10-Q 1 a15-7548_110q.htm 10-Q

Table of Contents

 

 

 

UNITED STATES SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

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

 

FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2015

 

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

 

FOR THE TRANSITION PERIOD FROM           TO          

 

Commission File No. 001-31298

 

LANNETT COMPANY, INC.

(Exact Name of Registrant as Specified in its Charter)

 

State of Delaware

 

23-0787699

(State of Incorporation)

 

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

 

9000 State Road

Philadelphia, PA 19136

(215) 333-9000

(Address of principal executive offices and telephone number)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 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 (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes x No o

 

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 the definitions of “large accelerated filer,” “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

(Do not check if a smaller reporting company)

 

 

 

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

 

Indicate the number of shares outstanding of each class of the registrant’s common stock, as of the latest practical date.

 

Class

 

Outstanding as of April 30, 2015

Common stock, par value $0.001 per share

 

36,242,710

 

 

 



Table of Contents

 

Table of Contents

 

 

 

 

Page No.

PART I. FINANCIAL INFORMATION

 

 

 

 

 

 

ITEM 1.

FINANCIAL STATEMENTS

 

 

 

 

 

 

 

Consolidated Balance Sheets as of March 31, 2015 (unaudited) and June 30, 2014

3

 

 

 

 

 

 

Consolidated Statements of Operations (unaudited) for the three and nine months ended March 31, 2015 and 2014

4

 

 

 

 

 

 

Consolidated Statements of Comprehensive Income (unaudited) for the three and nine months ended March 31, 2015 and 2014

5

 

 

 

 

 

 

Consolidated Statements of Changes in Stockholders’ Equity (unaudited) for the nine months ended March 31, 2015

6

 

 

 

 

 

 

Consolidated Statements of Cash Flows (unaudited) for the nine months ended March 31, 2015 and 2014

7

 

 

 

 

 

 

Notes to Consolidated Financial Statements (unaudited)

8

 

 

 

 

 

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

24

 

 

 

 

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

36

 

 

 

 

 

ITEM 4.

CONTROLS AND PROCEDURES

36

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

 

ITEM 1.

LEGAL PROCEEDINGS

37

 

 

 

 

 

ITEM 1A.

RISK FACTORS

37

 

 

 

 

 

ITEM 6.

EXHIBITS

37

 

2



Table of Contents

 

PART I.  FINANCIAL INFORMATION

 

ITEM 1.  FINANCIAL STATEMENTS

 

LANNETT COMPANY, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

 

 

 

(Unaudited)

 

 

 

 

 

March 31, 2015

 

June 30, 2014

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

208,772

 

$

105,587

 

Investment securities

 

16,614

 

40,693

 

Accounts receivable, net

 

79,715

 

61,325

 

Inventories, net

 

42,474

 

44,844

 

Prepaid income taxes

 

4,604

 

 

Deferred tax assets

 

11,894

 

11,265

 

Other current assets

 

3,157

 

1,833

 

Total current assets

 

367,230

 

265,547

 

Property, plant and equipment, net

 

80,265

 

61,704

 

Intangible assets, net

 

1,166

 

927

 

Deferred tax assets

 

12,777

 

14,234

 

Other assets

 

1,638

 

361

 

TOTAL ASSETS

 

$

463,076

 

$

342,773

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

16,994

 

$

20,982

 

Accrued expenses

 

3,843

 

3,901

 

Accrued payroll and payroll-related expenses

 

8,062

 

12,860

 

Rebates payable

 

5,889

 

4,558

 

Income taxes payable

 

 

4,569

 

Current portion of long-term debt

 

134

 

129

 

Total current liabilities

 

34,922

 

46,999

 

Long-term debt, less current portion

 

908

 

1,009

 

TOTAL LIABILITIES

 

35,830

 

48,008

 

Commitments and Contingencies (Note 13)

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

Common stock ($0.001 par value, 100,000,000 shares authorized; 36,651,983 and 36,088,272 shares issued; 36,134,991 and 35,571,280 shares outstanding at March 31, 2015 and June 30, 2014, respectively)

 

37

 

36

 

Additional paid-in capital

 

233,488

 

216,793

 

Retained earnings

 

199,630

 

83,654

 

Accumulated other comprehensive loss

 

(285

)

(54

)

Treasury stock (516,992 shares at March 31, 2015 and June 30, 2014)

 

(5,959

)

(5,959

)

Total Lannett Company, Inc. stockholders’ equity

 

426,911

 

294,470

 

Noncontrolling Interest

 

335

 

295

 

Total stockholders’ equity

 

427,246

 

294,765

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

463,076

 

$

342,773

 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

3



Table of Contents

 

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

(In thousands, except share and per share data)

 

 

 

Three months ended

 

Nine months ended

 

 

 

March 31,

 

March 31,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

99,352

 

$

79,997

 

$

307,561

 

$

193,152

 

Cost of sales

 

23,714

 

23,865

 

73,155

 

74,572

 

JSP contract renewal cost

 

 

 

 

20,100

 

Gross profit

 

75,638

 

56,132

 

234,406

 

98,480

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

9,159

 

10,583

 

23,358

 

21,113

 

Selling, general, and administrative

 

12,204

 

9,560

 

35,579

 

26,629

 

Total operating expenses

 

21,363

 

20,143

 

58,937

 

47,742

 

Operating income

 

54,275

 

35,989

 

175,469

 

50,738

 

Other income (loss):

 

 

 

 

 

 

 

 

 

Foreign currency gain (loss)

 

(21

)

1

 

(21

)

1

 

Gain (loss) on sale of assets

 

(5

)

 

15

 

(55

)

Gain (loss) on investment securities

 

(103

)

200

 

592

 

1,765

 

Interest and dividend income

 

95

 

109

 

303

 

204

 

Interest expense

 

(8

)

(13

)

(119

)

(117

)

Other

 

 

 

 

(87

)

Total other income (loss)

 

(42

)

297

 

770

 

1,711

 

Income before income tax

 

54,233

 

36,286

 

176,239

 

52,449

 

Income tax expense

 

17,973

 

13,280

 

60,208

 

18,838

 

Net income

 

36,260

 

23,006

 

116,031

 

33,611

 

Less: Net income attributable to noncontrolling interest

 

27

 

11

 

55

 

45

 

Net income attributable to Lannett Company, Inc.

 

$

36,233

 

$

22,995

 

$

115,976

 

$

33,566

 

 

 

 

 

 

 

 

 

 

 

Earnings per common share attributable to Lannett Company, Inc.:

 

 

 

 

 

 

 

 

 

Basic

 

$

1.01

 

$

0.66

 

$

3.25

 

$

1.01

 

Diluted

 

$

0.97

 

$

0.63

 

$

3.13

 

$

0.97

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

35,880,954

 

35,025,968

 

35,715,061

 

33,082,460

 

Diluted

 

37,210,138

 

36,769,593

 

37,082,138

 

34,586,007

 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

4



Table of Contents

 

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME

(UNAUDITED)

(In thousands)

 

 

 

Three months ended

 

Nine months ended

 

 

 

March 31,

 

March 31,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

 

 

 

 

 

 

 

 

Net Income

 

$

36,260

 

$

23,006

 

$

116,031

 

$

33,611

 

Other comprehensive income (loss), before tax:

 

 

 

 

 

 

 

 

 

Foreign currency translation gain (loss)

 

35

 

(11

)

(231

)

(2

)

Total other comprehensive income (loss), before tax

 

35

 

(11

)

(231

)

(2

)

Income tax related to items of other comprehensive income

 

 

 

 

 

Total other comprehensive income (loss), net of tax

 

35

 

(11

)

(231

)

(2

)

Comprehensive income

 

36,295

 

22,995

 

115,800

 

33,609

 

Less: Total comprehensive income attributable to noncontrolling interest

 

27

 

11

 

55

 

45

 

Comprehensive income attributable to Lannett Company Inc.

 

$

36,268

 

$

22,984

 

$

115,745

 

$

33,564

 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

5



Table of Contents

 

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(UNAUDITED)

(In thousands)

 

 

 

Stockholders’ Equity Attributable to Lannett Company Inc.

 

 

 

 

 

 

 

Common Stock

 

Additional

 

 

 

Accumulated
Other

 

 

 

Stockholders’
Equity

 

 

 

Total

 

 

 

Shares
Issued

 

Amount

 

Paid-In
Capital

 

Retained
Earnings

 

Comprehensive
Loss

 

Treasury
Stock

 

Attributable to
Lannett Co., Inc.

 

Noncontrolling
Interest

 

Stockholders’
Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, July 1, 2014

 

36,088

 

$

36

 

$

216,793

 

$

83,654

 

$

(54

)

$

(5,959

)

$

294,470

 

$

295

 

$

294,765

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares issued in connection with share-based compensation plans

 

564

 

1

 

4,164

 

 

 

 

4,165

 

 

4,165

 

Share-based compensation

 

 

 

4,729

 

 

 

 

4,729

 

 

4,729

 

Excess tax benefits on share-based compensation awards

 

 

 

7,802

 

 

 

 

7,802

 

 

7,802

 

Distribution to noncontrolling interests

 

 

 

 

 

 

 

 

(15

)

(15

)

Other comprehensive loss, net of income tax

 

 

 

 

 

(231

)

 

(231

)

 

(231

)

Net income

 

 

 

 

115,976

 

 

 

115,976

 

55

 

116,031

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2015

 

36,652

 

$

37

 

$

233,488

 

$

199,630

 

$

(285

)

$

(5,959

)

$

426,911

 

$

335

 

$

427,246

 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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Table of Contents

 

LANNETT COMPANY, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(UNAUDITED)

(In thousands)

 

 

 

Nine Months Ended
March 31,

 

 

 

2015

 

2014

 

OPERATING ACTIVITIES:

 

 

 

 

 

Net income

 

$

116,031

 

$

33,611

 

Adjustments to reconcile net income to net cash provided by operating activities:

 

 

 

 

 

Depreciation and amortization

 

4,020

 

4,775

 

Deferred income tax expense (benefit)

 

828

 

(7,240

)

Share-based compensation

 

4,729

 

5,833

 

Excess tax benefits on share-based compensation awards

 

(7,802

)

(5,234

)

Loss (gain) on sale of assets

 

(15

)

55

 

Gain on investment securities

 

(592

)

(1,765

)

JSP contract renewal cost

 

 

20,100

 

Other noncash expenses

 

61

 

175

 

Changes in assets and liabilities which provided (used) cash:

 

 

 

 

 

Trade accounts receivable

 

(18,390

)

(37,963

)

Inventories

 

2,370

 

(8,834

)

Prepaid income taxes/income taxes payable

 

(1,371

)

2,489

 

Prepaid expenses and other assets

 

(2,663

)

(210

)

Rebates payable

 

1,331

 

5,140

 

Accounts payable

 

(3,988

)

(1,398

)

Accrued expenses

 

(58

)

6,063

 

Accrued payroll and payroll-related expenses

 

(4,798

)

172

 

Net cash provided by operating activities

 

89,693

 

15,769

 

INVESTING ACTIVITIES:

 

 

 

 

 

Purchases of property, plant and equipment

 

(22,580

)

(20,194

)

Proceeds from sale of property, plant and equipment

 

76

 

48

 

Purchases of intangible assets

 

(300

)

 

Proceeds from sale of investment securities

 

61,334

 

20,640

 

Purchase of investment securities

 

(36,662

)

(49,778

)

Net cash provided by (used in) investing activities

 

1,868

 

(49,284

)

FINANCING ACTIVITIES:

 

 

 

 

 

Repayments of debt

 

(96

)

(5,345

)

Proceeds from issuance of stock

 

4,164

 

4,671

 

Excess tax benefits on share-based compensation awards

 

7,802

 

5,234

 

Proceeds from stock offering

 

 

71,478

 

Deferred financing fees

 

 

(402

)

Purchase of treasury stock

 

 

(695

)

Distributions to noncontrolling shareholders

 

(15

)

 

Net cash provided by financing activities

 

11,855

 

74,941

 

Effect on cash and cash equivalents of changes in foreign exchange rates

 

(231

)

(2

)

NET INCREASE IN CASH AND CASH EQUIVALENTS

 

103,185

 

41,424

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

105,587

 

42,689

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

208,772

 

$

84,113

 

SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:

 

 

 

 

 

Interest paid

 

$

123

 

$

117

 

Income taxes paid

 

$

60,750

 

$

23,589

 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

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Table of Contents

 

LANNETT COMPANY, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(UNAUDITED)

 

Note 1.  Interim Financial Information

 

The accompanying unaudited financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for the presentation of interim financial statements and with the instructions to Form 10-Q and Article 10 of Regulation S-X.  Accordingly, the unaudited financial statements do not include all the information and footnotes necessary for a comprehensive presentation of the financial position, results of operations, and cash flows for the periods presented.  In the opinion of management, the unaudited financial statements include all the normal recurring adjustments that are necessary for a fair presentation of the financial position, results of operations, and cash flows for the periods presented.  Operating results for the three and nine months ended March 31, 2015 are not necessarily indicative of the results that may be expected for the fiscal year ending June 30, 2015.  These unaudited financial statements should be read in combination with the other Notes in this section; “Management’s Discussion and Analysis of Financial Condition and Results of Operations” appearing in Item 2; and the Consolidated Financial Statements, including the Notes to the Consolidated Financial Statements, included in our Annual Report on Form 10-K for the fiscal year ended June 30, 2014.

 

Note 2.  The Business And Nature of Operations

 

Lannett Company, Inc. (a Delaware corporation) and subsidiaries (the “Company” or “Lannett”) develop, manufacture, package, market, and distribute solid oral (tablets and capsules), extended release, topical, and oral solution finished dosage forms of drugs, that address a wide range of therapeutic areas.  The Company also manufactures active pharmaceutical ingredients through its Cody Laboratories, Inc. (“Cody Labs”) subsidiary, providing a vertical integration benefit.  Additionally, the Company distributes products under various distribution agreements, most notably the Jerome Stevens Distribution Agreement.

 

The Company operates pharmaceutical manufacturing plants in Philadelphia, Pennsylvania and Cody, Wyoming.  Customers of the Company’s pharmaceutical products include generic pharmaceutical distributors, drug wholesalers, chain drug stores, private label distributors, mail-order pharmacies, other pharmaceutical manufacturers, managed care organizations, hospital buying groups, governmental entities and health maintenance organizations.

