as a result of the Patient Protection and Affordable Care Act and the associated reconciliation bill or any amendments thereto or any full or partial repeal thereof;

 

·                  our ability to forecast our performance accurately; and

 

·                  one-time events.

 

These risks and uncertainties are not exhaustive.  For a more detailed discussion of risks and uncertainties, see “Item 1A — Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2012, as updated by our Current Report on Form 8-K filed with the Securities and Exchange Commission (“SEC”) on April 29, 2013, “Item 1A — Risk Factors” of Part II of our Quarterly Report filed with the SEC on August 1, 2013, and “Item 1A — Risk Factors” of Part II of this Quarterly Report.  Other sections of this Quarterly Report and our other SEC filings, verbal or written statements and presentations may include additional factors which could materially and adversely impact our future results, performance, achievements and prospects.  Moreover, we operate in a very competitive and rapidly changing environment.  Given these risks and uncertainties, we cannot guarantee that the future results, performance, achievements and prospects reflected in forward-looking statements will be achieved or occur. Therefore, you should not place undue reliance on forward-looking statements.  We undertake no obligation to update publicly any forward-looking statement other than as required under the federal securities laws.  We qualify all forward-looking statements by these cautionary statements.

 

Special Note Regarding Market and Clinical Data

 

We obtained the market data used throughout this Quarterly Report from our own research,

 

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surveys and/or studies conducted by third parties and industry or general publications.  Industry publications and surveys generally state that they have obtained information from sources believed to be reliable, but do not guarantee the accuracy and completeness of such information.  While we believe that each of these studies and publications is reliable, we have not independently verified such data.  Similarly, we believe our internal research is reliable but it has not been verified by any independent sources.

 

This Quarterly Report may include discussion of certain clinical studies relating to our products and/or product candidates.  These studies typically are part of a larger body of clinical data relating to such products or product candidates, and the discussion herein should be considered in the context of the larger body of data.

 

Overview

 

We are a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences.  For the quarter ended September 30, 2013, we reported net revenues of $108.1 million, compared to net revenues of $71.0 million in the third quarter of 2012, an increase of 52%.  For the third quarter of 2013, XIAFLEX U.S. net revenues increased by 20% over the comparable 2012 period to $15.9 million and U.S. Testim net revenues decreased by 7% to $50.7 million.  Revenues from our recently acquired subsidiary, Actient, resulted in net revenues of $38.3 million for the third quarter of 2013.  This included TESTOPEL net revenues of $20.6 million and Edex net revenues of $8.0 million for the third quarter of 2013.  We reported a net loss of ($28.9) million, or ($0.59) per share (basic and fully diluted), compared to a net loss of ($10.5) million, or ($0.21) per share (basic and fully diluted), reported for the third quarter of 2012. As of September 30, 2013, we had $121.4 million in cash, cash equivalents and short-term investments, compared to $157.4 million at December 31, 2012, and outstanding debt of $291.0 million ($350 million at par value) in the form of the 2018 Convertible Notes and $257.8 million ($268.8 million par value) in a senior secured term loan (the “Term Loan”).

 

We are a fully integrated company and had approximately 653 employees at the end of the first nine months of 2013, including approximately 378 employees in our commercial organization, 145 employees in manufacturing and quality, 60 employees in research and development and 70 employees in administrative support.

 

We currently market 11 products in the urology, orthopedic, respiratory and other areas in the U.S. and, where indicated below, internationally through our respective collaborators:

 

·                  Testim® 1% (testosterone gel) for the topical treatment of hypogonadism;

·                        Ferring International Center S.A. (“Ferring”) markets Testim in certain countries of the EU and Paladin Labs Inc. (“Paladin”) markets Testim in Canada;

·                  TESTOPEL®, a long-acting implantable TRT product;

·                  Edex® the leading branded non-oral drug for ED;

·                  Osbon ErecAid®, the leading device for treating ED;

·                  Striant®, a buccal delivery system for TRT;

·                  XIAFLEX® for the treatment of adult Dupuytren’s patients with a palpable cord;

·                        Swedish Orphan Biovitrium AB (“Sobi”) has marketing rights for XIAPEX® (the EU tradename for collagenase clostridium histolyticum) in 71 Eurasian and African countries;.

·                        Asahi Kasei Pharma Corporation (“Asahi Kasei”) has development and commercial rights for XIAFLEX in Japan; and

·                        Actelion Pharmaceuticals Ltd (“Actelion”) has development and commercial rights for XIAFLEX in Canada, Australia, Brazil and Mexico.

·                  Five non-promoted products, including the following two respiratory products:

·                        Theo-24® for the treatment of COPD and asthma; and

·                        Semprex-D®, for the treatment of seasonal allergic rhinitis.

 

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We also have the exclusive marketing rights in the U.S. and Canada for STENDRATM, an FDA-approved oral therapy for ED.  We plan to begin shipping STENDRA in December 2013 and to commence promotional activities in January 2014.

 

We promote our six promoted products through three focused sales forces, totaling approximately 257 sales representatives.  These sales forces are now organized as follows:

 

·                  Team Primera consists of approximately 150 territories and is responsible for Testim and Edex, and will be responsible for STENDRA;

·                  Team Innovia consists of approximately 60 territories and is responsible for selling TESTOPEL and Osbon ErecAid.  Team Innovia will also have primary responsibility for selling XIAFLEX in Peyronie’s, if approved by the FDA.

·                  Team Agilis consists of 47 territories and is responsible for selling XIAFLEX in Dupuytren’s.

 

For the period covered by this Report, our pipeline included:

 

CCH

 

Regulatory Review:

 

· XIAFLEX for the treatment of Peyronie’s with our supplemental Biologics License Application (“sBLA”) having been accepted for filing in December 2012 with a PDUFA date scheduled for December 6, 2013

 

Phase III:

 

· XIAFLEX for the treatment of multiple Dupuytren’s cords, with top-line data expected to be reported in the fourth quarter of 2013

 

Phase II:

 

· XIAFLEX for the treatment of edematous fibrosclerotic panniculopathy (“EFP”), commonly known as cellulite, with top-line data having been reported in the fourth quarter of 2012 and a Phase IIa trial having commenced in October 2013

 

· XIAFLEX for the treatment of Adhesive Capsulitis, commonly known as Frozen Shoulder syndrome, with top-line data reported in the first quarter of 2013 and the initiation of a later stage study for the treatment of Frozen Shoulder syndrome in the fourth quarter of 2013

 

Testosterone

 

We expect to commence clinical studies in 2013 for our high concentration testosterone gel product.

 

Our vision is to build a rapidly growing, profitable and sustainable biopharmaceutical company. To achieve this vision we plan to:

 

· maximize revenues of our products in the currently approved indications;

 

· execute a successful launch of XIAFLEX for the treatment of Peyronie’s, if approved by the FDA;

 

· execute a successful launch of STENDRA for the treatment of ED;

 

· deliver on our current product pipeline;

 

· build out our business and development pipeline in specialty therapeutic areas through corporate development and licensing activities, such as the recent acquisition of Actient; and

 

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· continue our focus on financial discipline.

