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8-K - 8-K - LANNETT CO INCa16-10638_18k.htm

Exhibit 99.1

 

GRAPHIC

 

Contact:

 

Robert Jaffe Co., LLC

 

 

(424) 288-4098

 

 

Robert Jaffe

 

LANNETT REPORTS SOLID FISCAL 2016 THIRD QUARTER RESULTS

 

—Company Reports Record Net Sales of $164 Million, Adjusted Operating Income of $65 Million; Continues to Expect its Fourth Quarter to Be In Line with Previous Outlook—

 

Philadelphia, PA May 3, 2016 — Lannett Company, Inc. (NYSE: LCI) today reported financial results for its fiscal 2016 third quarter and nine months ended March 31, 2016.  As previously announced, the company completed the acquisition of Kremers Urban Pharmaceuticals Inc. (KU) on November 25, 2015.  Accordingly, fiscal 2016 third quarter and year-to-date financial results include the operations of KU since the acquisition date.

 

For the fiscal 2016 third quarter reported on a Non-GAAP basis, adjusted total net sales increased to $163.7 million from $99.4 million in last year’s third quarter.  Adjusted gross profit was $97.4 million, or 59% of net sales, compared with $75.7 million, or 76% of net sales, for the fiscal 2015 third quarter.  Adjusted research and development (R&D) expenses increased to $16.4 million from $9.2 million.  Adjusted selling, general and administrative (SG&A) expenses were $15.8 million compared with $11.6 million.  Adjusted operating income increased to $65.2 million from $54.9 million for the prior-year third quarter.  Adjusted net income attributable to Lannett was $27.9 million, or $0.75 per diluted share, compared with $36.6 million, or $0.98 per diluted share, for the fiscal 2015 third quarter.

 

On a GAAP basis, for the fiscal 2016 third quarter, total net sales before adjustment were $163.7 million compared with $99.4 million in last year’s third quarter.  As previously announced, the company recorded a pre-tax, non-recurring settlement agreement of $23.6 million during the fiscal 2016 third quarter, which was recorded as a reduction to net sales.  As a result, total net sales for the fiscal 2016 third quarter were $140.1 million.  Gross profit was $57.5 million compared with $75.6 million.  Primarily due to the inclusion of KU’s lower-margin business and the impact of the settlement agreement, gross profit as a percentage of net sales was 41% compared with 76% in last year’s third quarter.

 

R&D expenses increased to $16.5 million from $9.2 million for the fiscal 2015 third quarter.  SG&A expenses were $16.2 million compared with $11.6 million.  Acquisition and integration-related expenses were $1.5 million compared with $587 thousand in the prior-year third quarter.  The company implemented a restructuring plan in February 2016, which resulted in a charge of $4.7 million in the fiscal 2016 third quarter.  Operating income was $18.6 million compared with $54.3 million.  Interest expense was $27.0 million compared with $8 thousand for the third quarter of fiscal 2015.  Net loss attributable to Lannett was $5.5 million, or $0.15 per share, compared to net income attributable to Lannett of $36.2 million, or $0.97 per diluted share, for the fiscal 2015 third quarter.

 



 

“We continued with our strategy to enhance our near and longer term prospects,” said Arthur Bedrosian, chief executive officer of Lannett.  “In March, we met with a key former customer to attempt to re-establish a relationship with KU and initiate a relationship with Lannett; we appreciate their willingness to quickly resolve our minor differences and look forward to a long-term association.  In April, we expanded our collaboration with a strategic partner to co-develop a generic insulin product for the $21 billion U.S. market.  In addition, our efforts are on track to complete the integration of KU and implement substantial cost savings throughout the organization.  Looking ahead, we expect our financial performance in fiscal 2017 and beyond to benefit from three recent drug approvals and a deep pipeline that includes 31 product applications pending at the FDA.

 

“Our overall third quarter financial performance was affected by a number of factors.  The substantial increase in net sales was driven by the first full quarter of KU operations; however, our results were impacted by interest expense related to the debt financing of the KU acquisition.”