 

Note 3.  Summary of Significant Accounting Policies

 

Principles of consolidation

 

The Consolidated Financial Statements include the accounts of Lannett Company, Inc., and its wholly owned subsidiaries, as well as Cody LCI Realty, LLC (“Realty”), a variable interest entity (“VIE”) in which the Company has a 50% ownership interest.  Noncontrolling interest in Realty is recorded net of tax as net income attributable to the noncontrolling interest.  Additionally, all intercompany accounts and transactions have been eliminated.

 

Reclassifications

 

Certain prior year amounts have been reclassified to conform to the current year financial statement presentation.

 

Use of estimates

 

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Significant estimates and assumptions are required in the determination of revenue recognition and sales deductions for estimated chargebacks, rebates, returns and other adjustments including a provision for the Company’s liability under the Medicare Part D program.  Additionally, significant estimates and assumptions are required when determining the fair value of long-lived assets, income taxes, contingencies, and share-based compensation.  Because of the inherent subjectivity and complexity involved in these estimates and assumptions, actual results could differ from those estimates.

 

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Table of Contents

 

Foreign currency translation

 

The Consolidated Financial Statements are presented in U.S. Dollars, the reporting currency of the Company.  The financial statements of the Company’s foreign subsidiary are maintained in local currency and translated into U.S. dollars at the end of each reporting period.  Assets and liabilities are translated at period-end exchange rates, while revenues and expenses are translated at average exchange rates during the period.  The adjustments resulting from the use of differing exchange rates are recorded as part of stockholders’ equity in accumulated comprehensive income (loss).  Gains and losses resulting from transactions denominated in foreign currencies are recognized in the Consolidated Statements of Operations under Other income (loss).  Amounts recorded due to foreign currency fluctuations are immaterial to the consolidated financial statements.

 

Cash and cash equivalents

 

The Company considers all highly liquid investments with original maturities less than or equal to three months at the date of purchase to be cash and cash equivalents.  Cash and cash equivalents are stated at cost, which approximates fair value, and consist of bank deposits and certificates of deposit that are readily convertible into cash.  The Company maintains its cash deposits and cash equivalents at well-known, stable financial institutions.  Such amounts frequently exceed insured limits.

 

Investment securities

 

The Company’s investment securities consist of publicly traded equity securities and certificates of deposit with original maturities greater than three months which are classified as trading investments.  Investment securities are recorded at fair value based on quoted market prices from broker or dealer quotations or transparent pricing sources at each reporting date.  Gains and losses are included in the Consolidated Statements of Operations under Other income (loss).

 

Allowance for doubtful accounts

 

The Company continuously monitors collections and payments from its customers and maintains a provision for estimated credit losses.  The Company determines its allowance for doubtful accounts by considering a number of factors, including the length of time balances are past due, the Company’s previous loss history, the customer’s current ability to pay its obligation to the Company, and the condition of the general economy and the industry as a whole.  The Company writes off accounts receivable when they are determined to be uncollectible.

 

Inventories

 

Inventories are stated at the lower of cost or market determined by the first-in, first-out method.  Inventories are regularly reviewed and provisions for excess and obsolete inventory are recorded based primarily on current inventory levels and estimated sales forecasts.

 

Property, Plant and Equipment

 

Property, plant and equipment are stated at cost less accumulated depreciation.  Depreciation is computed on a straight-line basis over the assets’ estimated useful lives.  Depreciation expense for each of the three months ended March 31, 2015 and 2014 was $1.4 million and $1.2 million, respectively.  Depreciation expense for each of the nine months ended March 31, 2015 and 2014 was $4.0 million and $3.4 million, respectively.

 

Intangible Assets

 

Intangible assets are stated at cost less accumulated amortization.  Amortization is computed on a straight-line basis over the assets’ estimated useful lives, generally for periods ranging from 10 to 15 years.  The Company continually evaluates the reasonableness of the useful lives of these assets.  Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.  Costs to renew or extend the term of a recognized intangible asset are expensed as incurred.  The Company has several indefinite-lived intangible assets related to product Abbreviated New Drug Applications (“ANDAs”), valued at $449 thousand.  Amortization on these indefinite-lived intangibles will begin at such time as the Company begins shipping the products and determines a finite useful life.

 

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Segment Information

 

The Company operates one reportable segment, generic pharmaceuticals.  As such, the Company aggregates its financial information for all products.  The following table identifies the Company’s net sales by medical indication for the three and nine months ended March 31, 2015 and 2014:

 

(In thousands)

 

For the Three Months Ended
March 31,

 

For the Nine Months Ended
March 31,

 

Medical Indication

 

2015

 

2014

 

2015

 

2014

 

Antibiotic

 

$

3,005

 

$

3,361

 

$

9,355

 

$

11,069

 

Cardiovascular

 

8,457

 

21,331

 

45,729

 

42,779

 

Gallstone

 

20,489

 

988

 

48,969

 

3,490

 

Glaucoma

 

5,714

 

4,538

 

15,921

 

7,474

 

Gout

 

1,453

 

3,383

 

6,743

 

7,445

 

Migraine

 

6,722

 

4,787

 

19,455

 

9,851

 

Obesity

 

1,084

 

915

 

2,952

 

2,890

 

Pain Management

 

4,286

 

8,407

 

18,508

 

20,418

 

Thyroid Deficiency

 

36,720

 

28,292

 

114,601

 

74,560

 

Other

 

11,422

 

3,995

 

25,328

 

13,176

 

Total

 

$

99,352

 

$

79,997

 

$

307,561

 

$

193,152

 

 

Customer, Supplier and Product Concentration

 

The following table presents the percentage of total net sales, for the three and nine months ended March 31, 2015 and 2014, for certain of the Company’s products, defined as products containing the same active ingredient or combination of ingredients, which accounted for at least 10% of net sales in any of those periods:

 

 

 

For the Three Months Ended
March 31,

 

For the Nine Months Ended
March 31,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

 

 

 

 

 

 

 

 

Product 1

 

37

%

35

%

37

%

39

%

Product 2

 

21

%

1

%

16

%

2

%

Product 3

 

7

%

24

%

13

%

19

%

 

The following table presents the percentage of total net sales, for the three and nine months ended March 31, 2015 and 2014, for certain of the Company’s customers which accounted for at least 10% of net sales in any of those periods:

 

 

 

For the Three Months Ended
March 31,

 

For the Nine Months Ended
March 31,

 

 

 

2015

 

2014

 

2015

 

2014

 

 

 

 

 

 

 

 

 

 

 

Customer A

 

27

%

23

%

30

%

21

%

Customer B

 

15

%

7

%

10

%

7

%

Customer C

 

%

14

%

%

15

%

 

Customer concentration was impacted by the strategic partnership between Amerisource Bergen and Walgreens, whereby Amerisource Bergen began product distribution on behalf of Walgreens in third quarter of Fiscal Year 2014, as well as other strategic partnerships between industry wholesalers and retailers.

 

At March 31, 2015 and June 30, 2014, four customers accounted for 80% and 67% of the Company’s net accounts receivable balance, respectively.  Credit terms are offered to customers based on evaluations of the customers’ financial condition and collateral is generally not required.

 

The Company’s primary finished goods inventory supplier is Jerome Stevens Pharmaceuticals, Inc. (“JSP”), in Bohemia, New York.  Purchases of finished goods inventory from JSP accounted for approximately 66% and 65% of the Company’s inventory purchases during the three months ended March 31, 2015 and 2014, respectively.  Purchases of finished goods inventory from JSP accounted for approximately 68% and 67% of the Company’s inventory purchases during the nine months ended March 31, 2015 and 2014, respectively.  See Note 20 “Material Contracts with Suppliers” for more information.

 

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Revenue Recognition

 

The Company recognizes revenue when title and risk of loss have transferred to the customer and provisions for rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments are reasonably determinable.  The Company also considers all other relevant criteria specified in Securities and Exchange Commission Staff Accounting Bulletin No. 104, Topic No. 13, “Revenue Recognition”, in determining when to recognize revenue.

 

Net Sales Adjustments

 

When revenue is recognized a simultaneous adjustment to gross sales is made for chargebacks, rebates, returns, promotional adjustments, and other potential adjustments.  These provisions are primarily estimated based on historical experience, future expectations, contractual arrangements with wholesalers and indirect customers, and other factors known to management at the time of accrual.  Accruals for provisions are presented in the Consolidated Financial Statements as a reduction to gross sales with the corresponding reserve presented as a reduction of accounts receivable or included as rebates payable, depending on the nature of the reserve.  The reserves, presented as a reduction of accounts receivable, totaled $61.6 million and $51.9 million at March 31, 2015 and June 30, 2014, respectively.  Rebates payable at March 31, 2015 and June 30, 2014 were $5.9 million and $4.6 million, respectively, for certain rebate programs, primarily related to Medicare Part D and Medicaid, and certain sales allowances and other adjustments paid to indirect customers.

 

Cost of Sales

 

Cost of sales includes all costs related to bringing products to their final selling destination, which includes direct and indirect costs, such as direct material, labor, and overhead expenses.  Additionally, cost of sales includes product royalties, depreciation, amortization and costs to renew or extend recognized intangible assets, freight charges and other shipping and handling expenses.

 

Research and Development

 

Research and development costs are expensed as incurred, including all production costs until a drug candidate is approved by the FDA.  Research and development expenses include costs associated with internal projects as well as costs associated with third-party research and development contracts.

 

Valuation of Long-Lived Assets

 

The Company’s long-lived assets primarily consist of property, plant and equipment as well as definite-lived intangible assets.  Long-lived assets are reviewed for impairment whenever events or changes in circumstances (“triggering events”) indicate that the carrying amount of the asset may not be recoverable.  If a triggering event is determined to have occurred, the first step in the impairment test is to compare the asset’s carrying value to the future undiscounted cash flows expected to be generated by the asset.  If the carrying value exceeds the undiscounted cash flow of the asset then impairment exists.  An impairment loss is measured as the excess of the asset’s carrying value over its fair value, which in most cases is calculated using a discounted cash flow model.  Discounted cash flow models are highly reliant on various assumptions which are considered Level 3 inputs, including estimates of future cash flows (including long-term growth rates), discount rates, and the probability of achieving the estimated cash flows.

 

Contingencies

 

Loss contingencies, including litigation related contingencies, are included in the Consolidated Statements of Operations when the Company concludes that a loss is both probable and reasonably estimable.  Legal fees related to litigation-related matters are expensed as incurred and included in the Consolidated Statements of Operations under the Selling, general and administrative line item.

 

Share-based Compensation

 

Share-based compensation costs are recognized over the vesting period, using a straight-line method, based on the fair value of the instrument on the date of grant less an estimate for expected forfeitures.  The Company uses the Black-Scholes valuation model to determine the fair value of stock options and the stock price on the grant date to value restricted stock.  The Black-Scholes valuation model includes various assumptions, including the expected volatility, the expected life of the award, dividend yield, and the risk-free interest rate.  These assumptions involve inherent uncertainties based on market conditions which are generally outside the Company’s control.  Changes in these assumptions could have a material impact on share-based compensation costs recognized in the financial statements.

 

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Income Taxes

 

The Company uses the asset and liability method to account for income taxes as prescribed by Accounting Standards Codification (“ASC”) 740, Income Taxes.  Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities as measured by the enacted tax rates which will be in effect when these differences reverse.  Deferred tax expense (benefit) is the result of changes in deferred tax assets and liabilities.  Deferred income tax assets and liabilities are adjusted to recognize the effects of changes in tax laws or enacted tax rates in the period during which they are signed into law.

 

The Company may recognize the tax benefit from an uncertain tax position claimed on a tax return only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position.  The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement.  The authoritative standards issued by the Financial Accounting Standards Board (“FASB”) also provide guidance on de-recognition, classification, interest and penalties on income taxes, accounting in interim periods and requires increased disclosures.  The factors used to assess the likelihood of realization are the Company’s forecast of future taxable income and available tax planning strategies that could be implemented to realize the net deferred tax assets.  Under ASC 740, Income Taxes, a valuation allowance is required when it is more likely than not that all or some portion of the deferred tax assets will not be realized through generating sufficient future taxable income.  Failure to achieve forecasted taxable income in applicable tax jurisdictions could affect the ultimate realization of deferred tax assets and could result in an increase in the Company’s effective tax rate on future earnings.

 

Earnings Per Common Share

 

Basic earnings per common share attributable to Lannett Company, Inc. is computed by dividing net income attributable to Lannett Company, Inc. common stockholders by the weighted average number of shares outstanding during the period.  Diluted earnings per common share attributable to Lannett Company, Inc. is computed by dividing net income attributable to Lannett Company, Inc. common stockholders by the weighted average number of shares outstanding during the period including additional shares that would have been outstanding related to potentially dilutive securities.  These potentially dilutive securities primarily consist of stock options and unvested restricted stock.  Anti-dilutive securities are excluded from the calculation.

 

Comprehensive Income (Loss)

 

Comprehensive income (loss) includes all changes in equity during a period except those that resulted from investments by or distributions to the Company’s stockholders.  Other comprehensive income (loss) refers to revenues, expenses, gains and losses that are included in comprehensive income (loss), but excluded from net income as these amounts are recorded directly as an adjustment to stockholders’ equity.

 

Recent Accounting Pronouncements

 

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers.  The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.  The authoritative guidance is effective for annual reporting periods beginning after December 15, 2016.  Early application is not permitted.  The Company is currently in the process of assessing the impact this guidance will have on the consolidated financial statements.

 

In April 2015, the FASB issued ASU 2015-03, Simplifying the Presentation of Debt Issuance Costs which changes the presentation of debt issuance costs in financial statements. ASU 2015-03 requires an entity to present such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. It is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2015.  Early adoption is permitted. The new guidance will be applied retrospectively to each prior period presented.  The Company is currently in the process of assessing the impact this guidance will have on the consolidated financial statements.