 

In the short term, we plan to focus on commercial execution with respect to our promoted products, successfully launching STENDRA for the treatment of ED, successfully launching XIAFLEX for Peyronie’s, if approved by the FDA, continuing to integrate the operations of Actient, preparing the submissions of a proposed multi-cord label expansion for XIAFLEX for Dupuytren’s and of an approximately 15-minute onset of action efficacy claim for STENDRA, bringing additional indications for XIAFLEX/CCH to market, and pursuing opportunities for growth through in-licensing or acquisition activities in our current or additional specialty therapeutic areas. We believe that we are well positioned to be a profitable and sustainable specialty biopharmaceutical company by executing on these core strategic initiatives. We believe that we can further leverage our sales forces and our expertise in clinical development and regulatory strategy with the addition of new products. We plan to be opportunistic and nimble with respect to corporate development and licensing opportunities, as we believe our recent acquisition of Actient demonstrates. We will continue to explore opportunities to add marketed products and/or product opportunities that we believe represent a good strategic fit and are fiscally responsible. Although we may seek products that have a therapeutic fit with our current products and product candidates, we believe that the core competencies we have with respect to drug development and commercialization can be applied to a number of other specialty focused therapeutic areas.

 

The product candidates in our pipeline are at various stages of preclinical and clinical development. The path to regulatory approval includes several phases of nonclinical and clinical study to collect data to support an application to regulatory authorities to allow us to market a product for treatment of a specified disease indication. There are many difficulties and uncertainties inherent in research and development and the introduction of new products. There is a high rate of failure inherent in new drug discovery and development. To bring a drug from the discovery phase to regulatory approval, and ultimately to market, takes many years and incurs significant cost. Failure can occur at any point in the process, including after the product is approved based on post-market factors. New product candidates that appear promising in development may fail to reach the market or may have only limited commercial success because of efficacy or safety concerns, inability to obtain necessary regulatory approvals, limited scope of approved uses, reimbursement challenges, difficulty or excessive costs to manufacture, or infringement of the patents or intellectual property rights of others. Delays and uncertainties in the FDA approval process and the approval processes in other countries can result in delays in product launches and lost market opportunity. Consequently, it can be very difficult to predict which products will ultimately be submitted for approval, which have the highest likelihood of obtaining approval, and which will be commercially viable and generate profits for the Company. Successful results in preclinical or phase I/II/III clinical studies may not be an accurate predictor of the ultimate safety or effectiveness of a drug or product candidate and do not guarantee that the FDA or the European Medicines Agency (“EMA”) will approve a product that we believe has an attractive clinical profile.

 

Phase I Clinical Trials

 

Phase I human clinical trials begin when regulatory agencies allow a request to initiate clinical investigations of a new drug or product candidate and usually involve small numbers of healthy volunteers or subjects. The trials are designed to determine the safety, metabolism, dosing and pharmacologic actions of a drug in humans, the potential side effects of the product candidates associated with increasing drug doses and, if possible, to gain early evidence of the product candidate’s effectiveness. Phase I clinical studies generally take from 6 to 12 months or more to complete.

 

Phase II Clinical Trials

 

Phase II clinical trials are conducted on a limited number of patients with the targeted disease, usually involving no more than several hundred patients, to evaluate appropriate dosage and the effectiveness of a drug for a particular indication or indications and to determine the common short-term side effects and risks associated with the drug. An initial evaluation of the drug’s effectiveness on patients is performed and additional information on the drug’s safety and dosage range is obtained. Our Phase II clinical trials typically include up to 200 patients and may take approximately two years to complete.

 

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Phase III Clinical Trials

 

Phase III clinical trials are performed after preliminary evidence suggesting effectiveness of a drug has been obtained. Phase III clinical trials are intended to gather additional information about the effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. They typically include controlled multi-center trials and involve a larger target patient population, typically including from several hundred to several thousand patients to ensure that study results are statistically significant. During Phase III clinical trials, physicians monitor patients to determine efficacy and to gather further information on safety. These trials are generally global in nature and are designed to generate data necessary to submit the product to regulatory agencies for marketing approval. Phase III testing varies and can often last from 2 to 5 years.

 

Regulatory Review

 

If a product successfully completes a Phase III clinical trial and is submitted to governmental regulators, such as the FDA in the United States or the EMA in the European Union, the time to final marketing approval can vary from six months (for a U.S. filing that is designated for priority review by the FDA) to several years, depending on a number of variables, such as the disease state, the strength and complexity of the data presented, the novelty of the target or compound, risk-management approval and the time required for the agency(ies) to evaluate the submission. There is no guarantee that a potential treatment will receive marketing approval, or that decisions on marketing approvals or indications will be consistent across geographic areas.

 

Recent Developments

 

On October 23, 2013, we announced the dosing of the first cohort of patients in our Phase IIa study of CCH for the treatment of EFP, commonly known as cellulite.

 

On October 10, 2013, we entered into an agreement with VIVUS whereby we obtained the exclusive right to market VIVUS’s ED product, STENDRA (avanafil), in the United States and Canada.  The parties also simultaneously signed a Commercial Supply Agreement pursuant to which VIVUS will be initially responsible for the manufacture and supply of STENDRA to us.

 

On October 5, 2013, at the 68th Annual Meeting of the American Society for Surgery of the Hand (“ASSH”), we announced results from Year 4 of the Collagenase Optimal Reduction of Dupuytren’s - Long-term Evaluation of Success Study (“CORDLESS”) regarding XIAFLEX for the treatment of Dupuytren’s.  The study assessed 623 joints in adult Dupuytren’s patients with a palpable cord from earlier Auxilium studies, indicating that 42.1 percent of patients previously successfully treated with XIAFLEX experienced disease recurrence and 57.9 percent did not experience disease recurrence based on the study’s definition.  Study authors also presented an update on XIAFLEX safety data following three years (36 months) of post-approval use at the ASSH Annual Meeting.  After an estimated 49,078 XIAFLEX injections were administered to approximately 36,500 adult patients in the U.S. for the treatment of Dupuytren’s with a palpable cord, there was no clinically meaningful change in the nature of events reported relative to the one year post-marketing safety profile.

 

On September 19, 2013, we entered into an Incremental Assumption Agreement (“Incremental Agreement”) with Morgan Stanley Senior Funding, Inc. (“MSSF”) under our existing Term Loan with MSSF, which originally provided for a $225,000,000 senior secured term loan.  Under the Incremental Agreement, we raised an additional $50,000,000 from a syndicate of lenders, and this additional amount is on terms consistent with our initial $225,000,000 senior secured credit facility.