 

For the first nine months of fiscal 2016 reported on a Non-GAAP basis, adjusted total net sales increased to $397.2 million from $307.6 million in the comparable prior-year period.  Adjusted gross profit was $256.1 million, or 64% of net sales, compared with $234.5 million, or 76% of net sales, for the first nine months of fiscal 2015.  Adjusted R&D expenses were $32.0 million compared with $23.4 million.  Adjusted SG&A expenses were $41.2 million compared with $32.9 million for first nine months of the prior year.  Adjusted operating income increased to $182.9 million from $178.2 million.  Adjusted net income attributable to Lannett was $100.4 million, or $2.69 per diluted share, compared with $117.8 million, or $3.18 per diluted share, for the fiscal 2015 first nine months.

 

For the first nine months of fiscal 2016 reported on a GAAP basis, total net sales before adjustment rose 29% to $397.2 million from $307.6 million in the comparable prior-year period.  Total net sales, which includes the settlement agreement discussed above, were $373.6 million compared with $307.6 million.  Gross profit, including the impact of the settlement agreement, was $206.6 million, or 55% of net sales, compared with $234.4 million, or 76% of net sales.  R&D expenses increased to $32.1 million from $23.4 million for the first nine months of fiscal 2015.  SG&A expenses were $46.4 million compared with $32.9 million.  Acquisition and integration-related expenses were $23.0 million compared with $2.7 million in the prior-year period.  As noted above, restructuring expenses were $4.7 million for the nine months of fiscal 2016.  Operating income was $100.4 million compared with $175.5 million.  Interest expense was $38.8 million compared with $119 thousand for the first nine months of fiscal 2015.  Net income attributable to Lannett Company was $41.2 million, or $1.10 per diluted share, which includes the pre-tax settlement agreement discussed above.  For the comparable prior-year period, net income attributable to Lannett Company was $116.0 million, or $3.13 per diluted share.

 



 

Guidance for Fiscal 2016

 

The company’s fiscal 2016 third quarter was favorably impacted by a number of factors, including product mix and manufacturing efficiencies, which are not expected to continue in the fourth quarter.  The company continues to expect its fiscal 2016 fourth quarter performance on an adjusted basis to be in line with its previous outlook.

 

Conference Call Information and Forward-Looking Statements

 

Later today, the company will host a conference call at 4:30 p.m. ET to review its results of operations for the fiscal 2016 third quarter ended March 31, 2016.  The conference call will be available to interested parties by dialing 888-771-4371 from the U.S. or Canada, or 847-585-4405 from international locations, passcode 42449989.  The call will be broadcast via the Internet at www.lannett.com.  Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software.  A playback of the call will be archived and accessible on the same website for at least three months.

 

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s financial status and performance, regulatory and operational developments, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

 

Use of Non-GAAP Financial Measures

 

This news release contains references to Non-GAAP financial measures, including Adjusted net income attributable to the Company, and its components, as well as Adjusted earnings per diluted share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP).  The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business.  Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods.  Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP.

 

Adjusted net income and Adjusted earnings per diluted share exclude, among others, the effects of (1) the amortization of purchased intangibles, (2) acquisition and integration-related expenses and other purchase accounting entries, (3) non-cash interest expense, as well as (4) certain other items considered unusual or non-recurring in nature.

 

The company’s fiscal 2016 guidance has been provided only on a Non-GAAP basis.  This is due to the inherent difficulty of forecasting the timing or amount of items that would be included in the most

 



 

directly comparable forward-looking GAAP financial measures.  Because a reconciliation is not available without unreasonable effort, it is not included in this release.

 

About Lannett Company, Inc.:

 

Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of medical indications.  For more information, visit the company’s website at www.lannett.com.

 

This news release contains certain statements of a forward-looking nature relating to future events or future business performance.  Any such statements, including, but not limited to, realizing the expected benefits of optimizing operations, enhancing efficiencies or significantly reducing costs and achieving the financial metrics stated in the company’s guidance for fiscal 2016, whether expressed or implied, are subject to risks and uncertainties which can cause actual results to differ materially from those currently anticipated due to a number of factors which include, but are not limited to, the difficulty in predicting the timing or outcome of FDA or other regulatory approvals or actions, the ability to successfully commercialize products upon approval, including acquired products, and Lannett’s estimated or anticipated future financial results, future inventory levels, future competition or pricing, future levels of operating expenses, product development efforts or performance, and other risk factors discussed in the company’s Form 10-K and other documents filed with the Securities and Exchange Commission from time to time.  These forward-looking statements represent the company’s judgment as of the date of this news release.  The company disclaims any intent or obligation to update these forward-looking statements.