 

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Note 4.  Accounts Receivable

 

Accounts receivable consisted of the following components at March 31, 2015 and June 30, 2014:

 

(In thousands)

 

March 31,
2015

 

June 30,
2014

 

Gross accounts receivable

 

$

141,497

 

$

113,420

 

Less Chargebacks reserve

 

(32,061

)

(30,320

)

Less Rebates reserve

 

(9,321

)

(10,532

)

Less Returns reserve

 

(18,490

)

(9,341

)

Less Other deductions

 

(1,761

)

(1,787

)

Less Allowance for doubtful accounts

 

(149

)

(115

)

Accounts receivable, net

 

$

79,715

 

$

61,325

 

 

For the three months ended March 31, 2015, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns, and other deductions of $74.3 million, $18.4 million, $5.9 million, and $7.8 million, respectively.  For the three months ended March 31, 2014, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns, and other deductions of $33.3 million, $20.5 million, $2.3 million, and $1.1 million, respectively.

 

For the nine months ended March 31, 2015, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns, and other deductions of $252.3 million, $58.2 million, $14.2 million, and $22.9 million, respectively.  For the nine months ended March 31, 2014, the Company recorded a provision for chargebacks, rebates (including rebates presented as rebates payable), returns, and other deductions of $78.5 million, $40.5 million, $5.5 million, and $18.8 million, respectively.

 

Note 5.  Inventories

 

Inventories, net of allowances, at March 31, 2015 and June 30, 2014 consisted of the following:

 

(In thousands)

 

March 31,
2015

 

June 30,
2014

 

Raw Materials

 

$

18,868

 

$

19,767

 

Work-in-process

 

4,893

 

5,440

 

Finished Goods

 

16,558

 

17,592

 

Packaging Supplies

 

2,155

 

2,045

 

Total

 

$

42,474

 

$

44,844

 

 

The reserve for excess and obsolete inventory was $5.0 million and $2.4 million at March 31, 2015 and June 30, 2014, respectively.

 

Note 6.  Property, Plant and Equipment

 

Property, plant and equipment at March 31, 2015 and June 30, 2014 consisted of the following:

 

(In thousands)

 

Useful Lives

 

March 31,
2015

 

June 30,
2014

 

Land

 

 

$

4,641

 

$

4,641

 

Building and improvements

 

10 - 39 years

 

46,330

 

42,013

 

Machinery and equipment

 

5 - 10 years

 

44,311

 

37,678

 

Furniture and fixtures

 

5 - 7 years

 

1,719

 

1,416

 

Construction in progress

 

 

22,303

 

11,454

 

Property, plant and equipment, gross

 

 

 

119,304

 

97,202

 

Less accumulated depreciation

 

 

 

(39,039

)

(35,498

)

Property, plant and equipment, net

 

 

 

$

80,265

 

$

61,704

 

 

During each of the three and nine months ended March 31, 2015 and 2014, the Company had no impairment charges.  Property, plant and equipment, net included amounts held in foreign countries in the amount of $1.2 million and $1.1 million at March 31, 2015 and June 30, 2014, respectively.

 

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Note 7.  Fair Value Measurements

 

The Company’s financial instruments recorded in the Consolidated Balance Sheets include cash and cash equivalents, accounts receivable, investment securities, accounts payable, accrued expenses, and debt obligations.  Included in cash and cash equivalents are certificates of deposit with maturities less than or equal to three months at the date of purchase and money market funds.  The carrying value of certain financial instruments, primarily cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses approximate their estimated fair values based upon the short-term nature of their maturity dates.  The carrying amount of the Company’s debt obligations approximates fair value based on current interest rates available to the Company on similar debt obligations.

 

The Company follows the authoritative guidance of ASC Topic 820 “Fair Value Measurements and Disclosures.”  Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.  The authoritative guidance also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.  The Company’s financial assets and liabilities measured at fair value are entirely within Level 1 of the hierarchy as defined below:

 

Level 1 — Quoted prices (unadjusted) in active markets for identical assets or liabilities that the reporting entity can access at the measurement date.

 

Level 2 — Directly or indirectly observable inputs, other than quoted prices, such as quoted prices for similar assets or liabilities; quoted prices for identical or similar instruments in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable.

 

Level 3 — Unobservable inputs that are supported by little or no market activity and that are material to the fair value of the asset or liability. Financial instruments whose values are determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation are examples of Level 3 assets and liabilities.

 

If the inputs used to measure the financial assets and liabilities fall within more than one level described above, the categorization is based on the lowest level input that is significant to the fair value measurement of the instrument.

 

The Company’s financial assets and liabilities measured at fair value at March 31, 2015 and June 30, 2014, were as follows:

 

 

 

March 31, 2015

 

(In thousands)

 

Level 1

 

Level 2

 

Level 3

 

Total

 

Assets

 

 

 

 

 

 

 

 

 

Equity securities

 

$

16,614

 

$

 

$

 

$

16,614

 

Total Investment Securities

 

$

16,614

 

$

 

$

 

$

16,614

 

 

 

 

June 30, 2014

 

(In thousands)

 

Level 1

 

Level 2

 

Level 3

 

Total

 

Assets

 

 

 

 

 

 

 

 

 

Equity securities

 

$

15,193

 

$

 

$

 

$

15,193

 

Certificates of Deposit

 

25,500

 

 

 

25,500

 

Total Investment Securities

 

$

40,693

 

$

 

$

 

$

40,693

 

 

Note 8.  Investment Securities

 

The Company uses the specific identification method to determine the cost of securities sold, which consisted entirely of securities classified as trading.

 

The Company had a net loss on investment securities of $103 thousand during the three months ended March 31, 2015, which included an unrealized loss related to securities still held at March 31, 2015 of $666 thousand.  The Company had a net gain on investment securities of $200 thousand during the three months ended March 31, 2014, which included an unrealized loss related to securities still held at March 31, 2014 of $174 thousand.

 

The Company had a net gain on investment securities of $592 thousand during the nine months ended March 31, 2015, which included an unrealized loss related to securities still held at March 31, 2015 of $954 thousand.  The Company had a net gain on

 

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investment securities of $1.8 million during the nine months ended March 31, 2014, which included an unrealized gain related to securities still held at March 31, 2014 of $740 thousand.

 

Note 9.  Intangible Assets

 

Intangible assets, net as of March 31, 2015 and June 30, 2014, consisted of the following:

 

 

 

Gross Carrying Amount

 

Accumulated Amortization

 

Intangible Assets, Net

 

(In thousands)

 

March 31,
2015

 

June 30,
2014

 

March 31,
2015

 

June 30,
2014

 

March 31,
2015

 

June 30,
2014

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cody Labs Import License

 

582

 

582

 

(261

)

(232

)

321

 

350

 

Morphine Sulfate Oral Solution NDA

 

202

 

202

 

(74

)

(65

)

128

 

137

 

Other ANDA Product Rights

 

900

 

600

 

(183

)

(160

)

717

 

440

 

 

 

$

1,684

 

$

1,384

 

$

(518

)

$

(457

)

$

1,166

 

$

927

 

 

For the three months ended March 31, 2015 and 2014, the Company incurred amortization expense of $20 thousand and $467 thousand, respectively.  For the nine months ended March 31, 2015 and 2014, the Company incurred amortization expense of $61 thousand and $1.4 million, respectively.  There were no impairments related to intangible assets during each of the three and nine months ended March 31, 2015 and 2014.

 

Future annual amortization expense consisted of the following as of March 31, 2015:

 

(In thousands)
Fiscal Year Ending June 30,

 

Annual Amortization Expense

 

2015

 

$

20

 

2016

 

82

 

2017

 

82

 

2018

 

82

 

2019

 

79

 

Thereafter

 

372

 

 

 

$

717

 

 

The amounts above do not include the product line covered by the ANDA purchased in August 2009 for $149 thousand and ANDAs purchased in September 2014 for $300 thousand.  Amortization on these assets will begin when the Company begins shipping the product.

 

Note 10.  Bank Line of Credit

 

In December 2013, the Company entered into a credit agreement (the “Credit Agreement”) with Citibank, N.A., as administrative agent, and another financial institution. As of March 31, 2015, the Credit Agreement provided for a revolving loan commitment in the amount of up to $50.0 million.  Any loans under the Credit Agreement will bear interest at either a “Eurodollar Rate” or a “Base Rate” plus a specified margin.  The Company is also required to pay a commitment fee on any undrawn commitments under the Credit Agreement ranging from 0.2% - 0.3% per annum according to the average daily balance of borrowings under the agreement. The Credit Agreement is collateralized by substantially all of the Company’s assets. In connection with securing the Credit Agreement, the Company repaid substantially all of its outstanding debt. See Note 11 “Long-Term Debt” for more information. As of March 31, 2015 and June 30, 2014, the Company had $50.0 million available under the Credit Agreement.

 

The Credit Agreement contains representations and warranties, affirmative, negative and financial covenants, and events of default, applicable to the Company and its subsidiaries which are customary for credit facilities of this type.  As of March 31, 2015 and June 30, 2014, the Company was in compliance with all financial covenants.

 

The Credit Agreement was amended on April 21, 2015.  See Note 22 “Subsequent Events” for more information.

 

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Note 11.  Long-Term Debt

 

Long-term debt consisted of the following:

 

 

 

March 31,

 

June 30,

 

(In thousands)

 

2015

 

2014

 

First National Bank of Cody mortgage

 

$

1,042

 

$

1,138

 

Less current portion

 

134

 

129

 

Long-term debt

 

$

908

 

$

1,009

 

 

Current Portion of Long-term Debt:

 

 

 

March 31,

 

June 30,

 

(In thousands)

 

2015

 

2014

 

First National Bank of Cody mortgage

 

$

134

 

$

129

 

 

The Company is the primary beneficiary to a VIE called Realty.  The VIE owns land and a building which is leased to Cody Labs.  A mortgage loan with First National Bank of Cody has been consolidated in the Company’s financial statements, along with the related land and building.  The mortgage requires monthly principal and interest payments of $15 thousand.  As of March 31, 2015 and June 30, 2014, the effective interest rate was 4.5%.  The mortgage is collateralized by the land and building with a net book value of $1.5 million.

 

Long-term debt amounts due for the twelve month periods ending March 31 were as follows:

 

 

 

Amounts Payable

 

(In thousands)

 

to Institutions

 

2015

 

$

134

 

2016

 

140

 

2017

 

146

 

2018

 

153

 

2019

 

160

 

Thereafter

 

309

 

Total

 

$

1,042

 

 

Note 12.  Legal and Regulatory Matters

 

Richard Asherman

 

On April 16, 2013, Richard Asherman (“Asherman”), the former President of and a member in Realty, filed a complaint (“Complaint”) in Wyoming state court against the Company and Cody Labs.  At the same time, he also filed an application for a temporary restraining order to enjoin certain operations at Cody Labs, claiming, among other things, that Cody Labs is in violation of certain zoning laws and that Cody Labs is required to increase the level of its property insurance and to secure performance bonds for work being performed at Cody Labs.  Mr. Asherman claims Cody Labs is in breach of his employment agreement and is required to pay him severance under his employment agreement, including 18 months of base salary, vesting of unvested stock options and continuation of benefits.  The Company estimates that the aggregate value of the claimed severance benefits is approximately $350 thousand to $400 thousand, plus the value of any stock options.  Mr. Asherman also asserts that the Company is in breach of the Realty Operating Agreement and, among other requested remedies, he seeks to have the Company (i) pay him 50% of the value of 1.66 acres of land that Realty previously agreed to donate to an economic development entity associated with the City of Cody, Wyoming, which contemplated transaction has since been avoided and cancelled.  Although Mr. Asherman originally sought to require that Lannett acquire his interest in Realty for an unspecified price and/or to dissolve Realty; those claims were recently dismissed.

 

The Company strongly disputes the claims in the Amended Complaint, including that the Company is required to acquire Mr. Asherman’s interest in Realty.  If Mr. Asherman were successful on his claim for breach of his employment agreement, he would be entitled to his contractual severance — 18 months’ salary plus the vesting of certain stock options and continuation of benefits. The amount the Company would be required to pay to Mr. Asherman if he were successful in compelling the buyout of his interest in Realty is dependent upon the value of the real property owned by Realty.  If a buyout were required, Realty would become wholly

 

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owned by the Company.  At this time the Company is unable to reasonably estimate a range or aggregate dollar amount of Mr. Asherman’s claims or of any potential loss, if any, to the Company.  The Company does not believe that the ultimate resolution of the matter will have a significant impact on the Company’s financial position or results of operations.

 

Connecticut Attorney General Inquiry

 

In July 2014, the Company received interrogatories and subpoena from the State of Connecticut Office of the Attorney General concerning its investigation into pricing of digoxin.  According to the subpoena, the Connecticut Attorney General is investigating whether anyone engaged in any activities that resulted in (a) fixing, maintaining or controlling prices of digoxin or (b) allocating and dividing customers or territories relating to the sale of digoxin in violation of Connecticut antitrust law.  The Company maintains that it acted in compliance with all applicable laws and regulations and continues to cooperate with the Connecticut Attorney General’s investigation.

 

Federal Investigation into the Generic Pharmaceutical Industry

 

On November 3, 2014, the Senior Vice President of Sales and Marketing of the Company was served with a grand jury subpoena relating to a federal investigation of the generic pharmaceutical industry into possible violations of the Sherman Act.  The subpoena requests corporate documents of the Company relating to communications or correspondence with competitors regarding the sale of generic prescription medications, but is not specifically directed to any particular product and is not limited to any particular time period.  The Company maintains that it has acted in compliance with all applicable laws and regulations and continues to cooperate with the federal investigation.

 

On December 5, 2014, the Company was served with a grand jury subpoena related to the federal investigation of the generic pharmaceutical industry into possible violations of the Sherman Act. The subpoena requests corporate documents from the Company relating to corporate, financial, and employee information, communications or correspondence with competitors regarding the sale of generic prescription medications, and the marketing, sale, or pricing of certain products. The Company maintains that it has acted in compliance with all applicable laws and regulations and continues to cooperate with the federal investigation.

 

Class Action - David Schaefer

 

On August 27, 2014, David Schaefer, as an alleged class representative, filed a class action complaint in the United States District Court, Eastern District of Pennsylvania (14-cv-05008) against the Company and certain of its officers, alleging violations of federal securities laws arising out of statements about the Company made in its securities filings during the period of September 10, 2013 through July 16, 2014.  The complaint alleges that the statements were false and misleading because the defendants allegedly knew at the time the statements were made that the Company was in violation of Connecticut antitrust laws relating to its sale of digoxin.  Mr. Schaefer’s complaint was voluntarily dismissed in September 2014.