 

On August 28, 2013, we announced that the FDA extended the PDUFA goal date for our sBLA for XIAFLEX for the treatment of Peyronie’s from September 6, 2013 to December 6, 2013.

 

On August 1, 2013, we and GlaxoSmithKline LLC announced the mutual termination of our U.S. co-promotion of Testim for the treatment of male hypogonadism, effective August 2, 2013.

 

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On August 1, 2013, we also announced that we had finalized our plans for our new sales force allocation.  Moving forward, we will utilize three field forces with a total of approximately 257 sales representatives.  The Primera sales force will consist of approximately 150 territories and will be responsible for Testim and Edex. The Innovia sales force consists of approximately 60 territories and is responsible for selling TESTOPEL and Osbon ErecAid.  The Innovia team also has primary responsibility for selling XIAFLEX in Peyronie’s, assuming this indication receives approval by the U.S. FDA.  The Agilis sales force is responsible for selling XIAFLEX in Dupuytren’s and consists of approximately 47 territories.

 

On July 15, 2013, we and Sobi announced a long-term collaboration for the development, supply and commercialization of XIAPEX (collagenase clostridium histolyticum) (EU tradename for XIAFLEX) in 71 Eurasian and African countries.  In addition, work is on-going to file for approval of XIAPEX for the treatment of Peyronie’s in the EU. Under the terms of the agreement, we expect to receive significant tiered royalties within the range of 55-65%, 50-60% and 45-55% based on sales of XIAPEX in Sobi’s territories, which will also cover payment for product supply.  The tiered royalty percentages will decrease by approximately 10% upon the occurrence of certain manufacturing milestones or July 1, 2016, whichever is earlier.  Additionally, Sobi could make up to $40 million in potential sales milestone payments to us.

 

Results of Operations

 

Revision to previously issued financial statements

 

In connection with the preparation of the consolidated financial statements for the third quarter of 2013, an incorrect classification was identified with respect to the manner in which we classified the tenant improvement allowance of $3,204 provided by the lessor in the lease for our new corporate headquarters which commenced on January 1, 2013. At recognition of the tenant improvement allowance provided, we properly recorded in our Consolidated Balance Sheets the cost of the improvements as a fixed asset and the tenant improvement allowance as a deferred rent credit. In the Consolidated Statement of Cash Flows provided in our Quarterly Report on Form 10-Q for the quarterly periods ended March 31, 2013 and June 30, 2013, the tenant improvements were incorrectly classified as cash used in investing activities and the offsetting increase in deferred rent was incorrectly classified as an adjustment of cash flows provided by operating activities. We have now determined that the tenant improvement allowance should have been netted against the Purchases of property and equipment to reflect the non-cash nature of these transactions in the periods presented. The effect of the misclassification in the Consolidated Statement of Cash Flows for the three months ended March 31, 2013 and the six months ended June 30, 2013 was a $3.2 million overstatement of both net cash provided by operating activities and net cash used in investing activities. We assessed this misclassification and concluded that it was not material to our previously issued financial statements. We have properly presented the tenant improvement transaction in the Consolidated Statement of Cash Flows for the nine months ended September 30, 2013. The revision of the three month period ended March 31, 2013 and six month period ended June 30, 2013 will be reflected in our first and second quarter filings of fiscal 2014, respectively. Our Consolidated Statements of Operations for first and second quarters of 2013 and our Consolidated Balance Sheets as of March 31, 2013 and June 30, 2013 were not affected by this misclassification and remain unchanged.

 

Three Months Ended September 30, 2013 and 2012

 

Net revenues.  Net revenues for the three months ended September 30, 2013 and 2012 comprise the following:

 

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Three months ended September 30,

 

 

 

 

 

2013

 

2012

 

Change

 

% Change

 

 

 

(in millions)

 

 

 

Testim revenues-

 

 

 

 

 

 

 

 

 

Net U.S. revenues

 

$

50.7

 

$

54.6

 

$

(3.9

)

-7

%

International revenues

 

1.6

 

0.7

 

0.9

 

126

%

 

 

52.3

 

55.4

 

(3.0

)

-6

%

XIAFLEX revenues-

 

 

 

 

 

 

 

 

 

Net U.S. revenues

 

15.9

 

13.2

 

2.7

 

20

%

International revenues

 

1.7

 

2.5

 

(0.8

)

-32

%

 

 

17.6

 

15.7

 

1.9

 

12

%

Other net U.S. revenues-

 

 

 

 

 

 

 

 

 

TESTOPEL

 

20.6

 

 

20.6

 

N/A

 

Edex

 

8.0

 

 

8.0

 

N/A

 

Other

 

9.7

 

 

9.7

 

N/A

 

 

 

38.3

 

 

38.3

 

N/A

 

Total net revenues

 

$

108.1

 

$

71.0

 

$

37.1

 

52

%

 

 

 

 

 

 

 

 

 

 

Revenue allowance as a percentage of gross U.S. revenues

 

31

%

32

%

-1

%

 

 

 

Net U.S. revenues shown in the above table represent the product sales of the Company within the U.S. net of allowances provided on such sales. International revenues represent the amortization of deferred up-front and milestone payments the Company has received on its out-licensing agreements, together with royalties earned on product sales by the licensees.

 

Testim

 

The decrease in Testim net U.S. revenues is principally due to a loss in market share as a result of the continued efforts of competing products and changes in our managed care coverage.  According to NPA data from IMS, a pharmaceutical market research firm, Testim total prescriptions for the third quarter of 2013 decreased 18% compared to the comparable period of 2012. Offsetting this decline in prescription demand, Testim net U.S. product sales in the third quarter of 2013 benefited from a build-up of wholesaler inventories compared to 2012.

 

XIAFLEX

 

Total revenues for XIAFLEX in the third quarter of 2013 were $17.6 million compared to $15.7 million in the third quarter of 2012. Net revenues for the three months ended September 30, 2013 include $15.9 million of net U.S. product sales of XIAFLEX compared to the $13.2 million recorded in the third quarter of 2012. This increase represents the growth in product shipments and an increase in the net selling price of 1%. XIAFLEX international revenues for the three months ended September 30, 2013 amounted to $1.7 million compared to $2.5 million recorded in the third quarter of 2012.

 

Other net U.S. revenues

 

Other U.S. net revenues for the three months ended September 30, 2013 are sales of the products we acquired in the April 26, 2013 acquisition of Actient.  These revenues included sales of TESTOPEL,

 

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Edex and other U.S. products of $20.6 million, $8.0 million and $9.7 million, respectively. We did not have any sales of such products in the prior year since we had not yet acquired Actient.

 

Revenue allowances

 

Revenue allowances as a percentage of gross U.S. revenues for the third quarter of 2013 compared to that of 2012 decreased due to lower level of allowances on sales of Actient products offset in part by higher levels of managed care contract rebates and government health plan charge-backs on sales of Testim.