 

# # #

 

FINANCIAL SCHEDULES FOLLOW

 



 

LANNETT COMPANY, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

 

 

 

(Unaudited)

 

 

 

 

 

March 31, 2016

 

June 30, 2015

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

225,446

 

$

200,340

 

Investment securities

 

12,959

 

13,467

 

Accounts receivable, net

 

183,624

 

91,103

 

Inventories

 

116,511

 

46,191

 

Prepaid income taxes

 

15,253

 

 

Deferred tax assets

 

23,808

 

16,270

 

Other current assets

 

23,995

 

3,175

 

Total current assets

 

601,596

 

370,546

 

Property, plant and equipment, net

 

220,199

 

94,556

 

Intangible assets, net

 

598,418

 

29,090

 

Goodwill

 

313,451

 

141

 

Deferred tax assets

 

10,036

 

12,495

 

Other assets

 

8,676

 

1,938

 

TOTAL ASSETS

 

$

1,752,376

 

$

508,766

 

 

 

 

 

 

 

LIABILITIES

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

33,038

 

$

19,195

 

Accrued expenses

 

9,181

 

4,928

 

Accrued payroll and payroll-related expenses

 

6,717

 

10,397

 

Rebates payable

 

16,993

 

7,553

 

Royalties payable

 

5,779

 

 

Restructuring liability

 

3,008

 

 

Accrued interest payable

 

10,823

 

 

Settlement liability

 

10,700

 

 

Income taxes payable

 

 

1,340

 

Acquisition-related contingent consideration

 

35,000

 

 

Current portion of long-term debt

 

45,640

 

135

 

Total current liabilities

 

176,879

 

43,548

 

Long-term debt, net

 

1,008,212

 

874

 

Restructuring liability

 

77

 

 

Settlement liability

 

13,414

 

 

Other liabilities

 

6,268

 

578

 

TOTAL LIABILITIES

 

1,204,850

 

45,000

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY

 

 

 

 

 

Common stock ($0.001 par value, 100,000,000 shares authorized; 37,112,119 and 36,783,381 shares issued; 36,569,363 and 36,264,585 shares outstanding at March 31, 2016 and June 30, 2015, respectively)

 

37

 

37

 

Additional paid-in capital

 

279,874

 

236,178

 

Retained earnings

 

274,784

 

233,573

 

Accumulated other comprehensive loss

 

(280

)

(295

)

Treasury stock (542,756 and 518,796 shares at March 31, 2016 and June 30, 2015, respectively)

 

(7,277

)

(6,080

)

Total Lannett Company, Inc. stockholders’ equity

 

547,138

 

463,413

 

Noncontrolling interest

 

388

 

353

 

Total stockholders’ equity

 

547,526

 

463,766

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

1,752,376

 

$

508,766

 

 



 

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,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

163,712

 

$

99,352

 

$

397,204

 

$

307,561

 

Settlement agreement

 

(23,598

)

$

 

(23,598

)

$

 

Total net sales

 

140,114

 

99,352

 

373,606

 

307,561

 

Cost of sales

 

75,345

 

23,694

 

155,964

 

73,094

 

Amortization of intangibles

 

7,278

 

20

 

11,079

 

61

 

Gross profit

 

57,491

 

75,638

 

206,563

 

234,406

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development expenses

 

16,495

 

9,159

 

32,092

 

23,358

 

Selling, general, and administrative expenses

 

16,157

 

11,617

 

46,359

 

32,923

 

Acquisition and integration-related expenses

 

1,473

 

587

 

23,000

 

2,656

 

Restructuring expenses

 

4,749

 

 

4,749

 

 

Total operating expenses

 

38,874

 

21,363

 

106,200

 

58,937

 

Operating income

 

18,617

 

54,275

 

100,363

 

175,469

 

Other income (loss)

 

 

 

 

 

 

 

 

 

Investment income (loss)

 

204

 

(8

)

69

 

895

 

Interest expense

 

(26,988

)

(8

)

(38,820

)

(119

)

Other

 

(46

)

(26

)

(76

)

(6

)

Total other income (loss)

 

(26,830

)

(42

)

(38,827

)

770

 

Income (loss) before income tax

 

(8,213

)

54,233

 

61,536

 

176,239

 

Income tax expense (benefit)

 

(2,743

)

17,973

 

20,270

 

60,208

 

Net income (loss)

 

(5,470

)

36,260

 

41,266

 

116,031

 

Less: Net income attributable to noncontrolling interest

 

20

 

27

 

55

 

55

 

Net income (loss) attributable to Lannett Company, Inc.