 

Patent Infringement (Paragraph IV Certification)

 

There is substantial litigation in the pharmaceutical industry with respect to the manufacture, use, and sale of new products which are the subject of conflicting patent and intellectual property claims.  Certain of these claims relate to paragraph IV certifications, which allege that an innovator patent is invalid or would not be infringed upon by the manufacture, use, or sale of the new drug.

 

Zomig®

 

The Company filed with the Food and Drug Administration an Abbreviated New Drug Application (ANDA) No. 206350, along with a paragraph IV certification, alleging that the two patents associated with the Zomig® nasal spray product (U.S. Patent No. 6,750,237 and U.S. Patent No. 67,220,767) are invalid.  In July 2014, AstraZeneca AB, AstraZeneca UK Limited, and Impax Laboratories, Inc. filed two patent infringement lawsuits in the United States District Court for the District of Delaware, alleging that the Company’s filing of ANDA No. 206350 constitutes an act of patent infringement and seeking a declaration that the two patents at issue are valid and infringed.

 

In September 2014, the Company filed a motion to dismiss one patent infringement lawsuit for lack of standing and responded to the second lawsuit by denying that any valid patent claim would be infringed.  In the second lawsuit, the Company also counterclaimed for a declaratory judgment that the patent claims are invalid and not infringed.  The Court has consolidated the two actions and denied the motion to dismiss the first action without prejudice.

 

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Thalomid®

 

The Company filed with the Food and Drug Administration an Abbreviated New Drug Application (ANDA) No. 206601, along with a paragraph IV certification, alleging that the fifteen patents associated with the Thalomid drug product (U.S. Patent Nos. 6,045,501; 6,315,720; 6,561,976; 6,561,977; 6,755,784; 6,869,399; 6,908,432; 7,141,018; 7,230,012; 7,435,745; 7,874,984; 7,959,566; 8,204,763;  8,315,886; 8,589,188 and 8,626,53) are invalid, unenforceable and/or not infringed.  On January 30, 2015, Celgene Corporation and Children’s Medical Center Corporation filed a patent infringement lawsuit in the United States District Court for the District of New Jersey, alleging that the Company’s filing of ANDA No. 206601 constitutes an act of patent infringement and seeking a declaration that the patents at issue are valid and infringed.  The Company is preparing a response to the Complaint.

 

Although the ultimate resolution of these matters is unknown, the legal fees associated with these patent challenges may have a significant impact on the Company’s financial position or results of operations in future periods.

 

Note 13.  Commitments and Contingencies

 

Leases

 

The Company leases certain manufacturing and office equipment, in the ordinary course of business, with initial lease terms not greater than 12 months.  These leases are typically renewed annually.  Rental and lease expense was not material for all periods presented.

 

Note 14.  Accumulated Other Comprehensive Loss

 

The Company’s Accumulated Other Comprehensive Loss was comprised of the following components as of March 31, 2015 and 2014:

 

(In thousands)

 

March 31,
2015

 

March 31,
2014

 

Foreign Currency Translation

 

 

 

 

 

Beginning Balance, July 1

 

$

(54

)

$

(47

)

Net loss on foreign currency translation (net of tax of $0 and $0)

 

(231

)

(2

)

Reclassifications to net income (net of tax of $0 and $0)

 

 

 

Other comprehensive loss, net of tax

 

(231

)

(2

)

Ending Balance, March 31

 

(285

)

(49

)

Total Accumulated Other Comprehensive Loss

 

$

(285

)

$

(49

)

 

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Note 15.  Earnings Per Common Share

 

A dual presentation of basic and diluted earnings per common share is required on the face of the Company’s Consolidated Statement of Operations as well as a reconciliation of the computation of basic earnings per common share to diluted earnings per common share.  Basic earnings per common share excludes the dilutive impact of potentially dilutive securities and is computed by dividing net income attributable to Lannett Company, Inc. by the weighted average number of common shares outstanding for the period.  Diluted earnings per common share is computed using the treasury stock method and includes the effect of potential dilution from the exercise of outstanding stock options and treats unvested restricted stock as if it were vested.  Potentially dilutive securities have been excluded in the weighted average number of common shares used for the calculation of earnings per share in periods of net loss because the effect of such securities would be anti-dilutive.  A reconciliation of the Company’s basic and diluted earnings per common share was as follows:

 

 

 

Three Months Ended
March 31, 2015

 

(In thousands, except share and per share data)

 

2015

 

2014

 

 

 

 

 

 

 

Net Income Attributable to Lannett Company, Inc.

 

$

36,233

 

$

22,995

 

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

35,880,954

 

35,025,968

 

Effect of potentially dilutive stock options and restricted stock awards

 

1,329,184

 

1,743,625

 

Diluted weighted average common shares outstanding

 

37,210,138

 

36,769,593

 

 

 

 

 

 

 

Earnings per common share attributable to Lannett Company, Inc.:

 

 

 

 

 

Basic

 

$

1.01

 

$

0.66

 

Diluted

 

$

0.97

 

$

0.63

 

 

 

 

Nine Months Ended
March 31, 2015

 

(In thousands, except share and per share data)

 

2015

 

2014

 

 

 

 

 

 

 

Net Income Attributable to Lannett Company, Inc.

 

$

115,976

 

$

33,566

 

 

 

 

 

 

 

Basic weighted average common shares outstanding

 

35,715,061

 

33,082,460

 

Effect of potentially dilutive stock options and restricted stock awards

 

1,367,077

 

1,503,547

 

Diluted weighted average common shares outstanding

 

37,082,138

 

34,586,007

 

 

 

 

 

 

 

Earnings per common share attributable to Lannett Company, Inc.:

 

 

 

 

 

Basic

 

$

3.25

 

$

1.01

 

Diluted

 

$

3.13

 

$

0.97

 

 

The number of anti-dilutive shares that have been excluded in the computation of diluted earnings per share for the three months ended March 31, 2015 and 2014 were 77 thousand and 3 thousand, respectively.  The number of anti-dilutive shares that have been excluded in the computation of diluted earnings per share for the nine months ended March 31, 2015 and 2014 were 490 thousand and 9 thousand, respectively.

 

Note 16.  Share-based Compensation

 

At March 31, 2015, the Company had four share-based employee compensation plans (the “2003 Plan,” the 2006 Long-term Incentive Plan (“LTIP”), or “2006 LTIP”, the 2011 LTIP and the 2014 LTIP).  Together these plans authorized an aggregate total of 8.1 million shares to be issued.  The plans have a total of 2.5 million shares available for future issuances.

 

The Company issues share-based compensation awards with a vesting period ranging up to 3 years and a maximum contractual term of 10 years.  The Company issues new shares of stock when stock options are exercised.  As of March 31, 2015, there was $11.7 million of total unrecognized compensation cost related to non-vested share-based compensation awards.  That cost is expected to be recognized over a weighted average period of 2.2 years.

 

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Stock Options

 

The Company measures share-based compensation cost for options using the Black-Scholes option pricing model.  The following table presents the weighted average assumptions used to estimate fair values of the stock options granted during the nine months ended March 31, 2015 and 2014 and the estimated annual forfeiture rates used to recognize the associated compensation expense:

 

 

 

March 31, 2015

 

March 31, 2014

 

Risk-free interest rate

 

1.7

%

2.1

%

Expected volatility

 

52.1

%

62.9

%

Expected dividend yield

 

0.0

%

0.0

%

Forfeiture rate

 

6.5

%

7.5

%

Expected term (in years)

 

5.5 years

 

5.9 years

 

Weighted average fair value

 

$

17.67

 

$

8.14

 

 

Expected volatility is based on the historical volatility of the price of our common shares during the historical period equal to the expected term of the option.  The Company uses historical information to estimate the expected term, which represents the period of time that options granted are expected to be outstanding.  The risk-free rate for the period equal to the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.  The forfeiture rate assumption is the estimated annual rate at which unvested awards are expected to be forfeited during the vesting period.  This assumption is based on our actual forfeiture rate on historical awards.  Periodically, management will assess whether it is necessary to adjust the estimated rate to reflect changes in actual forfeitures or changes in expectations.  Additionally, the expected dividend yield is equal to zero, as the Company has not historically issued, and has no immediate plans to issue, a dividend.

 

A stock option roll-forward as of March 31, 2015 and changes during the nine months then ended, is presented below:

 

(In thousands, except for weighted average price and life data)

 

Awards

 

Weighted-
Average
Exercise
Price

 

Aggregate
Intrinsic
Value

 

Weighted
Average
Remaining
Contractual
Life (yrs.)

 

 

 

 

 

 

 

 

 

 

 

Outstanding at July 1, 2014

 

2,205

 

$

7.84

 

 

 

 

 

Granted

 

509

 

$

36.55

 

 

 

 

 

Exercised

 

(541

)

$

6.78

 

$

26,800

 

 

 

Forfeited, expired or repurchased

 

(73

)

$

17.82

 

 

 

 

 

Outstanding at March 31, 2015

 

2,100

 

$

14.73

 

$

111,267

 

7.3

 

 

 

 

 

 

 

 

 

 

 

Vested and expected to vest at March 31, 2015

 

2,017

 

$

14.29

 

$

107,723

 

7.2

 

Exercisable at March 31, 2015

 

975

 

$

5.84

 

$

60,354

 

5.7

 

 

Restricted Stock

 

The Company measures restricted stock compensation costs based on the stock price at the grant date less an estimate for forfeitures.  The annual forfeiture rate used to calculate compensation expense was 6.5% for the nine months ended March 31, 2015 and 7.5% for the nine months ended March 31, 2014.

 

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A summary of restricted stock awards as of March 31, 2015 and changes during the nine months then ended, is presented below:

 

(In thousands)

 

Awards

 

Weighted
Average Grant -
date Fair Value

 

Aggregate
Intrinsic Value

 

 

 

 

 

 

 

 

 

Non-vested at July 1, 2014

 

15

 

34.66

 

 

 

Granted

 

103

 

37.97

 

 

 

Vested

 

(9

)

36.77

 

$

345

 

Forfeited

 

(5

)

36.55

 

 

 

Non-vested at March 31, 2015

 

104

 

$

37.68

 

 

 

 

Employee Stock Purchase Plan

 

In February 2003, the Company’s stockholders approved an Employee Stock Purchase Plan (“ESPP”).  Employees eligible to participate in the ESPP may purchase shares of the Company’s stock at 85% of the lower of the fair market value of the common stock on the first day of the calendar quarter, or the last day of the calendar quarter.  Under the ESPP, employees can authorize the Company to withhold up to 10% of their compensation during any quarterly offering period, subject to certain limitations.  The ESPP was implemented on April 1, 2003 and is qualified under Section 423 of the Internal Revenue Code.  The Board of Directors authorized an aggregate total of 1.1 million shares of the Company’s common stock for issuance under the ESPP.  During the nine months ended March 31, 2015 and 2014, 9 thousand shares and 14 thousand shares were issued under the ESPP, respectively.  As of March 31, 2015, 435 thousand total cumulative shares have been issued under the ESPP.

 

The following table presents the allocation of share-based compensation costs recognized in the Consolidated Statements of Operations by financial statement line item:

 

 

 

Three Months Ended

 

Nine Months Ended

 

 

 

March 31,

 

March 31,

 

(In thousands)

 

2015

 

2014

 

2015

 

2014

 

Selling, general and administrative

 

$

1,195

 

$

2,240

 

$

3,805

 

$

4,763

 

Research and development

 

133

 

225

 

390

 

443

 

Cost of sales

 

182

 

324

 

534

 

627

 

Total

 

1,510

 

2,789

 

4,729

 

5,833

 

 

 

 

 

 

 

 

 

 

 

Tax benefit at statutory rate

 

$

514

 

$

1,053

 

$

1,589

 

$

2,160

 

 

Note 17.  Employee Benefit Plan

 

The Company has a 401k defined contribution plan (the “Plan”) covering substantially all employees.  Pursuant to the Plan provisions, the Company is required to make matching contributions equal to 50% of each employee’s contribution, not to exceed 4% of the employee’s compensation for the Plan year.  Contributions to the Plan during the three months ended March 31, 2015 and 2014 were $226 thousand and $169 thousand, respectively.  Contributions to the Plan during the nine months ended March 31, 2015 and 2014 were $582 thousand and $528 thousand, respectively.

 

Note 18.  Income Taxes

 

The Company uses the liability method to account for income taxes.  Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities as measured by the enacted tax rates which will be in effect when these differences reverse.  Deferred tax expense/(benefit) is the result of changes in deferred tax assets and liabilities.

 

The federal, state and local income tax expense for the three months ended March 31, 2015 and 2014 was $18.0 million and $13.3 million, respectively.  The effective tax rates for the three months ended March 31, 2015 and 2014 were 33% and 37%, respectively.  The effective tax rate for the three months ended March 31, 2015 was lower compared to the three months ended March 31, 2014 due primarily to the effect of changes in local tax laws and domestic manufacturing deductions recorded in Fiscal 2015.  Research-related tax credits also contributed to the lower rate.  The federal, state and local income tax expense for the nine months ended March 31, 2015 and 2014 was $60.2 million and $18.8 million, respectively.  The effective tax rates were 34% and 36%, respectively.  The effective tax rate for the nine months ended March 31, 2015 was lower compared to the nine months ended March 31, 2014 due

 

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primarily to the effect of changes in local tax laws and domestic manufacturing deductions recorded in Fiscal 2015.  Research-related tax credits also contributed to the lower rate.

 

The Company may recognize the tax benefit from an uncertain tax position claimed on a tax return only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position.  The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement.

 

As of March 31, 2015 and June 30, 2014, the Company reported total unrecognized tax benefits of $578 thousand and $428 thousand, respectively.  As a result of the positions taken during the period, the Company has not recorded any interest and penalties for the period ended March 31, 2015 in the statement of operations and no cumulative interest and penalties have been recorded in the Company’s statement of financial position as of March 31, 2015 and June 30, 2014.  The Company will recognize interest accrued on unrecognized tax benefits in interest expense and any related penalties in operating expenses.  The Company does not believe that the total unrecognized tax benefits will significantly increase or decrease in the next twelve months.

 

The Company files income tax returns in the United States federal jurisdiction, Pennsylvania, and New Jersey.  The Company’s tax returns for Fiscal Year 2011 and prior generally are no longer subject to review as such years generally are closed.  The Company believes that an unfavorable resolution for open tax years would not be material to the financial position of the Company.