 

Cost of goods sold. Cost of goods sold was $33.6 million and $15.8 million for the three months ended September 30, 2013 and 2012, respectively.  Cost of goods sold reflects the cost of product sold, royalty obligations for Testim and XIAFLEX due to the Company’s licensors, and the amortization of the deferred costs associated with the Pfizer Agreement. The increase in cost of goods sold for the three months ended September 30, 2013 compared to 2012 was principally attributable to the Actient acquisition, offset in part by the decrease in Testim units sold.  Gross margin on net revenues was 70% for the quarter ended September 30, 2013 compared to 78% for the comparable period in 2012.  The decrease in the gross margin rate is due to the $5.4 million acquisition accounting step-up of the acquired Actient inventory and a decline in XIAFLEX U.S. product sales margins due to costs related to XIAFLEX manufacturing initiatives, offset in part by the higher margin contribution of Actient products before the acquisition accounting step-up.

 

Research and development expenses. Investments in research and development for the quarter ended September 30, 2013 were $11.8 million, compared to $10.6 million for 2012.  This increase in expense results principally from spending on the ongoing XIAFLEX multi-cord Phase III clinical trial for Dupuytren’s, partially offset by lower spending on XIAFLEX clinical trials for the treatment of Peyronie’s.

 

Selling, general and administrative expenses. Selling, general and administrative expenses totaled $62.8 million for the quarter ended September 30, 2013 compared with $55.3 million for the year-ago quarter. This increase was primarily due to the added expenses of acquired Actient operations, transaction and integration costs of the Actient acquisition and an increase in marketing and advertising spend related to the potential launch, if approved, of XIAFLEX for the treatment of Peyronie’s, partially offset by lower advertising spending for Dupuytren’s and non-cash costs included in the third quarter of 2012 for the now mutually terminated Testim co-promotion agreement with GSK.

 

Amortization of purchased intangibles.  Amortization of purchased intangibles relates to the amortization of the finite-lived intangible assets acquired in the April, 2013 Actient acquisition.

 

Change in contingent consideration.  The change in contingent consideration represents the change in the fair value of the contingent consideration recorded as part of the April, 2013 Actient acquisition due to the time value of money and increases in forecasted TESTOPEL revenues. This expense may fluctuate significantly in future periods depending on changes in estimates, including probabilities associated with achieving forecasted Actient product revenues on which royalties are payable and the periods in which we estimate sales level milestones will be achieved.

 

Interest expense.  Interest expense in 2013 represents accrual of the cash interest and the amortization of the debt discount and issuance costs relating to the $350 million aggregate principal amount of the 1.5% Convertible Senior Notes we issued in January 2013 and the $275 million Term Loan facility.

 

Other income, net.  Other income (expense) relates primarily to interest earned on cash, cash equivalents and short-term investments.

 

Income tax expense.  The income tax expense for the three months ended September 30, 2013 represents income

 

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taxes payable in certain state jurisdictions.

 

Nine Months Ended September 30, 2013 and 2012

 

Net revenues.  Net revenues for the nine months ended September 30, 2013 and 2012 comprise the following:

 

 

 

Nine months ended Sptember 30,

 

 

 

 

 

2013

 

2012

 

Change

 

% Change

 

 

 

(in millions)

 

 

 

Testim revenues-

 

 

 

 

 

 

 

 

 

Net U.S. revenues

 

$

149.2

 

$

175.0

 

$

(25.8

)

-15

%

International revenues

 

3.0

 

2.8

 

0.2

 

8

%

 

 

152.2

 

177.8

 

(25.6

)

-14

%

XIAFLEX revenues-

 

 

 

 

 

 

 

 

 

Net U.S. revenues

 

42.8

 

37.7

 

5.1

 

14

%

International revenues

 

14.3

 

7.4

 

7.0

 

95

%

 

 

57.1

 

45.1

 

12.1

 

27

%

Other net U.S. revenues-

 

 

 

 

 

 

 

 

 

TESTOPEL

 

35.0

 

 

35.0

 

N/A

 

Edex

 

13.0

 

 

13.0

 

N/A

 

Other

 

17.5

 

 

17.5

 

N/A

 

 

 

65.5

 

 

65.5

 

N/A

 

Total net revenues

 

$

274.8

 

$

222.8

 

$

52.0

 

23

%

 

 

 

 

 

 

 

 

 

 

Revenue allowance as a percentage of gross U.S. revenues

 

31

%

32

%

-1

%

 

 

 

Net U.S. revenues shown in the above table represent the product sales of the Company within the U.S. net of allowances provided on such sales. International revenues represent the amortization of deferred up-front and milestone payments the Company has received through its out-licensing agreements, together with royalties earned on product sales by the licensees.

 

During the first quarter of 2012, the Company recorded a correction of an error in its financial statements for the year ended December 31, 2011 that resulted from an understatement of the accrual for government health plan charge-backs. This correction reduced Net revenues and Net income reported for the nine months ended September 30, 2012 in the amount of $820.  Management believes this adjustment is not material to the Company’s results of operations for 2012.

 

Testim

 

The decrease in Testim net U.S. revenues is principally due to a loss in market share as a result of the continued efforts of competing products and changes in our managed care coverage.  According to NPA data from IMS, a pharmaceutical market research firm, Testim total prescriptions for the first nine months of 2013 decreased 17% compared to the comparable period of 2012. Testim net U.S. product sales in the first nine months of 2013 benefited from an increase in net selling price of 3% compared to 2012 as contract rebates and government health plan charge-backs principally offset the benefit of the cumulative impact of gross price increases.

 

XIAFLEX

 

Total revenues for XIAFLEX in the first nine months of 2013 were $57.1 million compared to $45.1 million in the first nine months of 2012. Net revenues for the nine months ended September 30, 2013 include $42.8 million of net U.S. product sales of XIAFLEX compared to the $37.7 million recorded in

 

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the first nine months of 2012. This increase represents the growth in product shipments and an increase in the net selling price of 1%. The increase in XIAFLEX international revenues results from the increase in amortization resulting from the decision with Pfizer to mutually terminate the Pfizer Agreement effective April 24, 2013.  There will not be any such amortization applicable to periods after April 24, 2013.

 

Other net U.S. revenues

 

Other net U.S. revenues for the nine months ended September 30, 2013 are sales of the products we acquired in the April 26, 2013 acquisition of Actient.  These revenues included sales of TESTOPEL, Edex and other U.S. products of $35.0 million, $13.0 million and $17.5 million, respectively. We did not have any sales of such products in the prior year since we had not yet acquired Actient.

 

Revenue allowances

 

Revenue allowances as a percentage of gross U.S. revenues for the first nine months of 2013 compared to that of 2012 decreased due to lower level of allowances on sales of Actient products offset in part by higher levels of managed care contract rebates and government health plan charge-backs on sales of Testim.