 

$

(5,490

)

$

36,233

 

$

41,211

 

$

115,976

 

 

 

 

 

 

 

 

 

 

 

Earnings (loss) per common share attributable to Lannett Company, Inc.

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.15

)

$

1.01

 

$

1.13

 

$

3.25

 

Diluted

 

$

(0.15

)

$

0.97

 

$

1.10

 

$

3.13

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

36,495,961

 

35,880,954

 

36,398,030

 

35,715,061

 

Diluted

 

36,495,961

 

37,210,138

 

37,383,742

 

37,082,138

 

 



 

LANNETT COMPANY, INC.

RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (UNAUDITED)

(In thousands, except share and per share data)

 

 

 

Three months ended

 

Three months ended

 

 

 

March 31,

 

March 31,

 

 

 

GAAP

 

 

 

Non-GAAP

 

GAAP

 

 

 

Non-GAAP

 

 

 

Reported

 

Adjustments

 

Adjusted

 

Reported

 

Adjustments

 

Adjusted

 

 

 

2016

 

2016

 

2016

 

2015

 

2015

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

163,712

 

 

163,712

 

99,352

 

 

99,352

 

Settlement agreement

 

(23,598

)

23,598

(a) 

 

 

 

 

Total net sales

 

140,114

 

23,598

 

163,712

 

99,352

 

 

99,352

 

Cost of sales

 

75,345

 

(9,004

)(b) 

66,341

 

23,694

 

 

23,694

 

Amortization of intangibles

 

7,278

 

(7,278

)(c) 

 

20

 

(20

)(c) 

 

Gross profit

 

57,491

 

39,880

 

97,371

 

75,638

 

20

 

75,658

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

16,495

 

(90

)(b) 

16,405

 

9,159

 

 

9,159

 

Selling, general, and administrative expenses

 

16,157

 

(365

)(d) 

15,792

 

11,617

 

 

11,617

 

Acquisition and integration-related expenses

 

1,473

 

(1,473

)(e) 

 

587

 

(587

)(e) 

 

Restructuring expenses

 

4,749

 

(4,749

)(f) 

 

 

 

 

Total operating expenses

 

38,874

 

(6,677

)

32,197

 

21,363

 

(587

)

20,776

 

Operating income

 

18,617

 

46,557

 

65,174

 

54,275

 

607

 

54,882

 

Other income (loss):

 

(26,830

)

5,003

(g) 

(21,827

)

(42

)

 

(42

)

Income (loss) before income tax

 

(8,213

)

51,560

 

43,347

 

54,233

 

607

 

54,840

 

Income tax expense (benefit)

 

(2,743

)

18,180

(h) 

15,437

 

17,973

 

198

(h) 

18,171

 

Net income (loss)

 

(5,470

)

33,380

 

27,910

 

36,260

 

409

 

36,669

 

Less: Net income attributable to noncontrolling interest

 

20

 

 

20

 

27

 

 

27

 

Net income (loss) attributable to Lannett Company, Inc.

 

(5,490

)

33,380

 

27,890

 

36,233

 

409

 

36,642

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Earnings (loss) per common share attributable to Lannett Company, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

(0.15

)

 

 

$

0.76

 

$

1.01

 

 

 

$

1.02

 

Diluted

 

$

(0.15

)

 

 

$

0.75

 

$

0.97

 

 

 

$

0.98

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

36,495,961

 

 

 

36,495,961

 

35,880,954

 

 

 

35,880,954

 

Diluted

 

36,495,961

 

 

 

37,379,473

 

37,210,138

 

 

 

37,210,138

 

 


(a) To exclude expense related to a settlement agreement with a former customer

(b) To exclude amortization of a fair value step-up in inventory and depreciation of a fair value step-up in property, plant and equipment related to the acquisition of Kremers Urban Pharmaceuticals, Inc.

(c) To exclude amortization of purchased intangible assets primarily related to the acquisition of Kremers Urban Pharmaceuticals, Inc. and Silarx Pharmaceuticals, Inc.

(d) To exclude amortization of purchased intangibles related to the acquisition of Kremers Urban Pharmaceuticals, Inc.