 

Note 19.  Related Party Transactions

 

The Company had sales of $226 thousand and $375 thousand during the three months ended March 31, 2015 and 2014, respectively, to a generic distributor, Auburn Pharmaceutical Company (“Auburn”).  Sales to Auburn for the nine months ended March 31, 2015 and 2014 were $1.3 million and $1.4 million, respectively.  Jeffrey Farber, Chairman of the Board and the son of William Farber, Chairman Emeritus of the Board of Directors, is the owner of Auburn.  Accounts receivable includes amounts due from Auburn of $685 thousand and $980 thousand at March 31, 2015 and June 30, 2014, respectively.  In the Company’s opinion, the terms of these transactions were not more favorable to Auburn than would have been to a non-related party.

 

Note 20.  Material Contracts with Suppliers

 

Jerome Stevens Pharmaceuticals Distribution Agreement:

 

The Company’s primary finished goods inventory supplier is JSP, in Bohemia, New York.  Purchases of finished goods inventory from JSP accounted for approximately 66% and 65% of the Company’s inventory purchases in the three months ended March 31, 2015 and 2014, respectively. Purchases of finished goods inventory from JSP accounted for 68% and 67% of the Company’s inventory purchases in the nine months ended March 31, 2015 and 2014, respectively.

 

On March 23, 2004, the Company entered into an agreement with JSP for the exclusive distribution rights in the United States to the current line of JSP products, in exchange for 4.0 million shares of the Company’s common stock.  The JSP products covered under the agreement included Butalbital, Aspirin, Caffeine with Codeine Phosphate Capsules; Digoxin Tablets; Levothyroxine Sodium Tablets, sold generically and under the brand name Unithroid®.  On August 19, 2013, the Company entered into an agreement with JSP to extend its initial contract to continue as the exclusive distributor in the United States of three JSP products: Butalbital, Aspirin, Caffeine with Codeine Phosphate Capsules USP; Digoxin Tablets USP; Levothyroxine Sodium Tablets USP.  The amendment to the original agreement extends the initial contract, which was due to expire on March 22, 2014, for five years through March 2019.  In connection with the amendment, the Company issued 1.5 million shares of the Company’s common stock to JSP and JSP’s designees.  In accordance with its policy related to renewal and extension costs for recognized intangible assets, the Company recorded a $20.1 million expense in cost of sales, which represents the fair value of the shares on August 19, 2013.  If the parties agree to a second five year extension from March 23, 2019 to March 23, 2024, the Company is required to issue to JSP or its designees an additional 1.5 million shares of the Company’s common stock.  Both Lannett and JSP have the right to terminate the contract if one of the parties does not cure a material breach of the contract within thirty (30) days of notice from the non-breaching party.

 

During the renewal term of the agreement, the Company is required to use commercially reasonable efforts to purchase minimum dollar quantities of JSP products.  Specifically, the Company is required to purchase, in the aggregate, $31 million of products from JSP each year.  The Company has met the minimum purchase requirement for Fiscal 2015, but there is no guarantee that the Company will be able to continue to do so in Fiscal 2016 and in the future.  If the Company does not meet the minimum purchase requirements, JSP’s sole remedy is to terminate the agreement.

 

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Note 21.  Cody Expansion Project

 

On December 20, 2012, the Company, through its subsidiaries Realty and Cody, entered into an agreement (“the Agreement”) with the City of Cody, Wyoming (“City of Cody”) and Forward Cody Wyoming, Inc. (“Forward Cody”), an unrelated non-profit corporation, which involves the construction of a building of approximately 24,000 square feet (the “Project”).  As part of the Agreement, Cody was obligated to make an additional capital investment in its existing facilities in the amount of $5.2 million and create an additional 45 full time positions within three years starting June 30, 2011; Realty was required to contribute 1.66 acres of land to Forward Cody and enter into a 25 year lease agreement with Forward Cody for the Project.  Realty will make annual rent payments totaling $108 thousand beginning on the date a Certificate of Occupancy permit is issued by the City of Cody and the Project is legally available for occupancy.  Cody will sublease the property from Realty.  Upon the fifth anniversary of occupancy, Realty may, at its discretion, purchase the Project from Forward Cody.  The purchase option continues until Realty purchases the Project.  Nothing in the Agreement should be deemed to create any relationship between Forward Cody and Realty other than the relationship of landlord and tenant.

 

In June 2014, the Company amended the Agreement including changing the size of the building, eliminating the requirements to contribute any land, and removing Realty as a party to the agreement.  Additionally, Cody Labs is required to provide a capital contribution to the project in the amount of $565 thousand.  None of the revisions are expected to be material to the Company’s results of operations, financial position, or cashflows.

 

Note 22.  Subsequent Events

 

First Amendment to the Credit Agreement

 

On April 21, 2015, the Company entered into a First Amendment to the Credit Agreement (the “First Amendment”), pursuant to which the parties amended the terms of the Credit Agreement originally entered into on December 18, 2013 with Citibank, N.A., as administrative agent and certain other financial institutions party thereto as lenders.  The First Amendment increases the Company’s revolving line of credit from $50.0 million to $120.0 million (the “Credit Facility”), consisting of revolving loans, swingline loans not to exceed an aggregate principal amount of $5.0 million and letters of credit not to exceed a maximum aggregate principal amount of $5.0 million.  The First Amendment also includes an accordion feature that will allow the Company to increase the Credit Facility by a total of up to an additional $30.0 million, subject to securing additional commitments from existing lenders or new lending institutions.  The First Amendment also modified certain financial covenants, most notably permitted acquisitions and capital expenditures. Permitted acquisitions increased from $100.0 million to $200.0 million individually and in the aggregate for each fiscal year. Total permitted acquisitions over the remaining term of the Credit Agreement were increased to $600.0 million.  Capital expenditure covenants were also increased over the term of the Credit Agreement based on certain leverage ratios, as defined.  At closing, the Company had $120.0 million available for borrowing under the Credit Facility.

 

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ITEM 2.                MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following information should be read in conjunction with the consolidated financial statements and notes in Part I, Item 1 of this Quarterly Report and with Management’s Discussion and Analysis of Financial Condition and Results of Operations contained in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2014.

 

This Report on Form 10-Q and certain information incorporated herein by reference contains forward-looking statements which are not historical facts made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements are not promises or guarantees and investors are cautioned that all forward-looking statements involve risks and uncertainties, including but not limited to the impact of competitive products and pricing, product demand and market acceptance, new product development, the regulatory environment, including without limitation, reliance on key strategic alliances, availability of raw materials, fluctuations in operating results and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission. These statements are based on management’s current expectations and are naturally subject to uncertainty and changes in circumstances.  We caution you not to place undue reliance upon any such forward-looking statements which speak only as of the date made.  Lannett is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.

 

Company Overview

 

Lannett Company, Inc. (a Delaware corporation) and subsidiaries (the “Company” or “Lannett”) develop, manufacture, package, market, and distribute solid oral (tablets and capsules), extended release, topical, nasal, and oral solution finished dosage forms of drugs, that address a wide range of therapeutic areas.  The Company also manufactures active pharmaceutical ingredients through its Cody Labs subsidiary, providing a vertical integration benefit.  Additionally the Company is pursuing partnerships, research contracts and internal expansion for the development and production of other dosage forms including: ophthalmic, nasal, patch, foam, buccal, sublingual, soft gel, injectable, and oral dosages.

 

The Company operates pharmaceutical manufacturing plants in Philadelphia, Pennsylvania and Cody, Wyoming.  Customers of the Company’s pharmaceutical products include generic pharmaceutical distributors, drug wholesalers, chain drug stores, private label distributors, mail-order pharmacies, other pharmaceutical manufacturers, managed care organizations, hospital buying groups, governmental entities and health maintenance organizations.

 

Financial Summary

 

For the third quarter of Fiscal Year 2015, net sales increased to $99.4 million, representing 24% growth over the third quarter of Fiscal Year 2014.  Gross profit increased to $75.6 million compared to $56.1 million in the prior-year period and gross profit percentage increased to 76% compared to 70% in the prior-year period.  R&D expenses decreased 13% to $9.2 million compared to the third quarter of Fiscal Year 2014 while SG&A expenses increased 28% to $12.2 million from $9.6 million.  Operating income for the third quarter of Fiscal Year 2015 was $54.3 million compared to $36.0 million in the third quarter of Fiscal Year 2014.  Net income attributable to Lannett Company, Inc. for the third quarter of Fiscal Year 2015 was $36.2 million, or $0.97 per diluted share compared to $23.0 million or $0.63 per diluted share in the third quarter of Fiscal Year 2014.

 

For the first nine months of Fiscal 2015, net sales increased to $307.6 million representing 59% growth over the prior-year period.  Gross profit increased $135.9 million to $234.4 million, compared to the prior-year period which included the $20.1 million charge related to the JSP contract renewal.  Gross profit percentage increased to 76% compared to 51% in the prior-year period.  R&D expenses increased 11% to $23.4 million compared to the prior-year period while SG&A expenses increased 34% to $35.6 million from $26.6 million.  Operating income for the first nine months of Fiscal 2015 was $175.5 million compared to $50.7 million in the prior-year period.  Net income attributable to Lannett Company, Inc. for the first nine months of Fiscal 2015 was $116.0 million, or $3.13 per diluted share.  Comparatively, net income attributable to Lannett Company, Inc. in the prior year was $33.6 million, or $0.97 per diluted share and included the $20.1 million pre-tax charge related to the JSP contract renewal.

 

A more detailed discussion of the Company’s financial results can be found below.

 

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Results of Operations - Three months ended March 31, 2015 compared with the three months ended March 31, 2014

 

Net sales increased 24% to $99.4 million for the three months ended March 31, 2015.  The following table identifies the Company’s net product sales by medical indication for the three months ended March 31, 2015 and 2014:

 

(In thousands)

 

Three Months Ended March 31,

 

Medical Indication

 

2015

 

2014

 

Antibiotic

 

$

3,005

 

$

3,361

 

Cardiovascular

 

8,457

 

21,331

 

Gallstone

 

20,489

 

988

 

Glaucoma

 

5,714

 

4,538

 

Gout

 

1,453

 

3,383

 

Migraine

 

6,722

 

4,787

 

Obesity

 

1,084

 

915

 

Pain Management

 

4,286

 

8,407

 

Thyroid Deficiency

 

36,720

 

28,292

 

Other

 

11,422

 

3,995

 

Total

 

$

99,352

 

$

79,997

 

 

Product price increases contributed $29.5 million to the overall increase in net sales, partially offset by decreased volumes of $10.1 million.  The Company experienced favorable trends in product pricing on several key products during the period, as discussed below.  Although the Company has benefited from these favorable pricing trends, the level of competition in the marketplace is constantly changing and the Company cannot guarantee that these pricing trends will continue.

 

The following chart details price and volume changes by medical indication:

 

Medical indication

 

Sales volume
change %

 

Sales price
change %

 

Antibiotic

 

(3)

%

(7)

%

Cardiovascular

 

(41)

%

(20)

%

Gallstone

 

52

%

1923

%

Glaucoma

 

(6)

%

32

%

Gout

 

(57)

%

%

Migraine

 

(8)

%

48

%

Obesity

 

20

%

(1)

%

Pain Management

 

(22)

%

(27)

%

Thyroid Deficiency

 

(4)

%

34

%

 

Gallstone.  Net sales of drugs used for gallstones increased by $19.5 million.  The increase in net sales was primarily attributable to price increases on key products.  Higher volumes also contributed to the increase in net sales.

 

Thyroid Deficiency.  Net sales of drugs used for the treatment of thyroid deficiency increased by $8.4 million, primarily as a result of price increases on key products.

 

Migraine.  Net sales of drugs used to treat migraines increased by $1.9 million.  The increase in net sales was primarily attributable to price increases on key products.

 

Glaucoma.  Net sales of drugs used for the treatment of Glaucoma increased by $1.2 million.  The increase in net sales was primarily attributable to price increases on key products.

 

Cardiovascular.  Net sales of drugs used for cardiovascular treatment decreased by $12.9 million primarily as a result of several new entrants in the market for products used to treat congestive heart failure.  The Company experienced lower volumes and additional competition as expected.  The Company currently anticipates net sales from cardiovascular products in the fourth quarter of Fiscal 2015 to be comparable to net sales from cardiovascular products in the third quarter of Fiscal 2015.

 

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Pain Management.  Net sales of pain management products decreased $4.1 million.  The decrease in net sales was attributable to lower volumes as well as a lower average net sales price due to an increase in return reserves related to a voluntary recall of one lot of product manufactured at the Company’s facility in Cody, Wyoming due to incorrect labeling.  The Company continues to actively market its C-Topical® Solution product utilizing a group of brand representatives in anticipation of an NDA filing.  Higher volumes of the Company’s Oxycodone HCl Oral Solution product which was re-launched in the second quarter of Fiscal 2015 helped to offset the decrease in net sales.

 

The Company sells its products to customers in various distribution channels.  The table below presents the Company’s net sales to each distribution channel for the three months ended March 31:

 

(In thousands)
Customer Distribution Channel

 

March 31,
2015

 

March 31,
2014

 

Wholesaler/Distributor

 

$

75,740

 

$

50,418

 

Retail Chain

 

14,043

 

23,218

 

Mail-Order Pharmacy

 

9,569

 

6,361

 

Total

 

$

99,352

 

$

79,997

 

 

Net sales to wholesaler/distributor increased as a result of increased sales in a variety of products for thyroid deficiency and gallstone, partially offset by decreases in cardiovascular, as discussed above.  Additionally, the increase in net sales to wholesaler/distributor was impacted by the strategic partnership between Amerisource Bergen and Walgreens, whereby Amerisource Bergen began product distribution on behalf of Walgreens in third quarter of Fiscal Year 2014.  Other strategic partnerships between industry wholesalers and retailers also impacted net sales to wholesaler/distributor and retail chain.  Mail-order pharmacy net sales increased primarily as a result of increased sales of drugs used for the treatment of thyroid deficiency, as discussed above.