 

Cost of goods sold.  Cost of goods sold was $75.9 million and $50.3  million for the nine months ended September 30, 2013 and 2012, respectively.  Cost of goods sold reflects the cost of product sold, royalty obligations for Testim and XIAFLEX due to the Company’s licensors, and the amortization of the deferred costs associated with the Pfizer Agreement. The increase in cost of goods sold for the nine months ended September 30, 2013 compared to 2012 was principally attributable to the Actient acquisition, offset in part due to the decrease in Testim units sold.  Gross margin on our net revenues was 72% in the first nine months of 2013 compared to 77% in the comparable 2012 period. The decrease in the gross margin rate is due to the $9.9 million acquisition accounting step-up of the acquired Actient inventory, a decline in XIAFLEX U.S. product sales margins due to lower production volumes and costs related to XIAFLEX manufacturing initiatives and write-downs of XIAPEX international inventories to estimated net realizable value, offset in part by the benefit of the increased amortization resulting from the Pfizer Agreement termination and the higher margin contribution of Actient products before the acquisition accounting step-up.

 

Research and development expenses. Research and development spending for the nine months ended September 30, 2013 was $37.3 million, compared to $32.8 million for 2012.  This increase in expense results principally from spending on the ongoing XIAFLEX multi-cord phase III clinical trial for Dupuytren’s, partially offset by lower spending on XIAFLEX clinical trials for the treatment of Peyronie’s.

 

Selling, general and administrative expenses. Selling, general and administrative expenses totaled $182.0 million for the nine months ended September 30, 2013 compared with $144.9 million for the year-ago comparable period. This increase was primarily due to the added expenses of acquired Actient operations, transaction and integration costs of the Actient acquisition and merger related restructuring expenses and an increase in marketing and advertising spend related to the potential launch, if approved, of XIAFLEX for the treatment of Peyronie’s, partially offset by lower advertising spending for Dupuytren’s and non-cash costs included in 2012 for the now mutually terminated Testim co-promotion agreement with GSK.

 

Amortization of purchased intangibles.  Amortization of purchased intangibles relates to the amortization of the finite-lived intangible assets acquired in the April, 2013 Actient acquisition.

 

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Change in contingent consideration.  The change in contingent consideration represents the change in the fair value of the contingent consideration recorded as part of the April, 2013 Actient acquisition due to the time value of money and increases in forecasted TESTOPEL revenues. This expense may fluctuate significantly in future periods depending on changes in estimates, including probabilities associated with achieving forecasted Actient product revenues on which royalties are payable and the periods in which we estimate sales level milestones will be achieved.

 

Interest expense.  Interest expense in 2013 represents accrual of the cash interest and the amortization of the debt discount and issuance costs relating to the $350 million aggregate principal amount of the 1.5% Convertible Senior Notes we issued in January 2013 and the $275 million Term Loan facility.

 

Other income, net.  Other income (expense) relates primarily to interest earned on cash, cash equivalents and short-term investments.

 

Income tax benefit.  The tax benefit for 2013 represents the $92.6 million release of the valuation allowance for deferred tax assets, net of recognition of income taxes on current income in certain state jurisdictions and certain discrete items of tax, net of a current tax provision of $0.5 million for income taxes in certain state jurisdictions. As part of the required accounting for the Actient acquisition, we recorded deferred tax liabilities related to differences between the book basis and the tax basis of certain Actient amortizable assets.  These deferred tax liabilities will serve as reversible temporary differences that give rise to future taxable income and, therefore, they serve as a source of income that permits the recognition of certain existing deferred tax assets of the Company.

 

Liquidity and Capital Resources

 

We had $121.4 million and $157.4 million in cash, cash equivalents and short-term investments as of September 30, 2013 and December 31, 2012, respectively. We believe that our current financial resources and sources of liquidity will be adequate for the Company to fund our anticipated operations for the next twelve months. We may elect to raise additional funds in order to enhance our sales and marketing efforts for additional products we may acquire, commercialize any product candidates that receive regulatory approval, enhance our ability to acquire businesses or companies or to acquire or in-license approved products or product candidates or technologies for development, and to maintain adequate cash reserves to minimize financial market fundraising risks. Insufficient funds may cause us to delay, reduce the scope of, or eliminate one or more of our development, commercialization or expansion activities. Our future capital needs and the adequacy of our available funds will depend on many factors, including:

 

·                  our ability to integrate the operations of Actient and its subsidiaries into our operations successfully and efficiently;

 

·                  our ability to materialize the synergies and benefits, including revenue and profits growth, from the acquisition of Actient;

 

·                  the risks or costs associated with the Actient acquisition being greater than we anticipate;

 

·                  our ability to successfully market our products;

 

·                  our ability to successfully launch new products, including STENDRA, and to successfully launch new indications, or obtain label expansions, for existing products, including XIAFLEX for the treatment of Peyronie’s and XIAFLEX for the treatment of multiple cords in Dupuytren’s, in each case if approved by the U.S. Food and Drug Administration (“FDA”);

 

·                  entry into the marketplace of competitive products, including a generic or branded generic to Testim or a competing product;

 

·                  third-party payor coverage and reimbursement for our products;

 

·                  the cost of manufacturing, distributing, marketing and selling our products;

 

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·                  the scope, rate of progress and cost of our product development activities;

 

·                  the costs of supplying and commercializing our products and product candidates;

 

·                  the effect of competing technological and market developments;

 

·                  the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights, including costs associated with the matters described in Part II, Item 1 of this Quarterly Report under “Legal Proceedings”, or the outcome of any such matters, or any other matter that may result from a challenge to our intellectual property rights; and

 

·                  the extent to which we acquire or invest in businesses and technologies.

 

If additional funds are required, we may raise such funds from time to time through public or private sales of equity or debt securities or from bank or other loans. Financing may not be available on acceptable terms, or at all, and our failure to raise capital when needed could materially adversely impact our growth plans and our financial condition or results of operations. Additional equity financing, if available, may be dilutive to the holders of our common stock and may involve significant cash payment obligations and covenants that restrict our ability to operate our business.

 

Our Term Loan, filed on April 29, 2013 with the SEC as an exhibit to our Current Report on Form 8-K, generally restricts our ability to raise capital by issuing or incurring more debt or equity.  With respect to debt, we are free to exercise the remainder of the incremental facility under the Term Loan to borrow up to an additional $50 million and, separately, we are also free to issue or incur up to a further $25 million in additional indebtedness and certain other limited baskets of indebtedness for specified purposes, but we are generally not permitted to issue or incur additional indebtedness without either the consent of the Term Loan lenders or, in certain circumstances, the satisfaction of a total leverage ratio test which measures our total leverage ratio at the time of the issuance or incurrence of the new indebtedness against our total leverage ratio in effect when we entered into the Term Loan.  With respect to equity, we are generally free to issue new capital stock.  However, our ability to issue disqualified capital stock, which is generally equity with debt-like features (such as certain types of preferred stock and convertible securities), is generally capped at $10 million outstanding at any one time.  The Term Loan also restricts how we may use any additional capital we raise.