(e) To exclude acquisition and integration-related expenses primarily related to the acquisition of Kremers Urban Pharmaceuticals Inc.

(f) To exclude expenses associated with the 2016 Restructuring Plan

(g) To exclude non-cash interest expense associated with debt issuance costs

(h) The tax effect of the pre-tax adjustments included above at applicable tax rates

 



 

LANNETT COMPANY, INC.

RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION (UNAUDITED)

(In thousands, except share and per share data)

 

 

 

Nine months ended

 

Nine months ended

 

 

 

March 31,

 

March 31,

 

 

 

GAAP

 

 

 

Non-GAAP

 

GAAP

 

 

 

Non-GAAP

 

 

 

Reported

 

Adjustments

 

Adjusted

 

Reported

 

Adjustments

 

Adjusted

 

 

 

2016

 

2016

 

2016

 

2015

 

2015

 

2015

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

397,204

 

 

397,204

 

307,561

 

 

307,561

 

Settlement agreement

 

(23,598

)

23,598

(a) 

 

 

 

 

 

Total net sales

 

373,606

 

23,598

 

397,204

 

307,561

 

 

307,561

 

Cost of sales

 

155,964

 

(14,904

)(b) 

141,060

 

73,094

 

 

73,094

 

Amortization of intangibles

 

11,079

 

(11,079

)(c) 

 

61

 

(61

)(c) 

 

Gross profit

 

206,563

 

49,581

 

256,144

 

234,406

 

61

 

234,467

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

32,092

 

(90

)(b) 

32,002

 

23,358

 

 

23,358

 

Selling, general, and administrative expenses

 

46,359

 

(5,119

)(d) 

41,240

 

32,923

 

 

32,923

 

Acquisition and integration-related expenses

 

23,000

 

(23,000

)(e) 

 

2,656

 

(2,656

)(e) 

 

Restructuring expenses

 

4,749

 

(4,749

)(f) 

 

 

 

 

Total operating expenses

 

106,200

 

(32,958

)

73,242

 

58,937

 

(2,656

)

56,281

 

Operating income

 

100,363

 

82,539

 

182,902

 

175,469

 

2,717

 

178,186

 

Other income (loss):

 

(38,827

)

7,666

(g) 

(31,161

)

770

 

 

770

 

Income before income tax

 

61,536

 

90,205

 

151,741

 

176,239

 

2,717

 

178,956

 

Income tax expense

 

20,270

 

31,040

(h) 

51,310

 

60,208

 

928

(h) 

61,136

 

Net income

 

41,266

 

59,165

 

100,431

 

116,031

 

1,789

 

117,820

 

Less: Net income attributable to noncontrolling interest

 

55

 

 

55

 

55

 

 

55

 

Net income attributable to Lannett Company, Inc.

 

41,211

 

59,165

 

100,376

 

115,976

 

1,789

 

117,765

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Earnings per common share attributable to Lannett Company, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

$

1.13

 

 

 

$

2.76

 

$

3.25

 

 

 

$

3.30

 

Diluted

 

$

1.10

 

 

 

$

2.69

 

$

3.13

 

 

 

$

3.18

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average common shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

36,398,030

 

 

 

36,398,030

 

35,715,061

 

 

 

35,715,061

 

Diluted

 

37,383,742

 

 

 

37,383,742

 

37,082,138

 

 

 

37,082,138

 

 


(a) To exclude expense related to a settlement agreement with a former customer

(b) To exclude amortization of a fair value step-up in inventory and depreciation of a fair value step-up in property, plant and equipment related to the acquisition of Kremers Urban Pharmaceuticals, Inc.

(c) To exclude amortization of purchased intangible assets primarily related to the acquisition of Kremers Urban Pharmaceuticals, Inc. and Silarx Pharmaceuticals, Inc.

(d) To exclude separation expenses associated with certain employees as well as amortization of purchased intangibles related to the acquisition of Kremers Urban Pharmaceuticals, Inc.

(e) To exclude acquisition and integration-related expenses primarily related to the acquisition of Kremers Urban Pharmaceuticals Inc.

(f) To exclude expenses associated with the 2016 Restructuring Plan

(g) To exclude non-cash interest expense associated with debt issuance costs

(h) The tax effect of the pre-tax adjustments included above at applicable tax rates