 

Cost of Sales.  Cost of sales for the third quarter of Fiscal 2015 decreased slightly to $23.7 million.  The decrease is primarily related to lower amortization and other regulatory expenses partially offset by increased provisions for excess and obsolete inventory.  Amortization expense included in cost of sales totaled $20 thousand for the third quarter of Fiscal 2015 and $467 thousand for the third quarter of Fiscal 2014.

 

Gross Profit.  Gross profit for the third quarter of Fiscal 2015 increased 35% to $75.6 million or 76% of net sales.  In comparison, gross profit for the third quarter of Fiscal 2014 was $56.1 million or 70% of net sales.  The third quarter of Fiscal 2015 gross profit percentage increase was mainly attributable to product price increases and changes in the mix of products sold, as discussed above.

 

While the Company is continuously striving to keep product costs low, there can be no guarantee that gross profit percentages will stay consistent in future periods.  Pricing pressure from competitors and costs of producing or purchasing new drugs may also fluctuate in future periods.  Changes in future product sales mix may also occur.

 

Research and Development.  Research and development expenses for the third quarter decreased 13% to $9.2 million in Fiscal 2015 from $10.6 million in Fiscal 2014.  The decrease is primarily due to lower third party contract lab expenses costs totaling $2.0 million, partially offset by increased costs associated with bio-equivalency studies and the clinical trial for the Company’s C-Topical® Solution product totaling $684 thousand.

 

Selling, General and Administrative.  Selling, general and administrative expenses increased 28% to $12.2 million in the third quarter of Fiscal 2015 compared with $9.6 million in Fiscal 2014.  The increase was primarily due to increased compensation related expenses totaling $1.3 million, increased acquisition-related expenses totaling $991 thousand, higher legal expenses totaling $462 thousand as well as additional expenses related to marketing the Company’s C-Topical® Solution product.

 

While the Company is focused on controlling costs, increases in personnel costs may have an ongoing and lasting impact on the administrative cost structure.  Other costs are being incurred to facilitate improvements in the Company’s infrastructure.

 

Other Income (Loss).  Interest expense in the third quarter of Fiscal 2015 totaled $8 thousand compared to $13 thousand in Fiscal 2014.  Interest and dividend income totaling $95 thousand in the third quarter of Fiscal 2015 was lower compared with $109 thousand in the third quarter of Fiscal 2014.  The Company also recorded a net loss on investment securities during the third quarter of Fiscal 2015 totaling $103 thousand compared to a net gain on investment securities totaling $200 thousand in Fiscal 2014.

 

Income Tax.  The Company recorded income tax expense in the third quarter of Fiscal 2015 of $18.0 million compared to $13.3 million in the third quarter of Fiscal 2014.  The effective tax rate for the three months ended March 31, 2015 was 33%, compared to 37% for the three months ended March 31, 2014.  The effective tax rate for the three months ended March 31, 2015 was lower

 

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compared to the three months ended March 31, 2014 due primarily to the effect of changes in local tax laws and domestic manufacturing deductions recorded in Fiscal 2015.  Research-related tax credits also contributed to the lower rate.

 

Net Income.  For the three months ended March 31, 2015, the Company reported net income attributable to Lannett Company, Inc. of $36.2 million, or $0.97 per diluted share.  Comparatively, net income attributable to Lannett Company, Inc. in the prior year was $23.0 million, or $0.63 per diluted share.

 

Results of Operations - Nine months ended March 31, 2015 compared with the nine months ended March 31, 2014

 

Net sales increased 59% to $307.6 million for the nine months ended March 31, 2015.  The following table identifies the Company’s net product sales by medical indication for the nine months ended March 31, 2015 and 2014:

 

(In thousands)

 

Nine Months Ended March 31,

 

Medical Indication

 

2015

 

2014

 

Antibiotic

 

$

9,355

 

$

11,069

 

Cardiovascular

 

45,729

 

42,779

 

Gallstone

 

48,969

 

3,490

 

Glaucoma

 

15,921

 

7,474

 

Gout

 

6,743

 

7,445

 

Migraine

 

19,455

 

9,851

 

Obesity

 

2,952

 

2,890

 

Pain Management

 

18,508

 

20,418

 

Thyroid Deficiency

 

114,601

 

74,560

 

Other

 

25,328

 

13,176

 

Total

 

$

307,561

 

$

193,152

 

 

Product price increases contributed $133.5 million to the overall increase in net sales, partially offset by decreased volumes of $19.1 million.  The Company experienced favorable trends in product pricing on several key products during the period, as discussed below.  Although the Company has benefited from these favorable pricing trends, the level of competition in the marketplace is constantly changing and the Company cannot guarantee that these pricing trends will continue.

 

The following chart details price and volume changes by medical indication:

 

Medical indication

 

Sales volume
change %

 

Sales price
change %

 

Antibiotic

 

(7)

%

(9)

%

Cardiovascular

 

(44)

%

51

%

Gallstone

 

(12)

%

1315

%

Glaucoma

 

(11)

%

124

%

Gout

 

(10)

%

%

Migraine

 

(16)

%

113

%

Obesity

 

12

%

(10)

%

Pain Management

 

%

(9)

%

Thyroid Deficiency

 

(4)

%

58

%

 

Thyroid Deficiency.  Net sales of drugs used for the treatment of thyroid deficiency increased by $40.0 million, primarily as a result of price increases on key products.

 

Gallstone.  Net sales of drugs used for gallstones increased by $45.5 million.  The increase in net sales was primarily attributable to price increases on key products.

 

Migraine.  Net sales of drugs used to treat migraines increased by $9.6 million.  The increase in net sales was attributable to price increases on key products, partially offset by decreased volumes.

 

Glaucoma.  Net sales of drugs used for the treatment of Glaucoma increased by $8.4 million.  The increase in net sales was primarily attributable to price increases on key products.

 

Cardiovascular.  Net sales of drugs used for cardiovascular treatment increased by $3.0 million, primarily as a result of price increases on products used to treat congestive heart failure, partially offset by lower volumes. 

 

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The Company experienced lower volumes and additional competition beginning in the third quarter of Fiscal 2015.  The Company anticipates net sales from cardiovascular products in the fourth quarter of Fiscal 2015 to be comparable to net sales from cardiovascular products in the third quarter of Fiscal 2015.

 

Pain Management.  Net sales of pain management products decreased $1.9 million.  The decrease in net sales was primarily attributable to a lower average net sales price resulting from an increase in return reserves related to a voluntary recall of one lot of product manufactured at the Company’s facility in Cody, Wyoming due to incorrect labeling.  The Company continues to actively market its C-Topical® Solution product utilizing a group of brand representatives in anticipation of an NDA filing.  The decrease in net sales was partially offset by higher volumes of the Company’s Oxycodone HCl Oral Solution product which was re-launched in the second quarter of Fiscal 2015 as well as higher volumes of the Company’s C-Topical® Solution product.

 

The Company sells its products to customers in various distribution channels.  The table below presents the Company’s net sales to each distribution channel for the nine months ended March 31:

 

(In thousands)
Customer Distribution Channel

 

March 31,
2015

 

March 31,
2014

 

Wholesaler/Distributor

 

$

224,684

 

$

122,551

 

Retail Chain

 

47,059

 

57,172

 

Mail-Order Pharmacy

 

35,818

 

13,429

 

Total

 

$

307,561

 

$

193,152

 

 

Net sales to wholesaler/distributor increased as a result of increased sales in a variety of products for thyroid deficiency, gallstone and cardiovascular, as discussed above.  Additionally, the increase in net sales to wholesaler/distributor was impacted by the strategic partnership between Amerisource Bergen and Walgreens, whereby Amerisource Bergen began product distribution on behalf of Walgreens in third quarter of Fiscal Year 2014.  Other strategic partnerships between industry wholesalers and retailers also impacted net sales to wholesaler/distributor and retail chain.  Mail-order pharmacy net sales increased primarily as a result of increased sales of drugs used for the treatment of thyroid deficiency, as discussed above.

 

Cost of Sales.  Cost of sales for the first nine months of Fiscal 2015 decreased $21.5 million to $73.2 million.  The decrease was primarily attributable to the nonrecurring $20.1 million charge related to the JSP contract renewal recorded in the first quarter of Fiscal Year 2014. The remaining decrease primarily reflected the impact of decreased volumes and lower amortization, partially offset by increased provisions for excess and obsolete inventory.  Amortization expense included in cost of sales totaled $61 thousand for the first nine months of Fiscal 2015 and $1.4 million for the first nine months of Fiscal 2014.

 

Gross Profit.  Gross profit for the first nine months of Fiscal 2015 increased 138% to $234.4 million or 76% of net sales.  In comparison, gross profit for the first nine months of Fiscal 2014 was $98.5 million or 51% of net sales.  The charge related to the JSP contract renewal negatively impacted gross margin percentage by 10% points in the first nine months of Fiscal Year 2014.  The remaining increase in gross profit percentage was due to product price increases.

 

While the Company is continuously striving to keep product costs low, there can be no guarantee that gross profit percentages will stay consistent in future periods.  Pricing pressure from competitors and costs of producing or purchasing new drugs may also fluctuate in future periods.  Changes in future product sales mix may also occur.

 

Research and Development.  Research and development expenses for the first nine months increased 11% to $23.4 million in Fiscal 2015 from $21.1 million in Fiscal 2014.  The increase was primarily due to increased product development costs totaling $1.6 million as well as costs associated with bio-equivalency studies and the clinical trial for the Company’s C-Topical® Solution product totaling $1.7 million.  The increase was partially offset by decreased third-party contract lab expenses totaling $2.6 million.  Compensation-related and other miscellaneous expenses also contributed to the increase.

 

Selling, General and Administrative.  Selling, general and administrative expenses increased 34% to $35.6 million in the first nine months of Fiscal 2015 compared with $26.6 million in Fiscal 2014.  The increase was primarily due to additional acquisition-related expenses totaling $3.0 million as well as an increase in legal expenses totaling $1.5 million.  Compensation related expenses also contributed an additional $1.4 million.

 

While the Company is focused on controlling costs, increases in personnel costs may have an ongoing and longer lasting impact on the administrative cost structure.  Other costs are being incurred to facilitate improvements in the Company’s infrastructure.

 

Other Income (Loss).  Interest expense in the first nine months of Fiscal 2015 totaled $119 thousand compared to $117 thousand in Fiscal 2014.  Interest and dividend income totaling $303 thousand in the first nine months of Fiscal 2015 was higher compared with

 

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$204 thousand in the first nine months of Fiscal 2014.  The Company also recorded a net gain on investment securities during the first nine months of Fiscal 2015 totaling $592 thousand compared to a net gain on investment securities totaling $1.8 million in Fiscal 2014.

 

Income Tax.  The Company recorded income tax expense in the first nine months of Fiscal 2015 of $60.2 million compared to $18.8 million in the first nine months of Fiscal 2014.  The effective tax rate for the nine months ended March 31, 2015 was 34% compared to 36% for the nine months ended March 31, 2014.  The effective tax rate for the nine months ended March 31, 2015 was lower compared to the nine months ended March 31, 2014 due primarily to the effect of changes in local tax laws and domestic manufacturing deductions recorded in Fiscal 2015.  Research-related tax credits also contributed to the lower rate.  Additionally, the Company expects its overall effective tax rate will be 34% to 35% for the full year ended June 30, 2015.

 

Net Income.  For the nine months ended March 31, 2015, the Company reported net income attributable to Lannett Company, Inc. of $116.0 million, or $3.13 per diluted share.  Comparatively, net income attributable to Lannett Company, Inc. in the prior year was $33.6 million, or $0.97 per diluted share, which included the charge related to the JSP contract renewal equal to $0.36 per diluted share.

 

Liquidity and Capital Resources

 

Cash Flow

 

The Company has historically financed its operations with cash flow generated from operations supplemented with borrowings from various government agencies and financial institutions.  At March 31, 2015, working capital was $332.3 million as compared to $218.5 million at June 30, 2014, an increase of $113.8 million.  Current product portfolio sales as well as sales related to future product approvals are anticipated to continue to generate positive cash flow from operations.

 

Net cash provided by operating activities of $89.7 million for the nine months ended March 31, 2015 reflected net income of $116.0 million, adjustments for non-cash items of $1.3 million, as well as cash used by changes in operating assets and liabilities of $27.6 million.  In comparison, net cash provided by operating activities of $15.8 million for the nine months ended March 31, 2014 reflected net income of $33.6 million, adjustments for non-cash items of $16.7 million, as well as cash used by changes in operating assets and liabilities of $34.5 million.

 

Significant changes in operating assets and liabilities from June 30, 2014 to March 31, 2015 were comprised of:

 

·                  An increase in accounts receivable of $18.4 million mainly due to an increase in gross accounts receivable resulting from increased sales partially offset by increases in total revenue-related reserves.  The Company’s days sales outstanding (“DSO”) at March 31, 2015, based on gross sales for the three months ended March 31, 2015 and gross accounts receivable at March 31, 2015, was 63 days.  The level of DSO at March 31, 2015 was comparable to the Company’s expectation that DSO will be in the 60 to 70 day range based on 60 day payment terms for most customers.

·                  A decrease in accrued payroll and payroll related costs of $4.8 million primarily related to Fiscal Year 2015 payments of incentive compensation and tax withholdings accrued in Fiscal Year 2014, partially offset by incentive compensation costs accrued during Fiscal Year 2015.

·                  A decrease in accounts payable of $4.0 million due to the timing of payments at the beginning of Fiscal Year 2015.

·                  A decrease in inventories of $2.4 million.  The decrease was primarily due to an increase in excess and obsolescence reserves recorded during Fiscal 2015.

 

Significant changes in operating assets and liabilities from June 30, 2013 to March 31, 2014 were comprised of:

 

·                  An increase in accounts receivable of $38.0 million mainly due to an increase in gross accounts receivable as a result of increased sales, partially offset by increases in total revenue-related reserves.  The Company’s days sales outstanding (“DSO”) at March 31, 2014, based on annualized gross sales and gross accounts receivable at March 31, 2014, was 66 days.  The level of DSO at March 31, 2014 was comparable to the Company’s expectation that DSO will be in the 60 to 70 day range based on 60 day payment terms for most customers.

·                  A decrease in income taxes payable totaling $154 thousand and an increase in prepaid income taxes totaling $2.6 million, mainly resulting from Fiscal 2014 expected taxable income offset by the timing of estimated tax payments made during Fiscal 2014 and tax benefits from stock options exercised.