 

Sources and Uses of Cash

 

Cash used in operations was $0.3 million for the nine months ended September 30, 2013 compared to cash provided by operations of $11.3 million for the comparable 2012 period. Cash used in operations in 2013 resulted primarily from the net income for the period, net of the non-cash income tax benefit and non-cash charges to income. Cash provided by operations in 2012 resulted primarily from the 10.5 million of up-front and milestone payments received from Actelion, offset by BioSpecifics’s share of these payments amounting to $0.6 million.

 

Cash used in investing activities was $503.3 million for the nine months ended September 30, 2013 compared to cash used of $19.5 million for the nine months ended September 30, 2012. Cash used in investing activities for 2013 principally represents $588.3 million of cash paid in the acquisition of Actient and investments in property and equipment, offset by redemptions (net of purchases) of short-term marketable debt securities. The cash impact of investing activities 2012 relates primarily to purchases, net of redemptions, of short-term investments in marketable debt securities and investments in property and equipment.  Our investments in property and equipment relate primarily to improvements made to our Horsham biological manufacturing facility, our information technology infrastructure and, in 2013, our new headquarters building.

 

Cash provided by financing activities was $559.0 million and $12.0 million for the nine months ended September 30, 2013 and 2012, respectively.  Cash provided by financing activities in 2013

 

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principally represents the net proceeds of $338.9 million and $262.9 million from the issuance of the 2018 Senior Convertible Notes and the Term Loan, respectively, offset by net payments of $28.5 related to our hedge transactions for the convertible notes and $6.2 million of repayments on the Term Loan. Cash provided by financing activities for 2012 reflects cash receipts from Employee Stock Purchase Plan purchases and from stock option exercises, net of treasury shares acquired in satisfaction of tax withholding requirements on stock awards to certain officers and employees.

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements as defined in Item 303(a) (4) of Regulation S-K.

 

New Accounting Pronouncements

 

See Note 1(d) - New Accounting Pronouncements to the Company’s Consolidated Financial Statements.

 

Item 3.  Quantitative and Qualitative Disclosures About Market Risk.

 

We are subject to market risks in the normal course of our business, including changes in interest rates and exchange rates. There have been no significant changes in our exposure to market risks since December 31, 2012. Refer to “Item 7 A. Quantitative and Qualitative Disclosures About Market Risk” of our Annual Report on Form 10-K for the year ended December 31, 2012 for additional information.

 

Item 4.  Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures.

 

Our Chief Executive Officer and Chief Financial Officer have concluded, based on their respective evaluations as of the end of the period covered by this Report, that our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this Report are effective to provide reasonable assurance that the information required to be disclosed in the reports we file under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) is accumulated and communicated to management as appropriate to allow timely decisions regarding required disclosures. A controls system cannot provide absolute assurances, however, that the objectives of the controls system are met, and no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within a company have been detected.

 

Internal Control.

 

The Company acquired Actient on April 26, 2013.  The total assets and total revenues of Actient represented approximately 79% and 27%, respectively, of the related consolidated financial statements as of and for the period ended September 30, 2013.  As the acquisition occurred in April 2013 and Actient was previously not subject to SOX 404 requirements, the scope of the Company’s assessment of the design and effectiveness of internal control over financial reporting for the fiscal year 2013 will exclude Actient.  This exclusion is in accordance with the SEC’s general guidance that an assessment of a recently acquired business may be omitted from the scope in the year of acquisition.

 

Changes in Internal Control over Financial Reporting.

 

No change in our internal control over financial reporting occurred during our most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II.  OTHER INFORMATION

 

Item 1.  Legal Proceedings.

 

For a description of the ongoing litigations with each of Upsher-Smith Pharmaceuticals, Inc. (“Upsher-Smith”) and Watson Pharmaceuticals, Inc. (now known as Actavis, Inc.) (“Watson”), please see “Legal Proceedings” in Part II, Item 1 of our Quarterly Report on Form 10-Q for the three-month period ended June 30, 2013, filed with the SEC on August 1, 2013 (the “Q2 10-Q Litigation Disclosure”).

 

As previously disclosed in our Current Report on Form 8-K filed with the SEC on August 20, 2013, Upsher-Smith announced on August 16, 2013 that the FDA granted tentative approval of the Upsher-Smith NDA (as defined in the Q2 10-Q Litigation Disclosure) with the brand name VogelxoTM for the Upsher-Smith testosterone gel product.

 

As previously disclosed in the Q2 10-Q Litigation Disclosure, on March 26, 2013, Auxilium submitted a Citizen Petition to the FDA with respect to Upsher-Smith’s NDA referencing Testim in particular, and generic testosterone gels in general.  We requested that, in the event of FDA approval of Upsher-Smith’s NDA, the FDA refrain from designating Upsher-Smith’s testosterone gel as therapeutically equivalent to Testim, and require that the label state that the product is not interchangeable with other transdermal testosterone gels.  Although the FDA has not yet substantively replied to this Citizen Petition, the FDA did recently communicate to Auxilium that it has not yet resolved the issues raised in the Citizen Petition. The therapeutic equivalence rating may determine whether the Upsher-Smith testosterone product, if launched, would be launched as a generic, a branded generic, or simply another branded competitor in the TRT gel market.  It is unclear at this time when the FDA will substantively respond to our Citizen Petition.

 

We are party to various actions and claims arising in the normal course of business that we do not believe are material.  We believe that amounts accrued for awards or assessments in connection with all such matters are adequate and that the ultimate resolution of these matters will not have a material adverse effect on our financial position or the manner in which we conduct our business. However, there exists a reasonable possibility of loss in excess of the amounts accrued, the amount of which cannot currently be estimated. While we do not believe that the amount of such excess loss could be material to our financial position, any such loss could have a material adverse effect on our results of operations or the manner in which we conduct our business in the period(s) during which the underlying matters are resolved.

 

Item 1A.  Risk Factors.

 

In addition to the other information contained in this Report, you should carefully consider the factors discussed in Part I, Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2012 (our “Form 10-K”), as updated by our Current Report on Form 8-K filed with the SEC on April 29, 2013, in “Item 1A — Risk Factors” of Part II of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2013, and “Item 1A — Risk Factors” of Part II of our Quarterly Report on Form 10-Q for the quarter ended June, 2013, in evaluating our business, financial position, future results and prospects. The information presented below updates and supplements those risk factors for the matters  identified below and should be read in conjunction with the risks and other information contained in our Form 10-K and this Quarterly Report.  The risks described in our Form 10-K, as updated as described above and as set forth below, are not the only risks we face. Additional risks that we do not presently know or that we currently believe are immaterial could also materially and adversely affect any of our business, financial position, future results or prospects.