·                  An increase in inventories of $8.8 million primarily due to the timing of customer order fulfillment.

·                  An increase in accrued expenses of $6.1 million due to an increase in rebates accrued resulting from sales qualifying for existing rebate programs.

 

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Net cash provided by investing activities of $1.9 million for the nine months ended March 31, 2015 is mainly the result of proceeds from the sale of investment securities of $61.3 million, partially offset by purchases of investment securities of $36.7 million and purchases of property, plant and equipment of $22.6 million.  Net cash used in investing activities of $49.3 million for the nine months ended March 31, 2014 was primarily related to purchases of property, plant and equipment of $20.2 million, primarily two new building purchases, and purchases of investment securities of $49.8 million, partially offset by proceeds from the sale of investment securities of $20.6 million.

 

Net cash provided by financing activities of $11.9 million for the nine months ended March 31, 2015 was primarily due to proceeds from the issuance of stock pursuant to stock compensation plans of $4.2 million and excess tax benefits on stock option exercises of $7.8 million, partially offset by debt repayments of $96 thousand.  Net cash provided by financing activities of $74.9 million for the nine months ended March 31, 2014 was primarily due to proceeds from an offering of the Company’s common stock of $71.5 million, proceeds from the issuance of stock pursuant to stock compensation plans of $4.7 million and excess tax benefits on stock option exercises of $5.2 million, partially offset by debt repayments of $5.3 million.

 

Credit Facilities

 

The Company has previously entered into and may enter future agreements with various government agencies and financial institutions to provide additional cash to help finance the Company’s various capital investments and potential strategic opportunities.  These borrowing arrangements as of March 31, 2015 are as follows:

 

In December 2013, the Company entered into a credit agreement (the “Credit Agreement”) with Citibank, N.A., as administrative agent, and another financial institution.  As of March 31, 2015, the Credit Agreement provided for a revolving loan commitment in the amount of up to $50.0 million.  Any loans under the Credit Agreement will bear interest at either a “Eurodollar Rate” or a “Base Rate” plus a specified margin.  The Company is also required to pay a commitment fee on any undrawn commitments under the Credit Agreement ranging from 0.2% - 0.3% per annum according to the average daily balance of borrowings under the agreement.  The Credit Agreement is collateralized by substantially all of the Company’s assets.  In connection with securing the Credit Agreement, the Company repaid substantially all of its outstanding debt.  As of March 31, 2015 and June 30, 2014, the Company had $50.0 million available under the Credit Agreement.

 

The Credit Agreement contains representations and warranties, affirmative, negative and financial covenants, and events of default, applicable to the Company and its subsidiaries which are customary for credit facilities of this type.  As of March 31, 2015 and June 30, 2014, the Company was in compliance with all financial covenants.

 

The Credit Agreement was amended on April 21, 2015.  See Note 22 “Subsequent Events” for more information.

 

The Company is the primary beneficiary to a VIE called Realty.  The VIE owns land and a building which is being leased to Cody Labs.  A mortgage loan with First National Bank of Cody has been consolidated in the Company’s financial statements, along with the related land and building.  The mortgage requires monthly principal and interest payments of $15 thousand.  As of March 31, 2015 and June 30, 2014, the effective rate was 4.5%.  The mortgage is collateralized by the land and building with a net book value of $1.5 million.  As of March 31, 2015, $1.0 million is outstanding under the mortgage loan, of which $134 thousand is classified as currently due.

 

Other Liquidity Matters

 

We are continuously evaluating the potential for product and company acquisitions as a part of our future growth strategy.  In conjunction with a potential acquisition the Company may utilize current resources or seek additional sources of capital to finance any such acquisition, which could have an impact on future liquidity.

 

Research and Development Arrangements

 

In the normal course of business, the Company has entered into certain research and development and other arrangements.  As part of these arrangements the Company has agreed to certain contingent payments which generally become due and payable only upon the achievement of certain developmental, regulatory, commercial and/or other milestones.  In addition, under certain arrangements, we may be required to make royalty payments based on a percentage of future sales, or other metric, for products currently in development in the event that the Company begins to market and sell the product.  Due to the inherent uncertainty related to these developmental, regulatory, commercial and/or other milestones, it is unclear if the Company will ever be required to make such payments.

 

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Prospects for the Future

 

Lannett continues to experience substantial improvement year over year in many important financial metrics.  Each year, our knowledge, skills and talent increase, as the Company learns from its experience.  The Company is strengthening and building momentum to push to the next level within the generic pharmaceutical industry.  There are several strategic initiatives on which the Company is embarking to continue its growth.

 

One initiative at the core of the Company’s strategy is to continue leveraging the asset we acquired in 2007, Cody Labs.  In July 2008, the DEA granted Cody Labs a license to directly import concentrated poppy straw for conversion into opioid-based APIs for use in various dosage forms for pain management.  The value of this license comes from the fact that, to date, only six other companies in the U.S. have been granted this license.  This license, along with Cody Labs’ expertise in API development and manufacture, allows the Company to perform in a market with high barriers to entry, no foreign competition, and limited domestic competition.  Because of this vertical integration, the Company has direct control of its supply and can avoid increased costs associated with buying APIs from third-party manufacturers, thereby achieving higher margins than generic products historically produce.  The Company can also leverage this vertical integration not only for direct supply of opioid-based APIs, but also for the manufacture of non-opioid-based APIs.

 

The Company believes that the demand for controlled substance, pain management drugs will continue to grow as the “Baby Boomer” generation ages.  By concentrating additional resources in the development of opioid-based APIs and dosage forms, the Company is well-positioned to take advantage of this opportunity.  The Company is currently vertically integrated on two products, with several others in various stages of development.

 

One product which the Company manufactures is a cocaine hydrochloride solution.  This product is being manufactured and marketed under the brand name C-Topical® Solution.  This product is an analgesic topical solution, with vasoconstriction as a side effect, for use primarily by ear, nose and throat doctors during surgical procedures.  This product represents the Company’s first foray into the brand market.  Selling brand versus generic products requires a dedicated sales force to detail and educate physicians on the product.  The Company strongly believes that C-Topical®, once the clinical trials are completed and the FDA has granted approval, will be an important contributor to total revenue, with higher than average profit margins as a result of vertical integration.

 

The Company’s strategic goal is to continue investing in controlled substance product development so that, within five years, at least 50% of revenues from manufactured products are derived from controlled substance products which carry with them higher-than-average gross margins.  As the Company continues to invest in, and focus, on process and manufacturing optimization, Cody Labs will continue to be an important part of our future growth plan.

 

In addition to focusing on the development and manufacture of opioid-based APIs and dosage forms, the Company has made a strategic decision to develop products, both in-house and with external partners, which require a paragraph four (P-IV) certification when filing the ANDA.  A P-IV certification is required when an ANDA is submitted for a product for which the innovator’s patent has not expired.  The certification must state whether the patent on the reference listed drug (RLD) is being challenged on grounds of it being invalid, or if the patent is being circumvented.  This path to product approval represents a major opportunity for generic drug companies because they do not have to wait until a particular patent expires to potentially enter the market.  Secondly, if a company is the first to file a P-IV on a product, and they successfully invalidate or circumvent the patent, the FDA may grant 180 days of market exclusivity.  This allows the generic manufacturer to be the sole competitor to the brand company for six months, during which time it will capture a significant portion of the market from the brand company, albeit at lower prices.

 

One challenge for generic manufacturers with this strategy is the level of legal costs required.  Before a product is selected for development, the Company must perform a thorough review of the existing patents and determine if they are going to try to invalidate the patent or try to circumvent it.  In either case, once the Company submits a P-IV the brand company will have 45 days to respond with a determination on whether they are going to file a suit against the generic company to defend their patent.  A generic company needs to be prepared not only for the time and effort associated with a protracted legal challenge, but the associated fees which can easily reach in excess of several million dollars.  This strategy provides a ‘high risk, high reward’ path to product approval.  The Company filed its first ANDA with a P-IV certification in Fiscal Year 2013.  To date, we have filed five P-IV certifications.  In response to our P-IV certification with respect to the Zomig® nasal spray product, AstraZeneca AB, AstraZeneca UK Limited and Impax Laboratories, Inc. filed two patent infringement complaints against the Company in July 2014.  With the right research and analysis performed up front, the Company believes it can target suitable products for which to file a P-IV certification, be successful, and reap the rewards of limited competition.

 

Another area of focus for the Company relates to mergers, acquisitions and other strategic alliances, whether new or continuing.  The Company is party to supply and development agreements with international companies, including, Azad Pharma AG, Swiss Caps of Switzerland, Pharma 2B (formerly Pharmaseed), The GC Group of Israel and HEC Pharm Group, as well as domestic companies, including JSP, Cerovene, and Summit Bioscience LLC.  The Company is currently in negotiations on similar agreements with other companies, and is actively seeking additional strategic partnerships, through which it will market and distribute products manufactured in-house or by third parties.

 

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Critical Accounting Policies

 

The preparation of our consolidated financial statements in accordance with accounting principles generally accepted in the United States and the rules and regulations of the U.S. Securities & Exchange Commission requires the use of estimates and assumptions.  A listing of the Company’s significant accounting policies are detailed in Note 3 “Summary of Significant Accounting Policies.”  A subsection of these accounting policies have been identified by management as “Critical Accounting Policies”.  Critical accounting policies are those which require management to make estimates using assumptions that were uncertain at the time the estimate was made and for which the use of different assumptions, which reasonably could have been used, could have a material impact on the financial condition or results of operations.

 

Management has identified the following as “Critical Accounting Policies”:  Revenue Recognition, Inventories, Income Taxes, Valuation of Long-Lived Assets, and Share-based Compensation.

 

Revenue Recognition

 

The Company recognizes revenue when title and risk of loss have transferred to the customer and provisions for estimates, including rebates, promotional adjustments, price adjustments, returns, chargebacks, and other potential adjustments are reasonably determinable.  The Company also considers all other relevant criteria specified in Securities and Exchange Commission Staff Accounting Bulletin No. 104, Topic No. 13, “Revenue Recognition”, in determining when to recognize revenue.

 

When revenue is recognized a simultaneous adjustment to gross sales is made for chargebacks, rebates, returns, promotional adjustments, and other potential adjustments.  These provisions are primarily estimated based on historical experience, future expectations, contractual arrangements with wholesalers and indirect customers, and other factors known to management at the time of accrual.  Accruals for provisions are presented in the Consolidated Financial Statements as a reduction to gross sales with the corresponding reserve presented as a reduction of accounts receivable or included as rebates payable.  The reserves presented as a reduction of accounts receivable totaled $61.6 million and $51.9 million at March 31, 2015 and June 30, 2014, respectively.  Rebates payable at March 31, 2015 and June 30, 2014 were $5.9 million and $4.6 million, respectively, for certain rebate programs, primarily related to Medicare Part D and Medicaid, and certain sales allowances and other adjustments paid to indirect customers.

 

The following table identifies the activity and ending balances of each major category of revenue reserve for the nine months ended March 31, 2015 and 2014:

 

Reserve Category
(In thousands)

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

Balance at July 1, 2014

 

$

30,320

 

$

15,091

 

$

9,341

 

$

1,787

 

$

56,539

 

Current period provision

 

252,290

 

58,190

 

14,208

 

22,875

 

347,563

 

Credits issued during the period

 

(250,549

)

(58,071

)

(5,059

)

(22,901

)

(336,580

)

Balance at March 31, 2015

 

$

32,061

 

$

15,210

 

$

18,490

 

$

1,761

 

$

67,522

 

 

Reserve Category
(In thousands)

 

Chargebacks

 

Rebates

 

Returns

 

Other

 

Total

 

Balance at July 1, 2013

 

$

7,267

 

$

3,581

 

$

6,689

 

$

1,000

 

$

18,537

 

Current period provision

 

78,477

 

40,465

 

5,458

 

18,801

 

143,201

 

Credits issued during the period

 

(66,032

)

(28,119

)

(2,924

)

(17,909

)

(114,984

)

Balance at March 31, 2014

 

$

19,712

 

$

15,927

 

$

9,223

 

$

1,892

 

$

46,754

 

 

For the three months ending March 31, 2015 and 2014, as a percentage of gross sales the provision for chargebacks was 36.1% and 23.9%, the provision for rebates was 9.0% and 14.7%, the provision for returns was 2.9% and 1.6%, and the provision for other adjustments was 3.8% and 0.8%, respectively.

 

For the nine months ending March 31, 2015 and 2014, as a percentage of gross sales the provision for chargebacks was 38.5% and 23.3%, the provision for rebates was 8.9% and 12.0%, the provision for returns was 2.2% and 1.6%, and the provision for other adjustments was 3.5% and 5.6%, respectively.

 

The increase in total reserves from June 30, 2014 to March 31, 2015 was due to increases in substantially all reserve categories. The increases resulted from increased gross sales to wholesalers related to the strategic partnership between Amerisource Bergen and Walgreens, whereby Amerisource Bergen began product distribution on behalf of Walgreens in third quarter of Fiscal Year 2014.  Other strategic partnerships between industry wholesalers and retailers also impacted net sales to wholesaler/distributor and retail

 

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chain.  The return reserve increased due to a voluntary recall of one lot of product manufactured at the Company’s facility in Cody, Wyoming due to incorrect labeling.  The activity in the “Other” category for the nine months ended March 31, 2015 and 2014 includes shelf-stock, shipping and other sales adjustments including prompt payment discounts.  Historically, we have not recorded any material amounts in the current period related to reversals or additions of prior period reserves.  If the Company were to record a material reversal or addition of any prior period reserve amount it would be separately disclosed.