 

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Risks Related to Commercialization

 

Testim, TESTOPEL and Striant® (together our “TRT Products”) and Edex, Osbon ErecAid and, when launched, STENDRA (together our “ED Products”) compete in a very competitive market, and if we are unable to compete effectively with the other companies that market products for the treatment of urologic or sexual health disorders, our ability to generate revenues will be limited.

 

The TRT and ED markets are highly competitive. Our success will depend, in part, on our ability to grow our prescription volume and protect our share of the market from competitors. Potential competitors in North America, Europe and elsewhere include major pharmaceutical companies, specialty pharmaceutical companies and biotechnology firms, universities and other research institutions and government agencies. As competition has increased, access to managed care plans has also become more competitive in the TRT and ED markets.  Pricing, rebate and discount strategies required to gain or maintain access or in some cases preferential access to certain managed care plans may have a material adverse effect on the revenue we derive from our TRT Products and ED Products.  The loss of preferred status or any access at all for certain managed care plans may have a material adverse effect on our TRT Products’ and/or our ED Products’ share of their respective markets.

 

Other pharmaceutical or medical device companies may develop generic versions of our TRT Products or our ED Products or any products that compete with our TRT Products or ED Products that do not infringe our patents or other proprietary rights, and, as a result, our business may be adversely affected. Because the ingredients of our products and parts for our devices are commercially available to third parties, it is possible that competitors may design formulations, propose dosages or develop methods of administration that would be outside the scope of the claims of one or more, or of all, of the patent and other proprietary rights that we in-license. This would enable their products to effectively compete with our products. Governmental and other pressures to reduce pharmaceutical costs may result in physicians writing prescriptions for these generic products. The strategies that we deploy to make products price-competitive with lower cost generic products may reduce our profit margins on our products significantly.  Consequently, increased competition from the sale of competing generic products could cause a material decrease in revenue from our products and adversely affect our business.

 

In addition to potential generic competition, Androgel 1% and Androgel 1.62%, two additional competing TRT products were launched in the U.S. in the first quarter of 2011 and several other pharmaceutical companies have TRT products in development that may be approved for marketing in the U.S. and the rest of the world.

 

Risks Related to Collaborators

 

We do not control the actions of our collaborators, and breaches of our agreements by any of them as well as disagreements over strategic goals could affect our business, our regulatory approvals or our reputation.

 

We have agreements in place with our collaborators, including Pfizer, Sobi, Asahi Kasei, Actelion, VIVUS and BioSpecifics Technologies Corp. (“BioSpecifics”), and we expect that any future collaborators would similarly be engaged under contract. We also have entered into agreements with Ferring and Paladin under which we have granted them the right to commercialize Testim in Europe and Canada, respectively. Nevertheless, for reasons that we may not have an ability to foresee or control, any of our collaborators may breach their respective agreements. We also may disagree with our collaborators as to strategic issues or the manner in which our rights should be enforced. Depending on its nature, a breach could affect our regulatory approvals for our products and could affect our reputation if the consequences of a breach are imputed to us. We may need to engage in costly litigation to enforce our rights, and we may not prevail in such litigation. A breach by, or disagreement with, one of our

 

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collaborators may lead to termination of the applicable agreement, which, in the case of a license agreement, may affect the scope of our license, such as modifying an exclusive license to a non-exclusive license. Any such breach or disagreement and its consequences could have a material adverse effect on our business and financial condition.

 

Risks Related to Intellectual Property

 

If we breach any of the agreements under which we license development or commercialization rights to products or technology from others, we could lose license rights that are critical to our business.

 

We are a party to a number of license and other agreements by which we have rights to use the intellectual property of third parties that are necessary for us to operate our business. In particular, we have obtained the exclusive right to develop and commercialize Testim pursuant to a license agreement with FCB. FCB may unilaterally terminate the agreement if we fail to make payments under this agreement and this failure continues for a period of 30 days following written notice to us by FCB. If the agreement is properly terminated by FCB, we may not be able to manufacture or sell Testim.

 

We have also obtained exclusive worldwide rights from BioSpecifics to develop, market and sell products, other than dermal formulations labeled for topical administration, that contain BioSpecifics’s enzyme, which we refer to as XIAFLEX, for the treatment of Dupuytren’s, and, potentially, for the treatment of Peyronie’s, Frozen Shoulder syndrome and cellulite. Either party may terminate this agreement in the event of bankruptcy or insolvency by the other party. Additionally, either party may terminate this agreement if the other party is in material breach of its obligations under the agreement which continues for a period of 90 days following receipt of written notice of such material breach. We may terminate this agreement in its entirety, or on a country-by-country basis, on an indication-by-indication basis, or on a product-by-product basis, at any time upon 90 days prior written notice to BioSpecifics. If this agreement is properly terminated by BioSpecifics, we may not be able to execute our strategy to commercialize XIAFLEX for Dupuytren’s or to develop and potentially commercialize XIAFLEX for the treatment of Peyronie’s, Frozen Shoulder syndrome, cellulite or future product candidates utilizing BioSpecifics’ enzyme. If this agreement is properly terminated by us, we will retain a non-exclusive license for these rights.

 

VIVUS granted us the exclusive right to commercialize its pharmaceutical product STENDRA for the treatment of any urological disease or condition in humans, including male erectile dysfunction, in the U.S. and Canada and their respective territories. Either party may terminate this agreement as a result of the other party’s material breach or bankruptcy. VIVUS may terminate this agreement immediately upon written notice to us if we are excluded from participation in the U.S. federal healthcare programs.  After the first anniversary of the product launch in the U.S., we may terminate the agreement for any reason upon 180 days written notice.  If this agreement is properly terminated by VIVUS, we will no longer be able to commercialize STENDRA.

 

We expect to enter into additional licenses and other similar agreements in the future. These licenses and agreements may impose various development, commercialization, funding, royalty, diligence or other obligations on us. If we breach any of these obligations, the licensor may have the right to terminate the license or render the license non-exclusive, which could make it impossible for us to develop, manufacture or sell the products covered by the license.

 

Disputes may arise with respect to our licensing and other agreements regarding manufacturing, development and commercialization of any products relating to our in-licensed intellectual property. These disputes could lead to delays in or termination of the development, manufacture and

 

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commercialization of our products or our product candidates or to litigation and could have a material adverse effect on our business.

 

Item 2.  Unregistered Sales of Equity Securities and Use of Proceeds.

 

Issuer Purchases of Equity Securities

 

None.

 

Unregistered Sale of Equity Securities

 

None.

 

Use of Proceeds

 

None.

 

Item 5.  Other Information.

 

As previously disclosed on a Current Report on Form 8-K filed with the SEC Commission on May 21, 2013, we and GlaxoSmithKline LLC (“GSK”) entered into an agreement for the co-promotion of Testim in the U.S. on May 18, 2012 (the “GSK Agreement”).  On July 31, 2013, we and GSK entered into Amendment No. 1 to the GSK Agreement (the “Amendment”), whereby we mutually agreed to terminate the GSK Agreement, effective August 2, 2013.  The Amendment mutually terminates our co-promotion relationship with GSK for Testim in the U.S.  The Amendment also provides for a mutual release of all claims.  No other consideration was given or payable in connection with the Amendment and no monies are owed to either party.  No other relationship between us and GSK currently exists.  The Amendment is attached as an exhibit to our Quarterly Report on Form 10-Q for the three month period ended June 30, 2013, filed with the SEC on August 1, 2013, and is incorporated herein by reference.  The foregoing description of the Amendment is qualified in its entirety by reference to the full text of the Amendment.

 

Item 6.  Exhibits.

 

Exhibit
No.

 

Description

 

 

 

3.1

 

Fifth Restated Certificate of Incorporation of the Registrant (filed as Exhibit 3.1 to the Registrant’s Quarterly Report on Form 10-Q filed on August 16, 2004, File No. 000-50855, and incorporated by reference herein).

 

 

 

3.2

 

Amended and Restated Bylaws of the Registrant as amended on June 21, 2012 (filed as Exhibit 3.2 to the Registrant’s Quarterly Report on Form 10-Q filed on July 31, 2012, File No. 000-50855, and incorporated by reference herein).

 

 

 

10.1

 

Incremental Assumption Agreement dated September 19, 2013, by and among Auxilium Pharmaceuticals, Inc., as borrower, and its existing domestic subsidiaries, as guarantors, the incremental term loan lenders

 

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from time to time party thereto and Morgan Stanley Senior Funding, Inc. as administrative agent, and as sole lead arranger and bookrunner (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on September 20, 2013, File No. 000-50855, and incorporated by reference herein).

 

 

 

10.2#

 

Amendment No. 1 to the Co-Promotion Agreement, dated July 31, 2013, by and among Auxilium Pharmaceuticals, Inc. and GlaxoSmithKline LLC (filed as Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed on August 1, 2013, File No. 000-50855, and incorporated by reference herein).

 

 

 

10.3

 

Collaboration Agreement, dated July 15, 2013, by and among Swedish Orphan Biovitrum AB, AUXILIUM UK LTD, and Auxilium International Holdings, Inc. (filed as Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed on August 1, 2013, File No. 000-50855, and incorporated by reference herein).

 

 

 

31.1†

 

Certification of Adrian Adams, the Registrant’s Principal Executive Officer, required by Rule 13a-14(a) or Rule 15d-14(a).

 

 

 

31.2†

 

Certification of James E. Fickenscher, the Registrant’s Principal Financial Officer, required by Rule 13a-14(a) or Rule 15d-14(a).

 

 

 

32†

 

Certification of Adrian Adams, the Registrant’s Principal Executive Officer, and James E. Fickenscher, the Registrant’s Principal Financial Officer, required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).

 

 

 

101.INS§

 

XBRL Instance Document

 

 

 

101.SCH§

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL§

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.LAB§

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE§

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

101.DEF§

 

XBRL Taxonomy Extension Definition Linkbase Document

 


#                          Certain information in this exhibit has been omitted pursuant to an Order Granting Confidential Treatment issued by the SEC.

 

                          Filed herewith.

 

§                          XBRL (Extensible Business Reporting Language) information is furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934, and is not subject to liability under those sections, is not part of any registration statement or prospectus to which it relates and is not incorporated or deemed to be incorporated by reference into any registration statement, prospectus or other document.

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

AUXILIUM PHARMACEUTICALS, INC.

 

 

 

 

Date: November 6, 2013

/s/ Adrian Adams

 

Adrian Adams

 

Chief Executive Officer and President

 

(Principal Executive Officer)

 

 

 

 

 

AUXILIUM PHARMACEUTICALS, INC.

 

 

 

 

Date: November 6, 2013

/s/ James E. Fickenscher

 

James E. Fickenscher

 

Chief Financial Officer

 

(Principal Financial and Accounting Officer)

 

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EXHIBIT INDEX

 

Exhibit No.

 

Description

 

 

 

3.1

 

Fifth Restated Certificate of Incorporation of the Registrant (filed as Exhibit 3.1 to the Registrant’s Quarterly Report on Form 10-Q filed on August 16, 2004, File No. 000-50855, and incorporated by reference herein).

 

 

 

3.2

 

Amended and Restated Bylaws of the Registrant amended as of June 21, 2012 (filed as Exhibit 3.2 to the Registrant’s Quarterly Report on Form 10-Q filed on July 31, 2012, File No. 000-50855, and incorporated by reference herein).

 

 

 

10.1

 

Incremental Assumption Agreement dated September 19, 2013, by and among Auxilium Pharmaceuticals, Inc., as borrower, and its existing domestic subsidiaries, as guarantors, the incremental term loan lenders from time to time party thereto and Morgan Stanley Senior Funding, Inc. as administrative agent, and as sole lead arranger and bookrunner (filed as Exhibit 10.1 to the Registrant’s Current Report on Form 8-K filed on September 20, 2013, File No. 000-50855, and incorporated by reference herein).

 

 

 

10.2#

 

Amendment No. 1 to the Co-Promotion Agreement, dated July 31, 2013, by and among Auxilium Pharmaceuticals, Inc. and GlaxoSmithKline LLC (filed as Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q filed on August 1, 2013, File No. 000-50855, and incorporated by reference herein).

 

 

 

10.3

 

Collaboration Agreement, dated July 15, 2013, by and among Swedish Orphan Biovitrum AB, AUXILIUM UK LTD, and Auxilium International Holdings, Inc. (filed as Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q filed on August 1, 2013, File No. 000-50855, and incorporated by reference herein).

 

 

 

31.1†

 

Certification of Adrian Adams, the Registrant’s Principal Executive Officer, required by Rule 13a-14(a) or Rule 15d-14(a).

 

 

 

31.2†

 

Certification of James E. Fickenscher, the Registrant’s Principal Financial Officer, required by Rule 13a-14(a) or Rule 15d-14(a).

 

 

 

32†

 

Certification of Adrian Adams, the Registrant’s Principal Executive Officer, and James E. Fickenscher, the Registrant’s Principal Financial Officer, required by Rule 13a-14(b) or Rule 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350).

 

 

 

101.INS§

 

XBRL Instance Document

 

 

 

101.SCH§

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL§

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

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101.LAB§

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE§

 

XBRL Taxonomy Extension Presentation Linkbase Document

 

 

 

101.DEF§

 

XBRL Taxonomy Extension Definition Linkbase Document

 


#                          Certain information in this exhibit has been omitted pursuant to an Order Granting Confidential Treatment issued by the SEC.

 

                          Filed herewith.

 

§                          XBRL (Extensible Business Reporting Language) information is furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934, and is not subject to liability under those sections, is not part of any registration statement or prospectus to which it relates and is not incorporated or deemed to be incorporated by reference into any registration statement, prospectus or other document.

 

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