 

Provisions for chargebacks, rebates, returns and other adjustments require varying degrees of subjectivity.  While rebates generally are based on contractual terms and require minimal estimation, chargebacks and returns require management to make more subjective assumptions.  Each major category is discussed in detail below:

 

Chargebacks

 

The provision for chargebacks is the most significant and complex estimate used in the recognition of revenue.  The Company sells its products directly to wholesale distributors, generic distributors, retail pharmacy chains, and mail-order pharmacies.  The Company also sells its products indirectly to independent pharmacies, managed care organizations, hospitals, nursing homes, and group purchasing organizations, collectively referred to as “indirect customers.”  The Company enters into agreements with its indirect customers to establish pricing for certain products.  The indirect customers then independently select a wholesaler from which to purchase the products.  If the price paid by the indirect customers is lower than the price paid by the wholesaler, the Company will provide a credit, called a chargeback, to the wholesaler for the difference between the contractual price with the indirect customers and the wholesaler purchase price.  The provision for chargebacks is based on expected sell-through levels by the Company’s wholesale customers to the indirect customers and estimated wholesaler inventory levels.  As sales to the large wholesale customers, such as Cardinal Health, AmerisourceBergen, and McKesson increase (decrease), the reserve for chargebacks will also generally increase (decrease).  However, the size of the increase (decrease) depends on product mix and the amount of sales made to indirect customers with which the Company has specific chargeback agreements.  The Company continually monitors the reserve for chargebacks and makes adjustments when management believes that expected chargebacks may differ from the actual chargeback reserve.

 

Rebates

 

Rebates are offered to the Company’s key chain drug store, distributor and wholesaler customers to promote customer loyalty and increase product sales.  These rebate programs provide customers with credits upon attainment of pre-established volumes or attainment of net sales milestones for a specified period.  Other promotional programs are incentive programs offered to the customers.  Additionally, as a result of the Patient Protection and Affordable Care Act (“PPACA”) enacted in the U.S. in March 2010, the Company participates in a new cost-sharing program for certain Medicare Part D beneficiaries designed primarily for the sale of brand drugs and certain generic drugs if their FDA approval was granted under a New Drug Application (“NDA”) or 505(b) NDA versus an Abbreviated New Drug Application (“ANDA”).  Because our drugs used for the treatment of thyroid deficiency and our Morphine Sulfate Oral Solution product were both approved by the FDA as 505(b)(2) NDAs, they are considered “brand” drugs for purposes of the PPACA.  Drugs purchased within the Medicare Part D coverage gap (commonly referred to as the “donut hole”) result in additional rebates.  The Company estimates the reserve for rebates and other promotional credit programs based on the specific terms in each agreement when revenue is recognized.  The reserve for rebates increases (decreases) as sales to certain wholesale and retail customers increase (decrease).  However, since these rebate programs are not identical for all customers, the size of the reserve will depend on the mix of sales to customers that are eligible to receive rebates.

 

Returns

 

Consistent with industry practice, the Company has a product returns policy that allows customers to return product within a specified time period prior to and subsequent to the product’s expiration date in exchange for a credit to be applied to future purchases.  The Company’s policy requires that the customer obtain pre-approval from the Company for any qualifying return.  The Company estimates its provision for returns based on historical experience, changes to business practices, credit terms and any extenuating circumstances known to management.  While historical experience has allowed for reasonable estimations in the past, future returns may or may not follow historical trends.  The Company continually monitors the reserve for returns and makes adjustments when management believes that actual product returns may differ from the established reserve.  Generally, the reserve for returns increases as net sales increase.

 

Other Adjustments

 

Other adjustments consist primarily of price adjustments, also known as “shelf-stock adjustments” and “price protections,” which are both credits issued to reflect increases or decreases in the invoice or contract prices of the Company’s products.  In the

 

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case of a price decrease a credit is given for product remaining in customer’s inventories at the time of the price reduction.  Contractual price protection results in a similar credit when the invoice or contract prices of the Company’s products increase, effectively allowing customers to purchase products at previous prices for a specified period of time.  Amounts recorded for estimated shelf-stock adjustments and price protections are based upon specified terms with direct customers, estimated changes in market prices, and estimates of inventory held by customers.  The Company regularly monitors these and other factors and evaluates the reserve as additional information becomes available.  Other adjustments also include prompt payment discounts.

 

Inventories

 

Inventories are stated at the lower of cost or market determined by the first-in, first-out method.  Inventories are regularly reviewed and provisions for excess and obsolete inventory are recorded based primarily on current inventory levels and estimated sales forecasts.  During the three months ended March 31, 2015 and 2014, the Company recorded provisions for excess and obsolete inventory of $2.1 million and $811 thousand, respectively.  During the nine months ended March 31, 2015 and 2014, the Company recorded provisions for excess and obsolete inventory of $5.0 million and $1.9 million, respectively.

 

Income Taxes

 

The Company uses an asset and liability approach to account for income taxes as prescribed by ASC 740, Income Taxes.  Deferred taxes are recorded to reflect the tax consequences on future years of events that the Company has already recognized in the financial statement or tax returns.  Deferred income tax assets and liabilities are adjusted to recognize the effect of changes in tax law or tax rates in the period during which the new law is enacted.  Under ASC 740, Income Taxes, a valuation allowance is required when it is more likely than not that all or some portion of the deferred tax assets will not be realized through generating sufficient future taxable income.  Failure to achieve forecasted taxable income in applicable tax jurisdictions could affect the ultimate realization of deferred tax assets and could result in an increase in the Company’s effective tax rate on future earnings.

 

The Company may recognize the tax benefit from an uncertain tax position claimed on a tax return only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities, based on the technical merits of the position.  The tax benefits recognized in the financial statements from such a position should be measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement.  The benefit from uncertain tax positions recorded in the financial statements was immaterial for all period presented.

 

The Company’s future effective income tax rate is highly reliant on future projections of taxable income, tax legislation, and potential tax planning strategies.  A change in any of these factors could materially affect the effective income tax rate of the Company in future periods.

 

Valuation of Long-Lived Assets

 

The Company’s long-lived assets primarily consist of property, plant and equipment as well as definite-lived intangible assets.  Intangible assets are stated at cost less accumulated amortization and were not material to the consolidated financial statements at March 31, 2015 or June 30, 2014.  Amortization is computed on a straight-line basis over the assets’ estimated useful lives, generally for periods ranging from 10 to 15 years.  Property, plant and equipment are stated at cost less accumulated depreciation.  Depreciation is computed on a straight-line basis over the assets’ estimated useful lives, generally for periods ranging from 5 to 39 years.  The Company continually evaluates the reasonableness of the useful lives of these assets.

 

Long-lived assets are reviewed for impairment whenever events or changes in circumstances (“triggering events”) indicate that the carrying amount of the asset may not be recoverable.  The nature and timing of triggering events by their very nature are unpredictable; however management regularly considers the performance of an asset as compared to its expectations, industry events, industry and economic trends, as well as any other relevant information known to management when determining if a triggering event occurred.

 

If a triggering event is determined to have occurred, the first step in the impairment test is to compare the asset’s carrying value to the undiscounted cash flows expected to be generated by the asset.  If the carrying value exceeds the undiscounted cash flow of the asset then impairment exists.  An impairment loss is measured as the excess of the asset’s carrying value over its fair value, which in most cases is calculated using a discounted cash flow model.  Discounted cash flow models are highly reliant on various assumptions which are considered Level 3 inputs, including estimates of future cash flows (including long-term growth rates), discount rates, and the probability of achieving the estimated cash flows.

 

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Share-based Compensation

 

Share-based compensation costs are recognized over the vesting period, using a straight-line method, based on the fair value of the instrument on the date of grant less an estimate for expected forfeitures.  The Company uses the Black-Scholes valuation model to determine the fair value of stock options and the market price on the grant date to value restricted stock.  The Black-Scholes valuation model includes various assumptions, including the expected volatility, the expected life of the award, dividend yield, and the risk-free interest rate.  These assumptions involve inherent uncertainties based on market conditions which are generally outside the Company’s control.  Changes in these assumptions could have a material impact on share-based compensation costs recognized in the financial statements.

 

The following table presents the weighted average assumptions used to estimate fair values of the stock options granted during the nine months ended March 31, 2015 and 2014 and the estimated annual forfeiture rates used to recognize the associated compensation expense:

 

 

 

March 31,
2015

 

March 31,
2014

 

Risk-free interest rate

 

1.7

%

2.1

%

Expected volatility

 

52.1

%

62.9

%

Expected dividend yield

 

0.0

%

0.0

%

Forfeiture rate

 

6.5

%

7.5

%

Expected term (in years)

 

5.5 years

 

5.9 years

 

Weighted average fair value

 

$

17.67

 

$

8.14

 

 

Expected volatility is based on the historical volatility of the price of our common shares during the historical period equal to the expected term of the option.  The Company uses historical information to estimate the expected term, which represents the period of time that options granted are expected to be outstanding.  The risk-free rate for the period equal to the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of grant.  The forfeiture rate assumption is the estimated annual rate at which unvested awards are expected to be forfeited during the vesting period.  This assumption is based on our actual forfeiture rate on historical awards.  Periodically, management will assess whether it is necessary to adjust the estimated rate to reflect changes in actual forfeitures or changes in expectations.  Additionally, the expected dividend yield is equal to zero, as the Company has not historically issued, and has no immediate plans to issue, a dividend.

 

Recent Accounting Pronouncements

 

In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers.  The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services.  The authoritative guidance is effective for annual reporting periods beginning after December 15, 2016.  Early application is not permitted.  The Company is currently in the process of assessing the impact this guidance will have on the consolidated financial statements.

 

In April 2015, the FASB issued ASU 2015-03, Simplifying the Presentation of Debt Issuance Costs which changes the presentation of debt issuance costs in financial statements. ASU 2015-03 requires an entity to present such costs in the balance sheet as a direct deduction from the related debt liability rather than as an asset. Amortization of the costs will continue to be reported as interest expense. It is effective for fiscal years and interim periods within those fiscal years beginning after December 15, 2015.  Early adoption is permitted. The new guidance will be applied retrospectively to each prior period presented.  The Company is currently in the process of assessing the impact this guidance will have on the consolidated financial statements.

 

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ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

A mortgage loan with First National Bank of Cody has been consolidated in the Company’s financial statements, along with the related land and building.  The mortgage requires monthly principal and interest payments of $15 thousand.  As of March 31, 2015 and June 30, 2014, the effective interest rate was 4.5%.  The mortgage is collateralized by the land and building with a net book value of $1.5 million.  As of March 31, 2015, $1.0 million is outstanding under the mortgage loan.

 

In December 2013, the Company entered into a credit agreement (the “Credit Agreement”) with Citibank, N.A., as administrative agent and certain other financial institutions.  As of March 31, 2015, the Credit Agreement provided for a revolving loan commitment in the amount of up to $50.0 million.  Any loans under the Credit Agreement will bear interest at either a “Eurodollar Rate” or a “Base Rate” plus a specified margin.  The Company is also required to pay a commitment fee on any undrawn commitments under the Credit Agreement ranging from 0.2% - 0.3% per annum according to the average daily balance of borrowings under the agreement.  The Credit Agreement is collateralized by substantially all of the Company’s assets.  As of March 31, 2015 and June 30, 2014, the Company had $50.0 million available under the Credit Agreement.

 

The Credit Agreement contains representations and warranties, affirmative, negative and financial covenants, and events of default, applicable to the Company and its subsidiaries which are customary for credit facilities of this type.  As of March 31, 2015 and June 30, 2014, the Company was in compliance with all financial covenants.

 

The Credit Agreement was amended on April 21, 2015.  See Note 22 “Subsequent Events” for more information.

 

The Company invests in equity securities, U.S. government agency securities and corporate bonds, which are exposed to market and interest rate fluctuations.  The interest and dividends earned on these investments may vary based on fluctuations in interest rate and market conditions.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

As of the end of the period covered by this Form 10-Q, management performed, with the participation of our Chief Executive Officer and Chief Financial Officer, an evaluation of the effectiveness of our disclosure controls and procedures as defined in Rules 13a-15(e) and 15d-15(e) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed in the reports we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosures.

 

Based upon the evaluation, the Chief Executive Officer and Chief Financial Officer concluded that Lannett’s disclosure controls and procedures were effective as of the end of the period covered by this report.

 

Change in Internal Control Over Financial Reporting

 

There has been no change in Lannett’s internal control over financial reporting during the three and nine months ended March 31, 2015 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

 

Information pertaining to legal proceedings can be found in Note 12. “Legal and Regulatory Matters” of the Consolidated Financial Statements included in Part I, Item 1. of this Quarterly Report on Form 10-Q and is incorporated by reference herein.

 

ITEM 1A.  RISK FACTORS

 

Lannett Company, Inc’s Annual Report on Form 10-K for the fiscal year ended June 30, 2014 includes a detailed description of its risk factors.

 

In the third quarter of Fiscal 2015, the Company updated Item 1A. Risk Factors to include the following:

 

Under our Bylaws, individuals or entities that bring certain claims or join such claims may be obligated to reimburse the Company for the expenses it reasonably incurs in connection with such actions if the claim proves unsuccessful.

 

Our Bylaws provide, to the fullest extent permitted by law, in the event that any current or former stockholder (the “Claimant”) (x) initiates or asserts (1) any derivative action or proceeding brought on behalf of the Company, (2) any claim or counterclaim or other action against the Company or any of its directors, officers, employees or agents, including but not limited to federal securities law claims (each of the foregoing, a “Claim”), or joins any such Claim as a named party, or (y) joins, offers substantial assistance to or has a direct financial interest in any Claim and (z) the Claimant or the party who has brought such Claim does not thereby obtain a judgment on the merits that substantially achieves the full equitable, legal and monetary remedies or relief sought in the Claim, such Claimant shall be obligated to reimburse the Company for all costs, fees and expenses of any kind (including attorneys’ fees and the fees of experts) actually incurred by the Company in defending such Claim or in indemnifying any officer, director or third party for the costs, fees and expenses incurred by any such officer, director or third party in connection with such Claim. The Company believes that the term “judgment on the merits” means the determination of a court or jury after all relevant facts have been presented in evidence.  Additionally, the Company believes that a Claimant would need to prevail on a majority of the claims brought by such Claimant, be awarded a majority of the damages and other monetary relief sought by such Claimant, and be awarded a majority of the equitable and other relief sought by such Claimant in order to “substantially achieve” the full remedy sought in a claim.  Please note, however, that the court hearing any Claim would make the ultimate determination as to the meanings of such phrases and the applicability or non-applicability of this bylaw provision with respect to any Claim brought by a Claimant.  Although this provision of our Bylaws was adopted to deter frivolous lawsuits, it also may deter stockholder litigation that may be in the best interests of the Company or our stockholders.

 

ITEM 6.  EXHIBITS

 

(a)                          A list of the exhibits required by Item 601 of Regulation S-K to be filed as a part of this Form 10-Q is shown on the Exhibit Index filed herewith.